On February 11, 2021 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 quarter ended December 31, 2020 (Press release, Anavex Life Sciences, FEB 11, 2021, View Source [SID1234574897]).
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"We are thrilled to begin the new year with this business outlook, which adds to the breadth of strong clinical data we’ve reported across our precision medicine pipeline using orally once daily ANAVEX2-73 (blarcamesine) for Rett syndrome, Parkinson’s disease dementia and Alzheimer’s disease," said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. "We look forward to providing on a timely basis in 2021 multiple clinical data read-outs from these clinical programs. The converging biomarker-driven clinical data is giving us added confidence in our efforts to meet our goal of potentially bringing new therapeutic interventions to patients."
Anavex Life Sciences’ product portfolio includes small molecule drug lead candidate ANAVEX2-73 for the treatment of Alzheimer’s disease, Parkinson’s disease and Rett syndrome.
ANAVEX2-73 activates the sigma-1 receptor (SIGMAR1). Data suggests that activation of SIGMAR1 results in the restoration of complete housekeeping function within the body and is pivotal to restoring neural cell homeostasis and promoting neuroplasticity.[1]
Anavex Life Sciences’ 2021 Business and Clinical Outlook:
Underlying cause of Alzheimer’s disease and therapeutic intervention:
Researchers at the University of California San Diego have identified the underlying cause of Alzheimer’s disease in neurons. They discovered that changes in the structure of chromatin are responsible.[2] Sigma-1 Receptor (SIGMAR1), the direct target which gets activated with ANAVEX2-73 demonstrated to restore chromatin structures.[3]
ANAVEX2-73 linked to the prevention and treatment of age-associated diseases through induction of the autophagy "cellular recycling" process and enhanced protein clearance in cells.[4]
ANAVEX2-73 is currently in a Phase 2b/3 Alzheimer’s disease clinical trial utilizing differentiated patient selection criteria and study is presently over 86% recruited.[5]
ANAVEX2-73 program for Rett syndrome and other pipeline updates:
Potential accelerated approval strategy planning underway as Phase 2 U.S. Rett syndrome trial clinical data showed positive clinical activity and safety data with progress within ongoing Phase 2/3 AVATAR adult Rett syndrome and Phase 2/3 EXCELLENCE pediatric Rett syndrome studies.
U.S. Food and Drug Administration (FDA) approved extension of ANAVEX2-73 U.S. Rett syndrome Phase 2 open-label extension study from 12 weeks to 36 weeks.
Anavex received compassionate use Special Access Scheme (SAS) approval in Australia for Rett syndrome patients to continue treatment with ANAVEX2-73 after completing the Phase 2/3 AVATAR adult Rett syndrome clinical extension study.
Anavex has sufficient ANAVEX2-73 available to support all ongoing and planned clinical trials and first-year commercial launch needs for the Rett syndrome program.
ANAVEX2-73 drug substance and oral solution exhibit excellent chemical stability based upon 3 years of stability data in both cases.
New clinical pipeline compound ANAVEX3-71 Phase 1 study is on track: Independent Data Safety Monitoring Board (DSMB) for the Company’s Phase 1 study of its new investigational compound ANAVEX3-71, also a small molecule activating SIGMAR1, has completed its recent pre-planned review of the preliminary Phase 1 safety data. The DSMB recommendation is to continue the study without modification.[6]
Anavex is pioneering the approach of big data in clinical trials to leverage the relevance of phenotypic and genotypic precision medicine analyses of Whole Exome Sequencing (WES) and gene expression (RNAseq) data in drug development and in particular the potential to identify patients’ genetic variants and gene expression changes that may predict increased chances of success of Alzheimer’s disease, Parkinson’s disease and Rett syndrome treatments.
Further clinical milestones are provided in Anavex Life Sciences’ latest corporate presentation, available on anavex.com.
Recent Business Highlights:
In January 2021, Anavex announced that it has been awarded a research grant of $995,862.51 from the Michael J. Fox Foundation for Parkinson’s Research (MJFF) to develop ANAVEX2-73 (blarcamesine) for the treatment of Parkinson’s disease. The award will explore utilization of PET imaging biomarkers to enable measurement of target engagement and pathway activation of the sigma-1 receptor (SIGMAR1) with clinically relevant doses in people with Parkinson’s disease.
Financial Highlights:
On February 11, 2021, cash and cash equivalents of approximately $75 million, sufficient cash runway for up to three (3) years.
Cash and cash equivalents of $47.4 million as of December 31, 2020, compared to $29.2 million at September 30, 2020.
Net loss of $7.9 million, or $0.12 per share for the quarter, compared to net loss of $6.6 million, or $0.12 per share in comparative quarter of fiscal 2020.
Research and development expenses of $7.9 million for the quarter, compared to $6.3 million for comparable quarter of fiscal 2020.
The financial information for the fiscal quarter ended December 31, 2020 should be read in conjunction with the Company’s interim condensed 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) 451-7964 and international callers should dial 1 (847) 944-7134. Please use confirmation number 50097999, followed by the pound sign (#).
A replay of the conference call will also be available on www.anavex.com.