SIGA Enters into Exclusive License Agreement with Vanderbilt University for Novel Poxvirus Monoclonal Antibodies

NEW YORK, Oct. 22, 2024 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (NASDAQ:SIGA), a commercial-stage pharmaceutical company and leader in infectious diseases, today announced that it entered into an agreement with Vanderbilt University to obtain a license to a portfolio of preclinical fully human monoclonal antibodies (mAbs) which could be used as potential treatments for a broad range of orthopoxviruses, including smallpox and mpox. Under the agreement, SIGA has exercised its option to license the exclusive rights to develop, manufacture, and commercialize these mAbs globally.

"SIGA has cultivated deep expertise in orthopoxvirus, and we are thrilled to expand our pipeline with Vanderbilt's human monoclonal antibodies, which nicely complement our best-in-class TPOXX^® franchise. We believe these antibodies hold the potential to treat a broad spectrum of orthopoxviruses, both as a therapeutic and a prophylactic measure. By leveraging our unique capabilities in clinical development and our long-standing partnerships with U.S. Government agencies, we are well-positioned to maximize the impact of these potential new therapies," said Diem Nguyen, SIGA Chief Executive Officer. "This license marks a step forward in our strategy to leverage our existing capabilities to create new opportunities for growth over the long term."

Developed by James Crowe, Jr., M.D., Professor of Pediatrics, Pathology, Microbiology and Immunology at Vanderbilt University Medical Center, these mABs have demonstrated promise in preclinical models and could potentially be used as standalone treatments or in combination with TPOXX^®. The U.S. Department of Defense is currently funding the development of these mAbs as potential orthopoxvirus treatments through Phase 1 clinical trials under a contract awarded to a contract manufacturing organization with biologics expertise.

"Given the need for additional orthopoxvirus treatments in these unsettling times of recurring poxvirus outbreaks, my team and I are excited to work with SIGA in its future efforts to advance the development of these innovative antibodies," said Dr. Crowe.

The financial terms of the transaction were not disclosed.

About SIGA

SIGA is a commercial-stage pharmaceutical company and leader in global health focused on the development of innovative medicines to treat and prevent infectious diseases. With a primary focus on orthopoxviruses, we are dedicated to protecting humanity against the world's most severe infectious diseases, including those that occur naturally, accidentally, or intentionally. Through partnerships with governments and public health agencies, we work to build a healthier and safer world by providing essential countermeasures against these global health threats. Our flagship product, TPOXX^® (tecovirimat), is an antiviral medicine approved in the U.S. and Canada for the treatment of smallpox and authorized in Europe and the UK for the treatment of smallpox, mpox (monkeypox), cowpox, and vaccinia complications. For more information about SIGA, visit www.siga.com.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements relating to SIGA's future business development and plans including with respect to filling outstanding orders. The words or phrases "can be," "expects," "may affect," "may depend," "believes," "estimate," "will", "project" and similar words and phrases are intended to identify such forward-looking statements.   Such forward-looking statements are subject to various known and unknown risks and uncertainties, and SIGA cautions you that any forward-looking information provided by or on behalf of SIGA is not a guarantee of future performance. SIGA's actual results could differ materially from those anticipated by such forward-looking statements due to a number of factors, some of which are beyond SIGA's control, including, but not limited to, (i) the risk that BARDA elects, in its sole discretion as permitted under the 75A50118C00019 BARDA Contract (the "BARDA Contract"), not to exercise the remaining unexercised option under the BARDA Contract, (ii) the risk that SIGA may not complete performance under the BARDA Contract on schedule or in accordance with contractual terms, (iii) the risk that the BARDA Contract or U.S. Department of Defense contracts are modified or canceled at the request or requirement of, or SIGA is not able to enter into new contracts to supply TPOXX to, the U.S. Government, (iv) the risk that the nascent international biodefense market does not develop to a degree that allows SIGA to continue to successfully market TPOXX internationally, (v) the risk that potential products, including potential alternative uses or formulations of TPOXX that appear promising to SIGA or its collaborators, cannot be shown to be efficacious or safe in subsequent pre-clinical or clinical trials, (vi) the risk that target timing for deliveries of product to customers, and the recognition of related revenues, are delayed or adversely impacted by the actions, or inaction, of contract manufacturing organizations, or other vendors, within the supply chain, or due to coordination activities between the customer and supply chain vendors, (vii) the risk that SIGA or its collaborators will not obtain appropriate or necessary governmental approvals to market TPOXX for smallpox or additional uses, (viii) the risk that SIGA may not be able to secure or enforce sufficient legal rights in its products, including intellectual property protection, (ix) the risk that any challenge to SIGA's patent and other property rights, if adversely determined, could affect SIGA's business and, even if determined favorably, could be costly, (x) the risk that regulatory requirements applicable to SIGA's products may result in the need for further or additional testing or documentation that will delay or prevent SIGA from seeking or obtaining needed approvals to market these products, (xi) the risk that the volatile and competitive nature of the biotechnology industry may hamper SIGA's efforts to develop or market its products, (xii) the risk that changes in domestic or foreign economic and market conditions may affect SIGA's ability to advance its research or may affect its products adversely, (xiii) the effect of federal, state, and foreign regulation, including drug regulation and international trade regulation, on SIGA's businesses, (xiv) the risk of disruptions to SIGA's supply chain for the manufacture of TPOXX^®, causing delays in SIGA's research and development activities, causing delays or the re-allocation of funding in connection with SIGA's government contracts, or diverting the attention of government staff overseeing SIGA's government contracts, (xv) risks associated with actions or uncertainties surrounding the debt ceiling, (xvi) the risk that the U.S. or foreign governments' responses (including inaction) to national or global economic conditions or infectious diseases, are ineffective and may adversely affect SIGA's business, and (xvii) risks associated with responding to an mpox outbreak, as well as the risks and uncertainties included in Item 1A "Risk Factors" of our Annual Report on Form 10-K for the year ended December 31, 2023 and SIGA's subsequent filings with the Securities and Exchange Commission. SIGA urges investors and security holders to read those documents free of charge at the SEC's website at http://www.sec.gov. All such forward-looking statements are current only as of the date on which such statements were made. SIGA does not undertake any obligation to update publicly any forward-looking statement to reflect events or circumstances after the date on which any such statement is made or to reflect the occurrence of unanticipated events.

Contacts:

Suzanne Harnett

[email protected]

and