Accentia Reports Fiscal Third Quarter Financial Results
-- Prepares to seek FDA approval for anti-cancer vaccine
-- Poised to file IND to commence Phase 3 trial for MS drug
TAMPA, Fla.--(Business Wire)--
Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI) announced today
that the Company has filed its Quarterly Report (Form 10-Q) with the
SEC, reporting the results of its operations, including consolidated
results with its majority-owned subsidiary, Biovest International,
Inc. (OTCBB:BVTI), for its third fiscal quarter ended June 30, 2008.
Accentia is primarily focused on the commercialization of its
three late-stage potential blockbuster therapeutics which are in or
entering Phase 3 clinical trials including: BiovaxID(TM), a
personalized anti-cancer vaccine initially targeting indolent
follicular non-Hodgkin's lymphoma; Revimmune(TM) (ultra-high-dose
cyclophosphamide) targeting the treatment of up to 80 autoimmune
diseases, with an initial indication of multiple sclerosis; and
SinuNase(TM) for the treatment of chronic sinusitis.
Significant recent milestones include:
-- BiovaxID Phase 3 results demonstrated a clinically and
statistically significant improvement of disease-free
survival, providing highly encouraging safety and efficacy
data which is expected to provide the basis for seeking
accelerated and/or conditional approvals in the U.S. and
Europe, respectively. Discussions are now planned with the FDA
as to the pathway to commercialization of BiovaxID.
-- Leading researchers at Johns Hopkins University published
unprecedented study results in the treatment of multiple
sclerosis, showing therapy with Revimmune to be capable of
restoring physical and neurological functions with the
potential to eliminate autoimmunity. Preparations are now
ongoing to file an Investigational New Drug Application (IND)
in order to commence a Phase 3 clinical trial.
Based on these key achievements, Accentia and Biovest are
currently engaged in discussions and negotiations with regards to
securing strategic alliances and licensing agreements for its
products.
Financial Review:
Accentia has two operating segments consisting of specialty
pharmaceuticals (Accentia Pharmaceuticals) and product development and
market services (Analytica International). Accentia also has an
approximate 76% interest in Biovest International, Inc. (OTCBB:BVTI),
which is consolidated for reporting purposes with Accentia's product
development and market service business.
On a fully consolidated basis, including Biovest, net revenues for
the three months ended June 30, 2008 were $3.0 million, compared with
$3.8 million for the same period ended June 30, 2007. The decrease in
net revenues was attributed to a slight decrease in net sales reported
by our subsidiaries Biovest and Analytica and our specialty
pharmaceuticals division.
Consolidated research and development costs were $1.6 million for
the third fiscal quarter, compared with $5.2 million for the same
fiscal quarter in 2007. This 70% decrease was largely due to our
Biovest subsidiary reducing research and development expenses as its
clinical trial costs have declined considerably, as a result of our
decision, based on the independent Data Monitoring Committee's
recommendation, to stop the BiovaxID Fast-Tracked Phase 3 study early,
and seek accelerated and/or conditional approval with the FDA and
European regulatory authorities. There was also a decrease in SinuNase
research and development expenses due to the completion of its
Fast-Tracked Phase 3 clinical trial, which demonstrated statistically
significant objective evidence based on secondary endpoint analysis
measuring the most severe cases of polyposis and inflammation. The
Company is continuing to analyze the Phase 3 SinuNase results to
determine the optimal course for future clinical development.
Accentia's second quarter net loss, on a fully consolidated basis,
including Biovest, was $11.4 million, compared to $25.0 million
reported for the same three month period in fiscal 2007. Of this loss,
approximately $6.6 million was due to non-cash charges. The operating
loss, on a fully consolidated basis, was $7.3 million as compared to
$12.6 million for the comparable quarter in 2007, representing a 42%
reduction, as the Company's developmental pipeline matures.
The fully consolidated loss per share for the quarter was $0.25,
of which $0.08 per share was attributed to Biovest, which is
consolidated in Accentia's financial statements. Since February 2007,
Biovest has been self-funded. For the comparable 2007 quarter, the
fully consolidated loss per share was $0.71 of which $0.34 per share
was attributed to Biovest. The Company notes that the operating loss
for Biovest has been substantially reduced in part due to Biovest's
decision, based on the independent Data Monitoring Committee's
recommendation, to stop enrollment in the BiovaxID Fast-Tracked Phase
3 study and seek accelerated and/or conditional approval with the FDA
and European regulatory authorities.
At June 30, 2008, Accentia had approximately $4.5 million in cash.
With the recent positive results reported for BiovaxID and Revimmune,
Accentia and Biovest are currently evaluating new financing
opportunities, including potential partnering and licensing agreements
which are expected to be significant commercial events, providing
access to additional sources of capital.
Accentia also reported that on August 13, 2008, the Company
received notice from Nasdaq that it is not in compliance with Nasdaq
Marketplace Rule 4450(a)(5) because shares of its common stock had
closed at a per share bid price of less than $1.00 for 30 consecutive
business days. Accentia will be provided with 180 calendar days, or
until February 9, 2009, to regain compliance, which would be
accomplished when Accentia's common stock closing bid price is $1.00
per share or more for a minimum of ten consecutive business days. If
the Company does not regain compliance by February 9, 2009, the Nasdaq
staff will notify the Company that its common stock will be delisted.
In that event and at that time, the Company may appeal Nasdaq's
delisting determination to a Nasdaq Listing Qualifications Panel. This
notification has no effect on the listing of Accentia's common stock
at this time.
Accentia expects to regain compliance within this 180 day cure
period and will consider alternatives to address compliance with the
continued listing standards of The Nasdaq Stock Market.
About Accentia Biopharmaceuticals, Inc.
Accentia Biopharmaceuticals, Inc. (Nasdaq:ABPI) is committed to
building significant value for its stockholders through the
commercialization of patent-protected disruptive healthcare
technologies designed to be positioned as leading products for the
treatment of a broad range of chronic, debilitating and
life-threatening diseases including respiratory, autoimmune and cancer
indications. The Company generated more than $18 million in revenues
in fiscal-year 2007, primarily based on sales of its marketed
specialty pharmaceutical products and its analytical consulting
business serving biopharmaceutical clients.
Accentia is advancing a portfolio of potential blockbuster drug
candidates which target multi-billion dollar market opportunities.
These late-stage products include: BiovaxID(R), a novel anti-idiotype
cancer vaccine for the treatment of B-cell malignancies including
indolent follicular non-Hodgkin's lymphoma; Revimmune(TM), a novel
ultra-high-dose formulation of a previously approved chemotherapeutic
agent expected to show utility in the treatment of up to 80 autoimmune
diseases, with an initial focus on multiple sclerosis; and
SinuNase(TM), a novel formulation of a previously approved anti-fungal
for the topical, intranasal treatment of chronic sinusitis.
Accentia's interest in BiovaxID is based on its majority ownership
stake in Biovest International, Inc. (OTCBB:BVTI), and Accentia also
maintains a royalty interest in Biovest's biologic products. Accentia
is a portfolio company of the Hopkins Capital Group.
For further information, please visit: http://www.Accentia.net
Forward-Looking Statements:
Statements in this release that are not strictly historical in
nature constitute "forward-looking statements." Such statements
include, but are not limited to, statements about Revimmune(TM),
SinuNase(TM), BiovaxID(R), AutovaxID(TM), SinuTest(TM), AllerNase(TM)
and any other statements relating to products, product candidates,
product development programs, the FDA or clinical study process
including the commencement, process, or completion of clinical trials
or the regulatory process. Such statements may include, without
limitation, statements with respect to the Company's plans,
objectives, expectations and intentions, and other statements
identified by words such as "may," "could," "would," "should,"
"believes," "expects," "anticipates," "estimates," "intends," "plans,"
or similar expressions. Such forward-looking statements involve known
and unknown risks, uncertainties, and other factors that may cause the
actual results of Accentia to be materially different from historical
results or from any results expressed or implied by such
forward-looking statements. These factors include, but are not limited
to, risks and uncertainties related to the progress, timing, cost, and
results of clinical trials and product development programs;
difficulties or delays in obtaining regulatory approval for product
candidates; competition from other pharmaceutical or biotechnology
companies; and the additional risks discussed in filings with the
Securities and Exchange Commission. All forward-looking statements are
qualified in their entirety by this cautionary statement, and Accentia
undertakes no obligation to revise or update this news release to
reflect events or circumstances after the date hereof. The product
names used in this statement are for identification purposes only. All
trademarks and registered trademarks are the property of their
respective owners.
Accentia Biopharmaceuticals, Inc., Tampa
Douglas Calder, Director of Investor Relations &
Public Relations, 813-864-2554, ext. 258
dwcalder@accentia.net
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