On November 5, 2020 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, castration-resistant prostate cancer and leukemia, reported company highlights and financial results for the third quarter ended September 30, 2020. The Company is issuing this press release in lieu of conducting a conference call (Press release, Cardiff Oncology, NOV 5, 2020, View Source [SID1234570067]).

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"Cardiff Oncology has seen robust growth over the past few months, which has been driven primarily by clinical data sets demonstrating safety and efficacy of onvansertib in solid tumor indications," said Dr. Mark Erlander, chief executive officer of Cardiff Oncology. "Data from our lead KRAS-mutated metastatic colorectal cancer (mCRC) program presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) conference, shows that the addition of onvansertib to standard-of-care therapy has led to durable responses and a significant improvement in the objective response rate (ORR) versus historical ORR’s of standard-of-care alone, highlighting onvansertib’s ability to address a critical unmet need in second-line treatment. We have also seen progress in our metastatic castration-resistant prostate cancer (mCRPC) program, presenting positive biomarker and efficacy data demonstrating onvansertib’s ability to overcome Zytiga resistance across known androgen receptor resistance mechanisms, at the Prostate Cancer Foundation (PCF) Scientific Retreat."

Dr. Erlander continued, "alongside our recent clinical achievements, we also executed on a major corporate milestone in early October with the Company closing an underwritten public offering of its common stock for gross proceeds of approximately $100 million. These funds will enable us to continue executing on our current programs and also initiate new clinical programs in other cancer indications."

Program highlights for the quarter ended September 30, 2020 include:

KRAS-mutated Metastatic Colorectal Cancer (mCRC) Program:

Presented clinical data at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 confirming the efficacy of onvansertib and the durability of response in second line KRAS-mutated mCRC patients

Newly announced data from a Phase 1b/2 clinical trial evaluating onvansertib in combination with FOLFIRI/bevacizumab in second line KRAS-mutated mCRC were featured in an electronic poster at the ESMO (Free ESMO Whitepaper) Virtual Congress 2020. These data further demonstrate the safety, efficacy and durability of response of onvansertib in combination with FOLFIRI/bevacizumab and suggest that changes in plasma KRAS mutation levels may serve as a predictive biomarker of patient response. Data highlights from the presentation included:
•10 of 11 (91%) patients achieved disease control (SD – stable disease plus PR – partial response), with only 1 patient progressing in <6 months while on treatment
•5 of 11 (45%) patients achieved a PR; 4 patients had a confirmed PR with 1 patient going on to curative surgery; 1 patient with an initial PR went off study prior to confirmatory scan due to a non-treatment related event
8 of 11 (73%) patients demonstrated durable response ranging from 6 to >12 months, and 4 patients remain on treatment
•Patients achieving a PR showed the greatest decreases in plasma KRAS mutation levels (ranging from -78% to -100%) after one cycle of therapy
•Data demonstrated that onvansertib in combination with FOLFIRI/bevacizumab is safe and well tolerated

Hosted a Key Opinion Leader (KOL) call discussing KRAS-mutated colorectal cancer and highlighting data from the onvansertib Phase 1b/2 trial

The call featured KOLs Afsaneh Barzi, M.D., Ph.D. (City of Hope Comprehensive Cancer Center) and Heinz-Josef Lenz, M.D., FACP (USC Norris Comprehensive Cancer Center). In addition to a discussion of the latest data from the Phase 1b/2 trial of onvansertib in KRAS-mutated mCRC, the call also included an overview of the history of KRAS in clinical practice, the challenges of drug development and targeting of KRAS and the value of KRAS as a biomarker for patient selection and predicting response to treatment. You may access a replay of the event by clicking here.

Highlights for the period subsequent to the quarter end include:

Corporate Milestones:

Strengthened balance sheet with gross proceeds of approximately $100 million in offering of common stock

On October 2nd, Cardiff Oncology closed an underwritten offering of 6,500,000 shares of its common stock at a public offering price of $13.50 per share, before deducting underwriter discounts and commissions and estimated offering expenses. The underwriters also exercised an option to purchase an additional 975,000 shares at the public offering price (less underwriting discounts and commissions). Cardiff Oncology intends to use the net proceeds from this offering for clinical development of onvansertib, working capital and for other general corporate purposes.

Clinical Milestones:

Metastatic Castration Resistant Prostate Cancer (mCRPC) Program:

Presented positive efficacy and biomarker data from Phase 2 mCRPC trial demonstrating ability of onvansertib to overcome Zytiga resistance at the 27th Prostate Cancer Foundation (PCF) Scientific Retreat
An electronic poster presented at the PCF retreat featured new data and analyses related to an ongoing Phase 2 trial evaluating onvansertib in combination with Zytiga (abiraterone acetate) and prednisone in mCRPC patients. The poster included efficacy data demonstrating success in achieving the primary endpoint of disease control in patients showing initial resistance to Zytiga; safety across three different dose and dosing schedules, as well as the potential clinical benefit for patients with the basal molecular tumor subtype. Additional highlights from the presentation included:
•8 of 26 (31%) evaluable patients achieved the primary endpoint of disease control (defined by a lack of prostate specific antigen progression) after 12 weeks of treatment
•14 of 26 (54%) evaluable patients had stable disease (SD) after 12 weeks of treatment
•8 of 26 (31%) evaluable patients had a durable SD (>7 months)
Of 8 patients harboring androgen receptor alterations associated with Zytiga resistance, 3 achieved disease control at 12 weeks, 4 had SD at 12 weeks and 3 had a durable SD (>7 months)
•Median time on treatment was 9.2 months for patients with a decrease in circulating tumor cell (CTC) count (n=5) vs. 4.9 months for patients with a CTC increase (n=5)
•Genetic analyses identified a gene signature (biomarker) associated with onvansertib and Zytiga synergy in prostate cancer cells that is significantly enriched in the basal molecular subtype of prostate cancer patients
•Data shows that the combination of onvansertib and Zytiga is safe across all evaluated dosing schedules

Third Quarter 2020 Financial Results:

As of September 30, 2020, Cardiff Oncology had approximately $36.4 million in cash and cash equivalents.

Total operating expenses were approximately $4.5 million for the three months ended September 30, 2020, an increase of $0.2 million from $4.3 million for the same period in 2019. The increase in operating expenses is attributed to an increase in costs associated with clinical programs and outside services, stock-based compensation and staff costs.

Net cash used in operating activities in the third quarter of 2020 was $3.5 million, an increase of $0.3 million from $3.2 million for the same period in 2019. The increase is attributed to increases in operating expenses and the net changes in our operating assets and liabilities.

Research and development expenses increased by approximately $0.1 million to $2.9 million for the three months ended September 30, 2020, from $2.8 million for the same period in 2019. The increase in research and development expenses was primarily due to expenses associated with clinical programs and outside services.

Selling, general and administrative expenses increased by approximately $0.2 million to $1.6 million for the three months ended September 30, 2020 from $1.4 million for the same period in 2019. The increase is primarily due to an increase in stock-based compensation, staff costs and facilities, off-set by a decrease in outside services.