Cardiff Oncology Q2 2024 Earnings Call Transcript

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August 8, 2024

There are 6 speakers on the call.

Operator

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 speakers' presentation, there will be a question and answer Please be advised that today's conference is being recorded. I would now like to turn the conference call over to Kiki Patel of Gail Martin Group. Please go ahead.

Speaker 1

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 Vansertib 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.

Speaker 1

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 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?

Speaker 2

Thank you, Kiki, and good afternoon, everyone, and thank you for joining our business update conference call for the Q2 of 2024. These are certainly energizing times at Cardiff Oncology as we activate sites, enroll patients in our CARTIP-four trial in RAS mutated metastatic colorectal cancer or MCRC. The interactions we're having with the physicians and other professionals at the trial site reinforce our own excitement as 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.

Speaker 2

Specifically, the totality of the data from our Phase 1v2 and Ensembl second line mCRC trials demonstrates onvancertib has the potential to shift the treatment paradigm for all RAS mutated mCRC, not just subgroups of KRAS. We say this because first, there have been no new therapies approved for these patients over the past 20 years. 2nd, there are no competing clinical trials for this patient population. And 3rd, unlike prior PLK1 inhibitors, ombansertib 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.

Speaker 2

On today's call, we will cover 4 topics. First, I will discuss our lead program in MTRC and provide updates around our ongoing CARTWR trial. 2nd, I will provide an update on our pancreatic cancer program. 3rd, I will provide a brief overview of our continued encouraging preclinical data demonstrating on Vansertib's activity in 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 10 Q.

Speaker 2

So let's begin. This quarter, we have been intensely focused on the clinical execution of our CARDIP-four 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 of care, which consists of either FOLFIRI plus bev or FOLFOX 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 odevansertib plus standard of care or standard of care alone. Our team at Cardiff Oncology alongside our clinical execution partner Pfizer Ignite is diligently working on the enrollment of the trial.

Speaker 2

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 2nd agenda item, an update on our pancreatic cancer program focused on metastatic pancreatic ductal adenocarcinoma or PDAC.

Speaker 2

In September of last year, we released data from our Phase 2 trial for metastatic PDAC in the 2nd line setting. In this single arm trial, patients received onvansertib in combination with the chemotherapy regimen of liposomal, irinotecan, leucoborin and 5FU. 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 ombansertib with standard of care, gemAbraxane. Today, we are sharing an update to our plans in metastatic PDAC because earlier this year, Nalili Fox was approved for first line metastatic PDAC after the NAPOLE three trial showed significantly greater improvement in overall survival and progression 3 survival with first line malairefos compared to gemabraxane. 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 onvanceertib with Nelire FOX.

Speaker 2

And recall that 3 of the 4 drugs that comprised the Nelire FOX first line regimen were the same drug combined with ombansertib in our prior second line PDAC trial. This new trial will replace the first line PDAC investigator initiated trial combining omsertib with gemabrasing, which was still in an early stage and had not started to enroll patients. We will provide further updates on the onvansertib, now ERIFOX, investigator initiated trial in the coming months. Now I'd like to transition to the 3rd item on our agenda, which is our continued success in identifying other cancer indications where ovansertib may be clinically efficacious. Previously, in preclinical studies, ovansertib has been shown to have activity in BRAF's wild type mCRC, ER positive breast cancer, triple negative breast cancer and platinum resistant ovarian cancer.

Speaker 2

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 evaluated on Bancertib and ovarian cancers that are resistant to PARP inhibitors. In the published study, the combination of onvansertib and olaparib, a PARP inhibitor approved in ovarian cancer was tested both in vitro and in vivo and BRCA1 mutated and wild type ovarian cancer models. In vitro, the combination of onvancertib and olaparib was synergistic in ovarian cancer cell lines and demonstrate inhibition of tumor growth. In vivo, the combination was well tolerated, slowed tumor progression and prolonged survival in patient derived xenograft models resistant to olaparib.

Speaker 2

Resistance to olaparib has been observed in clinical settings and has been a challenge to overcome. Moreover, these findings underscore the ability of ONVATTRIB to overcome resistance to PARP inhibitors in high grade serous 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 demonstrates ONVASTRU's ability to effectively re sensitize ovarian cancer to treatment. Now, I would like to turn the call over to Jamie to discuss our final agenda item, our Q2 2024 financial update.

Speaker 3

Thank you, Mark. Earlier today, we issued a press release and filed a Form 10 Q with the SEC, which contain our financial results for the Q2 ending June 30, 2024. Turning to our balance sheet, cash and short term investments as of June 30, 2024 totaled $60,300,000 and our cash used in operating activities was $9,200,000 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 Q3 of 2025, whereas previously we had expected runway into the Q3 of 2025.

Speaker 3

With that, I'll turn the call back over to Mark.

Speaker 2

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 CARDIP-four later this year. Collectively, the data we have released throughout the past year from our Phase 1btwo study, ENSEMBLE trial and at AACR gives us conviction that adding onvanceertib to standard of 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.

Speaker 2

Operator?

Operator

Thank you. We'll now begin the question and answer session. And your first question comes from the line of Mark Frahm of TD Cowen. Please go ahead.

Speaker 4

Thanks for taking my questions. Maybe first off, last quarter, you noted that kind of enrollment trends in the 4 trial had maybe been a bit slower than you'd anticipate when you open the trial.

Speaker 3

Just

Speaker 4

curious, has that kind of held steady? Has that enrollment held steady over the summer? Or have you seen some acceleration in that enrollment trend?

Speaker 2

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 part of the reason why it's doing well is because we have Pfizer Ignite as a strong partner and we've been able to leverage a lot of their capabilities and 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.

Speaker 2

So to answer your question, yes, we're on track with the guidance of initial look later this year.

Speaker 4

Okay. Thanks. That's very helpful. And then maybe on the pancreatic trial that you are going to start up. I think nalfurion access 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.

Speaker 4

So I guess, why be kind of aggressive on adopting that now kind of for this initial proof of concept for in pancreatic versus maybe using some of the older regimens that are also potentially a bit better tolerated than that regimen?

Speaker 2

Yes. Really two answers to that question. I mean the first is that the now ARIFOX really 3 of the 4 chemo agents, we've already combined with onvanceertib in second line and 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.

Speaker 2

The second is really that we are showing really good tolerability of ombansertib or tip 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 null irrefoxed. But really oxaliplatin really does not have any overlapping toxicities with onvanceertib. 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 and efficacy in first line.

Speaker 4

Okay. Thank you.

Operator

Your next question comes from the line of Andy Scheife of William Blair. Please go ahead.

Speaker 4

Great. Thanks for taking our questions. Maybe

Speaker 5

kind of extend from Mark's question earlier in the call. Just curious about 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 onvansertib synergy with irinotecan, which is now included in the regimen versus the gimabraxane regimen before. I'm curious about your view on that. And then in terms of the potential ovarian cancer entry, there's obviously new therapy, new cancer in the form of ADCs.

Speaker 5

So you've looked at chemotherapy, you've looked at targeted therapy, combinations, PARP. So just curious about whether you've done or plan do any sort of combinatorial work in the ADC field as well? Thanks.

Speaker 2

Thanks Andy for both of those questions. I'd say to answer your first question, really the irinotecan synergy is one of the main reasons we are going with the combination with Naleri Fox in first line. Also the PI that is that we're working with for this new investigator initiated trial has already has experience in our second line pancreatic trial and really was the a huge proponent enthusiastic in going into first line. 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 pre clinically looking at ADCs in combination with onvansertib, not only ovarian, not specific only on ovarian, but we are really exploring that in several other areas that where ADCs have been approved.

Speaker 5

That's helpful. Thank you so much.

Speaker 2

Sure. Thanks, Andy.

Operator

There are no more questions. I will now turn the conference back over to Mark Erlander for closing remarks.

Speaker 2

Thank you, operator, and this concludes our conference call. Thank you again everybody for joining us this afternoon. Good day.

Operator

Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.

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Earnings Conference Call
Cardiff Oncology Q2 2024
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