Cardiff Oncology Inc. (NASDAQ:CRDF) on Tuesday closed around 32% lower after the management update and trial update.
Mani Mohindru, a board member since 2021, was named interim CEO, effective immediately. Mark Erlander, CEO, and James Levine, CFO, have stepped down.
To maintain financial continuity, Brigitte Lindsay was promoted to Chief Accounting Officer. She has been with the company for more than 14 years and most recently served as Senior Vice President of Finance. Cardiff Oncology has begun a search for a permanent CEO and CFO.
“The leadership transition reflects the Company’s focus on execution and clinical advancement as its programs mature,” the company said in a press release on Tuesday.
Colorectal Trial Data Update
Concurrently, Cardiff Oncology announced an update from CRDF-004, a randomized dose-finding Phase 2 trial evaluating onvansertib in combination with standard of care (SoC) regimens (FOLFIRI/bevacizumab (bev) or FOLFOX/bev) in patients with first-line (1L) RAS-mutated metastatic colorectal cancer (mCRC).
In an intent-to-treat analysis, the clinical data show dose-dependent benefits across multiple efficacy measures in patients receiving onvansertib with FOLFIRI/bev compared to patients receiving either the SoC regimen.
The 30 mg dose group demonstrated a 72.2% confirmed objective response rate versus 43.2% in the standard of care group, approaching statistical significance with a p-value of 0.051.
Progression-free survival data also showed improvement, with the 30 mg onvansertib plus FOLFIRI/bevacizumab group achieving statistical significance compared to standard care (p-value = 0.048). The median progression-free survival was not yet reached in the onvansertib treatment groups at the time of analysis.
In this trial, onvansertib with FOLFIRI/bev also performed better than onvansertib with FOLFOX/bev.
Based on these results, the company has selected the 30 mg dose of onvansertib with FOLFIRI/bev to bring forward in a registrational trial in 1L patients with RAS-mutated mCRC.
Cardiff Oncology plans to initiate a registrational program later this year, pending finalization of the trial design in consultation with the FDA, in which the company expects to compare onvansertib with FOLFIRI/bev to SoC regimens, FOLFIRI/bev, or FOLFOX/bev.
Onvansertib in combination with both chemo/bev regimens was well-tolerated. There were no major or unexpected toxicities observed and no additive adverse events. Grade 3 or higher adverse events were infrequent, with neutropenia being the most common treatment-emergent adverse event across both the onvansertib combination and standard of care arms.
Analyst Take
William Blair on Tuesday wrote, “Overall, given the abrupt management changes in the absence of a smooth transition plan, coupled with a narrowed focus on onvansertib in combination with FOLFIRI, as opposed to both FOLFIRI and FOLFOX, we view the update slants in a negative direction.”
Analyst Andy Hsieh reduced the probability of success to 45% from 50% previously. Assuming regulatory alignment with the FDA, focusing on the onvansertib plus FOLFIRI and Avastin reduces the total addressable market in the frontline setting to 12%-20% from 40%-50% previously.
William Blair maintains the Outperform rating.
Price Action: CRDF closed 31.9% lower to $2 on Tuesday, close to the lower end of the 52-week range of $1.85-$4.99 according to Benzinga Pro data.
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