Vir Biotechnology, Inc.

Hello and welcome to Veer Biotechnology's third quarter 2025 financial results and corporate update call. As a reminder, this conference call is being recorded. At this time, all participants are in a listen-only mode. After the speaker's remarks, there will be a question and answer session. I will now turn the call over to Jason O'Byrne, Chief Financial Officer. Please go ahead.

Thank you and good afternoon. With me today are Dr. Marianne DeBacker, our Chief Executive Officer, and Dr. Mark Eisner, our Chief Medical Officer. Before we begin, I would like to remind everyone that some of the statements we are making today are forward-looking statements under the securities laws. These forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by such forward-looking statements. These risks and uncertainties and risks associated with our business are described in the company's reports filed with the Securities and Exchange Commission, including forms 10-K, 10-Q, and 8-K. I will now turn the call over to our CEO, Marianne DeBacker. Please go ahead.

Good afternoon, everyone, and thank you for joining us for Vier Biotechnology's third quarter 2025 earnings call. Today's call will highlight the significant progress we've made and our clear path forward as an organization. We'll provide guidance on our VR5500 program timeline, discuss the upcoming Solstice data presentation, and highlight how our clinical execution this quarter positions us for the significant value-creating opportunities ahead. The third quarter has been marked by important achievements across both our hepatitis delta and T-cell engager programs that demonstrate our ability to execute on critical milestones. Our team remains committed to powering the immune system to transform patients' lives, and today we'll outline how our recent accomplishments set the stage for what we believe will be a pivotal period for Veerbio. I will now highlight the key accomplishments from this quarter that demonstrate this accelerating momentum. First, we completed enrollment in ECLIPSE-1, our first registrational Phase III study for hepatitis Delta. Second, we're excited to provide guidance that we plan to share a comprehensive data update for V5500, a ProX10-masked PSMA-targeted T-cell engager, in the first quarter of 2026. And third, we dose the first patient in our first-line metastatic gastration-resistant prostate cancer combination study with androgen receptor pathway inhibitors. Collectively, these achievements represent an acceleration in our development trajectory and provide clear line of sight to multiple value-creating catalysts ahead. We're executing with precision while advancing towards multiple important data readouts and regulatory milestones. I will now provide more detail on our hepatitis delta program, where we've made exceptional progress this quarter. The completion of Eclipse I enrollment represents a pivotal step towards bringing our differentiated combination regimen to patients with hepatitis delta in the United States and beyond. This achievement, accomplished ahead of our internal projections, reflects both strong investigator confidence and the substantial unmet medical need in this devastating disease. With Eclipse 1 enrollment complete, we now expect primary completion in the fourth quarter of 2026, with top-line data for all three Eclipse studies expected by the first quarter of 2027. This accelerated timeline positions us well for regulatory submissions and demonstrates our operational excellence in executing registrational studies. Eclipse 2 continues to enroll well across European sites and remains on track. Together, Eclipse 1 and Eclipse 2 are designed to form the backbone of our regulatory filing package. Eclipse 3, our Phase 2b head-to-head comparison against lever-type, is progressing ahead of schedule with strong enrollment momentum and will provide valuable comparative data to support access and reimbursement discussions, particularly in European markets. The hepatitis delta market represents a compelling commercial opportunity with approximately 61,000 RNA-positive patients in the United States and 113,000 in EU markets. The patient population's geographic concentration, particularly in major U.S. urban centers, supports an efficient commercial approach with a target specialty sales organization focused on hepatologists and infectious disease specialists. Looking ahead to this month, we're preparing to present the complete 48-week solstice data set at ASLD on November 9th. This presentation will provide important insights into the safety and efficacy profile of our combination regimen and is expected to provide supportive data that reinforces confidence in our registration program. Turning to our oncology portfolio, we are excited to provide guidance that we plan to share a data update for VIIRS 5500, our PSMA-targeted T-cell engager, in the first quarter of 2026. We've made substantial progress in our dose escalation across both weekly and every three-week schedules, and this dataset is expected to provide important insights into the program's potential. We are enthusiastic about this program and the differentiated PRO-X10 dual masking approach. As I mentioned, we recently dosed the first patient in our first-line metastatic, castration-resistant prostate cancer combination study with ARPIs, a third step towards addressing a significant unmet need for patients in earlier treatment lines. For VIIR-5818, our ProExtend-MOSC HER2-targeted T cell engager, we are continuing dose escalation in combination with pembrolizumab, which is actively enrolling. For VIIR-5525, our ProExtend-MOSC EGFR-targeted T cell engager, our program continues to advance with enrollment in our phase one study progressing as expected. We are leveraging the extensive learnings from both VEO 5818 and VEO 5500 to enable efficient development and accelerate decision-making. The clinical experience we're gaining across three distinct targets, PSMA, HER2, and EGFR, is building evidence for the versatility of the ProX10 universal masking platform. This emerging clinical validation gives us confidence as we advance our preclinical pipeline of additional T-cell engager candidates targeting various tumor-associated antigens, whether through internal development or strategic partnerships that leverage our platform technology. Finally, we ended the third quarter with approximately $810.7 million in cash, cash equivalents, and investments. Based on our current operating plan, we continue to project our cash runway extending into mid-2027. This strong financial foundation enables us to advance our registrational hepatitis delta program and our oncology pipeline with confidence. With that, I'll now turn the call over to Mark to provide a more detailed update on our clinical development program.

Thank you, Mary Ann. I'm pleased to provide detailed updates on our clinical development programs. Starting with our Hepatitis Delta program, the CLPS-1 enrollment was successfully completed with approximately 120 participants randomized two to one to our combination therapy versus deferred treatment. This achievement was accomplished approximately two months ahead of our aggressive internal enrollment assumptions. demonstrating exceptional execution by our study teams and reflecting the significant unmet medical need in this patient population. The strength of our enrollment reflects multiple factors. First, the robust solstice phase two study results. Second, strong engagement with our clinical investigator community. Third, the absence of FDA approved treatment for hepatitis delta in the United States and limited options globally. And fourth, the urgent need for more effective and convenient therapies for this devastating disease. Study team engagement throughout start-up led to accelerated country and site activation, allowing us to complete study enrollment faster than originally projected. This was further reinforced by consistent enrollment momentum across regions with investigators actively identifying and referring patients. Eclipse 2 continues with enrollment progressing well across multiple European sites. Today we'll outline how our recent accomplishments set the stage for what we believe will be in treatment naive patients and based on the strength of enrollment we're seeing is tracking toward a similar completion timeline as Eclipse 1 and 2. Eclipse 3 enrollment has progressed ahead of our projections and this study will provide critical comparative data for access and reimbursement discussions with top-line data expected in the first quarter of 2027 alongside the other Eclipse studies. Regarding our upcoming AASLD presentation, the complete solstice 48-week dataset for the combination regimen of tabivabar and alepsiram represents an important clinical milestone. This additional follow-up provides Important safety and efficacy insights and builds on our previously reported compelling phase two results that demonstrated 64% of patients achieving HDV RNA target not detected at week 36 with our monthly combination regimen. Turning to our oncology programs, we continue to advance our pro-extend mass T-cell engager portfolio across multiple targets. For VIIR 5500, our MAST PSMA-targeted T-cell engager, dose escalation is advancing in both weekly and every three-week schedules. We have not reached a maximum tolerated dose, and escalation continues as planned. The half-life of 8 to 10 days potentially supports our every three-week dosing evaluation with the potential for even longer dosing intervals. As Marianne mentioned, we achieved an important milestone this quarter with the first patient dose in our first line metastatic castration-resistant prostate cancer combination study with androgen receptor pathway inhibitors. This earlier line expansion offers the potential to address significant unmet need for patients earlier in their treatment journey. We're planning for a comprehensive data update in the first quarter of 2026, with a meaningful data set across dose levels and late-line patients. We expect this will include safety assessments and efficacy measures, including PSA responses and kinetics, imaging, and resist evaluations. The program is designed to leverage the potential advantages of the ProExtend platform, including a favorable safety profile and extended half-life. Our approach seeks to maximize the therapeutic index of solid tumor T cell engagers through selective tumor activation while minimizing systemic activity. For VIRA5818, our HER2-targeted T cell engager, combination dose escalation with pembrolizumab is actively enrolling and progressing according to plan. For VIRA5525, our EGFR-targeted T cell engager, Phase I study enrollment is also progressing as expected. The study design incorporates learnings from VERA 5818 and VERA 5500 to enable efficient dose escalation. We are evaluating both monotherapy and combination with pembrolizumab across multiple EGFR-expressing tumor types. As we've discussed on our second quarter call, we believe this program has the potential to address significant unmet need for patients across multiple solid tumor types, where current EGFR targeted approaches have important limitations. We also continue to advance multiple preclinical T-cell engager candidates targeting various tumor-associated antigens. The clinical experience from our current programs is informing the development of these preclinical candidates, and we're taking a strategic approach combines internal advancement with potential partnership opportunities to accelerate development and advance a broader pipeline that addresses unmet need across multiple cancer types. We've made exceptional progress across our entire clinical portfolio during the third quarter. Eclipse 1 enrollment completion provides a clear path to pivotal data in early 2027 for all three Eclipse studies. Our upcoming VEER 5500 data update will provide important insights into our oncology pipeline's potential, and our platform leaves us well-positioned to efficiently advance multiple future candidates. With that, I'll now hand the call over to Jason for a financial update.

Thank you, Mark. I am pleased to share our third quarter financial performance and overall financial position. R&D expense for the third quarter of 2025 was $151.5 million, which included $5.5 million of non-cash stock-based compensation and a $75 million milestone payment triggered by first in-human dosing of VEER 5525. This compares to $195.2 million for the same period in 2024, which included $8.9 million of stock-based compensation, and a $102.8 million upfront payment made to Sanofi at the closing of our exclusive worldwide license agreement. The year-over-year decrease was primarily driven by lower license expense and cost savings from previously announced restructuring initiatives, partially offset by increased clinical development expenses associated with our hepatitis delta and oncology programs. SG&A expense for the third quarter of 2025 was $22.2 million, which included $5.8 million of stock-based compensation expense, compared to $25.7 million for the same period in 2024, which included $7.8 million of stock-based compensation expense. The decrease was largely due to efficiencies and cost savings from previously announced restructuring initiatives. Our third quarter 2025 operating expense was totaled $100 a $46.2 million decrease from the same period in 2024. Net loss for the third quarter of 2025 was $163.1 million compared to a net loss of $213.7 million for the same period last year. Turning to cash, our net change in cash and investments in the third quarter was approximately $81.4 million. During the third quarter, we also made certain cash payments from restricted cash. including a $75 million payment to former Amunex shareholders. As described earlier, this payment was triggered by dosing the first patient in our BEER 5525 study and was fully anticipated, having been held in escrow as restricted cash since we signed the Sanofi agreement last year. As a reminder, restricted cash is excluded from our reported balances of cash, cash equivalents, and investments. As such, Disbursements from restricted cash accounts do not affect our projected cash runway. We ended the third quarter with approximately $810.7 million in cash, cash equivalents, and investments. Based on our current operating plan, we continue to project our cash runway extending into mid-2027. Our capital deployment strategy remains focused on our most promising programs. We are advancing our hepatitis delta eclipse registrational program, while also advancing our T-cell engager programs, including VIR 5500, VIR 5818, and VIR 5525. We continue to deploy capital strategically, prioritizing investments in programs with the greatest potential for both meaningful patient impact and value creation, while also advancing business development opportunities that can further optimize our resource allocation. This concludes our prepared remarks. We will now initiate the Q&A session. Please limit questions to two per person so that we can get to all of our covering analysts. I'll turn it over to you, operator.

We will now begin the question and answer session. In order to ask a question, simply press star then the number one on your telephone keypad. Our first question will come from the line of Gina Wong with Barclays. Please go ahead.

Hello. Hey, Kim. Thank you for taking our questions. This is on behalf of Gina Wong from Barclays. We have two questions. First one for the PSMA, the GenX actually setting higher bar for the PSA50. However, the durability doesn't seem good. So how do you think the PSMA could show actual differentiation of your asset? And we know the QLs we spoke to actually focus on durability of the PSA control. and more importantly, durability, the durable tumor response. The second question actually for the HDV. For the phase three readout, what's your clinical bar as the key differentiation? Thank you.

Yeah, thank you for those questions. So, maybe on PSMA, I will just start by saying that we're really excited to provide the guidance and share comprehensive data update for our The lead asset here, 5,500 in the first quarter of 2026. And, of course, at that point, we will have a really meaningful data set across multiple dose levels, obviously in the late-time patient setting. We will have data on both weekly and every three-week dosing. And there will be certainly sufficient patient numbers to provide robust insights. Maybe I'll ask Mark to add anything. Sure.

Thanks, Marianne. Well, we do think we have a differentiated approach with the PERCS and platform, and in particular for Vero 5500 PSMA. I'll comment on the fact that we use a steric hindrance mechanism for masking both the CD3 and the PSMA side of the molecule. We have a dual masking approach, which is unique in the mass PSMA space. It's a clinically validated approach. There's a product on the market called Altuvio that uses the ProExtend mask, so we know it's safe in that setting. And we think we can get to a really exceptional therapeutic index, which would include both depth and durability of PSA response. But stay tuned for our Q1 update. Your other question is about HDV and the Eclipse program and what we think the bar is, particularly for Eclipse 1. Just to remind people, we showed in the solstice trial 64% viral suppression at target not detected at week 36. That was at week 36 that we presented back at before, and we are going to be presenting the complete 48-week solstice phase 2 data at ASLD very shortly. In terms of the bar, you know, we think the combination of our to have exceptional ability to suppress HDV viral RNA and achieve target not detected. We can hit HP surface antigen down by three logs. So, I'm not going to give you a specific number today, but, you know, we are expecting to have a very exceptional efficacy in terms of the viral logic outcomes that I mentioned.

Our next question will come from the line of Mike Ols with Morgan Stanley. Please go ahead.

Hi, this is Rohit on for Mike. Thanks for taking our questions. In terms of the BEER 5500 data, will that be presented at a conference in early January, or do you think later in the quarter? And then secondly, is there anything you can point to that we should focus on on the upcoming presentations at AASLD? Thank you.

So, sure. So, the first question is about the update and exactly the timing in quarter one and the setting for quarter one. We haven't provided that guidance, exactly what, you know, month or what will be the setting. It could be a company event. It could be an academic conference. You know, that's to be announced at a subsequent time. In terms of the focus for ASLD and the solstice, we will be showing the complete 48-week data for tibibivar and elapsiran and tibibivar monotherapy arms. So, this will provide a complete update for target not detected, for HB surface antigen safety. So, you'll get a complete picture there, which I think will be a meaningful update from what we've shown before.

Thank you. Our next question will come from the line of Paul Choi with Goldman Sachs. Please go ahead.

Hi, good afternoon and thank you for taking our questions. My first is on 5500 as well. Can you please clarify if your planned update in the first quarter of next year will be just the monotherapy patients or will you have any data with regard to the combination group that are being tested with ARPIs? And my second question is, on Hep-D, Gilead announced that they're filing Volveratide, but at a 10-milligram dose versus the 2-milligram dose that is currently approved in Europe. You know, can you comment on, you know, how you think that might change the landscape here in the U.S. as you, you know, progress with your program, and also any potential regulatory implications, if any, if you think there are any there? Thank you very much.

Thank you. Yeah, thank you, Paul. Maybe just on your first question, as you know, we only recently started the first-line NCRPC combination study with the RPIs, but that data will not be part of the first quarter 2026 update. And then on the Lebertide, Mark, you want to take it?

Yeah, so your question, Paul, is about the Gilead announcement that they expect approval in H2 2026, and your question is specifically about the 10-milligram dose. I mean, we actually think it's a very net positive for VRBio that Gilead will launch Blubber Tide ahead of us. We think that they will help to drive disease awareness. We think that they will help to, you know, focus on testing, HDV testing, you know, which would make, prepare the landscape for our launch. We don't see the 10 milligram or 2 milligram We see those similarly. I mean, we still think our regimen of tabibibar and lepsiran can achieve really, really strong virologic suppression compared to the lever tide with either dose. In terms of regulatory implications, you know, we feel very confident that our program is designed to secure regulatory approval with Eclipse 1 and Eclipse 2 as being the core of the regulatory package, and Eclipse 3 is providing really strong head-to-head information, which will bolster the value proposition for patients and, in particular, for payers in the EU.

Our next question will come from the line of Corey Kosimov with Evercore ISI. Please go ahead.

Hi. Thank you for taking our question. This is Josh Jazar on for Corey Kosimov. Based off your PK and PD modeling data, are you surprised that you have not reached a maximum tolerated dose for 5500? And can you share on whether you have seen any great three CRS events? Thank you.

So, are we surprised that we have not reached the maximum tolerated dose? Well, we've been going through dose escalation systematically, and that's been going very well. I'm not really prepared to share any further details about dose escalation or results today. So, stay tuned for our event in quarter one next year. And regarding more updated information on safety, again, we will be discussing that in quarter one next year at our data release.

Our next question will come from the line of Alec Stranahan with Bank of America. Please go ahead.

Hey, guys. This is Matthew on for Alec. Appreciate you taking our questions. In terms of the 48-week HCV data, can you maybe speak to how meaningful this data is for physician education ahead of a potential launch and any reason to think that there would be a significant change from week 36 to 48?

So, great question. I do think that the data will be meaningful for educating physicians, clinicians, and others who are interested in HDV about what our regimen can deliver at week 48. In terms of what we expect to show you, I mean, I would just say it's not going to be a long time, so stay tuned for our presentation. But, you know, we've been seeing deepening of responses over time to date. So, you know, we're excited to have the presentation and look forward to sharing it with you.

Our next question will come from the line of Ellen Horst with TD Cowan. Please go ahead.

Hi, guys. Thanks for taking my question. Just to drill down a little bit more on the TCE update, can you talk a little bit more about how you're prioritizing the three TCE programs? Is there a world where you take all three of them forward, or are you imagining that this will be a no-go-go decision, you know, for all three such that you only move forward with the best data and maybe talk about the that you think are most important for that no-go decision, whether it's response rate or durability, safety, et cetera? Thank you.

Thank you, Ellen. I'll start by saying, you know, our capital allocation priorities, as we have said, are really based on progressing our registration study for hepatitis delta and then certainly accelerating as much as we can our peer 5500 prostate cancer program. Our other T-cell engagement programs, I mean, obviously are gated based on data as, you know, is typical. And as we have also shared before, we have a number of preclinical programs that have garnered a lot of external interest, so we're also looking at potential business development opportunities across our pipeline.

Our next question will come from the line of Sean McCutcheon with Raymond James. Please go ahead.

Hi, guys. Thanks for the question. How are you thinking about the optimal setting for the TCE program in prostate cancer? We got the results from PSM edition, albeit a tepid reaction at best, but a lot more patients going to be PSMA, radioligand exposed in coming years. I know you've started the pre-taxing cohort that's up and running, but should we expect some proof of concept results post-PSMA radioligand from your next update with more U.S. patient referrals? Thanks.

Sure. So, in terms of what to exactly expect in terms of the patient population for our update, just as a reminder, we, you know, we are currently doing dose escalation in both Q week and Q3 week in the third line plus MCRPC setting. That would, you know, include post-RLT patients as a population. We also started, as Mary Ann said, the frontline vaccine-naive, although we won't have that data for the update. In terms of, you know, where we're ultimately going to position this asset in terms of the patient population, I mean, we are interrogating the full gamut and intent to the patient populations from late line to earlier line to hormone-sensitive. So, you know, this will ultimately be a data-driven decision about how we ultimately position the molecule. But, you know, just to get back to the update in Q1, that will be the later line patients that were the part one or are part one of the phase one program.

Our next question will come from the line of Joseph Stringer with Needham & Company. Please go ahead.

Hi. Thanks for taking our question. You've shown that your HDV combo therapy can reduce the hep B surface antigen level over time. I guess how well does this data resonate with KLLs and physicians? Is this something that you believe could be beneficial and potentially differentiator given the long-term chronic treatment paradigm for HDVE, or is it not nearly as important as, say, ALT and virological response?

Well, thanks for the question. I mean, firstly, I would state that the most important objective of our program is to suppress the virus to target not detected in, you know, a large proportion of patients because we know that suppressing Delta virus to TND will translate into better outcomes for patients in terms of progression of the underlying liver disease. But I do think that the fact that we can reduce hepatitis B surface antigen levels by about three logs is important and does resonate with KOLs. Because as you recall, the surface antigen is critically important for the viral life cycle of Delta. It needs the surface antigen to form its own viral code. So the fact that we're starving the Delta virus of the surface antigen is another mechanism by which we suppress the virus with our combination regimen. So we do think that is important in differentiating.

Our next question will come from the line of Patrick Trucchio with HC Wainwright. Please go ahead.

Thanks. Just a follow-up question on HDV. First, just in terms of the addressable patients in the U.S. that you believe a combination of Tovevabar and Alepsarin could be relevant for at the time of launch, I'm wondering if that would include the 61,000 patients estimated in the U.S. were viremic with HDV. Or is there a subgroup of patients who would be best for treatment at the time of launch? And separately, just, you know, sort of what efforts are ongoing to identify these patients? I mean, I appreciate that Eclipse One are enrolled two months ahead of schedule. So just curious if, you know, as particular as, you know, Boulevard Tide maybe gets approved, if there's just going to be more awareness and how you'll actually go about discovering those patients and ultimately how many patients you think you can reach, you know, at the time of launch.

Yeah, so excellent question. So in terms of the HDV addressable population at launch, I mean, we're estimating approximately 60,000 patients in the U.S. who are viremic with HDV. We really think we can, you know, our regimen, the patients will be eligible for a regimen because we can treat patients effectively with high viral loads or lower viral loads. We can treat patients with compensated cirrhosis or non-cirrhotic. So we expect to be able to treat you know, very broad population of patients who are viremic with HDV. So, you know, we don't feel that that will be constrained to any kind of subgroup at all. We feel like it'll be a broad population. In terms of the, you know, how are we approaching the launch? Well, first of all, I would note that, you know, agree with you that the first enrollment of Eclipse 1 really speaks to the high on that medical need for a regimen that can meaningfully address the Delta virus patient, the patients with HDD and their viremia and the liver disease that follows. We also think that Gilead launching Glibertide out of us, like I said before, would be a real advantage because it'll drive disease awareness, drive testing and those things. We are in active discussions with, you know, KOLs, with advocacy groups, diagnostic companies, et cetera, about the best way forward to driving awareness ourselves. And, you know, back to an earlier question, you know, in terms of what will be the impact of our solstice presentation ASLD this year, and I think it's going to be very significant because this is the first time we'll present the 48-week complete data for the combination, which really undergirds our CLPS program and provides further confidence, I think, in what we're trying to achieve with Eclipse, which is really high rates of target not detected, HPV surface antigen suppression, and, you know, really hopefully driving good outcomes for patients.

Yeah, and Patrick, as you know, I mean, both from an efficacy perspective and also from a patient convenience perspective, our regimen being monthly dosing, you know, that is a very big differentiator.

This concludes the Q&A session of the call. Thank you for participating. I'll now turn the call back over to Mary Ann.

Thank you, Operator, and thank you all for joining us today. We look forward to updating you on our progress in the coming months. Operator, you may end the call.

This concludes our call today. Thank you for joining. You may now disconnect.