PALO ALTO, Calif., May 11 /PRNewswire-FirstCall/ -- Avicena Group, Inc. , a late stage biotechnology company focused on commercializing its proprietary cellular energy modulation technology, today announced full year 2006 financial results.
Net revenue for the full year 2006 was $374,952, compared to $477,199 for the full year 2005. This represented a year-over-year decrease of $102,247 largely attributed to an initial ramp-up in 2006 sales associated with Estee Lauder's initial inventory build up for Avicena's proprietary cellular energy- based skin care ingredients.
Net loss applicable to common stock for the full year 2006 was $5.8 million, or $0.11 per basic and diluted share, compared to a loss of $2.8 million, or $0.12 per basic and diluted share, for the full year 2005. This represents a year-over-year increase in net loss of approximately $3.0 million primarily resulting from the accounting treatment for warrants issued during the year and expanded research and development activities advancing several proprietary drug candidates into early and late stage clinical trials. On a per share basis, however, the year-over-year loss remained essentially unchanged.
Belinda Tsao-Nivaggioli, Avicena's Chief Executive Officer, said, "The full year 2006 results were fully in line with our expectations of a very modest cash burn rate, while we made significant progress advancing pharmaceutical candidates into later-stage clinical trials.
"In addition to meeting key clinical milestones for the year, we are particularly pleased with our year-over-year improvement in cash position. Our net cash and equivalents position rose by nearly one-half million dollars to $1.1 million at December 31, 2006. Subsequent to year-end, we raised additional capital to support our clinical development programs.
"We have also further strengthened our ongoing collaborations with the National Institutes of Health. We are very excited that the NIH has initiated patient enrollment of its Phase III trial of our Parkinson's drug candidate, PD-02, as a potential treatment for this indication. With the NIH funding this study, we are a major beneficiary of this research given that we will have access to the data for the purposes of any NDA filing for PD-02."
2006 KEY CORPORATE ACCOMPLISHMENTS:
Fourth Quarter
Avicena Advances Clinical Development of HD-02 for Huntington's Disease -- Avicena announced the initiation of a chronic toxicology study of HD-02, its lead candidate for Huntington's disease (HD). The study is expected to conclude during the second half of 2007. Upon successful completion of this study, Avicena intends to initiate a Phase III clinical trial.
Avicena Signs Agreement with NIH/NINDS for Phase III Trial in Parkinson's Disease -- Avicena announced the signing of an agreement with the National Institute of Neurological Disorders and Stroke (NINDS) to supply PD-02 for a Phase III trial. The trial is designed to evaluate PD-02's potential to slow the progression of Parkinson's disease. Subsequent to quarter-end, in March 2007, NIH initiated patient enrollment in this study.
Avicena Completes First Stage Patient Enrollment for ALS Phase II Trial -- Avicena announced the completion of patient enrollment for the first stage of its Phase II trial evaluating ALS-08 for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease).
Third Quarter
Avicena Initiates Study of Combinations Therapies for ALS -- Avicena announced initiation of a Phase II clinical trial of two combination therapies incorporating ALS-08 for the treatment of ALS. Designed as a two-stage Phase II trial, this study will assess the efficacy, safety, and tolerability of: 1) ALS-08 in combination with minocycline; and 2) ALS-08 in conjunction with celecoxib (a COX-2 inhibitor). This six-month, multi-center, double-blind controlled trial will enroll up to 120 ALS patients. The study's primary endpoint is a change in the revised ALS Functional Rating Scale (ALSFRS-R).
Second Quarter
Avicena Completes Clinical Trials for Nurigene(TM) -- Clinical results for Nurigene, a therapeutic skin care regimen, demonstrated that Nurigene elicited a statistically significant increase in the firmness and elasticity of subjects' skin at both Week 4 and Week 8 of the study. Nurigene also demonstrated a statistically significant improvement at Week 4 in the skin's ability to retain moisture.
Avicena Phase III ALS Trial Results -- Avicena announced results from a Phase III trial of ALS-02 for the treatment of ALS. Study data showed no statistically significant difference between ALS-02 (five grams per day) and placebo with regard to the study's primary and secondary endpoints. However, in a separate analysis when mortality data was combined and analyzed with mortality data from a second study of ALS-02 previously conducted by the North East ALS Consortium (NEALS), the analysis demonstrated a positive trend toward decreased mortality.
First Quarter
Avicena Stock Initiates Trading -- Avicena common stock commenced trading on the OTC Bulletin Board under the symbol "AVGO."
Avicena Promising Phase II Results from Parkinson's Disease Trial -- Avicena announced results from a Phase II study of PD-02 to evaluate whether further study of the drug candidate is warranted. Data demonstrated that PD-02 was not found to be futile as compared to predetermined thresholds suggesting it may be worthy of further consideration as a potential therapeutic. Results from this study, sponsored by the National Institute of Neurological Disorders and Stroke (NIH/NINDS), were published in the journal Neurology.
Avicena Demonstrates Potential of HD-02 in Treatment of Huntington's Disease in Phase I/II Trial -- Avicena announced findings from a Phase I/II study of HD-02, its proprietary drug candidate for the treatment of Huntington's disease, that demonstrated that the drug was safe and well- tolerated by patients at a dose of eight grams/day. Patients receiving HD-02 also experienced elevated serum and brain levels of creatine. Additional findings from the trial showed that serum 8-hydroxy-2'-deoxyguanosine (serum 8OH2'dG) levels, which are markedly elevated in Huntington's disease patients, were reduced for patients receiving HD-02.
ABOUT AVICENA
Avicena Group, Inc. is a late stage biotechnology company focused on developing products based on its proprietary understanding of the regulation of cellular energy processes. The company's core technologies, supported by a robust IP portfolio, have broad applications in both pharmaceuticals and dermaceuticals. Avicena's pharmaceutical program centers on rare neurological disorders (orphan diseases). The company is currently analyzing data from its Phase IIb/III trial in ALS. Near term, Avicena intends to initiate a Phase III trial in Huntington's disease in addition to the Phase III trial in Parkinson's disease described in this release. Avicena's science is well established and its products are safe and well tolerated. Unlike traditional biotechnology companies, Avicena's clinical programs are largely funded by government and non-profit organizations. Avicena presently derives revenue from the sale of proprietary ingredients to skin care manufacturers.
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" 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) 536-7029 / 7002 sephraim@theruthgroup.com Janine McCargo / Jason Rando (media) (646) 536-7033 / 7025 jmccargo@theruthgroup.com or jrando@theruthgroup.com
Avicena Group, Inc.CONTACT: The Ruth Group (on behalf of Avicena Group): Sara Ephraim,+1-646-536-7029, sephraim@theruthgroup.com, or investors, +1-646-536-7002;or Media, Janine McCargo, +1-646-536-7033, jmccargo@theruthgroup.com, orJason Rando, +1-646-536-7025, jrando@theruthgroup.com
