Anavex Life Sciences Reports Fiscal 2023 Second Quarter Financial Results

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 Alzheimers disease, Parkinsons disease, Rett syndrome and other central nervous system (CNS) diseases, today reported financial results for its fiscal quarter ended March 31, 2023.

Recent positive clinical study results and FDA approvals through the Accelerated Approval Pathway are positive for the Alzheimers disease community, especially for the patients, families and caregivers who fight everyday against this devastating disease. We look forward to presenting the complete dataset of the Phase 2b/3 Alzheimers disease trial of ANAVEX2-73 (blarcamesine), an orally available, small-molecule activator of the upstream sigma-1 receptor (SIGMAR1), involved in restoring neural cell homeostasis and promoting neuroplasticity, which might be at the forefront of patient-centric, next-generation biomarker-guided precision medicine Alzheimers disease treatments. With newly available preliminary efficacy results of surrogate biomarkers, we consider initiating discussions with regulatory agencies for Accelerated Approval Pathway for ANAVEX2-73 (blarcamesine), said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. "We also look forward to making meaningful advances in our neurodevelopmental and other neurodegenerative precision medicine portfolio this year with the expected topline data from the potentially pivotal ANAVEX2-73-RS-003 Phase 2/3 EXCELLENCE pediatric clinical trial in the second half of 2023. Additionally, we continue to focus on initiating our pivotal study of ANAVEX2-73 (blarcamesine) in patients with Parkinsons disease, the second largest neurodegenerative disease after Alzheimers disease.

Key Near Term Pipeline Updates:

Alzheimers disease: Full data ANAVEX2-73-AD-004, including newly available preliminary results of surrogate biomarkers of pivotal Phase 2b/3 clinical trial. The Company intends to discuss these findings with regulatory authorities in the context of the ongoing clinical development of ANAVEX2-73 in this indication, with the goal of providing a much-needed treatment to the millions of patients living with Alzheimers disease with a convenient once-daily oral treatment. The Company plans to proceed in parallel with the initiation of a confirmatory Alzheimers disease study.

Rett syndrome: Top-line data of potentially pivotal ANAVEX2-73-RS-003 Phase 2/3 EXCELLENCE pediatric clinical trial. Company expects to announce topline results from this study in the second half of 2023.

Parkinsons disease: Initiation of ANAVEX2-73 pivotal clinical trial.

Parkinsons disease: Initiation of ANAVEX2-73 imaging-focused clinical trial.

Fragile X: Initiation of potentially pivotal ANAVEX2-73 Phase 2/3 clinical trial.

Schizophrenia: Initiation of ANAVEX3-71 Phase 2 clinical trial.

New Rare disease: Initiation of potentially pivotal ANAVEX2-73 Phase 2/3 clinical trial.

Publications: Several clinical publications involving ANAVEX2-73, ANAVEX3-71 and Rett syndrome Burden of Illness study.

Recent Business Highlights:

On May 2nd, 2023, the Company participated in a fireside chat at the H.C.Wainright BioConnect Investor Conference at NASDAQ World Headquarters in New York.

On May 1st, 2023, the Company announced that it was granted a new U.S. Patent No. 11,622,955 entitled SIGMA-1 RECEPTOR AGONIST SYSTOLIC BLOOD PRESSURE THERAPY, from the United States Patent and Trademark Office (USPTO), expanding Anavexs coverage of treatment methods for ANAVEX2-73 (blarcamesine), to the treatment of systolic hypertension, or lowering systolic blood pressure.

On April 17th, 2023, the Company presented at the 22nd Annual Needham Virtual Healthcare Conference 2023.

On March 30th, 2023, the Company reported the preliminary 48-week open label extension Parkinsons disease dementia ANAVEX2-73-PDD-EP-001 Phase 2 clinical trial data, which demonstrated longitudinal beneficial effects of ANAVEX2-73 on the prespecified primary and secondary objectives, as well as planned primary and key secondary endpoints which will be utilized in a forthcoming pivotal study of ANAVEX2-73 in Parkinsons disease.

On March 9th, 2023, Anavex announced the appointment of Kun Jin, PhD, as Vice President, Head of Biostatistics. Dr. Jin will draw on his extensive experience, including recently as the Statistical Team Leader at the U.S. Food and Drug Administration (FDA).

Financial Highlights:

Cash and cash equivalents of $153.5 million at March 31, 2023 compared to $149.2 million at year end September 30, 2022.

General and administrative expenses for the quarter of $2.9 million compared to $2.9 million for the comparable quarter of fiscal 2022.

Research and development expenses for the quarter of $11.3 million compared to $8.6 million for the comparable quarter of fiscal 2022.

Net loss for the quarter of $13.1 million, inclusive of $4.8 million in non-cash items, or $0.17 per share, compared to a net loss of $10.4 million, inclusive of $4.4 million in non-cash items, or $0.14 per share for the comparable quarter of fiscal 2022.

The financial information for the quarter ended March 31, 2023, should be read in conjunction with the Companys interim condensed consolidated financial statements, which will appear on EDGAR, www.sec.gov and will be available on the Anavex website