Full Press Release Details
Update Conference Call
you, Eric. Good morning everyone and welcome to the first investor
update conference call hosted by SIGA Technologies. We expect this to
be the initiation of a series of conference calls that the Company will host
conjunction with its quarterly and annual results of operations.
initiation of our second human safety trial in mid-February, the Company has
passed another milestone on the road to its first FDA approval, and we thought
that our investors would appreciate the opportunity to hear more about our
organization and our business plans.
call is being broadcast over this conference line and is also available via
web as noted in our press release. It will be available after the
call in a recorded format through the conference service and on our website,
a transcript of this call will be furnished to the SEC on Form 8-K.
on the line today is Tom Konatich, our Chief Financial Officer, and Dr. Dennis
Hruby, our Chief Scientific Officer.
begin our review of operations, I will ask Al Palombo of our investor relations
firm, Cameron Associates, to read our disclaimer regarding forward-looking
morning's conference call will include certain "forward-looking statements''
within the meaning of the Private Securities Litigation Reform Act of 1995,
including statements regarding the efficacy of potential products, the timelines
for bringing such products to market and the availability of funding sources
continued development of such products. Forward-looking statements
are based on management's estimates and assumptions, 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 (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, (e)
SIGA may not be able to secure or enforce adequate legal protection, including
patent protection for its products and (f) regulatory approval for SIGA's
products may require further or additional testing that will delay or prevent
approval. More detailed information about SIGA and risk factors that may affect
the realization of forward-looking statements, including the forward-looking
statements made this morning, are set forth in SIGA's filings
SEC, including its Annual Report on Form 10-K for the fiscal year ended December
31, 2006. SIGA urges investors and security holders to read those
documents free of charge at the Commission's website at www.sec.gov or
obtain them from SIGA. Forward-looking statements speak only as of
the date they are made, and SIGA undertakes no obligation to publicly update
forward-looking statement as a result of new information, future events or
otherwise, except as required by law.
I need to say a word about the FDA approval process. As you know,
SIGA principal product is an unapproved drug. As such, the FDA has
strict rules regarding what can be said about the drug's safety and
effectiveness. SIGA respects those rules, and nothing said today
should be taken as a definitive claim regarding the safety and effectiveness
said, I will now turn the call back to Eric.
been an exciting and eventful year for SIGA from a number of perspectives,
am pleased to review with you our achievements in 2006 and some of the
objectives we look to achieve in 2007.
this is our first conference call, I would like to take a moment to welcome
those of you who are new to the SIGA Technologies story and briefly review
our Company does and some history. I will also provide you with some
background information on myself. Tom Konatich, our CFO, will provide a brief
synopsis of our year-end financials and our overall economics, and Dr. Hruby,
our Chief Scientific Officer, will give you an update on our progress with
ST-246. I will then provide some closing remarks regarding our
business strategy and the competitive landscape. At the end of the
call, we will have some time for your questions.
mission is to discover and develop effective, selective and safe oral anti-viral
drugs directed at treating, preventing, and complementing vaccines for
high-threat biowarfare agents. Our goal is to lead the development
and provision of these drugs domestically and throughout the world to assure
leading-edge biodefense capability and to prevent and treat naturally occurring
illness caused by the agents we target.
milestones to date include the following:
told you a little about where our Company is today, let me tell you a little
about myself. I have a long history of involvement with translational
research and development efforts. For 13 years, I chaired the Department of
Surgery at Columbia University, whose research efforts included the prior
development of Bacitracin and Silvadene, and whose more recent contributions
include crucial work in solid organ transplantation, artificial heart
technology, cancer vaccines, and the discovery of the Receptor for Advanced
Glycation End-Products (known as "RAGE"). Under my leadership, Columbia's heart
transplant and artificial circulatory support programs grew to be the largest
the nation. I co-founded TransTech Pharma, which licensed the RAGE technology
and developed a family of RAGE antagonists now licensed to Pfizer. As
a SIGA board member since 2001, I have been working with Tom and Dennis for
years, and have been an active participant in formulating and implementing
strategy that brought us ST-246 and that continues to generate novel anti-virals
in our earlier stage programs.
to hand over the call now to Tom Konatich, who will give you a brief financial
Eric. Before I review the information we reported in our year-end
financial statements and the numbers we have announced today for the fiscal
first quarter, I would like to provide you an overview of how our organization
currently generates revenues and the basic economics of SIGA.
the major highlights for the year ended December 31, 2006 were as
like to turn the call over to Dr. Dennis Hruby, my colleague here at SIGA for
over 9 years. Dennis will provide you with an update on the testing
of ST-246 and a quick overview of the general FDA process.
I'd like to give you a brief description of our drug development philosophy and
in particular the progress we have made to date on ST-246. I'd also
like to clarify for our listeners the general parameters of an FDA approval
process and how it relates to ST-246, as well as the other drug candidates
developing drugs to combat biothreat agents and emerging diseases. We