Cardiff Oncology Inc (CRDF)

Just waiting for Onvansertib approval or a buyout!!! Phase 3 here we come!

Cardiff Oncology Announces Presentation of Positive Results from its Randomized, Controlled Phase 2 Trial of Onvansertib in First-Line RAS-Mutated mCRC at the 2026 ASCO Annual Meeting
----------------------------------------------------------
- The trial achieved its primary goal of selecting the efficacious and safe dose of onvansertib + standard-of-care (SoC) regimen for the registrational program
- 30 mg onvansertib + FOLFIRI/bevacizumab arm showed a dose-dependent improvement in efficacy, including confirmed ORR of 72.2% compared to 42.1% for SoC
- Median PFS has not been reached in either 20 or 30 mg onvansertib + FOLFIRI/bevacizumab arm, with nine of the 14 patients remaining on treatment in these arms
- Onvansertib continues to be safe and well-tolerated with no overlapping or new toxicities when added to SoC
- Registrational trial planned in first-line RAS-mutated mCRC following successful End-of-Phase 2 meeting with FDA.

Following the completion of the End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), the Company has aligned on the design of the registrational trial with onvansertib in mCRC. The randomized, controlled Phase 3 trial will evaluate the safety and efficacy of onvansertib 30 mg + FOLFIRI/bev as first-line therapy versus standard-of-care FOLFIRI/bev in patients with RAS-mutated mCRC.

CRDF.................................https://stockcharts.com/sc3/ui/?s=CRDF&p=W&b=5&g=0&id=p86431144783

Ugly good news beatdown but in fairness have no cash $2.52

pretty

CRDF under $ 5

got stopped out 5.17
needs to gain traction another day

onwards way past the recent 6$ high.... was on ph1 readout.

Successful offering completed Dec 11
$5.58 + 39% 

the good report on colorectal drug , maybe someone big wants to buy.

why only now?

this is on no volume...

super action

crdf.................https://stockcharts.com/h-sc/ui?s=crdf&p=W&b=5&g=0&id=p86431144783

not bad
Maybe it can start a new rally soon

weeeeeeeee...

careful... explosive material
5$ in route

too bad they only got 2.60s
crooks gamed it on the VWAP

here it comes
pfizer darling

Colorectal cancer positive results and offering at $2.60
$3.22 +'30%

CRDF........................https://stockcharts.com/h-sc/ui?s=CRDF&p=W&b=5&g=0&id=p86431144783

What the ????

Awesome story - they will rival Mirati in KRAS mutated CRC and combination options are a plus. Pfizer really wants this compound, will freshen up the space and hopefully make it cheaper too.

CRDF................................https://stockcharts.com/h-sc/ui?s=CRDF&p=W&b=5&g=0&id=p86431144783

https://www.globenewswire.com/news-release/2024/10/30/2972135/0/en/Cardiff-Oncology-Announces-Journal-of-Clinical-Oncology-Publication-of-Data-from-Phase-2-Trial-in-Second-line-KRAS-Mutant-mCRC.html
Pfizer coming.... desperate for this compound

Back above :)

CRDF under $3

soon (H2 24) going to present its 1st line mCRC data in which they are partnered with Pfizer. Pfizer is desperate for a compound here..........
And this one beats Mirati (the most similar company) in the clinic which was sold for 4bn$$$ recently.

Going back to and above the old high of 6.50.

will probably marry Pfizer and bring real benefit to those with KRAS mutation instead of conning investors and patients to retire management.

CRDF under $3

CRDF under $3

compare evaluation to Mirati. KRAS mutation and better data.

Pfizer likes and needs it...
not many in KRAS mutation

CRDF under $5

CRDF...................................................https://stockcharts.com/h-sc/ui?s=CRDF&p=W&b=5&g=0&id=p86431144783

CRDF new 52 hi

CRDF.........................https://stockcharts.com/h-sc/ui?s=CRDF&p=W&b=5&g=0&id=p86431144783

CRDF................................https://stockcharts.com/h-sc/ui?s=CRDF&p=W&b=5&g=0&id=p86431144783

CRDF new 52 week hi

PIper Sandler raises price target on CRDF from $5 to $7. Stock up 25%.

Bladerunner

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

CRDF.........................................https://stockcharts.com/h-sc/ui?s=CRDF&p=W&b=5&g=0&id=p86431144783

4s then 5 coming

Is this company being taken out? Incredible volume.

That post wasn’t too long ago
What I did several weeks ago was access the Barchart.com website which has lists of stocks belonging to sectors
I clicked for the biomedical sector up and .came up with a list and I wrote down every stock priced under $2USD and stated posting about each one
The list was for over 100 stocks
Get over $2 and the stock has a chance for higher prices

CRDF..........................................https://stockcharts.com/h-sc/ui?s=CRDF&p=W&b=5&g=0&id=p86431144783

Here comes 3

CRDF over $2 heading for $3

GhosT

CRDF under $2

CRDF under $2

CRDF under $2