Conference Transcript - NVCT 2026-09-14

Patrick Trucchio, Analyst — H.C. Wainwright

Hello, everyone, and good afternoon, and welcome back to the H.C. Wainwright 20th Annual Global Investment Conference. I'm Patrick Trucchio, Senior Healthcare Analyst at H.C. Wainwright. It's my pleasure to introduce our next speaker, Ron Benzer, Chairman, CEO, and President of Nuvectis Pharma. Nuvectis Pharma is a clinical stage biopharmaceutical company that's focused on the development of innovative therapies for the treatment of immune complement related conditions and oncology. And with that, Ron, I'll turn it over to you.

Ron Bentsur, CEO

Thank you very much, Patrick. And thank you, H.C. Wainwright, for inviting us to present at the conference. It's very nice to be here. And I'll dive right into the Novectus Pharma story. So just a couple of words about the background of the founders of the company. So as a team, in the past, we've worked with three prior companies leading up to starting Novectis, Carex Biopharmaceuticals, Urogen Pharma, and Stemline Therapeutics. And in each one of these companies, we were able to get a drug approved. At Carex, it was a drug called Eryxia, which is actually approved for two indications. Urogen, Jalmito is an oncology indication, and Stemline, a drug called Elsonris for a small hematological oncology indication called DPDCN. So as a management team, we worked at these companies and have been together for the better part of the last 15, 20 years. And we started Novectis a few years ago. Hang on a second. Yep. A transformative moment for us came about two months ago with an in-licensing deal that we did with a Chinese company called Haisco Pharmaceuticals. And just a couple of words about Haisco. This is a company that's really taking kind of center stage presence over the last few months. So right before we did our deal with them in late June, they had closed two big pharma deals in the second quarter of this year, one with AbbVie followed by another deal with Eli Lilly. And they also actually closed two NUCO-type deals in the first half of the year. Both of these NUCOs were seeded with a lot of money and, you know, with some big-name VCs and funds that participated. So the reputation is really starting to precede them. And, you know, they've evolved into a very formidable, very sophisticated drug developer. And we licensed from them two compounds. I'll talk mostly about the first one that we call NXP100, and that's a once-a-day oral factor B inhibitor from the complement family of drugs. And the second drug that we brought in is a second-generation BRAF inhibitor, paradox-breaking BRAF inhibitor for oncology. In terms of financials, so right after we closed this transaction with AISCO, about a week later, we closed $150 million round, which puts us in a capital position of about $120 million as we speak, which is enough to get us into the first half of 2029. So again, to dive a little bit deeper into NXP100, because that has become our lead asset. So it's a best-in-class potential factor B inhibitor. The only one out there is a drug that is marketed by Novartis called Fabalta, and that's a twice-a-day factor B. So we have this convenience advantage over Fabalta, and these are the indications we're targeting are all lifelong therapies. where compliance is very important because if patients lose compliance, obviously that could be very risky. This is a late stage compound. It's already approved in China for PNH. PNH, for some of you that may not remember, is the indication where Alexion, you know, did very well in where they had a drug called Soliris that was approved about 10 or 12 years ago that was followed by Ultramiris, which is a second generation Soliris. And that actually got that Alexion sold to AstraZeneca for about $39 billion. The main focus was on PNH. So this is a drug that's already approved in China for PNH-naive patients. That came about a month and a half ago. The second approval in PNH-experienced patients is expected by year end. So obviously, we're very much looking forward to that. And obviously, the data package that exists for PNH is very extensive. But PNH is going to be the main focus for us in the near term. But the potential of this drug extends well beyond PNH. And we'll talk about the additional studies that are being conducted. And of course, the competitive landscape and what Novartis is doing with Fabalta in other indications. And of course, the dynamics of the PNH market. So let's dive into PNH a little bit deeper. So our key differentiation is the once a day versus twice a day, which we believe is something that could be quite substantial, particularly for these patient populations that I just described that require lifelong therapies. The data that we have is very robust, very strong. You know, I talked about the fact that it's already approved in China for PNH naive and the PNH experienced or pre-treated patient's approval is expected within a few months. and the market dynamics for PNH, I think, bode very well for the Factor Bs. When you look at the evolution of PNH, so obviously Soliris and Ultramiris, which are C5 inhibitors, complement 5 inhibitors, came onto the scene first. It's a very sizable indication. It's actually north of $5 billion as we speak, expected to grow to about $7, $7.5 billion by the end of the decade. So there's very strong organic growth within the PNH market. That's driven by the fact that a patient's diagnosis is easier nowadays and also by the fact that patients are living much longer. So the tenure of treatment has gone into decades, basically. So slowly but surely, this is an indication that's becoming a multi, multi-billion dollar indication. The C5s are still the, you know, the dominant players, but that's about to change. And the reason that's about to change is because the factor Bs have arrived onto the scene. So when you look at what Fabalta is doing, first of all, it's an oral versus the C5s, which are injectables. And also when you look at the head-to-head data that's been generated for the factor Bs versus the C5s, And there were two such studies that were conducted. I'll show you the data from our study that Haisco conducted. They did a head-to-head study against Soliris. And Fabalta did a similar study versus Soliris. It's not even close. The C5s are much more efficacious than the C5s. So it's just a matter of time before the factor Bs will start to dominate this market. And again, this is going to be a $7 to $7.5 billion market by the end of the decade. I don't think it would shock anybody. And put us aside for a second, I don't think it would shock anybody if Fivalta by the end of the decade will be a $3, $4, $5 billion player in P&H alone. And Fivalta is a twice a day and we're a once a day. And the data is very similar with even a slight optical advantage in favor of us. So just to give you an example of the kind of data that's been generated. So this was the treatment-naive study that was conducted by Haisco versus Solir's. This is the basis for the approval that came about a month and a half ago in China. And you can see on the right side there a very dramatic difference. Again, it's not even close. It's head and shoulders above Solir's. So the primary endpoint was patients that achieved hemoglobin above 12. That was the responder analysis to basically take them out of anemia land. That's a big problem for these patients. And you can see that the results were about 59, 60% for NXP100 versus about 8% for Solir. So again, it's a pretty dramatic difference there. And then when you look at the average hemoglobin increase, the difference is even more profound. So about a five-point increase in hemoglobin for NXP100 versus about 2.2 for Solir. So more than a double in terms of the hemoglobin increase. So as I said before, it's not even close. It's night and day of a difference. So the factor Bs are clearly superior to the C5s in terms of efficacy. And we saw a similar result in the Fabalta head-to-head study that was conducted versus Solir. So now we've got two examples that drive home the point of the factor Bs being just much more efficacious than the C5. So what that means in terms of the market dynamics, again, just to rehash, is that slowly but surely, the factories are going to start to dominate the market. Fabalta is doing all the heavy lifting as we speak. That's Novartis basically driving the ball down the field, you know, basically taking market share away from Soliris. And we're going to come in as a fast follower with a once a day. And I think we're very well positioned because by the time we make it onto the market, I think Fabalta will have established itself as a market leader with clear dominance or potential dominance of the space. And when you talk to the KOLs, everyone kind of is convinced there's very little dispute as to the fact that the Factor Bs are much more efficacious. They're oral. So, you know, why wouldn't they overtake this, you know, multibillion dollar market? it. So this is the treatment naive study, and this is the data that was generated for the treatment experience patients, so basically the previously treated patients. This is the second approval that's pending, which hopefully will arrive by the end of the year. And basically, these are patients who were on C5 treatment and failed, and now you need to basically kind of reboost these patients and increase their hemoglobin levels because they're really suffering from severe anemia. And you can see a very nice result here. Again, a very dramatic increase in hemoglobin of about 4.6. And look at the responder analysis here. So over 50% of the patients, close to 53% of the patients achieved a greater than the hemoglobin 12, which is basically out of anemia land. And the baseline here was below 8. So it's a pretty dramatic increase when you think about it. So this is the data supporting the second pending approval and hopefully AISCO will be able to achieve this by year end. And in terms of where we are on the U.S. side, so we expect to have a pre-IND meeting with the FDA in the next few weeks and we will receive marching orders from the FDA regarding what they want us to do on the U.S. side to get the drug approved. Our base case estimate is that the FDA will probably require a PK study in healthy volunteers or something like that, followed by probably two pivotal studies to something very similar to what Haisco did in treatment naive and treatment experienced patients. We'll be able to start all that, or the PK study can start even by year end, but the pivotal studies will start in the early part of 27. And if we need to run two studies, we'll run them in parallel, and whatever study reaches the finish line first, that will be the basis for the first NDA filing, whether it's naive or pre-treated, and that will be followed by the second study that will be completed to extend the NDA package. So that's where we stand in terms of PNH. So again, the dynamics and the way things are evolving in PNH are absolutely terrific from our vantage point with a big pharma company, very sophisticated big pharma company that's kind of plowing the way and doing all the heavy lifting, all the education, all the patient conversions and all that. And again, I think we truly believe that being a fast follower with a once a day represents a significant advantage, which hopefully we'll be able to capitalize. Some more indications that I think present tremendous potential for this compound. So IGN, IGN nephropathy. So we're all aware of everything that's going on with the April baths, and there are a lot of moving parts there. There are five or six of them kind of jockeying for position, and some of the data looks very, very good in fairness. But so does our data. So when you look at the phase two data here that was generated in China, when you look at the proteinuria reduction of 57, 58 percent, and you look at the EGFR increase that was generated by NXP100, that actually puts you right up there with the best April BAFs, okay? Now, this is a phase two, and it was a 24-week endpoint. This needs to be proven out in a phase three setting, 52-week endpoint, and so on. And that's ongoing as we speak. So there's a pivotal study that's being run in China as we speak. That's going to read out in March, April of next year, which hopefully will answer all these questions. and I can assure you that if the data that's generated in that phase three is in the neighborhood of what we see here, this will make NXP100, I think, a contender for frontline position. Keep in mind, it's an oral. All these April baths are injectables. And again, the data here, you know, is right up there with the best of them. When you look at the Fabalta data in IgA nephropathy, it comes up a little bit short of the top April baths, and it may be half a notch below. So that's why it's not part of the conversation for frontline therapy, whereas we truly have the potential to become a part of that conversation. And, you know, again, just, you know, basically fight for frontline position. So certainly we like our chances in IGEN. But there are a number of additional indications that also one can think about. So Novartis is actually running six clinical trials as we speak. So they've got three approvals already, PNH, IGAN, and C3G. They're marketing almost exclusively into the PNH setting. And certainly they have a PNH price point at the moment but they're also running studies in lupus and the general mastenia gravis dry imdm you can see the indications there some of them are extremely lucrative and extremely large think about uh gmg for a second where the factor b's could be the first oral class in that setting we've spoken to a few kols about that that could be very attractive from uh from their standpoint So all these cards are going to be basically flipped over over the next six months or so. And I think that would be a great roadmap for us to follow. So, you know, we don't know if all of them will be positive, but certainly a number of them will be positive. And, you know, that can open up, obviously, some tremendous potential opportunities for us. On the Haisco side, so Haisco is also running a phase two study in lupus as we speak. That study is expected to read out by the end of the year. Again, if that study is positive, all of a sudden lupus becomes a potential priority. So again, there's no shortage of opportunities here. And when you look at some of the analyst reports that are out there, certainly the analysts that cover Novartis envision Fibalta potentially becoming a multi-billion dollar drug. And again, that's music to our ears because we'll come in as a fast follower, as a once a day with a clear convenience advantage in some of these indications. and whether we take, you know, 20% market share or 80% market share, you know, obviously it matters because, you know, we want the higher number, but the numbers can become pretty compelling. So that's where we are with respect to the factor B. In just a couple words, Patrick, if we have time, I'll just mention a couple words about NXP200, which is the BRAF inhibitor that we licensed. So this is a compound that, hang on just one second, this is a compound that's a second generation BRAF inhibitor, so a paradox breaker. As you're all probably aware, the issue with the existing BRAFs is that you need to combine a MEK because patients start to escape, and even when you combine the MEK, patients still become relapsed and refractory and so on. So that's why these second-generation paradox-breaking BRAF inhibitors were invented. But when you look at the data that's been generated for the second-generation BRAFs, you can see that they do very well in CNS. So do we. Each one, there are about three or four second-generation BRAFs, and they all generate about a 40-45% response rate in CNS. So do we. The key, and that's okay as a base case, that's certainly okay. Certainly for a small or mid-sized company, that's a very worthwhile opportunity to pursue. But the big prize can be if you can show data in other tumor types where you see the BRAF mutations, or for example, colorectal, melanoma, non-small cell lung cancer, papillary, things like that. If you can show data in those settings in heavily pretreated patients, especially patients who are BRAF experienced, that would be a huge differentiator. And I can tell you that the other BRF or paradox-breaking second-generation BRF inhibitors are really unable to do that. They really don't have a path forward in these other tumor types. They do in CNS, but they really don't in colorectal and papillary and so on and so forth, whereas we truly have the potential to be the only game in town when it comes to second-generation BRF inhibition in those other tumor types. And there's a phase 1b that is ongoing in China. What you see here is a pilot, kind of a quick litmus test pilot study that was conducted by Haisco to make sure they're kind of barking up the right tree before they embarked on the phase 1b. And the phase 1b study started a few months ago. We'll have a preliminary data readout by the end of the year from the study, including in a specific cohort that has BRAF refractory patients or BRAF relapsed patients, rather. And, you know, I can assure you that if that data shows promise, we're going to be all over it. And that's going to be part of our phase 1B. And that's going to be a key differentiator in that setting. So that's, in a nutshell, where we are. I think I have to stop here. Maybe there's some time for a couple of questions. But, again, you know, we're very fortunate to have in-licensed these two compounds and to have done this transaction with Taisco. they're an unbelievable partner the relationship has been tremendous they you know first of all they're extremely cooperative and collaborative but they really get it I mean these guys are great drug developers and you know they just you know really understand how things can you know get done in this industry. And again, we're very fortunate.