Cardiff Oncology, Inc. 10-Q

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Forward-Looking Statements This Quarterly Report on Form 10-Q includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding the future financial position, business strategy and plans and objectives of management for future operations, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions. In addition, our business and financial performance may be affected by the factors that are discussed under “Risk Factors” in the Annual Report on Form 10-K for the year ended December 31, 2020, filed on February 25, 2021. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time and it is not possible for us to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. We cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. The following discussion and analysis is qualified in its entirety by, and should be read in conjunction with, the more detailed information set forth in the financial statements and the notes thereto appearing elsewhere in this Quarterly Report on Form 10-Q. This discussion should not be construed to imply that the results discussed herein will necessarily continue into the future, or that any conclusion reached herein will necessarily be indicative of actual operating results in the future. Such discussion represents only the best present assessment of our management. Overview We are a clinical-stage oncology company, developing new precision medicine treatment options for cancer patients in indications with the greatest unmet medical need. Our goal is to target tumor vulnerabilities with treatment combinations that overcome disease resistance and improve disease response to standard treatment regimens and to increase overall survival. We are developing onvansertib, a first-in-class, third-generation Polo-like Kinase 1 ("PLK1") inhibitor, in combination with standard-of-care anti-cancer therapeutics. Our clinical development programs incorporate tumor genomics and biomarker technology to refine assessment of patient response to treatment. We licensed onvansertib from Nerviano Medical Sciences ("NMS") pursuant to a license agreement with NMS dated March 13, 2017. This exclusive, world-wide license agreement includes 3 issued patents for onvansertib which cover composition of matter, salt forms of onvansertib and combination of onvansertib with other drugs. Onvansertib is a novel polo-like kinase ("PLK1")-selective adenosine triphosphate (ATP) competitive inhibitor with oral bioavailability, and a relatively short drug half-life of 24 hours. Onvansertib is highly potent against the PLK1 enzyme (concentration for 50% inhibition [IC 50 ]=5 ± 3 nM), whereas low or no activity was observed on a panel of 63 kinases (IC50>500 nM), including the PLK members PLK2 and PLK3 (IC 50 >10 μM). PLK1, a serine/threonine kinase, is a master regulator of mitotic progression with various roles and localizations during the different mitotic phases. Upon PLK1 depletion in cancer cells by RNA interference (RNAi), inhibition of proliferation, and decreased viability, resulting from cell cycle arrest with 4N DNA content followed by apoptosis, are observed. PLK1 depletion also results in an increase in the number of cells containing abnormal spindle formation and misaligned chromosomes. Expression of PLK1 is seen in all proliferating normal tissues, and PLK1 is overexpressed in a number of tumors (including breast, prostate, ovary, lung, gastric, and colon cancers), as well as in hematologic cancers. 21 Table of Contents Although 5 different PLK family members are described in humans, the inhibition of the enzymatic activity or the depletion of PLK1 is sufficient to induce a G2/M cell cycle block and apoptosis in tumor cell lines and tumor regression in xenograft models. In addition, a tumor suppressor function has been described for PLK2 and PLK3 (but not PLK1), and they are reported to be expressed in non-proliferating, differentiated postmitotic cells, such as neurons, indicating a potentially better safety profile for a PLK1-selective compound. Onvansertib is a highly selective inhibitor of PLK1. The fumarate salt of the compound was formulated for oral administration and is in clinical development for the treatment of a wide range of tumor types. There are 3 ongoing clinical studies of onvansertib in combination treatment: for second line treatment in patients with KRAS-mutated metastatic colorectal cancer ("mCRC"), in patients with metastatic pancreatic ductal adenocarcinoma ("mPDAC"), and in patients with metastatic castration-resistant prostate cancer ("mCRPC"). Combination studies in vitro showed synergistic effects when onvansertib was administered with different cytotoxic agents including antimicrotubule agents, topoisomerase 1 inhibitors, antimetabolites, alkylating agents, proteasome inhibitors, kinase inhibitors, BCL-2 inhibitors, and androgen biosynthesis inhibitors. In addition, in vivo combination studies confirmed the positive results obtained in vitro and synergistic effects were observed in xenograft models for onvansertib in combination with abiraterone, 5-fluorouracil (5 FU), irinotecan (including NKTR-102), quizartinib, venetoclax, and paclitaxel, while additive effects in combination with cytarabine or bevacizumab were reported. We believe the high-selectivity of onvansertib to PLK1, its 24-hour half-life and oral bioavailability, as well as evidence of safety and clinical benefit, with expected on-target, easy to manage and reversible side effects, may prove beneficial in addressing clinical therapeutic needs across a variety of cancers. Ongoing Clinical Programs Update: • TROV-054 is a Phase 1b/2 open-label multi- center clinical trial of onvansertib in combination with FOLFIRI and bevacizumab ("Avastin ® ") for the second line treatment of patients with KRAS-mutated mCRC, which is being conducted at 7 clinical trial sites across the U.S. - USC Norris Comprehensive Cancer Center, The Mayo Clinic Cancer Centers (Arizona, Minnesota and Florida), Kansas University Medical Center ("KUMC"), Inova Schar Cancer Institute and CARTI Cancer Center; • TROV-053 is a Phase 2 open-label multi-center clinical trial of onvansertib in combination with abiraterone acetate (Zytiga ® ) and prednisone in patients with mCRPC, which is being conducted at Beth Israel Deaconess Medical Center ("BIDMC"), Dana-Farber Cancer Institute ("DFCI"), and Massachusetts General Hospital ("MGH"); • CRDF-001 is a Phase 2 open-label multi-center clinical trial of onvansertib in combination with nanoliposomal irinotecan (“Onivyde ® ”), leucovorin, and fluorouracil for second line treatment of patients with metastatic pancreatic ductal adenocarcinoma ("mPDAC"), which is being conducted at 6 clinical trial sites across the U.S. – The Mayo Clinic Cancer Centers (Arizona, Minnesota and Florida), Kansas University Medical Center (“KUMC”), University of Nebraska Medical Center (“UNMC”) and Inova Schar Cancer Institute. KRAS-mutated mCRC TROV-054 is a Phase 1b/2 study of onvansertib for the second-line treatment of patients with KRAS-mutated metastatic colorectal cancer ("mCRC") in combination with standard-of-care FOLFIRI and bevacizumab (Avastin ® ). The primary objective of this study is to evaluate the dose-limiting toxicities ("DLTs") and maximum tolerated dose ("MTD") or recommended Phase 2 dose ("RP2D") of onvansertib in combination with FOLFIRI and bevacizumab (Phase 1b) and to continue to assess the safety and preliminary efficacy of onvansertib in combination with FOLFIRI and bevacizumab (Phase 2). The rationale for this clinical trial is based on three key principles including synthetic lethality, synergy and proof-of-concept clinical benefit. Synthetic lethality arises when a combination of deficiencies in the expression of two genes leads to cell death, whereas a deficiency in only one of these genes does not. The deficiencies can arise through mutations, epigenetic alterations or inhibitors of the protein encoded by one of the genes. In reference to onvansertib, CRC tumor cells harboring KRAS mutations are more vulnerable to cell death with PLK1 inhibition versus KRAS wild-type isogenic cells. Synergy occurs when the combination of two drugs results in an unexpected greater activity than an expected additive effect of the two drugs. Onvansertib in combination with irinotecan and in combination with 5-FU (components of FOLFIRI) demonstrate synergy in 22 Table of Contents colorectal cancer cell lines and both combinations have demonstrated significantly greater tumor growth inhibition than either drug alone. Proof-of-concept clinical response has been demonstrated in a previously completed Phase 1 trial in solid tumors in which 3 of 5 patients showing stable disease had tumors with a KRAS mutation; 2 in colorectal cancer and 1 in pancreatic cancer. Data presented on April 12, 2021, at a key opinion leader webinar, provided an update of the ongoing phase 1b/2 clinical study in KRAS-mutated metastatic colorectal cancer. Of the 18 patients evaluable for efficacy, 7 (39%) achieved an objective response (partial response; PR); 4 patients have had a confirmed PR; with 1 patient going on to curative surgery; 1 patient with a non-confirmed PR went off study due to an unrelated adverse event prior to their 16-week confirmatory scan and 2 patients were awaiting their respective confirmatory scans. This objective response rate (ORR) compares favorably with current standard of care benchmarks that range from 5 to 13%. To-date, the time to achieving a PR ranges from 2 to 6 months in patients on treatment. Objective responses were observed across different KRAS variants, including the 3 most common in CRC. Median progression free survival (mPFS) is currently 9.4 months which compares favorably with the current standard of care benchmarks that range from 4.5 to 5.7 months. 16 of 18 patients had a KRAS variant detected by ddPCR at baseline (all had a KRAS mutation detected by NGS). The greatest decreases in KRAS mutant allelic frequency (MAF) after 1 cycle of treatment were observed in patients achieving a PR (ranging from a decrease ranging from 78% to 100%), while the 2 patients who experienced disease progression showed a more modest reduction in KRAS MAF (decrease of 55% and 26%, respectively). Patients with PR and stable disease (SD) tended to have lower on-treatment KRAS MAF than patients with early progressive disease (PD). Of all adverse events (AEs) reported for onvansertib in combination with FOLFIRI/bevacizumab, only 11% have been grade 3 or 4. Grade 4 adverse events were attributed to the 5-FU bolus component of the combination regimen, which was eliminated in subsequent cycles of treatment per protocol and institutional guidelines. The only G3/G4 AE reported in ≥2 patients was neutropenia (n=8), which was managed by dose delay, growth factor therapy and/or discontinuation of the 5-FU bolus; no patients went off trial due to neutropenia. To-date, no major or unexpected toxicities have been attributed to onvansertib. Key News Releases We Announced the upcoming presentation of new data from Lead Clinical Program in KRAS-mutated Colorectal Cancer on Wednesday, September 8, 2021. Updated data from the Phase 1b/2 trial evaluating onvansertib in combination with standard-of-care FOLFIRI/bevacizumab for the second-line treatment of patients with KRAS-mutated metastatic colorectal cancer (mCRC) will be announced at a webinar featuring the clinical trial principal investigator, Heinz-Josef Lenz, M.D., FACP (USC Norris Comprehensive Cancer Center), and key clinical advisor Afsaneh Barzi, M.D., Ph.D., (City of Hope Comprehensive Cancer Center). On April 12, 2021, we announced a KOL Event Webinar presentation of Phase 1b/2 data from our ongoing trial in KRAS-mutated mCRC demonstrating continued robust response to treatment and progression-free survival. On April 10, 2021, we announced an electronic oral poster presentation of findings from our Expanded Access Program ("EAP") demonstrating the clinical benefit of onvansertib in KRAS-mutated mCRC at the American Association for Cancer Research ("AACR") Annual Meeting 2021. mCRPC TROV-053 is a Phase 2 study of onvansertib in combination with Zytiga ® (abiraterone) and prednisone for the treatment of patients with metastatic castration resistant prostate cancer ("mCRPC"). The primary objective of this study is to observe the effects of onvansertib in combination with abiraterone and prednisone on disease control as assessed by prostate specific antigen ("PSA") decline or stabilization after 12 weeks of study treatment in patients with mCRPC showing early signs of resistance to abiraterone. The rationale for this trial is based on the mechanism of action ("MOA") of onvansertib and Zytiga ® and the synergy of these two drugs when used in combination in pre-clinical experiments. Onvansertib inhibits tumor cell division (mitosis) by inducing G2/M arrest of tumor cells and the combination of onvansertib and Zytiga ® significantly increases mitotic arrest and is synergistic when used in combination. Additionally, PLK1 inhibition appears to enhance the efficacy of androgen signaling blockade in castration-resistant prostate cancer. Data presented on February 11, 2021, at the American Society of Clinical Oncology Genitourinary Cancers Symposium (“ASCO-GU”) provided evidence of the safety and efficacy of onvansertib in combination with abiraterone. Arms 23 Table of Contents A (n=17) and B (n=12) showed similar response with 29% and 25% of patients achieving the primary endpoint and 53% and 42% of patients with SD at 12 weeks, respectively. The more continuous dosing schedule of Arm C (n=8) has shown a higher response rate with 63% of patients, to-date, achieving the primary endpoint and 75% with SD at 12 weeks. Evidence of efficacy was observed in patients harboring AR alterations across all 3 arms. ctDNA analysis revealed differences in baseline genomic profiles of patients achieving SD at 12 weeks vs. patients progressing before or at 12 weeks. Mutations exclusively present in patients with SD were associated with cell cycle and DNA repair pathways that may result in increased sensitivity to onvansertib and efficacy of the combination. Onvansertib + abiraterone has demonstrated safety across all 3 dosing schedules. Key News Releases On April 10, 2021, we announced, in collaboration with MIT, an electronic oral poster presentation featuring gene signature analyses data identifying androgen-independent mechanism for onvansertib-abiraterone synergy in mCRPC. PDAC CRDF-001 is a Phase 2 Study of onvansertib in combination with nanoliposomal irinotecan and 5-FU for the second line treatment of patients with metastatic pancreatic ductal adenocarcinoma ("PDAC"). The first patient was dosed in June 2021. The objective of this trial is to assess the safety and preliminary efficacy of onvansertib in combination with nanoliposomal irinotecan (Onyvide ® ), 5-FU and leucovorin as a second-line treatment in patients with metastatic PDAC who have failed first-line gemcitabine-based therapy. The trial is expected to enroll approximately 45 patients across six sites in the U.S. including the three Mayo Clinic Cancer Centers (Arizona, Minnesota and Florida), Kansas University Medical Center, University of Nebraska Medical Center and Inova Schar Cancer Institute. Key News Releases On June 8, 2021, we announced that the first patient had been dosed in a Phase 2 Trial of Onvansertib in Combination with Irinotecan and 5-FU in Pancreatic Cancer. Company Updates Financial On June 28, 2021, we announced that Cardiff Oncology has been added as a member of the small-cap Russell 2000 ® Index, the all-cap Russell 3000 ® Index, and the Russell Microcap ® Index, as part of the 2021 Russell indexes reconstitution. Company On July 12, 2021, we announced the appointments of Katherine L. Ruffner, M.D., as Chief Medical Officer and James E. Levine as Chief Financial Officer. We entered into an employment agreement with Mr. Levine on July 12, 2021 and with Dr. Ruffner on August 4, 2021. On June 10, 2021, our shareholders elected eight members to our Board of Directors. The shareholders elected Mani Mohindru, Ph.D., and Renee P Tannenbaum, Pharm D., as new independent directors. Our accumulated deficit through June 30, 2021 is $243.4 million. To date, we have generated minimal revenues and expect to incur additional losses to perform further research and development activities. Our drug development efforts are in their early stages, and we cannot make estimates of the costs or the time that our development efforts will take to complete, or the timing and amount of revenues related to the sale of our drugs. The risk of completion of any program is high because of the many uncertainties involved in developing new drug candidates to market, including the long duration of clinical testing, the specific performance of proposed products under stringent clinical trial protocols, extended regulatory approval and review cycles, our ability to raise additional capital, the nature and timing of research and development expenses, and competing technologies being developed by organizations with significantly greater resources. Off-Balance Sheet Arrangements We had no off-balance sheet arrangements as of June 30, 2021. 24 Table of Contents Critical Accounting Policies Our accounting policies are described in ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS of our Annual Report on Form 10-K as of and for the year ended December 31, 2020, filed with the SEC on February 25, 2021. There have been no changes to our critical accounting policies since December 31, 2020. RESULTS OF OPERATIONS Three Months Ended June 30, 2021 and 2020 Revenues Total revenues was $68k for the three months ended June 30, 2021 as compared to $43k for the prior period. Revenues are from our sales-based or usage-based royalties on other intellectual property licenses, unrelated to onvansertib. Revenue recognition of the royalty depends on the timing and overall sales activities of the licensees. Research and Development Expenses Research and development expenses consisted of the following: Three Months Ended June 30, (in thousands) 2021 2020 Increase (Decrease) Salaries and staff costs $ 292 $ 425 $ (133) Stock-based compensation 72 70 2 Clinical trials, outside services, and lab supplies 3,606 1,809 1,797 Facilities and other 149 172 (23) Total research and development $ 4,119 $ 2,476 $ 1,643 Research and development expenses increased by $1.6 million for the three months ended June 30, 2021 compared to the same period in 2020. The overall increase in research and development expenses was primarily due to costs associated with clinical programs and outside service costs for three ongoing clinical trials related to the development of our lead drug candidate, onvansertib. Salaries and staff costs decreased primarily due to departmental changes of certain executives in the current period. Selling, General and Administrative Expenses Selling, general and administrative expenses consisted of the following: Three Months Ended June 30, (in thousands) 2021 2020 Increase (Decrease) Salaries and staff costs $ 513 $ 552 $ (39) Stock-based compensation 964 212 752 Outside services and professional fees 914 485 429 Facilities and other 447 420 27 Total selling, general and administrative $ 2,838 $ 1,669 $ 1,169 Selling, general and administrative expenses increased by $1.2 million for the three months ended June 30, 2021 compared to the same period in 2020. The significant components of the increase were outside services and stock-based compensation. The increase in stock-based compensation is primarily due to the modification of stock option grants for former directors who were no longer on the board as of June 2021. The increase in outside services and professional fees is primarily due to increased legal fees mainly related to the expansion of our patent portfolio and recruiting fees. 25 Table of Contents Change in Fair Value of Derivative Financial Instruments — Warrants We have issued warrants that are accounted for as derivative liabilities. As of June 30, 2021, the derivative financial instruments — warrants liabilities were revalued to $17 thousand, resulting in a decrease in value of $61 thousand from March 31, 2021, based primarily upon the fluctuation in our stock price as well as the decrease in the remaining life of the warrants. The decrease in value upon remeasurement at June 30, 2021 was recorded as a gain from the change in fair value of derivative financial instruments — warrants in the condensed statement of operations. Net Loss Net loss and per share amounts were as follows: Three Months Ended June 30, (in thousands, except per share amounts) 2021 2020 Increase (Decrease) Net loss (6,757) (4,124) $ 2,633 Preferred stock dividend $ (6) $ (3,273) $ (3,267) Net loss attributable to common shareholders $ (6,763) $ (7,397) $ (634) Net loss per common share — basic and diluted $ (0.17) $ (0.51) $ (0.34) Weighted average shares outstanding — basic and diluted 38,761 14,492 24,269 The $0.6 million decrease in net loss attributable to common shareholders was primarily the result of an increase of operating expenses, offset by a decrease in preferred stock dividend for the three months ended June 30, 2021, compared to the same period in the prior year. The $0.34 decrease in net loss per share was impacted by the increase in basic weighted average shares outstanding resulting primarily from the issuance of approximately 18.2 million shares of common stock and common stock equivalents from July 1, 2020 through June 30, 2021. Six Months Ended June 30, 2021 and 2020 Revenues Total revenues was $140 thousand for the six months ended June 30, 2021 as compared to $110 thousand for the prior period. Revenues are from our sales-based or usage-based royalties on other intellectual property licenses, unrelated to onvansertib. Revenue recognition of the royalty depends on the timing and overall sales activities of the licensees. Research and Development Expenses Research and development expenses consisted of the following: Six Months Ended June 30, (in thousands) 2021 2020 Increase (Decrease) Salaries and staff costs $ 574 $ 849 $ (275) Stock-based compensation 112 147 (35) Clinical trials, outside services, and lab supplies 6,406 3,782 2,624 Facilities and other 306 403 (97) Total research and development $ 7,398 $ 5,181 $ 2,217 Research and development expenses increased by $2.2 million for the six months ended June 30, 2021 compared to the same period in 2020. The overall increase in research and development expenses was primarily due to costs associated with clinical programs and outside service costs for three ongoing clinical trials related to the development of our lead drug candidate, onvansertib. Salaries and staff costs decreased primarily due to departmental changes of certain executives in the current period. 26 Table of Contents Selling, General and Administrative Expenses Selling, general and administrative expenses consisted of the following: Six Months Ended June 30, (in thousands) 2021 2020 Increase (Decrease) Salaries and staff costs $ 1,081 $ 1,045 $ 36 Stock-based compensation 1,192 312 880 Outside services and professional fees 1,886 980 906 Facilities and other 914 818 96 Total selling, general and administrative $ 5,073 $ 3,155 $ 1,918 Selling, general and administrative expenses increased by $1.9 million for the six months ended June 30, 2021 compared to the same period in 2020. The significant components of the increase were outside services and stock-based compensation. The increase in stock-based compensation is primarily due to the modification of stock option grants for former directors who were no longer on the board as of June 2021. The increase in outside services and professional fees is primarily due to increased legal fees mainly related to the expansion of our patent portfolio and recruiting fees. Change in Fair Value of Derivative Financial Instruments — Warrants We have issued warrants that are accounted for as derivative liabilities. As of June 30, 2021, the derivative financial instruments — warrants liabilities were revalued to $17 thousand, resulting in a decrease in value of $268 thousand from December 31, 2020, based primarily upon the fluctuation in our stock price as well as the decrease in the remaining life of the warrants. The change in value upon remeasurement at June 30, 2021 was recorded as a gain from the change in fair value of derivative financial instruments — warrants in the condensed statement of operations. Net Loss Net loss and per share amounts were as follows: Six Months Ended June 30, (in thousands, except per share amounts) 2021 2020 Increase (Decrease) Net loss $ (11,936) $ (8,213) $ 3,723 Preferred stock dividend (12) (3,279) (3,267) Net loss attributable to common shareholders $ (11,948) $ (11,492) $ 456 Net loss per common share — basic and diluted $ (0.31) $ (0.94) $ (0.63) Weighted average shares outstanding — basic and diluted 37,967 12,201 25,766 The $0.5 million increase in net loss attributable to common shareholders was primarily the result of an increase in operating expenses, offset by a decrease in preferred stock dividend for the six months ended June 30, 2021 compared to the same period in the prior year. The $0.63 decrease in basic net loss per share was impacted by the increase in weighted average shares outstanding resulting primarily from the issuance of approximately 18.2 million shares of common stock from July 1, 2020 through June 30, 2021. LIQUIDITY AND CAPITAL RESOURCES The COVID-19 outbreak in the United States has caused business disruptions. The extent of the impact of COVID-19 on our operational and financial performance will depend on certain developments, including the duration and spread of the outbreak, and impact on our clinical trials, employees and vendors, all of which are uncertain and cannot be predicted. The economic effects of the outbreak could also have an adverse effect on our ability to raise additional capital. At this point, the extent to which COVID-19 may impact our future financial condition or results of operations is uncertain. Net cash used in operating activities for the six months ended June 30, 2021 was $10.2 million, compared to $7.7 million for the six months ended June 30, 2020. Our use of cash was primarily a result of the net loss of $11.9 million for the 27 Table of Contents six months ended June 30, 2021, adjusted for non-cash items related to release of clinical trial funding commitment of $0.9 million, stock-based compensation of $1.3 million, and depreciation of $0.2 million. The net change in our operating assets and liabilities was $1.1 million increasing cash used in operations. At our current and anticipated level of operating loss, we expect to continue to incur an operating cash outflow for the next several years. Net cash used in investing activities was $130.7 million primarily related to net purchases of marketable securities during the six months ended June 30, 2021, compared to no investing activities for the same period in 2020. Net cash provided in financing activities was $20.5 million during the six months ended June 30, 2021, compared to $25.2 million for the same period in 2020. Net cash provided in financing activities during the six months ended June 30, 2021 was from $1.3 million of proceeds from the exercise of warrants and $19.2 million from the sale of common stock. Net cash provided in financing activities during the six months ended June 30, 2020 was from $6.1 million of proceeds from the exercise of warrants and $18.8 million from the sale of common stock, preferred stock and warrants. As of June 30, 2021, and December 31, 2020, we had working capital of $138.3 million and $127.2 million, respectively. We have incurred net losses since our inception and have negative operating cash flows. As of June 30, 2021, we had $140.1 million in cash, cash equivalents and short-term investments and we believe we have sufficient cash to meet our funding requirements for at least the next 12 months following the date of this Quarterly Report on Form 10-Q. For the foreseeable future, we expect to continue to incur losses and require additional capital to further advance its clinical trial programs and support its other operations. We cannot be certain that additional funding will be available on acceptable terms, or at all. To the extent that we can raise additional funds by issuing equity securities, our stockholders may experience additional dilution. The economic effects of COVID-19 could also have an adverse effect on our ability to raise additional capital. CONTRACTUAL OBLIGATIONS For a discussion of our contractual obligations see (i) our Financial Statements and Notes to Financial Statements Note 10. Commitments and Contingencies , and (ii) Item 7 Management Discussion and Analysis of Financial Condition and Results of Operations — Contractual Obligations and Commitments , included in our Annual Report on Form 10-K as of December 31, 2020. There have been no material changes to our contractual obligations in our Form 10-K for the year ended December 31, 2020. ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK Not applicable.