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Cardiff Oncology Inc. (CRDF) has reported its financial results for the fourth quarter of 2024, revealing a strategic focus on its lead program and a strong cash position. The company’s financial performance was underscored by a significant capital raise and promising clinical trial results, although market reactions were mixed following the earnings announcement. According to InvestingPro data, the company maintains a healthy financial position with more cash than debt on its balance sheet, a key strength in the biotechnology sector.
Key Takeaways
- Cardiff Oncology completed a $40 million capital raise, bolstering its cash reserves.
- The company’s lead program, ONVANSERTIB, showed promising results in clinical trials for metastatic colorectal cancer.
- Cardiff’s cash runway is projected to extend into the first quarter of 2027.
- The stock saw a decline of 8.97% in regular trading hours but rebounded by 2.71% in after-hours trading.
Company Performance
Cardiff Oncology’s performance in the fourth quarter of 2024 was marked by strategic advancements in its clinical programs and a robust financial position. The company focused on its ONVANSERTIB program, targeting RAS mutated metastatic colorectal cancer, a significant unmet medical need. The trial results showed a favorable safety profile and efficacy, positioning Cardiff as a potential leader in this therapeutic area.
Financial Highlights
- Cash and short-term investments: $91.7 million as of December 31, 2024
- Cash used in operating activities: $10.3 million in Q4 2024
- Capital raise: $40 million completed in December 2024
Market Reaction
Cardiff Oncology’s stock experienced a notable decline of 8.97% during regular trading hours, closing at $4.46. However, the stock price rebounded by 2.71% in after-hours trading, reaching $4.17. This movement reflects a mixed market sentiment, possibly influenced by the company’s financial results and clinical trial outcomes. InvestingPro analysis indicates the stock is slightly overvalued at current levels, despite impressive returns of 150.56% over the past year and 90.6% over the last six months. The stock trades between its 52-week range of $1.74 to $6.42, with notably volatile price movements typical of clinical-stage biotech companies.
Outlook & Guidance
Looking ahead, Cardiff Oncology plans to release additional clinical data in the first half of 2025 and engage with the FDA to discuss its registrational strategy for ONVANSERTIB. The company is also exploring further investigator-initiated trials and continues to strengthen its intellectual property portfolio.
Executive Commentary
CEO Mark Erlanger expressed optimism about ONVANSERTIB’s potential impact, stating, "We continue to believe that ONVANSERTIB has the potential to change the treatment paradigm for the large number of patients who are diagnosed with RAS mutated MCRC each year." CFO Jamie Levine highlighted the company’s financial discipline, noting, "Our cash used in operating activities was $10,300,000 in Q4 twenty twenty four, which is in line with our typical quarterly cash burn."
Risks and Challenges
- Regulatory hurdles: The need for FDA approval could delay product launches.
- Competitive landscape: Emerging therapies from competitors may impact market share.
- Financial sustainability: Continued capital requirements could pressure cash reserves.
- Market volatility: Stock price fluctuations may affect investor confidence.
Q&A
During the earnings call, analysts inquired about the timing of data updates, dose selection strategies, and comparisons with Pfizer (NYSE:PFE)’s encorafenib trial. There was also interest in the potential impact of KRAS G12C inhibitors, reflecting broader industry trends and competitive dynamics.
Full transcript - Cardiff Oncology Inc (CRDF) Q4 2024:
Conference Operator: Welcome to the Cardiff Oncology Fourth Quarter twenty twenty four Financial Results and Business Update Conference Call. At this time, all participants are in a listen only mode. After the speaker’s presentation, there will be a question and answer session. To ask a question during the session, you will need to press 11 on your telephone, and you will then hear an automated message advising your hand is raised. Please be advised that today’s conference is being recorded.
I would now like to turn the conference call over to Kiki Patel of Gilmartin Group, my reading. Please go ahead.
Kiki Patel, Investor Relations, Gilmartin Group: Thank you, operator. Joining us on the call today from Cardus Oncology are Chief Executive Officer, Mark Erlanger and Chief Financial Officer, Jamie Levine. During the conference call, management will make forward looking statements, including without limitation, statements related to guidance, results and timing of data readouts for onvansertib clinical trials. These forward looking statements are based on the company’s current expectations and inherently involve significant risks and uncertainties. Our actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties.
Factors that could cause results to be different from these statements include factors the company describes in the section titled Risk Factors in its annual report on Form 10 ks filed with the SEC for the year ended 12/31/2024. Cardiff Oncology undertakes no duty or obligation to update any forward looking statements as a result of new information, future events or changes in its expectations. With that, I turn the call over to Chief Executive Officer, Mark Erlander. Mark?
Mark Erlanger, Chief Executive Officer, Cardiff Oncology: Well, thank you, Kiki, and good afternoon, everyone, and thank you for joining our business update conference call. The fourth quarter of twenty twenty four was significant for Cardiff Oncology. On December 10, we released an initial cut of data from our ongoing CARTF004 trial in first line RAS mutated metastatic colorectal cancer or MCRC, which we believe was highly encouraging and served as a basis for us to successfully complete a $40,000,000 capital raise. On today’s call, we address four topics. First, we will briefly review the data we previously released from our lead program in MCRC and then provide an update on CARTF004 enrollment activity and our registrational plans for Avansertib.
Second, we’ll discuss our intellectual property strategy, including the advances made in 2024 and what we expect for 2025. Third, we will share highlights from two preclinical posters we presented at the San Antonio Breast Cancer Symposium in December. And finally, we’ll discuss our financial position that we disclosed today in our Form 10 ks filing. I begin with a review of the previously disclosed data from CARTF004, which is our ongoing randomized Phase two trial in first line RAS mutant MCRC evaluating two dose levels of onvacertib combined with current standard of care regimens FOLFIRI or FOLFOX plus bevacizumab or bev versus standard of care alone. In December, we released an initial data set as of 11/26/2024 for the first thirty patients on the trial.
Overall, we were pleased with the efficacy signal observed in the trial. First, as of the data cutoff date, patients on the thirty mg dose of omansertib demonstrate a 64% ORR compared to a 33% ORR in the control arm. Second, the thirty mg arm demonstrated deeper tumor responses than the other arms. Specifically, the five deepest tumor regressions seen across the entire trial are in patients receiving the thirty mg dose of onvansertib. Based on the data released, we believe this correlation between the dose of onvansertib and the magnitude of therapeutic effect serves as an initial signal that onvansertib is a biologically active drug candidate for the treatment of MCRC.
Finally, I would like to highlight ONVANSERTIP’s favorable safety profile, which is an important differentiating factor over previous PLK1 inhibitors that have failed in the clinic due to toxicity concerns. Over three eighty patients have been dosed with ONVANSERTIB across multiple clinical trials to date and the treatment has been well tolerated. For the full CARD F004 clinical trial results from the initial data cut, please refer to our corporate presentation or the investor call from December 10 posted on our Investor Relations website. We continue to expect to release additional clinical data from the CARD F-four trial in the first half of twenty twenty five. Next (LON:NXT), I will share the current status of our MCRC program as it pertains to enrollment and our registrational strategy.
First, regarding enrollment, in December, we mentioned that we expected to complete enrollment of the 90 evaluable patients planned in the CARD-four trial in early twenty twenty five. Today, I can share that this week we closed the trial to new patients entering screening. We anticipate complete enrollment in the trial in the next few weeks. Secondly, there is an important FDA approval in Q4 twenty twenty four from another company that validates our registrational strategy for the approval of ombansertib and McRC. Specifically, Pfizer announced the results from a MIDS BRAKEWATER trial evaluating its drug in corafenib in first line McRC patients with a BRAK mutation.
And to be clear, this is a totally separate patient population from our RAS mutated McRC focus. Pfizer’s BRAKEEWTR trial achieved accelerated approval using ORR from a subset of patients at an interim time point and subsequently achieved statistically significant and clinically meaningful improvement in progression free survival, which is their endpoint for full approval. The regulatory pathway used by Pfizer to pursue accelerated full approval for encorifenib from a single trial is the same as our registrational plans agreed with FDA for evansertib and therefore reinforces the validity of our strategy. I now move on to our second agenda topic, our intellectual property strategy. In Q4 twenty twenty four, we strengthened our intellectual property portfolio for ONVANSERTIB with the issuance of a new patent.
The claims cover the method of using ONVANSERTIB in combination with BEV for the treatment of KRAS mutated mCRC patients who have not previously been treated with bev. The patent aligns with the target patient population of our lead mCRC program and has an expected expiration date of no earlier than 02/1943. We believe the new patent underscores the groundbreaking nature of our discovery demonstrating on Vansertib’s powerful synergy with Beb in inhibiting angiogenesis. We continue to explore new opportunities to convert the novel discoveries we have made regarding the role of PLK1 inhibition into new intellectual property and you could expect to hear more on these efforts later this year. Now I will move to the third item of our agenda.
In December, we presented two poster presentations at the San Antonio Breast Cancer Symposium reporting preclinical data from our breast cancer program. The objective of the first poster was to evaluate onvansertib in combination with paclitaxel as a potential therapeutic strategy for hormone receptor positive or HR positive breast cancer patients after progression on endocrine therapy and CDK4six inhibitors. In vitro, onvansertib demonstrated synergistic activity with paclitaxel and HR positive breast cancer cell lines. In vivo, the combination exhibited robust anti tumor activity in eight patient derived xenograft or PDX models resistant to first line therapies. The second poster evaluated the combination of ovansertib and INHER2 in drug resistant HR positive breast cancer PDX models.
The combination of ovansertib plus INHER2 was well tolerated, overcame INHER2 resistance and displayed enhanced antitumor activity compared to each monotherapy. Overall, the combination of INHER2 with ONVANSRETIP represents a promising therapeutic strategy for HR positive breast cancer patients resistant to first line therapies. We believe these posters highlight the broad potential of ONVANSRETIB, some of which we are currently evaluating through our investigator initiated trials. For our last agenda item, I will turn the call over to Jamie to talk about our fourth quarter financials. Jamie?
Jamie Levine, Chief Financial Officer, Cardiff Oncology: Thank you, Mark. Earlier today, we issued a press release and filed a Form 10 ks with the SEC, which contain our financial results for the full year ending 12/31/2024. Turning to our balance sheet, cash and short term investments as of 12/31/2024 totaled $91,700,000 which includes the net proceeds of the $40,000,000 capital raise we successfully completed in December with new and existing healthcare dedicated institutional investors. Our cash used in operating activities was $10,300,000 in Q4 twenty twenty four, which is in line with our typical quarterly cash burn. Based on the cash spend forecasted for our ongoing clinical programs, we believe that our current cash resources provide us with runway into the first quarter of twenty twenty seven.
Finally, I’d like to point out that today we also filed a shelf registration statement on Form S3, which replaces our previous shelf that was due to expire in April of this year. It has always been our practice to maintain an active shelf registration statement. And for clarity, the S3 we filed today did not involve the issuance of any shares. With that, I’ll turn the call back over to Mark.
Mark Erlanger, Chief Executive Officer, Cardiff Oncology: Thank you, Jamie. As you could hear from our remarks today, we are highly encouraged by the efficacy results from the CARDIFF-four trial that we shared in December, and we look forward to sharing additional updates from the trial in the first half of this year. With that, I would like to take a moment to thank the clinical investigators and importantly the patients and their families whose participation in the trial is enabling our clinical development efforts. We continue to believe that ONVANSERTIP has the potential to change the treatment paradigm for the large number of patients who are diagnosed with RAS mutated MCRC each year. With that, I will now open the call up for questions.
Operator?
Conference Operator: Great. Thank you. Our first question comes from Mark Frum with TD Cowen. Your line is now open.
Alex/Andy Tsai, Analyst, Various (TD Cowen, William Blair): Hi, this is Alex on for Mark. Thanks for taking my question. So can you give us any sense of when exactly in the first half that data update is coming and in what context? And then in that update, how many new patients do you expect will become a valuable for ORR and also how mature do you expect those PFS curves to be? Thank you.
Mark Erlanger, Chief Executive Officer, Cardiff Oncology: Thanks, Alex, for that question. At this point in time, what our goal is, is to really to put our next update to actually give a more mature and substantive update since the 30 patient update. So at this point, that’s really what we had planned to do. When it comes to PFS, I think that this is probably early too early for PFS within the first half of this year, but that’s something that obviously we will be updating beyond this half, this first half.
Joe Catanzaro, Analyst, Piper Sandler: Great. Thank you.
Conference Operator: Please standby for the next question. Our next question comes from Joe Catanzaro at Piper Sandler. Your line is now open.
Joe Catanzaro, Analyst, Piper Sandler: Great. Hey, everybody. Thanks for your update. Thanks for taking my questions. Maybe a couple for me here.
Can you just sort of speak to your thoughts around when you will make the dose selection decision and whether that will come together with your interactions with the FDA and converting four to potential registrational trial. Just maybe walk through sort of the cadence of those decision points and I have a follow-up. Thanks.
Mark Erlanger, Chief Executive Officer, Cardiff Oncology: Thanks Joe for that question. Really our goal, as you know, this is the CARTA004 is based on Project Optimus. And our goal really is to get in front of the FDA as soon as possible. And there’s really two topics that we will be talking to the FDA about. The first, of course, is the dose, which is thirty versus twenty.
And then the second really is the really finalizing the trial design for the registrational trial, the five. So I mean, from our point of view, our goal is to get to the FDA as soon as possible. This may or may not be all 90 patients,
Alex/Andy Tsai, Analyst, Various (TD Cowen, William Blair): it could be less.
Mark Erlanger, Chief Executive Officer, Cardiff Oncology: Of course, it will depend on looking at that signal between with the thirty and twenty. So I think that that’s really where we are right now. And of course, after that meeting with the FDA, that will give us clarity and that will be the gating factor for going into the registrational five trial.
Joe Catanzaro, Analyst, Piper Sandler: Okay, got it. So my follow-up relates to your comments, Mark, on the breakwater trial of encorafenib. Yes. Not terribly familiar with the data off the top of my head here. So my question is whether the response rate delta that they observed in that trial that supported an accelerated approval aligns with what you’ve seen thus far in the four study?
Mark Erlanger, Chief Executive Officer, Cardiff Oncology: Yes, certainly Joe, great question. Certainly, it’s consistent. Their ORR was 61 versus 40. So I think that it’s certainly consistent Thank you.
Conference Operator: Thank you. Our next question comes from Andy Tsai at William Blair. Your line is now open.
Alex/Andy Tsai, Analyst, Various (TD Cowen, William Blair): Thanks for the updated taking our questions. Two for me, if you don’t mind. One is really kind of your evolving thinking in terms of the velocity of tumor size reduction. So basically looking at the December data, one of the most obvious observations is really the slope of the control arm is relatively flat over time. And then it deepens, as you alluded to Mark on the call for the twenty milligram and thirty milligram.
So I’m curious if that data based on some of the prior CRC experience could derisk or inform how you think about endpoint, approvable endpoint such as BFS and OS. So that’s question number one. Question number two has to do with also also breakwater. So in that trial, the patient number that’s required for the accelerator approval was about 100 patients each arm. So I’m curious if that’s kind of that could potentially form the framework of your upcoming discussion with the FDA in the context of the accelerated approval pathway?
Thank you.
Mark Erlanger, Chief Executive Officer, Cardiff Oncology: Thanks, Andy, for both of those questions. Yes, going after that first one, clearly there has been data in CRC first line in previous trials showing that earlier responses and deeper responses have a correlation and are associated with greater PFS and OS. So that’s something that is known. And I think moving on to the breakwater, well, certainly, their 110 per arm was what they went after for their interim. Certainly, we are looking at that.
We will be, of course, talking to the FDA to finalize the specifics around our assumptions and our trial design when we do meet with them. But certainly one point that you make, Andy, which is a good one is that what Breakwater showed was a fewer patients are needed for the accelerated and of course the full approval. So thank you for both those questions.
Alex/Andy Tsai, Analyst, Various (TD Cowen, William Blair): Great. Thank you. Thank you.
Conference Operator: Our next question comes from Robert Burns at H. C. Wainwright. Your line is now open.
Robert Burns, Analyst, H.C. Wainwright: Hi guys. Thanks for taking my questions. And again congrats on the amazing data that you reported late last year. I guess just one follow-up from me. So obviously we know about the code BREAK301 trial and although KRAS G12C is a minor component in colorectal cancer, I wanted to get your thoughts as to how you view that agent, especially also the pan RAS agents that are also being developed in the space?
Mark Erlanger, Chief Executive Officer, Cardiff Oncology: Great, Robert. Thanks for both those questions. The Dweeb G12C inhibitors, as you mentioned, there is an approval of the Amgen (NASDAQ:AMGN)’s drug last year, but that was really in second line. And that, of course, is just with G12C, which you know is a very small sliver of the KRAS and RAS mutated patients. It’s about makes up about four percent of RAS mutated patients.
So I think that from what we look at there, it’s really it’s not really too it doesn’t really impact what we’re doing in first line, since they are in second line and it’s such a small and we also do have G12C mutations patients with those mutations within our trials. So that’s the with the RevMed, the G12X program, clearly, they’re the signal is in the non small cell as well as the pancreatic or the PDAC. And so we don’t see as much activity with their agents or for what they’ve reported in the colorectal. But we certainly are keeping an eye on their progress and what they’re doing in this space.
Robert Burns, Analyst, H.C. Wainwright: Awesome. Thanks for taking my questions and congrats again.
Mark Erlanger, Chief Executive Officer, Cardiff Oncology: Thank you, Robert.
Alex/Andy Tsai, Analyst, Various (TD Cowen, William Blair): Thank
Conference Operator: you. The next question comes from Albert Lowe with Craig Hallum. Your line is now open.
Alex/Andy Tsai, Analyst, Various (TD Cowen, William Blair): Hi, everyone. Thanks for taking my question. I was just wondering, it’s great to see that enrollment is going to complete over the next few weeks here. So do you think we’ll be able to see all of the 90 patients included in this first half update?
Mark Erlanger, Chief Executive Officer, Cardiff Oncology: Yes. Albert, thank you for that question. Yes, we are very pleased and excited that we’re really within a couple of weeks of finishing the enrollment. We did have 60 patients dosed by in December when we reported out the 30 patients who had at least one post baseline scan. And so we continue to obviously, we’ll be continuing to treat these patients.
And our goal really for this first half and reporting out the next update is really to make sure it’s a substantive and really more mature update from the trial. So we leave it at that at this point. Okay. I see. Thank you.
Thanks, Albert.
Conference Operator: All right. I’m showing no other questions at this time. So this will conclude the question and answer session. I would now like to turn it back to Mark for closing remarks.
Mark Erlanger, Chief Executive Officer, Cardiff Oncology: Thank you, operator, and thank you all again for everyone here for joining us this afternoon for this call.
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