Tuesday, January 31, 2023

Aelis Farma Announces its 2023 Financial Calendar

BORDEAUX, France--(BUSINESS WIRE)--Regulatory News: Aelis Farma (ISIN: FR0014007ZB4 – Ticker: AELIS, PEA-PME eligible) (Paris: AELIS), a clinical-stage biopharmaceutical company specializing in the development of treatments for brain diseases, today announces its indicative financial calendar for the financial year 2023. Event Date of release* 2022 Annual Results Monday, April 3, 2023 Annual General Meeting Wednesday, May 24, 2023 2023 Half-Year Results Monday, September 25, 2023 (*) The press releases will be issued after the close of trading. Information may be subject to change. About AELIS FARMA Founded in 2013, Aelis Farma is a biopharmaceutical company that is developing a new class of drugs, the Signaling Specific inhibitors of the CB1 receptor of the endocannabinoid system (CB1-SSi). These new molecular entities hold great potential in the treatment of many brain diseases. CB1-SSi were developed by Aelis Farma on the basis of the discovery of a new natural defense mechanism of the brain made by the team of Dr. Pier Vincenzo Piazza, CEO of the Company, when he was Director of the Magendie Neurocenter of Inserm in Bordeaux. By reproducing this natural mechanism, CB1-SSi appear to be able to selectively inhibit the disease-related activity of the CB1 receptor, without disrupting its normal physiological activity. For these discoveries, Dr. Piazza was awarded the Inserm Grand Prix and the Grand Prix of Neurology of the French Academy of Sciences, which are among the most prestigious French awards in medicine and neurology. Aelis Farma is developing two first-in-class drug candidates that are at the clinical stage, AEF0117 and AEF0217, and has a portfolio of innovative CB1-SSi for the treatment of other diseases associated with a dysregulation of the activity of the CB1 receptor. AEF0117, which targets disorders due to excessive cannabis use (addiction and psychosis), has shown indications of efficacy in a phase 2a clinical trial and has entered a phase 2b clinical trial in Q2 2022, which will include 330 patients in 12 clinical centers in the United States. Aelis Farma has an exclusive option-license agreement with Indivior PLC, a leading pharmaceutical company in the treatment of addiction, for the development and commercialization of AEF0117 for disorders due to excessive cannabis use. As part of this agreement, Aelis Farma has already received $30 million (option payment). If Indivior exercises the license option at the end of the phase 2b, Aelis Farma will receive a $100 million license fee (potentially in 2024) and Indivior will carry any additional development costs. The agreement also includes up to $340 million in additional payments contingent on the achievement of development, regulatory and commercial milestones, as well as royalties on net sales of AEF0117 ranging between 12% and 20%. AEF0217, which targets various cognitive disorders including those associated with Down syndrome (trisomy 21), has successfully completed safety and pharmacokinetic trials (phase
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