SIGA Technologies Announces Relisting on Nasdaq
March 20 2018 - 7:30AM
SIGA Technologies, Inc. (SIGA) (Nasdaq:SIGA), a
health security company specializing in the development and
commercialization of solutions for serious unmet medical needs and
biothreats, today announced that The Nasdaq Stock Market LLC has
approved SIGA’s application to list its common stock on The Nasdaq
Global Market. SIGA’s common stock is expected to commence trading
on The Nasdaq Global Market at the opening of trading on Thursday,
March 22, 2018 under the ticker symbol “SIGA”. SIGA’s common stock
will continue to trade on the OTC Pink Sheets until market close on
March 21, 2018 under the ticker symbol "SIGA".
Pending TPOXX NDA
As previously announced, in December 2017, SIGA submitted a New
Drug Application (NDA) for oral TPOXX® (tecovirimat) developed to
treat smallpox. No FDA-approved cure or treatment for smallpox
exists. In February 2018, the FDA set the target action date for
this NDA at August 8, 2018. Should the FDA change the announced
target date, SIGA will provide an additional update.
BARDA RFP Update
SIGA also announced today that it intends to submit a response
to a Request for Proposal (RFP) by the U.S. government’s Biomedical
Advanced Research and Development Authority (BARDA) related to the
procurement and late-stage development of oral and intravenous (IV)
treatment for smallpox. While it is anticipated that competitors of
SIGA will also submit responses, SIGA believes that TPOXX®, its
smallpox antiviral drug candidate, is well-positioned to meet the
requirements set forth in this RFP. The RFP seeks to purchase oral
and IV drug to meet a stockpile requirement of 1.7 million courses.
The RFP outlines a 5-year base contract, along with options for a
potential 5 year extension. The RFP also includes a provision for
the immediate purchase of available courses of product meeting
technical specifications outlined in the RFP. The RFP sets forth
the minimum criteria for a qualifying response, including a
requirement to have demonstrated efficacy in at least two FDA
approved animal models for evaluation of smallpox countermeasures,
data demonstrating the candidate is safe and well tolerated in
human subjects, and the ability to supply both IV and oral drug,
all of which SIGA believes it can demonstrate based on work under
its existing BARDA contracts.
“We look forward to responding to the RFP and to the opportunity
presented by the RFP to augment our strong partnership with BARDA
to ensure TPOXX® is part of a sustainable stockpile to mitigate the
threat of a bioterror attack with smallpox,” added Dr. Gomez. “The
addition of an IV formulation would be critical in an outbreak to
treat those too sick to take the oral capsules, and the advancement
and procurement of the IV formulation would represent an important
next step in building our preparedness for smallpox.”
Pursuant to the RFP, responses are due by April 23, 2018. Any
award under the RFP would be subject to negotiation of final
contract terms and specifications. Once final negotiations are
completed, BARDA will issue a formal Notification of Award. There
can be no assurance that SIGA will receive the award under the RFP,
or, if it does, that it will be able to successfully negotiate
final contract terms and specifications with BARDA.
ABOUT SIGA TECHNOLOGIES, INC. and TPOXX®
SIGA Technologies, Inc. is a company specializing in the
development and commercialization of solutions for serious unmet
medical needs and biothreats. The company’s lead product
is TPOXX®, also known as tecovirimat and ST-246®, an orally
administered and IV formulation antiviral drug that
targets orthopoxvirus infections. While TPOXX® is
not yet approved as safe and effective by the U.S. Food &
Drug Administration, it is a novel small-molecule drug of which 2
million courses have been delivered to the Strategic National
Stockpile under Project BioShield. 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. No cure or treatment for smallpox exists. A vaccine
can prevent smallpox, but the risk of the vaccine's side effects is
too high to justify routine vaccination for people at low risk of
exposure to the smallpox virus.
1
http://www.mayoclinic.org/diseases-conditions/smallpox/basics/definition/con-20022769
FORWARD-LOOKING STATEMENTS
This press release contains certain "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995, as amended, including statements relating to the
submission and approval of TPOXX® by the FDA. 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. More detailed information about SIGA and risk
factors that may affect the realization of forward-looking
statements, including the forward-looking statements in this press
release, is set forth in SIGA's filings with the Securities and
Exchange Commission, including SIGA's Annual Report on Form 10-K
for the fiscal year ended December 31, 2017, and in other documents
that SIGA has filed with the SEC. SIGA urges investors and security
holders to read those documents free of charge at the SEC's web
site at http://www.sec.gov. Interested parties may also obtain
those documents free of charge from SIGA. Forward-looking
statements are current only as of the date on which such statements
were made, and except for our ongoing obligations under the United
States of America federal securities laws, we undertake no
obligation to update publicly any forward-looking statements
whether as a result of new information, future events, or
otherwise.
ContactsMediaGlenn
Silver646-871-8485gsilver@lazarpartners.com
Investor RelationsDavid
Carey212-867-1762dcarey@lazarpartners.com
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