Vir Biotechnology Q1 2024 Earnings Call Transcript

Quartr
Provided by Quartr
May 2, 2024

There are 11 speakers on the call.

Operator

Hello. Welcome to Vir Biotechnologies First 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 speakers' presentation, there will be a question and answer session.

Operator

I will now turn the call over to Sasha Damuni Ellis, Executive Vice President, Chief Corporate Affairs Officer. You may begin, Ms. Demoney Ellis.

Speaker 1

Thank you and good afternoon. With me today are Doctor. Mary Anne DeBacker, Chief Executive Officer Doctor. Carrie Huang, Senior Vice President, Clinical Research and Interim Chief Medical Officer and Sun 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.

Speaker 1

These forward looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by such forward looking statements. These risks and uncertainties and risks associated with our business are described in the company's reports filed with the Securities and Exchange Commission, including Form 10 ks, 10 Q and 8 ks. I will now turn the call over to our CEO, Doctor. Mary Anne DeBacker. Thank you, Sasha.

Speaker 1

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 Carrie to share an update on our clinical development programs and pipeline and then to Sung to summarize our Q1 financial results. We will then open the line for questions. Before we proceed, I would like to highlight 2 recent updates. First, our Board of Directors has nominated 2 new independent directors, Doctor.

Speaker 1

Norbert Bishopburger and Doctor. Ramil Farid for election at our upcoming Annual Stockholders Meeting. Doctor. Bischofberger's track record 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. Doctor.

Speaker 1

Farid's pioneering work applying advanced computational methods to drug discovery at Schrodinger aligns perfectly with our focus on leveraging AI in drug discovery. 2 of our long serving directors, Doctor. Philip Sharp and Robert Perez, won't be standing for reelection. As founding board members, they made tremendous contributions, and I want to thank them for their dedicated service. 2nd, Sung Ji, our Chief Financial Officer, will be stepping down at the end of this week to pursue another career opportunity.

Speaker 1

Tom's leadership during his time at Spirit 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 Sun's contribution and wish him all the best in his new opportunity. 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.

Speaker 1

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 2 SOLFETIS 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 need. At least 12,000,000 people globally are estimated to be living with hepatitis delta with most cases remaining undiagnosed.

Speaker 1

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 and reflux 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.

Speaker 1

There is approximately a 4 times greater risk of liver cancer, a 2 times 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 Q1, 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 poster presentation at the European Association For the Study of Delivered or EVO Congress 2024. We plan to host an investor conference call to discuss this of this data on June 5.

Speaker 1

In the Q3, 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, there are an estimated 253,000,000 people chronically infected and living with hepatitis B. Among this total population, only 13% of HBV positive patients had been diagnosed and with only 3% receiving treatment at the end of 2022. The WHO further estimated that 1,100,000 people died from viral hepatitis B in 2022 compared to an estimated 820,000 deaths in 2019.

Speaker 1

At Veo, we are committed to addressing this global health crisis and this concerning increase in deaths. And we believe our 2 therapeutic candidates, the bevybark and elapsiran have the potential to make a meaningful impact. Tbevibart and elapsediran are being studied in our ongoing Phase 2 MARCH trial in combination with and without spactiferon alpha. Our aim is that our 2 therapeutic candidates can help us achieve our goal of a 30% or higher functional cure rate. While this is our stated goal, KOLs we 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 free regimen.

Speaker 1

We expect to report 48 week end of treatment data for the MARCH PART B trial at a major medical Congress in the Q4. Subsequently, we expect to share functional pure data in the Q2 of 2025. Now I will briefly discuss SPEAR-thirteen eighty eight, our HIV T cell vaccine candidate currently being evaluated in a Phase 1 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 PR-nineteen forty nine, a preclinical therapeutic vaccine for control of precancerous lesions and cancers caused by HPV.

Speaker 1

This trial is supported by the National Institute of Allergy and Infectious Diseases, part of the NIH and the Bilermanente 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, neutralization, potency and develop ability 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 NPV and COVID-nineteen.

Speaker 1

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 and 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 returns for our shareholders.

Speaker 1

To conclude, I would like to acknowledge and thank our employees, partners, clinical trial participants and shareholders who helped make this all possible. With that, I'll turn the call over to Carey.

Speaker 2

Thank you, Mary Anne. I'll begin by reminding you about the initial results from our Phase 2 SOLTIS trial on hepatitis delta, which were shared in a late breaker presentation at ASLD last year and discussed earlier this year. The Solsys trial is evaluating tubizumabart in combination with lepsiran and tubizumabart alone as a potential chronic treatment for people living with chronic hepatitis delta. Based on the initial data reported, we observed rapid declines in hgvRNA. 5 out of 6 participants had undetectable hgvRNA and 6 out of 6 were below the lower limit of qualification within 12 weeks of starting combination therapy.

Speaker 2

2 out of 6 participants also achieved ALT normalization. As Mary Anne mentioned, we completed enrollments for greater than 60 participants across 2 cohorts 1 month earlier than anticipated. Physician enthusiasm at AFLD was significant and this contributed to the rapid rate of enrollment. One group is receiving tibezavar plus elifiran combination therapy every 4 weeks and a second group is receiving tibezavar monotherapy every 2 weeks. Approximately 50% of participants have compensated cirrhosis or CPTA.

Speaker 2

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 Solsys 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.

Speaker 2

Additional follow-up for the initial 6 Solsys trial participants will also be shared at that time. Complete 24 week treatment data for solstice participants in these two cohorts is expected in the Q4 of 2024. We foresee that the Solsys data update at EASL will be highly informative and will shed light on several key areas. First, we anticipate getting greater clarity on the safety profile of TAVISSAART and MISTR together with olivesiran. 2nd, we expect to obtain additional insight into biologic response rates and ALT normalization.

Speaker 2

3rd, 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 ASLT. 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 belivratide as a comparator, and we will have greater clarity on potential trial designs following discussions with health authorities. Switching gears to our Phase 2 program for chronic hepatitis B, our preliminary data suggests that when lepsiran was administered with pegminiferon alpha 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 maintain hepatitis B surface antigen loss 24 weeks after the end of treatment.

Speaker 2

Current therapies such as NRTIs require lifelong therapy, but rarely achieve functional cure. The only other therapy approved for hepatitis B is pectantifenalpha, which has a low functional cure rate of 3% to 7% with poor tolerability. In the March trial, when adding cabozapart to a regimen of elifiran alone or elifiran plus peginiferon alpha, 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 Q4.

Speaker 2

This readout will be followed by post treatment data the Q2 of 2025, which will allow us to assess functional cure rates. Finally, we've recently published a full VER-two thousand four hundred and eighty 2 Peninsula trial data manuscript in medRxiv. We are applying key learnings from the PRINISLA trial to our next generation prophylactic flu antibody vir-two thousand nine hundred and eighty one. Now turning to our early stage pipeline, vir-nineteen forty nine is an investigational therapeutic T cell based on our hCMV vector platform and is designed to treat precancerous lesions caused by the human papillomavirus. Despite advances in vaccination and screening, HPV associated cancers and conditions such as high grade squamous intraepithelial lesions remain significant global health concerns.

Speaker 2

We look forward to sharing more later this year about this program and the timing of a potential IND submission. MiR-seven thousand two hundred and twenty nine is a next generation COVID-nineteen monoclonal antibody candidate with increased potency, breadth and resistance to viral escape, thanks to AI engineering and optimization. The development of SER-seven thousand two hundred and twenty nine through the end of Phase 1 is supported by BARDA. We look forward to continuing to share our progress over the coming quarters and during a virtual R and D day planned for late November. I will now turn the call over to Sum.

Speaker 3

Thank you, Carrie. Before I get to the financial results, I would like to take this moment to thank Mary Anne and the Board for the opportunity to make an impact at Veer. 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 Q1 of 2024.

Speaker 3

Total revenues in the first quarter of 2024 were $56,400,000 compared to $63,000,000 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 Q1 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 Q1 of 2024 was nominal compared to $1,900,000 for the same period in 2023.

Speaker 3

R and D expenses in the Q1 of 2024 were $100,100,000 compared to $157,600,000 in the same period in 2023. The decrease was primarily driven by lower clinical development and manufacturing costs related to VERU-two thousand four hundred and eighty two. SG and A expenses in the Q1 of 2024 were $36,300,000 compared to $46,800,000 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.

Speaker 3

We ended the Q1 of 2024 with cash, cash equivalents and investments of $1,510,000,000 compared to $1,630,000,000 at the end of 2023, representing a $118,000,000 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 Sashna.

Speaker 1

Thank you, Sung. We will now start the Q and A section. Please limit questions to 2 per person so that we are able to get to all of our covering analysts. Operator, please open up the line for questions.

Operator

Thank you. We will now begin the question and answer session. Your first question comes from the line of Gena Wang of Barclays. Your line is now open.

Speaker 1

Thank you for taking my questions. So my best wishes to your next journey. I have two questions regarding HDV. First question is regarding patient with baseline cirrhosis, any restriction or exclusion criteria for cirrhotic condition? 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?

Speaker 1

And is the Phase 2 efficacy data setting a bar for EASL update? Thank you very much for that question for those questions, Gina, which are very, very relevant. I will ask Karim to address them.

Speaker 2

Great. Thank you, Tina. So for your first question around baseline cirrhosis and restrictions in our trial. So as I mentioned, in the 2 new cohorts that we enrolled in Solstice, we included CPTA patients, so they have compensated spirosis. And so we have about 50% of those participants in those 2 new cohorts.

Speaker 2

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 any 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.

Speaker 1

And a bar for EASL update?

Speaker 2

Right. And then the last question is, whether the EASL full system data we're able to achieve a 6 out of 6 that achieved htRNA less than the middle of classification and 5 out of 6 that were undetectable or less than 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.

Speaker 1

Thank you very much.

Operator

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

Speaker 4

Hi. Thank you. Good afternoon and thank you for taking our questions. I want to follow-up on Gina's question regarding the compensated cirrhosis population in Solsys. 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.

Speaker 4

Just how you're thinking that baseline of half the 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 8,190? Thank you.

Speaker 2

Yes. 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 that in this compensated cirrhotic population, we should not see any significant differences in terms of safety or efficacy profile between those two populations. And we will have that data coming out relatively soon.

Speaker 2

In terms of RSV and given the success of those vaccines from Pfizer and GSK, I think these are ongoing ninety or other potential modifiable 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 we'll have with our partners to make those decisions.

Speaker 4

Great. Thank you.

Operator

Your next question comes from the line of Alex Treynhan of Bank of America. Your line is open.

Speaker 3

Hey guys, thanks for taking our questions and 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 you think we'll have answered at EASL versus what will be still outstanding for the 4Q data? And as a follow-up, what would inform a gono go on a Phase 3 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?

Speaker 3

Thanks.

Speaker 2

Yes. Thank you, Alex. 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 in each cohort at week 24. So, four things that we would be looking at this time point.

Speaker 2

Number 1, the safety profile for the vibar and the lepsiran combination. Number 2, what the virologic response rates and ALT normalization rates are. 3rd, 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 reported ASLD 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 six and confirm the directionality of what we're seeing in terms of efficacy and safety.

Speaker 2

And then obviously the 24 week data would be the complete data set across those two populations. So in terms of your second question, So I think it depends on the strength of the data. I So I think it depends on the strength of the data. I think if our data with the EASL data cut, if 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.

Speaker 2

Obviously, 24 weeks would be the complete data set. But if we have a very strong indication of efficacy, then I think we can go earlier.

Speaker 3

Great. Makes sense. Thanks a lot.

Operator

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

Speaker 5

Good afternoon. Thanks for taking our questions and let us add our best wishes to Song as he moves on. 2 from us. So first, as you just highlighted durability response is a key question that's going to be answered by both the Eastland Q4 updates. Is there any reason to worry that the effect could be lost for the combination regimen or monotherapy regimen over time?

Speaker 5

Any preclinical signs that resistance could develop in hepatitis delta? And then second, totally unrelated on business development with $1,500,000,000 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? Thanks.

Speaker 1

Thank you for those questions, Phil. And maybe we'll get to your second question first. Yes, we have shared 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 V in our pipeline. However, we also have the opportunity to look for external innovation and especially early clinical programs would be of interest there.

Speaker 1

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 Cary to answer your question related to durability of response.

Speaker 2

Thank you, Marion. 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 plaque hepatitis delta regimen? So I think based on what we've seen to date, we have some vitro data, but 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, of elixir and bifilar coming together.

Speaker 2

And I think as with other chronic, infectious diseases, both elepsiiran and fezabar work through 2 different mechanisms. And because we're working through 2 different mechanisms in terms of inhibiting, levels of surface antigen and then hgvRNA, the likelihood of developing resistance is much less compared to if you were going forward with a 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 2 different independent mechanisms against the virus. My guess is that, rebounds and resistance would be rare.

Speaker 5

That's very helpful. Thank you.

Operator

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

Speaker 6

Thanks. Good afternoon. 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 Solsys and what that might look like in terms of potential Phase 3 and pathway to approval?

Speaker 6

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 at baseline would you patient cohort with relative lower baseline surface antigen, if patient cohort with relative lower baseline surface antigen, especially as you consider potential advancements to the program of the program to Phase 3?

Speaker 2

Thank you, Patrick, for the questions. So in terms of hepatitis delta and 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, paths to approval, such as fast track, breakthrough, prime 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 our and get alignment 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?

Speaker 2

So yes, in our trials 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. But we will be able to look at subgroups within our data sets to see whether certain cutoffs would increase sero clearance rates and surface antigen. So those will be areas that we will be evaluating and looking at in our data set.

Operator

Your next question comes from the line of Roana Ruiz of Leerink Partners. Your line is open.

Speaker 7

Hi. This is Rosa Chen on for Roan Reeves at Leerink Partners. Thanks so much for taking our question. 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?

Speaker 2

Great. Thank you, Rosa, for the question. I think the data set from our ASLD set was small numbers. We only had 6 participants. We had 2 out of 6 that achieved ALT normalization.

Speaker 2

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 double digitization with this regimen going forward.

Speaker 7

Okay. Got it. Thanks. And then another one on HDB. So we haven't heard too much recently about, HEPLUDEx's resubmission in the U.

Speaker 7

S. So can you share how you guys are thinking about maybe the competitive positioning of your regimen versus HEPLUDEX? How are you thinking about maybe the patients who could be more responsive to your regimen versus HEPLUDEX if both are available?

Speaker 2

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 bliprotide as our comparator in our trials going forward.

Speaker 2

And based on at least what we see from the first six participants and our ability to really get to undetectable levels very quickly only after 12 weeks of combination therapy, I think that is a 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.

Speaker 2

There's less of a concern with resistance or non response in different patient populations.

Speaker 7

Super helpful. If I could squeeze one for HBV. So as it relates to the Thrive, Thrive 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?

Speaker 2

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 initiated for 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.

Speaker 2

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 chronic suppressed population.

Speaker 7

Got it. Thanks so much for the clarity. That's it for me.

Operator

Your next question comes from the line of Joseph Stryner of Needham. Your line is open.

Speaker 8

Hi, thank you for taking our question. Just wanted to get your updated thoughts on functional cure rates for HBV. You mentioned based on some recent KLL 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 acceptable. 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.

Speaker 2

Great. Thank you for the question, Joey. Yes, we had a advisory board with many of the leading key opinion leaders within hepatitis back in November. And we did pose this question to them. And for them, at least at best tier, between 20% 30% of like a functional cure rate would be highly meaningful for them.

Speaker 2

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 to use interferon sparing regimens. If there is 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 rate. So it's hard to really kind of pin down exactly, because there's sliding scales for different factors that you have to consider.

Operator

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

Speaker 9

Hi. Thanks for taking the questions. You've noted, Keri, that potential Phase 3 trial in HCV would contemplate using bolterotide 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.

Speaker 9

S. Sites given this fact that it's not approved here? And then as a follow-up, I'll leave the question there and I

Speaker 3

have a follow-up to that.

Speaker 2

Yes. Thank you, Eric, for the question. So yes, as I mentioned, we would include beliviratide as a comparator even though it's currently not approved yet in the United States. These this would obviously be with our discussions with our regulators moving forward in terms of what would be a lot of pay a lot of payers now 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 belivratide's comparator.

Speaker 2

Because we have a global footprint in this trial, we've done these trials before. And even though blilbertide is not or may not be approved yet by the time we start a trial, there are mechanisms in which we will be able to conduct the trial in the U. S. With beliviratide even if it's not approved. So that would be the plan.

Speaker 9

Okay, great. And maybe just as a follow-up coming back to the topic of ALT LFT normalization in HCV effective patients. Is the prospect of normalization in cirrhotic patients any more challenging than it is on 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 cirrhotic and cirrhotic patient population? Thank you.

Speaker 2

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, whether they're higher or lower in cirrhotics versus non cirrhotics and then also looking at the rate of normalization. So yes, so we our data set will be able to help answer us answer that question for us moving forward.

Speaker 2

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.

Speaker 9

Okay, great. Excellent. Thanks for taking the questions.

Operator

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

Speaker 10

Good afternoon and thanks for taking the question. Maybe just a quick one on the Phase 1 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 endpoints 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? Thanks.

Speaker 2

All right. Thank you for the question. So, we do have this ongoing trial with VER-thirteen eighty eight, which is our hCMV vector as a potential HIV vaccine. And this is in partnership with the HVTM, who is helping us conduct the trial. And we have completed enrollment of Part A of that trial.

Speaker 2

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 is these immunologic endpoints specifically looking at T cell markers and MACE restricted kind of T cell responses and kind of seeing what we would see if we see similar types of immune responses that were observed in the macaques that were protective from SIV 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 with our VIR-nineteen forty nine vector.

Speaker 6

Great. Thank you.

Operator

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

Speaker 1

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 SOLVIST 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 4th quarter that could serve as important catalysts for the company. Thank you.

Speaker 1

And operator, you may conclude the call.

Operator

Thank you. That concludes today's call. Thank you all for joining. You may now disconnect.

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Key Takeaways

  • Vir has announced key leadership changes, nominating Dr. Norbert Bischofberger and Dr. Ramil Farid to the Board and noting CFO Sun Lee will step down at week’s end, with the finance team positioned for continuity.
  • The Phase 2 SOLSTICE trial in chronic hepatitis delta completed enrollment one month ahead of schedule, with a late-breaker poster accepted at EASL and a June 5 investor call followed by Q3 regulatory engagement.
  • In chronic hepatitis B, the MARCH trial aims for a ≥30% functional cure rate with bevybartide and elbasiran regimens, with 48-week end-of-treatment data due in Q4 2024 and post-treatment readouts in Q2 2025.
  • The HIV vaccine candidate SPEAR-1388 is in Phase 1 with immunologic proof-of-concept data expected in H2 2024, and AI-driven DAISY antibody programs against influenza, RSV, hMPV and COVID-19 continue to advance.
  • For Q1 2024, revenues were $56.4 M (down from $63 M), R&D and SG&A expenses fell year-over-year, and cash, equivalents and investments of $1.51 B fund programs through key inflection points.
A.I. generated. May contain errors.
Earnings Conference Call
Vir Biotechnology Q1 2024
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