PALO ALTO, Calif., Aug. 31 /PRNewswire-FirstCall/ -- Avicena Group, Inc. , 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 sephraim@theruthgroup.com Janine McCargo / Jason Rando (media) (646) 536-7033 / 7025 jmccargo@theruthgroup.com / jrando@theruthgroup.com
Avicena Group, Inc.
CONTACT: Investors, Sara Ephraim, +1-646-536-7002, orsephraim@theruthgroup.com, or Media, Janine McCargo, +1-646-536-7033,jmccargo@theruthgroup.com, or Jason Rando, +1-646-536 7025,jrando@theruthgroup, all of The Ruth Group for Avicena
