Anavex Life Sciences Corp (OTCMKTS:AVXL) shares were up 12.88% on Monday to $4.88 and flat in after-hours trading. Share prices have been trading in a 52-week range of $2.43 to $8.30. The company has a market cap of $174.27 million at 35.71 million shares outstanding.
Anavex Life Sciences Corp is a clinical-stage biopharmaceutical company that is engaged in the development of differentiated therapeutics for the treatment of neurodegenerative diseases, including drug candidates to treat Alzheimer’s disease, other central nervous system diseases, pain and various types of cancer.
Its lead compounds ANAVEX 2-73 and ANAVEX PLUS, a combination of ANAVEX 2-73 with donepezil, are being developed to treat Alzheimer’s and other central nervous system diseases. Its product pipeline also includes ANAVEX 3-71, ANAVEX 1-41 and ANAVEX 1037. Its SIGMACEPTOR Discovery Platform produces small molecule drug candidates with modes of action, based on its understanding of sigma receptors. Sigma receptors may be targets for therapeutics to combat many human diseases, including Alzheimer’s. ANAVEX 3-71 is a preclinical drug candidate with a mechanism of action through sigma-1 receptor activation and M1 muscarinic allosteric modulation.
This week, Anavex Life Sciences Corp reported financial results for its fiscal year ended September 30, 2016. Net loss for fiscal year 2016 was $14.7 million or $0.42 per share, larger than the net loss of $12.1 million or $0.65 per share for the 2015 fiscal year. This was likely due to the use of $9.2 million to fund operations, which was within the company’s spending plan guidance.
Operating expenses for the year ended September 30, 2016, were $15.6 million, which included $5.1 million non-cash charges, more than twice as much as the $7.1 million for the comparable period in fiscal year 2015. This increase was primarily attributable to ongoing clinical trial activities, preclinical work, and expansion of the team.
We are entering into 2017 with a stronger balance sheet and a strengthened corporate and scientific advisory team coupled with recently reported encouraging 57-week safety and tolerability data for ANAVEX 2-73, which restores cellular homeostasis, in a Phase 2a clinical trial in Alzheimer’s disease,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex Life Sciences Corp. “We are now analyzing the significant correlations observed between cognition, function and behavior in combination with PK/PD modeling of the population as well as of each individual patient in order to derive the optimal parameters for the subsequent planned placebo-controlled efficacy trials. We believe this coherent approach should reduce future clinical development risk.”
He concluded that, given the company’s stronger financial resources and scientific validation, Anavex Life Sciences Corp can be able to prepare for a Phase 2/3, placebo-controlled trial in Alzheimer’s disease as well as a Phase 2, placebo-controlled trial in Rett syndrome next year. As mentioned in its company highlights, Anavex Life Sciences Corp also added three prominent researchers in Parkinson’s and other CNS diseases to its Scientific Advisory Board.
Other prominent highlights for the period included the company’s material transfer agreement with Biogen under which Biogen will test Anavex’s lead drug candidate, ANAVEX 2-73, in an oligodendrocyte precursor cell differentiation assay. The company also entered into a collaboration with Ariana Pharma to use its proprietary KEM® (Knowledge, Extraction, Management) patient stratification technology, which is a comprehensive and FDA-tested clinical data analysis system that enables full exploitation of complex datasets including of smaller numbers of patients.
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