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, an oral highly-selective 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 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 [IC50]=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 (IC50>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 colorectal, pancreatic, prostate, ovary, breast and lung cancer), as well as in hematologic cancers.
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: second line treatment in patients with KRAS-mutated metastatic colorectal cancer ("mCRC"), second line treatment in patients with metastatic pancreatic ductal adenocarcinoma ("mPDAC"), and in patients with metastatic castration-resistant prostate cancer ("mCRPC") showing resistance to abiraterone.
In vitro studies have shown synergistic effects when onvansertib was administered in combination 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 have confirmed the positive results obtained in vitro and synergistic effects have been observed in xenograft models of 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 have been demonstrated.
We believe the high-selectivity of onvansertib to PLK1, its 24-hour half-life, oral bioavailability, and flexible dosing schedule, as well as evidence of favorable 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, Inova Schar Cancer Institute and CARTI Cancer Center;
•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 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, University of Nebraska Medical Center and Inova Schar Cancer Institute;
•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 3 clinical trial sites - Beth Israel Deaconess Medical Center, Dana-Farber Cancer Institute, and Massachusetts General Hospital.
KRAS-mutated mCRC
TROV-054 is a Phase 1b/2 clinical trial 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 trial 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 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 September 8, 2021, at a key opinion leader webinar, provided an update of the ongoing phase 1b/2 clinical trial in KRAS-mutated metastatic colorectal cancer.
•8 of 19 (42%) patients treated per protocol at the recommended Phase 2 dose ("RP2D") of onvansertib 15 mg/m2 who were evaluable for disease response as of the data cut-off achieved a partial response ("PR"). Historically, objective response rates ("ORR") of 5-13% have been reported in a similar patient population treated with standard of care chemotherapy;
•12 of 32 (38%) patients evaluable for response as of data cutoff date across all dose levels achieved a PR;
•Median progression-free survival ("mPFS") across all response-evaluable patients is 9.4 months and has not yet been reached in those treated per protocol at the RP2D. Historically, mPFS of ~4.5-5.7 months has been reported in a similar patient population treated with standard of care chemotherapy;
•The combination regimen of onvansertib plus FOLFIRI/bevacizumab is well tolerated.
mPDAC
CRDF-001 is a Phase 2 clinical trial of onvansertib in combination with nanoliposomal irinotecan and 5-FU for the second line treatment of patients with metastatic pancreatic ductal adenocarcinoma ("mPDAC"). 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 mPDAC 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.
mCRPC
TROV-053 is a Phase 2 clinical trial 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 trial 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 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 as of July 2, 2021, as follow-up to the 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 A (n=17) and B (n=20) and C (13) showed 29%, 40% and 54% of patients, respectively, achieving the primary endpoint of disease control at 12 weeks. The more continuous dosing schedule of Arm C has shown an increase in the rate of patients achieving disease stabilization, to-date. 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 plus abiraterone has demonstrated safety across all 3 dosing schedules.
Company Updates
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.
Our accumulated deficit through September 30, 2021 is $250.4 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 September 30, 2021.
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 September 30, 2021 and 2020
Revenues
Total revenues were $86,000 for the three months ended September 30, 2021 as compared to $136,000 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 September 30,
|
(in thousands)
|
2021
|
|
2020
|
|
Increase (Decrease)
|
Salaries and staff costs
|
$
|
521
|
|
|
$
|
412
|
|
|
$
|
109
|
|
Stock-based compensation
|
174
|
|
|
104
|
|
|
70
|
|
Clinical trials, outside services, and lab supplies
|
3,104
|
|
|
2,151
|
|
|
953
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Facilities and other
|
355
|
|
|
188
|
|
|
167
|
|
Total research and development
|
$
|
4,154
|
|
|
$
|
2,855
|
|
|
$
|
1,299
|
|
Research and development expenses increased by $1.3 million for the three months ended September 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. Facilities costs increased due to amending our operating lease. Salaries and staff costs increased primarily due to increased headcount in the current period.
Selling, General and Administrative Expenses
Selling, general and administrative expenses consisted of the following:
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
(in thousands)
|
2021
|
|
2020
|
|
Increase (Decrease)
|
Salaries and staff costs
|
$
|
671
|
|
|
$
|
520
|
|
|
$
|
151
|
|
|
|
|
|
|
|
Stock-based compensation
|
766
|
|
|
258
|
|
|
508
|
|
Outside services and professional fees
|
914
|
|
|
488
|
|
|
426
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Facilities and other
|
579
|
|
|
378
|
|
|
201
|
|
Total selling, general and administrative
|
$
|
2,930
|
|
|
$
|
1,644
|
|
|
$
|
1,286
|
|
Selling, general and administrative expenses increased by $1.3 million for the three months ended September 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 new stock option grants issued to employees and directors. The increase in outside services and professional fees is primarily due to increased investor relations fees, recruiting fees, and legal fees related to the expansion of our patent portfolio.
Change in Fair Value of Derivative Financial Instruments — Warrants
We have issued warrants that are accounted for as derivative liabilities. As of September 30, 2021, the derivative financial instruments—warrants liabilities were revalued to $5,000, resulting in an increase in value of $12,000 from June 30, 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 September 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:
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
(in thousands, except per share amounts)
|
2021
|
|
2020
|
|
Increase (Decrease)
|
Net loss
|
$
|
(6,913)
|
|
|
$
|
(4,497)
|
|
|
$
|
2,416
|
|
Preferred stock dividend
|
(6)
|
|
|
(6)
|
|
|
—
|
|
Net loss attributable to common shareholders
|
$
|
(6,919)
|
|
|
$
|
(4,503)
|
|
|
$
|
2,416
|
|
|
|
|
|
|
|
Net loss per common share — basic and diluted
|
$
|
(0.17)
|
|
|
$
|
(0.19)
|
|
|
$
|
(0.02)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding — basic and diluted
|
39,552
|
|
|
23,341
|
|
|
16,211
|
|
|
|
|
|
|
|
The $2.4 million increase in net loss attributable to common shareholders was primarily the result of an increase of operating expenses for the three months ended September 30, 2021, compared to the same period in the prior year. The $0.02 decrease in net loss per share was impacted by the increase in basic weighted average shares outstanding resulting primarily from the issuance of approximately 13.3 million shares of common stock and common stock equivalents from October 1, 2020 through September 30, 2021.
Nine Months Ended September 30, 2021 and 2020
Revenues
Total revenues were $226,000 for the nine months ended September 30, 2021 as compared to $247,000 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:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30,
|
(in thousands)
|
2021
|
|
2020
|
|
Increase (Decrease)
|
Salaries and staff costs
|
$
|
1,095
|
|
|
$
|
1,261
|
|
|
$
|
(166)
|
|
Stock-based compensation
|
286
|
|
|
251
|
|
|
35
|
|
Clinical trials, outside services, and lab supplies
|
9,510
|
|
|
5,933
|
|
|
3,577
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Facilities and other
|
661
|
|
|
591
|
|
|
70
|
|
Total research and development
|
$
|
11,552
|
|
|
$
|
8,036
|
|
|
$
|
3,516
|
|
Research and development expenses increased by $3.5 million for the nine months ended September 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:
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30,
|
(in thousands)
|
2021
|
|
2020
|
|
Increase (Decrease)
|
Salaries and staff costs
|
$
|
1,752
|
|
|
$
|
1,565
|
|
|
$
|
187
|
|
|
|
|
|
|
|
Stock-based compensation
|
1,958
|
|
|
570
|
|
|
1,388
|
|
Outside services and professional fees
|
2,799
|
|
|
1,468
|
|
|
1,331
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Facilities and other
|
1,494
|
|
|
1,197
|
|
|
297
|
|
Total selling, general and administrative
|
$
|
8,003
|
|
|
$
|
4,800
|
|
|
$
|
3,203
|
|
Selling, general and administrative expenses increased by $3.2 million for the nine months ended September 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 additional stock option grants to employees and directors during the period and the modification of stock option grants for departing directors in June 2021. The increase in outside services and professional fees is primarily due to increased legal fees related to the expansion of our patent portfolio. Outside services also increased from recruiting fees and board of directors fees.
Change in Fair Value of Derivative Financial Instruments — Warrants
We have issued warrants that are accounted for as derivative liabilities. As of September 30, 2021, the derivative financial instruments—warrants liabilities were revalued to $5,000, resulting in a decrease in value of $280,000 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 September 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:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30,
|
(in thousands, except per share amounts)
|
2021
|
|
2020
|
|
Increase (Decrease)
|
Net loss
|
$
|
(18,849)
|
|
|
$
|
(12,710)
|
|
|
$
|
6,139
|
|
Preferred stock dividend
|
(18)
|
|
|
(3,285)
|
|
|
(3,267)
|
|
Net loss attributable to common shareholders
|
$
|
(18,867)
|
|
|
$
|
(15,995)
|
|
|
$
|
2,872
|
|
|
|
|
|
|
|
Net loss per common share — basic and diluted
|
$
|
(0.49)
|
|
|
$
|
(1.00)
|
|
|
$
|
(0.51)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding — basic and diluted
|
38,501
|
|
|
15,942
|
|
|
22,559
|
|
|
|
|
|
|
|
The $2.9 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 nine months ended September 30, 2021 compared to the same period in the prior year. The $0.51 decrease in basic net loss per share was impacted by the increase in weighted average shares outstanding resulting primarily from the issuance of approximately 13.3 million shares of common stock from October 1, 2020 through September 30, 2021.
LIQUIDITY AND CAPITAL RESOURCES
The COVID-19 outbreak in the United States has caused business disruptions. Thus far COVID-19 has not caused material disruptions to our operational and financial performance. The extent of the impact of COVID-19 on our future 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.
Net cash used in operating activities for the nine months ended September 30, 2021 was $15.7 million, compared to $11.2 million for the nine months ended September 30, 2020. Our use of cash was primarily a result of the net loss of $18.8 million for the nine months ended September 30, 2021, adjusted for non-cash items related to stock-based compensation of $2.2 million, release of clinical trial funding commitment of $1.5 million, amortization of premiums on short-term investments $1.2 million, and depreciation of $0.3 million. The net change in our operating assets and liabilities was $1.8 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 $122.7 million primarily related to net purchases of marketable securities during the nine months ended September 30, 2021, compared to $0.2 million investing activities for the same period in 2020.
Net cash provided in financing activities was $20.5 million during the nine months ended September 30, 2021, compared to $37.6 million for the same period in 2020. Net cash provided in financing activities during the nine months ended September 30, 2021 was $19.2 million from the sale of common stock and $1.3 million proceeds from the exercise of warrants. Net cash provided in financing activities during the nine months ended September 30, 2020 was from $19.0 million of proceeds from the exercise of warrants and $18.3 million from the sale of common stock, preferred stock and warrants.
As of September 30, 2021, and December 31, 2020, we had working capital of $132.7 million and $127.2 million, respectively.
We have incurred net losses since our inception and have negative operating cash flows. As of September 30, 2021, we had $134.0 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 issuance 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 our clinical trial programs and support our 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.