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
is advancing a portfolio of potential blockbuster drug candidates which
target multi-billion dollar market opportunities. These late-stage products
include: BiovaxID®, a novel anti-idiotype cancer vaccine for the treatment
of B-cell malignancies including indolent follicular non-Hodgkin’s lymphoma;
Revimmune™, 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™, a novel formulation of a previously approved anti-fungal
for the topical, intranasal treatment of chronic sinusitis.
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.
Reports Fiscal Third Quarter Financial Results
08/14/08 05:40 PM EDTAccentia 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.
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™, a personalized anti-cancer vaccine initially targeting
indolent follicular non-Hodgkin’s lymphoma; Revimmune™ (ultra-high-dose
cyclophosphamide) targeting the treatment of up to 80 autoimmune diseases,
with an initial indication of multiple sclerosis; and SinuNase™ for the
treatment of chronic sinusitis.
recent milestones include:
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
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.
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.
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.
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.
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
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
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.
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
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.
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.