Anavex Life Sciences Reports Fiscal 2020 Second Quarter Financial Results And Provides Business Updates

On May 7, 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 2020 second quarter (Press release, Anavex Life Sciences, MAY 7, 2020, View Source [SID1234561603]).

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"We are pleased to report that we are approaching the conclusion of the double-blind Phase 2 Parkinson’s disease dementia trial with ANAVEX2-73 (blarcamesine) and we expect to report top line results by mid-2020," said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. "Both the Alzheimer’s disease Phase 2b/3 trial and clinical Rett syndrome programs are also proceeding as planned. Our focus on Precision Medicine studies for neurological disorders remains persistent."

Program Updates:

Enrollment for the two randomized, double-blind, placebo-controlled Phase 2 ANAVEX2-73 (blarcamesine) U.S. Phase 2 Rett syndrome trial[1] and the AVATAR Rett syndrome trial[2] each have surpassed the 50% mark and continue to enroll.
Despite the outbreak of COVID-19, all clinical trial programs continue to proceed. While Rett syndrome protocols have always by default allowed at-home visits, Anavex implemented contingency plans as recommended by local regulatory authorities for the Phase 2b/3 ANAVEX2-73 (blarcamesine) Alzheimer’s disease (AD) study[3] and the Phase 2 study in Parkinson’s Disease Dementia (PDD) study[4] to ensure remote or virtual assessments for all active patients and all respective extension studies. Because ANAVEX2-73 (blarcamesine) is an oral formulation, study participants are able to receive shipments of their study medication in a controlled and compliant fashion, and direct-to-patient delivery is occurring in multiple countries.
In January 2020, Anavex announced achieving the enrollment target for the ANAVEX2-73 (blarcamesine) Phase 2 study in Parkinson’s disease dementia (PDD). Topline results from this randomized, double-blind, placebo-controlled study are expected by mid-2020.
In February 2020, Anavex announced a publication in the peer-reviewed Journal of Neuroimmunology titled "Sigma-1 Receptor Agonists as Potential Protective Therapies in Multiple Sclerosis" featuring preclinical data of ANAVEX2-73 (blarcamesine) relevant to multiple sclerosis.
In April 2020, Anavex announced a publication in the peer-reviewed journal Alzheimer’s & Dementia: Translational Research & Clinical Interventions,entitled, "A precision medicine framework using Artificial Intelligence for the identification and confirmation of genomic biomarkers of response to an Alzheimer’s disease therapy: Analysis of the Blarcamesine (ANAVEX2-73) Phase 2a clinical study" highlights 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 treatments.
Financial Highlights:

Cash and cash equivalents of $26.6 million at March 31, 2020, compared to $22.2 million at fiscal year ended September 30, 2019.
Research and development expenses of $6.1 million for both the current quarter as well as the comparable quarter in 2019.
General and administrative expenses of $1.7 million for the quarter as compared to $2.1 million for the comparable quarter in 2019.
Net loss of $7.2 million, or $0.12 per share for the quarter, compared to net loss of $7.2 million, or $0.15 per share in the comparable quarter of 2019.
The financial information for the fiscal quarter ended March 31, 2020 should be read in conjunction with the Company’s consolidated interim 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

Anavex will host a conference call and webcast today at 4:30 p.m. ET.

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 49673201, followed by the pound sign (#).

A replay of the conference call will also be available on www.anavex.com.