bladerunner1717
9 월 전
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.
Bladerunner
stockguard
4 년 전
Analysts Say ‘Buy the Pullback
Cardiff Oncology (CRDF)
The first stock we’re looking at, Cardiff Oncology, is a clinical stage biopharma company with a laser-focus on cancer treatment. Specifically, the company focuses on the development of medication options for cancer patients whose current treatment has lost efficacy. Cardiff is developing onvansertib, a first-in-class, third generation Polo-like Kinase 1 (PLK1) inhibitor, designed to work in combination with existing medications to overcome treatment resistance, improve patient response, and increase survival rates.
Cardiff’s current research pipeline features onvansertib in three separate clinical programs, in combination with different existing drugs to combat three different cancers. The programs are a Phase 1b clinical trial of onvansertib plus Folfiri/Avastin for the treatment of KRAS-Mutated Metastatic Colorectal Cancer (mCRC), and two Phase 2 trials, one in combination with Zytiga to treat Metastatic Castration-Resistant Prostate Cancer (mCRPC) and one to treat Relapsed/Refractory Acute Myeloid Leukemia (AML) in combination with Decitabine.
Preliminary data on these studies shows positive responses to onvansertib in combination with existing therapies. In the mCRC program, 86% of evaluable patients have shown a clinical benefit, while in the mCRPC program 54% of patients across three cohorts showed a radiographic stable disease. In the AML program, 20% of patients achieved a complete remission. These early data are considered significant, and the company has plans to initiate further trials later this year.
This background, along with the stock’s 50% fall year-to-date, have combined to catch the attention of 5-star analyst Jason McCarthy of Maxim Group. McCarthy points out that the shares have retreated recently due to profit-taking and broader market changes.
“While valuation has pulled back since reaching a 52-week high in late 4Q, from a KRAS perspective, CRDF is not alone… and we view Cardiff as potentially having the more attractive asset in mCRC which continues to be supported with emerging data… we still see a KRAS space that will continue to be active and is of potential high value given the unmet need, a company in Cardiff that is well-financed ($130M in cash as of YE20), and a drug in onvansertib that has multiple opportunities. Combined, we see this as an opportunity to buy CRDF shares on the weakness,” McCarthy opined. McCarthy puts a Buy rating on CRDF, and his $30 price target implies a robust upside of 242% from current levels.
https://www.tipranks.com/news/article/analysts-say-buy-the-pullback-in-these-3-stocks-2/
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