SIGA Announces Enrollment of First Patients in the Final Cohort of Phase III Study of Tecovirimat

NEW YORK–(BUSINESS WIRE)– SIGA Technologies, Inc. (SIGA) (OTCMKTS:SIGA), a company specializing in
the development of pharmaceutical agents to combat bio-warfare
pathogens, announced today that it has begun enrolling the second and
final cohort of healthy subjects for the Phase III clinical study for
its lead drug candidate, TPOXX (tecovirimat), for the treatment of
orthopoxvirus. This Phase III study, which is wholly funded the by the
Biomedical Advanced Research and Development Authority (BARDA) will be
conducted at eleven approved investigative sites with a total of
approximately 360 subjects.

The initial Phase III lead cohort of 40 subjects in this trial has
already completed participation without any reports of serious adverse
events.

Screening of subjects for the second Phase III cohort initiated on April
11, 2016, and the first subject was enrolled and dosed on April 18,
2016. Since tecovirimat is being developed under the FDA “Animal Rule,”
there are no efficacy endpoints in this clinical trial. This study will
generate safety and pharmacokinetic data in support of the prescribing
information that will be part of the New Drug Application (NDA) filing.

ABOUT SIGA TECHNOLOGIES, INC.

We are a company specializing in the development and commercialization
of solutions for serious unmet medical needs and biothreats. Our lead
product is Tecovirimat, TPOXX, also known as ST-246®, an orally
administered antiviral drug that targets orthopoxviruses. While TPOXX is
not yet approved as safe and effective by the U.S. Food & Drug
Administration, it is a novel small-molecule drug that is being
delivered to the Strategic National Stockpile under Project BioShield.
For more information about SIGA, please visit SIGA’s web site at www.siga.com.

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 effect of the loss of our
litigation with PharmAthene, Inc., our ability to raise the funds
necessary to satisfy the judgment arising from such loss and our chapter
11 bankruptcy case. 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 potential
products that appear promising to SIGA or its collaborators cannot be
shown to be efficacious or safe in subsequent pre-clinical or clinical
trials, (ii) the risk that SIGA or its collaborators will not obtain
appropriate or necessary governmental approvals to market these or other
potential products, (iii) the risk that SIGA may not be able to obtain
anticipated funding for its development projects or other needed
funding, including from anticipated governmental contracts and grants,
(iv) the risk that SIGA may not complete performance under the
Biomedical Advanced Research Development Authority (BARDA) Contract on
schedule or in accordance with contractual terms, (v) the risk that SIGA
may not be able to secure or enforce sufficient legal rights in its
products, including intellectual property protection, (vi) 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, (vii) 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 seeking
or obtaining needed approvals to market these products, (viii) the risk
that one or more protests could be filed and upheld in whole or in part
or other governmental action taken, in either case leading to a delay of
performance under the BARDA Contract or other governmental contracts,
(ix) the risk that the BARDA Contract is modified or canceled at the
request or requirement of the U.S. government, (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 the
changes in domestic and 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 our chapter 11 bankruptcy case may make
it more difficult to obtain additional financing, (xiv) the risk that
our internal controls will not be effective in detecting or preventing a
misstatement in our financial statements, (xv) the risk that some
amounts received and recorded as deferred revenue may someday be
determined to have been more properly characterized as revenue when
received, (xvi) the risk that some amounts received and recorded as
deferred revenue ultimately may not be recognized as revenue, (xvii) the
risk associated with the loss of our appeal to the Delaware Supreme
Court in our litigation with PharmAthene, Inc., including, the risks
related to a failure to satisfy the judgment arising from the loss of
the litigation with PharmAthene, Inc. and (xviii) the costs and expenses
and other inherent uncertainty attendant to a chapter 11 case. 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, 2015, 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.

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