Anavex Life Sciences Corp. (NASDAQ:AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer, today reported financial results for the three and nine months ended June 30, 2016.
- The SEC staff recently advised Company’s legal counsel that the staff did not intend to recommend enforcement action by the Commission against the Company in connection with the investigation previously described in the Company’s 2015 Report on Form 10-K.
- Cash and cash equivalents of approximately $9.7 million at June 30, 2016, compared to approximately $15.3 million at September 30, 2015.
- Operating expenses for the third quarter of approximately $2.3 million compared to approximately $1.5 million for the third quarter of fiscal 2015. This increase was primarily attributable to ongoing clinical trial activities, preclinical work, an expansion of the Company’s team and increased legal fees.
- Net loss for the third quarter of approximately $2.2 million, or $0.06 per share, compared to a net loss of approximately $4.2 million, or $0.22 per share, for the same period in fiscal 2015.
“We are encouraged by the ongoing Phase 2a Alzheimer’s trial data and are especially excited about the observed reduction in insomnia, a condition correlated with multiple underlying psychiatric diseases,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “We look forward to the upcoming 9-month data release and the update of the clinical development plan for Phase 2 study for the treatment of Rett syndrome with ANAVEX 2-73.”
Recent Corporate Highlights
- July 24 and 27, 2016 – Anavex presented 31-week safety and efficacy data from the ongoing Phase 2a study of ANAVEX 2-73 in Alzheimer’s patients at the Alzheimer’s Association International Conference (AAIC) 2016. Data demonstrated favorable safety, maximum tolerated dose, positive dose response and sustained efficacy response through 31 weeks for both cognitive and functional measures, as well as positive unexpected therapeutic response events. ANAVEX 2-73 continues to demonstrate a favorable adverse event (AE) profile through 31 weeks in a patient population of elderly Alzheimer’s patients with varying degrees of physical fragility. ANAVEX 2-73 data presented allows the Company to progress into Phase 2/3 placebo-controlled studies.
- June 22, 2016 – The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for ANAVEX 2-73 for the treatment of infantile spasms.
- June 6, 2016 – Anavex presented positive preclinical data for ANAVEX 2-73 in Fragile X syndrome and Autism-related disorders at the Gordon Research Conference for Fragile X and Autism-Related Disorders. In a Fragile X model, ANAVEX 2-73 significantly improved all behaviors tested and reversed hyperactivity and impairment in learning and memory (p≤0.0001).
- May 20, 2016 – The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for ANAVEX 2-73 for the treatment of Rett syndrome.
- May 18, 2016 – Anavex reported positive preclinical data for ANAVEX 2-73 in infantile spasms. ANAVEX 2-73 significantly reduced the number of spasms in an animal model with infantile spasms (epileptic spasms) by 55 percent compared to vehicle (p=0.0002). (Original Source)
Shares of Anavex Life are up nearly 2% to $3.09 in after-hours trading Thursday. AVXL has a 1-year high of $14.84 and a 1-year low of $2.91. The stock’s 50-day moving average is $5.47 and its 200-day moving average is $4.84.
On the ratings front, Anavex has been the subject of a number of recent research reports. In a report issued on July 28, FBR analyst Christopher James reiterated a Buy rating on AVXL, with a price target of $10, which represents a potential upside of 222.6% from where the stock is currently trading. Separately, on July 27, Maxim Group’s Jason Kolbert reiterated a Buy rating on the stock and has a price target of $15.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Christopher James and Jason Kolbert have a total average return of -13.4% and -15.8% respectively. James has a success rate of 37.9% and is ranked #3981 out of 4022 analysts, while Kolbert has a success rate of 28.3% and is ranked #4021.
Anavex Life Sciences Corp. is a biopharmaceutical company. It is engaged in the discovery and development of new drugs for the treatment of neurological diseases and cancer, utilizing its proprietary drug discovery sigmaceptor platform. The company’s portfolio comprises novel, wholly owned sigma receptor agonists and antagonists.