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conference call contains or implies 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 and possible eventual approval 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 SIGA's
control. Actual results may differ materially from those anticipated in any
forward-looking statement. Factors that may cause such differences include the
risks that (i) potential products that appear promising to SIGA or its
collaborators cannot be shown to be efficacious or safe in subsequent
preclinical or clinical trials, (ii) SIGA or its collaborators will not obtain
appropriate or necessary governmental approvals to market these or other
potential products, (iii) SIGA may not be able to obtain anticipated funding for
its development projects or other needed funding, (iv) SIGA may not be able to
secure funding from anticipated government contracts and grants, (v) SIGA may
not be able to secure or enforce sufficient legal rights in its products,
including sufficient patent protection for its products, (vi) any challenge to
our patent and other proprietary rights, if adversely determined, could affect
our business and, even if determined favorably, could be costly, (vii)
regulatory approval for SIGA's products may require further or additional
testing that will delay or prevent approval, (viii) the Biomedical Advanced
Research & Development Authority may not complete the procurement set forth
in its solicitation for the acquisition of a smallpox antiviral for the
strategic national stockpile, or may complete it on different terms; (ix) the
volatile and competitive nature of the biotechnology industry may hamper SIGA's
efforts, (x) changes in domestic and foreign economic and market conditions may
adversely affect SIGA's ability to advance its research or its products, (xi)
changing federal, state and foreign regulation on SIGA's businesses may
adversely affect SIGA's ability to advance its research or its products and
(xii) market conditions may not permit an offering of securities or be
sufficiently attractive to market participants to allow any offering to succeed.
More detailed information about SIGA and risk factors that may affect the
realization of forward-looking statements, including the forward-looking
statements in this conference call, 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, 2008, 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.
for joining us this morning and for your interest in SIGA. My three objectives
for this call are to:
with the RFP, on Friday, December 11th, BARDA posted its 7th
amendment to the original solicitation announced on March 11,
2009. The changes include:
several important inferences from this most recent set of changes:
to turn now to a brief discussion of our smallpox anti-viral drug
a proprietary, orally bioavailable new chemical entity for the treatment of
smallpox, a deadly and disfiguring disease not effectively treated by any
currently marketed drug. Development of effective smallpox
therapeutics has been pursued for centuries, and has been a worldwide research
priority for at least several decades. While smallpox was eradicated
in 1977, the recent instances of global terrorism, the loss of population
immunity due to the cessation of routine smallpox vaccination in the United
State more than forty years ago, the complex logistics of rapid emergency
vaccination of the population, and the likelihood that a portion of the
population would refuse or would be unsuitable for vaccination have all served
to increase the need for an effective smallpox therapeutic.
kills 20 to 30% of its victims, while disfiguring the majority of its survivors.
In the event of an outbreak of smallpox infecting 1.7 million American adults,
an effective smallpox anti-viral has the potential to save hundreds of thousands
of lives. In an outbreak in 12 million or more, millions could be
saved. Because children and the elderly would also be affected by the
disease, special oral formulations of a smallpox anti-viral drug for children
and the elderly and intravenous formulations for those critically ill would
obviously be highly desirable as part of a
comprehensive preparedness strategy. Any outbreak of
smallpox would represent an international public health emergency, and we
believe that many other countries are interested in stockpiling an effective
smallpox anti-viral.
believe ST-246 mediates a protein-protein interaction of the virally encoded
gene product of F13L, which is essential for egress of the pathogenic form of
the virus from infected cells. The unraveling and exploitation of
this unique biology was accomplished entirely at SIGA. Our scientists
have successfully addressed risks and barriers associated with target validity,
medicinal chemistry, oral bioavailability, pharmacokinetics, and toxicology, and
ST-246 has shown unprecedented efficacy in non-human primate models, even where
the model disease is arguably more lethal than human smallpox. Any other
potential smallpox anti-viral drug candidate would need to overcome these same
risks and barriers. The composition of matter patents on the drug are wholly
owned by SIGA with expiry in 2025, while a new set of patents regarding key
issues of formulation and shelf-life have been filed this year.
Within this context, we strongly believe that ST-246 is a unique achievement
fostered by Project Bioshield.
now to questions we've been asked frequently:
short, we remain as highly confident of the commercialization prospects of our
drug in the near future as at any time in our corporate history.
this up, let me again thank you, our shareholders, for your interest in us at
SIGA. We enter 2010 with an outstanding, dedicated and energized team, a
strengthened balance sheet, more than $80 million of non-dilutive awarded yet
unspent federal grants and contracts to support our programs, and the highest
level of confidence in our corporate history that we can soon transition from a
development stage to a robust commercial stage company. We hope you
are as excited as we are about our prospects, and look forward to continuing to
update you on our progress.
does conclude today's conference. Thank you for your