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Vir Biotechnology, Inc.
11/2/2023
Mooney Ellis, Executive Vice President, Chief Corporate Affairs Officer. You may begin, Mr. Mooney 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, Dr. Marianne DeBacker.
Thank you, Sacha. Good afternoon and welcome. I'm Marianne DeBacker, CEO of VEER, and I'm pleased to welcome you all here today. Since the last time we spoke, VEER has made some impressive progress on driving our scientific platforms, our pipeline, and our clinical trials forward. All this positive momentum is encouraging as we seek to serve all the patients who are waiting, especially those with unmet medical needs in multiple infectious disease areas and beyond. Let me first call your attention to the updates we are most looking forward to at AESLD delivery meeting in Boston later this month. Our Phase II data readouts from two of our most advanced programs, Chronic Hepatitis B and chronic hepatitis delta. As a reminder, this includes initial data from Part B of the MARCH trial, where we are looking at combinations of our monoclonal antibody, PIER 3434, and our sIRNA, PIER 2218, for 24 and 48 weeks, with and without pachypnephrine alpha. We also look forward to sharing initial data from our ongoing solstice trial, which is evaluating whether our antibody, VR3434 alone, our siRNA, VR2218 alone, or the combination of these can be a viable chronic therapy for patients who are co-infected with hepatitis delta virus. Thanks to the approximately 50 million in new BARDA funding, we have had positive momentum on the development of VR7229. are investigational next-generation COVID-19 monoclonal antibodies with a distinct combination of potency, breath, and viral inescapability. This funding includes $40 million in Project NextGen non-diluted funding, which will support the development of VIRS7229 through Phase I. We expect the Phase I trial to initiate in 2024 and we will be exploring a partnership for the development of this antibody post-Phase 1. The BARDA funding also supports alternative monoclonal antibody delivery technologies, such as RNA-delivered monoclonal antibodies, which have the potential to revolutionize the field of antibody therapeutics with the ultimate benefit of enabling greater patient access and ease. This funding is another testament to VIIR's world-class antibody platform and our ability to discover rare, broad, and highly potent monoclonal antibodies with the hope of generating powerful new medicines. Switching gears to one of our newest clinical programs, in September, the first participant was dosed in a Phase I trial evaluating VIIR 1388. an investigational novel T-cell vaccine for the prevention of HIV. This trial is especially meaningful because it brings us and our supporters, which includes the Bill and Melinda Gates Foundation, the National Institute of Allergy and Infectious Diseases, and the HIV Vaccine Trials Network one step closer in our shared pursuit of developing an HIV vaccine. We are hopeful that our unique approach will help close the longstanding public health gap in HIV prevention, and we look forward to sharing initial data from this trial in the second half of 2024. Finally, I want to give you a glimpse into some of the transformative strategic decisions VEER has made to drive future growth and increase patient impact. As you know, our founding mission was a world without infectious disease. And we are now embarking on a broader vision, powering the immune system to transform lives. We have always seen ourselves as an immunology company first and are now ready to expand into new areas of growth by applying our deep immunology expertise beyond infectious disease with the first applications in autoimmune diseases and immuno-oncology. This is made possible by our platform that has already created monoclonal antibodies with enhanced selectivity and potency using AI-based protein engineering. We have existing in-house immuno-oncology experience, and we are already advancing enhanced antibodies for tumor immunotherapy with augmented selectivity and potency under the leadership of Dr. Alan Korman. Senior Vice President of Immune Targeting here at VIIR. Prior to joining VIIR, Alan led the discovery of three approved drugs for oncology. We are also embarking on a novel, agnostic way to identify T-cell receptors specific for tumor antigens, an effort led by our National Academy of Sciences Immunologist, Dr. Antonio Lanzavecchia. We look forward to keeping you updated on this in 2024. We believe all of this is within reach thanks to our strong balance sheet, which allows us to take our chronic hepatitis B and chronic hepatitis Delta programs through development inflection points, as well as invest in our core antibody platform and evaluate complementary external opportunities. Meanwhile, we will continue to be judicious in our spend and investments to ensure that we maximize the deployment of the $1.7 billion in cash and investments. Finally, I want to highlight that next week we will be welcoming our new Chief Scientific Officer, Dr. Jennifer Towne. Jennifer brings more than two decades of R&D experience and a proven track record of successfully developing breakthrough medicines and bringing multiple investigational new drug applications for innovative therapeutics forward. This includes bringing 16 drug candidates from preclinical research to IND and early clinical development. Her scientific and external innovation leadership experience, combined with her deep immunology expertise, will be critical to delivering on our strategy to go beyond infectious disease. I want to thank Phil Pang for expanding his responsibilities as interim head of research. Phil will continue to lead clinical research, development, and medical affairs as chief medical officer to bring our late-stage portfolio to fruition, which is our top priority at VIIRS. With that, I'll now turn the call over to Phil to provide an update on the progress we are making in our preclinical and clinical programs.
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