Please wait while we load the requested 10-K report or click the link below:
Anavex Life Sciences Reports Fiscal 2020 Year End Financial Results
And Clinical Program Updates
Conference Call and Webcast Today at 4:30 p.m. ET
NEW YORK – December 28, 2020 – Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today reported financial results for its fiscal year ended September 30, 2020.
Christopher U Missling, PhD, President and Chief Executive Officer of Anavex said: “Despite all of the new challenges, 2020 was an extraordinary year for Anavex, with significant progress across our portfolio, including our first positive, placebo-controlled, U.S. ANAVEX®2-73 (blarcamesine) Rett syndrome trial, a positive Parkinson’s disease dementia trial, and further progress in Alzheimer’s disease. I want to thank the patients, doctors, and the Anavex team who made all of this progress possible. We look forward to building on this momentum with key milestones expected from multiple programs, including data on the ongoing late-stage Rett syndrome trials AVATAR and EXCELLENCE, expanding the clinical biomarker-driven ANAVEX®2-73 rare disease program into additional late-stage studies with high unmet medical need, completing the late stage ANAVEX®2-73 Phase 2b/3 Alzheimer’s disease trial, and advancing ANAVEX®2-73 into clinical disease modifying testing in Parkinson’s disease.”
Key Clinical Updates:
|●||Plan to advance the AVATAR adult Rett syndrome study into a pivotal Phase 2/3 clinical trial.|
|●||Pipeline expansion for ANAVEX®2-73 using gene biomarkers of response, applying precision medicine for neurological disorders with unmet medical need:|
|o||Planned initiation of a pivotal Phase 2/3 study in Fragile X Syndrome, the most frequent genetic cause of autism spectrum disorder.|
|o||Planned initiation of a Phase 2/3 clinical trial for the treatment of a new, rare-disease indication.|
|●||Phase 2b/3 ANAVEX®2-73 Alzheimer’s disease (AD) study currently over 80% enrolled with complete enrollment expected in early 2021.|
|●||Planned initiation of ANAVEX®2-73 imaging-focused Parkinson’s disease clinical study.|
Recent Business Highlights:
|●||In December 2020, Anavex announced top-line results from a U.S. Phase 2 controlled trial of ANAVEX®2-73 in adult female patients with Rett syndrome. Primary safety, pharmacokinetics and secondary efficacy endpoints were met, with statistically significant and clinically meaningful consistent improvements in Rett Syndrome Behaviour Questionnaire (RSBQ) and Clinical Global Impression Improvement (CGI-I) scores. Improvements in RSBQ Total scores were correlated with decreases (improvements) in plasma glutamate. Based on the results, Anavex is planning to meet with the FDA to discuss an accelerated approval pathway.|
|●||In November 2020, Anavex presented data at the 13th Clinical Trials on Alzheimer’s Disease (CTAD) 2020 Conference, reporting top-line results from the proof-of-concept Phase 2 placebo-controlled trial with primary objectives of safety, tolerability, and efficacy in cognition of ANAVEX®2-73 in patients in Parkinson’s disease dementia (PDD) compared to placebo. Both primary objectives of the study were met. The results show clinically meaningful, dose-dependent, and statistically significant improvements in the Cognitive Drug Research (CDR) computerized assessment system analysis. The study confirmed the precision medicine approach of targeting SIGMAR1 as a genetic biomarker in response to ANAVEX®2-73 supporting progression to further development in upcoming Phase 2/3 studies.|
The following information was filed by Anavex Life Sciences Corp. (AVXL) on Monday, December 28, 2020 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.
View differences made from one year to another to evaluate Anavex Life Sciences Corp.'s financial trajectory
Compare this 10-K Annual Report to its predecessor by reading our highlights to see what text and tables were
removed , and by Anavex Life Sciences Corp..