Vir Biotechnology Q3 2024 Earnings Call Transcript

Quartr
Provided by Quartr
October 31, 2024

There are 14 speakers on the call.

Operator

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. I will now turn the call over to Rich Lepke, Senior Director, Investor Relations.

Operator

You may begin, Mr. Luebke.

Speaker 1

Thank you, and good afternoon. With me today are Doctor. Mary Anne DeBacher, our Chief Executive Officer Doctor. Mark Eisner, our Chief Medical Officer and Jason Obern, our Chief Financial 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.

Speaker 1

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 8 ks. I will now turn the call over to our CEO, Marianne DeBacher.

Speaker 2

Thank you, Rich. Good afternoon, everyone, and thank you for joining us today. I'm pleased to provide an update on the significant progress we've made this quarter, beginning with the successful closing of our exclusive worldwide licensing agreement with Sanofi. This landmark agreement includes 3 clinical stage masked T cell engagers and the use of Sanofi's proprietary Pro Xtend protease cleavable masking platform for oncology and infectious diseases. This strategic move aligns seamlessly with our mission to use the power of the immune system to fight disease.

Speaker 2

We believe that the 3 dual masked T cell engagers, PHYER5818 for HER2, PHYER 5,500 for T SMA and PHYER 5,525 for EGFR have the potential to be best in class therapies. These investigational treatments aim to minimize toxicity challenges typically associated with T cell engagers, allowing for higher dosing and thereby enhancing efficacy. As part of this agreement, we have welcomed key employees from Sanofi, which bring extensive scientific and development expertise in oncology and the ProExtend masking platform technology. These talented individuals have quickly proven to be an excellent fit within our organization. We believe that their expertise combined with our deep understanding of T cell immunology, our robust infrastructure and leading machine learning and antibody engineering capabilities will create significant synergies.

Speaker 2

Moving on to our mid stage clinical pipeline, we are making strong progress across our hepatitis programs with important upcoming data readouts. I'll now highlight our recent progress in the ongoing Phase II SOLSTIS trial in patients with chronic hepatitis delta. Hepatitis delta represents a highly promising growth opportunity for Vir, marking the next significant inflection point in our journey toward becoming a fully integrated and sustainable commercial company. Much like other orphan disease markets, the HDV market is characterized by significant unmet medical needs and severe clinical outcomes for patients. This underscores an opportunity for innovative and impactful therapies that address critical health challenges and offer substantial value to both patients and the healthcare system.

Speaker 2

We estimate there are approximately 100,000 people living with hepatitis delta in the United States and approximately 200,000 in Europe. Despite the severe and often life threatening impact of HDV, patients currently have very limited treatment options. There are no approved therapies in the U. S. And in Europe, the only available treatment requires daily self administered subcutaneous injections, presenting challenges for long term patient compliance and quality of life.

Speaker 2

Based on the preliminary Phase 2 clinical data we have shared to date, we believe our combination regimen of todevibart and elapsiran is highly differentiated compared to the current standard of care and has the potential to be a transformative treatment option for these patients in need. As we continue to advance this promising treatment, we anticipate an increase in both diagnosis and treatment rates. Feedback from physicians and advocacy groups has highlighted a growing interest in reflex testing for hepatitis delta. Reflex testing involves automatically testing for hepatitis delta in patients who test positive for hepatitis B without requiring a separate order from the healthcare provider. This proactive approach ensures early identification of HDV infections, even in regions like the United States where treatment options are currently limited.

Speaker 2

By identifying patients early, we can help ensure they receive timely treatment once a therapy is approved. While we are at the early stages of driving this awareness, we aim to improve early diagnosis and pave the way for effective treatment outcomes for patients with hepatitis delta as our HDV program advances closer towards a potential approval. We are committed to partnering with key stakeholders across the healthcare landscape to advocate for and adopt these testing practices. Looking ahead, we will present data from the SOLSTIS trial at the AASLD conference taking place November 15th to 19th in San Diego. We are making excellent progress advancing this program in the clinic and have engaged with the FDA to discuss our planned registrational program in HDV, which is expected to begin next year.

Speaker 2

Next, I'd like to address our functional cure program for chronic hepatitis B, which represents another substantial opportunity for our combination regimen of tobevibard and elapsiran with or without pegylated interferon alpha. Our goal is a functional cure in this setting, defined as a sustained loss of detectable hepatitis B surface antigen and hepatitis B virus DNA after a finite course of treatment. There are an estimated 1,600,000 hepatitis B patients in the United States alone and approximately 254,000,000 globally. We are looking forward to reporting end of treatment data from the March Part B trial in a late breaking presentation at the upcoming AASLD meeting in November. This end of treatment data will be followed by the functional cure data readout in the Q2 of 2025.

Speaker 2

Based on KOL feedback, our target for a functional cure is 30% for the interferon containing regimen and 20% for the regimen excluding interferon. Before I close, I would like to provide an update on our upcoming events and reaffirm our commitment to keeping you informed about our progress. While we had initially planned to host an R and D day in the Q4, we will instead conduct an in-depth investor event focused on our hepatitis franchise in November. Given the addition of the T cell engagers to our portfolio and the subsequent reprioritization of our pipeline, we have adjusted our plans. We now intend to discuss our T cell engager programs at a dedicated investor event in the Q1 of 2025.

Speaker 2

This timing also allows us to present initial clinical results, ensuring we provide insights into our progress and the future prospects of these programs. As mentioned, we will host an exclusively hepatitis focused investor event immediately following the AASLD conference in November. During this event, we will provide detailed updates on both the March and Solstice programs. This focused approach will allow us to delve deeply into these 2 critical development programs and their implications for patients and our broader clinical strategy. We understand the importance of clear and timely communication with our investors, and we are committed to keeping you updated on all the significant developments.

Speaker 2

Finally, I'm thrilled to have welcomed Jason O'Byrne as our new Executive Vice President and Chief Financial Officer earlier this month. Jason is an accomplished executive with more than 20 years of experience in finance and operations and a proven track record in financial strategy across public companies. His exceptional leadership and focus on excellence and execution make him a perfect fit as we embark on the next chapter for our organization. Since joining Veer, one of Jason's key priorities has been to ensure continued disciplined capital deployment and financial stewardship. As we recently announced, we have implemented a strategic restructuring initiative to prioritize our clinical stage pipeline opportunities and streamline our operations.

Speaker 2

These efforts are allowing us to allocate our resources more efficiently and focus on our core programs. In closing, I couldn't be more optimistic about Veer's future and the potential impact of our innovative therapies. We have a strong balance sheet, which allows us to fund operations through our next major inflection points. We are prudently managing our expenses with a focus on our most promising programs and maximizing shareholder value. I would like to thank our dedicated team, including our new colleagues, for their hard work and our investors for their continued support.

Speaker 2

And with that, I'll now turn the call over to our Executive Vice President and Chief Medical Officer, Mark Eisner, to provide an update on our clinical development programs and pipeline.

Speaker 3

Thank you, Mary Anne, and good afternoon, everyone. Let's begin with the SOLSTIS trial in hepatitis delta. As a reminder, we presented strong preliminary data from our Phase 2 SOLSTIS trial in HDV at the EASL Congress in June. In our rollover cohort of 6 non cirrhotic participants, we reported that all 6 achieved virologic suppression below the lower limit of quantification and 5 out of 6 achieved target not detected, indicating no measurable presence of HCV RNA. Additionally, 3 out of 6 achieved ALT normalization.

Speaker 3

Durable virologic suppression was observed in the combination rollover cohort suggesting the potential for sustained antiviral activity. There are 32 participants in the de novo combination cohort and 33 participants are in the monotherapy cohort. At the time of the analysis, 11 participants in the de novo combination cohort and 7 participants in the monotherapy cohort had reached 24 weeks of treatment. There were no discontinuations in the combination cohort. After 24 weeks of treatment, all 11 participants in the de novo combination cohort achieved virologic suppression below the lower limit of quantification and 6 out of 11 achieved target not detected.

Speaker 3

7 out of 11 also achieved ALT normalization. From a safety perspective, we observed no treatment related serious adverse events or ALT flares in either the monotherapy or de novo combination treatment regimens. The majority of adverse events were transient and mild, grade 1 or 2, with a low incidence of injection site reactions. Taken together, these preliminary data are extremely promising as all 3 cohorts demonstrated rapid and sustained virologic responses. We will be sharing the full data set for both cohorts of approximately 30 participants at 24 weeks of treatment, as well as available data for participants beyond 24 weeks of treatment at AASLD.

Speaker 3

We are pleased to have received fast track designation from the U. S. FDA for a combination of cabivivar and alexiran. We're also actively exploring all possible acceleration pathways to bring this promising investigational therapy to patients as quickly as possible. We have recently engaged with health authorities to line on our clinical development strategy for hepatitis delta.

Speaker 3

Based on these discussions, we are actively working to expedite the initiation of our registrational program. We look forward to sharing more information at our hepatitis focused investor event following the AASLD conference. Moving on to our Phase 2 program for chronic hepatitis B. At AASLD, we look forward to sharing the end of treatment data from the March Part B trial, which evaluates our doublet and triplet regimens. The data will include approximately 50 participants receiving our combination treatment and approximately 30 participants receiving the combination therapy plus interferon.

Speaker 3

This readout will be followed by post treatment data in the Q2 of 2025, which will allow us to assess functional cure for both regimens. Now, let's transition to oncology and discuss the T cell engager programs. As we described in our Q2 call, the agreement with Sanofi provided us with a robust portfolio of assets targeting clinically validated antigens in oncology. I'll briefly touch on the status of each program. VERA-five thousand eight hundred and eighteen, our dual masked HER2 CD3 T cell engager, is a highly differentiated asset with the potential to address significant unmet needs in HER2 expressing cancers.

Speaker 3

As the only masked HER2 T cell engager currently in clinical development, VERA-five thousand eight hundred and eighteen is designed to offer lower off tumor toxicity, allowing for higher doses and potentially improved efficacy compared to existing HER2 targeted therapies. There is a significant unmet need in HER2 positive cancers, particularly in metastatic breast cancer and metastatic colorectal cancer. The Phase 1 study is ongoing evaluating VER5818 as both a monotherapy and in combination with pembrolizumab initially in a basket of solid tumor indications. The study is currently being conducted at 10 active sites in Europe and Australia, and we are making good progress with continued dose escalation. We anticipate sharing preliminary monotherapy data in the Q1 of 2025.

Speaker 3

VERA-five thousand five hundred is a dual masked PSMA directed T cell engager currently in Phase 1 clinical trials. Prostate cancer represents a significant disease burden with many patients in need of more effective and well tolerated treatment options. As the only dual mass PSMA directed T cell engager currently in clinical development, VERA-five thousand five hundred is designed to offer lower off tumor toxicity, allowing for higher doses and potentially improved efficacy compared to existing PSMA targeted therapies. The study is currently ongoing evaluating VERIF-five thousand five hundred as a monotherapy in a step up dose escalation design with the potential to expand into combination therapy. The Phase 1 study for VERA-five thousand five hundred is earlier in its progression with fewer participants compared to VERA-five thousand eight hundred and eighteen.

Speaker 3

We anticipate sharing early monotherapy data in the Q1 of 2025. Finally, VERA-five thousand five hundred and twenty five, a dual masked EGFR CD3 T cell engager, has a cleared IND and we're preparing to initiate the Phase 1 clinical study. Despite available treatments, the unmet need for patients with EGFR expressing tumors remains high. The initial target tumor types for VER-five thousand five hundred and twenty five are metastatic head and neck squamous cell carcinoma, metastatic squamous non small cell lung cancer and metastatic colorectal cancer. We believe that VERA-five thousand five hundred and twenty five has the potential to provide a safe and tolerable treatment option for patients in the second line and beyond settings for these difficult to treat cancers.

Speaker 3

We are on track to initiate enrollment in a Phase 1 clinical study in the Q1 of 2025. With that, I'll now hand the call over to Jason.

Speaker 4

Thank you, Mark, and thank you, Mary Anne, for the warm welcome. It's an honor to join the talented Veer team at this important time in the company's evolution. I have long admired Veer's commitment to preventing and treating serious infectious disease and the team's impressive history of proven successful execution. Today, as Mark just shared, Veer continues its focus on infectious disease while also expanding into oncology with the addition of 3 T cell engager assets and the underlying ProExtend masking platform. In my role as CFO I look forward to working alongside the executive team and all the dedicated Veera employees to deliver meaningful benefit to patients and to create shareholder value.

Speaker 4

Mary Anne mentioned, one of my early focus areas will be disciplined capital deployment and financial stewardship. I am confident that with our strong financial position, compelling clinical programs and exceptional team, we are well positioned to deliver Veer's mission. I will now share highlights of the Q3 2024 financial results. R and D expenses for the Q3 of 2024 were approximately $195,000,000 compared to $145,000,000 for the same period in 20 23. The increase was primarily driven by approximately $103,000,000 of expense related to the Sanofi transaction this quarter, partially offset by reduced clinical development and manufacturing costs associated with the discontinued flu asset VER-two thousand four hundred and eighty two.

Speaker 4

SG and A expenses for the Q3 of 2024 were $25,700,000 compared to $40,900,000 for the same period in 2023. The decrease was largely related to cost saving initiatives announced at the end of 2023. Restructuring, long lived asset impairment and related charges for the Q3 of 2024 were $12,700,000 compared to $3,400,000 for the same period last year. The increase was primarily driven by our August 2024 restructuring severance charges and asset impairment charges related to the closing of our Portland, Oregon facility. We ended the Q3 with cash, cash equivalents and investments of approximately $1,190,000,000 compared to $1,430,000,000 at the end of the 2nd quarter.

Speaker 4

Excluding the effects of the Sanofi transaction, the decrease in cash and investments during the Q3 was approximately $66,000,000 Including the effects of the Sanofi agreement, The total decrease in cash and investments during the quarter was approximately $245,000,000 which included $104,000,000 in cash payments made to Sanofi at closing, plus a $75,000,000 escrowed milestone payment. The escrowed $75,000,000 milestone is subject to VER-five thousand five hundred and twenty five achieving 1st in human dosing by 2026, and that amount was reclassified to restricted cash in the quarter. As we approach the latter part of the year, we are adjusting our GAAP full year 2024 expense guidance to a range of $660,000,000 to $680,000,000 which includes the Sanofi transaction expenses, stock based compensation expense and restructuring charges. Excluding those three items, our updated net guidance is now modestly lower at a range of $430,000,000 to $470,000,000 compared to our Q2 guidance of $450,000,000 to $500,000,000 With that, I'll turn the call back over to Rich to begin the Q and A session.

Speaker 1

Thank you, Jason. This concludes our prepared remarks, and we will now start the Q and A section. Please limit questions to 2 per person so that we can get to all of our covering analysts. I'll turn it over to you, operator.

Operator

Thank you. At this time, we will begin conducting our analyst Q and A session. We'll go first to Paul Choi at Goldman Sachs.

Speaker 5

Hi, good afternoon and thank you for taking our questions. My first question is, can you just update us on the status of your plans and the Phase 2 meeting with the FDA? Apologies if I missed a mention of it in the press release. So I was just curious what the status of your regulatory discussions was. And my second question is for your new T cell engager program for 5,00818.

Speaker 5

Can you maybe comment on how you're thinking about the relative measures you're looking for both the monotherapy versus the pembrolizumab combination? Thank you very much.

Speaker 6

Okay. Thank you very much for that question, Paul. I'll give it to Mark, our CMO to answer those questions.

Speaker 7

Yes. Thanks for the question, Paul. We have engaged with the FDA, as you mentioned. We are just putting the very finishing touches on our clinical development program and we expect to be able to share further details about that at our hepatitis focused investor meeting on November 19. In terms of the T cell engager program in the 5,00818, HER2 CD3 program in particular, your question about efficacy is a good one.

Speaker 7

We are planning to share preliminary monotherapy data from that program, also the PSMA program in quarter 1 next year. And at that time, we'll be able to provide a bit more perspective on the data.

Speaker 5

Okay. Thank you.

Operator

Next, we'll move to Eric Joseph at JPMorgan.

Speaker 8

Thanks.

Speaker 9

If I remember correctly, just in terms of the pivotal path forward in HDV, you previously outlined a randomized study with heplodex as a comparator arm. I guess based on your latest regulatory interactions, should we still kind of carry out that expectation? And I guess within that, how should we be thinking about sort of the continued inclusion of or evaluation of combination or monotherapy with tupupifibar? Thanks.

Speaker 7

Yes. Thanks for the question. So as we've stated before, we are committed to going forward with the combination of tibibar and olivesiran because we achieved deep and sustained virologic responses with the combination regimen. And to remind everyone, we got, fast track designation for the combination regimen for the FDA. In terms of further details of the program, we do plan on discussing this in more detail in our investor event around the ASLD.

Speaker 9

Okay, great. Thanks very much.

Operator

We'll move next to Mike Ulz at Morgan Stanley.

Speaker 10

Good afternoon. Thanks for taking the question as well. Maybe I could just ask a follow-up on the Phase 3 trial design and your interactions with the FDA. I'm just curious if you're getting any feedback that might be unexpected at this point or things just on track and you're going to sort of reveal the final details at your investor event? Thanks.

Speaker 7

Yes. Thank you for the question. I will say we had a very productive meeting with the FDA. I think we aligned with them very closely on the plan and we'll be prepared to share more with the investor around ASLP.

Speaker 10

Great. Thank you.

Operator

Next we'll go to Gena Wang at Barclays.

Speaker 6

Thank you for taking my questions. I have two questions. The first one is regarding the HCV data. Thank you very much to putting the data together from the prior study. So Slide 21, you lay out the several data points here.

Speaker 6

But I assume the key focus for us should be the target not detectable rate and also LTL normalization. Should we expect those are the benchmark and that should be the level minimum level should achieve with more patient data now, 32 patients, 33 patients at week 24? And my second question is regarding the T cell engagers. And I remember, Mary Anne, you said you saw some initial Phase 1 data when the Sanofi deal discussion was ongoing. So now with the next year data update, have you seen the more patient data?

Speaker 6

And with the more patient, does the monotherapy activity hold as your initial expectation? Okay. Thank you very much, Gina. Mark, you want to comment on the HCV?

Speaker 7

Absolutely. So to source the study in HCV, we are going to have oral presentation at the AASLD meeting, which I think will give a lot more information, particularly all the patients who made it through week 24 of the study and some of the patients beyond that. So we're going to be presenting those data. In terms of your question around T and D, yes, absolutely. I mean, getting below the limit of quantification target not detected means there's undetectable delta viral levels.

Speaker 7

So that is kind of the most rigorous measurement that's out there. Our combination regimen that what we've revealed at EASL is a very, very profound reduction in the viral load and achieving high rates of target not detected above 50% at week 24. In terms of ALT normalization, that's also important and those data will be included. The FDA guidance includes a composite endpoint of TND plus ALT normalization. So that will be data we will also present at the ASLD meeting coming up.

Speaker 6

Yes. And then on your question related to the T cell engagers, Gina, remember that our agreement with Sanofi closed on September 9. So we are in the midst of transitions, for example, trial sponsorships and so on. Obviously, we have all the data available on the programs. And as I mentioned, we will be in a position to share initial data on the monotherapy of both the 5,500 and 5,518 5,818 assets in the Q1 of 2025.

Operator

We'll move next to Alex Stranahan at Bank of America.

Speaker 8

Hey guys, thanks for taking my questions. 2 from me as well. I was hoping you could help frame the sort of data we should expect for 5,818 and 5,500 in the Q1. Will it be mostly focusing on maybe safety and dosimetry or could we see some initial efficacy metrics as well? And if you could speak to how the dual mask for your assets might benefit your ability to reach a higher target dose?

Speaker 8

Is this baked into the dose escalation or is driving to reach a MTD maybe not even the right way to be thinking about things here? Thank you.

Speaker 7

Sure. So in terms of your first question, as we stated, we are planning to share preliminary monotherapy data from the ongoing Phase 1 studies, both for VERA-five thousand eight hundred and eighteen HER2 program and VERA-five thousand five hundred, the PSMA T cell engager program. At this point, we're not really providing more color on that, but we will be providing those data updates in quarter 1 of next year. And then your question about the dual masking, I think is important. All of our programs do have the dual masking.

Speaker 7

So we're masking both the CD3 T cell engager part of the MALT molecule and the tumor antigen part binding part of the molecule. So the working hypothesis here is that that will allow us to achieve a better therapeutic index. So higher levels of safety, I mean higher levels of efficacy with good safety. As we mentioned before for the HER2 program, we're the only dual mass program in clinical development for PSMA. The JanEx program masks the CD3 part, but at least the PSMA unmasked.

Speaker 7

So we think we may have a differentiated asset in terms of our dual masking of the PSMA molecule.

Speaker 8

Thank you.

Operator

We'll go next to Roanna Reyes at Leerink Partners.

Speaker 11

Hey, this is Nick Gassik on for Roanna. Thanks for taking our questions. Maybe first on the HCV Phase 3 trial design, just thinking about the target patient population. Are you going to be focusing on both cirrhotics and non cirrhotics? And I guess, are there any specific baseline characteristics you could enrich for here?

Speaker 11

A quick follow-up on HBV after that.

Speaker 7

Sure. So, thanks for the question. In terms so in Solstice, we've presented data including both cirrhotic and non cirrhotic patients, CPTAs. And back in EASL when we presented these data, you'll recall that the efficacy antiviral efficacy effect on ALT was very, very good in both cirrhotic and non cirrhotic. If anything, the non if anything, the cirrhotic patients fared a little bit better.

Speaker 7

So clearly, we want to base our Phase 3 program on the observations from the Phase 2 program. So we would include both cirrhotic and non cirrhotic patients. In terms of baseline characteristics that kind of predict response in any enrichment, I think we'll be able to provide more color on that at our investor focused hepatitis presentation around ASLD. So stay tuned for more detail there. Got it.

Speaker 7

That's helpful. And then on HBV,

Speaker 11

looking ahead, what sort of just read through could a 48 week end of treatment data have to the possible functional cure data in the Q2 of 'twenty five? I'm just curious what sort of HPS antigen suppression rates you could see at the 48 weeks, how that might mature heading into the off treatment data in 2Q? Thanks.

Speaker 7

Yes. No, that's a really good question. So just to summarize, we'll have the end of treatment data for the doublet of teprevart and elifiran and the triplet with pegylated interferon in addition at the upcoming liver meeting in San Diego. The functional cure data, as you said, comes in Q2 next year. So really what we said before for functional cure is we're looking for a minimum of 30% in the triplet functional cure, 20% in the doublet.

Speaker 7

In terms of end of treatment data, it's clear that there is going to be at least based on prior programs, the various mechanisms of action. There is a drop off between end of treatment and 24 weeks post treatment to our functional cure. But predicting that drop off is not straightforward and I know clearly established markers to do that. So what I'd say just in summary is we will have the end of treatment data soon. The functional cure rate will take a little bit longer to next year and taken together that will give a very complete picture of the regimens and what they can achieve for HBV patients.

Operator

We'll move next to Phil Nadeau at TD Cowen.

Speaker 12

Good afternoon. Thanks for taking our questions. 2 from us. So first on the HDV pivotal program, you've suggested you would be able to give us an update at the AASLD Analyst Meeting. Will you have the final trial design at that time?

Speaker 12

And would you be able to disclose the design and timelines at the meeting? That's the first question. And then second question, just broadly on the TCEs. You've mentioned the potential for differentiation versus either other TCEs in development or just broadly in the spaces of HER2 and PMSA to begin. Do you need to see differentiation in order to move those beyond Phase 1 or is simply safe and effective good enough at this point with additional differentiation to be established in future studies?

Speaker 12

Thanks.

Speaker 7

So for the HCV question, we are planning to disclose more information about the final trial design, the Phase 3 designs. So you'll be able to see that at the investor event around ASLD. So that more coming there. In terms of timelines, right now, we're not disclosing additional information about that and we will look to do that when we have full clarity on timelines. In terms of the TCE question, Mary Anne, would you like me to Sure.

Speaker 7

Okay. So your question is around what we would need to see to move these programs forward for HER2 and PSMA. To be honest, that's really something that is going to be a data driven decision. I think we are looking at this very early stage, of course, to look at proof of concept and the preliminary monotherapy data that we'll present in quarter 1, I think will give Stern to give a picture of what the programs look like. In terms of the more specific answer to your question, I don't think we're quite ready to repine on that yet, but we will look to provide more color on that at a future time point.

Speaker 12

Perfect. Thanks for taking my questions.

Operator

And we'll go next to Patrick Trucchio at H. C. Wainwright.

Speaker 10

Thanks. Good afternoon. Just a couple of follow-up questions for me. First in the HDV program, can you discuss more how the combination of olebsiran and tobevibar would be expected to be differentiated from bolivertide including at higher doses and the level of confidence that patients would maintain ALT normalization and biologic response switch from belivertide to the combination treatment regimen based on what we've seen in the clinical data so far? And then separately with the HBV program regarding the 20% functional cure rate without interferon and 30% functional cure rate with interferon.

Speaker 10

Can you tell us if these rates would be anticipated in the all comers or is it in the low S antigen at baseline patients? And if we look ahead to a potential Phase 3 pivotal program, can you talk about or tell us more if you're thinking about maybe stratifying based on S antigen at baseline? Would it make sense to explore combination this combination in patients

Speaker 9

with low S antigen at baseline?

Speaker 7

Okay. So your first question about HDV, the first part of that was about the combination of tibevivar and eloviran versus blubrutide. We do with the 2 milligram approved dose, we do expect to get much higher levels of target not detected based on our data represented at EASL than belabertide, which is 12% at 48 weeks. Your question about the higher dose, I mean, that dose isn't really isn't approved anywhere. So, but even so, I think the level of T and E efficacy that we expect to have should be superior to belabertide just thinking about what we're likely to see.

Speaker 7

In terms of level of confidence from belabertide switch, yes, I mean in terms of the patient population who's been on belabertide who is likely to enter such a trial or in a clinical practice, we would expect to be much higher in terms of our neurologic response with our combination and continued treatment with belabrutide. In terms of your HBV question, fundamentally, I think your question is around, is this going to be an all comers versus a stratified population based on baseline surface antigen? I guess I just asked you to stay tuned for the data and those questions should become much clearer at the March presentation at the liver meeting.

Speaker 10

Great. Thank you so much.

Operator

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

Speaker 13

Thank you all for your interest in beer and for participating in today's earnings call. We appreciate your continued support and look forward to providing further updates on our progress in the future. Audra, this concludes our call. Thank you. You may close the call.

Operator

Thank you. And that does conclude today's conference call. Thank you for your participation. You may now disconnect.

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Key Takeaways

  • Company closed a exclusive worldwide licensing agreement with Sanofi for three clinical-stage dual-masked T cell engagers (HER2, PSMA and EGFR) using Sanofi’s ProXtend masking platform, aiming to reduce off-tumor toxicity and enable higher dosing.
  • In the Phase II SOLSTIS trial for chronic hepatitis delta, the todevibart + elapsiran combination achieved 100% virologic suppression below the lower limit of quantification and high ALT normalization rates with no treatment-related serious adverse events, earning Fast Track designation and setting up a registrational program for next year.
  • The chronic hepatitis B program (todevibart + elapsiran ± pegylated interferon α) will report end-of-treatment data at AASLD in November and target functional cure rates of 30% (with interferon) and 20% (without) in Q2 2025, defined by sustained HBsAg loss and undetectable HBV DNA.
  • Management will host a dedicated hepatitis-focused investor event in November after AASLD and a T cell engager event in Q1 2025, following strategic restructuring to streamline operations and prioritize core clinical programs.
  • For Q3 2024, R&D expenses rose to $195 million due to the Sanofi deal, SG&A fell to $25.7 million from cost-savings initiatives, and cash and investments stood at $1.19 billion, with full-year net expense guidance adjusted to $430–470 million.
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Earnings Conference Call
Vir Biotechnology Q3 2024
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