10/31/2024

speaker
Operator

Hello, welcome to VEER Biotechnology's third quarter 2024 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 speaker's presentation, there will be a question and answer session. If you would like to ask a question during this time, simply press the star key followed by the number 1 on your telephone keypad. If you would like to withdraw your question, press star 1 again. I will now turn the call over to Rich Lepke, Senior Director, Investor Relations. You may begin, Mr. Lepke.

speaker
Lepke

Thank you, and good afternoon. With me today are Dr. Marianne DeBacher, our Chief Executive Officer, Dr. Mark Eisner, our Chief Medical Officer, and Jason O'Byrne, 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. 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 DeBacher.

speaker
Marianne DeBacher

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 three clinical stage masked T-cell engagers and the use of Sanofi's proprietary ProX10 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. We believe that the three dual-masked T-cell engagers, PURE5818 for HER2, PURE5500 for PSMA, and PURE5525 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 ProX10 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. 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 2 SALSTIS trial in patients with chronic hepatitis delta. Hepatitis Delta represents a highly promising growth opportunity for Veer, 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. We estimate there are approximately 100,000 people living with hepatitis delta in the United States and approximately 200,000 in Europe alone. Despite the severe and often life-threatening impact of HTV, 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. Based on the preliminary Phase II clinical data we have shared to date, we believe our combination regimen of dobevibart and elapseron 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. 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 SALSTIS 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. Next, I'd like to address our functional cure program for chronic hepatitis B, which represents another substantial opportunity for our combination regimen of tobevibar and elapseron with or without regulated 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 1.6 million hepatitis B patients in the United States alone and approximately 254 million 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 second quarter of 2025. 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&D day in the fourth quarter, 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 first quarter of of 2025. 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 two 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're committed to keeping you updated on all the significant developments. 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 in 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. 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 FEAR'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. 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
Mark Eisner

Thank you, Marianne, and good afternoon, everyone. Let's begin with the SOLSTICE trial in hepatitis delta. As a reminder, we presented strong preliminary data from our Phase 2 SOLSTICE trial in HDV at the Easel Congress in June. In our rollover cohort of six non-cirrhotic participants, we reported that all six achieved virologic suppression below the lower limit of quantification, and five out of six achieved target not detected, indicating no measurable presence of HDV RNA. Additionally, three out of six achieved ALT normalization. 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 seven 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 six out of 11 achieved target not detected. Seven 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 three 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. We are pleased to have received fast-track designation from the US FDA for a combination of tabivabart and lepsiram. We're also actively exploring all possible acceleration pathways to bring this promising investigational therapy forward. to patients as quickly as possible. We have recently engaged with health authorities to align on our clinical development strategy for hepatitis delta. 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 ASLD conference. Moving on to our Phase 2 program for chronic hepatitis B, at AISLD, 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. This readout will be followed by post-treatment data in the second quarter 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 second quarter 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. Vera5818, or dual-masked HER2 CD3 T-cell engager, is a highly differentiated asset with the potential to address significant unmet needs in HER2-expressing cancers. As the only masked HER2 T-cell engager currently in clinical development, Vera5818 is designed to offer lower off-tumor toxicity, allowing for higher doses and potentially improved efficacy in 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 I study is ongoing, evaluating VIR5818 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 first quarter of 2025. FIRA 5500 is a dual-masked PSMA-directed T-cell engager currently in Phase I 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 5500 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 VIR-5500 as a monotherapy in a step-up dose escalation design with the potential to expand into combination therapy. The phase one study for VIR-5500 is earlier in its progression with fewer participants compared to VIR-5818. We anticipate sharing early monotherapy data in the first quarter of 2025. Finally, VIR5525, a dual-masked EGFR CD3 T-cell engager, has a cleared IND, and we're preparing to initiate the Phase I clinical study. Despite available treatments, the unmet need for patients with EGFR-expressing tumors remains high. The initial target tumor types for VIR5525 are metastatic head and neck squamous cell carcinoma, metastatic squamous non-small cell lung cancer, and metastatic colorectal cancer. We believe that VIIR 5525 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. We are on track to initiate enrollment in a Phase I clinical study in the first quarter of 2025. With that, I'll now hand the call over to Jason.

speaker
Jason

Thank you, Mark. And thank you, Marianne, 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 three 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 Vera employees to deliver meaningful benefit to patients and to create shareholder value. As Marianne 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 Vera's mission. I will now share highlights of the third quarter 2024 financial results. R&D expenses for the third quarter of 2024 were approximately $195 million compared to $145 million for the same period in 2023. The increase was primarily driven by approximately $103 million of expense related to the Sanofi transaction this quarter, partially offset by reduced clinical development and manufacturing costs associated with the discontinued flu asset, VIR-2482. SG&A expenses for the third quarter of 2024 were $25.7 million, compared to $40.9 million 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 third quarter of 2024 were $12.7 million, compared to $3.4 million 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 third quarter with cash, cash equivalents, and investments of approximately $1.19 billion, compared to $1.43 billion at the end of the second quarter. Excluding the effects of the Santa Fe transaction, the decrease in cash and investments during the third quarter was approximately $66 million, including the effects of the Santa Fe agreement. The total decrease in cash and investments during the quarter was approximately $245 million, which included $104 million in cash payments made to Santa Fe at closing, plus a $75 million escrowed milestone payment. The escrowed $75 million milestone is subject to VERA 5525 achieving first 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 to $680 million, which includes the Santa Fe 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 to $470 million, compared to our second quarter guidance of $450 to $500 million. With that, I'll turn the call back over to Rich to begin the Q&A session.

speaker
Lepke

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

speaker
Operator

Thank you. At this time, we will begin conducting our analyst Q&A session. For our analysts, please raise your hand by pressing star one to indicate you would like to join the queue if you've not done so already. Once you hear the operator announce your name, you can unmute your line and ask your question. We'll go first to Paul Choi at Goldman Sachs.

speaker
Paul Choi

Hi, good afternoon, and thank you for taking our questions. My first question is, can you just update us on the status of your planned end of phase two 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 5818, can you maybe comment on how you're thinking about the relative measures you're looking for for both the monotherapy versus the pembrolizumab combination? Thank you very much.

speaker
Mary Ann

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

speaker
Mark Eisner

Yeah, 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 19th. In terms of the T-cell engager program in the 5818 HER2 CD3 program in particular, your question about efficacy is a good one. We are planning to share preliminary monotherapy data from that program, also the PSMA program in quarter one next year. And at that time, we'll be able to provide a bit more perspective you know, on the data.

speaker
Paul Choi

Okay, thank you.

speaker
Operator

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

speaker
Eric Joseph

Oh, thanks. 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 you know, 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 tibupipir? Thanks.

speaker
Mark Eisner

Yeah, thanks for the question. So, as we've stated before, we are committed to going forward with the combination of tabibabar and melepsiran 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, you know, we do plan on discussing this in more detail in our investor event around the ASLD.

speaker
Alex Stranahan

Okay, great. Thanks very much.

speaker
Operator

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

speaker
Mike Ulz

Good afternoon. Thanks for taking the question as well. Maybe I could just ask a follow-up on the phase three 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 are things just on track and you're going to sort of reveal the final details at your investor event? Thanks.

speaker
Mark Eisner

Yeah, 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, yeah, we'll be prepared to share more details at the investor event around ASLD.

speaker
Mike Ulz

Great. Thank you.

speaker
Operator

Next, we'll go to Gina Wang at Barclays.

speaker
Gina Wang

Thank you for taking my questions. I have two questions. The first one is regarding the HD. data. Thank you very much to, you know, putting the data together from the prior study. So slide 21, you lay out the several data points here. But I assume the key focus for us should be the target not detectable rate and also ALT normalization. Should we expect, you know, those at the benchmark and that should be the level, minimum level should achieve? with more patient data now, 32 patients, 33 patients at the week 24. And my second question is regarding the T-cell engagers. I remember, Mary Ann, you said you saw some initial phase one data when the Sanofi DO discussion was ongoing. So now with the next year data update, have you seen the more patient data? And with the more patient, does the monotherapy activity hold as your initial expectation?

speaker
Mary Ann

Okay. Thank you very much, Gina. Mark, do you want to comment on the HDV data?

speaker
Mark Eisner

Absolutely. So, to source the study of HDV, we are going to have an oral presentation at the ASLD meeting, which I think will give, a lot more information, particularly all the patients 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 TND, yes, absolutely. I mean, getting below the limit of quantification target not detected means there's undetectable delta viral levels. So that is, you know, kind of the most rigorous measurement that's out there, you know, our combination regimen, what we revealed at easel is a very, very profound reduction in the viral load in 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. You know, the FDA guidance includes a composite endpoint TND plus ALT normalization. So that will be data we will also present at the ASLD meeting coming up.

speaker
Mary Ann

Yeah, and then on your question related to the T-cell engagers, Gina, remember that our agreement with Sanofi closed on September 9th. So we are in the midst of transitions, for example, trial sponsorship and so on. Obviously, you know, 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 5500 and the 5818 assets in the first quarter of 2025. We'll move next to Alex Stranahan at Bank of America.

speaker
Alex Stranahan

hey guys thanks for taking my questions um two two from me as well uh was hoping you could help frame the sort of data we should expect for 58 18 and 5500 in the first quarter will it be mostly focusing on on maybe safety and dosimetry or could we see some initial efficacy metrics as well and if you could speak to how the dual map for your assets might benefit your ability to reach a higher target dose is this baked into the dose escalation or It's driving to reach a MTB, maybe not even the right way to be thinking about things here. Thank you.

speaker
Mark Eisner

Sure. So, in terms of your first question, as we stated, we are planning to share preliminary monotherapy data from the ongoing Phase I studies, both for VIIR 5018 HER2 program and VIIR 5500, 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 one of next year. And then your question about the dual masking I think is important. You know, all of our programs do have the dual masking, so we're masking both the CD3 T cell engager part of the molecule and the tumor antigen part of binding part of the molecule. So, you know, 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. You know, the GenX program masks the CD3 part, but leaves the PSMA unmasked. So, we think we may have a differentiated asset in terms of our dual masking of the PSMA molecule.

speaker
Eric Joseph

Thank you.

speaker
Operator

We'll go next to Rowana Reyes at Learing Partners.

speaker
spk11

Hey, this is Nick Gassick on Berwana. Thanks for taking our questions. Maybe first on the HDV phase three trial design, just thinking about the target patient population. Are you going to be focusing on both serotics and non-serotics? And I guess, are there any specific baseline characteristics you could enrich for here? A quick follow-up on HPV after that.

speaker
Mark Eisner

Sure. So thanks for the question. So in solstice, we've presented data including both cirrhotic and non-cirrhotic patients, CPTAs. And, you know, back in easel when we presented these data, you'll recall that the efficacy, anti-viral efficacy effect on ALT was very, very good in both cirrhotic and non-cirrhotic. If anything, the cirrhotic patients fared a little bit better. So, you know, clearly we want to base our phase three programs on the observations from the Phase II program, so we would include both cirrhotic and non-cirrhotic patients. In terms of baseline characteristics that kind of predict response and any enrichment, you know, 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.

speaker
spk11

Got it. That's helpful. And then at HBV, you know, looking ahead, what sort of is the read-through? Could a 48-week end-of-treatment data add to the possible functional cure data in the second quarter of 25? I'm just, you know, curious what sort of HBS antigen suppression rates, you know, you could see at the 48 weeks, you know, how that might mature heading into the off-treatment data in 2Q. Thanks.

speaker
Mark Eisner

Yeah, no, that's a really good question. So, just to summarize, we'll have the end-of-treatment data for the doublet of tivibirbard and lepsiran 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 cures, we're looking for a minimum of a 30% in the triplet functional cure, 20% in the doublet. In terms of end-of-treatment data, it's clear that there is going to be, at least based on prior programs of various mechanisms of action, there's a drop-off between end-of-treatment and 24 weeks post-treatment functional cure. But predicting that drop-off is not straightforward, and there are no clearly stop-loss markers to do that. What I'd say just in summary is, you know, we will update the treatment data soon. You know, the functional TRA will take a little bit longer, Q2 next year. And taken together, that will give a very complete picture of the regimens and what they can achieve for HPV patients.

speaker
Operator

We'll move next to Phil Nadal at TD Callen.

speaker
Phil Nadal

Good afternoon. Thanks for taking our questions. Two from us. So first, on the HDV Pivotal Program, you've suggested you'll be able to give us an update at the ASLD Endless Meeting. Will you have the final trial design at that time? And would you be able to disclose the design and timelines at the meeting? That's the first question. And the second question, just broadly on the TCEs, you've mentioned the potential for differentiation. versus either other TCs 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 one, or is simply safe and effective good enough at this point with additional differentiation to be established in future studies? Thanks.

speaker
Mark Eisner

So for the HDV question, we are planning to disclose more information about the final trial design, the phase three designs. So you'll be able to see that at the investor event around ASLD. So that, you know, 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, Marianne, would you like me to? Sure. Okay, so your question is around, you know, 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, you know, we are looking at this very early stage, of course, to look at. proof of concept, then the preliminary monotherapy data that we'll present in quarter one, I think, will start 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 refine on that yet, but we will look to provide more color on that at a future time point.

speaker
Phil Nadal

Perfect. Thanks for taking our questions.

speaker
Operator

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

speaker
Patrick Trucchio

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 alebserin and tobevibart would be expected to be differentiated from bullavertide, including at higher doses, and the level of confidence that patients would maintain ALT normalization and virologic response switch from bullavertide 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, 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 three pivotal program, can you talk about or tell us more if you're thinking about maybe stratifying based on S antigen at baselines? Would it make sense to explore this combination in patients with low S antigen at baseline?

speaker
Mark Eisner

Okay. So, your first question about HDV, the first part of that was about the combination of tabivobard and leuceran versus blovertide. We do, you know, with the two milligram approved dose, you know, we do expect to get much higher levels of target not detected based on our data we presented at Eazl, than Belabratide, which is 12% at 48 weeks. Your question about the higher dose, I mean, that dose isn't really approved anywhere. So, you know, but even so, I think, you know, the level of TND efficacy that we expect to have should be superior to Belabratide, just thinking about what we're likely to see. In terms of level of confidence for the Glovertide switch, yeah, I mean, in terms of the patient population who's been on Glovertide who is likely to enter such a trial or in a clinical practice, you know, we would expect to be much higher in terms of our logic response with our combination and continued treatment with Glovertide. In terms of your HPV question, fundamentally, I think your question's around, you know, is this going to be an all-comers versus a stratified population based on baseline surface antigen? I guess I just ask you to stay tuned for the data, and those questions should become much clearer at the March presentation at the liver meeting.

speaker
Patrick Trucchio

Great. Thank you so much.

speaker
Operator

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

speaker
Lepke

Thank you all for your interest in VEER 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.

speaker
Operator

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

Disclaimer

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