What changed in this filing

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Item 2. Management’s Discussion and Analysis

2021-08-05 compared with 2021-05-06 · 109 added, 53 removed, 124 unchanged (57% of the section changed)

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Such discussion represents only the best present assessment of our management.

We are a clinical stage biotechnology company, developing new treatment options for cancer patients in indications with the greatest medical need.

Our goal is to overcome resistance, extend duration of response and 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 chemotherapy and targeted therapeutics.

Our clinical development programs incorporate tumor genomics and biomarker technology to enable assessment of patient response to treatment.

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).

Onvansertib was developed to have ideal pharmacokinetics, including oral bioavailability and administration and a drug half-life of approximately 24 hours, allowing for flexible dosing and scheduling, with only mild to moderate side effects reported to-date.

A Phase 1 safety study of onvansertib was successfully completed in patients with advanced metastatic solid tumors and published in 2017 in Investigational New Drugs .

PLK1, a serine/threonine kinase, is a master regulator of mitotic progression with various roles and localizations during the different mitotic phases.

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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.

Onvansertib has been tested for antiproliferative activity on a panel of 148 tumor cell lines and appeared highly active with an IC 50 (a measure concentration for 50% target inhibition) below 100 nM in 75 cell lines and IC 50 values below 1 uM in 133 out of 148 cell lines.

Onvansertib also appears active in cells expressing multi-drug resistant (“MDR”) transporter proteins and we believe its apparent ability to overcome the MDR transporter resistance mechanism in cancer cells could prove useful in broader drug combination applications.

Additionally, onvansertib has been tested in in-vivo xenograft and transgenic models of different cancer types with the demonstration of tumor growth inhibition or tumor regression.

Onvansertib has been evaluated preclinically and has demonstrated to have synergy with chemotherapies, including irinotecan, 5-FU, cisplatin, cytarabine, doxorubicin, gemcitabine and paclitaxel, and with targeted therapeutics including abiraterone, PARP inhibitor, venetoclax, histone deacetylase ("HDAC") inhibitors, fms-like tyrosine kinase 3 ("FLT3") inhibitors, sorafenib, and bortezomib.

These therapies are used clinically for the treatment of many hematologic and solid cancers, including acute myeloid leukemia ("AML"), non-Hodgkin’s lymphoma ("NHL"), metastatic CRC, metastatic castration resistant prostate cancer ("mCRPC"), adrenocortical carcinoma ("ACC"), triple negative breast cancer ("TNBC"), small cell lung cancer ("SCLC"), and ovarian cancer.

These preclinical studies are the foundation of the scientific rationale for the use of specific combinations in indicated cancer types within our ongoing and planned clinical trials for the drug development of onvansertib.

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.

Clinical Program Updates

Significant clinical updates:

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") and CARTI Cancer Center;

- 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 mutli-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 ("PDAC"), which is being conducted at 6 clinical trial sites across the U.S.

• 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.

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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 5-FU (components of FOLFIRI) demonstrate synergy in colorectal cancer cell lines and the combination has demonstrated significantly greater tumor growth inhibition than either drug alone.

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 a KRAS mutation;

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.

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4 patients have had a confirmed PR;

1 patient with a non-confirmed PR went off study due to an unrelated event prior to their 16-week confirmatory scan and 2 patients await their respective confirmatory scans.

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%.

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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 progressed showed a more modest reduction in KRAS MAF (decrease of 55% and 26%, respectively).

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) associated with onvansertib in combination with FOLFIRI/bevacizumab, only 11% have been grade 3 or 4.

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.

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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.

On January 15, 2021, we announced an electronic poster presentation of clinical data further demonstrating the clinical benefit of onvansertib in KRAS-mutate mCRC and initial findings from our Expanded Access Program ("EAP") in mCRC.

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.

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.

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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=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.

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.

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, the presentation of an electronic oral poster presentation featuring gene signature analyses data identifying androgen-independent mechanism for onvansertib-abiraterone synergy in mCRPC.

On February 11, 2021, we announced an electronic poster presentation of clinical data further demonstrating the safety, efficacy and durability of response in patient with mCRPC at the American Society of Clinical Oncology Genitourinary Cancers Symposium (“ASCO-GU”).

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.

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 enrolled is anticipated in the first half of 2021.

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.

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Key News Releases

On January 26, 2021, we announced that the FDA provided a "study may proceed" notification to the Company to initiate our study in metastatic PDAC.

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

Our accumulated deficit through March 31, 2021 is $236.7 million.

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.

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.

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Off-Balance Sheet Arrangements

We had no off-balance sheet arrangements as of March 31, 2021.

We had no off-balance sheet arrangements as of June 30, 2021.

Critical Accounting Policies

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There have been no changes to our critical accounting policies since December 31, 2020.

Three Months Ended March 31, 2021 and 2020

Total revenues was $0.1 million for three months ended March 31, 2021 as compared to $0.1 million for the prior period.

RESULTS OF OPERATIONS

Three Months Ended June 30, 2021 and 2020

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.

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Research and development expenses consisted of the following:

Three Months Ended March 31,

Three Months Ended June 30,

(in thousands) 2021 2020 Increase (Decrease)

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Total research and development $ 4,119 $ 2,476 $ 1,643

Research and development expenses increased by $0.6 million for the three months ended March 31, 2021 compared to the same period in 2020.

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.

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Selling, general and administrative expenses consisted of the following:

Three Months Ended March 31,

Three Months Ended June 30,

(in thousands) 2021 2020 Increase (Decrease)

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Total selling, general and administrative $ 2,838 $ 1,669 $ 1,169

Selling, general and administrative expenses increased by $0.7 million for the three months ended March 31, 2021 compared to the same period in 2020.

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.

The increase in stock-based compensation is primarily due to stock options granted in June 2020.

Change in Fair Value of Derivative Financial Instruments — Warrants

We have issued warrants that are accounted for as derivative liabilities.

As of March 31, 2021, the derivative financial instruments — warrants liabilities were revalued to $0.1 million, resulting in an decrease in value of $0.2 million 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, volatility, and risk-free interest rates for the expected term.

The change in value upon remeasurement at March 31, 2021 was recorded as a gain from the change in fair value of derivative financial instruments — warrants in the condensed statement of operations.

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 and per share amounts were as follows:

Three Months Ended March 31,

Three Months Ended June 30,

(in thousands, except per share amounts) 2021 2020 Increase (Decrease)

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Weighted average shares outstanding — basic and diluted 38,761 14,492 24,269

The $1.1 million increase in net loss attributable to common shareholders was primarily the result of an increase in operating expenses for the three months ended March 31, 2021 compared to the same period in the prior year.

The $0.27 decrease in basic net loss per share was impacted by the increase in basic weighted average shares outstanding resulting primarily from the issuance of approximately 26.5 million shares of common stock from April 1, 2020 through March 31, 2021.

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

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.

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:

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 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

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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 three months ended March 31, 2021 was $5.9 million, compared to $3.4 million for the three months ended March 31, 2020.

Our use of cash was primarily a result of the net loss of $5.2 million for the three months ended March 31, 2021, adjusted for non-cash items related to release of clinical trial funding commitment of $0.4 million, stock-based compensation of $0.3 million, and depreciation of $0.1 million.

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

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 $111.7 million during the three months ended March 31, 2021, compared to no investment activities for the same period in 2020, investment activities during the current period were primarily related to net purchases of marketable securities.

Net cash provided in financing activities was $1.3 million during the three months ended March 31, 2021, compared to $2.5 million for the same period in 2020.

Net cash provided in financing activities during the three months ended March 31, 2021 was from $1.3 million of proceeds from the exercise of warrants.

Net cash provided in financing activities during the three months ended March 31, 2020 was from $1.5 million of proceeds from the exercise of warrants and $1.0 million from the sale of common stock and warrants.

As of March 31, 2021, and December 31, 2020, we had working capital of $124.1 million and $127.2 million, respectively.

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 March 31, 2021, we had $125.6 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 these financial statements.

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.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis