ANAVEX®2-73 Program and other Near-Term Pipeline Data Updates:
Top-line results from the randomized, placebo-controlled Phase 2b/3 study ANAVEX®2-73-AD-004 for the treatment of Alzheimer’s disease are expected 2H 2022.
Top-line results from the randomized, placebo-controlled EXCELLENCE Phase 2/3 study ANAVEX®2-73-RS-003 for the treatment of pediatric patients with Rett syndrome are expected 2H 2022.
ANAVEX will host a R&D Day for investors and analysts on Tuesday, June 21, 2022.
Anavex’s R&D Day will include presentations from the Company’s leadership team with a focus on the Company’s clinical development pipeline. Additional details will follow closer to the event.
Oral presentation of ‘Effects of the Sigma-1 receptor agonist blarcamesine (ANAVEX®2-73) in a murine model of fragile X syndrome: Neurobehavioral phenotypes and receptor occupancy’ to be presented at 18th NFXF International Fragile X Conference, July 14-17, 2022, in San Diego, California.
Pipeline expansion of the ANAVEX platform using gene biomarkers of response, applying precision medicine for neurological disorders with unmet medical need are expected 2022:
Meeting with FDA for discussing ANAVEX®2-73 Parkinson’s disease program including pivotal Phase 3 study.
Planned initiation of ANAVEX®2-73 imaging-focused Parkinson’s disease clinical study.
Planned initiation of a potentially pivotal Phase 2/3 study in Fragile X Syndrome, the most frequent genetic cause of autism spectrum disorder.
Planned initiation of a Phase 2/3 clinical trial for the treatment of a new rare-disease indication.
Planned initiation of ANAVEX®3-71 Phase 2 clinical trials for FTD, schizophrenias and Alzheimer’s disease indications.
Recent Business Highlights:
Anavex presented Phase 2 clinical biomarker data from the ANAVEX®2-73-PDD-001 Parkinson’s Disease Dementia (PDD) study at the AD/PDTM 2022 International Conference on Alzheimer’s & Parkinson’s Diseases and related neurological disorders in Barcelona, Spain, March 15–20, 2022.
Anavex announced presentations of Psychometric Evaluation of the Rett Syndrome Behaviour Questionnaire (RSBQ) and Burden of Illness (BOI) study in Rett syndrome by the respective working groups, at the 2022 International Rett Syndrome Foundation (IRSF) Rett Syndrome Scientific Meeting in Nashville, TN, April 26–27, 2022.
Financial Highlights:
Continued fiscal responsible management of cash utilization.
Cash and cash equivalents of $153.3 million on March 31, 2022, compared to $152.1 million at fiscal year end September 30, 2021.
Net loss of $10.4 million, or $0.14 per share for the quarter compared to net loss of $8.1 million, or $0.12 per share for the comparable quarter of fiscal 2021.
Research and development expenses of $8.6 million compared to $6.7 million for the comparable quarter of fiscal 2021.
General and administrative expenses of $2.9 million compared to $2.2 million for the comparable quarter of fiscal 2021.
Thanks to Georgejj! over at IHUB. |
