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x
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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o
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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, 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 o
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Accelerated filer o
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Non-accelerated filer x
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Smaller reporting company x
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Emerging growth company o
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Page
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•
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the timing of regulatory submissions;
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•
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our ability to obtain and maintain regulatory approval of our existing product candidate and any other product candidates we may develop, and the labeling under any approval we may obtain;
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•
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approvals for clinical trials may be delayed or withheld by regulatory agencies;
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•
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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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•
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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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•
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competition;
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•
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risks related to market acceptance of products;
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•
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intellectual property risks;
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•
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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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•
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risks associated with the uncertainty of future financial results;
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•
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our ability to attract collaborators and partners; and
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•
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risks associated with our reliance on third party organizations.
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•
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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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•
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it has a relatively short half-life of approximately 24 hours;
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•
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it is available in an oral gelcap formulation;
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•
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it allows for flexible dosing and scheduling;
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•
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it has demonstrated safety, tolerability and preliminary efficacy; and
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•
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it is synergistic in combination with numerous chemotherapies and targeted therapeutics, which may enhance efficacy and duration of response.
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•
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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;
|
•
|
implementation of the federal physician payment transparency requirements, sometimes referred to as the “Physician Payments Sunshine Act”;
|
•
|
a licensure framework for follow-on biologic products;
|
•
|
a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;
|
•
|
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 (“AMP”);
|
•
|
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;
|
•
|
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
|
•
|
expansion of the entities eligible for discounts under the Public Health program.
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•
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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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•
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be proven to be safe and effective in current and future preclinical studies or clinical trials;
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•
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have the desired effects;
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•
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be free from undesirable or unexpected effects;
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•
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meet applicable regulatory standards;
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•
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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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•
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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 IRB or Ethical Committee (“EC”), not authorizing us to commence or conduct a clinical trial at a prospective trial site;
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•
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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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•
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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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•
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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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•
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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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•
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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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•
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adversely affect our ability to further develop or commercialize our product candidate;
|
•
|
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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•
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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.
|
•
|
the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials;
|
•
|
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;
|
•
|
the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval;
|
•
|
the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;
|
•
|
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;
|
•
|
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;
|
•
|
the FDA or comparable foreign regulatory authorities may fail to approve the companion diagnostics we contemplate developing with partners; and
|
•
|
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.
|
•
|
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;
|
•
|
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 payors that are false or fraudulent, and which may apply to entities like us which provide coding and billing information to customers;
|
•
|
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;
|
•
|
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
|
•
|
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 payor, 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.
|
•
|
successfully identify and develop key points of product differentiations from currently available therapies;
|
•
|
successfully and rapidly complete clinical trials and submit for and obtain all requisite regulatory approvals in a cost-effective manner;
|
•
|
maintain a proprietary position for our products and manufacturing processes and other related product technology;
|
•
|
attract and retain key personnel;
|
•
|
develop relationships with physicians prescribing these products; and
|
•
|
build an adequate sales and marketing infrastructure for our product candidates.
|
•
|
demonstration of safety and efficacy;
|
•
|
changes in the practice guidelines and the standard of care for the targeted indication;
|
•
|
relative convenience and ease of administration;
|
•
|
the prevalence and severity of any adverse side effects;
|
•
|
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;
|
•
|
pricing, reimbursement and cost effectiveness, which may be subject to regulatory control;
|
•
|
effectiveness of our or any of our partners’ sales and marketing strategies;
|
•
|
the product labeling or product insert required by the FDA or regulatory authority in other countries; and
|
•
|
the availability of adequate third-party insurance coverage or reimbursement.
|
•
|
our third-party contractors failing to develop an acceptable formulation to support later-stage clinical trials for, or the commercialization of, our product candidates;
|
•
|
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;
|
•
|
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;
|
•
|
our contract manufacturers placing a priority on the manufacture of their own products, or other customers’ products;
|
•
|
our contract manufacturers failing to perform as agreed or not remain in the contract manufacturing business; and
|
•
|
our contract manufacturers’ plants being closed as a result of regulatory sanctions or a natural disaster.
|
•
|
manage our clinical studies effectively;
|
•
|
integrate additional management, administrative, manufacturing and regulatory personnel;
|
•
|
maintain sufficient administrative, accounting and management information systems and controls; and
|
•
|
hire and train additional qualified personnel.
|
•
|
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;
|
•
|
implementation of the federal physician payment transparency requirements, sometimes referred to as the “Physician Payments Sunshine Act”;
|
•
|
a licensure framework for follow-on biologic products;
|
•
|
a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;
|
•
|
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 AMP;
|
•
|
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;
|
•
|
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
|
•
|
expansion of the entities eligible for discounts under the Public Health program.
|
•
|
technological innovations or new products and services introduced by us or our competitors;
|
•
|
clinical trial results relating to our tests or those of our competitors;
|
•
|
announcements or press releases relating to the industry or to our own business or prospects;
|
•
|
coverage and reimbursement decisions by third party payors, such as Medicare and other managed care organizations;
|
•
|
regulation and oversight of our product candidates and services, including by the FDA, Centers for Medicare & Medicaid Services and comparable foreign agencies;
|
•
|
the establishment of partnerships with clinical reference laboratories;
|
•
|
healthcare legislation;
|
•
|
intellectual property disputes;
|
•
|
additions or departures of key personnel;
|
•
|
sales of our common stock;
|
•
|
our ability to integrate operations, technology, products and services;
|
•
|
our ability to execute our business plan;
|
•
|
operating results below expectations;
|
•
|
loss of any strategic relationship;
|
•
|
industry developments;
|
•
|
economic and other external factors; and
|
•
|
period-to-period fluctuations in our financial results.
|
|
Number of Shares of Common Stock to be Issued upon Exercise of Outstanding Options, Warrants and Rights(1)
|
|
Weighted-Average Exercise Price of Outstanding Options, Warrants and Rights
|
|
Number of Options Remaining Available for Future Issuance Under Equity Compensation Plans
(excluding securities reflected in column (a))
|
||||
|
(a)
|
|
(b)
|
|
(c)
|
||||
Equity Compensation Plans Approved by Stockholders
|
1,014,665
|
|
|
$
|
12.60
|
|
|
167,888
|
|
Equity Compensation Plans Not Approved by Stockholders(2)
|
753
|
|
|
$
|
240.96
|
|
|
—
|
|
Total
|
1,015,418
|
|
|
|
|
167,888
|
|
(1)
|
Total excludes 11,301 non-vested restricted stock units.
|
(2)
|
Represents the following options to purchase common stock granted on November 17, 2010: (i) an option to purchase 463 shares with an exercise price of $216.00 per share, (ii) an option to purchase 174 shares with an exercise price of $324.00 per share, and (iii) an option to purchase 116 shares with an exercise price of $216.00 per share. All the options were vested in full on the date of grant and will expire on November 17, 2020.
|
•
|
Initiated enrollment and evaluation of 3 safety lead-in patients in the second arm (2-week dosing schedule) with onvansertib at 18 mg/m2 in combination with abiraterone acetate (Zytiga) and prednisone.
|
•
|
Provide safety and preliminary efficacy data of onvansertib in combination with abiraterone acetate (Zytiga®) and prednisone in patients treated through the end of 2019 and into 2020.
|
•
|
Presented data from the mCRPC trial at key oncology conferences throughout 2019, including the Asia-Pacific Prostate Cancer Conference ("APPC"), and first quarter of 2020 including ASCO-GU.
|
•
|
Completed enrollment and evaluation of the initial dose level cohort of onvansertib 12 mg/m2 and fully enrolled the second dose level (onvansertib 15 mg/m2) cohort.
|
•
|
Presented data from the mCRC trial at key oncology conferences throughout 2019, including the European Society for Medical Oncology (“ESMO”), and first quarter of 2020 including ASCO-GI.
|
•
|
Completed Phase 1b dose escalation safety segment of trial, identified the recommended Phase 2 dose (“RP2D”) of onvansertib at 60mg/m2.
|
•
|
Initiated the Phase 2 segment of the AML trial, which will enroll approximately 32 patients, for continued evaluation of safety and efficacy of onvansertib in combination with decitabine.
|
•
|
Presented data from the AML trial at key oncology conferences, including the European Society for Medical Oncology ("ESMO") and the American Society of Hematology (“ASH”) annual meetings.
|
•
|
Announced positive data presented in an oral session at the American Society of Hematology (“ASH”) conference response to treatment in patients with acute myeloid leukemia.
|
•
|
Announced data showing the ability of onvanserib to rescue patients previously treated with, and resistant to, venetoclax in acute myeloid leukemia.
|
•
|
Announced positive response to treatment in Phase 2 trial of onvansertib in patients with metastatic castration-resistant prostate cancer.
|
•
|
Announced positive response to treatment in Phase 1b/2 trial of onvansertib in patients with KRAS-mutated metastatic colorectal cancer.
|
•
|
Announced data presented at ESMO providing rationale for a clinical trial of onvansertib in subset of patients with Highly-Aggressive Triple Negative Breast Cancer (TNBC).
|
•
|
Announced presentation of a poster at ESMO of Phase 1b/2 trial of onvansertib in patients with KRAS-mutated mCRC.
|
•
|
Announced oral presentation of positive data from Trovagene Phase 1b/2 AML Study of onvansertib at ESMO Conference.
|
•
|
Announced Successful Completion of the AML Phase 1b Trial and Initiation of the Phase 2 Continuation Trial.
|
•
|
Announced the Presentation of Positive Clinical Data from Ongoing Phase 2 Study of Onvansertib in mCRPC at the Asia-Pacific Prostate Cancer Conference.
|
•
|
Announced research collaboration with Nektar Therapeutics to evaluate the efficacy of the combination of onvansertib and ONZEALDTM in models of colorectal cancer.
|
•
|
Announced Data Demonstrating Significant Synergy of Onvansertib in Combination with Venetoclax in Cell Model of Venetoclax-Resistant AML.
|
•
|
Announced New Patent Issued for Combination of Onvansertib with Anti-Androgen Drugs to Treat Non-Metastatic and Metastatic Prostate Cancer.
|
|
For the years ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
Increase/(Decrease)
|
||||||
Royalty income
|
$
|
243,137
|
|
|
$
|
250,453
|
|
|
$
|
(7,316
|
)
|
Service revenue
|
1,495
|
|
|
127,872
|
|
|
(126,377
|
)
|
|||
Total revenues
|
$
|
244,632
|
|
|
$
|
378,325
|
|
|
$
|
(133,693
|
)
|
|
For the years ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
Increase/(Decrease)
|
||||||
Salaries and staff costs
|
$
|
1,585,381
|
|
|
$
|
1,652,071
|
|
|
$
|
(66,690
|
)
|
Stock-based compensation
|
399,687
|
|
|
752,127
|
|
|
(352,440
|
)
|
|||
Clinical trials, outside services, and lab supplies
|
8,250,313
|
|
|
4,744,448
|
|
|
3,505,865
|
|
|||
Facilities and Other
|
926,855
|
|
|
1,015,365
|
|
|
(88,510
|
)
|
|||
Total research and development expenses
|
$
|
11,162,236
|
|
|
$
|
8,164,011
|
|
|
$
|
2,998,225
|
|
|
For the years ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
Increase/(Decrease)
|
||||||
Salaries and staff costs
|
$
|
1,955,305
|
|
|
$
|
2,797,588
|
|
|
$
|
(842,283
|
)
|
Stock-based compensation
|
485,256
|
|
|
1,392,012
|
|
|
(906,756
|
)
|
|||
Outside services and professional fees
|
1,986,039
|
|
|
2,091,657
|
|
|
(105,618
|
)
|
|||
Facilities and other
|
1,334,290
|
|
|
1,724,326
|
|
|
(390,036
|
)
|
|||
Total selling, general and administrative
|
$
|
5,760,890
|
|
|
$
|
8,005,583
|
|
|
$
|
(2,244,693
|
)
|
|
For the years ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
Increase/(Decrease)
|
||||||
Net loss attributable to common stockholders
|
$
|
(16,706,668
|
)
|
|
$
|
(19,254,951
|
)
|
|
$
|
(2,548,283
|
)
|
Net loss per common share — basic and diluted
|
$
|
(2.80
|
)
|
|
$
|
(8.26
|
)
|
|
$
|
(5.46
|
)
|
|
|
|
|
|
|
||||||
Weighted-average shares outstanding — basic and diluted
|
5,973,906
|
|
|
2,330,180
|
|
|
3,643,726
|
|
|
Payments Due by period
|
||||||||||||||||||
|
Total
|
|
Less than 1
Year |
|
1-2 Years
|
|
3-5 Years
|
|
More than 5
Years |
||||||||||
Operating leases
|
$
|
1,842,835
|
|
|
$
|
865,379
|
|
|
$
|
974,033
|
|
|
$
|
3,423
|
|
|
$
|
—
|
|
Total obligations
|
$
|
1,842,835
|
|
|
$
|
865,379
|
|
|
$
|
974,033
|
|
|
$
|
3,423
|
|
|
$
|
—
|
|
|
Name
|
|
Age
|
|
Position
|
Thomas H. Adams, Ph.D.
|
|
77
|
|
Chief Executive Officer and Chairman of the Board
|
Mark Erlander, Ph.D.
|
|
60
|
|
Chief Scientific Officer
|
John Brancaccio
|
|
71
|
|
Director
|
Gary S. Jacob, Ph.D.
|
|
72
|
|
Director
|
Dr. Rodney S. Markin, M.D., Ph.D.
|
|
63
|
|
Director
|
Name and Principal Position
|
|
Year
|
|
Salary ($)
|
|
Non-Equity Incentive Plan Compensation ($)(1)
|
|
Option Awards ($) (2)
|
|
Stock Awards ($) (3)
|
|
Total ($)
|
||||||||
Thomas H. Adams, CEO
|
|
2019
|
|
491,132
|
|
|
|
244,625
|
|
|
|
568,877
|
|
|
|
—
|
|
|
1,304,634
|
|
|
|
2018
|
|
286,346
|
|
(4)
|
|
79,167
|
|
|
|
11,679
|
|
(5)
|
|
—
|
|
|
377,192
|
|
Mark Erlander, CSO
|
|
2019
|
|
398,729
|
|
|
|
198,600
|
|
|
|
255,622
|
|
|
|
—
|
|
|
852,951
|
|
|
|
2018
|
|
387,155
|
|
|
|
342,576
|
|
|
|
144,008
|
|
|
|
34,785
|
|
|
908,524
|
|
|
(1)
|
The amounts in this column relate to bonuses earned by the Named Executive Officers in 2019 and 2018.
|
(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 2019 and 2018 amounts are described in Note 6 to our financial statements included in our Annual Reports on Form 10-K for the fiscal years ended December 31, 2019 and 2018. Our named executive officers 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.
|
(3)
|
This reflects the grant date fair value of awards granted during fiscal years ended December 31, 2019 and 2018.
|
(4)
|
Of this amount, $60,000 was the compensation paid for non-employee director service in 2018.
|
(5)
|
Stock option awards were granted for non-employee director service in 2018.
|
|
|
Option Awards(1)
|
|
Stock Awards
|
|||||||||||||
Name
|
|
Number of Securities
Underlying Unexercised Options (#)
Exercisable
|
|
Number of Securities
Underlying Unexercised Options (#)
Unexercisable
|
|
Option
Exercise Price ($)
|
|
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 ($)
|
|||||
Thomas H. Adams
|
|
4,219
|
|
|
—
|
|
|
216.00
|
|
|
8/5/2021
|
|
|
|
|
||
|
|
98
|
|
|
—
|
|
|
237.60
|
|
|
1/26/2022
|
|
|
|
|
||
|
|
175
|
|
|
—
|
|
|
499.68
|
|
|
2/14/2023
|
|
|
|
|
||
|
|
272
|
|
|
—
|
|
|
447.84
|
|
|
2/25/2024
|
|
|
|
|
||
|
|
223
|
|
|
—
|
|
|
516.96
|
|
|
3/17/2025
|
|
|
|
|
||
|
|
223
|
|
|
—
|
|
|
372.96
|
|
|
1/4/2026
|
|
|
|
|
||
|
|
530
|
|
|
—
|
|
|
51.84
|
|
|
10/4/2027
|
|
|
|
|
||
|
|
755
|
|
|
—
|
|
|
21.60
|
|
|
1/23/2028
|
|
|
|
|
||
|
|
—
|
|
|
298,230
|
|
|
2.48
|
|
|
6/20/2029
|
|
|
|
|
||
Mark Erlander
|
|
70
|
|
|
—
|
|
|
204.48
|
|
|
9/13/2022
|
|
521
|
|
|
646
|
|
|
|
139
|
|
|
—
|
|
|
350.64
|
|
|
12/10/2022
|
|
1,250
|
|
|
1,550
|
|
|
|
2,778
|
|
|
—
|
|
|
506.88
|
|
|
1/28/2023
|
|
|
|
|
||
|
|
1,389
|
|
|
—
|
|
|
398.16
|
|
|
12/11/2023
|
|
|
|
|
||
|
|
2,778
|
|
|
—
|
|
|
236.88
|
|
|
7/16/2024
|
|
|
|
|
||
|
|
834
|
|
|
—
|
|
|
316.08
|
|
|
12/11/2024
|
|
|
|
|
||
|
|
2,040
|
|
|
44
|
|
|
372.96
|
|
|
1/4/2026
|
|
|
|
|
||
|
|
5,348
|
|
|
—
|
|
|
61.20
|
|
|
8/22/2027
|
|
|
|
|
||
|
|
7,948
|
|
|
1,388
|
|
|
21.60
|
|
|
1/23/2028
|
|
|
|
|
||
|
|
—
|
|
|
134,203
|
|
|
2.48
|
|
|
6/20/2029
|
|
|
|
|
|
(1)
|
For each executive officer, the shares listed in this table are subject to a single stock option award carrying the varying exercise prices as set forth herein. The option awards remain exercisable until they expire ten years from the date of grant, subject to earlier expiration following termination of employment.
|
Name
|
|
Fees Earned or Paid in Cash ($)
|
|
Option Awards ($)(1)
|
|
Total ($)
|
|||
John Brancaccio(2)
|
|
76,000
|
|
|
83,963
|
|
|
159,963
|
|
Gary S. Jacob(3)
|
|
56,000
|
|
|
83,963
|
|
|
139,963
|
|
Rodney S. Markin(4)
|
|
76,000
|
|
|
83,963
|
|
|
159,963
|
|
Athena Countouriotis(5)
|
|
62,000
|
|
|
83,963
|
|
|
145,963
|
|
|
(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 2019 amounts are described in Note 6 to our financial statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019. 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)
|
As of December 31, 2019, 47,806 stock options were outstanding, of which 3,072 were exercisable.
|
(3)
|
As of December 31, 2019, 47,376 stock options were outstanding, of which 2,642 were exercisable.
|
(4)
|
As of December 31, 2019, 46,969 stock options were outstanding, of which 2,235 were exercisable.
|
(5)
|
As of December 31, 2019, 46,019 stock options were outstanding, of which 1,109 were exercisable. Dr. Countouriotis resigned from the Board on January 24, 2020.
|
|
Termination
|
||||||
By Trovagene Without
Cause Outside a Change
In Control
|
|
By Trovagene Without
Cause or by Dr. Erlander for
Good Reason in Connection
with a Change In Control(1)
|
|||||
Value of Equity Securities Accelerated
|
$
|
—
|
|
|
$
|
118,764
|
|
Cash Payments
|
397,201
|
|
|
397,201
|
|
||
Total Cash Benefits and Payments
|
$
|
397,201
|
|
|
$
|
515,965
|
|
|
(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 H. Adams
|
|
11,384
|
|
(3)
|
|
*
|
John Brancaccio
|
|
5,339
|
|
(4)
|
|
*
|
Gary S. Jacob
|
|
4,711
|
|
(5)
|
|
*
|
Rodney S. Markin
|
|
9,416
|
|
(6)
|
|
*
|
Athena Countouriotis
|
|
1,109
|
|
(7)
|
|
*
|
Mark Erlander
|
|
30,438
|
|
(8)
|
|
*
|
All Officers and Directors as a Group (6 persons)
|
|
62,397
|
|
(9)
|
|
*
|
|
(1)
|
The address of each person is c/o Trovagene, Inc., 11055 Flintkote Avenue, San Diego, CA 92121 unless otherwise indicated herein.
|
(2)
|
The calculation in this column is based upon 10,209,587 shares of common stock outstanding on February 20, 2020. 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 20, 2020 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 6,495 shares of common stock issuable upon exercise of stock options that are exercisable within 60 days after February 20, 2020.
|
(4)
|
Includes 3,072 shares of common stock issuable upon exercise of stock options that are exercisable within 60 days after February 20, 2020.
|
(5)
|
Includes 2,642 shares of common stock issuable upon exercise of stock options that are exercisable within 60 days after February 20, 2020.
|
(6)
|
Includes 2,235 shares of common stock issuable upon exercise of stock options that are exercisable within 60 days after February 20, 2020.
|
(7)
|
Includes 1,109 shares of common stock issuable upon exercise of stock options that are exercisable within 60 days after February 20, 2020. Dr. Countouriotis resigned from the Board on January 24, 2020.
|
(8)
|
Includes 24,062 shares of common stock issuable upon exercise of stock options that are exercisable within 60 days after February 20, 2020.
|
(9)
|
Includes 39,615 shares of common stock issuable upon exercise of stock options that are exercisable within 60 days after February 20, 2020.
|
|
2019
|
|
2018
|
||||
Audit fees (1)
|
$
|
339,507
|
|
|
$
|
226,646
|
|
Tax fees (2)
|
17,925
|
|
|
14,263
|
|
||
|
$
|
357,432
|
|
|
$
|
240,909
|
|
|
(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
|
|
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).
|
|
|
Certificate of Amendment of Amended and Restated Certificate of Trovagene, Inc. (incorporated by reference to Exhibit 3.1 to the Company’s Form 8-K filed on June 1, 2018).
|
|
|
Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock. (incorporated by reference to Exhibit 3.1 to Form 8-K filed on June 12, 2018).
|
|
|
Certificate of Designation of Preferences, Rights and Limitations of Series C Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to Form 8-K filed on January 29, 2019).
|
|
|
Amendment to Certificate of Designation of Preferences, Rights and Limitations of Series C Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to Form 8-K filed on January 31, 2019).
|
|
|
Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Trovagene, Inc. (incorporated by reference to Exhibit 3.1 to the Company’s Form 8-K filed on February 20, 2019).
|
|
|
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)
|
|
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).
|
|
4.5+
|
|
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).
|
|
|
Form of Warrant to Purchase Common Stock (Incorporated by reference to Exhibit 4.1 to Form 8-K filed on June 12, 2018).
|
|
|
Form of Warrant (incorporated by reference to Exhibit 4.1 to Form 8-K filed on January 29, 2019).
|
|
|
Form of Series A Warrant (incorporated by reference to Exhibit 10.2 to Form 8-K filed on April 5, 2019).
|
|
|
Form of Series B Warrant (incorporated by reference to Exhibit 10.3 to Form 8-K filed on April 5, 2019).
|
|
|
Form of Series C Warrant (incorporated by reference to Exhibit 10.2 to Form 8-K filed on May 13, 2019).
|
|
|
Form of Series D Warrant (incorporated by reference to Exhibit 10.3 to Form 8-K filed on May 13, 2019).
|
|
|
Form of Series E Pre-Funded Warrant (incorporated by reference to Exhibit 10.2 to Form 8-K filed on August 21, 2019).
|
|
|
Form of Series F Warrant (incorporated by reference to Exhibit 10.3 to Form 8-K filed on August 21, 2019).
|
|
|
Form of Series G, H and Pre-Funded Warrant and Placement Agent Warrant (incorporated by reference to Exhibit 10.2 to Form 8-K filed on October 28, 2019).
|
|
Description of the Registrant's Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934.
|
|
|
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).
|
|
10.8+
|
|
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).
|
10.9+
|
|
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).
|
|
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).
|
|
|
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).
|
|
|
Stock and Warrant Subscription Agreement entered into as of January 25, 2019 by and between Trovagene, Inc. and PoC Capital, LLC (incorporated by reference to Exhibit 10.1 to Form 8-K filed on January 29, 2019).
|
|
|
Securities Purchase Agreement dated April 4, 2019 by and between Trovagene, Inc. and the Purchaser (incorporated by reference to Exhibit 10.1 to Form 8-K filed on April 5, 2019).
|
|
|
Securities Purchase Agreement dated May 10, 2019 by and between Trovagene, Inc. and the Purchaser (incorporated by reference to Exhibit 10.1 to Form 8-K filed on May 13, 2019).
|
|
|
Securities Purchase Agreement dated August 20, 2019 by and between Trovagene, Inc. and the Purchaser (incorporated by reference to Exhibit 10.1 to Form 8-K filed on August 21, 2019).
|
|
|
Form of Purchase Agreement (incorporated by reference to Exhibit 10.1 to Form 8-K filed on October 28, 2019).
|
|
|
Form of Registration Rights Agreement (incorporated by reference to Exhibit 10.3 to Form 8-K filed on October 28, 2019).
|
|
|
Consent of BDO USA, LLP.
|
|
|
Power of Attorney (included on signature page hereto).
|
|
|
Certification of Principal Executive Officer required under Rule 13a-14(a)/15d-14(a) under the Exchange Act.
|
|
|
Certification of Principal Financial Officer required under Rule 13a-14(a)/15d-14(a) under the Exchange Act.
|
|
|
Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
Certification of 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/ Thomas H. Adams
|
2/27/2020
|
Chief Executive Officer (Principal Executive Officer)
|
SIGNATURE
|
|
TITLE
|
|
DATE
|
|
|
|
|
|
|
|
|
|
|
|
|
|
/s/ Thomas H. Adams
|
|
Chief Executive Officer and Chairman of the Board
|
|
2/27/2020
|
|
Thomas H. Adams
|
|
(Principal Executive Officer)
|
|
|
|
|
|
|
|
|
|
/s/ Brigitte Lindsay
|
|
VP, Finance
|
|
2/27/2020
|
|
Brigitte Lindsay
|
|
(Principal Financial and Accounting Officer)
|
|
|
|
|
|
|
|
|
|
/s/ John Brancaccio
|
|
Director
|
|
2/27/2020
|
|
John Brancaccio
|
|
|
|
|
|
|
|
|
|
|
|
/s/ Gary S. Jacob
|
|
Director
|
|
2/27/2020
|
|
Gary S. Jacob
|
|
|
|
|
|
|
|
|
|
|
|
/s/ Rodney S. Markin
|
|
Director
|
|
2/27/2020
|
|
Rodney S. Markin
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2019
|
|
December 31, 2018
|
||||
Assets
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
10,195,292
|
|
|
$
|
11,453,133
|
|
Accounts receivable and unbilled receivable
|
203,480
|
|
|
167,755
|
|
||
Prepaid expenses
|
954,957
|
|
|
1,144,377
|
|
||
Total current assets
|
11,353,729
|
|
|
12,765,265
|
|
||
Property and equipment, net
|
877,823
|
|
|
1,304,433
|
|
||
Operating lease right-of-use assets
|
697,418
|
|
|
—
|
|
||
Other assets
|
157,576
|
|
|
102,798
|
|
||
Total Assets
|
$
|
13,086,546
|
|
|
$
|
14,172,496
|
|
|
|
|
|
||||
Liabilities and Stockholders’ Equity
|
|
|
|
|
|
||
Current liabilities:
|
|
|
|
|
|
||
Accounts payable
|
$
|
656,304
|
|
|
$
|
664,840
|
|
Accrued liabilities
|
3,260,061
|
|
|
1,771,842
|
|
||
Deferred rent
|
—
|
|
|
486,636
|
|
||
Operating lease liabilities
|
865,379
|
|
|
—
|
|
||
Total current liabilities
|
4,781,744
|
|
|
2,923,318
|
|
||
Derivative financial instruments—warrants
|
4,127
|
|
|
32,315
|
|
||
Operating lease liabilities, net of current portion
|
860,963
|
|
|
—
|
|
||
Deferred rent, net of current portion
|
—
|
|
|
1,090,671
|
|
||
Other liabilities
|
128,368
|
|
|
42,000
|
|
||
Total liabilities
|
5,775,202
|
|
|
4,088,304
|
|
||
|
|
|
|
||||
Commitments and contingencies (Note 11)
|
|
|
|
|
|
||
|
|
|
|
|
|
||
Stockholders’ equity
|
|
|
|
||||
Preferred stock, $0.001 par value, 20,000,000 shares authorized; 277,100 designated as Series A Convertible Preferred Stock; 60,600 shares outstanding at December 31, 2019 and December 31, 2018 with liquidation preference of $606,000 at December 31, 2019 and December 31, 2018; 8,860 designated as Series B Convertible Preferred Stock; 0 shares outstanding at December 31, 2019 and 2018, respectively; 200,000 designated as Series C Convertible Preferred Stock; 0 shares outstanding at December 31, 2019 and December 31, 2018
|
60
|
|
|
60
|
|
||
Common stock, $0.0001 par value, 150,000,000 shares authorized; 8,593,633 and 3,831,879 shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively
|
8,312
|
|
|
7,742
|
|
||
Additional paid-in capital
|
217,172,528
|
|
|
202,267,605
|
|
||
Service receivables
|
(971,673
|
)
|
|
—
|
|
||
Accumulated deficit
|
(208,897,883
|
)
|
|
(192,191,215
|
)
|
||
Total stockholders’ equity
|
7,311,344
|
|
|
10,084,192
|
|
||
Total Liabilities and Stockholders’ Equity
|
$
|
13,086,546
|
|
|
$
|
14,172,496
|
|
|
Year Ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
Revenues:
|
|
|
|
||||
Royalties
|
$
|
243,137
|
|
|
$
|
250,453
|
|
Services
|
1,495
|
|
|
127,872
|
|
||
Total revenues
|
244,632
|
|
|
378,325
|
|
||
Costs and expenses:
|
|
|
|
|
|
||
Cost of revenue
|
—
|
|
|
597,457
|
|
||
Research and development
|
11,162,236
|
|
|
8,164,011
|
|
||
Selling, general and administrative
|
5,760,890
|
|
|
8,005,583
|
|
||
Restructuring charges
|
—
|
|
|
664,686
|
|
||
Total operating expenses
|
16,923,126
|
|
|
17,431,737
|
|
||
|
|
|
|
||||
Loss from operations
|
(16,678,494
|
)
|
|
(17,053,412
|
)
|
||
|
|
|
|
||||
Interest income
|
234,169
|
|
|
219,430
|
|
||
Interest expense
|
—
|
|
|
(25,409
|
)
|
||
Other gain (loss), net
|
1,978
|
|
|
(236,833
|
)
|
||
Gain on extinguishment of debt
|
—
|
|
|
17,974
|
|
||
Gain from changes in fair value of derivative financial instruments—warrants
|
28,188
|
|
|
617,072
|
|
||
Net loss
|
(16,414,159
|
)
|
|
(16,461,178
|
)
|
||
|
|
|
|
||||
Preferred stock dividend payable on Series A Convertible Preferred Stock
|
(24,240
|
)
|
|
(24,240
|
)
|
||
Deemed dividend recognized on beneficial conversion features of Series B Convertible Preferred Stock issuance
|
—
|
|
|
(2,769,533
|
)
|
||
Deemed dividend recognized on beneficial conversion features of Series C Convertible Preferred Stock issuance
|
(268,269
|
)
|
|
—
|
|
||
Net loss attributable to common stockholders
|
$
|
(16,706,668
|
)
|
|
$
|
(19,254,951
|
)
|
|
|
|
|
||||
Net loss per common share — basic and diluted
|
$
|
(2.80
|
)
|
|
$
|
(8.26
|
)
|
|
|
|
|
||||
Weighted-average shares outstanding — basic and diluted
|
5,973,906
|
|
|
2,330,180
|
|
|
Preferred Stock
Shares
|
|
Preferred Stock
Amount
|
|
Common Stock
Shares
|
|
Common Stock
Amount
|
|
Additional
Paid-In Capital
|
|
Service Receivable
|
|
Accumulated Deficit
|
|
Total
Stockholders’ Equity
|
||||||||||||||
Balance, January 1, 2018
|
60,600
|
|
|
$
|
60
|
|
|
733,217
|
|
|
$
|
5,279
|
|
|
$
|
179,546,954
|
|
|
$
|
—
|
|
|
$
|
(173,046,186
|
)
|
|
$
|
6,506,107
|
|
Sale of common stock and warrants, net of expenses
|
—
|
|
|
—
|
|
|
1,523,333
|
|
|
914
|
|
|
11,778,611
|
|
|
—
|
|
|
—
|
|
|
11,779,525
|
|
||||||
Sale of Series B Convertible Preferred Stock, net of expenses
|
8,860
|
|
|
9
|
|
|
—
|
|
|
—
|
|
|
4,386,753
|
|
|
—
|
|
|
—
|
|
|
4,386,762
|
|
||||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,174,627
|
|
|
—
|
|
|
—
|
|
|
2,174,627
|
|
||||||
Issuance of common stock upon exercise of warrants
|
—
|
|
|
—
|
|
|
78,917
|
|
|
569
|
|
|
1,612,098
|
|
|
—
|
|
|
—
|
|
|
1,612,667
|
|
||||||
Issuance of common stock upon vesting of restricted stock units
|
—
|
|
|
—
|
|
|
18,609
|
|
|
94
|
|
|
(94
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Deemed dividend recognized on beneficial conversion features of Series B Convertible Preferred Stock issuance
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,769,533
|
|
|
—
|
|
|
(2,769,533
|
)
|
|
—
|
|
||||||
Issuance of common stock upon conversion of Series B Convertible Preferred Stock
|
(8,860
|
)
|
|
(9
|
)
|
|
1,476,667
|
|
|
886
|
|
|
(877
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Preferred stock dividend payable on Series A Convertible Preferred Stock
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(24,240
|
)
|
|
(24,240
|
)
|
||||||
Issuance of common stock for share rounding as a result of reverse stock split
|
—
|
|
|
—
|
|
|
1,136
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Cumulative effect of change in accounting principle related to revenue recognition
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
109,922
|
|
|
109,922
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(16,461,178
|
)
|
|
(16,461,178
|
)
|
||||||
Balance, December 31, 2018
|
60,600
|
|
|
60
|
|
|
3,831,879
|
|
|
7,742
|
|
|
202,267,605
|
|
|
—
|
|
|
(192,191,215
|
)
|
|
10,084,192
|
|
||||||
Sale of common stock and warrants, net of expenses
|
—
|
|
|
—
|
|
|
1,994,929
|
|
|
199
|
|
|
8,817,573
|
|
|
—
|
|
|
—
|
|
|
8,817,772
|
|
||||||
Issuance of common stock, preferred stock and warrants for clinical trial funding commitment, net of expenses and discount
|
200,000
|
|
|
200
|
|
|
183,334
|
|
|
110
|
|
|
1,634,690
|
|
|
(1,675,000
|
)
|
|
—
|
|
|
(40,000
|
)
|
||||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
884,942
|
|
|
—
|
|
|
—
|
|
|
884,942
|
|
||||||
Issuance of common stock upon exercise of warrants
|
—
|
|
|
—
|
|
|
2,221,635
|
|
|
223
|
|
|
3,299,287
|
|
|
—
|
|
|
—
|
|
|
3,299,510
|
|
||||||
Issuance of common stock upon vesting of restricted stock units
|
—
|
|
|
—
|
|
|
22,057
|
|
|
5
|
|
|
(5
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Deemed dividend recognized on beneficial conversion features of Series C Convertible Preferred Stock issuance
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
268,269
|
|
|
—
|
|
|
(268,269
|
)
|
|
—
|
|
||||||
Issuance of common stock upon conversion of Series C Convertible Preferred Stock
|
(200,000
|
)
|
|
(200
|
)
|
|
333,333
|
|
|
33
|
|
|
167
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Preferred stock dividend payable on Series A Convertible Preferred Stock
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(24,240
|
)
|
|
(24,240
|
)
|
||||||
Issuance of common stock for share rounding as a result of reverse stock split
|
—
|
|
|
—
|
|
|
6,466
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Release of clinical trial funding commitment
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
703,327
|
|
|
—
|
|
|
703,327
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
|
(16,414,159
|
)
|
|
(16,414,159
|
)
|
|||||||
Balance, December 31, 2019
|
60,600
|
|
|
$
|
60
|
|
|
8,593,633
|
|
|
$
|
8,312
|
|
|
$
|
217,172,528
|
|
|
$
|
(971,673
|
)
|
|
$
|
(208,897,883
|
)
|
|
$
|
7,311,344
|
|
|
Year ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
Operating activities
|
|
|
|
|
|
||
Net loss
|
$
|
(16,414,159
|
)
|
|
$
|
(16,461,178
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
||
Loss on disposal of assets
|
—
|
|
|
362,949
|
|
||
Impairment loss
|
—
|
|
|
187,500
|
|
||
Depreciation and amortization
|
494,232
|
|
|
859,487
|
|
||
Stock-based compensation expense
|
884,943
|
|
|
2,174,627
|
|
||
Gain on extinguishment of debt
|
—
|
|
|
(17,974
|
)
|
||
Deferred rent
|
—
|
|
|
59,206
|
|
||
Change in fair value of derivative financial instruments—warrants
|
(28,188
|
)
|
|
(617,072
|
)
|
||
Release of clinical trial funding commitment
|
703,327
|
|
|
—
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
|
|
||
Other assets
|
(54,778
|
)
|
|
(23,755
|
)
|
||
Accounts receivable and unbilled receivable
|
(35,725
|
)
|
|
19,262
|
|
||
Prepaid expenses
|
115,459
|
|
|
21,451
|
|
||
Operating lease right-of-use assets
|
302,491
|
|
|
—
|
|
||
Accounts payable and accrued expenses
|
1,455,336
|
|
|
214,484
|
|
||
Operating lease liabilities
|
(776,806
|
)
|
|
—
|
|
||
Other liabilities
|
86,368
|
|
|
22,000
|
|
||
Net cash used in operating activities
|
(13,267,500
|
)
|
|
(13,199,013
|
)
|
||
|
|
|
|
||||
Investing activities
|
|
|
|
|
|
||
Capital expenditures
|
(67,622
|
)
|
|
(5,100
|
)
|
||
Proceeds from disposals of capital equipment
|
—
|
|
|
27,942
|
|
||
Purchases of short-term investments
|
—
|
|
|
(31,500
|
)
|
||
Sales of short-term investments
|
—
|
|
|
31,500
|
|
||
Net cash provided (used) by investing activities
|
(67,622
|
)
|
|
22,842
|
|
||
|
|
|
|
||||
Financing activities
|
|
|
|
|
|
||
Proceeds from sale of common stock and warrants, net of expenses of $158,678 and $1,336,123 respectively
|
8,817,772
|
|
|
11,779,525
|
|
||
Proceeds from sales of Series B Convertible Preferred Stock, net of expenses of $0 and $497,617 respectively
|
—
|
|
|
4,386,762
|
|
||
Costs related to the clinical trial funding commitment
|
(40,000
|
)
|
|
—
|
|
||
Proceeds from exercise of warrants
|
3,299,509
|
|
|
1,612,667
|
|
||
Repayments under equipment line of credit
|
—
|
|
|
(1,200,033
|
)
|
||
Payment upon debt extinguishment
|
—
|
|
|
(175,381
|
)
|
||
Net cash provided by financing activities
|
12,077,281
|
|
|
16,403,540
|
|
||
Net change in cash and cash equivalents
|
(1,257,841
|
)
|
|
3,227,369
|
|
||
Cash and cash equivalents—Beginning of period
|
11,453,133
|
|
|
8,225,764
|
|
||
Cash and cash equivalents—End of period
|
$
|
10,195,292
|
|
|
$
|
11,453,133
|
|
Supplementary disclosure of cash flow activity:
|
|
|
|
|
|
||
Cash paid for taxes
|
$
|
800
|
|
|
$
|
800
|
|
Cash paid for interest
|
$
|
—
|
|
|
$
|
22,482
|
|
Supplemental disclosure of non-cash investing and financing activities:
|
|
|
|
|
|
||
Preferred stock dividend payable on Series A Convertible Preferred Stock
|
$
|
24,240
|
|
|
$
|
24,240
|
|
|
Year ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
Deemed dividend recognized for beneficial conversion features of Series B Convertible Preferred Stock issuance
|
$
|
—
|
|
|
$
|
2,769,533
|
|
Deemed dividend recognized for beneficial conversion features of Series C Convertible Preferred Stock issuance
|
$
|
268,269
|
|
|
$
|
—
|
|
Common stock, Series C Convertible Preferred Stock and warrants issued in connection with clinical trial funding commitment, net of discount of $235,640
|
$
|
1,675,000
|
|
|
$
|
—
|
|
Common stock issued upon conversion of Series B Convertible Preferred Stock
|
$
|
—
|
|
|
$
|
886
|
|
Common stock issued upon conversion of Series C Convertible Preferred Stock
|
$
|
33
|
|
|
$
|
—
|
|
•
|
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;
|
•
|
Introducing operation and business development initiatives to bring in new revenue streams;
|
•
|
Reducing operating costs by identifying internal synergies; and
|
•
|
Engaging in strategic partnerships.
|
•
|
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,
|
||||
|
2019
|
|
2018
|
||
Options to purchase Common Stock
|
1,015,418
|
|
|
83,345
|
|
Warrants to purchase Common Stock
|
10,589,482
|
|
|
3,649,341
|
|
Restricted Stock Units
|
11,301
|
|
|
30,132
|
|
Series A Convertible Preferred Stock
|
877
|
|
|
877
|
|
|
11,617,078
|
|
|
3,763,695
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Numerator:
|
|
|
|
|
|
||
Net loss attributable to common stockholders
|
$
|
(16,706,668
|
)
|
|
$
|
(19,254,951
|
)
|
Net loss used for basic and diluted loss per share
|
$
|
(16,706,668
|
)
|
|
$
|
(19,254,951
|
)
|
|
|
|
|
||||
Denominator:
|
|
|
|
|
|
||
Weighted-average shares used to compute basic and diluted net loss per share
|
5,973,906
|
|
|
2,330,180
|
|
||
|
|
|
|
||||
Net loss per share attributable to common stockholders:
|
|
|
|
||||
Basic and diluted
|
$
|
(2.80
|
)
|
|
$
|
(8.26
|
)
|
Unaudited
|
Three Months Ended
|
|
Six Months Ended June 30, 2019
|
|
Nine Months Ended September 30, 2019
|
||||||||||
|
June 30, 2019
|
|
September 30, 2019
|
|
|||||||||||
Weighted-average shares used to compute basic and diluted net loss per share:
|
|
|
|
|
|
|
|
||||||||
Previously Reported
|
5,241,924
|
|
|
5,822,818
|
|
|
4,667,434
|
|
|
5,056,794
|
|
||||
Adjustment
|
166,200
|
|
|
201,862
|
|
|
83,559
|
|
|
123,427
|
|
||||
Revised
|
5,408,124
|
|
|
6,024,680
|
|
|
4,750,993
|
|
|
5,180,221
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Basic and diluted loss per share:
|
|
|
|
|
|
|
|
||||||||
Previously reported
|
$
|
(0.79
|
)
|
|
$
|
(0.71
|
)
|
|
$
|
(1.78
|
)
|
|
$
|
(2.46
|
)
|
Adjustment
|
0.03
|
|
|
0.02
|
|
|
0.03
|
|
|
0.06
|
|
||||
Revised
|
$
|
(0.76
|
)
|
|
$
|
(0.69
|
)
|
|
$
|
(1.75
|
)
|
|
$
|
(2.40
|
)
|
|
As of December 31,
|
||||||
|
2019
|
|
2018
|
||||
Furniture and office equipment
|
$
|
775,030
|
|
|
$
|
775,030
|
|
Leasehold improvements
|
1,962,230
|
|
|
1,962,230
|
|
||
Laboratory equipment
|
744,856
|
|
|
677,234
|
|
||
|
3,482,116
|
|
|
3,414,494
|
|
||
Less—accumulated depreciation and amortization
|
(2,604,293
|
)
|
|
(2,110,061
|
)
|
||
Property and equipment, net
|
$
|
877,823
|
|
|
$
|
1,304,433
|
|
|
As of December 31,
|
||||||
|
2019
|
|
2018
|
||||
Accrued compensation
|
$
|
1,003,383
|
|
|
$
|
780,848
|
|
Preferred stock dividend
|
365,255
|
|
|
341,015
|
|
||
Research agreements and clinical trials
|
1,686,068
|
|
|
319,898
|
|
||
Director fees
|
67,500
|
|
|
80,008
|
|
||
Professional fees and outside services
|
21,000
|
|
|
107,006
|
|
||
Patent, license and other fees
|
69,950
|
|
|
58,398
|
|
||
Other accrued liabilities
|
46,905
|
|
|
84,669
|
|
||
Total accrued liabilities
|
$
|
3,260,061
|
|
|
$
|
1,771,842
|
|
|
|
Twelve Months Ended December 31, 2019
|
||
Operating lease cost
|
|
$
|
444,878
|
|
Operating sublease income
|
|
(381,653
|
)
|
|
Net operating lease cost
|
|
$
|
63,225
|
|
|
|
December 31, 2019
|
||
Operating lease ROU assets
|
|
$
|
697,418
|
|
|
|
|
||
Current operating lease liabilities
|
|
$
|
865,379
|
|
Non-current operating lease liabilities
|
|
860,963
|
|
|
Total operating lease liabilities
|
|
$
|
1,726,342
|
|
|
|
|
||
Weighted-average remaining lease term–operating leases
|
|
2.0 years
|
|
|
Weighted-average discount rate–operating leases
|
|
6.5
|
%
|
|
|
Twelve Months Ended December 31, 2019
|
||
Cash paid for amounts included in the measurement of lease liabilities:
|
|
|
||
Operating cash flows from operating leases
|
|
$
|
916,762
|
|
Year Ending December 31,
|
|
Operating Leases
|
|
Sublease Income
|
|
Net Operating Leases
|
||||||
2020
|
|
$
|
865,379
|
|
|
$
|
(291,173
|
)
|
|
$
|
574,206
|
|
2021
|
|
968,165
|
|
|
(291,173
|
)
|
|
676,992
|
|
|||
2022
|
|
5,868
|
|
|
—
|
|
|
5,868
|
|
|||
2023
|
|
3,423
|
|
|
—
|
|
|
3,423
|
|
|||
Total future minimum lease payments
|
|
1,842,835
|
|
|
$
|
(582,346
|
)
|
|
$
|
1,260,489
|
|
|
Less imputed interest
|
|
(116,493
|
)
|
|
|
|
|
|||||
Total
|
|
$
|
1,726,342
|
|
|
|
|
|
Year Ending December 31,
|
Operating Leases
|
|
Sublease Income
|
|
Net Operating Leases
|
||||||
2019
|
$
|
914,540
|
|
|
$
|
(333,124
|
)
|
|
$
|
581,416
|
|
2020
|
941,670
|
|
|
—
|
|
|
941,670
|
|
|||
2021
|
968,165
|
|
|
—
|
|
|
968,165
|
|
|||
2022
|
5,868
|
|
|
—
|
|
|
5,868
|
|
|||
2023
|
3,423
|
|
|
—
|
|
|
3,423
|
|
|||
Total
|
$
|
2,833,666
|
|
|
$
|
(333,124
|
)
|
|
$
|
2,500,542
|
|
•
|
2,221,635 shares of common stock were issued upon exercise of pre-funded warrants and warrants, 1,724,322 and 497,313, respectively;
|
•
|
1,994,929 shares of common stock were issued through private placements with certain accredited investors;
|
•
|
333,333 shares were issued upon conversion of Series C Convertible Preferred Stock;
|
•
|
183,334 shares of common stock in connection with a clinical trial funding commitment;
|
•
|
22,057 shares were issued upon vesting of RSU's; and
|
•
|
6,466 shares were issued for share rounding as a result of the reverse stock split.
|
•
|
1,523,333 shares of common stock were sold through an underwritten public offering;
|
•
|
1,476,667 shares were issued upon conversion of Series B Convertible Preferred Stock;
|
•
|
78,917 shares were issued upon exercise of warrants;
|
•
|
18,609 shares were issued upon vesting of RSU's; and
|
•
|
1,136 shares were issued for share rounding as a result of the reverse stock split.
|
|
Number of
Warrants (1)
|
|
Weighted-Average
Exercise Price
Per Share (1)
|
|
Weighted-Average Remaining Contractual Term (1)
|
|||
Balance outstanding, December 31, 2017
|
322,774
|
|
|
$
|
68.07
|
|
|
4.4 years
|
Granted
|
3,450,000
|
|
|
$
|
6.60
|
|
|
|
Exercised
|
(74,518
|
)
|
|
$
|
21.60
|
|
|
|
Expired
|
(48,915
|
)
|
|
$
|
217.17
|
|
|
|
Balance outstanding, December 31, 2018
|
3,649,341
|
|
|
$
|
8.91
|
|
|
4.4 years
|
Granted
|
7,437,454
|
|
|
$
|
1.87
|
|
|
|
Exercised
|
(497,313
|
)
|
|
$
|
6.60
|
|
|
|
Balance outstanding, December 31, 2019
|
10,589,482
|
|
|
$
|
4.08
|
|
|
3.7 years
|
|
•
|
On April 5, 2019 the Company issued Series B Warrants to purchase an aggregate of 382,166 shares of common stock at an exercise price of $3.80 per share, which vested 6 months after issuance and expire 5.5 years from the issuance date;
|
•
|
On May 13, 2019 the Company issued Series D Warrants to purchase an aggregate of 458,015 shares of common stock at an exercise price of $3.15 per share, which vested 6 months after issuance and expire 5.5 years from the issuance date;
|
•
|
On August 22, 2019 the Company issued Series F Warrants to purchase an aggregate of 727,802 shares of common stock at an exercise price of $1.936 per share, which vested 6 months after issuance and expire 5.5 years from the issuance date;
|
•
|
On October 30, 2019 the Company issued Series G Warrants to purchase an aggregate of 2,756,340 shares of common stock at an exercise price of $1.56 per share, which vested immediately and expire 5.5 years from the issuance date;
|
•
|
On October 30, 2019 the Company issued Series H Warrants to purchase an aggregate of 2,756,340 shares of common stock at an exercise price of $1.56 per share, which vested immediately and expire 1.5 years from the issuance date; and
|
•
|
On October 30, 2019 the Company issued Placement Agent Warrants to purchase an aggregate of 206,726 shares of common stock at an exercise price of $2.2675 per share, which vested immediately and expire 5.5 years from the issuance date.
|
|
Years ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
Cost of revenue
|
$
|
—
|
|
|
$
|
30,488
|
|
Research and development expenses
|
399,687
|
|
|
752,127
|
|
||
Selling, general and administrative expenses
|
485,256
|
|
|
1,392,012
|
|
||
Total stock-based compensation
|
$
|
884,943
|
|
|
$
|
2,174,627
|
|
|
Years ended December 31,
|
||
|
2019
|
|
2018
|
Risk-free interest rate
|
1.66% - 2.33%
|
|
2.42% - 2.93%
|
Dividend yield
|
0%
|
|
0%
|
Expected volatility (range)
|
95% - 99%
|
|
89% - 98%
|
Expected volatility (weighted-average)
|
96%
|
|
91%
|
Expected term (in years)
|
5.9 years
|
|
5.2 years
|
|
Number of Options
|
|
Weighted-Average Exercise Price Per Share
|
|
Intrinsic
Value
|
|
Weighted-Average
Remaining
Contractual Life
|
|||||
Balance outstanding, December 31, 2017
|
62,376
|
|
|
$
|
291.10
|
|
|
$
|
—
|
|
|
7.1 years
|
Granted
|
52,791
|
|
|
$
|
18.69
|
|
|
|
|
|
|
|
Forfeited
|
(31,590
|
)
|
|
$
|
219.03
|
|
|
|
|
|
|
|
Expired
|
(232
|
)
|
|
$
|
216.00
|
|
|
|
|
|
||
Balance outstanding, December 31, 2018
|
83,345
|
|
|
$
|
146.09
|
|
|
$
|
—
|
|
|
7.3 years
|
Granted
|
971,313
|
|
|
$
|
2.49
|
|
|
|
|
|
|
|
Forfeited
|
(36,148
|
)
|
|
$
|
26.55
|
|
|
|
|
|
|
|
Expired
|
(3,092
|
)
|
|
$
|
220.27
|
|
|
|
|
|
||
Balance outstanding, December 31, 2019
|
1,015,418
|
|
|
$
|
12.77
|
|
|
$
|
—
|
|
|
9.1 years
|
Vested and exercisable, December 31, 2019
|
71,518
|
|
|
$
|
147.46
|
|
|
$
|
—
|
|
|
4.8 years
|
|
Number of Shares
|
|
Weighted Average
Grant Date Fair Value
Per Share
|
|
Intrinsic
Value |
|||||
Non-vested RSU's outstanding, December 31, 2017
|
17,700
|
|
|
$
|
103.32
|
|
|
$
|
391,878
|
|
Granted
|
34,125
|
|
|
$
|
4.64
|
|
|
|
||
Vested
|
(18,609
|
)
|
|
$
|
59.06
|
|
|
|
||
Forfeited
|
(3,084
|
)
|
|
$
|
147.60
|
|
|
|
||
Non-vested RSU's outstanding, December 31, 2018
|
30,132
|
|
|
$
|
14.36
|
|
|
$
|
95,005
|
|
Granted
|
9,167
|
|
|
$
|
1.61
|
|
|
|
||
Vested
|
(22,057
|
)
|
|
$
|
8.68
|
|
|
|
||
Forfeited
|
(5,941
|
)
|
|
$
|
13.82
|
|
|
|
||
Non-vested RSU's outstanding, December 31, 2019
|
11,301
|
|
|
$
|
15.38
|
|
|
$
|
14,013
|
|
|
Year ended December 31,
|
||
|
2019
|
|
2018
|
Fair value of Trovagene common stock
|
$1.24 - $3.75
|
|
$3.15 - $25.14
|
Expected warrant term
|
3.1 - 4.1 years
|
|
0 - 5.1 years
|
Risk-free interest rate
|
1.56% - 2.49%
|
|
1.76% - 2.92%
|
Expected volatility
|
102% - 111%
|
|
47% - 131%
|
Dividend yield
|
—%
|
|
—%
|
Date
|
|
Description
|
|
Number of Warrants
|
|
Derivative
Instrument
Liability
|
|||
December 31, 2017
|
|
Balance of derivative financial instruments—warrants liability
|
|
77,942
|
|
|
$
|
649,387
|
|
|
|
Expiration of derivative financial instruments
|
|
(13,446
|
)
|
|
—
|
|
|
|
|
Change in fair value of derivative financial instruments—warrants during the year recognized as a gain in the statement of operations
|
|
—
|
|
|
(617,072
|
)
|
|
December 31, 2018
|
|
Balance of derivative financial instruments—warrants liability
|
|
64,496
|
|
|
32,315
|
|
|
|
|
Change in fair value of derivative financial instruments—warrants during the year recognized as a gain in the statement of operations
|
|
—
|
|
|
(28,188
|
)
|
|
December 31, 2019
|
|
Balance of derivative financial instruments—warrants liability
|
|
64,496
|
|
|
$
|
4,127
|
|
|
Fair Value Measurements at
December 31, 2019 |
||||||||||||||
|
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)
|
$
|
10,131,240
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
10,131,240
|
|
Total Assets
|
$
|
10,131,240
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
10,131,240
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Derivative financial instruments—warrants
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
4,127
|
|
|
$
|
4,127
|
|
Total Liabilities
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
4,127
|
|
|
$
|
4,127
|
|
|
Fair Value Measurements at
December 31, 2018 |
||||||||||||||
|
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)
|
$
|
11,392,093
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
11,392,093
|
|
Total Assets
|
$
|
11,392,093
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
11,392,093
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Derivative financial instruments—warrants
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
32,315
|
|
|
$
|
32,315
|
|
Total Liabilities
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
32,315
|
|
|
$
|
32,315
|
|
|
|
Years ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
Current:
|
|
|
|
||||
State
|
$
|
1
|
|
|
$
|
1
|
|
Total current provision
|
1
|
|
|
1
|
|
||
Deferred:
|
|
|
|
||||
Federal
|
(2,634
|
)
|
|
(1,307
|
)
|
||
State
|
(148
|
)
|
|
(2,428
|
)
|
||
Total deferred (benefit) expense
|
(2,782
|
)
|
|
(3,735
|
)
|
||
Valuation allowance
|
2,781
|
|
|
3,734
|
|
||
Total income tax provision
|
$
|
—
|
|
|
$
|
—
|
|
|
Years ended December 31,
|
||||||||||||
|
2019
|
|
2018
|
||||||||||
Tax computed at the federal statutory rate
|
$
|
(3,447
|
)
|
|
21
|
%
|
|
$
|
(3,457
|
)
|
|
21
|
%
|
State tax, net of federal tax benefit
|
(177
|
)
|
|
1
|
%
|
|
(184
|
)
|
|
1
|
%
|
||
Permanent Items
|
353
|
|
|
(2
|
)%
|
|
481
|
|
|
(3
|
)%
|
||
Stock options true-up
|
875
|
|
|
(5
|
)%
|
|
—
|
|
|
—
|
%
|
||
Tax credits
|
(384
|
)
|
|
2
|
%
|
|
(574
|
)
|
|
3
|
%
|
||
Valuation allowance increase (decrease)
|
2,780
|
|
|
(17
|
)%
|
|
3,734
|
|
|
(22
|
)%
|
||
Provision for income taxes
|
$
|
—
|
|
|
—
|
%
|
|
$
|
—
|
|
|
—
|
%
|
|
Years ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
Deferred tax assets:
|
|
|
|
|
|
||
Tax loss carryforwards
|
$
|
38,494
|
|
|
$
|
35,019
|
|
Research and development credits and other tax credits
|
3,710
|
|
|
3,595
|
|
||
Stock-based compensation
|
531
|
|
|
1,301
|
|
||
Other
|
1,252
|
|
|
1,126
|
|
||
Total deferred tax assets
|
43,987
|
|
|
41,041
|
|
||
Deferred tax liabilities:
|
|
|
|
||||
Operating lease right-of-use assets
|
(154
|
)
|
|
—
|
|
||
Other
|
(12
|
)
|
|
—
|
|
||
Total deferred tax liabilities
|
(166
|
)
|
|
—
|
|
||
Net deferred tax assets before valuation allowance
|
43,821
|
|
|
41,041
|
|
||
Valuation allowance
|
(43,821
|
)
|
|
(41,041
|
)
|
||
Net deferred tax asset
|
$
|
—
|
|
|
$
|
—
|
|
2/27/2020
|
/s/ Thomas H. Adams
|
|
|
|
Thomas H. Adams
|
|
Chief Executive Officer (Principal Executive Officer)
|
2/27/2020
|
/s/ Brigitte Lindsay
|
|
|
|
Brigitte Lindsay
|
|
VP, Finance (Principal Financial and Accounting Officer)
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
2/27/2020
|
/s/ Thomas H. Adams
|
|
|
|
Thomas H. Adams
|
|
Chief Executive Officer (Principal Executive Officer)
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
2/27/2020
|
/s/ Brigitte Lindsay
|
|
|
|
Brigitte Lindsay
|
|
VP, Finance (Principal Financial and Accounting Officer)
|