Nuvectis Pharma, Inc. (NVCT) Q3 2026 Earnings Report, Transcript and Summary

Good morning, and welcome to the Nuvectis Pharma Third Quarter 26 Financial Results and Business Update Conference Call. At this time, all participants are in a listen-only mode. Following the prepared remarks, we will conduct a question-and-answer session. As a reminder, this call is being recorded. I would like to now turn the call over to Ron Bentsur, chairman and CEO of Nuvectis Pharma. Please go ahead.

Thank you, and good morning, everyone. Before we begin, I would like to remind everyone that statements made during this call that are not historical facts are forward looking statements within the meaning of the Private Securities Litigation Reform Act of 2000. These statements are based on management's current expectations, and our interpretation of information available to date and they are subject to substantial risks and uncertainties, that could cause actual results to differ materially. For a discussion of these risks, please refer to the section titled risk factors in our quarterly report on Form 10 Q for the quarter ended 09/30/2026, and our other filings with the SEC. These risks are not exhaustive and new risks emerge from time to time. Any forward looking statements made on this call speak only as of today, Wednesday, 11/04/2026. And Nuvectis undertakes no obligation to update or revise them except as required by law. Okay. Now let's get to the interesting part of this call. Today is the first time we are hosting a call alongside the release of our quarterly results. And the reason is simple. The third quarter was transformational for Nuvectis, we have a great deal to share with you. We have transformed Nuvectis into a late stage development company with the addition of 2 exciting drug candidates with best in class potential through our licensing agreement for ex China rights with our new partner, Haisco. These additions have fundamentally changed the opportunity ahead of us. Our lead drug candidate, ciprocfeltin, which we also interchangeably refer to as NXP-100, is an oral complement factor B inhibitor for once daily oral administration that is approved in China for the treatment of newly diagnosed paroxysmal nocturnal hemoglobinuria, or PNH in short. And in development for the treatment of other complement mediated diseases including an ongoing phase 3 study in IgA nephropathy a phase 2 study in lupus nephritis, both being conducted in China by our partner, Haisco. The second drug, NXP-200, is an oral brain penetrant paradox-breaker BRAF inhibitor for the treatment of BRAF mutated solid tumors and I will expand on these 2 products and on our legacy compound NXP-900 during the call. We closed the licensing deal with Haisco in late June. After which we completed a follow on offering of a $150 million in gross proceeds that was anchored by leading health care dedicated institutional investors, Also in the third quarter, we placed approximately $37 million with a single healthcare dedicated fund through our ATM facility. Ended the quarter with approximately $140 million in cash, which we expect will fund our operations into the second half of 29 and, importantly, beyond multiple value inflection points. Let's start with the key pipeline development highlights before taking a slightly deeper dive into our plans going forward. In July, ciprocfeltin or NXP-100 received its first marketing approval in China for the treatment of patients with PNH who were not previously treated with complement inhibitors. The approval was based on a phase 3 study in which NXP-100 demonstrated clear superiority versus SOLIRIS on the primary and all key secondary endpoints. A second marketing application for ciprocfeltin in China is currently under review. This application covers patients with PNH who were previously treated with C5 inhibitors and is supported by another very successful phase 3 study in this patient population. We expect Haisco to announce this approval in the first quarter of 27. We are in active dialogue with the FDA about our development plan for PNH in The U. S. These discussions are going well, and we feel that the FDA is very engaged. We expect to provide an update on the FDA interaction by year end. Several additional phase 2 and phase 3 studies with NXP-100 are ongoing. We are also carefully watching the phase 2 and phase 3 studies being conducted with FABALTA or iptacopan, Novartis' twice a day oral complement factor B inhibitor. All these study results could provide an excellent roadmap for the additional indications that we may want to pursue with NXP-100. We expect the coming months to be packed with important relevant news on the NXP-100 front. Turning to NXP200. In September, the drug was granted the drug candidate was granted breakthrough designation in China for the treatment of BRAF V600 mutant recurrent or progressive high grade glioma. In October, NXP200 was the subject of an oral presentation at the ESMO conference. Updated phase 1b data from Haisco study in China demonstrated deep and durable single agent activity with NXP200, including complete responses in patients with recurrent or progressive gliomas Importantly, responses were also observed in patients previously treated with a BRAF inhibitor. Both of these aspects, complete responses and responses in NXP-100 compared to the other second generation BRAF inhibitors in development. The emerging clinical profile for NXP-200 demonstrates best in class potential. NXP-200 is currently being investigated in a broad clinical program in China, to unlock its full therapeutic potential. For our legacy NXP-900 oncology candidate, the phase 1 b program continues. This includes ongoing osimertinib and lorlatinib combination studies, and the planned investigator initiated study of NXP-900 in combination with the newly approved KRAS inhibitor sotorasib in pancreatic cancer. This investigator initiated study will be led by 2 top medical centers in the country. So as you can see, we are off to a very good start on all fronts, since completing the licensing deal in late June. Now let's take a closer look at our plans for each program. Importantly, we are doing so from a very strong financial position, with estimated cash runway into the second half of 2029. Let's start with ciprocfeltin. Or NXP-100. NXP-100 inhibits factor B of the complement system. Factor B is a key component of the alternative pathway 1 of 3 pathways of the complement system. By inhibiting factor B NXP-100 blocks the amplification the alternative pathway while preserving the other 2. PNH and other complement mediated diseases result from uncontrolled complement activation, Blocking different targets within the complement system has proven to be a very successful strategy. Treatments like SOLIRIS, ULTOMIRIS, and FABALTA are approved in several different indications and generate significant revenue. As I mentioned, the first approval of NXP-100 in China was based on a randomized head-to-head Phase III study versus SOLIRIS in treatment naive PNH patients. NXP-100 was superior to Soliris on the primary endpoint and all key secondary endpoints. The second marketing application in China that is currently under review is based on a phase III study conducted in patients with PNH who fail treatment with a C5 inhibitor. This study also met the primary endpoint and key secondary endpoints with plenty of room to spare. it is important to mention that the overall hemoglobin increase demonstrated by NXP-100 in the Phase III studies conducted was rather unprecedented with average hemoglobin increase of 5 and 4.4 grams per deciliter in the treatment naive and previously treated studies, respectively. Importantly, the safety profile of NXP-100 appears consistent with that of other complement inhibitors. Okay. So what does the opportunity in PNH look like for NXP-100? The PNH market is estimated to be around $5 billion today and is expected to double within the next 8 to 10 years. Historically, this market has been dominated by the injectable C5 inhibitors, which were the centerpiece of AstraZeneca's $39 billion acquisition of Alexion in 2021. Factor B inhibitors offer the potential for better efficacy compared to the C5 inhibitors along with the convenience of oral administration. So with much better efficacy and this convenience advantage, we expect the Factor B inhibitors to become the leading class in PNH over time. As of today, the only FDA approved factor B inhibitors, from Novartis, FABALTA is approved for PNH, IgA nephropathy, and C3G, a smaller nephrology indication, and is off to a fast start. It is on an annualized run rate of approximately $1 billion already, and this is about, 2 years out of the gate. We see a potentially substantial advantage for NXP-100 in its once daily dosing compared to the twice per day for FABALTA. This convenience advantage could be very meaningful and should not be underestimated in chronic diseases like PNH that require continuous lifelong treatment I think most of you would agree that there is nothing easier for a patient suffering from a condition requiring lifelong therapy than a once a day oral treatment. And as you have likely gathered by now, PNH is only the beginning. In China, NXP-100 is in an ongoing phase 3 study in nephropathy. Following a successful 24 week phase 2 study. In this study, NXP-100 demonstrated a statistically and clinically meaningful reduction in proteinuria. And importantly, the study also showed an almost 3-point increase in eGFR, the NXP-100 arm compared to 1.5-point decline in the placebo arm over this 24 week time horizon. We know that there is a lot of excitement around the APRIL/BAFF class of drugs in the IgA nephropathy space, and for good reason. In IgA nephropathy, the new standard established by the best APRIL/BAFF drugs, is the ability to stabilize eGFR long term, and that is considered disease modifying. It appears that FABALTA comes up just shy of being able to do that, whereas NXP-100 based on the phase 2 data generated, definitely has the potential to deliver that. This is where the favorable pharmacokinetic and pharmacodynamic profile of NXP-100 versus FABALTA may be coming into play. Hence, NXP-100 has the potential to deliver this competitive efficacy which can compare to the best APRIL/BAFFs, but with the clear convenience advantage of once daily oral dosing versus the APRIL/BAFFs are all injectables. Together, the PNH and IgA nephropathy markets alone are estimated to exceed $20 billion within the next 10 years. Our priority is to advance NXP-100 towards a marketing application in The United States for PNH. We also see significant potential in additional indications. Our US regulatory efforts in PNH are well underway. With 2 positive phase 3 studies from China, we believe we have a strong clinical data package. This puts us in a good position as we work with the FDA to define The US regulatory path. We continue to have constructive dialogue with the FDA as I mentioned before, we feel is very engaged. We expect to provide an update on The US regulatory path before year end. In addition, we are planning to submit an IND for another indication outside of PNH later this year. We also plan to initiate clinical trials in additional indications in the first half of 27. Novartis is currently running 5 phase 2 and 5 Phase III clinical trials for FABALTA in additional indications beyond the 3 approvals that they already have. These studies include areas such as dry AMD, and myasthenia gravis. We eagerly await the results from the FABALTA and Haisco run clinical trials. These results will help inform additional indications for us to pursue and where to focus our resources. As you can appreciate, there is no shortage of opportunities where we believe ciprocfeltin or NXP-100 can work and be very impactful. Our job is to prioritize these opportunities carefully taking into account the clinical and regulatory path, market potential, and our resources. Shay tuned for further updates on PNH and additional opportunities later in the year and into early 27. To support our development efforts in complement, we have made several key hires towards this end. These include doctor Dustin Little who joined in. Us in September as senior vice president, head of the complement program. Doctor. Little is a physician, scientist, and board certified nephrologist with a decade of industry experience in AstraZeneca, having most recently served as the global clinical head, late cardiovascular, renal, and metabolism, providing clinical leadership for renal disease area strategy at AstraZeneca, as well as multiple first in class or potential first in class treatments for people living with kidney cardiovascular or hematologic diseases. Doctor. Little brings a wealth of complement knowledge experience in the nephrology hematology settings, And he has really hit the ground running for us and is fully immersed in all facets of the NXP 100 program. Now let's switch gears and talk about NXP-200. BRAF is a commercially validated target in oncology with first generation BRAF generating well over $4 billion in combined annual revenue. While initially effective, first-generation BRAF inhibitors often cause paradoxical activation of the MAP kinase pathway. This results in treatment resistance and that is why the BRAFs are then combined with a MEK inhibitor to try to prolong the treatment effect. First generation inhibitors also do not address class 2 and class 3 BRAF mutations. there is a clear need to try to overcome the paradoxical activation of the existing BRAF inhibitors and the paradox breakers such as NXP-200 represent the next generation approach to targeting BRAF. Last week, we reported updated data from the phase 1b study in China with BRAF mutated solid tumors conducted in China by Haisco. The study also included patients previously treated with BRAF and MEK inhibitors, and NXP-200 generated responses in 2 of the 3 patients with this prior BRAF exposure. And this represents an important potential differentiator for NXP-200. We also believe that NXP-200 has the potential to expand beyond CNS tumors. Durable responses in non small cell lung cancer, colorectal and papillary thyroid cancers support the opportunity in a broad range of solid tumors and further data from the ongoing phase 1b study in China could substantiate this further. We should be receiving an update from this program in the next couple of months. In comparison looking at data from the competitor, paradox breakers being developed, it appears that these drugs are struggling to demonstrate meaningful activity outside of CNS tumors. Turning to the NXP-200 data reported last week at the ESMO conference. In this 27-patient Phase 1b study, NXP-200 demonstrated an objective response rate of 40% in the high grade glioma cohort group, which included 20 patients, And this included 3 complete responses. 2 confirmed and 1 pending. The objective response rate was 42.9% in the low-grade glioma cohort, including 1 confirmed complete response. The responses were assessed based on RANO 2.0 criteria, the FDA regulatory standard for brain tumors. Want to spend a moment on this assessment criteria because we have been asked how our results compare with data recently reported for another second generation BRAF inhibitor. That company reported 6 responses out of 9 patients or a 66.7% response rate in their glioma study. there is an important distinction in how the responses were assessed. The other companies reported results included radiographic responses rather than relying entirely on RANO criteria. Based on their disclosure, only 3 of 9 patients or 33 percent appear to have achieved a RANO response with no complete responses. In the high grade glioma group, only 1 out of 5 patients achieved appeared to have achieved a RANO response. This comparison reflects our interpretation only, of that company's most recent disclosure. We remain on track to submit a US IND for NXP-200 by the end of the year with the goal of starting a US phase 1 b in early 27. For some perspective on the opportunity, in April of this year, Servier acquired Day 1 Biopharmaceuticals for $2.5 billion Day 1's only approved drug, OJEMDA, is a first generation BRAF inhibitor approved in pediatric low grade glioma. At the time of the acquisition, OJEMDA was projected to generate $225 million to $250 million in sales this year representing only approximately 7% of the current BRAF market. Providing, we believe, an interesting benchmark for potential deals in this setting. Given the emerging profile in CNS and the potential in other solid tumors, we believe NXP-200 could emerge as a best in class next generation BRAF inhibitor in CNS, and also across a much broader range of tumors. Now turning to NXP-900, where the shift in our corporate focus towards NXP-100, we are concentrating NXP-900's development on the most promising combination opportunities. 2 studies are ongoing with NXP-900 with TAGRISSO, osimertinib, and LORBRENA, lorlatinib. And we also have an investigator initiated study planned for NXP-900 in combination with a newly approved KRAS inhibitor LUMAKRAS, or sotorasib. We expect to provide further NXP-900 clinical updates in the first half of 27. Now to some financial results and cash runway information. I would like to briefly review our third quarter financial results. Our net loss for the quarter was $30.1 million excluding the upfront license payment and the onetime milestone associated with NXP 9 hundred and the noncash stock based compensation our adjusted net loss was $5.8 million. We ended the quarter with approximately $140 million in cash, Based on our current plans, we expect that cash to fund-- that we have cash to fund operations into the second half of 29. With that runway, we have the financial strength to reach multiple value inflection points across our pipeline. So looking ahead, we have a number of important catalysts over the next several months. For NXP-100, we expect to provide an update on The US regulatory path for PNH as well as an IND filing by year end. We also anticipate regulatory approval in China for previously treated PNH patients in the first quarter of 27, and near term clinical updates from the FABALTA and the Haisco run clinical trials, which could all provide important data read throughs for NXP-100. For NXP200, we are targeting a US IND filing by year end. We also expect Additional Data From The Phase Ib Study In China across solid tumors, including colorectal melanoma, non small cell lung, and papillary thyroid cancers, in early 27. And for NXP 9 hundred, we expect clinical updates from the phase 1b program in the first half of 27. We have several opportunities to deliver meaningful news in the near term, with the potential to create significant value across our pipeline. As I look at Nuvectis today, I see a very different company. NXP-100 is a once daily oral Factor B inhibitor already approved in China for PNH, the potential to become a best in class treatment. NXP-200 is a next generation BRAF inhibitor with breakthrough therapy designation in China for high grade glioma already achieved. We believe it has the potential for significant differentiation and best in class attributes across multiple tumor types. NXP-900 adds further opportunities through our combination studies. At this time, I would like to thank our incredible partner, Haisco, for all their hard work and cooperation. We are privileged to be the shepherds of the NXP-100 and NXP200 programs ex China. I am also deeply grateful to our team for an extraordinary last few months and, of course, thank you all, our shareholders, for your continued trust and support. With that, operator, let's open it up for Q and A.

Thank you. Thank you. We will now begin the question and answer session. We ask that you please limit yourself to 1 question and 1 follow-up. If you would like to ask a question, please press star 1 on your telephone keypad. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before you. Pressing the star keys. 1 moment please while we pull for questions. Our first question is from Peter Stavropoulos with Cantor Fitzgerald. Please proceed with your question.

Hi. Congrats on the progress team. This is Samantha on the line for Pete. Thanks so much for taking our question.

Good morning, Samantha.

So Good morning. Could you tell us more about your interactions with the FDA regarding NXP-100 you have had so far? You have guided to pre IND meeting in 2H with the FDA and an IND submission in 4Q26. What are the possible outcomes for the path forward in PNH? And any color here would be helpful. Thank you.

Sure. Thank you for the question. So basically, the first formal interaction that we had with the FDA regarding the PNH program was in late September. And it is been basically open dialogue since then. And, essentially, if you think about the phase 3 studies that were conducted in China, obviously, the results were very robust. there is no question about that. there is obviously no dispute about that. And then when you look at the FABALTA studies, that were conducted, the 2 phase 3 studies that Novartis conducted, it is important to mention that about 40% of the patient population in those studies combined were Asian. Okay? And on top of that, 1 study was entirely ex US. And then to overlay another aspect to the story on top of what I just mentioned, is the fact that our drug NXP-100 is essentially an analog of FIBALTA. So Haisco in a very clever fashion was able to optimize FABALTA to come up with much better half life and we think much better pharmacodynamic properties, etcetera. And of course, this constitutes a new chemical entity and there is a composition of matter patent issued and so on and so forth. But that adds, obviously, another, I think, very strong reason to. Or, basically, what we laid out in front of the FDA And, you know, as you can imagine, they are bookends to the possibilities here. So 1 possibility is we believe that they will ask for 2 clinical trials, let's say 1 in naive and 1 in pretreated. And if we have to do that, we are more than capable. We will start those studies at the same time. And whatever study reads out first will be the basis for the NDA approval at that time. And then there will be an NDA supplement for the study that will complete. That will be completed afterwards. that is if they require 2 studies. The other end of the spectrum is that they are going to require no studies based on all this evidence that I just laid out. Now we believe that from a purely regulatory, statutory perspective, we have a very strong leg to stand on. But at the same time, we also realize that there are other reasons for FDA decision making. There could be some, you know, obviously, some policy issues and not wanting to open up floodgates and things like that. So, you know, realistically, we believe that we are going to have to run a study We are fully prepared to do that. We are gearing up internally for that. And, you know, we are just, kind of fine tuning and waiting for final marching orders from the FDA. But it could be any 1 of these 3. It still has not been finalized. What I will say is that in the prior interaction, the FDA asked specific questions about the studies that were conducted in China to see if you can, you know, level the playing field versus The US guidelines and the FIBALTA studies, in fact, So for example, 1 of their questions was, just to give you a sense of the types of questions that they asked was, regarding the transfusion protocol. So they wanted to make sure that the transfusion protocol criteria in the phase 3 studies in China was basically the same or substantially the same as The U. S. Guidelines. And ideally, you know, also substantially the same as what was done in the FABALTA studies. And in fact, it was. The criteria for the transfusion was pretty much identical to the FIBALTA protocol and to The US guidelines. And they asked a couple questions along those lines, and I think we are able to put all those questions or concerns to bed. So, you know, that is kind of where we are. The FDA, we feel, is very engaged. I think the dialogue is very positive. But, again, it has not been finalized yet. It could be anyone-- we believe, any 1 of these 3 you know, different alternatives that I described. Hopefully, that answers your question.

Really helpful. Thanks so much. Thank you.

Our next question is from Joe Pantginis with H. C. Wainwright. Please proceed with your question.

Hey, Ron. Good morning.

Hey, Joe. Good morning.

Good. Good morning.

So 2 questions, please. I wanted to follow-up regarding the FDA. Obviously, you know, these are ongoing discussions. You just gave some, important nuance. To the prior question. So I guess I will ask it this way. What would you consider to be the outstanding questions? And, you know, are there any that are still up for debate or you are finalizing that need to be able to get to an IND. And fast forward then with regard to potential study designs, they emphasize potential because it could change tomorrow. You know, you said maybe randomized. You know, could this be a placebo controlled study, you know, with FABALTA out there? And, how would you look to, you know, identify sites and how-- and potential competition for sites or, you know, drugs moving forward.

Yeah. So in terms of the key questions or concerns that the FDA has So they ask very specific questions. And we were able to answer all those. And, again, they were mostly related to trying to even the playing field vis a vis the Chinese studies and what is going on in the US and to some extent, the FABALTA studies and things like that. And I think we are able to answer those questions to-- I think fully That does not mean that they are not gonna require a study because there could be some other concerns or some other reasons as to why they would want that. Things like we know-- as-- And I. That not a state secret, that there are, you know, many, many drugs that have come in from China recently. And there is an issue of maybe not wanting to open up the floodgates and sending a precedent or things of that nature. I think our situation is very unique in that sense. But, you know, without getting into detail, our expectation is that, they will require a study. Now when you think about the different studies that, that they could ask for a randomized study versus placebo versus an active control, let's say, in a patient-naive-- in a patient-naive population versus a C or something like that, very similar to the study that Haisco ran in China. which is the basis of the first approval, was achieved in July for the patient-naive population. Another 1 could be obviously pretreated patients. A third 1 could be a switch study where you take patients who are, let's say, on a C5. You wash them out for, you know, a week or 2, and you put them on treatment. there is a pretty wide variety. What I will say is that, and this kind of ties into your second question, when you look at the patient numbers in these studies, typically it is about 35, maybe 40 patients. per arm. that is what we saw in the Haisco study. that is what we saw in the FABALTA studies. And I think that is kind of the guideline that we are going to follow more or less. So if you are thinking about a single arm study, it will be about 35 patients. Obviously, a controlled study will be about 70 patients ish, something like that. And in terms of reaching out to sites, there is a lot that is happening behind the scenes. And this is where the work of Dr. Little and some of the other folks that have come in is, I think, really starting to pay off. You know, they bring, obviously, their Rolodex and their connections and their know how. And understanding into the mix. And, you know, we have already established, I think, very good contact with a lot of the KOLs, a lot of the Top Recruiting Sites From The Prior Studies. in the US, ex-US. So there is a lot going on that front. So I think we will be ready to hit the ground running once we have the final marching orders. And, you know, we tie it up in a bow, and, we start, you know, we start whatever program we need to start. I think we are gonna be ready. that is fantastic details.

I really appreciate. And my quick follow-up is, you know, for NXP-200, you know, since China has breakthrough designation, is it safe to assume you would be looking to achieve the same in The United States with the FDA? And, you know, what sort of data do you think you will need to get there?

So, you know, regarding NXP-200, I think that is a complete sleeper. I do not think anyone's paying any attention to it. And, you know, I think that, this drug can emerge very quickly. I mean, literally within the next few months once we get an update from China from the Phase Ib study that is ongoing in China, you know, with respect to the other tumor types, this could very quickly emerge as, you know, with a best in class profile. And on top of that, I would add that if we see, for example, data, let's say, colorectal or melanoma or what have you, in BRAF relapse patients, that is not just best in class type of potential. That is kind of 1 of the new hot oncology compounds period. You know, it is that kind of a profile. So, you know, tuned for that, and, hopefully, the data will support what I just said. But with respect to breakthrough designation in The US, so obviously, we are chomping at the bit to get started with the Phase Ib. The IND is going to go in this year, with the goal of starting the phase 1 b as quickly as possible in early 27. CNS is a given. We are going to do that. And at the same time, I think it would behoove us to try to file for breakthrough designation. And keep in mind that Haisco already has 27 patients in gliomas. 20 of which are high grade, 7 of which are low grade. The data I am not gonna repeat it. You saw it. So I think we have we can add another 25, 30, 35 patient cohort to that, that could be very substantial. In terms of driving the case vis a vis the FDA. Not just for breakthrough designation but beyond that. So, you know, we are definitely gearing up for that as well. As you can imagine, trying to file 2 or 3 INDs for 2 different drugs. For a small company, it is no small feat, but we are gonna do it. And, we are gonna achieve it. And, and, the goal is to get these things going and moving We want to start clinical trials. We wanna put the wheels in motion. Thank you, Ron.

Thank you. Our next question is from Nas Raman with Maxim Group. Please proceed with your question.

Congrats on all the progress and thanks for taking my question. I wanted to dig forward on NXP-100.

Good morning.

Pretty straightforward on NXP 200. So, obviously, the data in gliomas is highly positive, and you are about to see the solid tumor data come out soon. Could you kind of walk us through, 1, what data will we see? And more specifically, what would you consider meaningful or important to incorporate that tumor type in your next study in The United States? Thanks.

Thanks, Nas. So the data that we are going to see is an update from the Phase 1b that started in the early part of this year in additional tumor types. So just to give you a little bit of history here and try to do it literally in 30 seconds. So back in a year and a half or 2 years ago, Haisco used an older version of the formulation, what they call the free based formulation. In this free based formulation, they saw very good data in CNS. And they saw inklings of activity in other solid tumors, colorectal, melanoma, etcetera. But it was not good enough. So they knew that they would need to improve the formulation namely to improve the PK parameters of the drug, to try to basically improve the activity of the drug in the other solid tumors. So what they did was they reformulated the drug into what is called the salt form, and then they conducted a small pilot study just as a litmus test to see whether they were basically marching down the right path or, you know, barking up the right tree. Basically, whether they were seeing an uptick in activity to justify starting the phase 1b in these other solid tumors. And in fact, they did. Was a small pilot, so no 1's saying, you know, these were large patient numbers or anything. But they had 3 out of 7 responders. Deep responses, excellent durability. So that gave them the confidence to start the phase 1b in these other solid tumors. What we are going to get is an update from that phase 1B, including a specific arm looking at BRAF relapse patients. We expect that there will be maybe as many as 15 to 17 patients worth of update in that subset. And obviously, there are going to be other kind of subgroups that we are going to receive updates on. And as you can imagine, to be able to rechallenge a patient who was on a BRAF, responded for as long as they did, and then relapsed, or failed, that is the holy grail. And that is quite substantial if you are able to do that. And in terms of what constitutes success in that setting, I would argue that even a 20 percent or 25 percent response rate would certainly be you know, definitely would definitely constitute success. Anything above that, I you start getting into kind of the triple home run grand slam, you know, type of territory. So, because it is never been done before. We saw an inkling of that in CNS now at the ESMO presentation where they had 3 patients that were BRAF relapsed, and 2 of them responded. So that is hopefully a good bellwether. We are going to wait patiently for that data, and we expect to have it within the next, you know, 2 or 3 months or so. And if, in fact, we do see visible activity in that setting, just as an example, that could really set the tone and, you know, really put this drug on, you know, I think much, much greater visibility And I truly believe that this could transform the drug's profile into not just a better paradox breaker, But in fact, you know, 1 of these, you know, very new attractive oncology compounds that are out there in the industry, and there are not many of them at any given point in time. But I think it could, in fact, join that very prestigious club of drugs that fall into that category.

Thank you. That was helpful. Thank you.

Our next question is from Yale Jen with Wade Law and Company. Please proceed with your question.

Good morning, and thanks for taking the questions and congrats on all the progress.

You mentioned about the IGA. And the recent ASN meetings has several highlights, including what Vera has-- data and try to file for approval later this-- but if I do have day later this year. How do you see NXP-100 in that sort of overall context of that as well.

In the context of the approved drug. And you mentioned something earlier that you may file another IND for NXP-100 besides the PNH. So would that be also IgAN? And then I have a follow-up question.

Yeah. Thank you. Yeah. We are fully aware of all the data that is been generated in IgA nephropathy and the APRIL/BAFFs. And the APRIL/BAFFs, obviously, some of them, not all of them, but some of them look absolutely terrific with the ability to control eGFR that being as we all know, a very important parameter to be able to control because that obviously basically can curtail the disease progression. So that is very good news for patients. But we believe that NXP 100 can fall into that category of activity. When you look at the phase 2 data, with. Albeit it was a small study. It was a phase 2, 25 patients per arm, and on and so forth in the 24 week endpoint, and we need to see it in the phase 3. Which, by the way, is a fully powered phase 3, 370 patients. 1 year treatment horizon, including a 1 year follow-up. So they will have all of the information that is necessary to be able to make that comparison. But when you look at the Phase II data, especially at the key components, which are the proteinuria reduction of 57%, just pretty unprecedented. And also the eGFR increase of almost 3 points that definitely gives you a reason to be encouraged about what you could possibly see come April or May when the data reads out in China from the phase 3 study. So we believe that NXP-100 could definitely have a seat at the table as it relates to frontline therapy and being a once-a-day, you know, oral treatment, I do not care if you are a Democrat, Republican, or an independent. Everyone knows that is so much easier than having to deal with injectables. And all the APRIL/BAFFs are injectables. Right? So we feel that would put us in a very good position And just going back to what I said on the call, when you look at the FABALTA data in IGAN, they come up just a little bit short. So they see a drop of about 2 or 3 points annually in eGFR, So that puts them kind of below that threshold. it is almost like having a p value of 0.049 versus a 0.051. Right? Something like that. But there is a distinction. There is a distinction. You wanna be-- you want to be, you know, EGFR stabilizing.

1 thing I will add to that whole equation is that when we talk to KOLs, they believe that patients need to be controlled to a level of less than a 1-point drop per year. Why 1-point? Because not all patients are gonna be stabilized or go higher. Some patients are going to drop. But if a patient drops only at an average of 1-point per year, realistically, they will never get to dialysis.

They will die of natural causes, and dialysis will not be an issue. So that is an acceptable number. So when you think.

When you look at that APRIL/BAFF data, put you know, our data aside for a second. When you look at the APRIL/BAFF data, not all patients achieve that. Obviously, when you have an average of eGFR stabilization, some patients are above that, some patients are below that, some patients are below the 1-point drop. And those patients going to require combination therapy based on what the emerging, not quite the formal guidelines yet, but the emerging guidelines that we believe are going to be established based on the data that we have seen with the APRIL/BAFFs.

So at a minimum, I think that the oral complement Factor B's are going to be a mainstay for those combination therapies because no 1's going to start to combine 2 injectables. So when you think about the messenger RNA Factor B's and all that, you know, it is great science. Do not get me wrong. I mean, it is very exciting science, but again, there is nothing easier on the planet than the once a day oral And I am not even going to talk about the potential safety issues, but no 1's going to combine those with another injectable with different timing of the injectables and things like that. So I think everybody assumes that at a minimum, the oral factor Bs are going to be the mainstay for the combination therapies. And when you look at the APRIL/BAFF data, roughly half the patients are going to fall into that category. But we have higher aspirations than that, as I just mentioned, we believe that NXP-100 could be a frontline therapy, could be a frontline target therapy based on the data that we have seen. Does that answer your question, Yale?

Sure. I appreciate that. it is a very comprehensive. I just want maybe just 2 quick ones. First is when you anticipate potential to start that trial and the other question is that in terms of manufacture, both of the NXP-100 and NXP-200 where you guys are, in The US. And thanks for taking the questions.

Yeah. So in terms of INDs, we want to file INDs this year. NXP 200 is pretty straightforward. NXP 100, we want file at least 1 IND, maybe even 2 this year. Obviously, nephrology is important. IgAN, C3G, which we believe is kind of low-hanging fruit. You know, because of the success that FABALTA has had in C3G, and there is also a pediatric component there. So that is nephrology. With respect to hematology, PNH obviously is front and center. There are also some additional indications that we are thinking about potentially. And I think there is going to be no shortage of activity but the goal for NXP-100 is to file at least 1 IND by the end of the year. And be in a position to start clinical trials as soon as possible in 2027. In terms of manufacturing, over time, we want to migrate the manufacturing to our CMO again, just to try to seclude ourselves and insulate ourselves from you know, any political issues or anything like that may arise, you know, a year, 2 years, 5 years from now. Who knows? So, you know, we wanna make sure we are able to secure our own manufacturer. So all that kind of tech transfer is happening as we speak, but that is not going to stop or slow down the start of clinical trials. So, you know, so all that is gonna happen in parallel. And, hopefully, that answers your question.

Sure and I appreciate that. Again, congrats on all the progress in the very fast speed.

Thank you.

Thank you. There are no further questions at this time. I would like to turn the call back over to Ron Bentsur for closing remarks.

Thank you very much, and thank you all for joining us this morning. We look forward to updating you on our progress Have a good day. And, again, we sincerely thank you for your time. Be well. Thanks.

This concludes today's conference call. Thank you for your You may now disconnect.