Conference Transcript - VOR 2026-06-03

James Stamos, Analyst — Jefferies

Hello, everyone. I'm James Stamos, representing my colleague Farzeen Haq, one of the biotech analysts here at Jefferies. It's my pleasure to introduce Jeremy Sokolov, Chief Medical Officer, and Dan Lynn Murray of Chief Commercial Officer of Vore. This is a fireside chat format. Thank you for joining us today. To start off, Jeremy, could you kindly provide a quick overview of the company for those who are new to the story?

Jeremy Sokolove, Other

Sure. So this is Vore 2.0. So Vore 1.0 was a cell therapy company. It winded down in the 2024 to 2025 range, and through a collaboration of a consortium of investors led by RA Capital and others, VOR 2.0 was formed from that shell with an asset called teletacicept. Teletacicept is licensed from Remagen in China. It's a drug that's approved for rheumatoid arthritis, systemic lupus, as well as myasthenia gravis. and is now in registration for two additional indications in IgA nephropathy and Sjogren's disease. We've licensed global rights, taken over global development, and are now executing in two indications, primarily in myasthenia gravis, and more recently we've initiated our phase three registrational study for Sjogren's disease.

Dallin Murray, Other

Yeah, just to add on to that, we're in this unique position. We're less than a year into this new 4.0 but as we sit here today uh we're on the back half of this global phase three we're gonna have results first half of next year an approval uh within the year following that and as jeremy said we just started the show prince trial so uh an incredibly de-risked asset it's the most extensively studied and the most advanced bath april globally as jeremy said with multiple approvals in China, and incredibly de-risked because of the safety database that we have and the efficacy data that we have to support these launches.

James Stamos, Analyst — Jefferies

Great. Thanks. So let's start off with myasthenia gravis. In GMG, we're ACHR antibodies, predominantly IgG1 and IgG3 are the primary drivers. Can you articulate the mechanistic advantage of dual BAF-APRIL inhibition over selective IgG reduction via FCRN blockade?

Jeremy Sokolove, Other

Yeah, there's two. So one is actually even more simplistic, which is that although a large number of the anti-ACHR antibodies are IgG, there's also IgA and IgM isotypes, which target that ACHR receptor as well as musk. And those are not targeted by the FCRN receptors. So FCRN very specifically inhibits the recycling of IgG, resulting in a lowering of IgG levels across the systemic circulation. But that unabrogated IgA and IgM are critical for that subpopulation in that it would probably be associated with a significant amount of non-response. And we think that contributes to the increased breadth of response we see with teletacicept relative to FCRNs. The other advantage, I think, is the durability. And so FCRNs are great. They've really revolutionized the way we think about MG. One of the challenges is that you treat with an FCRN inhibitor, you clear your IgG, and as fast as your body can remake IgG, that disease comes back. The cyclic nature of FCRNs is challenging. Even when you don't do the cyclic nature of FCRNs, you never really affect the underlying immunobiology of the disease. With a BAF-APRIL mechanism, the APRIL side is rapidly decreasing the antibody-producing cells and dropping pathologic immunoglobulins. But the BAF side is also affecting upstream development and repopulation of those pathogenic B cells. And that's really why we think there's a twofold opportunity both to drop the IgG, both to drop the pathologic immunoglobulins, but also to work upstream to really remodulate the immune repertoire so that we get that durability and continued improvement. And our data is really interesting from China in that between week zero and 24, there's significant robust improvement, but the continued improvement from 24 to 48 weeks is what really impresses the field, and we think that's that continued remodulation of the upstream B cells, which cannot repopulate the pathologic antibody-producing cell population.

Dallin Murray, Other

Yeah, and in the context, James, of the market as a whole, the biologic era kicked off in 2017 the market is five billion today it's been growing at 60 percent per year as jeremy outlined our mechanism is perfectly suited for where the market is going and if you look at the emerging guidelines that's towards upstream targeting and durability and so we think we're perfectly positioned for what the unmet needs are today where the market is going and that's a good thing because the consensus projection for the market is that it's going to double in the next few years, and it's going to be a $10 billion market in the very near future.

James Stamos, Analyst — Jefferies

Great. How is the global phase three trial and GMG enrolling, and what has been the feedback from site investigators on patient demand?

Jeremy Sokolove, Other

Yeah, so right now the enrollment is going quite well. We're on track or a little ahead right now. We brought on China. They're enrolling very nicely. They're going to be just about 8% to 10% of the patients. But we are also opening a couple of new geographies, which will contribute to our contribution. We opened about another eight U.S. sites. So we are guiding towards last patient in the fall and top-line data in the first half of 2027. As far as the investigators, the feedback we're getting is very good. They say it looks like a lot of the other drugs in terms of tolerability. The one thing that, again, most of the investigators only have one to three patients in their cohort, but we are getting a lot of requests for an extended open-label extension. So we have the first patients finishing the one-and-a-half years from the initiation of the study when Remogen started it several years ago. And so we have a lot of patients doing very well in that open-label extension, and the investigators really pushed us. And what we've done is an extended open-label extension, whereby patients who finish that one-year OLE can get continued access to the drug. And, you know, we're really hearing them ask for that, and we've given it to them.

James Stamos, Analyst — Jefferies

Great. How are you addressing potential differences between the Chinese trial population and the global population in terms of patient population differences, ACHR positive versus broader stereotypes, and background standard of care use?

Jeremy Sokolove, Other

Yeah, so I think MG is one place where there's a pretty good consistency between China and the U.S. in terms of underlying disease biology. So I think that's one very positive translational confidence that we get for China to global. The background demographics are also quite similar. The patients in China had a slightly shorter disease duration, slightly younger age than some of the more global studies. Otherwise, the background rate of immunosuppressant use steroids was almost identical. China does have a little more use of tacrolimus and azathioprine relative to globally, where there's a little more use of mycophenolate. But otherwise, the baseline MGADLs, the baseline QMG, and the baseline ACHR and musk breakdown was pretty similar. So we think it's pretty consistent. And if you look at the one example of a MG study, which was initiated in China and then repeated globally, that's botoclamab. Botoclamab in China had a delta of two for their MG-ADL. And then when they ran a global study, the placebo went up, but they still had a delta of two. So we think that we're looking at a very similar pattern that we anticipate globally.

Dallin Murray, Other

And, you know, it's also important to note that we're really on the leading edge of taking data from China and taking it to the global market. And so in less than a year, we've built an exceptional medical affairs team. We've got a standing U.S. and global advisory committee with the top KOLs in MG. We've got a med affairs team that really has expertise in this area. And one of the things we're putting a big focus on is connecting the experts in the U.S. and outside of China globally with these Chinese investigators. So we've established a scientific advisory board of top experts in the U.S. and China. Jeremy and I will be going to Shanghai in the next couple of weeks. And as we get the translation and the communication going, it's really going to facilitate, you know, Jeremy's efforts on the clinical side to translate the data.

Jeremy Sokolove, Other

One thing I think is nice is this is a drug that's commercially available in China, and it's getting rapid acceptance. The neurologists who treat MG are using this drug now across a range of immunologic, autoimmune, neurologic diseases because they like it so much. So I think that, you know, that communication from the Chinese investigators, Chinese clinicians, Chinese KOLs will provide confidence to the global community as well.

James Stamos, Analyst — Jefferies

Great. Can you talk about the powering assumptions in the China phase three tele-attack is that achieved a 4.8 point reduction versus placebo 24, 8 weeks. How much dilution of effect size are you anticipating in the global phase three and to be still considered differentiating for commercial uptake?

Jeremy Sokolove, Other

Yeah, so I'll speak to the first part. So we're not anticipating a huge drop, but we are powering for a huge drop. So we're powering for a more conventional delta in the range of two. We want to make sure that if our MGADL delta does fall off, we still have an approvable drug because we think that the mechanism provides for opportunistic differentiation in terms of both breadth of response as well as the durability beyond just the depth of response. So we are powering for that. We're dramatically overpowered for that Chinese delta, but we're well-powered for a more contemporary delta if we look more like the other drugs in the class. I'll let Dallin speak to the commercial.

Dallin Murray, Other

Yeah, the MGADL is the gold standard gauge of efficacy in the market. So it's natural that people hone in on that. And it's our splashiest piece of efficacy data because we're essentially double the competitive field in terms of that delta. And we do expect to maintain an advantage there, but will it still be double? It certainly doesn't need to be, and we can actually lose that delta entirely and still win in the market because we really win in efficacy on three ways. That delta is one of them, and that's what we call the depth of efficacy. But we also have two other efficacy advantages, one being the breadth of response. the the current market leader was approved on a 67 percent of patients having a two-point or greater mgadl response that's the label data for for teletacicep that's a hundred percent of responders and so that's a very important advantage is the proportion of responders we call that the breadth of response from an efficacy standpoint and that's absolutely going to continue you know there's no no risk really on that one at all and then the third advantage and is because we're targeting upstream and targeting B cells is the durability and to that on the global phase three we have a full one year open label extension after the 24 week placebo control portion so we expect to have great data longer term on durability and as I said earlier that's that's where the market is moving, long-term sustained symptom control for MG. So even if we were to lose the delta entirely, which would be disappointing, we would still win on these other

James Stamos, Analyst — Jefferies

two components. And just another follow-up question for the global phase three trial. Is it explicitly stratifying or evaluating efficacy in patients who are refractory to

Jeremy Sokolove, Other

existing fcrn or complement inhibitors so we are allowing patients who have exposure to fcrn and complement inhibitors we do have a stratification the numbers are relatively small I think we're it probably going to be in a sweet spot where we have just enough patients to be able to provide some some empiric evidence that there's a response to fcrn inadequate responders with teletacis except but not a large enough number that we think it'll affect our statistical evaluation overall of the population effect size. Great. And I guess let's move on to

James Stamos, Analyst — Jefferies

your Sjogren's trial strategy. So the global phase three upstream Sjogren's trial dosed its first patient in late March, and target enrollment is 250 patients. What is your anticipated timeline for enrolling the study given multiple phase threes enrolling? Yeah, we're looking at about

Jeremy Sokolove, Other

a two-year enrollment timeline, and that's both because of the competitive nature of the environment, but also because the population we're enrolling is a very specific Sjogren's population. We anticipate, obviously, there's a one-year study conduct, so it'll be about a three, you know, but just under three years to data is what we're anticipating. We'll have better guidance as we see the trajectory of the study enrollment. Right now, you know, we're getting a lot of screening in the U.S. There's a lot of enthusiasm among U.S. investigators to get patients into this study. So if we see that globally, we could have better news in the coming months.

James Stamos, Analyst — Jefferies

And for the Estee training for Sjogren's investigators, it's notoriously challenging. It's a 12-domain, somewhat subjective scale. Can you elaborate on your site selection strategy, particularly in the context of investigators' familiarity with Estee and Esprit?

Jeremy Sokolove, Other

Yeah, definitely. So we're actually very lucky that a number of Sjogren studies have been conducted ahead of ours, including the two Neptunus studies from Novartis. So Novartis ran two very large studies, and in doing so, they had to bring a lot of sites on that didn't have a lot of Sjogren's experience. I think that might have been to their detriment in terms of their placebo effect, but it's to our advantage in terms of now having these well-trained sites who have a lot of experience with the S-dye. So the key to S-Di precision is repeated use of the S-Di tool. And I think that we've grabbed as many of those former Novartis sites as possible, people with experience with the nipicalumab J&J studies, people with the Horizon, now Amgen, Dazadalabep studies. And so, you know, we've taken investigators almost exclusively who have S-Di experience. We've also trained or retrained all of them with the Sjogren's Foundation S-Di training tools and ESPRI training tools. And we think that, you know, by selecting these sites with experience, you know, not better investigators, just more experience with the tool, we'll be able to get better precision and reduce that placebo that was, you know, a challenge to the Novartis study.

James Stamos, Analyst — Jefferies

And what learnings from the Chinese study in terms of dose selection, patient stratification center were implemented in design of the global pivotal? And are there any notable differences compared to Novartis' Ianalumab and JJ's nipocalumab

Jeremy Sokolove, Other

in Argenix's F-Cartigy Mod? Yeah, the main difference, so the China study was, China ran two great studies, Remagen and China, for Sjogren's. The first study was a small phase two dose ranging study where they looked at 240 and 160 milligrams, and this was to ask the question, is there any advantage of the 240 milligrams over the approved 160 milligrams for lupus? And the answer was no, 240 didn't improve on 160. The phase three study was a much larger study and evaluated two doses, 160 milligrams and 80 milligrams, and showed that 160 was superior to 80 milligrams, but 80 milligrams still worked. In fact, 80 milligrams looked pretty similar to what other people have seen in their Phase II Sjogrens studies. So we think that really did a good job confirming the dose ranging. Now, there was a major difference in the China Phase III Sjogrens study versus inalumab, and that was the use of background medications, and in the China study, they weren't allowed to be on any background immunosuppressants other than hydroxychloroquine, and there could be no steroids. In the INLMAP study, 30% to 40% of patients were on steroids and or background immunosuppressants. Whether that contributed to that placebo response or not isn't 100% clear. We're waiting to see the sub-analysis of the placebo in the patients who were or were not on background immunomodulators. We do have immunomodulators in our Phase III study. For that reason, we anticipate we will not reproduce the very low placebo that was seen in China, but we don't need to. Even if the placebo goes up to the average placebo of two and a half, our delta is still two and a half to three, which would be best in disease. And that assumes no increase in the active arm from that background therapy. And we anticipate we'll see at least an increase, if not a directly proportional increase in the active arm, maintaining that delta between placebo and active.

Dallin Murray, Other

Yeah, and if you'll indulge me for one second, I just want to sing Jeremy's praises. He came on board right around the time of the Novartis readout, and it was pretty impressive for me to watch. He immersed himself to find every lesson learned from that trial and incorporated that into the design of our Phase III trial. And we're grateful we've been able to learn from the Novartis experience, and Jeremy, as a rheumatologist, could really take those lessons quickly, adapt them, and apply them to our own trial design.

Jeremy Sokolove, Other

We're in a unique place where the field leader is really actually paving the way for us to do better. Dallin can speak more about the commercial opportunity of what Novartis is doing to help us. But if nothing, we're grateful.

James Stamos, Analyst — Jefferies

Sjokren's disease is a highly heterogeneous disease with about 30 to 40 percent of patients showing extra glandular organ involvement, skin, lung, kidney, joints. Are you stratifying for extra glandular disease?

Jeremy Sokolove, Other

disease. So all patients have extra glandular disease, so basically this is a high S-di population, so all patients have to have some component of disease outside the glands, so some systemic organ involvement. You can get points from the biologic score, but otherwise everyone will have joints, skin, lymph nodes, systemic symptoms, lung, kidney, something else, so everyone has systemic involvement.

Dallin Murray, Other

And we think this is the most compelling population, too, commercially, to pursue. It's estimated to be about 100,000 patients or so in the U.S., the high S-di with severe systemic organ involvement. And the value proposition there is the strongest, and that allows us to, you know, lead the way in terms of this new era of biologics for Sjogren's patients.

Jeremy Sokolove, Other

Yeah. But just to answer your question, we're stratifying by S-di greater than or less than 10, if that's But that's very similar to what other people have done. But everyone has extra glandular involvement.

James Stamos, Analyst — Jefferies

In the China Phase III trial, teletachyceps achieved statistically significant improvement on both SDA and ESPRI. Placebo responses at 24 weeks were meaningful lower than the benchmarks. Why is that, and how are you addressing the potential for larger placebo responses to global Phase III driven by partially subjective SDA endpoint?

Jeremy Sokolove, Other

I think you may have touched on that, but maybe you want to elaborate a little bit more. Yeah, so the SDA is a little less subjective. The S-Di is physician-assessed, and the variability in the S-Di is really the precision of the investigator in reproducibly performing the assessments. So, again, we overcome that by getting well-trained, well-experienced investigators. The S-Bri is patient-reported, and there there's a lot of subjectivity and variability. And we think the most important thing there is that the systemic disease activity is driving that patient's symptomatology. So the better you can control the patient's systemic disease activity, the more likely you are to have better and more deep control of patient symptomatology. I think the failures in Sjogren's have often been from drugs that did work, but didn't work well enough to overcome the heterogeneity and variability underlying the disease. And I think what you need to really win in Sjogren's is a drug that has a strong enough effect size across the heterogeneous population to overcome the inherent variability of the disease itself. I think Inalimab was the first one to do that, though they didn't do it with a lot of room to spare, shall we say. Their delta on Esti was 1.1, which is below the minimal clinically important difference. They did not see a difference in Esprit, and so I think that they've done a great contribution to the field at getting us to where we are now with our first positive Phase III study. But we think that by targeting upstream on the BATH mechanism, downstream on the APRIL mechanism, we're able to really get that dual improvement across the heterogeneity of Sjogren's biology, and that'll get us a larger delta, which is easier to overcome that heterogeneity and variability in the outcome measure.

James Stamos, Analyst — Jefferies

And can you elaborate on the powering assumptions for the trial?

Jeremy Sokolove, Other

Yeah, so we're powering for a clinically and statistically significant outcome. Um, we, uh, you know, the, the MCID for, uh, for SDI is about two, uh, to three. The, the MCID for ESPRI is one. And so we're powering for, uh, that, that minimal clinically important difference as well as the ability to target the secondary and the key secondary endpoints.

James Stamos, Analyst — Jefferies

Got it. Um, and can, well, I guess you've kind of already talked about this. Um, so for, uh, let's move on, I guess, to pricing reimbursement. a commercial strategy with multiple FCR inhibitors now approved, how do you envision the sequencing of telisacacept in the treatment paradigm? Do you see it as a first-line biologic, post-FCRN failure, or a complement alternative specifically for GMG?

Dallin Murray, Other

We certainly see it as a first-line biologic, and, you know, this is not a one-time therapy. It's not one and done. If you've got a better, superior efficacy profile, the physicians will, you know, prefer this first line. That said, we've got a really strong market leader with Argenix. And the natural default position, if you look at the models out there, is we fit very nicely. Second line, for the reasons that Jeremy outlined earlier, we address not only just IgG, but also IgA and IgM. 20 to 30 percent of mg patients have iga and igm and there's about a 20 to 30 percent non-response to the fcrns and so it's perfectly positioned if if there's a non-response to the fcrns to go straight who are driving the market right now to go straight to um teletasticept and to put just that opportunity in context uh in what will be a 10 billion dollar market in the not too distant future 30 percent gives us a you know a total opportunity of three billion that we get by default and and and i think uh if we were satisfied with that maybe we would stop there but really we want to become number one in the market and so we want to go directly head to head against the fcrns and we want to position ourselves for that first line business um of course we know that our genics is going to have an ocular mg indication zero negative indication they're driving the market right now and will in the couple years leading up up to our launch and even if we you know uh never become the number one in that first line business a real pathway to becoming number one in the market is dominating in that second line part of the market where we are going to be the default and and even getting modest share in the first line gets us to number one we think we've We've got the profile to really become the first line agent of choice. But, of course, we know that it's a competitive market, and we'll have to get the whole commercial strategy right, including our pricing market access strategy, and then go into a very competitive promotional market as well.

James Stamos, Analyst — Jefferies

And how are you thinking about pricing in the context of this increasingly crowded GMG market? Will you pursue parity pricing with FCR inhibitors, which are about $400,000 to $500,000 per year?

Dallin Murray, Other

Well, we're a couple years out, so we're not guiding on price yet. And we have some time to do our research and be thorough about that. And I think there's a couple ways you could look at it. If we really were satisfied with that second-line business, you could potentially price it higher. If we really want to become the number one drug, you could. It's still very, very compelling to price it at parity with the FCRNs. And I think we are in a really nice position from a pricing standpoint with a lot of latitude and flexibility as we go into this, especially with regards to these first two indications. Because if you do even assume, for example, we go at parity with the FCRNs, we're at about a 44% lower dose for Sjogrens. So it's 240 mg per week for MG, 160 mg per week for Sjogrens. And we think that, you know, the parity pricing with FCRNs in MG gets you to where the field thinks the pricing is going to land in Sjogren's as well. So we've actually got a good pathway from a pricing standpoint for both of the first two indications. But, of course, we're going to do rigorous pricing research. We're going to make sure we get it right to maximize the success in the short and long term in the U.S. and globally.

James Stamos, Analyst — Jefferies

Got it. And what are your assumptions around market penetration and peak sales for teletachyceps in both GMG and Sjogren's?

Dallin Murray, Other

Well, these are huge markets, right? These are $10 billion potential market for MG and even larger than that for Sjogren's. So starting with MG, you know, despite there being seven approved drugs today, there's just three modalities. There's FCRN, there's Complement, and just the recently launched of LISDA, which is a CD19 V-cell depletor. And as I said, we believe we can, the profile warrants us becoming number one in the market, but for us to be a multi-billion dollar brand, you don't even have to become number one. So we're not guiding on revenue at this early stage, but we think both MG and Sjogren's represents multi-billion opportunities. Sjogren's, you know, there's been a lot of discussion. Novartis just filed for ianilumab, and we see that as the biggest untapped large autoimmune market with a big, big unmet need. So ultimately, even a bigger market opportunity for Sjogren's, there's going to be a lot of room for everybody. It's even further out than MG. As Jeremy said, we think we can beat the bar of efficacy of the first approved drug, what we think will be the first approved drug. Therefore, we believe we have a path to the number one as well in Sjogren's. But again, you can be a very strong multi-billion dollar drug. there's plenty of room for everybody in this emerging global children's market okay and so

James Stamos, Analyst — Jefferies

we're about to close uh the session so just the last two final questions i'll kind of pull together what is your appetite for potentially in licensing another asset for the pipeline and uh can you remind us what your cash runway and key catalysts from uh over the next six months

Dallin Murray, Other

are yeah um in terms of we're always open we are you know i think one thing that's notable about us in less than a year we've gone from we say internally zero to a hundred which is we're already approaching a hundred employees and we're attracting really the best and brightest in the industry because of the profile of the drug people right now we're attracting have experienced and established relationships in MG and also we're starting to hire the same from the rheumatology, Sjogren's market, and so, and I'll let you answer the other.

Jeremy Sokolove, Other

Yeah, so we're well positioned to take on another asset in the sense of our development capabilities. We'd like something, if we did, that would be synergistic or, you know, with our current capabilities and teletasticept, the other, but, you know, we're opportunistic there. Right now, our focus is on delivery of the MG study because that's really the value inflection for us in the short term. As far as our cash runway, we have about $490 million. That gives us cash runway through 2029. That includes the MG readout, MG filing, Sjogren's readout, and the money down we'll need for commercialization for MG. So I think we're in a good position. We have enough money to do a small bit of elective activities, whether it be indication expansion or asset BD. But again, our focus is on delivery

Dallin Murray, Other

of the MG and Sjogren's studies. Sure. Sorry, I had a frog in my throat there. Yeah. You know, as we're always open on other indications, we are also ultra-focused on winning in MG and Sjogren's. And that's our near-term focus. And we're going to be responsible with our capital deployment and doing that great thank you so much for joining us today Jeremy and Dallin thanks thanks everyone thanks for having us