Cardiff Oncology Inc

Previous wording

CRDF-004 is a Phase 2 open-label, randomized multi-center clinical trial of onvansertib in combination with SoC 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 SoC, as well as to evaluate two doses of onvansertib, 20mg and 30mg, given in combination with SoC, against SoC alone. The primary endpoint of the trial is objective response rate ("ORR"). Progression-free survival and duration of response will be secondary endpoints. We anticipate releasing initial data from the CRDF-004 trial in the second half of 2024. This trial is conducted in partnership with Pfizer Ignite, an end-to-end service for biotech companies, and it is expected to enroll approximately 90 evaluable patients. In February 2024 it was announced that the first patient dosed for this trial. For more information, please visit NCT06106308 atwww.clinicialtrials.gov.

Current wording

CRDF-004 is a Phase 2 open-label, randomized multi-center clinical trial of onvansertib in combination with SoC 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 SoC, as well as to evaluate two doses of onvansertib, 20mg and 30mg, given in combination with SoC, against SoC alone. The primary endpoint of the trial is objective response rate ("ORR"). Progression-free survival and duration of response will be secondary endpoints. We anticipate releasing initial data from the CRDF-004 trial in the fourth quarter of 2024. This trial is conducted in partnership with Pfizer Ignite, an end-to-end service for biotech companies, and it is expected to enroll approximately 90 evaluable patients. In February 2024 it was announced that the first patient dosed for this trial. For more information, please visit NCT06106308 atwww.clinicialtrials.gov.

Previous wording

The ORR data from the randomized ONSEMBLE trial validates the findings observed in our earlier single-arm Phase 1b/2 KRAS-mutated mCRC trial (TROV-054). In the ONSEMBLE trial, objective responses were observed only in bevacizumab naïve patients versus bevacizumab exposed patients. In addition, these objective responses were present only in bevacizumab naïve patients randomized to the experimental arms of onvansertib in combination with FOLFIRI and bevacizumab versus bevacizumab naïve patients randomized to the FOLFIRI and bevacizumab alone control arm.

Current wording

The ORR data from the randomized ONSEMBLE trial validates the findings observed in our earlier single-arm Phase 1b/2 KRAS-mutated mCRC trial (TROV-054). In the ONSEMBLE trial, objective responses were observed only in bevacizumab naïve patients versus bevacizumab exposed patients. In addition, these objective responses were present only in bevacizumab naïve patients randomized to the experimental arms of onvansertib in combination with FOLFIRI and bevacizumab vs. bevacizumab naïve patients randomized to the FOLFIRI and bevacizumab alone control arm.

Previous wording

In February 2024, the FDA approved NALIRIFOX as a first-line treatment option for mPDAC. As a result, we are currently planning to support a new investigator-initiated mPDAC Phase 2 trial of onvansertib in combination with first-line SoC NALIRIFOX, details of which we will announced when available. The trial would replace a previously planned two-cohort, non-randomized Phase 2 trial of onvansertib in combination with first-line SoC Gemzar® and Abraxane® which was to be conducted at the OHSU Knight Cancer Institute.

Current wording

In February 2024, the FDA approved NALIRIFOX as a first-line treatment option for mPDAC. As a result, we are currently planning to support a new investigator-initiated mPDAC Phase 2 trial of onvansertib in combination with first-line SoC NALIRIFOX, details of which we will announce when available. The trial would replace a previously planned two-cohort, non-randomized Phase 2 trial of onvansertib in combination with first-line SoC Gemzar® and Abraxane® which was to be conducted at the OHSU Knight Cancer Institute.

Previous wording

A single-arm, two-stage, Phase 2 trial of onvansertib monotherapy in patients with relapsed SCLC at the University of Pittsburgh Medical Center ("UPMC"), completed enrollment in July 2023. The primary endpoint of the trial is ORR, while key secondary endpoints include PFS and overall survival. For more information, please visit NCT05450965 atwww.clinicialtrials.gov.

Current wording

A single-arm, two-stage, Phase 2 trial of onvansertib monotherapy in patients with relapsed SCLC at the University of Pittsburgh Medical Center ("UPMC"), completed enrollment in July 2023.In October 2024, the trial was re-opened for enrollment at the University of Maryland Greenebaum Comprehensive Cancer Center (“UMGCCC”) following the investigator’s relocation to this location. The primary endpoint of the trial is ORR, while key secondary endpoints include PFS and overall survival. For more information, please visit NCT05450965 atwww.clinicialtrials.gov.

Previous wording

Total revenues were $163,000 for the three months ended June 30, 2024, as compared to $108,000 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.

Current wording

Total revenues were $0.2 million for the three months ended September 30, 2024, as compared to $0.1 million 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.

Previous wording

Selling, general and administrative expenses decreased by $1.0 million for the six months ended June 30, 2024, compared to the same period in 2023. The overall decrease in expenses was primarily due to salaries and staff costs due to an employee severance agreement which was expensed during the prior period. Stock-based compensation expense decreased due to a modification of stock options that occurred during the prior period. The decrease in facilities and other costs was primarily due to reduced insurance costs compared to the prior period.

Current wording

Selling, general and administrative expenses increased by $0.2 million for the three months ended September 30, 2024, compared to the same period in 2023. The overall increase in expenses was primarily from outside services and professional fees, due to the settlement of litigation during the quarter, offset by a decreases in corporate legal expenses. Stock-based compensation expense increased due to new grants issued during the current year. The decrease in facilities and other costs was primarily due to reduced insurance costs compared to the prior period.

Previous wording

Interest income, net was $0.8 million for the three months ended June 30, 2024 as compared to $1.1 million for the same period of 2023. The decrease in interest income was primarily due to a lower balance of our short-term investments portfolio and money market accounts for the three months ended June 30, 2024 as compared to the same period of 2023.

Current wording

Interest income, net was $0.7 million for the three months ended September 30, 2024 as compared to $1.1 million for the same period of 2023. Our interest income is primarily from our our short-term investment portfolios and money market accounts. The amount of interest income earned varies each period based on the balance of our accounts and interest rates.

Previous wording

Total revenues were $368,000 for the six months ended June 30, 2024, as compared to $191,000 for the same period in 2023. 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.

Current wording

Total revenues were $0.5 million for the nine months ended September 30, 2024, as compared to $0.3 million for the same period in 2023. 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.

Previous wording

Research and development expenses increased by $1.5 million for the three months ended June 30, 2024, compared to the same period in 2023. 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. The increase in salaries and staff costs was primarily from key hires in research and development and clinical operations (research and development average headcount grew by 19% over the comparative period).

Current wording

Research and development expenses increased by $2.0 million for the nine months ended September 30, 2024, compared to the same period in 2023. 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 generally from key hires in research and development and clinical operations (research and development average headcount grew by 19% over the comparative period).

Previous wording

Selling, general and administrative expenses decreased by $1.1 million for the three months ended June 30, 2024, compared to the same period in 2023. The overall decrease in expenses was primarily due to salaries and staff costs due to an employee severance agreement which was expensed during the prior period. Stock-based compensation expense decreased due to a modification of stock options that occurred during the prior period. The decrease in facilities and other costs was primarily due to reduced insurance costs compared to the prior period.

Current wording

Selling, general and administrative expenses decreased by $0.8 million for the nine months ended September 30, 2024, compared to the same period in 2023. The overall decrease in expenses was primarily within salaries and staff costs due to an employee severance agreement which was expensed during the prior period. Stock-based compensation expense decreased due to a modification of stock options that occurred during the prior period. The decrease in facilities and other costs was primarily due to reduced insurance costs compared to the prior period. The increase in outside services and professional fees, was due to the settlement of litigation during the current period, offset by a decreases in corporate legal expenses.

Previous wording

Interest income, net was $1.7 million for the six months ended June 30, 2024 as compared to $2.0 million for the same period of 2023. The decrease in interest income was primarily due to a lower balance of our short-term investments portfolio and money market accounts for the six months ended June 30, 2024 as compared to the same period of 2023.

Current wording

Interest income, net was $2.5 million for the nine months ended September 30, 2024 as compared to $3.1 million for the same period of 2023. Our interest income is primarily from our our short-term investment portfolios and money market accounts. The amount of interest income earned varies each period based on the balance of our accounts and interest rates.

Previous wording

As of June 30, 2024, and December 31, 2023, we had working capital of $49.7 million and $67.0 million, respectively.

Current wording

As of September 30, 2024, and December 31, 2023, we had working capital of $46.8 million and $67.0 million, respectively.

Previous wording

We have incurred net losses since our inception and have negative operating cash flows. As of June 30, 2024, we had $60.3 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 through the end of the third quarter of 2025.

Current wording

We have incurred net losses since our inception and have negative operating cash flows. As of September 30, 2024, we had $57.7 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 the first quarter of 2026.

Previous wording

From July 1, 2024 through August 6, 2024, we raised gross proceeds of $2.3 million from the sale of 0.9 million shares of our Common Stock.

Current wording

From October 1, 2024 through November 4, 2024, we raised gross proceeds of $7.0 million from the sale of 2.4 million shares of our Common Stock.

Previous wording

Net cash used in operating activities for the six months ended June 30, 2024, was $17.0 million. Our primary use of cash was from our net loss of $21.8 million, adjusted for non-cash items of $2.2 million primarily related to stock-based compensation. The net change in our operating assets and liabilities decreased cash used in operations by $2.6 million.

Current wording

Net cash used in operating activities for the nine months ended September 30, 2024, was $27.4 million. Our primary use of cash was from our net loss of $33.6 million, adjusted for non-cash items of $3.4 million primarily related to stock-based compensation. The net change in our operating assets and liabilities decreased cash used in operations by $2.8 million.

Previous wording

Net cash used in operating activities for the six months ended June 30, 2023, was $15.8 million. Our primary use of cash was from our net loss of $22.4 million, adjusted for non-cash items of $2.4 million primarily related to stock-based compensation. The net change in our operating assets and liabilities decreased cash used in operations by $4.2 million.

Current wording

Net cash used in operating activities for the nine months ended September 30, 2023, was $23.7 million. Our primary use of cash was from our net loss of $32.1 million, adjusted for non-cash items of $3.2 million primarily related to stock-based compensation. The net change in our operating assets and liabilities decreased cash used in operations by $5.2 million.

Previous wording

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

Current wording

Net cash provided by investing activities for the nine months ended September 30, 2024 was $9.2 million, primarily related to maturities and sales in excess of purchases of marketable securities.

Previous wording

Net cash provided by investing activities for the six months ended June 30, 2024 was $18.7 million, primarily related to maturities in excess of purchases of marketable securities.

Current wording

Net cash provided by investing activities for the nine months ended September 30, 2023 was $22.6 million, primarily related to maturities and sales in excess of purchases of marketable securities.

Previous wording

Net cash provided by financing activities for the six months ended June 30, 2024 was $2.2 million, from the sale of common stock and employee stock options exercises.

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2024 was $9.6 million, from the sale of common stock and employee stock options exercises.

Previous wording

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

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2023 was $0.