Q1 2024 Vir Biotechnology Inc Earnings Call

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Operator: Hello. Welcome to Vir Biotechnology's 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 the listen-only mode. After the speaker's presentation, there will be a question and answer session. I will now turn the call over to Sasha Damouni-Ellis, Executive Vice President, Chief Corporate Affairs Officer. You may begin, Ms.

Speaker Change: Hello, welcome to Vir Biotechnology first quarter 'twenty to 'twenty, four financial results and business update call.

Speaker Change: Minder. This conference call is being recorded at this time all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session. I will now turn the call over to Sasha <unk> Ellis Executive Vice President Chief Corporate Affairs Officer, you May.

Sasha Damouni Ellis: Begin Mr ammonia Alice.

Sasha Damouni Ellis: Thank you and good afternoon with me today are Dr. Marianne de backer, Chief Executive Officer Dr.

Sasha Damouni Ellis: Thank you and good afternoon. With me today is Dr. Marianne DeBacker, Chief Executive Officer. Dr. Carey Hwang, Senior Vice President, Clinical Research and Interim Chief Medical Officer, and Sung Lee, Executive Vice President and Chief Financial Officer. Before we begin, I would like to remind everyone that some of the statements we are making today are forward-looking statements under the securities laws. These forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs' future results, performance, or achievements to differ significantly from those expressed or implied by such forward-looking statements.

Sasha Damouni Ellis: Dr carried Wong senior Vice President clinical research and interim Chief Medical Officer.

Sasha Damouni Ellis: And sung Lee Executive Vice President and Chief Financial Officer.

Sasha Damouni Ellis: Before we begin I would like to remind everyone that some of the statements. We're making today are forward looking statements under the securities laws.

Sasha Damouni Ellis: 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.

Sasha Damouni Ellis: These risks and uncertainties and risks associated with our business are described in the company's reports filed with the Securities and Exchange Commission, including forms 10-K, 10-Q and 8-K.

Sasha Damouni Ellis: These risks and uncertainties and risks associated with our business are described in the company's report, followed by the Securities and Exchange Commission, including Forms 10-K, 10-Q, and 8-K. I will now turn the call over to our CEO, Dr. Marianne DeBacker.

Speaker Change: I will now turn the call over to our CEO, Dr. Marianne tobacco.

Marianne De Backer: Thank you Sasha good afternoon to everyone on the West Coast and thank you all for joining us today.

Marianne De Backer: 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 pipelines and then to Sung to summarize our first quarter financial results. We will then open the line for questions.

Marianne De Backer: This afternoons call I will provide the initial remarks before returning Kerry to share an update on our clinical development programs and pipeline and then some to summarize our first quarter financial results.

Kerry: I'll open the line for questions.

Marianne De Backer: Before we proceed, I would like to highlight two recent updates. First, our board of directors has nominated two new independent directors. Dr. Norbert Bischofberger and Dr. Rami Fareed for election at our upcoming annual stockholders meeting. Dr. 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. Dr. Farid's pioneering work applying advanced computational methods to drug discovery at Schrodinger aligns perfectly with our focus on leveraging AI in drug discovery. Additionally, two of our long-serving directors, Dr. Philip Sharp and Robert Perez, won't be standing for re-election.

Kerry: Before we put C I would like to highlight two week update.

Sasha Damouni Ellis: First our board of Directors has nominated two new independent directors, Dr. Norbert Bischofberger and off to Rami ferry for election at our upcoming annual stockholders meeting.

Sasha Damouni Ellis: Officials brokers drive backwards overseeing more than 75 clinical development programs and drug approvals, including in hepatitis. During his tenure at Gilead is direct you would rather than I felt one programs progressed through mid and late stage trials.

Sasha Damouni Ellis: The far east pioneering work applying advanced computational methods to drug discovery, that's schrodinger aligns perfectly with our focus on leveraging AI and drug discovery.

Sasha Damouni Ellis: Two of our long serving director stopped to feel it's sharp and public threat won't be standing for reelection as founding board members.

Marianne De Backer: As founding board members, they made tremendous contributions, and I want to thank them for their dedicated service. Second, Sung Lee, our Chief Financial Officer, will be stepping down at the end of this week to pursue another career opportunity. Sung's leadership during his time at FEAR has been instrumental in building a talented financial team and implementing rigorous financial practices and controls. As a result, our finance organization is well positioned for continued success while we search for a successor. I would like to express my and the company's gratitude for Sung's contribution and wish him all the best in his new opportunities. Looking ahead, we expect 2024 to be a transformational year for VEER.

Speaker Change: Tremendous contributions and I want to thank them for their dedicated service.

Sasha Damouni Ellis: Second sung Lee, our Chief Financial Officer will be stepping down at the end of this week.

Sasha Damouni Ellis: Another career opportunity.

Sasha Damouni Ellis: Leadership during his time at fear has been instrumental in building a talented financial team and implementing rigorous financial practices and controls.

Sasha Damouni Ellis: Finance organization is well positioned for continued success, while we search for a successor.

Sasha Damouni Ellis: I would like to express my and the company's gratitude for subs contribution and wish him all the best in his new opportunity.

Sasha Damouni Ellis: Looking ahead, we expect 'twenty 'twenty four it could be a transformational year for year.

Marianne De Backer: 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 provincial markets. We continue to make progress on the goals we laid out in January. A key priority is to deliver on a mid-stage clinical pipeline, and I'll begin by discussing our ongoing phase 2 SOLSTICS trial in people living with chronic hepatitis delta. Our goal is to provide lifelong therapy that is impactful and convenient for patients in this area of substantial unmet medical need.

Sasha Damouni Ellis: 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 and large potential markets.

Sasha Damouni Ellis: Continue to make progress on the goals, we laid out in January.

Sasha Damouni Ellis: A key priority is to deliver on our mid stage clinical pipeline and I'll begin by discussing our ongoing phase II solstice trial in people living with chronic hepatitis Delta.

Sasha Damouni Ellis: Our goal is to provide a lifelong therapy that is impactful and convenient for patients in this area of substantial unmet medical need.

Marianne De Backer: 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 underdiagnosis and a lack of robust epidemiological data for chronic hepatitis delta, we do see positive momentum toward greater awareness and patient screening. For example, in March, the World Health Organization published updated guidelines for the prevention, diagnosis, care, and treatment of people with chronic hepatitis B, and this update included recommending hepatitis delta reflex testing for everyone who tests positive for hepatitis B.

Sasha Damouni Ellis: At least 12 million people globally are estimated to be living with hepatitis Delta.

Sasha Damouni Ellis: Used cases remain undiagnosed.

Sasha Damouni Ellis: While there are significant challenges, which are under diagnosis and Lego blocks. If you give me a logical data for chronic hepatitis Delta you do see positive momentum towards greater awareness and patient screening.

Sasha Damouni Ellis: For example in March the World Health organization published updated guidelines for prevention diagnosis and.

Sasha Damouni Ellis: And treatment of people with chronic hepatitis B and this update included recommending hepatitis Delta reflex testing, but everyone who tested positive for hepatitis B.

Marianne De Backer: This is a major step forward for both patients and researchers within the Hepatitis Delta community. Chronic hepatitis delta infection increases the risk of poor outcomes for patients compared to hepatitis B alone. There is approximately a four times greater risk of liver cancer, a two times greater risk of death, and more than half of these patients will die from liver disease within 10 years.

Sasha Damouni Ellis: This is a major step forward for both patients and researchers, but then the hepatitis Delta community.

Sasha Damouni Ellis: 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, two times greater risk of death and more than half of these patients will die from liver disease within 10 years.

Marianne De Backer: The need for a safe, efficacious, and convenient treatment for these patients is critical. In the first quarter, we completed enrollment of the current cohorts in the SALCIS trial one month ahead of schedule, and our late-breaker SALCIS Data Abstract was accepted for poster presentation at the European Association for the Study of the Liver, or EIVO, Congress 2024. We plan to host an investor conference call to discuss this data on June 5th. In the third quarter, we intend to engage with regulatory authorities to discuss the next steps for the development program.

Sasha Damouni Ellis: The need for a safe efficacious eye convenient treatment for these patients is critical.

Sasha Damouni Ellis: In the first quarter, we completed enrollment of the current cohorts into solve this 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 or equal Congress 'twenty 'twenty four right.

Sasha Damouni Ellis: Plan to host an Investor conference call to discuss its all this data on June 6th.

Sasha Damouni Ellis: In the third quarter, we intend to engage with regulatory authority to discuss the next steps for the development program.

Sasha Damouni Ellis: Shifting our focus to another area of high unmet medical need chronic hepatitis B, we are making progress in our efforts to achieve functional cure.

Marianne De Backer: Shifting our focus to another area of high 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 million people chronically infected and living with hepatitis B. Among this total population, only 13% of HPV-positive patients had been diagnosed, and only 3% were receiving treatment at the end of 2022. The WHO further estimated that 1.1 million people would die from viral hepatitis B in 2022 compared to an estimated 820,000 deaths in 2019.

Sasha Damouni Ellis: According to the World Health organization Global Hepatitis reports 2020 for an estimated 250 million people chronically infected with hepatitis B.

Sasha Damouni Ellis: Among the total population.

Sasha Damouni Ellis: 13% of HPV positive patients had been diagnosed and with only 3% receiving treatment at the end of 2022.

Sasha Damouni Ellis: So duffy it shows sort of estimated at $1 1 million people die from a viral hepatitis b in 2022.

Sasha Damouni Ellis: <unk> to an estimated 820000 deaths in 2019.

Marianne De Backer: At Veo, we are committed to addressing this global health crisis and this concerning increase in deaths, and we believe our two therapeutic candidates, Bevy Bart and Elapseron, have the potential to make a meaningful impact. Tobetti, Bard, and Lapseron are being studied in our ongoing Phase 2 MARSH trial in combination with and without speck interferon alpha. Our aim is that our two therapeutic candidates can help us achieve our goal of a 30% or higher functional cure rate.

Sasha Damouni Ellis: And here, we are committed to addressing this global health crisis and its concerning increase in deaths.

Sasha Damouni Ellis: I believe our two therapeutic candidate to Betsy Bart and <unk> has the potential to make a meaningful impact.

Sasha Damouni Ellis: So Betsy Barton that's wrong are being studied in our ongoing phase two March trial in combination with and without peg interferon Alpha.

Sasha Damouni Ellis: Our aim is that our two therapeutic candidates can help us achieve our goal of 30% or higher functional cure rate.

Marianne De Backer: While this is our stated goal, KOLs we hosted at an advisory board last year at AESLD expressed a 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 Part B trial at a major medical congress in the fourth quarter.

Sasha Damouni Ellis: Well. This is a stated goal Kols, we hosted an advisory board last year at E. S. L. D expressed the desire for 20% or better for a regimen that includes interferon and less than that we're an interferon free regimen.

Sasha Damouni Ellis: We expect to report 48 week Amdocs treatment data for the March part B trial at a major medical Congress in the fourth quarter.

Marianne De Backer: Subsequently, we expect to share functional cure data in the second quarter of 2025. Now, I will briefly discuss PR1388, our HRV 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 PIR-1949, a preclinical therapeutic vaccine for the control of precancerous lesions and cancers caused by HPV.

Sasha Damouni Ellis: Subsequently, we expect to share functional cure data in the second quarter of 2025.

Sasha Damouni Ellis: Now I will briefly discuss pier 13, 88, our HIV T cell vaccine candidates currently being evaluated in a phase one trial.

Sasha Damouni Ellis: Looking forward to sharing initial immunologic proof of concept data in the second half of this year.

Sasha Damouni Ellis: If the data supports the validity of the platform it could be a springboard into other indications, including <unk> 1949, a preclinical therapeutic vaccine for control precancerous lesions and cancers caused by HPV.

Sasha Damouni Ellis: This trial is supported by the National Institute of allergy and infectious diseases part of the NIH under development the Gates Foundation.

Marianne De Backer: This trial is supported by the National Institute of Allergy and Infectious Diseases, part of the NIH, and the Bill and 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 Daily, BASI enables fast and cost-efficient optimization of multiple properties, such as binding affinity, neutralization, potency, and developability, and we have applied it to over 10 investigational monoclonal antibodies across multiple projects.

Sasha Damouni Ellis: Yeah.

Sasha Damouni Ellis: In research, we continue to advance multiple investigational antibody therapeutics optimized for increased likelihood of development success.

Sasha Damouni Ellis: Thanks to our proprietary platform powered by AI and machine learning called Daisy.

Sasha Damouni Ellis: Safety enabled fast and cost efficient optimization of multiple properties such as binding affinity trial.

Sasha Damouni Ellis: Asia potency and develop ability.

Sasha Damouni Ellis: Have applied it to over 10, investigational monoclonal antibodies across multiple projects.

Sasha Damouni Ellis: Our most advanced preclinical programs are prophylactic antibody for influenza and RSV <unk> MPV and COVID-19. In addition, we are developing a cocktail of broadly neutralizing antibodies for an HIV cure.

Marianne De Backer: Our most advanced preclinical programs are prophylactic antibodies for Influenza A and B, RNC and or MPV, and COVID-19. In addition, we are developing a cocktail of broadly neutralizing antibodies for an HIV cure. We look forward to sharing more about these programs during the course of the year and at our R&D day in late November. Now turning to our cash and investments, our balance sheet enables us to fund our clinical programs through major inflection points while providing the flexibility to invest in external innovation.

Sasha Damouni Ellis: Look forward to sharing more about these programs during the course of the year and that's our R&D day in late November.

Sasha Damouni Ellis: Now turning to our cash and investments our balance sheet enables us to fund our clinical program to a major inflection points, while providing the flexibility to invest in external innovation.

Marianne De Backer: We are closely managing our expenses and prudently investing in programs with the greatest opportunity to drive returns 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, Mary.

Sasha Damouni Ellis: We are closely managing our expenses and prudently investing in programs with the greatest opportunity to drive return for our shareholders.

Speaker Change: To conclude I would like to acknowledge and thank our employees partners clinical trial participants and shareholders, who help make this all possible.

Speaker Change: With that I'll turn the call over to Kerry.

Kerry: Thank you Mary Anne.

Carey Hwang: 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 SOLSTICE trial is evaluating tubivibart in combination with lepsoran and tubivibart alone as a potential chronic treatment for people living with chronic hepatitis delta. Based on the initial data reported, we observed rapid declines in HGV RNA. Five out of six participants had undetectable HGV RNA, and six out of six were below the lower limit of quantification within 12 weeks of starting combination therapy.

Kerry: I'll begin by reminding you about the initial results from our phase III trial on hepatitis Delta, which was shared a late breaker presentation at <unk> last year and discussed earlier this year.

Kerry: The focused trial is evaluating <unk> in combination with <unk> and <unk> as a potential product treatment for people living with chronic hepatitis Delta.

Kerry: Based on the initial data reported we observed a rapid declines in HCV RNA five out of six participants had undetectable HBV RNA and six out of six were below the limit a lower limit of qualification within 12 weeks starting combination therapy.

Carey Hwang: Two out of the six participants also achieved ALT. As Marianne mentioned, we completed enrollments for greater than 60 participants across two cohorts one month earlier than anticipated. Physician enthusiasm at ASLD was significant, and this contributed to the rapid rate of enrollment.

Kerry: Two out of six participants also achieved ALG liberalization.

Kerry: As Barry mentioned, we completed enrollment for greater than 60 participants across two cohorts one month earlier than anticipated.

Kerry: Physician enthusiasm that <unk> was significant and this contributed to the rapid rate of enrollment.

Carey Hwang: One group is receiving Tabitha BART plus Alep Seren combination therapy every four weeks, and a second group is receiving Tabitha BART 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.

Kerry: One group is receiving <unk> plus <unk> combination therapy every four weeks and the second group because we're seeking to deliver Bart monotherapy every two weeks.

Kerry: Approximately 50% of participants of compensated cirrhosis or CPT.

Kerry: Overall around 40% of patients with hepatitis Delta develop cirrhosis with an average of approximately five years to progression.

Carey Hwang: 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 design. We plan to share updated data on additional SOSUS participants in a Late Breaker Data Abstract that was accepted for poster presentation at the ESL Congress. Specifically, we will share data on approximately 15 participants per regimen at 12 weeks and approximately 10 participants per regimen at 24 weeks.

Kerry: Therefore, it is important to include patients with cirrhosis and trial to understand how our treatment impacts those with more progressive disease.

Kerry: This type of information can help optimize treatment strategies in the future and inform our future trial designs.

Kerry: We plan to share updated data on additional posters participants as a late breaker data abstract was accepted for poster presentation I think diesel Congress.

Kerry: Specifically, we will share data on approximately 15 participants per regimen at 12 weeks in approximately 10 participants per regimen at 24 weeks.

Carey Hwang: Additional follow-up for the initial six Solstice to Child participants will also be shared. Complete 24-week treatment data for Salsas participants in these two courts is expected in the fourth quarter of 2024. We foresee that the Solstice Data Update at ESO will be highly informative and will shed light on several key areas. First, we anticipate gaining greater clarity on the safety profiles of Biffle Park and MIS-TER together with Alephster

Kerry: Follow up for the initial fixed pulsar trial participants will also be shared at that time.

Kerry: Complete 24 week treatment data for solstice participants of these two courts is expected in the fourth quarter of 2024.

Kerry: We foresee that the solstice data update on diesel will be highly informative who will shed light on several key areas.

Kerry: First we anticipate getting greater clarity on the safety profile for <unk> administered together with the <unk>.

Carey Hwang: Second, 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 ASLT. If the data are supportive, we will dialogue with health authorities about the development program later this year.

Kerry: Second we expect to obtain additional insight the biologic response rates in <unk>.

Kerry: Third we aim to evaluate whether there are initial efficacy or safety differences between cirrhotic and non cirrhotic participants.

Kerry: 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 <unk>.

Kerry: If the data are supportive we will dialogue with health authorities about the development program later this year.

Carey Hwang: We expect Vir's next trial will be designed with Belivertide 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 suggest that when lefseran was administered with PEG-interferon 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 maintained hepatitis B surface antigen loss 24 weeks after the end of treatment.

Kerry: We expect veers next trial will be designed with deliver tied as a comparator.

Kerry: Have greater clarity on potential trial designs following discussions with health authorities.

Kerry: Switching gears for a phase III program for chronic hepatitis B. Our preliminary data suggests that when <unk> was administered with peg interferon alpha for up to 48 weeks about 26% of participants achieve hepatitis b surface antigen loss at the end of treatment and a 16% achieve functional cure, meaning they may.

Kerry: Train hepatitis B surface antigen loss 24 weeks after the end of treatment.

Carey Hwang: Current therapies, such as NRTIs, require lifelong therapy but rarely achieve functional cure. The only other therapy approved for hepatitis B is titanoferone alpha, which has a low functional cure rate of 3% to 7% and poor tolerability. In the March trial, when adding tobivibart to a regimen of Elefseran alone or Elefseran plus PEG interferon alpha, we observed an almost three-fold increase in end-of-treatment response rates at 24 weeks of treatment. These data were the first indication of the potentially important role of an HPV-directed antibody in hepatitis B functional cure.

Kerry: Current therapies, such as <unk> require lifelong therapy, but rarely achieve functional cure.

Kerry: The only other therapy approved for hepatitis B as peg interferon Alpha, which has a low functional cure rate of 3% to 7% with poor tolerability.

Kerry: As of March trial, while adding this apart to a regimen of ellipse around alone or less ramp up peg interferon Alpha we observed an almost threefold increase in the treatment response rates at 24 weeks of treatment.

Kerry: These data were the first indications are potentially important role of an HPV directed antibody in hepatitis B functional cure.

Carey Hwang: 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 VR2482 Peninsula trial data manuscript in MedArchive. We are applying key learnings from the Peninsula trial to our next generation prophylactic flu antibody, BIRD2981.

Kerry: We look forward to sharing and the treatment data from the March part B trial, which is evaluating 48 weeks of the doublet and triplet regimens in the fourth quarter.

Kerry: This readout will be followed by post treatment data in the second quarter of 2025, which will allow us to assess functional cure rates.

Kerry: Finally, we recently published the full year 2482 collateral of trial data manuscript and met archives.

Kerry: We are applying key learnings from the political trials of our next generation of prophylactic flu antibody 2009 to 81.

Carey Hwang: Now turning to our early stage pipeline, Vir 1949 is an investigational therapeutic T cell vaccine based on our HCMV vector platform and is designed to treat precancerous lesions caused by the human papillomavirus. Despite advances in vaccination and screening, HPV-associated cancers and conditions, such as high-grade squamous intraepithelial lesions, remain significant global health concerns. We look forward to sharing more later this year about this program and the timing of a potential IND submission.

Kerry: Now turning to our early stage pipeline beer <unk> 1949 is an investigational therapeutic T cell vaccine based on our <unk> platform and is designed to treat pre cancerous lesions caused by the human papilloma virus.

Kerry: Despite advances and vaccination of screening HPV associated cancers in conditions, such as high grade squamous epithelium lesions remains significant global health concerns.

Kerry: We look forward to sharing more later this year about this program and the timing of a potential IND submission.

Kerry: We are 7% to nine is a next generation COVID-19, monoclonal antibody candidate with increased potency breadth and resistance to <unk>, thanks to AI engineering and optimization the.

Carey Hwang: MIR7229 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 FEAR-7229 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&D day planned for late November. I will now turn the call over to Sung.

Kerry: The development of your someone through two nine through the end of phase one is supported by BARDA.

Kerry: We look forward to continuing to share our progress over the coming quarters and during a virtual R&D day planned for late November.

Kerry: I will now turn the call over to sung.

Sung H. Lee: Before I get to the financial results, I would like to take this moment to thank Marianne and the board for the opportunity to make an impact at 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.

Sung H. Lee: Thank you Gary 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 as the year I've.

Sung H. Lee: Truly enjoying my time as CFO and I am proud of what we have to accomplish.

Sung H. Lee: I'm confident that the company in the finance organization are well positioned for continued success with that I will now share the financial results for the first quarter of 2024.

Sung H. Lee: 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 revenue. However, 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.

Sung H. Lee: Total revenues in the first quarter of 2024 were $56 4 million compared to $63 million for the same period in 2023.

Sung H. Lee: As anticipated we saw year over year declines in collaboration in grant revenues.

Sung H. Lee: 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.

Sung H. Lee: 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 for the same period in 2023. The decrease was primarily driven by lower clinical development and manufacturing costs related to VR-2482. SG&A expenses in the first quarter of 2024 were $36.3 million, compared to $46.8 million in the same period of 2023. The decrease was primarily driven by disciplined expense management, which resulted in a significant reduction in external expenses.

Sung H. Lee: Turning to operating expenses cost of revenue for the first quarter of 2020 forward was nominal compared to $1 9 million for the same period in 2023.

Kerry: R&D expenses in the first quarter of 2024 were $100 $1 million compared to $157 6 million in the same period in 2023.

Kerry: The decrease was primarily driven by lower clinical development and manufacturing costs related to severe 2482.

Kerry: SG&A expenses in the first quarter of 2024 were $36 3 million compared to $46 8 million in the same period in 2023.

Kerry: The decrease was primarily driven by disciplined expense management, which resulted in a significant reduction in external expenses.

Sung H. Lee: 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. Now, turning to our financial guidance for 2024. The year is progressing as expected, and we are reiterating all aspects of our guidance, which can be found on slide 28 of our corporate presentation. We will continue to be disciplined in managing our expenses and focus our investments on programs with the greatest opportunity to drive return for shareholders. I will now turn the call back to Sasha.

Kerry: Moving to the balance sheet. We ended the first quarter of 2024 with cash cash equivalents and investments of $1 $5 1 billion compared to $1 $63 billion at the end.

Kerry: End of 2023.

Kerry: Presenting a $118 million decline quarter over quarter.

Kerry: 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.

Kerry: 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.

Kerry: I will now turn the call back to Sasha.

Sasha Damouni Ellis: Thank you, Sung. We will now start the Q&A section. Please limit 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.

Sasha Damouni Ellis: Thank you sung will now start the Q&A session. Please limit questions to two per person. So that we are able to get to all of our covering analysts.

Speaker Change: Operator, please open up the line for questions.

Operator: Thank you. We will now begin the question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. If you wish to cancel the request, please press star 1 again. Your first question comes from the line of Gina Wang of Barclays. Your line is now open.

Sasha Damouni Ellis: Thank you we will now begin the question and answer session. If you would like to ask a question. Please press star one on your telephone keypad, if you wish to cancel their request. Please press star one again.

Sasha Damouni Ellis: Your first question comes from the line of Gena Wang.

Gena Wang: Of Barclays. Your line is now open.

Huidong Wang: Thank you for taking my questions. Sung, my best wishes for your next journey.

Gena Wang: Thank you for taking my questions.

Gena Wang: My best wishes to your next journey.

Gena Wang: I have two questions regarding HBV.

Huidong Wang: I have two questions regarding HDV. First, regarding patients with baseline cirrhosis, any restriction or exclusion criteria for cirrhotic conditions? And my second question is, which measurement will be more meaningful in your view regarding the lower limit of quantification and the limit of detection? And is the phase 2 efficacy data setting a bar for ease or update?

Gena Wang: First question is.

Analyst: Guarding patient with baseline cirrhosis, any restriction or exclusion criteria fusaro condition and my second question is which measurement will be more meaningful in your view regarding the lower limit of <unk>.

Analyst: Quantification and limit of detection and is the phase two efficacy data setting a bar for easily update.

Marianne De Backer: Thank you very much for that question and for those questions, Gina, which are very, very relevant. I will ask Kareem to address them. Great. Thank you, Gina.

Speaker Change: Thank you very much for that question.

Speaker Change: For those questions Gena with shelf Orange very relevant I will ask Kerry to address them.

Carey Hwang: Great. Thank you, Gina.

Carey Hwang: So for your first question around baseline cirrhosis and restrictions in our trial, so as I mentioned, in the two new cohorts that we enrolled in Solstice, we included CPTA patients, so they have compensated cirrhosis, and so we have about 50% of those participants in those two new cohorts, and so this will help us inform, you know, going forward, the safety and efficacy of our regimen in those populations. So we look forward to, you know, looking at whether there are any differences between cirrhotics and non-cirrhotics in that population.

Kerry: Thank you Tina so for your first question around baseline fibrosis restrictions of our trial. So as I mentioned, the two new cohorts that we enrolled and solstice. We included CPG a ah patients. So they have compensated cirrhosis and so we have about 50% of those participants.

Speaker Change: Two new cohorts and so this will help us.

Gena Wang: Going forward.

Gena Wang: Safety and efficacy of our regimen in those populations. So.

Gena Wang: So we look forward to looking at.

Gena Wang: Any if there are any differences between cirrhotic and novelty products about population.

Carey Hwang: And in regards to your second question around which measurement, lower limit of quantification, or limited detection, different assays have different cutoffs for those parameters. And so this 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 clarify with regulators.

Speaker Change: In regards to your second question, our output measurement are lower than the qualification of our limit of detection.

Gena Wang: Different assays have different cutoffs.

Gena Wang: Those.

Gena Wang: Parameters.

Gena Wang: These will be discussed with regulatory authorities in terms of which of these parameters would be acceptable from our endpoint perspective, So I can't answer that right now, but we'll see.

Gena Wang: That will be something that we will have it will be will clarify with regulators.

Gena Wang: And the boss legal update.

Carey Hwang: Right, and then the last question is whether the EPO-FULSIS data will be setting a new efficacy bar. As you're familiar with from our ASLD presentation with our first six participants, we were able to achieve 6 out of 6 that achieved httpRNA less-than-limit quantification and 5 out of 6 that were undetectable or less-than-limit 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 Change: Alright, and then the last question.

Speaker Change: Other than the Eagle Ford is that data with me, starting a new efficacy bar.

Gena Wang: As you're familiar with from our ALLL day presentation from our six purchase first six participants were able to achieve $6 six that achieved HBV RNA last time, and the qualification and $5 six that were undetectable or lessor in the detection I think if we are able to demonstrate these.

Gena Wang: <unk> in a larger population than I think that that could set a new efficacy bar because as with any chronic viral disease. The goal is always to suppress.

Gena Wang: Viral replication to unsustainable levels, such as in HIV and so if we're able to do that I think that with the benchmark.

Speaker Change: Thank you very much.

Gena Wang: Okay.

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

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

Paul Choi: 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 Solstice, and could you maybe just clarify for us, particularly among the patients for which you'll have the 12-week, additional 12-week update versus those who have had the 24-week treatment update, you know, how you think that baseline of half the patients having cirrhosis might affect those particular updates.

Paul Choi: Hi, Thank you good afternoon, and thank you for taking our questions.

Paul Choi: I want to follow up on <unk> questions regarding.

Paul Choi: The compensated cirrhosis population.

Paul Choi: And solstice and could you maybe just clarify for us, particularly among.

Paul Choi: Among the patients for which you will have the 12 week additional topic update versus those who had the 24 week treatment update.

Paul Choi: How youre thinking that baseline of applications, having cirrhosis might affect those particular.

Paul Choi: 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 81-90? Thank you.

Paul Choi: Updates.

Paul Choi: Then my second question is in terms of the earlier stage pipeline.

Paul Choi: Just given the success that we've seen with the Bay area.

Paul Choi: RSV drugs from both GSK and Pfizer in terms of recent market success.

Paul Choi: 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 80 190 <unk>. Thank you.

Speaker Change: Yes. Thank.

Carey Hwang: So, thank you, Paul, for the question. In terms of how we think cirrhosis might affect safety or efficacy, we have done an 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 the safety or efficacy profile between those two populations.

Speaker Change: Thank you Paul for the question. So in terms of how we think cirrhosis might affect safety or efficacy and we have done.

Speaker Change: Initial hepatic impairment study in CPA participants have not seen any safety signals or any clinically significant changes.

Speaker Change: P J.

Speaker Change: Cause us any concern.

Speaker Change: So our expectation is that this compensated.

Speaker Change: Compensated cirrhotic cirrhotic population.

Speaker Change: We should not see any significant differences in terms of the safety or efficacy profile between those two populations.

Speaker Change: We'll have that data coming out relatively soon.

Carey Hwang: And, you know, we will have that data coming out relatively soon. In terms of, you know, 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, you know, looking at the profile of BR8190 or other potential monoclonal antibodies. And so we certainly only want to present or kind of progress antibodies that fill an unmet need in the space.

Speaker Change: 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.

Speaker Change: At the profile of BRL 190, or other potential mothball antibodies and so we've probably.

Speaker Change: Only one.

Speaker Change: Kind of progressed antibodies that fill an unmet need in the space and so those are ongoing discussions that will help our partners to make those decisions.

Speaker Change: Great. Thank you.

Speaker Change: Your next question comes from the line of Alex China Head of Bank of America. Your line is open.

Alec Warren Stranahan: Your next question comes from the line of Alec Stranahan of Bank of America. Your line is open. Hey guys.

Alec Warren Stranahan: 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, you know, 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 go, no-go on a Phase 3 in this setting? Sounds like you'll likely wait until the additional 24-week data becomes available, even though you may have already...

Unknown Executive: Hey, guys. Thanks for taking my questions just a couple from us as well I guess first how should we be thinking about the ego update in the context of the more advanced update expected in <unk> I guess.

Unknown Executive: In terms of which question do you think we will have to answer that diesel versus what it'll be.

Speaker Change: Outstanding for the <unk> data and as a follow up what would inform a go no go on the phase III.

Speaker Change: In the setting it sounds like Youll likely wait until the additional 24 week data becomes available even though you may have already aligned with regulators on that our next steps in <unk>.

Carey Hwang: Great. Yeah, thank you, Alec. So in terms of the data that we will have at ESOL, we will have about 15 participants in each of the cohorts at week 12, and about 10 participants in each cohort at week 24. So, you know, four things that we would be looking at at this time point. Number one, the safety profiles of the VBAR and the left upsurge combination. Number two, what the virologic response rates and ALT normalization rates are. Third, the potential efficacy and safety differences between serotic and non-serotic participants.

Speaker Change: Great.

Speaker Change: Thank you Alex so in terms of how we would think about the data that we will have is also 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.

Unknown Executive: For things that we would be looking at.

Unknown Executive: At this time point number one the safety profile of the bar.

Unknown Executive: Threat simulation number too, but the Virologic response rates on LTE normalization rates, our third the potential efficacy and safety differences between cirrhotic and non cirrhotic patient participants and then finally.

Carey Hwang: And then finally, the longer-term follow-up data on the initial six participants that we reported at ASLB to see if we have durability of response over time. So I think, you know, the ESOL data will 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. And then, obviously, the 24-week data would be the complete data set across those two populations.

Unknown Executive: But longer term follow up data on the initial six participants that we reported <unk> to see if we have durability of response over time. So I think the evil data wall further hopefully further expand the data set that we have from the initial fixed and confirm the directionality of what we're seeing in terms of efficacy and safety.

Unknown Executive: And then obviously the 24 week data would be the complete data set across those two populations.

Unknown Executive: So in terms of your second question around what would inform a go no go on.

Carey Hwang: So in terms of your second question around what would inform a go-no-go decision on a phase three for Delta, I think, you know, it depends on the strength of the data. I think if our data is strong enough, I think that would be a possibility of taking that forward for conversations.

Unknown Executive: Phase III adult trial.

Unknown Executive: So I think yes.

Unknown Executive: It depends on the strength of the data I think if our data what biodiesel data cutoff. We believe that is strong enough I think that would be a possibility of taking that.

Unknown Executive: Forward for conversations.

Unknown Executive: But it all depends on the strength of that data going forward. Obviously, the 24 weeks will be the complete dataset, but if we have a very strong indication of efficacy.

Unknown Executive: I think we can go earlier.

Speaker Change: Great. Thanks, Dan Thanks, a lot.

Alec Warren Stranahan: Great, it makes sense. Thanks a lot.

Speaker Change: Your next question comes from the line of <unk> <unk> of TD Cowen. Your line is now open.

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

Philip M. Nadeau: Good afternoon. Thanks for taking our questions, and let us add our best wishes to Sung as he moves on. Two from us.

Speaker Change: Good afternoon, and thanks for taking my questions and what is our best wishes to song as he moves on.

Philip M. Nadeau: So first, as you just highlighted, durability response is a key question that's going to be answered by both the ECL and Q4 updates. Is there any reason to worry that the effect could be lost for the combination regimen or monotherapy regimen over time? Are there any preclinical signs that resistance could develop in hepatitis delta?

Speaker Change: Two from us so first.

TD Cowen: As you just highlighted durability of response is a key question that's going to be answered by put that 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.

Speaker Change: Preclinical signs that resistance could develop.

Speaker Change: And that price Delta.

Speaker Change: Then second totally unrelated on business development with one 5 billion in cash can you talk a bit about the environment youre seeing in business development.

Philip M. Nadeau: And then second, totally unrelated to business development with $1.5 billion in cash. Can you talk a bit about the environment you're seeing in business development and what your most recent thoughts are on priorities for investing externally? Thanks.

Unknown Executive: Most recent thoughts are on priorities for investing externally. Thanks.

Marianne De Backer: Thank you for those questions, Phil. And maybe we'll get to your second question first.

Speaker Change: Thank you for those questions Phil maybe bill.

Speaker Change: Getting to your second question first yes.

Marianne De Backer: Yes, we have shared. You know, we are in a great position where 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, you know, early clinical programs would be of interest there. And we continue to be very thoughtful and strategic in looking at those opportunities and discerning whether those would be a great fit for us and creating value for the company and our shareholders.

Speaker Change: Yes, we have shared.

Speaker Change: We are in and integrate position that we can really use our strong balance sheet to fund our priorities and of course that is hepatitis Delta and hepatitis B and our pipeline. However, we also have the opportunity to look for external.

Unknown Executive: Ovation and especially you know early clinical programs would be of interest there and we continue to be very thoughtful and strategic in looking at those opportunities.

Unknown Executive: Discerning whether dose would be a great fit for us and creating value for the company and our shareholders.

Unknown Executive: I will ask Gary to answer your question relates to durability of response.

Marianne De Backer: Thank you, Marianne. And thank you, Phil, for the question.

Gary: Thank you Mara and thank you Phil for the question. So your question around durability of response would we expect to see.

Gary: Resistance or loss of durable durability with our client hepatitis Delta regimen.

Carey Hwang: So your question around durability of response, would we expect to see any resistance or loss of durability with our applied hepatitis delta regimen? So I think, you know, based on what we've seen to date. We have some in vitro data, and we haven't seen any resistance to date. We have a lot of hepatitis B data, like looking at surface antigen, and we haven't seen rebalancing of the hepatitis surface antigen over time with a combination of the lepsor and the VAR coming together.

Gary: So I think based on what we've seen to date, we have some in vitro data and we haven't seen any resistance to date, we have a lot of hepatitis b data looking at surface antigen and we haven't seen.

Unknown Executive: Rebalancing hepatitis surface antigen over time with a combination of.

Unknown Executive: <unk> are coming together and I think.

Carey Hwang: And I think, As with other chronic infectious diseases, both Alec Stranahan and Joseph Barr work through two different mechanisms. And because we're working through two different mechanisms in terms of inhibiting levels of surface antigen and then HDB RNA, the likelihood of developing resistance is much less compared to if you were going forward with a model therapy. So time will tell, but based on what we know so far from hepatitis B, some of our in vitro work, and what the expectations are with having two different independent mechanisms against the virus, my guess is that rebound and resistance would be rare.

Unknown Executive: As with other chronic infectious diseases, both <unk>, both a bar work through two different mechanisms and because we're working through two different mechanisms in terms of inhibiting <unk>.

Unknown Executive: Levels of surface antigen and HBV RNA.

Unknown Executive: The likelihood of developing resistance is much less compared to if you were going forward with a model therapy. So time will tell but based on what we know so far from hepatitis B some of our in vitro work.

Unknown Executive: What the expectations are with having two different independent mechanism against the virus.

Unknown Executive: My guess is that.

Unknown Executive: Rebalanced and resistance would be rare.

Speaker Change: That's very helpful. Thank you.

Patrick Ralph Trucchio: Your next question comes from the line of Patrick Trucchio of HC Wainwright. Your line is now open.

Unknown Executive: Your next question comes from the line of Patrick <unk> of H C. Wainwright. Your line is now open.

Patrick Ralph Trucchio: Thanks. Good afternoon. I have just a couple of questions from me. The first is about the DELTA program.

Unknown Executive: Thanks.

Patrick: Good afternoon, just a couple of questions from me. The first is just on the Delta program.

Patrick Ralph Trucchio: Given the lack of treatments available, I'm wondering if there is a possibility for an accelerated pathway to approval depending on the outcome from Solstice and what that might look like in terms of potential phase 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, you know, related to this, how important is it to demonstrate loss of surface antigen and all comers relative to the patient cohort with relative risk?

Patrick: Given the lack of treatments available I'm wondering if you can talk about if there is a possibility for an accelerated pathway to approval depending on the outcome from solstice.

Patrick: What that might look like in terms of potential phase III in pathway to approval.

Patrick: And then just on the.

Patrick: <unk> HBV program Im wondering if you can talk about.

Patrick: Whether you expect to have data segmented based on surface antigen levels at baseline and if so what levels of baseline would you expect to report this data.

Patrick: Related to this how important is it to demonstrate loss of surface antigen and all comers relative to patient cohort.

Patrick: Relative lower foreign circumstances, especially as you consider potential advancements to the program of the program to phase III.

Speaker Change: Great. Thank you Patrick for the questions.

Carey Hwang: Thank you, Patrick, for the question. 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 can accelerate paths to approval, such as fast track, breakthrough, prime, and these other methods that are available to us from regulatory agencies.

Patrick: So in terms of hepatitis Delta pop.

Speaker Change: Possibilities for accelerated pathways as you know there is no therapy is 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.

Speaker Change: Paths to approval such as fast track breakthrough Prime and these other methods that are available to us from a regulatory agencies. So we will be looking at those pathways to move forward and to facilitate discussions with regulators as we.

Carey Hwang: So, we will be looking at those pathways to move forward and to facilitate discussions with regulators as we develop and get alignment on our registrational pathway going forward. And then, in terms of your second question around hepatitis B, will we be looking at the segmented data by surface antigen levels? 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 levels less than 3,000 or 1,000.

Speaker Change: A quick follow up or get alignment on our registrational pathway going forward.

Speaker Change: And then in terms of your second question around hepatitis B.

Carey Hwang: These segment looking at the segment data by surface antigen levels. So absent an arch files actually to date in our hepatitis B trials, we have taken all commerce.

Speaker Change: We are not just enrolling participants with surface antigen less than 3000, or 1000 were taking a broader view, but we will be able to look at subgroups within our datasets to see whether certain cutoff increase.

Carey Hwang: 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 seroclearance rates for surface antigens. So those will be areas that we will be evaluating and looking at in our data sets.

Speaker Change: Fewer clearance rates in surface antigen. So those will be areas that we will be evaluating in forecasting our datasets.

Speaker Change: Your next question comes from the line of <unk> of Leerink Partners. Your line is open.

Roanna Clarissa H. Ruiz: Your next question comes from the line of Roanna Ruiz of Lyrinc Partners. Your line is open.

Roanna Clarissa H. Ruiz: Hi, this is Rosa Chen speaking on behalf of Roanna Ruiz at Learning Partners. Thanks so much for taking our questions. First, a couple on HDV. So for Solstice, what level of ALT normalization are you expecting to see in the upcoming data at ESL, given that we didn't really see meaningful normalization in the early data that you presented last year?

Speaker Change: Hi, This is Rosa Chen on for <unk> at Leerink partners. Thanks, So much for taking our question.

Roanna Clarissa H. Ruiz: First a couple on H D D. So first of all did well.

Rosa Chen: Level of LT normalization are you expecting to see in the upcoming data at <unk> given that we didn't really see meaningful normalization and the early data that you presented last year.

Carey Hwang: Great. Thank you. Thank you, Rosa, for the question.

Speaker Change: Greg. Thank you. Thank you Rosemarie further question, so I think that the data set from our ASR D.

Carey Hwang: It was small numbers, we only have six participants we had two out of six that achieved ALG normalization, but.

Carey Hwang: Participants, who did not achieve <unk> amortization, 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.

Carey Hwang: So I think the data set from our ASLD set was small numbers; we only had six participants; we had two out of the six that achieved ALT normalization. But of the participants who did not achieve ALT normalization, a majority of those were just around that upper limit of normal. And so I think with potential longer treatment, we may see more normalization. But with this data set coming out at ESL, 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, you know, with this regimen going forward.

Carey Hwang: But this data set coming out.

Carey Hwang: So we will have a more robust data set so that will help inform us further in terms of what we would expect to see in terms of ALG normalization.

Carey Hwang: With this regimen going forward.

Roanna Clarissa H. Ruiz: Okay, I got it. Thanks. And then another one on HDV.

Speaker Change: Okay got it thanks, and then another one on H D V. So we haven't heard too much recently about have crew, Texas Resubmission in the U S.

Roanna Clarissa H. Ruiz: So, we haven't heard too much recently about hepacludex's resubmission in the U.S. So, can you share how you guys are thinking about maybe the competitive positioning of your regimen versus hepacludex? And how are you thinking about maybe the patients who could be more responsive to your regimen versus hepacludex if both are available? Yeah, thanks for that question.

Roanna Clarissa H. Ruiz: So can you share how you guys are thinking about maybe the competitive positioning of your regimen versus how codecs.

Roanna Clarissa H. Ruiz: How are you thinking about maybe the patients who can be more responsive to your regimen versus <unk>. If both are available.

Speaker Change: Yes, thanks for that question.

Carey Hwang: So I think, as you said, it's not approved in the US, but as I mentioned in my prepared remarks, that we would plan to have Bolivar Tide as our comparator in our trials going forward. And based on, you know, at least what we've seen 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.

Speaker Change: So I think as we've said, it's not approved in the U S. But as I mentioned in my prepared remarks that we would plan to have delivered height of our comparator in our trials going forward.

Carey Hwang: Based on what we see from the first six participants at our ability to really get to undetectable level 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 virological suppression.

Carey Hwang: 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 sub-Q once monthly, which is also a potential differentiator there as well. And also because, as I mentioned previously in a previous answer, we are attacking the Delta virus through two different mechanisms. You know, there's less of a concern with

Carey Hwang: For any therapy in chronic viral diseases.

Carey Hwang: We're able to.

Carey Hwang: Demonstrate that in a larger data set that gives us further confidence in moving forward. In addition, I think the regimen that we are developing is also being administered sub Q. Once monthly which is also a potential differentiator there as well I think also because as I mentioned previously in a previous answer.

Carey Hwang: We are attacking the delta virus through two different mechanisms.

Carey Hwang: Theres less of a concern with with resistance or non response.

Carey Hwang: Different patient populations.

Roanna Clarissa H. Ruiz: 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?

Carey Hwang: Super helpful. If I could squeeze one for HBV. So as it relates to that fiber to drive 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.

Carey Hwang: Yeah, the reason we are studying these populations is because these populations have kind of the strongest immune responses to be able to be in that stage of hepatitis B. However, you know, in these populations, they're not 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 the overall prevalence of these subpopulations overall, it's a little bit unclear, but this is something that we are looking at specifically in these populations, trying to recruit and find to be able to determine whether we can achieve functional cures at higher rates in these populations compared to your chronic suppressed population.

Roanna Clarissa H. Ruiz: Yes. The reason we are studying these populations because these populations have kind of the strongest immune response would be able to be about stage of hepatitis b.

Speaker Change: However, these populations thereabout normally.

Carey Hwang: Guidelines indicated for treatment and so piece.

Carey Hwang: Patient populations are a little bit more difficult to find southern terms.

Carey Hwang: The overall prevalence of these subpopulations overall I mean is this 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.

Carey Hwang: These populations compared to your.

Carey Hwang: The chronic suppressed population.

Roanna Clarissa H. Ruiz: Got it. Thanks so much for the clarification. That's it for me.

Speaker Change: Got it thanks, so much for Macquarie.

Speaker Change: That's it for me.

Roanna Clarissa H. Ruiz: Your next question comes from the line of Joseph Stringer of Needham Your line is open.

Joseph Robert Stringer: Your next question comes from the line of Joseph Stringer of Needham. Your line is open.

Joseph Robert Stringer: Hi, Thank you for taking our question just wanted to get your updated thoughts on functional cure rates for HBV.

Joseph Robert Stringer: Hi, thank you for taking our question. I just wanted to get your updated thoughts on functional curatives for HBV. You mentioned, based on some recent KLL feedback, 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 curate where, say, a certain percentage of docs would use the treatment? And would that be higher than the sort of numbers that you're providing? Any additional color on that would be helpful.

Joseph Robert Stringer: Mentioned based on some recent TLLP back that you believe that 25 plus percent for an interferon containing regimen, then 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.

Joseph Robert Stringer: Or it is.

Joseph Robert Stringer: 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.

Joseph Robert Stringer: Providing any.

Joseph Robert Stringer: Additional color on that would be helpful.

Speaker Change: Great. Thank you for the question Joe Yes.

Carey Hwang: Right. Thank you for the question, Joey. Yeah, you know, we had an advisory board with many of the leading key opinion leaders within hepatitis back in November, and we did pose this question to them.

Carey Hwang: We had a advisory board with many of the leading key opinion leaders with hepatitis back in November and we did pose this question to them.

Carey Hwang: And for them, at least at this tier, 20% and 30% of like a functional cure rate would be highly meaningful for them. I think the other piece, component to think about in these regimens is whether a regimen contains interferon or not. Interferon-sparing regimens are certainly much more tolerable, easier for patients to take, and easier for physicians to monitor. However, they would likely tolerate a lower functional cure rate if they used interferon-sparing regimens. If there's an interferon-containing regimen, then the bar is a little bit higher in terms of what they would like to see in terms of functional cure rates. So it's hard to really kind of pin down exactly because there are sliding scales for different factors that have to...

Carey Hwang: At least our best tier between 20% and 30% looks like a functional cure rate would be highly meaningful for them.

Carey Hwang: The other piece a component to think about these regimens is whether a regimen contains interferon or not interfering sparing regimens.

Carey Hwang: There are certainly much more tolerable easier for patients to take easier for physicians to monitor.

Carey Hwang: They would likely tolerate a lower functional cure rates using a free on <unk>.

Carey Hwang: Sparing regimens et cetera.

Carey Hwang: <unk> regiment in the bars, 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 pin down exactly kester sliding scales for different factors to consider.

Carey Hwang: Your next question comes from the line of Eric Joseph of JP Morgan Your line is open.

Joseph Robert Stringer: Your next question comes from the line of Eric Joseph of J.P. Morgan. Your line is open.

Eric William Joseph: Hi, thanks for taking the questions. You've noted, Carey, that a potential phase 3 trial in HDV would contemplate fusing Bilt or Tide as a comparator. Can you maybe just talk about sort of the investigator or regulatory feedback that informs that, and if you do move forward with that plan operationally, would you intend to include U.S. sites given that it's not approved? Here, and then as a follow-up. I'll leave the question there, and I have a follow-up.

Eric William Joseph: Hi, Thanks for taking the questions.

Eric William Joseph: You've noted carry that potential phase III trial in HCV would contemplate using goals are tied as a comparator.

Speaker Change: Maybe just talk about sort of.

Eric William Joseph: The investigator or regulatory feedback that informs that.

Speaker Change: If you do go forward with.

Speaker Change: That plan operationally would you intend to include U S sites given.

Speaker Change: So it is not approved here.

Speaker Change: Here and then as a follow up.

Speaker Change: I'll get the question that I have a follow up to that.

Eric William Joseph: Okay.

Carey Hwang: Yeah, thank you, Eric, for the question. So, yeah, as I mentioned, we would include Bolivertide as a comparator, even though it's currently not approved in the United States. You know, this would obviously be, with our discussions with regulators moving forward in terms of what would be included and the study design of what that would look like. But I think also, because we are looking globally for this therapy, a lot of payers now will want you to be compared against the standard of care, especially in Europe.

Speaker Change: Yes, Thank you Eric for the question.

Carey Hwang: So yes as I mentioned, we would include delivered Hyatt as a comparator even though it is currently not approved yet in the United States.

Carey Hwang: This will obviously be with our discussions with our regulators will make forward in terms of what would be included in the study design of what that would look like.

Carey Hwang: But I think also because we are looking globally.

Carey Hwang: This therapy.

Carey Hwang: A lot of payers now wants you to be compared against the standard of care, especially in Europe. So that's another reason that we would wanted to be including deliberate highest comparator.

Carey Hwang: So, that's another reason that we would want to include Bolivertide as a comparator. Because we have a global footprint in this trial, you know; we've done these trials before, and even though Bolivertide is not or may not be approved yet by the time we start a trial, there are mechanisms through which we will be able to conduct the trial in the U.S. with Bolivertide, even if it's not approved.

Carey Hwang: Because we have a global footprint in this trial.

Carey Hwang: We felt these trials for.

Carey Hwang: 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 won't 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.

Speaker Change: Okay great.

Eric William Joseph: Okay, great. And maybe just as a follow-up, coming back to the topic of ALT, LFT normalization in HDV-infected patients. Is the prospect of normalization in cirrhotic patients any more challenging than it is in non-cirrhotics? And I guess, is there sort of a difference in sort of baseline LFT normalization? present, I guess.

Carey Hwang: Just as a follow up coming back to the topic is.

Eric William Joseph: ALC LLC normalization in HCV infected patients.

Eric William Joseph: Is the is the prospect of normalization in cirrhotic patients any more challenging than it is in non cirrhotic.

Eric William Joseph: I guess is there sort of a difference.

Eric William Joseph: Sort of baseline MSG.

Eric William Joseph: Presence I guess that we should be thinking about.

Eric William Joseph: Here between the non <unk> population. Thank you.

Carey Hwang: Yeah, no, thank you for the question. Yeah, no, I think it's a very good question and that's something that, you know, we'll be able to show with our data in terms of looking at if there are baseline differences in ALT levels, you know, whether they're higher or lower in serotics versus non-serotics, and then also looking at the rate of normalization. So yeah, so our data set will be able to help answer that question for us moving forward. But I think, as I mentioned earlier, in terms of antiviral efficacy and then potential impact on ALT, you know, we don't really, we don't know.

Speaker Change: Yes. Thank you for the question, Yes, I think it's a.

Carey Hwang: It's a very good question and Thats something that we will be able to show with our data in terms of looking at if there are baseline differences in ALG levels.

Carey Hwang: There are higher or lower.

Carey Hwang: Cirrhotic versus non cirrhotic and then also looking at the rate of normalization. So yes. So we are our.

Carey Hwang: Our dataset, we'll be able to help answer us answer that question for us moving forward.

Carey Hwang: But I think as I mentioned earlier in terms of the anti viral efficacy and potential impact on <unk>. Yeah. We don't really we don't expect to see significant differences between cirrhotic and non cirrhotic subjects with CPA population, but obviously in the data center.

Carey Hwang: On that.

Eric William Joseph: Okay, great. Excellent. Thanks for taking the questions.

Speaker Change: Okay great.

Eric William Joseph: Thanks for taking the questions.

Eric William Joseph: Your next question comes from the line of Mike <unk> of Morgan Stanley. Your line is now open.

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

Michael Eric Ulz: 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 endpoints in that early study and what we should be looking for, and maybe what

Carey Hwang: All right, thank you for the question. So we do have this ongoing trial with FEAR 1388, which is our HCMV vector as a potential HIV vaccine. And this is in partnership with HVTM, who is helping us conduct the trial. And we have completed enrollment in part A of that trial. And as we've guided to, we expect to see initial immunologic data from that trial in the second half of this year. And so what we are really looking for is

Carey Hwang: Immunologic Endpoints, specifically looking at T cell markers and MECE-restricted 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-1949 vector.

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

Marianne De Backer: Thank you, operator. To conclude, our company is beginning to realize benefits from the cost-saving initiatives we implemented in 2023, and we look forward to sharing important data from our solstice trial at ESL. 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.

Operator: Thank you, and operator, you may conclude the call. Thank you. That concludes today's call. Thank you all for joining. You may now disconnect.