Cardiff Oncology Inc【CRDF】株式ニュース

CRDF: Change of opinion by "Seeking Alpha" analyst

Cardiff Oncology: Why The Bulls Are Winning Right Now (Rating Upgrade)

Mar. 08, 2024 7:37 PM ET Cardiff Oncology, Inc. (CRDF) Stock 8 Comments2 Likes

Galzus Research

Summary
Cardiff Oncology is focused on developing a drug for colorectal cancer and pancreatic cancer, with promising early activity shown in colorectal cancer patients.
The company is now focused on moving their drug to the first-line setting and has started a clinical trial to evaluate its efficacy.
Cardiff Oncology has a strong financial position with enough funds to operate through Q3 2025, but the success of their drug is heavily dependent on the outcomes of a single trial.

Topline Summary and UpdateCardiff Oncology (NASDAQ: CRDF) is a cancer-focused biotech working on developing a drug that exploits a novel target, particularly in colorectal cancer. In my past articles, I have been lukewarm to slightly pessimistic about their findings presented to date and their overall outlook. But recent news has sent them on a meteoric rise, and the ensuing roller coaster has readers asking me directly for input on this company. So let's examine what happened to lead to this strong rise in value, as well as where I think they might be headed next.

Pipeline UpdatesOnvansertib

Today, the PLK1 inhibitor onvansertib remains the one and only drug in development by CRDF, meaning its entire future rests on the success or failure of this agent. It is being studied mainly in a few forms of gastrointestinal cancer, namely colorectal cancer and pancreatic cancer, both representing critical unmet needs in oncology.

Most of the focus I've given in my previous writings has been for the colorectal cancer program, which has demonstrated some encouraging (though early) activity in the setting of KRAS -mutant, metastatic disease. Updated findings using add-on onvansertib with FOLFIRI-bevacizumab in the second-line setting have since been published in Clinical Cancer Research, showing a 44% response rate among 18 patients, with reasonable toxicity.

Now, the company's focus is on moving onvansertib to the first-line setting, hurdling over the typical path we have taken in targeted therapy development of starting with more "dire" clinical settings, establishing efficacy, and then moving them up. The phase 2 CRDF-004 study is seeking to randomize 90 patients with newly diagnosed, metastatic, KRAS or NRAS mutated CRC to receive first-line doublet chemotherapy plus bevacizumab, with or without one of 2 doses of onvansertib. The primary endpoint is objective response rate. CRDF announced that the first patient was dosed in this study on leap day. Initial top-line findings are anticipated later this year.

The phase 2 ONSEMBLE second-line study has been discontinued to focus on the frontline study, but CRDF provided an update in their most recent guidance that they interpret as evidence that patients who had no prior bevacizumab seemed to have better response rates, as high as 50%. It is worth keeping in mind that the patient numbers are small here, and in the standard of care, most patients with KRAS mutated mCRC are going to receive bevacizumab as part of their care, so it's difficult to interpret these findings with any real de

We've also gotten glimpses of clinical development for onvansertib in non-CRC settings. Most notably, a report of activity back in September suggests preliminary benefit from onvansertib in metastatic pancreatic cancer and extensive-stage small cell lung cancer. In particular, 4 of 21 patients with pancreatic cancer treated with add-on onvansertib (plus nal-IRI and 5-FU) yielding a 19% objective response rate, which tracks favorably with the findings from NAPOLI-1. A single response was observed with onvansertib monotherapy in the 7 patients with SCLC.

Financial OverviewAs of their most recent earnings report, CRDF held $77.4 million in total current assets, including $21.7 million in cash and equivalents, and another $53.2 million in short-term investments. Their reported annual loss was $45.4 million, with a recognized net loss of $41.4 million after interest income and other expenses.

Given these expenses, CRDF has upwards of 2 years of cash and assets on hand to fund activities, with a serious going concern emerging about a year from now at the current burn rate, by my estimation. This is consistent with guidance from the company saying they have funds to operate through Q3 2025.

Strengths and RisksStrength - CRDF's fiscal management focuses on high-priority studies

For a company in the middle of developing a drug, CRDF has a rather low cash burn rate. This could help give them time to get a data readout that propels them to the levels that we've seen recently with the likes of Janux Therapeutics, where relatively small numbers rev up a huge cash raise. Such penny-pinching stewardship is admirable, although there is a catch

Risk - Careful prioritization places most eggs in one basket

CRDF is now resting almost everything on the CRDF-004 study, and this trial is taking a risky step moving things into the frontline setting. Despite it being at the FDA's recommendation (according to the company), the observation in their 2 early studies that bevacizumab-naive patients seemed to derive the most benefit from onvansertib is shaky to me. These are small patient numbers, and I don't feel this is a hypothesis that's been carried through rigorously enough at this point.

That doesn't mean I think they're wrong, and I don't think it's a wantonly reckless step to go first line. If onvansertib really does work best in bev-naive patients, then this should end up being the exact play they need to make. But it's based on an idea that comes from pretty small patient numbers, and CRDF-004 may not generate convincing-enough findings to really show that onvansertib is moving the needle. All investors should be aware of that risk before jumping in.

Bottom-Line Summary: Why the Rating Change?As of late, developmental biotech companies are undergoing a surge of interest, with multiple companies showing promising phase 1 data sending them into market caps of billions. I do not think this is necessarily justified, but it speaks to the power of encouraging early data. CRDF, even after its recent gains, has the opportunity to surge even higher if their anticipated mid-2024 data readout in CRC shows support for their idea that onvansertib has more benefit in patients with no exposure to bevacizumab (which would be true of all first-line patients).

Tackling KRAS would be a huge coup, since there are currently no approved therapies that are specifically beneficial for patients in the frontline setting of mCRC with KRAS mutations. It's only used right now to help determine what therapies patients should not receive.

All said, I'm upgrading my rating to a "strong buy," which means that I think you should take a serious look at their portfolio and consider entering into a limited position. I would warn heavily against overextending, though, since so much of the company's value is now going to be tied to the outcomes of a single trial, and a lot can go wrong there. But it is clear now that the ceiling is too high to ignore for this company.

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