PALO ALTO, Calif., May 16 /PRNewswire-FirstCall/ -- The Avicena Group, Inc. (Avicena), a developer of novel pharmaceutical and therapeutic products, today announced its accomplishments and financial results for the first quarter of 2006.
PRODUCT DEVELOPMENT HIGHLIGHTS FOR THE FIRST QUARTER OF 2006: -- Avicena’s HD-02 Demonstrates Potential In Treatment Of Huntington’s Disease -- Findings from a Phase I/II study of its proprietary drug candidate for the treatment of Huntington’s disease (HD-02) demonstrated that the drug was safe and well-tolerated by patients at a dose of eight grams/day. Additionally, patients receiving HD-02 experienced elevated serum and brain levels of creatine. Results from this study, which was supported by the National Center for Complementary and Alternative Medicine (NIH/NCCAM), were published in the journal Neurology. -- Avicena Announces Promising Phase II Results from Parkinson’s Disease Trial -- Avicena announced results from a Phase II study designed to evaluate whether further study is warranted for PD-02, a proprietary Avicena drug candidate, and the antibiotic minocycline, as potential treatments for Parkinson’s disease. Data demonstrated that neither PD-02 nor minocycline was found to be futile as compared to predetermined thresholds, suggesting both agents may be worthy of further consideration as potential therapeutics. Results from this study, which was sponsored by the National Institute of Neurological Disorders and Stroke (NIH/NINDS), were published in the journal Neurology. -- Avicena Compound Receives Orphan Drug Designation for Huntington’s Disease -- The United States Food and Drug Administration (FDA) granted orphan drug designation to HD-02, the company’s proprietary drug candidate for the treatment of Huntington’s disease. CORPORATE DEVELOPMENT HIGHLIGHTS FOR THE FIRST QUARTER OF 2006: -- Avicena Announces Initiation of Stock Trading -- On March 20, 2006, Avicena announced that 21,000,000 shares of its common shares initiated trading on the NASD Over-the-Counter Bulletin Board under the symbol “AVGO.”
“The first quarter of 2006 was a highly significant time in Avicena’s history,” stated Belinda Tsao-Nivaggioli, Ph.D., Avicena’s chief executive officer. “During this period, we achieved a key financial milestone as our stock began trading for the first time in the public market. Scientifically, our programs for the treatment of Huntington’s disease and Parkinson’s disease received important validation as favorable Phase II clinical results for both programs were reported and published in the journal Neurology during the quarter. We look forward to the balance of the year and the numerous opportunities that lie ahead for Avicena.”
FINANCIAL RESULTS FOR THE FIRST QUARTER OF 2006: -- Revenues for first quarter 2006 decreased 52.2% to $91,428 compared to $191,440 for the same period in 2005. First quarter 2006 revenue was derived from the sale of proprietary cosmetic ingredient formulations to Estee Lauder and the direct sale of the Company’s branded creatine supplement product. The decline in revenue during the first quarter of 2006 was primarily due to a one-time product ramp-up by Estee Lauder during the fourth quarter of 2004 and the first quarter of 2005. No such ramp-up occurred in the first quarter of 2006. -- Operating loss for first quarter 2006 was $786,591 compared to an operating loss of $794,739 for first quarter 2005. -- Net loss for first quarter 2006 was $785,081 or ($0.02) per fully diluted share, versus a net loss of $795,426 or ($0.06) per fully diluted share, for first quarter 2005. ABOUT AVICENA
Based in Palo Alto, CA, Avicena is a biotechnology company that seeks to develop and commercialize therapeutic products that regulate the critical energy processes which occur within human cells. Avicena’s focus is on the development of pharmaceutical products to treat patients with rare diseases (orphan drugs), as well as dermaceutical products. To date, the company has advanced certain compounds for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease) into Phase III trials and treatments for Huntington’s disease (HD) into Phase II development. Having completed Phase II trials, the company is now considering a Phase III trial for the treatment of Parkinson’s disease.
SAFE HARBOR
This release may contain forward-looking statements within the meaning of the federal securities laws. Such forward-looking statements reflect, among other things, management’s current expectations, plans and strategies, and anticipated financial results, 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” in the company’s prospectus 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 early state 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: Vida Communication (on behalf of Avicena) Stephanie Diaz (investors) Tim Brons (media) 415-675-7400 415-675-7402 sdiaz@vidacommunication.comtbrons@vidacommunication.com AVICENA GROUP, INC. Condensed Balance Sheets March 31, December 31, 2006 2005 (unaudited) ASSETS Current Assets: Cash and cash equivalents $138,443 $619,042 Accounts receivable 58,760 59,036 Inventory 2,567 2,766 Prepaid expenses 77,023 101,357 Total current assets 276,793 782,201 Equipment, net 5,296 6,129 Deposits 9,335 9,335 Total assets 291,424 797,665 LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) Current Liabilities: Accounts payable 936,150 619,948 Accrued expenses 83,603 161,499 Note payable to a shareholder 75,000 75,000 Total current liabilities 1,094,753 856,447 Total liabilities 1,094,753 856,447 Commitments Stockholders’ equity (deficit): Preferred stock; $0.001 par value, 5,000,000 shares authorized; no shares issued or outstanding -- -- Common stock; $0.001 par value, 100,000,000 shares authorized; 51,082,616 shares issued and outstanding 51,083 51,083 Additional paid-in capital 8,334,471 8,435,559 Deferred compensation -- (141,622) Accumulated deficit (9,188,883) (8,403,802) Total stockholders’ deficit (803,329) (58,782) Total liabilities and stockholders’ deficit $291,424 $797,665 AVICENA GROUP, INC. Condensed Statements of Operations Three months ending March 31, March 31, 2006 2005 (unaudited) Revenue $91,428 $191,440 Cost of revenue 12,128 20,068 Gross margin 79,300 171,372 Research and development 221,291 118,556 Selling and marketing expenses 178,085 124,050 General and administrative expenses 466,515 723,505 Total costs and expenses 865,891 966,111 Loss from operations (786,591) (794,739) Interest income (expense) 1,510 (687) Net loss $(785,081) $(795,426) Net loss per common share-basic and diluted $(0.02) $(0.06) Weighted average common shares outstanding - basic and diluted 51,082,616 13,740,415
The Avicena Group
CONTACT: investors, Stephanie Diaz, +1-415-675-7400, orsdiaz@vidacommunication.com, or media, Tim Brons, +1-415-675-7402, ortbrons@vidacommunication.com, both of Vida Communication, for Avicena
Web site: http://www.avicenagroup.com//
