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.


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.


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 1 clinical program) in healthy volunteers and started in December 2022 a phase 1/2 trial in people with Down syndrome. This new study will assess the safety and the pharmacokinetics of AEF0217 and could also provide the first indications of its activity as a treatment of cognitive disorders. The results are expected in Q2 2023. AEF0217 has undergone an extensive preclinical proof-of-concept program using highly innovative tests to assess cognitive functions in animals. In this context, AEF0217 demonstrated its ability to completely reverse the cognitive impairments observed in several animal models of cognitive disorders, such as Down syndrome and Fragile X syndrome, as well as in certain cognitive deficits associated with aging.

Based in Bordeaux, within the Magendie Neurocenter, Aelis Farma has a team of 23 highly qualified employees and has benefited from investments from the Nouvelle-Aquitaine Region, Inserm Transfert Initiative, Bpifrance, regional funds ACI, NACO and Aqui-invest and from IRDI Capital Investissement.

For more information:

ISIN: FR0014007ZB4 Ticker: AELIS B Compartment of Euronext Paris


Forward-looking statements Some information contained in this press release are forward-looking statements, not historical data. These forward-looking statements are based on current beliefs, expectations, and assumptions, including, but not limited to, assumptions about Aelis Farma's current and future strategy and the environment in which Aelis Farma operates. They involve known and unknown risks, uncertainties, and other factors, which may cause actual results, performance or achievements, or industry results or other events, to differ materially from those described or implied by such forward-looking statements. These risks and uncertainties include those set out and detailed in Chapter 3 "Risk Factors" of Aelis Farma's registration document approved by the Autorité des marchés financiers on 14 January 2022 under number I.22-003. These forward-looking statements are made only as of the date of this press release and Aelis Farma expressly disclaims any obligation or undertaking to release any updates or corrections to the forward-looking statements included in this press release to reflect any change in expectations or events, conditions or circumstances on which any such forward-looking statement is based. Forward-looking information and statements are not guarantees of future performance and are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond Aelis Farma's control. Actual results could differ materially from those described in, or implied or projected by, forward-looking information and statements.

AELIS FARMA Pier Vincenzo Piazza CEO

NewCap Dusan Oresansky/Aurélie Manavarere Investor Relations +33 1 44 71 94 92

NewCap Arthur Rouillé Media Relations +33 1 44 71 00 15

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