Vir Biotechnology Q1 2025 Earnings Call Transcript

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Provided by Quartr
May 7, 2025
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Operator

Hello. Welcome to Veer Biotechnologies First Quarter twenty twenty five Financial Results and Business Update Call. As a reminder, this conference call is being recorded. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session.

Operator

I will now turn the call over to Rich Lepke, Senior Director, Investor Relations. You may begin, Mr. Leppke.

Richard Lepke
Richard Lepke
Senior Director of Investor Relations at Vir Biotechnology

Thank you, and good afternoon. With me today are Doctor. Marianne DeBacher, our Chief Executive Officer Doctor. Mark Eisner, our Chief Medical Officer Jason O'Burn, our Chief Financial Officer and Doctor. Mika Derink, our Executive Vice President of Oncology, who will be available during the Q and A session.

Richard Lepke
Richard Lepke
Senior Director of Investor Relations at Vir Biotechnology

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 ks, 10 Q and eight ks. I will now turn the call over to our CEO, Doctor. Marianne DeBacher.

Richard Lepke
Richard Lepke
Senior Director of Investor Relations at Vir Biotechnology

Please go ahead.

Marianne De Backer
Marianne De Backer
Chief Executive Officer and Director at Vir Biotechnology

Thank you, Rich, and good afternoon, everyone. Thank you for joining us for VIRBY Technologies first quarter twenty twenty five earnings call. I'm pleased to share our progress and achievements with you today as we continue to execute on our strategic priorities. Before we dive in, I want to express my gratitude for your continued support and interest in our mission of powering the immune system to transform patients' lives. We've had a strong start to 2025 with meaningful progress across our pipeline.

Marianne De Backer
Marianne De Backer
Chief Executive Officer and Director at Vir Biotechnology

Our strategic focus on advancing both our infectious disease and oncology programme continues to position us well for future growth and value creation. I'm pleased to share that we successfully initiated our ECLIPSE Phase three registrational program with the first patient enrolled in ECLIPSE one during the first quarter. This is a significant milestone in our commitment to develop a potential new standard of care for patients with hepatitis delta virus infection. The ECLIPSE program builds on our Solstice Phase two data, which demonstrated impressive virological responses with our combination therapy. Today, I'd also like to provide a refined assessment of the hepatitis delta market opportunity, which reflects the pre launch work we have initiated in parallel with our Phase three trials to better characterize the addressable patient population.

Marianne De Backer
Marianne De Backer
Chief Executive Officer and Director at Vir Biotechnology

Based on our comprehensive market analysis, we estimate that there are approximately seven million active phyremic HBV RNA positive In The United States, we estimate approximately sixty one thousand RNA positive patients. In EU member countries, plus The UK, we estimate approximately one hundred and thirteen thousand RNA positive patients, and additional geographies beyond these could represent long term opportunities. I want to emphasize that these figures specifically focus on RNA positive patients with active viremic disease who would be candidates for treatment. This distinction is important because we focus specifically on patients with detectable viral replication who face the highest risk of disease progression.

Marianne De Backer
Marianne De Backer
Chief Executive Officer and Director at Vir Biotechnology

We've conducted an extensive evaluation of multiple epidemiological sources and consulted with leading experts in the field to arrive at these estimates. It's important to note that our updated understanding of the market size underscores that hepatitis delta has the characteristics of a rare disease market with significant commercial potential. Let me highlight a few key points. First, this is a disease with severe outcomes. More than fifty percent of hepatitis delta patients succumb to liver related deaths within ten years of diagnosis, and there are no FDA approved treatments in The United States.

Marianne De Backer
Marianne De Backer
Chief Executive Officer and Director at Vir Biotechnology

Second, treatment is managed by a concentrated group of hepatologists and liver specialists, allowing for a focused commercial engagement. Third, the severe clinical outcomes and EMA orphan disease designation support a value based pricing model, similar to other rare disease therapies. Fourth, the high cost burden of untreated disease progression, including liver transplantation and end stage liver disease management provides a compelling economic case for effective treatment. And finally, our market research indicates high physician intent to treat these patients given the lack of effective options. The regulatory designations we've received, breakthrough therapy, Fast Track in The United States and prime and orphan drug in The EU underscore the potential impact of our approach and may help accelerate our development timeline.

Marianne De Backer
Marianne De Backer
Chief Executive Officer and Director at Vir Biotechnology

We are focused on driving enrollment in our ECLIPSE one trial and preparing for the ECLIPSE two and three study initiation. As we advance our hepatitis delta program, I'm also pleased to report that during the quarter, we reached an agreement with Alnylam whereby they elected not to opt into the profit sharing arrangement for Elapsiran, resulting in a continued milestone and royalty based structure. This decision provides clarity for our approach to advance our hepatitis delta programme and gives us the flexibility to partner the programme in Europe and other international markets. The outcome of this agreement was anticipated and factored into our long term financial planning and was already included in our projected cash runway extending into mid-twenty twenty seven. Jason will provide additional details on the financial aspects of this agreement later in the call.

Marianne De Backer
Marianne De Backer
Chief Executive Officer and Director at Vir Biotechnology

Turning briefly to our hepatitis B program. We are presenting twenty four week post treatment follow-up data from our March Phase two study at the upcoming EASL Congress on May 9. Specifically, we will be sharing functional cure data from participants who have completed twenty four weeks of follow-up after treatment discontinuation. Shifting gears to our oncology portfolio. We continue to make steady progress with the Pro X10 dual mast T cell engager program.

Marianne De Backer
Marianne De Backer
Chief Executive Officer and Director at Vir Biotechnology

As a reminder, we have worldwide rights to the Pro X10 platform in infectious disease and oncology. For VER5818, our dual masked HER2 targeted T cell engager, we're continuing to dose escalate as monotherapy and in combination with pembrolizumab. Our data presented in January showed a thirty three percent confirmed partial response rate in HER2 positive colorectal cancer patients at doses of four hundred micrograms per kilogram and above, with one response lasting over eighteen months. We're particularly encouraged by these results in colorectal cancer, where there remains a significant unmet need for effective therapies. These responses were observed in microsatellite stable tumors, which are typically resistant to immunotherapy, suggesting VIR-five thousand eight hundred eighteen could potentially address an important treatment gap for these patients.

Marianne De Backer
Marianne De Backer
Chief Executive Officer and Director at Vir Biotechnology

For VER-five thousand five hundred, our dual masked PSMA targeted T cell engager, we continue to dose escalate given our favorable safety profile and the learnings from VER-five thousand eight hundred and eighteen. We've evaluated multiple additional dose levels since our last update. Our January data showed that one hundred percent of patients at doses above one hundred and twenty micrograms per kilogram experienced PSA declines with fifty eight percent achieving a PSA 50 response, all without prophylactic steroids and with minimal cytokine release syndrome. We continue to see strong investigator enthusiasm for this program based on the early signals we've observed. We're also on track to initiate our Phase one study for VER-five 525, our dual masked EGFR targeted T cell engager this quarter.

Marianne De Backer
Marianne De Backer
Chief Executive Officer and Director at Vir Biotechnology

This program has the potential to address multiple high value indications, including non small cell lung cancer, colorectal cancer, head and neck squamous cell carcinoma, and other EGFR expressing tumors. The Pro X10 universal dual masking approach continues to demonstrate potential advantages in terms of safety profile and dosing flexibility. Beyond our clinical stage programs, we are rapidly advancing several next generation targets in areas of high unmet medical need. Our antibody discovery and protein engineering capabilities are key to the discovery of new tumor associated antigen binders to quickly advance new TCE programs. And the universal nature of the Pro X TEM platform allows us to efficiently apply our dual masking approach.

Marianne De Backer
Marianne De Backer
Chief Executive Officer and Director at Vir Biotechnology

The synergies between antibody discovery capabilities and the Pro X10 platform have begun to translate into meaningful progress with seven targets progressing in preclinical development across a number of solid tumor indications with high unmet need. These research efforts represent important long term value drivers for our oncology portfolio. We're also exploring potential collaborations that could further unlock and maximize value from the Pro X10 platform. Additionally, leveraging our expertise in infectious disease immunology, we have advanced a broadly neutralizing antibody to development candidate status in our HIV cure program. Looking ahead, our financial position remains strong with approximately CHF1 billion in cash, cash equivalents and investments at the end of the first quarter.

Marianne De Backer
Marianne De Backer
Chief Executive Officer and Director at Vir Biotechnology

This provides us with cash runway extending into mid-twenty twenty seven, giving us the resources to advance our key programs through critical value inflection points. We're maintaining a disciplined approach to capital allocation, focusing our resources on our most promising programs. As we continue to execute on our strategic priorities, we recognize the challenging market environment facing the biotechnology sector as a whole. In times like these, we believe the most important thing we can do for our shareholders is to remain focused on operational excellence and advancing our pipeline with discipline and purpose. Our strong cash position allows us to weather market volatility.

Marianne De Backer
Marianne De Backer
Chief Executive Officer and Director at Vir Biotechnology

I'm confident that our focused approach to developing potentially transformative medicines for patients with significant unmet needs will make a difference in the lives of patients while driving value creation for our shareholders. With that, I'll now turn the call over to Mark to provide a more detailed update on our clinical development programs.

Mark Eisner
Mark Eisner
EVP & Chief Medical Officer at Vir Biotechnology

Thank you, Mary Anne. I'm pleased to provide an update on our clinical development programs. We've made significant progress across both our infectious disease and oncology portfolios during the first quarter, and I'll walk you through the key developments. Let me start with our hepatitis delta program, where we've achieved an important milestone with the initiation of our registrational ECLIPSE Phase III program. I'm pleased to report that we enrolled the first patient in ECLIPSE I during the first quarter, keeping us on track with our development time line.

Mark Eisner
Mark Eisner
EVP & Chief Medical Officer at Vir Biotechnology

ECLIPSE I is designed to evaluate our combination therapy in regions where velveretide is not available or has limited use, including The United States. The study will enroll 120 participants, randomized two to one, to receive either our combination therapy or deferred treatment. The primary endpoint is a composite endpoint of HDV RNA target not detected, meaning that there is no measurable presence of the virus in the blood and ALT normalization at week forty eight. The key secondary endpoint is HDV RNA target not detected. We're also preparing for the initiation of ECLIPSE two, which will evaluate switching to our combination therapy in patients who have not adequately responded to blebirtat.

Mark Eisner
Mark Eisner
EVP & Chief Medical Officer at Vir Biotechnology

CLIPSE two will have a twenty four week primary endpoint of HBV target not detected. Together, ECLIPSE one and two are designed to form the backbone of our regulatory submissions in The United States and Europe. This comprehensive approach addresses different patient populations and treatment scenarios, providing a robust evidence package for regulatory review. These studies will include both non cirrhotic participants and those with compensated cirrhosis. This broad eligibility is important as it reflects the real world patient population and will provide valuable insights into the treatment effects across different stages of disease.

Mark Eisner
Mark Eisner
EVP & Chief Medical Officer at Vir Biotechnology

The regulatory designations we've received, breakthrough therapy and fast track in The United States and prime and orphan drug in The EU, reflect the significant unmet need and the potential of our approach to address it. These designations may help accelerate our development and review timelines, potentially bringing this important therapy to patients sooner. At the upcoming EASL Congress, we'll be presenting a poster showcasing data from a twenty four week subgroup analysis of our Solstice trial, examining the impact of baseline viral parameters and cirrhosis status on responses to our combination therapy. For our hepatitis B program, we'll be presenting twenty four week post treatment follow-up data from our March Phase II study at EASL on May 9. This presentation will provide insights into functional cure after treatment discontinuation.

Mark Eisner
Mark Eisner
EVP & Chief Medical Officer at Vir Biotechnology

As a reminder, advancement of this program into further clinical development is contingent on securing a partner. Now I'd like to turn to our oncology portfolio, where we continue to make progress with the PRO XTEN masked T cell engager programs. Our dual masked approach is designed to selectively activate T cell engagers in the tumor microenvironment, potentially providing a wider therapeutic window than traditional unmasked approaches. Our PRO XTEN masked TCEs achieve this through the addition of long hydrophilic polypeptide XTEN masks that shield both the CD3 and tumor associated antigen binding domains via steric hindrance. Importantly, these universal masks are cleaved by proteases found within the tumor microenvironment, enabling selective activation where it's needed most.

Mark Eisner
Mark Eisner
EVP & Chief Medical Officer at Vir Biotechnology

This technology allows for higher dosing with reduced systemic toxicity, which we believe could translate to improved efficacy and safety profiles. The selective activation in the tumor microenvironment is key to minimizing off target effects while maximizing antitumor activity. For VERU-five thousand eight hundred eighteen, our HER2 targeted T cell engager, we're continuing dose escalation in both monotherapy and in combination with pembrolizumab. As a reminder, our data presented in January showed a thirty three percent confirmed partial response rate in HER2 positive colorectal cancer at doses of four hundred micrograms per kilogram and above, with one response lasting over eighteen months. This durability is particularly encouraging in this heavily pretreated population.

Mark Eisner
Mark Eisner
EVP & Chief Medical Officer at Vir Biotechnology

Importantly, as Mary Anne mentioned, the responses we observed in microsatellite stable colorectal cancer are noteworthy from a mechanistic perspective. These tumors typically have low tumor mutational burden and limited T cell infiltration, creating significant challenges for immunotherapy approaches. Our data suggests that VER5818's ability to redirect T cells to HER2 expressing tumor cells may provide a way to overcome these immunological barriers. The durability of response we've seen further supports the potential of this approach in a setting where patients typically experience rapid progression after exhausting standard treatment options. We remain focused on evaluating the potential of this program across multiple HER2 expressing tumor types as we believe our approach could address significant unmet needs in various solid tumors where HER2 expression plays a role.

Mark Eisner
Mark Eisner
EVP & Chief Medical Officer at Vir Biotechnology

For VER-five thousand five hundred, our PSMA targeted T cell engager, we're advancing our dose escalation strategy in both weekly and Q3 week dosing regimens. Our January data showed that one hundred percent of patients at doses above one hundred and twenty micrograms per kilogram experienced PSA declines, with fifty eight percent achieving a PSA 50 response, all without prophylactic steroids and with minimal cytokine release syndrome. This favorable safety profile differentiates our approach from other PSMA targeted therapies in development. The program continues to evaluate the potential of our PRO XTEN dual masked approach in metastatic castration resistant prostate cancer, a setting with significant unmet need despite recent therapeutic advances. We are particularly encouraged by the potential for Q3 week dosing.

Mark Eisner
Mark Eisner
EVP & Chief Medical Officer at Vir Biotechnology

With a half life of eight to ten days for VERU-five thousand five hundred, we believe we can offer a much more convenient dosing schedule. This would be especially important for patients in earlier lines of treatment where quality of life considerations become increasingly significant. We've successfully evaluated multiple dose levels since the data we shared in our January 8 event and are continuing with dose escalation. This ongoing dose optimization is critical to identifying the regimen that provides the optimal balance of efficacy and safety. We believe VERU-five thousand five hundred has the potential to be a best in class treatment option in this area of significant unmet medical need, offering a combination of efficacy, safety and convenience that could meaningfully improve outcomes for patients with prostate cancer.

Mark Eisner
Mark Eisner
EVP & Chief Medical Officer at Vir Biotechnology

Building on our progress with our first two TCE programs, we're now expanding our portfolio with our third clinical candidate. We're on track to initiate our Phase I study, REVERA-five 525, our EGFR targeted T cell engager, during this quarter. This program has the potential to address multiple high unmet need and high value indications with EGFR expression, including non small cell lung cancer, colorectal cancer, head and neck squamous cell carcinoma, and other EGFR expressing tumors. The unmet need in these indications remains substantial despite recent advances, with hundreds of thousands of patients diagnosed annually with EGFR expressing tumors across these indications. VERA-five thousand five hundred twenty five has the potential to address the substantial unmet need through a novel modality that harnesses the patient's T cells to kill EGFR expressing cancer cells.

Mark Eisner
Mark Eisner
EVP & Chief Medical Officer at Vir Biotechnology

Our PRO XTEN dual masked approach could offer a differentiated safety profile, potentially allowing for more aggressive targeting of EGFR expressing tumors compared to traditional approaches. The universal nature of the ProExtend platform enables us to leverage our learnings from our earlier T cell engager programs to optimize study design and dose escalation for VERU-five thousand five hundred twenty five. In conclusion, I'm very pleased with the progress we're making across our entire portfolio. The initiation of our ECLIPSE Phase III program and continued advancement of our T cell engager programs demonstrates our commitment to addressing significant unmet medical needs. We remain focused on executing our clinical development plans with scientific rigor and operational excellence, always keeping in mind the patients who could benefit from these potential therapies.

Mark Eisner
Mark Eisner
EVP & Chief Medical Officer at Vir Biotechnology

With that, I'll now hand over the call to Jason.

Jason O’Byrne
Jason O’Byrne
EVP & CFO at Vir Biotechnology

Thank you, Mark. I'm pleased to share our first quarter financial performance and overall financial position. We continue to maintain a strong financial foundation while advancing our key programs, and I'll start with several key financial metrics for this past quarter. R and D expenses for the first quarter of twenty twenty five were $118,600,000 which included $7,000,000 of non cash stock based compensation expense compared to $100,100,000 for the same period in 2024, which included $13,600,000 of stock based compensation expense. The increase in R and D expenses was primarily driven by a $30,000,000 payment to Alnylam and expenses related to the initiation of the ECLIPSE registrational program.

Jason O’Byrne
Jason O’Byrne
EVP & CFO at Vir Biotechnology

These increases were partially offset by lower R and D expenses associated with past headcount reductions, deprioritized programs and the closing of our St. Louis, Missouri and Portland, Oregon sites. SG and A expenses for the first quarter of twenty twenty five were CAD23.9 million, which included CAD7.1 million of stock based compensation expense compared to CAD36.3 million for the same period in 2024, which included CAD10.2 million of stock based compensation expense. The decrease was largely due to ongoing cost savings realized through headcount reductions and other initiatives. Combined, our first quarter operating expense of $142,600,000 increased modestly by approximately $6,000,000 year over year.

Jason O’Byrne
Jason O’Byrne
EVP & CFO at Vir Biotechnology

Net loss for the first quarter of twenty twenty five was $121,000,000 compared to a net loss of $65,300,000 for the same period in 2024. The higher net loss was largely driven by $52,000,000 of revenue in the first quarter of twenty twenty four compared to approximately $3,000,000 of revenue in the first quarter of twenty twenty five. Turning to cash. Our net cash consumed in the first quarter was $75,600,000 which is in line with our expectations. We ended the quarter with approximately $1,000,000,000 in cash, cash equivalents and investments.

Jason O’Byrne
Jason O’Byrne
EVP & CFO at Vir Biotechnology

Based on our current operating plan, we continue to project our cash runway extending into mid-twenty twenty seven. This provides us with the resources to advance key programs through planned value inflection points. As Mary Anne mentioned earlier, Alnylam has elected not to opt into the profit sharing arrangement for elexiran. As a result, we recognized CAD 30,000,000 as R and D expense in the first quarter, which was paid in cash to Alnylam in April of this year. This payment reduced potential future development and regulatory milestones that were described in our most recent 10 ks from CAD175 million to CAD145 million.

Jason O’Byrne
Jason O’Byrne
EVP & CFO at Vir Biotechnology

The amended terms are further described in our first quarter '10 Q. The agreement with Alnylam remains a milestone and royalty based arrangement. This was our base case outcome and was assumed in our current runway guidance. Our capital deployment strategy remains focused on our most promising programs advancing our hepatitis delta ECLIPSE registrational studies with ECLIPSE one continuing to enroll and preparations underway for ECLIPSE two and ECLIPSE three Continuing dose escalation for our T cell engager programs, VER5818 and VER5500. And finally, initiating and advancing the Phase I study for 05/2025.

Jason O’Byrne
Jason O’Byrne
EVP & CFO at Vir Biotechnology

For our hepatitis B program, any further development will be contingent upon securing a development and commercialization partner. We continue to apply financial discipline as we deploy resources toward advancing these key programs to create value and benefit for patients. With that, I'll hand it back to Rich to initiate the Q and A session.

Richard Lepke
Richard Lepke
Senior Director of Investor Relations at Vir Biotechnology

Thank you, Jason. This concludes our prepared remarks, and we will now start the Q and A session.

Operator

Your first question comes from the line of Gina Wang with Barclays. Please go ahead.

Gena Wang
Gena Wang
MD - Biotech Equity Research at Barclays

Thank you. I have two questions. So maybe the first one regarding the Alnylam decision. Did they see most up to date data for both HBV and HBV? And what was the reason they provided for not opting?

Gena Wang
Gena Wang
MD - Biotech Equity Research at Barclays

And the second question is, thinking about you have so many programs progress so rapidly in the oncology space. So when should we see the next update from the programs? And which will be likely the venue we will see those data update?

Marianne De Backer
Marianne De Backer
Chief Executive Officer and Director at Vir Biotechnology

Yes. Thank you, Gina, for those questions. Maybe I'll start with the last one first. So when, a next oncology data update will be coming. So the way we think about it for any next data update, what we would be anticipating to share is, first of all, obviously, mature data at higher dose levels beyond what we presented just a couple of months ago in January.

Marianne De Backer
Marianne De Backer
Chief Executive Officer and Director at Vir Biotechnology

We would also want to share comparative data between weekly and and every three week dosing. You think the latter is especially relevant for our ambition to go into earlier lines. Also a clearer picture obviously on those response relationships, additional insights into safety profile at higher doses and of course also PSA responses. So once we have all that for five thousand five hundred and for five thousand eight hundred and eighteen, We will be sharing it, of course, either through a medical congress or through a more focused investor event. So as soon as, you know, we are ready, we will we will do so.

Marianne De Backer
Marianne De Backer
Chief Executive Officer and Director at Vir Biotechnology

Your second question, Gina, related to Alnylam. So Alnylam made their decision to opt out of the profit sharing arrangements before our most recent HCV functional pure data was available. As you know, that data is only going to be presented, for the first time on Friday at EASL on May 9. So this decision was really based on their own strategic portfolio prioritization.

Gena Wang
Gena Wang
MD - Biotech Equity Research at Barclays

Thank you.

Mark Eisner
Mark Eisner
EVP & Chief Medical Officer at Vir Biotechnology

Sure.

Operator

The next question comes from the line of Paul Choi with Goldman Sachs. Please go ahead.

Paul Choi
Paul Choi
Analyst at Goldman Sachs

Hi, everyone. Thanks for taking our questions. I want to ask about first about EASL, and it looks like, you have a late breaker of of the doublet in combination with the the Viron, 200, asset. Just curious, I I think that's the first look we'll we'll get at the, get at that program. And so, just curious sort of what the rationale is behind that trip that new Triplic combination strategy there and just sort of how you think about the development plans for that versus other, your other combinations?

Paul Choi
Paul Choi
Analyst at Goldman Sachs

And my second question is, can you comment maybe in broad strokes on how you're thinking about completing enrollment or completing either the ECLIPSE one or ECLIPSE two studies. This would be helpful to understand in the context of your cash guidance runway to 2027 since you're just putting in first patient in the first quarter here. Just some context on that timing would be helpful. Thank you very much.

Marianne De Backer
Marianne De Backer
Chief Executive Officer and Director at Vir Biotechnology

Okay. Thank you, Paul. So maybe the first question on the Therion combination. Mark, do you want to, answer that?

Mark Eisner
Mark Eisner
EVP & Chief Medical Officer at Vir Biotechnology

Yeah. So thanks, Paul, for the questions. I mean, first of all, that that's a study conducted by Therion, and, you know, we did provide access to to bevovar and lebsiran for that study. But we're we're not you know, it's being run by Vireon, and it's in their portfolio and not ours. So I think, you know, the day the data are interesting in terms of, you know, some of the early responses in terms of surface antigen decline, but, you know, that's really in in their portfolio rather rather than ours.

Mark Eisner
Mark Eisner
EVP & Chief Medical Officer at Vir Biotechnology

You're asking a really good question about HDD and our timelines. You know, we did announce first patient dose for ECLIPSE one, and, we have a study estimated completion date of the end of twenty twenty six. So that means we would be aiming to complete enrollment in that study by the end of this year. I mean, that's an aggressive target, but we are putting all of our resources behind getting these ECLIPSE trials up and running. For ECLIPSE two, we haven't provided guidance yet, but I can assure you that we are laser focused on getting that study up and running.

Mark Eisner
Mark Eisner
EVP & Chief Medical Officer at Vir Biotechnology

It's important to note that the ECLIPSE two actually has a twenty four week endpoint. So even though it's starting dosing a little bit later, we will have a twenty four versus forty eight week readout. So the timing will provide some more guidance when we're able to do that, but that's an important point to consider.

Paul Choi
Paul Choi
Analyst at Goldman Sachs

Got it. That's helpful color, Mark. Thank you very much.

Operator

Your next question comes from the line of Mike Ulz with Morgan Stanley. Please go ahead.

Avraham Novick
Avraham Novick
Biotech Equity Research Associate at Morgan Stanley

Hi, good afternoon. This is Avi Novak on line for Mike. Thank you for taking our So a competitor of yours recently shared updated data from its TCA TCE PSMA targeting program in metastatic CRPC. So was wondering if you had any updated thoughts on your on the competitive positioning of the AR five five zero zero. And do you see a median PFS of around seven and a half months as, I guess, a fair and achievable benchmark for your program?

Avraham Novick
Avraham Novick
Biotech Equity Research Associate at Morgan Stanley

Thanks.

Mika Derynck
Mika Derynck
Executive Vice President, Therapeutic Area Head Oncology at Vir Biotechnology

So, yeah. I can take that question. First of all, we're actually very encouraged about the continued progress, for T cell engagers in general, including the fact that Jan X continues to prove proof of concept that masking technology actually extends the therapeutic index. And while I can't comment directly on how we would be because we are relatively earlier in our dose escalation compared to where they are, we do think that we are quite differentiated in that. Our product stand is a dual mask technology.

Mika Derynck
Mika Derynck
Executive Vice President, Therapeutic Area Head Oncology at Vir Biotechnology

It's quite a different masking technology than the other masks that are are out there. It's a universal mask. It's the only clinically validated mask in terms of having clinical validation in other platforms such as the drug out a hemophilia drug. And we do think that we have a really very favorable safety profile. We we demonstrated in our January update that we have a very low rate of CRS.

Mika Derynck
Mika Derynck
Executive Vice President, Therapeutic Area Head Oncology at Vir Biotechnology

We do not use any prophylactic steroids. We we know that every other t cell engager program needs some form of prophylaxis, and and despite the lack of use of corticosteroids, we have this very low grade CRS and also no evidence of significant I l six elevation. And and despite that, we are seeing some nice, really early activity. The other big differentiator, which I think is important both for safety and is and is in the frontline is is that we have a longer half life of eight to ten days, which enables our q three week dosing schedule. We know that for convenience and quality of life the frontline setting for prostate cancer in particular, these types of differentiation is gonna be critically important, for overall tolerability, a huge unmet need, where we think these drugs could could potentially offer significant convenience for that.

Avraham Novick
Avraham Novick
Biotech Equity Research Associate at Morgan Stanley

Great. Thank you.

Operator

The next question comes from the line of Eric Joseph with JPMorgan. Please go ahead.

Ron Feiner
Ron Feiner
Equity Research Associate at JP Morgan

Hi, guys. This is Ron on for Eric. I wanted to ask, how does the recent, Boliviratide update in past two second around the potential finite versus long term chronic treatment, with the combination for, HPV? Thanks.

Marianne De Backer
Marianne De Backer
Chief Executive Officer and Director at Vir Biotechnology

Sure. Mark, do you wanna take question.

Mark Eisner
Mark Eisner
EVP & Chief Medical Officer at Vir Biotechnology

Yeah. Sure. So, I think your question is about, belabertide and and their long term outcome data and their ability to achieve finite treatment, how does that affect our program? So we just to remind everybody, I mean, we achieved in our Solstice study very high rates of target not detected or complete viral suppression. We're achieving it in the majority of patients by week twenty four and week thirty six.

Mark Eisner
Mark Eisner
EVP & Chief Medical Officer at Vir Biotechnology

And we're getting to sixty four percent at week thirty six. So that compares to bleveratide in week forty eight of only twelve percent. So we think we can achieve very high rates of viral suppression in terms of long term suppression. The Gilead, blebirtide data that, are related to, you know, finite treatment or with their higher dose. So, that's one thing to consider.

Mark Eisner
Mark Eisner
EVP & Chief Medical Officer at Vir Biotechnology

And it's not really something that's in their label right now. So we are aiming for chronic viral suppressive regimen. We think we can suppress the virus in the vast majority of patients. We're also achieving three log declines in hepatitis B surface antigen. Again, just pointing to the potency and the depth and breadth of our viral suppression for Delta.

Mark Eisner
Mark Eisner
EVP & Chief Medical Officer at Vir Biotechnology

So we're really excited to be moving into the Phase III program.

Operator

Your next question comes from the line of Roana Ruiz with Leerink Partners. Please go ahead.

Nik Gasic
VP - Biotech Equity Research at Leerink Partners

Hey, good afternoon. This is Nick Gasik on for Roana. Thanks for taking our questions. Maybe first on HBV, how should we think about your expectations heading into the twenty four week off treatment data for March at EASL? What are you hoping to see from a functional cure standpoint relative to the end of treatment data we got at ASLD?

Nik Gasic
VP - Biotech Equity Research at Leerink Partners

And maybe, you know, what implications could this new data have, for potential partnership discussions in HBV? Thanks.

Marianne De Backer
Marianne De Backer
Chief Executive Officer and Director at Vir Biotechnology

Thanks for the

Marianne De Backer
Marianne De Backer
Chief Executive Officer and Director at Vir Biotechnology

question.

Mark Eisner
Mark Eisner
EVP & Chief Medical Officer at Vir Biotechnology

Go

Mark Eisner
Mark Eisner
EVP & Chief Medical Officer at Vir Biotechnology

ahead, Simon. Sorry.

Marianne De Backer
Marianne De Backer
Chief Executive Officer and Director at Vir Biotechnology

Go ahead,

Marianne De Backer
Marianne De Backer
Chief Executive Officer and Director at Vir Biotechnology

Mark. No. No. Go ahead.

Mark Eisner
Mark Eisner
EVP & Chief Medical Officer at Vir Biotechnology

Yeah. So I was just gonna say we are looking forward to, presentation of our March, data, twenty four week off treatment data this Friday at EASL. This will be the look at our functional cure rates. As you might imagine, we are going into a quiet period because it is just a very short period between now and then. So we don't want to comment extensively except to say that we have been signaled in the past that we're looking for a twenty percent in the doublet and a 30% functional curate in the triplet.

Mark Eisner
Mark Eisner
EVP & Chief Medical Officer at Vir Biotechnology

But, you know, I think, you know, stay tuned, and you'll see see the full data at EASL in just a couple days.

Marianne De Backer
Marianne De Backer
Chief Executive Officer and Director at Vir Biotechnology

Yeah. The only thing I would add is that, as we have already mentioned, in January, any further development on on the HBV program is contingent on securing a worldwide development and commercial securitization partner.

Operator

Your next question comes from the line of Phil Nadeau with TD Cowen. Please go ahead.

Phil Nadeau
Managing Director, Health Care – Biotechnology Research Analyst at TD Cowen

Good afternoon. Thanks for taking our questions. Two from us. First, on May, you mentioned that there have been multiple doses tested since the data in January. We're wondering if you would care to comment on whether those additional doses have continued to suggest a dose response in efficacy in terms of PSA response rate and durability?

Phil Nadeau
Managing Director, Health Care – Biotechnology Research Analyst at TD Cowen

That's first question. And then second, on HDV, the RNA positive figures that you gave for the prevalence of the condition, can you clarify, are those overall prevalence or patients diagnosed having a positive RNA? And and if it's not diagnosed, do you have a sense of what the diagnosis rate is? Thanks.

Marianne De Backer
Marianne De Backer
Chief Executive Officer and Director at Vir Biotechnology

Yes. Thank you, Phil. Maybe I'll start with your last question on on delta prevalence. So so what we did is is we really looked across all available studies, all available reports on delta prevalence, and we sort of started out with determining that, you know, based on all the numbers we could get our hands on, that are about two two million patients in US that are, HPV positive. And, again, through a very extensive literature search talking to KOLs, different sources, we found that on average about four point seven percent of those B patients are delta antibody positive.

Marianne De Backer
Marianne De Backer
Chief Executive Officer and Director at Vir Biotechnology

And, again, that further drilling down, so that gives you about ninety two thousand patients actually in in United States. But if you then think about patients that are actually going to get treated, those are the patients that, you know, are RNA positive, you know, that are actively viremic. And so, again, based on on a lot of, sources, we came to the conclusion as we shared that about sixty one thousand patients in The United States, would be RNA positive and eligible for treatment for our regimen. So that's sort of the breakdown of how we got to the numbers. And then your first question related to fifty five hundred dosing, maybe, Nika, you can comment.

Mika Derynck
Mika Derynck
Executive Vice President, Therapeutic Area Head Oncology at Vir Biotechnology

Yeah. We we have continued the dose escalation, both at the q week and the q three week dosing, but, really, we are not prepared to make any comments. You know, we we are encouraged, with this the 5818 data that also showed a nice dose response. We have that one patient who clearly had a dose response within that while he intra patient dose escalated a colorectal cancer patient who went from sixty micrograms per kg up to six hundred micrograms per kg and continued to have a long durability of response, of lasting over eighteen months. So, but, sit tight and hopefully we'll be able to say something soon.

Operator

Your next question comes from the line of Alec Stranahan with Bank of America. Please go ahead.

Analyst

Hey, guys. This is Matthew on for Alec here. Thanks for taking our questions. Maybe a couple from us on 5525. We saw recently that the trial sign on clin trials for 5525 includes four parts, monotherapy escalation slash expansion and then combos with pembro escalation slash expansion.

Analyst

Would be helpful to have any color on why you chose this design, maybe the ordering of the parts, and whether you would still explore combination options if initial monotherapy data looks good.

Mika Derynck
Mika Derynck
Executive Vice President, Therapeutic Area Head Oncology at Vir Biotechnology

So, yeah, I'm happy to answer that. Thank you for the question. Yes, we're very excited about having our third PRO XTEN T cell engager program going to the clinic. We we believe we've shown some nice early proof of concept with the prior two molecules. And in terms of the trial design, we we do know that that there's good scientific rationale for combining with a checkpoint inhibitor.

Mika Derynck
Mika Derynck
Executive Vice President, Therapeutic Area Head Oncology at Vir Biotechnology

What we've seen with prior T cell engagers is that you can see upregulation of p d l one upon treatment with a T cell engager, and so really makes sense in terms of combining with a checkpoint inhibitor as well with combinations, again, in the context of other T cell engagers, is that we've seen deeper responses and more durable responses with the combination. Hence, we are we are considering the combination for the five five two five program as well. And as you mentioned, there are four parts. The first part is dose escalation as monotherapy. The second part is to look at specific indications and expansion cohorts as monotherapy.

Mika Derynck
Mika Derynck
Executive Vice President, Therapeutic Area Head Oncology at Vir Biotechnology

And then parts three and four is similar except in combination, a dose escalation component with pembrolizumab followed by an expansion cohort with a combination at, again, a data driven decision on which combination which indications that we would we would pursue.

Operator

Your next question comes from the line of Patrick Trucchio with H. C. Wainwright. Please go ahead.

Marianne De Backer
Marianne De Backer
Chief Executive Officer and Director at Vir Biotechnology

Hey, Patrick. We cannot hear you.

Patrick Trucchio
Managing Director at H.C. Wainwright & Co.

Oh, sorry. Hi there. Good afternoon. Just the first question is on the CHB program. I'm wondering if you can tell us, you know, in terms of the functional cure rates that you're looking for, would you be looking for those rates in kind of certain levels of, HBs surface antigen at baseline?

Patrick Trucchio
Managing Director at H.C. Wainwright & Co.

And, separately, I'm wondering on the HBV program, do you need data from all the ECLIPSE trials in order to submit for regulatory approval? Or how should we think about potential for mix you know, accelerated approval? Is that a possibility? And then, just the last question is, just in terms of partnering or collaborations, how should we think about, both the CHB program, but as well any of the ProExTEM programs? And in particular, is there seven additional programs in preclinical development?

Patrick Trucchio
Managing Director at H.C. Wainwright & Co.

Thanks so much.

Marianne De Backer
Marianne De Backer
Chief Executive Officer and Director at Vir Biotechnology

Yes. Thank you, Patrick, for that question. Maybe I'll ask Mark first to address your questions on, the hepatitis b and delta programs.

Mark Eisner
Mark Eisner
EVP & Chief Medical Officer at Vir Biotechnology

Sure. Thanks for the question. So for, the March, phase two study in chronic hepatitis b, you know, as we presented at ASLD, we saw, the best responses at end of treatment in those patients with surface antigen levels at baseline of less than a thousand. This is very consistent with what others are seeing with different mechanisms of action in the field that patients with low surface antigen baseline are responding better than patients who have surface antigens that are very elevated at baseline. So we will present the data both all comers and divided by surface antigen as we did for the end of treatment data for the functional cure data in two days.

Mark Eisner
Mark Eisner
EVP & Chief Medical Officer at Vir Biotechnology

So look forward to that. For your HCV question, your question was, you know, do we need all three ECLIPSE studies for approval? I do not believe so. I believe we need, you know, ECLIPSE one and ECLIPSE two as our base case for filing package that should be sufficient for approval. We would be looking for an accelerated approval based on, in ECLIPSE one, the composite of target target not detected ALT normalization and for ECLIPSE two, target not detected virologic endpoint.

Mark Eisner
Mark Eisner
EVP & Chief Medical Officer at Vir Biotechnology

We are of course, we have breakthrough therapy designation in The US, and we have prime in Europe as well as orphan in Europe. So we are in active dialogue with regulators globally about the program, how to accelerate the program and how to get this drug combination to patients as quickly as possible because of the unmet need is so high. Just one other comment about partnering, and I'll turn back to Maryannis. For hepatitis b, as we've said that we are only gonna be able to move hepatitis b forward if we have a global development and commercialization partner. Whereas for hepatitis delta, we are, in full study start up mode for all three ECLIPSE studies, and we are running those studies as Vera Biotechnology on our

Mark Eisner
Mark Eisner
EVP & Chief Medical Officer at Vir Biotechnology

own.

Marianne De Backer
Marianne De Backer
Chief Executive Officer and Director at Vir Biotechnology

Thank

Marianne De Backer
Marianne De Backer
Chief Executive Officer and Director at Vir Biotechnology

you, Mark. And I would just add related to your question on partnering of the preclinical programs, Patrick. I mean, what is really unique is that, you know, the universal nature of the ProAxtend platform allows us to come up very efficiently with new potential therapeutic molecules, right, which are going to be, from a t cell engager perspective, very well engineered because that's the capability we've had here at SEER for a very long time, and we can now combine it really with that masking capability. So the seven preclinical programs that we are that we have started, it will be, you know, we envision a mix of approaches. Some of them will be kept for internal development of, you know, a number of select really high priority targets that align well with our strategic focus.

Marianne De Backer
Marianne De Backer
Chief Executive Officer and Director at Vir Biotechnology

And some are open to partnerships, and especially, you know, those where we think there could be complementary expertise, elsewhere. So it's gonna be really a a mix of both strategies.

Operator

Your next question comes from the line of Joseph Stringer with Needham and Company. Please go ahead.

Joseph Stringer
Managing Director, Equity Research at Needham & Company

Hi. Thanks for taking our Just given some of your recent work updating your HBV patient estimates, I had a question on the HBV diagnosis. Have there been any changes to U.

Joseph Stringer
Managing Director, Equity Research at Needham & Company

S. Guidelines? And I suppose, do you anticipate any updates to this in the near term? And how big of an impact could this be, to the, potentially addressable patient population in The US? Thanks.

Marianne De Backer
Marianne De Backer
Chief Executive Officer and Director at Vir Biotechnology

Yeah. Thank you for that, question. No changes yet to the to the guidelines for, delta diagnosis or reflex testing here in The United States. You know, we do believe that there is a heightened awareness also in the context of, you know, the American Association of Liver Diseases. So we are hopeful that, you know, we will continue to have that conversation, obviously, and that's when we have ASOP coming up later in the year that there might be some some announcements in that regard.

Marianne De Backer
Marianne De Backer
Chief Executive Officer and Director at Vir Biotechnology

But thus far, no changes, on reflex testing. That is, however, very, effectively already deployed in Europe. And they're, you know, they are really seeing that if you just base diagnosis based on risk factors, etcetera, you're really not finding the patients. It's really only when patients are tested for hepatitis b, and when they are found to be positive, they're automatically tested for delta that you end up, identifying many more patients. Mark, anything to add there from your perspective?

Mark Eisner
Mark Eisner
EVP & Chief Medical Officer at Vir Biotechnology

No. I think you captured it very well, Mary Anne. Just to state that I we do believe that the prevalence of diagnosed HDV or delta is is underestimated because the lack of reflex testing in The United States. It's just you know, I think once we have our therapy approved on the market assuming a success that we would expect with with such an effective product that this will drive more diagnosis and and more disease prevalence. I think there's other examples of, similar cases like this in medicine.

Mark Eisner
Mark Eisner
EVP & Chief Medical Officer at Vir Biotechnology

But, to your point, we're still not seeing, the reflex testing deployed in The United States at this time.

Operator

This concludes the Q and A session of the call. Thank you for participating. And I'll turn the call back over to Rich.

Richard Lepke
Richard Lepke
Senior Director of Investor Relations at Vir Biotechnology

Thank you, Eric, and thank you all for your continued support and for joining us today. We look forward to updating you on our progress in

Avraham Novick
Avraham Novick
Biotech Equity Research Associate at Morgan Stanley

the coming months. Operator, you may now end the call.

Executives
    • Richard Lepke
      Richard Lepke
      Senior Director of Investor Relations
    • Marianne De Backer
      Marianne De Backer
      Chief Executive Officer and Director
    • Mark Eisner
      Mark Eisner
      EVP & Chief Medical Officer
    • Jason O’Byrne
      Jason O’Byrne
      EVP & CFO
    • Mika Derynck
      Mika Derynck
      Executive Vice President, Therapeutic Area Head Oncology
Analysts
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Key Takeaways

  • We initiated our ECLIPSE Phase III registrational program for hepatitis delta with the first patient dosed in ECLIPSE 1 and estimate ~61,000 RNA-positive US patients (113,000 EU) with active disease, underscoring a rare-disease opportunity.
  • Our balance sheet remains robust with ~CHF 1 billion cash and equivalents, supporting operations into mid-2027, and we finalized an amended elapsiran deal with Alnylam that retains a milestone-and-royalty structure.
  • We will present 24-week post-treatment functional cure data from our March Phase II hepatitis B triplet study at EASL on May 9, noting that further HBV development depends on securing a global partner.
  • Our PROX10 dual-mask T cell engager VER5818 achieved a 33% confirmed partial response rate in HER2-positive colorectal cancer at ≥400 µg/kg—including a durable >18-month response in microsatellite-stable tumors.
  • VER5500, our PSMA-targeted TCE, showed 100% PSA declines and 58% PSA50 responses at doses >120 µg/kg without prophylactic steroids and minimal CRS, and we’re set to initiate Phase I for EGFR-targeted VER5525 this quarter.
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Earnings Conference Call
Vir Biotechnology Q1 2025
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