Successful High-Dose Safety & Toxicology Studies
U.S. Phase IIIa On-Track to Commence This Quarter
Menerba® Could Be First Botanical Blockbuster Drug
Download Full 24-Page Report with Important Disclosures: BNVI Update 08-03-11
1.) Successful High-Dose Safety & Toxicology Studies: Bionovo completed the 40-patient 28-day safety trial of high-dose Menerba® (3x higher than tested in Phase II) there were no safety concerns, no serious adverse events, no blood pressure, heart rate or lab value changes and no abnormal uterine endometrial biopsies. The toxicology studies in two animal species had no serious adverse events or toxicities. The Phase III dosing strategy has now been established.
2.) Bionovo Completes Validation of New Manufacturing Facility: Bionovo completed the validation of their new manufacturing facility in Hayward CA for Menerba®, and is preparing to submit the 10 batch records to the FDA as required under their CMC agreement before initiation of the Phase IIIa trial.
3.) Phase IIIa Trial in U.S. Expected to Commence Dosing in Q3: Bionovo has already received clinical trial guidance from both the FDA and the European Medicines Agency (EMA) and anticipates initiating dosing for the Phase IIIa trials in Q3 at 45 clinical trial sites. There will be 5 safety reviews by the Data Safety Monitoring Board during the Phase IIIa trial with data expected Q4 2012.
4.) Menopause Market – Large and Underserved: With approximately 80 million women in the U.S. and Europe transitioning through menopause and at least 70% experiencing hot flashes, night sweats and associated insomnia, we estimate the worldwide market at approximately $10 billion. Current hormone replacement therapy (HRT) carries warnings for increased risk of breast cancer, strokes, heart attacks, and blood clots while alternatives to HRT, such as antidepressant drugs, are not FDA approved and can cause significant side-effects as well. Menerba® could become the first botanical blockbuster drug which we believe represents an intriguing opportunity for patient investors.
5.) Maintaining Strong Speculative-Reducing Target to $5.00: While Menerba® could become the first botanical blockbuster drug, we note that R&D costs are ramping up faster than anticipated necessitating earlier financing with appropriate changes to our model. Therefore, we are maintaining Bionovo, Inc. with a Strong Speculative Buy rating and 12-18 month Price Target of $5.00 (from $7.50) based on a 35x multiple on projected fiscal year 2015 EPS and discounted 45% for cumulative risk.
Download Full 24-Page Report with Important Disclosures: BNVI Update 08-03-11
