Key Highlights

  • CRDF shares are indicated up 2.23% at $0.89 in premarket, against a prior close of $0.88.
  • Leila Alland, MD, is interim Chief Medical Officer, succeeding Roger Sidhu, who stepped down.
  • Median PFS has not been reached in the onvansertib 30 mg plus FOLFIRI and bevacizumab arm.
  • All patients remaining on the trial have been on treatment for more than 18 months.
  • A registrational Phase 3 study is planned to start in the first quarter of 2027.

New Interim Medical Chief Arrives Ahead of Phase 3

Cardiff Oncology (NASDAQ:CRDF) shares are indicated up 2.23% at $0.89 in premarket after the company appointed Leila Alland, MD, as interim Chief Medical Officer. She succeeds Roger Sidhu, MD, who stepped down. The stock closed Tuesday up 8.80% at $0.88.

Cardiff Oncology, a San Diego-based clinical-stage biotechnology company founded in 1999 and formerly known as Trovagene, develops cancer therapies built around PLK1 inhibition. Its lead asset, onvansertib, is an oral, highly selective PLK1 inhibitor being tested in a randomized Phase 2 trial in first-line RAS-mutated metastatic colorectal cancer. CEO Mani Mohindru leads the company.

Phase 2 Data Underpin the Planned Phase 3

The 30 mg onvansertib plus FOLFIRI and bevacizumab arm showed a 72.2% confirmed objective response rate versus 43.2% for standard of care, with a progression-free survival hazard ratio of about 0.37 and no significant added toxicity. Median PFS has not been reached in the arm, which is the proposed Phase 3 regimen, and all patients remaining on trial have been on treatment for more than 18 months.

Cardiff plans to start its registrational Phase 3 study in the first quarter of 2027.

Alland Brings Oncology Development Experience

Dr. Alland has served as Chief Medical Officer at several clinical-stage biotechnology companies, including PMV Pharma (NASDAQ:PMVP), and held leadership roles at large pharmaceutical companies, where she contributed to the development and approvals of oncology therapies including Tagrisso, Opdivo, Tasigna and Caelyx. She serves on the board of Abeona Therapeutics (NASDAQ:ABEO).

Micro-Cap Valuation Keeps Focus on Phase 3 Start-Up

Cardiff has a market cap of $68.08 million and a loss of $0.60 per share, and the 52-week range runs from $0.76 to $3.31. The net takeaway is that the appointment is a modest catalyst, and investors will focus on Phase 3 start-up and funding.