Vir Biotechnology, Inc.

Hello, welcome to VEER 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. Simone Ellis.

Thank you, and good afternoon. With me today are Dr. Marianne DeBacker, Chief Executive Officer, Dr. Carrie Huang, Senior Vice President, Clinical Research and Interim Chief Medical Officer, and Sun Li, Executive Vice President and Chief Financial Officer. Before we begin, I would like to remind everyone that some of the statements we are making today are forward-looking statements under the securities laws. These forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs' future results, performance, or achievements to differ significantly from those expressed or implied by such forward-looking statements. These risks and uncertainties and risks associated with our business are described in the company's reports, followed with the Securities and Exchange Commission, including Form 10-K, Ken Hieu, and A.K. I will now turn the call over to our CEO, Dr. Marianne DeBacker.

Thank you, Sasha. Good afternoon to everyone on the webcast, and thank you all for joining us today. During this afternoon's call, I will provide initial remarks before returning to Carrie 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. 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 Farid, 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. Two of our long-serving directors, Dr. Philip Sharp and Robert Perez, won't be standing for re-election. 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 VEER has been instrumental in building a talented financial team and implementing rigorous financial practices and controls. Our finance organization is well positioned for continued success while we search for a successor. I would like to express my and the company's gratitude for Sam's contribution and wish him all the best in his new opportunity. Looking ahead, we expect 2024 to be a transformational year for VEER. Our teams are mission-driven, and we aim to play an important role in serving patients in areas of high unmet medical needs while creating significant value in large potential markets. We continue to make progress on the goals we laid out in January. A key priority is to deliver on a mid-stage clinical pipeline. And I'll begin by discussing our ongoing phase two solstice trials in people living with chronic hepatitis delta. Our goal is to provide a lifelong therapy that is impactful and convenient for patients in this area of substantial unmet medical need. At least 12 million people globally are estimated to be living with hepatitis delta, with most cases remaining undiagnosed. While there are significant challenges with the underdiagnosis and lack of robust epidemiological data for chronic hepatitis delta, we do see positive momentum towards greater awareness and patient screening. For example, in March, the World Health Organization published updated guidelines for the prevention, diagnosis, care, and treatment of people with chronic hepatitis B. And this update included recommending hepatitis delta reflex testing for everyone who tests positive for hepatitis B. This is a major step forward for both patients and researchers within the hepatitis delta community. Chronic hepatitis delta infection increases the risk of poor outcomes for patients compared to hepatitis B alone. There is approximately 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. 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 SOLSTIS trial one month ahead of schedule. And our late-breaker SOLSTIS data abstract was accepted for poster presentation at the European Association for the Study of the Liver, or EFL, Congress 2024. We plan to host an investor conference call to discuss the SOLSTIS data on June 5th. In the third quarter, we intend to engage with regulatory authorities to discuss the next steps for the development program. Shifting our focus to another area of high unmet medical need, chronic hepatitis B, where we are making progress in our efforts to achieve a functional cure. According to the World Health Organization Global Hepatitis Report 2024, 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 with only 3% receiving treatment at the end of 2022. The WHO further estimated that 1.1 million people died from viral hepatitis B in 2022, compared to an estimated 820,000 deaths in 2019. At VEER, we are committed to addressing this global health crisis. and this concerning increase in deaths. And we believe our two therapeutic candidates, Tobevibart and Elapseron, have the potential to make a meaningful impact. Tobevibart and Elapseron are being studied in our ongoing Phase II MARCH trial in combination with and without SPECT interferon-alpha. Our aim is that our two therapeutic candidates can help us achieve our goal of a 30% or higher functional cure rate. While this is our stated goal, KOLs we hosted at an advisory board last year at AASLD 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. Subsequently, we expect to share functional cure data in the second quarter of 2025. Now, I will briefly discuss Pier 1388, our HIV T-cell vaccine candidate, currently being evaluated in a phase one trial. We are looking forward to sharing initial immunologic proof of concept data in the second half of this year. If the data supports the validity of the platform, it could be a springboard to other indications, including Pier 1949 a preclinical therapeutic vaccine for control of precancerous lesions and cancers caused by HPV. This trial is supported by the National Institute of Allergy and Infectious Diseases, part of the NIH, and the Bill 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 DAISY. DAISY 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. 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. 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 to help make this all possible. With that, I'll turn the call over to Cary.