SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15 (d) OF
THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): December 13, 2005
SIGA TECHNOLOGIES, INC.
(Exact name of registrant as specified in its charter)
Delaware 0-23047 13-3864870
(State or other jurisdiction of (Commission (I.R.S. employer
incorporation or organization) file number) identification no.)
420 Lexington Avenue, Suite 408
New York, New York
(Address of principal 10170
executive offices) (Zip code)
Registrant's telephone number, including area code: (212) 672-9100
-------------------------------------------------------------------------
Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any
of the following provisions (see General Instruction A.2. below):
|_| Written communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
|_| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
|_| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange
Act (17 CFR 240.14d-2(b))
|_| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange
Act (17 CFR 240.13e-4(c))
Item 8.01 Other Events.
On December 13, 2005, SIGA Technologies, Inc., a Delaware corporation
("SIGA"), issued a press release pursuant to which SIGA announced that the U.S.
Food and Drug Administration (FDA) accepted its Investigational New Drug (IND)
application to begin Phase I clinical trials of SIGA-246, its lead smallpox
drug. SIGA also announced that in order to expedite the program, the FDA granted
SIGA-246 Fast-Track status.
A copy of the press release is attached hereto as Exhibit 99.1.
Item 9.01. Financial Statements and Exhibits.
(c) Exhibits
Exhibit No. Description
- ----------- -----------
99.1 Press Release, dated December 13, 2005.
-2-
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
SIGA TECHNOLOGIES, INC.
By: /s/ Thomas N. Konatich
-------------------------------
Name: Thomas N. Konatich
Title: Chief Financial Officer
Date: December 14, 2005
-3-
EXHIBIT 99.1
SiGA[LOGO]
Contact:
Dr. Bernard Kasten
SIGA Technologies, Inc.
Chief Executive Officer
(212) 672-9100
FDA APPROVES SIGA'S INVESTIGATIONAL NEW DRUG APPLICATION FOR ITS
SMALLPOX DRUG SIGA-246
New York, December 13, 2005 -- SIGA Technologies, Inc. (NASDAQ: SIGA) announced
today that the U.S. Food and Drug Administration (FDA) accepted its
Investigational New Drug (IND) application to begin Phase I clinical trials of
SIGA-246, its lead smallpox drug. In order to expedite the program, the FDA
granted SIGA-246 Fast-Track status.
SIGA Technologies will start Phase I clinical trials to evaluate SIGA-246 in
healthy volunteers. The Phase I human trials will be performed at the Biodefense
Clinical Research Branch of the National Institute of Allergy and Infectious
Diseases (NIAID), which is part of the federal government's National Institutes
of Health (NIH). The primary objective of the study will be to evaluate the
safety and tolerability of single escalating doses of SIGA-246.
SIGA-246, an orally active compound, has demonstrated significant antiviral
activity in various animal models of poxvirus disease, including the complete
protection of golden ground squirrels from lethal doses of monkeypox virus.
Smallpox virus, classified as a Category A agent by the Center for Disease
Control (CDC), is considered one of the most significant threats for use as a
biowarfare agent. It is easily transmissible from person to person, is hardy in
the environment, and can be readily delivered. Routine smallpox vaccinations
were discontinued in the United States in 1972. More than 223 million Americas
have never been vaccinated. Smallpox has high mortality rates (30%) with up to
90% morbidity. Weaponized smallpox virus may have an incubation period as short
as 7 days, allowing very little time for vaccine administration.
The use of current live vaccines for mass immunizations of the general
population is not recommended because available vaccines are known to cause
complications in certain individuals, including encephalitis, myocarditis,
disseminated vaccinia virus infection, and death. 10% to 20% of the population
cannot be vaccinated because of immunocompromised status or other medical
conditions. At present there is no smallpox treatment stockpiled for the general
population.
Dr. Dennis E. Hruby, SIGA's Chief Scientific Officer, said, "A Phase I clinical
trial of SIGA-246 is a critical step towards insuring the availability of a
smallpox drug that can fight this dreaded disease without serious side effects.
This nation needs a self-administrable antiviral drug in order to provide
immediate protection in the event of the deliberate release of smallpox virus.
Based upon the data generated to date, we believe that SIGA-246 will be a safe
and effective drug for the treatment of smallpox."
SIGA's Chief Executive Officer, Bernard L. Kasten, MD stated, "The success of
SIGA-246 in animal trials and pre-clinical studies is very encouraging. We look
forward to initiating human safety trials and advancing SIGA-246 toward New Drug
Application approval." Dr. Kasten continued, "We appreciate the support we have
received from the NIAID and the NIH in bringing SIGA-246 to this stage of its
development."
About SIGA Technologies, Inc.
SIGA Technologies is applying viral and bacterial genomics and sophisticated
computational modeling in the design and development of novel products for the
prevention and treatment of serious infectious diseases, with an emphasis on
products for biological warfare defense. SIGA has the potential to
become a significant force in the discovery of vaccine and pharmaceutical agents
to fight emerging pathogens. SIGA's product development programs emphasize the
increasingly serious problem of drug resistant bacteria. In addition to
smallpox, SIGA has antiviral programs targeting other Category A viral
pathogens, including arenaviruses (Lassa Fever Virus, Junin, Macupo, Guanarito,
and Sabia), Lymphocytic choriomeningitis virus (LCMV), Dengue, the filoviruses,
Ebola and Marburg. 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 regarding the efficacy of potential products, the timelines
for bringing such products to market and the availability of funding sources for
continued development of such products. Forward-looking statements are based on
management's estimates, assumptions and projections, and are subject to
uncertainties, many of which are beyond the control of SIGA. Actual results may
differ materially from those anticipated in any forward-looking statement.
Factors that may cause such differences include the risks that (a) 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, (b) SIGA
or its collaborators will not obtain appropriate or necessary governmental
approvals to market these or other potential products, (c) SIGA may not be able
to obtain anticipated funding for its development projects or other needed
funding, (d) SIGA may not be able to secure funding from anticipated government
contracts and grants, and (e) SIGA may not be able to secure or enforce adequate
legal protection, including patent protection, for its products. 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 and the above-mentioned presentation, 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, 2004, and in other
documents that SIGA has filed with the Commission. SIGA urges investors and
security holders to read those documents free of charge at the Commission's Web
site at http://www.sec.gov. Interested parties may also obtain those documents
free of charge from SIGA. Forward-looking statements speak only as to the date
they are made, and except for any obligation under the U.S. federal securities
laws, SIGA undertakes no obligation to publicly update any forward-looking
statement as a result of new information, future events or otherwise.
###