Hello everyone and good afternoon, and welcome back to the H.C. Wainwright 28th 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 Bentsur, 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. With that, Ron, I'll turn it over to you.
Thank you very much, Patrick. Thank you H.C. Wainwright for inviting us to present at the conference. It's very nice to be here. I'll dive right into the Nuvectis Pharma story. Just a couple words about, hang on a second. Yep. A couple words about the background of the founders of the company. As a team, in the past, we've worked with three prior companies leading up to starting Nuvectis, Keryx Biopharmaceuticals, UroGen Pharma, and Stemline Therapeutics. At each one of these companies, we were able to get a drug approved. At Keryx, it was a drug called Auryxia, which is actually approved for two indications. UroGen, JELMYTO, is an oncology indication, and Stemline, a drug called ELZONRIS for a small hematological oncology indication called BPDCN.
As a management team, we worked at these companies and have been together for the better part of the last 15, 20 years. We started Nuvectis 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. Just a couple of words about Haisco. This is a company that's really taking center stage presence over the last few months. 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. They also actually closed two NewCo type deals in the first half of the year.
Both of these NewCos were seeded with a lot of money and with some big name VCs and funds that participated. The reputation is really starting to precede them and they've evolved into a very formidable, very sophisticated drug developer. We in-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. The second drug that we brought in is a second-generation BRAF inhibitor, paradox breaking BRAF inhibitor, for oncology. In terms of financials, right after we closed this transaction with Haisco, about a week later, we closed a $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. It is a best-in-class potential factor B inhibitor. The only one out there is a drug that is marketed by Novartis called FABHALTA, and that is a twice a day factor B. So we have this convenience advantage over FABHALTA, and the indications we are 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 is already approved in China for PNH. PNH, for some of you that may not remember, is the indication where Alexion did very well in, where they had a drug called SOLIRIS that was approved about 10 or 12 years ago.
That was followed by ULTOMIRIS, which is a second generation SOLIRIS, and that actually got Alexion sold to AstraZeneca for about $39 billion. The main focus was on PNH. So this is a drug that is 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 are very much looking forward to that. O bviously, 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. W e will talk about the additional studies that are being conducted. O F course, the competitive landscape and what Novartis is doing with FABHALTA in other indications, and of course, the dynamics of the PNH market.
Let us dive into PNH a little bit deeper. So our key differentiation is the once a day versus a 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. I talked about the fact that it is already approved in China for PNH- naive and the PNH- experienced or pretreated patients 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, obviously SOLIRIS and ULTOMIRIS, which are C5 inhibitors, complement five inhibitors, came onto the scene first. It is a very sizable indication.
It is actually north of $5 billion as we speak, expected to grow to about $7 billion-$7.5 billion by the end of the decade. So there is very strong organic growth within the PNH market that is driven by the fact that a patient's diagnosis is easier nowadays, and also by the fact that our patients are living much longer. So the tenure of treatment has gone into decades, basically. So slowly but surely, this is an indication that is becoming a multi-billion-dollar indication. The C5s are still the dominant players, but that is about to change. T he reason that is about to change is because the factor Bs have arrived onto the scene. When you look at what FABHALTA is doing, first of all, it is an oral versus the C5s which are injectables.
When you look at the head-to-head data that has been generated for the factor Bs versus the C5s, there were two such studies that were conducted. I will show you the data from our study that Haisco conducted. They did a head-to-head study against SOLIRIS, and FABHALTA did a similar study versus SOLIRIS. It is not even close. The factor Bs are much more efficacious than the C5s. It is just a matter of time before the factor Bs will start to dominate this market. Again, this is going to be a $7 billion-$7.5 billion market by the end of the decade. I do not think it would shock anybody, and put us aside for a second, I do not think it would shock anybody if FABHALTA, by the end of the decade, will be a $3 billion, $4 billion, $5 billion player in PNH alone.
FABHALTA is a twice a day, and we are a once a day. The data is very similar with even a slight optical advantage in favor of us. Just to give you an example of the kind of data that has been generated. This was the treatment-naive study that was conducted by Haisco versus SOLIRIS. This is the basis for the approval that came about a month and a half ago in China. You can see on the right side there a very dramatic difference. Again, it is not even close. It is head and shoulders above SOLIRIS. The primary endpoint was patients that achieved hemoglobin above 12. That was the responder analysis to basically take them out of anemia land. That is a big problem for these patients. You can see that the results were about 59%, 60% for NXP100 versus about 8% for SOLIRIS.
Again, it is a pretty dramatic difference there. When you look at actually the average hemoglobin increase, the difference is even more profound. About a five-point increase in hemoglobin for NXP100 versus about 2.2 for SOLIRIS. More than a double in terms of the hemoglobin increase. As I said before, it is not even close. It is night and day of a difference. The factor Bs are clearly superior to the C5s in terms of efficacy. We saw a similar result in the FABHALTA head-to-head study that was conducted versus SOLIRIS. Now we have got two examples that drive home the point of the factor Bs being just much more efficacious than the C5. What that means in terms of the market dynamics, again, just to rehash, is that slowly but surely, the factor Bs are going to start to dominate the market.
FABHALTA is doing all the heavy lifting as we speak. That is Novartis basically driving the ball down the field, basically taking market share away from SOLIRIS. We are going to come in as a fast follower with a once a day, and I think we are very well-positioned because by the time we make it onto the market, I think FABHALTA will have established itself as a market leader with clear dominance or potential dominance of the space. When you talk to the KOLs, everyone kind of is convinced there is very little dispute as to the fact that the factor Bs are much more efficacious. They are oral, so why would not they overtake this multi-billion-dollar market? This is the treatment-naive study, and this is the data that was generated for the treatment-experienced patients, so basically the previously treated patients.
This is the second approval that is pending, which hopefully will arrive by the end of the year. Basically, these are patients who were on C5 treatment and failed, now you need to basically kind of reboost these patients and increase their hemoglobin levels because they are really suffering from severe anemia. You can see a very nice result here. Again, a very dramatic increase in hemoglobin of about 4.6. Look at the responder analysis here. Over 50% of the patients, close to 53% of the patients achieved a greater than hemoglobin 12, which is basically out of anemia land. The baseline here was below 8. It is a pretty dramatic increase when you think about it. This is the data supporting the second pending approval. Hopefully, Haisco will be able to achieve this by year-end.
In terms of where we are on the U.S. side, we expect to have a pre-IND meeting with the FDA in the next few weeks. 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. Something very similar to what Haisco did in treatment-naive and treatment-experienced patients. We will 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 2027.
If we need to run two studies, we will run them in parallel. Whatever study reaches the finish line first, that will be the basis for the first NDA filing, whether it is naive or pre-treated. That will be followed by the second study that will be completed to extend the NDA package. That is where we stand in terms of PNH. 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 is plowing the way and doing all the heavy lifting, all the education, all the patient conversions, and all that. Again, I think we truly believe that being a fast follower with a once-a-day represents a significant advantage, which hopefully we will be able to capitalize. Some more indications that I think present tremendous potential for this compound.
IgAN, IgA nephropathy. We are all aware of everything that is going on with the APRIL/BAFFs. There are a lot of moving parts there. There are five or six of them jockeying for position. Some of the data looks very, very good, in fairness. So does our data. When you look at the phase II data here that was generated in China, when you look at the proteinuria reduction of 57%-58%, and you look at the eGFR increase that was generated by NXP100, that actually puts you right up there with the best APRIL/BAFFs. This is a phase II, and it was a 24-week endpoint. This needs to be proven out in a phase III setting, 52-week endpoint and so on, and that is ongoing as we speak.
So there is a pivotal study that is being run in China as we speak that is going to read out in March, April of next year, which hopefully will answer all these questions. I can assure you that if the data that is generated in that phase III is in the neighborhood of what we see here, this will make NXP100, I think, a contender for frontline position. Keep in mind, it is an oral. All these APRIL/BAFFs are injectables. Again, the data here is right up there with the best of them. When you look at the FABHALTA data in IgA nephropathy, it comes up a little bit short of the top APRIL/BAFFs, and it may be half a notch below.
That is why it is not part of the conversation for frontline therapy, whereas we truly have the potential to become a part of that conversation and, again, just basically fight for frontline position. Certainly, we like our chances in IgAN. There are a number of additional indications that also one can think about. Novartis is actually running six clinical trials as we speak. They have got three approvals already, PNH, IgAN, and C3G. They are marketing almost exclusively into the PNH setting. Certainly, they have a PNH price point at the moment. They are also running studies in lupus and generalized myasthenia gravis, or gMG. You can see the indications there. Some of them are extremely lucrative and extremely large. Think about gMG for a second, where the factor Bs could be the first oral class in that setting. We have spoken to a few KOLs about that.
That could be very attractive from their standpoint. All these cards are going to be basically flipped over the next six months or so. I think that would be a great roadmap for us to follow. We do not know if all of them will be positive, but certainly a number of them will be positive, and that can open up, obviously, some tremendous potential opportunities for us. On the Haisco side, Haisco is also running a phase II 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. Again, there is no shortage of opportunities here.
When you look at some of the analyst reports that are out there, certainly the analysts that cover Novartis envision FABHALTA potentially becoming a multi-billion-dollar drug. Again, that is music to our ears because we will come in as a fast follower, as a once a day with a clear convenience advantage in some of these indications. Whether we take 20% market share or 80% market share, obviously it matters because we want the higher number, but the numbers can become pretty compelling. That is where we are with respect to the factor B. In just a couple words, Patrick, if we have time, I will just mention a couple words about NXP200, which is the BRAF inhibitor that we licensed. This is a compound that, hang on just one second. This is a compound that is 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. That's why these second-generation paradox-breaking BRAF inhibitors were invented. 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. 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-size company, that's a very worthwhile opportunity to pursue.
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 pre-treated patients, especially patients who are BRAF experienced, that would be a huge differentiator. I can tell you that the other BRAF or paradox breaking second generation BRAF 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 BRAF inhibition in those other tumor types. There's a phase I-B 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 I-B. The phase I-B 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 relapse patients rather. 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 I-B, and that's going to be a key differentiator in that setting. 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, we're very fortunate to have in-licensed these two compounds and to have done this transaction with Haisco. They're an unbelievable partner. The relationship has been tremendous. First of all, they're extremely cooperative and collaborative, but they really get it. I mean, these guys are great drug developers, and they just really understand how things get done in this industry, and again, we're very fortunate.