And Provides Clinical Study Updates
Conference Call and Webcast Today at 4:30 p.m. ET
NEW YORK – February 6, 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, today reported financial results for its fiscal 2020 first quarter.
“We are excited about the progress across our pipeline, including the receipt of Fast Track designation for the ANAVEX®2-73 (blarcamesine) clinical development program from the U.S. Food and Drug Administration (FDA) for the treatment of Rett syndrome,” commented Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “Our clinical Rett syndrome programs are on track with continued enrollment. While our enrollment and early data have been exciting, we are humbled by the needs of the rare disease and Alzheimer’s and Parkinson’s disease communities with whom we engage. They impress a sense of urgency on our work to deliver a new paradigm that underscores the need for new treatment options for patients and their families.”
Program Updates and Milestones:
On February 3, 2020, we announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the ANAVEX®2-73 (blarcamesine) clinical development program for the treatment of Rett syndrome.
We announced January 8, 2020 that the United States Patent and Trademark Office (USPTO) granted U.S. Patent No. 10,507,196 to support Anavex’s leading drug candidate, ANAVEX®2-73 (blarcamesine) for the treatment of neurodevelopmental disorders including Rett syndrome, and multiple sclerosis. This patent is expected to remain in force at least until 2037, not including any patent term extensions.
On January 27, 2020, we announced that we have met our enrollment target for the ANAVEX®2-73 (blarcamesine) Phase 2 study in Parkinson’s Disease Dementia (PDD). The study enrolled over 120 patients at 20 sites across Spain and 3 sites in Australia. We expect to announce topline results from this study by mid-2020.
Enrollment for the Phase 2b/3 ANAVEX®2-73 (blarcamesine) Alzheimer’s disease (AD) study is 50% complete. Recruitment is expected to accelerate given the anticipated international expansion of the study, which will increase the total number of sites from 15 to approximately 45 in 2020.
ANAVEX®3-71 successfully completed IND-enabling toxicology studies and drug product manufacturing. ANAVEX®3-71 previously received Orphan Drug Designation from the U.S. FDA for Frontotemporal dementia (FTD). Initiation of the first Phase 1 clinical trial of ANAVEX®3-71 is expected in 2020. ANAVEX®3-71 has demonstrated disease-modifying activity against the major hallmarks of Alzheimer’s disease in transgenic (3xTg-AD) mice, including cognitive deficits, inflammation, amyloid and tau pathologies.
Cash and cash equivalents of $27.5 million at December 31, 2019, compared to $22.2 million at September 30, 2019.
Anavex reported a net loss of $6.6 million, or $0.12 per share for the first quarter of 2020, compared to a net loss of $6.9 million, or $0.15 per share in the comparable first quarter 2019. This decrease was due to increased research and development incentive income.
Research and development expenses were $6.3 million for the first quarter of 2020 as compared to $5.7 million for the comparable period in 2019. This increase was driven by increased program development activities related to the advancement of the Company’s pipeline.
General and administrative expenses were $1.4 million for the first quarter of 2020 as compared to $1.8 million for the comparable period in 2019. This decrease was primarily due to lower non-cash stock-based compensation.
The financial information for the fiscal quarter ended December 31, 2019 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 may be accessed online at http://www.wsw.com/webcast/cc/avxl12.
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 49361235, followed by the pound sign (#).
A replay of the conference call will also be available on www.anavex.com.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of 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, pain and various types of cancer. Anavex’s lead drug candidate, ANAVEX®2-73 (blarcamesine), recently completed a successful Phase 2a clinical trial for Alzheimer’s disease. ANAVEX®2-73 (blarcamesine) is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. ANAVEX®2-73 (blarcamesine) also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson’s Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 (blarcamesine) for the treatment of Parkinson’s disease. ANAVEX®3-71, which targets sigma-1 and muscarinic receptors, is a promising preclinical drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer’s disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation.
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
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 ClinicalTrials.gov Identifier: NCT03774459
 ClinicalTrials.gov Identifier: NCT03790709