Conference Transcript - CRBP 2026-06-04

Amin Makarem, Analyst — Jeffries

Hello, everyone. I'm Amin Makarem, one of the biotech analysts here at Jeff Bees. I'm happy to introduce and welcome Yuval Cohen, CEO of Corbis. This is a fireside chat format, and with that, thank you for joining us today.

Yuval Cohen, CEO

Thank you for having me, Amin.

Amin Makarem, Analyst — Jeffries

Just to start, can you give us a brief overview of the company and the two lead drug candidates you have currently in development?

Yuval Cohen, CEO

With pleasure. Sure. Corbis is based just south of Boston in the town of Norwood. There are just under 40 people at Corbis. We are a drug development company. And we have a pipeline that has two assets that are very, very, very different from each other. The one is a Nectin 4 ADC that we licensed from CSPC in China in 2023. And the other one is a small oral daily drug targeting the CB1 receptor in obesity. Both of them are in the clinic. They have, we just read out data on the one, we'll have data on the other later in the summer, then it goes back to data on the ADC. and so we have a cadence of clinical readouts at the moment between these two assets.

Amin Makarem, Analyst — Jeffries

All right. With that, let's dive into CRV701, your negatin-4 ADC asset. So you recently presented some interesting data at ASCO. Since it's pretty fresh, can you give us a quick recap on the key takeaways from that data?

Yuval Cohen, CEO

With pleasure. This was the maturing data from phase one we had previously shown at ESMO. The data matures and continues to also crystallize. It is around two solid tumor types. One is head and neck. The other one is cervical. So that was ESMO as well. At ESMO, we still had both confirmed and unconfirmed responses. The data set was too young for durability. And around head and neck, there was a real question, or not a real question, there was a sort of a question that kept being asked around, does the drug have a preference for one of the two forms of head and neck, the HPV positive or the HPV negative? Or the other way to think about it is the oral pharyngeal version of head and neck, which is HPV positive, versus the non-oral pharyngeal, which is HPV negative. ASCO provided answers to those questions and so what we saw was I'll start with cervical because that's even easier in cervical we saw the data continue to mature our confirmed overall response rate I mean now is in the mid-30s that's about twice the response rate we see with TivDAC which is an ADC the only ADC approved in second-line cervical. Our durability coming out of for the first time is looking very promising, very attractive. We have a DOR that's already at eight months and growing. PFS that's at four months and something and growing. We have still a very meaningful number of patients who are on the drug. It's a good problem to have and so that all needs to mature and on cervical we have an alignment with FDA around a single registrational study which will be based on physician's choice as a control arm with accelerated approval based on or interim or are and a final approval based on OS so that's pretty straightforward head and neck is more exciting in some ways and there's some more novelty there versus our ESMO data so we have now confirmed responses we have the durability is growing for the first time we can see it but the biggest sort of reveal for us was when we started getting the HPV data in terms of stratifying the patients that were responding or not and what we saw was that the drug had a very, very, very strong bias in favor of HPV positive. And again, the other way to think about it is the anatomical version of the head and neck, which is driven by the virus, which is known as oral pharyngeal, or colloquially that's throat cancer. It's interesting that the other solid tumor that we work well in is cervical, which is almost entirely driven by HPV. So we have two solid tumors where HPV is the main driver of efficacy. The other interesting thing, if you start to dive into our oral pharyngeal data, is that the bias we are seeing with our Nectin-4 MMAE for the oral pharyngeal was actually previously noted with PADSA, which, of course, is the poster child for Nectin-4 MMAE ADCs. It's a very successful drug in bladder. And last year at ESMO, Pfizer presented their phase one data in head and neck. For them, the focus was on frontline patients, first-line patients with combination with PEMBRO. And they showed an equally dramatic bias towards the HPV positive or the oral pharyngeal. Like us, they had barely any responses in HPV negative patients. And like us, they had a dramatic response in the HPV positive. So that's reassuring. Passive, Pfizer have already announced publicly that they will not be pursuing head and neck with passive. We speculate, but I think we're right, that their obstacle there are their high rates of peripheral neuropathy. It's incompatible, especially with oropharyngeal and especially with frontline patient clinical practice. It just would be a price that would be very difficult to pay for patients or to bear for patients. And so where we're going from here, I mean, is now we know which patients respond best. We have alignment there as well with FDA around a single registrational study, accelerated approval based on interim RR, final approval based on OS, control armist physician's choice. And that study will start this summer, and we think it will enroll relatively quickly. We are the only study that will be enrolling oropharyngeal patients. The three experimental EGFR bispecifics, Johnson & Johnson and Bikera, and what was Maris and is now Genmab, Two of those exclude oropharyngeal entirely. And the third one, which is pitocentimab from Genmab, limits the number of oropharyngeal patients in their study and is unlikely to be including those anymore. And so it looks as though we will be enrolling in the context of a tumor type that now represents half the patients in the West at those second line level and secondly that is not being pursued by the EGFR

Amin Makarem, Analyst — Jeffries

by specifics all right that's very helpful just thinking deep into the data you had around 43% or are for HPV neg positive but the efficacy in HPV negative was very modest what mechanistically what did drive that difference in the

Yuval Cohen, CEO

efficacy between these two cohorts? It's the same phenomena that was seen for PADSEV in frontline. So PADSEV in frontline in HPV negative has an ORR that is equivalent to PEMBRO on its own. PADSEV plus PEMBRO in HPV positive had an astonishing response rate of 82% confirmed ORR. So a really dramatic bias, the same bias we're seeing. And what's driving it amine is Nectin-4. That's our target. There's no magic here. There are a number of publications out there that highlighted, well before we started down this path, that within head and neck, it is the oral pharyngeal head and neck patients who are the most enriched in Nectin-4. And I go back again to, I think, an interesting observation that oral pharyngeal, in a sense, is the male equivalent of cervical cancer. These are two solid tumors, oral pharyngeal is overwhelmingly male, cervical cancer is exclusively female, that are driven by the HPV virus. I think the more we focus on it, the more work gets done within head and neck, the more we will see a bifurcation into what's known as HPV negative or non-oral pharyngeal, where it's the EGFRs bispecific that do so well, and the oral pharyngeal, where it's the nectin-4 ADCs that do very, very well, and there is almost no overlap between them to put it in context the amount or the frequency of HPV positive non oral pharyngeal patients in head and neck is something like four percent so if you're oral pharyngeal you're almost certainly HPV positive if you're non oral pharyngeal you're almost certainly HPV negative and how does it do

Amin Makarem, Analyst — Jeffries

you're seeing compared to the current second line options I know there is not

Yuval Cohen, CEO

much of an option right now so yeah it's pretty tragic at the moment second line options for oral pharyngeal patients because remember these are patients that are unlikely to be getting stetuximab the virus suppresses EGFR so we've known for many years now that they don't respond well to tituximab, you're really down to either taxanes, assuming you haven't had them in your front line, or things like occasionally methotrexate or 5-FU. All of these are very, very, very modest in efficacy. An interesting benchmark to think about is pitocentimab in their HPV negative. In other words, pitocentimab in the population that they do well in. And we are already seeing our durability match and perhaps even exceed that. And so that's a very good start. We still have patients on study, and so that needs to fully mature but we're certainly exceeded the six months right now and is there a bar

Amin Makarem, Analyst — Jeffries

for your pivotal study that you think you need to hit that PFS bar to be

Yuval Cohen, CEO

largely adopted in real world it's if we look at the current available options for that second line we've exceeded that already so those bars are typically two to three months it's it's so it's so tragic that we've done third party commissioned third party market research and a lot of KOL and looked at publications we estimate that there are 14,000 patients per annum in the US who are eligible for second line oral pharyngeal the key here is eligible because of those, only about 5,000 actually elect to have a second-line therapy. The remainder are patients who failed the front line and having consulted with their oncologist of what the available options are post-failure and front line, elect to do nothing. That's how tragic the current situation in second-line oral pharyngeal is.

Amin Makarem, Analyst — Jeffries

Okay, that's helpful. So, from the data you currently have, when should we expect to see the OS data from these patients?

Yuval Cohen, CEO

Are you talking about the registrational study or about the current running phase two? The current running phase two. We don't know. It needs to mature. It's certainly encouraging that the durability is looking good. That tends to be a good predictor of OS. Stay tuned. We'd like to talk through scientific conferences. And so we'll see when we have the data, then we'll need to see where we can submit the data for a conference, et cetera.

Amin Makarem, Analyst — Jeffries

But as of now, do you think it's going to get to the maturity soon, or it will take some time?

Yuval Cohen, CEO

We don't know. We certainly are not there yet, which is probably a good sign. We'll see how it matures.

Amin Makarem, Analyst — Jeffries

Okay, sounds good. So you've chosen to focus on anatomical oropharyngeal cancer rather than requiring the HPV testing. Where do you see the biggest upside in this strategy?

Yuval Cohen, CEO

Versus the...

Amin Makarem, Analyst — Jeffries

Versus doing the HPV testing.

Yuval Cohen, CEO

I'll start by saying that what we're doing follows other examples. So we are the second ADC company that has gone ahead to FDA and agreed on an anatomical definition and not an HPV definition. But also if you look at the EGFR bispecifics, if we look at the exclusion criteria of BICARA and Johnson & Johnson, so if we think about it, we think of BICARA and Johnson & Johnson as targeting the HPV negative. But the exclusion criteria, I mean, is actually more interesting. What they exclude for are oral pharyngeal patients who are only allowed to be in their study if they are oral pharyngeal and can prove that they're HPV negative, something that is effectively impossible to do. And so they themselves are using the anatomical. Now, for them, the anatomical is the exclusion. for us the anatomical is the inclusion the reason you don't want to include or exclude based on a p16 test are the following a whenever possible you want to avoid the CDX they're expensive they cause delays in dosing of patients and they cause they obviously an enrollment of patients as well there is no validated target for P16. P16 is tested locally. And lastly, P16 as a test is notoriously inaccurate. It has error rates of 10 to 20 percent. So for example, we have, oddly enough, our best responder patient, eight of our nine patients were P16 positive. Our best responder is p16 negative but that doesn't actually mean that a they're not HPV positive they might be or they could have been infected and clear the infection decades ago the damage was done what we will do I mean is so we will enroll based on the anatomy as is the precedent and then stratify based on p16 which is done locally then without the need for a CDX okay that's that's

Amin Makarem, Analyst — Jeffries

helpful moving to your phase three tempo one study can you highlight the key element of the design and you also have an adaptive feature in that if you can highlight that as well it's wonderfully

Yuval Cohen, CEO

boring so the design we have is effectively identical for example for the Marist design in their second line including the adaptive design which is becoming more and more common it really boils down I mean to the inclusion criteria so the Marist design has an old comers inclusion with the HPV positive being limited to 30% otherwise we are exactly the same except our inclusion criteria is oral pharyngeal in that sense like I said we're a lot more similar to Johnson & Johnson and like here on the front line, where we literally, our inclusion is their exclusion criteria, and vice versa.

Amin Makarem, Analyst — Jeffries

And are you saying anything on powering of the study, the expectations for the control and the active arm?

Yuval Cohen, CEO

Yeah, so it's 125 patients in each arm. We can afford to have a smaller study than Marist had in second line, precisely because we don't need to compensate for a population of patients. where we work less well which they did I think that and you heard this in the in the KOL event we had at ASCO it really boils down to how the taxanes will do we know the literature data on taxane but since then the anecdotal evidence out there is taxane have gone have grown more effective in the in the era of PEMBRO pretreatment but still the consensus is you're looking at something like an ORR in the mid to high teens so we certainly power for that and the adaptive design is for exactly for that it's to make sure that at a certain point through the study we test that and if that is turns out to be underpowered that we have the mechanism to add patients, which is what Marist, for example, are doing as we speak.

Amin Makarem, Analyst — Jeffries

All right. So I also wanted to, I think we have enough time, to also talk about the front line plus Keturda. Of course. So where does that study stand today? When should we expect to see the data? how should we set our expectations for that data?

Yuval Cohen, CEO

We should have about two dozen patients or so in time for early next year to look at objective response rate. I think that what we would be very keen to see is do we get the same type of efficacy that pads have saw in their, again, oropharyngeal-slash-HPV-positive patients. If we do, that's wonderful. I mean, that's highly actionable. We are not burdened by their very high levels of peripheral neuropathy. So that's a meaningful advantage. And if the data looks promising, then we would be interested in gauging FDA around the design of a frontline study in combination with PEMBRO. It's not particularly difficult to figure out what that would look like. Again, it would look very similar to the EGFR bispecific frontline studies, except it's the opposite patients. They go for the 50% of the patients who are HPV, who are non-oral pharyngeal, in their definition. We will go for the 50% of patients who are oral pharyngeal.

Amin Makarem, Analyst — Jeffries

Okay. Okay. So just to go back on the second line, this is one of the questions we get a lot on the opportunity there, the market size there, since you are going after Orofarin Joe. Specifically, how should we think about the market sizing?

Yuval Cohen, CEO

it's the number one question we got in the last week and it's slide 14 I think in our deck for those of you watching later eligibility annual so US numbers annual eligibility second line 14,000 patients frontline 18,000 patients and And that translates roughly into about one in two head and neck patients in total in those settings. And so what's been interesting, I mean, was just educating by sight and continuing to do so. And I think there are two reasons that are important to educate them. The one is we've had, for very sensible reasons, the EGFR bispecifics whose narrative has been, look, these non-HPV negative, right? The HPV positive, these oral pharyngeal throat cancer patients, they're only about 20% of the market. That's not accurate, and it's certainly not accurate in the West and especially the United States. The dynamic in head and neck are very, very interesting. The HPV negative patients are, the average HPV negative patient is a man in his mid-70s who smoke three packs of cigarettes a day or drank too much. That demographic, tragically, is literally dying off. And so what we see in the West is that the HPV-negative population is shrinking. Your HPV-positive or oral pharyngeal, remember that's the manifestation of HPV-positive, your HPV-positive oral pharyngeal patient is on average 12 years younger. They can be as young as in their 30s now. They have no history of excessive smoking, no history of excessive drinking. What they did, I mean, is they contracted HPV, which is the most common STD in the Western world and is typically completely asymptomatic. That population is actually increasing. Data out there indicates that your oropharyngeal patients or your HPV-positive patients are already the majority in the United States, And that dynamic is only going to increase more and more. It's been fascinating to talk to KOLs who are in large academic urban centers in the United States. Some of them are reporting that 80% now, 8-0% of their patients walking in to the late settings of the disease are oropharyngeal patients.

Amin Makarem, Analyst — Jeffries

Certainly interesting. Just moving back to Frontline, I wonder, I'm trying to understand the, what's the standard of care in Frontline for HPV-positive patients, what's the unmet need there that you think 701 can help?

Yuval Cohen, CEO

Pembro's approved for all patients in Henenek and Frontline. um it's not so much what the standard of care i think is but what will be the standard of care that's particularly fascinating to us so if you are an hpv negative patient in other words you have anything but oral pharyngeal so you're that older smoker male patient you are almost certainly going to get an egfr bispecific there are three of them they all seem to work really really nicely and you'll combine it with PEMBRO. However, if you are an oral pharyngeal patient, which almost certainly means you're HPV positive, those EGFR bispecifics, two of them will be excluded from the label already in any way. And the third one, it's not exactly clear if they're going to end up with that label or not. And in any case, the data they've shown to date has shown a reduced efficacy compared to how they do in the HPV negative. For that population, in Nectin-4 MMAE armed ADC seems to be a much better solution combined with Pembro based on the example of Patsive in front line and then the example of us in second line. Patsive is not going to be a label issue and so that leaves us as a potential in the future for those, again, half the patients out there who are oral pharyngeal. Of course, the data has to fit that, but we think that's how the market's going to end up looking or potentially could end up looking.

Amin Makarem, Analyst — Jeffries

All right. We can probably talk more about the head and neck space, 30 minutes more, but let's switch to your obesity program, 913. What's the latest status of Canyon 1 study data are expected this summer? Can you narrow the timing for us and clarify whether this will be a medical meeting or a company event?

Yuval Cohen, CEO

So the last patient, first visit was April 10th. He or she, typically it's a she, 70% of our patients are women, which is standard. He or she walks out of the study, I mean, four months later. so figure about April 10th I mean August 10th or so it's about a dozen sites they're all in the United States so we figure sometime in September we should have the top line data there is an academic obesity conference that we really like that happens this year in November we'll see if we can get in the last second or not. If not, it will be probably something like ADA. In any case, we will not sit on the data. We will release top line data with the expectation of releasing a fuller picture of the data at the closest possible academic center or clinical, sorry, clinical conference.

Amin Makarem, Analyst — Jeffries

So, you showed some interesting weight loss signal in your SAT-MAT cohort. How should we interpret that 3% placebo-adjusted weight loss at day 14 when thinking about that 16-week readout that you have in lower doses like 20, 40, and 60?

Yuval Cohen, CEO

You shouldn't. So, what I mean by that is it's a phase one. its small numbers it was a surprisingly strong signal none of the placebo patients gained weight sorry lost weight well actually gained weight which is normal for in clinic and every one of the volunteers on CRB 913 lost weight Again, that's a little bit unusual. The weight loss was surprisingly deep and consistent. But still, it is small numbers. It is early days. What I will say is every CB1 inverse agonist ever tested in the clinic, there's no exceptions, has always led to weight loss. I'm going to hazard a guess and say I don't think anyone out there is wondering if we'll see weight loss. We may be wondering the degree of weight loss, and that's fair. Are we going to look more like that first generation? Or are we going to look more like Montlunaband that was markedly more potent than the first generation? We don't know. Now, the main question, pretty much the only question, is are we going to look safer than Montlunaband in terms of the neuropsych AEs? Certainly the SAD-MAD study looked very different than Montlunaband. But Canyon 1 is a much bigger study. It's meaningfully longer. and we'll see what what that looks like I think it's it's going to be pretty binary I think either we look like my lunar band in terms of safety in which case that's the end of that but if we look markedly safer than my lunar band then not only are we the only cb1 inverse agonist standing and we will be much farther ahead than any competition that could possibly appear but beyond that I mean this is the only mechanism of action outside the incretins that actually is known to lead to model therapy weight loss so how do you define

Amin Makarem, Analyst — Jeffries

the bar for neuropsych toxicity here? Nothing horrible has to happen. That's one.

Yuval Cohen, CEO

Manunaband in 180 patients who were dosed on the drug had 111 neuropsych events. That's not great. And then the last one, oh, a couple more things. When does it show up? Does it last and the last thing is what is the weight loss in other words if you have a signal of neuropsych is it worth the signal of neuropsych the more weight loss you have the more worth it it is but nothing horrible that that's for sure we can't we can't afford that and we'll do what's responsible but that

Amin Makarem, Analyst — Jeffries

sad mad did look very promising from that perspective all right uh we are at the end of our session we are uh in closing uh maybe talk about the cash runway assumptions and highlight the key updates in the next uh by the end of the year and the next year sure so we have a hundred

Yuval Cohen, CEO

We had $138 million in the bank. That gets us into Q1 of 2028. The next milestones are not even that far away. They are in sort of summer, September-ish, would be the Canyon 1 readout. And then the pendulum swings back to early next year, which will be the frontline data in 701 plus Keytruda. all right should be interesting thank you very much i mean thank you so much and thanks for our audience appreciate it