SIGA Announces New Contract Awarded by U.S. Department of Defense for the Procurement of $9 Million of TPOXX®
August 21 2024 - 4:00PM
SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage
pharmaceutical company and leader in infectious diseases, today
announced a new contract with the U.S. Department of
Defense (DOD) for the procurement of approximately $9
million of TPOXX® (Contract number: W911SR24C0030). This award
is comprised primarily of oral TPOXX®, with a small amount of
intravenous (IV) TPOXX®, and represents the third procurement
contract award from the DOD over the past three years.
SIGA has been collaborating with the DOD’s Joint Program
Executive Office for Chemical, Biological, Radiological and Nuclear
Defense (JPEO-CBRND) to develop the Post-exposure Prophylaxis (PEP)
indication for oral TPOXX®, and this work has been supported by a
development contract with a value of approximately $27
million (Contract number: MCDC1901-001-2019-400) as well as a
Cooperative Research and Development Agreement.
“We are pleased to announce this new contract, continuing our
long-term partnership with the Department of Defense. Providing
TPOXX® plays a critical role in protecting and supporting our
military personnel against orthopoxvirus risks, such as smallpox.
This underscores our commitment to ensuring the safety of our
troops while also developing innovative treatments that benefit
people worldwide as we advance the PEP indication,” said Diem
Nguyen, Chief Executive Officer.
Inclusive of this award, SIGA currently has approximately $154
million of outstanding oral and IV TPOXX® orders, of which more
than 85% of this amount was generated within the past three
months.
Reference to the DOD, JPEO-CBRND, or other agency of the United
States does not constitute or imply an endorsement or
recommendation by the U.S. government or any agency thereof.
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
StatementsThis 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.
Investor and Media Contact:Suzanne
Harnettsharnett@siga.com
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