On August 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,reported financial results for its fiscal 2020 third quarter (Press release, Anavex Life Sciences, AUG 6, 2020, View Source [SID1234563125]).
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"It is an accomplishment having three ongoing clinical studies in Rett syndrome in progress with ANAVEX2-73 (blarcamesine) and we expect respective clinical trial results to be reported as we progress," said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. "It is important to point out that all clinical studies with ANAVEX2-73 (blarcamesine), including the ongoing Alzheimer’s disease Phase 2b/3 trial and Parkinson’s disease dementia Phase 2 study, which read out is upcoming, includes the entire genome and exome sequencing, opens the possibility of using big data-driven unbiased genome-wide patient analysis, hence, maintaining the focus on Precision Medicine for neurological disorders."
Program Updates:
Yesterday Anavex announced it has received compassionate use Special Access Scheme (SAS) approval for Alzheimer’s disease patients continued treatment with ANAVEX2-73 (blarcamesine) by the Australian Government Department of Health – Therapeutic Goods Administration (TGA).
In June 2020, Anavex announced it has received Clinical Trial Authorization (CTA) from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) as well as a ‘No Objection Letter’ from Health Canada to expand the footprint of the international Phase 2b/3 double-blind, randomized, placebo-controlled safety and efficacy trial (Study ANAVEX2-73-AD-004) of ANAVEX2-73 (blarcamesine) for the treatment of early Alzheimer’s disease into the UK and Canada, respectively.
In June 2020, Anavex announced it exceeded by 50% its enrollment target for the ANAVEX2-73 (blarcamesine) U.S. Phase 2 study in Rett syndrome. The Company expects to announce topline results from this study in calendar Q4 2020.
In July 2020, Anavex announced that the first pediatric patient was dosed in the Phase 2/3 ANAVEX2-73-RS-003 EXCELLENCE clinical trial for the treatment of Rett syndrome with ANAVEX2-73 (blarcamesine).
In July 2020, Anavex announced the enrollment of the first participant in a Phase 1 clinical trial of ANAVEX3-71 (AF710B), an orally-administered small molecule targeting sigma-1 and M1 muscarinic receptors that is designed to be beneficial for neurodegenerative diseases, with topline data anticipated in the first half of 2021.
Financial Highlights:
Cash and cash equivalents of $27.6 million at June 30, 2020, compared to $22.2 million at fiscal year ended September 30, 2019.
Research and development expenses of $6.7 million for the quarter, compared to $5.8 million in the comparable quarter in 2019.
General and administrative expenses of $1.4 million for the quarter as well as for the comparable quarter in 2019.
Net loss of $6.5 million, or $0.11 per share for the quarter, compared to net loss of $6.5 million, or $0.13 per share in the comparable quarter of 2019.
The financial information for the fiscal quarter ended June 30, 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
Anavex will host a conference call and webcast today at 11:00 a.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) 901-2585 and international callers should dial 1 (404) 835-7099. Please use confirmation number 49865428, followed by the pound sign (#).
A replay of the conference call will also be available on www.anavex.com.