Conference Transcript - NVCT 2026-06-22

Operator

Greetings, and welcome to the Nuvectis Pharma conference call. At this time, all participants are in a listen-only mode. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to the professor, Chairman and CEO of Nuvectis Pharma. Sir, please go ahead.

Ron Bentsur, CEO

Thank you very much. Good morning to everyone joining our call today. Following our safe harbor statement, I will review the details of the strategic in-licensing deal that we announced earlier this morning. Before we begin, I'd like to remind everyone on this call that we'll be making forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements within the meaning of the federal securities laws are subject to substantial risks and uncertainties. During this call, all statements other than statements of historical fact are considered forward-looking statements and are based on our interpretations of past events as well as current expectations, estimates, and projections about future events. These and other risks and uncertainties are subject to market and other conditions and are described more fully in the section titled Risk Factors in our Form 10-Q for the quarter-ended March 31, 2026 and our other public filings with the Securities and Exchange Commission. However, these risks are not exhaustive, and new risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements made in this call or on other filings made with the SEC. Now, for the reason we're having the call today. Today is a momentous day for Novectis. Earlier this morning, we announced a strategic portfolio expansion through an in-licensing deal with Haisco Pharmaceutical Group for the global ex-China rights to two potentially best-in-class drug candidates. Overnight, this agreement transforms us into a late-stage development company with a new focus on complement-mediated diseases and bolsters our already exciting oncology pipeline. During today's call, I would like to introduce you to these two new exciting pipeline products. First, our new lead drug candidate, the once-daily orally-administered complement factor B inhibitor in late-stage development, which we have named NXP100. We believe that NXP100 is the most advanced once-a-day oral complement factor B inhibitor in development today. NXP100 is currently the subject of two marketing authorization applications in China, the equivalent of NDAs in the U.S. for the treatment of a disease called paroxysmal nocturnal hemoglobinuria, or PNH in short. NXP100 is also currently being studied in additional clinical trials in China, including a Phase III study in IgA nephropathy, which follows a successfully completed randomized Phase II study in this indication, as well as a Phase II study in lupus nephritis. Additionally, this transaction expands our already exciting oncology pipeline with the addition of a Paradox Breaker BRAF inhibitor for the treatment of BRAF-altered cancers with a drug that we name NXP200. NXP200 has demonstrated single-agent activity across a variety of tumor types with objective, durable responses achieved in CNS, colorectal, non-small cell lung cancer, and other cancers, and is currently in a Phase I-B study in China. Both companies come with very strong IP protection, including issued composition of matter patents for both NXP100 and NXP200, expiring in 2043 and 2042, respectively, and that's without any patent term extensions that we may be eligible for. Before we dive into the details on these two exciting candidates, I want to recognize our partner, Haisco, a company that many of you may already be familiar with because of two successful licensing deals recently announced, one with Eli Lilly and one with AbbVie before that, that involved several Haisco discovered and developed products. Also, at the beginning of this year, Alumis, a U.S. publicly traded biotech company, reported resounding success in two pivotal phase three studies in plaque psoriasis for a drug candidate that was originally discovered and developed by Haisco. Haisco is now well-known as a leading pharmaceutical company with global reach, and we're very happy that they recognized us as a quality partner for the continued work on these two important compounds. I believe that our management track record, including obtaining FDA and XUS approvals for two oncology drugs and one nephrology-slash-anemia drug in companies that we led in the past, as well as our successful prior partnership history with ex-U.S. companies played a role in consummating this licensing transaction. We are thankful for this partnership and look forward to working together with the outstanding team at Haisco. Now let's get back to NXP100 and NXP200. Let's start with NXP100, which we believe is the most advanced once-a-day oral factor B inhibitor in clinical development today. As a reminder, the current development status for NXP100 in China includes two marketing authorization applications under review for the treatment of PNH, one for previously treated patients and one for treatment-naive patients, with Chinese approvals expected in late 2026 and early 2027. In addition, a phase 2 study in IgA nephropathy in China has been successfully completed, and a pivotal phase three study for this indication and ongoing. And also, a phase two study in lupus nephritis is also ongoing in China. Let me start with a little bit of background on the class of immune complement inhibitors, and then I will share with you why we're so excited about the potential of NXP100. Immune complement inhibitors are a well-established and continuously growing multi-drug pharmaceutical category comprised of several classes that are cumulatively generating billions of dollars in annual sales. One of the greatest success stories of this class are the complement C5 inhibitors, Soliris and Ultramiris, which is basically the next generation Soliris. These two drugs were originally developed by Alexion and now marketed by AstraZeneca Rare Disease and were the centerpiece for the $39 billion acquisition of Alexion by AstraZeneca in 2021. We'll touch on these two drugs in just a moment. As of today, complement inhibitors are approved for the treatment of several diseases, including PNH, IJ nephropathy, C3 glomerulopathy, myasthemia gravis, and others. The list of approved indications is expected to grow as late-stage clinical trials continue to demonstrate the efficacy of complement inhibitors in additional diseases. However, it's important to note that not all complement inhibitors are created equal. Let's take the case of PNH, for example. PNH currently is a $5 billion-plus market, expected to more than double within the next eight years. Currently, Soliris and Ultramiris dominate the market with more than $4.5 billion in annual sales into the PNH indication. PNH is a rare and life-threatening blood disorder that is caused by uncontrolled activation of the immune complement. The approval of Soliris had a substantial effect on the outcomes of PNH patients, but there was still much room for improvement, which the field saw in 2024 with a launch of a drug called Fabalta, which is being developed and marketed by Novartis. Unlike the C5 inhibitors comprised exclusively of injectable drugs, Fabalta is a complement factor B inhibitor that is administered orally twice a day. So basically, the same target as NXP100, but in order to achieve effective inhibition of the target, it requires two daily doses versus NXP100 that should only require one daily dose. Importantly, NXP100 and Fabalta have demonstrated striking superiority over Soliris in their respective head-to-head phase 3 PNH trials. This sets the stage for factor B inhibitors to potentially become by far the most dominant player in the PNH market over time. Fabalta is currently the only FDA-approved Factor B inhibitor, and it has seen robust market adoption. In addition to PNH, Fabalta is also approved in IJ nephropathy and C3 glomerulopathy. Novartis is also investigating Fabalta in additional multibillion-dollar diseases such as myasthenia gravis, lupus nephritis, and dry AMD. Recent analyst reports project peak annual sales for Fabalta in the range of $5 to $10 billion. So, now back to NXP100, which is an optimized chemical analog of Fabalta. The modifications introduced to the chemistry of NXP100, which make it a new chemical entity, were meant to improve the PK properties of Fabalca while maintaining excellent efficacy and a similar safety profile. The composition of matter patent for NXP100 was recently issued, and as I mentioned before, expires no earlier than 2043, and that's without taking account any potential patent term extensions. And indeed, the completed clinical development of NXP100 and PNH in China demonstrated similar efficacy to that shown with Hivalta in its PNH studies, including clear superiority over Soliris in the head-to-head Phase III study, while requiring only a single daily administration of NXP100 versus the twice-daily administration required with Hivalta. In addition to PNH, NXP100 successfully completed a Phase II randomized placebo-controlled study in IgA nephropathy and is now being investigated in a pivotal Phase III study in China. The Phase II data showed that treatment with MXP100 resulted in meaningful reduction in proteinuria, as well as an increase in EGFR, with proteinuria and EGFR being the hallmark endpoints for this indication. To provide context for these data with MXP100, we can look at the previous clinical trials of Fabalta on this indication, and we can clearly see that while this comparison comes from cross-study analyses, the data points to a potentially greater treatment effect on both of these endpoints for NXP100 versus Fabalta. In the context of IJ nephropathy, it is also important to mention a new class of therapies called APRIL or BATH-APRIL inhibitors, which have been getting a lot of attention recently. The BATH-APRIL inhibitors, which are all injectable drugs, compete with Fabalta only in IGA nephropathy. In IGA nephropathy, cross-trial comparisons of these drugs to Fabalta show that they are potentially a bit more efficacious than Fabalta, both in terms of proteinuria reduction and EGFR maintenance. However, the phase two data with NXP100 suggests that NXP100 can potentially achieve a similar therapeutic effect as the best bath aprils in development in both proteinuria reduction and EGFR stabilization as an oral therapy as opposed to the injectable BRAFs, as opposed to the BAF APRILs. I'm emphasizing the fact that NXP100 is administered once a day because this could translate into meaningful convenience and compliance advantages. Although the data is from a relatively small phase 2 study conducted in China, it points to a real possibility of having disease-modifying capabilities potentially in line with the best BATH-APRIL inhibitors in development today. And the last sentence about BATH-APRIL drugs, unlike Fabalta and NXP100, which block the alternative complement factor B pathway, BATH-APRIL inhibitors target B cell activation, which is why they are not a factor in PNH, dry AMD, and several other complement-mediated diseases. Beyond PNH and IJ nephropathy, NXP100 is also being investigated in an ongoing phase two trial in China for lupus nephritis, which also represents a substantial market opportunity. We believe that coming on the heels of Novartis' Havalda's continued growth in the market penetration across several blockbuster indications represents a tremendous second mover advantage for us. We also believe that we potentially have an important and clear convenience advantage over Fabalta, and in certain indications, we may also have an efficacy advantage, which is an excellent position for NXP100 to be in. As potentially the first once-a-day Factor B inhibitor on the market, we believe that NXP100 clearly represents a blockbuster opportunity. Novartis continues to blaze the trail for factor B inhibitors in several indications, including PNH, IGA nephropathy, C3G, and possibly also doing so in lupus nephritis, dry AMD, masthenia gravis, and other indications through the clinical trials that they're currently conducted. Their work to educate the market about complement factor Bs is extremely favorable to us. PNH as a case study represents the indication with the most established data for complement factor B inhibitors, a soon-to-be $10 billion indication, and as I mentioned before, we firmly believe that factor B inhibitors are positioned to dominate this disease over time. To put the spotlight on dosing convenience, it is a very important feature in treating these lifelong diseases. And as a once-a-day oral candidate, NXP100 potentially offers an important convenience advantage that could translate into better compliance and overall outcomes for patients requiring these lifelong therapies. Now, let's switch gears to our second in-licensed compound, NXP200. I want to start by briefly mentioning NXP900, our exciting, unique SARC inhibitor pipeline product, and then introduce the opportunity for NXP200. For NXP900, many of you may be familiar with this drug candidate, and I want to underscore our enthusiasm for this program. We're looking forward to the upcoming clinical trial data readouts from the ongoing single-agent and combination Phase I-B study starting this summer. Now back to NXP200, our new paradox-breaking BRAF inhibitor. The BRAF inhibitor class is an established greater-than-$4 billion class targeting several solid tumors in patients harboring the BRAF V600 mutation. However, these existing first-generation BRAF inhibitors on the market come with significant limitations, specifically the phenomenon called paradoxical activation. Paradoxical activation occurs when the mutated BRAF that drives the cancer's growth is effectively inhibited by the BRAF inhibitor, but at the same time, the non-mutated RAF proteins interact and activate the pro-cancer MAP kinase pathway, leading to acquired resistance in other problematic side effects, such as secondary skin cancers. The current solution is to administer the BRAF inhibitors with a MEK inhibitor. This helps to reduce acquired resistance and side effects, but does not eliminate them. And these challenges continue for both physicians and patients. Paradox-breaking BRAF inhibitors aim to overcome this problem. There are currently no FDA-approved paradox-breaking BRAF inhibitors, and several are in development. We believe that NXP200 has the potential to be the best in class. Based on superior paradox-breaking capability observed relative to other candidates, as demonstrated in preclinical studies and its potential for robust brain penetrating capabilities as well. However, more importantly, in early-stage clinical trials in China, NXP200 has demonstrated clear preliminary single-agent activity with responses across several tumor types. These include in heavily pretreated patients with low- and high-grade adult glioma, colorectal, non-small cell lung cancer, papillary thyroid, and other cancers, with some responses extending now greater than 14 months and ongoing. More specifically, for example, treatment with single-agent NXP200 resulted in a response rate of greater than 40% in low- and high-grade adult gliomas, including in patients previously treated with BRAS MEK inhibitors, and this also included one patient who achieved a complete response. This data was presented at this year's AACR conference. To be fair, other paradox breakers in development have also demonstrated reasonable data in brain tumors, but what we believe truly sets NXP900 apart from the rest of the paradox breakers in development is its potential for single-agent activity in other tumor types. To the best of our knowledge, no other paradox-breaking BRAF inhibitor in development has shown consistent single-agent activity outside of CNS, let alone across multiple other tumor types. With a phase 1b study currently ongoing in China, in various BRAF-mutated tumor types, we're excited about the manifestation of the full therapeutic potential of NXP200 over time as data will continue to be generated. From a business perspective, as mentioned before, the size of the BRAF inhibitor market is estimated at approximately $4 billion today, all generated by first-generation BRAF inhibitors. Recently, a compelling M&A transaction was the $2.5 billion acquisition of day one biopharmaceuticals by Cerviae in the second quarter of 2026. Day one's only approved drug, Agenda, is a first-generation BRAF inhibitor approved for the treatment of relapsed refractory pediatric low-grade glioma, which is a rare subset of CNS tumors. Prior to the acquisition, Agenda 2026 revenue was projected to be at approximately $250 million, representing only 6% or so of the overall $4 billion BRAF market. This signals that the marketplace is willing to place significant value on BRAF inhibition, even in the narrow indication. A next-generation paradox-breaking BRAF inhibitor with broader activity across multiple tumor types could represent a substantially larger opportunity. Taken together, NXP200 and NXP900 represent an exciting and compelling oncology pipeline with multiple opportunities ahead, and we're poised to build on the great work done by Haisco so far and advance the NXP200 development program outside of China. So now a few words about the terms of the transaction and the expected near-term news flow. We enlicensed the exclusive worldwide ex-China rights for NXP100 and NXP200 from Haisco. Haisco also retains rights for NXP100 in India and certain small Southeast Asia territories. With regard to financial terms, Haisco is entitled to receive upfront and near-term payments of up to $40 million. Haisco is also eligible to receive up to $1.4 billion in additional development, regulatory, and commercial milestone payments, as well as tiered royalties on future net sales. While we prepare our IND submissions in the U.S. for NXP100 and NXP200, we expect a number of meaningful catalysts to emerge from China, including potential drug approvals for NXP100 and P&H, as well as data readouts from the ongoing studies for both NXP100 and NXP200. I hope that this call and this morning's press release convey to you why we're so excited about this strategic in-licensing transaction and the product candidates being added to our pipeline. We believe that Novectis has the knowledge, experience, and proven track record of capital efficient execution to advance these programs and create meaningful value to our stakeholders. We look forward to updating investors on our progress and the milestones ahead. Thank you very much for your time. And operator, this concludes our call today. Once again, thank you all very much for your time. We appreciate your attention. Thank you.

Operator

Thank you. Ladies and gentlemen, this concludes today's conference. You may disconnect your lines at this time. We thank Thank you for your participation.