Cardiff Oncology Reports First Quarter 2024 Results and Provides Business Update

About this update from Cardiff Oncology, Inc.

- 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

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