Anavex Life Sciences Corp (NASDAQ:AVXL) Executed Full Enrollment of Three Precision Medicine Clinical Trials

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Anavex Life Sciences Corp (NASDAQ:AVXL) stock rose 5.68% (As on Nov 25, 7:56:06 AM UTC-4, Source: Google Finance) after the company in the third quarter of FY 21 has reported the Net loss of $37.9 million, or $0.54 per share for the year, compared to net loss of $26.3 million, or $0.45 per share in fiscal 2020. The company incurred research and development expenses of $33.0 million for the year, compared to $25.2 million in fiscal 2020. General and administrative expenses of $9.0 million for the year, compared to $5.9 million in fiscal 2020. Cash and cash equivalents of $152.1 million on September 30, 2021, an increase of $122.9 million compared to $29.2 million from September 30, 2020.

Meanwhile, the company concluded an exceptional fiscal year 2021 while continuing its momentum, highlighted by the efficient execution and full enrollment of three Precision Medicine clinical trials, including the Phase 2b/3 ANAVEX 2-73 clinical trial in Alzheimer’s disease, the Phase 2/3 ANAVEX 2-73 clinical trial in Rett syndrome as well as the Phase 1 of ANAVEX 3-71. The Top-line results from the second placebo-controlled AVATAR Phase 2/3 ANAVEX 2-73-RS-002 study for the treatment of adult patients with Rett syndrome are expected around year end 2021. A scientific presentation on ANAVEX®2-73 for the potential treatment of amyotrophic lateral sclerosis (ALS) will be shared at the 4th Annual ALS ONE Research Symposium, November 29th & 30th, 2021. Top-line results from the placebo-controlled EXCELLENCE Phase 2/3 ANAVEX®2-73-RS-003 study for the treatment of pediatric patients with Rett syndrome are expected 1H 2022. Pipeline expansion for ANAVEX®2-73 using gene biomarkers of response, applying precision medicine for neurological disorders with unmet medical need are expected 1H 2022. This includes planned initiation of ANAVEX 2-73 imaging-focused Parkinson’s disease clinical study, planned initiation of a pivotal Phase 2/3 study in Fragile X Syndrome, the most frequent genetic cause of autism spectrum disorder and planned initiation of a Phase 2/3 clinical trial for the treatment of a new, rare-disease indication.

In addition, 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 ANAVEX 2-73 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 ANAVEX®2-73 Phase 2b/3 Alzheimer’s disease clinical study ANAVEX 2-73-AD-004 and its Open Label Extension (OLE) ANAVEX 2-73-AD-EP-004 ATTENTION-AD study. Upon review of the interim safety data, the DSMB recommendation is to continue the studies without modification.

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