What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2023-08-09 compared with 2023-05-04 · 68 added, 51 removed, 109 unchanged (52% of the section changed)

17 unchanged sentences

Our goal is to target tumor vulnerabilities with treatment combinations of onvansertib, our oral and highly selective PLK1 inhibitor, and standard-of-care ("SoC") therapeutics.

We are focusing our clinical program in indications such as KRAS/NRAS-mutated metastatic colorectal cancer ("mCRC") and metastatic pancreatic ductal adenocarcinoma ("mPDAC"), as well as in investigator-initiated trials in triple negative breast cancer ("TNBC") and small cell lung cancer ("SCLC").

We are focusing our clinical program in indications such as RAS-mutated metastatic colorectal cancer ("mCRC") and metastatic pancreatic ductal adenocarcinoma ("mPDAC"), as well as in investigator-initiated trials in triple negative breast cancer ("TNBC") and small cell lung cancer ("SCLC").

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

10 unchanged sentences

Combining onvansertib with standard-of-care cancer agents provides opportunities for synergy with many cancer therapies.

There are five ongoing clinical trials of onvansertib:

two trials (TROV-054 and ONSEMBLE) in second line treatment in patients with KRAS-mutated Metastatic Colorectal Cancer ("mCRC"), one trial in second line treatment in patients with Metastatic Pancreatic Ductal Adenocarcinoma ("mPDAC"), and two investigator-initiated trials in patients with unresectable locally advanced or metastatic Triple Negative Breast Cancer ("TNBC") and relapsed Small Cell Lung Cancer ("SCLC").

There are five ongoing and planned clinical trials of onvansertib:

one trial (CRDF-004) in first line treatment in patients with RAS-mutated mCRC, one trial (TROV-054) in second line treatment in patients with KRAS-mutated Metastatic Colorectal Cancer ("mCRC"), one trial in second line treatment in patients with Metastatic Pancreatic Ductal Adenocarcinoma ("mPDAC"), and two investigator-initiated trials in patients with locally advanced or metastatic Triple Negative Breast Cancer ("TNBC") and relapsed Small Cell Lung Cancer ("SCLC").

CRDF-004 Clinical Trial in RAS-mutated mCRC

CRDF-004 is a Phase 2 open-label, randomized multi-center clinical trial of onvansertib in combination with standard-of-care FOLFIRI and bevacizumab or FOLFOX and bevacizumab for the first line treatment of patients with RAS-mutated mCRC.

The primary objectives of the CRDF-004 trial are to evaluate onvansertib’s safety and efficacy in combination with the standard-of-care, as well as to evaluate two doses of onvansertib, 20mg and 30mg given in combination with standard-of-care, against standard-of-care alone.

The primary endpoint of the trial is objective response rate.

Progression-free survival and duration of response will be secondary endpoints.

We expect to begin enrollment during the second half of 2023, with initial data anticipated in mid-2024.

The trial is expected to enroll approximately 90 patients.

Phase 1b/2 Clinical Trial in KRAS-mutated mCRC

TROV-054 is a Phase 1b/2 open-label multi-center clinical trial of onvansertib in combination with standard of care FOLFIRI and bevacizumab for the second line treatment of patients with KRAS-mutated mCRC, which is being conducted at seven 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.

TROV-054 is a Phase 1b/2 open-label multi-center clinical trial of onvansertib in combination with standard-of-care FOLFIRI and bevacizumab for the second line treatment of patients with KRAS-mutated mCRC.

This trial completed enrollment in October 2022.

6 unchanged sentences

For more information, please visit NCT03829410 at www.clinicialtrials.gov .

Data presented on September 12, 2022, provided an update of the ongoing TROV-054 Phase 1b/2 single arm clinical trial in KRAS-mutated metastatic colorectal cancer:

Data presented on August 7, 2023, provided an update of the ongoing TROV-054 Phase 1b/2 single arm clinical trial in KRAS-mutated metastatic colorectal cancer:

• Objective response rate ("ORR") across all evaluable patients was 29%, with 19 of 66 evaluable patients achieving an objective response.

6 unchanged sentences

In contrast, patients previously treated with bevacizumab (n=51) had an ORR of 16% and mPFS of 7.8 months.

Phase 2 Randomized Clinical Trial in KRAS-mutated mCRC (the ONSEMBLE trial)

The ONSEMBLE trial (CRDF-003), is a Phase 2 open-label, randomized multi-center clinical trial of onvansertib in combination with standard of care FOLFIRI and bevacizumab for the second line treatment of patients with KRAS/NRAS-mutated mCRC.

The trial is currently open for enrollment and will be conducted at approximately 40 clinical trial sites across the U.S.

The primary objectives of the ONSEMBLE trial is to evaluate onvansertib’s safety and efficacy in combination with the standard-of-care FOLFIRI/bevacizumab regimen in patients with second-line KRAS/NRAS-mutated mCRC.

The trial is expected to enroll approximately 150 patients who will be randomized 1:1:1 to receive standard of care alone, standard of care plus 20 mg onvansertib, or standard of care plus 30 mg onvansertib, with onvansertib administered on days 1-5 and 15-19 of 28-day treatment cycles.

The primary endpoint of the trial is objective response rate, defined as a tumor reduction in size of at least 30% as per RECIST 1.1.

Progression-free survival and duration of response will be key secondary endpoints.

The trial was activated during the fourth quarter of 2022, with topline data anticipated in the second-half of 2024.

For more information, please visit NCT05593328 at www.clinicialtrials.gov .

The first patient was dosed in the ONSEMBLE trial during March 2023.

In reviewing the TROV-054 clinical data, we originally designed the ONSEMBLE trial (CRDF-003) as the next phase of our mCRC program.

Upon review of the clinical data from the bev naïve subgroup (those patients who did not receive bev in their 1 st line therapy), the preclinical data on the mechanism of action and the feedback from the FDA on our clinical development strategy, we made the decision to discontinue enrollment in the ONSEMBLE trial and to initiate CRDF-004.

Phase 2 Clinical Trial in mPDAC

25 unchanged sentences

Recent Updates

Appointment of Chief Medical Officer

On February 2, 2023, we announced the appointment of Fairooz Kabbinavar, M.D., FACP, as Chief Medical Officer.

Scientific Advisory Board

On March 6, 2023, we formally introduced our Scientific Advisory Board ("SAB").

The SAB is comprised of a distinguished group of academic and industry experts who bring depth and breadth of knowledge in oncology drug development, clinical trial design, translational science and clinical research.

In most cases, these individuals have been advising us for several years and will now collectively serve a critical role as we advance the clinical development of onvansertib.

We anticipate that over time the membership of the SAB may expand to add additional expertise in new indications or stages of clinical development.

Pfizer Ignite to Conduct CRDF-004 Clinical Trial

Pfizer Ignite will conduct the clinical activities of our new CRDF-004 trial in 1st line RAS-mutated mCRC, which expands the relationship established in November 2021 when Pfizer made an investment in Cardiff Oncology through its Pfizer Breakthrough Growth Initiative.

Pfizer VP and Development head Adam Schayowitz sits on the Cardiff Oncology Scientific Advisory Board.

Critical Accounting Policies

2 unchanged sentences

There have been no changes to our critical accounting policies since December 31, 2022.

Three Months Ended March 31, 2023 and 2022

Total revenues were $83,000 for the three months ended March 31, 2023, as compared to $74,000 for the same period in 2022.

RESULTS OF OPERATIONS

Three Months Ended June 30, 2023 and 2022

Total revenues were $108,000 for the three months ended June 30, 2023, as compared to $91,000 for the prior period.

Revenues are from our sales-based or usage-based royalties on other intellectual property licenses, unrelated to onvansertib.

2 unchanged sentences

Research and development expenses consisted of the following:

Three Months Ended March 31,

Three Months Ended June 30,

(in thousands) 2023 2022 Increase (Decrease)

4 unchanged sentences

Total research and development $ 8,020 $ 7,448 $ 572

Research and development expenses increased by $1.8 million for the three months ended March 31, 2023, compared to the same period in 2022.

Research and development expenses increased by $0.6 million for the three months ended June 30, 2023, compared to the same period in 2022.

The overall increase in expenses was primarily related to salaries and staff costs from additional hires in senior management and our clinical operations team (research and development average headcount grew by 35% over the comparative period).

The increase in facilities and other is primarily due to increased allocation of facilities cost resulting from headcount growth compared to the prior period.

The decrease in clinical trials, outside services, and lab supplies was primarily related to costs incurred in the prior period related to CMC and clinical pharmacology for studies to support the development of our lead drug candidate, onvansertib.

Selling, General and Administrative Expenses

Selling, general and administrative expenses consisted of the following:

Three Months Ended June 30,

(in thousands) 2023 2022 Increase (Decrease)

Salaries and staff costs $ 1,358 $ 792 $ 566

Stock-based compensation 1,284 929 355

Outside services and professional fees 1,070 673 397

Facilities and other 584 692 (108)

Total selling, general and administrative $ 4,296 $ 3,086 $ 1,210

Selling, general and administrative expenses increased by $1.2 million for the three months ended June 30, 2023, compared to the same period in 2022.

Salaries and staff costs increased due to an employee severance agreement.

The increase in outside services and professional fees was due to additional contract review legal fees, public relations and external accounting fees.

Interest Income, Net

Interest income, net was $1.1 million for the three months ended June 30, 2023 as compared to $0.3 million for the same period of 2022.

The increase in interest income was primarily due to higher interest rates on our short-term investments portfolio for the three months ended June 30, 2023 as compared to the same period of 2022.

Six Months Ended June 30, 2023 and 2022

Total revenues were $191,000 for the six months ended June 30, 2023, as compared to $165,000 for the same period in 2022.

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) 2023 2022 Increase (Decrease)

Salaries and staff costs $ 2,860 $ 2,130 $ 730

Stock-based compensation 691 460 231

Clinical trials, outside services, and lab supplies 12,515 11,419 1,096

Facilities and other 1,006 647 359

Total research and development $ 17,072 $ 14,656 $ 2,416

Research and development expenses increased by $2.4 million for the six months ended June 30, 2023, compared to the same period in 2022.

The overall increase in expenses was primarily due to costs associated with clinical programs and outside service costs related to the development of our lead drug candidate, onvansertib.

Salaries and staff costs increased primarily due to the expansion of our clinical operations team (research and development average headcount grew by 25% over the comparative period).

Salaries and staff costs increased primarily from additional hires in senior management and our clinical operations team (research and development average headcount grew by 30% over the comparative period).

The increase in facilities and other is primarily due to increased allocation of facilities cost resulting from headcount growth compared to the prior period.

1 unchanged sentence

Selling, general and administrative expenses consisted of the following:

Three Months Ended March 31,

Six Months Ended June 30,

(in thousands) 2023 2022 Increase (Decrease)

4 unchanged sentences

Total selling, general and administrative $ 7,379 $ 7,026 $ 353

Selling, general and administrative expenses decreased by $0.9 million for the three months ended March 31, 2023, compared to the same period in 2022.

Outside services decreased due to the completion of strategic valuation consulting related to our lead drug candidate, onvansertib, during the prior period.

Stock-based compensation decreased due to a change in the timing of stock option grants to our board of directors.

Facilities and other costs decreased primarily due to lower insurance costs as compared to the prior period.

Net loss and per share amounts were as follows:

Three Months Ended March 31,

(in thousands, except per share amounts) 2023 2022 Increase (Decrease)

Net loss $ (11,223) $ (10,993) $ 230

Preferred stock dividend (6) (6) —

Net loss attributable to common shareholders $ (11,229) $ (10,999) $ 230

Net loss per common share — basic and diluted $ (0.25) $ (0.25) $ —

Weighted average shares outstanding — basic and diluted 44,677 43,231 1,446

The $0.2 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, 2023, compared to the same period in 2022.

There was no change in basic and diluted net loss per share with the addition of 1.4 million shares of common stock issued from April 1, 2022 through March 31, 2023.

Selling, general and administrative expenses increased by $0.4 million for the six months ended June 30, 2023, compared to the same period in 2022.

Salaries and staff costs increased due to an employee severance agreement.

Interest Income, Net

Interest income, net was $2.0 million for the six months ended June 30, 2023 as compared to $0.4 million for the same period of 2022.

The increase in interest income was primarily due to higher interest rates on our short-term investments portfolio for the six months ended June 30, 2023 as compared to the same period of 2022.

LIQUIDITY AND CAPITAL RESOURCES

Net cash used in operating activities for the three months ended March 31, 2023, was $8.7 million, compared to $10.2 million for the three months ended March 31, 2022.

Our use of cash was primarily a result of the net loss of $11.2 million for the three months ended March 31, 2023, adjusted for non-cash items related to stock-based compensation of $1.1 million.

The net change in our operating assets and liabilities was primarily the result of decreasing cash used in operations of $1.6 million.

Net cash used in operating activities for the six months ended June 30, 2023, was $15.8 million, compared to $16.9 million for the six months ended June 30, 2022.

Our use of cash was primarily a result of the net loss of $22.4 million for the six months ended June 30, 2023, adjusted for non-cash items related to stock-based compensation of $2.6 million.

The net change in our operating assets and liabilities decreased cash used in operations by $4.2 million.

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 provided by investing activities was $7.3 million primarily related to sales and maturities in excess of purchases of marketable securities for the three months ended March 31, 2023, compared to net cash used in investing activities

of $18.4 million primarily related to sales and maturities in excess of purchases of marketable securities during the same period in 2022.

Net cash provided in financing activities was $0 for the three months ended March 31, 2023, and 2022.

As of March 31, 2023, and December 31, 2022, we had working capital of $93.6 million and $103.5 million, respectively.

Net cash provided by investing activities was $18.8 million primarily related to sales and maturities in excess of purchases of marketable securities for the six months ended June 30, 2023, compared to net cash provided by investing activities of $26.0 million primarily related to sales and maturities in excess of purchases of marketable securities during the same period in 2022.

Net cash provided in financing activities was $0 for the six months ended June 30, 2023, and 2022.

As of June 30, 2023, and December 31, 2022, we had working capital of $83.6 million and $103.5 million, respectively.

We have incurred net losses since our inception and have negative operating cash flows.

As of March 31, 2023, we had $97.0 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.

As of June 30, 2023, we had $89.4 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.

Based on our current projections we expect that our capital resources are sufficient to fund our operations into 2025.

7 unchanged sentences

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