Cardiff Oncology Reports Fourth Quarter and Full Year 2024 Results and Provides Business Update

- Robust initial efficacy signal with onvansertib + chemo/bev in ongoing first-line RAS-mut metastatic colorectal cancer ("mCRC") clinical trial (CRDF-004) -

- Priced oversubscribed $40 million underwritten registered direct offering with participation from new and existing healthcare dedicated investors -

- Issuance of new patent with claims for the use of onvansertib for treating KRAS-mut mCRC -

- Cash and equivalents of $91.7 million as of December 31, 2024, projected runway into Q1 2027 -

- Company will hold a conference call today at 4:30 p.m. ET/1:30 p.m. PT -

SAN DIEGO, Feb. 27, 2025 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced financial results for the fourth quarter and full year ended December 31, 2024, and provided a business update.

"2024 was a significant year for Cardiff Oncology as we shared positive data from the first 30 patients in our lead program in first-line RAS-mut mCRC," said Mark Erlander, Ph.D., Chief Executive Officer of Cardiff Oncology. "We were excited to report that patients on the 30mg onvansertib dose arm demonstrated a 64% response rate, compared to a 33% response rate in the control arm. In the experimental arm, we observed a dose response relationship with the 30mg dose of onvansertib demonstrating increased ORR and deeper tumor regression compared to the 20mg dose of onvansertib with similar safety profiles for both doses. We believe this correlation between the dose of onvansertib and the magnitude of therapeutic effect serves as validation that onvansertib is a biologically active drug for the treatment of cancer, which we believe may translate to additional oncology indications in our pipeline. In addition to the robust efficacy signal in the CRDF-004 trial, these data suggest that onvansertib could safely be combined with both standard of care first-line chemotherapy options for mCRC in the U.S. With our balance sheet strengthened by a $40M investment from biotech specialist investors, we now look forward to sharing additional clinical updates from CRDF-004 in H1 2025."

Upcoming expected milestones

   -- Additional clinical data from CRDF-004 trial expected in 1H 2025 

Company highlights for the quarter ended December 31, 2024, and subsequent weeks include:

   -- Announced positive initial data from ongoing first-line RAS-mutated mCRC 
      clinical trial (CRDF-004) 
 
          -- Phase 2 trial is currently enrolling patients with mCRC who have a 
             documented KRAS or NRAS mutation. Onvansertib is added to 
             standard-of-care (SoC) consisting of FOLFIRI plus bevacizumab 
             ("bev") or FOLFOX plus bev. Patients will be randomized to either 
             20mg of onvansertib plus SoC, 30mg of onvansertib plus SoC, or SoC 
             alone. 
 
          -- Patients on the 30mg onvansertib dose arm demonstrated 64% 
             objective response rate $(ORR.AU)$ versus 33% ORR in the control arm. 
 
          -- The 30mg dose of onvansertib demonstrated a higher ORR and deeper 
             tumor regression compared to the 20mg dose of onvansertib (64% vs. 
             50%). 
 
          -- Onvansertib was well tolerated at both doses. 
 
   -- Raised $40 million in an oversubscribed underwritten registered direct 
      offering 
 
          -- The financing included participation from new and existing 
             healthcare dedicated investors. 
 
   -- Patent issuance from the United States Patent and Trademark Office 
      (USPTO) 
 
          -- U.S. patent No. 12,144,813 has an expected expiration date of no 
             earlier than 2043. The patent claims cover the method of using 
             onvansertib in combination with bev for the treatment of KRAS 
             mutated mCRC patients who have not previously been treated with 
             bev ("bev naïve"). This patent is supported by the unexpected 
             benefits of the treatment in such bev naïve patients. 
 
   -- Presented two posters at the San Antonio Breast Cancer Symposium 
 
          -- Onvansertib demonstrated synergy in combination with paclitaxel in 
             hormone receptor positive (HR+) breast cancer cell lines and 
             robust antitumor activity in patient-derived xenograft $(PDX)$ 
             models resistant to first-line therapies. These data support that 
             onvansertib in combination with paclitaxel represents a promising 
             therapeutic strategy for HR+ breast cancer patients after 
             progression on endocrine therapy and CDK4/6 inhibitors. A phase 
             1b/2 clinical trial is ongoing to evaluate the safety and efficacy 
             of onvansertib in combination with paclitaxel in advanced triple 
             negative breast cancer (NCT05383196). 
 
          -- Onvansertib in combination with trastuzumab deruxtecan (T-DXd) was 
             well tolerated, overcame T-DXd resistance, and displayed enhanced 
             anti-tumor activity compared to monotherapies in drug resistant 
             HR+ breast cancer patient derived xenograft (PDX) models. The 
             combination of T-DXd with onvansertib represents a promising 
             therapeutic strategy for HR+ breast cancer patients resistant to 
             first-line therapies. 
 
   -- Published clinical data of the combination of onvansertib with FOLFIRI 
      and bev in second-line KRAS mutant mCRC in the peer-reviewed Journal of 
      Clinical Oncology, the flagship publication of the American Society of 
      Clinical Oncology (ASCO) 
 
          -- Phase 2 clinical trial treating patients with KRAS-mutant mCRC 
             (NCT03829410) demonstrated that onvansertib combined with FOLFIRI 
             and bev was well-tolerated and exhibited clinical activity in the 
             second-line setting. 
 
          -- A post hoc analysis revealed a greater clinical benefit in bev 
             naïve patients, who demonstrated an ORR of 77% and mPFS of 
             14.9 months compared to an ORR of 10% and mPFS of 6.6 months in 
             those previously exposed to bev. 

Full Year 2024 Financial Results:

Liquidity, cash burn, and cash runway

As of December 31, 2024, Cardiff Oncology had approximately $91.7 million in cash, cash equivalents, and short-term investments.

Net cash used in operating activities for the full year 2024 was approximately $37.7 million, an increase of approximately $6.8 million from $30.9 million for the same period in 2023.

Based on its current expectations and projections, the Company believes its current cash resources are sufficient to fund its operations into Q1 2027.

Operating results

Total operating expenses were approximately $49.3 million for the full year ended December 31, 2024, an increase of $3.4 million from $45.9 million for the same period in 2023. The increase in operating expenses was primarily due to costs associated with clinical programs and outside service costs related to the development of our lead drug candidate, onvansertib, and higher salaries and staff costs primarily due to increased headcount and stock-based compensation for additional grants to employees.

Conference Call and Webcast

Cardiff Oncology will host a corresponding conference call and live webcast today at 4:30 p.m. ET/1:30 p.m. PT. Individuals interested in listening to the live conference call may do so by using the webcast link in the "Investors" section of the company's website at www.cardiffoncology.com. A webcast replay will be available in the investor relations section on the company's website following the completion of the call.

About Cardiff Oncology, Inc.

Cardiff Oncology is a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers. The Company's lead asset is onvansertib, a PLK1 inhibitor being evaluated in combination with standard of care (SoC) therapeutics in clinical programs targeting indications such as RAS-mutated metastatic colorectal cancer (mCRC), as well as in ongoing and planned investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC) and triple negative breast cancer (TNBC). These programs and the Company's broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver superior clinical benefit compared to the SoC alone. For more information, please visit https://www.cardiffoncology.com.

Forward-Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe, " "forecast," "estimated" and "intend" or other similar terms or expressions that concern Cardiff Oncology's expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; risks related to business interruptions, including the outbreak of COVID-19 coronavirus and cyber-attacks on

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