SIGA CEO Phil Gomez, PhD, to Present on Smallpox and Orthopox Preparedness at NATO Chemical, Biological, Radiological & Nuclear Medical Symposium
June 27 2023 - 4:05PM
SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage
pharmaceutical company focused on the health security market, today
announced that SIGA CEO Phil Gomez, PhD, will present an overview
of the role of therapeutics in global planning and response to
potential outbreaks of smallpox and other orthopox viruses during
the upcoming NATO Chemical, Biological, Radiological & Nuclear
Medical Symposium in Oak Ridge, Tennessee. His presentation,
entitled “Therapeutics role in smallpox and orthopox virus
preparedness”, will be held on Thursday June 29th at 2:20 PM ET.
“We are very pleased that this important inaugural
NATO Symposium will include a focus on biological health risks
including smallpox and other orthopox viruses, which require both
careful preparation including stockpiling available and
proven-effective treatments as well as the ability to mobilize and
respond rapidly to emerging threats,” said Phil Gomez, CEO of SIGA.
“SIGA is actively responding to global efforts to stockpile
therapies to treat smallpox, mpox and other orthopox viruses. In
just one example, we are currently preparing for a $112.5 million
order for oral TPOXX® in the third quarter by the U.S. Department
of Health and Human Services that we expect to be delivered this
year to the U.S. Strategic National Stockpile. In
addition, SIGA has been proactively building inventory in our
supply chain to enable a response to additional demand given the
evolving threat landscape for othropoxviruses. We believe that
participation in events such as the symposium, in conjunction with
stockpiling activities by the U.S. government, will increasingly
encourage governments around the world to focus on strategies to
prepare for smallpox and other orthopox virus outbreaks.”
ABOUT SIGA TECHNOLOGIES, INC. and
TPOXX®
SIGA Technologies, Inc. is a commercial-stage
pharmaceutical company focused on the health security market.
Health security comprises countermeasures for biological, chemical,
radiological and nuclear attacks (biodefense market), vaccines and
therapies for emerging infectious diseases, and health
preparedness. Our lead product is TPOXX®, also known as tecovirimat
and ST-246®, an orally administered and IV formulation antiviral
drug for the treatment of human smallpox disease caused by variola
virus. TPOXX is a novel small-molecule drug and the US maintains a
supply of TPOXX under Project BioShield. The oral formulation of
TPOXX was approved by the FDA for the treatment of smallpox in
2018, and the IV formulation was approved for the same indication
in 2022. The full label is available by clicking here. Oral
tecovirimat received approval from the European Medicines Agency
(EMA) and the Medicines and Healthcare Products Regulatory Agency
(MHRA) in the United Kingdom in 2022. The EMA and UK approvals
include labeling for oral tecovirimat indicating its use for the
treatment of smallpox, monkeypox, cowpox, and vaccinia
complications following vaccination against smallpox. The full
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, for additional procurement and development
related to both oral and intravenous formulations of TPOXX. For
more information about SIGA, please visit www.siga.com.
About Smallpox
Smallpox is a contagious, disfiguring and often
deadly disease that has affected humans for thousands of years.
Naturally occurring smallpox was eradicated worldwide by 1980, the
result of an unprecedented global immunization campaign. Samples of
smallpox virus have been kept for research purposes. This has led
to concerns that smallpox could someday be used as a biological
warfare agent. A vaccine can prevent smallpox, but the risk of the
current vaccine's side effects is too high to justify routine
vaccination for 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 timelines for
bringing products to market, delivering products to the Strategic
Stockpile, the enforceability of our procurement contracts,
such as the 19C BARDA Contract (the "BARDA Contract"),
with BARDA, the impact of the COVID pandemic and responding to the
global outbreak of monkeypox. The words or phrases “can be,”
“expects,” “may affect,” “may depend,” “believes,” “estimate,”
“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 BARDA Contract, not to
exercise all, or any, of the remaining unexercised options under
those contracts, (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, DoD Contract #2 or PEP Label Expansion R&D
Contract are modified or canceled at the request or
requirement of 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 SIGA or its collaborators will not 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 secure or enforce sufficient legal rights in its
products, including intellectual property protection, (viii) 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, (ix) 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, (x) the risk that the volatile
and competitive nature of the biotechnology industry may hamper
SIGA’s efforts to develop or market 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 may affect its
products adversely, (xii) the effect of federal, state, and foreign
regulation, including drug regulation and international trade
regulation, on SIGA’s businesses, (xiii) 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, (xiv) risks associated with actions or
uncertainties surrounding the debt ceiling, (xv) the risk that the
U.S. or foreign governments' responses (including inaction)
to national or global economic conditions or infectious
diseases, such as COVID-19, are ineffective and may adversely
affect SIGA’s business, and (xvi) risks associated with responding
to the current 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,
2022 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.
The information contained in this press release
does not necessarily reflect the position or the policy of the
Government and no official endorsement should be inferred.
Contacts:
Investor ContactLaine Yonker, Edison
Grouplyonker@edisongroup.com
Public RelationsHolly Stevens, Berry &
Companyhstevens@berrypr.com
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