Conference Transcript - CRDF 2026-09-14

Mani Mohindru, Ph.D., CEO

for mutations and all are not there, or resistance is not there. So we think it synergizes very well in cancer where there are RAS mutations, irrespective of the elite-specific mutations.

Speaker 2

So, you know, in your 2Q update, you stated plans that, you know, you plan on initiating the registrational trial in 1Q, subject to additional financing. Maybe talk to us a little bit about what sort of, you know, financial mechanisms that are currently on the table in order to fully capitalize on that phase three trial, whether that be strategic partnerships, royalty modernizations, or even secondary offerings. How do you think about funding this trial?

Mani Mohindru, Ph.D., CEO

And sort of, you know, given the size of the expected enrollment, what sort of funds do you think you would need in order to complete that trial? yes um so one let's start with the last part first how much monies do we need i think that's the biggest question in on everyone's minds uh we haven't given specific guidance as to how much money is needed but you know again if you do the math but anywhere from 200 000 to 275 000 ish or so per patient costs are what is industry standard so you can come to some conclusion as to what would the trial cost now in terms of you know mechanisms of getting the study funded you know we've said that our goal is to get the study up and running in first quarter of next year pending funding and we still stand by that we are spending a lot of this time preparing for this global phase three study this is going to be a global phase three study with global registrational intent we've talked to the FDA we are going to start up on I mean we are already in conversations with a european agency a regulatory agency and there's a lot that needs to get done um there are just like for any other biotech we are going to pursue multiple ways of making sure that we get uh the study the company capitalized and the trial financed be it by um you know tapping the capital markets or looking into non-dilutive funding be it by collaborations regional collaborations, and any other mechanism that the companies like us seek.

Speaker 2

Okay. You know, when we think about the opportunity for on-vent search outside of colorectal cancer, how do you see the evolution of on-vent search clinical trial development sort of evolving over time into other sorts of indications?

Mani Mohindru, Ph.D., CEO

So one of the mechanisms that we have at Cardiff have sort of gone into to look into life cycle management or pipeline expansion, so to speak, is by mechanism of investigator-initiated studies. So we have a number of investigator-initiated studies that allow us to pick, should there be any, you know, promising signals in any of the other cancer types, and the few that are ongoing are in CMML, chronic myelomonocytic leukemia, small cell lung cancer, pancreatic, and triple negative breast. The one that I actually sort of want to highlight is a CMML, chronic monocytic leukemia, relapsed refractory setting. Nothing is approved for patients in that setting. And we have started seeing some promising signals there from this investigator-initiated study from Mayo Clinic. And here we are using unvancetib in monotherapy. So it is not combined with any other agent in a patient population where overall survival is less than a year. The drug is showing some clinical benefit, and these data were actually presented at ASH last year, 2025, by the investigator. This trial is still ongoing. You see benefits. This was MPN-like CMML. There were benefits in thrombocytopenia, spleen size reduction, even marrow blast control. So they are promising signals. So I just sort of I wanted to highlight, you know, that between the various investigator-initiated studies, we are already seeing some that are showing more promise than others.

Speaker 2

Maybe you can walk us through the market opportunity and patient sizes, other potential treatment-eligible patient population sizes for both CRC. I'm curious about the CMML as well.

Mani Mohindru, Ph.D., CEO

So CRC, you know, it is a big market. there are 150,000 plus patients who are diagnosed with colon cancer. And as you may know, more and more younger patients are getting diagnosed. So I do want to say, if you go back to the data, we've done some forest plot analysis. Despite a small number of patients, we do see that our drug shows benefit irrespective of the age of the patients. We had patients who were on liver mets, multi-organ involvement, and across many of these baseline characteristics, our drug candidate did show benefit. But out of the 150,000 patients, a good size, a good proportion of fourth or so of those patients are, they become metastatic. And this is the drug that we are using is for RAS mutated, which is approximately 45 to 50% of the frontline patients who have RAS mutations, KRAS, NRAS.

Speaker 2

Okay.

Mani Mohindru, Ph.D., CEO

And CMML, it's a rare disease. It's a rare orphan kind of disease. And the numbers are still out there, but certainly less than 250,000 or so. However, the numbers are less because these patients are misdiagnosed. They are either diagnosed as MDS or MPN, because there are no therapies available, especially in relapsed refractory setting, the HMAs, the hypermethylating agents are approved in the first-line setting, there hasn't been a great deal of diagnosis. So what we hear anecdotally from experts in the field that there are more patients than we think that's out there. Okay.

Speaker 2

You know, going back to the trial design for your phase three in colorectal cancer, you stated that there is an interim analysis, which could support accelerated approval, and then PFS would eventually potentially support full approval. Talk to me a little bit about the timings with which you think that you could get to that interim OR analysis for accelerated approval and ultimately for the PFS as well.

Mani Mohindru, Ph.D., CEO

So you have to wait for the trial to initiate to help us give you full guidance, given there's a lot more math involved in figuring out worldwide enrollment. You know, it's not just in the U.S., depending on the countries we choose, so stay tuned for that. However, approximate, I mean, it's not really an interim analysis. We will wait for the patients, all patients, to be enrolled in the study to get to an ORR analysis, which could support an accelerated approval should the data hold. So, you know, it's not really an interim analysis in that way. but however you know the study continues for full pfs assessment down the road um typically you know it takes i mean again without giving very specific guidance but you know industry-wise like you know could it take between 18 to 24 months in enrollment and whatever other time is needed for pfs i guess the last question for me since we're coming up on time so you know what other cows can investors expect over the next let's say 12 to 18 months i know that you said that you know we haven't really seen what the MPFS is as of yet for CRDF004.

Speaker 2

So I'm curious when we might be able to sort of get a glimmer as to that data point specifically.

Mani Mohindru, Ph.D., CEO

Yes. So as of the ASCO data, the median PFS in Unvancidib plus Folfuribeb had not been reached. When we released our quarterly results, we mentioned that there were 12 patients still on study, out of which eight patients were on either 20 or 30 milligram on vansative plus 4-3-bapalm. We didn't give any guidance on median BFS, but we will continue to follow these patients, and depending on when the data emerge, whether it's in conjunction with a medical meeting or otherwise, we will release those data. uh that's really all the questions i have are there any questions from from the audience today all money thank you for joining us today thank you