Vir Biotechnology Provides Corporate Update and Reports First Quarter 2022 Financial Results

Vir Biotechnology Announces New Data From MARCH Hepatitis B Trial, Unveils New Clinical Program for Hepatitis D, and Highlights Extensive Hepatitis Portfolio at Virtual Hepatitis Portfolio R&D Day

Vir Biotecnologie, Inc.

– Strategic clinical program for hepatitis B and D with potential drivers of value in 2022 –

Virtual webcast of the research and development day scheduled for today, Wednesday, April 27 TO 12pm ET / 9am PT

SAN FRANCISCO, April 27, 2022 (GLOBE NEWSWIRE) – Vir Biotechnology, Inc. (Nasdaq: VIR) announced today that the Company will review its robust hepatitis portfolio, including initial data from the first cohort of MARCH (Monoclonal Antibody siRNA Combination against hepatitis B) which evaluates VIR-2218 in combination with VIR-3434, as well as a new program targeting chronic hepatitis D. Details will be discussed today at 12:00 ET / 9:00 PT during the virtual portfolio of the Vir’s hepatitis Research and development day.

“We are pleased to share the encouraging data from the MARCH study, which suggests that VIR-2218 and VIR-3434 are additives in the reduction of hepatitis B surface antigen, with no drug-related safety signals reported so far, a supporting our strategy of combining antivirals with immunomodulators, “said George Scangos, Ph.D., chief executive officer of Vir. “We are also excited to announce a new synergistic program that will leverage our differentiated resources to treat hepatitis D, the most aggressive form of viral hepatitis for which limited treatment options exist. Together with the other combined trials underway in our pipeline, we believe we have multiple opportunities to achieve meaningful results for both hepatitis B and hepatitis D. “

Webcast details of the hepatitis portfolio research and development day
Vir’s hepatitis portfolio research and development day will include presentations from Vir’s senior management team, as well as an overview of the epidemiology and impact of hepatitis B and D by Jordan Feld, hepatitis physician-scientist viral and liver disease. The agenda is as follows:

  • introduction – George Scangos, Ph.D., chief executive of Vir

  • Overview and challenges of hepatitis treatment B and D – Dr. Feld, R. Phelan Chair in Translational Liver Disease Research, Professor of Medicine, University of Toronto, Research Director, Toronto Center for Liver Disease, Senior Scientist, Sandra Rotman Center for Global Health, TGRI, Toronto General Hospital

  • Vir’s hepatitis portfolio: rationale and strategyPhil Pang, MD, Ph.D., Chief Medical Officer of Vir

  • Review Vir’s hepatitis B development pipeline and announce new program guidelines Carey Hwang, MD, Ph.D., senior vice president of Vir, clinical research, responsible for chronic infections

  • Questions and answers and concluding comments

Attendees can register for Hepatitis Portfolio Research and Development Day here. A live webcast of the event will be accessible under Events and Presentations in the Investors section of Vir’s website at www.vir.bio and will be archived there for 30 days.

Expected milestones for hepatitis

In 2022, the Company plans to report data from multiple studies for the treatment of chronic hepatitis B virus (HBV) infection, including:

  • Additional data from the Phase 1 monotherapy study of VIR-3434 and the Phase 2 monotherapy study of VIR-2218 (first half of 2022).

  • Additional data from the phase 2 study of VIR-2218 in combination with PEG-IFN-α (second half of 2022).

  • Additional data from the first cohort (Part A) of the Phase 2 MARCH study evaluating the safety, pharmacokinetics and suppression of hepatitis B surface antigen (HBsAg) (second half of 2022).

  • Initial data from the phase 2 study evaluating VIR-2218 in combination with BRII-179, an investigational T-cell vaccine, for the potential treatment of chronic HBV infection, led by Brii Biosciences (second half of 2022).

Beyond 2022, the Company plans to report:

  • Initial data from the phase 2 study evaluating various combinations of VIR-2218, selgantolimod, Gilead’s experimental TLR-8 agonist, and nivolumab, a PD-1 inhibitor approved for HBV (first half of 2023).

  • Initial data from the second cohort (Part B) of the Phase 2 MARCH HBV study to determine dose, treatment duration, and evaluate triple cocktails, when VIR-3434 is given every four weeks (second half of 2023).

  • Initial data from a phase 2 viraemic study (STRIVE / THRIVE) of VIR-2218 in combination with VIR-3434 in the second half of 2023, following the start of the trial in the second half of 2022.

  • Initial data from a phase 2 study of VIR-2218 in combination with VIR-3434 for the treatment of HDV in 2023, after starting the study in the second half of 2022.

Recent publications
The Company recently sponsored a Supplement to the perspectives of nature titled “The Push to Eliminate Viral Liver Disease”. This special edition, focusing on chronic HBV, features independent news and commentary articles by prominent academics focusing on the latest advances in treatment, efforts to improve diagnosis and screening, and why equal access to treatments and methods of prevention will be key to eradicating HBV by 2030.

Information on chronic hepatitis B and D
Chronic hepatitis B virus (HBV) infection remains an urgent global public health challenge associated with significant morbidity and mortality. About 300 people around the world are living with HBV, and about 900,000 of them die from associated complications each year. These patients are significantly underserved by existing therapies with low functional cure rates, lifelong daily therapy, and poor tolerability.

Hepatitis D virus (HDV) infection occurs as a simultaneous co-infection or superinfection with HBV. It is estimated that around 12 million patients worldwide are infected with HDV, which represents about 5% of those infected with HBV. HDV-HBV coinfection is considered the most severe form of chronic viral hepatitis due to the more rapid progression to hepatocellular carcinoma and liver-related death.

About VIR-2218
VIR-2218 is an investigational siRNA for HBV administered subcutaneously that has the potential to stimulate an effective immune response and has antiviral activity directed against HBV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus (ESC +) technology to improve stability and minimize off-target activity, which can potentially lead to an increase in therapeutic index. VIR-2218 is the first resource in the company’s partnership with Alnylam Pharmaceuticals, Inc. to enter clinical trials.

About VIR-3434
VIR-3434 is an investigational monoclonal antibody for HBV neutralization administered subcutaneously designed to block all 10 HBV genotypes from entering hepatocytes and also to reduce the level of virions and subviral particles in the blood. VIR-3434, which incorporates Xencor’s Xtend ™ and other FC technologies, is designed to potentially function as a T-cell vaccine against HBV in infected patients, as well as having an extended half-life.

About Biotechnology Vir
Vir Biotechnology is a commercial stage immunology company focused on combining immunological knowledge with cutting-edge technologies for the treatment and prevention of severe infectious diseases. Vir assembled four technology platforms designed to stimulate and enhance the immune system by leveraging critical observations of natural immune processes. Its current development pipeline consists of candidate products targeting COVID-19, hepatitis B virus, influenza A, and human immunodeficiency virus. Vir regularly posts information that may be important to investors on its website.

Forward-Looking Statements
This press release contains forward-looking statements under the Private Securities Litigation Reform Act of 1995. Words such as “may”, “will”, “potential”, “aim”, “expect”, “promise”, “target,” “anticipate” , “May” and similar expressions (as well as other words or expressions that refer to future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir’s expectations and assumptions as of the date of this release. press release. Each of these forward-looking statements involve risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements regarding your clinical trial data VIR-2218 and VIR-3434, the ability of VIR-2218 and VIR-3434 (as monotherapies or combination therapies) to treat and / or pr even with chronic HBV infection, initial data from the combination of VIR-2218 with TLR-8 agonist and nivolumab, phase 2 study by Brii Biosciences evaluating VIR-2218 in a combined study with BRII-179, timing, design and enrollment plans for the MARCH Phase 2 studio and Vir’s plans for its HDV program. Many factors can cause differences between current expectations and actual outcomes, including unexpected safety or efficacy data or results observed during clinical trials, difficulty in obtaining regulatory approval, difficulty in collaborating with other companies, difficulty in accessing capacity production, clinical site activation rates or trial enrollment rates lower than expected, successful development and / or commercialization of alternative products by Vir’s competitors, changes in anticipated or existing competition, delays or interruptions in Vir’s business or clinical trials due to the COVID-19 pandemic, geopolitical changes (including the ongoing conflict between Russia and Ukraine) or other external factors and unforeseen litigation or other disputes. Drug development and commercialization carry a high degree of risk and only a small number of research and development programs lead to the commercialization of a product. Results from early stage clinical trials may not be indicative of full results or the results of later stage or large-scale clinical trials and do not warrant regulatory approval. You should not place undue reliance on these claims or the scientific data presented. Other factors that could cause actual results to differ from those expressed or implied in the forward-looking statements contained in this press release are discussed in Vir’s filings with the US Securities and Exchange Commission, including the section entitled “Risk Factors” contained therein. . Except as required by law, Vir undertakes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even if new information becomes available.

This press release contains hyperlinks to third party information. Such information is not believed to be incorporated by reference in this press release. Vir disclaims any responsibility for such third party information.

CONTACT: Contacts: Investors Heather Rowe Armstrong VP, Investor Relations harmstrong@vir.bio +1-415-915-4228 Media Cara Miller VP, Corporate Communications cmiller@vir.bio +1-415-941-6746

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