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REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 |
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
Ordinary Shares |
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| Large accelerated filer | ☐ | ☒ | ||||
| Non-accelerated filer | ☐ | Emerging growth company | ||||
| U.S. GAAP ☐ | |
Other ☐ | ||||||
| by the International Accounting Standards Board ☒ |
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TABLE OF CONTENTS
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| Item 1 |
Identity of Directors, Senior Management and Advisers | 2 | ||||
| Item 2 |
Offer Statistics and Expected Timetable | 2 | ||||
| Item 3 |
Key Information | 2 | ||||
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| Item 4. |
Information on the Company | 23 | ||||
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| Item 4A. |
Unresolved Staff Comments | 38 | ||||
| Item 5. |
Operating and Financial Review and Prospects | 38 | ||||
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| Item 6. |
Directors, Senior Management and Employees | 45 | ||||
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| Item 7. |
Major Shareholders and Related Party Transactions | 59 | ||||
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| Item 8. |
Financial Information | 59 | ||||
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| Item 9. |
The Offer and Listing | 60 | ||||
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| Item 10. |
Additional Information | 60 | ||||
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| Item 11. |
Quantitative and Qualitative Disclosures About Market Risk | 70 | ||||
| Item 12. |
Description of Securities Other than Equity Securities | 70 | ||||
| 70 | ||||||
| 70 | ||||||
| 70 | ||||||
| 71 | ||||||
| Item 13. |
Defaults, Dividend Arrearages and Delinquencies | 73 | ||||
| Item 14. |
Material Modifications to the Rights of Security Holders and Use of Proceeds | 73 | ||||
| Item 15. |
Controls and Procedures | 73 | ||||
| Item 16. |
Reserved | 73 | ||||
| Item 16A. |
Audit Committee Financial Expert | 73 | ||||
| Item 16B. |
Code of Ethics | 73 | ||||
| Item 16C. |
Principal Accountant Fees and Services | 74 | ||||
| Item 16D. |
Exemptions from the Listing Standards for Audit Committees | 74 | ||||
| Item 16E. |
Purchases of Equity Securities by the Issuer and Affiliated Purchasers | 74 | ||||
| Item 16F. |
Change in Registrant’s Certifying Accountant | 74 | ||||
| Item 16G. |
Corporate Governance | 74 | ||||
| Item 16H. |
Mine Safety Disclosure | 74 | ||||
| Item 16I. |
Disclosure Regarding Foreign Jurisdiction that Prevent Inspections | 74 | ||||
| Item 17. |
Financial Statements | 75 | ||||
| Item 18. |
Financial Statements | 75 | ||||
| Item 19. |
Exhibits | |||||
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INTRODUCTION
Immutep Limited was incorporated under the laws of the Commonwealth of Australia on May 21, 1987. The principal listing of our ordinary shares is the Australian Securities Exchange, or ASX. We filed a registration statement on Form 20-F with respect to our ordinary shares with the U.S. Securities and Exchange Commission, or SEC, which was declared effective on April 12, 2012. Our American Depositary Shares, or ADSs, each of which represents 10 of our ordinary shares, are listed on the NASDAQ Global Market, or NASDAQ, under the symbol “IMMP”. The Bank of New York Mellon acts as our depositary and registers and delivers our ADSs. As used in this Annual Report on Form 20-F, the terms “we,” “us,” “our”, “Immutep” and the “Company” mean Immutep Limited and its subsidiaries, unless otherwise indicated.
FINANCIAL AND OTHER INFORMATION
Our consolidated financial statements appearing in this Annual Report on Form 20-F are prepared in Australian dollars and in accordance with the International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB. Our consolidated financial statements appearing in this Annual Report on Form 20-F comply with both the IFRS and Australian Accounting Standards. In this Annual Report, all references to “U.S. dollars” or “US$” are to the currency of the United States, all references to “euro”, “€” or “EUR” are to the currency of certain states of the European Union, all references to “£” or “GBP” are to the currency of the United Kingdom and all references to “Australian dollars” or “$” or “A$” are to the currency of Australia. In this Annual Report, “fiscal year” refers to the period between July 1 and June 30 of the following year.
Statements made in this Annual Report on Form 20-F concerning the contents of any contract, agreement or other document are summaries of such contracts, agreements or documents and are not complete descriptions of all of their terms. If we filed any of these documents as an exhibit to this Annual Report or to any registration statement that we previously filed, you may read the document itself for a complete description of its terms.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
Except for the historical information contained in this Annual Report on Form 20-F, the statements contained in this Annual Report on Form 20-F are “forward-looking statements” which reflect our current view with respect to future events and financial results. We urge you to consider that statements which use the terms “anticipate,” “believe,” “do not believe,” “expect,” “plan,” “intend,” “estimate,” and similar expressions are intended to identify forward-looking statements and these forward-looking statements, include, without limitation, any statements relating to:
| • | our product development and business strategy, including the potential size of the markets for our products and future development and/or expansion of our products and therapies in our markets; |
| • | our current and future research and development activities, including clinical testing and manufacturing and the costs and timing thereof; |
| • | the impact that any pandemic could have on business operations; |
| • | sufficiency of our cash resources; |
| • | our ability to commercialize products and generate product revenues; |
| • | our ability to achieve and collect milestone and royalty payments from our collaboration partners and other contract counterparties; |
| • | our ability to raise additional funding when needed; |
| • | any statements concerning anticipated regulatory activities or licensing or collaborative arrangements, including our ability to obtain regulatory clearances; |
| • | our research and development and other expenses; |
| • | our operations and intellectual property risks; |
| • | our ability to remain compliant with ASX and NASDAQ’s continuing listing standards; and |
| • | any statement of assumptions underlying any of the foregoing. |
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We remind investors that forward-looking statements are merely predictions and therefore inherently subject to uncertainties and other factors and involve known and unknown risks that could cause the actual results, performance, levels of activity, our achievements or industry results, to be materially different from any future results, performance, levels of activity, or our achievements expressed or implied by such forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by applicable law, including the securities laws of the United States, we undertake no obligation to publicly release any update or revision to any forward-looking statements to reflect new information, future events or circumstances, or otherwise after the date hereof. Please see the Risk Factors section that appears in “Item 3. Key Information – D. Risk Factors.”
PART I
| ITEM 1. | IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS |
Not applicable.
| ITEM 2. | OFFER STATISTICS AND EXPECTED TIMETABLE |
Not applicable.
| ITEM 3. | KEY INFORMATION |
A. [Reserved]
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B. Capitalization and Indebtedness
Not applicable.
C. Reasons for the Offer and Use of Proceeds
Not applicable.
D. Risk Factors
The following risks relate specifically to our business and should be considered carefully. Our business, financial condition and results of operations could be harmed by any of the following risks. As a result, the trading price of our ordinary shares and our American Depositary Shares, or ADSs, could decline and the holders could lose part or all of their investment.
Risks Related to Our Business
We have a history of operating losses and may not achieve or maintain profitability in the future.
We have experienced significant recurring operating losses and negative cash flows from operating activities since inception. For example, for the fiscal years ended June 30, 2022, and 2021, we had net losses of A$32.2 million and A$29.9 million, respectively.
We are a development stage biotech company developing pharmaceutical product candidates and the success of our product candidates is therefore uncertain. We focus on the development of immunotherapeutic products for the treatment of cancer and autoimmune diseases. We, and our partners, have four product candidates under development: eftilagimod alpha (also known as “IMP321” or “efti”), IMP761, IMP701 and IMP731, all of which are related to lymphocyte activation gene 3, or LAG-3, a gene linked to the regulation of T cells in immune responses.
We expect to continue to incur losses from operations for the foreseeable future and expect the costs of drug development to increase in the future as more patients are recruited to the clinical trials. In particular, we expect to continue to incur significant losses in carrying out clinical trials of IMP321 and ongoing research and preclinical development in terms of immunotherapy product candidates, such as IMP761. Because of the numerous risks and uncertainties associated with the development, manufacturing, sales and marketing of therapeutic products such as IMP321 and IMP761, we may experience larger than expected future losses and may never become profitable.
Moreover, there is a substantial risk that we, or our development partners, may not be able to complete the development of our current product candidates or develop other pharmaceutical products. It is possible that none of them will be successfully commercialized, which would prevent us from ever achieving profitability.
We have no medicinal products approved for commercial sale and no source of consistent material revenue.
Currently, we have no products approved for commercial sale and to date have not generated material revenue from product sales. We are largely dependent on the future success of our product candidates.
The LAG-3 related product candidates were acquired by us through the acquisition of the French privately owned and venture capital backed company Immutep SA, a biopharmaceutical company in the field of Immuno-Oncology in December 2014. This acquisition significantly expanded our clinical development product portfolio to other categories of immunotherapies. It also provided the business with partnerships with two of the world’s largest pharmaceutical companies.
We have four LAG-3 product candidates. The most advanced of the four is IMP321 (INN: eftilagimod alpha). IMP321 is a recombinant protein typically used in conjunction with other therapies (e.g. chemotherapy or other immunotherapy) to amplify a patient’s immune response. The development and manufacturing of IMP321 is being conducted in conjunction with our licensee EOC Pharma in China. We entered into two clinical trial collaboration and supply agreements with Merck Co., Inc., Kenilworth, NJ, USA (known as MSD outside the United States and Canada), through a subsidiary, to evaluate the combination of our immune activator, IMP321 with MSD’s anti-PD-1 therapy pembrolizumab in phase II clinical trials. We also entered into a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany, and Pfizer for a Phase I clinical trial that evaluated the clinical benefits of combining our immune stimulator, IMP321, with avelumab, a PD-L1 blocking antibody. We also have agreements in place with CYTLIMIC to evaluate efti as part of CYTLIMIC’s peptide cancer vaccine, called CYT001. We entered into another clinical trial collaboration and supply agreement with Merck KGaA to evaluate IMP321 in combination with bintrafusp alpha in solid tumors.
Our second LAG-3 product candidate is IMP701 (INN: ieramilimab), an antagonist antibody that acts to stimulate T cell proliferation in cancer patients. IMP701 was licensed to CoStim Pharmaceuticals, which was subsequently acquired by Novartis. Novartis is solely responsible for development and manufacturing of IMP701. Our third LAG-3 product candidate is IMP731, a depleting antibody that could remove T cells involved in autoimmunity. IMP731 has been licensed to GlaxoSmithKline, or GSK, which is solely responsible for its development and manufacturing. Our fourth LAG-3 product candidate is IMP761, an early-stage product candidate which is being developed as our first agonist antibody of LAG-3. In addition to these products Immutep has a dedicated RD laboratory close to Paris with ongoing research capabilities as well as external research collaborations. Immutep also currently generates modest income from sales of LAG-3 research reagents.
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Our ability to generate potential future product revenue depends on a number of factors, including but not limited to our ability to:
| • | successfully complete preclinical and clinical development of, and receive regulatory approval for, our product candidates; |
| • | set an acceptable price for our products, if approved, and obtain adequate coverage and reimbursement from third-party payors; |
| • | obtain commercial quantities of our products, if approved, at acceptable cost levels; and |
| • | successfully market and sell our products, if approved. |
There can be no assurance that our or our partners’ ability to develop any product candidate, will be successful or our ability to obtain the necessary regulatory approvals with respect to any of the foregoing will be successful. As a result, the prolonged inability to generate revenue may adversely impact our business operations.
The increase in expenses may adversely impact our business if our sources of funding and revenue are insufficient.
We anticipate that as the costs related to the clinical trials for IMP321 will increase, we will require additional funds to achieve our long-term goals of commercialization and further development of IMP321 and other product candidates. In addition, we will require funds to pursue regulatory applications, defend intellectual property rights, increase contracted manufacturing capacity, potentially develop marketing and sales capability and fund operating expenses. We intend to seek such additional funding through public or private financings and/or through licensing of our assets or other arrangements with corporate partners. However, such financing, licensing opportunities or other arrangements may not be available from any sources on acceptable terms, or at all. Any shortfall in funding could result in us having to curtail or cease our operations including research and development activities, thereby harming our business, financial condition and results of operations.
In addition, because of the numerous risks and uncertainties associated with product candidate development, we are unable to predict the timing or amount of increased expenses, or when, or if, we will be able to achieve or maintain profitability. Our expenses could significantly increase beyond current expectations if the applicable regulatory authorities require further studies in addition to those currently anticipated. In any case, even if our product candidates are approved for commercial sale, we anticipate incurring significant costs associated with the commercial launch of such products and there can be no guarantee that we will ever generate significant revenues.
We will require additional financing and may be unable to raise sufficient capital, which could have a material impact on our research and development programs or commercialization of our products or product candidates.
We have historically devoted most of our financial resources to research and development, including pre-clinical and clinical development and manufacturing activities. To date, we have financed a significant amount of our operations through public and private financings. The amount of our future net losses will depend, in part, on the rate of our future expenditures and our ability to obtain funding through equity or debt financings or strategic collaborations. The amount of such future net losses, as well as the possibility of future profitability, will also depend on our success in developing and commercializing products that generate significant revenue. Our failure to become and remain profitable would depress the value of our ordinary shares or ADSs and could impair our ability to raise capital, expand our business, maintain our research and development efforts, diversify our product offerings or even continue our operations.
We anticipate that our expenses will increase substantially for the foreseeable future if, and as, we:
| • | continue our research and preclinical and clinical development of our product candidates; |
| • | expand the scope of our current proposed clinical studies for our product candidates; |
| • | initiate additional preclinical, clinical or other studies for our product candidates; |
| • | change or add additional manufacturers or suppliers; |
| • | seek regulatory and marketing approvals for our product candidates that successfully complete clinical studies; |
| • | seek to identify and validate additional product candidates; |
| • | acquire or in-license other product candidates and technologies; |
| • | maintain, protect and expand our intellectual property portfolio; |
| • | attract and retain skilled personnel; |
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| • | create additional infrastructure to support our operations as a publicly quoted company and our product development and planned future commercialization efforts; |
| • | add an internal sales force; and |
| • | experience any delays or encounter issues with any of the above. |
Until our product candidates become commercially available, we will need to obtain additional funding in connection with the further development of our product candidates. Our ability to obtain additional financing will be subject to a number of factors, including market conditions, our operating performance and investor sentiment. As such, additional financing may not be available to us when needed, on acceptable terms, or at all. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research and development programs or any future commercialization efforts or obtain funds by entering agreements on unattractive terms. Our resource allocation decisions and the elimination of development programs may result in the failure to capitalize on profitable market opportunities. Furthermore, any additional equity fundraising in the capital markets may be dilutive for shareholders and any debt-based funding may bind us to restrictive covenants and curb our operating activities and ability to pay potential future dividends even when profitable. We cannot guarantee that future financing will be available in sufficient amounts or on acceptable terms, if at all. If we are unable to raise additional capital in sufficient amounts or on acceptable terms, we will be prevented from pursuing research and development efforts. This could harm our business, operating results and financial condition and cause the price of our common stock and ADSs to fall.
If we are unable to secure sufficient capital to fund our operations, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to third parties to develop and market products or product candidates that we would otherwise prefer to develop and market ourselves. For example, additional strategic collaborations could require us to share commercial rights to our product candidates with third parties in ways that we do not intend currently or on terms that may not be favorable to us. Moreover, we may also have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us.
We may find it difficult to enroll patients in our clinical trials, and patients who do enroll could discontinue their participation, which could delay or prevent clinical trials for our product candidates or make those trials more expensive to undertake.
Identifying and qualifying patients to participate in current and any future clinical trials of our product candidates is critical to our success. The timing of our clinical trials depends, among other things, on the speed at which we can recruit patients to participate in testing our product candidates. Patients may be unwilling to participate in any future clinical trials because of negative publicity from adverse events in the biotechnology industry. Patients may be unavailable for other reasons, including competitive clinical trials for similar patient populations, and the timeline for recruiting patients, conducting trials and obtaining regulatory approval of potential products may be delayed. If we have difficulty enrolling a sufficient number of patients to conduct any future clinical trials as planned, we may need to delay, limit or discontinue those clinical trials. Clinical trial delays could result in increased costs, slower product development, setbacks in testing the safety and effectiveness of our technology or discontinuation of the clinical trials altogether.
We may not be able to identify, recruit and enroll a sufficient number of patients, or those with required or desired characteristics to achieve diversity in a trial, to complete any future clinical trials in a timely manner. Patient enrollment is affected by factors including:
| • | finding and diagnosing patients; |
| • | severity of the disease under investigation; |
| • | design of the clinical trial protocol; |
| • | size and nature of the patient population; |
| • | eligibility criteria for the trial in question; |
| • | perceived risks and benefits of the product candidate under study; |
| • | proximity and availability of clinical trial sites for prospective patients; |
| • | availability of competing therapies and clinical trials; |
| • | clinicians’ and patients’ perceptions of the potential advantages of the product being studied in relation to other available therapies, including any new products that may be approved for the indications we are investigating; |
| • | patient referral practices of physicians; and |
| • | ability to monitor patients adequately during and after treatment. |
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If we are unable to successfully develop related diagnostics for our therapeutic product candidates, or experience significant delays in doing so, we may not achieve marketing approval or realize the full commercial potential of our therapeutic product candidates.
We may have to develop related diagnostics for some of our therapeutic product candidates. Such related diagnostics are subject to regulation by the FDA and typically to comparable foreign regulatory authorities and typically require separate regulatory approval or clearance prior to commercialization. Marketing approval or clearance of the diagnostic will require sufficient data to support its safety and efficacy. In addition, at least in some cases, the FDA and comparable foreign regulatory authorities may require the development and regulatory approval or clearance of a related diagnostic as a condition to approving our therapeutic product candidates. While we have some limited experience in developing diagnostics, we plan to rely in large part on third parties to perform these functions. We may seek to enter into arrangements with one or more third parties to create a related diagnostic for use with our current or future product candidates.
If we or any third parties that we engage to assist us, are unable to successfully develop or obtain marketing approval or clearance for related diagnostics for our therapeutic product candidates, or experience delays in doing so:
| • | the development of relevant product candidates may be delayed or impaired altogether if we are unable to appropriately select patients for enrollment in our clinical trials; |
| • | our relevant therapeutic product candidate may not receive marketing approval if its effective use depends on a related diagnostic in the regulatory authority’s judgment; and |
| • | we may not realize the full commercial potential of any therapeutic product candidates that receive marketing approval if, among other reasons, we are unable to appropriately identify patients with the specific genetic alterations targeted by our therapeutic product candidates. |
If any of these events were to occur, our business would be harmed.
We are exposed to significant risks related to our ongoing research and development efforts and might not be in a position to successfully develop any product candidate. Any failure to implement our business strategy could negatively impact our business, financial condition and results of operations.
The development and commercialization of IMP321, IMP701, IMP761 and IMP731, or any other product candidate we may develop, is subject to many risks, including:
| • | additional clinical or pre-clinical trials may be required beyond what we currently expect; |
| • | regulatory authorities may disagree with our interpretation of data from our preclinical studies and clinical studies or may require that we conduct additional studies; |
| • | regulatory authorities may disagree with our proposed design of future clinical trials; |
| • | regulatory authorities may delay approval of our product candidates, thus preventing milestone payments from our collaboration partners; |
| • | regulatory authorities may not accept data generated at our clinical study sites; |
| • | we may be unable to obtain and maintain regulatory approval of our product candidate in any jurisdiction; |
| • | the prevalence and severity of any side effects of any product candidate could delay or prevent commercialization, limit the indications for any approved product candidate, require the establishment of a risk evaluation and mitigation strategy, or REMS, or cause an approved product candidate to be taken off the market; |
| • | regulatory authorities may identify deficiencies in our manufacturing processes or facilities or those of our third-party manufacturers; |
| • | regulatory authorities may change their approval policies or adopt new regulations; |
| • | the third-party manufacturers we expect to depend on to supply or manufacture our product candidates may not produce adequate supply; |
| • | we, or our third-party manufacturers, may not be able to source or produce current Good Manufacturing Practice (cGMP) materials for the production of our product candidates; |
| • | we may not be able to manufacture our product candidates at a cost or in quantities necessary to make commercially successful products; |
| • | we may not be able to obtain adequate supply of our product candidates for our clinical trials; |
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| • | we may experience delays in the commencement of, enrolment of patients in and timing of our clinical trials; |
| • | we may not be able to demonstrate that our product candidates are safe and effective as a treatment for its indications to the satisfaction of regulatory authorities, and we may not be able to achieve and maintain compliance with all regulatory requirements applicable to our product candidates; |
| • | we may not be able to maintain a continued acceptable safety profile of our products following approval; |
| • | we may be unable to establish or maintain collaborations, licensing or other arrangements; |
| • | the market may not accept our product candidates; |
| • | we may be unable to establish and maintain an effective sales and marketing infrastructure, either through the creation of a commercial infrastructure or through strategic collaborations, and the effectiveness of our own or any future strategic collaborators’ marketing, sales and distribution strategy and operations will affect our profitability; |
| • | we may experience competition from existing products or new products that may emerge; |
| • | we and our licensors may be unable to successfully obtain, maintain, defend and enforce intellectual property rights important to protect our product candidates; and |
| • | we may not be able to obtain and maintain coverage and adequate reimbursement from third-party payors. |
If any of these risks materializes, we could experience significant delays or an inability to successfully develop and commercialize IMP321 and IMP761, or any other product candidate we or our partners may develop, which would have a material adverse effect on our business, financial condition and results of operations.
Positive results from preclinical studies of our product candidates are not necessarily predictive of the results of our planned clinical trials of our product candidates.
Positive results in preclinical proof of concept and animal studies of our product candidates may not result in positive results in clinical trials in humans. Many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in clinical trials after achieving positive results in preclinical development or early-stage clinical trials, and we cannot be certain that we will not face similar setbacks. These setbacks can be caused by, among other things, preclinical findings made while clinical trials were underway or safety or efficacy observations made in clinical trials, including adverse events. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that believed their product candidates performed satisfactorily in preclinical studies and clinical trials nonetheless failed to obtain FDA or other regulatory authority approval. If we fail to produce positive results in our clinical trials of our product candidates, the development timeline and regulatory approval and commercialization prospects for our product candidates, and, correspondingly, our business and financial prospects, would be negatively impacted.
We may not make acquisitions in the future, or if we do, we may not be successful in integrating the acquired company, either of which could have a materially adverse effect on our business.
Identifying strategic acquisitions is part of our business plan. There is, however, no assurance that we will be successful in identifying, negotiating, or consummating any future acquisitions. If we fail to make any future acquisitions, our growth rate could be materially and adversely affected. Any additional acquisitions we undertake could involve the dilutive issuance of equity securities, incurring indebtedness and/or incurring large one-time expenses. In addition, acquisitions involve numerous risks, including difficulties in assimilating the acquired company’s operations, the diversion of our management’s attention from other business concerns, risks of entering into markets in which we have had no or only limited direct experience, and the potential loss of customers, key employees and drivers of the acquired company, all of which could have a materially adverse effect on our business and operating results. If we make acquisitions in the future, we cannot guarantee that we will be able to successfully integrate the acquired companies or assets into our business, which would have a materially adverse effect on our business, financial condition, and results of operations.
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Ongoing and future clinical trials of product candidates may not show sufficient safety or efficacy to obtain requisite regulatory approvals for commercial sale.
Phase I and Phase II clinical trials are not primarily designed to test the efficacy of a product candidate but rather to test safety and to understand the product candidate’s side effects at various doses and schedules. Furthermore, success in preclinical and early clinical trials does not ensure that later large-scale trials will be successful, nor does it predict final results. Acceptable results in early trials may not be repeated in later trials. Further, Phase III clinical trials may not show sufficient safety or efficacy to obtain regulatory approval for marketing. In addition, clinical results are frequently susceptible to varying interpretations that may delay, limit or prevent regulatory approvals. Negative or inconclusive results or adverse medical events during a clinical trial could require that the clinical trial be redone or terminated. The length of time necessary to complete clinical trials and to submit an application for marketing approval by applicable regulatory authorities may also vary significantly based on the type, complexity and novelty of the product candidate involved, as well as other factors. If we suffer any significant delays, quality issues, setbacks or negative results in, or termination of, our clinical trials, we may be unable to continue the development of our products or product candidates or generate revenue and our business may be severely harmed.
If we do not obtain the necessary regulatory approvals, we will be unable to commercialize our products.
The clinical development, manufacturing, sales and marketing of our products are subject to extensive regulation by regulatory authorities in the United States, the United Kingdom, the European Union, Australia and elsewhere. Despite the substantial time and expense invested in preparation and submission of a Biologic License Application or equivalents in other jurisdictions, regulatory approval is never guaranteed. The number, size and design of preclinical studies and clinical trials that will be required will vary depending on the product, the disease or condition for which the product is intended to be used and the regulations and guidance documents applicable to any particular product. The FDA or other regulators can delay, limit or deny approval of a product for many reasons, including, but not limited to, the fact that regulators may not approve our or a third-party manufacturer’s processes or facilities or that new laws may be enacted or regulators may change their approval policies or adopt new regulations requiring new or different evidence of safety and efficacy for the intended use of a product.
IMP321 and our other product candidates are undergoing clinical trials; however, successful results in the trials and in the subsequent application for marketing approval are not guaranteed. Without additional clinical trials any other product candidate in the current portfolio cannot obtain a regulatory approval. If we are unable to obtain regulatory approvals, we will not be able to generate revenue from this product candidate or any other candidate. Even if we receive regulatory approval for IMP321 or any product candidate, our profitability will depend on our ability to generate revenues from their sale or the licensing of our technology.
Even if our product candidates receive regulatory approval, it may still face development and regulatory difficulties that may delay or impair future sales of product candidates.
Even if we or our licensing partners receive regulatory approval to sell IMP321 or any other product candidate, the relevant regulatory authorities may, nevertheless, impose significant restrictions on the indicated uses, manufacturing, labelling, packaging, adverse event reporting, storage, advertising, promotion and record keeping or impose ongoing requirements for post-approval studies. In addition, regulatory agencies subject a marketed product, its manufacturer and the manufacturer’s facilities to continual review and periodic inspections. Previously unknown problems with the product candidate, including adverse events of unanticipated severity or frequency, may result in restrictions on the marketing of the product, and could include withdrawal of the product from the market. In addition, new statutory or regulatory requirements could be enacted that could prevent or delay regulatory approval of our products.
We have limited manufacturing experience with our product candidates.
We have no manufacturing capabilities and are dependent on third parties for cost effective manufacture and manufacturing process development of the company’s product candidates. Problems with third party manufacturers or the manufacturing process, or the scaling up of manufacturing activities as such may delay clinical trials and commercialization of our product candidates. To minimize the chance of these kinds of disruption, we enter into advance purchase agreements for reagents wherever possible.
Biological product candidates like IMP731, IMP701, IMP761 or IMP321 usually have more complicated manufacturing procedures than chemically produced therapies. The change of manufacturing partners, manufacturing process changes or changes of other nature could impact the product quality and affect the comparability of different product batches. A lack of comparability could significantly impact the development timelines and could even lead to a situation where regulatory bodies require additional or new pre-clinical or clinical development.
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To the extent we rely significantly on contractors, we will be exposed to risks related to the business and operational conditions of our contractors.
We are a small company, with few internal staff and limited facilities. We are and will be required to rely on a variety of contractors to manufacture and transport our products, to perform clinical testing and to prepare regulatory dossiers. Adverse events that affect one or more of our contractors could adversely affect us, such as:
| • | a contractor is unable to retain key staff that have been working on our product candidates; |
| • | a contractor is unable to sustain operations due to financial or other business issues; |
| • | a contractor loses their permits or licenses that may be required to manufacture our products or product candidates; or |
| • | errors, negligence or misconduct that occur within a contractor may adversely affect our business. |
We depend on and will continue to depend on collaboration and strategic alliances with third partners. To the extent we are able to enter into collaborative arrangements or strategic alliances, we will be exposed to risks related to those collaborations and alliances.
An important element of our strategy for developing, manufacturing and commercializing our product candidates is entering into partnerships and strategic alliances with other pharmaceutical companies or other industry participants. For example, we currently have collaborative arrangements with EOC Pharma for the development of IMP321 for China, Hong Kong, Macau and Taiwan. Any revenues from sales of any of our partnered product candidates will depend on the success of the collaboration partner.
Any partnerships or alliance we have or may have in the future may be terminated for reasons beyond our control or we may not be able to negotiate future alliances on acceptable terms, if at all. These arrangements may result in us receiving less revenue than if it sold its products directly, may place the development, sales and marketing of its products outside of its control, may require it to relinquish important rights or may otherwise be on unfavorable terms. Collaborative arrangements or strategic alliances will also subject us to a number of risks, including the risk that:
| • | we may not be able to control the amount and timing of resources that our strategic partner/collaborators may devote to the product candidates; |
| • | strategic partner/collaborators may experience financial difficulties; |
| • | the failure to successfully collaborate with third parties may delay, prevent or otherwise impair the development or commercialization of our product candidates or revenue expectations; |
| • | products being developed by partners/collaborators may never reach commercial stage resulting in reduced or even no milestone or royalty payments; |
| • | business combinations or significant changes in a collaborator’s business strategy may also adversely affect a collaborator’s willingness or ability to complete their obligations under any arrangement; |
| • | a collaborator could independently move forward with a competing product developed either independently or in collaboration with others, including our competitors; and |
| • | collaborative arrangements are often terminated or allowed to expire, which would delay the development and may increase the cost of developing product candidates. |
Because we rely on third-party manufacturing and supply partners, our supply of research and development, preclinical and clinical development materials may become limited or interrupted or may not be of satisfactory quantity or quality.
We rely on third-party supply and manufacturing partners to manufacture and supply the materials for our research and development and preclinical and clinical study supplies. We do not own manufacturing facilities or supply sources for such materials.
There can be no assurance that our supply of research and development, preclinical and clinical development biologics and other materials will not be limited, interrupted or restricted in certain geographic regions, be of satisfactory quality or continue to be available at acceptable prices. Replacement of a third-party manufacturer could require significant effort, cost and expertise because there may be a limited number of qualified replacements.
The manufacturing process for a product candidate is subject to FDA and foreign regulatory authority review. Suppliers and manufacturers must meet applicable manufacturing requirements and undergo rigorous facility and process validation tests required by regulatory authorities in order to comply with regulatory standards, such as cGMP. In the event that any of our suppliers or manufacturers fails to comply with such requirements or to perform its obligations to us in relation to quality, timing or otherwise, or if our supply of components or other materials becomes limited or interrupted for other reasons, we may be forced to manufacture the materials ourselves or enter into an agreement with another third party, which would be costly and delay any future clinical trials.
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In some cases, the technical skills or technology required to manufacture our product candidates may be unique or proprietary to the original manufacturer and we may have difficulty, or there may be contractual restrictions prohibiting us from, transferring such skills or technology to another third party. These factors increase our reliance on our manufacturers and may require us to obtain a license from a manufacturer in order to have another third-party manufacture our product candidates. If we are required to change manufacturers for any reason, we will be required to verify that the new manufacturer maintains facilities and procedures that comply with quality standards and with all applicable regulations and guidelines of the FDA and comparable foreign regulatory authorities. The delays and costs associated with the verification of a new manufacturer could increase our costs and delay the development of our product candidates.
We expect to continue to rely on third-party manufacturers for preclinical and clinical grade product candidates and if we receive regulatory approval for any product candidate. To the extent that we have existing, or enter into future, manufacturing arrangements with third parties, we will depend on these third parties to perform their obligations in a timely manner consistent with contractual and regulatory requirements, including those related to quality control and assurance. If we are unable to obtain or maintain third-party manufacturing for product candidates, or to do so on commercially reasonable terms, we may not be able to develop and commercialize our product candidates successfully. Our or a third party’s failure to execute on our manufacturing requirements could adversely affect our business in a number of ways, including:
| • | an inability to conduct necessary preclinical studies to progress our product candidates to clinical trials; |
| • | an inability to initiate or continue any future clinical trials of product candidates under development; |
| • | delay in submitting regulatory applications, or receiving regulatory approvals, for product candidates; |
| • | loss of the cooperation of a collaborator; |
| • | subjecting our product candidates to additional inspections by regulatory authorities; |
| • | requirements to cease distribution or to recall batches of our product candidates; and |
| • | in the event of approval to market and commercialize a product candidate, an inability to meet commercial demands for our products. |
We and our collaborators may disagree over our right to receive payments under our collaboration agreements, potentially resulting in costly litigation and loss of reputation.
Our ability to receive payments under our collaboration agreements depends on our ability to clearly delineate our rights under those agreements. We have out-licensed portions of our intellectual property to our collaborators with the intent that our collaborators will develop product candidates. However, a collaborator may use our intellectual property without our permission, dispute our ownership of intellectual property rights, or argue that our intellectual property does not cover, or add value to, any product candidates they develop. If a dispute arises, it may result in costly patent office procedures and litigation, and our collaborator may refuse to pay us while the dispute is ongoing. Furthermore, regardless of any resort to legal action, a dispute with a collaborator over intellectual property rights may damage our relationship with that collaborator and may also harm our reputation in the industry. Even if we are entitled to payments from our collaborators, we may not actually receive these payments, or we may experience difficulties in collecting the payments to which we believe we are entitled. After our collaborators launch commercial products containing our licensed traits, we will need to rely on the good faith of our collaborators to report to us the sales they earn from these products and to accurately calculate the payments we are entitled to, a process that will involve complicated and difficult calculations. Although we seek to address these concerns in our collaboration agreements by reserving our right to audit financial records, such provisions may not be effective.
Our research and development efforts will be jeopardized if we are unable to retain key personnel and cultivate key academic and scientific collaborations.
Changes in our senior management may be disruptive to our business and may adversely affect our operations. For example, when we have changes in senior management positions, we may elect to adopt different business strategies or plans. Any new strategies or plans, if adopted, may not be successful and if any new strategies or plans do not produce the desired results, our business may suffer.
Moreover, competition among biotechnology and pharmaceutical companies for qualified employees is intense and as such we may not be able to attract and retain personnel critical to our success. Our success depends on our continued ability to attract, retain and motivate highly qualified management, clinical and scientific personnel, manufacturing personnel, sales and marketing personnel and on our ability to develop and maintain important relationships with clinicians, scientists and leading academic and health institutions. If we fail to identify, attract, retain and motivate these highly skilled personnel, we may be unable to continue our product development and commercialization activities.
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In addition, biotechnology and pharmaceutical industries are subject to rapid and significant technological change. Our product candidates may be or become uncompetitive. To remain competitive, we must employ and retain suitably qualified staff that are continuously educated to keep pace with changing technology but may not be in a position to do so.
Future potential sales of our products may suffer if they are not accepted in the marketplace by physicians, patients and the medical community.
There is a risk that IMP321 or any other product candidate may not gain market acceptance among physicians, patients and the medical community, even if they are approved by the regulatory authorities. The degree of market acceptance of any of our approved products will depend on a variety of factors, including:
| • | timing of market introduction, number and clinical profile of competitive products; |
| • | our ability to provide acceptable evidence of safety and efficacy and our ability to secure the support of key clinicians and physicians for our products; |
| • | cost-effectiveness compared to existing and new treatments; |
| • | availability of coverage, reimbursement and adequate payment from health maintenance organizations and other third-party payers; |
| • | prevalence and severity of adverse side effects; and |
| • | other advantages over other treatment methods. |
Physicians, patients, payers or the medical community may be unwilling to accept, use or recommend our product candidates which would adversely affect our potential revenues and future profitability.
We face competition from entities that have developed or may develop product candidates for our target disease indications, including companies developing novel treatments and technology platforms based on modalities and technology similar to ours.
The development and commercialization of pharmaceutical products is highly competitive. We compete with a variety of multinational pharmaceutical companies and specialized biotechnology companies, as well as technology being developed at universities and other research institutions. Our competitors have developed, are developing or could develop product candidates and processes competitive with our product candidates. Competitive therapeutic treatments include those that have already been approved and accepted by the medical community, patients and third-party payers, and any new treatments that enter the market.
There may be a significant number of products that are currently under development, and may become commercially available in the future, for the treatment of conditions for which we are developing, and may in the future try to develop, product candidates.
Many of our competitors have significantly greater financial, technical, manufacturing, marketing, sales and supply resources and experience than we have. If we successfully obtain approval for any product candidate, we will face competition based on many different factors, including the safety and effectiveness of our products, the ease with which our products can be administered and the extent to which patients accept relatively new routes of administration, the timing and scope of regulatory approvals for these products, the availability and cost of manufacturing, marketing and sales capabilities, price, reimbursement coverage and patent position.
Competing products could present superior treatment alternatives, including by being more effective, safer, less expensive or marketed and sold more effectively than any products we may develop. Competitive products may make any products we develop obsolete or non-competitive before we recover the expense of developing and commercializing our product candidates. Such competitors could also recruit our employees, which could negatively impact our level of expertise and our ability to execute our business plan.
If healthcare insurers and other organizations do not pay for our products or impose limits on reimbursement, our future business may suffer.
Our product candidates may be rejected by the market due to many factors, including cost. The continuing efforts of governments, insurance companies and other payers of healthcare costs to contain or reduce healthcare costs may affect our future revenues and profitability. In Australia and certain foreign markets, the pricing of pharmaceutical products is already subject to government control. We expect initiatives for similar government control to continue in the United States and elsewhere. The adoption of any such legislative or regulatory proposals could harm our business and prospects.
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Successful commercialization of our product candidates will depend in part on the extent to which reimbursement for the cost of our products and related treatment will be available from government health administration authorities, private health insurers and other organizations. Our product candidates may not be considered cost-effective, and reimbursement may not be available to consumers or may not be sufficient to allow our products to be marketed on a competitive basis. Third-party payers are increasingly challenging the price of medical products and treatment. If third party coverage is not available for our products the market acceptance of these products will be reduced. Cost-control initiatives could decrease the price we might establish for products, which could result in product revenues lower than anticipated. If the price for our product candidates decreases or if governmental and other third-party payers do not provide adequate coverage and reimbursement levels our potential revenue and prospects for profitability will suffer.
We may be exposed to product liability claims which could harm our business.
The testing, marketing and sale of therapeutic products entails an inherent risk of product liability. We rely on a number of third-party researchers and contractors to produce, collect, and analyze data regarding the safety and efficacy of our product candidates. We also have quality control and quality assurance in place to mitigate these risks, as well as professional liability and clinical trial insurance to cover financial damages in the event that human testing is done incorrectly, or the data is analyzed incorrectly.
Notwithstanding our control procedures, we may face product liability exposure related to the testing of our product candidates in human clinical trials. If any of our products are approved for sale, we may face exposure to claims by an even greater number of persons than were involved in the clinical trials once marketing, distribution and sales of our products begin. Regardless of merit or eventual outcome, liability claims may result in:
| • | decreased demand for our product candidates; |
| • | injury to our reputation; |
| • | withdrawal of clinical trial participants; |
| • | costs of related litigation; |
| • | substantial monetary awards to patients and others; |
| • | loss of revenues; and |
| • | the inability to commercialize products and product candidates. |
With respect to product liability claims, we could face additional liability beyond insurance limits if testing mistakes were to endanger any human subjects. In addition, if a claim is made against us in conjunction with these research testing activities, the market price of our ordinary shares or ADSs may be negatively affected.
We and our development partners, third-party manufacturers and suppliers use biological materials and may use hazardous materials, and any claims relating to improper handling, storage or disposal of these materials could be time consuming or costly.
We and our development partners, third-party manufacturers and suppliers may use hazardous materials, including chemicals and biological agents and compounds that could be dangerous to human health and safety or the environment. Our operations and the operations of our third-party manufacturers and suppliers may also produce hazardous waste products. National, State and local laws and regulations in the United States, Australia and other countries govern the use, generation, manufacture, storage, handling and disposal of these materials and wastes. Compliance with applicable environmental laws and regulations may be expensive, and current or future environmental laws and regulations may impair our product development and commercialization efforts. In addition, we cannot entirely eliminate the risk of accidental injury or contamination from these materials or wastes. We do not carry specific biological or hazardous waste insurance coverage, and our property, casualty and general liability insurance policies specifically exclude coverage for damages and fines arising from biological or hazardous waste exposure or contamination. Accordingly, in the event of contamination or injury, we could be held liable for damages or be penalized with fines in an amount exceeding our resources, and any future clinical trials, regulatory approvals or product commercialization progress could be suspended.
The outbreak of war, the novel strain of coronavirus, SARS-CoV-2, which causes COVID-19, and macroeconomic factors, could adversely impact our business, including our non-clinical studies and clinical trials.
Public health crises such as pandemics or similar outbreaks might adversely impact our business. In December 2019, a novel strain of coronavirus, SARS-CoV-2, which causes coronavirus disease 2019 (COVID-19), surfaced in Wuhan, China. Since then, COVID-19 has spread throughout the world.
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As a result of the COVID-19 outbreak, or similar pandemics, the outbreak of war and macroeconomic factors, we have and may in the future experience disruptions that could severely impact our business, preclinical studies and clinical trials, including:
| • | delays or difficulties in enrolling patients in our clinical trials; |
| • | delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff; |
| • | delays or disruptions in non-clinical experiments and investigational new drug application-enabling good laboratory practice standard toxicology studies due to unforeseen circumstances at contract research organizations and vendors along their supply chain; |
| • | increased rates of patients withdrawing from our clinical trials following enrollment as a result of contracting COVID-19, being forced to quarantine, or not wanting to attend hospital visits; |
| • | diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials; |
| • | interruption of key clinical trial activities, such as clinical trial site data monitoring, due to limitations on travel imposed or recommended by national, state or local governments, employers and others or interruption of clinical trial subject visits and study procedures (particularly any procedures that may be deemed non-essential), which may impact the integrity of subject data and clinical study endpoints; |
| • | interruption or delays in the operations of the U.S. Food and Drug Administration, the European Medicines Agency, the Australian Therapeutic Goods Administration or other foreign regulatory agencies, which may impact approval timelines; |
| • | interruption of, or delays in receiving, supplies of our product candidates from our contract manufacturing organizations due to staffing shortages, production slowdowns or stoppages and disruptions in our supply chain or distribution vendors’ ability to ship product candidates; and |
| • | limitations on employee resources that would otherwise be focused on the conduct of our non-clinical studies and clinical trials, including because of sickness of employees or their families, the desire of employees to avoid contact with large groups of people, an increased reliance on working from home or mass transit disruptions. |
These and other factors arising from the COVID-19 pandemic could worsen in countries that are afflicted with COVID-19, could continue to spread to additional countries, or could return to countries where the pandemic has been partially contained, each of which could further adversely impact our ability to conduct clinical trials and our business generally, and could have a material adverse impact on our operations and financial condition and results.
In addition, the trading prices for our American Depositary Shares, or ADSs, and for the securities of other biotech companies have been highly volatile as a result of the COVID-19 pandemic, the outbreak of war in the Ukraine and macroeconomic factors, such as inflation. As a result, we may face difficulties raising capital through sales of our ADSs or such sales may be on unfavorable terms. The extent to which these factors may impact our business, preclinical studies and clinical trials will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the outbreak, travel restrictions and actions to contain the outbreak or treat its impact, such as social distancing and quarantines or lock-downs in countries, business closures or business disruptions and the effectiveness of actions taken in countries to contain and treat the disease.
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Additionally, COVID-19 may hinder the ability of our license partners to continue the development of our licensed product candidates. This may result in the delay or the inability of the partners to execute on their development plans which, in turn, may cause delays in or the inability to achieve the clinical, regulatory and sales milestones which trigger payments to us under the terms of our license agreements. This may have a material adverse effect on our financial results and operations as the related milestone payments may not be received at the expected time, if at all.
Risks Related to Intellectual Property
Our success depends on our ability to protect our intellectual property and our proprietary technology.
Our success is to a certain degree also dependent on our ability to obtain and maintain patent protection or where applicable, to receive/maintain orphan drug designation/status and resulting marketing exclusivity for our product candidates.
We may be materially adversely affected by our failure or inability to protect our intellectual property rights. Without the granting of these rights, the ability to pursue damages for infringement would be limited. Similarly, any know-how that is proprietary or particular to our technologies may be subject to risk of disclosure by employees or consultants despite having confidentiality agreements in place.
Any future success will depend in part on whether we can obtain and maintain patents to protect our own products and technologies; obtain licenses to the patented technologies of third parties; and operate without infringing on the proprietary rights of third parties. Biotechnology patent matters can involve complex legal and scientific questions, and it is impossible to predict the outcome of biotechnology and pharmaceutical patent claims. Any of our future patent applications may not be approved, or we may not develop additional products or processes that are patentable. Some countries in which we may sell our product candidate or license our intellectual property may fail to protect our intellectual property rights to the same extent as the protection that may be afforded in the United States or Australia. Some legal principles remain unresolved and there has not been a consistent policy regarding the breadth or interpretation of claims allowed in patents in the United States, the United Kingdom, the European Union, Australia or elsewhere. In addition, the specific content of patents and patent applications that are necessary to support and interpret patent claims is highly uncertain due to the complex nature of the relevant legal, scientific and factual issues. Changes in either patent laws or in interpretations of patent laws in the United States, the United Kingdom, the European Union or elsewhere may diminish the value of our intellectual property or narrow the scope of our patent protection. Even if we are able to obtain patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors from competing with us or otherwise provide us with any competitive advantage. Our competitors may be able to circumvent our patents by developing similar or alternative technologies or products in a non-infringing manner. We may also fail to take the required actions or pay the necessary fees to maintain our patents.
Moreover, any of our pending applications may be subject to a third-party pre-issuance submission of prior art to the U.S. Patent and Trademark Office, or USPTO, the European Patent Office, or EPO, the Australian Patent and Trademark Office and/or any patents issuing thereon may become involved in opposition, derivation, reexamination, inter parties review, post grant review, interference proceedings or other patent office proceedings or litigation, in the United States or elsewhere, challenging our patent rights. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, and allow third parties to commercialize our technology or products and compete directly with us, without payment to us. In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating with us to exploit our intellectual property or develop or commercialize current or future product candidates.
The issuance of a patent is not conclusive as to the inventorship, scope, validity or enforceability, and our patents may be challenged in the courts or patent offices in the U.S., the EU, Australia and elsewhere. Such challenges may result in loss of ownership or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit the duration of the patent protection of our technology and products. As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.
In addition, other companies may attempt to circumvent any regulatory data protection or market exclusivity that we obtain under applicable legislation, which may require us to allocate significant resources to preventing such circumvention. Such developments could enable other companies to circumvent our intellectual property rights and use our clinical trial data to obtain marketing authorizations in the EU, Australia and in other jurisdictions. Such developments may also require us to allocate significant resources to prevent other companies from circumventing or violating our intellectual property rights.
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Our attempts to prevent third parties from circumventing our intellectual property and other rights may ultimately be unsuccessful.
Intellectual property rights of third parties could adversely affect our ability to commercialize our products, such that we could be required to litigate with or obtain licenses from third parties in order to develop or market our products. Such litigation or licenses could be costly or not available on commercially reasonable terms.
Our commercial success may somewhat depend upon our future ability and the ability of our potential collaborators to develop, manufacture, market and sell our product candidates without infringing valid intellectual property rights of third parties.
If a third-party intellectual property right exists it may require the pursuit of litigation or administrative proceedings to nullify or invalidate the third-party intellectual property right concerned, or entry into a license agreement with the intellectual property right holder, which may not be available on commercially reasonable terms, if at all.
Third-party intellectual property right holders, including our competitors, may bring infringement claims against us. We may not be able to successfully settle or otherwise resolve such infringement claims. If we are unable to successfully settle future claims or otherwise resolve such claims on terms acceptable to us, we may be required to engage in or continue costly, unpredictable and time-consuming litigation and may be prevented from, or experience substantial delays in, marketing our product candidate.
If we fail to settle or otherwise resolve any such dispute, in addition to being forced to pay damages, we or our potential collaborators may be prohibited from commercializing any product candidates we may develop that are held to be infringing, for the duration of the patent term. We might, if possible, also be forced to redesign our formulations so that we no longer infringe such third-party intellectual property rights. Any of these events, even if we were ultimately to prevail, could require us to divert substantial financial and management resources that we would otherwise be able to devote to our business.
Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
Because we rely on third parties to manufacture our product candidates, and because we collaborate with various organizations and academic institutions on the advancement of our technology and product candidates, we may, at times, share trade secrets with them. We seek to protect our proprietary technology in part by entering into confidentiality agreements and, if applicable, material transfer agreements, collaborative research agreements, consulting agreements or other similar agreements with our collaborators, advisors, employees and consultants prior to beginning research or disclosing proprietary information. These agreements typically limit the rights of the third parties to use or disclose our confidential information, such as trade secrets. Despite these contractual provisions, the need to share trade secrets and other confidential information increases the risk that such trade secrets become known by potential competitors, are inadvertently incorporated into the technology of others, or are disclosed or used in violation of these agreements. Given that our proprietary position is based, in part, on our know-how and trade secrets, discovery by a third party of our trade secrets or other unauthorized use or disclosure would impair our intellectual property rights and protections in our product candidates.
In addition, these agreements typically restrict the ability of our collaborators, advisors, employees and consultants to publish data potentially relating to our trade secrets. Our academic collaborators typically have rights to publish data, provided that we are notified in advance and may delay publication for a specified time in order to secure our intellectual property rights arising from the collaboration. In other cases, publication rights are controlled exclusively by us. In other cases, we may share these rights with other parties. Despite our efforts to protect our trade secrets, our competitors may discover our trade secrets, either through breach of these agreements, independent development or publication of information including our trade secrets in cases where we do not have proprietary or otherwise protected rights at the time of publication.
Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and applications are required to be paid to the USPTO and various governmental patent agencies outside of the United States in several stages over the lifetime of the patents and applications. The USPTO and various corresponding governmental patent agencies outside of the United States require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process and after a patent has issued. There are situations in which non-compliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.
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We may become involved in lawsuits to protect and defend our patents or other intellectual property, which could be expensive, time consuming and unsuccessful.
Competitors may infringe our patents or other intellectual property and we may inadvertently infringe the patent or intellectual property of others. To counter infringement or unauthorized use, we may be required to file claims, and any related litigation and/or prosecution of such claims can be expensive and time consuming. Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe their intellectual property. In addition, in a patent infringement proceeding, a court may decide that a patent of ours is invalid in whole or in part, unenforceable, or construe the patent’s claims narrowly allowing the other party to commercialize competing products on the grounds that our patents do not cover such products.
Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and could distract our technical and management personnel from their normal responsibilities. Such litigation or proceedings could substantially increase our operating losses and reduce our resources available for development activities. We may not have sufficient financial or other resources to adequately conduct such litigation or proceedings. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their substantially greater financial resources. The effects of patent litigation or other proceedings could therefore have a material adverse effect on our ability to compete in the marketplace.
If we do not obtain patent term extension for our products, our business may be materially harmed.
Depending upon the timing, duration and specifics of any FDA marketing approval of any products we may develop, we may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Action of 1984 (“Hatch-Waxman Act”). The Hatch- Waxman Act permits a patent term extension of up to five years as compensation for patent term lost during the drug testing phase and the FDA regulatory review process. A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, only one patent may be extended and only those claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended. However, we may not be granted an extension because of, for example, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents, or otherwise failing to satisfy applicable requirements. Moreover, the applicable time period or the scope of patent protection afforded could be less than we request. If we are unable to obtain patent term extension or the term of any such extension is less than we request, our competitors may obtain approval of competing products following our patent expiration, and our business, financial condition, results of operations, and prospects could be materially harmed. Other jurisdictions including Australia, Europe and Japan have similar extension of term provisions, whilst other countries do not have any such provisions.
Confidentiality and invention assignment agreements with our employees, advisors and consultants may not adequately prevent disclosure of trade secrets and protect other proprietary information.
We consider proprietary trade secrets and/or confidential know-how and unpatented know-how to be important to our business. We may rely on trade secrets and/or confidential know-how to protect our technology, especially where patent protection is believed by us to be of limited value. However, trade secrets and/or confidential know-how can be difficult to maintain as confidential.
To protect this type of information against disclosure or appropriation by competitors, our policy is to require our employees, advisors and consultants to enter into confidentiality and invention assignment agreements with us. However, current or former employees, advisors and consultants may unintentionally or willfully disclose our confidential information to competitors, and confidentiality and invention assignment agreements may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. Enforcing a claim that a third-party obtained illegally and is using trade secrets and/or confidential know-how is expensive, time consuming and unpredictable. The enforceability of confidentiality and invention assignment agreements may vary from jurisdiction to jurisdiction.
Failure to obtain or maintain trade secrets and/or confidential know-how trade protection could adversely affect our competitive position. Moreover, our competitors may independently develop substantially equivalent proprietary information and may even apply for patent protection in respect of the same. If successful in obtaining such patent protection, our competitors could limit our use of our trade secrets and/or confidential know-how.
Intellectual property rights do not address all potential threats to our competitive advantage.
The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations, and may not adequately protect our business, or permit us to maintain our competitive advantage. The following examples are illustrative:
| • | Others may be able to make products that are similar to ours but that are not covered by our intellectual property rights. |
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| • | Others may independently develop similar or alternative technologies or otherwise circumvent any of our technologies without infringing our intellectual property rights. |
| • | We or any of our collaboration partners might not have been the first to conceive and reduce to practice the inventions covered by the patents or patent applications that we own, license or will own or license. |
| • | We or any of our collaboration partners might not have been the first to file patent applications covering certain of the patents or patent applications that we or they own or have obtained a license or will own or will have obtained a license. |
| • | It is possible that any pending patent applications that we have filed, or will file, will not lead to issued patents. |
| • | Issued patents that we own may not provide us with any competitive advantage, or may be held invalid or unenforceable, as a result of legal challenges by our competitors. |
| • | Our competitors might conduct research and development activities in countries where we do not have patent rights, or in countries where research and development safe harbor laws exist, and then use the information learned from such activities to develop competitive products for sale in our major commercial markets. |
| • | Ownership of our patents or patent applications may be challenged by third parties. |
| • | The patents of third parties or pending or future applications of third parties, if issued, may have an adverse effect on our business. |
Changes in patent laws or patent jurisprudence could diminish the value of patents in general, thereby impairing our ability to protect our products or product candidate.
As is the case with other biopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining and exploiting patents in the biopharmaceutical industry involve both technological and legal complexity. Therefore, obtaining and exploiting biopharmaceutical patents is costly, time-consuming and inherently uncertain. For example, the U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations.
In addition, the America Invents Act, or AIA, has been enacted in the United States, resulting in significant changes to the U.S. patent system. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, the combination of the U.S. Supreme Court decisions and AIA has created uncertainty with respect to the value of patents, once obtained. A few highlights of changes to U.S. patent law under the AIA are:
| • | Under the AIA, a patent is awarded to the “first-inventor-to-file” rather than the first to invent. |
| • | There is a new definition of prior art which removes geographic and language boundaries found in the pre-AIA law. At the same time, certain categories of “secret” prior art have been eliminated. |
| • | The AIA introduced new procedures for challenging the validity of issued patents: post-grant review and inter partes review. |
| • | Patent owners under the AIA may now request supplemental examination of a patent to consider, reconsider, or correct information believed to be relevant to the patent. |
| • | The AIA allows third parties to submit any patent, published application, or publication relevant to examination of a pending patent application with a concise explanation for inclusion during prosecution of the patent application. |
The “first-inventor-to-file” system and the new definitions of prior art apply to U.S. patent applications with claims having an effective filing date on or after March 16, 2013. Until at least 2034, patent practice will involve both pre-AIA and AIA laws. Depending on decisions by the U.S. Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that could weaken our ability to obtain new patents or to exploit our existing patents and patents that we might obtain in the future. Similarly, the complexity and uncertainty of European patent laws has also increased in recent years. In addition, the European patent system is relatively stringent in the type of amendments that are allowed during prosecution. Changes in patent law or patent jurisprudence could limit our ability to obtain new patents in the future that may be important for our business.
We may face difficulties with protecting our intellectual property in certain jurisdictions, which may diminish the value of our intellectual property rights in those jurisdictions.
The laws of some jurisdictions do not protect intellectual property rights to the same extent as the laws in the U.S. and the EU, and many companies have encountered significant difficulties in protecting and defending such rights in such jurisdictions. If we or our collaboration partners encounter difficulties in protecting, or are otherwise precluded from effectively protecting, the intellectual property rights important for our business in such jurisdictions, the value of these rights may be diminished, and we may face additional competition from others in those jurisdictions.
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Some countries in Europe and China have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In addition, many countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent. If we are, or any of our licensors is, forced to grant a license to third parties with respect to any patents relevant to our business, our competitive position or commercial advantage may be impaired, and our business and results of operations may be adversely affected.
Risks Relating to Our Securities
Our stock price is volatile and could decline significantly.
The market price of our ordinary shares and ADSs historically has been, and we expect will continue to be, subject to significant fluctuations over short periods of time. These fluctuations may be due to factors specific to us, to changes in analysts’ recommendations and earnings estimates, to arbitrage between our Australian-listed ordinary shares and our NASDAQ-listed ADSs, to changes in exchange rates, or to factors affecting the biopharmaceutical industry or the securities markets in general. Market fluctuations, as well as general political and economic conditions, such as a recession, interest rate or currency fluctuations, could adversely affect the market price of our securities.
For example, during the last two fiscal years, the market price for our ordinary shares on the Australian Securities Exchange and ADSs on NASDAQ has ranged from a low of A$0.29 and US$1.85, respectively, to a high of A$0.71 and US$5.00, respectively. We may experience a material decline in the market price of our shares, regardless of our operating performance. Therefore, a holder of our ordinary shares or ADSs may not be able to sell those ordinary shares or ADSs at or above the price paid by such holder for such shares or ADSs. Price declines in our ordinary shares or ADSs could result from a variety of factors, including many outside our control. These factors include:
| • | the results of pre-clinical testing and clinical trials by us and our competitors; |
| • | unforeseen safety issues or adverse side effects resulting from the clinical trials or the commercial use of our product candidate; |
| • | regulatory actions in respect of any of our products or the products of any of our competitors; |
| • | announcements of the introduction of new products by us or our competitors; |
| • | market conditions, including market conditions in the pharmaceutical and biotechnology sectors; |
| • | increases in our costs or decreases in our revenues due to unfavorable movements in foreign currency exchange rates; |
| • | developments or litigation concerning patents, licenses and other intellectual property rights; |
| • | litigation or public concern about the safety of our potential products; |
| • | changes in recommendations or earnings estimates by securities analysts; |
| • | actual and anticipated fluctuations in our quarterly operating results; |
| • | deviations in our operating results from the estimates of securities analysts; |
| • | rumors relating to us or our competitors; |
| • | additions or departures of key personnel; |
| • | changes in third-party reimbursement policies; and |
| • | developments concerning current or future strategic alliances or acquisitions. |
In addition, volatility and low market price of our ordinary shares and/or ADSs may adversely impact investors’ interest in our securities. A decline in investors’ interest may prompt further volatility and decrease in market price.
We have become subject to the auditor attestation requirement under the Sarbanes-Oxley Act, thus imposing significant cost and administrative burden on us.
Given the aggregate worldwide market value of our voting equity held by non-affiliates exceeded US$75.0 million as of our most recently completed second fiscal quarter and we no longer qualify as an “emerging growth company”, we have become subject to the auditor attestation requirement under Section 404 of the Sarbanes-Oxley Act of 2002 in the assessment of internal control over financial reporting.
Accelerated filers that are not “emerging growth companies” (as defined by the SEC rules), are subject to the auditor attestation requirement for internal control over financial reporting. While the U.S. Securities and Exchange Commission has acknowledged the significant cost of the auditor attestation requirement for small companies and provides an exemption from the accelerated filer definition for “smaller reporting companies” with less than $100.0 million in revenue, the SEC rules state that “foreign private issuers” that present their financial statements in accordance with IFRS as issued by the IASB, such as the Company, are excluded from the definition of a “smaller reporting company”. Accordingly, currently, the only way for the Company to avoid being classified as an accelerated filer and avoid the auditor attestation requirement would be for the Company to report on U.S. domestic forms as a “smaller reporting company”, have less than $100 million in revenue, and present its financial statements in accordance with U.S. generally accepted accounting principles . Such alternative, however, is not currently prudent for us given the significant cost (including preparing financial statements in accordance U.S. generally accepted accounting principles as well as IFRS), administrative burden on our limited number of personnel and our obligations under ASX Listing Rules and the Australian Corporations Act.
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As a result, the Company is now subject to new significant compliance costs (which the SEC estimated to be US$210,000 per annum in 2019 in SEC Release No. 34-88365 and which were more than double that amount for us in relation to fiscal year 2022). If such costs are too significant in future years, we could seek to delist from NASDAQ, deregister our securities under the Securities Exchange Act so the Company would no longer be subject to such compliance burden and retain a listing solely on ASX. As the SEC acknowledged in its release providing the exemption from the accelerated filer definition for “smaller reporting companies” with less than $100 million in revenues, the savings for a small company could be put to more productive use such as developing the company.
Our ordinary shares may be considered a “penny stock” under SEC regulations which could adversely affect market trading in our ADSs.
The SEC has adopted regulations which generally define “penny stock” to be an equity security that has a market price of less than $5.00 per share, subject to specific exemptions. During the fiscal year ended June 30, 2022, our American Depository Shares traded on the NASDAQ from low of US$1.85 to a high of US$5.00 per share. Penny stock rules impose additional sales practice requirements on broker-dealers who sell to persons other than established customers and “accredited investors” The term “accredited investor” refers generally to institutions with assets in excess of US$5,000,000 or individuals with a net worth in excess of US$1,000,000 or annual income exceeding US$200,000 or US$300,000 jointly with their spouse in each of the prior two years.
The penny stock rules require a broker-dealer, prior to a transaction in a penny stock not otherwise exempt from the rules, to deliver a standardized risk disclosure document in a form prepared by the SEC, which provides (a) contains a description of the nature and level of risk in the market for penny stocks in both public offerings and secondary trading; (b) contains a description of the broker’s or dealer’s duties to the customer and of the rights and remedies available to the customer with respect to a violation of such duties or other requirements of the securities laws; (c) contains a brief, clear, narrative description of a dealer market, including bid and ask prices for penny stocks and the significance of the spread between the bid and ask price; (d) contains a toll-free telephone number for inquiries on disciplinary actions; (e) defines significant terms in the disclosure document or in the conduct of trading in penny stocks; and (f) contains such other information and is in such form, including language, type size and format, as the SEC shall require by rule or regulation.
The broker-dealer also must provide, prior to effecting any transaction in a penny stock, the customer with (a) bid and offer quotations for the penny stock; (b) the compensation of the broker-dealer and its salesperson in the transaction; (c) the number of shares to which such bid and ask prices apply, or other comparable information relating to the depth and liquidity of the market for such stock; and (d) a monthly account statement showing the market value of each penny stock held in the customer’s account.
In addition, the penny stock rules require that prior to a transaction in a penny stock not otherwise exempt from those rules, the broker-dealer must make a special written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser’s written acknowledgment of the receipt of a risk disclosure statement, a written agreement as to transactions involving penny stocks, and a signed and dated copy of a written suitability statement.
These disclosure requirements may significantly burden trading in, and delay the execution of transactions in, our ADSs. Thus, if our ADSs are considered penny stock, these disclosure requirements may adversely impact market trading in our ADSs.
If we are or become a passive foreign investment company (PFIC), then that would subject our U.S. shareholders to adverse tax rules.
Holders of our ADSs who U.S. residents could face income tax risks if we are a passive foreign investment company, or PFIC, which could result in a reduction in the after-tax return to a “U.S. Holder” of our ADSs and reduce the value of our ADSs. For U.S. federal income tax purposes, we will be classified as a PFIC for any taxable year in which (i) 75% or more of our gross income is passive income, or (ii) at least 50% of the average value of all of our assets for the taxable year produce or are held for the production of passive income. For this purpose, cash is considered to be an asset that produces passive income.
If we are classified as a PFIC in any year that a U.S. Holder owns ADSs, the U.S. Holder will generally continue to be treated as holding ADSs of a PFIC in all subsequent years, notwithstanding that we are not classified as a PFIC in a subsequent year. Dividends received by the U.S. Holder and gains realized from the sale of our ADSs would be taxed as ordinary income and subject to an interest charge. We urge U.S. investors to consult their own tax advisors about the application of the PFIC rules and certain elections that may help to minimize adverse U.S. federal income tax consequences in their particular circumstances.
We have never paid a dividend and we do not intend to pay dividends in the foreseeable future which means that holders of shares and ADSs may not receive any return on their investment from dividends.
To date, we have not declared or paid any cash dividends on our ordinary shares and currently intend to retain any future earnings for funding growth. We do not anticipate paying any dividends in the foreseeable future. Dividends may only be paid out of our profits. Payment of cash dividends, if any, in the future will be at the discretion of our board of directors. Our holders of shares and ADSs may not receive any return on their investment from dividends. The success of your investment will likely depend entirely upon any future appreciation of the market price of our ordinary shares and ADSs, which is uncertain and unpredictable. There is no guarantee that our ordinary shares and ADSs will appreciate in value or even maintain the price at which you purchased your ordinary shares and ADSs.
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Currency fluctuations may adversely affect the price of the ADSs relative to the price of our ordinary shares.
The price of our ordinary shares is quoted in Australian dollars and the price of our ADSs is quoted in U.S. dollars. Movements in the Australian dollar/U.S. dollar exchange rate may adversely affect the U.S. dollar price of our ADSs and the U.S. dollar equivalent of the price of our ordinary shares. In the last two years, the value of the Australian dollar remained relatively stable against the U.S. dollar. There can be no assurance, however, that this trend will continue. If the Australian dollar weakens against the U.S. dollar, the U.S. dollar price of the ADSs could decline, even if the price of our ordinary shares in Australian dollars increases or remains unchanged.
The requirements of being a public company may strain our resources and divert management’s attention and if we are unable to maintain effective internal control over financial reporting in the future, the accuracy and timeliness of our financial reporting may be adversely affected.
As a publicly traded company, we are subject to the reporting requirements of the U.S. Securities Exchange Act of 1934, as amended (the Exchange Act), the Sarbanes-Oxley Act, the Dodd-Frank Act, the listing requirements of the NASDAQ Global Market and other applicable securities rules and regulations. Compliance with these rules and regulations increases our legal and financial compliance costs, make some activities more difficult, time-consuming or costly and increase demand on our systems and resources. The Exchange Act requires, among other things, that we file certain reports with respect to our business and results of operations. The Sarbanes-Oxley Act requires, among other things, that we maintain effective disclosure controls and procedures and internal control over financial reporting and that our independent auditor provides us with an attestation report on the effectiveness of our internal controls over financial reporting as required by Section 404(b) of the Sarbanes-Oxley Act. In order to maintain and, if required, improve our disclosure controls and procedures and internal control over financial reporting to meet the applicable requirements of Section 404 of the Sarbanes-Oxley Act, significant resources and management oversight are required. As a result, management’s attention may be diverted from other business concerns, which could adversely affect our business and results of operations.
The Sarbanes-Oxley Act requires, among other things, that we assess the effectiveness of our internal control over financial reporting annually and disclosure controls and procedures. In particular, beginning with fiscal year ended on June 30, 2013, we have performed system and process evaluation and testing of our internal control over financial reporting to allow our management to report on the effectiveness of our internal control over financial reporting, as required by Section 404 of the Sarbanes-Oxley Act.
If either we are unable to conclude that we have effective internal controls over financial reporting or our independent auditors are unwilling or unable to provide us with an unqualified report on the effectiveness of our internal controls over financial reporting as required by Section 404(b) of the Sarbanes-Oxley Act, investors may lose confidence in our operating results, the price of the ADSs could decline and we may be subject to litigation or regulatory enforcement actions. In addition, if we are unable to meet the requirements of Section 404 of the Sarbanes-Oxley Act, we may not be able to remain listed on NASDAQ.
The listing of our securities on stock exchanges in different countries may adversely impact their liquidity.
Our ordinary shares are listed and traded on the ASX, NASDAQ and on Over The Counter markets within Germany. Price levels for our ordinary shares could fluctuate significantly on either market, independent of our share price on the other market. Investors could seek to sell or buy our shares to take advantage of any price differences between the three markets through a practice referred to as arbitrage. Any arbitrage activity could create unexpected volatility in our share prices on either exchange and the volumes of shares available for trading on either exchange. In addition, holders of shares in either jurisdiction will not be immediately able to transfer such shares for trading on the other markets without effecting necessary procedures with our transfer agent. This could result in time delays and additional cost for our shareholders. Further, if we are unable to continue to meet the regulatory requirements for listing on the ASX and NASDAQ, we may lose our listing on any of these exchanges, which could impair the liquidity of our shares.
Risks Related to an Investment in Our ADSs
Our ADS holders are not shareholders and do not have shareholder rights.
The Bank of New York Mellon, as depositary, registers and delivers our American Depositary Shares, or ADSs. Our ADS holders will not be treated as shareholders and do not have the rights of shareholders. The depositary will be the holder of the shares underlying our ADSs. Holders of our ADSs will have ADS holder rights. A deposit agreement among us, the depositary and our ADS holders, and the beneficial owners of ADSs, sets out ADS holder rights as well as the rights and obligations of the depositary. New York law governs the deposit agreement and the ADSs. For a description of ADS holder rights, see “Item 12. Description of Securities Other than Equity Securities—D. American Depositary Shares.”
Our shareholders have shareholder rights. Australian law and our constitution govern shareholder rights. For a description of our shareholders’ rights, see “Item 10. Additional Information—B. Memorandum and Articles of Association.” Shareholders are entitled to our notices of general meetings and to attend and vote at our general meetings of shareholders. At a general meeting, every shareholder present (in person or by proxy, attorney or representative) and entitled to vote has one vote on a show of hands. Every shareholder present (in person or by proxy, attorney or representative) and entitled to vote has one vote per fully paid ordinary share on a poll. This is subject to any other rights or restrictions which may be attached to any shares.
Our ADS holders do not have the same voting rights as our shareholders. ADS holders may exercise voting rights with respect to the underlying ordinary shares only in accordance with the provisions of the deposit agreement. Under the deposit agreement, ADS holders vote by giving voting instructions to the depositary. Upon receipt of instructions, the depositary will try to vote in accordance with those instructions. Otherwise, ADS holders will not be able to vote unless they withdraw the ordinary shares underlying their ADSs.
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If we ask for our ADS holders’ instructions, the depositary will notify our ADS holders of the upcoming vote and arrange to deliver our voting materials and form of notice to them. The depositary will try, as far as practical, subject to Australian law and the provisions of the depositary agreement, to vote the shares as our ADS holders instruct. The depositary will not vote or attempt to exercise the right to vote other than in accordance with the instructions of the ADS holders. We cannot assure our ADS holders that they will learn of ordinary shareholders’ meetings and receive the voting materials in time to instruct the depositary or withdraw the underlying ordinary shares. This means that there is a risk that our ADS holders may not be able to exercise voting rights and there may be nothing they can do if their shares are not voted as they requested.
Our ADS holders do not have the same rights to receive dividends or other distributions as our shareholders.
Subject to any special rights or restrictions attached to a share, the directors may determine that a dividend will be payable on a share and fix the amount, the time for payment and the method for payment (although we have never declared or paid any cash dividends on our ordinary stock and we do not anticipate paying any cash dividends in the foreseeable future). Dividends may be paid on shares of one class but not another and at different rates for different classes. Dividends and other distributions payable to our shareholders with respect to our ordinary shares generally will be payable directly to them. Any dividends or distributions payable with respect to ordinary shares will be paid to the depositary, which has agreed to pay to our ADS holders the cash dividends or other distributions it or the custodian receives on shares or other deposited securities, after deducting its fees and expenses. Our ADS holders will receive these distributions in proportion to the number of shares their ADSs represent. In addition, there may be certain circumstances in which the depositary may not pay to our ADS holders amounts distributed by us as a dividend or distribution.
There are circumstances where it may be unlawful or impractical to make distributions to the holders of our ADSs.
The deposit agreement with the depositary generally requires the depositary to convert foreign currency it receives in respect of deposited securities into U.S. dollars and distribute the U.S. dollars to ADS holders, provided the depositary can do so on a reasonable basis. If it does not convert foreign currency, the depositary may distribute the foreign currency only to those ADS holders to whom it is possible to do so. If a distribution is payable by us in Australian dollars, the depositary will hold the foreign currency it cannot convert for the account of the ADS holders who have not been paid. It will not invest the foreign currency and it will not be liable for any interest. If the exchange rates fluctuate during a time when the depositary cannot convert the foreign currency, our ADS holders may lose some of the value of the distribution. The depositary is not responsible if it decides that it is unlawful or impractical to make a distribution available to any ADS holders. This means that our ADS holders may not receive the distributions we make on our shares or any value for them if it is illegal or impractical for us to make them available.
If we fail to comply with the Nasdaq listing requirements, Nasdaq could delist the ADSs, which could limit liquidity of the ADSs and adversely affect our business and access to future capital.
The ADSs are listed on the Nasdaq Global Market under the symbol “IMMP.” In the past we have failed, and in the future we may again fail, to comply with the Nasdaq Global Market regulations and listing requirements as to minimum shareholders’ equity, minimum market value, minimum total assets and revenue, minimum bid price, minimum public float and/or other requirements, and as a result Nasdaq may initiate procedures to delist the ADSs from the Nasdaq Global Market, which may adversely affect our business.
If we fail to meet Nasdaq’s continued listing rules, the ADSs may be delisted from the Nasdaq Global Market. Delisting from the Nasdaq Global Market could have an adverse effect on our business, including our ability to access future capital, and on the trading of the ADSs. If a delisting of the ADSs were to occur, the ADSs may trade in the over-the-counter market such as on the OTC Bulletin Board or on the “pink sheets”. The over-the-counter market is generally considered to be a less efficient market, and this could diminish investors’ interest in the ADSs as well as significantly impact the price and liquidity of the ADSs. Any such delisting may also adversely affect the trading of the ADSs by ADS holders or impede them from liquidating their holdings. Delisting may also adversely impact the success of future issues of securities or the possibility to receive additional financing, particularly in the United States.
Risks Relating to Our Location in Australia
Currency fluctuations may expose us to increased costs and revenue decreases.
Our business is affected by fluctuations in foreign exchange rates. Our expenses are denominated in Australian dollars, U.S. dollars and European euro. During fiscal year 2022, the Australian dollar generally appreciated against European Euro and depreciated against the U.S. dollar, whereas in fiscal year 2021, the Australian dollar had appreciated against the U.S. dollar and European Euro. We conduct clinical trials in many different countries, and we have manufacturing of our product candidate undertaken outside of Australia, which exposes us to potential cost increases resulting from fluctuations in exchange rates. In fiscal year 2022, there was a foreign exchange gain of A$1.2 million as a result of currency fluctuations. Currency fluctuations could, therefore, cause our costs to increase and revenues to decline.
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Australian takeovers laws may discourage takeover offers being made for us or may discourage the acquisition of large numbers of our shares.
We are incorporated in Australia and are subject to the takeovers laws of Australia. Amongst other things, we are subject to the Corporations Act 2001 (Commonwealth of Australia). Subject to a range of exceptions, the Corporations Act prohibits the acquisition of a direct or indirect interest in our issued voting shares (including through the acquisition of ADSs) if the acquisition of that interest would lead to a person’s or someone else’s voting power in us increasing from 20% or below to more than 20% or increasing from a starting point that is above 20% and below 90%. Exceptions to the general prohibition include circumstances where the person makes a formal takeover bid for us, if the person obtains shareholder approval for the acquisition or if the person acquires less than 3% of the voting power of us in any rolling six-month period. Australian takeovers laws may discourage takeover offers being made for us or may discourage the acquisition of large numbers of our shares.
Rights as a holder of ordinary shares are governed by Australian law and our Constitution which differ from the rights of shareholders under U.S. law. Holders of our ordinary shares or ADSs may have difficulty in effecting service of process in the United States or enforcing judgments obtained in the United States.
We are a public company incorporated under the laws of Australia. Therefore, the rights of holders of our ordinary shares are governed by Australian law and our Constitution. These rights differ from the typical rights of shareholders in U.S. corporations. The rights of holders of ADSs are affected by Australian law and our Constitution but are governed by U.S. law. Circumstances that under U.S. law may entitle a shareholder in a U.S. company to claim damages may also give rise to a cause of action under Australian law entitling a shareholder in an Australian company to claim damages. However, this will not always be the case. Holders of our ordinary shares or ADSs may have difficulties enforcing, in actions brought in courts in jurisdictions located outside the U.S., liabilities under U.S. securities laws. In particular, if such a holder sought to bring proceedings in Australia based on U.S. securities laws, the Australian court might consider:
| • | that it did not have jurisdiction; and/or |
| • | that it was not an appropriate forum for such proceedings; and/or |
| • | that, applying Australian conflict of laws rule, U.S. law (including U.S. securities laws) did not apply to the relationship between holders of our ordinary shares or ADSs and us or our directors and officers; and/or |
| • | that the U.S. securities laws were of a public or penal nature and should not be enforced by the Australian court. |
Holders of our ordinary shares and ADSs may also have difficulties enforcing in courts outside the U.S. judgments obtained in the U.S. courts against any of our directors and executive officers or us, including actions under the civil liability provisions of the U.S. securities laws.
As a foreign private issuer whose shares are listed on the NASDAQ Global Market, we may follow certain home country corporate governance practices instead of certain NASDAQ requirements.
As a foreign private issuer whose shares are listed on the NASDAQ Global Market, we are permitted to follow certain home country corporate governance practices instead of certain requirements of The NASDAQ Marketplace Rules. As an Australian company listed on the NASDAQ Global Market, we may follow home country practice with regard to, among other things, the composition of the board of directors, director nomination process, compensation of officers and quorum at shareholders’ meetings. In addition, we may follow Australian law instead of the NASDAQ Marketplace Rules that require that we obtain shareholder approval for certain dilutive events, such as for the establishment or amendment of certain equity-based compensation plans, an issuance that will result in a change of control of the company, certain transactions other than a public offering involving issuances of a 20% or more interest in the company and certain acquisitions of the stock or assets of another company. As a foreign private issuer that has elected to follow a home country practice instead of NASDAQ requirements, we have submitted to NASDAQ a written statement from our independent counsel certifying that our practices are not prohibited by Australian laws. Accordingly, our shareholders may not be afforded the same protection as provided under NASDAQ’s corporate governance rules. Please see “Item 6. Directors, Senior Management and Employees—C. Board Practices” for further information.
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We are exposed to differing legal and tax laws in multiple jurisdictions, including complex transfer pricing rules in Australia.
We and our subsidiaries are located in a number of jurisdictions and therefore have exposure to different legal and taxation requirements in multiple jurisdictions, which requirements are subject to change. Immutep Limited is incorporated in, and a tax resident of, Australia. It has a number of intercompany arrangements with its subsidiaries (resident outside Australia also for tax purposes), including, for example, funding and employee sourcing arrangements. In Australia there are complex and material requirements on transfer pricing of intercompany loan arrangements with overseas entities. The multiple jurisdictional structure of the Company and its subsidiaries can expose the Group to substantial compliance and taxation liabilities. While we believe we are compliant with these tax laws, there is a risk that we and our subsidiaries could be subject to tax audits (with the resulting compliance costs) or exposed to fines or penalties.
| ITEM 4. | INFORMATION ON THE COMPANY |
A. History and Development of the Company
Our legal and commercial name is Immutep Limited. We were incorporated under the laws of the Commonwealth of Australia on May 21, 1987. Immutep, formerly called Prima BioMed, was originally created as a mining company (Prima Resources) in Australia in 1987 and was first publicly traded in 1988 on the Australian Stock Exchange. The Company was repositioned as a biotechnology company in 2001 following the acquisition of the rights to develop technologies from the Austin Research Institute (now the Burnet Institute).
In December 2014, we completed the acquisition of Immutep S.A., a private French company. In December 2014, Immutep S.A. underwent a change of company organization and become known as Immutep S.A.S. In November 2017, what was then known as Prima BioMed Ltd, changed its name to Immutep Limited to reflect the new strategic direction and management of the business to focus on the development of its portfolio of LAG-3 based immunotherapy assets.
Our registered office is located at Level 33, Australia Square, 264 George Street, Sydney 2000 New South Wales, Australia and our telephone number is +61 (0)2 8315 7003. Our address on the Internet is www.immutep.com. Our agent for service of process is Immutep U.S., Inc. The information on, or accessible through, our website is not part of this Annual Report on Form 20-F. We have included our website address in this Annual Report on Form 20-F solely as an inactive textual reference. All information we file with the SEC is available through the SEC’s Electronic Data Gathering, Analysis and Retrieval system, which may be accessed through the SEC’s website at www.sec.gov.
B. Business Overview
Background
Immutep is a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease. Our lead clinical candidate is Eftilagimod Alpha (“Efti” or “IMP321”) for the treatment of different types of cancers.
Efti (IMP321) is a soluble LAG-3Ig fusion protein that is first-in-class antigen-presenting cell (APC) agonist designed to capitalize on LAG-3’s unique ability to drive the adaptive and innate immune systems against cancer. Efti binds to and activates antigen presenting cells via MHC II molecules leading to expansion and proliferation of CD8+ (cytotoxic) T cells, CD4+ (helper) T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules that further boost the immune system’s ability to fight cancer. Efti’s favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy.
Efti is being evaluated as part of a combination therapy with an immune checkpoint inhibitor in 1st and 2nd line non-small cell lung carcinoma as well as 2nd line head and neck squamous cell carcinoma in a Phase II clinical trial called TACTI-002 (clinicaltrials.gov identifier NCT03625323), as part of a combination therapy an immune checkpoint inhibitor in 1st line head and neck squamous cell carcinoma in a Phase IIb clinical trial called TACTI-003 (clinicaltrials.gov identifier NCT04811027), and in an investigator-initiated Phase I platform trial in a variety of solid tumors called INSIGHT (clinicaltrials.gov identifier NCT03252938). Efti has completed a Phase IIb clinical trial as a chemo-immunotherapy combination for metastatic breast cancer termed AIPAC (clinicaltrials.gov identifier NCT02614833), and a Phase I combination therapy trial in metastatic melanoma termed TACTI-mel (clinicaltrials.gov identifier NCT02676869).
Two LAG-3 product candidates including antibodies for immune response modulation in autoimmunity and cancer are licensed to and being developed by Immutep’s pharmaceutical partners. Immutep is also developing an agonist of LAG-3 (IMP761) for autoimmune disease.
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The following graphic depicts Immutep’s pipeline:
Operations Summary
Immutep has administrative offices in Sydney, Australia, Leipzig, Germany and in Berlin, Germany. We also have a laboratory located close to Paris, France for the conduct of research and development relating to the LAG-3 program, under which we have four product candidates: efti (IMP321), IMP761, IMP701 and IMP731. Background IP supporting the development of LAG-3 products was licensed from Merck Serono in 2002. Development milestones and royalties are payable on earnings of efti, IMP701 and IMP731. Further details are provided under the intellectual property section. As of June 30, 2022, we employed 35 people. Our internal staff manages the Company’s finances, business development, intellectual property, investor relations, oversight of manufacturing, and clinical development. We make extensive use of outside contractors and consultants to help manage and conduct manufacturing and clinical trials.
Efti (IMP321) Clinical Development
Immutep’s lead clinical candidate is efti (IMP321), a soluble LAG-3Ig fusion protein that is first-in-class APC activator designed to capitalize on LAG-3’s unique ability to drive the adaptive and innate immune systems against cancer. Efti binds to and activates antigen presenting cells via MHC II molecules leading to expansion and proliferation of CD8+ (cytotoxic) T cells, CD4+ (helper) T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules that further boost the immune system’s ability to fight cancer. Efti’s favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. These alternative combination applications of efti are the subject of various clinical programs described below.
TACTI-mel
Efti has been utilized in multiple clinical trials in combination with immune checkpoint inhibitors, including anti-PD-1 and anti-PD-L1 immunotherapies. The first such trial was initiated during fiscal 2016 called Two ACTive Immunotherapeutics in melanoma (TACTI-mel), a Phase I study on efti’s effectiveness in enhancing immune responses to PD-1 inhibitors in melanoma patients. The primary purpose of the TACTI-mel trial, which had a study group of up to 24 patients, was to determine safety and dosage levels for combining the two products in future trials. In December 2016, we announced first clinical data from its TACTI-mel Phase I clinical trial for efti combined with PD-1 checkpoint inhibitor pembrolizumab (KEYTRUDA®) in melanoma cancer. The results confirmed that efti is safe and well tolerated at the first dose level of 1 mg, paving the way for 6 mg dosage. In January 2017, we commenced recruitment for the second cohort of six patients for the TACTI-mel melanoma trial, which was fully recruited by March 2017.
After reporting additional encouraging interim data regarding the efficacy and safety of efti combined with pembrolizumab (KEYTRUDA®), in March 2018 we expanded the clinical trial to include a fourth cohort (Part B) of six patients evaluating dosing of efti at 30mg in combination with pembrolizumab. In May 2018, interim data for the initial three cohorts (Part A) yielded an overall response rate of 61% when the response rates from the initial four cycles of pembrolizumab monotherapy are used, and an overall rate response (ORR) of 33% measured from the start of the combination therapy when efti was added at cycle five of pembrolizumab. Two complete responses according to RECIST were reported from the trial, out of 18 patients. Full recruitment of the expanded TACTI-mel trial was reached in August 2018, bringing the participation number to 24 patients.
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In November 2018, Immutep presented new interim data from the TACTI-mel trial which were reconfirmed with more mature data in March 2019. It reported efficacy data from Part A was encouraging and supportive of previously disclosed response rates. The first efficacy data from Part B of the trial was also reported in November 2018, where the combination treatment is administered to patients from the beginning of cycle 1, day 1 of pembrolizumab treatment. In October 2019, Immutep reported final efficacy data from the TACTI-mel trial. Deep and durable responses were observed with 56% and 66% of patients showing tumor shrinkage in Parts A and B, respectively.
TACTI-002
In March 2018, we announced that we had entered into a clinical trial collaboration and supply agreement with Merck Co., Inc., Kenilworth, NJ, USA (known as MSD outside the United States and Canada) to evaluate the safety and efficacy of the combination of efti and pembrolizumab (KEYTRUDA®) in a new Phase II clinical trial (TACTI-002) for 2nd line head and neck squamous cell carcinoma as well as 1st and 2nd line non-small cell lung carcinoma in up to 109 patients across various centers in the United States, Europe and Australia. In July 2018, the FDA granted approval of the IND regarding TACTI-002 Phase II clinical trial which allowed us to initiate the study in the United States. Immutep obtained competent authority approval from the UK’s Medicines Healthcare products Regulatory Agency (MHRA) for TACTI-002, as well as a number of Ethics Committee approvals and completed the site selection process for the trial in November 2018. The first patient was dosed with the combination of KEYTRUDA and efti in March 2019 and in August 2019 the trial had 26 patients participating, including full enrolment (17 patients) into the first cohort of the first line non-small cell lung cancer (NSCLC) arm (Part A).
In September 2019, Part A was expanded to include a further 19 patients because a predefined number of patient responses to the combination treatment was observed. Recruitment is ongoing and in November 2019 first data from Part A was reported from the trial which showed an initial response rate (ORR) of 41%. In January 2020, Part C (2nd line HNSCC) of the trial was expanded to include a further 19 patients because of a predefined number of patient responses to the treatment. In February 2020, Immutep presented encouraging data from Parts A and C of the trial. In Part A of the trial, we reported an improving response rate of 47% and responses were seen across all PD-L1 expression groups ( 1%, 1-49% and ≥50%). In Part C, Immutep reported an initial response rate of 33%. In April 2020, Immutep reported more mature data showing an improved response rate of 53% for Part A and a response rate of 33% for Part C (consistent with earlier data). In June 2020, Immutep announced more mature data showing a response rate of 53% for Part A (consistent with earlier data) and an improved response rate of 39% for Part C. In June 2020, Immutep reported that Part A of the trial had been fully recruited with a total of 36 patients. In August 2020, Immutep announced that recruitment of Stage 1 of Part B of the trial (2nd line NSCLC) was complete. In September 2020, TACTI-002 data presented at a major scientific conference, ESMO, showed three patients had had a complete response, or complete disappearance of all lesions when treated with the combination of efti and pembrolizumab. This includes complete responses from two patients with 2nd line head and neck squamous cell carcinoma (HNSCC) and one with 1st line non-small cell lung cancer (NSCLC). In addition, patients with 1st line NSCLC had a median progression-free survival (PFS) of 11.8 months and those patients who responded, had durable responses. In November 2020, Immutep announced the presentation of further encouraging interim data from TACTI-002 at SITC 2020, including when compared to historical studies with checkpoint inhibitor monotherapy in comparable patient groups.
In June 2021, Immutep also announced the presentation of further interim data from TACTI-002 at the ASCO 2021 Annual Meeting. The interim data from Part A (1st line NSCLC) of the TACTI-002 trial presented showed sustained and durable responses in 15 patients with responses giving an ORR of 41.7% on an intention-to-treat basis and 48.4% in evaluable patients, as assessed by blinded independent committee read. Two out of the 36 patients (5.6%) had a Complete Response (complete disappearance of tumor lesions) and 23/36 (63.9%) of patients had a target lesion decrease (this includes the 2 with Complete Reponses). Data presented for Part C (2nd line HNSCC) showed 11 patients with responses giving an ORR of 29.7% on an intention-to-treat basis and 35.5% in evaluable patients and durable responses with 5 patients (13.5%) having a Complete Response.
In November 2021, Immutep also reported more mature data in 2nd line HNSCC from TACTI-002 at the SITC Annual Meeting 2021. The data continued to be encouraging with an ORR of 29.7% (11/37) on an intention to treat basis and 35.5% (11/31) in evaluable patients, as assessed by local investigator read. The ORR in patients in the PD-L1 ≥ 1 and PD-L1 ≥ 20 subgroups was 40.7% and 64.3%, respectively. Additionally, Immutep announced that it had completed recruitment of patients across all cohorts of TACTI-002 including the expansion stage of Part A, and it announced that a total of 185 patients were participating across Parts A, B, and C of the clinical study.
In March 2022, Immutep announced interim data from Part B of TACTI-002 (2nd line NSCLC) at ESMO’s European Lung Cancer Congress (ELCC) 2022. In particular, Immutep reported that 73.7% of evaluable patients (14/19) had tumor shrinkage or tumor growth deceleration, according to tumor growth kinetics analysis. The Disease Control Rate (DCR) was 36.1% (13/36) with 26% of patients being progression free at 6 months. The ORR was 5.6% (2/36) with both patients reporting confirmed and durable partial responses. The median OS had not yet been reached, which was encouraging given the advanced nature of the disease in this patient population.
In June 2022, Immutep announced new data from Part A of TACTI-002 (1st line NSCLC) from 114 patients. The data was presented as an Oral Presentation at the American Society of Clinical Oncology’s (ASCO) 2022 Annual Meeting. Immutep reported an ORR of 38.6% in the intent to treat group (44/114 patients) and 42.7% for evaluable patients (44/103) by local read. The reported ORR was favorable compared to historical studies of anti-PD-1 monotherapy. Favorable results were also reported in the individual PD-L1 status groups.
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In August 2022, Immutep reported new interim data from Part B of TACTI-002 (2nd line NSCLC). The data was presented as an electronic poster presentation at the IASLC 2022 World Conference on Lung Cancer (WCLC 2022). In particular, Immutep reported a median OS of 9.7 months which is comparable with current standard of care chemotherapy options in this 2nd line setting. Immutep also reported favorable sustained survival with 36.5% of patients alive at 18 months.
In September 2022, Immutep announced an update to its clinical trial strategy. In particular, Immutep announced that it was prioritizing 1st line NSCLC for late-stage development of efti based on the compelling data reported in TACTI-002, coupled with the large market opportunity and continued high unmet need.
In October 2022, Immutep announced the United States Food and Drug Administration (FDA) had granted Fast Track designation to eftilagimod alpha (“efti” or “IMP321”) in combination with pembrolizumab for the treatment of 1st line non-small cell lung cancer (NSCLC). The designation was based on the encouraging TACTI-002/KEYNOTE-798 Phase II clinical data in 1st line NSCLC for PD-L1 all-comers.
TACTI-003
In March 2021, Immutep announced a second clinical trial collaboration and supply agreement with Merck Co., Inc., Kenilworth, NJ, USA (known as MSD outside the United States and Canada) to conduct a new randomized and controlled Phase IIb trial (TACTI-003) evaluating efti in combination with pembrolizumab in 1st line HNSCC. TACTI-003 is a 1:1 randomised, controlled clinical study in approximately 154 1st line HNSCC patients to evaluate the safety and efficacy of efti in combination with pembrolizumab, compared to pembrolizumab alone.
In April 2021, Immutep announced the grant of Fast Track designation by the FDA for efti in 1st line recurrent or metastatic HNSCC. Fast Track was granted based on the promising data package, including from Immutep’s Phase II TACTI-002 trial (Keynote-798) in 2nd line HNSCC.
In July 2021, Immutep announced it completed all the necessary competent authority steps with the US Food and Drug Administration (FDA) and has received IRB approval to commence the Phase IIb TACTI-003 trial in the United States.
In November 2021, Immutep shared the trial design for TACTI-003 via a poster presentation at the SITC Annual Meeting 2021. Patients will be enrolled into two cohorts. Cohort A (approximately 130 patients) will evaluate the safety and efficacy of efti in combination with MSD’s KEYTRUDA® (pembrolizumab), compared to pembrolizumab alone in 1st line metastatic or recurrent HNSCC patients with PD-L1 positive tumors (CPS ≥ 1). Cohort B (up to 24 patients) is an experimental arm which will determine the efficacy and safety of efti plus pembrolizumab in patients with PD-L1 negative tumors (CPS 1).
In April 2022, the Phase IIb TACTI-003 trial design was also presented in a Trial-in-Progress Poster Presentation at the ASCO 2022 Annual Meeting. Later that month, it was disclosed that 21 patients out of approximately 154 have been enrolled into the trial and 21 sites out of 30 sites had been activated. In September 2022, Immutep disclosed 47/154 patients (approximately 30%) have been recruited into the ongoing randomised Phase IIb TACTI-003 trial in 1L HNSCC, and that recruitment is accelerating as further sites have been activated.
INSIGHT-004
In July 2017, Immutep announced its collaboration partner, the Institute of Clinical Cancer Research, Krankenhaus Nordwest GmbH in Frankfurt Germany (“IKF”), has received the regulatory and ethical approvals for the clinical trial investigating efti in new settings, called “INSIGHT”. The investigator sponsored INSIGHT clinical trial was designed to explore different routes of administration of efti in solid tumors.
In September 2018, the investigator initiated “INSIGHT” clinical trial was amended through a collaboration with Merck KGaA, Darmstadt, Germany and Pfizer, Inc. IKF was the sponsor of the amended Phase I clinical trial (called INSIGHT-004) conducted under the existing protocol of the ongoing INSIGHT clinical study. The new collaborative study tested the safety and efficacy of subcutaneous injections of efti combined with avelumab, a human anti-PD-L1 antibody that is a stimulator of the immune system to detect and fight tumor cells, in 12 patients with advanced solid tumors. Prof. Dr. Salah-Eddin Al-Batran, the lead investigator of INSIGHT and member of Immutep’s clinical advisory board, was also the lead investigator of INSIGHT-004.
The first patient in (FPI) the INSIGHT-004 trial was enrolled in Germany and received the first dose of treatment in June 2019. In April 2020, Immutep announced that it had completed patient enrollment (12 patients) for the INSIGHT-004 trial.
In June 2020, Immutep reported first data from INSIGHT-004 in which 33% of patients showed a partial response to the combination of efti and avelumab. In September 2020, INSIGHT-004 data reported at the ESMO conference showed promising early anti-tumor activity signals in a variety of cancer indications not typically sensitive to immune checkpoint inhibitor therapy. Overall, 41.7% of patients in the trial showed a Partial Response to the combination therapy of efti with avelumab.
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INSIGHT-003
In June 2021, Immutep announced it had signed an agreement to commence a new Phase I trial, called INSIGHT-003, to evaluate the combination of lead product candidate eftilagimod alpha (“efti” or “IMP321”) in conjunction with an existing approved standard of care therapy consisting of a chemotherapy agent and an anti-PD-1 therapy. INSIGHT-003 is an investigator-initiated trial conducted by IKF and will be run as an amendment to the protocol of the ongoing INSIGHT trial as the third arm (Stratum C) with Prof. Dr. Salah-Eddin Al-Batran as lead investigator. Up to 20 patients with various solid tumors will be recruited to participate in the trial, which expands the evaluation of efti into a triple combination therapy of efti, chemotherapy and anti-PD-1 therapy for the first time.
In August 2021, Immutep announced that the first patient had been enrolled and safely dosed in INSIGHT-003. This patient with metastatic non-small cell lung carcinoma received pembrolizumab plus doublet chemotherapy (carboplatin and pemetrexed) combined with Immutep’s lead product candidate eftilagimod alpha (efti or IMP321). In December 2021, announced the first five patients had been treated in the INSIGHT-003 study. No additional safety signals had been observed in the study of this triple combination therapy consisting of efti, an existing approved standard of care combination of chemotherapy (carboplatin) and an anti-PD-1 therapy.
In September 2022, Immutep disclosed that initial results from the ongoing INSIGHT-003 trial evaluating efti in combination with anti-PD-1 therapy and chemotherapy are expected in Q4 2022. These results may help to further inform the design of our late-stage trial in 1st line NSCLC. In October 2022, Immutep announced that first interim data from the INSIGHT-003 clinical trial would be disclosed in a poster presentation at the SITC Annual Meeting 2022.
AIPAC
In fiscal 2016, Immutep started Active Immunotherapy PAClitaxel (AIPAC), a Phase IIb study on efti’s effectiveness in treating metastatic breast cancer. The primary purpose of the AIPAC trial, which had a study group of 227 patients in the randomized part of the study and 15 patients for the safety run-in (242 patients in total), was to determine the clinical benefit of efti in terms of Progression-Free Survival as the primary clinical endpoint and a number of secondary endpoints such as Overall Survival in this patient population.
In December 2016, Immutep announced interim data, with respect to tests of efti plus paclitaxel chemotherapy, with all 15 patients in the safety run-in phase confirming previous trial results as well as the safety, pharmacokinetics and pharmacodynamics of efti at two dosage levels. In January 2017, we commenced the enlarged randomized phase of its AIPAC Phase IIb clinical trial for efti in breast cancer. The randomized phase entailed half of the 227 patients receiving paclitaxel plus a placebo and half receiving paclitaxel in conjunction with efti.
In fiscal year 2018, we continued our AIPAC Phase IIb and clinical trials sites were opened across Germany, the UK, France, Hungary, Belgium, Poland and the Netherlands. Recruitment of all 227 patients for the AIPAC study was completed in June 2019 and first data was reported in March 2020 when Immutep reported supportive efficacy data with a response rate of 48.3% for patients treated with a combination of efti and paclitaxel compared with 38.4% for patients treated with placebo and paclitaxel. 63% of patients who received paclitaxel plus efti were progression-free at the 6-month landmark (at the end of the chemo- immunotherapy combination phase) and according to RECIST 1.1 based on blinded independent central readers (BICR). This compared favorably to 54% of patients who received paclitaxel plus placebo. The PFS data yielded an unadjusted hazard ratio (HR) of 0.93. Encouraging results were observed in multiple predefined patient subgroups.
In December 2020, Immutep announced the presentation of first Overall Survival data from AIPAC at the San Antonio Breast Cancer Symposium 2020. The data showed a statistically significant survival benefit in certain pre-defined patient sub-groups. Immutep also announced that EOC Pharma will commence a Phase II clinical trial evaluating IMP321 in combination with chemotherapy in metastatic breast cancer in China. Also in December 2020, Immutep announced plans to commence upscaling of manufacturing of IMP321 to 2000L scale in preparation for late-stage clinical development and subsequent commercialization.
In October 2021 Immutep announced it had received positive feedback from the European Medicines Agency (EMA) regarding its clinical development program for IMP321 in metastatic breast cancer (MBC). In November 2021, Immutep announced final OS data from AIPAC in a late breaker poster presentation at the SITC Annual Meeting 2021. The study demonstrated a statistically significant and clinically relevant survival benefit in the efti group in three key predefined patient subgroups: 65 years of age, low monocytes and luminal B. Both the magnitude and statistical significance of the benefit had improved across the three groups, compared with the interim OS results reported in December 2020. In addition, Immutep reported that immune monitoring studies showed a statistically significant increase in peripheral CD8 T cells in patients from the efti group of the total population which was significantly correlated with improved OS.
In March 2022, Immutep announced that it had received constructive feedback from the FDA regarding its clinical development program for IMP321 in MBC. In May 2022, Immutep reported new biomarker and exploratory analysis data from AIPAC at ESMO’s Breast Cancer Congress. Immutep reported that through exploratory analyses, six subgroups of patients showed an improvement in OS in the efti group, compared to placebo. Five of the six subgroups ( 65 years, low baseline monocytes, high neutrophil to lymphocyte ratio (NLR), 5 years since diagnosis and luminal B) showed a statistically significant improvement in OS. Biomarker analysis showed that efti significantly increased the number of circulating immune cells (monocytes, activated CD8 T cells) and CXCL10 serum levels, compared to baseline. The increase was not observed in the placebo group.
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Additional Efti Manufacturing and Development Collaborations
In November 2016, Immutep announced the signing of a non-binding MOU and strategic development and manufacturing partnership it entered into with WuXi Biologics. Under the partnership, WuXi Biologics will be the exclusive clinical and commercial manufacturer for efti for Immutep worldwide (excluding: China, Macau, Taiwan and Hong Kong where rights are retained by EOC, Immutep’s development partner in China).
During 2019, Immutep commenced a collaboration project with Cardiff University to advance the discovery and development of a new generation of small molecule anti-LAG-3 therapies. The ultimate aim of the project is to make an oral treatment available to cancer patients and at a lower cost compared with the current anti-LAG-3 antibodies being developed by several companies.
In addition, in October 2020, Immutep entered into a licence and collaboration agreement with Laboratory Corporation of America Holdings (LabCorp). The agreement is unrelated to any of Immutep’s own development programs and will support the development of immuno-oncology products or services by LabCorp.
In September 2022, Immutep announced it had entered into a new clinical trial collaboration with Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw, Poland to enable an investigator-initiated open label Phase II clinical trial. The trial will evaluate IMP321 in combination with pembrolizumab and radiotherapy in the neoadjuvant setting (prior to surgery) in up to 40 patients with select soft tissue sarcoma (STS).
Immutep has global rights to efti ex-China. Under a licensing agreement between Immutep S.A.S and EOC Pharma, EOC Pharma has the exclusive development right of the efti product in China, Hong Kong, Macau and Taiwan, while the development right in other countries is retained by Immutep. Eddingpharm originally held these rights but transferred the right to develop efti to its affiliate, EOC Pharma. Eddingpharm paid for the past manufacture of efti GMP grade material needed for the conduct of clinical trials of efti. Immutep will offer technical assistance to EOC Pharma to facilitate its application to register efti in China, Hong Kong, Macau and Taiwan. EOC Pharma is also required to make further milestone payments to Immutep if efti achieves specific development milestones as well as undisclosed royalties on sales. EOC Pharma’s co-development of efti is supported by a sublicense from Immutep to the background Serono licensed IP. Following the grant of EOC Pharma’s Investigational New Drug (IND) application in December 2017, Immutep received a US$1.0 million milestone payment from EOC Pharma. In October 2018, EOC Pharma, commenced the clinical development of IMP321 in China and reported that the first patient in its Phase I clinical study in metastatic breast cancer was safely dosed. In March 2020, Immutep announced that EOC Pharma had completed recruitment of its Phase I study. In April 2020, Immutep announced that it had discussed the results of its Phase IIb AIPAC study with EOC Pharma and that EOC Pharma had confirmed its plans to continue advancing efti in metastatic breast cancer in China. EOC Pharma announced in mid-2021 that they will commence a Phase II clinical trial in metastatic breast cancer in China.
IMP761 Preclinical Development
In January 2017, we announced a new early-stage product candidate to be known as IMP761, developed in our laboratory in Paris, and believed to be the first agonist antibody of LAG-3. IMP761, our fourth LAG-3 related product candidate, is our first agonist antibody related to LAG-3. The product candidate is not partnered. In September 2018, Immutep commenced cell line development and the associated GMP manufacturing steps for IMP761 to progress the product candidate towards clinical development. This work is ongoing.
Encouraging positive results from the preclinical studies of IMP761, were reported in March 2019. Consistent with earlier in vitro studies conducted by Immutep on the immunosuppressive activity of IMP761, in vivo studies in a non-human primate animal model showed that IMP761decreases inflammatory T cell infiltration induced by intra-dermal injection of an antigen. This demonstrates that IMP761 may have potential to address the root cause of autoimmune diseases by specifically silencing the autoimmune memory T cells accumulating at the disease site.
In April 2020, Immutep announced that its manufacturing partner, Batavia Biosciences, had developed a pharmaceutical grade CHO cell line which is able to produce significant quantities of IMP761. In December 2021, Immutep announced that it had appointed Northway Biotech to manufacture IMP761 for future clinical studies.
Work to progress GMP manufacturing steps for IMP761 was ongoing throughout fiscal year 2022.
Research Reagents used in the Development of LAG-3 Products
Our French subsidiary, Immutep S.A.S. manufactures, sells and distributes research reagents used by scientists in the research of LAG-3 products. The reagents are manufactured by Immutep S.A.S. and distributed through third party distributers. These third parties include Adipogen and Enzo.
The research reagents were originally manufactured and sold based on background licensed technology from Serono. Since 2018, the relevant patents have expired and Immutep therefore has no further obligation to make royalty payments on these sales to Serono under the licensing agreement dated December 2002 between Immutep and Serono.
IMP731 Clinical Development
A second key product candidate of Immutep is IMP731, a depleting antibody that removes T cells involved in autoimmunity. The product candidate was acquired through our acquisition of Immutep S.A.S (formerly known as Immutep S.A.) in December 2014. Immutep S.A.S obtained the exclusive intellectual property rights of IMP731 from the Institut national de la santé et de la recherche médicale (INSERM Transfert) under a commercial co-ownership and exploitation agreement dated July 2010. In return, Immutep S.A.S has the obligation to make customary milestone payments when the product achieves market authorization, plus additional minor royalty payments on sales.
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The development of IMP731 was licensed to Glaxo Smith Kline (GSK) under a license and research collaboration agreement dated December 2010 between Immutep S.A.S and GSK. Under the sublicense, GSK has the exclusive development right of IMP731 and will fund all the development costs and make potential milestone payments in the aggregate amount of up to £64.0 million as well as potential royalty payments to Immutep. In January 2015, Immutep collected a milestone payment from GSK for the development of GSK2831781 (derived from Immutep’s IMP731 antibody) for a first time in human clinical trial. GSK announced in July 2018 that the lead indication for GSK2831781 will be ulcerative colitis with Proof-of-Concept data expected in 2020. This new Phase II clinical study commenced in May 2019 (clinicaltrials.gov identifier NCT03893565) and will build on GSK’s Phase I clinical trial of the product candidate in psoriasis, which was completed in March 2018 (clinicaltrials.gov identifier NCT02195349). Another Phase I study in 36 Japanese and Caucasian healthy volunteers in Japan was started in June 2019 (clinicaltrials.gov identifier NCT03965533).
In September 2019, Immutep announced that it would receive a £4,000,000 milestone payment from GSK related to the first patient being dosed in GSK’s Phase II clinical trial evaluating GSK2831781 in ulcerative colitis, which was subsequently received by Immutep in the fiscal year 2020. In January 2021, Immutep announced that GSK had stopped the Phase II trial as part of a planned interim analysis conducted in consultation with the trial’s Data Review Committee. GSK is conducting further reporting, assessment and analyses of the efficacy and safety data and evaluating the biology to determine the next steps for the GSK2831781 development program.
IMP701 Clinical Development
The third key product candidate of Immutep is IMP701, an antagonist (blocking) antibody targeting the LAG-3 molecule with potential application in the treatment of cancer. It is designed to block the negative signal in cytotoxic T cells, which may stop T cells from responding to the cancer. The product candidate was acquired through our acquisition of Immutep S.A.S in December 2014.
The development of IMP701 was licensed to CoStim Pharmaceuticals under an exclusive license and collaboration agreement dated September 2012 between Immutep and CoStim. Under the license, CoStim has the exclusive development right of IMP701, in consideration for the obligation to fund all the development costs and to make milestone and royalty payments to Immutep S.A.S. In February 2014, CoStim became a wholly owned subsidiary of Novartis, but the obligations of the Agreement remained with CoStim.
In August 2017, we received a milestone payment of US$1,000,000 from Novartis relating to our IMP701 LAG-3 antibody. Novartis is continuing its clinical development program for IMP701, known as LAG525 (INN: ieramilimab) by Novartis, in oncology. Currently, there are five ongoing Phase I/II clinical trials evaluating this product candidate, with a total target enrolment of 1,100 patients. More information about these clinical trials can be found at www.clinicaltrials.gov.
Novartis presented two posters on LAG525 at ESMO 2021. One poster included data from its PLATForM Phase II study of novel spartalizumab combinations in melanoma, concluding that patients with LAG-3+ melanoma may be more likely to respond to spartalizumab + ieramilimab (LAG525) treatment.
Novartis also presented data from its Phase II, open-label, 3-arm study, in patients with advanced TNBC regardless of PD-L1 status progressing after adjuvant or 1 prior line of systemic therapy for metastatic disease, but who had not received an immune checkpoint inhibitor, where patients were randomized 1:1:1 to LAG525 + spartalizumab, LAG525 + spartalizumab + carboplatin, or LAG525 + carboplatin. As no arms met the proof of preliminary efficacy PPE criteria, no further investigation is planned for this study.
Intellectual Property
As of June 30, 2022, Immutep owns or co-owns 13 patent families relating to our development candidates IMP321, IMP761, IMP701 and IMP731.
On the December 9, 2002, Ares Trading SA (a fully owned subsidiary of Serono, now Merck Serono) and Immutep S.A. entered into an exclusive License Agreement for the development of the LAG-3 technology. The license covers use of background patents and know-how necessary for the development of certain LAG-3 products. Confidential milestones and royalties are payable to Serono while the patent or know-how license is in force. As the license is exclusive it provides a greater level of protection to the development of LAG-3 products. The license is sub-licensable and has been sublicensed in agreements with GSK, Co-Stim, Eddingpharm and Cytlimic. Improvements to the technology and new developments in intellectual property covered by the license are the property of Immutep S.A. The last of the licensed patents expired on July 23, 2018 and so the license continues as only a know-how license.
In addition to patent protection for all of our assets, we rely on unpatented trade secrets, know-how and other confidential information as well as proprietary technological innovation and expertise that are protected in part by confidentiality and invention assignment agreements with our employees, advisors and consultants.
Patent matters in biotechnology are highly uncertain and involve complex legal and factual questions. The availability and breadth of claims allowed in biotechnology and pharmaceutical patents cannot be predicted. Statutory differences in patentable subject matter may limit the protection Immutep can obtain on some or all of their licensed inventions or prevent us from obtaining patent protection either of which could harm our business, financial condition and results of operations. Since patent applications are not published until at least 18 months from their first filing date and the
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publication of discoveries in the scientific literature often lags behind actual discoveries, we cannot be certain that we, or any of our licensors, were the first creator of inventions covered by pending patent applications, or that we or our licensors, were the first to file patent applications for such inventions. Additionally, the grant and enforceability of a patent is dependent on a number of factors that may vary between jurisdictions. These factors may include the novelty of the invention, the requirement that the invention not be obvious in the light of prior art (including prior use or publication of the invention), the utility of the invention and the extent to which the patent clearly describes the best method of working the invention. In short, this means that claims granted in various territories may vary and thereby influence commercial outcomes.
While we have applied and will continue to file for protection as appropriate for our therapeutic products and technologies, we cannot be certain that any future patent applications filed by the company, or licensed to us, will be approved, or that Immutep will develop additional proprietary products or processes that are patentable or that we will be able to license any other patentable products or processes. Immutep cannot be certain that others will not independently develop similar products or processes, duplicate any of the products or processes developed or being developed by the company or licensed to us, or design around the patents owned or licensed by us, or that any patents owned or licensed by us will provide us with competitive advantages.
Furthermore, we cannot be certain that patents held by third parties will not prevent the commercialization of products incorporating the technology developed by us or licensed to us, or that third parties will not challenge or seek to narrow, invalidate or circumvent any of the issued, pending or future patents owned or licensed by us.
Our commercial success will also depend, in part, on our ability to avoid infringement of patents issued to others. If a court determines that we were infringing any third-party patents, we could be required to pay damages, alter our products or processes, obtain licenses or cease certain activities. We cannot be certain that the licenses required under patents held by third parties would be made available on terms acceptable to us or at all. To the extent that we are unable to obtain such licenses, we could be foreclosed from the development, export, manufacture or commercialization of the product requiring such license or encounter delays in product introductions while we attempt to design around such patents, and any of these circumstances could have a material adverse effect on our business, financial condition and results of operations. We may have to resort to litigation to enforce any patents issued or licensed to us or to determine the scope and validity of third-party proprietary rights. Such litigation could result in substantial costs and diversion of effort by us. We may have to participate in opposition proceedings before the Australian Patent and Trademark Office or another foreign patent office, or in interference proceedings declared by the United States Patent and Trademark Office, to determine the priority of invention for patent applications filed by competitors. Any such litigation interference or opposition proceeding, regardless of outcome, could be expensive and time consuming, and adverse determinations in any such proceedings could prevent us from developing, manufacturing or commercializing our products and could have a material adverse effect on our business, financial condition and results of operations.
As of June 30, 2022, the Company also owns trademark registrations for IMMUTEP in Australia, United States, Europe, China and Japan.
In fiscal year 2022, Immutep has continued its active intellectual property protection program for its technologies with 9 new patents being granted for IMP321, IMP761 and IMP701.
Immutep was granted two new patents by the Chinese Patent Office for IMP321 during the financial year. Both relate to combined therapeutic preparations comprising IMP321 and either a PD-1 pathway inhibitor or a chemotherapy agent. Immutep was also granted a new Australian patent protecting its intellectual property for therapeutic preparations comprising IMP321 and a PD-1 pathway inhibitor.
The Russian Patent Office granted a new patent protecting IMP761, and to the use of IMP761 in the treatment of T-cell mediated inflammatory and autoimmune diseases.
Immutep and its partner Novartis were granted five new patents relating to the protection of ieramilimab (LAG525), a humanized LAG-3 antagonist antibody derived from Immutep’s IMP701 antibody. The patents were granted by the Eurasian, Japanese, Chinese, Indian and Malaysian patent offices.
In August 2022, Immutep announced the grant of a new Japanese patent protecting its intellectual property for therapeutic preparations comprising IMP321 and a PD-1 pathway inhibitor.
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Patent Portfolio
The following table presents our portfolio of patents and patent applications, including their status (as at June 30, 2022) and title.
| Patent Family |
Title |
Status |
Expires | |||
| 550 (Immutep S.A.S. INSERM) | Cytotoxic anti-LAG-3 monoclonal antibody and its use in the treatment or prevention of organ transplant rejection and autoimmune disease | Pending China, US, Europe Granted US, Canada, Europe and Japan (x2) | 2028 | |||
| 650 (Immutep S.A.S.) | Use of recombinant LAG-3 or the derivatives thereof for eliciting monocyte immune response | Pending China, Macau, Europe, Hong Kong and US
Granted Australia, China, Europe (x4), Japan (x2) and US (x2) |
2028 | |||
| 660 (Immutep S.A.S.) | Combined preparations for the treatment of cancer | Pending in China, Europe, Japan, Korea, US and Hong Kong
Granted in Australia, China, Europe, Hong Kong, Japan and US |
2034 | |||
| 661 (Immutep S.A.S.) | Treatment of Cancer | PCT application filed | 2041 | |||
| 662 (Immutep S.A.S.) | Treatment of Cancer | GB priority application filed | 2043 | |||
| 670 (Immutep S.A.S.) | Combination of IMP321 and a checkpoint inhibitor | Pending in Europe, Russia, US, Canada, Australia, New Zealand, China, Macau, Hong Kong, Korea, Japan, Brazil, India and Israel Granted in Australia, China, Europe (x2), Hong Kong (x2), US (x2) and Mexico (x2) | 2036 | |||
| 671 (Immutep SAS) | Triple combination therapy | PCT application filed | 2042 | |||
| 700 (Immutep S.A.S. Novartis) | Antibody molecules to LAG-3 and uses thereof | National phase in 50 territories Granted Australia, China, US (x2), Europe, Eurasia, Japan (x2), India, Iraq, Malaysia, Lebanon, Algeria and Colombia | 2035 | |||
| 710 (Immutep S.A.S. Novartis) | Combination therapies comprising antibody molecules to LAG-3 | Pending in Europe and US Granted in Europe | 2036 | |||
| 761 (Immutep S.A.S.) | Anti-LAG-3 antibodies | Pending in Europe, Russia, US, Canada, Mexico, Brazil, Australia, New Zealand, China, Hong Kong, Korea, Japan, India, Israel, Indonesia, Malaysia, Philippines and Singapore Granted in Europe, Russia, South Africa and Nigeria | 2036 | |||
| 762 (Immutep S.A.S.) | Anti-LAG-3 Binding Molecules | Pending in Europe and US | 2040 | |||
| 800 (Immutep S.A.S.) | Binding assay | Pending in Europe, Russia, US, Canada, Mexico, Australia, New Zealand, China, Korea, Japan, India, Brazil, and Israel | 2037 | |||
| 810 (Immutep S.A.S.) | Assays | Pending in Europe, Russia, US, Canada, Mexico, Australia, New Zealand, China, Korea, Japan, India, Brazil, and Israel | 2040 | |||
Competition
The biopharma industry, including the immunotherapy subsector, is intensely competitive and characterized by ongoing and extensive research and development efforts devoted to developing innovative and proprietary technologies. Our product candidates target oncology and autoimmune diseases. We compete with many organizations who have developed and/or are developing products, or product candidates for the same indications or employing a mechanism-of-action (MOA) principle that is similar or competitive to ours, including large and specialty pharmaceutical and biotechnology companies, academic research institutes, governmental agencies, and public and private research institutes. We anticipate that we may face increasing competition as new drugs or therapies targeting oncology or autoimmune diseases are developed and enter the market.
There is great industry interest in the field of immuno-oncology, particularly given the therapeutic benefits achieved by FDA-approved checkpoint inhibitors targeting CTLA-4, PD-1, PD-L1 or LAG-3. These positive results for checkpoint monotherapies are typically only seen in a relatively small subset of the targeted patient population which has led to hundreds of immune-oncology combination treatments being tested in clinical trials.
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Our lead product candidate, eftilagimod alpha (IMP321 or efti), is being developed as a cancer therapeutic. Efti’s MOA stimulates and augments the human body’s natural immune response to fight cancer tumors, and it is a member of a class of drugs known as “antigen presenting cell (APC) activators.” Other types of APC activators include toll like receptor (TLR) agonists, stimulator of interferon genes (STING) agonists, CD40 agonists, or oncolytic viral therapies. Efti’s unique MOA leads to the activation of APCs, such as monocytes and dendritic cells, which results in increased T cell levels.
We are aware of other companies that are developing cancer therapeutics in the same specific indications we are currently targeting and may target in the future. Some of these competitors are developing APC product candidates, other immune-modulating therapeutics that promote an immunological response against cancer and therapies targeting patients who have received prior anti-PD-1/PD-L1 therapies. These companies include, but are not limited to Birdie Biotech, Inc., AstraZeneca PLC, Arcus Biosciences Inc., Curevac NV, Gilead Sciences Inc., GlaxoSmithKline plc, Hoffmann-La Roche Ltd., Idera Pharmaceuticals, Inc., AbbVie, Inc., Incyte Corporation, ImmunityBio, Inc, Merck Co, Idera Pharmaceuticals, Inc., Nektar Therapeutics, Eisai Co Ltd. and Regeneron Pharmaceuticals, Inc.
Current treatments for metastatic breast cancer, include chemotherapies/cytotoxics, parp inhibitors, CDK4/6 inhibitors, angiogenesis inhibitors, nonsteroidal aromatase inhibitors and immunotherapies. Efti is developed for a specific subset of metastatic breast cancer, specifically human epidermal growth factor receptor 2-negative (HER2-), metastatic breast cancer patients that have previously undergone endocrine based therapy (possibly with CDK4/6 therapy and/or PI3Kinase inhibitors) and are eligible to receive chemotherapy. Efti is also being investigated in patients with recurrent/metastatic head and neck squamous cell carcinomas (R/M HNSCC). Current treatments for recurrent HNSCC include combination therapy with cetuximab, cisplatin, and 5-fluoruracil (5-FU). More recently, immunotherapy through PD-1 blockade has become an option, either alone or in combination with platinum plus 5-FU. Similarly in non-EGFR/ALK targetable metastatic non-small cell lung cancer, another indication where efti is tested, platinum based chemotherapies were mostly replaced as 1st line therapy by anti-PD-(L)1 monotherapies or anti-PD-(L)1 + chemotherapy combination treatments in recent years. Despite all the progress made in these three indications, there is still a high unmet medical need as the median overall survival in these indications is still between 12-24 months dependent on the indication.
Many competitors, or potential competitors, either alone, or with their strategic partners, have substantially greater financial, technical and human resources than we do. Therefore, our competitors may be more successful than us in obtaining approval for treatments and achieving widespread market adoption which may render our treatments obsolete or non-competitive. In addition, many of our competitors have significantly greater experience than we have in undertaking preclinical studies and human clinical trials of new pharmaceutical products, obtaining FDA and other regulatory approvals of products for use in health care, manufacturing and marketing and selling approved products. Our competitors may also obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours.
We expect our product candidates, if approved and commercialized, to compete with other products on a number of factors including, but not limited to, product safety and efficacy, time to market, price, insurance coverage and reimbursement by third-party payors, extent of adverse side effects, and convenience of treatment. We may not be able to effectively compete in any of these areas.
Regulatory Authorities
Our ongoing research and development, clinical, regulatory, commercial and manufacturing activities of our pharmaceutical products are subject to extensive regulation by numerous governmental authorities, including (i) in Australia, principally the Therapeutics Goods Administration, or TGA; (ii) in the United States, principally the Food and Drug Administration, or FDA; and (iii) in Europe, principally the European Medicines Agency, or EMA and local competent authorities, human research ethic committee (HREC), ethics committees (ECs), institutional research boards (IRBs) and other regulatory authorities at federal, state or local levels. We, along with our third-party contractors, will be required to navigate the various preclinical, clinical and commercial approval and post-approval requirements of the governing regulatory agencies of the countries in which we wish to conduct studies or seek approval or licensure of our product candidates.
United States – FDA process
In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or the FDCA, and its implementing regulations. Regulations that govern the testing, manufacturing, safety, efficacy, labeling, storage, record keeping, advertising and promotion of such products under the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, and their implementing regulations. The process of obtaining FDA approval and achieving and maintaining compliance with applicable laws and regulations requires the expenditure of substantial time and financial resources. Failure to comply with applicable FDA or other requirements may result in refusal to approve pending applications, a clinical hold, warning letters, civil or criminal penalties, recall or seizure of products, partial or total suspension of production or withdrawal of the product from the market. FDA approval is required before any new drug or biologic, including a new use of a previously approved drug, can be marketed in the United States. All applications for FDA approval must contain, among other things, information relating to safety and efficacy, stability, manufacturing, processing, packaging, labeling and quality control.
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Government oversight of the pharmaceutical industry is usually classified into pre-approval and post-approval categories. Most of the therapeutically significant innovative products marketed today are the subject of New Drug Applications, or NDAs, or Biologics License Applications, or BLAs. Pre-approval activities, based on these detailed applications, are used to assure the product is safe and effective before marketing.
Drug Approval Process—FDA
None of our drug product candidates may be marketed in the United States until the drug has received FDA approval. The steps required before a drug may be marketed in the United States generally include the following:
| • | completion of extensive pre-clinical laboratory tests, animal studies, and formulation studies in accordance with the FDA’s GLP regulations; |
| • | submission to the FDA of an Investigational New Drug, or IND, application for human clinical testing, which must become effective before human clinical trials may begin; |
| • | performance of adequate and well-controlled human clinical trials in accordance with GCP requirements to establish the safety and efficacy of the drug for each proposed indication; |
| • | submission to the FDA of an NDA/BLA after completion of all pivotal clinical trials; |
| • | satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the active pharmaceutical ingredient, or API, and finished drug product are produced and tested to assess compliance with current Good Manufacturing Practices, or cGMPs; and |
| • | FDA review and approval of the NDA/BLA prior to any commercial marketing or sale of the drug in the United States. |
The manufacturing and quality, as well as preclinical and clinical testing and approval process requires substantial time, effort and financial resources, and we cannot guarantee approval of our product candidates will be granted on a timely basis, if at all.
The FDA may inspect and audit the development facilities, planned production facilities, clinical trial sites and laboratory facilities. After the product is approved and marketed, the FDA uses different mechanisms for assuring that firms adhere to the terms and conditions of approval described in the application and that the product is manufactured in a consistent and controlled manner. This is done by periodic unannounced inspections of production and quality control facilities by FDA’s field investigators and analysts.
Preclinical tests include laboratory evaluation of toxicity and immunogenicity in animals. The results of preclinical tests, together with manufacturing information and analytical data, are submitted as part of an IND application to the FDA.
Further, an independent institutional review board, or IRB, covering each medical center proposing to conduct clinical trials must review and approve the protocol for any clinical trial before it commences at that center, and it must monitor the study until completed. The FDA, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk. Clinical testing also must satisfy extensive Good Clinical Practice, or GCP, regulations, which include requirements that all research subjects provide informed consent and that all clinical studies be conducted under the supervision of one or more qualified investigators.
Clinical trials (under an IND) involve administration of the investigational drug to human subjects under the supervision of qualified investigators. Clinical trials are conducted under protocols detailing the objectives of the study, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. Each protocol must be provided to the FDA as part of a separate submission to the IND. Further, an Institutional Review Board, or IRB, for each medical center proposing to conduct the clinical trial must review and approve the study protocol and informed consent information for study subjects for any clinical trial before it commences at that center, and the IRB must monitor the study until it is completed. There are also requirements governing reporting of ongoing clinical trials and clinical trial results to public registries. Study subjects must sign an informed consent form before participating in a clinical trial.
Progress reports detailing the results of the clinical studies must be submitted at least annually to the FDA and safety reports must be submitted to the FDA and the investigators for serious and unexpected adverse reactions in case of an open IND. For purposes of a BLA submission and approval, human clinical trials are typically conducted in the following sequential phases, which may overlap:
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| • | Phase I: Trials are initially conducted in a limited population of healthy human (in oncology Phase I trials are often conducted in patients) subjects or patients to test the product candidate for safety and dose tolerance. These studies are designed to test the safety, dosage tolerance, absorption, metabolism and distribution of the investigational product in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. |
| • | Phase II: The investigational product is administered to a limited patient population with a specified disease or condition to evaluate the preliminary efficacy, optimal dosages and dosing schedule and to identify possible adverse side effects and safety risks. Multiple Phase 2 clinical trials may be conducted to obtain information prior to beginning larger and more expensive Phase 3 clinical trials. |
| • | Phase III: The investigational product is administered to an expanded patient population in adequate and well-controlled studies to further evaluate dosage, to provide statistically significant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk/benefit relationship of the investigational product and to provide an adequate basis for product approval. |
| • | Phase IV: In some cases, the FDA may condition approval of a BLA on the sponsor’s agreement to conduct additional clinical trials to further assess the product candidate’s safety, purity and potency after BLA approval. Such post-approval trials are typically referred to as Phase IV clinical trials. |
Concurrent with clinical studies, sponsors usually complete additional animal studies and must also develop additional information about the product and finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things, the manufacturer must develop and validate methods for testing the identity, strength, quality and purity of the final product. Moreover, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.
The results of product development, preclinical studies and clinical trials, along with the aforementioned manufacturing information, are submitted to the FDA as part of a BLA/NDA. Under the Prescription Drug User Fee Act, or PDUFA, the FDA agrees to specific goals for BLA review time. The testing and approval process requires substantial time, effort and financial resources. The FDA will review the BLA/NDA and may deem it to be inadequate to support approval, and we cannot be sure that any approval will be granted on a timely basis, if at all. The FDA may also refer the application to the appropriate advisory committee, typically a panel of clinicians, for review, evaluation and a recommendation as to whether the application should be approved. The FDA is not bound by the recommendations of the advisory committee, but it typically follows such recommendations.
The FDA may deny approval of a BLA/NDA if the applicable regulatory criteria are not satisfied, or it may require additional clinical data or additional pivotal Phase III clinical trials. Even if such data are submitted, the FDA may ultimately decide that the BLA does not satisfy the criteria for approval. Data from clinical trials are not always conclusive and the FDA may interpret data differently than the sponsor does. Once issued, product approval may be withdrawn by the FDA if ongoing regulatory requirements are not met or if safety problems occur after the product reaches the market. In addition, the FDA may require testing, including Phase IV clinical trials, Risk Evaluation and Mitigation Strategies, or REMS, and surveillance programs to monitor the effect of approved products that have been commercialized, and the FDA has the power to prevent or limit further marketing of a product based on the results of these post-marketing programs. Products may be marketed only for the approved indications and in accordance with the provisions of the approved label. Further, if there are any modifications to the drug, including changes in indications, labeling or manufacturing processes or facilities, approval of a new or supplemental BLA may be required, which may involve conducting additional preclinical studies and clinical trials.
Expedited Review and Approval
The FDA has various programs, including fast track designation, priority review, accelerated approval, and breakthrough therapy designation, which are intended to expedite or simplify the process for reviewing drugs and/or provide for approval on the basis of surrogate endpoints. Even if a drug qualifies for one or more of these programs, the FDA may later decide that the drug no longer meets the conditions for qualification or that the time period for FDA review or approval will not be shortened. Generally, drugs that may be eligible for these programs are those for serious or life-threatening diseases or conditions, those with the potential to address unmet medical needs, and those that offer meaningful benefits over existing treatments.
Other U.S. Regulatory Requirements
After approval, products are subject to extensive continuing regulation by the FDA, which include company obligations to manufacture products in accordance with GMP, maintain and provide to the FDA updated safety and efficacy information, report adverse experiences with the product, keep certain records and submit periodic reports, obtain FDA approval of certain manufacturing or labelling changes and comply with FDA promotion and advertising requirements and restrictions. Failure to meet these obligations can result in various adverse consequences, both voluntary and FDA-imposed, including product recalls, withdrawal of approval, restrictions on marketing, and the imposition of civil fines and criminal penalties against the BLA holder. In addition, later discovery of previously unknown safety or efficacy issues may result in restrictions on the product, manufacturer or BLA holder.
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We, and any manufacturers of our products, are required to comply with applicable FDA manufacturing requirements contained in the FDA’s GMP regulations. GMP regulations require, among other things, quality control and quality assurance as well as the corresponding maintenance of records and documentation. The manufacturing facilities for our products must meet GMP requirements. We, and any third-party manufacturers, are also subject to periodic inspections of facilities by the FDA and other authorities, including procedures and operations used in the testing and manufacture of our products to assess our compliance with applicable regulations.
With respect to post-market product advertising and promotion, the FDA imposes a number of complex regulations on entities that advertise and promote pharmaceuticals, which include, among others, standards for direct-to-consumer advertising, promoting products for uses or in patient populations that are not described in the product’s approved labelling (known as “off-label use”), industry-sponsored scientific and educational activities, and promotional activities involving the Internet. Failure to comply with FDA requirements can have negative consequences, including adverse publicity, enforcement letters from the FDA, mandated corrective advertising or communications with doctors and civil or criminal penalties. Although physicians may prescribe legally available drugs for off-label uses, manufacturers may not market or promote such off-label uses.
Changes to some of the conditions established in an approved application, including changes in indications, labelling, or manufacturing processes or facilities, require submission and FDA approval of a new BLA or BLA supplement before the change can be implemented. A BLA supplement for a new indication typically requires clinical data similar to that in the original application, and the FDA uses the same procedures and actions in reviewing BLA supplements as it does in reviewing BLAs.
Adverse event reporting and submission of periodic reports is required following FDA approval of a BLA. The FDA also may require post-marketing testing, known as Phase IV testing, risk mitigation strategies, and surveillance to monitor the effects of an approved product or place conditions on an approval that could restrict the distribution or use of the product.
Foreign Regulation
In addition to regulations in the United States, we are subject to a variety of foreign regulations governing clinical trials and commercial sales and distribution of our products. Whether or not we obtain FDA approval for a product, we must obtain approval of a product by the comparable regulatory authorities of foreign countries before we can commence clinical trials or marketing of the product in those countries. The approval process varies from country to country and the time may be longer or shorter than that required for FDA approval. The requirements governing the conduct of clinical trials vary greatly from country to country.
European Union
In the European Economic Area, or EEA, which is comprised of the Member States of the EU plus Norway, Iceland and Liechtenstein, medicinal products can only be commercialized after obtaining a Marketing Authorization, or MA by the EMA. Under European Union regulatory systems, we must submit and obtain authorization for a clinical trial application in each member state in which we intend to conduct a clinical trial. When conducting clinical trials in the EU, we must adhere to the provisions of the European Union Clinical Trials Regulation (Regulation 536/2014), which is directly applicable in all EU member states. This Regulation requires that the prior authorization of an Ethics Committee and the competent Member State authority is obtained before commencing the clinical trial. Under the Regulation, sponsors are required to publish all clinical trial documentation via the EMA although there are certain possibilities to postpone publication and certain parts may be redacted.
After we have completed our clinical trials, we must obtain marketing authorization before we can market our product. We plan to submit applications for marketing authorizations under a centralized procedure. The centralized procedure provides for the grant of a single marketing authorization that is valid for all European Union member states.
The European Medicines Agency, or EMA, is a body of the European Union located in Amsterdam. The EMA is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. The EMA is involved in the scientific evaluation of medicines that fall within the scope of the centralized procedure. Like the FDA there is a harmonization between regulators and the EMA may inspect and audit the development facilities, planned production facilities, clinical trial sites and laboratory facilities. Additionally, after the product is approved and marketed, the EMA uses different mechanisms for assuring that firms adhere to the terms and conditions of approval described in the application and that the product is manufactured in a consistent and controlled manner. This is done by periodic unannounced inspections of production and quality control facilities.
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If any of our products receive marketing approval in the EEA, we expect they will benefit from 8 years of data protection and 10 years of market protection. The periods run in parallel so effectively 8 years of data protection plus 2 years of market protection is granted. This means that a biosimilar application referencing Immutep’s safety and efficacy data held on file at the EMA cannot be filed until the end of the data protection period of 8 years, and the biosimilar cannot be placed on the market until after a further 2 years have elapsed (8 + 2). Furthermore, an additional 1 year of market protection is available (8 + 2 + 1) where we obtain approval of a second indication having a significant clinical benefit in the initial 8-year period.
Similarly, since the Biologics Price Competition and Innovation Act (BPCIA) came into force in 2010, the United States provides 4 years of data exclusivity and 12 years of marketing exclusivity for a new biologic. The periods of exclusivity run in parallel, meaning that the FDA will not accept a biosimilar filing for 4 years and will not approve the biosimilar for a further 8 years (4 + 8).
Australia
In Australia, the relevant regulatory body responsible for the pharmaceutical industry is the Therapeutics Goods Administration, or TGA. As with the EMA and FDA there is a harmonization and collaboration between regulatory authorities. The TGA requires notification of all clinical trials via an electronic submission of a Clinical Trial Notification (CTN) prior to commencing the clinical trial.
In addition to the above mentioned competent authorities there are local competent authorities, human research ethic committee (HREC), ethics committees (ECs), institutional research boards (IRBs) and other regulatory authorities at federal, state or local levels who may need to be consulted based on the applicable laws and regulations.
Third-Party Payer Coverage and Reimbursement
Although our product candidates have not been commercialized for any indication, if they are approved for marketing, commercial success of our product candidate will depend, in part, upon the availability of coverage and reimbursement from third-party payers at the federal, state and private levels.
In the United States and internationally, sales of any other product that we market in the future, and our ability to generate revenues on such sales, are dependent, in significant part, on the availability of adequate coverage and reimbursement from third-party payors, such as state and federal governments, managed care providers and private insurance plans.
Private insurers, such as health maintenance organizations and managed care providers, have implemented cost-cutting and reimbursement initiatives and likely will continue to do so in the future. These include establishing formularies that govern the drugs and biologics that will be offered and the out-of-pocket obligations of member patients for such products. We may need to conduct pharmacoeconomic studies to demonstrate the cost- effectiveness of our products for formulary coverage and reimbursement. Even with such studies, our products may be considered less safe, less effective or less cost-effective than existing products, and third-party payors may not provide coverage and reimbursement for our product candidates, in whole or in part. In addition, particularly in the United States and increasingly in other countries, we are required to provide discounts and pay rebates to state and federal governments and agencies in connection with purchases of our products that are reimbursed by such entities. It is possible that future legislation in the United States and other jurisdictions could be enacted to potentially impact reimbursement rates for the products we are developing and may develop in the future and could further impact the levels of discounts and rebates paid to federal and state government entities. Any legislation that impacts these areas could impact, in a significant way, our ability to generate revenues from sales of products that, if successfully developed, we bring to market. Political, economic and regulatory influences are subjecting the healthcare industry in the United States to fundamental changes. There have been, and we expect there will continue to be, legislative and regulatory proposals to change the healthcare system in ways that could significantly affect our future business.
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Similar political, economic and regulatory developments are occurring in the EU and may affect the ability of pharmaceutical companies to profitably commercialize their products. In addition to continuing pressure on prices and cost containment measures, legislative developments at the EU or member state level may result in significant additional requirements or obstacles. The delivery of healthcare in the EU, including the establishment and operation of health services and the pricing and reimbursement of medicines, is almost exclusively a matter for national, rather than EU, law and policy. National governments and health service providers have different priorities and approaches to the delivery of health care and the pricing and reimbursement of products in that context. In general, however, the healthcare budgetary constraints in most EU member states have resulted in restrictions on the pricing and reimbursement of medicines by relevant health service providers. Coupled with ever-increasing EU and national regulatory burdens on those wishing to develop and market products, this could restrict or regulate post-approval activities and affect the ability of pharmaceutical companies to commercialize their products. In international markets, reimbursement and healthcare payment systems vary significantly by country, and many countries have instituted price ceilings on specific products and therapies. In the future, there may continue to be additional proposals relating to the reform of the U.S. healthcare system and international healthcare systems. Future legislation, or regulatory actions implementing recent or future legislation may have a significant effect on our business. Our ability to successfully commercialize products depends in part on the extent to which reimbursement for the costs of our products and related treatments will be available in the United States and worldwide from government health administration authorities, private health insurers and other organizations. The adoption of certain proposals could limit the prices we are able to charge for our products, the amounts of reimbursement available for our products, and limit the acceptance and availability of our products. Therefore, substantial uncertainty exists as to the reimbursement status of newly approved health care products by third-party payors.
Inflation and Seasonality
Management is monitoring the impact of inflation on our operations and financial condition and continues to carefully negotiate the prices paid for required services and supplies to minimize any impact. Management further believes that our operations are not currently subject to seasonal influences due to our current lack of marketed products. Moreover, cancer and autoimmune diseases, which are the targets of our product candidates, are not seasonal diseases. Accordingly, once we have marketed products, management does not expect that our business will be subject to seasonal influences.
Manufacturing and Raw Materials
Immutep has no manufacturing capabilities and is dependent on third parties for cost effective manufacture and manufacturing process development of their product candidates. Problems with third party manufacturers or the manufacturing process as such may delay or jeopardize clinical trials and commercialization of Immutep’s product candidates.
Biological product candidates like IMP731, IMP761, IMP701 or IMP321 usually have more complicated manufacturing procedures than chemically produced therapies. The change of manufacturing partners, manufacturing process changes or changes of other nature could impact the product quality and affect the comparability of different product batches. A lack of comparability could significantly negatively impact the development timelines and could even lead to a situation where regulatory bodies require additional or new pre-clinical or clinical development.
C. Organizational Structure
Below is a list of the significant subsidiaries of Immutep, including our ownership percentage, its date of formation and its jurisdiction. These subsidiaries were established to allow us to conduct commercial and clinical operations in Europe and the United States and expand our operations in Australia.
| Subsidiary |
Ownership | Date of Formation/Acquisition | Jurisdiction | |||||
| Immutep U.S., Inc. |
100 | % | April 2010 (formed) | Delaware, United States | ||||
| Immutep GmbH |
100 | % | September 2010 (formed) | Germany | ||||
| Immutep Australia Pty Ltd |
100 | % | November 2011 (formed) | Australia | ||||
| Immutep S.A.S. |
100 | % | December 2014 (acquired) | France | ||||
D. Property, Plants and Equipment
We own computer equipment, office furniture and laboratory equipment, which is primarily placed at our own offices and laboratories.
| Office Location | Lease expiry date | |||
| Sydney, Australia |
January 31, 2024 | |||
| Paris region, France |
March 31, 2025 | |||
| Berlin, Germany |
February 28, 2023 | |||
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| ITEM 4A. | UNRESOLVED STAFF COMMENTS |
None.
| ITEM 5. | OPERATING AND FINANCIAL REVIEW AND PROSPECTS |
Overview
We are a development stage enterprise at an early stage in the development of our product candidate. We have incurred net losses since inception and expect to incur substantial and increasing losses for the next several years as we expand our research and development activities and move our product candidate into later stages of development. The process of carrying out the development of our products to later stages of development may require significant additional research and development expenditures, including pre-clinical testing and clinical trials, as well as for obtaining regulatory approval. To date, we have funded our operations primarily through the sale of equity securities, proceeds from the exercise of options, grants and interest income. For details of the business overview, see “Item 4. Information on the Company—B. Business Overview.”
We receive tax incentives from the Australian and French Governments for research and development activities (RD activities).
Subject to certain exclusions, the Australian Government tax incentive scheme provides benefits for eligible RD activities. Under the Australian RD tax incentive scheme, entities are entitled to either (i) a 43.5% refundable tax offset for eligible companies with an aggregated turnover of less than A$20.0 million per annum or (ii) a non-refundable 38.5% tax offset for all other entities with an aggregate turnover of A$20.0 million or more or controlled by any exempt entity (exempt entity is, entity which is exempted from income tax). Our aggregated turnover is less than A$20.0 million and not controlled by an exempt entity, we anticipate being entitled to a claim of 43.5% refundable tax offset for costs relating to eligible RD activities during the year.
The French RD tax credit is determined on the basis of the eligible RD expenses incurred during the calendar year. Currently, the RD credit equals 30% of the RD eligible expenses incurred during the year, up to EUR 100.0 million in eligible RD expenses, and 5% beyond this amount. As our turnover is currently less than EUR 100.0 million p.a., we anticipate being entitled to claim a 30% refundable tax offset for costs relating to eligible RD activities during the year.
We are exposed to foreign currency risk via trade and other payables we hold. We are required to make certain payments in U.S. dollars, European Euro and other currencies. See “Note 2. Financial Risk Management—(a) Market Risk” to our notes to the financial statements for a further discussion of market risk and sensitivity analysis.
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A. Operating Results
Results of Operations
Comparison of Fiscal Year Ended June 30, 2022 to Fiscal Year Ended June 30, 2021
Revenue
Licensing revenue was A$170,000 in the fiscal year 2022 compared to nil in fiscal year 2021. In fiscal year 2022 the Company received licensing revenue as a licensing partner achieved a predetermined milestone, which triggered a payment to Immutep. No such milestones were recognised during fiscal year 2021.
Other Income
The research material sales decreased from A$313,000 in fiscal year 2021 to A$84,000 in fiscal year 2022.
Other income increased by A$2.6 million to A$6.6 million for fiscal year 2022 from A$4.0 million for fiscal year 2021.
In fiscal year 2022, Immutep recognised A$1.2 million of grant income from the Australian Federal Government’s RD tax incentive program, which was provided mainly in respect of expenditure incurred on eligible research and development activities conducted in fiscal year 2022 for the TACTI-002 and TACTI-003 trials. Immutep has recognised approximately A$3.6 million in grant income from the Australian Federal Government’s RD tax incentive program for fiscal year 2021.
Also in fiscal year 2022, the Company’s French subsidiary recognised A$3.3 million of grant income from the French Crédit d’Impôt Recherche scheme for expenditure incurred on eligible research and development activities conducted in fiscal year 2022 and in September 2022, the Company’s French subsidiary received A$2.7 million of grant income from the French Crédit d’Impôt Recherche scheme for expenditure incurred on eligible research and development activities conducted in calendar year 2021.
Net gain on foreign exchange was A$1.2 million in fiscal year 2022 compared net loss of A$507,000 in fiscal year 2021.
Interest income increased from A$105,000 in fiscal year 2021 to A$225,000 in fiscal year 2022. The increase was mainly due to the increase in our cash in the bank.
Research Development and Intellectual Property Expenses
Research and development and intellectual property expenses increased from A$17.2 million in fiscal year 2021 to A$31.3 million in year 2022. The increase is mainly attributable to increases of A$4.5 million in clinical trial costs and A$8.3 million relates to IMP 321 and IMP 761 manufacturing costs in fiscal year 2022. Whilst clinical trial costs related to AIPAC declined given the trial has completed, costs related to TACTI-002 rose with the expansion of that clinical trial, which included an additional 74 patients in 1st line NSCLC.
Clinical trial costs related to TACTI-003 also increased significantly in FY 2022 due to the commencement of the clinical trial.
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Corporate Administrative Expenses
Corporate administrative expenses increased A$0.9 million (15%) from A$6.3 million for fiscal year 2021 to A$7.2 million in fiscal year 2022, primarily due to external auditor and other administrative expenses incurred in fiscal year 2022 as a result of Immutep becoming subject to the auditor attestation requirement under Section 404 of the Sarbanes-Oxley Act of 2002 in the assessment of internal control over financial reporting. See Item 3.D (Risk Factors) – “We have become subject to the auditor attestation requirement under the Sarbanes-Oxley Act, thus imposing significant cost and administrative burden on us.”
Net change in fair value of convertible note liability
The net change in fair value of the convertible note liability was A$325,000 for fiscal year 2022 compared to A$1.2 million for fiscal year 2021. The increase was attributable to the liability component of the convertible note being measured at fair value.
Net change in fair value of warrants
The non-cash gain of A$591,000 for fiscal year 2022 was from the net change in fair value of warrants due to the share price decrease, whilst in fiscal year 2021 the loss of A$8.7 million was from the net change in fair value of warrants due to the share price increase.
Net Loss
The loss after tax for fiscal year 2022 of A$32.2 million was higher compared to A$29.9 million for fiscal year 2021. This increase was mainly attributable to increase in clinical trial costs and manufacturing activities undertaken during the financial year.
Comparison of Fiscal Year Ended June 30, 2021 to Fiscal Year Ended June 30, 2020
Revenue
Licensing revenue was A$nil in the fiscal year 2021 compared to A$7.5 million in fiscal year 2020. In fiscal year 2020 the Company received licensing revenue as a licensing partner achieved a predetermined milestone, which triggered a payment to Immutep. No such milestones were recognised during fiscal year 2021.
Other Income
The research material sales increased from A$280,000 in fiscal year 2020 to A$313,000 in fiscal year 2021.
Other income decreased by A$4.0 million to A$5.0 million for fiscal year 2021 from A$9.0 million for fiscal year 2020.
Immutep has recognised approximately A$986,000 in grant income from the Australian Federal Government’s RD tax incentive program for fiscal year 2021. In April 2021, Immutep received a cash rebate of A$1.2 million from the Australian Federal Government’s RD tax incentive program, which was provided mainly in respect of expenditure incurred on eligible research and development activities conducted in fiscal year 2020 for the TACTI-mel and TACTI-002 trials.
In fiscal year 2021, our French subsidiary recognised A$2.4 million of grant income from the French Crédit d’Impôt Recherche scheme for expenditure incurred on eligible research and development activities conducted in calendar year 2020. In September 2021, the Company’s French subsidiary received A$3.4 million of grant income from the French Crédit d’Impôt Recherche scheme for expenditure incurred on eligible research and development activities conducted in calendar year 2020.
Interest income decreased from A$200,000 in fiscal year 2020 to A$105,000 in fiscal year 2021. The decrease was mainly due to the decrease in weighted average interest rates. Total revenue and other income decreased from A$16.5 million in fiscal year 2020 to A$4.0 million in fiscal year 2021.
Research Development and Intellectual Property Expenses
Research and development and intellectual property expenses decreased from A$22.5 million in fiscal year 2020 to A$17.2 million in year 2021. This decrease was mainly attributable to the significant decrease of clinical trial costs related to the completion of the TACTI-mel trial and the winding down of the AIPAC trial as all patients have completed the treatment and moved into the follow-up phase.
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Whilst clinical trial costs related to AIPAC are expected to decline further given the trial is being finalized, costs related to TACTI-002 are expected to rise further with the expansion announced in November 2020, which includes an additional 74 patients with 1st line non-small cell lung cancer (NSCLC).
Clinical trial costs related to TACTI-003 are also expected to increase significantly in fiscal year 2022 due to the planned progress of the clinical trial.
Corporate Administrative Expenses
Corporate administrative expenses were A$6.3 million in each of fiscal years 2021 and 2020.
Net change in fair value of convertible note liability
The net change in fair value of the convertible note liability was A$1.17 million for fiscal year 2021 compared to A$1.15 million for fiscal year 2020. The increase was attributable to the liability component of the convertible note being measured at fair value.
Net change in fair value of warrants
The loss of A$8.7 million for fiscal year 2021 was from the net change in fair value of warrants due to the share price increase, whilst in fiscal year 2020 a gain of A$2.2 million in the net change in fair value of warrants was recognised.
Net Loss
The loss after tax for fiscal year 2021 of A$29.9 million was significantly higher compared to A$13.5 million for fiscal year 2020. This increase was mainly attributable to a decrease in licensing revenues as well as an increase in non-cash changes in the fair value of financial liabilities. Removing the impact of this non-cash item results in a loss after tax for fiscal year 2021 of A$21.2 million
New Accounting Standards and Interpretations Not Adopted
Certain new accounting standards and interpretations have been published that are not mandatory for June 30, 2022 reporting periods and have not been early adopted by the Group. The Group’s assessment of the impact of these new standards and interpretations is set out below.
The AASB issued a narrow-scope amendment to AASB 101(IAS1) Presentation of Financial Statements to clarify that liabilities are classified as either current or non-current, depending on the rights that exist at the end of the reporting period. Classification is unaffected by the expectations of the entity or events after the reporting date (e.g. the receipt of a waiver or a breach of covenant). The amendment also clarifies what AASB 101(IAS 1) means when it refers to the ‘settlement’ of a liability.
Entities should reconsider their existing classification in light of the amendment and determine whether any changes are required. The amendment should be applied for annual periods beginning on or after January 1, 2022. There is no significant impact on adopting the amendment to AASB 101 (IAS 1) on the Company.
B. Liquidity and Capital Resources
Since our inception, our operations have mainly been financed through the issuance of equity securities. Additional funding has come through convertible notes, exercise of US warrants, operating grants and interest earned from cash on term deposit. For further information, refer to notes 15, 16 and 20 to our audited financial statements included in this annual report.
Capital Requirements
As of June 30, 2022, we had cash and cash equivalents of A$80.0 million. We anticipate that our current cash and cash equivalents will be sufficient to fund our operations at least until early 2024. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. If we are unable to raise additional capital when required or on acceptable terms, we may have to significantly delay, scale back or discontinue one or more of our clinical trials or our operations.
We anticipate that we will require substantial additional funds in order to achieve our long-term goals and complete the research and development of our current product candidates. We do not expect to generate significant revenue until we obtain regulatory approval to market and sell our product candidate and sales of our product candidate have commenced. We therefore expect to continue to incur substantial losses in the near future.
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Our future capital requirements are difficult to forecast and will depend on many factors, including:
| • | the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; |
| • | the scope, results and timing of preclinical studies and clinical trials; |
| • | the costs and timing of regulatory approvals; and |
| • | the costs of establishing sales, marketing and distribution capabilities. |
Off-Balance Sheet Arrangements
During fiscal years 2022, 2021 and 2020, we did not have any relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities, which would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes.
Tabular Disclosure of Contractual Obligations
The amounts disclosed in the table are the contractual undiscounted cash flows. Balances due within 12 months equal their carrying balances as the impact of discounting is not significant.
| Contractual maturities of financial liabilities | Total | |||||||||||||||||||
| Less than 12 months |
Between 1 and 5 years |
5 years | contractual cash flows |
Carrying Amount |
||||||||||||||||
| At June 30, 2022 |
$ | $ | $ | $ | $ | |||||||||||||||
| Convertible note liability |
— | 2,234,510 | — | 2,234,510 | 1,452,950 | |||||||||||||||
| Lease liability |
178,510 | 108,706 | — | 287,216 | 280,869 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
| Total |
178,510 | 2,343,216 | — | 2,521,726 | 1,733,819 | |||||||||||||||
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|
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Contingent liabilities
Immutep did not have any material contingent liabilities outstanding as of June 30, 2022.
Capital commitments
Immutep did not have any material capital expenditure commitments as of June 30, 2022.
We have agreements with clinical sites and contract research organizations, which specify the total cost for each project. We make payments to these sites and organizations based upon the number of patients enrolled and the period of follow-up in the trial. Immutep has the legal right to terminate the contract early with a written notice to the contract research organization.
Equity Issuances
The following table summarizes our issuances of ordinary shares for cash, share-based payments and executive and employee compensation in the last five fiscal years.
| Fiscal Year |
Number of Shares |
Net Proceeds | ||||||||||
| (in A$) | ||||||||||||
| Ordinary Shares – private placement, share purchase plan and exercise of performance rights and options |
2018 | 94,633,973 | 16,142,679 | |||||||||
| Ordinary Shares – private placement and exercise of warrants |
2019 | 36,251,563 | 5,792,343 | |||||||||
| Ordinary Shares – private placement and fully underwritten entitlement offer |
2020 | 148,769,070 | 20,555,622 | |||||||||
| Ordinary Shares – private placement, share purchase plan, conversion of convertible notes, exercise of performance rights and warrants |
2021 | 260,521,997 | 52,429,303 | |||||||||
| Ordinary Shares – private placement, share purchase plan, conversion of convertible notes, exercise of performance rights |
2022 | 118,086,880 | 53,985,452 | |||||||||
All number of shares in the table above has been adjusted for the 10 to 1 share consolidation completed in November 2019.
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In July 2017, we issued American Depositary Shares (ADSs) for cash consideration totaling A$6,561,765. We issued warrants to purchase up to 1,973,451 of its ADSs. The warrants will expire on January 5, 2023. The warrants do not confer any rights to dividends or a right to participate in a new issue without exercising the warrant. During the fiscal years 2022, no warrant was exercised and 206,507 Warrants remain as at June 30, 2022.
In December 2018, issued 2,600,000 ADSs, at a price per ADS of US$2.00 in a registered direct offering, for total gross proceeds of approximately US$5.2 million. In a concurrent private placement, we issued warrants to purchase up to 208,000,000 ordinary shares represented by 2,080,000 ADSs. Each warrant has an exercise price of US$2.50. In December 2020, 2,080,000 of these warrants were exercised at US$2.49 each. As a result, none of these warrants were outstanding as at June 30, 2022.
In July 2019, we completed a private placement of our ordinary shares. In August 2019, we completed an underwritten pro rata non-renounceable entitlement offer. In total, we raised A$10.0 million before transaction costs.
In May 2020, we completed a private placement of our ordinary shares that raised A$12.0 million before transaction costs.
In November 2020, we completed a private placement of our ordinary shares that raised A$29.6 million before transaction costs.
During fiscal year 2021, US investors exercised total of 3,427,211 warrants at an exercise price of US$2.49 each. Immutep received US$8.5 million (A$11.3 million) cash payment in total.
In June 2021, we conducted a private placement that raised proceeds of A$67.2 million before transaction costs.
Cash Flows
The following table summarizes our cash flows for the periods presented:
| Fiscal Year Ended June 30, | ||||||||||||
| 2022 | 2021 | 2020 | ||||||||||
| A$ | A$ | A$ | ||||||||||
| Net cash used in operating activities |
(30,229,752 | ) | (17,640,342 | ) | (10,839,339 | ) | ||||||
| Net cash used in investing activities |
(22,914 | ) | (15,601 | ) | (19,348 | ) | ||||||
| Net cash provided by (used in) financing activities |
50,325,639 | 52,679,925 | 20,478,081 | |||||||||
| Net increase (decrease) in cash and cash equivalents |
20,072,973 | 35,023,982 | 9,619,394 | |||||||||
| Effect of exchange rate on cash and cash equivalents |
(671,035 | ) | (752,838 | ) | 134,671 | |||||||
| Cash and cash equivalents at beginning of period |
60,593,191 | 26,322,047 | 16,567,982 | |||||||||
| Cash and cash equivalents at end of period |
79,995,129 | 60,593,191 | 26,322,047 | |||||||||
Operating Activities
Net cash used in operating activities was A$30.2 million, A$17.6 million and A$10.8 million during fiscal years 2022, 2021 and 2020, respectively. Payments to suppliers and employees in the net cash used in operating activities mainly relates to RD and administrative costs. Payments to suppliers and employees increased by A$14.3 million during fiscal year 2022. This increase was mainly attributable to a significant increase in costs related to the TACTI-002 and TACTI-003 clinical trials.
During fiscal years 2022, 2021 and 2020, our payments to suppliers and employees were offset by license revenue received of A$87,000, nil and A$7.5 million, respectively, interest income received of A$0.2 million, A$0.1 million and A$0.2 million, respectively, and grant income received of A$3.3 million, A$1.3 million and A$7.7 million, respectively.
Investing Activities
Net cash used in investing activities was A$22,914 during fiscal year 2022, Net cash used in investing activities was A$15,601 during fiscal year 2021 and A$19,348 during fiscal year 2020. The net cash outflow for fiscal year 2022 and 2021 was due to the purchase of equipment.
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Financing Activities
Net cash provided by financing activities decreased A$2.4 million (5%) from $52.7 million during fiscal year 2021 to A$50.3 million in fiscal year 2022. Net cash provided by financing activities during (i) fiscal year 2022 was primarily attributable to the placement of ordinary shares of A$45.8 million and a Share Purchase Plan of A$7.2 million (ii) fiscal year 2021 was primarily attributable to the two placements of A$41.2 million and exercising of warrants of A$11.3 million and advance payment from Australian and New Zealand shareholders under a Share Purchase Plan of A$0.5 million, (iii) fiscal year 2020 was primarily attributable to the placement of A$4.0 million, underwritten entitlement offer of A$6.0 million and another placement of A$12.0 million.
At June 30, 2022, we had A$80.0 million in cash and cash equivalents compared with 2021, where we had A$60.6 million in cash and cash equivalents. At June 30, 2020, we had A$26.3 million in cash and cash equivalents.
C. Research and Development, Patents and Licenses
For a description of our research and development programs and activities, see “Item 4. Information on the Company—B—. Business Overview—Background”. For a description of the amount spent during each of the last three fiscal years on company-sponsored research and development activities, as well as the four components of research and development expenses, see “Item 5. Operating and Financial Review and Prospects—A. Operating Results—Results of Operations.”
D. Trend Information
We are a development stage company and it is not possible for us to predict with any degree of accuracy the outcome of our research or commercialization efforts.
Our research and development expenditure is our primary expenditure. Increases or decreases in research and development expenditure are attributable to the level of clinical trial activity and the amount of expenditure on those trials. The main ongoing clinical trials are the TACTI-002 Phase II study in up to 189 patients who are being dosed with IMP321 in combination with KEYTRUDA® (pembrolizumab) and TACTI-003, which is a randomised, controlled Phase IIb clinical study in up to 154 patients and marks Immutep’s second collaboration with MSD to evaluate KEYTRUDA® (pembrolizumab) in combination with efti.
It is expected that our RD expenses will increase as we continue to progress our ongoing clinical trials with IMP321. Expenses will also increase as we continue to progress the pre-clinical development of IMP761.
E. Critical Accounting Estimates
See note 3 to our financial statement for the fiscal year ended June 30, 2022 for a discussion of critical accounting judgements, estimates and assumptions.
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| ITEM 6. | DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES |
A. Directors and Senior Management
The following table sets forth our directors and senior management, their age and the positions they held as of September 1, 2022.
| Name |
Age | Position | ||||
| Russell Howard, Ph.D. (1) |
72 | Non-Executive Chairman | ||||
| Pete Meyers (3) |
53 | Deputy Chairman and Non-Executive Director | ||||
| Marc Voigt |
49 | Executive Director, Chief Executive Officer, and Chief Financial Officer | ||||
| Frédéric Triebel |
67 | Executive Director, Chief Scientific Officer Chief Medical Officer | ||||
| Deanne Miller |
45 | Chief Operating Officer, General Counsel Company Secretary | ||||
| Lucy Turnbull, AO (2) |
64 | Non-Executive Director | ||||
| (1) | Chair of the Remuneration Committee and member of the Audit Risk Committee. |
| (2) | Member of the Remuneration Committee and Audit Risk Committee. |
| (3) | Chair of the Audit Risk Committee and member of the Remuneration Committee. |
Dr. Russell Howard, Ph.D. Dr. Russell Howard has been a Non-Executive Director of Immutep since May 8, 2013 and has been appointed as Non-Executive Chairman on November 17, 2017. He is an Australian scientist, executive manager and entrepreneur. He was a pioneer in molecular parasitology and commercialization of “DNA Shuffling”. He is an inventor of 9 patents and has over 140 scientific publications. After his PhD in biochemistry from the University of Melbourne, he held positions at several research laboratories, including the National Institutes of Health in the USA where he gained tenure. In industry, Dr. Howard worked at Schering-Plough’s DNAX Research Institute in Palo Alto, CA; was the President and Scientific Director of Affymax, Inc. and co-founder and CEO of Maxygen, Inc. After its spin-out from GlaxoWellcome, as Maxygen’s CEO, Dr. Howard led its IPO on NASDAQ and a secondary offering, raising US$ 260.0 million. Maxygen developed and partnered dozens of technology applications and products over 12 years of his tenure as CEO. After leaving Maxygen in 2008, he started the Cleantech company NovoNutrients Inc. (formerly Oakbio, Inc.) and remains involved in several innovative companies in the USA and Australia. He is currently Executive Chairman of NeuClone Pty Ltd.
Mr. Pete Meyers. Pete Meyers has been a Non-Executive Director of Immutep since February 12, 2014, and appointed as Non-Executive Deputy Chairman on November 17, 2017. He is also the Chief Financial Officer of Slayback Pharma LLC. Prior to joining Slayback Pharma LLC, Mr. Meyers served in Chief Financial Officer roles at Eagle Pharmaceuticals, Inc., Motif BioSciences Inc. and TetraLogic Pharmaceuticals Corporation. Prior to his role at TetraLogic, Mr. Meyers spent 18 years in health care investment banking, holding positions of increasing responsibility at Dillon, Read Co., Credit Suisse First Boston LLC and, most recently, as Co-Head of Global Health Care Investment Banking at Deutsche Bank Securities Inc. Mr. Meyers is the Chairman and President of The Thomas M. Brennan Memorial Foundation, Inc., and also serves on the Board of Directors of East End Hospice, Inc. He earned a Bachelor of Science degree in Finance from Boston College and a Master of Business Administration degree from Columbia Business School.
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Mr. Grant Chamberlain. Mr Chamberlain became a Director of Immutep on August 21, 2017. He passed away on January 28, 2022. He was a partner of OneVentures, one of Australia’s leading venture capital firms. Prior to joining OneVentures in 2017 Mr. Chamberlain was Head of Mergers Acquisitions and Financial Sponsors Australia at Bank of America Merrill Lynch. Prior to joining Bank of America Merrill Lynch in 2013, Mr Chamberlain held senior positions at Nomura Australia and Deutsche Bank. He has over 20 years’ experience in investment banking and advised on many of the largest mergers and acquisitions transactions in Australia during that time. He began his career as a corporate lawyer at Freehill Hollingdale Page. Mr Chamberlain earned a Bachelor of Laws with Honours and a Bachelor of Commerce from the University of Melbourne.
Mr. Marc Voigt. Marc has been Chief Executive Officer of Immutep since July 9, 2014. He has more than 21 years of experience in the financial and biotech industry, having joined the Immutep team in 2011 as the General Manager, European Operations based in Berlin, Germany. In May 2012, he became Immutep’s Chief Business Officer and in November 2012 its Chief Financial Officer, as well as continuing to focus on its European operations. Having started his career at the Allianz Group working in pension insurances and funds, he moved to net.IPO AG, a publicly listed boutique investment bank in Frankfurt where he was focused on IPOs and venture capital investments. Marc then worked for a number of years as an investment manager for a midsize venture capital fund based in Berlin, specialising in healthcare. He also gained considerable operational experience while serving in different management roles with Revotar Biopharmaceuticals, Caprotec Bioanalytics and Medical Enzymes AG respectfully, where he handled several successful licensing transactions and financing rounds. Since 2001, Marc has been a judge and coach in BPW, Germany’s largest regional start-up initiative.
Dr. Frédéric Triebel, MD Ph.D., Dr Triebel is our Chief Scientific Officer and Chief Medical Officer and has been with the Company since December 2014, following the completion of the acquisition of Immutep S.A. Dr Triebel was the scientific founder of Immutep S.A. (2001) and served as the Scientific and Medical Director at Immutep from 2004. Before starting Immutep S.A., he was Professor in Immunology at Paris University. While working at Institut Gustave Roussy (IGR), a large cancer center in Paris, he discovered the LAG-3 gene in 1990 and continued working on this research program since then, identifying the functions and medical usefulness of this molecule. He headed a research group at IGR while also being involved in the biological follow-up of cancer patients treated in Phase I/II immunotherapy trials. He was Director of an INSERM Unit from 1991 to 1996. First trained as a clinical hematologist, Prof. Triebel holds a Ph.D. in immunology (Paris University) and successfully developed several research programs in immunogenetics and immunotherapy, leading to more than 153 publications and 31 patents.
Ms. Deanne Miller. Ms. Miller joined Immutep as General Counsel and Company Secretary in October 2012 and was promoted to the role of Chief Operating Officer in November 2016. She has broad commercial experience having held legal, investment banking, regulatory compliance and tax advisory positions, including, Legal Counsel at RBC Investor Services, Associate Director at Westpac Group, Legal Compliance Manager at Macquarie Group, Regulatory Compliance Analyst at the Australian Securities and Investment Commission, and Tax Advisor at KPMG. She has a Combined Bachelor of Laws (Honours) and Bachelor of Commerce, Accounting and Finance (double major) from the University of Sydney. She is admitted as a solicitor in NSW and member of the Law Society of NSW.
Ms. Lucy Turnbull. Ms. Turnbull is a distinguished Australian businesswoman, philanthropist and former local government politician. With a background in commercial law and investment banking, she was the first female Lord Mayor of the City of Sydney from 2003 to 2004 and has served on the boards of the NSW Cancer Institute, the Sydney Children’s Hospital Foundation, the Sydney Cancer Centre and the Sydney Festival. In 2011, Ms. Turnbull was appointed an Officer of the Order of Australia for her service to the community, local government and business, including through her philanthropic contributions and fundraising for a range of medical, social welfare, educational, youth and cultural organisations. From 2015 to 2020 she served as the inaugural Chief Commissioner of the Greater Sydney Commission, a New South Wales state government body focused on delivering strategic planning for the whole of metropolitan Sydney. Ms Turnbull rejoined Immutep’s Board in February 2022, having previously served as its Chairman from October 2010 to November 2017, stepping down from the role only due to her elevated professional and personal commitments at the time.
B. Compensation
Remuneration Principles
Remuneration of all executive and non-executive directors and officers is determined by the Remuneration Committee.
We are committed to remunerating senior executives and executive directors in a manner that is market-competitive and consistent with “Best Practice” including the interests of shareholders. Remuneration packages are based on fixed and variable components, determined by the executives’ position, experience and performance, and may be satisfied via cash or equity.
Non-executive directors are remunerated out of the aggregate amount approved by shareholders and at a level that is consistent with industry standards. Non-executive directors do not receive performance-based bonuses and prior shareholder approval is required to participate in any issue of equity. No retirement benefits are payable other than statutory superannuation, if applicable.
Our remuneration policy is not directly based on our financial performance, rather on industry practice, given we operate in the biotechnology sector and our primary focus is research activities with a long-term objective of developing and commercializing the research and development results.
We envisage our performance in terms of earnings will remain negative while we continue in the research and development phase.
The purpose of a performance bonus is to reward individual performance in line with our objectives. Consequently, performance-based remuneration is paid to an individual where the individual’s performance clearly contributes to a successful outcome. This is regularly measured in respect of performance against key performance indicators.
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We use a variety of key performance indicators to determine achievement, depending on the role of the executive being assessed. These include:
| • | Successful contract negotiations. |
| • | Achievement of research project milestones within scheduled time and/or budget. |
| • | Our share price reaching a targeted level on the ASX over a period of time. |
Executive Compensation
The following table sets forth all of the compensation awarded to, earned by or paid to each individual who served as directors and executive officers in fiscal year 2022.
| June 30, 2022 |
Short-term Benefits | Post Employment Benefits |
Long- term Benefits |
Share-based Payments |
Total | |||||||||||||||||||||||||||
| Salary and fees | Cash bonus |
Non Monetary* |
Super- annuation |
Long service leave |
Executive Performance rights* |
Non-executive Performance Rights |
||||||||||||||||||||||||||
| A$ | A$ | A$ | A$ | A$ | A$ | A$ | A$ | |||||||||||||||||||||||||
| Directors |
||||||||||||||||||||||||||||||||
| Dr. R. Howard |
82,192 | — | — | 8,219 | — | — | 95,191 | 1 | 185,602 | |||||||||||||||||||||||
| Mr. P. Meyers |
— | — | — | — | — | — | 102,219 | 2 | 102,219 | |||||||||||||||||||||||
| Mr G Chamberlain |
— | — | — | — | — | — | 72,470 | 3 | 72,470 | |||||||||||||||||||||||
| Ms Lucy Turnbull |
14,155 | — | — | 1,415 | — | — | 40,354 | 4 | 55,924 | |||||||||||||||||||||||
| Mr. M. Voigt |
427,989 | ** | 84,472 | 24,125 | # | — | — | 406,710 | 5 | — | 943,296 | |||||||||||||||||||||
| Other Key Management Personnel |
— | |||||||||||||||||||||||||||||||
| Dr. F. Triebel**** |
264,212 | * | 19,410 | 122,021 | # | 5,856 | — | 232,716 | 6 | — | 644,215 | |||||||||||||||||||||
| Ms. D. Miller |
242,550 | *** | 60,000 | — | 32,121 | 13,091 | 161,097 | 6 | — | 508,859 | ||||||||||||||||||||||
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|
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| 1,031,098 | 163,882 | 146,146 | 47,611 | 13,091 | 800,523 | 310,234 | 2,512,585 | |||||||||||||||||||||||||
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*The cash salary for Dr Triebel remains the same as FY 2021. The variances are from the foreign currency translation.
**The cash salary for Mr. Voigt increased by EUR13,100 per annum. effective July 2021.
*** The cash salary for Ms. Miller increased by A$11,500 per annum effective July 2021.
**** Dr. F. Triebel was appointed as an Executive Director on September 13, 2022.
#Non-monetary benefits include compulsory employer funded social security contributions (A$24,125 for Mr. Voigt and $122,021 for Dr. Triebel) which are paid directly by the Company to government authorities in line with French and German regulations.
| (1) | On December 1, 2021, Dr Russell Howard was issued 339,621 performance rights to vest over 3 tranches in lieu of additional cash fees, in accordance with shareholder approval received at our Annual General Meeting of shareholders (“AGM”) in November 2021. The number of performance rights was calculated based on 3 years of directors’ fees at A$60,000 per annum divided by A$0.53 (being the 5-day VWAP up to and including September 21, 2021). However, the fair value of his performance rights reflects the prevailing share price as at the date of shareholder approval. |
The first tranche of 113,207 performance rights will vest on December 1, 2022 (being for service from December 1, 2021 to November 30, 2022). The second tranche of 113,207 performance rights will vest on December 1, 2023 (being for service from December 1, 2022 to November 30, 2023). The third tranche of 113,207 performance rights will vest on December 1, 2024 (being for service from December 1, 2023 to November 30, 2024).
| (2) | On December 2, 2019, Mr Pete Meyers was issued 1,500,000 performance rights to vest over 3 tranches in lieu of cash for his services as a non-executive director, in accordance with shareholder approval received our Annual General Meeting of shareholders (“AGM”) in November 2019. The number of performance rights was calculated based on 3 years of directors’ fees at $105,000 per annum divided by $0.21 (being the closing share price on August 14, 2019). However, the fair value of his performance rights reflects the prevailing share price as at the date of shareholder approval. The first tranche of 500,000 performance rights vested on October 1, 2021 (being for service from October 1, 2020 to September 30, 2021). The second tranche of 500,000 performance rights due to vest on October 1, 2022 (being for service from October 1, 2021 to September 30, 2022). The third tranche of 500,000 performance rights due to vest October 1, 2023 (being for service from October 1, 2022 to September 30, 2023). |
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| (4) | Ms Lucy Turnbull was appointed in February 2022. Ms Turnbull will be issued 457,832 performance rights to vest over 4 tranches in lieu of cash for her services as a non-executive director, subject to shareholder approval at the 2022 Annual General Meeting of shareholders (“AGM”). As indicated in the Appendix 3X released to ASX on the date of Ms Turnbull’s appointment on February 25, 2022, the number of performance rights was calculated based on 3.76 years of directors’ fees at $45,000 p.a. divided by $0.37(being the 5-day VWAP up to and including February 18, 2022). However, the future fair value of the performance rights will be revised to reflect the actual prevailing share price as at the date of shareholder approval. The first tranche of 92,966 performance rights will vest on December 1, 2022 (in recognition of service from February 25, 2022 to November 30, 2022). The second tranche of 121,622 performance rights will vest on December 1, 2023 (in recognition of service from December 1, 2022 to November 30, 2023). The third tranche of 121,622 performance rights will vest on December 1, 2024 (in recognition of service from December 1, 2023 to November 30, 2024). The fourth tranche of 121,622 performance rights will vest on December 1, 2025 (in recognition of service from December 1, 2024 to November 30, 2025). |
| (5) | Mr Marc Voigt was issued 3,600,000 performance rights to vest over 3 tranches, in accordance with shareholder approval received at the AGM on November 1, 2019. One-third vested on October 1, 2020; One-third vested on October 1, 2021 and One-third is due to vest on October 1, 2022. Vesting is contingent upon the employee being continuously employed in good standing through the vesting period. |
On December 1, 2021, Mr Marc Voigt was issued 3,600,000 performance rights to vest over 3 tranches, in accordance with shareholder approval received at the AGM on November 26, 2021. One-third will vest on October 1, 2023; one-third will vest on October 1, 2024 and one-third is due to vest on October 1, 2025. Vesting is contingent upon the employee being continuously employed in good standing through the vesting period and dependent upon Mr Voigt meeting KPIs as determined by the Board.
The performance rights are subject to accelerated vesting according to agreed terms in each person’s contract. For vesting details of the other Performance Rights please refer to Section D on Share-based compensation below.
| (6) | On October 3, 2019, Ms Deanne Miller and Dr Frederic Triebel were issued 1,800,000 and 2,700,000 performance rights respectively under the Executive Incentive Plan (EIP). The vesting date for the Performance Rights issued to Ms D Miller and Dr F Triebel during the year are as follows: One-third vested on October 1, 2020; one -third vested on October 1, 2021 and one-third is due to vest on October 1, 2022. |
On December 1, 2021, Ms Deanne Miller and Dr Frederic Triebel were issued 1,800,000 and 2,700,000 performance rights respectively under the Executive Incentive Plan (EIP). The vesting date for the Performance Rights issued to Ms D Miller and Dr F Triebel during the year are as follows: One-third will vest on October 1, 2023; one -third will vest on October 1, 2024 and one-third is due to vest on October 1, 2025. Vesting is contingent upon the executives being continuously employed in good standing through the vesting period and meeting KPIs. The performance rights are subject to accelerated vesting according to agreed terms in each person’s contract. Dr. Triebel was appointed an executive director in September 2022.
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Service Agreements
The following members of key personnel have service agreements as at June 30, 2022 as follows:
| Mr. Marc Voigt |
Managing Director, Chief Executive Officer and Chief Financial Officer | |
| Agreement commenced: |
July 9, 2014 | |
| Details |
The initial term was for a period of 3 years. This term was subsequently extended for a further 3 years and extended again for an additional term that will expire on July 9, 2026, unless terminated earlier by either party in accordance with the Agreement. Each party is to provide at least 6 months’ notice of its intention to extend the term of the contract. | |
| The contract can be terminated by the company giving 12 months’ notice or by Marc giving 6 months’ notice. Immutep may make payments in lieu of the period of notice, or for any unexpired part of that notice period. | ||
| Base salary |
€275,625 | |
| Dr. Frédéric Triebel |
Chief Scientific Officer Chief Medical Officer | |
| Agreement commenced: |
December 12, 2014 | |
| Details |
Each of the parties may terminate the employment contract and the present Amendment, subject to compliance with the law and the Collective Bargaining Agreement (“CBA”) and notably to a 6-month notice period as set forth in the CBA. | |
| The party which fails to comply with the notice period provisions shall be liable to pay the other an indemnity equal to the salary for the remainder of the notice period. | ||
| Base salary |
€170,040 | |
| Ms. Deanne Miller |
Chief Operating Officer, General Counsel Company Secretary | |
| Agreement commenced: |
October 17, 2012 | |
| Details |
The agreement can be terminated with 6 months’ notice. | |
| The termination terms are payment of base salary in lieu of notice period. | ||
| Base salary |
A$242,550 | |
Under the cash bonus scheme approved by the Board of directors in February 2020, Mr. Marc Voigt, Dr. Frederic Triebel and Ms. Deanne Miller are each entitled to a cash bonus of A$300,000 conditional on meeting predetermined KPIs that are designed to support our corporate strategy to develop product candidates to sell, license or partner with large pharmaceutical companies at key value inflection points or on a change of control. As at June 30, 2022, no obligation has arisen for recognition.
Key management personnel have no entitlement to termination payments in the event of removal for misconduct or gross negligence.
Executive Incentive Plan
A new Executive Incentive Plan, or EIP, was approved by shareholders at our Annual General Meeting in November 2021. The key terms of the EIP are as follows:
Operation
The Board is responsible for administering the EIP in accordance with the EIP Rules. A grant of performance rights and/or options under the EIP will be subject to both the EIP Rules and the terms and conditions of the specific grant.
Eligibility
The EIP is open to employees (including Directors employed in an executive capacity) of the Company who are invited by the Board to participate in the EIP. The EIP is not open to non-executive directors of the Company. All non-executive directors are ineligible to participate in any current employee incentive scheme of the Company. The Board may invite employees to apply for performance rights and/or options under the EIP in its absolute discretion.
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Grant
No payment is required on the grant of a performance right and no exercise price is payable upon the performance right vesting. No payment is required on the grant of an option. The exercise price of an option will be determined by the Board in its discretion and specified in the participant’s invitation letter.
Vesting
The vesting of a performance right will be conditional on the satisfaction of any performance conditions attaching to the performance right. Performance conditions will be determined by the Board in its discretion and specified in the participant’s invitation letter. Where relevant performance conditions are met, then the performance right will vest and be automatically be exercised into Shares. The vesting of an option will be conditional on the satisfaction of any performance conditions attaching to the option. Performance conditions will be determined by the Board in its discretion and specified in the participant’s invitation letter.
Where a participant ceases to be an employee of the Company because of total and permanent disability, death, or any other circumstance determined by the Board in its discretion, the Board may determine that any of the performance rights and/or options granted to a participant will vest, whether or not any performance conditions attaching to the performance right and/or option have been met. Notwithstanding this and subject to the ASX Listing Rules:
| (i) | the Board may vest some or all of a participant’s performance rights and/or options even if a performance condition has not been met, if the Board considers that to do so would be in the interests of the Company; and |
| (ii) | the vesting of a participant’s performance rights and/or options may be made subject to further conditions as determined by the Board. |
Lapse of Performance Rights and Options
Performance rights and options will lapse if the applicable performance conditions attaching to them are not met within a prescribed period determined by the Board in its discretion. If a participant ceases to be an employee of the Company (other than in the circumstances referred to above), the participant’s performance rights and/or options will lapse automatically on cessation of the participant’s employment unless the Board determines otherwise within 60 days of the date of cessation of the participant’s employment.
Conversion
A participant may at any time request the Board to convert any or all of the participant’s unvested performance rights to Options, or vice versa, at a rate of conversion determined by the Board in its absolute discretion. Any converted performance rights or Options will be subject to the same terms and conditions of the original performance rights or options (as applicable) granted to the participant unless otherwise determined by the Board in its discretion.
Dealing with Performance Rights and Options
Performance rights and options are not transferable, except on the participant’s death, to their legal personal representative.
Shares
Each performance right will entitle a participant to one share upon vesting. Each option will entitle a participant upon vesting to subscribe for one share at the exercise price specified by the Board in the participant’s invitation letter. Shares issued as a result of the vesting of a performance right or vesting and exercise of an option will rank equally with the shares currently on issue.
Maximum Number of Performance Rights and Options
The Board may grant such number of performance rights and/or options under the EIP as the Board determines so long as no limit specified, imposed or calculated by any relevant policy or guideline of ASIC, including any regulatory guide, class order or condition for relief, is exceeded.
Takeovers
If the event of a takeover bid (as defined in the Corporations Act), a participant’s performance rights and options will vest immediately to the extent that the performance conditions attaching to those performance rights and/or options have been satisfied and the remaining performance rights and/or options will lapse.
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Reconstruction of Capital
If the Company makes a bonus issue, then a participant will become entitled to a proportionately greater number of shares on vesting of the performance rights and/or options held, as if the performance rights and/or options had vested before the bonus issue. If there is any other form of capital reconstruction, the number of performance rights and/or options will be adjusted in accordance with the ASX Listing Rules. A participant is not entitled to participate in any new issue of securities in the Company other than as described above.
Amendment of Incentive Plan
Subject to the ASX Listing Rules, the Board may amend the rules of the EIP, but no amendment may materially reduce the rights of participants generally in respect of the performance rights and/or options granted to them, except an amendment made primarily to enable compliance with the law governing or regulating the EIP, to correct a manifest error or mistake, to take into account changes in development in taxation law or to enable compliance with the Corporations Act or the ASX Listing Rules.
Details of bonuses and share-based compensation
The percentage of the available bonus or grant that was paid, or that vested, in the year, and the percentage that was forfeited because the person did not meet the vesting criteria is set out below.
| Cash bonus | Share-based compensation benefits (performance rights) | |||||||||||||||||||||||||||||||||||||||
| Paid | Forfeited | Year granted |
No Granted(A) |
Value of rights at grant date |
Vested | Number of rights vested/ exercised during the year(A) |
Value of rights at exercise date****** |
Forfeited | Fiscal years in which rights may vest |
|||||||||||||||||||||||||||||||
| Name |
% | % | $ | % | $ | % | ||||||||||||||||||||||||||||||||||
| Mr R Howard |
— | — | 2018 | * | 1,000,000 | 390,000 | 100 | % | 250,000 | 118,750 | — | 2019, 2020, 2021 | ||||||||||||||||||||||||||||
| — | — | 2021 | * | 339,621 | 166,414 | — | — | — | — | 2022, 2023, 2024 | ||||||||||||||||||||||||||||||
| Mr P Meyers |
— | — | 2019 | ** | 1,500,000 | 420,000 | 33 | % | 500,000 | 267,500 | — | 2021, 2022 2023 | ||||||||||||||||||||||||||||
| Mr G |
— | — | ||||||||||||||||||||||||||||||||||||||
| Chamberlain(1) |
2020 | 1,350,000 | 344,249 | 33 | % | 450,000 | 240,750 | 33.3 | % | 2022 | # | |||||||||||||||||||||||||||||
| Mr M Voigt |
100 | % | — | 2019 | *** | 3,600,000 | 1,008,000 | 67 | % | — | — | — | 2021, 2022 2023 | |||||||||||||||||||||||||||
| — | 2021 | **** | 3,600,000 | 1,764,000 | — | — | — | 2023, 2024, 2025 | ||||||||||||||||||||||||||||||||
| Dr F Triebel(2) |
100 | % | — | 2019 | *** | 2,700,000 | 702,000 | 67 | % | 900,000 | 481,500 | — | 2021, 2022 2023 | |||||||||||||||||||||||||||
| — | 2021 | **** | 2,700,000 | 1,323,000 | 2023, 2024, 2025 | |||||||||||||||||||||||||||||||||||
| Ms D Miller |
100 | % | — | 2019 | *** | 1,800,000 | 468,000 | 67 | % | 600,000 | 321,000 | — | 2021, 2022 2023 | |||||||||||||||||||||||||||
| 2021 | **** | 1,800,000 | 882,000 | 2023, 2024, 2025 | ||||||||||||||||||||||||||||||||||||
| * | Dr Russell Howard was issued 1,000,000 performance rights in lieu of cash for his services as a non-executive director, in accordance with shareholder approval received at the AGM on November 16, 2018. |
The first tranche of 250,000 performance rights vested on December 1, 2018 (being for continued service from November 18, 2017 to November 17, 2018). The second tranche of 250,000 performance rights vested on December 1, 2019 (being for continued service from November 18, 2018 to November 17, 2019). The third tranche of 250,000 performance rights vested on December 1, 2020 (being for continued service from November 18, 2019 to November 17, 2020). The final 250,000 rights vested on December 1, 2021 (being continued service from November 18, 2020 to November 17, 2021).
On December 1, 2021, Dr Russell Howard was issued 339,621 performance rights in lieu of cash for his services as a non-executive director, in accordance with shareholder approval received at the AGM on November 16, 2021. The first tranche of 113,207 performance rights will vest on December 1, 2022 (being for continued service from December 1, 2021 to November 30, 2022). The second tranche of 113,207 performance rights will vest on December 1, 2023 (being for continued service from December 1, 2022 to November 30, 2023). The third tranche of 113,207 performance rights will vest on December 1, 2024 (being for continued service from December 1, 2023 to November 30, 2024).
| ** | Mr Pete Meyers was issued 1,500,000 performance rights to vest over 3 tranches in lieu of cash for his services as a non-executive director, in accordance with shareholder approval received at the AGM on November 1, 2019. As indicated in the 2019 AGM notice of meeting, the number of performance rights was calculated based on 3 years of directors’ fees at $105,000 p.a. divided by $0.21 (being the closing share price on August 14, 2019). However, the fair value of his performance rights reflects the prevailing share price as at the date of shareholder approval. |
The first tranche of 500,000 performance rights vested on October 1, 2021 (being for service from October 1, 2020 to September 30, 2021). The second tranche of 500,000 performance rights will vest on October 1, 2022 (being for service from October 1, 2021 to September 30, 2022). The third tranche of 500,000 performance rights will vest on October 1, 2023 (being for service from October 1, 2022 to September 30, 2023).
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| *** | Performance rights were granted under the EIP. Long-term incentive performance rights vest in three tranches as follows: |
| • | 1/3 vested on October 1, 2020 |
| • | 1/3 vested on October 1, 2021 |
| • | 1/3 are due to vest on October 1, 2022 |
Vesting is contingent upon the employee being continuously employed in good standing through the vesting period. The performance rights are subject to accelerated vesting according to agreed terms in each person’s contract.
| **** | Performance rights were granted under the EIP. Long-term incentive performance rights vest in three tranches as follows: |
| • | 1/3 are due to vest on October 1, 2023 |
| • | 1/3 are due to vest on October 1, 2024 |
| • | 1/3 are due to vest on October 1, 2025 |
Vesting is contingent upon the employee being continuously employed in good standing through the vesting period. The performance rights are subject to accelerated vesting according to agreed terms in each person’s contract.
| ***** | The value at the exercise date of performance rights that were granted as part of remuneration and were exercised during the year has been determined as the intrinsic value of the performance rights at that date. |
| # | The first tranche of 450,000 performance rights vested on October 1, 2021 (being for service from October 1, 2020 to September 30, 2021). The second tranche of 450,000 performance rights that were due to vest on October 1, 2022 (being for service from October 1, 2021 to September 30, 2022) was gifted to Grant’s estate following his death on January 28, 2022 as approved by the Board of Directors and have been recognised to be fully vested as at June 30, 2022. The third tranche of 450,000 performance rights (being for service from October 1, 2022 to September 30, 2023) have been cancelled. |
Equity instruments held by key management personnel
The tables below show the number of:
| (i) | Options over ordinary shares in the Company; |
| (ii) | Performance rights over ordinary shares in the Company; |
| (iii) | Shares in the company that were held during the fiscal year by key management personnel of the Group, including their close family members and entities related to them. |
There were no shares granted during the reporting period as compensation.
(i) Options holdings
There were no options holdings outstanding and no movements during the fiscal years June 30, 2022, June 30, 2021 and June 30, 2020.
(ii) Performance Rights holdings
| 2022 | Balance at start of the year |
Granted | Exercised | Other Changes |
Balance at end of the year |
Vested and exercisable |
Unvested | |||||||||||||||||||||
| Performance rights over ordinary shares |
||||||||||||||||||||||||||||
| Dr Russell Howard |
250,000 | 339,621 | (250,000 | ) | — | 339,621 | — | 339,621 | ||||||||||||||||||||
| Mr Pete Meyers |
1,500,000 | — | (500,000 | ) | — | 1,000,000 | — | 1,000,000 | ||||||||||||||||||||
| Mr Marc Voigt |
2,400,000 | 3,600,000 | — | — | 6,000,000 | 1,200,000 | 4,800,000 | |||||||||||||||||||||
| Mr Grant Chamberlain |
1,350,000 | — | (450,000 | ) | (900,000 | )* | — | — | — | |||||||||||||||||||
| Ms Deanne Miller |
1,200,000 | 1,800,000 | (600,000 | ) | — | 2,400,000 | — | 2,400,000 | ||||||||||||||||||||
| Dr Frédéric Triebel |
1,800,000 | 2,700,000 | (900,000 | ) | — | 3,600,000 | — | 3,600,000 | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
| 8,500,000 | 8,439,621 | (2,700,000 | ) | (900,000 | ) | 13,339,621 | 1,200,000 | 12,139,621 | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
*The change during the year represents derecognition due to the cessation of the director’s position.
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(iii) Ordinary Share holdings
| 2022 | Balance at start of the year |
Received during the year on exercise of performance rights |
Received during the year on the exercise of options |
Other changes during the year# |
Balance at end of the year |
|||||||||||||||
| Ordinary shares |
||||||||||||||||||||
| Dr Russell Howard |
750,000 | 250,000 | — | — | 1,000,000 | |||||||||||||||
| Mr Pete Meyers |
1,774,395 | 500,000 | — | — | 2,274,395 | |||||||||||||||
| Mr Marc Voigt |
8,847,445 | — | — | — | 8,847,445 | |||||||||||||||
| Mr Grant Chamberlain |
1,728,023 | 450,000 | — | (2,178,023 | )* | — | ||||||||||||||
| Ms Lucy Turnbull |
— | — | — | 3,284,126 | ** | 3,284,126 | ||||||||||||||
| Ms Deanne Miller |
2,963,892 | 600,000 | — | (796,587 | ) | 2,767,305 | ||||||||||||||
| Dr Frédéric Triebel |
6,853,764 | 900,000 | — | — | 7,753,764 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
| Total ordinary shares |
22,917,519 | 2,700,000 | — | 309,516 | 25,927,035 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
| ADRs |
||||||||||||||||||||
| Mr Marc Voigt |
45 | — | — | — | 45 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
| Total ADR |
45 | — | — | — | 45 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
# Other changes during the year includes on market acquisitions and/or disposals.
*The change during the year represents derecognition due to the director’s death.
**The change during the year represents Ms. Lucy Turnbull’s shareholding before she became director on February 25, 2022. The shareholding includes 302,500 shares held indirectly.
Shares under option
Unissued ordinary shares of Immutep Limited under option at June 30, 2022 are as follows:
| Date options granted |
Expiration Date | Exercise Price | Number** | Listed/Unlisted Options | ||||||||||||
| August 5, 2015 |
August 4, 2025 | $ | 0.248 | 847,600 | Unlisted | |||||||||||
| July 4, 2017 |
January 5, 2023 | US$ | 0.249 | * | 2,065,070 | * | Unlisted | |||||||||
| 2,912,670 | ||||||||||||||||
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*1 American Depository Shares (ADS) listed on NASDAQ equals 10 ordinary shares listed on ASX thus the number of warrants on issue have been grossed up and their exercise prices adjusted accordingly in the above table to be comparable.
Set out below are summaries of STI and LTI performance rights granted under the EIP excluding the performance rights issued to non-executive directors up to June 30, 2022.
| 2022 |
Fair value A$ |
Balance at start of the year Number |
Granted during the year Number |
Exercised during the year Number |
Lapsed during the year Number |
Balance at end of the year Number |
Vested and exercisable at end of the year Number |
|||||||||||||||||||||
| Grant date |
||||||||||||||||||||||||||||
| October 3, 2019 |
0.260 | 3,000,000 | — | (1,500,000 | ) | — | 1,500,000 | — | ||||||||||||||||||||
| November 1, 2019 |
0.280 | 2,400,000 | — | — | — | 2,400,000 | 1,200,000 | |||||||||||||||||||||
| January 2, 2020 |
0.260 | 1,900,000 | — | (500,000 | ) | — | 1,400,000 | 450,000 | ||||||||||||||||||||
| October 2, 2020 |
0.235 | 263,502 | — | — | — | 263,502 | 263,502 | |||||||||||||||||||||
| October 1, 2021 |
0.550 | — | 206,404 | — | — | 206,404 | — | |||||||||||||||||||||
| November 26, 2021 |
0.490 | — | 3,600,000 | — | — | 3,600,000 | — | |||||||||||||||||||||
| November 26, 2021 |
0.490 | — | 4,500,000 | — | — | 4,500,000 | — | |||||||||||||||||||||
| November 26, 2021 |
0.490 | — | 2,900,000 | — | — | 2,900,000 | — | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| 7,563,502 | 11,206,404 | (2,000,000 | ) | — | 16,769,906 | 1,913,502 | ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
On November 5, 2019, there was a 10 to 1 share consolidation. The number of performance rights and fair value have therefore been adjusted retrospectively for the share consolidation.
C. Board Practices
Introduction
Our Board of Directors is elected by and accountable to our shareholders. It currently consists of four directors, including three non-executive directors, of which one is the non-executive Chairman of our Board of Directors. The Chairman of our Board of Directors is responsible for the management of the Board of Directors and its functions.
Election of Directors
Directors are elected at our annual general meeting of shareholders. Under our Constitution, a director, other than a managing director, must not hold office for more than three years or beyond the third annual general meeting following his appointment (whichever is the longer period) without submitting himself for re-election. Our Board of Directors has the power to appoint any person to be a director, either to fill a vacancy or as an additional director (provided that the total number of directors does not exceed the maximum allowed by law), and any director so appointed may hold office only until the next annual general meeting (“AGM”) when he or she shall be eligible for election.
The appointment and expiration dates of each director in office at the date of this report is as follows:
| Name |
Position |
Year first appointed |
Current term expires | |||
| Russell Howard |
Non-Executive Director | 2013 | November 2024 | |||
| Pete Meyers |
Non-Executive Director | 2014 | November 2022* | |||
| Lucy Turnbull |
Non-Executive Director | 2022 | November 2022 | |||
| Frederic Triebel |
Executive Director | 2022 | November 2022 | |||
| Marc Voigt |
Managing Director, CEO | 2014 | N/A (managing director exempt from election under constitution and Australian corporate law) |
| * | The Company’s Constitution requires that at least one of the Company’s directors must retire from office at every AGM. The director who retires in this manner is required to be the director longest in office since last being elected or as agreed between Directors who have been in office an equal length of time. Pete Meyers will stand for re-election at the Company’s AGM in 2022. Lucy Turnbull and Frederic Triebel will also stand for re-election at the Company’s AGM in 2022 as any newly appointed director may hold office only until the next AGM following their appointment when they shall be eligible for election. |
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Corporate Governance
ASX Corporate Governance Principles
In Australia there are no defined corporate governance structures and practices that must be observed by a company listed on the ASX, except that entities of a certain size are required to have audit and remuneration committees and in some instances trading policies for key management personnel. Instead, the ASX Corporate Governance Council has published the Corporate Governance Principles and Recommendations, which contains what are called the Recommendations which articulate eight core principles which are intended to provide a reference point for companies about their corporate governance structures and practices. Under ASX Listing Rule 4.10.3, companies are required to attach a copy (or the URL page on its website) of the Company’s corporate governance statement (which has been approved by the Board) and provide a statement in their Annual Report to shareholders disclosing the extent to which they have followed the Recommendations in the reporting period and where they have not followed all the Recommendations, identify the Recommendations that have not been followed, and the reasons for not following them and what (if any) alternative governance practices it adopted in lieu of the recommendations during that period . It is not mandatory to follow the Recommendations. We believe we are in material compliance with the Recommendations. Set forth below are the material provisions of the Recommendations together with the reasons, where applicable, for variations therefrom.
| 1. | Lay solid foundations for management and oversight. Companies should establish and disclose the respective roles and responsibilities of board and management and how their performance is monitored and evaluated. During fiscal year June 30, 2022, we varied from the Recommendations in the following area: |
| • | The Board adopted a formal diversity policy as recommended by the ASX Corporate Governance Council’s Principles and Recommendations in June 2020; however the board believes that the Company is still not of a size and does not have large enough workforce to warrant the setting of formal gender diversity objectives. |
| 2. | Structure the Board to be effective and add value. Companies should have a board of an effective composition, size, and commitment to adequately discharge its responsibilities and duties effectively. During the year ended June 30, 2022, we varied from the Recommendations in the following area: |
| • | The Board believes that the Company is not of a size, nor are its financial affairs of such complexity, to justify the establishment of a Nomination Committee of the Board of Directors. All matters which might be properly dealt with by a Nomination Committee are considered by the full Board of Directors. The Board considers the necessity to establish a Nomination Committee annually. |
| 3. | Instill a culture of acting lawfully, ethically and responsibly. Companies should act lawfully, ethically and responsibly. Further to implementing the Whistleblower Policy in 2019, the Company adopted a statement of Immutep’s values and Anti-Bribery and Corruption Policy in 2020 to promote ethical and responsible decision-making. |
| 4. | Safeguard the integrity of corporate reports. Companies should have formal and rigorous processes to independently verify and safeguard the integrity of their corporate reporting. |
| 5. | Make timely and balanced disclosure. Companies should make timely and balanced disclosure of all matters concerning it that a reasonable person would expect to have a material effect on the price or value of its securities. |
| 6. | Respect the rights of security holders. Companies should respect the rights of shareholders by providing them with appropriate information and facilities to allow them the effective exercise of those rights. |
| 7. | Recognize and manage risk. Companies should establish a sound system of risk management and periodically review the effectiveness of that internal control. |
| 8. | Remunerate fairly and responsibly. Companies should ensure that the level and composition of remuneration is sufficient and reasonable and that its relationship to performance is clear. |
Non-Executive and Independent Directors
Australian law does not require a company to appoint a certain number of independent directors to its board of directors or audit committee. However, under the Corporate Governance Principles and Recommendations, the ASX recommends, but does not require, that an ASX-listed company have a majority of independent directors on its board of directors and that the audit committee be comprised of independent directors, within the meaning of the rules of the ASX. Our Board of Directors currently has four directors, of which three are non-executive directors within the meaning of the Corporate Governance Principles and Recommendations, and our audit committee consists of three such non-executive directors. Accordingly, we currently comply with the Recommendations.
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Under NASDAQ Marketplace Rules, in general a majority of our Board of Directors must qualify as independent directors within the meaning of the NASDAQ Marketplace Rules and our audit committee must have at least three members and be comprised only of independent directors, each of whom satisfies the respective “independence” requirements of NASDAQ and the U.S. Securities and Exchange Commission.
The Board of Directors does not have regularly scheduled meetings at which only independent directors are present. The Board of Directors does meet regularly and independent directors are expected to attend all such meetings. Our practices are consistent with the Recommendations, in that the Recommendations do not provide that independent directors should meet separately from the Board of Directors.
Our Board of Directors has determined that each of Pete Meyers, Lucy Turnbull and Russell Howard qualifies as an independent director under the requirements of the ASX, NASDAQ Marketplace Rules and U.S. Securities and Exchange Commission.
Committees of the Board of Directors
Audit Committee. NASDAQ Marketplace Rules require us to establish an audit committee comprised of at least three members, each of whom is financially literate and satisfies the respective “independence” requirements of the U.S. Securities and Exchange Commission and NASDAQ and one of whom has accounting or related financial management expertise at senior levels within a company.
Our Audit Committee assists our Board of Directors in overseeing the accounting and financial reporting processes of our company and audits of our financial statements, including the integrity of our financial statements, compliance with legal and regulatory requirements, our independent public accountants’ qualifications and independence, and independent public accountants, and such other duties as may be directed by our Board of Directors. The Audit Committee is also required to assess risk management.
Our Audit Committee currently consists of three board members, each of whom satisfies the “independence” requirements of the U.S. Securities and Exchange Commission, NASDAQ Marketplace Rules and ASX Rules. Our Audit Committee is currently composed of Russell Howard, Pete Meyers and Lucy Turnbull. The audit committee meets at least two times per year.
Remuneration Committee. Our Board of Directors has established a Remuneration Committee, which is comprised solely of independent directors, within the meaning of NASDAQ Marketplace Rules. The Remuneration Committee is responsible for reviewing the salary, incentives and other benefits of our directors, senior executive officers and employees, and to make recommendations on such matters for approval by our Board of Directors. The Remuneration Committee is also responsible for overseeing and advising our Board of Directors with regard to the adoption of policies that govern our compensation programs. Russell Howard, Pete Meyers and Lucy Turnbull are the current members of the Remuneration Committee, each of whom qualifies as an “independent director” within the meaning of NASDAQ Marketplace Rules.
Nominations Committee. Our Board of Directors has not established a Nominations Committee. The Recommendations provide that the Nominations Committee of a company should have a charter that clearly sets out its roles and responsibilities, composition, structure, membership requirements and the procedures for inviting non-committee members to attend meetings. We have not established a Nominations Committee as we do not believe the size of our financial affairs justify the establishment of a separate committee at this time.
Corporate Governance Requirements — Nasdaq Global Market Marketplace Rules.
Our shares in the form of ADRs are quoted on the Nasdaq Global Market. The Sarbanes-Oxley Act of 2002, as well as related new rules subsequently implemented by the SEC, require companies which are considered to be foreign private issuers in the U.S., such as us, to comply with various corporate governance practices. In addition, Nasdaq has made certain changes to its corporate governance requirements for companies that are listed on the Nasdaq Global Market. These changes allow us to follow Australian “home country” corporate governance practices in lieu of the otherwise applicable Nasdaq corporate governance standards, as long as we disclose each requirement of Rule 5600 that we do not follow and describe the home country practice we follow in lieu of the relevant Nasdaq corporate governance standards. We intend to take all actions necessary to maintain compliance with applicable corporate governance requirements of the Sarbanes-Oxley Act of 2002, rules adopted by the SEC and listing standards of Nasdaq. We follow Australian corporate governance practices in lieu of the corporate governance requirements of the Nasdaq Marketplace Rules in respect of:
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| • | Nasdaq requirement under Rule 5620(c) that a quorum consist of holders of 33 1/3% of the outstanding ordinary shares—The ASX Listing Rules do not have an express requirement that each issuer listed on ASX have a quorum of any particular number of the outstanding ordinary shares, but instead allow a listed issuer to establish its own quorum requirements. Our quorum is currently two persons who are entitled to vote. We believe this quorum requirement is consistent with the requirements of the ASX and is appropriate and typical of generally accepted business practices in Australia. |
| • | The Nasdaq requirements under Rules 5605(b)(1) and (2) relating to director independence, including the requirements that a majority of the board of directors must be comprised of independent directors and that independent directors must have regularly scheduled meetings at which only independent directors are present—The Nasdaq and ASX definitions of what constitute an independent director are not identical and the requirements relating to the roles and obligations of independent directors are not identical. The ASX, unlike Nasdaq, permits an issuer to establish its own materiality threshold for determining whether a transaction between a director and an issuer affects the director’s status as independent and it does not require that a majority of the issuer’s board of directors be independent, as long as the issuer publicly discloses this fact. In addition, the ASX does not require that the independent directors have regularly scheduled meeting at which only independent directors are present. We believe that our Board composition is consistent with the requirements of the ASX and that it is appropriate and typical of generally accepted business practices in Australia. |
| • | We have relied on and expect to continue to rely on an exemption from the requirement that our independent directors meet regularly in executive sessions under Nasdaq Listing Rules. The ASX Listing Rules and the Corporations Act do not require the independent directors of an Australian company to have such executive sessions and, accordingly, we seek to claim this exemption. |
| • | The Nasdaq requirements under Rules 5605(d) that compensation of an issuer’s officers must be determined, or recommended to the Board for determination, either by a majority of the independent directors, or a compensation committee comprised solely of independent directors, and that director nominees must either be selected, or recommended for the Board’s selection, either by a majority of the independent directors, or a nominations committee comprised solely of independent directors. The Nasdaq compensation and nomination committee requirements are not identical to the ASX remuneration and nomination committee requirements. Issuers listed on the ASX are recommended under applicable listing standards to establish a remuneration committee consisting of a majority of independent directors and an independent chairperson, or publicly disclose that it has not done so. We have a Remuneration Committee that is consistent with the requirements of the ASX and which we believe is appropriate and typical of generally accepted business practices in Australia. However, we do not have a nomination committee and do not expect to establish it. |
| • | We have relied on and expect to continue to rely on an exemption from the requirement prescribed by Nasdaq Listing Rules that issuers obtain shareholder approval prior to the issuance of securities in connection with certain acquisitions, private placements of securities, or the establishment or amendment of certain stock option, purchase or other compensation plans. Applicable Australian law and the ASX Listing Rules differ from Nasdaq requirements, with the ASX Listing Rules providing generally for prior shareholder approval in numerous circumstances, including (i) issuance of equity securities exceeding 15% (or 25% under certain circumstances) of our issued share capital in any 12-month period (but, in determining the 15% limit, securities issued under an exception to the rule or with shareholder approval are not counted), (ii) issuance of equity securities to related parties (as defined in the ASX Listing Rules) and (iii) issuances of securities to directors or their associates under an employee incentive plan. Due to differences between Australian law and rules and the Nasdaq shareholder approval requirements, we seek to claim this exemption. |
We do not have a ‘diverse’ board of directors as defined in Nasdaq Rule 5605(f). Immutep is a small company with four Directors. All of our Directors have been with Immutep several years so there has not been an opportunity to consider ‘diverse’ candidates. That being said, we believe in having a diverse workforce and will consider ‘diverse’ director candidates when an opportunity arises.
Directors’ Service Contracts
For details of directors’ service contracts providing for benefits upon termination of employment, see “Item 6. Directors, Senior Management and Employees-B. Compensation-Service Agreements.”
Indemnification of Directors and Officers
Our Constitution provides that, we may indemnify a person who is, or has been, an officer of our company, to the full extent permissible by law, out of our property against any liability incurred by such person as an officer in defending proceedings, whether civil or criminal, and whatever their outcome.
In addition, our Constitution provides that to the extent permitted by law, we may pay, or agree to pay, a premium in respect of a contract insuring a person who is or has been an officer of our company or one of our subsidiaries against any liability:
| • | incurred by the person in his or her capacity as an officer of our company or a subsidiary of our company, and |
| • | for costs and expenses incurred by that person in defending proceedings relating to that person acting as an officer of Immutep, whether civil or criminal, and whatever their outcome. |
We maintain a directors’ and officers’ liability insurance policy. We have established a policy for the indemnification of our directors and officers against certain liabilities incurred as a director or officer, including costs and expenses associated in successfully defending legal proceedings.
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D. Employees
As of June 30, 2022, Immutep had 35 employees, including 25 employed in research and development, 1 in intellectual property management and 9 in general management and administration. Of these 35 employees, 7 were located in Australia, 6 were located in France and 22 were located in Germany. As at the end of fiscal years 2020 and 2021 we had 26 and 28 employees, respectively. The number of employees increased by approximately 25% during fiscal year 2022.
Each of our full-time employees has entered into an agreement with a term of employment of between one to four years or for an unlimited term. We also engage part-time employees. We may only terminate the employment of any of our employees in accordance with the relevant employee’s contract of employment.
Our standard contract of employment for full time and part-time employees provides that we can terminate the employment of an employee without notice for serious misconduct or with between one to three months’ notice without cause (as set out in the relevant employee’s contract of employment). We can terminate the employment of a casual employee without notice. For a summary of the key terms of employment of each of our senior management, see “Item 6. Directors, Senior Management and Employees-B. Compensation-Service Agreements.”
E. Share Ownership
For a description of arrangements involving the employees in the capital of the company, including any arrangement that involves the issue or grant of options or shares or securities of the company, see “Item 6. Directors, Senior Management and Employees-B. Compensation-Global Employee Share Option Plan,” “-Employee Share Option Plan” and “-Executive Incentive Plan.”
Beneficial Ownership of Senior Management and Directors
Beneficial ownership is determined in accordance with the rules of the U.S. Securities and Exchange Commission, and generally includes voting or investment power with respect to securities. Ordinary shares relating to options currently exercisable or exercisable within 60 days of the date of the above table are deemed outstanding for computing the percentage of the person holding such securities but are not deemed outstanding for computing the percentage of any other person. Except as indicated by footnote, and subject to community property laws where applicable, the persons named in the table below have sole voting and investment power with respect to all shares shown as beneficially owned by them.
The following table sets forth certain information as of June 30, 2022 regarding the beneficial ownership of our ordinary shares by each of our directors and senior management and by all of our directors and senior management as a group. The shares are beneficially owned, held directly or via an entity related to the individual. The percentages shown are based on 879,089,453 ordinary shares issued and outstanding as of October 18, 2022.
| Name | Number of Ordinary Shares Beneficially Owned |
Percentage of Ownership |
||||||
| Dr Russell Howard |
1,000,000 | 0.11 | % | |||||
| Mr Pete Meyers |
2,774,395 | 0.32 | % | |||||
| Mr Marc Voigt |
11,247,445 | * | 1.29 | % | ||||
| Mr Marc Voigt |
450 | ** | — | |||||
| Ms Lucy Turnbull*** |
3,284,126 | 0.38 | % | |||||
| Ms Deanne Miller |
3,267,305 | 0.37 | % | |||||
| Dr Frédéric Triebel |
8,653,764 | 0.99 | % | |||||
| Dr Frédéric Triebel |
170,610 | **** | 0.02 | % | ||||
| All directors and executive officers as a group (6 persons) |
30,398,095 | 3.46 | % | |||||
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| * | This amount includes 55,750 ordinary shares held indirectly by Mr Marc Voigt via JP Morgan Nominees Australia Limited. |
| ** | Held by Marc Voigt in the form of 45 ADSs listed on the NASDAQ Global Market. |
| *** | This amount includes 302,500 ordinary shares held indirectly Ms Lucy Turnbull via Turnbull Partners Pty Limited (Nominee account) and Turnbull Partners Pty Limited (Broker account). |
| **** | Held by Dr Frédéric Triebel in the form of 17,061 ADSs listed on the NASDAQ Global Market. |
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| ITEM 7. | MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS |
A. Major Shareholders
To our knowledge, the only beneficial owner of 5% or more of our ordinary shares as of October 31, 2022 was Fidelity Limited.
On July 30, 2021, Fidelity Limited (“Fidelity”) became a substantial holder with 6.21% of ownership of our ordinary shares. FIL participated in the Company’s two-tranche placement which was completed on July 30, 2021.
On June 28, 2021, National Nominees Ltd ACF Australian Ethical Investment Limited (AEF) held 5.56% of ordinary shares of the company. On July 30, 2021, AEF’s ownership decreased to 4.89%. We received the “Notice of ceasing to be a substantial Holder” on October 7, 2021.
On September 30, 2022, AEF became a substantial holder again with 5.00% of ownership of our ordinary shares. Due to dilution from the issue of additional shares, in October 2022, AEF’s ownership decreased to 4.98% and consequently it ceased to be substantial holder on October 3, 2022.
The Bank of New York Mellon Corporation (BNYM), as depositary of the ADR program, owned 27.83% of our ordinary shares as at October 14, 2022. BNYM has a relevant interest in 235,234,609 ordinary shares as depositary for Immutep Limited ADR program administered under the Deposit Agreement. BNYM’s relevant interest in these securities arises as a result of the Deposit Agreement containing rights for BNYM to dispose of securities held under the ADR program in limited circumstances. Under the Deposit Agreement, ADR holders retain their rights to dispose of those securities and to give voting Instructions for the exercise of voting rights attached to the securities. BNYM’s power to vote or dispose of these securities is qualified accordingly. By an instrument of relief dated April 29, 2019, ASIC has granted certain relief to BNYM and its related bodies corporate from certain provisions of Chapter 6 of the Corporations Act in relation to the acquisition of, or increase in, voting power in securities held by BNYM as depositary under the ADR program.
As of June 30, 2022, there were 13,153 holders of record of our ordinary shares, of which 8 holders, holding approximately 0.27% of our ordinary shares, had registered addresses in the United States and 2 registered holders of our ADRs. These numbers are not representative of the number of beneficial holders of our shares or ADRs nor are they representative of where such beneficial holders reside, as many of these ordinary shares and ADRs were held of record by brokers or other nominees. The estimated number of beneficial ADR holders is 9,626 based on the last broker search conducted, with the record date of October 18, 2022.
To our knowledge, we are not directly or indirectly controlled by another corporation, by any foreign government or by any other natural or legal person severally or jointly. There are no agreements known to us, the operation of which may at a subsequent date result in a change in control of Immutep. All shareholders have the same voting rights.
B. Related Party Transactions
During fiscal years 2022, 2021 and 2020, there were no related party transactions.
C. Interests of Experts and Counsel
Not applicable.
| ITEM 8. | FINANCIAL INFORMATION |
A. Consolidated Statements and Other Financial Information
Our audited consolidated financial statements for the fiscal years ending June 30, 2022, 2021 and 2020 are included in Item 18 of this Annual Report on Form 20-F, which is found immediately following the text of this Annual Report on Form 20-F. The audit report of PricewaterhouseCoopers Australia for each of the three years in the period ended June 30, 2022 is included therein immediately preceding the financial statements.
Legal Proceedings
We are not involved in any legal or arbitration proceedings, including those relating to bankruptcy, receivership or similar proceedings and those involving any third party, which may have, or have had in the recent past, significant effects on our financial position or profitability. The company is not involved in any governmental proceedings pending or known by us to be contemplated.
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Dividend Distribution Policy
We have never paid cash dividends to our shareholders. We intend to retain future earnings for use in our business and do not anticipate paying cash dividends on our ordinary shares in the foreseeable future. Any future dividend policy will be determined by the Board of Directors and will be based upon various factors, including our results of operations, financial condition, current and anticipated cash needs, future prospects, contractual restrictions and other factors as the Board of Directors may deem relevant. There is no assurance that dividends will ever be paid. See “Special Note Regarding Forward Looking Statements”.
B. Significant Changes
No significant changes occurred since the date of the annual financial statements.
| ITEM 9. | THE OFFER AND LISTING |
| A. | Offer and Listing Details |
The Company’s ordinary shares trade on the ASX under the symbol “IMM”. The ADSs of the Company trade on the NASDAQ Global Market under the symbol “IMMP”.
For a description of the rights of our ADSs, see “Item 12. Description of Securities Other Than Equity Securities—D. American Depositary Shares.”
| B. | Plan of Distribution |
Not applicable.
| C. | Markets |
Our ordinary shares are listed and traded on the Australian Securities Exchange Ltd., or ASX, on the NASDAQ Global Market where our ordinary shares in the form of ADSs are traded on the NASDAQ Global Market.
| D. | Selling Shareholders |
Not applicable.
| E. | Dilution |
Not applicable.
| F. | Expenses of the Issue |
Not applicable.
| ITEM 10. | ADDITIONAL INFORMATION |
A. Share Capital
Not applicable.
B. Memorandum and Articles of Association
General
Our constituent document is a Constitution. The Constitution is subject to the terms of the Listing Rules of ASX Limited and the Corporations Act 2001. The Constitution may be amended or repealed and replaced by special resolution of shareholders, which is a resolution of which notice has been given and that has been passed by at least 75% of the votes cast by shareholders entitled to vote on the resolution.
Purposes and Objects
As a public company we have all the rights, powers and privileges of a natural person. Our Constitution does not provide for or prescribe any specific objects or purposes.
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The Powers of the Directors
Under the provision of our Constitution our directors may exercise all the powers of our company in relation to:
Members Approval to Significant Changes
The directors must not make a significant change (either directly or indirectly) to the nature and scale of our activities except after having disclosed full details to ASX in accordance with the requirements of the Listing Rules of the ASX and the directors must not sell or otherwise dispose of the main undertaking of our company without the approval of shareholders in general meeting in accordance with the requirements of the Listing Rules.
Interested Directors
A director may not vote in respect of any contract or arrangement in which the director has, directly or indirectly, any material interest according to our Constitution. Such director must not be counted in a quorum, must not vote on the matter and must not be present at the meeting while the matter is being considered. However, that director may execute or otherwise act in respect of that contract or arrangement notwithstanding any material personal interest.
Unless a relevant exception applies, the Corporations Act requires our directors to provide disclosure of certain interests or conflicts of interests and prohibits directors from voting on matters in which they have a material personal interest and from being present at the meeting while the matter is being considered. In addition, the Corporations Act and the ASX Listing Rules require shareholder approval of any provision of related party benefits to our directors.
Directors’ compensation
Our directors are paid remuneration for their services as directors (but excluding any remuneration payable to a director under any executive services contract with us or one of our related bodies corporate) which is determined in a general meeting of shareholders. The aggregate, fixed sum for directors’ remuneration is to be divided among the directors in such proportion as the directors themselves agree and in accordance with our Constitution. The fixed sum remuneration for directors may not be increased except at a general meeting of shareholders and the particulars of the proposed increase are required to have been provided to shareholders in the notice convening the meeting. In addition, executive directors may be paid remuneration as employees of Immutep.
Fees payable to our non-executive directors must be by way of a fixed sum and not by way of a commission on or a percentage of profits or operating revenue. Remuneration paid to our executive directors must also not include a commission or percentage of operating revenue.
Pursuant to our Constitution, any director who performs services that in the opinion of our board of directors, are outside the scope of the ordinary duties of a director may be paid extra remuneration, which is determined by our board of directors.
In addition to other remuneration provided in our Constitution, all of our directors are entitled to be paid by us for reasonable travel accommodation and other expenses incurred by the directors in attending general meetings, board meetings, committee meetings or otherwise in connection with our business.
In addition, in accordance with our Constitution, a director may be paid a retirement benefit as determined by our board of directors subject to the limits set out in the Corporations Act and the ASX Listing Rules which broadly restrict our ability to pay our officers a termination benefit in the event of a change of control of the Company or our subsidiaries as well as impose requirements for shareholder approval to be obtained to pay certain retirement benefits to our officers.
Borrowing powers exercisable by Directors
Pursuant to our Constitution, the management and control of our business affairs are vested in our board of directors. Our board of directors has the power to raise or borrow money and charge any of our property or business or any uncalled capital, and may issue debentures or give any other security for any of our debts, liabilities or obligations or of any other person, in each case, in the manner and on terms it deems fit.
Retirement of Directors
Pursuant to our Constitution and the ASX Listing Rules, each director, other than the managing director, must not hold office for more than three years or beyond the third annual general meeting following his or her appointment (whichever is longer). Further, at least one director is required to retire by rotation at each annual general meeting (such director being the director who has been longest in office since their last election). Directors who retire by rotation are eligible for a re-election to the board of directors unless disqualified from acting as a director under the Corporations Act or our Constitution.
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Rights Attached to Our Ordinary Shares
The concept of authorized share capital no longer exists in Australia and as a result, our authorized share capital is unlimited. All our outstanding ordinary shares are validly issued, fully paid and non-assessable. The rights attached to our ordinary shares are as follows:
Dividend Rights.
The directors may declare that a dividend be paid to the members according to the shareholders’ pro rata shareholdings and the directors may fix the amount, the time for payment and the method of payment. No dividend is payable except in accordance with the Corporations Act as amended from time to time and no dividend carries interest as against the Company.
Voting Rights.
Holders of ordinary shares have one vote for each ordinary share held on all matters submitted to a vote of shareholders. Such voting rights may be affected by the grant of any special voting rights to the holders of a class of shares with preferential rights that may be authorized in the future.
The quorum required for an ordinary meeting of shareholders consists of at least two shareholders present in person, or by proxy, attorney or representative appointed pursuant to our Constitution. A meeting adjourned for lack of a quorum generally is adjourned to the same day in the following week at the same time and place. At the reconvened meeting, the required quorum consists of any two members present in person, or by proxy, attorney or representative appointed pursuant to our Constitution. The meeting is dissolved if a quorum is not present within 15 minutes from the time appointed for the meeting.
An ordinary resolution, such as a resolution for the declaration of dividends, requires approval by the holders of a majority of the voting rights represented at the meeting, in person, by proxy, or by written ballot and voting thereon. Under our Constitution, the Corporations Act and the ASX Listing Rules, certain matters must be passed by way of a special resolution. A special resolution must be passed by at least 75% of the votes cast by shareholders entitled to vote on the resolution and who vote at the meeting in person. Matters which are not required to be passed by special resolution are required to be passed by ordinary resolution.
Rights in Our Profits.
Our shareholders have the right to share in our profits distributed as a dividend and any other permitted distribution.
Rights in the Event of Liquidation.
In the event of our liquidation, after satisfaction of liabilities to creditors, our assets will be distributed to the holders of ordinary shares in proportion to the capital at the commencement of the liquidation paid up or which ought to have been paid up on the shares held by them respectively. This right may be affected by the grant of preferential dividend or distribution rights to the holders of a class of shares with preferential rights, such as the right in winding up to payment in cash of the amount then paid up on the share, and any arrears of dividend in respect of that share, in priority to any other class of shares.
Directors may make calls.
Our Constitution provides that subject to the terms on which the shares have been issued directors may make calls on a shareholder for amounts unpaid on shares held by that shareholder, other than monies payable at fixed times under the conditions of allotment. Shares represented by the ADSs issued in our initial public offering in the United States were fully paid and are not subject to calls by directors.
Changing Rights Attached to Shares
According to our Constitution, the rights attached to any class of shares, unless otherwise provided by the terms of the class, may be varied with either the written consent of the holders of not less than 75% of the issued shares of that class or the sanction of a special resolution passed at a separate general meeting of the shares of that class.
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Annual and Extraordinary Meetings
Our directors must convene an annual meeting of shareholders at least once every calendar year, within five months of our last fiscal year-end balance sheet data. Notice of at least 28 days prior to the date of the meeting is required. A general meeting may be convened by any director, or one or more shareholders holding in the aggregate at least 5% of our issued capital. A general meeting must be called not more than 21 days after the request is made. The meeting must be held not later than two months after the request is given.
Limitations on the Rights to Own Securities in Our Company
Subject to certain limitations on the percentage of shares a person may hold in our company, neither our Constitution nor the laws of the Commonwealth of Australia restrict in any way the ownership or voting of shares in our company.
Changes in Our Capital
Pursuant to the Listing Rules, our directors may in their discretion issue securities to persons who are not related parties of our company, without the approval of shareholders, if such issue, when aggregate with securities issued by our company during the previous 12 month period would be an amount that would not exceed 15% of our issued capital at the commencement of the 12 month period. Other allotments of securities require approval by an ordinary resolution of shareholders.
| C. | Material Contracts |
On March 15, 2021 we entered into our second Clinical Trial Collaboration and Supply Agreement with Merck Sharp Dohme B.V (“MSDBV”) and MSD International GmbH (“MSDIG”) (collectively “MSD”) to evaluate the combination of our lead immunotherapy product candidate eftilagimod alpha (“efti”) with MSD’s anti-PD-1 therapy KEYTRUDA® in a Phase IIb clinical trial in 1st line HNSCC patients, called TACTI-003 (Two Active Immunotherapies). The trial will be a 1:1 randomised, controlled clinical study in approximately 160 1st line HNSCC patients. It will evaluate the safety and efficacy of Immutep’s lead product candidate, eftilagimod alpha (efti or IMP321), when given in combination with MSD’s KEYTRUDA® (pembrolizumab), compared to pembrolizumab alone. TACTI-003 will take place in 20+ clinical sites in the United States, Australia and Europe. Under the terms of the agreement, Immutep is the sponsor and is funding the clinical trial from its existing budget whilst MSD will provide pembrolizumab for the duration of the trial. The agreement will run for an indefinite term until final reports of the study have been completed. It includes customary termination and intellectual property provisions for a clinical collaboration agreement. The agreement also includes customary provisions for use of the clinical data to obtain regulatory approval of efti and to promote the drug with a relevant label indication.
| D. | Exchange Controls |
Australia has largely abolished exchange controls on investment transactions. The Australian dollar is freely convertible into U.S. dollars. In addition, there are currently no specific rules or limitations regarding the export from Australia of profits, dividends, capital or similar funds belonging to foreign investors, except that certain payments to non-residents must be reported to the Australian Cash Transaction Reports Agency, which monitors such transaction, and amounts on account of potential Australian tax liabilities may be required to be withheld unless a relevant taxation treaty can be shown to apply.
The Foreign Acquisitions and Takeovers Act 1975
Under Australian law, in certain circumstances foreign persons are prohibited from acquiring more than a limited percentage of the shares in an Australian company without approval from the Australian Treasurer. These limitations are set forth in the Australian Foreign Acquisitions and Takeovers Act 1975 (Cth) (“FATA”), associated legislation and regulations. These limitations are in addition to the more general overarching Takeovers Prohibition of an acquisition of more than a 20% interest in a public company (in the absence of an applicable exception) under the takeover provisions of Australia’s Corporations Act by any person whether foreign or otherwise.
If an investment is subject to foreign investment approval, it may have compulsory prior notification requirements, being a “notifiable action” or “notifiable national security action” or voluntary prior notification requirements being a “significant action” or “reviewable national security action”. If an investment falls in this voluntary application category, the seeking of approval will extinguish certain future rights the Australian Treasurer has to review and approve the investment. Not applying for approval where the voluntary notification provisions apply will not be a breach of the FATA.
The Australian foreign investment regime applies differently to ‘foreign government investors’ and private foreign persons. Broadly, entities are considered as foreign persons if (i) a foreign holder (together with its associates) holds a direct or indirect interest of 20% or more in the entity or (ii) multiple foreign holders hold an aggregate interest (direct or indirect) of at least 40%. An entity will be a ‘foreign government investor’ if (i) a foreign government or foreign government owned entity, or a number of foreign government owned entities from the same country own a direct or indirect interest of 20% or (ii) or multiple foreign governments or foreign government owned entities from any country own a direct or indirect interest of 40%.
Under the FATA, foreign persons are required to notify and obtain prior approval from the Foreign Investment Review Board for a range of acquisitions of an interest in an Australian entity on a mandatory basis, including:
| • | acquisitions of a direct interest (generally 10% or more) by a foreign government investor in an Australian entity, irrespective of value; |
| • | acquisitions by any foreign person of: |
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| – | a ‘substantial interest’ (generally 20% or more) in an Australian entity valued above the relevant monetary threshold. This is generally A$289 million (indexed annually) or A$1,250 million in case of U.S. investors where the investment is being made directly by a U.S investor, in each case calculated by the higher of the total asset value and the total value of the issued securities of the Australian entity; or |
| – | a direct interest in a ‘national security business’ or entity that carries on a national security business, or holds ‘national security land’, irrespective of value; and |
| • | acquisitions of interests in Australian entities operating in sensitive industries (such as media, telecommunications, and encryption and security technologies), land-rich Australian entities or agribusiness Australian entities. |
Each foreign person seeking to acquire holdings in excess of the above caps (including their associates) would need to complete an application form setting out the proposal and relevant particulars of the acquisition/shareholding and pay the relevant application fees. The Australian Treasurer then has 30 days to consider the application and make a decision and a further 10 days to notify the applicant. However, the Australian Treasurer has broad powers to extend this time period, including extending the period by up to a further 90 days by publishing an interim order. Most commonly, the Australian Treasurer will request an applicant agree to an extension to avoid needing to publish the interim order, such agreement is usually in the best interest of the applicant as interim orders are made public and by agreeing to an extension the application process is kept confidential. Otherwise applications are strictly confidential and not released to the public.
The Australian Foreign Investment Review Board, an Australian advisory board to the Australian Treasurer has provided a guideline titled Australia’s Foreign Investment Policy, which provides an outline of the policy. As for the risk associated with seeking approval, the policy provides, among other things, that the Treasurer will reject an application if it is contrary to the national interest.
If an application is made to the Australian Treasurer (whether voluntary or compulsory), the Australian Treasurer may either issue a non-objection notice, a non-objection notice with conditions or a rejection notice.
If the necessary approvals are not obtained, the Treasurer has a range of enforcement powers, including the power to make an order requiring the acquirer to dispose of the shares it has acquired within a specified period of time. Once a foreign person (together with any associate) holds a direct interest or a substantial interest in an entity, any further acquisition of interests, including in the course of trading in the secondary market, would require a new FIRB approval unless an exemption applies.
Once granted, a FIRB approval is valid for a 12 month period, meaning the proposed acquisition which was the subject of an application can occur any time during that 12 month period.
Our Constitution does not contain any additional limitations on a non-resident’s right to hold or vote our securities.
Australian law requires the transfer of shares in our company to be made in writing or electronically through the Clearing House Electronic Sub-register System.
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E. Taxation
The following is a discussion of Australian and United States tax consequences material to our shareholders. To the extent that the discussion is based on tax legislation which has not been subject to judicial or administrative interpretation, the views expressed in the discussion might not be accepted by the tax authorities in question or by court. The discussion is not intended, and should not be construed, as legal or professional tax advice and does not exhaust all possible tax considerations.
Holders of our ADSs should consult their own tax advisors as to the United States, Australian or other tax consequences of the purchase, ownership and disposition of ADSs, including, in particular, the effect of any foreign, state or local taxes.
AUSTRALIAN TAX CONSEQUENCES
In this section we discuss the material Australian tax considerations that apply to non-Australian tax residents with respect to the acquisition, ownership and disposal of the absolute beneficial ownership of ADSs, which are evidenced by ADSs. This discussion is based upon existing Australian tax law as of the date of this Annual Report, which is subject to change, possibly retrospectively. This discussion does not address all aspects of Australian income tax law which may be important to particular investors in light of their individual investment circumstances, such as ADSs or shares held by investors subject to special tax rules (for example, financial institutions, insurance companies or tax exempt organizations). In addition, this summary does not discuss any foreign or state tax considerations, other than stamp duty. Prospective investors are urged to consult their tax advisors regarding the Australian and foreign income and other tax considerations of the purchase, ownership and disposition of the ADSs or shares.
Nature of ADSs for Australian Taxation Purposes
Holders of our ADSs are treated as the owners of the underlying ordinary shares for Australian income tax and capital gains tax purposes. Therefore, dividends paid on the underlying ordinary shares will be treated for Australian tax purposes as if they were paid directly to the owners of ADSs, and the disposal of ADSs will be treated for Australian tax purposes as the disposal of the underlying ordinary shares. In the following analysis we discuss the application of the Australian income tax and capital gains tax rules to non-Australian resident holders of ADSs.
Taxation of Dividends
Australia operates a dividend imputation system under which dividends may be declared to be “franked” to the extent they are paid out of company profits that have been subject to income tax. Fully franked dividends are not subject to dividend withholding tax. Dividends that are not franked or are partly franked and are paid to non-Australian resident shareholder are subject to dividend withholding tax, but only to the extent the dividends are not franked.
Dividends paid to a non-Australian resident shareholder are subject to withholding tax (a) except to the extent they have been franked and (b) at 30%, unless the shareholder is a resident of a country with which Australia has a double taxation agreement.
In accordance with the provisions of the Double Taxation Convention between Australia and the United States, the maximum rate of Australian withholding tax on any unfranked portion of a dividend to which a resident of the United States is beneficially entitled is 15%, where the U.S. resident holds less than 10% of the voting rights in our company, or 5% where the U.S. resident holds 10% or more of the voting rights in our company. Special rules apply to Regulated Investment Companies and Real Estate Investment Trusts that hold shares and receive dividends. The Double Taxation Convention between Australia and the United States does not apply to impose withholding tax on dividends where the ADSs are effectively connected to a permanent establishment or a fixed base carried on by the owner of the ADSs in Australia through which the shareholder carries on business or provides independent personal services, respectively. In such a case, the provisions of Article 7 (Business profits) or Article 14 (Independent personal services) of the Double Taxation Convention, as the case may be, would apply.
Tax on Sales or other Dispositions of Shares—Capital Gains Tax
Australian capital gains derived by non-Australian residents in respect of the disposal of capital assets that are not taxable Australian property will be disregarded. Non-Australian resident shareholders will not be subject to Australian capital gains tax on the capital gain made on a disposal of our shares, unless they, together with associates, hold 10% or more of our issued capital, tested either at the time of disposal or over any continuous 12 month period in the 24 months prior to disposal, and the value of our shares at the time of disposal is principally attributable to Australian real property assets.
Australian capital gains tax applies to net capital gains at a taxpayer’s marginal tax rate. Net capital gains are calculated after reduction for capital losses including certain prior year capital losses. Any remaining capital gain can be reduced by tax losses, including certain prior year tax losses.
Broadly, where there is a disposal of certain taxable Australian property, the purchaser will be required to withhold and remit to the Australian Taxation Office (“ATO”) 12.5% of the proceeds from the sale. A transaction is excluded from the withholding requirements in certain circumstances, including where the value of the taxable Australian property is less than A$750,000, the transaction is an on-market transaction conducted on an approved stock exchange or is conducted using a broker operated crossing system. There is also an exception to the requirement to withhold where the entity selling the shares provides the purchaser a declaration specifying either that they are an Australian resident or that the shares are not taxable Australian property (specifically, not ‘indirect Australian real property interests’). The non-Australian resident stockholder may be entitled to receive a tax credit for the tax withheld by the purchaser that they may claim in their Australian income tax return.
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Tax on Sales or other Dispositions of Shares—Shareholders Holding Shares on Revenue Account
Some non-Australian resident shareholders may hold shares on revenue account rather than on capital account, for example, stock traders. These shareholders may have the gains made on the sale or other disposal of the shares included in their assessable income under the ordinary income provisions of the income tax law, if the gains are sourced in Australia.
Non-Australian resident shareholders assessable under these ordinary income provisions in respect of gains made on shares held on revenue account would be assessed for such gains at the Australian tax rates for non-Australian residents, which start at a marginal rate of 32.5% for
non-Australian resident individuals. Some relief from the Australian income tax may be available to such non-Australian resident shareholders under the Double Taxation Convention between the United States and Australia, for example, because the shareholder does not have a permanent establishment in Australia.
To the extent an amount would be included in a non-Australian resident shareholder’s assessable income under both the capital gains tax provisions and the ordinary income provisions, the capital gain amount would generally be reduced to the extent the amount has been included in the assessable income of the shareholder. As a result, so that the shareholder would not be subject to double tax on any part of the income gain or capital gain.
Dual Residency
If a shareholder were a resident of both Australia and the United States under those countries’ domestic taxation laws, then such shareholder could be primarily subject to tax as an Australian resident. If, however, the shareholder is determined to be a U.S. resident for the purposes of the Double Taxation Convention between the United States and Australia, then the Australian tax applicable would be limited by the Double Taxation Convention (albeit the tie-breaker rules only apply for individuals). Shareholders should obtain specialist taxation advice in these circumstances.
Stamp Duty
A transfer of shares of a company listed on the Australian Securities Exchange is not subject to Australian stamp duty.
Australian Death Duty
Australia does not have estate or death duties. No capital gains tax liability is realized upon the inheritance of a deceased person’s shares. The disposal of inherited shares by beneficiaries, may, however, give rise to a capital gains tax liability.
Goods and Services Tax
The issue or transfer of shares will not incur Australian goods and services tax.
UNITED STATES FEDERAL INCOME TAX CONSEQUENCES
The following is a summary of material U.S. federal income tax consequences that generally apply to U.S. Holders (as defined below) who hold ADSs as capital assets within the meaning of Section 1221 of the Internal Revenue Code of 1986, as amended (the “Code”). This summary is based on the Code, its legislative history, final, temporary and proposed United States Treasury regulations promulgated thereunder, published rulings and court decisions, and the bilateral income tax convention between Australia and the United States (the “Treaty”), all as in effect on the date hereof and all of which are subject to change, or changes in interpretation, either prospectively or retroactively. This discussion does not address all of the tax consequences relating to the purchase, ownership, and disposition of ADSs and does not take into account U.S. Holders who may be subject to special rules, including: financial institutions, insurance companies, tax-exempt organizations, real estate investment trusts, regulated investment companies, grantor trusts, non-resident aliens of the United States or taxpayers whose functional currency is not the U.S. dollar, persons who hold the ADSs through partnerships or other pass-through entities, persons who acquired their ADSs through the exercise or cancellation of any employee stock options or otherwise as compensation for their services, investors that actually or constructively own 10% or more of our shares, dealers or traders in securities or currencies, certain former citizens or long-term residents of the United States, dual resident corporations, persons that generally mark their securities to market for United States federal income tax purposes, persons who are residents of Australia for Australian income tax purposes, and investors holding ADSs as part of a straddle or appreciated financial position or as part of a hedging or conversion transaction. This summary does not address the Medicare tax imposed on certain investment income, any state, local and foreign tax considerations or any U.S. federal estate, gift or alternative minimum tax considerations relevant to the purchase, ownership and disposition of our ADSs. In addition, this discussion is based in part upon representations of the depositary and the assumption that each obligation in the deposit agreement and any related agreements will be performed according to its terms.
If a partnership or an entity or arrangement treated as a partnership for U.S. federal income tax purposes owns ADSs, the U.S. federal income tax treatment of its partners will generally depend upon the status of the partner and the activities of the partnership. A partnership should consult its tax advisors regarding the U.S. federal income tax consequences applicable to it and its partners of the purchase, ownership and disposition of ADSs.
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For purposes of this summary, the term “U.S. Holder” means a beneficial owner of ADSs that is for U.S. federal income tax purposes: an individual who is a citizen or resident of the United States; a corporation that is created or organized in or under the laws of the United States or any political subdivision thereof; an estate whose income is subject to U.S. federal income tax regardless of its source; or a trust if (a) a court within the United States is able to exercise primary supervision over administration of the trust, and one or more U.S. persons have the authority to control all substantial decisions of the trust or (b) it has a valid election in effect under applicable U.S. Treasury regulations to be treated as a U.S. person.
Distributions
For U.S. federal income tax purposes, a U.S. Holder of ADSs will be treated as owning the ordinary shares underlying the ADSs. Subject to the passive foreign investment company rules discussed below, the gross amount of any distribution received by a U.S. Holder with respect to our ordinary shares or ADSs, including the amount of any Australian taxes withheld therefrom, will be included in gross income as a dividend to the extent the distribution is paid out of our current or accumulated earnings and profits (as determined under U.S. federal income tax principles). Distributions in excess of our earnings and profits will be treated first as a non-taxable return of capital to the extent of a U.S. Holder’s tax basis in the ADSs and thereafter will be treated as gain from the sale or exchange of the ADSs. We have not maintained and do not plan to maintain calculations of earnings and profits for U.S. federal income tax purposes. As a result, a U.S. Holder may need to include the entire amount of any such distribution in income as a dividend. Dividends will not, however, be eligible for the “dividends received deduction” generally allowed to corporate shareholders with respect to dividends received from U.S. corporations.
The U.S. dollar value of any distribution on the ADSs made in Australian dollars generally should be calculated by reference to the spot exchange rate between the U.S. dollar and the Australian dollar in effect on the date the distribution is actually or constructively received by the U.S. Holder regardless of whether the Australian dollars so received are in fact converted into U.S. dollars. A U.S. Holder who receives payment in Australian dollars and converts those Australian dollars into U.S. dollars at an exchange rate other than the rate in effect on such day may have a foreign currency
exchange gain or loss, which would generally be treated as ordinary income or loss from sources within the United States for U.S. foreign tax credit purposes.
Subject to complex limitations and certain holding period requirements, a U.S. Holder may elect to claim a credit for Australian tax withheld from distributions against its U.S. federal income tax liability. The limitations set out in the Code include computational rules under which foreign tax credits allowable with respect to specific classes of income cannot exceed the U.S. federal income taxes otherwise payable with respect to each such class of income. Dividends generally will be treated as foreign-source passive category income for U.S. foreign tax credit purposes or in the case of certain U.S. Holders as foreign source “general category” income. A U.S. Holder that does not elect to claim a U.S. foreign tax credit may instead claim a deduction for Australian tax withheld.
Subject to certain limitations, dividends received by a non-corporate U.S. Holder are subject to tax at a reduced maximum tax rate of 20 percent if the dividends are “qualified dividends”. Dividends are qualified dividends if: (a)(i) the issuer is entitled to benefits under the Treaty or (ii) the shares are readily tradable on an established securities market in the United States and (b) certain other requirements are met. We believe that we are entitled to benefits under the Treaty and that the ADSs currently are readily tradable on an established securities market in the United States. However, no assurance can be given that the ADSs will remain readily tradable. Further, the reduced rate does not apply to dividends if we are a PFIC in the year prior to or the year in which the dividend is paid.
The U.S. Treasury has expressed concerns that intermediaries in the chain of ownership between the holder of an ADS and the issuer of the security underlying the ADS may be taking actions that are inconsistent with the claiming of foreign tax credits for U.S. Holders of ADSs. Such actions would also be inconsistent with the claiming of the reduced rate of tax, described above, applicable to dividends received by certain non-corporate holders. Accordingly, the analysis of the creditability of Australian taxes and the availability of the reduced tax rate for dividends received by certain non-corporate holders, each described above, could be affected by actions taken by intermediaries in the chain of ownership between the holder of an ADS and our Company.
Disposition of ADSs
If you sell or otherwise dispose of ADSs, you will recognize gain or loss for U.S. federal income tax purposes in an amount equal to the difference between the U.S. dollar value of the amount realized on the sale or other disposition and your adjusted tax basis in the ADSs. Subject to the passive foreign investment company rules discussed below, such gain or loss generally will be capital gain or loss and will be long-term capital gain or loss if you have held the ADSs for more than one year at the time of the sale or other disposition. In general, any gain that you recognize on the sale or other disposition of ADSs will be gain from U.S. sources for purposes of the foreign tax credit limitation; losses will generally be allocated against U.S. source income. The deduction of capital losses is subject to certain limitations under the Code.
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In the case of a cash-basis U.S. Holder who receives Australian dollars in connection with the sale or other disposition of ADSs, the amount realized will be calculated based on the U.S. dollar value of the Australian dollars received as determined by reference to the spot rate in effect on the settlement date of such exchange. A U.S. Holder who receives payment in Australian dollars and converts Australian dollars into U.S. dollars at a conversion rate other than the rate in effect on the settlement date may have foreign currency exchange gain or loss that would be treated as ordinary income or loss from sources within the United States for U.S. foreign tax credit purposes.
An accrual-basis U.S. Holder may elect the same treatment required of cash-basis taxpayers with respect to a sale or disposition of ADSs, provided that the election is applied consistently from year to year. Such election may not be changed without the consent of the Internal Revenue Service (“IRS”). In the event that an accrual-basis U.S. Holder does not elect to be treated as a cash-basis taxpayer (pursuant to the Treasury regulations applicable to foreign currency transactions), such U.S. Holder may have foreign currency gain or loss for U.S. federal income tax purposes because of differences between the U.S. dollar value of the currency received prevailing on the trade date and the settlement date. Any such currency gain or loss would be treated as ordinary income or loss from sources within the United States for U.S. foreign tax credit purposes. However, if foreign currency is converted into U.S. dollars on the date received by the U.S. Holder, a cash-basis or electing accrual-basis U.S. Holder should not recognize any gain or loss on such conversion.
Passive Foreign Investment Companies
There is a risk that we may be a passive foreign investment company(“PFIC”), for U.S. federal income tax purposes. Our treatment as a PFIC could result in a reduction in the after-tax return to the U.S. Holders of our ADSs and may cause a reduction in the value of such securities.
For U.S. federal income tax purposes, we will be classified as a PFIC for any taxable year in which (i) 75% or more of our gross income is passive income, or (ii) at least 50% of the average value of all of our assets for the taxable year produce or are held for the production of passive income. For
this purpose, cash is considered to be an asset which produces passive income. Passive income generally includes dividends, interest, royalties, rents, annuities and the excess of gains over losses from the disposition of assets which produce passive income. In making a PFIC determination, we will be treated as owning our proportionate share of the assets and earning our proportionate share of the income of any other corporation in which we own, directly or indirectly, 25% or more (by value) of the stock. Based on the composition of our assets and income, we believe that we should not be treated as a PFIC for U.S. federal income tax purposes with respect to fiscal year 2022. However, the determination of PFIC status is a factual determination that must be made annually at the close of each taxable year and therefore, there can be no certainty as to our status in this regard until the close of the current or any future taxable year. Changes in the nature of our income or assets or a decrease in the trading price of our ADSs may cause us to be considered a PFIC in the current or any subsequent year. If we were a PFIC in any year during a U.S. Holder’s holding period for our ADSs, we would ordinarily continue to be treated as a PFIC for each subsequent year during which the U.S. Holder owned the ADSs.
Under the default PFIC “excess distribution” regime, if we are a PFIC in any taxable year during which a U.S. Holder owns ADSs, such U.S. Holder could be liable for additional taxes and interest charges upon (i) certain distributions by us (generally any distribution paid during a taxable year that is greater than 125 percent of the average annual distributions paid in the three preceding taxable years, or, if shorter, the U.S. Holder’s holding period for the ADSs), and (ii) any gain realized on a sale, exchange or other disposition, including a pledge, of the ADSs, whether or not we continue to be a PFIC for the year of the disposition. In these circumstances, the tax will generally be determined by allocating such distributions or gain ratably
over the U.S. Holder’s holding period for the ADSs. The amount allocated to the current taxable year and any year prior to the first taxable year in which we are a PFIC will be taxed as ordinary income (rather than capital gain) earned in the current taxable year. The amount allocated to other taxable years will be taxed at the highest applicable marginal rates for the year and an interest charge at the rate applicable to underpayments of tax will also be imposed on the amount of taxes allocated to such other taxable years.
An indirect shareholder may be taxed on a distribution paid to the direct owner of a PFIC and on a disposition of the stock indirectly owned. Indirect shareholders are strongly urged to consult their tax advisors regarding the application of these rules.
If we are a PFIC and subsequently cease to be a PFIC in a future year, a U.S. Holder may avoid the continued application of the tax treatment described above by electing to be treated as if it sold its ADSs on the last day of the last taxable year in which we were a PFIC. Any gain would generally be recognized and subject to tax under the excess distribution regime described above. Loss would not be recognized. A U.S. Holder’s basis in its ADSs would be increased by the amount of gain, if any, recognized on the deemed sale. A U.S. Holder would be required to treat its holding period for its ADSs as beginning on the day following the last day of the last taxable year in which we were a PFIC.
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If the ADSs are considered “marketable stock” and if a U.S. Holder properly elects to “mark-to-market” its ADSs in a timely fashion, the U.S. Holder would not be subject to tax under the excess distribution regime described above. Instead, the U.S. Holder would generally include in income any excess of the fair market value of the ADSs at the close of each tax year over the adjusted tax basis of the ADSs. If the fair market value of the ADSs had depreciated below the adjusted basis at the close of the tax year, the U.S. Holder would be entitled to deduct the excess of the adjusted basis of the ADSs over their fair market value at that time. However, such deductions generally would be limited to the net mark-to-market gains, if any, the U.S. Holder included in income with respect to such ADSs in prior years. Income recognized and deductions allowed under the mark-to-market provisions, as well as any gain or loss on the disposition of ADSs with respect to which the mark-to-market election is made, is treated as ordinary income or loss (except that loss is treated as capital loss to the extent the loss exceeds the net mark-to-market gains, if any, that a U.S. Holder included in income with respect to such ordinary shares in prior years). However, gain or loss from the disposition of ADSs (as to which a “mark-to-market” election was properly made) in a year in which we are no longer a PFIC, will be capital gain or loss. Our ordinary shares or ADSs will be “marketable” stock as long as they remain regularly traded on a national securities exchange, such as the Nasdaq, or a foreign securities exchange regulated by a governmental authority of the country in which the market is located and which meets certain requirements, including that the rules of the exchange effectively promote active trading of listed stocks. If such stock is traded on such a qualified exchange or other market, such stock generally will be “regularly traded” for any calendar year during which such stock is traded, other than in de minimis quantities, on at least 15 days during each calendar quarter, but no assurances can be given in this regard. Our ordinary shares are traded on the ASX, which may qualify as an eligible foreign securities exchange for this purpose. Because a mark-to-market election cannot be made for any lower-tier PFICs that we may own, a U.S. Holder may continue to be subject to the PFIC rules with respect to such holder’s indirect interest in any investments held by us that are treated as an equity interest in a PFIC for U.S. federal income tax purposes, including shares in any of our subsidiaries that are treated as PFICs.
A U.S. Holder of ADSs will not be able to avoid the tax consequences described above by electing to treat us as a qualified electing fund. In general, a qualified electing fund is, with respect to a U.S. person, a PFIC if the U.S. person has elected to include its proportionate share of a company’s ordinary earnings and net capital gains in U.S. income on an annual basis. A qualified electing fund election can only be made with respect to us if we provide U.S. Holders with certain information on an annual basis and we do not intend to prepare the information that U.S. Holders would need to make the qualified electing fund election.
Backup Withholding and Information Reporting
Payments in respect of ADSs may be subject to information reporting to the IRS and to U.S. backup withholding tax (at a rate of 24% under current law). Backup withholding will not apply, however, if a U.S. Holder (i) is a corporation, (ii) satisfies an applicable exemption, or (iii) furnishes correct taxpayer identification.
Backup withholding is not an additional tax. Amounts withheld under the backup withholding rules may be credited against a U.S. Holder’s U.S. tax liability, and a U.S. Holder may obtain a refund of any excess amounts withheld under the backup withholding rules by filing the appropriate claim for refund with the IRS.
| F. | Dividends and Paying Agents |
Not applicable.
G. Statement by Experts
Not applicable.
H. Documents on Display
We are subject to the reporting requirements of the U.S. Securities Exchange Act of 1934, as amended, or the Exchange Act, as applicable to “foreign private issuers” as defined in Rule 3b-4 under the Exchange Act. As a foreign private issuer, we are exempt from certain provisions of the Exchange Act. Accordingly, our proxy solicitations are not subject to the disclosure and procedural requirements of regulation 14A under the Exchange Act, transactions in our equity securities by our officers and directors are exempt from reporting and the “short-swing” profit recovery provisions contained in Section 16 of the Exchange Act. In addition, we are not required under the Exchange Act to file periodic reports and financial statements as frequently or as promptly as U.S. companies whose securities are registered under the Exchange Act. However, we file with the U.S. Securities and Exchange Commission an Annual Report on Form 20-F containing financial statements that have been examined and reported on, with and opinion expressed by an independent registered public accounting firm, and we submit reports to the U.S. Securities and Exchange Commission on Form 6-K containing (among other things) press releases and unaudited financial information for the first six months of each fiscal year. We post our Annual Report on Form 20-F on our website promptly following the filing of our Annual Report with the U.S. Securities and Exchange Commission. The information on our website is not incorporated by reference into this Annual Report.
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This document and the exhibits thereto and any other document we file pursuant to the Exchange Act may be inspected without charge and copied at prescribed rates at the U.S. Securities and Exchange Commission public reference room at 100 F Street, N.E., Room 1580, Washington D.C. 20549. You may obtain information on the operation of the Securities and Exchange Commission’s public reference room in Washington, D.C. by calling the U.S. Securities and Exchange Commission at 1-800-SEC-0330.
The U.S. Securities and Exchange Commission maintains a website at www.sec.gov that contains reports, proxy and information statements and other information regarding registrants that make electronic filings with the U.S. Securities and Exchange Commission using its EDGAR (Electronic Data Gathering, Analysis, and Retrieval) system.
The documents concerning our company which are referred to in this document may also be inspected at our office located at Level 33, Australia Square, 264 George Street, Sydney New South Wales 2000, Australia.
| I. | Subsidiary Information |
We currently have the following significant subsidiaries:
| • | Immutep USA Inc, a 100% owned subsidiary of Immutep Limited, incorporated in the State of Delaware in the United States. |
| • | Immutep GmbH, a 100% owned subsidiary of Immutep Limited, incorporated in Germany. |
| • | Immutep Australia Pty Ltd, a 100% owned subsidiary of Immutep Limited, incorporated in Australia. |
| • | Immutep S.A.S., a 100% owned subsidiary of Immutep Limited, incorporated in France |
These subsidiaries were established to allow us to conduct commercial and clinical operations in Europe and the United States.
| ITEM 11. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
Our cash and cash equivalents consist primarily of cash and money market funds. We invest our excess cash and cash equivalents in interest- bearing accounts and term deposits with banks in Australia. Our primary exposure to market risk is interest income sensitivity, which is affected by changes in the general level of Australian interest rates. However, because of the short-term nature of the instruments in our portfolio, a sudden change in market interest rates would not be expected to have a material impact on our financial condition and/or results of operation.
We conduct our activities predominantly in Australia. However, we are exposed to foreign currency risk via trade and other payables we hold. We are required to make certain payments in U.S. dollars, European Euro and other currencies. See “Note 2. Financial Risk Management—(a) Market Risk” to our notes to the financial statements for a further discussion of market risk and sensitivity analysis.
Our exposure to foreign currency risk at the end of the reporting period, expressed in Australian dollar, was as follows:
| June 30, 2022 | June 30, 2021 | |||||||||||||||
| USD | EUR | USD | EUR | |||||||||||||
| Cash in bank |
11,897,759 | 42,964,345 | 14,016,277 | 14,320,386 | ||||||||||||
| Trade and other receivables |
15,568 | 4,094,262 | 49,880 | 4,312,691 | ||||||||||||
| Trade and other payables |
(1,068,539 | ) | (1,717,675 | ) | (690,847 | ) | (663,196 | ) | ||||||||
| ITEM 12. | DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES |
| A. | Debt Securities |
Not applicable.
| B. | Warrants and Rights |
Not applicable.
| C. | Other Securities |
Not applicable.
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| D. | American Depositary Shares |
On December 28, 2016, we changed the ordinary share-to-ADS ratio from 30:1 to 100:1. ADS sale prices for dates prior to such change are adjusted to give effect to such change. After the completion of 10 to 1 share consolidation in November 2019, we changed the ADS ratio from 100:1 to 10:1, Each ADS now represents 10 ordinary shares.
The following are fees and charges that a holder of our ADSs may have to pay to the Bank of New York Mellon, as depositary:
| Persons depositing or withdrawing ordinary shares or ADS holders must pay: | For: | |
| US$5.00 (or less) per 100 ADSs (or portion of 100 ADSs) | • Issuance of ADSs, including issuances resulting from a distribution of ordinary shares or rights or other property | |
| • Cancellation of ADSs for the purpose of withdrawal, including if the deposit agreement terminates | ||
| US$0.05 (or less) per ADS | • Any cash distribution to ADS holders | |
| A fee equivalent to the fee that would be payable if securities distributed to an ADS holder had been ordinary shares and the ordinary shares had been deposited for issuance of ADSs, i.e., US$5.00 or less per 100 ADSs (or portion of 100 ADSs) | • Distribution of securities distributed to holders of deposited securities which are distributed by the depositary to ADS holders | |
| US$0.05 (or less) per ADSs per calendar year | • Depositary services | |
| Registration or transfer fees | • Transfer and registration of ordinary shares on our ordinary share register to or from the name of the depositary or its agent when an ADS holder deposits or withdraws ordinary shares | |
| Expenses of the depositary | • Cable, telex and facsimile transmissions (when expressly provided in the deposit agreement) | |
| • converting foreign currency to U.S. dollars | ||
| Taxes and other governmental charges the depositary or the custodian have to pay on any ADS or ordinary share underlying an ADS, for example, stock transfer taxes, stamp duty or withholding taxes | • As necessary | |
| Any charges incurred by the depositary or its agents for servicing the deposited securities | • As necessary | |
The depositary collects its fees for delivery and surrender of ADSs directly from investors depositing shares or surrendering ADSs for the purpose of withdrawal or from intermediaries acting for them. The depositary collects fees for making distributions to investors by deducting those fees from the amounts distributed or by selling a portion of distributable property to pay the fees. The depositary may collect its annual fee for depositary services by deduction from cash distributions or by directly billing investors or by charging the book-entry system accounts of participants acting for them. The depositary may collect any of its fees by deduction from any cash distribution payable to ADS holders that are obligated to pay those fees. The depositary may generally refuse to provide fee-attracting services until its fees for those services are paid.
From time to time, the depositary may make payments to us to reimburse and/or share revenue from the fees collected from ADS holders, or waive fees and expenses for services provided, generally relating to costs and expenses arising out of establishment and maintenance of the ADS program. In performing its duties under the deposit agreement, the depositary may use brokers, dealers or other service providers that are affiliates of the depositary and that may earn or share fees or commissions.
The depositary may convert currency itself or through any of its affiliates and, in those cases, acts as principal for its own account and not as agent, advisor, broker or fiduciary on behalf of any other person and earns revenue, including transaction spreads, that it will retain for its own account. The revenue is based on, among other things, the difference between the exchange rate assigned to the currency conversion made under the deposit agreement and the rate that the depositary or its affiliate receives when buying or selling foreign currency for its own account. The depositary makes no representation that the exchange rate used or obtained in any currency conversion under the deposit agreement will be the most favorable rate that could be obtained at that time or that the method by which that rate will be determined will be the most favorable to ADS holders, subject to the depositary’s obligations under the deposit agreement. The methodology used to determine exchange rates used in currency conversions is available upon request to the depositary.
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ADS holders are responsible for any taxes or other governmental charges payable on its ADSs or on the deposited securities represented by any of its ADSs. The depositary may refuse to register any transfer ADSs or allow an ADS holder to withdraw the deposited securities represented by its ADSs until such taxes or other charges are paid. It may apply payments owed to an ADS holder or sell deposited securities represented by an ADS holder’s ADSs to pay any taxes owed and such ADS holder will remain liable for any deficiency. If the depositary sells deposited securities, it will, if appropriate, reduce the number of ADSs to reflect the sale and pay to the holders of ADSs holder any proceeds, or send to the holders of ADSs any property, remaining after it has paid the taxes.
See Exhibit 2.4 “Description of Securities” for additional information on the ADSs.
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PART II
| ITEM 13. | DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES |
Not applicable.
| ITEM 14. | MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS |
Not applicable.
| ITEM 15. | CONTROLS AND PROCEDURES |
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has performed an evaluation of the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act) as of June 30, 2022, as required by Rule 13a-15(b) under the Exchange Act. Based on that evaluation, our management has concluded that, as of June 30, 2022, our disclosure controls and procedures were effective.
Management’s Annual Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rule 13a-15(f). Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting as of June 30, 2022 based on the criteria set forth in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO 2013). Based on our evaluation under the criteria set forth in Internal Control — Integrated Framework, our management concluded that our internal control over financial reporting was effective as of June 30, 2022.
Our auditor, PricewaterhouseCoopers, an independent registered public accounting firm, have provided an attestation report on our internal control over financial reporting, which is included herein.
Inherent Limitations on Effectiveness of Controls
In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints, and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs.
Changes in Internal Control Over Financial Reporting
There has been no change in our internal control over financial reporting (as defined in Rule 13a-15(f) of the Exchange Act) for the fiscal year ended June 30, 2022 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
| ITEM 16. | RESERVED |
Not applicable.
| ITEM 16A. | AUDIT COMMITTEE FINANCIAL EXPERT |
Pete Meyers is a member of our board of directors and serves on our audit committee. Our board has determined that Pete Meyers is an audit committee financial expert and satisfies the “independence” requirements of the U.S. Securities and Exchange Commission, the NASDAQ Marketplace Rules and ASX Rules.
| ITEM 16B. | CODE OF ETHICS |
We have adopted a code of conduct that applies to our directors, chief executive officer and all senior financial officers of our company, including the chief financial officer, chief accounting officer or controller, or persons performing similar functions. The code of conduct is publicly available as attachment C to our Board Charter on our website at www.immutep.com.
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Written copies are available upon request. If we make any substantive amendment to the code of conduct or grant any waivers, including any implicit waiver, from a provision of the code of conduct, we will disclose the nature of such amendment or waiver on our website.
| ITEM 16C. | PRINCIPAL ACCOUNTANT FEES AND SERVICES |
We retained PricewaterhouseCoopers as our independent registered public accounting firm. Set forth below is a summary of the fees paid to PricewaterhouseCoopers for services provided in fiscal years 2022 and 2021.
PricewaterhouseCoopers
| Fiscal 2022 A$ |
Fiscal 2021 A$ |
|||||||
| Audit fees |
561,485 | 289,202 | ||||||
| Other audit-related services in relation to US regulatory filings |
— | — | ||||||
|
|
|
|
|
|||||
| Total remuneration of PricewaterhouseCoopers Australia |
561,485 | 289,202 | ||||||
Pre-Approval Policies and Procedures
Our Audit Committee has adopted policies and procedures for the pre-approval of audit and non-audit services rendered by our independent registered public accounting firm. Pre-approval of an audit or non-audit service may be given as a general pre-approval, as part of the audit committee’s approval of the scope of the engagement of our independent registered public accounting firm, or on an individual basis. Any proposed services exceeding general pre-approved levels also requires specific pre-approval by our audit committee. The policy prohibits retention of the independent registered public accounting firm to perform the prohibited non-audit functions defined in Section 201 of the Sarbanes-Oxley Act or the rules of the Securities and Exchange Commission, and also requires the audit committee to consider whether proposed services are compatible with the independence of the registered public accounting firm.
| ITEM 16D. | EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES |
Not applicable.
| ITEM 16E. | PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS |
Not applicable
| ITEM 16F. | CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT |
Not applicable.
| ITEM 16G. | CORPORATE GOVERNANCE |
Under NASDAQ Stock Market Rule 5615(a)(3), foreign private issuers, such as our company, are permitted to follow certain home country corporate governance practices instead of certain provisions of the NASDAQ Stock Market Rules. A foreign private issuer that elects to follow a home country practice instead of any such NASDAQ rules must submit to NASDAQ, in advance, a written statement from an independent counsel in such issuer’s home country certifying that the issuer’s practices are not prohibited by the home country’s laws. We submitted such a written statement to NASDAQ. See “Item 6. Directors, Senior Management and Employees—C. Board Practices—Corporate Governance Requirements— Nasdaq Global Market Marketplace Rules” for a summary of such differences.
| ITEM 16H. | MINE SAFETY DISCLOSURE |
Not applicable.
| ITEM 16I. | DISCLOSURE REGARDING FOREIGN JURISDICTION THAT PREVENT INSPECTIONS |
Not applicable.
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PART III
| ITEM 17. | FINANCIAL STATEMENTS |
We have elected to furnish financial statements and related information specified in Item 18.
| ITEM 18. | FINANCIAL STATEMENTS |
The following financial statements are filed as part of this annual report on Form 20-F.
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Page |
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F-2 |
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F-3 |
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F-4 |
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F-5 |
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F-6 |
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F-7 |
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Report of Independent Registered Public Accounting Firm |
June 30, |
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Note |
2022 A$ |
2021 A$ |
||||||||||
| ASSETS |
||||||||||||
| Current Assets |
||||||||||||
| Cash and cash equivalents |
|
7 | |
|
||||||||
| Current receivables |
|
8 | |
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| Other current assets |
|
9 | |
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|||||||
| Total Current Assets |
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| Non-Current Assets |
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| Plant and equipment |
|
11 | |
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| Intangibles |
|
12 | |
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| Right of use assets |
|
19 | |
|||||||||
| Other non-current assets |
|
10 | |
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| |
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|
|
|||||||
| Total Non-Current Assets |
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| |
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| TOTAL ASSETS |
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| |
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|||||||
| Current Liabilities |
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| Trade and other payables |
|
14 | |
|||||||||
| Employee benefits |
|
17 | |
|||||||||
| Warrant liability |
|
15 | |
|||||||||
| Lease liability |
|
19 | |
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| |
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|
|
|||||||
| Total Current Liabilities |
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| |
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| Non-Current Liabilities |
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||||||||||
| Convertible note liability |
|
16 | |
|||||||||
| Warrant liability |
|
15 | |
|||||||||
| Employee benefits |
|
18 | |
|||||||||
| Lease liability |
|
19 | |
|||||||||
| Deferred tax liability |
|
13 | |
|||||||||
| |
|
|
|
|
|
|||||||
| Total Non-Current Liabilities |
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| |
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| TOTAL LIABILITIES |
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| NET ASSETS |
|
|
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| |
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|
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|
|
|||||||
| EQUITY |
|
|
||||||||||
| Contributed equity |
|
20 | |
|||||||||
| Reserves |
|
21 | |
|||||||||
| Accumulated losses |
|
21 | |
( |
) | ( |
) | |||||
| |
|
|
|
|
|
|||||||
| Equity attributable to the owners of Immutep Limited |
|
|
||||||||||
| |
|
|
|
|
|
|||||||
| TOTAL EQUITY |
|
|
||||||||||
Note |
Years ended June 30, |
|||||||||||||||
2022 A$ |
2021 A$ |
2020 A$ |
||||||||||||||
Revenue |
||||||||||||||||
License revenue |
||||||||||||||||
Other income |
||||||||||||||||
Research material sales |
||||||||||||||||
Grant income |
||||||||||||||||
Net gain on foreign exchange |
||||||||||||||||
Net gain on fair value movement of warrants |
15 | |||||||||||||||
Interest income |
||||||||||||||||
Total revenue and other income |
||||||||||||||||
Expenses |
||||||||||||||||
Research development and intellectual property |
5 | ( |
) | ( |
) | ( |
) | |||||||||
Corporate administrative expenses |
5 | ( |
) | ( |
) | ( |
) | |||||||||
Net loss on fair value movement of warrants |
15 | ( |
) | |||||||||||||
Net loss on foreign exchange |
( |
) | ||||||||||||||
Finance costs |
( |
) | ( |
) | ( |
) | ||||||||||
Changes in fair value of convertible note liability |
16 | ( |
) | ( |
) | ( |
) | |||||||||
Loss before income tax expense |
( |
) |
( |
) |
( |
) | ||||||||||
Income tax (expense)/ benefit |
6 | ( |
) | ( |
) | ( |
) | |||||||||
Loss after income tax expense for the year |
( |
) |
( |
) |
( |
) | ||||||||||
Other Comprehensive Income/(Loss) |
||||||||||||||||
Items that may be reclassified to profit or loss |
||||||||||||||||
Exchange differences on the translation of foreign operations |
( |
) | ( |
) | ||||||||||||
Other comprehensive income/(loss) for the year net of tax |
( |
) |
( |
) |
||||||||||||
Total comprehensive loss for the year |
( |
) |
( |
) |
( |
) | ||||||||||
Loss for the year is attributable to: |
||||||||||||||||
Owners of Immutep Limited |
( |
) | ( |
) | ( |
) | ||||||||||
( |
) |
( |
) |
( |
) | |||||||||||
Total comprehensive loss for the year is attributable to: |
||||||||||||||||
Owners of Immutep Limited |
( |
) | ( |
) | ( |
) | ||||||||||
( |
) |
( |
) |
( |
) | |||||||||||
Cents |
Cents |
Cents |
||||||||||||||
Basic loss per share |
31 | ( |
) | ( |
) | ( |
) | |||||||||
Diluted loss per share |
31 | ( |
) | ( |
) | ( |
) | |||||||||
Note |
Years Ended June 30, |
|||||||||||||||
2022 A$ |
2021 A$ |
2020 A$ |
||||||||||||||
| Cash flows related to operating activities |
||||||||||||||||
| Payments to suppliers and employees (inclusive of GST) |
( |
) | ( |
) | ( |
) | ||||||||||
| Cash receipts from grant income and government incentives |
||||||||||||||||
| Cash receipts from license revenue |
||||||||||||||||
| Cash receipts from research material sales |
||||||||||||||||
| Interest received |
||||||||||||||||
| Advance from customers |
||||||||||||||||
| Income Tax paid |
( |
) | ( |
) | ( |
) | ||||||||||
| Payment for security deposit |
||||||||||||||||
| Payment for interest on leases |
( |
) | ( |
) | ( |
) | ||||||||||
| |
|
|
|
|
|
|||||||||||
| Net cash flows used in operating activities |
30 | ( |
) |
( |
) |
( |
) | |||||||||
| |
|
|
|
|
|
|||||||||||
| Cash flows related to investing activities |
||||||||||||||||
| Payments for plant and equipment |
( |
) | ( |
) | ( |
) | ||||||||||
| |
|
|
|
|
|
|||||||||||
| Net cash flows used in investing activities |
11 | ( |
) |
( |
) |
( |
) | |||||||||
| |
|
|
|
|
|
|||||||||||
| Cash flows related to financing activities* |
||||||||||||||||
| Proceeds from issue of shares |
20 | |||||||||||||||
| Proceeds from issue of warrants |
||||||||||||||||
| Proceeds from exercising of warrants |
15 | |||||||||||||||
| Share issue transaction costs |
20 | ( |
) | ( |
) | ( |
) | |||||||||
| Principal elements of lease payments |
19 | ( |
) | ( |
) | ( |
) | |||||||||
| Advance payment from shareholders for SPP |
||||||||||||||||
| Transaction costs of warrant issues |
||||||||||||||||
| |
|
|
|
|
|
|||||||||||
| Net cash flows provided by (used in) financing activities |
||||||||||||||||
| |
|
|
|
|
|
|||||||||||
| Net increase/(decrease) in cash and cash equivalents |
||||||||||||||||
| Effect of exchange rate on cash and cash equivalents |
( |
) | ( |
) | ||||||||||||
| Cash and cash equivalents at the beginning of the year |
||||||||||||||||
| |
|
|
|
|
|
|||||||||||
| Cash and cash equivalents at the end of the year |
7 | |||||||||||||||
* |
Non-cash investing and financing activities relate mainly to the following: |
• |
Fair value movement of convertible notes disclosed in Note 16 to the financial statements. |
• |
Fair value movement of warrant liability disclosed in Note 15 to the financial statements. |
• |
Exercise of vested performance rights for no cash consideration disclosed in Note 21 to the financial statements. |
| Consolidated |
Issued Equity A$ |
Reserve A$ |
Accumulated losses A$ |
Total equity A$ |
||||||||||||
| Balance at July 1, 2019 |
( |
) |
||||||||||||||
| Other comprehensive income for the year, net of tax |
||||||||||||||||
| Loss after income tax expense for the year |
( |
) | ( |
) | ||||||||||||
| Total comprehensive income/(loss) for the year |
( |
) |
( |
) | ||||||||||||
| Transactions with owners in their capacity as owners: |
||||||||||||||||
| Contributions of equity, net of transaction costs |
||||||||||||||||
| Employee share based payment |
||||||||||||||||
| Exercise of vested performance rights |
( |
) | ||||||||||||||
| Balance at June 30, 2020 |
( |
) |
||||||||||||||
Consolidated |
Issued Equity A$ |
Reserves A$ |
Accumulated losses A$ |
Total equity A$ |
||||||||||||
| Balance at July 1, 2020 |
( |
) |
||||||||||||||
| Other comprehensive income for the year, net of tax |
( |
) | ( |
) | ||||||||||||
| Loss after income tax expense for the year |
( |
) | ( |
) | ||||||||||||
| |
|
|
|
|
|
|||||||||||
| Total comprehensive income/(loss) for the year |
( |
) |
( |
) |
( |
) | ||||||||||
| |
|
|
|
|
|
|||||||||||
| Transactions with owners in their capacity as owners: |
||||||||||||||||
| Contributions of equity, net of transaction costs |
||||||||||||||||
| Conversion of Convertible Notes |
( |
) | ||||||||||||||
| Exercise of Warrants net of transaction costs |
||||||||||||||||
| Employee share based payment |
||||||||||||||||
| Exercise of vested performance rights |
( |
) | ||||||||||||||
| Balance at June 30, 2021 |
( |
) |
||||||||||||||
Consolidated |
Issued Equity A$ |
Reserves A$ |
Accumulated losses A$ |
Total equity A$ |
||||||||||||
| Balance at July 1, 2021 |
( |
) |
||||||||||||||
| Other comprehensive income for the year, net of tax |
( |
) | ( |
) | ||||||||||||
| Loss after income tax expense for the year |
( |
) | ( |
) | ||||||||||||
| Total comprehensive income/(loss) for the year |
( |
) |
( |
) |
( |
) | ||||||||||
| Transactions with owners in their capacity as owners: |
||||||||||||||||
| Contributions of equity, net of transaction costs |
||||||||||||||||
| Conversion of Convertible Notes |
( |
) | ||||||||||||||
| Employee share based payment |
||||||||||||||||
| Exercise of vested performance rights |
( |
) | ||||||||||||||
| Balance at June 30, 2022 |
( |
) |
||||||||||||||
| • | AASB 2020-8 Amendments to Australian Accounting Standards – Interest Rate Benchmark Reform Phase 2 |
| • | AASB 2014-10 Amendments to Australian Accounting Standards – Sale or Contribution of Assets between an Investor and its Associate or Joint Venture (effective from January 1, 2025) |
| • | assets and liabilities for each balance sheet presented are translated at the closing rate at the date of that balance sheet; |
| • | income and expenses for each income statement and statement of comprehensive loss are translated at average exchange rates (unless this is not a reasonable approximation of the cumulative effect of the rates prevailing on the transaction dates, in which case income and expenses are translated at the dates of the transactions), and |
| • | all resulting exchange differences are recognized in other comprehensive income. |
• |
The payment terms of the variable consideration relate specifically to the Group’s efforts to satisfy that performance obligation or transfer the distinct good or service (or to a specific outcome from satisfying that separate performance obligation). |
• |
Allocating the variable amount entirely to the separate performance obligation or the distinct good or service reflects the amount of consideration to which the Group expects to be entitled in exchange for satisfying that particular performance obligation when considering all of the performance obligations and payment terms in the contract. |
• |
financial assets at amortized cost |
• |
financial assets at fair value through profit or loss |
• |
financial assets at fair value through other comprehensive income |
• |
The entity’s business model for managing the financial asset |
• |
The contractual cash flow characteristics of the financial assets |
• |
they are held within a business model whose objective is to hold the financial assets and collect its contractual cash flows. |
• |
the contractual terms of the financial assets give rise to cash flows that are solely payments of principal and interest on the principal amount outstanding. |
| • | Computers – |
| • | Plant and equipment – 5 |
| • | Furniture – 5 |
• |
the profit or loss attributable to owners of the Company |
• |
by the weighted average number of ordinary shares outstanding during the fiscal year, adjusted for bonus elements in ordinary shares issued during the year. Bonus elements have been included in the calculation of the weighted average number of ordinary shares and has been retrospectively applied to the prior fiscal year. |
| • | the after income tax effect of interest and other financing costs associated with dilutive potential ordinary shares, and |
| • | the weighted average number of additional ordinary shares that would have been outstanding assuming the conversion of all dilutive potential ordinary shares. |
| • | fixed payments (including in-substance fixed payments), less any lease incentives receivable |
| • | variable lease payment that are based on an index or a rate, initially measured using the index or rate as at the commencement date |
| • | amounts expected to be payable by the Group under residual value guarantees |
| • | the exercise price of a purchase option if the Group is reasonably certain to exercise that option, and |
| • | payments of penalties for terminating the lease, if the lease term reflects the Group exercising that option. |
| • | the amount of the initial measurement of lease liability |
| • | any lease payments made at or before the commencement date less any lease incentives received |
| • | any initial direct costs, and |
| • | restoration costs. |
June 30, 2022 |
June 30, 2021 |
|||||||||||||||
USD |
EUR |
USD |
EUR |
|||||||||||||
Cash in bank |
||||||||||||||||
Trade and other receivables |
||||||||||||||||
Trade and other payables |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
June 30, 2022 |
June 30, 2021 |
|||||||
$ |
$ |
|||||||
Cash at bank and short-term bank deposits excluding restricted cash |
||||||||
Minimum rating of A |
||||||||
Contractual maturities of financial liabilities |
Less than 12 months |
Between 1 and 5 years |
More than 5 years |
Total contractual cash flows |
Carrying Amount (assets) / liabilities |
|||||||||||||||
At June 30, 2022 |
$ |
$ |
$ |
$ |
$ |
|||||||||||||||
Non-Derivatives |
||||||||||||||||||||
Trade and other payables |
— | — | ||||||||||||||||||
Convertible note liability (refer note 16) |
— | — | ||||||||||||||||||
Lease liability |
||||||||||||||||||||
Contractual maturities of financial liabilities |
Less than 12 months |
Between 1 and 5 years |
More than 5 years |
Total contractual cash flows |
Amount (assets) / liabilities |
|||||||||||||||
At June 30, 2021 |
$ |
$ |
$ |
$ |
$ |
|||||||||||||||
Non-Derivatives |
||||||||||||||||||||
Trade and other payables |
— | — | ||||||||||||||||||
Convertible note liability (refer note 16) |
— | — | ||||||||||||||||||
Lease liability |
||||||||||||||||||||
— |
||||||||||||||||||||
At June 30, 2022 |
Level 1 $ |
Level 2 $ |
Level 3 $ |
Total $ |
||||||||||||
Liabilities |
||||||||||||||||
Convertible note liability |
— | — | ||||||||||||||
Warrant liability |
— | — | ||||||||||||||
Total liabilities |
— |
|||||||||||||||
At June 30, 2021 |
Level 1 $ |
Level 2 $ |
Level 3 $ |
Total $ |
||||||||||||
Liabilities |
||||||||||||||||
Convertible note liability |
— | — | ||||||||||||||
Warrant liability |
— | — | ||||||||||||||
Total liabilities |
— |
|||||||||||||||
| • | The use of quoted market prices or dealer quotes for similar instruments |
| • | The fair value of interest rate swaps is calculated as the present value of the estimated future cash flows based on observable yield curves |
| • | The fair value of forward foreign exchange contracts is determined using forward exchange rates at the balance sheet date |
| • | The fair value of the remaining financial instruments is determined using discounted cash flow analysis. |
| • | There are |
| • | Level 2 financial instruments consist of warrant liabilities. Refer to Note 15 for details of fair value measurement. |
| • | Level 3 financial instruments consist of convertible notes. Refer to Note 16 for details of fair value measurement. |
Description |
Fair Value at June 30, 2022 $ |
Unobservable inputs |
Range of inputs | |||||
Convertible note |
Face Value | |||||||
| Interest Rate of Note | % | |||||||
| Risk adjusted Interest rate | % | |||||||
| • | The continued pandemic has led to volatility in the global capital markets, which could adversely affect the company’s ability to access the capital markets. |
| • | It is possible that the continued spread of COVID-19 could delay the future recruitment of clinical trials and therefore could lead to an indication of impairment in the intangible assets. |
| • | The continued pandemic could cause the delay of clinical trials conducted by our partners, which could potentially have an adverse impact on the future license income. |
| • | Cash held with bank |
| • | Intellectual property |
| • | Accounts receivables and payables with external parties |
| Operating segment information June 30, 2022 |
Immunotherapy A$ |
Unallocated A$ |
Consolidated A$ |
|||||||||
| Revenue |
||||||||||||
| License revenue* |
— | |||||||||||
| Other income |
||||||||||||
| Research material sales |
— | |||||||||||
| Grant income |
— | |||||||||||
| Net gain on fair value movement of warrants |
— | |||||||||||
| Net gain on foreign exchange |
— | |||||||||||
| Interest income |
— | |||||||||||
| |
|
|
|
|
|
|||||||
| Total revenue and other income |
||||||||||||
| |
|
|
|
|
|
|||||||
| Segment Result |
( |
) | ( |
) | ||||||||
| |
|
|
|
|
|
|||||||
| Profit/(loss) before income tax expense |
( |
) |
( |
) | ||||||||
| Income tax expense |
( |
) | ||||||||||
| |
|
|||||||||||
| Loss after income tax expense |
( |
) | ||||||||||
| |
|
|||||||||||
| Total segment assets |
— |
|||||||||||
| Total segment liabilities |
— |
|||||||||||
| Operating segment information June 30, 2021 |
Immunotherapy A$ |
Unallocated A$ |
Consolidated |
|||||||||
| Revenue |
||||||||||||
| License revenue* |
— | — | — | |||||||||
| Other income |
||||||||||||
| Research material sales |
— | |||||||||||
| Grant income |
— | |||||||||||
| Net gain on fair value movement of warrants |
— | — | — | |||||||||
| Net gain on foreign exchange |
— | — | — | |||||||||
| Interest income |
— | |||||||||||
| |
|
|
|
|
|
|||||||
| Total revenue and other income |
||||||||||||
| |
|
|
|
|
|
|||||||
| Segment Result |
( |
) | ( |
) | ( |
) | ||||||
| |
|
|
|
|
|
|||||||
| Profit/(loss) before income tax expense |
( |
) |
( |
) |
( |
) | ||||||
| Income tax expense |
( |
) | ||||||||||
| |
|
|||||||||||
| Loss after income tax expense |
( |
) | ||||||||||
| |
|
|||||||||||
| Total segment assets |
— |
|||||||||||
| Total segment liabilities |
— |
|||||||||||
| Operating segment information June 30, 2020 |
Immunotherapy A$ |
Unallocated A$ |
Consolidated A$ |
|||||||||
| Revenue |
||||||||||||
| License revenue* |
— | |||||||||||
| Other income |
||||||||||||
| Research material sales |
— | |||||||||||
| Grant income |
— | |||||||||||
| Net gain on fair value movement of warrants |
— | |||||||||||
| Net gain on foreign exchange |
— | |||||||||||
| Interest income |
— | |||||||||||
| |
|
|
|
|
|
|||||||
| Total revenue and other income |
||||||||||||
| |
|
|
|
|
|
|||||||
| Segment Result |
( |
) | ( |
) | ||||||||
| |
|
|
|
|
|
|||||||
| Profit/(loss) before income tax expense |
( |
) |
( |
) | ||||||||
| Income tax benefit |
( |
) | ||||||||||
| |
|
|||||||||||
| Loss after income tax expense |
( |
) | ||||||||||
| |
|
|||||||||||
| Total segment assets |
— |
|||||||||||
| Total segment liabilities |
— |
|||||||||||
| * | Licensing revenue relates mainly of GSK milestone payment of GBP |
Consolidated |
||||||||||||
June 30, 2022 |
June 30, 2021 |
June 30, 2020 |
||||||||||
$ |
$ |
$ |
||||||||||
| Breakdown of expenses by nature |
||||||||||||
| Research and development* |
||||||||||||
| Employee benefits expenses |
||||||||||||
| Amortisation of Intellectual property |
||||||||||||
| Employee share-based payment expenses |
||||||||||||
| Intellectual property management |
||||||||||||
| Auditor’s remuneration |
||||||||||||
| Depreciation |
||||||||||||
| Other administrative expenses |
||||||||||||
| |
|
|
|
|
|
|||||||
| Total Research Development and Corporate administrative expenses |
||||||||||||
| |
|
|
|
|
|
|||||||
| * | Research and development expense consists of expenditure incurred with third party vendors mainly related to contract research and contract manufacturing activities. |
Consolidated |
||||||||||||
June 30, 2022 |
June 30, 2021 |
June 30, 2020 |
||||||||||
A$ |
A$ |
A$ |
||||||||||
| Current tax |
||||||||||||
| Current tax on profits for the fiscal year |
||||||||||||
| |
|
|
|
|
|
|||||||
| Total current tax expense |
||||||||||||
| |
|
|
|
|
|
|||||||
| Deferred income tax |
||||||||||||
| Decrease in deferred tax assets |
||||||||||||
| Decrease in deferred tax liabilities |
( |
) | ( |
) | ( |
) | ||||||
| |
|
|
|
|
|
|||||||
| Total deferred tax (benefit)/expense |
||||||||||||
| |
|
|
|
|
|
|||||||
| Income tax expense |
||||||||||||
| |
|
|
|
|
|
|||||||
Consolidated |
||||||||||||
June 30, 2022 |
June 30, 2021 |
June 30, 2020 |
||||||||||
A$ |
A$ |
A$ |
||||||||||
| Numerical reconciliation of income tax expense to prima facie tax expense |
||||||||||||
| Loss before income tax expense |
( |
) | ( |
) | ( |
) | ||||||
| Tax at the Australian tax rate of |
( |
) | ( |
) | ( |
) | ||||||
| Tax effect amounts which are not deductible/(taxable) in calculating taxable income: |
||||||||||||
| Non-deductible share based payments |
||||||||||||
| Other non-deductible expenses |
||||||||||||
| Non-assessable income |
( |
) | ( |
) | ( |
) | ||||||
| Capital listing fee |
( |
) | ( |
) | ( |
) | ||||||
| Adjustment of current tax for prior period |
||||||||||||
| Difference in overseas tax rates* |
||||||||||||
| |
|
|
|
|
|
|||||||
| ( |
) |
( |
) |
( |
) | |||||||
| Net adjustment to deferred tax assets and liabilities for tax losses and temporary differences not recognized |
||||||||||||
| |
|
|
|
|
|
|||||||
| Income tax expense** |
( |
) |
( |
) |
( |
) | ||||||
| |
|
|
|
|
|
|||||||
| * | Difference in overseas tax rate is largely as a result of the corporate income tax rate of |
| ** | Income tax expense relates to tax payable for the Immutep subsidiary in the United States. |
Consolidated |
||||||||||||
June 30, 2022 |
June 30, 2021 |
June 30, 2020 |
||||||||||
A$ |
A$ |
A$ |
||||||||||
Deferred tax assets for tax losses not recognised comprises: |
||||||||||||
Carried forward tax losses benefit |
||||||||||||
Total deferred tax assets for tax losses not recognized |
||||||||||||
Consolidated |
||||||||
June 30, 2022 |
June 30, 2021 |
|||||||
A$ |
A$ |
|||||||
Cash on hand |
||||||||
Cash at bank |
||||||||
Restricted cash |
— | |||||||
Cash on deposit |
||||||||
Consolidated |
||||||||
June 30, 2022 |
June 30, 2021 |
|||||||
A$ |
A$ |
|||||||
GST and VAT receivables |
||||||||
Receivable for grant income |
||||||||
Accounts receivables |
||||||||
Consolidated |
||||||||
June 30, 2022 |
June 30, 2021 |
|||||||
A$ |
A$ |
|||||||
Prepayments* |
||||||||
Security deposit |
||||||||
Accrued interest |
||||||||
Consolidated |
||||||||
June 30, 2022 |
June 30, 2021 |
|||||||
A$ |
A$ |
|||||||
Prepayments |
||||||||
Plant and Equipment A$ |
Computers A$ |
Furniture and fittings A$ |
Total A$ |
|||||||||||||
| At June 30, 2020 |
||||||||||||||||
| Cost or fair value |
||||||||||||||||
| Accumulated depreciation |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Net book amount |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Fiscal Year ended June 30, 2021 |
||||||||||||||||
| Opening net book amount |
||||||||||||||||
| Exchange differences |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
| Additions |
||||||||||||||||
| Disposals |
||||||||||||||||
| Depreciation charge |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Closing net book amount |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Cost or fair value |
||||||||||||||||
| Accumulated depreciation |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Net book amount |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Fiscal Year ended June 30, 2022 |
||||||||||||||||
| Opening net book amount |
||||||||||||||||
| Exchange differences |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
| Additions |
||||||||||||||||
| Disposals |
||||||||||||||||
| Depreciation charge |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Closing net book amount |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| At June 30, 2022 |
||||||||||||||||
| Cost or fair value |
||||||||||||||||
| Accumulated depreciation |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Net book amount |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
Patents A$ |
Intellectual Property Assets A$ |
Goodwill A$ |
Total A$ |
|||||||||||||
| At June 30, 2020 |
||||||||||||||||
| Cost or fair value |
||||||||||||||||
| Accumulated amortization |
( |
) | ( |
) | — | ( |
) | |||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Net book amount |
— | |||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Fiscal Year ended June 30, 2021 |
||||||||||||||||
| Opening net book amount |
— | |||||||||||||||
| Exchange difference |
— | ( |
) | — | ( |
) | ||||||||||
| Amortization charge |
— | ( |
) | — | ( |
) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Closing net book amount |
— | |||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| At June 30, 2021 |
||||||||||||||||
| Cost or fair value |
||||||||||||||||
| Accumulated amortization |
( |
) | ( |
) | — | ( |
) | |||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Net book amount |
— | |||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Fiscal Year ended June 30, 2022 |
||||||||||||||||
| Opening net book amount |
— | |||||||||||||||
| Exchange difference |
— | ( |
) | — | ( |
) | ||||||||||
| Amortization charge |
— | ( |
) | — | ( |
) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Closing net book amount |
— | |||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| At June 30, 2022 |
||||||||||||||||
| Cost or fair value |
||||||||||||||||
| Accumulated amortization |
( |
) | ( |
) | — | ( |
) | |||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Net book amount |
— | |||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| • | Patents, trademark and licenses – |
| • | Intellectual property assets – |
Consolidated |
||||||||
June 30, 2022 $ |
June 30, 2021 $ |
|||||||
| Employee benefits |
||||||||
| Accruals |
||||||||
| Unrealized exchange loss |
||||||||
| Unused tax loss |
||||||||
| Set-off of deferred tax liabilities pursuant to set-off provisions |
( |
) | ( |
) | ||||
| |
|
|
|
|||||
| Net Deferred tax assets |
||||||||
| |
|
|
|
|||||
Consolidated |
||||||||
June 30, 2022 |
June 30, 2021 |
|||||||
$ |
$ |
|||||||
| Intangible assets |
||||||||
| Unrealized exchange gain |
||||||||
| Accrued income |
||||||||
| |
|
|
|
|||||
| Total deferred tax liabilities |
||||||||
| Set-off of deferred tax liabilities pursuant to set-off provisions |
( |
) | ( |
) | ||||
| |
|
|
|
|||||
| Net deferred tax liabilities |
||||||||
| |
|
|
|
|||||
Deferred Tax Asset |
Deferred Tax Liability |
Total |
||||||||||
Movements |
$ |
$ |
$ |
|||||||||
| At June 30, 2021 |
( |
) | ||||||||||
| (Charged)/credited to profit or loss |
( |
) | ||||||||||
| |
|
|
|
|
|
|||||||
| At June 30, 2022 |
( |
) | ||||||||||
| |
|
|
|
|
|
|||||||
Consolidated |
||||||||
June 30, 2022 |
June 30, 2021 |
|||||||
A$ |
A$ |
|||||||
| Trade payables |
||||||||
| Other payables and accruals |
||||||||
| |
|
|
|
|||||
| |
|
|
|
|||||
Consolidated |
||||||||
June 30, 2022 |
June 30, 2021 |
|||||||
A$ |
A$ |
|||||||
| Opening balance |
||||||||
| Fair value movements |
( |
) | ||||||
| Exercising of warrants* |
( |
) | ||||||
| |
|
|
|
|||||
| Closing Balance |
||||||||
| |
|
|
|
|||||
| * | During the year, US investors exercised |
| ** | Balance as at June 30, 2022 is presented as current liability since the US Warrants will expire on non-current liability since it was due to expire after 12 months from balance sheet date of June 30, 2021. |
| Assumption |
At issue date |
At June 30, 2022 |
Rationale | |||
| Historic volatility |
Based on 12-month historical volatility data for the Company | |||||
| Exercise price |
US$ |
US$ |
As per subscription agreement | |||
| Share price |
US$ |
US$ |
Closing share price on valuation date from external market source | |||
| Risk-free interest rate |
Based on the US Government securities yields which match the term of the warrant | |||||
| Dividend yield |
Based on the Company’s nil dividend history | |||||
| Fair value per warrant |
US$ |
US$ |
||||
A$ |
A$ |
Determined using Black-Scholes models with the inputs above | ||||
| Fair value |
A$ |
A$ |
Fair value of |
| * | Exercising price has been adjusted as per anti- dilutio n clause in the share purchase agreement. |
Consolidated |
||||||||
June 30, 2022 |
June 30, 2021 |
|||||||
A$ |
A$ |
|||||||
| Convertible note at fair value at beginning of reporting period |
||||||||
| Net change in fair value |
||||||||
| Transfer to contributed equity on conversion of Convertible Notes |
( |
) | ( |
) | ||||
| Transfer to accumulated losses on conversion of Convertible Notes |
( |
) | ( |
) | ||||
| |
|
|
|
|||||
| Convertible note at fair value at end of reporting period |
||||||||
| |
|
|
|
|||||
| • | |
| • | |
| • | |
| • | |
| Assumption |
Convertible notes |
Rationale | ||||
| Historic volatility |
% | Based on the Company’s historical volatility data | ||||
| Share price |
$ | Closing market share price on July 31, 2015 | ||||
| Risk free interest rate |
% | Based on Australian Government securities yields which match the term of the convertible note | ||||
| Risk adjusted interest rate |
% | An estimate of the expected interest rate of a similar non-convertible note issued by the company | ||||
| Dividend yield |
% | Based on the Company’s nil dividend history | ||||
Note – Liability |
Conversion feature – Equity |
|||||||
| Fair value at issuance |
||||||||
| Fair value movements |
— | |||||||
| Conversion to ordinary shares |
( |
) | ( |
) | ||||
| |
|
|
|
|||||
| Balance at June 30, 2022 |
||||||||
| |
|
|
|
|||||
Consolidated |
||||||||
June 30, 2022 A$ |
June 30, 2021 A$ |
|||||||
| Annual leave |
||||||||
| |
|
|
|
|||||
Consolidated |
||||||||
June 30, 2022 A$ |
June 30, 2021 A$ |
|||||||
| Long service leave |
||||||||
| Provision for retirement payment |
||||||||
| |
|
|
|
|||||
| |
|
|
|
|||||
Consolidated June 30, 2022 |
Consolidated June 30, 2021 |
|||||||
Right-of-use |
$ |
$ |
||||||
| Buildings |
||||||||
| |
|
|
|
|||||
| |
|
|
|
|||||
Consolidated June 30, |
Consolidated June 30, |
|||||||
Lease Liabilities |
$ |
$ |
||||||
| Current |
|
|
|
| ||||
| Non-current |
|
|
|
| ||||
| Balance at June 30, 2022 |
|
|
|
| ||||
ROU asset |
A$ |
|||
| Initial value of ROU asset recognised as at July 1, 2019 |
||||
| Less: lease incentives |
( |
) | ||
| Net ROU asset recognised under AASB 16 (IFRS 16) as at July 1, 2019 |
||||
| Depreciation for the fiscal year ended June 30, 2020 |
( |
) | ||
| Foreign exchange differences |
||||
| Closing balance of ROU asset as at June 30, 2020 |
||||
| Closing balance of ROU asset as at July 1, 2020 |
||||
| Lease addition and modification for the fiscal year ended June 30, 2021 |
||||
| Depreciation for the fiscal year ended June 30, 2021 |
( |
) | ||
| Foreign exchange differences |
( |
) | ||
| Closing balance of ROU asset as at June 30, 2021 |
||||
| Opening balance of ROU asset as at July 1, 2021 |
||||
| Lease addition and modification for the fiscal year ended June 30, 2022 |
||||
| Lease disposals for the financial year ended June 30 2022, |
( |
) | ||
| Depreciation for the fiscal year ended June 30, 2022 |
( |
) | ||
| Foreign exchange differences |
( |
) | ||
| Closing balance of ROU asset as at June 30, 2022 |
||||
Consolidated June 30, 2022 |
Consolidated June 30, 2021 |
|||||||
Lease Liabilities Reconciliation |
$ |
$ |
||||||
| Opening Balance |
||||||||
| Lease additions and modifications |
||||||||
| Interest charged for the year |
||||||||
| Disposals |
( |
) | ||||||
| Principal paid for the year |
( |
) | ( |
) | ||||
| Interest expense paid for the year |
( |
) | ( |
) | ||||
| Foreign exchange adjustments |
( |
) | ( |
) | ||||
| |
|
|
|
|||||
| Closing Balance |
||||||||
| |
|
|
|
|||||
Lease Liabilities |
Less than 1 year |
Between 1 and 2 years |
Between 2 and 5 years |
Over 5 years |
Total contractual cashflows |
Carrying amount |
||||||||||||||||||
$ |
$ |
$ |
$ |
$ |
||||||||||||||||||||
| 2022 |
||||||||||||||||||||||||
| 2021 |
||||||||||||||||||||||||
Note |
Consolidated |
|||||||||||
June 30, 2022 A$ |
June 30, 2021 A$ |
|||||||||||
| Fully paid ordinary shares |
20(a) |
|||||||||||
| Options over ordinary shares – listed |
||||||||||||
| |
|
|
|
|||||||||
| |
|
|
|
|||||||||
Note |
June 30, 2022 |
June 30, 2021 |
||||||||||||||||||
No. |
A$ |
No. |
A$ |
|||||||||||||||||
| At the beginning of reporting period |
||||||||||||||||||||
| Shares issued during the year (pre-share consolidation) |
20(b) |
— | — | — | — | |||||||||||||||
| Transaction costs relating to share issues |
— | ( |
) | — | ( |
) | ||||||||||||||
| Exercise of performance rights (pre-share consolidation) |
20(b) |
— | — | — | — | |||||||||||||||
| Share consolidation |
— | — | — | — | ||||||||||||||||
| Exercise of performance rights (post share consolidation) |
20(b) |
|||||||||||||||||||
| Shares issued during the year (post share consolidation) |
20(b) |
|||||||||||||||||||
| Conversion of Convertible Notes (shares issued during the period) |
20(b) |
|||||||||||||||||||
| Exercise of warrants (shares issued during the period) |
20(b) |
— | — | |||||||||||||||||
| Transaction costs relating to exercise of warrants |
— | — | — | ( |
) | |||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||||||
| At reporting date |
||||||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||||||
| 2022 Details |
Number |
Issue Price A$ |
Total A$ |
|||||||||
| Shares issued under Securities Purchase Plan |
||||||||||||
| Share placement July 2022 |
||||||||||||
| Performance rights exercised (transfer from share-based payment reserve) |
||||||||||||
| Convertible Notes exercised |
||||||||||||
| |
|
|
|
|||||||||
| |
|
|
|
|||||||||
| 2021 Details |
Number |
Issue Price A$ |
Total A$ |
|||||||||
| Share placement November 2020 |
||||||||||||
| Share placement June 2021 |
||||||||||||
| Performance rights exercised pre share consolidation (transfer from share-based payment reserve) * |
||||||||||||
| Convertible Notes exercised |
||||||||||||
| Exercise of warrants |
||||||||||||
| |
|
|
|
|||||||||
| |
|
|
|
|||||||||
| * | All number of shares have been adjusted for the 10 to 1 share consolidation. |
| Expiration Date |
Exercise Price |
Number |
||||||
| August 4, 2025 |
$ | |||||||
| January 5, 2023 |
US$ | |
* | * | ||||
| |
|
|||||||
| Total |
||||||||
| |
|
|||||||
| * | |
Consolidated |
||||||||
June 30, 2022 |
June 30, 2021 |
|||||||
A$ |
A$ |
|||||||
| (a) Reserves |
||||||||
| Options issued reserve |
||||||||
| Conversion feature of convertible note reserve |
||||||||
| Foreign currency translation reserve |
||||||||
| Share-based payment reserve |
||||||||
| |
|
|
|
|||||
| |
|
|
|
|||||
| Movement in options issued reserve were as follows: |
||||||||
| Opening balance and closing balance |
||||||||
| |
|
|
|
|||||
| Movements in conversion feature of convertible note reserve: |
||||||||
| Opening balance |
||||||||
| Transfer to accumulated losses on conversion of Convertible Notes |
( |
) | ( |
) | ||||
| Transfer to contributed equity on conversion of Convertible Notes |
( |
) | ( |
) | ||||
| |
|
|
|
|||||
| Ending balance |
||||||||
| |
|
|
|
|||||
| Movement in foreign currency translation reserve were as follows: |
||||||||
| Opening balance |
||||||||
| Currency translation differences arising during the year |
( |
) | ( |
) | ||||
| |
|
|
|
|||||
| Ending balance |
||||||||
| |
|
|
|
|||||
| Movement in share-based payment reserve were as follows: |
||||||||
| Opening balance |
||||||||
| Option and Performance rights expensed during the year |
||||||||
| Exercise of vested performance rights transferred to contributed equity |
( |
) | ( |
) | ||||
| |
|
|
|
|||||
| Ending balance |
||||||||
| |
|
|
|
|||||
| (b) Accumulated losses |
||||||||
| Movement in accumulated losses were as follows: |
||||||||
| Opening balance |
( |
) |
( |
) | ||||
| Net loss for the year |
( |
) | ( |
) | ||||
| Conversion of Convertible Notes* |
||||||||
| Exercise of warrants |
||||||||
| |
|
|
|
|||||
| Balance |
( |
) |
( |
) | ||||
| |
|
|
|
|||||
| * | The conversion of convertible notes to accumulated losses amounted to $ |
Consolidated |
||||||||||||
June 30, 2022 A$ |
June 30, 2021 A$ |
June 30, 2020 A$ |
||||||||||
| Short-term employee benefits |
||||||||||||
| Long-term employee benefits |
||||||||||||
| Post-employment benefits |
||||||||||||
| Share-based payments |
||||||||||||
| |
|
|
|
|
|
|||||||
| |
|
|
|
|
|
|||||||
| June 30, 2022 |
Balance at start of the fiscal year |
Received during the fiscal year on exercise of performance rights |
Received during the fiscal year on the exercise of options |
Other changes during the fiscal year # |
Balance at end of the fiscal year |
|||||||||||||||
| Ordinary shares |
||||||||||||||||||||
| Dr Russell Howard |
||||||||||||||||||||
| Mr Pete Meyers |
||||||||||||||||||||
| Mr Marc Voigt |
||||||||||||||||||||
| Mr Grant Chamberlain |
( |
)* | ||||||||||||||||||
| Ms Lucy Turnbull |
** | |||||||||||||||||||
| Ms Deanne Miller |
( |
) | ||||||||||||||||||
| Dr Frédéric Triebel |
||||||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||||||
| Total ordinary shares |
||||||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||||||
| ADSs |
— |
|||||||||||||||||||
| Mr Marc Voigt |
— | — | — | |||||||||||||||||
| Total ADSs |
||||||||||||||||||||
# |
Other changes during the year includes on market acquisitions and/or disposals |
* |
This change during the year represents derecognition due to the cessation of the director’s position |
** |
This change during the year represents Ms Lucy Turnbull’s shareholding before she became director on February 25, 2022. The shareholding includes 2,981,626 302,500 shares held indirectly. |
| June 30, 2021 |
Balance at start of the fiscal year |
Received during the fiscal year on exercise of performance rights |
Received during the fiscal year on the exercise of options |
Other changes during the fiscal year * |
Balance at end of the fiscal year |
|||||||||||||||
| Ordinary shares |
||||||||||||||||||||
| Dr Russell Howard |
||||||||||||||||||||
| Mr Pete Meyers |
||||||||||||||||||||
| Mr Marc Voigt |
||||||||||||||||||||
| Mr Grant Chamberlain |
||||||||||||||||||||
| Ms Deanne Miller |
( |
) | ||||||||||||||||||
| Dr Frédéric Triebel |
||||||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||||||
| Total ordinary shares |
( |
) |
||||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||||||
| ADSs |
||||||||||||||||||||
| Mr Marc Voigt |
||||||||||||||||||||
| Total ADSs |
||||||||||||||||||||
June 30, 2020 |
Balance at start of the fiscal year |
Received during the fiscal year on exercise of performance rights |
Received during the fiscal year on the exercise of options |
Other changes during the fiscal year * |
Balance at end of the fiscal year |
|||||||||||||||
| Ordinary shares |
||||||||||||||||||||
| Dr Russell Howard |
||||||||||||||||||||
| Mr Pete Meyers |
||||||||||||||||||||
| Mr Marc Voigt |
||||||||||||||||||||
| Mr Grant Chamberlain |
||||||||||||||||||||
| Ms Deanne Miller |
( |
) | ||||||||||||||||||
| Dr Frédéric Triebel |
||||||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||||||
| Total ordinary shares |
||||||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||||||
| ADSs |
||||||||||||||||||||
| Mr Marc Voigt |
||||||||||||||||||||
| Total ADSs |
||||||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||||||
| * | Other changes during the year include the shares acquired via the Entitlements Offer, on market acquisition and disposals. |
| June 30, 2022 |
Balance at start of the fiscal year |
Granted |
Exercised |
Other Changes |
Balance at end of the fiscal year |
Vested and exercisable |
Unvested |
|||||||||||||||||||||
| Performance Rights over ordinary shares |
||||||||||||||||||||||||||||
| Dr. Russell Howard |
( |
) | ||||||||||||||||||||||||||
| Mr. Pete Meyers |
( |
) | ||||||||||||||||||||||||||
| Mr. Marc Voigt |
||||||||||||||||||||||||||||
| Mr Grant Chamberlain |
( |
) | ( |
)* | ||||||||||||||||||||||||
| Ms. Deanne Miller |
( |
) | ||||||||||||||||||||||||||
| Dr. Frédéric Triebel |
( |
) | ||||||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
( |
) |
( |
) |
|||||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
| * | The change during the year represents derecognition due to the cessation of the director’s position. |
June 30, 2021 |
Balance at start of the fiscal year |
Granted |
Exercised |
Other Changes |
Balance at end of the fiscal year |
Vested and exercisable |
Unvested |
|||||||||||||||||||||
| Rights over ordinary shares |
||||||||||||||||||||||||||||
| Dr. Russell Howard |
( |
) | ||||||||||||||||||||||||||
| Mr. Pete Meyers |
( |
) | ||||||||||||||||||||||||||
| Mr. Marc Voigt |
( |
) | ||||||||||||||||||||||||||
| Mr Grant Chamberlain |
( |
) | ||||||||||||||||||||||||||
| Ms. Deanne Miller |
( |
) | ||||||||||||||||||||||||||
| Dr. Frédéric Triebel |
( |
) | ||||||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
( |
) |
|||||||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
| June 30, 2020 |
Balance at start of the fiscal year |
Granted |
Exercised |
Other Changes |
Balance at end of the fiscal year |
Vested and exercisable |
Unvested |
|||||||||||||||||||||
| Rights over ordinary shares |
||||||||||||||||||||||||||||
| Dr. Russell Howard |
( |
) | ||||||||||||||||||||||||||
| Mr. Pete Meyers |
( |
) | ||||||||||||||||||||||||||
| Mr. Marc Voigt |
( |
) | ||||||||||||||||||||||||||
| Mr Grant Chamberlain |
( |
) | ||||||||||||||||||||||||||
| Ms. Deanne Miller |
( |
) | ||||||||||||||||||||||||||
| Dr. Frédéric Triebel |
( |
) | ||||||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
( |
) |
|||||||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
| |
Consolidated |
|
||||||||||
June 30, 2022 A$ |
June 30, 2021 A$ |
June 30, 2020 A$ |
||||||||||
| Audit fees |
||||||||||||
| PricewaterhouseCoopers Australia |
||||||||||||
| Audit or review of the financial report |
||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|
| Other audit and assurance services in relation to regulatory filings overseas |
||||||||||||
| |
|
|
|
|
|
|||||||
| Total remuneration of PricewaterhouseCoopers Australia |
||||||||||||
| |
|
|
|
|
|
|||||||
Equity holding |
||||||||||||
| Name of entity |
Country of incorporation |
June 30, 2022 % |
June 30, 2021 % |
|||||||||
| Immutep U.S., Inc |
||||||||||||
| PRR Middle East FZ LLC |
||||||||||||
| Immutep GmbH |
||||||||||||
| Immutep Australia Pty Ltd |
||||||||||||
| Immutep IP Pty Ltd |
||||||||||||
| Immutep S.A.S. |
||||||||||||
Consolidated |
||||||||||||
June 30, 2022 A$ |
June 30, 2021 A$ |
June 30, 2020 A$ |
||||||||||
Loss after income tax expense for the year |
( |
) | ( |
) | ( |
) | ||||||
Adjustments for: |
||||||||||||
Depreciation and amortization |
||||||||||||
Share based payments |
||||||||||||
Changes in fair value of US investor warrants |
( |
) | ( |
) | ||||||||
US warrants transaction costs |
||||||||||||
Unrealized gain on exchange through the profit and loss |
( |
) | ||||||||||
Net change in fair value of convertible note liability |
||||||||||||
Change in operating assets and liabilities: |
||||||||||||
Decrease/(Increase) in current receivables |
( |
) | ( |
) | ||||||||
Decrease/(Increase) in other operating assets |
( |
) | ( |
) | ||||||||
Increase/(Decrease) in trade and other payables |
( |
) | ||||||||||
Increase in employee benefits |
||||||||||||
Net cash used in operating activities |
( |
) |
( |
) |
( |
) | ||||||
Consolidated |
||||||||||||
June 30, 2022 A$ |
June 30, 2021 A$ |
June 30, 2020 A$ |
||||||||||
Loss after income tax attributable to the owners of Immutep Limited |
( |
) |
( |
) |
( |
) | ||||||
Number |
Number |
Number |
||||||||||
Weighted average number of ordinary shares used in calculating basic earnings per share |
||||||||||||
Weighted average number of ordinary shares used in calculating diluted earnings per share |
||||||||||||
Cents |
Cents |
Cents |
||||||||||
Basic earnings per share |
( |
) | ( |
) | ( |
) | ||||||
Diluted earnings per share |
( |
) | ( |
) | ( |
) | ||||||
Consolidated |
||||||||||||
June 30, 2022 A$ |
June 30, 2021 A$ |
June 30, 2020 A$ |
||||||||||
Unlisted options |
||||||||||||
Convertible notes |
||||||||||||
Performance rights |
||||||||||||
Non-executive director rights |
||||||||||||
US warrants* |
||||||||||||
| * |
| Grant date |
Fair value |
Balance at start of the fiscal year Number |
Granted during the fiscal year Number |
Exercised during the fiscal year Number |
Lapsed during the fiscal year Number |
Balance at end of the fiscal year Number |
Vested and exercisable at end of the fiscal year Number |
|||||||||||||||||||||
| October 3, 2019 |
— | ( |
) | — | — | |||||||||||||||||||||||
| November 1, 2019 |
— | — | ||||||||||||||||||||||||||
| January 2, 2020 |
— | ( |
) | — | ||||||||||||||||||||||||
| October 2, 2020 |
— | — | ||||||||||||||||||||||||||
| October 1, 2021 |
— | — | — | — | ||||||||||||||||||||||||
| November 26, 2021 |
— | — | — | — | ||||||||||||||||||||||||
| November 26, 2021 |
— | — | — | — | ||||||||||||||||||||||||
| November 26, 2021 |
— | — | — | — | ||||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Total |
( |
) |
— |
|||||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Grant date |
Fair value |
Balance at start of the fiscal year Number |
Granted during the fiscal year Number |
Exercised during the fiscal year Number |
Lapsed during the fiscal year Number |
Balance at end of the fiscal year Number |
Vested and exercisable at end of the fiscal year Number |
|||||||||||||||||||||
| November 28, 2017 |
— | ( |
) | — | — | |||||||||||||||||||||||
| October 2, 2018 |
— | ( |
) | — | — | |||||||||||||||||||||||
| October 3, 2019 |
( |
) | — | — | ||||||||||||||||||||||||
| November 1, 2019 |
( |
) | — | — | ||||||||||||||||||||||||
| January 2, 2020 |
( |
) | — | — | ||||||||||||||||||||||||
| October 2, 2020 |
— | — | — | — | ||||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Total |
( |
) |
— |
|||||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Grant date |
Fair value |
Balance at start of the fiscal year Number |
Granted during the fiscal year Number |
Exercised during the fiscal year Number |
Lapsed during the fiscal year Number |
Balance at end of the fiscal year Number |
Vested and exercisable at end of the fiscal year Number |
|||||||||||||||||||||
| November 17, 2017 |
— | ( |
) | — | — | |||||||||||||||||||||||
| November 28, 2017 |
— | — | — | |||||||||||||||||||||||||
| November 29, 2017 |
— | ( |
) | — | — | |||||||||||||||||||||||
| October 2, 2018 |
( |
) | — | — | ||||||||||||||||||||||||
| October 3, 2019 |
— | — | — | — | ||||||||||||||||||||||||
| November 1, 2019 |
— | — | — | — | ||||||||||||||||||||||||
| January 2, 2020 |
— | — | — | — | ||||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Total |
( |
) |
||||||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Grant date |
June 30 2022* |
November 26 2021* |
||||||
| Share price at grant date |
$ | $ | ||||||
| Expected price volatility of the Company’s shares |
% | % | ||||||
| Expected dividend yield |
||||||||
| Risk-free interest rate |
% | % | ||||||
* |
Tranches 2 and 3 of performance rights granted during the year ended June 30, 2022 have not met the definition of grant date under AASB 2 - Share Based payments. Accordingly, the share based expense recognised was using an estimate of the grant date fair value at June 30, 2022. The value will be re-assessed at each reporting date until grant date has been identified. |
| Grant date |
October 2, 2020 |
|||
| Share price at grant date |
$ | |||
| Expected price volatility of the Company’s shares |
% | |||
| Expected dividend yield |
||||
| Risk-free interest rate |
% | |||
| Grant date |
October 3, 2019 |
November 1, 2019 |
January 2, 2020 |
|||||||||
| Share price at grant date |
$ | $ | $ | |||||||||
| Expected price volatility of the Company’s shares |
% | % | % | |||||||||
| Expected dividend yield |
||||||||||||
| Risk-free interest rate |
% | % | % | |||||||||
| 2022 Grant date |
Type of performance right granted |
Fair value |
Balance at start of the fiscal year Number |
Granted during the fiscal year Number |
Exercised during the fiscal year Number |
Lapsed during the fiscal year Number |
Balance at end of the fiscal year Number |
Vested and exercisable at end of the fiscal year Number |
||||||||||||||||||||||
| |
— | ( |
) | — | — | |||||||||||||||||||||||||
| |
— | ( |
) | — | ||||||||||||||||||||||||||
| |
— | ( |
) | ( |
)* | — | ||||||||||||||||||||||||
| |
— | — | — | |||||||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
| Total |
( |
) |
( |
) |
||||||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
* |
The change during the year represents derecognition due to the cessation of the director. |
| 2021 Grant date |
Type of performance right granted |
Fair value |
Balance at start of the fiscal year Number |
Granted during the fiscal year Number |
Exercised during the fiscal year Number |
Lapsed during the fiscal year Number |
Balance at end of the fiscal year Number |
Vested and exercisable at end of the fiscal year Number |
||||||||||||||||||||||
| |
— | ( |
) | — | ||||||||||||||||||||||||||
| |
— | ( |
) | — | ||||||||||||||||||||||||||
| |
— | ( |
) | — | ||||||||||||||||||||||||||
| |
— | — | ||||||||||||||||||||||||||||
| |
— | — | — | — | ||||||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
| Total |
( |
) |
— |
|||||||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
| 2020 Grant date |
Type of performance right granted |
Fair value |
Balance at start of the fiscal year Number |
Granted during the fiscal year Number |
Exercised during the fiscal year Number |
Lapsed during the fiscal year Number |
Balance at end of the fiscal year Number |
Vested and exercisable at end of the fiscal year Number |
||||||||||||||||||||||
| |
— | ( |
) | — | ||||||||||||||||||||||||||
| |
— | ( |
) | — | ||||||||||||||||||||||||||
| |
— | ( |
) | — | — | |||||||||||||||||||||||||
| |
— | — | — | — | ||||||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
| Total |
( |
) |
— |
|||||||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
| Grant date |
June 30, 2022* |
November 26, 2021* | ||
| Share price at grant date |
$ |
$ | ||
| Expected price volatility of the Company’s shares |
||||
| Expected dividend yield |
||||
| Risk-free interest rate |
* |
Tranches 2 and 3 of performance rights granted during the year ended June 30, 2022 have not met the definition of grant date under AASB 2 - Share Based payments. Accordingly, the share based expense recognised was using an estimate of the grant date fair value at June 30, 2022. The value will be re-assessed at each reporting date until grant date has been identified. |
| Grant date |
||||
| Share price at grant date |
$ |
|||
| Expected price volatility of the Company’s shares |
% | |||
| Expected dividend yield |
||||
| Risk-free interest rate |
% |
| Grant date |
||||
| Share price at grant date |
$ |
|||
| Expected price volatility of the Company’s shares |
% | |||
| Expected dividend yield |
||||
| Risk-free interest rate |
% |
| 2022 Grant date |
Expiry date |
Exercise price |
Balance at start of the fiscal year Number |
Granted during the fiscal year Number |
Exercised during the fiscal year Number |
Forfeited during the fiscal year Number |
Balance at end of the fiscal year Number |
Vested and exercisable at end of the fiscal year Number |
||||||||||||||||||||||
| |
|
|
||||||||||||||||||||||||||||
| |
|
|
||||||||||||||||||||||||||||
| |
|
|
||||||||||||||||||||||||||||
| |
|
|
||||||||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Total |
|
|
||||||||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Consolidated |
||||||||
June 30, 2022 A$ |
June 30, 2021 A$ |
|||||||
| Employee share-based payment expense |
||||||||
| |
|
|
|
|||||
| |
|
|
|
|||||
Parent |
||||||||||||
June 30, 2022 A$ |
June 30, 2021 A$ |
June 30, 2020 A$ |
||||||||||
| Loss after income tax |
( |
) | ( |
) | ( |
) | ||||||
| |
|
|
|
|
|
|||||||
| Total comprehensive loss |
( |
) |
( |
) |
( |
) | ||||||
| |
|
|
|
|
|
|||||||
Parent |
||||||||
June 30, 2022 A$ |
June 30, 2021 A$ |
|||||||
| Total current assets |
||||||||
| Total non current assets |
||||||||
| |
|
|
|
|||||
| Total assets |
||||||||
| |
|
|
|
|||||
| Total current liabilities |
||||||||
| Total non current liabilities |
||||||||
| |
|
|
|
|||||
| Total liabilities |
||||||||
| |
|
|
|
|||||
| Equity |
||||||||
| — Contributed equity |
||||||||
| — Reserves |
||||||||
| — Accumulated losses |
( |
) | ( |
) | ||||
| |
|
|
|
|||||
| Total equity |
||||||||
| |
|
|
|
|||||
Table of Contents
| ITEM 19. | EXHIBITS |
The following exhibits are filed as part of this Annual Report on Form 20-F:
EXHIBIT INDEX
Table of Contents
| * | Confidential treatment has been granted with respect to certain portions of this exhibit. Omitted portions have been submitted separately with the Securities and Exchange Commission. |
| + | Indicates management contract or compensatory plan. |
| # | Filed herewith. |
| ✓ | Certain confidential portions of this exhibit were omitted by means of marking such portions with brackets (“[***]”) because the identified confidential portions are not material and would be competitively harmful if publicly disclosed. |
| † | Certain confidential information in this exhibit was omitted by means of marking such information with brackets (“[***]”) because the identified confidential information is not material and is the type that the registrant treats as private or confidential. |
In accordance with SEC Release Nos. 33-8238 and 34-47986, Final Rule: Management’s Reports on Internal Control Over Financial Reporting and Certification of Disclosure in Exchange Act Periodic Reports, and the instruction to Form 20-F, the certifications furnished in Exhibit 13.1 hereto is deemed to accompany this Annual Report on Form 20-F and will not be deemed “filed” for purpose of Section 18 of the Exchange Act. Such certification will not be deemed to be incorporated by reference into any filing under the U.S. Securities Act of 1933, as amended, or the U.S. Securities Exchange Act of 1934, as amended, except to the extent that we specifically incorporate it by reference.
Table of Contents
SIGNATURES
The registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned to sign this annual report on its behalf.
| Immutep Limited |
| /s/ Marc Voigt |
| By: Marc Voigt |
| Title: Chief Executive Officer and Chief Financial Officer |
Date: October 31, 2022