Cardiff Oncology, Inc. (CRDF)

In our clinic reviewing the CRDF-004 trial data presented at ASCO by Dr. Heinz-Josef Lenz, the 72.2% overall response rate for the 30 mg onvansertib plus FOLFIRI and bevacizumab arm stands out remarkably against the 42.1% control arm. From a purely clinical and protocol standpoint, the progression-free survival hazard ratio of 0.37 and the generally well-tolerated safety profile of this PLK1 inhibitor give us profound optimism for first-line RAS-mutated metastatic colorectal cancer protocols. However, clinicians must monitor how trial logistics navigate the corporate backdrop.

On our desk, CRDF is a textbook high-risk, high-reward biopharma play right now. TD Cowen's move to downgrade the stock to Hold following NMS's notice of termination over patent inventorship has suppressed the multiple, sending shares trading 58% below their 52-week high. Even with the $10 million registered direct offering completed in July extending the cash runway, management explicitly noted that additional capital will be required to launch the pivotal study planned for 1Q:27. We are watching the preliminary injunction developments and Early Neutral Evaluation very closely before sizing up.

Watching the 50-day MA and SEC filings, the fundamental disconnect here is stark. On one hand, you have compelling Phase 2 efficacy data backed by Pfizer Ignite partnerships; on the other hand, the 10-K warns of going concern risks paired with a 2025 net loss of $45.9 million. The legal dispute with Nerviano alleges failure to correct inventorship on two U.S. patents and failure to use commercially reasonable efforts. Until the preliminary injunction motion is formally resolved by the court, the overhang on CRDF will likely cap upside momentum despite favorable oncology data.