SIGA Receives FDA Approval for Intravenous (IV) Formulation of TPOXX® (tecovirimat) – FDA Approval Provides Important Option for Those Unable to Take TPOXX Oral Formulation –

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NEW YORK, May 19, 2022 (GLOBE NEWSWIRE) — SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company focused on the health safety market, today announced that Food and The United States Drug Administration (FDA) has approved the intravenous (IV) formulation of TPOXX for the treatment of smallpox. The IV formulation is an important option for those unable to swallow TPOXX oral capsules.

“We are grateful to the FDA for their work that led to the approval of IV TPOXX, which will provide access to a broader patient population,” said Dr. Dennis Hruby, CSO of SIGA. “We are also grateful to our colleagues at BARDA who have worked with us for many years to include oral and IV TPOXX in prepping efforts in the United States and we look forward to continuing to work with them on our liquid pediatric formulation. “

The oral formulation of TPOXX (tecovirimat) is approved in the United States, Canada and Europe for the treatment of smallpox. The European approval also includes the treatment of monkeypox, cowpox and complications of vaccinia vaccination. The IV formulation of TPOXX was cited in the recent US President’s budget request as being used to treat a patient in the United States with monkeypox.

ABOUT SIGA TECHNOLOGIES, INC. and TPOXX®

SIGA Technologies, Inc. is a commercial-stage pharmaceutical company focused on the health safety market. Health security includes countermeasures to biological, chemical, radiological and nuclear attacks (biodefense market), vaccines and therapies against emerging infectious diseases and health preparedness. Our flagship product is the TPOXX®also known as tecovirimat and ST-246®, an antiviral drug given by mouth and IV for the treatment of human smallpox caused by the variola virus. Funding and technical support for this work is provided by the Biomedical Advanced Research and Development Authority (BARDA), under the direction of the Assistant Secretary for Preparedness and Response (ASPR), within the U.S. Department of Health and Human Resources. Human Services (HHS), under an ongoing USG contract. No. 75A50118C00019 (19C). For more information about BARDA, see https://www.medicalcountermeasures.gov/. TPOXX is a new small molecule drug and the United States maintains a supply of TPOXX through Project BioShield. The oral formulation of TPOXX was approved by the FDA for the treatment of smallpox in 2018. The complete label is available by clicking here. In September 2018, SIGA signed a contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, to purchases and additional developments related to both oral and intravenous formulations of TPOXX. For more information about SIGA, visit www.siga.com.

About smallpox1

Smallpox is a contagious, disfiguring and often fatal disease that has affected humans for thousands of years. Naturally occurring smallpox was eradicated worldwide in 1980, the result of an unprecedented global vaccination campaign. Smallpox virus samples were retained for research purposes. This led to fears that smallpox could one day be used as a biological warfare agent. A vaccine can prevent smallpox, but the risk of side effects from the current vaccine is too high to justify routine vaccination of people at low risk of exposure to the smallpox virus.

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 the progress of SIGA’s development programs and product time to market, as well as the impact of COVID-19 on SIGA’s business. Forward-looking statements may be identified by words or phrases such as “believes”, “estimates”, “expects”, “may”, “will”, “would”, “may”, “could”, and similar words and phrases. These forward-looking statements are based on current expectations and assumptions and 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 these 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 the US Biomedical Advanced Research and Development (“BARDA”) elects, in its sole discretion, as permitted by the BARDA Agreements (as defined below), not to exercise any or all of the remaining unexercised Options under such contracts, (ii) the risk that SIGA may not be able to fully perform its contracts with BARDA (the “BARDA Contracts”) on time or in accordance with the contractual terms, (iii) the risk that the BARDA Contracts will be modified or terminated at the request or requirement of the U.S. government, (iv) the risk that the nascent international biodefense market will not develop to a degree that will allow SIGA to successfully commercialize TPOXX internationally, (v ) I the risk that potential products, including potential alternative uses or formulations of TPOXX that show promise to SIGA or its collaborators, may not be demonstrated to be effective or safe in subsequent preclinical or clinical trials, (vi) the risk that SIGA or its associates fail to obtain appropriate or necessary governmental approvals to market these or other potential products or uses, (vii) the risk that SIGA may not be able to obtain or enforce sufficient legal rights over its products, including intellectual property protection, (viii) the risk that any challenge to SIGA’s patent and other proprietary rights, if determined adversely, could affect SIGA’s business and, even if is determined favourably, could be costly, (ix) the risk that regulatory requirements applicable to SIGA’s products may cause the need for further or additional testing or documentation that will delay or prevent SIGA from seeking or obtaining the necessary approvals to commercialize such products, (x) the risk that the volatile and competitive nature of the biotechnology industry may impede SIGA’s efforts to o develop or commercialize its products, (xi) the risk that changes in domestic or foreign economic and market conditions may affect SIGA’s ability to advance its research or adversely affect its products, (xii) l the effect of federal, state and foreign regulations, including drug regulations and international trade regulations, on SIGA’s business, (xiii) the risk that the COVID-19 pandemic could impact SIGA’s operations, SIGA by disrupting SIGA’s supply chain for the manufacture of TPOXX, causing delays in the activities of SIGA research and development, resulting in delays or reallocation of funds in connection with SIGA government contracts, or diversion of the attention of government personnel overseeing SIGA government contracts, (xiv) the risk that government responses U.S. or foreign (including inaction) domestic or global economic conditions or infectious diseases such as COVID-19 are ineffective and may adversely affect SIGA’s business, and (xv) other risk factors discussed in point 1A. “Risk Factors” in SIGA’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and in SIGA’s subsequent filings with the United States Securities and Exchange Commission. These documents are publicly available on the SEC’s website at http://www.sec.gov and on SIGA’s website at https://investor.siga.com. Forward-looking statements speak only as of the date such statements were made, and except as otherwise required by law, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise.

The information in this press release does not necessarily reflect government position or policy and no official endorsement should be inferred.

contacts:

Contact Investor

Yonker Wool, Edison Group

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Michael Crawford, Edison Group

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Public relations
Doug Haslam
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1http://www.mayoclinic.org/diseases-conditions/smallpox/basics/definition/con-20022769


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