On May 13, 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 March 31, 2021 (Press release, Anavex Life Sciences, MAY 13, 2021, View Source [SID1234579943]).

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"Positive momentum continues to build this quarter and affirms the strength of our pipeline and execution capabilities," said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. "For our lead drug candidate, ANAVEX2-73 in Alzheimer’s disease, we are close to complete enrollment for our Phase 2b/3 study, and we expect a very data-rich current quarter with data readouts from multiple clinical trials and the remainder of 2021 to be a catalyst-rich year for Anavex. This is an exciting time for Anavex and I look forward to advancing our impressive pipeline of mid- and late-stage clinical trials with a commitment to bringing innovative therapies to patients in need around the globe."

Anavex Life Sciences’ Business and Near-Term Clinical Outlook:

ANAVEX2-73 Program and other Near-Term Pipeline Data Updates:

Complete data ANAVEX2-73 U.S. Rett syndrome Phase 2 study.
Complete data ANAVEX2-73 Parkinson’s disease dementia (PDD) Phase 2 study.
Top-line data AVATAR: Potentially pivotal Phase 2/3 ANAVEX2-73 adult Rett syndrome clinical trial.
Top-line data Phase 1 ANAVEX3-71 clinical trial.
Complete enrollment of Phase 2b/3 ANAVEX2-73 Alzheimer’s disease clinical trial.
Recent Business Highlights:

In March 2021, Anavex announced that the Independent Data Safety Monitoring Board (DSMB) for the Company’s Phase 2b/3 Alzheimer’s disease study of its investigational compound ANAVEX2-73 (blarcamesine) has completed its recent pre-planned review of the preliminary Phase 2b/3 study data. As specified in the protocol, the DSMB reviewed the interim safety data for the ANAVEX2-73 Phase 2b/3 Alzheimer’s disease clinical study ANAVEX2-73-AD-004 and its Open Label Extension (OLE) ANAVEX2-73-AD-EP-004 ATTENTION-AD study. Upon review of the interim safety data, the DSMB made the following recommendation: The DSMB recommendation is to continue the studies without modification.
In April 2021, Anavex announced that the Independent Data Safety Monitoring Board (DSMB) for the Company’s ongoing clinical trial program, including the late-stage AVATAR (ANAVEX2-73-RS-002), EXCELLENCE (ANAVEX2-73-RS-003) and the U.S. Rett syndrome extension study (ANAVEX2-73-RS-EP-001) of its investigational compound ANAVEX2-73 (blarcamesine) has completed its recent pre-planned review of the respective interim safety data for these three separate clinical studies. Upon review of the interim safety data, the DSMB made the following recommendation for each of the three studies: The DSMB recommendation is to continue the studies without modification.
In March 2021, Anavex announced that ANAVEX2-73 (blarcamesine) is featured in a recent peer-reviewed publication in the journal of Neuropharmacology, titled "Future avenues for Alzheimer’s disease detection and therapy: liquid biopsy, intracellular signaling modulation, systems pharmacology drug discovery" from the series of the special issue on ‘The Quest for Disease-Modifying Therapies for Neurodegenerative Disorders’.
In May 2021, Anavex announced the appointment of former FDA officer as Senior Vice President for Nonclinical Development.
Further clinical milestones are provided in Anavex Life Sciences’ latest corporate presentation, available on anavex.com.
Financial Highlights:

Continued fiscal responsible management of cash utilization.
Cash and cash equivalents at March 31, 2021 of approximately $75.9 million, sufficient cash runway for up to three (3) years.
Net loss of $8.2 million, or $0.12 per share for the quarter, compared to net loss of $7.2 million, or $0.12 per share in comparative quarter of fiscal 2020.
Research and development expenses of $6.7 million for the quarter, compared to $6.1 million for comparable quarter of fiscal 2020.
General and administrative expenses were $2.2 million for the quarter, as compared to $1.7 million for the prior year period.
The financial information for the fiscal quarter ended March 31, 2021 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) 866-1333 and international callers should dial 1 (404) 260-1421. Please use confirmation number 50162864, followed by the pound sign (#).

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