Item 1.01 Entry into a Material Definitive Agreement.
On September 29, 2023, Vir Biotechnology, Inc. (the “Company” or “Vir”) and the Biomedical Advanced Research and Development Authority (“BARDA”), part of the U.S. Department of Health and Human Services’ (“HHS”) Administration for Strategic Preparedness and Response, entered into Amendment No. P00001 to their Other Transaction Authority Agreement (as amended, the “BARDA Agreement”) pursuant to which BARDA awarded the Company $50 million in new funding to advance the development of novel monoclonal antibody (“mAb”) candidates and delivery solutions to widen the applicability of mAbs in COVID-19 and in pandemic preparedness and response.
BARDA is providing $40 million of the new funding as part of Project NextGen, an initiative by the HHS to advance a pipeline of new, innovative vaccines and therapeutics for COVID-19. Vir will use such funds to support the development of VIR-7229 through a Phase 1 clinical trial in the context of developing alternative mAb delivery technologies. Vir expects to complete a Phase 1 trial in the second half of 2025. VIR-7229 is a next-generation COVID-19 mAb that has been shown in preclinical studies to have potency against historical and currently circulating variants, and that has the potential to be the best in class. The remaining $10 million falls under support from the Division of Chemical, Biological, Radiological and Nuclear medical countermeasures of BARDA, which will support the discovery of new mAbs against a second pathogen of pandemic potential in the context of further advancing alternative mAb delivery technologies.
As previously announced, on September 28, 2022, the Company and BARDA entered into the BARDA Agreement to help advance the Company’s development of a full portfolio of innovative solutions to address influenza and potentially other infectious disease threats. The BARDA Agreement provides for potential total investments by BARDA of up to $1 billion, of which $55 million of funding was initially provided by BARDA to support the development of VIR-2482, an investigational prophylactic mAb designed with the aim to protect against symptomatic influenza A illness, including expenses related to the Phase 2 pre-exposure prophylaxis trial of VIR-2482 (the “PENINSULA trial”). The Company will also receive approximately $11 million of additional funding under the BARDA Agreement to wind down activities for the PENINSULA trial.
The balance of BARDA’s potential total investment of up to $1 billion is subject to representatives of the Company and BARDA, agreeing to exercise up to 12 options in further support of the development of pre-exposure prophylactic antibodies for the prevention of influenza illness or possibly supporting medical countermeasures for other pathogens of pandemic potential. The term of the BARDA Agreement expires on January 13, 2027, and may be extended by mutual written agreement of the Company and BARDA, if funding is available and research opportunities within scope reasonably warrant, or, if any of the options are exercised (as described above), to cover the period of such exercised option set forth in the BARDA Agreement. The BARDA Agreement is terminable by BARDA or the Company at any time for any reason with 60 days written notice or for cause, if the Company materially fails to comply with the provisions of the BARDA Agreement (subject to a cure period of at least 30 business days following receipt of notice of such failure to comply). In the case of termination other than for cause, certain termination costs incurred by the Company may be reimbursable by BARDA.
These programs have been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under OT number: 75A50122C00081.
The foregoing descriptions of the terms of the BARDA Agreement is qualified in its entirety by reference to the full text of the BARDA Agreement, a copy of which the Company plans to file as an exhibit to its Quarterly Report on Form 10-Q for the quarter ending September 30, 2023.