Cardiff Oncology Reports First Quarter 2024 Results and Provides Business Update

- In RAS-mutated mCRC, clinical data from ONSEMBLE trial, and preclinical data presented at AACR, demonstrated strong efficacy signal in bev naïve patients and support ongoing first-line RAS-mutated mCRC lead program -

- In RAS wild-type mCRC, preclinical data presented at AACR demonstrated onvansertib’s antitumor activity both as a single agent and in combination, highlighting its broad activity across all mCRC -

- In SCLC and ovarian cancer, preclinical data presented at AACR highlighted onvansertib’s activity in combination treatments -

- Cash and equivalents of $67 million as of March 31, 2024, projected runway into Q3 2025 -

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

SAN DIEGO, May 02, 2024 (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 first quarter ended March 31, 2024, and provided a business update.

“During the start of 2024, we presented several important new data sets supporting our first-line RAS-mutated mCRC strategy and the broader opportunity for onvansertib,” said Mark Erlander, Ph.D., Chief Executive Officer of Cardiff Oncology. “The data from the ONSEMBLE trial replicated, in a second independent and randomized dataset, the bev naïve signal from our earlier Phase 1b/2 KRAS-mutated mCRC trial. And the Phase 1b data published in the peer-reviewed journal Clinical Cancer Research, and the additional data we presented in one of our five posters at AACR, further substantiated our lead program in RAS-mutated mCRC. The additional AACR posters also point toward new indications for onvansertib in RAS wild-type mCRC, small cell lung cancer and ovarian cancer. Looking ahead, we believe that our upcoming data readout from our first-line trial in RAS-mutated mCRC has the potential to serve as a key value inflection point for our company and revolutionize the treatment of RAS-mutated mCRC, an area with no new treatments approved in over two decades.”

Upcoming expected milestones

• The Company has updated its expectation of the timing for an initial readout from the first-line RAS-mutated metastatic colorectal cancer (mCRC) randomized CRDF-004 trial to 2H 2024, based on the enrollment trends observed from active clinical trial sites.

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

• Presented updated data at AACR Annual Meeting 2024 that supports ongoing first-line RAS-mutated mCRC clinical study.
  • In a poster titled “A Phase 1b/2 Clinical Study of Onvansertib in Combination with FOLFIRI/Bev Revealed a New Role of PLK1 in regulating the Hypoxia Pathway in KRAS-mutated mCRC,” updated clinical and preclinical data further supported the ongoing CRDF-004 Phase 2 trial of onvansertib + chemo/bev for the first-line treatment of RAS-mutated mCRC patients, who by definition are bev naïve.
  • In vitro, onvansertib inhibited activation of the hypoxia pathway through the regulation of transcription factor HIF1α and its downstream targets.
  • Bev naïve patients treated with onvansertib + FOLFIRI/bev demonstrated a significantly greater overall response rate [odds ratio=13.64, p