Q3 2024 Vir Biotechnology Inc Earnings Call
The End
Speaker Change: Hello, welcome to Veer Biotechnologies, 3rd 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 one on your telephone keypad. If you would like to withdraw your question, press star one again.
I went out to turn the call over to Rich Lepke, Senior Director and Vester Relations. You may begin Mr. Lepke.
Thank you and get afternoon. With me today, our Doctor Marianne Debacher, our Chief Executive Officer, Dr. Mark Eisner, our Chief Medical Officer, and Jason O'Burn, our Chief Financial Officer.
Rich Lepke: 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.
Speaker Change: These risks and uncertainties, and risks associated with our business, are described in the company's reports filed with the Securities and Exchange Commission, including Forms 10-K, 10-Q, and 8-K. I will now turn the call over to our CEO, Marianne DeBacker.
Marianne DeBacker: Thank you, Rich. Good afternoon, everyone, and thank you for joining us today.
Marianne DeBacker: 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.
Marianne DeBacker: We believe that the three dual-masked T-cell engagers, PUR5818 for HER2, PUR5500 for TSMA, and PUR5525 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 program with important upcoming data readouts.
I'll now highlight a recent progress in the ongoing Phase II solstice 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.
Marianne DeBacker: 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 Change: Thank you. Thank you.
Despite the severe and often life-threatening impact of HDV, patients currently have very limited treatment options.
Rich Lepke: 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 todevibart 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.
Thank you. Thank you. Thank you.
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.
Rich Lepke: This proactive approach ensures early identification of HPV infections even in regions like the United States where treatment options are currently limited.
Thank you. Thank you. Thank you.
Rich Lepke: By identifying patients early we can help ensure they receive timely treatment once a therapy is approved.
Rich Lepke: Thank you for joining us. Thank you.
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 the potential approval.
Rich Lepke: We are committed to partnering with key stakeholders across the healthcare landscape to advocate for and adopt these testing practices.
Rich Lepke: Looking ahead, we will present data from the SOLSTICE trial at the AASLB conference taking place November 15th to 19th in San Diego.
Rich Lepke: 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.
Rich Lepke: Next, I'd like to address our Functional Cure Program for Chronic Hepatitis B, which represents another substantial opportunity for our combination regimen of tobevibart and elepserone 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.
Rich Lepke: 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.
Rich Lepke: 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.
Given the addition of the T-cell engagers to our portfolio and the subsequent reprioritization of our pipeline, we have adjusted our plan.
Rich Lepke: We now intend to discuss our T-Cell Engager program at a dedicated investor event in the first quarter 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.
Rich Lepke: During this event, we will provide detailed updates on both the MARCH and FALSIS programs.
Rich Lepke: 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 are 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 to our next major inflection point.
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 Change: 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.
Rich Lepke: [inaudible]
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 two solstice trial in HDV at the Easel Congress in June.
In our rollover cohort of six non-serotic 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.
Rich Lepke: There are 32 participants in the de novo combination cohort, and 33 participants are in the monotherapy cohort.
Rich Lepke: 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.
Rich Lepke: 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 observe no treatment-related serious adverse events or ALT flares in either the monotherapy or de novo combination treatment regimens.
Rich Lepke: 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 tabivobart and lepserine. We're also actively exploring all possible acceleration pathways to bring this promising investigational therapy to patients as quickly as possible.
Rich Lepke: We have recently engaged with health authorities to align on our clinical development strategy for hepatitis delta.
Rich Lepke: Based on these discussions, we're 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 two program for chronic hepatitis B. At AISLG, 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 and oncology. I'll briefly touch on the status of each program.
Rich Lepke: Vera 5818, or dual masked HER2 CD3 T cell engager, is a highly differentiated asset with a potential to address significant unmet needs in HER2 expressing cancers.
As the only masked HER2 T cell engager currently in clinical development, VIRA5818 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 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.
FEAR 5500 is a dual masked PSMA-directed T-cell engager currently in phase one 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, FEAR 5500 is designed to offer lower off-tumor toxicity, allowing for higher doses and potentially improved efficacy compared to existing PSMA-targeted therapies.
Speaker Change: 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 I study for VIR 5500 is earlier in its progression with fewer participants compared to VIR 5818.
Rich Lepke: We anticipate sharing early monotherapy data in the first quarter of 2025.
Thank you for watching. See you next time.
Finally, VIRA5525, a dual masked EGFR-CD3 T-cell engager, has a cleared IND and we're preparing to initiate the Phase I clinical study.
Rich Lepke: Despite available treatments, the unmet need for patients with EGFR-expressing tumors remains high.
Rich Lepke: 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 VR 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.
Speaker Change: 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.
Thank you, Mark.
Jason: And thank you, Marianne, for the warm welcome.
Jason: It's an honor to join the talented beer team at this important time in the company's evolution.
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 ProXtend masking platform.
Speaker Change: In my role as CFO, I look forward to working alongside the executive team and all the dedicated beer 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.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: Thank you. Thank you. Thank you.
Restructuring long-lived asset impairments 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.
Speaker Change: Excluding the effects of the Sanofi transaction, the decrease in cash and investments during the third quarter was approximately $66 million.
Including the effects of the Santa Fe agreements, 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 VEER 5525 achieving first-in-human dosing by 2026.
Speaker Change: And that amount was reclassified to restricted cash in the quarter.
Speaker Change: 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 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 to $470 million compared to our second quarter guidance of $450 to $500 million.
Speaker Change: With that, I'll turn the call back over to Rich to begin the Q&A session.
Rich Lepke: Thank you, Jason. This concludes our prepared remarks, and we will now start the Q&A section.
Rich Lepke: 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.
Thank you. At this time, we will begin conducting our analyst Q&A session. For our analysts, please raise your hand by pressing star 1 to indicate you would like to join the queue if you have 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.
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 2 meeting with the FDA? Apologies if I missed a mention of it in the press release. I was just curious what the status of your regulatory discussions was.
And my second question is for your new QCEL 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 plembrolizumab combination? Thank you very much.
Okay, thank you very much for that question, Paul. I'll give it to Mark, our CMO, to answer those questions.
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 and the 5818,
Speaker Change: Thank you. Bye bye. Bye bye.
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 on the data.
and more. Thank you. Thank you. Thank you. Thank you.
Okay, thank you.
Next we'll move to Eric Joseph at J.P. Morgan.
Speaker Change: combination or monotherapy with tubefiber. Thanks.
Thank you for watching. Bye.
Speaker Change: Yeah, thanks for the question. So, as we've stated before, we are committed to going forward with a combination of tibetan bar and the lepserine because we achieve deep and sustained virologic responses with the combination.
Speaker Change: Rudgeman, and to remind everyone, we've got...
Speaker Change: 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.
Okay, great. Thanks very much.
We'll move next to Mike Ulf at Morgan Stanley.
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 are things just on track and you're going to sort of reveal the final details at your investor event? Thanks.
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 we'll be prepared to share more details at the investor event around ASLB.
Speaker Change: Great, thank you.
Next we'll go to Gina Wang at Barclays.
Thank you for taking my questions. I have two questions. The first one is regarding the HDV 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. I assume the key focus for us should be the target not detectable rate and also AOT normalization. Should we expect, you know, those at the benchmark and that should be the level, minimum level should achieve?
Speaker Change: with more patient data now, 32 patients, 33 patients at week 24.
Speaker Change: And my second question is regarding the T-cell engagers. I remember, Marianne, you said you saw some initial Phase I data when the Sanofi deal discussion was ongoing.
Speaker Change: So, now with the next year data update, have you seen the more patient data, and with the more patients, does the monotherapy activity hold as your initial expectation?
Thank you very much, Gina. Mark, do you want to comment on the HDV data? Absolutely. So, to source the study of HDV, we...
are going to have an oral presentation at the ASLT.
meeting, which I think will give a lot more information, particularly all the patients who made it through.
We are going to be presenting today, 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. So that is, you know, kind of
The most rigorous measurement that's out there, our combination regimen, what we 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. You know, the FDA guidance.
includes a composite endpoint of TND plus ALT normalization. So that will be data we will also present.
Speaker Change: at the ASLD meeting coming up.
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 sponsorships 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 5,500 and the 5,818 assets in the first quarter of 2025.
We'll move next to Alex Stranahan at Bank of America.
Hey guys, thanks for taking my questions. Two for me as well. I was hoping you could help frame the sort of data we should expect for 5818 and 5500 in the first quarter. 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? 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 Change: So, in terms of your first question, as we stated, we are
Speaker Change: planning to share preliminary monotherapy data from the ongoing Phase I studies, both for VR-5818 HER2 program and VR-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.
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...
Speaker Change: um
Speaker Change: tumor antigen part, binding part of the molecule. So, you know, the, the,
Speaker Change: The working hypothesis here is that that will allow us to achieve a better therapeutic index.
Speaker Change: 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...
Speaker Change: dual mask program in clinical development for PSMA. You know, the Janux 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.
Speaker Change: of the PSMA molecule.
Thank you.
Speaker Change: We'll go next to Rhoanna Rez at Lyrinc Partners.
Speaker Change: Hey, this is Nick Gassick on for Rwanda. Thanks for taking our questions. Maybe first on the HDV.
Phase 3 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.
Sure, so thanks for the question.
Speaker Change: So, in solstice, we've presented data.
Speaker Change: including both cirrhotic and non-cirrhotic patients, CPTAs.
Speaker Change: very, very good in both serotics and non-serotics. If anything, the serotic patients fared a little bit better. So clearly we want to base our phase three program on the observations from the phase two program. So we would include both serotic and non-serotic patients.
In terms of baseline characteristics that kind of predict response and any enrichment, I think we'll be able to provide more color now that our investor-focused hepatitis...
Speaker Change: presentation around ASLD, so stay tuned
Speaker Change: That's helpful. And then at HBV, you know, looking ahead, what sort of, it's a read-through, could a 48-week end of treatment data have to the possible functional cure data in the second quarter of 25? I'm just curious what sort of HBS antidepressant rates, you know, you could see at the 48 weeks.
How that might mature heading into the off-treatment data in 2Q. Thanks.
Yeah, no, that's a really good question. So just to summarize, we'll have the end-of-treatment data.
Speaker Change: for the doublet of To Cover Bard in a Love Saran.
and the triplet with Pegylated Interferon in addition at the
upcoming liver meeting in San Diego. The functional care data, as you said, comes in Q2 next year. So really, what we said before.
Thank you for joining us today. Thank you.
Speaker Change: post-treatment.
Speaker Change: Soraya, Functional Cure.
But you're predicting that drop-off is...
It's not straightforward. And there are no clearly established markers to do that. So, what I'd say just in summary is, you know, we will have the end of treatment data soon. You know, the functional cure rate 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.
We'll move next to Phil Nadal at TD Cowan.
Thank you. Bye.
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.
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 1 or is simply safe and effective?
Speaker Change: Good enough at this point with additional differentiation to be established in future studies. Thanks.
So, for the HDV question, we are planning, as I said, to
disclose more information about the final trial design, the phase three designs, that so you'll be able to see that at the investor event around ASLD so that
Speaker Change: 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...
Okay, so your question is around, you know, what we would need to see
Speaker Change: to move these programs forward for HER-CHU 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, then the preliminary monotherapy data that we'll present in quarter one, I think we'll start to give a picture of what the ...
the programs look like? In terms of, you know, the more specific answer to your question, I don't think we're quite ready to reply on that yet, but we will look to provide more color on that at a future time point.
Speaker Change: Thank you.
Perfect. Thanks for taking our questions.
Thank you for watching. I'll see you next time.
And we'll go next to Patrick Truccio at H.C. Wainwright.
Speaker Change: Thank you. Thank you.
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 elebsirin and tobevibar would be expected to be differentiated from bulivertide?
including at higher doses and the level of confidence that patients would maintain ALT normalization and virologic response switch from Bolivar tied 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 Alzheimer's?
Speaker Change: 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 baseline, would it make sense to explore combination, this combination in patients with low S antigen at baseline?
Okay, so your first question about HDV, the first part of that was about the combination of tabivabard and lepsoran versus blobertide. We do, you know, with the two milligram approved dose,
Speaker Change: We do expect to get much higher levels of target not detected based on our data we presented at EASL than bilabatide, which is 12% at 48 weeks. Your question about the higher dose, I mean, that dose isn't really a...
Rau suggest have should be should be
Speaker Change: Superior to Bellavertide just thinking about what we're likely to see. In terms of the level of confidence for Bellavertide switch, in terms of the patient population who has been on Bellavertide and who is likely to enter such a trial or in the clinical practice, you can
You know, we would expect to be much higher in terms of our virologic response with our combination and continued treatment with Pilevertide.
Speaker Change: In terms of your HPV 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'd just ask you to stay tuned for the data, and those questions should become much clearer at the end.
Speaker Change: March presentation at the liver meeting.
Great. Thank you so much.
Speaker Change: Thank you. Thank you.
And this concludes the Q&A session of the call. Thank you for participating. And I'll turn the call back over to Rich.
Rich 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.
Thank you. And that does conclude today's conference call. Thank you for your participation. You may now disconnect.
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