VIR - NASDAQ

Hello. Welcome to Vir Biotechnology's First Quarter 2024 Financial Results and Business Update Call. As a reminder, this conference call is being recorded. [Operator Instructions] I will now turn the call over to Sasha Damouni Ellis, Executive Vice President, Chief Corporate Affairs Officer. You may begin, Ms. Damouni Ellis.

Thank you, and good afternoon. With me today are Dr. Marianne De Backer, Chief Executive Officer; Dr. Carey Hwang, Senior Vice President, Clinical Research and Interim Chief Medical Officer; and Sung Lee, Executive Vice President and 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, Dr. Marianne De Backer.

Thank you, Sasha. Good afternoon to everyone on the webcast, and thank you all for joining us today. During this afternoon's call, I will provide initial remarks before returning to Carey to share an update on our clinical development programs and pipeline and then to Sung to our first quarter financial results. We will then open the line for questions. Before we proceed, I would like to highlight two recent updates. First, our Board of Directors has nominated two new independent directors. Dr. Norbert Bischofberger; and Dr. Ramy Farid for election at our upcoming Annual Stockholders' Meeting. Dr. Bischofberger's track records of overseeing more than 25 clinical development programs and drug approvals, including in hepatitis, during his tenure at Gilead, is directly relevant as our own programs progress through mid- and late-stage trials. Dr. Farid's pioneering work, applying advanced computational methods to drug discovery at Schrödinger, aligns perfectly with our focus on leveraging AI and drug discovery. Two of our long-serving directors, Dr. Phillip Sharp and Robert Perez, won't be standing for reelection. As founding Board members, they made tremendous strong contributions, and I want to thank them for their dedicated service. Second, Sung Lee, our Chief Financial Officer, will be stepping down at the end of this week to pursue another career opportunity. Sung's leadership during his time at Vir has been instrumental in building a talented financial team and implementing rigorous financial practices and controls. Our finance organization is well positioned for continued success, while we search for a successor. I would like to express my and the company's gratitude for Sung's contribution and wish him all the best in his new opportunities. Looking ahead, we expect 2024 to be a transformational year for Vir. Our teams are mission-driven, and we aim to play an important role in serving patients in areas of high unmet medical need while creating significant value in large potential markets. We continue to make progress on the goals we laid out in January. A key priority is to deliver on our mid-stage clinical pipeline, and I'll begin by discussing our ongoing Phase II SOLSTICE trial in people living with chronic hepatitis delta. Our goal is to provide a lifelong therapy that is impactful and convenient for patients in this area of substantial unmet medical needs. At least 12 million people globally are estimated to be living with hepatitis delta, with most cases remaining undiagnosed. While there are significant challenges which are under diagnosis and lack of robust epidemiological data for chronic hepatitis delta, we do see positive momentum towards greater awareness and patient screening. For example, in March, the World Health Organization published updated guidelines for the prevention, diagnosis, care and treatment of people with chronic hepatitis B. And this update included recommending hepatitis delta reflex testing for everyone who tests positive for hepatitis B. This is a major step forward for both patients and researchers within the hepatitis delta community. Chronic hepatitis delta infection increases the risk of poor outcomes for patients compared to hepatitis B alone. There is approximately 4x greater risk of liver cancer, a 2x greater risk of death and more than half of these patients will die from liver disease within 10 years. The need for a safe, efficacious and continued treatment for these patients is critical. In the first quarter, we completed enrollment of the current cohorts in the SOLSTICE trial, 1 month ahead of schedule. And our late-breaker SOLSTICE data abstract was accepted for a poster presentation at the European Association for the Study of Liver or EASL Congress 2024. We plan to host an investor conference call to discuss the SOLSTICE data on June 5. In the third quarter, we intend to engage with regulatory authorities to discuss the next steps for the development program. Shifting our focus to another area of high unmet medical need, chronic hepatitis B, where we are making progress in our efforts to achieve a functional cure. According to the World Health Organization, Global Hepatitis Report 2024, around estimated 253 million people currently infected and living with hepatitis B. Among this total population, only 13% of HPV-positive patients had been diagnosed and with only 3% receiving treatment at the end of 2022. The WHO further estimated that 1.1 million people died from viral hepatitis B in 2022, compared to an estimated 820,000 deaths in 2019. At Vir, we are committed to addressing this global health crisis and its concerning increase in death, and we believe our two therapeutic candidates tobevibart and elebsiran have the potential to make a meaningful impact. Tobevibart and elebsiran are being studied in our ongoing Phase II MARCH trial, in combination with and without peg-interferon alfa. Our aim is that our 2 therapeutic candidates can help us achieve our goal of a 30% or higher functional cure rates. While this is our stated goal, KOL hosted at an advisory board last year at AASLD, expressed the desire for 25% or better for a regimen that includes interferon and less than that, for an interferon 3 regimens. We expect to report 48-week end of treatment data for the MARCH part B trial at a major medical congress in the fourth quarter. Subsequently, we expect to share functional cure data in the second quarter of 2025. Now I will briefly discuss VIR-1388, our HIV T-cell vaccine candidate closely being evaluated in a Phase I trial. We are looking forward to sharing initial immunologic proof of concept data in the second half of this year. If the data supports the validity of the platform, it could be a springboard to other indications including VIR-1949, our preclinical therapeutic vaccine for control of precancerous lesions and cancers caused by HPV. This trial is supported by the National Institute of Allergy and Infectious Diseases, part of the NIH and the Bill & Melinda Gates Foundation. In research, we continue to advance multiple investigational antibody therapeutics, optimized for increased likelihood of development success. Thanks to our proprietary platform powered by AI and machine learning called dAIsY. dAIsY enables fast and cost-efficient optimization of multiple properties such as binding affinity, the transition, potency and availability, and we have applied it to over 10 investigational monoclonal antibodies across multiple projects. Our most advanced preclinical programs are prophylactic antibodies for influenza A and B, RSV and/or MPV and COVID-19. In addition, we are developing a cocktail of broadly neutralizing antibodies for an HIV cure. We look forward to sharing more about these programs during the course of the year and at our R&D Day in late November. Now turning to our cash and investments. Our balance sheet enables us to fund our clinical programs through major inflection points while providing the flexibility to invest in external innovation. We are closely managing our expenses and prudently investing in programs with the greatest opportunity to drive return for our shareholders. To conclude, I would like to acknowledge and thank our employees, partners, clinical trial participants and shareholders, who help make this all possible. With that, I'll turn the call over to Carey.

Thank you, Marianne. I'll begin by reminding you about the initial results from our Phase II SOLSTICE trial on hepatitis delta, which were shared in a late-breaker presentation at AASLD last year and discussed earlier this year. The SOLSTICE trial is evaluating tobevibart in combination with blood strand and tobevibart alone as a potential chronic treatment for people living with chronic hepatitis delta. Based on the initial data reported, we have served rapid declines in HCV RNA. 5 out of 6 participants had undetectable HCV RNA and 6 out of 6 were below the lower limit of qualification within 12 weeks of starting combination therapy. 2 out of 6 participants also achieved ALT normalization. As Marianne mentioned, we completed enrollment for greater than 60 participants across two cohorts, 1 month earlier than anticipated. Physician enthusiasm at AASLD was significant and this contributed to the rapid rate of enrollment. One group is receiving tobevibart plus elebsiran combination therapy every 4 weeks and a second group is receiving tobevibart monotherapy every 2 weeks. Approximately 50% of participants have compensated cirrhosis or CPTA. Overall, around 40% of patients with hepatitis delta develop cirrhosis with an average of approximately 5 years to progression. Therefore, it's important to include patients with cirrhosis in trials to understand how our treatment impacts those with more progressive disease. This type of information can help optimize treatment strategies in the future and inform our future trial designs. We plan to share updated data on additional SOLSTICE participants in a late-breaker data abstract that was accepted for poster presentation at the EASL Congress. Specifically, we will share data on approximately 15 participants per regimen at 12 weeks and approximately 10 participants per regimen at 24 weeks. Additional follow-up for the initial 6 SOLSTICE trial participants will also be shared at that time. Complete 24-week treatment data for SOLSTICE participants in these 2 cohorts is expected in the fourth quarter of 2024. We foresee that the SOLSTICE data update at EASL will be highly informative and will shed light on several key areas. First, we anticipate gaining greater clarity on the safety profile of tobevibart administered together with elebsiran. Second, we expect to obtain additional insight into biologic response rates and ALT normalization. Third, we aim to evaluate whether there are initial efficacy or safety differences between cirrhotic and non-cirrhotic participants. And finally, we are looking forward to seeing longer follow-up data on durability of viral suppression and safety from the initial 6 participants previously reported at AASLD. If the data are supportive, we will dialogue with health authorities about the development program later this year. We expect Vir's next trial will be designed with bulevirtide as a comparator, and we will have greater clarity on potential trial designs following discussions with health authorities. Switching gears to our Phase II program for chronic hepatitis B. Our preliminary data suggests that when elebsiran was administered with peg-interferon alfa for up to 48 weeks, about 26% of participants achieved hepatitis B surface antigen loss, at the end of treatment and 16% achieved functional cure, meaning they maintained hepatitis B surface antigen loss, 24 weeks after the end of treatment. Current therapies such as NRTIs require lifelong therapy, but rarely achieve functional cure. The only other therapy approved for hepatitis B is peg-interferon alfa, which has a low functional cure rate of 3% to 7% with poor tolerability. In the MARCH trial when adding tobevibart to a regimen of elebsiran alone or elebsiran plus peg-interferon alfa, we observed an almost threefold increase in end of treatment response rates at 24 weeks of treatment. These data were the first indication of a potentially important role of an HBV directed antibody in hepatitis B functional cure. We look forward to sharing end of treatment data from the MARCH Part B trial, which is evaluating 48 weeks of the doublet and triplet regimens in the fourth quarter. This readout will be followed by post-treatment data in the second quarter of 2025, which will allow us to assess functional cure rates. Finally, we recently published a full VIR-2482 PENINSULA trial data manuscript and met archives. We are applying key learnings from the PENINSULA trial to our next-generation prophylaxis flu antibody, VIR-2981. Now turning to our early-stage pipeline. VIR-1949 is an investigational therapeutic T-cell vaccine based on our HCMV-vector platform and is designed to treat precancerous lesions caused by the human papillomavirus. Despite advances in vaccination of screening, HPV-associated cancers and conditions such as high grade famous intraepithelial lesions remain significant global health concerns. We look forward to sharing more later this year about this program and the timing of a potential IND submission. VIR-7229 is a next-generation COVID-19 monoclonal antibody candidate with increased potency, breadth and resistance to viral scape, thanks to AI engineering and optimization. The development of VIR-7229 through the end of Phase I is supported by BARDA. We look forward to continuing to share our progress over the coming quarters and during a virtual R&D Day planned for late November. I will now turn the call over to Sung.

Thank you, Carey. Before I get to the financial results, I would like to take this moment to thank Marianne and the Board for the opportunity to make an impact at Vir. I have truly enjoyed my time as CFO, and I'm proud of what we have accomplished. I'm confident that the company and the finance organization are well positioned for continued success. With that, I'll now share the financial results for the first quarter of 2024. Total revenues in the first quarter of 2024 were $56.4 million compared to $63 million for the same period in 2023. As anticipated, we saw year-over-year declines in collaboration and grant revenues. These declines were partially offset by higher contract revenue in the first quarter of 2024 driven primarily by the recognition of deferred revenue related to our 2021 agreement with GSK. Turning to operating expenses. Cost of revenue for the first quarter of 2024 was nominal compared to $1.9 million for the same period in 2023. R&D expenses in the first quarter of 2024 were $100.1 million compared to $157.6 million in the same period in 2023. The decrease was primarily driven by lower clinical development and manufacturing costs related to VIR-2482. SG&A expenses in the first quarter of 2024 were $36.3 million compared to $46.8 million in the same period in 2023. The decrease was primarily driven by disciplined expense management, which resulted in a significant reduction in external expenses. Moving to the balance sheet. We ended the first quarter of 2024 with cash, cash equivalents and investments of $1.51 billion compared to $1.63 billion at the end of 2023, representing a $118 million decline quarter-over-quarter. Turning to our financial guidance for 2024. The year is progressing as expected, and we are reiterating all aspects of our guidance, which can be found on Slide 28 of our corporate presentation. We will continue to be disciplined in managing our expenses and focus our investments on programs with the greatest opportunity to drive return for shareholders. I will now turn the call back to Sasha.

Thank you, Sung. We will now start the Q&A section. [Operator Instructions] Operator, please open up the line for questions.

[Operator Instructions] Your first question comes from the line of Gena Wang of Barclays.

Sung, my best wishes to next journey. I have two questions regarding HDV. First question is regarding patients with baseline cirrhosis, any restriction or exclusion criteria for cirrhotic conditions? And my second question is, which measurement will be more meaningful in your view regarding the lower limit of quantification and the limit of detection. And is the Phase II efficacy data setting a bar for EASL update?

Thank you very much for that question for those questions, Gena, which are very, very relevant. I will ask Carey to address them.

Great. Thank you, Gena. So for your first question around baseline cirrhosis and restrictions in our trials. So as I mentioned, in the two new cohorts that we enrolled in SOLSTICE, we included CPTA patients, so they have compensated cirrhosis. And so we have about 50% of those participants in those two new cohorts. And so this will help us inform -- going forward the safety and efficacy of our regimen in those populations. So we look forward to looking at the -- if there are any differences between cirrhotics and non-cirrhotics in that population. In regards to your second question around which measurement lower than the quantification or limited detection. Different assays have different cutoffs for those parameters. And so these will be discussed with regulatory authorities in terms of which of these parameters would be acceptable from an endpoint perspective. So I can't answer that right now, but that will be something that we will have to -- we will clarify with regulators.

And the bar for EASL update?

All right. And then the last question is whether the EASL SOLSTICE data would be setting a new efficacy bar. As you're familiar with -- from our AASLD presentation from our first 6 participants, we're able to achieve 6 out of 6 that achieved HDV RNA [indiscernible] quantification and 5 out of 6 that were undetectable or lesser in the detection. I think if we are able to demonstrate these results in a larger population, then I think that it could set a new efficacy bar. Because as with any chronic viral disease, the goal is always to suppress viral replication to undetectable levels such as in HIV. And so if we're able to do that, I think that would set the benchmark.

Your next question comes from the line of Paul Choi of Goldman Sachs.

I wanted to follow up on Gena's question regarding the compensated cirrhosis population in SOLSTICE. And could you maybe just clarify for us, particularly among the patients for which you'll have the 12-week -- additional 12-week update versus those who have had the 24-week treatment update. Just how you're thinking that baseline of [indiscernible] patients having cirrhosis might affect those particular updates? And then my second question is in terms of the earlier-stage pipeline, just given the success that we've seen with the various RSV drugs from both GSK and Pfizer in terms of recent market success, can you maybe elaborate on sort of what the criteria that you and your partner, GSK, are looking at for sort of a go or no go decision in terms of advancing 8190.

So thank you, Paul, for the question. So in terms of how we think cirrhosis might affect safety or efficacy. We have done initial hepatic impairment study in CPTA participants and have not seen any safety signals or any clinically significant changes in PK that would cause us any concern. And so our expectation is compensated cirrhotic population, we should not see any significant differences in terms of the safety or efficacy profile between those two populations. And we will have that data coming out relatively soon. In terms of RSV and given the success of those vaccines from Pfizer and GSK, I think these are ongoing discussions that we have with our partner in terms of looking at the profile of VIR-8190 or other potential monoclonal antibodies. And so we certainly only want to present or kind of progress antibodies that fill an unmet need in the space. And so those are ongoing discussions and we'll help our partners to make those decisions.

Your next question comes from the line of Alec Stranahan of Bank of America.

Just a couple from us as well. I guess, first, how should we be thinking about the EASL update in the context of the more advanced update expected in 4Q. I guess, in terms of, which questions do you think will have answered in EASL versus what will be still outstanding for the 4Q data? And as a follow-up, what would inform a go, no go on a Phase III in this setting. It sounds like you'll likely wait until the additional 24-week data becomes available, even though you may have already aligned with regulators on next steps in 3Q?

Thank you, Alec. So in terms of how we would think about the data that we will have at EASL, so we will have about 15 participants in each of the cohorts at week 12 and about 10 of participants each cohort at week 24. So 4 things that we would be looking at, at this time point. Number one, the safety profile for tobevibart and elebsiran combination. Number two, what the virologic response rates in ALT moralization rates are. Third, the potential efficacy and safety differences between cirrhotic and non-cirrhotic participants. And then finally, the longer-term follow-up data on the initial 6 participants that we report at AASLD to see if we have durability of response over time. So I think the EASL data will further -- hopefully further expand the data set that we have from the initial 6 and confirm the directionality of what we're seeing in terms of efficacy and safety. And then obviously, the 24-week data would be the complete data set across those 2 populations. So in terms of your second question around what would inform a go, no go on a Phase III for delta. So I think it depends on the strength of the data. I think if our data -- with the EASL data cuts, we believe that is strong enough, I think that would be a possibility of taking that forward for conversations. But it all depends on the strength of that data going forward. Obviously, the 24-weeks will be a complete data set, but if we have a very strong indication of efficacy, then I think we can go earlier.

Your next question comes from the line of Phil Nadeau of TD Cowen.

Let us add our best wishes to Sung as he moves on. Two from us. So first, as you just highlighted, durability response is a key question that's going to be answered by the EASL and Q4 updates. Is there any reason to worry that the effect could be lost for the combination regimen or monotherapy regimen over time? Any preclinical signs that resistance could develop in hepatitis delta? And then second, totally unrelated on business development with $1.5 billion in cash, can you talk a bit about the environment you're seeing in business development and what your most recent thoughts are on priorities for investing externally?

Thank you for those questions, Phil. And maybe we'll get to your second question first. Yes, we have shares -- we are in a great position that we can really use our strong balance sheet to fund our priorities. And of course, that is hepatitis delta and hepatitis B in our pipeline. However, we also have the opportunity to look for external innovation and especially early clinical programs would be of interest there. And we continue to be very thoughtful and strategic in looking at those opportunities and discerning whether those would be a great fit for us and creating value for the company and our shareholders. I will ask Carey to answer your question related to durability of response.

Thank you, Marianne. And thank you, Phil, for the question. So your question around durability of response would we expect to see any resistance or loss of durability with our planned hepatitis delta regimen? So I think based on what we've seen to date, we have some vitro data, and we haven't seen any resistance to date. We have a lot of hepatitis B data, like looking at surface antigen, and we haven't seen rebalance in hepatitis surface antigen over time with a combination of elebsiran and tobevibart given together. And I think as with other chronic infectious diseases, both elebsiran and tobevibart work through two different mechanisms. And because we're working through two different mechanisms in terms of inhibiting levels of surface antigen and then HDV RNA, the likelihood of developing resistance is much less compared to if you were going forward with monotherapy. So time will tell. But based on what we know so far from hepatitis B, some of our in vitro work, and what the expectations are with having two different independent mechanisms against the virus. My guess is that rebalance and resistance would be rare.

Your next question comes from the line of Patrick Trucchio of H.C. Wainwright.

Just a couple of questions from me. The first is just on the delta program. Given the lack of treatments available, I'm wondering if you can talk about, if there is a possibility for an accelerated pathway to approval depending on the outcome from SOLSTICE and what that might look like in terms of potential Phase III and pathway to approval? And then just on the HBV program, I'm wondering if you can talk about whether you expect to have data segmented based on surface antigen levels at baseline? And if so, at what levels of baseline would you expect to report this data? And related to this, how important is it to demonstrate loss of surface antigen and all comers relative to patient cohort with a relative lower baseline service antigen, especially as you consider potential advancement to the program -- of the program to Phase III.

Thank you, Patrick, for the questions. So in terms of hepatitis delta possibilities for accelerated pathways. As you know, there's no therapy that's currently approved in the United States at this time. And so based on the strength of our data, we will look for any of those mechanisms that we can accelerate path to approval, such as fast track, breakthrough time and these other methods that are available to us from regulatory agencies. So we will be looking at those pathways to move forward and to facilitate discussions with regulators as we develop and get aligned on our registrational pathway going forward. And then in terms of your second question around hepatitis B, will we be segment -- looking at the segment data by surface antigen levels. So yes, in our files actually to date in our hepatitis B trials, we have taken all comers, not just enrolling participants with surface antigen less than 3,000 or 1,000, we're taking a broader view. We will be able to look at subgroups within our data sets to see whether certain cutoffs would increase [indiscernible] rates and surface antigens. So those will be areas that we will be evaluating and working out in our data set.

Your next question comes from the line of Roanna Ruiz of Leerink Partners.

This is Rosa Chen on for Roanna Ruiz at Leerink Partners. First, a couple on HDV. So for SOLSTICE, what level of ALT normalization are you expecting to see in the upcoming data at EASL, given that we didn't really see meaningful normalization in the early data that you presented last year.

Thank you, Rosa, for the question. So I think the data set from our AASLD set was small numbers. We only had 6 participants. We had 2 out of 6 that achieved ALT normalization. But of the participants who did not achieve ALT normalization, a majority of those were just around that upper limit of normal. And so I think with potential longer treatment, we may see more normalization. With this data set coming out at EASL, we will have a more robust data set and so that will help inform us further in terms of what we would expect to see in terms of ALT normalization with this regimen going forward.

Okay. Got it. And then another one on HDV. So we haven't heard too much recently about Hepcludex resubmission in the U.S. So can you share how you guys are thinking about maybe the competitive positioning of your regimen versus Hepcludex? How are you thinking about maybe the patients who could be more responsive to your regimen versus Hepcludex, if both are available?

Yes. Thanks for that question. So I think, as you said, it's not approved in the U.S., but as I mentioned in my prepared remarks, that we would plan to have bulevirtide as our comparator in our trials going forward. And based on at least what we've seen from first 6 participants and our ability to really get to a detectable level very quickly only after 12 weeks of combination therapy, I think that is the potential differentiator for us going forward. As I mentioned, the goal is always to achieve virologic suppression for any therapy in chronic viral diseases. And if we're able to demonstrate that in a larger data set, then that gives us further confidence in moving forward. In addition, I think the regimen that we are developing is also being administered subcu once monthly, which is also a potential differentiator there as well. And I think also because as I mentioned previously in a previous answer, we are attacking the delta virus through 2 different mechanisms, there's less of a concern with resistance or nonresponse in different patient populations.

Super helpful. If I could squeeze one for HBV. So as it relates to the STRIVE trial. Can you give us a sense of the real-world prevalence of these immune active chronic HBV patients versus the inactive carriers and how we should think about the data in these populations?

Yes. The reason we are studying these populations is because these populations have kind of the strongest immune response to be able to be in that stage of hepatitis B. However, in these populations, they're not normally as guidelines in the [indiscernible] treatment. And so these patient populations are a little bit more difficult to find. So in terms of kind of overall prevalence of these subpopulations overall, I mean, it's a little bit unclear. But this is something that we are looking at specifically in these populations trying to recruit and find to be able to determine whether we can achieve functional cure at higher rates in these populations compared to your -- the chronic suppressed population.

Your next question comes from the line of Joseph Stringer of Needham.

Just wanted to get your updated thoughts on functional cure rates for HBV. You mentioned, based on some recent KOL feedback that you believe that 25-plus percent for an interferon containing regimen and perhaps less than that for a non-interferon containing regimen would be considered successful. Just curious if that's sort of a minimum bar for success amongst treating physicians? Or is there a functional cure rate where, say, a certain percentage of docs would use the treatment? And would that be higher than sort of the numbers that you're providing? Any additional color on that would be helpful.

Right. Thank you for the question, Joey. Yes, we had an advisory board with many of the leading key opinion leaders within hepatitis back in November. And we did post this question to them. And for them, at least the best tier between 20% and 30% of like a functional cure rate would be highly meaningful for them. I think the other piece component to think about in these regimens is whether a regimen contains interferon or not. Interferon sparing regimens are certainly much more tolerable, easier to -- for patients to take, easier for physicians to monitor. So they would likely tolerate a lower functional cure rate using Interferon sparing [indiscernible] interferon containing regimen then the bar is a little bit higher in terms of what they would like to see in terms of functional cure rates. So it's hard to really kind of pin down exactly because there's sliding scales for different factors that you have to consider.

Your next question comes from the line of Eric Joseph of JPMorgan.

You've noted Carey that potential Phase III trial in HDV with contemplate using bulevirtide as a comparator. Can you maybe just talk about sort of the investigator or regulatory feedback that informs that? And if you do move forward with that plan, operationally, would you intend to include U.S. sites given the fact that it's not approved here? And then as a follow-up, I'll leave the question there, and I have a follow-up to that.

Yes. Thank you, Eric, for the questions. So yes, as I mentioned, we would include bulevirtide as a comparator, even though it's currently not approved yet in the United States. These -- this will obviously be part of our discussions with the regulators, we export in terms of what would be included in the study design of what that would look like. But I think also from -- because we are looking globally for this therapy, a lot of payers now will want you to be compared against the standard of care, especially in Europe. So that's another reason that we would want to be including bulevirtide as comparator. Because we have a global footprint in this trial, we've done these trials before. And even though bulevirtide is not, or may not be approved yet by the time we start a trial, there are mechanisms in which we won't be able to conduct the trial in the U.S. with bulevirtide even if it's not approved. So that will be the plan.

Okay. Great. And maybe just as a follow-up, coming back to the topic of ALT LFT normalization in HDV effective patients. Is the prospect of normalization in cirrhotic patients, any more challenging than it is in non-cirrhotics? And I guess is there sort of a difference in sort of baseline LST presence? I guess, that we should be thinking about here between the non-cirrhotics and cirrhotic patient population?

Yes, thank you for the question. Yes. No, I think it's a very good question, and that's something that we'll be able to show with our data in terms of looking at, if there are baseline differences in ALT levels of the -- they are higher or lower in cirrhotics versus non-cirrhotics and then also looking at the rate of normalization. So our data set will be able to help answer us -- answer that question for us moving forward. But I think as I mentioned earlier, in terms of the antiviral efficacy and then potential impact on ALT, we don't really -- we don't expect to see significant differences between cirrhotics and non-cirrhotics, at least in the CPTA population, but obviously, the data set will inform us on that.

Your next question comes from the line of Mike Ulz of Morgan Stanley.

Maybe just a quick one on the Phase I HIV program. I think you'll have data in the second half of this year. Maybe you can just talk about some of the key points in that -- key end points in that early study and what we should be looking for? And maybe what would be positive in your view to sort of keep that program moving forward?

Thank you for the question. So we do have this ongoing trial with VIR-1388, which is our HCMV vector as a potential HIV vaccine and this is in partnership with [indiscernible], who is helping us conduct the trial. And we have completed enrollment of part A of that trial. And as we've guided to, we expect to see initial immunologic data from that trial, second half of this year. And so what we are really looking for these immunologic endpoints, specifically looking at T-cell markers and we see -- probably restricted kind of T-cell responses and kind of seeing what we would see if we see similar types of the mean responses that were observed in the [indiscernible] that were protective from SIP in those animals. And so if we're able to see this proof of immunology, then this opens up this platform to other areas, potential areas of exploration, such as in human papillomavirus virus with our VIR-1949 vector.

There are no further questions at this time. I will now turn the conference back over to Marianne for the closing remarks.

Thank you, operator. To conclude, our company is beginning to realize benefits from the cost savings initiatives we implemented in 2023 and we look forward to sharing important data from our SOLSTICE trial at EASL. This is a milestone that brings us closer to addressing the significant unmet medical need for millions of people that are living with hepatitis delta. Looking ahead, we also anticipate additional data readouts in the fourth quarter that could serve as important catalysts for the company. Thank you. And operator, you may conclude the call.