Q4 2024 Cardiff Oncology Inc Earnings Call
Okay.
Welcome to the card up oncology fourth quarter 'twenty 'twenty four financial results and business update conference call. At this time, all participants are in a listen only mode.
Speaker Change: 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 star one one on your telephone and you will then hear an automated message advising your hand is raised please be advised today's conference is being recorded I would now like to turn the conference call over to <unk>.
Speaker Change: We keep a tell of Gilman group, Oh, sorry, Gilmartin group My reading [laughter]. Please go ahead.
Speaker Change: Thank you operator, joining us on the call today from cortisol ecology, our Chief Executive Officer, Mark early under and Chief Financial Officer, Jamie Levine.
Speaker Change: During the conference call management will make forward looking statements, including without limitation statements related to guidance results and timing of data readouts for on vans are good clinical trials.
Speaker Change: These forward looking statements are based on the company's current expectations and inherently involve significant risks and uncertainties.
Speaker Change: 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.
Speaker Change: Doctors 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-K filed with the SEC for the year ended December 31 2024.
Speaker Change: Curtis 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.
Speaker Change: With that I'll turn the call over to Chief Executive Officer, Mark early under Mark well. Thank you Jackie and good afternoon, everyone and thank you for joining our business update conference call.
Speaker Change: The fourth quarter of 2024 was significant for card up oncology on December 10th we released an initial cut of data from an ongoing part of 004 trial in first line Ras mutated metastatic colorectal cancer or M. CRC, which we believe was highly encouraging and served.
Speaker Change: As a basis for us to successfully complete a $40 million capital raise.
Speaker Change: On today's call we address four topics.
Speaker Change: We will briefly review the data we previously released from our lead program in <unk> and then provide an update on Carter's, Georgia for enrollment activity and our Registrational plans for an answer to.
Speaker Change: Second we will discuss our intellectual property strategy, including the advances made in 2024 and what we expect for 2025.
Speaker Change: Third we will share highlights from two preclinical posters, we presented at the San Antonio breast cancer Symposium in December.
Speaker Change: And finally, we'll discuss our financial position that we disclosed today in our Form 10-K filings.
Speaker Change: I begin with a review of the previously disclosed data from Cardiff 004, which is our ongoing randomized phase II trial in first line Ras mutant M. CRC evaluating two dose levels of <unk> combined with current standard of care regimen.
Speaker Change: Full theory, or full Fox, plus bevacizumab or bev versus standard of care alone.
Speaker Change: In December we released the initial dataset as of November 26, 2024 for the first 30 patients on the trial.
Speaker Change: Overall, we were pleased with the efficacy signal observed in the trial first as of the data cutoff date patients on the 30 Mig dose of advance or to demonstrate at 64% or are compared to a 33% or are in the control arm.
Speaker Change: Second the 30, Meg 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 30 Mig dose upon the answer Jim.
Speaker Change: Based on the data released we believe this correlation between the dose of an advance or tip and the magnitude of therapeutic effect serves as an initial signal that on balance or TIB is a biologically active drug candidate for the treatment of M. CRC finally, I would like to highlight on <unk> favorable safety profile.
Which is an important differentiating factor over previous <unk> inhibitors that have failed in the clinic due to toxicity concerns over 380 patients have been dosed with <unk> across multiple clinical trials to date and the treatment has been well tolerated.
Speaker Change: For the full cart zero-zero for clinical trial results from the initial data cut please refer to our corporate presentation or the investor call from December 10th posted on our Investor Relations website.
Speaker Change: We continue to expect to release additional clinical data from the <unk> 004 trial in the first half of 2025.
Speaker Change: Yes.
Next I will share the current status of our <unk> 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 <unk>.
Speaker Change: While in early 2025 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.
Speaker Change: Currently there isn't an important FDA approval in Q4 24.
Speaker Change: From another company that validates our Registrational strategy for the approval of <unk> in EM, CRC, specifically Pfizer announced the results from our midst breakwater trial evaluating its dropped an in court for nib in first line <unk> CRC patients with BRAF mutation and to be clear.
Speaker Change: This is a totally separate patient population from our RASK reaches mcse focus.
Speaker Change: Pfizer's breakwater trial achieved accelerated approval using or are from a subset of patients at an interim time point and subsequently achieved a statistically significant and clinically meaningful improvement in progression free survival, which is their endpoint for full approval.
Speaker Change: The regulatory pathway used by Pfizer to pursue accelerated and full approval for and core for them from a single trial is the same as our Registrational plans agreed with FDA for advance our chip and therefore reinforces the validity of our strategy.
Speaker Change: I now move on to our second agenda topic, our intellectual property strategy in Q4, 2024, we strengthened our intellectual property portfolio for advanced chip with the issuance of a new patent.
Speaker Change: The claims cover the method of using an advance or two in combination with Beth.
Speaker Change: The treatment of K, Ras mutated <unk> patients, who have not previously been treated with Beth.
Speaker Change: The patent aligns with the target patient population of our lead <unk> program.
Speaker Change: Program and has an expected exploration date of no earlier than 2043.
Speaker Change: We believe the new patent underscores the groundbreaking nature of our discovery demonstrating on Bachelor tips powerful synergy with Bev in inhibiting angiogenesis.
Speaker Change: We continue to explore new opportunities to convert the novel discoveries. We have made regarding the role of <unk> inhibition into new intellectual property and you could expect to hear more on these efforts later this year.
Speaker Change: 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.
Speaker Change: The objective of the first poster was to evaluate on <unk> in combination with Paclitaxel as a potential therapeutic strategy for hormone receptor positive our HR positive breast cancer patients after progression on endocrine therapy, and CDK <unk> inhibitors.
Speaker Change: In vitro, an advance or tip demonstrated synergistic activity with paclitaxel in HR positive breast cancer cell lines.
Speaker Change: In vivo the combination exhibited robust anti tumor activity in a patient derived xenograft or pdx models resistance to first line therapies.
Speaker Change: The second poster evaluated the combination of on the answer tip and then hurt you in drug resistant HR positive breast cancer Pdx models. The combination of <unk> plus in her two was well tolerated overcame and Hershey resistance and displayed enhanced anti tumor activity compared to each monotherapy.
Speaker Change: Overall, the combination of and it hurts you without <unk> represents a promising therapeutic strategy for HR positive breast cancer patients resistant to first line therapies.
Speaker Change: We believe these posters highlight the broad potential of on the answer to some of which we are currently evaluating two or investigator initiated trials.
Speaker Change: For our last agenda item I will turn the call over to Jamie to talk about our fourth quarter financials Jamie.
Jamie Levine: Thank you Mark.
Jamie Levine: Earlier today, we issued a press release and filed a Form 10-K with the SEC, which contain our financial results for the full year ending December 31 2024.
Jamie Levine: Turning to our balance sheet cash and short term investments as of December 31, 2024 totaled $91 $7 million, which includes the net proceeds of the $40 million capital raise we successfully completed in December with new and existing healthcare dedicated institutional investors.
Jamie Levine: Our cash used in operating activities was $10 $3 million in Q4, 2024, which is in line with our typical quarterly cash burn.
Jamie Levine: 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 2027.
Jamie Levine: Finally, I'd like to point out that today, we also filed a shelf registration statement on form S. Three which replaces our previous shelf that was due to expire in April of this year.
Mark Early: It has always been our practice to maintain an active shelf registration statement and for clarity. The S. Three we filed today did not involve the issuance of any shares with that I'll turn the call back over to Mark.
Mark Early: Thank you Jamie.
Mark Early: As you could hear from our remarks today, we are highly encouraged by the efficacy results from the card at the Georgia for trial and we that we shared in December and we look forward to sharing additional updates from the trial in the first half of this year.
Mark Early: 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.
Mark Early: We continue to believe that <unk> has the potential to change the treatment paradigm for the large number of patients who are diagnosed with Ras mutated M CRC each year.
Mark Early: With that I will now open the call up for questions operator.
Speaker Change: Great. Thank you at this time, we will conduct a question and answer session. As a reminder to ask a question you will need to press star one one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again, please standby, while we compile the Q&A roster.
Speaker Change: Our first question comes from Mark from with TD Cowen. Your line is now open.
Speaker Change: Hi, This is Alex on for Mark Thanks for taking my question. So.
Speaker Change: So can you give us any sense of when exactly in the first half that data update is coming in what context and then.
Speaker Change: That update how many new patients do you expect will become a valuable for <unk>.
Speaker Change: And also how mature do you expect those PFS curves to be thank you.
Alex: Oh, Thanks, Alex for that question.
Alex: At this point in time, what our goal is is to really to our next update to to actually give a more mature and substantive update since the 30 patient update so at that point at this point that's really.
Alex: What we had planned to do.
Alex: When it comes to PFS.
Alex: I think that this is probably early too early for PFS.
Within the first half of this year.
Alex: But that's something that obviously, we will be updating.
Alex: Beyond this half this first half.
Speaker Change: Great. Thank you.
Speaker Change: Please standby for the next question.
Speaker Change: Yeah.
Speaker Change: Our next question comes from Joe Catanzaro of Piper Sandler Your line is now open.
Joe Catanzaro: Hey, everybody. Thanks for your update thanks for taking my questions maybe.
Joe Catanzaro: A couple for me here could you just sort of speak to your thoughts around when you will make the dose selection decision.
Joe Catanzaro: And whether that will come together with your interactions with the FDA and converting Oh forward to potential Registrational trial, just maybe walk through sort of the cadence of those.
Joe Catanzaro: Cision point, then I have a follow up thanks.
Joe Catanzaro: Oh, Thanks, Joe for that question.
Joe Catanzaro: Really our goal as you know this is the part of Joe's or foresee is based on project Optimists 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.
Joe Catanzaro: At which is 30 versus 'twenty and then the second really is the really finalizing the trial design for the Registrational trials is 005.
Joe Catanzaro: So I mean from our point of view.
Joe Catanzaro: Our goal is to get to the FDA as soon as possible.
Joe Catanzaro: This may or may not be all 90 patients could be less.
Joe Catanzaro: Of course, it will depend on looking at that signal between 30% and 20.
Joe Catanzaro: 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 005 trial.
Joe Catanzaro: Okay got it.
Speaker Change: So my follow up relates to your comment Mark on the breakwater trial of <unk>.
Joe Catanzaro: Yes.
Speaker Change: 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 and accelerated approval aligns with what you've seen thus far in the <unk> study.
Joe Catanzaro: Yes, certainly Joe Great question, certainly is consistent there.
Speaker Change: <unk> was <unk> 61 versus <unk> 40.
Speaker Change: So I think that it's certainly consistent with what we have shown so far.
Speaker Change: With the the first 30 patients.
Okay, Great. That's it from me. Thanks for taking my question. Thank you Joe I appreciate it.
Speaker Change: Thank you please standby for the next question.
Speaker Change: Our next question comes from Andrew Tsai at William Blair. Your line is now open.
Andrew Tsai: Thanks for the updated taking our questions two for me if you don't mind.
Andrew Tsai: One is really kind of your evolving thinking in terms of.
Andrew Tsai: Of the velocity of tumor tumor size reduction so basically looking at the December data one of the most obvious observations it's really.
The slope of the control arm is relatively flat over time and then it deepens.
Mark Early: You alluded to mark on the call.
Mark Early: For the 20 milligram 30 milligram, so I'm curious if that data.
Mark Early: Based on some of the prior CRC experience could derisk or inform how you think about endpoint.
Mark Early: Michael endpoints, such as PFS and OS.
Speaker Change: Question number one.
Speaker Change: Question number two has to do with also also breakwater. So soon that trial.
Speaker Change: The patient number thats required for the accelerated approval.
Speaker Change: 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.
Speaker Change:
Speaker Change: In the context of.
Speaker Change: The accelerated approval pathway. Thank you.
Speaker Change: Thanks, Andy for both of those questions.
Speaker Change: Yes, youre going after that first one.
Speaker Change: Clearly there has been data in CRC first line.
Speaker Change: Previous trials showing that.
Speaker Change: Earlier responses and deeper responses have a COO.
Speaker Change: Correlation and associated with greater PFS and OS. So that's something that is known.
Speaker Change: And I think moving on to the breakwater.
Speaker Change: Well certainly.
Speaker Change: There are 110 per arm was what they went after for their interim.
Speaker Change: We are looking at that.
Speaker Change: We will be of course talking to the FDA to finalize.
Speaker Change: The specifics around our assumptions and our our trial design.
Andrew Tsai: When we do meet with them, but certainly one point that you make Andy which is a good one is that.
Andrew Tsai: What breakwater showed was fewer and fewer patients are needed for the accelerated and of course the full approval.
Andrew Tsai: So thank you for both those questions.
Andrew Tsai: Great. Thank you.
Andrew Tsai: Thank you.
Andrew Tsai: Please standby for the next question.
Speaker Change: Our next question comes from Robert Burns at H C. Wainwright. Your line is now open.
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 break 301 trial and although <unk> is a minor component and colorectal cancer I wanted to get your thoughts as to how you view that as a.
Speaker Change: And especially also the Pan RAF agents that are also being developed in this space.
Speaker Change: Great Robert Thanks for both those questions.
Speaker Change: <unk> inhibitors as you mentioned.
Speaker Change: There is an approval of the amgen's drug.
Speaker Change: Last year, but that was really in second line and that of course is just with GE 12 C, which you know is a.
Speaker Change: A very small sliver of the of the K Ras and Ras mutated patients it's about.
Speaker Change: It makes up about 4% of Ras mutated patients. So I think that from what we look at there.
Speaker Change: It's really.
It's not really too it doesn't really impact what we're doing in first flight.
Speaker Change: Since they are in second line and it's such a small and we also do have <unk> mutations.
Speaker Change: <unk> with those mutations within our trials.
Speaker Change: So thats it.
Speaker Change: The <unk> the.
Speaker Change: The <unk> program.
Speaker Change: Clearly.
Speaker Change: Sure.
Speaker Change: They are through the signal is in the non small cell and as well as the pancreatic or the <unk> and so.
Speaker Change: We don't see as much.
Speaker Change: Activity with their agents for what they've reported in the colorectal.
Speaker Change: But we certainly are keeping an eye on on their progress in what they're doing in this space.
Speaker Change: Awesome. Thanks for taking my questions and congrats again, thank you Robert.
Okay.
Speaker Change: Thank you please standby for the next question.
Speaker Change: The next question comes from Robert <unk> with Craig Hallum. Your line is now open.
Speaker Change: Hi, everyone.
Speaker Change: Thanks for taking my question I was just wondering it's great to see the enrollment is going <unk>.
Speaker Change: Complete over the next few weeks here. So you think we'll be able to see all of the 90 patients included in this first half update.
Speaker Change: Yes Oliver.
Oliver: Thank you for that question.
Oliver: Yes, we are very pleased and excited that.
Oliver: We're really within a couple of weeks of finishing the enrollment.
Oliver: We did have 60 patients dosed by in December when we reported out the 30 patients who were Chad.
Oliver: At least one post baseline scan and so we continue to.
Oliver: Obviously, we'll be continuing to treat these patients and.
Oliver: Our goal really for.
Oliver: For this first half and reporting out the next update is really to make sure is a substantive.
Oliver: And really more mature update from the trial. So we leave it at that at this point.
Speaker Change: Okay I see thank you.
Speaker Change: Thanks Albert.
Speaker Change: And as a reminder, if anyone would like to ask an additional question you will need to press star one on your telephone and wait for your name to me.
Speaker Change: <unk>.
Speaker Change: Please standby, while we compile the Q&A roster.
Speaker Change: Okay.
Speaker Change: Alright, I am 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 Early: Thank you operator, and thank you all again for everyone here for joining US this afternoon for this call.
Mark Early: For your participation in today's conference. This does conclude the program and you may now disconnect.
Mark Early: Yes.
Mark Early: Okay.
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