Vir Biotechnology, Inc.

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. Damouni-Ellis.

Thank you, and good afternoon. With me today are Dr. Marianne DeBacker, Chief Executive Officer, Dr. Phil Pang, Chief Medical Officer, and Sun Lee, Chief Financial Officer. Before we begin, I would like to remind everyone that some of the statements we are making today are forward-looking statements under the securities laws. These forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by such forward-looking statements. These risks and uncertainties and risks associated with our business are described in the company's reports filed with the Securities and Exchange Commission, including Forms 10-K, 10-Q, and 8-K. I will now turn the call over to our CEO, Marianne DeBacker.

Thank you, Sasha. Good afternoon to everyone on the webcast, and thank you all for joining us today. Before we discuss the tremendous progress we made in 2023 and what's ahead in 2024, I want to touch on the announcement we made earlier this week that Phil Pang, our chief medical officer, has decided to step down at the end of March to spend more time with his family. We have initiated a search for a successor. I want to sincerely thank Phil for his leadership. He leaves a strong clinical development team in place. positioning us well for continued success, and I wish him the very best. Stepping in as Interim Chief Medical Officer is Dr. Kerry Wong, currently VIIRS Senior Vice President, Clinical Research. As I reflect on 2023, I'm proud of the clinical progress we have made towards developing a potential treatment for patients with chronic hepatitis Delta, a potential functional cure for the millions living with chronic hepatitis B, as well as a differentiated approach to preventing HIV. Our priority is to deliver on our mid-stage clinical pipeline while also refocusing our research and early pipeline to programs beyond infectious disease. We anticipate significant data readouts this year, which build off last year's progress across all our clinical programs. Specifically, already in the first quarter, we anticipate completing the enrollment of approximately 60 participants across two cohorts in SOFTIS, our Phase II hepatitis Delta trial. We attribute this rapid rate of enrollment to the positive clinician and patient interest following the initial data we reported at AASLD last year. In the second quarter, we finally share early biologic and safety data on a subset of these participants. It is important to appreciate that there is a significant underserved patient population in need of a safe, highly efficacious, and convenient therapy for treating hepatitis Delta. We estimate that there are at least 12 million people diagnosed with this disease and an estimated 60 million or more undiagnosed globally. We aim to develop a best-in-class treatment, which we believe will drive increased diagnosis rates and position fear to become the leader in hepatitis Delta. To position us for success, we are collaborating with patient advocacy groups and policymakers to improve surveillance and screening. In addition, crucial work is ongoing to understand who and where Delta patients are. These efforts will support a targeted, rapid, and successful commercial launch in the future. Switching gears, I will now discuss our functional cure program for chronic hepatitis B, another area of high unmet medical need. Based on the data reported in our ongoing Phase II trials thus far, we believe our two therapeutic candidates, the BIVI-BART and the Lesteron, have the potential to play a critical role in delivering high functional cure rates for chronic hepatitis B patients. We look forward to reporting end-of-treatment data from the MARCH-PAR-B trials at a major medical congress in the fourth quarter. Finally, in the second half of the year, we are looking forward to sharing initial immunologic proof of concept data for year 1388, an HIV T cell vaccine candidate currently being evaluated in a phase one trial. If the data supports the validity of the platform, it could be a springboard for other indications, including our preclinical therapeutic vaccine for control of pre-cancerous lesions and HPV cancers. Switching to research. We continue to advance antibody therapeutics optimized for increased likelihood of development success thanks to our proprietary platform powered by AI and machine learning. Our focus is on prophylactic antibodies for influenza A and B, RNC-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 and the timing of potential IND submissions during the year. On February 21st, BEER and GSK terminated our collaboration to research, develop, and commercialize our molecular antibodies targeting the influenza virus under our Definitive Collaboration Agreement that we established in May of 2021. FEAR retains sole rights to continue advancing our investigation of therapies for influenza. With that in mind, we are actively pursuing external partnership opportunities for our next-generation influenza A and B antibodies and ADCs. Meanwhile, our respiratory collaboration with GSK continues. Turning to our cash and investments, our financial strength allows us to fund our clinical programs through major infection points while enabling the flexibility to invest in external innovation opportunities. In evaluating external innovation, we are thoughtful, selective, and strategic with a focus on opportunities capable of augmenting our pipeline and platforms. To recap, we are preparing for a transformational year at VEER, anticipating critical value inspection points in our program focused on chronic hepatitis Delta, hepatitis B, and HIV. With that, I'll now turn the call over to Phil.