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): October 6, 2005
-------------
SIGA TECHNOLOGIES, INC.
(Exact name of registrant as specified in its charter)
Delaware 0-23047 13-3864870
(State or other jurisdiction of (Commission file number) (I.R.S. employer
incorporation or organization) identification no.)
420 Lexington Avenue, Suite 408 10170
New York, New York (Zip code)
(Address of principal executive offices)
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 October 6, 2005, SIGA Technologies, Inc., a Delaware corporation, issued a
press release pursuant to which it announced that the company's lead smallpox
compound, SIGA-246, completely protected golden ground squirrels from lethal
doses of monkeypox virus. Monkeypox virus is closely related to human
smallpox virus, and causes a similar disease in both monkeys and humans.
SIGA-246, administered orally, demonstrated significant antiviral activity
against the golden ground squirrel model of monkeypox disease. The study was
conducted in the BSL-3 facility at the University of Texas Medical Branch
(UTMB). SIGA had announced in October 2004 that it had established the
efficacy of SIGA-246 in several mouse models. A copy of the press release is
attached hereto as Exhibit 99.1, which is incorporated in this Item 8.01 by
reference.
Item 9.01. Financial Statements and Exhibits.
(c) Exhibits
Exhibit No. Description
- ----------- -----------
99.1 Press Release, dated October 6, 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: October 6, 2005
3
Exhibit 99.1
SIGA
Contact:
Dr. Bernard L. Kasten
SIGA Technologies, Inc.
CEO
bkasten@siga.com
(212) 672-9100
SIGA ANNOUNCES SUCCESS OF ITS SMALLPOX COMPOUND
IN A MONKEYPOX MODEL
New York, October 6, 2005 -- SIGA Technologies, Inc. (NASDAQ: SIGA) today
announced that the company's lead smallpox compound, SIGA-246, completely
protected golden ground squirrels from lethal doses of monkeypox virus.
Monkeypox virus is closely related to human smallpox virus, and causes a similar
disease in both monkeys and humans. SIGA-246, administered orally, demonstrated
significant antiviral activity against the golden ground squirrel model of
monkeypox disease. The study was conducted in the BSL-3 facility at the
University of Texas Medical Branch (UTMB). SIGA had announced in October 2004
that it had established the efficacy of SIGA-246 in several mouse models.
"The successful outcome of this study is important," said Dr. Dennis E. Hruby,
Chief Scientific Officer of SIGA. "It is the first demonstration of SIGA-246
efficacy against monkeypox in a lethal challenge model using a genetically
diverse population of wild rodents."
Smallpox virus is considered one of the most significant threats for use as a
biowarfare agent due to the fact that since 1972 people in the United States
have not been vaccinated against it. Smallpox is very easily transmitted from
person to person, and has high mortality rates (30-60%) with 90% morbidity.
Weaponized smallpox virus may have an incubation period as short as 3-7 days. It
is classified as a Category A agent by the Center for Disease Control (CDC).
Mass immunizations of the general population using the current live vaccines are
not recommended. Available vaccines are known to cause complications in certain
individuals, including encephalitis, myocarditis, disseminated vaccinia virus
infection, and death. At present there is no treatment for smallpox that can be
safely administered to the general population without significant risk of
adverse reactions.
SIGA's CEO Dr. Bernard L. Kasten stated, "The results of this study demonstrate
that SIGA-246 is an orally active compound that can prevent the systemic spread
of monkeypox virus. The drug performance continues to be very promising as we
expedite 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 and emerging pathogens.
SIGA's vaccine and drug platforms are based on its pioneering research into the
structure, function and processing of bacterial surface proteins. In addition to
smallpox, SIGA also has antiviral programs targeting other Category A pathogens
which cause hemorrhagic fevers. Included are the arenaviruses (Lassa Fever
Virus, Junin, Macupo, Guanarito, and Sabia), Lymphocytic choriomeningitis virus
(LCMV), Dengue, and 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, and (d) SIGA may not be able to secure funding from anticipated
government contracts and grants, (e) SIGA may not be able to secure or enforce
adequate legal protection, including patent protection, for its products and (f)
unanticipated internal control deficiencies or weaknesses or ineffective
disclosure controls and procedures. 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 our obligations under the U.S. federal securities laws, we undertake no
obligation to publicly update any forward-looking statements as a result of new
information, future events or otherwise.
# # #