Avicena Reports Second Quarter 2007 Results
August 31 2007 - 3:19PM
PR Newswire (US)
PALO ALTO, Calif., Aug. 31 /PRNewswire-FirstCall/ -- Avicena Group,
Inc. (OTC:AVGO) (BULLETIN BOARD: AVGO) , a late stage biotechnology
company that develops central nervous system therapeutics for
neurodegenerative diseases, today announced financial results for
the three month period ended June 30, 2007. Net revenue for second
quarter of 2007 was $108,850, a 22% increase compared to $89,319 in
the second quarter of 2006. Net loss applicable to common stock for
the second quarter of 2007 was $2,520,674, or $(0.05) per basic and
diluted share, compared to a net loss of $1,686,164, or $(0.03) per
basic and diluted share, in the second quarter of 2006.
Year-over-year net loss increased by $834,510, or $(0.02) per basic
and diluted share, primarily as a result of increased research and
development expenses associated with clinical development and
stock-based compensation expense Net loss during the most recent
quarter was also affected by dividends and accretion associated
with the Company's redeemable convertible preferred stock. "We have
made significant advancements in both our pharmaceutical and
dermaceutical programs, and are pleased to have hit several
milestones during the most recent quarter," stated Belinda
Tsao-Nivaggioli, Avicena's Chief Executive Officer. "In terms of
our clinical programs, we are extremely encouraged by the pace of
enrollment in our NIH-funded Phase III Parkinson's disease trial,
and received positive feedback from the FDA for advancing our
Huntington's disease program into a Phase III trial in early 2008.
Overall we are very pleased with how both our neurology and
dermaceutical programs are progressing." Research and development
expenses for the second quarter of 2007 were $826,233, up from
$175,191 in the second quarter of 2006 primarily based on clinical
development costs to support late-stage clinical programs,
including the supply of drugs and placebo for ongoing trials, as
well as patent-related legal expenses. Selling and marketing
expenses were $360,741 for the three month period ended June 30,
2007, an increase of 33% from $271,246 for the corresponding 2006
period. General and administrative expenses of $1,248,605 for the
second quarter of 2007 were up from $628,366 in the prior year
period, primarily based on non-cash stock based compensation
expense from options issued in April of 2007, and estimated accrued
expenses associated with the delay in filing registration
statements from previous preferred offerings RECENT CORPORATE
ACHIEVEMENTS: Avicena announced plans for a confirmatory Phase III
Amyotrophic Lateral Sclerosis (ALS) trial after meeting with the
Food and Drug Administration (FDA). The confirmatory Phase III
trial of the drug candidate, AL-02, for the treatment of
amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease),
follows two completed studies demonstrating a positive trend
towards increased survival. Avicena announced patient enrollment on
target in National Institutes of Health (NIH) Phase III Parkinson's
Disease Trial. The Phase III trial, sponsored by the NIH's National
Institute of Neurological Disorders and Stroke (NINDS), is designed
to evaluate the potential of Avicena's lead Parkinson's disease
drug candidate, PD-02, in slowing disease progression. This trial
will enroll over 1,720 patients and is one of the largest
Parkinson's disease trials ever conducted. Avicena announced
advancement of Huntington's disease clinical program into Phase III
in early 2008. Based on a dose-ranging study, Avicena selected an
optimal dose of its novel drug candidate HD-02 for the treatment of
Huntington's disease. The Company plans to initiate a Phase III
trial in early 2008. ABOUT AVICENA Avicena Group, Inc. is a Palo
Alto, California-based late stage biotechnology company that
develops central nervous system therapeutics for neurodegenerative
diseases. The company's core technologies, supported by a robust
intellectual property portfolio, have broad applications in both
pharmaceuticals and dermaceuticals. Avicena's pharmaceutical
program centers on rare neurological disorders (orphan diseases).
The company's pipeline includes drugs for Parkinson's disease,
Amyotrophic Lateral Sclerosis (ALS) and Huntington's disease.
Avicena's Parkinson's disease candidate, PD-02, is currently in
Phase III testing with the National Institutes of Health in one of
the largest Parkinson's disease trials ever conducted. AL-02, the
company's ALS candidate, and HD-02, its treatment for Huntington's
disease, are soon expected to enter Phase III testing. Unlike
traditional biotechnology companies, government and non-profit
organizations largely fund Avicena's clinical programs. Avicena
presently derives revenue from the sale of proprietary
dermaceutical ingredients to skin care manufacturers. SAFE HARBOR
This release contains forward-looking statements that reflect,
among other things, management's current expectations, plans and
strategies, all of which are subject to known and unknown risks,
uncertainties and factors that may cause our actual results to
differ materially from those expressed or implied by these
forward-looking statements. Many of these risks are beyond our
ability to control or predict. See "Risk Factors" under "Item 6.
Management's Discussion and Analysis of Financial Condition and
Results of Operation" from our Annual Report on Form 10-KSB for the
year ended December 31, 2006, and other descriptions in the
company's public filings with the Securities and Exchange
Commission for a discussion of such risks, including the company's
need for additional funds, the company's dependence on a limited
number of therapeutic compounds, the stage of the products the
company is developing, uncertainties relating to clinical trials
and regulatory reviews, competition and dependence on collaborative
partners, the company's ability to avoid infringement of the patent
rights of others, and the company's ability to obtain adequate
patent protection and to enforce these rights. Because of these
risks, uncertainties and assumptions, you should not place undue
reliance on these forward-looking statements. Furthermore,
forward-looking statements speak only as of the date they are made.
Avicena does not undertake any obligation to update or review any
such forward-looking information, whether as a result of new
information, future events or otherwise. Contact: The Ruth Group
(on behalf of Avicena Group) Sara Ephraim (investors) (646)
536-7002 Janine McCargo / Jason Rando (media) (646) 536-7033 / 7025
/ DATASOURCE: Avicena Group, Inc. CONTACT: Investors, Sara Ephraim,
+1-646-536-7002, or , or Media, Janine McCargo, +1-646-536-7033, ,
or Jason Rando, +1-646-536 7025, jrando@theruthgroup, all of The
Ruth Group for Avicena
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