Q2 2025 Vir Biotechnology Inc Earnings Call
Hello, welcome to vert biotechnology, second quarter, 2025 Financial results and corporate update call.
As a reminder, this conference call is being recorded.
At this time, all participants are in a listen-only mode.
After the speaker's remarks, there will be a question and answer session.
I will now turn the call over to Rich leki, senior director investor relations you may begin with your lucky.
Thank you and good afternoon with me today are Dr. Marion deburr, our chief executive officer, Dr. Mark, Eisner, our chief medical Officer, Jason Ober, our Chief Financial Officer and Dr. Mika, during our Executive Vice, President of oncology who will be available during the Q&A session.
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 four 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 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 Mary and de backer. Please. Go ahead.
Good afternoon, everyone. And thank you for joining us for nearby Technologies. Second quarter 2025 earnings call.
I'm excited to share our progress with you today as we've achieved several important, Milestones across our pipeline this quarter.
The past few months have been remarkably productive with significant advances in both our hepatitis Delta and oncology programs.
These achievements, reflect our team's commitment to our mission of powering the immune system to transform patients lives, and I'm grateful for both their dedication and your continued interest in our journey.
Our key accomplishments this quarter demonstrate our continued momentum across our pipeline.
First, we've made significant progress in our Eclipse registration program for hepatitis Delta.
Following our first quarter Milestone of enrolling. The first patient in Eclipse 1, we have now recently enrolled, the first stations in both Eclipse 2 and Eclipse 3 and all 3. Registrational studies are now actively recruiting patients globally.
We are 5525 our egfr, targeted T-cell engager marking, our third clinical stage diesel engager program.
And third, we've continued to make progress in our existing T-cell engager programs with both fear, 5818 and 0 5500 advancing in their respective Phase 1 studies.
We also received IMD clearance to evaluate your 5500 in earlier lines of prostate cancer, treatment in combination with Androgen receptor pathway inhibitors.
Let me now. Elaborate on our chronic hepatitis Delta program which represents a significant near-term commercial opportunity for Via bio.
The eclipse registration of program is designed to address different patient. Populations across the treatment continuing from treatment, naive patients to those who have not adequately responded, to existing Therapies.
This comprehensive approach Builds on our compelling Solstice face 2 data, which demonstrated impressive biological responses with our combination therapy of Tovey bar. Plus elapsed room,
The hepatitis Delta opportunity is particularly compelling from a commercial perspective for several reasons.
Our comprehensive market analysis indicates approximately 7 million active pharmicy,
The patient population is geographically concentrated particularly in the United States, where Delta patients are predominantly clustered in major Urban centers, like New York, Chicago Los Angeles, and San Francisco.
The situation would allow for an efficient commercial approach with a targeted specialty sales force focused on hepatologists and infectious disease specialists.
This disease has severe clinical outcomes, including accelerated progression to pyrosis, and are more than 50% 50 mortality rate within 10 years,
Creating a compelling case for Effective intervention.
The EMA, orphan disease designation, and the lack of FDA-approved treatments in the U.S. support a value-based pricing model similar to other rare disease therapies.
Additionally, the high economic burden of untreated disease. Progression provides a strong economic rationale for effective treatment.
While the regulatory designations we've received may help accelerate our development timelines.
As we advance our hepatitis, Delta program to potential commercialization, our strategy includes pursuing commercialization Partnerships in Europe and other key International markets,
Turning to our oncology portfolio as mentioned. I'm very excited about your 55525, our dual, masked, egfr targeted, T-cell, engagers,
This program addresses, a significant unmet need across multiple solid tumor types, through egfr is expressed.
Despite years of development of EGFR-targeted therapies, including Paris and kindness inhibitors, and monoclonal antibodies, these approaches have limitations.
Tkis are primarily effective only in the subset of patients with specific egfr mutations while antibodies like detoxi map and Puma map face resistance, mechanisms and significant toxicities that limit their use.
For example, these therapies are not used in tumors with cos or bras, mutations in colorectal cancer and head and neck squamous cell carcinoma as they typically derive minimum or no benefit from current egfr, targeted treatments leaving a substantial unmet need.
The pro extent approach fundamentally changes this paradigm.
By redirecting, T cells to kill tumor cells, expressing egfr. Your 5525 has the potential to work across a much broader patient population, regardless of their mutation of status including those with cos mutations.
Is low.
Marco provide more details on the clinical development plan, but I want to emphasize that fear 5525 exemplifies, how we leveraging our platform to potentially address major limitations of existing Therapies,
For VR. 5818 our dual masked, her 2 Target details and engager. We have completed the monotherapy dose escalation portion of our study and are now analyzing that data. As we continue those escalation in combination with temporal map,
For a view of 5,500 are dual masked psma. Targeted T Cell engager. We continue our dose escalation study and recently obtained, using clearance to evaluate the program in earlier lines of prostate cancer.
this expansion into first time, metastatic castration resistant, prostate, cancer, and hormone sensitive disease in combination with erpi represents an important step in exploring, your 5500 full potential across the prostate cancer treatment, continuum
The prox 10 Universal masking approach continues to demonstrate potential advantages in terms of safety, profile and dozing flexibility across our T-cell engager portfolio.
This platform technology allows us to apply an identical masking approach across multiple targets. Accelerating our development, timelines for future programs.
Beyond our clinical stage programs. We continue to advance multiple pre-clinical T Cell engager, candidates targeting, various tumor Associated, antigens,
for these preclinical candidates were taking a strategic approach to development advancing. Some internally while exploring potential Partnerships for others who are combining our platform with complimentary expertise.
Could maximize value and accelerate development timelines.
Our financial position remains strong with approximately, 892 million dollars in cash, cash, equivalents and Investments at the end of the second quarter.
This provides us with a cash Runway extending into mid 2027, giving us resources to advance our Key Programs through critical value inspection points.
Looking ahead. We're focused on several key priorities.
Driving enrollment, across all 3. Eclipse. Studies to advance our chronic hepatitis Delta program towards registration.
Advancing our clinical stage T Cell engager programs, including exploring fear 5,500 potential in earlier lines of prostate cancer treatment.
And executing on our business development strategies, to maximize the value of our assets.
With that. I'll now turn the call over to Mark to provide a more detailed update on our clinical development programs.
Thank you Marianne. We've made significant progress across both our infectious disease and oncology portfolios, during the second quarter, and I'll walk you through the key developments. I'm excited to report. Substantial progress in our Eclipse registration program for hepatitis Delta,
Building on our first quarter Milestone of enrolling. The first patient in Eclipse 1, we have now just recently enrolled, the first patients in both Eclipse 2 and Eclipse 3 and all 3 studies are now actively recruiting patients globally.
We remain on track with our overall, development timeline with primary completion for Eclipse, 1 expected, by December 2026.
Let me now provide details on each study.
Eclipse 1 is designed to evaluate our combination therapy in regions where belover tide is not available or has a limited use including the United States.
The study will enroll 120 participants, randomized 2 to 1 to receive either our combination therapy or deferred treatment.
The primary endpoint is a composite endpoint of hdv. RNA Target, not detected and ALT normalization a week 48.
Eclipse 2 will enroll approximately 150 patients, randomized 2 to 1, and evaluates switching to our combination therapy in patients who have not adequately responded to Beloved type.
this study, addresses, an important unmet need for patients who have limited options after Bolivar tide treatment,
protected, which could potentially provide a readout at a similar time Point as Eclipse 1,
Eclipse, 3 is our phase. 2B study that will enroll approximately 100 patients comparing. Our combination therapy to bellver tide and belt. Tied naive patients.
This head-to-head comparison will provide important data to support access and reimbursement discussions.
Together, Eclipse, 1 and 2 are designed to form the backbone of our regulatory submissions in the US and Europe.
This comprehensive approach, addresses different patient, populations and treatment scenarios. Providing a robust evidence package for regulatory review and approval.
The regulatory designations we've received including breakthrough therapy and Fastrac in the US, plus Prime, and orphan drug in the EU. Continue to facilitate productive interactions with regulatory authorities.
These designations reflect the significant unmet need in hepatitis Delta and the compelling data from our Solstice phase to study or a combination regimen. Demonstrated impressive, viral logic responses.
I'd now like to turn to our oncology portfolio, where we've also made important advances this quarter across our T Cell engager programs.
As Marianne mentioned earlier, I'm pleased to report that we've successfully dosed our first patient in our Phase 1, study for Vera 5525, our egfr targeted T Cell engager, which has the potential to address several critical limitations of current egfr targeted Therapies.
Egfr has been a validated oncology Target for many years with multiple approved therapies, demonstrated, clinical benefits and specific patient populations. However, current approaches face significant challenges, first tkas, like Asam. Mart nib or primarily effective only in the subset of patients with specific egfr. Mutations leaving the majority of egfr expressing tumors, unadjusted second in colorectal cancer, or monoclonal antibodies, like the two and pinat are ineffective in patients, with Corrales mutations which represent approximately 30 to 45% of cases.
Similarly in non small cell, lung cancer, where 25 to 30% of non-squamous tumors Harbor, K Ross mutations.
Current egfr targeted therapies have limited efficacy in this population.
Third Kats Inhibitors have been important advances in lung and colorectal cancer but redundancy of the pathway and other resistance mechanisms result in eventual progression.
Our Veer 555205 program, takes a fundamentally different approach of redirecting, the patients own immune system to eradicate egfr expressing tumors.
The universal Pro extend, dual Mass design allows for Selective activation in the tumor micro environment, where proteases can unmask via 5525 to unleash a potent T-cell engager against egfr expressing tumors.
in normal tissues, where egfr expression may occur, The Masks remain intact and prevent any T-cell activation
Preclin 55525 is. Demonstrated potentiate, dependent tumor, killing in xenograft models, to a similar extent as the unmasked version.
Importantly, no cell. Killing was observed in normal cells, even at very high concentrations in vitro
In safety studies with non-human primates Vera 5525 showed an approximate 2550. Volt safety margin compared to the unmasked version with only minimal Saito release syndrome and Isis. Elevation substantially less than seen with the unmasked T cell engager in these models.
With particular incursion, the VERT 5525 uses the same masking technology as our other two clinical programs.
Both of which have demonstrated promising. Safety profiles so far.
This consistent performance, across multiple targets, gives us confidence to verify, 55525 will show a similar safety profile.
In contrast to traditional oncology therapies that inhibit signaling through wild type or mutated egfr.
Effectively redirect tea cells to kill egfr expressing tumors.
Through this tumor specific unmasking mechanism. Beer 5525, has the potential to treat a wide spectrum of tumors regardless of their underlying mutational status or resistance mechanisms while sparing normal tissues, that Express egfr.
With this broad potential in mind. Our Phase 1 Study is designed to address significant unmet needs across a focused group of tumor types, with high egfr expression.
in Osmos cell lung cancer of year, 5525 May benefit patients regardless of their tumors specific driver mutations, whether they have egfr mutations kras, mutations braf, mutations or others, our approach is potentially applicable to both major historical subsets squamous and non-squamous
This includes tumors with high PD-L1 expression, where we can leverage the existing T-cell infiltration to enhance tumor killing.
We will also be exploring combinations with pierisim map in this Phase 1 study.
For colorectal cancer, Approximately 80% of tumors Express efr yet current antibody therapies. Like situa, milab are not effective for the 30 to 45% of patients with Keras. Mutations. Our experience with zero, 5818 has shown promising activity in colorectal, cancer demonstrating the T-cell. Engagers using our Pro xtend platform. Can be effective in this disease.
In head and neck exocellular carcinoma, over 90% of HPV-negative tumors significantly express EGFR, and these HPV-negative cases represent the majority of this cancer type.
Despite tux approval response rates, remain low and resistance develops quickly. The overall prognosis and quality of life for these patients remains poor introducing a T-cell redirecting therapy. You like if you're a 5525 potentially in combination with parosmia,
Metastatic cutaneous, squamous cell, carcinoma Approximately 80% of the tumors Express egfr and advanced disease has limited treatment options, Beyond checkpoint Inhibitors to which nearly half of patients, don't respond.
Collectively these indications represent. Hundreds of thousands of patients diagnosed annually with egfr expressing. Tumors who face significant treatment challenges?
our Pro extend approach is designed to address these limitations through its unique dual masking technology in tell engaging mechanism,
The Phase 1 Study design. For 5525, has been optimized to efficiently. Assess proof of concept and incorporates extensive learning from our Vera, 5818 and V 5500 programs, potentially allowing for Accelerated dose, escalation and more efficient decision-making. While prioritizing patient safety, we've designed a focused approach, that includes both monotherapy and combination approaches with temporal map.
We believe the combination with pembrolizumab.
Tsong gaugers, like vert 5525. Can potentially convert cold tumors to hot tumors by recruiting tea cells to the tumor micro environment. Potentially enhancing the efficacy of checkpoint inhibitors.
With this strong scientific rationale, we've designed a robust to get focused clinical development program for year. 5525, that is now recruiting at multiple sites.
Having discussed our newest clinical program, I'd now like to provide updates on our other T cell engager programs.
For viewer 581818, are her two Target T Cell engagers. We have recently completed the monotherapy dose escalation portion of our study and are now analyzing that data. As we continue dose escalation in combination with Temporal Isml, we're taking a comprehensive approach to determine the optimal dose and schedule for advancing this program.
Progressing on the standard Therapies.
This activity in microsatellite stable patients who have traditionally immunotherapy resistant, tumors underscores, the potential of our products then platform approach.
Among these responses, we've observed 1 colorectal cancer, patient was maintained a durable response for over 18 months as of our January update further supporting the promise of this approach.
For viya, 5500 our psma, targeted T Cell engager. We continue to dose escalate on a 2 week in Q3 week dosing schedule. The program is progressing with no maximum tolerated dose reached yet.
The half-life of 8 to 10 days supports our Q3 week dosing evaluation which could offer significant convenience advantages for patients.
We're excited about the recent us. IND clearance to evaluate via 5500 in combination, with arpis and first line, metastatic castration resistant, prostate, cancer patients, and patients, with hormone-sensitive prostate cancer.
This expansion into earlier lines of therapy and combination settings represents an important step in exploring. The full potential of the VR 5500 across the prostate cancer treatment continuum
We look forward to generating a more comprehensive data set as we continue to advance this program and remain committed to sharing meaningful updates as our programs progress.
As we look to the Future our pros and platforms clinical validation across 3. Distinct targets is demonstrating its versatility and provides a strong foundation for our pipeline of pre-clinical candidates.
This validation enables us to advance additional T Cell engager candidates more efficiently and with greater predictability, whether independently or through strategic partnerships.
In conclusion, I'm very pleased with the progress. We're making across our entire portfolio.
We remain focused on executing, our clinical development plans with scientific rigor and operational excellence with that. I'll now hand the call over to Jason.
Thank you, Mark. I'm pleased to share our second quarter of financial performance and overall financial position.
R&D expenses for the second quarter of 2025, were 97.5 million, which included 6.9 million of non-cash, stock-based compensation expense,
this compares to 105.1 million for the same period in 2024, which included 13.1 million of stock-based, compensation expense,
The decrease was primarily driven by cost savings from previously announced restructuring initiatives.
Partially offset by clinical expenses from the initiation of our Eclipse registrational program.
Expenses associated with the progression of our oncology programs.
And expenses incurred due to an increase in the fair value of potential future hepatitis Delta Milestone payments.
Sgna expenses for the second quarter of 2025, or 22.3 million, which included 5.5 million of stock-based, compensation expense.
Compared to 30.3 million for the same period in 2024, which included 9.1 million of stock-based, compensation expense.
The decrease was largely due to ongoing cost savings realized through headcount reductions and other restructuring initiatives.
Our second quarter of 2025 operating expenses totaled. 119.6 million representing a 42.1 million decrease from the same period in 2024. This year-over-year reduction reflects the changes. I just noted in R&D and sgna expenses. Plus the absence of 26.3 million in restructuring and impairment charges that were incurred in the second quarter of 20.
24.
Net loss for the second quarter of 2025 was 111 million compared to a net loss of 138.4 million for the same period in 2024.
Turning to cash our net cash consumed. In the second quarter was approximately 127.7 million.
Which includes 50.5 million in Milestone payments related to the first patient dose in Eclipse 1.
These amounts were previously expensed in Prior quarters.
These Milestone payments were anticipated and are described in our SEC filings including the 2024 10K.
.2 million.
We ended the second quarter with approximately 892 million in cash, cash equivalents and Investments. Based on our current operating plan, we continue to project our cash Runway extending into mid 2027.
Our Capital deployment strategy remains focused on our most promising programs. First advancing. Our hepatitis Delta Eclipse registration program with all 3, registrational studies Eclipse 1 2 and 3. Now actively enrolling patients globally following the recent enrollment of the first patients in Eclipse 2 and Eclipse 3.
second advancing our T Cell engager programs in clinical development, including beer 5500 beer, 5818 and the recently initiated beer 55525
We maintain strict Financial discipline while focusing. Our resources on programs that can both create shareholder value and address significant unmet patient. Need
With that, I'll hand it back to Rich to initiate the Q&A session.
Thank you, Jason. This concludes our prepared remarks and we will now start the Q&A session. Please limit your questions to 2 per person, so that we can get to all of our covering analysts. I'll turn it over to you operator.
At this time, we will begin conducting our analysts Q&A session.
Our first question comes from the line of Mike OLS from Morgan Stanley. Please go ahead.
Hey, uh, uh, thanks for sharing our question. It's obvious on the line for Mike. Um, yeah. So I guess just on HTV. Um, you know, could you, uh, perhaps give us a little bit of enrollment update on the eclipse programs, uh, particularly for Eclipse 1 and then, um, this might be a little bit premature. But, um, you know, I guess the, as we think about the Tam and hdv, can you tell us, uh, about any sort of prep work or thoughts on, you know, how to further identify the uh, prevalent patient population? Thanks,
Thank you, Ravi. I'll ask Mark to comment on that.
Yeah, thanks for the
So yeah, we're really excited that we now have all 3 Eclipse registration studies up and running with uh enrolling patients. Um, enrollment in Eclipse 1 is going very well, we we're not in a position yet to provide more specific updates. But you know, we have said, before we we anticipate, um, completing enrollment by the end of this year, with a completion date for the primary endpoint of the end of 26. Um, you know, Eclipse 2 and Eclipse 3. We're, we've just gotten up and running so it's a little premature to make it. Um, you know, statements about enrollment is going. But so far, we're working really hard executing those
Really well, really excited about the investigator, um, excitement and responsiveness, you know, for these programs. Um, in terms of the work on on,
TV. I mean I think what you're alluding to is it is a challenge estimating, the epidemiology of HTV. Um because particularly in the US because there's no approved therapy, there's no reflex testing, which is automatic testing in hbv, positive, patients, for Delta. So it's a little bit unclear right now. Um, you know, how many patients there may be? I mean, we're estimating about 61,000 who are vying in the US right now. We suspect that's probably an underestimate. And once we uh, get to the finish line and launch our therapy, which would be um you know a very attractive for patients that they'll be more education screening and effort to find patients.
All right. Great, thank you for taking our questions.
Our next question comes from the line of genuine Wong from Barkley's.
Thank you for taking my questions.
I have a $2.1 billion eclipse, and the other day is for $55,525. So regarding Eclipse, if I heard correctly, you said the primary completion is in December 2026.
Eclipse, 1 is a fair to say that you already enrolled majority.
Of the 120 patients since the study is a 48 weeks.
Um, my second question is regarding 5525. I saw your starting dose is only 3 micrograms per kilogram. Since you expect a similar safety profile for 5525 versus the other two targets, why not start at a higher dose?
also will you test the books like a once weekly dosing and once every dosing
Maybe market and comment on that. Yeah, I I would say we're not providing specific updates on enrollment, but recall that the enrollment in Trials, always starts off slower than ramps up as sites are activated. Enrolling patients. Um, you know, all I can say is we're I'm we're really pleased with how we're doing and um, you know, we'll we'll provide an update in the future, so stay tuned for that.
Okay. And then as it related to your question, on our uh, egfr tell engage of 5525. So if I understood you correctly, you were asking why not start at a higher dose given sort of what we have learned from our prior programs. M, you want to comment on that? Sure sure. Yeah, no, thanks for the question. Um, so we are basically starting at a dose, um, that is uh, uh, sort of standard by regulatory authorities for, uh, T-cell engagers, which is using the maple dose. Uh, and so each each molecule has, you know, they're in the same range, but they're in the same, you know, they have their own estimated Mabel dose. And that's, that's, you know, we just have to do our start dose from there. Uh, but we do have a lot of confidence that we have the potential for a wide therapeutic index. For 5525 in that, you know, this is a universal platform um in that the masks are identical for
5005818. Um, and the, uh, as as are the uh, Proteus linkers and so in, in terms of you look at the pre-clinical data for 5500 and 5818, uh, both of those programs have shown really robust potential for a wide, therapeutic margin and and and safety profile. Uh, and similar, when we make those comparisons preclin with 5525 again we we we see this very encouraging and promising potential uh for a wide, therapeutic margin, looking at safety studies, toxicology studies and and and and and animals and so forth. So uh, we do believe that there is this wide potential for for this molecule and we'll be able to accelerate this program, much faster. Given the learnings that we've had from both the 2 previous or 2 and uh and psma programs.
And as far as testing other dosing regimens uh just for as standard you uh, from the IND, you know? Uh, studies uh we uh we are required to study this initially weekly. Um, but we are certainly uh, again our our preclinical data does suggest that we would have a, a potentially good uh, Half-Life to be able to dose less frequently Q3 week and and potentially later.
Our next question comes from the line of Paul Choi from Goldman Sachs. Please go ahead.
Hi, this is Danielle on for Paul, we're wondering if they're going to be additional data cuts from The Phase 2, Solace study for the hdv program. And uh, we're also wondering for the next data cut for viya 55000 for tsma. Are you going to share PF, PFS data or Radiology based measurements in addition to PSA biomarkers? Thank you.
So thanks for the question. Um we um do plan to provide an update on the solstice study, the complete 48 week data, um by the end of the year. So um, stay tuned for that for 55500. Next data cut. You know, we we haven't provided guidance about exactly when that will be. We do want it to be a very meaningful update. Uh, we, we're currently escalating in q1 and Q3 weeks and it's going very, very well. Um, in terms of what specific data will will present. Also, we haven't provided guidance there, but we, we will try to provide, you know, clear evidence of dose response of, you know, depth and durability, the PSA responses and you know, other biomarkers and other measures. So, um, you know, we'll provide more more detail.
On my text, back at a later date.
Thank you.
Our next question comes from the line of Alex Trahan from Bank of America. Please go ahead.
500 to be sort of the go no-go point for these studies. And you know, would we expect a final decision on dosing frequency for those programs as well? Thanks
So, uh, thank you for those questions. Uh, the first question is around whether we expect to need both Eclipse 1 and Eclipse 2 for the first, uh, registrational filing. That is our base case. Um, that said, we have other scenarios that we could consider. If, for example, Eclipse 1 completed much ahead of Eclipse 2, we could consider following that along with Solstice for an initial approval in the US. That would have to depend on, you know, the gate strength of the data, discussions with regulators including the FDA, and having breakthrough therapy designation status in the US and PRIME in Europe. This does allow us to have those conversations, but it's going to depend on the relative, uh, speed of enrollment of the trials. And as a reminder, our Eclipse 2, although it started a little bit later, is a 24-week program as opposed to a 48-week program. So it, you know, could complete, you know, around the same time as Eclipse 1, but it's a little early to say for sure. I think your next question will...
Was around data updates for the 5818 and 5500 and what to expect there. Um, you know, we haven't made final decision about exactly what those updates will look like, whether it'll be together or whether they'll be separate. Um, you know, for 5818, you know, we uh, have said that we are, we've completed monotherapy dose escalation but we're continuing with escalation with crism app and we're currently analyzing all of the data of PK PD. Efficacy looking at dose and schedule and making will be making decisions about next steps of development. So we would expect to provide that at a, at an upcoming time and for 5,500, again, it's a little early to be a definitive about what will provide. But as I was saying before, we want to be able to provide a meaningful update where you get a strong sense of depth durability, those response, you know, other other key pieces of information,
Our next question comes from the line of Phil Nadu foren. Please go ahead.
Good afternoon. Thanks for taking our questions. Congrats on the progress. First, 1 on Eclipse to. Um, I believe that you are defining the enrollment criteria for that of patients who are on hepcludex, who don't achieve hdv RNA, less than 500, international units per ml. Can you talk about how your identifying, those patients, and, and, um, how, how easy you expect it to be to recruit that, that trial?
that's the first question and then second just in terms of um,
Updated data for, for 5518, in particular, sounds like the monotherapy does escalation is completed. Are there any thoughts to releasing that monotherapy data? Once you're done, analyzing it, or will you hold that data to, um, have the combo data as well? Thanks,
Sure. So, thanks for questions. Um, on the first question for Eclipse 2, correct. These are patients, who are have been on Bel ever died for at least, 6 months or so of our Remick and uh, they are then eligible. You know, they meet other sort of criteria as well for enrollment. Um, we actually identification of these patients relatively straightforward because the investigators all know which are their patients are on blood tide. So it's, you know, they can then test them to see what their level of iremia is. And then, if they're eligible, they can be enrolled. So, I mean, identifying, those patients is relatively straightforward and then, I think, you know, we randomize them, or, of course, to switch to, to Barton, the Webster versus continued blood over time, with the 24 week, primary endpoint of hdv Target, not detected. So our logic endpoint, I think it's a very appealing trial because you know, patients who are still vmic on whoever tied, you know, then we'll have the opportunity to uh,
Contestant on our regimen where we've been able to show, you know, approximately 2/3 of patients are uh are achieving complete viral suppression. Um for your question about 5518, what's the next data release? Look like is it going to be you know monotherapy or we're going to hold for combination? Yeah. We we really haven't decided. I mean we're looking at the totality of the data. Now we're escalating in combination with crumb that's going very well. So we'll just have to make a decision about what would be the most appropriate update and what would be the most appropriate setting for that update.
Our next question comes from the line of Rana Ruiz from blaring Park Partners. Please go ahead.
Hepatitis Delta. And then, what advantages do you see for your accommodation approach in terms of market positioning?
Sure. So um,
In terms of the competitive landscape.
You know, it's um, a couple comments 1 is, you know, Gilead apparently has or is refiling uh, available advertised hepcludex for the US. And um, you know, we don't know about the timing specifically, but assuming that they would get approved sometime in 2026. We actually think that would be a big positive for us because having Gilead, um, going out, it's starting that education of Physicians and and Healthcare Providers. And you know, promoting testing for HTV would help prepare uh, the way for Via and our launch. So we we would welcome that uh, opportunity and particularly since, you know, we have a drug regimen with our combo. If the left turn where we're achieving, you know, high levels of Target, not detected a week 48, you know, and we we've shown we expect to have above 60%, you know, all told that compared to 12% with the lever time. So we think
We have a very compelling clinical case to make their in terms of the combo approach. You know, I think we're very excited about it because we're suppressing the virus to undetectable, and the majority of patients, it's clearly, uh, better than our monotherapy with Teva guard or antibody. So we think we can be, um, other, monoclonal antibodies as well terms of viral suppression. We also can suppress Hepatitis B surface antigen by 3 logs, which is multiple logs greater than a monoclonal antibody alone and recall that you need the hbv surface antigen for the Delta virus to replicate itself. So we're starving the Delta virus of of what it needs for its viral, uh, life cycle. So I think all in all we, we feel like we have a best and disease best-in-class approach and we're you know, executing the trials as well. And we're looking forward to helping as many patients as possible.
Thank you, Mark. I would just add that, you know, as Mark mentioned, we have a profile that really has the potential to set a new standard of care. And obviously, you know, with more entrants entering the market, it's also a testament to the unmet need that we are seeing in hepatitis Delta and, obviously, the commercial opportunity that it represents.
Yeah, that that's great. Really great comments. And the other point would be that, you know, with a monthly Administration, we feel we have, we're going to have a very, very secure convenience to deliver type which is daily and other competitors are more likely going to be weekly within antibodies. So um, we think from a convenience and adherence point of view, um, we're feeling very good about where we're Landing.
On our next question comes from the line of Shun makkachin from Raymond James. Please go ahead.
Hi guys, thanks for the question. Just a couple on 5500 for us. Can you speak to the patience? You've been enrolling since the prior update for 5500. Obviously a lot of focus on the post psma radio, like in setting. Are you prioritizing this paid patient population? And should we anticipate a meaningful? Look at activity in uh, that patient population at the next update. Um, and then, uh, additionally can you provide your view on the relative importance of less frequent dosing, uh for 55500? And maybe perhaps speak to the biologic rationale for Less frequent dosing or dosing holiday? Uh, as it relates to Tesla Johnson for Tesla and Gators, thanks.
Yeah, so thank you for that question. Um so the types of patients that we are currently enrolling in sort of a standard person human Phase 1 where they must have exhausted all standard of care. Um, now saying having said that where we are currently open right now is in Australia and in Europe. And and and in those settings, there aren't as many there are some, but there aren't as many patients who have had um, prior radio Lian. So we don't have quite yet a lot of data uh in in that patient setting but we do plan on opening in the US and we do plan on trying to generate uh that data in late line setting. Uh, but we're also excited about going into the early line setting as well. Uh, We've recently, uh, as Market mentioned that uh, opened uh, have a ID clearance to combine with Androgen receptor pathway Inhibitors in the Frontline setting and a very early.
April for me being, you know, quite meaningful for uh, something something like this with our current toxicity profile. Uh, and then then that's sort of also relates to the less frequent dosing. So, uh, we have demonstrated with the, the her 2 program that we can dose less frequently, uh, at Q3 week and see a similar safety and, and efficacy profile thus far. Uh, we are currently encourage of what we're seeing where, you know, we're now dosing at Q3 week and the 5500 program as well.
Um, and what what, we've learned from the heru program at least, is that we don't see resensitization during that we holiday. So I I think this is an important factor in, uh, in the in T Cell engager space is that you, you know, most people have to step up dosing, everybody has to step up dose and, and, and then, and the reason to get that, um, is to desensitize so that you can, um, you can get to much higher doses. Uh, but then once you get up there, what's really next important is to have a, a reasonable Half-Life that allows you to then do less frequent dosing and then you don't have that resensitization. Uh, and that's been proven out, uh, with the her 2 program, uh, and similar similarly, um, you know, efficacy we've seen at the same doses, uh, either Q week or Q3 week.
Uh, efficacy in in the heru program. So we think that this bodes well for the 55 program, uh, it has a slightly longer Half-Life than, uh, than the her 2 program. Uh, and then this is going to be so important in the early line setting where, you know, that that have where dosing strategies are often for months, if not years and to have a much less frequent dosing is going to be a c key differentiator for our program,
Our next question comes from the line of Patrick kucho from HC way right? Let's go ahead.
Thanks um good afternoon, just a couple of follow-ups from us. Just a a clarification question on whether the US regulatory filing could proceed based on Eclipse 1 and Solstice or is the base case. Still for both Eclipse 1 and 2. And then just with um with Eclipse 3 this is the head-to-head comparison versus Boulevard tied can you talk about? You know what you would need to see in that program and is that primarily, you know where the for the European or or xus reimbursement, and what would you need to see to give confidence in that, in that Pro? You know, in that in that, you can get reimbursement in that program internationally and then just separately on the, um, on the prox, 10 on the prox 10. I'm just wondering, you know, given this unique opportunity and Care us, uh, mutant tumors, um, particularly in CRC and lung. How, how, how are you designed?
The the 5525 program to ensure you capture that population.
Okay, so a couple of good questions on Delta. The first 1 has to do with the US regulatory filing and what we expect, we need. You're right. Uh, we do expect, uh, Eclipse 1 and 2 to be the best case for filing. Um,
I do think that there, you know, if they finish in the similar time frame, which we expect that would be ideal and we would use both of those as the sort of core part of the filing for the US uh Clips. If if for some reason Eclipse 1 were to finish substantially ahead, we could talk to FDA about whether Eclipse 1 and Solstice could comprise the initial filing package and leverage. Our breakthrough therapy designation in the ufs and a crime designation in Europe that to have those discussions. Um, so you know, those are those do remain, uh, potential options down the road for Klipsch 3. Yes, that remind everyone to head-to-head study, uh, to deliver art and the luxurian versus blobber tide and beloved tide and naive patients. And, uh, we are looking at V violent endpoint Target, not detected week, 48, compared to belover tide. You know, beloved tide is expected to be about 12%. You know, we expect to be north of 60% for our combination. So, you know, we are looking for
Superiority based on the biological endpoint. Um, the the primary driver for the study of Russian Alpha study is deniable. Uh, European pear, HDA, negotiations around price and access. Um, it will comprise data that will be useful for all of our filings globally, uh, on the safety data side and also head-to-head data are always helpful but, you know, primarily we are looking um, at that as a a payer and access oriented study.
Yes, I can take on the pro extend question. So our 5525 Phase 1 Study as standard again. We we have to enroll patients, who must have exhausted, all all standard care and, uh, and that includes if they in any case, uh, uh, Inhibitors that are approved in in either lung cancer or any other space. Uh, and so, um, we do anticipate that we will be able to enroll these patients. But I think a really very important point is that the T Cell engager our Mass T, cell engager is a different mechanism of action altogether. Um, it is, you know, redirecting your immune cells to kill, uh, uh, any tumor cells, expressing, uh, egfr. Uh, and by doing so, it uses it as an address.
Um, and so, it's regardless of the downstream mutations that are there. So it should work and, and tumor types that are driven by cos, um, as well as any other, uh, mutation. We even Egypt our mutation as well as the multitude of other other, uh, uh,
Mutations that happen in in lung cancer. So uh I think this is a unique modality that could either go anywhere in the Journey of a patient with lung cancer. Uh potentially it could combine with a K raas inhibitor. Um again because of that differential uh uh mechanism of action.
Our final question comes from the line of Joseph. Stringer from Phnom company. Let's go ahead.
Hi, thanks for taking our question. Uh, the eclipse 1 trial has a 12-week deferred treatment, period versus 24 weeks for a phase 3 competitor. So can you remind us the rationale for the 12 weeks here in what, what's the potential impact on trial success or potential differentiation? Thanks?
Yep, so a good question. So Eclipse, 1 randomized us to our regimen of The Bard and the left are in versus a 12-week deferred treatment period. And the primary endpoint is actually a 40, uh, 8 weeks for our our combination versus 12 weeks in the Deferred treatment arm, the rationale for that. Is that, um,
The virus without any treatment. Essentially we expect essentially zero patience to spontaneously clear. The Delta virus. So 12 week to per treatment arm, um, is really acceptable because it's going to protect almost perfectly. What's going to happen a week 48. You know, we have agreement from FDA and EMA on that point. Um, 12 weeks is, uh, in our mind better than 24 weeks operationally, because it's a more appealing patient was designed for patients, because you, you know, they don't have a long time to wait. If they get randomized to the Deferred treatment, arm to cross over to the active treatment arm. So we think it's a very patient friendly design from that standpoint. From a probability of success. I would say 12 versus 24 weeks is essentially the same because in night or time period. Do we expect splitenz?
You know, I think, in terms of probably a success, it's it's also a very attractive.
This concludes the Q&A session of the call, thank you for participating and I'll turn the call back over to Rich.
Thank you, operator. Thank you all for your continued support and for joining us today. Look forward to updating you on our progress, in the coming months. Operator, you may end the call.