On 05/15/2013, Anavex Life Sciences Corp. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.

Anavex Life Sciences Corp. announced that it has been invited to submit a full grant application to the Alzheimer's Drug Discovery Foundation for a Phase 2a trial of ANAVEX 2-73. In pre-clinical studies, ANAVEX2-73 demonstrated cognitive benefit, the ability to protect neurons to prevent cell death, and a clear synergic effect with Aricept(R) (donepezil HCl, FDA-approved Alzheimer's treatment. A Phase 1 human clinical trial of ANAVEX 2-73 has also been successfully completed. The objective of the proposed Phase 2a clinical trial is to demonstrate objective biomarker data that can be correlated to clinical findings. It would also seek to confirm the pre-clinical synergy observed when combining ANAVEX 2-73 with donepezil in patients with Alzheimer's disease. Data generated would help determine the decision to proceed to a larger Phase 2 trial. The invitation to submit a full application was received following the filing by Anavex of a Letter of Intent for a grant titled, Clinical phase 2a study of ANAVEX 2-73 in patients using FDG-PET imaging as a functional biomarker. Anavex now intends to file a full application with the ADDF. There can be no assurance that the company's application for a grant from the ADDF will be approved.

Anavex Life Sciences Corp. commented on the United States Food and Drug Administration's (FDA) plan to expedite the approval of new treatments for Alzheimer's disease. As reported by the New York Times, drugs in clinical trials would qualify for approval if people with very early-stage Alzheimer's showed even subtle improvement in memory or reasoning tests. ANAVEX 2-73, the company's lead compound for Alzheimer's disease, has successfully completed a Phase 1 clinical trial in humans. Data from the ANAVEX 2-73 Phase 1 human clinical trial indicates that the drug is well tolerated with no dose-limiting toxicities unrelated to the drug's mechanism of action. World-renowned Alzheimer's scientists have published studies showing that ANAVEX 2-73 protects neurons to prevent cell death and reverses symptoms of the disease in mouse models. Pre-clinical animal studies showed early signs of efficacy, improvement in the memory of animals and, in some cases, a disease-modifying effect. ANAVEX 2-73 was developed to treat Alzheimer's through a mechanism of action that modifies the disease, rather than temporarily addressing symptoms of the disease.