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These terms and conditions govern your use of the website alphaminr.com and its related services.
These Terms and Conditions (“Terms”) are a binding contract between you and Alphaminr, (“Alphaminr”, “we”, “us” and “service”). You must agree to and accept the Terms. These Terms include the provisions in this document as well as those in the Privacy Policy. These terms may be modified at any time.
Your subscription will be on a month to month basis and automatically renew every month. You may terminate your subscription at any time through your account.
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You represent that you are of legal age to form a binding contract. You are responsible for any
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time.
The Services are intended for your own individual use. You shall only use the Services in a
manner that complies with all laws. You may not use any automated software, spider or system to
scrape data from Alphaminr.
Alphaminr is not a financial advisor and does not provide financial advice of any kind. The service is provided “As is”. The materials and information accessible through the Service are solely for informational purposes. While we strive to provide good information and data, we make no guarantee or warranty as to its accuracy.
TO THE EXTENT PERMITTED BY APPLICABLE LAW, UNDER NO CIRCUMSTANCES SHALL ALPHAMINR BE LIABLE TO YOU FOR DAMAGES OF ANY KIND, INCLUDING DAMAGES FOR INVESTMENT LOSSES, LOSS OF DATA, OR ACCURACY OF DATA, OR FOR ANY AMOUNT, IN THE AGGREGATE, IN EXCESS OF THE GREATER OF (1) FIFTY DOLLARS OR (2) THE AMOUNTS PAID BY YOU TO ALPHAMINR IN THE SIX MONTH PERIOD PRECEDING THIS APPLICABLE CLAIM. SOME STATES DO NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL OR CERTAIN OTHER DAMAGES, SO THE ABOVE LIMITATION AND EXCLUSIONS MAY NOT APPLY TO YOU.
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This privacy policy describes how we (“Alphaminr”) collect, use, share and protect your personal information when we provide our service (“Service”). This Privacy Policy explains how information is collected about you either directly or indirectly. By using our service, you acknowledge the terms of this Privacy Notice. If you do not agree to the terms of this Privacy Policy, please do not use our Service. You should contact us if you have questions about it. We may modify this Privacy Policy periodically.
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We use Google Analytics and we use Stripe for payment processing. We will not share the information we collect with third parties for promotional purposes. We may share personal information with law enforcement as required or permitted by law.
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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27-2004382
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification No.)
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11055 Flintkote Avenue, Suite B, San Diego, California
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92121
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(Address of principal executive offices)
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(Zip Code)
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(858) 952-7570
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(Registrant’s telephone number, including area code)
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Name of each exchange on which registered
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Common Stock, $0.0001 par value
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The NASDAQ Capital Market
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Securities registered pursuant to Section 12(g) of the Act:
None
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Large accelerated filer
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Accelerated filer
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Non-accelerated filer
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(Do not check if a smaller reporting company)
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Smaller reporting company
x
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Emerging growth company
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the timing of regulatory submissions;
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our ability to obtain and maintain regulatory approval of our existing product candidates and any other product candidates we may develop, and the labeling under any approval we may obtain;
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approvals for clinical trials may be delayed or withheld by regulatory agencies;
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pre-clinical and clinical studies will not be successful or confirm earlier results or meet expectations or meet regulatory requirements or meet performance thresholds for commercial success;
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risks relating to the timing and costs of clinical trials, the timing and costs of other expenses;
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risks associated with obtaining funding from third parties;
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management and employee operations and execution risks;
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loss of key personnel;
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competition;
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risks related to market acceptance of products;
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intellectual property risks;
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assumptions regarding the size of the available market, benefits of our products, product pricing, timing of product launches;
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risks associated with the uncertainty of future financial results;
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our ability to attract collaborators and partners; and
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risks associated with our reliance on third party organizations.
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its inhibition of PLK1 is highly-selective and the half maximal inhibitory concentration (IC50) for PLK2 and PLK3 is over 5,000-fold of that for PLK1;
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it has a relatively short half-life of approximately 24 hours;
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it is available in an oral gelcap formulation.
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an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain government healthcare programs;
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implementation of the federal physician payment transparency requirements, sometimes referred to as the “Physician Payments Sunshine Act”;
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a licensure framework for follow-on biologic products;
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a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;
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establishment of a Center for Medicare Innovation at the Centers for Medicare & Medicaid Services to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending;
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an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program, to 23.1% and 13% of the average manufacturer price for most branded and generic drugs, respectively and capped the total rebate amount for innovator drugs at 100% of the Average Manufacturer Price, or AMP;
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a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for certain drugs and biologics, including our product candidates, that are inhaled, infused, instilled, implanted or injected;
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extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;
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expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for individuals with income at or below 133% of the federal poverty level, thereby potentially increasing manufacturers’ Medicaid rebate liability;
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a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D; and
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expansion of the entities eligible for discounts under the Public Health program.
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offer therapeutic or other medical benefits over existing drugs or other product candidates in development to treat the same patient population;
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be proven to be safe and effective in current and future preclinical studies or clinical trials;
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have the desired effects;
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be free from undesirable or unexpected effects;
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meet applicable regulatory standards;
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be capable of being formulated and manufactured in commercially suitable quantities and at an acceptable cost; or
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be successfully commercialized by us or by collaborators.
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communications with the FDA, or similar regulatory authorities in different countries, regarding the scope or design of a trial or trials;
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regulatory authorities (including an Institutional Review Board or Ethical Committee) or IRB or EC, not authorizing us to commence or conduct a clinical trial at a prospective trial site;
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enrollment in our clinical trials being delayed, or proceeding at a slower pace than we expected, because we have difficulty recruiting patients or participants dropping out of our clinical trials at a higher rate than we anticipated;
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our third party contractors, upon whom we rely for conducting preclinical studies, clinical trials and manufacturing of our trial materials, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner;
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having to suspend or ultimately terminate our clinical trials if participants are being exposed to unacceptable health or safety risks;
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IRBs, ECs or regulators requiring that we hold, suspend or terminate our preclinical studies and clinical trials for various reasons, including non-compliance with regulatory requirements; and
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the supply or quality of drug material necessary to conduct our preclinical studies or clinical trials being insufficient, inadequate or unavailable.
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adversely impact our ability to raise sufficient capital to fund the development of our product candidate;
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adversely affect our ability to further develop or commercialize our product candidate;
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diminish any competitive advantages that we or our collaborators may have or attain; and
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adversely affect the receipt of potential milestone payments and royalties from the sale of our products or product revenues.
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delays, suspension or termination of clinical trials related to our products;
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refusal by regulatory authorities to review pending applications or supplements to approved applications;
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product recalls or seizures;
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suspension of manufacturing;
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withdrawals of previously approved marketing applications; and
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fines, civil penalties and criminal prosecutions.
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the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials;
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we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate is safe and effective for its proposed indication;
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the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval;
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the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;
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the data collected from clinical trials of our product candidates may not be sufficient to support the submission of an NDA or other submission or to obtain regulatory approval in the United States or elsewhere;
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the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies;
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the FDA or comparable foreign regulatory authorities may fail to approve the companion diagnostics we contemplate developing with partners; and
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the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.
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the federal healthcare program anti-kickback law, which prohibits, among other things, persons from soliciting, receiving or providing remuneration, directly or indirectly, to induce either the referral of an individual, for an item or service or the purchasing or ordering of a good or service, for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs;
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federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payers that are false or fraudulent, and which may apply to entities like us which provide coding and billing information to customers;
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the federal Health Insurance Portability and Accountability Act of 1996, which prohibits executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters and which also imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information;
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the Federal Food, Drug, and Cosmetic Act, which among other things, strictly regulates drug manufacturing and product marketing, prohibits manufacturers from marketing drug products for off-label use and regulates the distribution of drug samples; and
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state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by federal laws, thus complicating compliance efforts.
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successfully identify and develop key points of product differentiations from currently available therapies;
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successfully and rapidly complete clinical trials and submit for and obtain all requisite regulatory approvals in a cost-effective manner;
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maintain a proprietary position for our products and manufacturing processes and other related product technology;
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attract and retain key personnel;
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develop relationships with physicians prescribing these products; and
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build an adequate sales and marketing infrastructure for our product candidates.
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demonstration of safety and efficacy;
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changes in the practice guidelines and the standard of care for the targeted indication;
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relative convenience and ease of administration;
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the prevalence and severity of any adverse side effects;
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budget impact of adoption of our product on relevant drug formularies and the availability, cost and potential advantages of alternative treatments, including less expensive generic drugs;
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pricing, reimbursement and cost effectiveness, which may be subject to regulatory control;
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effectiveness of our or any of our partners’ sales and marketing strategies;
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the product labeling or product insert required by the FDA or regulatory authority in other countries; and
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the availability of adequate third-party insurance coverage or reimbursement.
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our third-party contractors failing to develop an acceptable formulation to support later-stage clinical trials for, or the commercialization of, our product candidates;
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our contract manufacturers failing to manufacture our product candidate according to their own standards, our specifications, cGMPs, or otherwise manufacturing material that we or the FDA may deem to be unsuitable in our clinical trials;
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our contract manufacturers being unable to increase the scale of, increase the capacity for, or reformulate the form of our product candidate. We may experience a shortage in supply, or the cost to manufacture our products may increase to the point where it adversely affects the cost of our product candidate. We cannot assure you that our contract manufacturers will be able to manufacture our products at a suitable scale, or we will be able to find alternative manufacturers acceptable to us that can do so;
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our contract manufacturers placing a priority on the manufacture of their own products, or other customers’ products;
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our contract manufacturers failing to perform as agreed or not remain in the contract manufacturing business; and
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our contract manufacturers’ plants being closed as a result of regulatory sanctions or a natural disaster.
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manage our clinical studies effectively;
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integrate additional management, administrative, manufacturing and regulatory personnel;
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maintain sufficient administrative, accounting and management information systems and controls; and
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hire and train additional qualified personnel.
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Medicare billing and payment regulations applicable to clinical laboratories;
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the Federal Anti-kickback Law and state anti-kickback prohibitions;
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the Federal physician self-referral prohibition, commonly known as the Stark Law, and the state equivalents;
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the Federal Health Insurance Portability and Accountability Act of 1996;
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the Medicare civil money penalty and exclusion requirements;
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the Federal False Claims Act civil and criminal penalties and state equivalents; and
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the Foreign Corrupt Practices Act, the United Kingdom Anti-bribery Act and the European Data Protection Directive, all of which apply to our international activities.
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an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain government healthcare programs;
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•
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implementation of the federal physician payment transparency requirements, sometimes referred to as the “Physician Payments Sunshine Act”;
|
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•
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a licensure framework for follow-on biologic products;
|
|
•
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a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;
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|
•
|
establishment of a Center for Medicare Innovation at the Centers for Medicare & Medicaid Services to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending;
|
|
•
|
an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program, to 23.1% and 13% of the average manufacturer price for most branded and generic drugs, respectively and capped the total rebate amount for innovator drugs at 100% of the Average Manufacturer Price, or AMP;
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|
•
|
a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for certain drugs and biologics, including our product candidates, that are inhaled, infused, instilled, implanted or injected;
|
|
•
|
extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;
|
|
•
|
expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for individuals with income at or below 133% of the federal poverty level, thereby potentially increasing manufacturers’ Medicaid rebate liability;
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•
|
a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D; and
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expansion of the entities eligible for discounts under the Public Health program.
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technological innovations or new products and services introduced by us or our competitors;
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clinical trial results relating to our tests or those of our competitors;
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announcements or press releases relating to the industry or to our own business or prospects;
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coverage and reimbursement decisions by third party payors, such as Medicare and other managed care organizations;
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regulation and oversight of our product candidates and services, including by the FDA, Centers for Medicare & Medicaid Services and comparable foreign agencies;
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the establishment of partnerships with clinical reference laboratories;
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healthcare legislation;
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intellectual property disputes;
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additions or departures of key personnel;
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sales of our common stock;
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our ability to integrate operations, technology, products and services;
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our ability to execute our business plan;
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operating results below expectations;
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loss of any strategic relationship;
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industry developments;
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economic and other external factors; and
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period-to-period fluctuations in our financial results.
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delaying, deferring or preventing a change in control of our company;
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impeding a merger, consolidation, takeover or other business combination involving us; or
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discouraging a potential acquirer from making a tender offer or otherwise attempting to obtain control of us.
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2017
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2016
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High
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Low
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High
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Low
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||||||||
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First Quarter
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$
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2.40
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$
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0.95
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$
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6.93
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$
|
2.85
|
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Second Quarter
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$
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1.45
|
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$
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0.61
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$
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6.67
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$
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3.31
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Third Quarter
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$
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1.63
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$
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0.65
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|
$
|
5.98
|
|
|
$
|
4.25
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Fourth Quarter
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$
|
1.08
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$
|
0.24
|
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$
|
4.75
|
|
|
$
|
1.78
|
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|
Number of Shares of Common Stock to be Issued upon Exercise of Outstanding Options, Warrants and Rights
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|
Weighted-Average Exercise Price of Outstanding Options, Warrants and Rights
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Number of Options Remaining Available for Future Issuance Under Equity Compensation Plans
(excluding securities reflected in column (a))
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||||
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(a)
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(b)
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(c)
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Equity Compensation Plans Approved by Stockholders
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5,710,611
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$
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3.15
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3,436,788
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Equity Compensation Plans Not Approved by Stockholders
(1)
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54,166
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$
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3.35
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|
—
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Total
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5,764,777
|
|
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3,436,788
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||
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(1)
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Represents the following options to purchase common stock granted on November 17, 2010: (i) an option to purchase 8,333 shares with an exercise price of $3.00 per share, (ii) an option to purchase 33,333 shares with an exercise price of $3.00 per share, and (iii) an option to purchase 12,500 shares with an exercise price of $4.50 per share. All the options were vested in full on the date of grant and will expire on November 17, 2020.
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Activated the first two clinical trial sites for the Phase1b/2 multicenter trial of PCM-075 in patients with AML.
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Completed a public offering of 14,683,333 shares of common stock and common warrants to purchase up to 15,000,000 shares of common stock. The net proceeds from the public offering were approximately $4.1 million in December 2017.
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Submitted protocol to FDA for Phase 2 Clinical Trial of PCM-075 in combination with Zytiga
®
(abiraterone acetate) for mCRPC.
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Announced the launch of NextCollect™ urine collection and DNA preservation kit to research laboratories and pharmaceutical customers.
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Presented data showing sensitivity of TNBC cell lines to PCM-075 and Synergy with Zytiga
®
at San Antonio Breast Cancer Symposium.
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Announced preclinical research demonstrating synergy of PCM-075 with Zytiga
®
in Castration-Resistant Prostate Cancer tumor cells.
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Announced that the FDA granted Orphan Drug Designation to PCM-075 for the treatment of patients with AML.
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Announced the expansion and strengthening of our Board of Directors with the appointment of Athena Countouriotis, M.D. Dr. Countouriotis brings significant experience in oncology clinical development and orphan indications.
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Announced PCM-075 synergy with a HDAC Inhibitor in Non-Hodgkin Lymphoma Cell Lines. Additionally, PCM-075 demonstrates synergy in combination with more than ten chemotherapeutic and targeted therapies across a broad range of solid tumor and hematologic cancers.
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Announced preclinical AML data showing that PCM-075 significantly enhances the efficacy of a FLT3 inhibitor in combination therapy.
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Announced FDA approval of IND for Phase 1b/2 trial of PCM-075 in patients with AML.
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Announced peer-reviewed publication of first-in-human Phase 1 trial results with PCM-075 in the journal Investigational New Drugs. The data from the trial demonstrated PCM-075’s potential as safe and effective treatment for solid tumor and hematological malignancies.
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Completed a registered direct offering of 6,191,500 shares of common stock and a concurrent private placement issuing warrants to purchase up to 4,643,626 shares of common stock. The net proceeds from the registered direct offering and concurrent private placement were approximately $6.5 million in July 2017.
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Entered into an agreement with Novogene Co. Ltd. (“Novogene”), a leading global provider of genomic services and solutions and the largest sequencing capacity in the world, whereby Novogene will purchase NextCollect™, our proprietary urine collection and nucleic acid preservation device for validation in the Chinese market.
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Engaged PRA Health Sciences, a leading, global contract research organization, to conduct our Phase 1b/2 clinical trial of PCM-075.
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Executed a supplier agreement with NerPharMa, S.r.l., a pharmaceutical manufacturing company and a subsidiary of Nerviano Medical Sciences S.r.l., to manufacture drug product for PCM-075.
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Submitted an IND application to FDA to conduct a Phase 1b/2 clinical trial of PCM-075 in AML.
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Announced expansion of key claims for our NPM1 patent portfolio for AML.
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Entered into an agreement with a global biopharmaceutical company to utilize Trovera
®
ctDNA tests and services in cancer clinical trials.
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Entered into an agreement with AstraZeneca to utilize Trovera
®
ctDNA test and services in prospective biomarker study.
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Announced phase 1 safety study conducted by Nerviano Medical Sciences supports planned development of PCM-075 in AML.
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•
|
Entered into a license agreement with Nerviano that grants us exclusive global development and commercialization rights to NMS-1286937, which we refer to as PCM-075. PCM-075 is an oral, investigative drug and a highly-selective PLK 1 inhibitor for the treatment of AML.
|
|
•
|
Up-front nonrefundable license fees pursuant to agreements under which we have no continuing performance obligations are recognized as revenues on the effective date of the agreement and when collection is reasonably assured.
|
|
•
|
Minimum royalties are recognized as earned, and royalties are earned based on the licensee’s use. The Company is unable to predict licensee’s sales and thus revenue is recognized upon receipt of notification from licensee and payment when collection is assured. Notification is generally one quarter in arrears.
|
|
|
For the years ended December 31,
|
||||||
|
|
2017
|
|
2016
|
||||
|
Salaries and staff costs
|
$
|
2,568,263
|
|
|
$
|
7,698,632
|
|
|
Outside services, consultants and lab supplies
|
2,125,374
|
|
|
5,573,362
|
|
||
|
Facilities
|
1,064,561
|
|
|
1,434,101
|
|
||
|
Other
|
2,124,452
|
|
|
300,547
|
|
||
|
Total research and development
|
$
|
7,882,650
|
|
|
$
|
15,006,642
|
|
|
•
|
Level 1 — Quoted prices for identical instruments in active markets.
|
|
•
|
Level 2 — Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations where inputs are observable or where significant value drivers are observable.
|
|
•
|
Level 3 — Instruments where significant value drivers are unobservable to third parties.
|
|
|
For the years ended December 31,
|
||||||||||
|
|
2017
|
|
2016
|
|
(Decrease)/Increase
|
||||||
|
Royalty income
|
$
|
285,444
|
|
|
$
|
258,062
|
|
|
$
|
27,382
|
|
|
Diagnostic service revenue
|
196,111
|
|
|
86,137
|
|
|
109,974
|
|
|||
|
Clinical research services
|
23,849
|
|
|
36,873
|
|
|
(13,024
|
)
|
|||
|
Total revenues
|
$
|
505,404
|
|
|
$
|
381,072
|
|
|
$
|
124,332
|
|
|
|
For the years ended December 31,
|
||||||||||
|
|
2017
|
|
2016
|
|
Increase/(Decrease)
|
||||||
|
Salaries and staff costs
|
$
|
1,541,766
|
|
|
$
|
5,277,936
|
|
|
$
|
(3,736,170
|
)
|
|
Stock-based compensation
|
1,026,497
|
|
|
2,420,696
|
|
|
(1,394,199
|
)
|
|||
|
Outside services, consultants and lab supplies
|
2,125,374
|
|
|
5,573,362
|
|
|
(3,447,988
|
)
|
|||
|
Facilities
|
1,064,561
|
|
|
1,434,101
|
|
|
(369,540
|
)
|
|||
|
Travel and scientific conferences
|
80,714
|
|
|
213,419
|
|
|
(132,705
|
)
|
|||
|
Fees, license and other
|
2,043,738
|
|
|
87,128
|
|
|
1,956,610
|
|
|||
|
Total research and development expenses
|
$
|
7,882,650
|
|
|
$
|
15,006,642
|
|
|
$
|
(7,123,992
|
)
|
|
|
For the years ended December 31,
|
||||||||||
|
|
2017
|
|
2016
|
|
Increase/(Decrease)
|
||||||
|
Salaries and staff costs
|
$
|
1,004,887
|
|
|
$
|
5,336,941
|
|
|
$
|
(4,332,054
|
)
|
|
Stock-based compensation
|
676,635
|
|
|
2,111,366
|
|
|
(1,434,731
|
)
|
|||
|
Outside services and consultants
|
250,550
|
|
|
1,260,354
|
|
|
(1,009,804
|
)
|
|||
|
Facilities and insurance
|
273,099
|
|
|
496,881
|
|
|
(223,782
|
)
|
|||
|
Trade shows, conferences and marketing
|
398,425
|
|
|
1,312,749
|
|
|
(914,324
|
)
|
|||
|
Travel
|
74,662
|
|
|
889,265
|
|
|
(814,603
|
)
|
|||
|
Other
|
57,152
|
|
|
115,588
|
|
|
(58,436
|
)
|
|||
|
Total selling and marketing expenses
|
$
|
2,735,410
|
|
|
$
|
11,523,144
|
|
|
$
|
(8,787,734
|
)
|
|
|
For the years ended December 31,
|
||||||||||
|
|
2017
|
|
2016
|
|
Increase/(Decrease)
|
||||||
|
Personnel and outside services costs
|
$
|
3,445,296
|
|
|
$
|
4,058,213
|
|
|
$
|
(612,917
|
)
|
|
Stock-based compensation
|
2,350,962
|
|
|
2,910,156
|
|
|
(559,194
|
)
|
|||
|
Board of Directors’ fees
|
474,676
|
|
|
456,498
|
|
|
18,178
|
|
|||
|
Legal and accounting fees
|
3,885,613
|
|
|
2,916,508
|
|
|
969,105
|
|
|||
|
Facilities and insurance
|
963,285
|
|
|
641,715
|
|
|
321,570
|
|
|||
|
Travel
|
96,134
|
|
|
184,217
|
|
|
(88,083
|
)
|
|||
|
Fees, licenses, taxes and other
|
281,500
|
|
|
308,640
|
|
|
(27,140
|
)
|
|||
|
Total general and administrative expenses
|
$
|
11,497,466
|
|
|
$
|
11,475,947
|
|
|
$
|
21,519
|
|
|
|
For the years ended December 31,
|
||||||||||
|
|
2017
|
|
2016
|
|
Increase/(Decrease)
|
||||||
|
Net loss attributable to common stockholders
|
$
|
(24,930,984
|
)
|
|
$
|
(39,227,959
|
)
|
|
$
|
(14,296,975
|
)
|
|
Net loss per common share — basic
|
$
|
(0.72
|
)
|
|
$
|
(1.30
|
)
|
|
$
|
(0.58
|
)
|
|
Net loss per common share — diluted
|
$
|
(0.72
|
)
|
|
$
|
(1.37
|
)
|
|
$
|
(0.65
|
)
|
|
|
|
|
|
|
|
||||||
|
Weighted-average shares outstanding — basic
|
34,680,362
|
|
|
30,174,838
|
|
|
4,505,524
|
|
|||
|
Weighted-average shares outstanding — diluted
|
34,680,362
|
|
|
30,281,263
|
|
|
4,399,099
|
|
|||
|
|
Payments Due by period
|
||||||||||||||||||
|
|
Total
|
|
Less than 1
Year |
|
1-3 Years
|
|
3-5 Years
|
|
More than 5
Years |
||||||||||
|
Operating leases
|
$
|
3,679,552
|
|
|
$
|
881,815
|
|
|
$
|
1,838,336
|
|
|
$
|
959,401
|
|
|
$
|
—
|
|
|
Debt obligation (1)
|
1,461,327
|
|
|
1,461,327
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
|
Service agreement (2)
|
1,414,117
|
|
|
222,717
|
|
|
1,191,400
|
|
|
—
|
|
|
—
|
|
|||||
|
Total obligations
|
$
|
6,554,996
|
|
|
$
|
2,565,859
|
|
|
$
|
3,029,736
|
|
|
$
|
959,401
|
|
|
$
|
—
|
|
|
|
|
(1)
|
Debt is in default. Represents principal, interest under default rate and final fee payment.
|
|
(2)
|
Represents amounts that will become due upon future delivery of supplies and services from various parties under service contracts as of
December 31, 2017
.
|
|
Name
|
|
Age
|
|
Position
|
|
Thomas H. Adams, Ph.D.
|
|
75
|
|
Chairman of the Board
|
|
William (Bill) Welch
|
|
56
|
|
Chief Executive Officer and Director
|
|
Mark Erlander, Ph.D.
|
|
58
|
|
Chief Scientific Officer
|
|
John Brancaccio
|
|
69
|
|
Director
|
|
Gary S. Jacob, Ph.D.
|
|
70
|
|
Director
|
|
Dr. Paul Billings
|
|
65
|
|
Director
|
|
Dr. Stanley Tennant
|
|
66
|
|
Director
|
|
Dr. Rodney S. Markin
|
|
61
|
|
Director
|
|
Dr. Athena Countouriotis
|
|
46
|
|
Director
|
|
•
|
had a bankruptcy petition filed by or against any business of which such person was a general partner or executive officer either at the time of the bankruptcy or within two years prior to that time;
|
|
•
|
been convicted in a criminal proceeding or been subject to a pending criminal proceeding, excluding traffic violations and other minor offenses;
|
|
•
|
been subject to any order, judgment or decree, not subsequently reversed, suspended or vacated, of any court of competent jurisdiction, permanently or temporarily enjoining, barring, suspending or otherwise limiting his involvement in any type of business, securities or banking activities;
|
|
•
|
been found by a court of competent jurisdiction (in a civil action), the Securities and Exchange Commission, or SEC, or the Commodities Futures Trading Commission to have violated a federal or state securities or commodities law, and the judgment has not been reversed, suspended or vacated; and
|
|
•
|
been the subject of, or a party to, any sanction or order, not subsequently reversed, suspended or vacated, of any self-regulatory organization, any registered entity, or any equivalent exchange, association, entity or organization that has disciplinary authority over its members or persons associated with a member.
|
|
Name and Principal Position
|
|
Year
|
|
Salary ($)
|
|
Non-Equity Incentive Plan Compensation ($)
(1)
|
|
Option Awards ($)
(2)
|
|
Stock Awards ($)
(3)
|
|
Total ($)
|
||||||
|
William Welch, CEO
|
|
2017
|
|
475,000
|
|
|
811,388
|
|
(4)(5)
|
|
—
|
|
|
1,123,314
|
|
|
2,409,702
|
|
|
|
|
2016
|
|
319,712
|
|
|
115,781
|
|
|
|
3,204,294
|
|
|
—
|
|
|
3,639,787
|
|
|
Dr. Mark Erlander, CSO
|
|
2017
|
|
374,400
|
|
|
125,229
|
|
(2)(6)
|
|
225,866
|
|
|
296,252
|
|
|
1,021,747
|
|
|
|
|
2016
|
|
374,400
|
|
|
234,000
|
|
|
|
458,166
|
|
|
199,500
|
|
|
1,266,066
|
|
|
|
|
(1)
|
The amounts in this column relate to amounts earned by the Named Executive Officers in 2017 and 2016, as applicable, pursuant to our variable pay program described above under “Elements of our Compensation Program-Variable Pay”.
|
|
(2)
|
Amounts shown in this column do not reflect dollar amounts actually received by our named executive officers. Instead, these amounts represent the aggregate grant date fair value of stock option awards determined in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 718. The valuation assumptions used in determining 2017 and 2016 amounts are described in Note 5 to our financial statements included in our Annual Reports on Form 10-K for the fiscal years ended December 31, 2017 and 2016. Our named executive officers will only
|
|
(3)
|
This reflects the grant date fair value of awards granted during fiscal 2017.
|
|
(4)
|
Amounts shown in this column do not reflect dollar amounts actually received by our named executive officer. Instead, these amounts represent (1) a total of $652,511 income taxes we paid for our named executive officer related to the restricted stock awards granted and vested during the fiscal year ended December 31, 2017; and (2) the aggregate grant date fair value of stock option awards determined in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 718. The valuation assumptions used in determining 2017 and 2016 amounts are described in Note 5 to our financial statements included in our Annual Reports on Form 10-K for the fiscal years ended December 31, 2017 and 2016. Our named executive officer will only realize compensation to the extent the trading price of our common stock is greater than the exercise price of such stock options on the date the options are exercised.
|
|
(5)
|
Received stock options to purchase 662,500 shares of common stock in lieu of cash bonus.
|
|
(6)
|
Received stock options to purchase 522,189 shares of common stock in lieu of cash bonus.
|
|
|
|
Option Awards
(1)
|
|
Stock Awards
|
||||||||||||||
|
Name
|
|
Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable
|
|
Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable
|
|
Option
Exercise
Price ($)
|
|
Option
Expiration
Date
|
|
Number of
shares or units of
stock that
have not vested (#)
|
|
Market value of
shares or units of
stock that
have not vested ($)
|
||||||
|
William Welch
|
|
312,500
|
|
|
437,500
|
|
|
4.73
|
|
|
4/25/2026
|
|
|
200,000
|
|
|
61,500
|
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
130,000
|
|
|
39,975
|
|
|
Mark Erlander
|
|
5,000
|
|
|
—
|
|
|
2.84
|
|
|
9/13/2022
|
|
|
75,000
|
|
|
23,063
|
|
|
|
|
10,000
|
|
|
—
|
|
|
4.87
|
|
|
12/10/2022
|
|
|
90,000
|
|
|
27,675
|
|
|
|
|
200,000
|
|
|
—
|
|
|
7.04
|
|
|
1/28/2023
|
|
|
|
|
|
||
|
|
|
100,000
|
|
|
—
|
|
|
5.53
|
|
|
12/11/2023
|
|
|
|
|
|
||
|
|
|
150,000
|
|
|
50,000
|
|
|
3.29
|
|
|
7/16/2024
|
|
|
|
|
|
||
|
|
|
45,000
|
|
|
15,000
|
|
|
4.39
|
|
|
12/11/2024
|
|
|
|
|
|
||
|
|
|
71,875
|
|
|
78,125
|
|
|
5.18
|
|
|
1/4/2026
|
|
|
|
|
|
||
|
|
|
96,250
|
|
|
288,750
|
|
|
0.85
|
|
|
8/22/2027
|
|
|
|
|
|
||
|
|
|
(1)
|
For each executive officer, the shares listed in this table are subject to a single stock option award carrying the varying exercise prices as set forth herein. The option awards remain exercisable until they expire ten years from the date of grant, subject to earlier expiration following termination of employment.
|
|
Name
|
|
Fees Earned or Paid in Cash ($)
|
|
Option Awards ($)
(1)
|
|
Stock Awards ($)
(2)
|
|
Total ($)
|
||||
|
Thomas H. Adams
(3)
|
|
90,000
|
|
|
18,768
|
|
|
52,220
|
|
|
160,988
|
|
|
John P. Brancaccio
(4)
|
|
70,000
|
|
|
18,768
|
|
|
60,135
|
|
|
148,903
|
|
|
Gary S. Jacob
(5)
|
|
54,000
|
|
|
18,768
|
|
|
53,206
|
|
|
125,974
|
|
|
Stanley Tennant
(6)
|
|
64,000
|
|
|
18,768
|
|
|
51,560
|
|
|
134,328
|
|
|
Paul Billings
(7)
|
|
64,000
|
|
|
18,768
|
|
|
47,488
|
|
|
130,256
|
|
|
Rodney Markin
(8)
|
|
72,000
|
|
|
18,768
|
|
|
46,351
|
|
|
137,119
|
|
|
|
|
(1)
|
Amounts shown in this column do not reflect dollar amounts actually received by our non-employee directors. Instead, these amounts represent the aggregate grant date fair value of stock option awards determined in accordance with FASB ASC Topic 718. The valuation assumptions used in determining 2017 amounts are described in Note 5 to our financial statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2017. Our non-employee directors will only realize compensation to the extent the trading price of our common stock is greater than the exercise price of such stock options on the date the options are exercised.
|
|
(2)
|
This reflects the grant date fair value of awards granted during fiscal 2017.
|
|
(3)
|
As of December 31, 2017, 412,995 stock options were outstanding, of which 374,849 were exercisable. 16,667 stock awards were unvested as of December 31, 2017.
|
|
(4)
|
As of December 31, 2017, 170,517 stock options were outstanding, of which 132,411 were exercisable. 16,667 stock awards were unvested as of December 31, 2017.
|
|
(5)
|
As of December 31, 2017, 185,445 stock options were outstanding, of which 147,339 were exercisable. 16,667 stock awards were unvested as of December 31, 2017.
|
|
(6)
|
As of December 31, 2017, 131,264 stock options were outstanding, of which 93,158 were exercisable. 16,667 stock awards were unvested as of December 31, 2017.
|
|
(7)
|
As of December 31, 2017, 121,336 stock options were outstanding, of which 83,230 were exercisable. 16,667 stock awards were unvested as of December 31, 2017.
|
|
(8)
|
As of December 31, 2017, 106,336 stock options were outstanding, of which 68,230 were exercisable. 16,667 stock awards were unvested as of December 31, 2017.
|
|
|
Termination
|
||||||
|
By Trovagene Without
Cause Outside a Change
In Control
|
|
By Trovagene Without
Cause or by Mr. Welch for
Good Reason in Connection
with a Change In Control(1)
|
|||||
|
Value of Equity Securities Accelerated
|
$
|
—
|
|
|
$
|
129,641
|
|
|
Cash Payments
|
998,195
|
|
|
998,195
|
|
||
|
Total Cash Benefits and Payments
|
$
|
998,195
|
|
|
$
|
1,127,836
|
|
|
|
|
(1)
|
Relates to the termination of the Welch Employment Agreement: (a) by us without cause within 12 months prior to a change of control that was pending during such 12 month period, (b) by Mr. Welch for good reason within 12 months after a change of control, or (c) by us without cause at any time upon or within 12 months after a change of control.
|
|
|
Termination
|
||||||
|
By Trovagene Without
Cause Outside a Change
In Control
|
|
By Trovagene Without
Cause or by Mr. Erlander for
Good Reason in Connection
with a Change In Control(1)
|
|||||
|
Value of Equity Securities Accelerated
|
$
|
—
|
|
|
$
|
110,772
|
|
|
Cash Payments
|
386,813
|
|
|
386,813
|
|
||
|
Total Cash Benefits and Payments
|
$
|
386,813
|
|
|
$
|
497,585
|
|
|
|
|
(1)
|
Relates to the termination of the Erlander Employment Agreement: (a) by us without cause within 12 months prior to a change of control that was pending during such 12 month period, (b) by Dr. Erlander for good reason within 12 months after a change of control, or (c) by us without cause at any time upon or within 12 months after a change of control.
|
|
Name of Beneficial Owner (1)
|
|
Shares of Common
Stock Beneficially
Owned
|
|
Percentage(2)
|
|||
|
Executive officers and directors:
|
|
|
|
|
|
||
|
Thomas Adams
|
|
772,494
|
|
(3)
|
|
1.4
|
|
|
William Welch
|
|
1,864,520
|
|
(4)
|
|
3.3
|
|
|
Paul Billings
|
|
106,395
|
|
(5)
|
|
*
|
|
|
John Brancaccio
|
|
189,441
|
|
(6)
|
|
*
|
|
|
Gary Jacob
|
|
306,793
|
|
(7)
|
|
*
|
|
|
Stanley Tennant
|
|
394,219
|
|
(8)
|
|
*
|
|
|
Rodney S. Markin
|
|
90,840
|
|
(9)
|
|
*
|
|
|
Athena Countouriotis
|
|
—
|
|
|
|
—
|
|
|
Mark Erlander
|
|
1,365,310
|
|
(10)
|
|
2.4
|
|
|
All Officers and Directors as a Group (9 persons)
|
|
5,090,012
|
|
(11)
|
|
8.7
|
|
|
|
|
(1)
|
The address of each person is c/o Trovagene, Inc., 11055 Flintkote Avenue, Suite A, San Diego, CA 92121 unless otherwise indicated herein.
|
|
(2)
|
The calculation in this column is based upon 55,290,162 shares of common stock outstanding on February 12, 2018. Beneficial ownership is determined in accordance with the rules of the SEC and generally includes voting or investment power with respect to the subject securities. Shares of common stock that are currently exercisable or exercisable within 60 days of February 12, 2018 are deemed to be beneficially owned by the person holding such securities for the purpose of computing the percentage beneficial ownership of such person, but are not treated as outstanding for the purpose of computing the percentage beneficial ownership of any other person.
|
|
(3)
|
Includes (i) 374,849 shares of common stock issuable upon exercise of stock options that are exercisable within 60 days after February 12, 2018, and (ii) 45,686 shares of common stock issuable upon exercise of warrants that are exercisable within 60 days after February 12, 2018.
|
|
(4)
|
Includes 1,021,875 shares of common stock issuable upon exercise of stock options that are exercisable within 60 days after February 12, 2018.
|
|
(5)
|
Includes 83,230 shares of common stock issuable upon exercise of stock options that are exercisable within 60 days after February 12, 2018.
|
|
(6)
|
Includes (i) 132,441 shares of common stock issuable upon exercise of stock options that are exercisable within 60 days after February 12, 2018, and (ii) 13,833 shares of common stock issuable upon exercise of warrants that are exercisable within 60 days after February 12, 2018.
|
|
(7)
|
Includes (i) 147,339 shares of common stock issuable upon exercise of stock options that are exercisable within 60 days after February 12, 2018, and (ii) 10,500 shares of common stock issuable upon exercise of warrants that are exercisable within 60 days after February 12, 2018.
|
|
(8)
|
Includes (i) 93,158 shares of common stock issuable upon exercise of stock options that are exercisable within 60 days after February 12, 2018, and (ii) 75,000 shares of common stock issuable upon exercise of warrants that are exercisable within 60 days after February 12, 2018.
|
|
(9)
|
Includes 68,230 shares of common stock issuable upon exercise of stock options that are exercisable within 60 days after February 12, 2018.
|
|
(10)
|
Includes 1,260,943 shares of common stock issuable upon exercise of stock options that are exercisable within 60 days after February 12, 2018.
|
|
(11)
|
Includes (i) 3,182,065 shares of common stock issuable upon exercise of stock options that are exercisable within 60 days after February 12, 2018 and (ii) 145,019 shares of common stock issuable upon exercise of warrant to purchase shares of common stock.
|
|
|
2017
|
|
2016
|
||||
|
Audit fees (1)
|
$
|
272,618
|
|
|
$
|
275,952
|
|
|
Tax fees (2)
|
23,947
|
|
|
10,689
|
|
||
|
|
$
|
296,565
|
|
|
$
|
286,641
|
|
|
|
|
(1)
|
Audit fees consist of fees for professional services performed by BDO for the audit and review of our financial statements, preparation and filing of our registration statements, including issuance of comfort letters.
|
|
(2)
|
Tax fees consist of fees for professional services performed by BDO with respect to tax compliance.
|
|
Exhibit
Number
|
|
Description of Exhibit
|
|
|
|
(a)(1)
Financial Statements
|
|
|
|
The financial statements required by this item are submitted in a separate section beginning on page F-1 of this Annual Report on Form 10-K.
|
|
(b) Exhibits
|
||
|
|
|
|
|
Exhibit
Number
|
|
Description
|
|
|
Controlled Equity Offering
SM
Sales Agreement dated January 25, 2013 by and between Trovagene, Inc. and Cantor Fitzgerald & Co. (incorporated by reference to Exhibit 1.2 to the Company’s Form S-3 filed on January 25, 2013).
|
|
|
|
Amended and Restated Certificate of Incorporation of Trovagene, Inc. (incorporated by reference to Exhibit 3.1 to the Company’s Form 10-12G filed on November 25, 2011).
|
|
|
|
Certificate of Amendment of Amended and Restated Certificate of Incorporation of Trovagene, Inc. (incorporated by reference to Appendix B to the Company’s Proxy Statement on Schedule 14A filed on March 20, 2012).
|
|
|
|
By-Laws of Trovagene, Inc. (incorporated by reference to Exhibit 3.2 to the Company’s Form 10-12G filed on November 25, 2011).
|
|
|
|
Form of Common Stock Certificate of Trovagene, Inc. (incorporated by reference to Exhibit 4.1 to the Company’s Form 10-12G filed on November 25, 2011).
|
|
|
4.2
+
|
|
2004 Stock Option Plan (incorporated by reference to Exhibit 4.3 to the Company’s Current Report on Form 8-K filed on July 19, 2004)
|
|
4.3
+
|
|
Stock Award Agreement dated August 15, 2017 by and between Trovagene, Inc. and William J. Welch (incorporated by reference to Exhibit 4.1 to the Company’s Form 10-Q filed on November 9, 2017).
|
|
|
Form of Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on November 28, 2012).
|
|
|
|
Form of Warrant to Purchase Common Stock (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed on July 1, 2014).
|
|
|
4.7
+
|
|
Trovagene, Inc. 2014 Equity Incentive Plan (incorporated by reference to Appendix A to the Company’s Definitive Proxy Statement on Schedule 14A filed on July 23, 2014).
|
|
|
Form of Warrant to Purchase Common Stock (Incorporated by reference to Exhibit 4.1 to Form 8-K filed on July 26, 2016).
|
|
|
|
Summary of Terms of Lease Agreement dated as of October 28, 2009 between Trovagene, Inc. and BMR-Sorrento West LLC (incorporated by reference to Exhibit 10.3 to the Company’s Form 10-12G/A filed on February 15, 2012).
|
|
|
|
Form of First Amendment to Standard Industrial Net Lease dated September 28, 2011 between Trovagene, Inc. and BMR-Sorrento West LLC (incorporated by reference to Exhibit 10.4 to the Company’s Form 10-12G/A filed on February 15, 2012).
|
|
|
|
Form of Second Amendment to Standard Industrial Net Lease dated October 2011 between Trovagene, Inc. and BMR-Sorrento West LLC (incorporated by reference to Exhibit 10.5 to the Company’s Form 10-12G/A filed on February 15, 2012).
|
|
|
|
Form of Third Amendment to Standard Industrial Net Lease dated October 22, 2012 between Trovagene, Inc. and BMR-Sorrento West, LP. (incorporated by reference to Exhibit 10.6 to the Company’s Annual Report on Form 10-K filed on March 12, 2015).
|
|
|
|
Form of Fourth Amendment to Standard Industrial Net Lease dated December 2, 2013 between Trovagene, Inc. and BMR-Coast 9 LP. (incorporated by reference to Exhibit 10.7 to the Company’s Annual Report on Form 10-K filed on March 12, 2015).
|
|
|
|
Form of Fifth Amendment to Standard Industrial Net Lease dated May 14, 2014 between Trovagene, Inc. and BMR-Coast 9 LP. (incorporated by reference to Exhibit 10.8 to the Company’s Annual Report on Form 10-K filed on March 12, 2015).
|
|
|
|
Sixth Amendment to Standard Industrial Net Lease dated June 11, 2015 between Trovagene, Inc. and BMR-Coast 9 LP (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed on August 10, 2015).
|
|
|
|
Co-Exclusive Sublicense Agreement dated October 22, 2007 between Trovagene, Inc. and Asuragen, Inc. (incorporated by reference to Exhibit 10.6 to the Company’s Form 10-12G/A filed on February 15, 2012).
|
|
|
|
Amendment to Co-Exclusive Sublicense Agreement dated June 1, 2010 between Trovagene, Inc. and Asuragen, Inc. (incorporated by reference to Exhibit 10.7 to the Company’s Form 10-12G/A filed on February 15, 2012).
|
|
|
|
Sublicense Agreement dated as of August 27, 2007 between Trovagene, Inc. and Ipsogen SAS (incorporated by reference to Exhibit 10.8 to the Company’s Form 10-12G/A filed on February 15, 2012).
|
|
|
|
Amendment to Co-Exclusive Sublicense Agreement dated as of September 1, 2010 between Trovagene, Inc. and Ipsogen SAS (incorporated by reference to Exhibit 10.9 to the Company’s Form 10-12G/A filed on February 15, 2012).
|
|
|
|
Sublicense Agreement dated as of July 20, 2011 between Trovagene, Inc. and Fairview Health Services (incorporated by reference to Exhibit 10.11 to the Company’s Form 10-12G/A filed on February 15, 2012).
|
|
|
|
Sublicense Agreement dated as of December 1, 2008 by and between Trovagene, Inc. and InVivoScribe Technologies, Inc. (incorporated by reference to Exhibit 10.13 to the Company’s Form 10-12G/A filed on February 15, 2012).
|
|
|
|
Sublicense Agreement dated as of August 25, 2008 by and between Trovagene, Inc. and Laboratory Corporation of America Holdings (incorporated by reference to Exhibit 10.14 to the Company’s Form 10-12G/A filed on February 15, 2012).
|
|
|
|
Form of Sublicense Agreement effective as of February 8, 2011 by and between Trovagene, Inc. and MLL Munchner Leukamielabor GmbH (incorporated by reference to Exhibit 10.15 to the Company’s Form 10-12G/A filed on February 15, 2012).
|
|
|
|
Sublicense Agreement effective as of June 15, 2010 by and between Trovagene, Inc. and Skyline Diagnostics BV (incorporated by reference to Exhibit 10.16 to the Company’s Form 10-12G/A filed on February 15, 2012).
|
|
|
|
Exclusive License Agreement effective as of December 12, 2011 by and between Columbia University and Trovagene, Inc. (incorporated by reference to Exhibit 10.20 to the Company’s Form 10-12G/A filed on February 15, 2012).
|
|
|
|
Form of Exclusive License Agreement effective as of October 2011 by and between Gianluca Gaidano, Robert Foa and Davide Rossi and Trovagene, Inc. (incorporated by reference to Exhibit 10.21 to the Company’s Form 10-12G/A filed on February 15, 2012).
|
|
|
|
Exclusive License Agreement effective as of May 2006 by and between Brunangelo Falini, Cristina Mecucci and Trovagene, Inc. (incorporated by reference to Exhibit 10.23 to the Company’s Form 10-12G/A filed on February 15, 2012).
|
|
|
|
Form of First Amendment to Exclusive License Agreement effective as of August 2010 by and among Brunangelo Falini, Cristina Mecucci and Trovagene, Inc. (incorporated by reference to Exhibit 10.24 to the Company’s Form 10-12G/A filed on February 15, 2012).
|
|
|
10.21
+
|
|
Form of Indemnification Agreement to be entered into between the Company and its directors and executive officers (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on December 15, 2015).
|
|
10.22
*
|
|
Patent Assignment and License Agreement dated April 23, 2014 between Trovagene, Inc. and GenSignia IP Ltd. (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed on May 12, 2014).
|
|
10.23
+
|
|
Employment Agreement, dated February 18, 2016, by and between the Company and Mark Erlander (incorporated by reference to Exhibit 10.33 to the Company’s Quarterly Report on Form 10-Q filed on May 10, 2016).
|
|
10.24
+
|
|
Employment Agreement dated as of May 6, 2016 by and between the Company and William J. Welch (incorporated by reference to Exhibit 10.35 to the Company’s Quarterly Report on Form 10-Q filed on May 10, 2016).
|
|
|
Loan and Security Agreement dated as of November 17, 2015 by and between the Company and Silicon Valley Bank (incorporated by reference to Exhibit 10.32 to the Company’s Annual Report on Form 10-K filed on March 10, 2016).
|
|
|
|
Form of Seventh Amendment to Standard Industrial Net Lease dated April 4, 2016 between Trovagene, Inc. and BMR-Coast 9 LP (incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q filed on August 4, 2016).
|
|
|
10.27
**
|
|
License Agreement dated as of March 13, 2017 between Nerviano Medical Sciences S.r.l. and Trovagene, Inc. (incorporated by reference to Exhibit 10.34 to the Company’s Annual Report on Form 10-K filed on March 15, 2017).
|
|
|
Consent of BDO USA, LLP.
|
|
|
|
Power of Attorney (included on signature page hereto).
|
|
|
|
Certification of Chief Executive Officer and Principal Financial Officer required under Rule 13a-14(a)/15d-14(a) under the Exchange Act.
|
|
|
|
Certification of Chief Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
101.INS
|
|
XBRL Instance Document.
|
|
101.SCH
|
|
XBRL Taxonomy Extension Schema.
|
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase.
|
|
101.LAB
|
|
XBRL Taxonomy Extension Labels Linkbase.
|
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase.
|
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase.
|
|
|
|
|
TROVAGENE, INC.
|
|
|
|
|
|
|
|
|
/s/ William J. Welch
|
|
February 26, 2018
|
Chief Executive Officer (Principal Executive Officer and Principal Financial Officer)
|
|
SIGNATURE
|
|
TITLE
|
|
DATE
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
/s/ William J. Welch
|
|
Chief Executive Officer and Director
|
|
February 26, 2018
|
|
|
William J. Welch
|
|
(Principal Executive Officer and Principal Financial Officer)
|
|
|
|
|
|
|
|
|
|
|
|
/s/ Thomas H. Adams
|
|
Chairman of the Board
|
|
February 26, 2018
|
|
|
Thomas H. Adams
|
|
|
|
|
|
|
|
|
|
|
|
|
|
/s/ John P. Brancaccio
|
|
Director
|
|
February 26, 2018
|
|
|
John P. Brancaccio
|
|
|
|
|
|
|
|
|
|
|
|
|
|
/s/ Gary S. Jacob
|
|
Director
|
|
February 26, 2018
|
|
|
Gary S. Jacob
|
|
|
|
|
|
|
|
|
|
|
|
|
|
/s/ Paul Billings
|
|
Director
|
|
February 26, 2018
|
|
|
Paul Billings
|
|
|
|
|
|
|
|
|
|
|
|
|
|
/s/ Stanley Tennant
|
|
Director
|
|
February 26, 2018
|
|
|
Stanley Tennant
|
|
|
|
|
|
|
|
|
|
|
|
|
|
/s/ Rodney S. Markin
|
|
Director
|
|
February 26, 2018
|
|
|
Rodney S. Markin
|
|
|
|
|
|
|
|
|
|
|
|
|
|
/s/ Athena Countouriotis
|
|
Director
|
|
February 26, 2018
|
|
|
Athena Countouriotis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2017
|
|
December 31, 2016
|
||||
|
Assets
|
|
|
|
||||
|
Current assets:
|
|
|
|
||||
|
Cash and cash equivalents
|
$
|
8,225,764
|
|
|
$
|
13,915,094
|
|
|
Short-term investments
|
—
|
|
|
23,978,022
|
|
||
|
Accounts receivable
|
77,095
|
|
|
100,460
|
|
||
|
Prepaid expenses and other current assets
|
1,165,828
|
|
|
956,616
|
|
||
|
Total current assets
|
9,468,687
|
|
|
38,950,192
|
|
||
|
Property and equipment, net
|
2,426,312
|
|
|
3,826,915
|
|
||
|
Other assets
|
389,942
|
|
|
1,173,304
|
|
||
|
Total Assets
|
$
|
12,284,941
|
|
|
$
|
43,950,411
|
|
|
|
|
|
|
||||
|
Liabilities and Stockholders’ Equity
|
|
|
|
|
|
||
|
Current liabilities:
|
|
|
|
|
|
||
|
Accounts payable
|
$
|
825,244
|
|
|
$
|
1,130,536
|
|
|
Accrued liabilities
|
1,454,587
|
|
|
4,021,365
|
|
||
|
Deferred rent
|
334,424
|
|
|
285,246
|
|
||
|
Current portion of long-term debt (in default)
|
1,331,515
|
|
|
2,360,109
|
|
||
|
Total current liabilities
|
3,945,770
|
|
|
7,797,256
|
|
||
|
Long-term debt, less current portion
|
—
|
|
|
14,176,359
|
|
||
|
Derivative financial instruments—warrants
|
649,387
|
|
|
834,940
|
|
||
|
Deferred rent, net of current portion
|
1,183,677
|
|
|
1,373,717
|
|
||
|
Total liabilities
|
5,778,834
|
|
|
24,182,272
|
|
||
|
|
|
|
|
||||
|
Commitments and contingencies (Note 10)
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
|
Stockholders’ equity
|
|
|
|
||||
|
Preferred stock, $0.001 par value, 20,000,000 shares authorized, 60,600 shares outstanding at each of December 31, 2017 and 2016, designated as Series A Convertible Preferred Stock with liquidation preference of $606,000 at each of December 31, 2017 and 2016
|
60
|
|
|
60
|
|
||
|
Common stock, $0.0001 par value, 150,000,000 shares authorized at December 31, 2017 and 2016; 52,791,584 and 30,696,791 issued and outstanding at December 31, 2017 and 2016, respectively
|
5,279
|
|
|
3,070
|
|
||
|
Additional paid-in capital
|
179,546,954
|
|
|
167,890,984
|
|
||
|
Accumulated other comprehensive loss
|
—
|
|
|
(10,773
|
)
|
||
|
Accumulated deficit
|
(173,046,186
|
)
|
|
(148,115,202
|
)
|
||
|
Total stockholders’ equity
|
6,506,107
|
|
|
19,768,139
|
|
||
|
Total Liabilities and Stockholders’ Equity
|
$
|
12,284,941
|
|
|
$
|
43,950,411
|
|
|
|
Year Ended December 31,
|
||||||
|
|
2017
|
|
2016
|
||||
|
Revenues:
|
|
|
|
||||
|
Royalties
|
$
|
285,444
|
|
|
$
|
258,062
|
|
|
Diagnostic services
|
196,111
|
|
|
86,137
|
|
||
|
Clinical research services
|
23,849
|
|
|
36,873
|
|
||
|
Total revenues
|
505,404
|
|
|
381,072
|
|
||
|
Costs and expenses:
|
|
|
|
|
|
||
|
Cost of revenue
|
1,811,424
|
|
|
1,730,512
|
|
||
|
Research and development
|
7,882,650
|
|
|
15,006,642
|
|
||
|
Selling and marketing
|
2,735,410
|
|
|
11,523,144
|
|
||
|
General and administrative
|
11,497,466
|
|
|
11,475,947
|
|
||
|
Restructuring charges
|
2,174,251
|
|
|
790,438
|
|
||
|
Total operating expenses
|
26,101,201
|
|
|
40,526,683
|
|
||
|
|
|
|
|
||||
|
Loss from operations
|
(25,595,797
|
)
|
|
(40,145,611
|
)
|
||
|
|
|
|
|
||||
|
Interest income
|
147,883
|
|
|
298,829
|
|
||
|
Interest expense
|
(1,033,939
|
)
|
|
(1,674,341
|
)
|
||
|
Other loss, net
|
(170,138
|
)
|
|
(144,733
|
)
|
||
|
Loss on extinguishment of debt
|
(1,655,825
|
)
|
|
—
|
|
||
|
Gain from changes in fair value of derivative financial instruments—warrants
|
3,401,072
|
|
|
2,462,137
|
|
||
|
Net loss
|
(24,906,744
|
)
|
|
(39,203,719
|
)
|
||
|
|
|
|
|
||||
|
Preferred stock dividend
|
(24,240
|
)
|
|
(24,240
|
)
|
||
|
|
|
|
|
||||
|
Net loss attributable to common stockholders
|
$
|
(24,930,984
|
)
|
|
$
|
(39,227,959
|
)
|
|
|
|
|
|
||||
|
Net loss per common share — basic
|
$
|
(0.72
|
)
|
|
$
|
(1.30
|
)
|
|
Net loss per common share — diluted
|
$
|
(0.72
|
)
|
|
$
|
(1.37
|
)
|
|
|
|
|
|
||||
|
Weighted-average shares outstanding — basic
|
34,680,362
|
|
|
30,174,838
|
|
||
|
Weighted-average shares outstanding — diluted
|
34,680,362
|
|
|
30,281,263
|
|
||
|
|
Year Ended December 31,
|
||||||
|
|
2017
|
|
2016
|
||||
|
Net loss
|
$
|
(24,906,744
|
)
|
|
$
|
(39,203,719
|
)
|
|
Other comprehensive loss:
|
|
|
|
||||
|
Foreign currency translation loss or reversal of previous loss
|
1,708
|
|
|
(1,708
|
)
|
||
|
Unrealized gain or reversal of previous loss on securities available-for-sale
|
9,065
|
|
|
(9,065
|
)
|
||
|
Total other comprehensive loss
|
10,773
|
|
|
(10,773
|
)
|
||
|
|
|
|
|
||||
|
Total comprehensive loss
|
(24,895,971
|
)
|
|
(39,214,492
|
)
|
||
|
|
|
|
|
||||
|
Preferred stock dividend
|
(24,240
|
)
|
|
(24,240
|
)
|
||
|
|
|
|
|
||||
|
Comprehensive loss attributable to common stockholders
|
$
|
(24,920,211
|
)
|
|
$
|
(39,238,732
|
)
|
|
|
Preferred Stock
Shares
|
|
Preferred Stock
Amount
|
|
Common Stock
Shares
|
|
Common Stock
Amount
|
|
Additional
Paid-In Capital
|
|
Accumulated other
comprehensive loss
|
|
Accumulated Deficit
|
|
Total
Stockholders’ Equity
|
||||||||||||||
|
Balance, January 1, 2016
|
60,600
|
|
|
$
|
60
|
|
|
29,737,601
|
|
|
$
|
2,974
|
|
|
$
|
157,585,498
|
|
|
$
|
—
|
|
|
$
|
(108,887,243
|
)
|
|
$
|
48,701,289
|
|
|
Sale of common stock, net of expenses
|
—
|
|
|
—
|
|
|
421,810
|
|
|
42
|
|
|
2,285,373
|
|
|
—
|
|
|
—
|
|
|
2,285,415
|
|
||||||
|
Stock based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
7,504,316
|
|
|
—
|
|
|
—
|
|
|
7,504,316
|
|
||||||
|
Issuance of warrant in connection with debt agreement
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
148,885
|
|
|
—
|
|
|
—
|
|
|
148,885
|
|
||||||
|
Issuance of common stock upon net exercise of stock options
|
—
|
|
|
—
|
|
|
341,333
|
|
|
34
|
|
|
(34
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
|
Issuance of common stock upon exercise of stock options
|
—
|
|
|
—
|
|
|
98,396
|
|
|
10
|
|
|
366,956
|
|
|
—
|
|
|
—
|
|
|
366,966
|
|
||||||
|
Issuance of common stock upon net exercise of warrant
|
—
|
|
|
—
|
|
|
2,651
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
|
Issuance of common stock upon vesting of restricted stock units
|
—
|
|
|
—
|
|
|
95,000
|
|
|
10
|
|
|
(10
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
|
Unrealized loss from foreign currency translation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,708
|
)
|
|
—
|
|
|
(1,708
|
)
|
||||||
|
Unrealized loss on securities available-for-sale
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(9,065
|
)
|
|
—
|
|
|
(9,065
|
)
|
||||||
|
Preferred stock dividend
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(24,240
|
)
|
|
(24,240
|
)
|
||||||
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(39,203,719
|
)
|
|
(39,203,719
|
)
|
||||||
|
Balance, December 31, 2016
|
60,600
|
|
|
60
|
|
|
30,696,791
|
|
|
3,070
|
|
|
167,890,984
|
|
|
(10,773
|
)
|
|
(148,115,202
|
)
|
|
19,768,139
|
|
||||||
|
Sale of common stock, net of expenses
|
—
|
|
|
—
|
|
|
20,976,914
|
|
|
2,097
|
|
|
10,859,016
|
|
|
—
|
|
|
—
|
|
|
10,861,113
|
|
||||||
|
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4,012,585
|
|
|
—
|
|
|
—
|
|
|
4,012,585
|
|
||||||
|
Derivative liability-fair value of warrants issued
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(3,215,519
|
)
|
|
—
|
|
|
—
|
|
|
(3,215,519
|
)
|
||||||
|
Issuance of common stock upon vesting of restricted stock units
|
—
|
|
|
—
|
|
|
372,487
|
|
|
37
|
|
|
(37
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
|
Issuance of common stock upon vesting of restricted stock awards
|
—
|
|
|
—
|
|
|
745,392
|
|
|
75
|
|
|
(75
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
|
Reversal of previous loss from foreign currency translation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,708
|
|
|
—
|
|
|
1,708
|
|
||||||
|
Reversal of previous loss on securities available-for-sale
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
9,065
|
|
|
—
|
|
|
9,065
|
|
||||||
|
Preferred stock dividend
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(24,240
|
)
|
|
(24,240
|
)
|
||||||
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(24,906,744
|
)
|
|
(24,906,744
|
)
|
||||||
|
Balance, December 31, 2017
|
60,600
|
|
|
$
|
60
|
|
|
52,791,584
|
|
|
$
|
5,279
|
|
|
$
|
179,546,954
|
|
|
$
|
—
|
|
|
$
|
(173,046,186
|
)
|
|
$
|
6,506,107
|
|
|
|
Year ended December 31,
|
||||||
|
|
2017
|
|
2016
|
||||
|
Operating activities
|
|
|
|
|
|
||
|
Net loss
|
$
|
(24,906,744
|
)
|
|
$
|
(39,203,719
|
)
|
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
||
|
Loss on disposal of assets
|
455,051
|
|
|
577,314
|
|
||
|
Impairment loss
|
589,700
|
|
|
—
|
|
||
|
Depreciation and amortization
|
1,247,576
|
|
|
1,069,547
|
|
||
|
Stock-based compensation expense
|
4,012,585
|
|
|
7,504,316
|
|
||
|
Loss on extinguishment of debt
|
1,655,825
|
|
|
—
|
|
||
|
Accretion of final fee premium
|
293,614
|
|
|
390,548
|
|
||
|
Amortization of discount on debt
|
113,780
|
|
|
173,803
|
|
||
|
Net realized loss on short-term investments
|
6,400
|
|
|
—
|
|
||
|
Amortization of premiums on short-term investments
|
9,230
|
|
|
107,261
|
|
||
|
Deferred rent
|
(140,863
|
)
|
|
(201,037
|
)
|
||
|
Interest income accrued on short-term investments
|
(90,330
|
)
|
|
(84,182
|
)
|
||
|
Change in fair value of derivative financial instruments—warrants
|
(3,401,072
|
)
|
|
(2,462,137
|
)
|
||
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
||
|
Increase in other assets
|
—
|
|
|
(789,739
|
)
|
||
|
Decrease (increase) in accounts receivable
|
23,365
|
|
|
(1,724
|
)
|
||
|
Increase in prepaid expenses and other current assets
|
(208,185
|
)
|
|
(277,327
|
)
|
||
|
(Decrease) increase in accounts payable and accrued expenses
|
(2,940,999
|
)
|
|
2,157,221
|
|
||
|
Net cash used in operating activities
|
(23,281,067
|
)
|
|
(31,039,855
|
)
|
||
|
|
|
|
|
||||
|
Investing activities
|
|
|
|
|
|
||
|
Capital expenditures
|
(101,101
|
)
|
|
(823,483
|
)
|
||
|
Proceeds from disposals of capital equipment
|
1,540
|
|
|
—
|
|
||
|
Maturities of short-term investments
|
16,431,837
|
|
|
13,750,000
|
|
||
|
Purchases of short-term investments
|
(8,804,604
|
)
|
|
(37,760,166
|
)
|
||
|
Sales of short-term investments
|
16,434,553
|
|
|
—
|
|
||
|
Net cash provided by (used in) investing activities
|
23,962,225
|
|
|
(24,833,649
|
)
|
||
|
|
|
|
|
||||
|
Financing activities
|
|
|
|
|
|
||
|
Proceeds from sale of common stock and warrants
|
11,727,153
|
|
|
2,364,801
|
|
||
|
Payments of stock issuance costs
|
(866,039
|
)
|
|
(79,386
|
)
|
||
|
Proceeds from exercise of options
|
—
|
|
|
366,966
|
|
||
|
Borrowings under equipment line of credit
|
—
|
|
|
792,251
|
|
||
|
Repayments under equipment line of credit
|
(626,104
|
)
|
|
(52,175
|
)
|
||
|
Proceeds from borrowings under long-term debt, net of costs
|
—
|
|
|
7,805,085
|
|
||
|
Payment upon debt extinguishment
|
(1,613,067
|
)
|
|
—
|
|
||
|
Repayments of long-term debt
|
(15,000,000
|
)
|
|
(8,896,166
|
)
|
||
|
Net cash (used in) provided by financing activities
|
(6,378,057
|
)
|
|
2,301,376
|
|
||
|
Effect of exchange rate changes on cash and cash equivalents
|
7,569
|
|
|
(5,825
|
)
|
||
|
Net change in cash and cash equivalents
|
(5,689,330
|
)
|
|
(53,577,953
|
)
|
||
|
Cash and cash equivalents—Beginning of period
|
13,915,094
|
|
|
67,493,047
|
|
||
|
Cash and cash equivalents—End of period
|
$
|
8,225,764
|
|
|
$
|
13,915,094
|
|
|
Supplementary disclosure of cash flow activity:
|
|
|
|
|
|
||
|
Cash paid for taxes
|
$
|
800
|
|
|
$
|
4,560
|
|
|
Cash paid for interest
|
$
|
668,465
|
|
|
$
|
1,103,677
|
|
|
Supplemental disclosure of non-cash investing and financing activities:
|
|
|
|
|
|
||
|
Warrants issued in connection with long-term debt
|
$
|
—
|
|
|
$
|
148,885
|
|
|
Preferred stock dividends accrued
|
$
|
24,240
|
|
|
$
|
24,240
|
|
|
Leasehold improvements paid for by lessor
|
$
|
—
|
|
|
$
|
1,860,000
|
|
|
•
|
Seek collaborators for product candidates at an earlier stage than otherwise would be desirable and on terms that are less favorable than might otherwise be available; and
|
|
•
|
Relinquish licenses or otherwise dispose of rights to technologies, product candidates or products that the Company would otherwise seek to develop or commercialize themselves, on unfavorable terms.
|
|
•
|
Raising capital through public and private equity offerings;
|
|
•
|
Adding capital through short-term and long-term borrowings;
|
|
•
|
Introducing operation and business development initiatives to bring in new revenue streams;
|
|
•
|
Reducing operating costs by identifying internal synergies;
|
|
•
|
Engaging in strategic partnerships; and
|
|
•
|
Taking actions to reduce or delay capital expenditures.
|
|
•
|
Level 1 — Quoted prices for identical instruments in active markets.
|
|
•
|
Level 2 — Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations where inputs are observable or where significant value drivers are observable.
|
|
•
|
Level 3 — Instruments where significant value drivers are unobservable to third parties.
|
|
|
December 31,
|
||||
|
|
2017
|
|
2016
|
||
|
Options to purchase Common Stock
|
4,490,475
|
|
|
5,528,628
|
|
|
Warrants to purchase Common stock
|
23,555,520
|
|
|
4,538,606
|
|
|
Restricted Stock Units
|
1,274,302
|
|
|
272,000
|
|
|
Series A Convertible Preferred Stock
|
63,125
|
|
|
63,125
|
|
|
|
29,383,422
|
|
|
10,402,359
|
|
|
|
December 31,
|
||||||
|
|
2017
|
|
2016
|
||||
|
Numerator:
|
|
|
|
|
|
||
|
Net loss attributable to common stockholders
|
$
|
(24,930,984
|
)
|
|
$
|
(39,227,959
|
)
|
|
Adjustment for gain from change in fair value of derivative financial instruments—warrants
|
—
|
|
|
(2,321,053
|
)
|
||
|
Net loss used for diluted loss per share
|
$
|
(24,930,984
|
)
|
|
$
|
(41,549,012
|
)
|
|
|
|
|
|
||||
|
Denominator:
|
|
|
|
|
|
||
|
Weighted-average shares used to compute basic net loss per share
|
34,680,362
|
|
|
30,174,838
|
|
||
|
Adjustments to reflect assumed exercise of warrants
|
—
|
|
|
106,425
|
|
||
|
Weighted-average shares used to compute diluted net loss per share
|
34,680,362
|
|
|
30,281,263
|
|
||
|
|
|
|
|
||||
|
Net loss per share attributable to common stockholders:
|
|
|
|
||||
|
Basic
|
$
|
(0.72
|
)
|
|
$
|
(1.30
|
)
|
|
Diluted
|
$
|
(0.72
|
)
|
|
$
|
(1.37
|
)
|
|
|
|
|
|
|
Unrealized
|
|
|
||||||||||
|
|
Maturity in Years
|
|
Cost
|
|
Gains
|
|
Losses
|
|
Fair Value
|
||||||||
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
Corporate debt securities
|
Less than 1 year
|
|
$
|
14,165,915
|
|
|
$
|
44
|
|
|
$
|
(5,273
|
)
|
|
$
|
14,160,686
|
|
|
Commercial paper
|
Less than 1 year
|
|
1,195,444
|
|
|
—
|
|
|
—
|
|
|
1,195,444
|
|
||||
|
U.S. treasury securities
|
Less than 1 year
|
|
8,625,728
|
|
|
330
|
|
|
(4,166
|
)
|
|
8,621,892
|
|
||||
|
Total investment
|
|
|
$
|
23,987,087
|
|
|
$
|
374
|
|
|
$
|
(9,439
|
)
|
|
$
|
23,978,022
|
|
|
|
As of December 31,
|
||||||
|
|
2017
|
|
2016
|
||||
|
Furniture and office equipment
|
$
|
1,076,709
|
|
|
$
|
1,144,741
|
|
|
Leasehold improvements
|
1,994,514
|
|
|
1,994,514
|
|
||
|
Laboratory equipment
|
1,426,581
|
|
|
2,449,645
|
|
||
|
|
4,497,804
|
|
|
5,588,900
|
|
||
|
Less—accumulated depreciation and amortization
|
(2,071,492
|
)
|
|
(1,761,985
|
)
|
||
|
Property and equipment, net
|
$
|
2,426,312
|
|
|
$
|
3,826,915
|
|
|
|
As of December 31,
|
||||||
|
|
2017
|
|
2016
|
||||
|
Accrued compensation
|
$
|
618,128
|
|
|
$
|
2,203,876
|
|
|
Accrued research agreements
|
135,139
|
|
|
736,199
|
|
||
|
Accrued professional fees
|
—
|
|
|
421,314
|
|
||
|
Other accrued liabilities
|
701,320
|
|
|
659,976
|
|
||
|
Total accrued liabilities
|
$
|
1,454,587
|
|
|
$
|
4,021,365
|
|
|
|
Number of
Warrants (1)
|
|
Weighted-Average
Exercise Price
Per Share (1)
|
|
Weighted-Average Remaining Contractual Term (1)
|
|||
|
Balance outstanding, December 31, 2015
|
5,533,242
|
|
|
$
|
3.86
|
|
|
2.5
|
|
Granted
|
30,992
|
|
|
$
|
4.84
|
|
|
|
|
Exercised
|
(8,333
|
)
|
|
$
|
3.00
|
|
|
|
|
Expired
|
(50,000
|
)
|
|
$
|
8.00
|
|
|
|
|
Balance outstanding, December 31, 2016
|
5,505,901
|
|
|
$
|
3.83
|
|
|
1.6
|
|
Granted
|
19,643,626
|
|
|
$
|
0.56
|
|
|
|
|
Expired
|
(1,910,674
|
)
|
|
$
|
5.32
|
|
|
|
|
Balance outstanding, December 31, 2017
|
23,238,853
|
|
|
$
|
0.95
|
|
|
4.4
|
|
|
|
|
Years ended December 31,
|
||||||
|
|
2017
|
|
2016
|
||||
|
In cost of revenue
|
$
|
83,713
|
|
|
$
|
122,301
|
|
|
In research and development expenses
|
1,026,497
|
|
|
2,420,696
|
|
||
|
In selling and marketing expense
|
676,635
|
|
|
2,111,366
|
|
||
|
In general and administrative expenses
|
2,350,962
|
|
|
2,910,156
|
|
||
|
Benefit from restructuring
|
(125,222
|
)
|
|
(60,203
|
)
|
||
|
Total stock-based compensation
|
$
|
4,012,585
|
|
|
$
|
7,504,316
|
|
|
|
Years ended December 31,
|
||
|
|
2017
|
|
2016
|
|
Risk-free interest rate
|
1.82% - 2.03%
|
|
0.93% - 1.89%
|
|
Dividend yield
|
0%
|
|
0%
|
|
Expected volatility (range)
|
86% - 117%
|
|
80% - 134%
|
|
Expected volatility (weighted-average)
|
87%
|
|
103%
|
|
Expected term (in years)
|
5.3 years
|
|
5.5 years
|
|
|
Number of Options
|
|
Weighted-Average Exercise Price Per Share
|
|
Intrinsic
Value
|
|
Weighted-Average
Remaining
Contractual Life
|
|||||
|
Balance outstanding, December 31, 2015
|
6,948,630
|
|
|
$
|
5.45
|
|
|
$
|
5,903,466
|
|
|
7.8 years
|
|
Granted
|
3,246,250
|
|
|
$
|
5.02
|
|
|
|
|
|
|
|
|
Exercised
|
(1,335,271
|
)
|
|
$
|
3.81
|
|
|
|
|
|
||
|
Forfeited
|
(3,330,981
|
)
|
|
$
|
5.63
|
|
|
|
|
|
|
|
|
Balance outstanding, December 31, 2016
|
5,528,628
|
|
|
$
|
5.49
|
|
|
$
|
—
|
|
|
7.7 years
|
|
Granted
|
1,059,242
|
|
|
$
|
0.82
|
|
|
|
|
|
|
|
|
Forfeited
|
(2,079,938
|
)
|
|
$
|
6.24
|
|
|
|
|
|
|
|
|
Expired
|
(17,457
|
)
|
|
$
|
4.74
|
|
|
|
|
|
||
|
Balance outstanding, December 31, 2017
|
4,490,475
|
|
|
$
|
4.04
|
|
|
$
|
—
|
|
|
7.1 years
|
|
Vested and exercisable, December 31, 2017
|
2,745,350
|
|
|
$
|
4.66
|
|
|
$
|
—
|
|
|
6.0 years
|
|
|
Number of Shares
|
|
Weighted Average
Grant Date Fair Value
Per Share
|
|
Intrinsic
Value |
|||||
|
Non-vested RSU outstanding, December 31, 2015
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Granted
|
402,000
|
|
|
$
|
4.06
|
|
|
|
||
|
Vested
|
(95,000
|
)
|
|
$
|
4.27
|
|
|
|
||
|
Forfeited
|
(35,000
|
)
|
|
$
|
3.99
|
|
|
|
||
|
Non-vested RSU outstanding, December 31, 2016
|
272,000
|
|
|
$
|
3.99
|
|
|
$
|
571,200
|
|
|
Granted
|
2,249,242
|
|
|
$
|
1.59
|
|
|
|
||
|
Vested
|
(372,487
|
)
|
|
$
|
3.47
|
|
|
|
||
|
Forfeited
|
(874,453
|
)
|
|
$
|
1.75
|
|
|
|
||
|
Non-vested RSU outstanding, December 31, 2017
|
1,274,302
|
|
|
$
|
1.43
|
|
|
$
|
391,848
|
|
|
|
Year ended December 31
|
||
|
|
2017
|
|
2016
|
|
Estimated fair value of Trovagene common stock
|
$0.31 - $1.26
|
|
$2.10 - $4.65
|
|
Expected warrant term
|
1.0 - 5.5 years
|
|
2.0 - 2.8 years
|
|
Risk-free interest rate
|
1.27% - 2.21%
|
|
0.71% - 1.20%
|
|
Expected volatility
|
86% - 116%
|
|
82% - 94%
|
|
Dividend yield
|
—%
|
|
—%
|
|
Date
|
|
Description
|
|
Number of Warrants
|
|
Derivative
Instrument
Liability
|
|||
|
December 31, 2015
|
|
Balance of derivative financial instruments
—
warrants liability
|
|
967,295
|
|
|
$
|
3,297,077
|
|
|
|
|
Change in fair value of derivative financial instruments
—
warrants during the year recognized as a gain in the statement of operations
|
|
—
|
|
|
(2,462,137
|
)
|
|
|
December 31, 2016
|
|
Balance of derivative financial instruments
—
warrants liability
|
|
967,295
|
|
|
834,940
|
|
|
|
|
|
Issuance of Derivative Financial Instruments
|
|
4,643,626
|
|
|
3,215,519
|
|
|
|
|
|
Change in fair value of derivative financial instruments
—
warrants during the year recognized as a gain in the statement of operations
|
|
—
|
|
|
(3,401,072
|
)
|
|
|
December 31, 2017
|
|
Balance of derivative financial instruments
—
warrants liability
|
|
5,610,921
|
|
|
$
|
649,387
|
|
|
|
Fair Value Measurements at
December 31, 2017 |
||||||||||||||
|
|
Quoted Prices in Active Markets for Identical Assets and Liabilities
(Level 1) |
|
Significant Other Observable Inputs
(Level 2) |
|
Significant Unobservable Inputs
(Level 3) |
|
Total
|
||||||||
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Money market fund (1)
|
$
|
4,522,631
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
4,522,631
|
|
|
Total Assets
|
$
|
4,522,631
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
4,522,631
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Derivative financial instruments
—
warrants
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
649,387
|
|
|
$
|
649,387
|
|
|
Total Liabilities
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
649,387
|
|
|
$
|
649,387
|
|
|
|
Fair Value Measurements at
December 31, 2016 |
||||||||||||||
|
|
Quoted Prices in Active Markets for Identical Assets and Liabilities
(Level 1) |
|
Significant Other Observable Inputs
(Level 2) |
|
Significant Unobservable Inputs
(Level 3) |
|
Total
|
||||||||
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Money market fund (1)
|
$
|
12,095,620
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
12,095,620
|
|
|
Corporate debt securities (2)
|
—
|
|
|
14,160,686
|
|
|
—
|
|
|
14,160,686
|
|
||||
|
Commercial paper (3)
|
—
|
|
|
2,393,948
|
|
|
—
|
|
|
2,393,948
|
|
||||
|
U.S. treasury securities (2)
|
—
|
|
|
8,621,892
|
|
|
—
|
|
|
8,621,892
|
|
||||
|
Total Assets
|
$
|
12,095,620
|
|
|
$
|
25,176,526
|
|
|
$
|
—
|
|
|
$
|
37,272,146
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Derivative financial instruments
—
warrants
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
834,940
|
|
|
$
|
834,940
|
|
|
Total Liabilities
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
834,940
|
|
|
$
|
834,940
|
|
|
|
|
Description
|
|
Balance at
December 31, 2016 |
|
Issuance of Derivative Financial Instruments
|
|
Unrealized (gains) or losses
|
|
Balance at
December 31, 2017 |
||||||||
|
Derivative financial instruments
—
Warrants
|
|
$
|
834,940
|
|
|
$
|
3,215,519
|
|
|
$
|
(3,401,072
|
)
|
|
$
|
649,387
|
|
|
Description
|
|
Balance at
December 31, 2015 |
|
Unrealized (gains) or losses
|
|
Balance at
December 31, 2016 |
||||||
|
Derivative financial instruments
—
Warrants
|
|
$
|
3,297,077
|
|
|
$
|
(2,462,137
|
)
|
|
$
|
834,940
|
|
|
|
Years ended December 31,
|
||||||
|
|
2017
|
|
2016
|
||||
|
Current:
|
|
|
|
||||
|
State
|
$
|
1
|
|
|
$
|
—
|
|
|
Total current provision
|
1
|
|
|
—
|
|
||
|
Deferred:
|
|
|
|
||||
|
Federal
|
9,781
|
|
|
(14,035
|
)
|
||
|
State
|
3,171
|
|
|
(2,443
|
)
|
||
|
Foreign
|
—
|
|
|
(114
|
)
|
||
|
Total deferred expense (benefit)
|
12,952
|
|
|
(16,592
|
)
|
||
|
Valuation allowance
|
(12,953
|
)
|
|
16,592
|
|
||
|
Total income tax provision
|
$
|
—
|
|
|
$
|
—
|
|
|
|
Years ended December 31,
|
||||||||||||
|
|
2017
|
|
2016
|
||||||||||
|
Tax computed at the federal statutory rate
|
$
|
(8,591
|
)
|
|
34
|
%
|
|
$
|
(13,206
|
)
|
|
34
|
%
|
|
State tax, net of federal tax benefit
|
(697
|
)
|
|
3
|
%
|
|
(2,286
|
)
|
|
6
|
%
|
||
|
Foreign tax
|
—
|
|
|
—
|
%
|
|
(114
|
)
|
|
—
|
%
|
||
|
Permanent Items
|
(706
|
)
|
|
3
|
%
|
|
(114
|
)
|
|
—
|
%
|
||
|
Tax credits
|
(431
|
)
|
|
2
|
%
|
|
(1,276
|
)
|
|
3
|
%
|
||
|
Valuation allowance increase
|
(11,029
|
)
|
|
43
|
%
|
|
16,996
|
|
|
(43
|
)%
|
||
|
Tax rate change
|
21,454
|
|
|
(85
|
)%
|
|
—
|
|
|
—
|
%
|
||
|
Provision for income taxes
|
$
|
—
|
|
|
—
|
%
|
|
$
|
—
|
|
|
—
|
%
|
|
|
Years ended December 31,
|
||||||
|
|
2017
|
|
2016
|
||||
|
Deferred tax assets:
|
|
|
|
|
|
||
|
Tax loss carryforwards
|
$
|
29,713
|
|
|
$
|
41,502
|
|
|
Research and development credits and other tax credits
|
3,084
|
|
|
2,817
|
|
||
|
Stock-based compensation
|
3,565
|
|
|
4,658
|
|
||
|
Other
|
945
|
|
|
1,283
|
|
||
|
Total deferred tax assets
|
37,307
|
|
|
50,260
|
|
||
|
Valuation allowance
|
(37,307
|
)
|
|
(50,260
|
)
|
||
|
Net deferred tax asset
|
$
|
—
|
|
|
$
|
—
|
|
|
|
Operating
Leases
|
|
Sublease
Income
|
|
Net Operating
Leases
|
||||||
|
2018
|
$
|
881,815
|
|
|
$
|
(216,504
|
)
|
|
$
|
665,311
|
|
|
2019
|
906,879
|
|
|
(183,124
|
)
|
|
723,755
|
|
|||
|
2020
|
931,457
|
|
|
—
|
|
|
931,457
|
|
|||
|
2021
|
959,401
|
|
|
—
|
|
|
959,401
|
|
|||
|
2022
|
—
|
|
|
—
|
|
|
—
|
|
|||
|
Thereafter
|
—
|
|
|
—
|
|
|
—
|
|
|||
|
Total
|
$
|
3,679,552
|
|
|
$
|
(399,628
|
)
|
|
$
|
3,279,924
|
|
|
|
Quarter Ended(1)
|
||||||||||||||
|
|
March 31
|
|
June 30
|
|
September 30
|
|
December 31
|
||||||||
|
|
(dollars in thousands, except per share data)
|
||||||||||||||
|
2017
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Revenues
|
$
|
95
|
|
|
$
|
102
|
|
|
$
|
123
|
|
|
$
|
185
|
|
|
Operating expenses
|
$
|
10,221
|
|
|
$
|
5,990
|
|
|
$
|
5,921
|
|
|
$
|
3,969
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
Net loss attributable to common stockholders
|
$
|
(10,005
|
)
|
|
$
|
(8,052
|
)
|
|
$
|
(4,298
|
)
|
|
$
|
(2,576
|
)
|
|
Net loss per common share - basic
|
$
|
0.32
|
|
|
$
|
(0.26
|
)
|
|
$
|
(0.12
|
)
|
|
$
|
(0.06
|
)
|
|
Net loss per common share - diluted
|
$
|
(0.32
|
)
|
|
$
|
(0.26
|
)
|
|
$
|
(0.12
|
)
|
|
$
|
(0.06
|
)
|
|
|
|
|
|
|
|
|
|
||||||||
|
Shares used in the calculation of net loss attributable to common stockholders - basic
|
30,961,014
|
|
|
30,991,740
|
|
|
36,465,672
|
|
|
40,182,071
|
|
||||
|
Shares used in the calculation of net loss attributable to common stockholders - diluted
|
30,961,014
|
|
|
30,991,740
|
|
|
36,465,672
|
|
|
40,182,071
|
|
||||
|
|
|
|
|
|
|
|
|
||||||||
|
2016
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Revenues
|
$
|
120
|
|
|
$
|
104
|
|
|
$
|
89
|
|
|
$
|
68
|
|
|
Operating expenses
|
$
|
10,579
|
|
|
$
|
10,084
|
|
|
$
|
10,013
|
|
|
$
|
9,850
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
Net loss attributable to common stockholders
|
$
|
(10,269
|
)
|
|
$
|
(10,208
|
)
|
|
$
|
(10,197
|
)
|
|
$
|
(8,554
|
)
|
|
Net loss per common share - basic
|
$
|
(0.35
|
)
|
|
$
|
(0.34
|
)
|
|
$
|
(0.34
|
)
|
|
$
|
(0.28
|
)
|
|
Net loss per common share - diluted
|
$
|
(0.36
|
)
|
|
$
|
(0.34
|
)
|
|
$
|
(0.34
|
)
|
|
$
|
(0.34
|
)
|
|
|
|
|
|
|
|
|
|
||||||||
|
Shares used in the calculation of net loss attributable to common stockholders - basic
|
29,755,184
|
|
|
29,958,037
|
|
|
30,339,774
|
|
|
30,639,440
|
|
||||
|
Shares used in the calculation of net loss attributable to common stockholders - diluted
|
30,108,377
|
|
|
29,958,037
|
|
|
30,339,774
|
|
|
30,711,946
|
|
||||
|
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|