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AVANT Immunotherapeutics Reports Third Quarter and Nine-Month Financial Results NEEDHAM, Mass.--(BUSINESS WIRE)

Key Takeaway: AVANT Immunotherapeutics Reports Third Quarter and Nine-Month Financial Results NEEDHAM, Mass.--(BUSINESS WIRE)--Oct. 31, 2007--AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN) today reported financial results for the third quarter and first nine-month period of fiscal year 2007.

Full Press Release Details

AVANT Immunotherapeutics Reports Third Quarter and Nine-Month Financial Results
NEEDHAM, Mass.--(BUSINESS WIRE)--Oct. 31, 2007--AVANT Immunotherapeutics,
Inc. (Nasdaq: AVAN) today reported financial results for the third quarter and
first nine-month period of fiscal year 2007. The Company reported a net loss of
$5.3 million, or $.07 per share, for the third quarter of 2007 compared to a net
loss of $5.5 million, or $.07 per share, for the third quarter of 2006. For the
nine months ended September 30, 2007, AVANT reported a net loss of $16.4
million, or $.22 per share, compared to a net loss of $14.2 million, or $.19 per
share, for the nine months ended September 30, 2006. The 2007 nine month losses
include one-time restructuring charges of $765,204. AVANT reported cash and cash
equivalents of $20.3 million at September 30, 2007.
On October 22, 2007, AVANT and Celldex Therapeutics, Inc., a privately-held
company, announced the signing of a definitive merger agreement. The merger
creates a NASDAQ-listed, fully-integrated and diversified biopharmaceutical
company with a deep pipeline of product candidates addressing high-value
indications including oncology and infectious and inflammatory diseases. The
all-stock transaction, approved by both companies' Boards of Directors, will
combine the two companies under the name AVANT, and is currently expected to
close in the first quarter of 2008. Closing of the merger is contingent upon a
vote of approval by AVANT's current shareholders at a special meeting of
shareholders expected to take place in the first quarter of 2008.
"AVANT's third quarter 2007 financial results are in line with our
expectations and leave us in a strong financial position to execute on the
business plan of the proposed combined company of AVANT and Celldex," said Una
S. Ryan, Ph.D., AVANT's President and Chief Executive Officer. "We expect the
merger with Celldex to close in the first quarter of 2008 and believe that the
result will be a promising biopharmaceutical company with a robust portfolio of
immunotherapy-based product candidates in development for serious indications in
significant markets."
Further Financial Highlights
The net loss for the third quarter of 2007 showed a decrease of $267,086
compared to the net loss for the same period in 2006. The decrease in net loss
reflected an increase in revenues primarily due to increased product royalties
from net sales on Rotarix(R) offset by reduced levels of vaccine development
work billable to DVC LLC (DVC) during the third quarter of 2007. In the third
quarter of 2007, AVANT recognized $988,462 in Rotarix-related product royalty
revenue consisting of $540,374 related to Paul Royalty Fund's (PRF) purchased
interest in Rotarix net royalties and $448,088 related to royalty expense
payable to Cincinnati Children's Hospital Medical Center (CCH). Research and
development (R&D) expenses in the third quarter of 2007 were comparable to R&D
expenses in 2006 and included $448,088 of royalty expense payable to CCH.
General and Administrative (G&A) expenses increased $181,472 due primarily to an
increase in professional services expenses. AVANT had lower investment income in
2007, primarily reflecting lower cash balances between periods.
The nine-month results for 2007 reflect an increase in net loss compared to
the same period in 2006. This increase in net loss primarily reflected a
decrease in revenue, an increase in operating expense, and a decrease in
investment income. Revenues for the first nine months of 2007 were $3.4 million,
compared with revenues of $4.6 million for the first nine months of 2006. The
decrease in product development and licensing revenue in 2007 reflects a
one-time milestone payment of $2.6 million recorded in the first quarter of
2006. In the first nine months of 2007, AVANT recognized $2.8 million in product
royalty revenue consisting primarily of $1.4 million related to PRF's purchased
interest in Rotarix net royalties and $1.3 million related to royalty expense
payable to CCH. In the first nine months of 2006, AVANT recognized $550,803 in
product royalty revenue related to PRF's purchased interests in Rotarix net
royalties. The decrease in government contracts and grants revenue in 2007
compared to 2006 primarily reflects reduced levels of vaccine development work
billable to DVC in 2007.
Increased operating expenses in the nine-month results for 2007 primarily
resulted from an increase in research and development expense of approximately
$1,154,880, due primarily to restructuring charges of $765,204 recorded during
the first nine months of 2007 and an increase in royalty expense. R&D expenses
included $1,298,631 and $600,000 of royalty expense payable to CCH during the
nine-month periods ended September 30, 2007 and 2006, respectively. The increase
in operating expenses was partly offset by lower general and administrative
expenses, which are primarily due to decreases in personnel-related expenses and
consulting costs. AVANT had higher investment income in the first nine months of
2006 primarily reflecting higher cash balances between periods.
GlaxoSmithKline (GSK) has continued to pursue the global commercialization
of Rotarix, which has now been approved in over 90 markets worldwide, including
the European Union. In August, AVANT reported that GSK's application for Rotarix
marketing approval had been accepted for review by the FDA. If GSK achieves U.S.
approval for Rotarix and launches the vaccine in 2008, AVANT will receive a $10
million royalty payment from PRF.
Clinical Development Program Update
In February 2006, the National Institute of Allergy and Infectious Diseases
(NIAID) of the National Institutes of Health (NIH) initiated an investigational
double-blind, placebo-controlled Phase 1/2 in-patient dose-escalation clinical
trial aimed at demonstrating the safety and immunogenicity of AVANT's Ty800
typhoid fever vaccine. In May 2007, AVANT announced preliminary results in which
the NIAID researchers found the single-dose, oral vaccine to be well tolerated
and immunogenic, with over 90% of vaccinated subjects generating immune
responses. Based on these excellent results, AVANT plans to continue development
of Ty800 to compete in the expanding typhoid fever vaccine market, which
currently has annual sales of over $200 million. In July 2007, AVANT announced
the initiation of a company-sponsored double-blind, placebo-controlled Phase 2
dose-ranging trial of Ty800 in approximately 180 healthy adult volunteers. The
Phase 2 study is an out-patient, dose-ranging clinical trial that will evaluate
two dose levels of the single-dose, oral Ty800 vaccine and will follow each
subject for six months post-vaccination. Enrollment was completed in late
September 2007. Results are expected to be reported in the first half of 2008.
In 2005, AVANT and its partner, the International Vaccine Institute (IVI),
announced the successful completion of a Phase 2 trial of CholeraGarde(R),
AVANT's cholera vaccine, in Bangladesh where cholera is endemic. With support
from the Gates Foundation, IVI is now planning to initiate further Phase 2 and
Phase 3 studies of CholeraGarde beginning around year-end 2007.
In early 2008, AVANT expects to initiate a Phase 1/2 trial of its ETEC E.
coli vaccine candidate. AVANT's long-term goal is to develop a combination
vaccine containing CholeraGarde, Ty800, S. paratyphi A and ETEC as a "super
Last updated: Oct 31, 2007