Turning the Tide on Cancer March 2021 | --- | --- ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 ☐ 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 CARDIFF ONCOLOGY, INC. (Exact name of registrant as specified in its charter) Delaware 27-2004382 (State or other jurisdiction of ...

Onvansertib: A Promising Cancer Therapy - Onvansertib is a 3rd generation, 1st-in-class, oral PLK1 inhibitor with high selectivity and a 24-hour half-life, targeting a key mechanism of cell division required for tumor cell viability[2,8,11] - Clinical data supports the use of onvansertib in combination regimens across numerous aggressive cancers, including mCRC, mCRPC, and AML[2] - The company has a diversified pipeline across numerous cancers and an integrated biomarker strategy, including circulating tumor DNA and circulating tumor cells, to predict therapeutic response[2,5] mCRC (Metastatic Colorectal Cancer) Program - In a Phase 1b/2 trial in KRAS-mutated mCRC, preliminary clinical data showed a ten-fold improvement in Overall Response Rate (ORR) compared to Standard of Care (SOC)[2] - Current second-line standard-of-care treatment in KRAS-mutated mCRC has an overall response rate of 4% and progression-free survival (PFS) of 5.5 months[17] - In the Phase 1b/2 trial, 10 of 11 (91%) patients had clinical benefit, with 5 (45%) patients achieving a partial response (PR)[42] - Monitoring KRAS mutations in plasma ctDNA may enable rapid predictions of therapeutic response, with the greatest changes in KRAS observed in patients achieving a PR[47] mCRPC (Metastatic Castration-Resistant Prostate Cancer) Program - Resistance develops to treatment with standard of care ARSi's within 9-15 months, and ARSi's offer a median overall survival (mOS) benefit of only ~4 months[52] - Phase 2 data demonstrated that 5 (29%) in Arm A, 3 (33%) in Arm B and 2 (67%) in Arm C achieved disease control at 12 weeks[64] - In the Phase 2 trial, 5 (50%) patients had an ≥80% CTC decrease, and 4 (40%) patients converted from unfavorable to favorable CTC level[68] Corporate Information - As of October 31, 2020, the company had $131.8 million in cash and cash equivalents, with an average quarterly cash burn of $3.8 million for Q1-Q3 2020[88]

PART I FINANCIAL INFORMATION [Item 1. Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20%28unaudited%29) Unaudited financial statements for Q3 2020 show significant increases in cash and total assets, driven by financing, despite continued net losses from R&D [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) As of September 30, 2020, total assets more than doubled to $39.5 million, primarily due to a substantial increase in cash and cash equivalents Condensed Balance Sheet Highlights (Unaudited) | Account | September 30, 2020 | December 31, 2019 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $36,405,432 | $10,195,292 | | Total current assets | $38,188,657 | $11,353,729 | | **Total Assets** | **$39,450,449** | **$13,086,546** | | **Liabilities & Equity** | | | | Total current liabilities | $5,442,070 | $4,781,744 | | **Total Liabilities** | **$5,927,899** | **$5,775,202** | | **Total stockholders' equity** | **$33,522,550** | **$7,311,344** | [Condensed Statements of Operations](index=4&type=section&id=Condensed%20Statements%20of%20Operations) For Q3 2020, the company reported higher net losses despite increased royalty revenues, with net loss per share decreasing due to more shares outstanding Condensed Statements of Operations Summary (Unaudited) | Metric | Three Months Ended Sep 30, 2020 | Three Months Ended Sep 30, 2019 | Nine Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2019 | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $136,401 | $51,687 | $246,738 | $152,055 | | Total operating expenses | $4,499,023 | $4,259,163 | $12,835,682 | $12,541,253 | | Loss from operations | $(4,362,622) | $(4,207,476) | $(12,588,944) | $(12,389,198) | | Net loss attributable to common stockholders | $(4,502,591) | $(4,147,609) | $(15,994,289) | $(12,458,072) | | Net loss per common share | $(0.19) | $(0.69) | $(1.00) | $(2.40) | | Weighted-average shares outstanding | 23,341,218 | 6,024,679 | 15,941,665 | 5,180,221 | [Condensed Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Statements%20of%20Stockholders%27%20Equity) Stockholders' equity significantly increased from $7.3 million to $33.5 million, primarily driven by capital raised from stock and warrant issuances - The significant increase in stockholders' equity was a result of multiple financing activities, including the sale of common stock and warrants, issuance of preferred stock, and the exercise of warrants, which collectively raised substantial capital[13](index=13&type=chunk) [Condensed Statements of Cash Flows](index=11&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2020, operating activities used $11.2 million cash, offset by $37.6 million from financing, resulting in a $26.2 million net cash increase Cash Flow Summary (Nine Months Ended September 30) | Cash Flow Activity | 2020 | 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | $(11,191,025) | $(9,990,636) | | Net cash used in investing activities | $(153,784) | $(67,622) | | Net cash provided by financing activities | $37,554,949 | $7,637,331 | | **Net change in cash and cash equivalents** | **$26,210,140** | **$(2,420,927)** | | Cash and cash equivalents—End of period | $36,405,432 | $9,032,206 | [Notes to Condensed Financial Statements](index=13&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) Notes detail the company's liquidity, accounting policies, fair value measurements, derivative liabilities, equity transactions, and subsequent events including a major public offering - The company believes its cash of **$36.4 million** as of September 30, 2020, is **sufficient to fund requirements** for at least the **next 12 months**. This position was further strengthened by a subsequent public offering in October 2020 that raised gross proceeds of approximately **$100.9 million**[32](index=32&type=chunk)[33](index=33&type=chunk) - The company recognized non-cash deemed dividends totaling approximately **$3.3 million** related to the beneficial conversion features of its Series D and Series E Convertible Preferred Stock issuances, which increased the net loss attributable to common stockholders[67](index=67&type=chunk)[70](index=70&type=chunk) - Subsequent to the quarter's end, the company completed an underwritten public offering raising net proceeds of approximately **$94.0 million**, received an additional **$3.4 million** from warrant exercises, and repaid its **$305,000** PPP loan in full[86](index=86&type=chunk)[87](index=87&type=chunk)[88](index=88&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses clinical-stage biotech focus on onvansertib, positive trial updates, increased net loss from expenses, and strengthened liquidity via financing activities [Overview](index=25&type=section&id=Overview) Cardiff Oncology, a clinical-stage biotech, focuses on developing onvansertib, a PLK1 inhibitor, for various cancers, highlighting three ongoing clinical trials - The company's primary focus is the clinical development of onvansertib, a first-in-class, third-generation Polo-like Kinase 1 (PLK1) inhibitor, for use in combination with standard-of-care treatments[94](index=94&type=chunk) - In May 2020, the company changed its name from Trovagene, Inc. to Cardiff Oncology, Inc. and its ticker to 'CRDF'[117](index=117&type=chunk) [Clinical Program Updates](index=26&type=section&id=Clinical%20Program%20Updates) Encouraging updates on three clinical trials show high disease control rates in mCRC, mCRPC on track, and a 24% complete response rate in AML - **KRAS-mutated mCRC (TROV-054):** Of 11 evaluable patients, 10 (**91%**) achieved disease control, and 5 (**45%**) achieved a partial response, with durable responses ranging from 6 to over 12 months[105](index=105&type=chunk) - **mCRPC (TROV-053):** The trial is on track to meet its primary endpoint, with a **31% disease control rate** in evaluable patients from cohorts A and B[110](index=110&type=chunk) - **AML (TROV-052):** The Phase 1b portion was completed, and a **complete response rate of 24%** was observed across all dose levels[115](index=115&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) For the nine months ended September 30, 2020, revenues increased, R&D decreased, SG&A rose, and net loss attributable to common shareholders increased to $16.0 million Comparison of Operations (Nine Months Ended September 30) | Metric | 2020 | 2019 | Change | | :--- | :--- | :--- | :--- | | Total revenues | $246,738 | $152,055 | +$94,683 | | Research and development | $8,036,225 | $8,297,763 | -$261,538 | | Selling, general and administrative | $4,799,457 | $4,243,490 | +$555,967 | | Net loss attributable to common shareholders | $(15,994,289) | $(12,458,072) | +$3,536,217 | [Liquidity and Capital Resources](index=32&type=section&id=Liquidity%20and%20Capital%20Resources) The company ended Q3 2020 with $36.4 million cash, bolstered by $37.6 million from financing, with management asserting sufficient funds for 12 months - As of September 30, 2020, the company had working capital of **$32.7 million**, a **significant increase** from **$6.6 million** at year-end 2019[142](index=142&type=chunk) - In October 2020, a public offering was completed, generating gross proceeds of approximately **$100.9 million** and net proceeds of approximately **$94.0 million**, **substantially enhancing the company's capital resources**[145](index=145&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable to the company - The company has indicated that quantitative and qualitative disclosures about market risk are **not applicable**[147](index=147&type=chunk) [Item 4. Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were effective as of September 30, 2020, with no material changes in internal control over financial reporting - Management concluded that the company's disclosure controls and procedures were **effective as of September 30, 2020**, to provide reasonable assurance that required information is properly recorded and reported[148](index=148&type=chunk) PART II OTHER INFORMATION [Item 1. Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) The company reported no legal proceedings during the period - The company has **no legal proceedings to report**[153](index=153&type=chunk) [Item 1A. Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) The COVID-19 pandemic is identified as a material risk, potentially impacting clinical trials, regulatory reviews, and supply chain operations - The COVID-19 pandemic could cause significant disruptions to clinical trials, including delays in patient enrollment and retention[156](index=156&type=chunk) - Operations of the FDA and other regulatory authorities may be interrupted, potentially impacting review and approval timelines[156](index=156&type=chunk) - The company may face interruptions or delays in receiving supplies of its product candidate from contract manufacturing organizations[156](index=156&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=35&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities - The company **reports 'None' for this item**[162](index=162&type=chunk) [Item 6: Exhibits](index=36&type=section&id=Item%206%3A%20Exhibits) This section lists exhibits filed with Form 10-Q, including the Underwriting Agreement, officer certifications, and Inline XBRL data files

Table of Contents Title of each class: Trading Symbol(s) Name of each exchange on which registered: Common Stock CRDF Nasdaq Capital Market UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to COMMISSION FILE NUMBER 001-3555 ...

Turning the Tide on Cancer OS Cardiff Oncology May, 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 Cardiff Oncology's expectations, strategy, plans or intentions. These forward-looking statements are based on Cardi ...

PART I FINANCIAL INFORMATION [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) Presents unaudited condensed financial statements for Q1 2020, including Balance Sheets, Statements of Operations, Stockholders' Equity, and Cash Flows, with notes [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) Condensed Balance Sheet Summary (Unaudited) | Account | March 31, 2020 | December 31, 2019 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $9,277,025 | $10,195,292 | | Total current assets | $10,282,908 | $11,353,729 | | **Total Assets** | **$11,815,403** | **$13,086,546** | | **Liabilities & Equity** | | | | Total current liabilities | $4,881,300 | $4,781,744 | | **Total Liabilities** | **$5,671,985** | **$5,775,202** | | **Total stockholders' equity** | **$6,143,418** | **$7,311,344** | [Condensed Statements of Operations](index=4&type=section&id=Condensed%20Statements%20of%20Operations) Condensed Statement of Operations (Unaudited) | Metric | Three Months Ended March 31, 2020 | Three Months Ended March 31, 2019 | | :--- | :--- | :--- | | Total revenues | $67,704 | $62,021 | | Total operating expenses | $4,191,710 | $4,023,784 | | Loss from operations | ($4,124,006) | ($3,961,763) | | Net loss | ($4,088,562) | ($3,904,771) | | Net loss attributable to common stockholders | ($4,094,622) | ($4,179,100) | | Net loss per common share — basic and diluted | ($0.41) | ($1.02) | | Weighted-average shares outstanding | 9,910,306 | 4,086,561 | [Condensed Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Statements%20of%20Stockholders'%20Equity) - Total stockholders' equity decreased from **$7,311,344** to **$6,143,418** at March 31, 2020, primarily due to a **$4.1 million** net loss, partially offset by common stock sales and warrant exercises[18](index=18&type=chunk) [Condensed Statements of Cash Flows](index=7&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Condensed Statement of Cash Flows (Unaudited) | Cash Flow Activity | Three Months Ended March 31, 2020 | Three Months Ended March 31, 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | ($3,374,637) | ($3,360,046) | | Net cash used in investing activities | $0 | ($5,274) | | Net cash provided by financing activities | $2,456,370 | $3,242,266 | | **Net change in cash and cash equivalents** | **($918,267)** | **($123,054)** | | Cash and cash equivalents—End of period | $9,277,025 | $11,330,079 | [Notes to Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) - The company is a clinical-stage biotechnology firm focused on developing new cancer treatments, particularly for KRAS-mutated colorectal cancer, prostate cancer, and acute myeloid leukemia[28](index=28&type=chunk) - Management has substantial doubt about the company's ability to continue as a going concern, as existing cash resources are projected to fund operations only into the fourth quarter of 2020, necessitating additional capital[32](index=32&type=chunk) - The COVID-19 outbreak is identified as a significant risk that could adversely impact the company's financial condition, clinical trials, and ability to raise capital[77](index=77&type=chunk) - Subsequent to the quarter's end, the company raised approximately **$1.084 million** through a private placement and received a **$305,000** loan under the Paycheck Protection Program (PPP)[80](index=80&type=chunk)[83](index=83&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's oncology business, Q1 2020 operating results, liquidity, and highlights significant 'going concern' risks [Overview](index=18&type=section&id=Overview) - The company is a clinical-stage oncology therapeutics firm developing drugs targeting cell division, with lead candidate onvansertib, a PLK1 inhibitor[92](index=92&type=chunk)[93](index=93&type=chunk) - Three active clinical trials for onvansertib are underway, targeting KRAS-mutated metastatic colorectal cancer, metastatic castration-resistant prostate cancer, and acute myeloid leukemia[94](index=94&type=chunk) - Subsequent to the quarter, the company announced a name change to Cardiff Oncology, Inc. (ticker: CRDF), effective May 8, 2020, and appointed a new CEO[100](index=100&type=chunk) - Positive clinical data from the Phase 1b/2 trial in KRAS-mutated mCRC was presented at the AACR conference in April 2020, showing consistent tumor regression and durable response[101](index=101&type=chunk) [Results of Operations](index=21&type=section&id=RESULTS%20OF%20OPERATIONS) Comparison of Results for Three Months Ended March 31 | Item | 2020 | 2019 | Change | | :--- | :--- | :--- | :--- | | **Revenues (Royalties)** | **$67,704** | **$62,021** | **$5,683** | | **Research and Development Expenses** | **$2,705,691** | **$2,648,599** | **$57,092** | | **Selling, General and Administrative Expenses** | **$1,486,019** | **$1,375,185** | **$110,834** | | **Net Loss Attributable to Common Shareholders** | **($4,094,622)** | **($4,179,100)** | **($84,478)** | - The increase in R&D expenses was primarily due to costs associated with the three ongoing clinical trials for onvansertib[113](index=113&type=chunk) - The increase in SG&A expenses was mainly driven by higher insurance costs and outside professional services[114](index=114&type=chunk) [Liquidity and Capital Resources](index=22&type=section&id=LIQUIDITY%20AND%20CAPITAL%20RESOURCES) - As of March 31, 2020, the company had **$9.3 million** in cash and cash equivalents and working capital of **$5.4 million**[121](index=121&type=chunk)[125](index=125&type=chunk) - Net cash used in operating activities was **$3.4 million** for the three months ended March 31, 2020[121](index=121&type=chunk) - Management states that existing resources are only sufficient to fund planned operations into the fourth quarter of 2020, raising substantial doubt about the company's ability to continue as a going concern[126](index=126&type=chunk) - The company is evaluating options to strengthen its liquidity, including raising capital through equity offerings, new business initiatives, cost reductions, and strategic partnerships[127](index=127&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=23&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is deemed not applicable to the company's current operations - The company states that this item is not applicable[131](index=131&type=chunk) [Item 4. Controls and Procedures](index=24&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were effective as of March 31, 2020, with no material changes in internal control over financial reporting - Management, including the principal executive and financial officers, concluded that the company's disclosure controls and procedures were effective as of March 31, 2020[133](index=133&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, these controls[135](index=135&type=chunk) PART II OTHER INFORMATION [Item 1. Legal Proceedings](index=25&type=section&id=Item%201.%20Legal%20Proceedings) The company reported no legal proceedings during the period - The company reports that there are no legal proceedings[138](index=138&type=chunk) [Item 1A. Risk Factors](index=25&type=section&id=Item%201A.%20Risk%20Factors) Introduces a new material risk factor: the COVID-19 pandemic's potential adverse impact on business, operations, and capital access - A new risk factor has been added concerning the potential material and adverse effects of a pandemic, such as COVID-19, on the company's business and operations[139](index=139&type=chunk) - The COVID-19 pandemic may disrupt the supply of product candidates, delay clinical trials, affect regulatory reviews, and reduce the company's ability to access capital[140](index=140&type=chunk) [Other Items (Items 2, 3, 4, 5)](index=25&type=section&id=Other%20Items) Reports no unregistered equity sales, senior security defaults, or other material information; mine safety disclosures are not applicable - Item 2: No unregistered sales of equity securities and use of proceeds are reported[141](index=141&type=chunk) - Item 3: No defaults upon senior securities are reported[142](index=142&type=chunk) - Item 4: Mine safety disclosures are not applicable[143](index=143&type=chunk) - Item 5: No other information is reported[144](index=144&type=chunk) [Item 6: Exhibits](index=26&type=section&id=Item%206%3A%20Exhibits) Lists all exhibits filed with Form 10-Q, including securities purchase agreements, warrants, officer certifications, and XBRL data files - The report includes several exhibits, such as securities purchase agreements from March and April 2020, forms of warrants, and certifications by the Principal Executive Officer and Principal Financial Officer[146](index=146&type=chunk)

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 ...