Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) x QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2020 o TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to COMMISSION FILE NUMBER 001-35558 TROVAGENE, INC. (Exact Name of registrant as specified in its charter) 11055 Flintkote Avenue, San Diego, California 92 ...

Part I [Business Overview](index=4&type=section&id=Item%201%20Business) Trovagene, Inc. is a clinical-stage oncology therapeutics company developing onvansertib, a first-in-class, oral, and highly-selective PLK1 inhibitor, currently in three clinical trials - The company is a clinical-stage oncology therapeutics company focused on developing its drug candidate, onvansertib, a first-in-class, third-generation, oral and highly-selective Polo-like Kinase 1 (PLK1) inhibitor[11](index=11&type=chunk)[12](index=12&type=chunk) - Onvansertib was licensed from Nerviano Medical Sciences S.r.l. in March 2017[13](index=13&type=chunk) - The company utilizes its Precision Cancer Medicine™ (PCM™) technology and biomarker strategy to identify patients most likely to respond to onvansertib and to monitor therapeutic response[35](index=35&type=chunk)[36](index=36&type=chunk) [Clinical Development Programs](index=4&type=section&id=Clinical%20Development%20Programs) The company has three active Investigational New Drug (IND) applications with the FDA and is conducting three ongoing clinical trials for onvansertib Ongoing Onvansertib Clinical Trials | Trial Name | Phase | Indication | Combination Therapy | Status | | :--- | :--- | :--- | :--- | :--- | | TROV-052 | Phase 1b/2 | Relapsed/Refractory Acute Myeloid Leukemia (AML) | Low-dose cytarabine (LDAC) or decitabine | Ongoing; Phase 1b completed in 2019, Phase 2 initiated | | TROV-053 | Phase 2 | Metastatic Castration-Resistant Prostate Cancer (mCRPC) | Zytiga® (abiraterone acetate)/prednisone | Ongoing | | TROV-054 | Phase 1b/2 | KRAS-mutated metastatic Colorectal Cancer (mCRC) | FOLFIRI and Avastin® (bevacizumab) | Ongoing | - The FDA granted Orphan Drug Designation to onvansertib for the treatment of AML in October 2017, and the European Medicinal Agency granted the same in August 2018[31](index=31&type=chunk) [Intellectual Property](index=8&type=section&id=Intellectual%20Property) As of December 31, 2019, Trovagene's intellectual property portfolio included 62 issued patents and 13 pending applications, notably exclusive licenses for onvansertib and combination therapies - As of December 31, 2019, the company's wholly-owned and licensed intellectual property included **62 issued patents** and **13 pending patent applications** in the U.S. and abroad[52](index=52&type=chunk) - The license agreement with Nerviano for onvansertib covers composition of matter, related compounds, pharmaceutical compositions, and synergistic combinations, with patents expiring between **2026 and 2029**[54](index=54&type=chunk) - The company holds an exclusive patent license agreement with MIT for combination therapies involving anti-androgens and Polo-like kinase inhibitors in prostate cancer, expanding potential indications for onvansertib[58](index=58&type=chunk) [Competition](index=15&type=section&id=Competition) Onvansertib is positioned as the only oral PLK1 inhibitor in active clinical development, differentiated by its high selectivity and oral administration compared to failed competitors like volasertib - Onvansertib is positioned as the only oral PLK1 inhibitor currently in active clinical development, differentiated by its high selectivity, which may lead to a better safety profile compared to previous pan-PLK inhibitors[110](index=110&type=chunk) - The most prominent competitor, volasertib (Boehringer Ingelheim), failed its Phase 3 trial in AML due to not meeting its primary endpoint and an unfavorable safety profile, possibly due to its lack of selectivity and long half-life[112](index=112&type=chunk)[113](index=113&type=chunk) - Other PLK inhibitors like GSK461364 (GSK) and rogosertib (Oncova) have also faced development setbacks or failures in clinical trials[114](index=114&type=chunk)[115](index=115&type=chunk) [Risk Factors](index=16&type=section&id=Item%201A%20Risk%20Factors) The company faces substantial risks including significant financial losses, an accumulated deficit of $208.9 million, going concern doubt, and high dependence on its single product candidate, onvansertib - The company is a development-stage company with a history of losses, an accumulated deficit of approximately **$208.9 million** as of December 31, 2019, and has never earned a profit[119](index=119&type=chunk) - The company's financial statements include an explanatory paragraph expressing substantial doubt about its ability to continue as a going concern, contingent on raising additional capital[124](index=124&type=chunk)[125](index=125&type=chunk) - The business is almost entirely dependent on the success of its single product candidate, onvansertib, which is in the early stages of development and faces numerous risks inherent in pharmaceutical development[126](index=126&type=chunk) - The company relies on a third-party manufacturer in Italy for the API of onvansertib, exposing it to risks of production disruption, including those from natural disasters or epidemics like the coronavirus outbreak[226](index=226&type=chunk) - The company's ability to use its net operating loss (NOL) carryforwards of approximately **$159.3 million** is limited by Sections 382 and 383 of the Internal Revenue Code due to past ownership changes[263](index=263&type=chunk)[264](index=264&type=chunk)[616](index=616&type=chunk) [Properties](index=38&type=section&id=Item%202%20Properties) The company leases its San Diego headquarters, with the current agreement expiring in December 2021, and subleases portions of the facility - The company leases its headquarters in San Diego, CA, under a lease agreement that expires in **December 2021**[289](index=289&type=chunk) [Legal Proceedings](index=38&type=section&id=Item%203%20Legal%20Proceedings) As of the report date, management believes there are no legal claims against the company that would result in a material adverse effect on its business or financial condition - The company is not currently involved in any legal proceedings that are expected to have a material adverse effect on its business[290](index=290&type=chunk) Part II [Market for Common Equity and Related Matters](index=39&type=section&id=Item%205%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on Nasdaq under "TROV", has approximately 57 stockholders, and has never paid dividends, with equity compensation plan details provided - The company's common stock has traded on The Nasdaq Capital Market under the symbol "**TROV**" since **May 30, 2012**[294](index=294&type=chunk) - The company has never paid dividends and does not anticipate paying them in the foreseeable future[296](index=296&type=chunk) Equity Compensation Plan Information as of December 31, 2019 | Plan Category | Number of Shares to be Issued Upon Exercise (a) | Weighted-Average Exercise Price (b) ($) | Number of Shares Remaining for Future Issuance (c) | | :--- | :--- | :--- | :--- | | Equity Compensation Plans Approved by Stockholders | 1,014,665 | $12.60 | 167,888 | | Equity Compensation Plans Not Approved by Stockholders | 753 | $240.96 | — | | **Total** | **1,015,418** | | **167,888** | [Management's Discussion and Analysis (MD&A)](index=39&type=section&id=Item%207%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition, reporting a net loss of $16.7 million in 2019, increased R&D expenses, and expressing substantial doubt about its going concern ability [Results of Operations (2019 vs. 2018)](index=44&type=section&id=Results%20of%20Operations) Total revenues decreased to $0.24 million in 2019, while R&D expenses increased to $11.2 million, and SG&A expenses decreased to $5.8 million, resulting in a net loss of $16.7 million Revenue Comparison (2019 vs. 2018) | Revenue Type | 2019 ($) | 2018 ($) | Change ($) | | :--- | :--- | :--- | :--- | | Royalty income | $243,137 | $250,453 | $(7,316) | | Service revenue | $1,495 | $127,872 | $(126,377) | | **Total revenues** | **$244,632** | **$378,325** | **$(133,693)** | Research & Development Expenses (2019 vs. 2018) | Expense Category | 2019 ($) | 2018 ($) | Change ($) | | :--- | :--- | :--- | :--- | | 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 R&D expenses** | **$11,162,236** | **$8,164,011** | **$2,998,225** | Selling, General & Administrative Expenses (2019 vs. 2018) | Expense Category | 2019 ($) | 2018 ($) | Change ($) | | :--- | :--- | :--- | :--- | | 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 SG&A** | **$5,760,890** | **$8,005,583** | **$(2,244,693)** | Net Loss Comparison (2019 vs. 2018) | Metric | 2019 ($) | 2018 ($) | | :--- | :--- | :--- | | 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 | 5,973,906 | 2,330,180 | [Liquidity and Capital Resources](index=47&type=section&id=Liquidity%20and%20Capital%20Resources) As of December 31, 2019, cash and cash equivalents were $10.2 million, with $13.3 million used in operations, and management expressed substantial doubt about the company's going concern ability - As of December 31, 2019, cash and cash equivalents were **$10,195,292**, and working capital was **$6,571,985**[361](index=361&type=chunk) - Management expects existing resources will be sufficient to fund planned operations only into the third quarter of 2020, which raises substantial doubt about the company's ability to continue as a going concern[364](index=364&type=chunk) - In 2019, the company raised approximately **$12.1 million** through various financing activities, including securities purchase agreements with Lincoln Park Capital and a private placement with institutional investors[363](index=363&type=chunk)[371](index=371&type=chunk)[372](index=372&type=chunk)[373](index=373&type=chunk)[374](index=374&type=chunk) - In March 2019, the company regained compliance with Nasdaq's minimum bid price requirement after effecting a **1-for-6 reverse stock split**[286](index=286&type=chunk)[378](index=378&type=chunk) [Financial Statements and Supplementary Data](index=50&type=section&id=Item%208%20Financial%20Statements%20and%20Supplementary%20Data) Audited financial statements for 2019 and 2018 are presented, with the auditor's report highlighting substantial doubt about the company's ability to continue as a going concern - The Report of Independent Registered Public Accounting Firm expresses an opinion on the financial statements and includes a 'Going Concern Uncertainty' paragraph, noting the company has suffered recurring losses from operations that raise substantial doubt about its ability to continue as a going concern[490](index=490&type=chunk) Balance Sheet Highlights (as of Dec 31) | Account | 2019 ($) | 2018 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $10,195,292 | $11,453,133 | | Total current assets | $11,353,729 | $12,765,265 | | **Total Assets** | **$13,086,546** | **$14,172,496** | | **Liabilities & Equity** | | | | Total current liabilities | $4,781,744 | $2,923,318 | | Total liabilities | $5,775,202 | $4,088,304 | | Total stockholders' equity | $7,311,344 | $10,084,192 | | **Total Liabilities & Equity** | **$13,086,546** | **$14,172,496** | Statement of Operations Highlights (Year Ended Dec 31) | Account | 2019 ($) | 2018 ($) | | :--- | :--- | :--- | | Total revenues | $244,632 | $378,325 | | Research and development | $11,162,236 | $8,164,011 | | Selling, general and administrative | $5,760,890 | $8,005,583 | | Total operating expenses | $16,923,126 | $17,431,737 | | Loss from operations | $(16,678,494) | $(17,053,412) | | **Net loss** | **$(16,414,159)** | **$(16,461,178)** | | **Net loss attributable to common stockholders** | **$(16,706,668)** | **$(19,254,951)** | Statement of Cash Flows Highlights (Year Ended Dec 31) | Cash Flow Activity | 2019 ($) | 2018 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | $(13,267,500) | $(13,199,013) | | Net cash (used)/provided by investing activities | $(67,622) | $22,842 | | 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** | [Controls and Procedures](index=50&type=section&id=Item%209A%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures and internal control over financial reporting were effective as of December 31, 2019 - The principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective as of December 31, 2019[388](index=388&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of December 31, 2019, based on the COSO framework (2013)[390](index=390&type=chunk) Part III [Directors, Executive Officers, and Corporate Governance](index=51&type=section&id=Item%2010%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) This section provides information on the company's executive officers and board of directors, detailing the board's leadership, risk oversight, committee composition, and adopted Code of Business Conduct and Ethics Executive Officers and Directors (as of Feb 20, 2020) | 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 | - The Board has three standing committees: Audit, Compensation, and Corporate Governance/Nominating, all composed of independent directors[406](index=406&type=chunk) - The Audit Committee is chaired by John P. Brancaccio, who is the designated audit committee financial expert[411](index=411&type=chunk) [Executive Compensation](index=55&type=section&id=Item%2011%20Executive%20Compensation) This section details 2019 compensation for named executive officers, including CEO Thomas H. Adams ($1.3 million) and CSO Mark Erlander ($0.85 million), and outlines non-employee director compensation policy 2019 Summary Compensation Table | Name and Principal Position | Year | Salary ($) | Non-Equity Incentive Plan Compensation ($) | Option Awards ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | :--- | | Thomas H. Adams, CEO | 2019 | 491,132 | 244,625 | 568,877 | 1,304,634 | | Mark Erlander, CSO | 2019 | 398,729 | 198,600 | 255,622 | 852,951 | - Non-employee directors receive an annual retainer of **$50,000**, an annual equity grant of options equal to **0.1%** of outstanding shares, and additional fees for committee chair and membership roles[433](index=433&type=chunk) - Dr. Mark Erlander's employment agreement provides for a severance payment equal to **12 months** of base compensation and bonus if terminated without cause or by him for good reason[441](index=441&type=chunk) [Security Ownership](index=58&type=section&id=Item%2012%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) As of February 20, 2020, all executive officers and directors as a group beneficially owned less than 1% of the company's outstanding common stock, with no individual owning more than 5% - As of February 20, 2020, all officers and directors as a group (**6 persons**) beneficially owned **62,397 shares**, representing **less than 1%** of the company's common stock[447](index=447&type=chunk)[452](index=452&type=chunk) [Related Transactions and Director Independence](index=59&type=section&id=Item%2013%20Certain%20Relationship%20and%20Related%20Transactions%2C%20and%20Director%20Independence) The company engaged in a significant related party transaction with Leucadia Life Sciences, incurring $1.0 million in R&D expenses, while the Board determined a majority of its members are independent - The company entered into a Material Transfer Agreement with Leucadia Life Sciences, where CEO Dr. Thomas Adams is a principal stockholder, incurring approximately **$1,005,000** in R&D expenses in 2019 for services from Leucadia and the CEO's son[456](index=456&type=chunk) - The Board has determined that directors Gary S. Jacob, Rodney S. Markin, and John Brancaccio are independent[461](index=461&type=chunk) [Principal Accountant Fees and Services](index=60&type=section&id=Item%2014%20Principal%20Accountant%20Fees%20and%20Services) The company paid BDO $357,432 in fees for 2019, primarily for audit and tax services, all pre-approved by the Audit Committee Accountant Fees (2019 vs. 2018) | Fee Type | 2019 ($) | 2018 ($) | | :--- | :--- | :--- | | Audit fees | $339,507 | $226,646 | | Tax fees | $17,925 | $14,263 | | **Total** | **$357,432** | **$240,909** | Part IV [Exhibits and Financial Statement Schedules](index=61&type=section&id=Item%2015%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists all financial statements and exhibits filed with the Form 10-K, including corporate governance documents, material contracts, and required certifications - Lists all exhibits filed with the report, including corporate governance documents, material contracts, and certifications required by the Sarbanes-Oxley Act[468](index=468&type=chunk)

| --- | --- | |--------------------------------------------------------|-------| | | | | | | | | | | Trovagene Oncology Investor Presentation January 2020 | | | | | Forward-Looking Statements Certain statements in this presentation are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as "anticipate," "believe," "forecast," "estimated" and "intend," or other similar terms or expressions that concern Trovage ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) x QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2019 o TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to COMMISSION FILE NUMBER 001-35558 TROVAGENE, INC. (Exact Name of registrant as specified in its charter) 11055 Flintkote Avenue, San Diego, Californi ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) x QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2019 o TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to COMMISSION FILE NUMBER 001-35558 TROVAGENE, INC. (Exact Name of registrant as specified in its charter) 11055 Flintkote Avenue, San Diego, California 921 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) x QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2019 o TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to COMMISSION FILE NUMBER 001-35558 TROVAGENE, INC. (Exact Name of registrant as specified in its charter) Delaware 27-2004382 (State or other jurisdiction ...

| --- | --- | |-------|-------| | | | | | | Forward-Looking Statements Certain statements in this presentation are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Trovagene's expectations, strategy, plans or intentions. These forward-looking statements are based on Trovagene's current expect ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K (Mark One) x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2018 o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from to Commission File Number: 001-35558 TROVAGENE, INC. (Exact name of registrant as specified in its charter) Delaware 27-2004382 (State or other jurisdiction of incorp ...