SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage
pharmaceutical company focused on the health security market, today
announced that its Chief Executive Officer, Phil Gomez, and Chief
Scientific Officer, Dennis Hruby, will be participating in a panel
on Thursday, June 23rd at 12pm ET to discuss the recent outbreaks
of monkeypox in the U.K., EU, and U.S. The chat will be hosted by
Alliance Global Partners and will also include representatives from
Emergent Biosolutions and Tonix Pharmaceuticals.
For further information on the panel,
please see below:
Date & Time: Thursday, June 23rd from
12pm-1pm ETLink to join:
https://us02web.zoom.us/webinar/register/WN_NQzQ-ceWTUiDpxShNw6XfA
SIGA’s lead product tecovirimat (TPOXX) was
approved in January 2022 by the European Medicines Agency (EMA) for
the treatment of smallpox, monkeypox, cowpox, and vaccinia
complications following vaccination against smallpox. SIGA has also
supplied TPOXX as a compassionate use treatment for a monkeypox
case in the United Kingdom, and in the U.S., where TPOXX is
approved for use against smallpox, the CDC has used TPOXX to treat
at least one monkeypox patient during the current outbreak. The FDA
has not approved TPOXX for monkeypox in the US.
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. The full label is available by clicking here. Oral
tecovirimat received approval from the European Medicines Agency
(EMA) in 2022. The EMA approval includes 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
SMALLPOX1
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.
ABOUT
MONKEYPOX2
Monkeypox is a rare disease that is caused by
infection with monkeypox virus. Monkeypox virus belongs to
the Orthopoxvirus genus in the family Poxviridae.
The Orthopoxvirus genus also includes variola virus
(which causes smallpox), vaccinia virus (used in the smallpox
vaccine), and cowpox 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, 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,” “can,” “could,” and similar words and phrases.
Such 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 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 the U.S.
Biomedical Advanced Research and Development Authority (“BARDA”)
elects, in its sole discretion as permitted under the BARDA
Contracts (as defined below), not to exercise all, or any, of the
remaining unexercised options under those contracts, (ii) the risk
that SIGA may not complete performance under its contracts with
BARDA (the “BARDA Contracts”) on schedule or in accordance with
contractual terms, (iii) the risk that the BARDA Contracts 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
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 that the COVID-19
pandemic could impact SIGA’s operations by disrupting 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) 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 affect SIGA’s business
adversely, and (xv) other risk factors discussed in Item 1A. “Risk
Factors” of SIGA’s Annual Report on Form 10-K for the year ended
December 31, 2021, and in SIGA’s subsequent filings with the U.S.
Securities and Exchange Commission. These documents are publicly
available at the SEC’s website at http://www.sec.gov and SIGA’s
website at https://investor.siga.com. Forward-looking statements
are current only as of the date on which such statements were made,
and except as may be otherwise required by law, we undertake no
obligation to update publicly any forward-looking statements
whether as a result of new information, future events, or
otherwise.
The information contained in this press release
does not necessarily reflect the position or the policy of the U.S.
government and no official endorsement should be inferred. The
information contained on the websites referenced herein is not
incorporated by reference into this press release.
Contacts:
Investor ContactLaine Yonker, Edison
Grouplyonker@edisongroup.com
Michael Crawford, Edison
Groupmcrawford@edisongroup.com
Public RelationsDoug
Haslamdhaslam@berrypr.com
1 http://www.mayoclinic.org/diseases-conditions/smallpox/basics/definition/con-20022769
2 https://www.cdc.gov/poxvirus/monkeypox/about.html
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