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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File No.
(Exact Name of Registrant as Specified in Its Charter)
| ||
(State or other jurisdiction of | (I.R.S. Employer |
(Address of Principal Executive Offices, including zip code)
(
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
| Trading symbol(s) |
| Name of each exchange on which registered |
The |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ⌧
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit). ⌧
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large Accelerated filer | ☐ | Accelerated filer | ☐ |
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⌧ | Smaller reporting company | ||
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| Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act.)
At August 10, 2022, there were
KIORA PHARMACEUTICALS, INC.
Table of Contents
QUARTERLY REPORT ON FORM 10-Q
For the Period Ended June 30, 2022
INDEX
1
FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains statements that are not statements of historical fact and are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. The forward-looking statements are principally, but not exclusively, contained in “Item 2: Management’s Discussion and Analysis of Financial Condition and Results of Operations.” These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements include, but are not limited to, statements about management’s confidence or expectations, and our plans, objectives, expectations, and intentions that are not historical facts. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “goals,” “sees,” “estimates,” “projects,” “predicts,” “intends,” “think,” “potential,” “objectives,” “optimistic,” “strategy,” and similar expressions intended to identify forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Forward-looking statements include, but are not limited to, statements about:
| ● | the timing and success of preclinical studies and clinical trials conducted by us and our development partners; |
| ● | the ability to obtain and maintain regulatory approval of our product candidates, and the labeling for any approved products; |
| ● | the scope, progress, expansion, and costs of developing and commercializing our product candidates; |
| ● | the size and growth of the potential markets for our product candidates and the ability to serve those markets; |
| ● | our expectations regarding our expenses and revenue, the sufficiency of our cash resources and needs for additional financing; |
| ● | the rate and degree of market acceptance of any of our product candidates; |
| ● | our expectations regarding competition; |
| ● | our anticipated growth strategies; |
| ● | our ability to attract or retain key personnel; |
| ● | our ability to establish and maintain development partnerships; |
| ● | our expectations regarding federal, state and foreign regulatory requirements; |
| ● | regulatory developments in the U.S. and foreign countries; |
| ● | our ability to obtain and maintain intellectual property protection for our product candidates; |
| ● | the anticipated trends and challenges in our business and the market in which we operate; and |
| ● | the impact of the evolving COVID-19 pandemic and the global response thereto. |
2
We discuss many of these risks in detail under the heading “Item 1A. Risk Factors” beginning on page 23 of our Annual Report on Form 10-K/A, as filed with the Securities and Exchange Commission, or the SEC, on July 7, 2022, or the Annual Report. You should carefully review all of these factors, as well as other risks described in our public filings, and you should be aware that there may be other factors, including factors of which we are not currently aware, that could cause these differences.
Also, these forward-looking statements represent our estimates and assumptions only as of the date of this report. We may not update these forward-looking statements, even though our situation may change in the future, unless we have obligations under the federal securities laws to update and disclose material developments related to previously disclosed information.
Kiora Pharmaceuticals, Inc. is referred to herein as “we,” “our,” “us,” and “the Company.”
3
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
KIORA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| June 30, 2022 |
| ||||
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| (unaudited) |
| December 31, 2021 | ||
ASSETS |
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Current Assets: |
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Cash and Cash Equivalents | $ | | $ | | ||
Prepaid Expenses |
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Tax Receivables | |
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Total Current Assets |
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Non-Current Assets: | ||||||
Property and Equipment, Net |
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Restricted Cash |
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Intangible Assets and In-Process RD, Net |
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Operating Lease Assets | | | ||||
Other Assets |
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Total Assets | $ | | $ | | ||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current Liabilities: |
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Accounts Payable | $ | | $ | | ||
Accrued Expenses |
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Operating Lease Liabilities |
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Contingent Consideration | | — | ||||
Total Current Liabilities |
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Non-Current Liabilities: |
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Contingent Consideration, Non-Current |
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Deferred Tax Liability |
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Operating Lease Liabilities, Non-Current | | | ||||
Total Non-Current Liabilities |
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Total Liabilities |
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Commitments and Contingencies (Note 9) |
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Stockholders’ Equity: |
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Preferred Stock, $ |
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Common Stock, $ |
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Additional Paid-In Capital |
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Accumulated Deficit |
| ( |
| ( | ||
Accumulated Other Comprehensive Loss |
| ( |
| ( | ||
Total Stockholders’ Equity |
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Total Liabilities and Stockholders’ Equity | $ | | $ | | ||
See Accompanying Notes to Condensed Consolidated Financial Statements.
4
KIORA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited)
Three Months Ended | Six Months Ended | |||||||||||
June 30, | June 30, |
| June 30, |
| June 30, | |||||||
|
| 2022 |
| 2021 |
| 2022 |
| 2021 | ||||
Operating Expenses: |
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| ||||||||
General and Administrative | $ | | $ | | $ | | $ | | ||||
Research and Development | | | | | ||||||||
Executive Severance | — | — | | — | ||||||||
Change in Fair Value of Contingent Consideration | | | | ( | ||||||||
Total Operating Expenses | | |
| |
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Operating Loss Before Other Expense | ( | ( |
| ( |
| ( | ||||||
Other Expenses, Net: |
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Gain on Forgiveness of Loan | — | | — | | ||||||||
Gain on Disposal | — | — | | — | ||||||||
Interest Income | | |
| |
| | ||||||
Interest Expense | — | ( |
| — |
| ( | ||||||
Total Other Expenses, Net | | |
| |
| | ||||||
Net Loss | $ | ( | $ | ( | $ | ( | $ | ( | ||||
Net Loss per Common Share - Basic and Diluted | ( | ( | ( | ( | ||||||||
Weighted Average Shares Outstanding - Basic and Diluted | | | |
| | |||||||
Other Comprehensive Loss: |
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Net Loss | $ | ( | $ | ( | $ | ( | $ | ( | ||||
Foreign Currency Translation Adjustments | ( | ( |
| ( |
| ( | ||||||
Comprehensive Loss | $ | ( | $ | ( | $ | ( | $ | ( | ||||
See Accompanying Notes to Condensed Consolidated Financial Statements.
5
KIORA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY
Three Months Ended June 30, 2022 and 2021
(unaudited)
Accumulated | ||||||||||||||||||||||
Additional | Other | Total | ||||||||||||||||||||
Preferred Stock | Common Stock | Paid-In | Accumulated | Comprehensive | Stockholders’ | |||||||||||||||||
|
| Shares |
| Amount |
| Shares |
| Amount |
| Capital |
| Deficit |
| Loss |
| Equity | ||||||
Balance at March 31, 2022 |
| | $ | — |
| | $ | | $ | | $ | ( | $ | ( | $ | | ||||||
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Stock-Based Compensation |
| — |
| — |
| — |
| — |
| |
| — |
| — |
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Issuance of Common Stock from Panoptes Holdback Shares | — | — | | | ( | — | — | — | ||||||||||||||
Foreign Currency Translation Adjustment | — | — | — | — | — | — | ( | ( | ||||||||||||||
Net Loss |
| — |
| — |
| — |
| — |
| — |
| ( |
| — |
| ( | ||||||
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Balance at June 30, 2022 |
| | $ | — | | $ | | $ | | ( | $ | ( | $ | | ||||||||
Accumulated |
| |||||||||||||||||||||
Additional | Other | Total | ||||||||||||||||||||
Preferred Stock | Common Stock | Paid-In | Accumulated | Comprehensive | Stockholders’ | |||||||||||||||||
| Shares |
| Amount |
| Shares |
| Amount |
| Capital |
| Deficit |
| Loss |
| Equity | |||||||
Balance at March 31, 2021 |
| | $ | |
| | $ | | $ | | $ | ( | $ | | $ | | ||||||
Stock-Based Compensation |
| — |
| — |
| — |
| — |
| |
| — |
| — |
| | ||||||
Foreign Currency Translation Adjustment |
| — |
| — |
| — |
| — |
| — |
| — |
| ( |
| ( | ||||||
Net Loss |
| — |
| — |
| — |
| — |
| — |
| ( |
| — |
| ( | ||||||
Balance at June 30, 2021 |
| | $ | |
| | $ | | $ | | $ | ( | $ | ( | $ | | ||||||
6
KIORA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY
Six Months Ended June 30, 2022 and 2021
(unaudited)
Accumulated | ||||||||||||||||||||||
Additional | Other | Total | ||||||||||||||||||||
Preferred Stock | Common Stock | Paid-In | Accumulated | Comprehensive | Stockholders’ | |||||||||||||||||
| Shares |
| Amount |
| Shares |
| Amount |
| Capital |
| Deficit |
| Loss |
| Equity | |||||||
Balance at December 31, 2021 |
| | $ | — |
| | $ | | $ | | $ | ( | $ | ( | $ | | ||||||
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Stock-Based Compensation |
| — | — |
| — | — |
| |
| — |
| — |
| | ||||||||
Issuance of Common Stock from Panoptes Holdback Shares | — | — | | | ( | — | — | — | ||||||||||||||
Foreign Currency Translation Adjustment |
| — | — |
| — |
| — |
| — |
| — |
| ( |
| ( | |||||||
Net Loss |
| — | — |
| — |
| — |
| — |
| ( |
| — |
| ( | |||||||
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Balance at June 30, 2022 |
| | $ | — |
| | $ | | $ | | ( | $ | ( | $ | | |||||||
Accumulated |
| |||||||||||||||||||||
Additional | Other | Total | ||||||||||||||||||||
Preferred Stock | Common Stock | Paid-In | Accumulated | Comprehensive | Stockholders’ | |||||||||||||||||
| Shares |
| Amount |
| Shares |
| Amount |
| Capital |
| Deficit |
| Loss |
| Equity | |||||||
Balance at December 31, 2020 |
| | $ | |
| | $ | | $ | | $ | ( | $ | ( | $ | | ||||||
Stock-Based Compensation |
| — |
| — |
| — |
| — |
| |
| — |
| — |
| | ||||||
Issuance of Common Stock from Warrants, Net | — | — | | |
| | — | — | | |||||||||||||
Issuance of Common Stock from Private Placement, Net of Offering Costs of $ | — | — | | |
| | — | — | | |||||||||||||
Foreign Currency Translation Adjustment |
| — |
| — |
| — |
| — |
| — |
| — |
| ( |
| ( | ||||||
Net Loss |
| — |
| — |
| — |
| — |
| — |
| ( |
| — |
| ( | ||||||
Balance at June 30, 2021 |
| | $ | |
| | $ | | $ | | $ | ( | $ | ( | $ | | ||||||
See Accompanying Notes to Condensed Consolidated Financial Statements.
7
KIORA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
Six Months Ended June 30, | ||||||
|
| 2022 |
| 2021 | ||
Operating Activities: |
|
|
|
| ||
Net Loss | $ | ( | $ | ( | ||
Adjustments to Reconcile Net Loss to Net Cash Used in Operating Activities: |
|
|
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| ||
Depreciation and Amortization |
| |
| | ||
Reduction of Right-of-Use Assets |
| |
| | ||
Stock-Based Compensation |
| |
| | ||
Change in Fair Value of Contingent Consideration | | ( | ||||
Paycheck Protection Program Loan Forgiveness | — | ( | ||||
Gain on Disposal of Equipment | ( | — | ||||
Changes in Operating Assets and Liabilities: |
|
|
|
| ||
Prepaid Expenses |
| ( |
| | ||
Tax Receivable |
| ( |
| ( | ||
Other Assets |
| ( |
| | ||
Accounts Payable |
| |
| ( | ||
Lease Liabilities |
| ( |
| ( | ||
Accrued Expenses |
| |
| ( | ||
Net Cash Used in Operating Activities |
| ( |
| ( | ||
Investing Activities: | ||||||
Purchases of Property and Equipment | — | ( | ||||
Proceeds on Sale of Equipment | | — | ||||
Net Cash Provided by (Used in) Investing Activities | | ( | ||||
Financing Activities: |
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Proceeds from Stock Offerings, Net of Offering Costs |
| |
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Exercise of Warrants | — | | ||||
Net Cash Provided by Financing Activities |
| |
| | ||
Effect of Exchange Rate Changes on Cash |
| ( |
| ( | ||
Net (Decrease) Increase in Cash |
| ( |
| | ||
Cash, Cash Equivalents and Restricted Cash, Beginning of Period |
| |
| | ||
Cash, Cash Equivalents and Restricted Cash, End of Period | $ | | $ | | ||
Supplemental Disclosures of Noncash Operating and Financing Activities |
|
| ||||
Creation of Right-of-Use Assets and Related Lease Liabilities | $ | | $ | | ||
See Accompanying Notes to Condensed Consolidated Financial Statements.
8
KIORA PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2022
1. Business, Presentation and Recent Accounting Pronouncements
Overview
Kiora Pharmaceuticals, Inc. (“Kiora” or the “Company”) was formed as a Delaware corporation December 28, 2004, as amended. Kiora is a clinical-stage specialty pharmaceutical company developing and commercializing therapies for the treatment of ophthalmic diseases.
Since its inception, Kiora has devoted substantially all of its efforts to business planning, research and development, and raising capital.
Going Concern
The accompanying condensed consolidated financial statements have been prepared assuming that Kiora will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. At June 30, 2022, Kiora had unrestricted Cash and Cash Equivalents of $
Unaudited Interim Financial Information
The accompanying unaudited consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. Pursuant to these rules and regulations, they do not include all information and notes required by U.S. GAAP for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the Company’s financial condition and results of operations have been included. Operating results for the periods presented are not necessarily indicative of the results that may be expected for the full year. We believe that the disclosures provided herein are adequate to make the information presented not misleading when these unaudited interim condensed consolidated financial statements are read in conjunction with the audited financial statements and notes previously distributed in the Company’s 2021 Annual Report on Form 10-K/A dated July 7, 2022. The balance sheet as of December 31, 2021 was derived from audited consolidated financial statements of the Company but does not include all the disclosures required by U.S. GAAP.
Recent Accounting Pronouncements
We have evaluated all issued and unadopted Accounting Standards Updates and believe the adoption of these standards will not have a material impact on our condensed consolidated statements of operations and comprehensive loss, balance sheets or cash flows.
9
KIORA PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2022
2. Balance Sheet Information
Cash, Cash Equivalents and Restricted Cash
A summary of cash and cash equivalents and restricted cash is as follows:
June 30, 2022 | ||||||
| (unaudited) |
| December 31, 2021 | |||
Cash and Cash Equivalents | $ | | $ | | ||
Restricted Cash, Non-current |
| |
| | ||
Total Cash, Cash Equivalents and Restricted Cash | $ | | $ | | ||
Non-current restricted cash consists of deposits with financial institutions for corporate credit cards.
Prepaid Expenses
Prepaid expenses consist of the following:
| June 30, 2022 |
| ||||
(unaudited) | December 31, 2021 | |||||
Research and Development | $ | | $ | | ||
Insurance |
| |
| | ||
Other |
| |
| | ||
Total Prepaid Expenses | $ | | $ | | ||
Accrued Expenses
Accrued expenses consist of the following:
June 30, 2022 | ||||||
|
| (unaudited) |
| December 31, 2021 | ||
Executive Severance | $ | | $ | | ||
Payroll and Benefits | | | ||||
Professional Fees |
| |
| | ||
Clinical Trials |
| |
| | ||
Other | — | | ||||
Total Accrued Expenses | $ | | $ | | ||
3. Acquisition
Effective October 21, 2021, the Company acquired all of the capital stock of Bayon Therapeutics, Inc. (“Bayon”), a privately held ophthalmic specialty pharmaceutical company focused on developing light sensitive small molecules.
10
KIORA PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2022
The fair value of the consideration for the Bayon acquisition as of the acquisition date is comprised of the following:
Common | Price per | |||||||
|
| Shares |
| Share (a) |
| Amount | ||
Contingent Consideration at Fair Value |
| $ | | |||||
Cash Consideration |
|
|
|
| | |||
Kiora Common Stock |
| | $ | |
| | ||
Total Fair Value of Consideration |
|
|
| | ||||
| (a) | Average closing price of the Company’s common stock for five trading days immediately preceding October 21, 2021. |
The former stockholders of Bayon are eligible to receive up to $
The Company accounted for the Bayon acquisition using the acquisition method of accounting whereby the total purchase price was preliminarily allocated to tangible and intangible assets acquired and liabilities assumed based on respective fair values. The following table summarizes the preliminary fair value of the assets acquired and liabilities assumed at the date of acquisition.
Current Assets |
| $ | |
Intangible Assets |
| | |
Goodwill |
| | |
Accounts Payable |
| ( | |
Deferred Tax Liability |
| ( | |
Total Fair Value of Asset and Liabilities Purchased | $ | |
As of June 30, 2022, the purchase price allocation for the Bayon acquisition was preliminary in nature and subject to completion. Adjustments to the current fair value estimates in the above table may occur as the process conducted for various valuations and assessments is finalized, including tax liabilities and other working capital accounts. Nearly
The acquired intangible assets, which consist solely of in-process RD, will not be amortized until the underlying development programs are completed. Upon obtaining regulatory approval, the intangible assets are then accounted for as finite-lived intangible assets and amortized on a straight-line basis over its estimated useful life.
Consolidated Pro Forma Results
Net loss in the Condensed Consolidated Statement of Operations for the three and six months ended June 30, 2022 includes net losses of Bayon of $
11
KIORA PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2022
4. Fair Value Disclosures
Fair value is the price that would be received from the sale of an asset or paid to transfer a liability assuming an orderly transaction to a third party under current market conditions at the measurement date. U.S. GAAP establishes a hierarchical disclosure framework that prioritizes and ranks the level of observability of inputs used in measuring fair value. In connection with historical acquisitions, additional consideration may be paid related to the achievement of certain milestones. The following table provides information for liabilities measured at fair value on a recurring basis using Level 3 inputs:
June 30, 2022 | ||||||
| (unaudited) |
| December 31, 2021 | |||
Contingent Consideration: | ||||||
Current |
| |
| — | ||
Noncurrent |
| |
| | ||
Total Contingent Consideration | $ | | $ | | ||
The Company initially values contingent consideration related to business combinations using a probability-weighted calculation of potential payment scenarios discounted at rates reflective of the risks associated with the expected future cash flows for certain milestones. Key assumptions used to estimate the fair value of contingent consideration include projected financial information, market data and the probability and timing of achieving the specific targets as discussed in Note 3. Acquisition. After the initial valuation, the Company generally uses its best estimate to measure contingent consideration at each subsequent reporting period using the following unobservable Level 3 inputs:
| Valuation Technique |
| Unobservable Inputs |
| June 30, 2022 | December 31, 2021 |
| ||
| Discounted cash flow |
| Payment discount rate |
| | % | | % | |
Bayon |
|
| Payment period |
| 2023 - 2028 | 2023 - 2028 | |||
Panoptes |
|
| Payment period |
| 2024 - 2028 | 2024 - 2028 | |||
Jade |
|
| Payment period |
| 2026 | 2026 |
Bayon |
| Probability of Success for payment |
| % | % | ||
Panoptes | Probability of Success for payment | % | % | ||||
Jade |
| Probability of Success for payment |
| | % | | % |
Significant changes in these assumptions could result in a significantly higher or lower fair value. The contingent consideration reported in the above table resulted is adjusted quarterly based upon the passage of time or the anticipated success or failure of achieving certain milestones. There was a nominal change in fair value of contingent consideration for the three months ended June 30, 2022 and 2021 of $
5. Capital Stock
On January 6, 2021, the Company completed a private placement of
12
KIORA PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2022
In connection with the Company’s acquisition of Panoptes Pharma Ges.m.b.H in December 2020 (“Panoptes Acquisition”), on June 18, 2022, the Company issued an aggregate of
The following is a summary of the Company’s reserved common stock as of June 30, 2022:
Common Stock Warrants |
| |
Preferred Stock outstanding |
| |
Total |
| |
6. Warrants
The following is a summary of warrant activity for the Company’s equity-classified warrants for the six months ended June 30, 2022 and 2021:
Weighted Average | Weighted Average | ||||||
Number of | Exercise | Remaining | |||||
| Warrants |
| Price |
| Term in Years | ||
Outstanding at December 31, 2021 | | $ | |
| |||
Expired | ( | $ | | ||||
Outstanding at June 30, 2022 | | $ | | ||||
Outstanding at December 31, 2020 | | $ | | ||||
Issued | | $ | | ||||
Exercised | ( | $ | | ||||
Outstanding at June 30, 2021 |
| | $ | | |||
7. Net Loss per Share
Basic net loss per share does not include the weighted-average unvested restricted common stock that has been issued and is subject to forfeiture totaling
| 2022 |
| 2021 | |
Common Stock Warrants |
| |
| |
Employee Stock Options |
| |
| |
Preferred Stock |
| |
| |
Total |
| |
| |
8. Stock-Based Compensation
2014 Plan
The Company operates an equity-based compensation plan (the “2014 Plan”). The 2014 Plan provides for the granting of stock options (incentive and nonqualified), restricted stock or other stock-based awards to employees, officers, directors, consultants, and advisors. As of June 30, 2022,
13
KIORA PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2022
Stock-based compensation expense is presented in the same expense line items as cash compensation paid and for the three and six months ended June 30 are as follows:
| Three months ended June 30 |
| Six months ended June 30 | |||||||||
| 2022 | 2021 |
| 2022 |
| 2021 | ||||||
Research and Development | $ | | $ | | | | ||||||
General and Administrative | | | | | ||||||||
Total Stock-Based Compensation Expense | $ | | $ | | | | ||||||
Stock Options
The Company grants time-based stock options which generally vest of the underlying shares on the one-year anniversary of the grant date and the remainder over a 24-month period. The fair value of time-based stock options is determined using the Black-Scholes Option Pricing Model, with such value recognized as expense over the service period, which is typically 3 years, net of actual forfeitures. A summary of the Company’s assumptions used in determining the fair value of the stock options granted during the six months ended June 30, 2022 and 2021 is shown in the following table.
2022 | 2021 | |||||
Risk-Free Interest Rate |
| | % |
| | % |
Expected Life (years) |
|
| ||||
Expected Stock Price Volatility |
| | % |
| | % |
Expected Dividend Yield |
| — | % |
| — | % |
The weighted-average grant date fair value of options granted during the six months ended June 30, 2022 and 2021 was $
Following is a summary of stock option activity for the six months ended June 30, 2022:
Weighted-Average | |||||||
Number of | Weighted- Average | Remaining | |||||
|
| Options |
| Exercise Price |
| Term in Years | |
Outstanding at December 31, 2021 |
| | $ | |
| ||
Granted |
| | $ | |
| ||
Expired |
| ( | $ | | |||
Forfeited | ( | $ | | ||||
Outstanding at June 30, 2022 |
| | $ | |
| ||
Exercisable and vested at June 30, 2022 |
| | $ | |
| ||
|
|
| |||||
Outstanding at December 31, 2020 |
| | $ | |
| ||
Granted |
| | $ | |
| ||
Expired | ( | $ | | ||||
Forfeited |
| ( | $ | |
| ||
Outstanding at June 30, 2021 |
| | $ | |
| ||
Exercisable and vested at June 30, 2021 |
| | $ | |
| ||
14
KIORA PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2022
The stock options outstanding and exercisable as of June 30, 2022 had no aggregate intrinsic value. The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the market price of the Company’s common stock for options that had exercise prices lower than $
Restricted Stock Units
There were no grants of time-based restricted stock units during the three and six months ended June 30, 2022. Restricted stock options compensation expense is recognized over the vesting period, which is typically of the underlying shares on the one-year anniversary of the grant date and the remainder over a 24-month period. Unamortized expense is nominal. The following is a summary of restricted stock activity for the six months ended June 30, 2022:
Weighted- Average | |||||||
Number of | Weighted- Average | Remaining | |||||
|
| Units |
| Grant Date Fair Value |
| Term in Years | |
Non-vested at December 31, 2021 |
| | $ | |
| ||
Vested |
| ( | $ | |
| ||
Forfeited | ( | $ | | ||||
Non-vested at June 30, 2022 |
| | $ | |
| ||
Non-vested Outstanding at December 31, 2020 |
| | $ | |
| ||
Vested | ( | $ | | ||||
Forfeited |
| ( | $ | |
| ||
Non-vested Outstanding at June 30, 2021 |
| | $ | |
| ||
Employee Stock Purchase Plan
The Company has a non-qualified Employee Stock Purchase Plan (ESPP), which provides for the issuance of shares of the Company’s common stock to eligible employees of the Company that elect to participate in the plan and purchase shares of common stock through payroll deductions at a discounted price. Six month offering periods are made at the Board’s discretion. The ESPP provides for
9. Commitments and Contingencies
Leases
The Company leases its office facilities as well as other property under operating leases. In February 2022, the Company entered into a lease for an office facility in Encinitas, California and took possession of the space May 1, 2022. The Company recorded an ROU asset and lease liability upon lease commencement in May 2022. On May 16, 2022, a nominal short-term lease commenced in Australia. Lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise the option. The remaining lease terms range from less than
Total operating lease cost for the three months ended June 30, 2022 and 2021 was $
15
KIORA PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2022
Supplemental cash flow information and non-cash activity related to operating leases for the six months ended June 30 were as follows:
Cash paid for amounts included in the measurement of lease liabilities:
| 2022 |
| 2021 | |||
Operating cash flows from operating leases | $ | | $ | | ||
Supplemental balance sheet and other information related to operating leases were as follows:
| June 30, 2022 |
| December 31, 2021 |
| |
Weighted Average Discount Rate |
| | % | | % |
Weighted Average Remaining Lease Term (years) |
|
|
Future annual minimum lease payments under non-cancellable operating leases as of June 30, 2022 are as follows:
Years Ending December 31, |
|
| |
2022 (remaining months) | $ | | |
2023 |
| | |
Total Lease Liabilities |
| | |
Less Amounts Representing Interest |
| ( | |
Total |
| | |
Less Current Portion |
| ( | |
$ | |
License and Exclusive Rights Agreements
We are a party to seven license agreements as described below. These license agreements require us to pay or receive royalties or fees to or from the licensor based on revenue or milestones related to the licensed technology.
On July 2, 2013, we (through our subsidiary, Kiora Pharmaceuticals, GmbH) entered into a patent and know-how assignment agreement with 4SC Discovery GmbH (“4SC”) transferring to us all patent rights and know-how to the compound KIO-101. We are responsible for paying royalties of
On July 2, 2013, we (through our subsidiary, Kiora Pharmaceuticals, GmbH) entered into an out-license agreement with 4SC granting 4SC the exclusive worldwide right to commercialize the compound KIO-101 for rheumatoid arthritis and inflammatory bowel disease, including Crohn’s Disease and Ulcerative Colitis. We are eligible to receive milestone payments totaling up to
On September 12, 2013, we (through our subsidiary, Jade Therapeutics, Inc.) entered into an agreement with Lineage Cell Therapeutics, Inc. (“Lineage”), formerly known as BioTime, Inc. granting to us the exclusive worldwide right to commercialize cross-linked thiolated carboxymethyl hyaluronic acid (“modified HA”) for ophthalmic treatments in humans. The agreement requires us to pay an annual fee of $
On November 17, 2014, we (through our subsidiary Kiora Pharmaceuticals GmbH) entered into an intellectual property and know-how licensing agreement with Laboratoires Leurquin Mediolanum S.A.S. (“Mediolanum”) for the commercialization of KIO-101 (the “Mediolanum agreement”) in specific territories. Under the Mediolanum agreement, we out-licensed rights to commercialize KIO-101 for uveitis, dry eye and viral conjunctivitis in Italy, and France. This Agreement was amended on December 10, 2015 to also include
16
KIORA PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2022
Belgium and The Netherlands. Under the Mediolanum Agreement, Mediolanum is obligated to pay up to approximately
On September 26, 2018, we entered into an intellectual property licensing agreement (the “SentrX Agreement”) with SentrX, a veterinary medical device company that develops and manufactures veterinary wound care products. Under the SentrX Agreement, we in-licensed the rights to trade secrets and know- how related to the manufacturing of KIO-201. The SentrX Agreement enables us to pursue a different vendor with a larger capacity for manufacturing and an FDA-inspected facility for commercialization of a product for human use. Under the SentrX Agreement, SentrX is eligible to receive milestone payments totaling up to $
On May 1, 2020, we (through our subsidiary, Kiora Pharmaceuticals Pty Ltd) entered into an agreement with the University of California (“UC”) granting to us the exclusive rights to its pipeline of photoswitch molecules. The agreement requires us to pay an annual fee to UC of $
On May 1, 2020, we (through our subsidiary, Kiora Pharmaceuticals Pty Ltd) entered into an agreement with Photoswitch Therapeutics, Inc. (“Photoswitch”) granting to us access to certain patent applications and IP rights with last-to-expire patent terms of January 2030. The agreement calls for payments to Photoswitch upon the achievement of certain development milestones and upon first commercial sale of the product.
Contingent Consideration
The purchase price of various acquisitions in prior periods included contingent consideration, which consisted of various cash earn-out payments upon the achievement of certain milestones. Below are the maximum obligation payments per the respective agreements and estimated fair value of contingent consideration payments remaining as of June 30, 2022.
| Maximum Obligation | Current Fair | ||||
| per Agreements |
| Value Estimated | |||
Bayon | $ | | $ | | ||
Panoptes |
| | | |||
Jade |
| | | |||
$ | | $ | | |||
Other
In the normal course of business, the Company periodically becomes involved in various claims and lawsuits, as well as governmental proceedings and investigations that are incidental to the business. The Company accrues a liability when a loss is considered probable and the amount can be reasonably estimated. When a material loss contingency is reasonably possible but not probable, the Company does not record a liability, but instead discloses the nature and amount of the claim, and an estimate of the possible loss or range of loss, if such an estimate can be made. Legal fees are expensed as incurred. With respect to governmental proceedings and investigations, like other companies in the industry, the Company is subject to extensive regulation by national, state and local governmental agencies in the U.S. and in other jurisdictions in which the Company and its affiliates operate. As a result, interaction with governmental agencies is ongoing. The Company’s standard practice is to cooperate with regulators and investigators in responding to inquiries.
17
KIORA PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2022
The Company currently maintains insurance for risks associated with the operation of its business, provision of professional services and ownership of property. These policies provide coverage for a variety of potential losses, including loss or damage to property, bodily injury, general commercial liability, professional errors and omissions and medical malpractice.
10. Subsequent Events
On July 22, 2022, the Company entered into an Underwriting Agreement (the “Underwriting Agreement”) with Ladenburg Thalmann Co. Inc., as underwriter (the “Underwriter”), pursuant to which the Company agreed to issue and sell, in a firm commitment underwritten public offering by the Company (the “Public Offering”), (i)
On July 26, 2022, the Public Offering closed, and the Company issued and sold (i)
During July 2022, the Company became aware of an apparent payroll irregularity that occurred in June 2022 and resulting in approximately $
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following section of this Quarterly Report on Form 10-Q entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contains statements that are not statements of historical fact and are forward-looking statements within the meaning of federal securities laws. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Factors that may cause our actual results to differ materially from those in the forward-looking statements include those factors described in “Item 1A. Risk Factors” beginning on page 23 of our Annual Report on Form 10-K/A as filed with the Securities and Exchange Commission on July 7, 2022. You should carefully review all of these factors, as well as the comprehensive discussion of forward-looking statements on page 1 of this Quarterly Report on Form 10-Q.
Kiora Pharmaceuticals, Inc. is referred to herein as “Kiora”, “we,” “our,” “us,” and “the Company”.
Executive Summary
We are a specialty clinical-stage pharmaceutical company developing and commercializing products for the treatment of ophthalmic diseases.
Our lead product is KIO-301 with an initial focus on patients with later stages of disease progression due to Retinitis Pigmentosa (any and all sub-forms). KIO-301 is a potential vision-restoring small molecule that acts as a “photoswitch” specifically designed to restore vision in patients with inherited and age-related degenerative retinal diseases. The molecule is specifically designed to restore the eyes’ ability to perceive and interpret light in visually impaired patients. It selectively enters viable downstream retinal ganglion cells (no longer receiving electrical input due to degenerated rods and cones) and is intended to turn them into light sensing cells, capable of signaling the brain as to the presence or absence of light. We expect to initiate a Phase 1b clinical trial in the third quarter of 2022. On March 17, 2022, we were granted Orphan Drug Designation by the United States (“U.S.”) Food and Drug Administration (“FDA”) for the Active Pharmaceutical Ingredient (“API”) in KIO-301. KIO-301 (formerly known as B-203) was acquired through the Bayon transaction which closed October 21, 2021.
KIO-101 is a product that focuses on patients with Ocular Presentation of Rheumatoid Arthritis (“OPRA”). KIO-101 is a next generation, non-steroidal, immuno-modulatory, small-molecule inhibitor of Dihydroorotate Dehydrogenase (“DHODH”) with what we believe to be best-in-class picomolar potency and a validated immune modulating mechanism designed to overcome the off-target side effects and safety issues associated with commercially available DHODH inhibitors. In a 14-Day GLP intravenous (IV) repeated dose toxicity study in rats, no adverse or test item related effects were observed in any of the tested parameters (mortality, clinical observations, ophthalmoscopy, body weight and food consumption, hematology and coagulation, clinical biochemistry, organ weight, pathology and histopathology) at the highest doses tested (1.0 mg/kg). In the fourth quarter of 2021, we reported topline safety and tolerability data from a Phase 1b proof-of-concept (“POC”) study evaluating KIO-101 in patients with ocular surface inflammation. As a further sign of safety, there were zero clinically significant laboratory (including liver enzymes) findings observed in both healthy patients and those with ocular surface inflammation. We expect to initiate a Phase 2 clinical trial in the second half of 2022. KIO-101 (formerly known as PP-001) was acquired through the acquisition of Panoptes in the fourth quarter of 2020.
In addition, we are developing KIO-201 for patients with Persistent Corneal Epithelial Defects (PCED), which is an orphan disease and as such, we are currently seeking orphan drug designation. We also are evaluating KIO-201 in patients recovering from surgical wounds, such as those undergoing photorefractive keratectomy (“PRK”) surgery. KIO-201 is a modified form of the natural polymer hyaluronic acid, designed to protect the ocular surface to permit re-epithelialization of the cornea and improve and maintain ocular surface integrity. KIO-201 has unique properties that help hydrate and protect the ocular surface. We are currently evaluating KIO-201 in a Phase 2 clinical trial in patients with PCEDs and expect topline results in Q1 2023. We also are in planning stages of a potential Phase 3b trial for patients recovering from the laser vision correction procedure PRK and could initiate the study before the end of 2023.
Throughout our history, we have not generated significant revenue. We have never been profitable and from inception through June 30, 2022, our losses from operations have aggregated $126.845 million. Our net loss was $5.966 million and $4.554 million for the six months ended June 30, 2022 and 2021, respectively. We expect to incur significant expenses and increasing operating losses for the foreseeable future as we continue the development and clinical trials of and seek regulatory approval for our product candidates. If we
19
obtain regulatory approval for our product candidates, we expect to incur significant expenses in order to create an infrastructure to support their commercialization including sales, marketing, and distribution functions.
We will need additional financing to support our continuing operations. We will seek to fund our operations through public or private equity, debt financings, license and development agreements, or other sources, which may include collaborations with third parties. Adequate additional financing may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy. These conditions raise substantial doubt about our ability to continue as a going concern. We will need to generate significant revenue to achieve profitability, and we may never do so.
COVID-19 pandemic impact
Our business, results of operations and financial condition have been and may continue to be impacted by the COVID-19 pandemic and could be further impacted by supply chain interruptions, extended “shelter-in-place” orders or advisories, facility closures or other reasons related to the pandemic. As of the date of this Quarterly Report on Form 10-Q, the extent to which COVID-19 could materially impact our financial conditions, liquidity or results of operations is uncertain.
To the extent COVID-19 disruptions continue to adversely impact our business, results of operations and financial condition, it may also have the effect of heightening risks relating to our ability to successfully commercialize newly developed or acquired products, consolidation in the healthcare industry, and maintenance of our contractual relationships.
Recent Developments
On February 23, 2022, we received a written notification (the “Notice Letter”) from Nasdaq indicating that we were not in compliance with Nasdaq Listing Rule 5450(a)(1), as the closing bid price for our common stock was below the $1.00 per share requirement for the last 30 consecutive business days. The Notice Letter stated that we have 180 calendar days, or until August 22, 2022 (the “Initial Compliance Period”), to regain compliance with the minimum bid price requirement. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we can regain compliance if the closing bid price of our common stock is at least $1.00 for a minimum of 10 consecutive business days.
In the event that we do not regain compliance with Listing Rule 5450(a)(1) prior to the expiration of the compliance period, we will receive written notification that our securities are subject to delisting. At that time, we may appeal the delisting determination to a hearings panel pursuant to the procedures set forth in the applicable Nasdaq Listing Rules. A delisting of our common stock would have an adverse effect on the market liquidity of our common stock and, as a result, the market price for our common stock could become more volatile. Further, a delisting also could make it more difficult for us to raise additional capital. We intend to monitor the closing bid price of our common stock and may conduct a reverse stock split, if necessary, to regain compliance with the Nasdaq bid price rule.
Results of Operations
Comparison of Three Months ended, June 30, 2022 and 2021
The following table summarizes the results of our operations for the three months ended June 30, :
| 2022 |
| 2021 |
| Change | ||||
Operating Expenses: |
|
|
|
|
|
| |||
General and Administrative | $ | 1,801,878 | $ | 1,305,865 | $ | 496,013 | |||
Research and Development | 567,227 | 1,439,922 | (872,695) | ||||||
Change in Fair Value of Contingent Consideration | 32,943 | 73,717 | (40,774) | ||||||
Total Operating Expenses |
| 2,402,048 |
| 2,819,504 |
| (417,456) | |||
Other Expense, Net |
| 1,237 |
| 276,489 |
| (275,252) | |||
Net Loss | $ | (2,400,811) | $ | (2,543,015) | $ | (142,204) | |||
General and Administrative Expenses. The increase of $0.496 million was primarily due to increases in professional fees of $0.706 million for consulting and audit, travel and other office expenses of $0.044 million offset by a decrease in personnel related expenses of $0.255 million.
20
Research and Development Expenses. The decrease of $0.873 million was primarily development costs for KIO-101 of $0.725 million and for KIO-201 of $0.119 million and personnel related costs of $0.269 million offset by development costs for KIO-301 of $0.117 million and research and development refundable credit of $0.133 million.
Change in Fair Value of Contingent Consideration. Contingent consideration decreased by $0.041 million and the change is primarily due to a change in the discount rate for the calculation of fair value of the contingent consideration.
Other Expense, Net. The decrease of $0.275 million was due to recording a gain as a result of the full forgiveness of the loan under the PPP in second quarter of 2021.
Comparison of Six Months ended, June 30, 2022 and 2021
The following table summarizes the results of our operations for the six months ended June 30, :
2022 |
| 2021 |
| Change | |||||
Operating Expenses: |
|
|
|
|
|
| |||
General and Administrative | $ | 3,466,669 | $ | 2,606,008 | $ | 860,661 | |||
Research and Development |
| 1,275,155 |
| 2,720,164 |
| (1,445,009) | |||
Executive Severance |
| 962,833 |
| — |
| 962,833 | |||
Change in Fair Value of Contingent Consideration |
| 266,833 |
| (496,486) |
| 763,319 | |||
Total Operating Expenses |
| 5,971,490 |
| 4,829,686 |
| 1,141,804 | |||
Other Expense, Net |
| 5,665 |
| 276,053 |
| (270,388) | |||
Net Loss | $ | (5,965,825) | $ | (4,553,633) | $ | (1,412,192) | |||
General and Administrative Expenses. The increase of $0.861 million was primarily due to increases in professional fees of $0.744 million for consulting, audit and legal related costs, travel and other office expenses of $0.216 million offset by a decrease in personnel related expenses of $0.099 million.
Research and Development Expenses. The decrease of $1.445 million was primarily development costs for KIO-101 of $0.740 million and KIO-201 of $0.463 million and personnel related costs of $0.417 million.
Executive Severance. The increase was due primarily to an accrual for the severance agreement with the Company’s former Chief Executive Officer.
Change in Fair Value of Contingent Consideration. The change in fair value of contingent consideration of $0.267 million for the six months ended June 30, 2022, was primarily driven by changes in estimated probabilities of success related to the orphan drug status designation of the Bayon drug candidate which occurred in March of 2022. The change in fair value of contingent consideration of ($0.496) million for the six months ended June 30, 2021 was primarily driven by changes in the estimated probabilities of success derived from an updated industry study published in the first quarter of 2021.
Other Expense, Net. The decrease of $0.270 million was due to recording a gain as a result of the full forgiveness of the loan under the PPP in second quarter of 2021.
Liquidity and Capital Resources
Our principal liquidity needs have historically been for acquisitions, working capital, research and development, and capital expenditures. We expect these needs to continue as we develop and work toward commercialize new products. We will need additional financing to support our continuing operations. We will seek to fund our operations through public or private equity, debt financings, license and development agreements, or other sources, which may include collaborations with third parties.
21
If we raise additional funds by issuing equity securities or convertible debt, our stockholders will experience dilution. Debt financing, if available, would result in increased fixed payment obligations and may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, or making capital expenditures. If we raise additional funds through collaboration and licensing arrangements with third parties, it may be necessary to relinquish valuable rights to our products, future revenue streams or product candidates, or to grant licenses on terms that may not be favorable to us. Although historically the Company has been successful at raising capital, most recently raising net proceeds of approximately $5.297 million in a registered direct offering that closed on July 26, 2022, net of underwriting discount and commissions of $0.435 million and expense of $0.287 million. Additional capital may not be available on terms favorable to Kiora, if at all. The Company does not know if any future offerings will succeed. Our failure to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy. These conditions raise substantial doubt about our ability to continue as a going concern. We will need to generate significant revenue to achieve profitability, and we may never do so.
Information regarding cash flows
As of June 30, 2022, we had unrestricted cash and cash equivalents totaling $2.428 million and restricted cash totaling $0.049 million for a total of $2.477 million compared to $7.900 million at December 31, 2021. The following table sets forth the primary uses of cash for the six months ended June 30,:
| 2022 |
| 2021 | |||
Net Cash Used in Operating Activities | $ | (5,331,325) | $ | (5,485,615) | ||
Net Cash Provided by (Used in) Investing Activities | $ | 6,375 | $ | (63,865) | ||
Net Cash Provided by Financing Activities | $ | — | $ | 8,038,862 | ||
Operating Activities. Net cash used in operating activities decreased $0.154 million due to timing of payments in the first half of 2022.
Investing Activities. The increase in cash from investing activities is due to a sale of an asset in 2022 as opposed to assets acquired in 2021.
Financing Activities. During the six months ended June 30, 2021, we received net proceeds of $8.000 million from the completion of a private placement.
Funding Requirements and Other Liquidity Matters
Our KIO-301, KIO-101 and KIO-201 product pipeline is still in various stages of preclinical and clinical development. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. We anticipate that our expenses will increase substantially if and as we:
| ● | seek marketing approval for our KIO-301, KIO-101 or KIO-201 products or any other products that we successfully develop; |
| ● | establish a sales and marketing infrastructure to commercialize our KIO-301, KIO-101 or KIO-201 products in the United States, if approved; and |
| ● | add operational, financial and management information systems and personnel, including personnel to support our product development and future commercialization efforts. |
22
Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances and licensing arrangements. We do not have any committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of holders of common stock. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic alliances or licensing arrangements with pharmaceutical partners, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, including our KIO-301, KIO-101 and KIO-201 products, on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market KIO-301, KIO-101 and KIO-201 products, or any other products that we would otherwise prefer to develop and market ourselves.
Based on our cash on hand at June 30, 2022, we believe we will have sufficient cash to fund planned operations through March 2023. However, the acceleration or reduction of cash outflows by management can significantly impact the timing for raising additional capital to complete development of its products. To continue development, we will need to raise additional capital through debt and/or equity financing, or access additional funding through grants. Although historically the Company has been successful at raising capital, most recently raising net proceeds of approximately $5.297 million in a registered direct offering that closed on July 26, 2022, additional capital may not be available on terms favorable to Kiora, if at all. The Company does not know if any future offerings will succeed. Accordingly, no assurances can be given that management will be successful in these endeavors. Our recurring losses from operations have caused management to determine there is substantial doubt about our ability to continue as a going concern. Our Condensed Consolidated Financial Statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities or any other adjustments that might be necessary should we be unable to continue as a going concern.
Other
For information regarding Commitments and Contingencies, refer to Note 9. Commitments and contingencies and Note 3. Acquisitions to the Notes to the Unaudited condensed consolidated financial statements of Part 1, Item 1. Financial Statements of this Form 10-Q.
Critical Accounting Estimates
Our discussion of operating results is based upon the unaudited condensed consolidated financial statements and accompanying notes. The preparation of these statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amount of revenues and expenses during the reporting period. Our critical accounting estimates are detailed in Item 7 of our Annual Report on Form 10-K/A for the year ended December 31, 2021 and we have no material changes from such disclosures.
Recently Issued Accounting Pronouncements
Refer to Note 1. Business, Presentation and Recent Accounting Pronouncements, in the Notes to the Unaudited condensed consolidated financial statements of Part 1, Item 1. Financial Statements of this Form 10-Q for detailed information regarding the status of recently issued accounting pronouncements.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
Not applicable.
Item 4. Controls and Procedures.
This Report includes the certifications of our Chief Executive Officer (who is our principal executive and financial / accounting officer) required by Rule 13a-14 of the Exchange Act. See Exhibit 31.1. This Item 4 includes information concerning the controls and control evaluations referred to in those certifications.
23
Evaluation of Disclosure Controls and Procedures
Disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) are designed to ensure that information required to be disclosed in reports filed or submitted under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms and that such information is accumulated and communicated to management, including the Chief Executive Officer, to allow timely decisions regarding required disclosures.
In connection with the preparation of this Quarterly Report on the Form 10-Q, the Company’s Management, under the supervision of, and with the participation of, our Chief Executive Officer, conducted an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures as of June 30, 2022. Our disclosure controls and procedures are designed to provide reasonable assurance that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and our management necessarily was required to apply its judgment in evaluating and implementing our disclosure controls and procedures. Based upon the evaluation described above and material weaknesses identified in our Form 10-K/A as of December 31, 2021, our Chief Executive Officer has concluded that they believe that our disclosure controls and procedures were not effective as of the end of the period covered by this report.
Changes in Internal Control over Financial Accounting and Reporting
Our management, with the participation of the Chief Executive Officer, has evaluated whether any change in our internal control over financial accounting and reporting occurred during the three months ended June 30, 2022 and concluded that changes did occur. These changes were made to address the material weaknesses identified in the Form 10-K/A as of December 31, 2021. We have identified and implemented and continue to implement, certain remediation efforts to improve the effectiveness of our internal control over financial reporting and disclosure controls and procedures. The following changes are underway.
· | We hired consultants who began working with the company in March 2022 and we are in the process of hiring additional full time resources with the appropriate levels of experience and reallocated responsibilities across the team. |
· | We are in the process of performing a detailed financial reporting risk assessment to identify areas that require improvement and are currently implementing changes to address these areas. |
While progress has been made to enhance our internal control over financial reporting, we are still in the process of implementing, documenting and testing these processes, procedures and controls. Additional time is required to complete implementation and to assess and ensure the sustainability of these procedures. We will continue to devote significant time and attention to these remedial efforts. However, the material weaknesses cannot be considered remediated until the applicable remedial controls operate for a sufficient period of time and management has concluded, through testing, that these controls are operating effectively.
PART II - OTHER INFORMATION
Item 1. Legal Proceedings.
While we are not currently a party to any legal proceedings as of June 30, 2022, from time to time we may be a party to a variety of legal proceedings that arise in the normal course of our business.
Item 1A. Risk Factors.
In addition to the other information set forth in this report, you should carefully consider the risk factor below in this Item 1A as well as the risk factors discussed in Part I, “Item 1A. Risk Factors” in our Annual Report on Form 10-K/A for the year ended December 31, 2021, which is incorporated herein by reference and which could materially affect our business, financial condition or future results. The risks described in our Annual Report on Form 10-K/A are not the only risks facing our Company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition and/or operating results. Except as disclosed below in this Item 1A, we do not believe that there have been any material changes from the risk factors previously disclosed in our Annual Report on Form 10-K/A for the year ended December 31, 2021.
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We have identified material weaknesses in our internal control over financial reporting. If we are unable to remediate these material weaknesses, or if we experience additional material weaknesses in the future or otherwise fail to maintain an effective system of internal controls, we may not be able to accurately or timely satisfy the requirements applicable to public companies, which may adversely affect investor confidence in us, and, as a result, the market price of our common stock.
Our management is responsible for establishing and maintaining adequate internal control over financial reporting designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements for external purposes in accordance with GAAP. Our management is likewise required, on a quarterly basis, to evaluate the effectiveness of our internal controls and to disclose any changes and material weaknesses identified through such evaluation in those internal controls. A material weakness is a deficiency, or combination of deficiencies in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our consolidated financial statements will not be prevented or detected on a timely basis.
We have previously identified the following material weaknesses:
| ● | We did not design or maintain an effective control environment commensurate with our financial reporting requirements. We lacked a sufficient number of professionals with an appropriate level of accounting knowledge, training and experience to appropriately analyze, record and disclose accounting matters timely and accurately. Additionally, the limited personnel resulted in our inability to consistently establish appropriate authorities and responsibilities in pursuit of our financial reporting objectives, as demonstrated by, among other things, our insufficient segregation of duties in our accounting function. This material weakness further contributed to the material weakness below. |
| ● | We did not design and maintain formal accounting policies, processes, and controls to analyze, account for and disclose significant and unusual transactions, including business combinations, accounting for stock-based compensation, analysis of goodwill and indefinite-lived asset impairment and contingent consideration. |
| ● | For our systems, some of the former finance staff-maintained IT access to systems and controls. |
As a result of these material weaknesses, our management concluded that our internal control over financial reporting was not effective as of June 30, 2022. Additionally, we have identified and are investigating apparent payroll irregularities that occurred in June 2022, and have retained an independent firm to review our internal control over financial reporting in light of such irregularities.
To respond to these material weaknesses, we have devoted, and plan to continue to devote, significant effort and resources to the remediation and improvement of our internal control over financial reporting. While we have processes to identify and appropriately apply applicable accounting requirements, we plan to enhance these processes to better evaluate our research and understanding of the nuances of the complex accounting standards that apply to our consolidated financial statements. Our plans currently include providing enhanced access to accounting literature, research materials and documents and increased communication among our personnel and third-party professionals with whom we consult regarding complex accounting applications. The elements of our remediation plan can only be accomplished over time, and we can offer no assurance that these initiatives will ultimately have the intended effects.
Any failure to maintain such internal control could adversely impact our ability to report our financial position and results from operations on a timely and accurate basis. If our consolidated financial statements are not accurate, investors may not have a complete understanding of our operations. Likewise, if our consolidated financial statements are not filed on a timely basis, we could be subject to sanctions or investigations by the stock exchange on which our ordinary shares and other securities are listed, the SEC or other regulatory authorities. In either case, there could result a material adverse effect on our business. Ineffective internal controls could also cause investors to lose confidence in our reported financial information which could have a negative effect on the trading price of our stock.
We can give no assurance that the measures we have taken and plan to take in the future will remediate the material weaknesses identified or that any additional material weaknesses or restatements of financial results will not arise in the future due to a failure to implement and maintain adequate internal control over financial reporting or circumvention of these controls. In addition, even if we are successful in strengthening our controls and procedures, in the future those controls, and procedures may not be adequate to prevent or identify irregularities or errors or to facilitate the fair presentation of our consolidated financial statements.
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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
Unregistered Sales of Equity Securities
None.
Purchase of Equity Securities
We did not purchase any of our registered equity securities during the period covered by this Quarterly Report on Form 10-Q.
Item 3. Defaults Upon Senior Securities.
Not applicable.
Item 4. Mine Safety Disclosure.
Not applicable.
Item 5. Other Information.
None.
Item 6. Exhibits.
The exhibits filed as part of this Quarterly Report on Form 10-Q are set forth on the Exhibit Index immediately preceding such exhibits and are incorporated herein by reference.
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SIGNATURES
Pursuant to the requirements of Section 13 and 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Date: August 12, 2022 | By: | /s/ Brian M. Strem, Ph.D. |
|
| President and Chief Executive Officer |
|
| (Principal executive officer and Principal financial and accounting officer) |
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EXHIBIT INDEX
The following exhibits are filed as part of this Quarterly Report on Form 10-Q. Where such filing is made by incorporation by reference to a previously filed document, such document is identified.
Exhibit |
| |
Number |
| Description of Exhibit |
3.1 | ||
4.1 | ||
4.2 | ||
4.3 | ||
31.1 | ||
32.1** | ||
101.INS | XBRL Instance Document (embedded within the Inline XBRL document) | |
101.SCH | XBRL Taxonomy Extension Schema Document | |
101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document | |
101.DEF | XBRL Taxonomy Extension Definition Linkbase Document | |
101.LAB | XBRL Taxonomy Extension Labels Linkbase Document | |
101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document | |
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
# | Management contract or compensatory plan or arrangement. |
** | This certification shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section, nor shall it be deemed to be incorporated by reference into any filing under the Securities Act. |
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