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8-K - CURRENT REPORT - SIGA TECHNOLOGIES INC | kl12015.htm |
EX-99.2 - PRESS RELEASE - SIGA TECHNOLOGIES INC | kl12015_ex99-2.htm |
Exhibit
99.1
Moderator:
This
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.
Dr.
Eric Rose:
Thanks
Mary Beth.
Thanks
for joining us this morning and for your interest in SIGA. My three objectives
for this call are to:
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First,
offer our view on the changes to RFP-BARDA-09-35 for the acquisition of a
smallpox anti-viral drug for therapeutic use into the Strategic National
Stockpile
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Second,
explain the unique nature of our drug candidate ST-246 to the many of you
on the call new to SIGA and to enhance the understanding of those of you
who know us already, and
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Third,
to address important, frequent questions we’ve been asked over the past
several days.
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Starting
with the RFP, on Friday, December 11th, BARDA posted its 7th
amendment to the original solicitation announced on March 11,
2009. The changes include:
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First,
the intent to contract with one or more offerors
versus a single
offeror,
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Second,
relaxation of the mandatory eligibility requirement for the provision of
evidence of product efficacy in non-human primates,
and
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Third,
affirmation of the need to provide evidence for therapeutic index in
non-human primate models under an eventual
contract. Therapeutic index is the ratio of the drug dose which
produces an undesired effect to the dose which causes the desired
effect.
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We draw
several important inferences from this most recent set of changes:
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First,
BARDA continues to actively pursue its objective to acquire a therapeutic
smallpox antiviral drug into the Strategic National
Stockpile.
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Second,
we believe SIGA remains uniquely qualified as an offeror for this RFP,
with consistent evidence of the excellent therapeutic index of ST-246 in
multiple non-human primate tests using the smallpox virus itself and
monkeypox.
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Third,
proof of efficacy in non-human primates remains a substantial barrier to
entry that our competitors will need to overcome to commercialize their
product candidates. We believe we have at least a three year lead compared
to any other potential product candidate in regard to non-human primate
efficacy testing.
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I’d like
to turn now to a brief discussion of our smallpox anti-viral drug
candidate.
ST-246 is
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.
Smallpox
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.
We
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.
Turning
now to questions we’ve been asked frequently:
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First,
were we aware of BARDA’s intention to amend its smallpox anti-viral RFP
prior to its posting at 10:01 am eastern time on Friday, December
11?
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We
were not informed beforehand by BARDA. We learned of the amendment at the
same time as the public and our investors when the amendment was posted to
the FedBizOpps website.
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This
was the seventh time BARDA has amended the agency’s original solicitation.
We have not had either informal or formal advance notice from BARDA
personnel regarding any of these
amendments.
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Next
Question: Why did we undertake an offering of the stock last
week?
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We
took advantage of the rising demand for our stock and favorable market
conditions. This opportunity provided us with the ability to strengthen
our balance sheet, add liquidity to invest in our programs over the next
several years,
and bring in new
long-term institutional investors. We accomplished this with minimal
dilution to our shareholders.
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Next
Question: What is the Company’s confidence level toward the
commercialization of ST-246 in light of this RFP
Amendment?
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We
continue to believe that ST-246 remains the best candidate under the
RFP. In particular, we believe ST-246’s safety and efficacy
data best meet the RFP’s criteria and we believe that SIGA is also best
positioned to meet all of the other criteria in the RFP. Those
additional criteria include having a validated manufacturing process and a
secure supply chain. We have consistently disclosed, however that BARDA
may or may not complete the purchase of a smallpox antiviral or may do so
on terms that differ from the current
RFP.
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While
Friday’s changes to the RFP may make it possible for another drug to
qualify and win an award as well, we believe that any award on the merits
should result in an award to SIGA.
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In
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.
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Will
the changes in the RFP delay a contract for the
RFP?
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The
original RFP solicitation stated the intent to come to contract by
September 2009, while BARDA officials have previously stated their
expectation to complete a contract by the end of calendar year
2009. We believe it is unlikely we will consummate a contract
in this calendar year, but we have been engaged with BARDA contracting
personnel in an active, diligent process regarding technical aspects of
our proposal, physical and informational security at our laboratories and
our manufacturing contractors’ plants, and pricing. We don’t
believe that Friday’s amendments to the RFP will adversely affect our
prospects in this process.
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Also,
we don’t believe the December 11th
amendment will create a long process delay, so we continue to await the
finalization of the amendment on or about December 28. We find
this process to be entirely consistent with the contracting processes we
have engaged in with HHS and DOD for our prior grants and contracts. We
have the highest respect for the diligence and integrity of the process
and our government partners.
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If
BARDA makes awards to multiple contractors, will that diminish SIGA’s
share of the base acquisition of 1.7 million courses of
drug?
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While
this is certainly possible, we believe we are best able to deliver the
entire 1.7 million courses as rapidly as possible. Our pricing
proposal only contemplated an order for the entire 1.7 million
courses. We believe that BARDA has shown an understanding both
in this RFP and its acquisitions that lower volumes deserve higher unit
pricing.
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Will
these delays postpone potential delivery of ST-246 into the strategic
national stockpile?
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We
have already produced 20,000 courses of ST-246 in our FDA registration
batches and plan to produce 300,000 more courses in early 2010 in our
commercial validation process. This activity is funded by the $20 million
increase to our ST-246 therapeutic development contract which BARDA
awarded to us in September 2008. We believe that if we complete
a contract in the first quarter of 2010, we can fulfill our plan to begin
delivery of our drug into the strategic national stockpile in late
2010.
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To wrap
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.
Thanks
very much.
Moderator:
And that
does conclude today’s conference. Thank you for your
participation.