Q1 2024 Vir Biotechnology Inc Earnings Call

Participants

Sasha Damouni Ellis; Executive Vice President and Chief Corporate Affairs Officer; Vir Biotechnology Inc

Carey Hwang; SVP of Clinical Research & Interim Chief Medical Officer; Vir Biotechnology Inc

Sung Lee; Chief Financial Officer, Executive Vice President; Vir Biotechnology Inc

Phil Nadeau; Analyst; TD Cowen

Gena Wang; Analyst; Barclays

Paul Choi; Analyst; Goldman Sachs

Presentation

Operator

Hello, and welcome to veer biotechnologies 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.

Sasha Damouni Ellis

You may begin. Sasha Damouni Ellis, thank you and good afternoon. With me today are Dr. Marianne Bakker, Chief Executive Officer, Dr. Carey Blount, 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 eight K.
I will now turn the call over to our CEO, Dr. Marianne de Bakker.
Thank you, Sasha, and 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 some to summarize 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 official Burger and Dr. Randy sorry, for election at our upcoming Annual Stockholders Meeting subdivisions brokers 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. Sally pioneering work, applying advanced computational methods to drug discovery and choosing our aligns perfectly with our focus on leveraging AI in drug discovery.
Two of our long-serving directors, Dr. Phillip sharp and Robert thread want to be standing for reelection as founding board members. They made tremendous contributions, and I want to thank them with a dedicated service.
Second Sunday, our Chief Financial Officer will be stepping down at the end of this week to pursue another career opportunity. Sales leadership during his time at fear 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 contributions and wish him all the best in his new opportunities.
Looking ahead, we expect 2024 to be a transformational year for the year. 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 two Solstice trial in people living with chronic hepatitis delta. Our goal this abrupt provide a lifelong therapy that is impactful and convenient for patients in this area of substantial unmet medical need at least 12 million people globally are estimated to be living with hepatitis delta with most cases remaining undiagnosed. While there are significant challenges with the underdiagnosis 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 reflex testing, but everyone with test positive for hepatitis B, this is a major step forward for both patients and researchers within hepatitis delta community, chronic hepatitis delta infection increases the risk of poor outcomes for patients compared to hepatitis B alone, there is approximately a four times greater risk of liver cancer, the two 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 continuous treatment for these patients is critical. In the first quarter, we completed enrollment of the current cohorts in the Solstice trial, one month ahead of schedule, and our late-breaker Solstice data abstract was accepted for poster presentation at the European Association for the Study of the Liver for April Congress 2024, we plan to host an investor conference call to discuss resources data on June fifth. 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 reports 2024 for an estimated 253 million people chronically infected and living with hepatitis B. Among this total population, only 13% of HPV-positive patients had been diagnosed and with only 3% specific treatments 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 in 2019. And here, we are committed to addressing this global health crisis, and it's concerning increase in debts, and we believe our two therapeutic candidates to bury Bard and Napster on has the potential to make a meaningful impact to bear. The burden and Epsilon are being studied in our ongoing Phase two March trial in combination with and without that interferon alpha, our aim is that our two 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 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. We expect to report 48 week end of treatment data for the March 14th 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 peers 1388 RHRT. and T. cell vaccine candidate currently being evaluated in a Phase one 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, which could be a springboard to other indications, including period 1949, our preclinical therapeutic vaccine for control, precancerous lesions and cancers caused by each patient in 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 safety enables fast and cost-efficient optimization of multiple properties such as binding affinity neutralization, potency and developed ability, and we have applied it to over 10 investigational monoclonal antibodies across multiple projects for our most advanced preclinical programs are prophylactic antibodies for influenza A. and B ROC and or NPV and COVID-19. In addition, we are developing a cocktail of drug neutralizing antibodies for an HIV cure. We look forward to sharing more about these programs during the course of the year, and that's 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 helped make this all possible. With that, I'll turn the call over to Carey.

Thank you, Maria.

Carey Hwang

I'll begin by reminding you about the initial results from our Phase two psoriasis trial on hepatitis Delta, which was shared at a late-breaker presentation at ASLD. last year and discussed earlier this year. The Solstice trial is evaluating two because of our the commendation of blistering and to build up our alone as a potential chronic treatment for people living with chronic hepatitis delta. Based on initial data reported, we have certain rapid declines in these two. The RNA five out of six participants had undetectable HCV RNA and six other six were below the limit, a lower limit of qualification within 12 weeks of starting combination therapy. Two out of six participants also achieved ALT normalization as Marion mentioned, we completed enrollment for greater than 60 participants across two cohorts one month earlier than anticipated. Physician enthusiasm at AASLD was significant, and this contributed to the rapid rate of enrollment, one group receiving TSR plus Elixir and combination therapy. Every four weeks and a second group is receiving TellApart monotherapy. Every two 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 five years to progression. Therefore, it's important to include patients with cirrhosis and trial 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 posters participants, the late-breaker data abstract that was accepted for poster presentation at the ESMO 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 six Solstice 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 fourth quarter of 2024. We foresee that the Solstice data update at Easel will be highly informative, who will shed light on several key areas. First, we anticipate gaining greater clarity on the safety profiles that are administered together with the Luxtera second, and we expect to obtain additional insight into virologic 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 six 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 Vera next trial will be designed with deliver tied as a comparator, and we will have greater clarity on potential trial designs following discussions with health authorities.
Switching gears to our Phase two program for chronic hepatitis B, our preliminary data suggests that on the left, Søren was administered with peginterferon alfa for up to 40 weeks, about 26% of participants achieved hepatitis B surface antigen loss at the end of treatment and 16% achieve functional cure, meaning they maintain hepatitis B surface antigen loss 24 weeks after the end of treatment. Current therapies such as NRTI.s require lifelong therapy, but rarely achieve functional cure. The only other therapy approved for hepatitis B is peg interferon alpha, which has a low functional cure rate of 3% to 7% with poor tolerability in the March trial. When added to this apart to a regimen of a lesser and alone or less around plus peginterferon alfa, we observed an almost threefold increase in the treatment response rates at 24 weeks of treatment These data were the first indication of the potentially important role of an HBV directed antibody and 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 year of 24 82 Peninsula trial data manuscript and met archives we are applying key learnings from the political trials, our next-generation prophylactic flu antibody beyond 29 81.
Now turning to our early stage pipeline beyond 1949 is an investigational therapeutic T cell vaccine based on our HCLD. vector platform and is designed to treat precancerous lesion caused by the Human Papilloma Virus Despite advances in vaccination and scream HPV-associated cancers and conditions such as high grade squamous interest affiliate lesions. We made significant global health concerns. We look forward to sharing more later this year of this program and the timing of a potential IND submission. We are seven to nine is a next-generation COVID-19 monoclonal antibody candidate with increased potency, breadth and resistance to viral escape. Thanks to AI engineering and optimization. The development of your sum of two to nine to the end of Phase one is supported by Barta. 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.

Sung Lee

Thank you, Karri. Before I came to the financial results, I would like to take this moment to thank Marianne and the Board for the opportunity to make an impact there. I've 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 periods in 2023. The decrease was primarily driven by lower clinical development and manufacturing costs related severe 24 82. Sg&a expenses in the first quarter of 2024 were 36.3 million compared to 46.8 million in the same period in 2020. Three. 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 2020 for 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.

Sasha Damouni Ellis

Thank you, John. We will now start the Q&A section. Please limit your questions to two per person. So that we are able to get to all of our covering analysts. Operator, please open up the line for questions.

Question and Answer Session

Operator

(Operator Instructions) Gena Wang, Barclays.

Gena Wang

Thank you for taking my questions. So my best wishes to your next journey. And I have a two questions regarding HDV, our first question is and regarding patients with baseline cirrhosis, any restriction or exclusion criteria for cirrhotic condition? And my second question is of which measurement will be more meaningful in your view regarding the lower limit of quantification and the limit of detection? And is the Phase two efficacy data setting a bar for Easel?

Sasha Damouni Ellis

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

Carey Hwang

Thank you, Gena. So for your first question around baseline cirrhosis and restrictions in our trials. So as I mentioned, the two new cohorts that we enrolled in Solstice, we included CPTA., how 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 for going forward the safety and efficacy of our regimen in those populations. So we look forward to looking at that, any if there are any differences between cirrhotics and U.S. robotics in that population?
In regards to your second question around which measurement lower than the quantification or limit of detection at different assets have different cutoff for the 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 was something that will be something that we will have to.
We will clarify with regulators and the bar for Eagle update.

Right.

Carey Hwang

And then the last question is whether that people thought that data would be setting a new efficacy bar that you're familiar with from our AFLD. presentation from our six purchased first six participants were able to achieve a six out of six that achieved HCV RNA less than a minimum of complications and five out of six that were undetectable or less on the detection. I think if we are able to demonstrate these results in a larger population than 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 that benchmark.

Operator

Paul Choi, Goldman Sachs.

Paul Choi

I thank you.
Good afternoon and thank you for taking our questions. I want to follow up on Julian's question regarding on the compensated cirrhosis population in Mount and Solstice. And could you maybe just clarify for us, particularly among the patients for which we'll have the 12 week additional public update versus those who have had the 24 week treatment update on just how you're thinking that baseline of asthma 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 mark recent market success on, 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 of 81 90. Thank you.

Yes.

Carey Hwang

So thank you, Paul, for the question. So in terms of how we think cirrhosis might affect safety or efficacy, and we have done initial hepatic impairment study and CPTA. participants, and we have not seen any safety signals or any clinically significant changes in a PK. that would cause us any concern. And so our expectation is that and this compensated for raw fibrotic population we should not see any significant differences in terms of the safety or efficacy profile of between those two populations. And we will have that data for the 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 the beer 80 or 90 or other potential monoclonal antibodies. And so we've certainly only want to present or kind of progress antibodies that fill an unmet need in the space. And so those are ongoing discussions that will help our partners that make those decisions.

Paul Choi

Great.

Carey Hwang

Thank you.

Operator

[Alex China], Bank of America.

You guys.

Carey Hwang

Thanks for taking our questions.

Sung Lee

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

Yes.

Carey Hwang

Well, yes.
Thank you, Alex. So in terms of how we would think about the data that we will have at Easel. 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 we have four things that we would be looking at at this time point.
Number one, the safety profile of a bar and a lot of store explanation number two, but the virologic response rates and ALT normalization rates, our third, the potential efficacy and safety differences between cirrhotic and non-cirrhotic patient participants.
And then finally, the longer-term follow-up data on the initial six participants that we reported SLV. to see if we have durability of response over time. So I think we are the Eagle Sadara will further, hopefully further expand the dataset that we have from the initial six for and confirm the directionality of what we're seeing in terms of efficacy and safety. And then obviously, the 24-week data will be a complete data set across those two populations.
So in terms of your second question around what would inform a go no go on a Phase three of our Delta.
So I think, yes, it depends on the strength of the data.
I think if our data with the equal data cutoff, we believe that is strong enough I think that would be a possibility of taking that path forward for conversations. But it all depends on the strength of that data going forward. Obviously, the 24 weeks would be the complete dataset. But if we have a very strong indication of efficacy, then I think we can go earlier group recruit.
Thanks a lot.

Operator

Phil Nadeau, TD Cowen.

Phil Nadeau

Good afternoon and thanks for taking our questions and let us add our best wishes to Song as he moves on to from us. First on, as you just highlighted, durability response as a key question that's going to be answered by what you saw in 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 and 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 some priorities for investing externally?

Sasha Damouni Ellis

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 B in our pipeline. However, we also have the opportunity to look for external innovation and especially in our 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 dose would be a great fit for us and creating value for the Company and our shareholders.
And I will ask Gary to answer your question related to durability of response Thank you, Matt, and thank you, Phil, for the question.

So your question around durability of response, would we expect to see any resistance or loss of zero durability with our client hepatitis delta regimen. So I mean, based on what we've seen to date, we have from vitro data. We haven't seen any resistance to date, and we have a lot of hepatitis B data looking at surface antigen. And we haven't seen a rebalance and hepatitis surface antigen over time with a combination of a lot sort of argument together. And I think as with other chronic infectious diseases on the left or end of our 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. But the likelihood of developing resistance is much less compared to if you were going forward with the monotherapy. So time will tell. But based on what we know so far from hepatitis B from our in vitro work and what the expectations are with having two different independent mechanisms against the virus. And my my guess is that a rebalance and resistance would be rare.
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.

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's 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 three and pathway to approval.
And then just on the HPV. 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 in all comers relative to patient cohort with relative lower baseline surface antigen, especially as you consider potential advancements to the program of the program to Phase three.

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 our path to approval, such as Fast Track breakthrough prime. And then these other matters 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 get the ballpark and get alignment on our registrational pathway going forward.
And then in terms of your second question around hepatitis B with the segment, looking at the segment data by surface antigen levels, so you have some large files actually to date in our hepatitis B trials, we have taken all comers and we are 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 cutoff. So we'd increase serum clearance rates in surface antigen. So those will be areas that we will be evaluating and working out our data set.

Operator

Your next question comes from the line of Erwan Reeves, Leerink Partners.

Your line is open sciences research in Ontario, honorees at Leerink Partners.
Thanks so much for taking your question on first a couple on HDV. So first Solstice, what level of ALT normalization Are you expecting to see in the upcoming data at Easel, given that we didn't really see meaningful normalization in the early data that you presented last?

Carey Hwang

Yes, Greg, thank you, Rossa, for the question.

So I think that the data set from our ASLD. said it was small numbers. We only have six participants. We have two out of six that achieved ALT normalization, but other participants who did not achieve ALT normalization. A majority of those were tests around that upper limit of normal. And so I think with potential longer treatment, we may see more call normalization, but the data set coming out at E. So 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. Thanks. And then another one on HDV. two. We haven't heard too much recently about of Corixa's resubmission in the US. So can you share how you guys are thinking about maybe the competitive positioning of your regimen versus therapeutics? And how are you thinking about maybe the patients who could be more responsive to your regimen versus accrued X if both are available?

Yes.

Thanks for that question. So I think as you said, Bill is not approved in the US, but as I mentioned in my prepared remarks, that we would plan to have delivered side of our comparator in our trials going forward. And based on the 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 as a potential differentiator for us going forward. As I mentioned, the goal is always to achieve a biologic suppression for any therapy in chronic viral diseases. And if we're able to demonstrate that in a larger data set than that 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.
I think also because as I mentioned previously in a previous answer, we are attacking the delta virus through two different mechanisms there's less of a concern was with resistance or nonresponse a different patient population.

Sasha Damouni Ellis

Super helpful.

If I could squeeze one for HBV. So as it relates to the thrive and survive 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 rate 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 about normally as guidelines indicated 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, and it is 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 on a chronic suppression population.

But thanks so much for the Clarix.

Carey Hwang

That's it for me.

Operator

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

Carey Hwang

I thank you for taking our question.

I 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 interferon containing regimen and perhaps less than that for a non interferon containing regimen would be considered acceptable.

Phil Nadeau

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?

Carey Hwang

And would that be higher than sort of the numbers that you're providing?

Any additional color on that would be?

Carey Hwang

Yes, instruments.

Thank you for the question, Joe. We yes, we had a advisory board with many of the leading key opinion leaders within hepatitis back in November. And we did post a question to them 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 of component to think about in these regimens is whether a regimen containing interferon or not interferon sparing regimens. We 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, fillers like interferon containing regimen, the bars 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 pin down exactly customer sliding scales for different factors to consider.

Operator

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

Hi.

Phil Nadeau

Thanks for taking the questions. And you've noted carry that potential Phase three trial in HCV was the consequence using both retired as a comparator arm. 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 US sites given the fact that it's not approved here? And then as a follow-up, I'll give the question then I had a follow-up to that.

Yes.

Thank you, Eric, for the question. So we are, as I mentioned, we would include delivery side as a comparator, even though it's currently not approved yet in the United States. They'll be there, I guess and obviously be with our discussions with regulators moving forward in terms of what would be included in the study design and what that would look like. But I think also from because we are looking globally for this therapy and 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 deliberate, highest comparator because we have a global footprint in this trial. We have we've done these trials before and even though delivered high 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 delivered high even if it's not approved. So that would be the plan.

Okay.

Phil Nadeau

Rich, maybe just a follow-up. Coming back to the topic of <unk> ALTLT. normalization in HCV-infected patients is the is the prospect of normalization in cirrhotic patients. Any more challenging than it is on non cirrhotics and I guess is there sort of a difference in them sort of baseline LFT?
Yes, presence, I guess that we should be thinking about here between the non-cirrhotic and sort of patient population?

Thank you.
Yes. Thank you for the question. Yes, and I think it's a very good question, and that's something that we will be able to show with our data in terms of looking at iStar, if there are baseline differences in ALT levels, if there are no public or higher or lower in SaRonix versus non SaRonix and then also looking at the rate of normalization. So yes, so we outsource 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.?
Yes, we don't really we don't expect to see significant differences between SaRonix and on SurModics on these in the CPTA. population.

Carey Hwang

But obviously the data set will inform us on that figure.

Excellent. Thanks for taking the questions.

Operator

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

Carey Hwang

Your line is now open, but Good afternoon and thanks for taking the question.

Sung Lee

Maybe just a quick one on the Phase one HIV program.

Carey Hwang

I think you'll have data in the second half of this year.

Phil Nadeau

Maybe you can just talk about some of the key points and the key endpoints in that early study and what we should be looking for?

Carey Hwang

And and maybe what would be would be positive in your view to sort of keep that program moving forward? Thanks.
Thank you for the question. So we do have this ongoing trial with fear 1388, which is our HCMV. vector of both potential HIV vaccine. And this is in partnership with the HBTM., 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 far, we are really looking for is these immunologic endpoints, specifically looking at T cell markers and we see restricted CAR T cell responses and kind of seeing what we would we at least see similar types of immune responses that were observed in them attacks that were protective from SIP in those animals. And so so if we're able to see the proof of immunology, then we have this opens up this platform to other areas, potential areas of exploration such as in human papilloma virus that with our beer 1949 vector.
Yes.

Phil Nadeau

Great. Thank you.

Operator

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

Sasha Damouni Ellis

Thank you, operator. To concludes our companies 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 Easel. 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.

Operator

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