On 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, reported financial results for its fiscal year ended September 30, 2020 (Press release, Anavex Life Sciences, DEC 28, 2020, View Source [SID1234573277]).
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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. ANAVEX2-73 (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 ANAVEX2-73 rare disease program into additional late-stage studies with high unmet medical need, completing the late stage ANAVEX2-73 Phase 2b/3 Alzheimer’s disease trial, and advancing ANAVEX2-73 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 ANAVEX2-73 using gene biomarkers of response, applying precision medicine for neurological disorders with unmet medical need:
Planned initiation of a pivotal Phase 2/3 study in Fragile X Syndrome, the most frequent genetic cause of autism spectrum disorder.
Planned initiation of a Phase 2/3 clinical trial for the treatment of a new, rare-disease indication.
Phase 2b/3 ANAVEX2-73 Alzheimer’s disease (AD) study currently over 80% enrolled with complete enrollment expected in early 2021.
Planned initiation of ANAVEX2-73 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 ANAVEX2-73 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 ANAVEX2-73 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 ANAVEX2-73 supporting progression to further development in upcoming Phase 2/3 studies.
In November 2020, Anavex received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for its patent application number 16/717,921 expected to remain in force at least until 2037, expanding coverage of treatment methods using its lead drug candidate, ANAVEX2-73, as well as drug candidate ANAVEX1-41 for treating a range neurodevelopmental disorders including Rett syndrome, autism spectrum disorder, Angelman syndrome, cerebral palsy and multiple sclerosis, among other indications.
Financial Highlights:
Cash and cash equivalents of $47.6 million as of today and $29.2 million at September 30, 2020, compared to $22.2 million at September 30, 2019.
Net loss of $26.3 million, or $0.45 per share for the year, compared to net loss of $26.3 million, or $0.54 per share in fiscal 2019.
Research and development expenses of $25.2 million for the year, compared to $22.3 million for fiscal 2019.
General and administrative expenses of $5.9 million for the year, compared to $6.8 million for fiscal 2019.
The financial information for the fiscal year ended September 30, 2020 should be read in conjunction with the Company’s consolidated financial statements, which will appear on EDGAR, www.sec.gov and will be available on the Anavex website at www.anavex.com.
Conference Call / Webcast Information
The live webcast of the conference call can be accessed online at View Source
To join the conference call, live via telephone, interested parties within the U.S. should dial, toll-free, 1 (866) 939-3921 and international callers should dial 1 (678) 302-3550. Please use confirmation number 50061077, followed by the pound sign (#).
A replay of the conference call will also be available on www.anavex.com.