This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk02: Welcome to the Cardiff Oncology Second Quarter 2024 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 star 1 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 Gale Martin Group. Please go ahead.
spk00: Thank you, Operator. Joining us on the call today from Cardiff Oncology are Chief Executive Officer Mark Erlander and Chief Financial Officer Jamie Levine. During this conference call, management will make forward-looking statements including, without limitation, statements related to guidance, results, and the timing of data readouts for our advanced research 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-K filed with the SEC for the year ended December 31, 2023. 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?
spk05: Thank you, Kiki, and good afternoon, everyone, and thank you for joining our Business Update Conference call for the second quarter of 2024. These are certainly energizing times at Cardiff Oncology as we activate sites, enroll patients in our Cardiff 004 trial in RAS-mutated metastatic colorectal cancer, or MCRC. The interactions we're having with the physicians and other professionals at the trial sites reinforce our own excitement at the potential to bring a more effective therapy to this large patient population of nearly 50,000 new patients a year in the U.S. alone. Specifically, the totality of the data from our Phase 1b2 and Ensembl second-line MCRC trials demonstrates Onvancitib has the potential to shift the treatment paradigm for all RAS-mutated MCRC, not just subgroups of K-RAS. We say this because, first, There have been no new therapies approved for these patients over the past 20 years. Second, there are no competing clinical trials for this patient population. And third, unlike prior PLK1 inhibitors, Onvansertib is well-tolerated when combined with chemotherapy, which also opens the door to other chemo combinations for additional cancer indications. So let's dive in. On today's call, we will cover four topics. First, I will discuss our lead program in MCRC and provide updates around our ongoing CARTF004 trial. Second, I will provide an update on our pancreatic cancer program. Third, I will provide a brief overview of our continued encouraging preclinical data demonstrating on vascular tubes activity and other cancer indications with unmet clinical need beyond RAS-mutated MCRC. And finally, we will talk about our financial position that we disclosed today in our Form 10Q. So let's begin. This quarter, we have been intensely focused on the clinical execution of our CARTF004 trial, evaluating the contribution of Onvansertib in first-line RAS-mutated MCRC. As a reminder, CARTF004 is our ongoing Phase 2 trial evaluating Onvansertib in combination with current standard care, which consists of either Fulfuri plus Bev or Fulfox plus Bev. The trial is currently active in 33 sites, and we plan to enroll 90 patients who will be randomized to receive either a 20-milligram or a 30-milligram dose of Onvansertib plus standard care or standard care alone. Our team at Cardiff Oncology, alongside our clinical execution partner, Pfizer Ignite, is diligently working on the enrollment of the trial. We continue to leverage Pfizer's resources and capabilities in multiple areas to drive enrollment. We also appreciate the commitment and the clinical efforts of our enthusiastic investigators who have been judiciously screening patients across our active sites. Based on the current pace of enrollment over the past few months, we continue to plan on releasing an initial data readout later this year as we previously guided. We expect this will include objective response rate data for approximately half of the patients we plan to enroll in the trial. Now I'd like to turn to our second agenda item, an update on our pancreatic cancer program focused on metastatic pancreatic ductal adenocarcinoma, or PDAC. In September of last year, we released data from our Phase II trial for metastatic PDAC in the second-line setting. In this single-arm trial, patients received on vansartib in combination with the chemotherapy regimen of liposomal, arenatecan, leukoborin, and 5-FU. After discussing the results with our investigators, we decided the next step of our PDAC program would be an investigator-initiated trial in the first-line setting, combining on Banser-TIB with standard of care gem Abraxas. Today, we are sharing an update to our plans in metastatic PDAC because earlier this year, Nellie Fox was approved for first-line metastatic PDAC after the NAPOLE-3 trial showed significantly greater improvement in overall survival and progression-free survival with first-line nalarifox compared to jamabraxane. As a result of this change to the first-line standard of care, we have decided to support a first-line investigator-initiated PDAC trial that combines onvansertib with nalarifox. And recall that three of the four drugs that comprise the nalarifox first-line regimen for the same drug combined with ondansertib in our prior second-line PDAC trial. This new trial will replace the first-line PDAC investigator-initiated trial combining ondansertib with gemabraxane, which was still in an early stage and had not started to enroll patients. We will provide further updates on the ondansertib Malary Fox investigator-initiated trial in the coming months. Now I'd like to transition to the third item on our agenda, which is our continued success in identifying other cancer indications where Onvancitib may be clinically efficacious. Previously, in preclinical studies, Onvancitib has been shown to have activity in GRAS wild-type MCRC, ER-positive breast cancer, triple negative breast cancer, and platinum-resistant ovarian cancer. Last month, we published preclinical data on a new indication within ovarian cancer in the peer-reviewed journal, Cell Death and Disease, which is a portfolio member of the journal, Nature. Specifically, the data evaluate on vancertib and ovarian cancers that are resistant to PARP inhibitors. In the published study, the combination of on vancertib and allopurib, a PARP inhibitor approved in ovarian cancer, was tested both in vitro and in vivo in BRCA1-mutated and wild-type ovarian cancer models. In vitro, the combination of Onvancitib and Alloperib was synergistic in ovarian cancer cell lines and demonstrated inhibition of tumor growth. In vivo, the combination was well-tolerated, slowed tumor progression, and prolonged survival in patient-derived xenograft models resistant to Alloperib. Resistance to Alloperib has been observed in clinical settings and has been a challenge to overcome. Moreover, these findings underscore the ability of Onvancitib to overcome resistance to PARP inhibitors in high-grade serious ovarian carcinomas, which could make a significant impact in the treatment landscape for ovarian cancer. Overall, we are still determining our path forward in ovarian cancer. However, we are highly encouraged by the totality of the data generated from our recent publication and AACR poster that demonstrate Onvancitib's ability to effectively resensitize ovarian cancer to treatment. Now, I would like to turn the call over to Jamie to discuss our final agenda item, our second quarter 2024 financial update.
spk04: Thank you, Mark. Earlier today, we issued a press release and filed a Form 10-Q with the SEC, which contained our financial results for the second quarter ending June 30, 2024. Turning to our balance sheet, Cash and short-term investments as of June 30, 2024, totaled $60.3 million, and our cash used in operating activities was $9.2 million in Q2 2024. Today, we're also updating our cash runway guidance based on our most up-to-date cash forecast. As a result, we believe that our current cash resources provide us with runway through the end of the third quarter of 2025. whereas previously we had expected runway into the third quarter of 2025. With that, I'll turn the call back over to Mark.
spk05: Thank you, Jamie. I would now like to close the call by emphasizing our confidence in our clinical development strategy for our lead program in RAS mutated MCRC and enthusiasm for our upcoming data readout of CARTIC-004 later this year. Collectively, the data we have released throughout the past year from our Phase 1b2 study, Ensembl-TRI, and SAACR gives us conviction that adding on Vansartip to standard care has the potential to change the treatment paradigm for the entire first-line RAS-mutated MCRC patient population. And we believe that such an outcome would create enormous value for our stakeholders and positively impact the large population of patients living with RAS-mutated MCRC. With that, I will now open the call up for questions. Operator?
spk02: Thank you. We'll now begin the question and answer session. If you have dialed in and would like to ask a question, please press star 1 on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star 1 again. If you are called upon to ask a question and are listening via loudspeaker on your device, please pick up your handset and make sure that your phone is not on mute when asking your question. And your first question comes from the line of Mark Fram of TD Cowen. Please go ahead.
spk01: Thanks for taking my question. Maybe, first off, last quarter you noted that enrollment trends in the 004 trial had maybe been a bit slower than you'd anticipated when you opened the trial. Just curious, has that kind of held steady? Has enrollment held steady over the summer, or have you seen some acceleration in that enrollment trend?
spk05: Thanks, Mark. Enrollment is tracking quite well and is tracking with our guidance. of having an initial look at the data later this year. And, you know, part of the reason why we're doing well is because we have Pfizer Ignite as a strong partner, and we've been able to leverage a lot of their capabilities in being able to drive the enrollment. I think the other things that really do help that I mentioned earlier on the call is that there are no new drugs for 20 years for these RAS mutated patients in first line in CRC. And also, importantly, there are no competing trials. So to answer your question, yes, we're on track with the guidance of initial look later this year.
spk01: Okay, thanks. That's very helpful. And then maybe on the pancreatic trial that you are going to start up, I think You know, now fear and noxious are obviously been approved, but at least in our conversations with physicians, it's not 100% clear that it's going to get broadly adopted as a true kind of broad standard of care. So I guess why be kind of aggressive on adopting that now for this initial proof of concept in pancreatic versus maybe using some of the older regimens that are also potentially a bit better tolerated than that regimen?
spk05: Yeah, really two answers to that question. I mean, the first is that the now Airy Fox, really three of the four chemo agents we've already combined with Onvansertip and SecondLine have good data from that. And so we believe that along with our preclinical work in this area. So that's really the first part of the answer to the question. The second is really that we are showing really good tolerability of Onvansertib in combination with these chemo agents. And really the only chemo that we haven't combined it with is the oxaliplatin, which is part of the nol-irifox. But really, oxaliplatin really does not have any overlapping toxicities with Onvansertib. So we do feel confident that we can come in with this more aggressive chemo and combining and adding value to that because we believe that this is really the type of regimen that is showing the superiority in efficacy in first line.
spk06: Okay, thank you.
spk02: Your next question comes from the line of Andy Hsieh of William Blair. Please go ahead.
spk03: Great. Thanks for taking our questions. Maybe kind of extend from Mark's question earlier in the call. I'm just curious about, you know, whether you could comment on the level of excitement and kind of scientific validation with the change of the IST in pancreatic cancer. Obviously, I think it's well validated that on the answer to synergy with adrenotecan, which is now included in the regimen versus the gemabraxane regimen before. I'm curious about your view on that. And then in terms of the potential ovarian cancer entry, There's, you know, obviously new therapy for cancer in the form of ADCs. So you've looked at chemotherapy, you've looked at targeted therapy, you know, combinations, you know, PARP. So just curious about whether you've done or plan to do any sort of combinatorial work in the ADC field as well. Thanks.
spk05: Oh, thanks, Andy, for both of those questions. I'd say to answer your first question, Really, the ARENA-TCAN synergy is one of the main reasons we are going with the combination with Nalurifox and Firstline. Also, the PI that we're working with for this new investigative trial has already had experience in our second-line pancreatic trial and really was a huge proponent and enthusiastic in going into Firstline. So that was really, he knows our drug. He knows it's well-tolerated, and he's very excited about going into first line. To answer your other question about ovarian cancer and ADC combination, we are currently preclinically looking at ADCs in combination with Donvansertib. Not only ovarian, not specific only on ovarian, but we are really exploring that in several other areas where ADCs have been approved.
spk06: That's helpful. Thank you so much. Sure. Thanks, Andy.
spk02: Again, if you would like to ask a question, press star, then the number one on your telephone keypad. There are no more questions. I will now turn the conference back over to Mark Erlander for closing remarks.
spk05: Thank you, operator, and this concludes our conference call. Thank you again, everybody, for joining us this afternoon. Good day.
spk02: Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.
Disclaimer