Announcement • Apr 25
Aelis Farma SA, Annual General Meeting, Jun 03, 2026 Aelis Farma SA, Annual General Meeting, Jun 03, 2026. Location: iecb 2 rue robert escarpit, pessac France New Risk • Apr 13
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 2025. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (18% average weekly change). Earnings have declined by 25% per year over the past 5 years. Minor Risks Latest financial reports are more than 6 months old (reported June 2025 fiscal period end). Revenue is less than US$5m (€2.3m revenue, or US$2.7m). Market cap is less than US$100m (€18.2m market cap, or US$21.3m). Announcement • Apr 07
Aelis Farma Receives €458,000 Grant Under France 2030 in Nouvelle-Aquitaine to Support Development of Its Program in Obesity and Associated Metabolic Diseases Aelis Farma had been selected under the regional component of France 2030 in Nouvelle-Aquitaine and had been awarded a grant of EUR 458,000. This non-dilutive funding will help accelerate the Company’s research and development activities in the field of obesity and associated metabolic diseases. This non-dilutive public support, granted under the “Projet d’Avenir Innovation” call for projects, recognizes the scientific quality of the project led by Aelis Farma, its innovative nature, and its value creation potential in a rapidly expanding therapeutic field. The program was selected as part of the regional call for projects operated on behalf of the French State and the Nouvelle-Aquitaine Region, with the support of Bpifrance. The funds awarded will be used to finance research and development work focused on the identification and characterization of new drug candidates derived from the Company’s proprietary platform of specific signaling inhibitors of the CB1 receptor (CB1-SSi). This work is intended to advance the preclinical development of new molecules for the treatment of obesity-related metabolic disorders, as well as other peripheral diseases associated with dysregulation of the CB1 receptor. For Aelis Farma, this support strengthens both the external credibility of its “metabolism” program and its ability to secure competitive funding to support its development. It is fully aligned with the Company’s strategy to bring forward a new generation of treatments based on its proprietary CB1-SSi platform, with applications in both brain disorders and certain peripheral diseases. The regional component of France 2030 in Nouvelle-Aquitaine, presented by the Regional Prefecture, represents EUR 23 million over the 2025–2026 period, under a mechanism whereby each euro invested by the French State is matched by one euro invested by the Region. Aelis Farma is among the 8 new winners announced in this selection wave. Aelis Farma expresses its deep gratitude and wishes to acknowledge the key role played by the Nouvelle-Aquitaine Region, the Regional Prefecture and Bpifrance in supporting innovative high-potential projects capable of fostering the emergence of future French technology and biopharmaceutical leaders. This support reinforces the Company’s trajectory toward its value creation objectives and the development of breakthrough therapeutic innovations. Announcement • Mar 21
Aelis Farma Announces Successful Start of Recruitment of Phase 2B Clinical Trial with Aef0217 for Treatment of Behavioral and Cognitive Impairments of People with Down Syndrome Aelis Farma announced the successful launch of its Phase 2B clinical trial with AEF0217 for the treatment of the behavioral and cognitive impairments associated with Down syndrome (Trisomy 21), with recruitment now underway across the three countries involved (Spain, France and Italy). The first patient first visit (FPFV) was performed in December 2025 shortly after receiving initial regulatory approval. Screening and recruitment are now actively progressing across the centres of the three participating countries. The protocol of this Phase 2B was submitted through the EU Clinical Trials Information System (CTIS) and has received the required approvals from the European Medical Agency (EMA, the relevant national competent authorities and ethics committees in France, Italy and Spain under Regulation (EU) No 536/2014 (EU CT number: 2025-521013-10-00). AEF0217 is a first-in-class Signalling Specific inhibitor of the CB1 receptor (CB1-SSi) developed as a treatment for impairments in adaptive behaviours and cognition in neurodevelopmental disorders, with Down syndrome as the first indication. Down syndrome seems associated with an hyperactivity of the CB1 receptor, and an inhibition of the CB1 has been shown to improve cognitive performance and neurobiological activity in several genetic animal models of neurodevelopmental disorders, including Down syndrome. AEF0217 and the CB1-SSi class are designed to selectively inhibit the disease-related activity of the CB1 while preserving the physiological activity of the receptor. This molecular selectivity provides the first pharmacological approach allowing to obtain the positive effects of a CB1-inhibition without the adverse effects that halted the development of the previous-generation of CB1 antagonists, which blocked the whole activity of the CB1. In a prior Phase 1/2 randomized, double-blind, placebo-controlled study in young adults with Down syndrome (29 participants aged 18 to 32 years), AEF0217 showed a very favorable safety and pharmacokinetic profile. In addition, AEF0217 induced a statistically significant improvement in key adaptative behaviours, as measured by the Vineland Adaptive Behaviour Scales (VABS), such as the ability to communicate, to take care of oneself and to develop social interactions, paralleled by an improvement in brain activity. This international multicenter Phase 2B clinical trial (AEF0217-201) is designed to confirm and extend the Phase 1/2 findings in a larger population (188 vs 29 participants) and over a longer treatment duration (six-month vs one-month). It is a randomized, double-blind, placebo-controlled, parallel-group study expected to enroll 188 participants aged 16 to 32 years across 10 specialized expert centers (five in France, three in Italy and two in Spain). Participants will be randomized 1:1:1:1 to receive once-daily oral AEF0217 (0.1 mg, 0.2 mg or 0.6 mg) or placebo for 24 weeks, followed by an 8-week treatment free follow-up. The primary endpoint of the study is the change from baseline after six months of treatment in adaptive behaviors, assessed using the normalized raw scores of the nine subdomains of the Vineland Adaptive Behaviour Scales, Third Edition (VABS-3). Secondary endpoints include measures of cognition (fluid and crystallized), quality of life and sleep efficiency. Safety will be closely monitored throughout the study period, and an independent data monitoring committee (IDMC) will perform an interim safety analysis after at least 40 participants have completed 12 weeks of treatment. Recruitment is expected to be completed by the end of 2026, and preliminary results are expected in the second half of 2027. Aelis Farma’s current cash runway (First Quarter 2028) extends well beyond the end of this study. New Risk • Jan 14
New major risk - Revenue and earnings growth Earnings have declined by 25% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risk Earnings have declined by 25% per year over the past 5 years. Minor Risks Revenue is less than US$5m (€2.3m revenue, or US$2.7m). Market cap is less than US$100m (€16.1m market cap, or US$18.8m). Announcement • Jan 12
Aelis Farma Receives Positive Opinion from EMA Pediatric Committee on the Pediatric Investigation Plan for AEF0217 in Down Syndrome Aelis Farma announced that the Paediatric Committee (PDCO) of the European Medicines Agency (EMA) has emitted a favorable opinion on the Paediatric Investigation Plan (PIP) for AEF0217 (EMA/PE/0000243385; IRIS: 0075800000532) in the treatment of Down syndrome. Enables a pragmatic stepwise approach allowing the programme to progress sequentially based on data generated in earlier studies before expanding into progressively younger populations. The PIP is fully in line with Aelis Farma's extensive clinical development plan assessing the efficacy and safety of AEF0217 in people with Down syndrome, structured in two parts: The first part includes a Phase 2B study in older adolescents and young adults with Down syndrome aged 16 to 32 years. The second part, covered by the PIP, foresees subsequent studies progressively including children aged 6 to "The PDCO's favorable opinion on Paediatric Investigation Plan for AEF0217, is a major milestone for AEF0217 and--most importantly--for the Down syndrome community. It validates the robustness of clinical development strategy and provides a clear, agreed framework to evaluate AEF0217 across the full paediatric age range (from birth to 18 years of age) fulfilling a major demand from families and patients' associations. After obtaining positive results of ongoing Phase 2B study, which will include older adolescents and adults, will continue the paediatric development including children of younger ages. The ability to reach children early in their development should lead to greater gains in learning, adaptive behavior and cognition and a stronger impact on quality of life. After this important milestone, are even more committed to fulfill a major unmet medical need by delivering a treatment that could meaningfully improve quality of life for people with Down syndrome and their families. AEF0217 is Aelis Farma's second clinical-stage drug candidate. It belongs to a new class of drugs discovered by the company, the Signaling Specific inhibitors of the CB1 receptor of the endocannabinoid system (CB1-SSi). Aelis Farma currently has two first-in-class clinical-stage drug candidates. AF0117 for the treatment of cannabis use disorders (CUD), that has shown to be able to decrease cannabis use across two studies. AF0217 for cognitive disorders, which has shown in a Phase 1/2 to be safe and able to improve adaptive behavior in young adults with Down syndrome (Trisomy 21) and has started a Phase 2B in Europe aiming to confirm its efficacy and safety. The clinical results obtained with these 2 compounds have confirmed the safety and therapeutic activity of CB1-SSi in humans. The Company also develops a portfolio of new innovative CB1-SSi for the treatment of other disorders associated with a dysregulation of the activity of the CB1 receptor, including diseases involving peripheral organs, including diseases involving peripheral organs and peripheral diseases involving peripheral organs, and other diseases involving peripheral organs, and the development of brain and peripheral diseases involving the CB1 receptor, including peripheral organs, and is a major regulatory milestone. The PIP is full clinical program for the treatment of brain and peripheral diseases involving peripheral diseases involving theCB1 receptor, including diseases involving central organs and peripheral diseases involving the CB 1 receptor. The PIP is a major regulatory milestone, for a treatment that is likely to be destined to be destined to children, reinforces the program's credibility, de-risks late-stage regulatory requirements, and strengthens visibility on the European path toward marketing authorization for AEF0217. AEF0217. Announcement • Dec 02
Aelis Farma Obtains Regulatory Approval of the Phase 2B Trial with AEF0217 in People with Down Syndrome Aelis Farma announced that it has received the approvals from the European Medical Agency (EMA) and from the competent authorities and ethics committees in France, Italy and Spain of the protocol of the Phase 2B clinical study of AEF0217 for the treatment of adaptive behaviours and cognitive impairments in people with Down syndrome (Trisomy 21). Authorizations were granted via the EU Clinical Trials Information System (CTIS) under Regulation (EU) No536/2014 and by the relevant competent authorities and ethics committees in French, Italy and Spain. People with Down syndrome frequently present lifelong impairments in adaptive behaviour and cognition for which no pharmacological treatment is currently approved. In this trial, participants were treated for four weeks with AEF0217 at 0.2 mg/day. The positive results of this study were communicated in November 2024. The study showed a very favourable safety and pharmacokinetic profile. In addition, after only four weeks of treatment, AEF0217 induced a statistically significant improvement in key adaptative behaviors, as measured by the Vineland Adaptive Behaviour Scales (VABS), such as the ability to communicate, to take care of oneself and to develop social interactions, paralleled with an improvement in brain activity. The newly approved international multicenter Phase 2B study ("AEF0217-201") is designed to confirm and extend these promising results in a larger population and over a longer treatment duration. This randomized, double-blind, placebo-controlled, parallel-group clinical trial will enrol 188 participants with Down syndrome aged 16 to 32 years across 10 specialised clinical centres in France, Italy and Spain (five in France, three in Italy and two in Spain). Eligible participants will be randomised into four groups receiving once-daily oral treatment with one of three doses of AEF0217 (0.1 mg, 0.2 mg or 0.6 mg) or placebo for 24 weeks, with a subsequent eight-week follow-up period. Reported Earnings • Oct 01
First half 2025 earnings released: €0.32 loss per share (vs €0.27 loss in 1H 2024) First half 2025 results: €0.32 loss per share (further deteriorated from €0.27 loss in 1H 2024). Net loss: €4.32m (loss widened 21% from 1H 2024). Revenue is forecast to grow 109% p.a. on average during the next 3 years, compared to a 23% growth forecast for the Biotechs industry in France. Over the last 3 years on average, earnings per share has increased by 34% per year but the company’s share price has fallen by 50% per year, which means it is significantly lagging earnings. New Risk • Sep 22
New minor risk - Revenue size The company makes less than US$5m in revenue. Total revenue: €2.3m (US$2.8m) This is considered a minor risk. Companies with a small amount of revenue are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risk Share price has been highly volatile over the past 3 months (27% average weekly change). Minor Risks Revenue is less than US$5m (€2.3m revenue, or US$2.8m). Market cap is less than US$100m (€16.2m market cap, or US$19.2m). Announcement • Apr 19
Aelis Farma SA, Annual General Meeting, May 27, 2025 Aelis Farma SA, Annual General Meeting, May 27, 2025. Location: 1 rue lafaurie de monbadon, bordeaux France Breakeven Date Change • Apr 06
Forecast breakeven date pushed back to 2026 The analyst covering Aelis Farma previously expected the company to break even in 2024. New forecast suggests losses will reduce by 65% to 2025. The company is expected to make a profit of €2.40m in 2026. Average annual earnings growth of 107% is required to achieve expected profit on schedule. Board Change • Feb 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 10 experienced directors. 1 highly experienced director. Censor Francois Thomas was the last director to join the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. New Risk • Jan 22
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of French stocks, typically moving 10% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risk Share price has been highly volatile over the past 3 months (10% average weekly change). Minor Risk Market cap is less than US$100m (€26.0m market cap, or US$27.1m). Price Target Changed • Nov 27
Price target decreased by 39% to €9.10 Down from €15.00, the current price target is an average from 2 analysts. New target price is 214% above last closing price of €2.90. Stock is down 78% over the past year. The company is forecast to post a net loss per share of €0.19 next year compared to a net loss per share of €0.39 last year. Announcement • Nov 19
Aelis Farma Announces the Positive Results of Its Clinical Phase 1/2 Study with AEF0217 in Young Adults with Down Syndrome Aelis Farma announced the positive results of a Phase 1/2 clinical study with AEF02171 in young adults with Down syndrome. This Phase 1/2 clinical trial with AEF0217 was a randomized, double-blind, parallel study comparing one dose of AEF0217 (0.2mg oral dose) to placebo after 28 days of treatment once a day in young adults (between 18 and 35 years old) with Down syndrome. The primary objective of the trial was to assess the safety and tolerability of AEF0217, which is particularly relevant in the fragile population with Down syndrome. The secondary and exploratory objectives investigated the pharmacokinetic and the efficacy of AEF0217 on the behavioral impairments of young adults with Down syndrome. 29 young adults with Down syndrome with mild to moderate intellectual disability were included in the study by the teams of Prof. de la Torre Fornell at the Hospital del Mar Medical Research Institute (HMRIB) in Barcelona (Spain), the principal investigator, and Dr. Real de Asua at the Hospital de la Princesa in Madrid (Spain). The effects of a treatment with AEF0217 were also studied as a function of the APOE4 genotype (APOE4-positive versus APOE4-negative). This genetic marker has been shown to be related to endocannabinoid physiology and to the susceptibility to develop Alzheimer disease. The study successfully met its safety (primary), pharmacokinetics (secondary) and efficacy (secondary and exploratory) objectives. AEF0217 was well tolerated, and no safety concerns were observed. The adverse events were similar in the placebo and AEF0217 groups. Most of the adverse events observed were of mild severity and considered unrelated to treatment. No serious or severe adverse events were observed nor was there any discontinuations of the treatment due to adverse events. AEF0217 also showed a favorable pharmacokinetic profile with plasma exposure on average slightly higher in young adult with down syndrome than in healthy volunteers. These results are consistent with previous Phase 1 clinical studies conducted in healthy volunteers, in which AEF0217 also demonstrated a very favorable safety and pharmacokinetic profile. The effects of AEF0217 on the behavioral impairments of young adults with Down syndrome were studied using two assessment tools. The Vineland Adaptive Behavior Scale (VABS), which directly measures the potential improvements in everyday life functioning of people with Down syndrome and the NIH-Toolbox Cognitive Battery for intellectual disabilities which directly measures different cognitive functions. Of the nine behavioral skills investigated by the VABS, AEF0217 improved five: (i) expression abilities (P<0.002); daily living skills: (ii) of the personal sphere (P<0.003), and (iii) in the community (P<0.03, in APOE4-negative participants); (iv) interpersonal relationships skills (P<0.01), and (v) a strong trend to an improvement in writing abilities in APOE4-negative participants. It is noteworthy that AEF0217 seemed to induce larger improvements in participants with the greater impairments before starting the treatment (P< between 0.04 and 0.003). Of the five different cognitive functions investigated by the NIH-Toolbox Cognitive Battery for intellectual disability, AEF0217 induced a clear trend to increase cognitive flexibility, an effect close to statistical significance (P<0.09) in APOE4-negative people with Down syndrome. Cognitive flexibility is a very important cognitive function, impaired in Down syndrome. This cognitive function is also improved by AEF0217 in genetic animal models of down syndrome, confirming the translation of AEF0217 effects across species. AEF0217 also significantly (P<0.012) decreased the Electro Encephalographic (EEG) activity associated with a working memory task that is higher in young adults with Down syndrome indicating a higher strain in performing this task compared with neurotypical controls. Finally, AEF0217 also showed clear indications of target engagement, significantly modifying (P<0.05) a CB1 dependent EEG parameter: the Gamma Intertrial Coherence (ITC) during Auditory Steady State Response (ASSR) at 40 Hz (ITC-ASSR-40 HZ). It is noteworthy that the results on adaptative behavior and cognition were observed after only four weeks of treatment, whereas it is generally believed by experts in the field that at least several months of treatment are needed before a pharmacological intervention is able to modify adaptative behavior and cognitive performances in neurodevelopmental disabilities. Reported Earnings • Oct 01
First half 2024 earnings released: €0.27 loss per share (vs €0.13 loss in 1H 2023) First half 2024 results: €0.27 loss per share (further deteriorated from €0.13 loss in 1H 2023). Revenue: €4.12m (down 28% from 1H 2023). Net loss: €3.58m (loss widened 119% from 1H 2023). Revenue is expected to decline by 6.4% p.a. on average during the next 3 years, while revenues in the Biotechs industry in France are expected to grow by 33%. New Risk • Sep 05
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of French stocks, typically moving 15% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risk Share price has been highly volatile over the past 3 months (15% average weekly change). Minor Risks Shareholders have been diluted in the past year (9.2% increase in shares outstanding). Market cap is less than US$100m (€74.3m market cap, or US$82.5m). Price Target Changed • Sep 04
Price target decreased by 27% to €15.00 Down from €20.67, the current price target is provided by 1 analyst. New target price is 32% above last closing price of €11.40. Stock is down 17% over the past year. The company is forecast to post a net loss per share of €0.76 next year compared to a net loss per share of €0.39 last year. Announcement • Sep 04
Aelis Farma Announces the Results of Its Clinical Phase 2B Study with AEF0117, Among Participants with Cannabis Use Disorder (CUD) Aelis Farma announced results from the clinical Phase 2B trial conducted by Aelis Farma with AEF01171, evaluating its efficacy and safety in treatment-seeking participants with moderate to severe Cannabis Use Disorder (CUD) that used cannabis 5 days/week at baseline. In this study population, 82% of the participants had severe CUD. The purpose of this pioneering phase 2B trial was to show that AEF0117 lowers cannabis use and to determine the endpoints and optimal dosage of AEF0117 for use in future studies. At the end of the treatment period, AEF0117 (1 mg/day) improved, with a nearly statistically significant effect, anxiety and depression scores on the Hamilton scales and sleep quality. These findings suggest that AEF0117's pharmacological profile differs from that of CB1 receptor antagonists, including rimonabant, which have been shown to increase anxiety and depression. These data indicate that AEF0117 is pharmacologically active, providing a supplementary validation of the new pharmacological class developed by Aelis Farma, the "Signalling Specific Inhibitors of the CB1 receptor (CB1-SSi"). Aelis Farma continues to explore the results of the study further in order to determine the best course of strategic and regulatory actions. This clinical Phase 2B study is part of the strategic collaboration between Aelis Farma and Indivior, which includes an exclusive option for Indivior to license the global rights to AEF0117, a first-in-class synthetic Signaling Specific Inhibitors ("SSI") engineered to inhibit the cannabinoid type 1 ("CB1-SSI").2 Indivior has communicated Aelis Farma that it does not intend to exercise the option on AEF0117 before seeing the additional analysis of the clinical data. The Phase 2B study is part the AEF0117 clinical development program of AEF0117. The completed Phase 2B trial (NCT05322941) performed by Aelis Farma was a randomized, double-blind, placebo-controlled, 4-arm, parallel-group, prospective, multicentre study ("Effect of AEF0117 on Treatment-seeking Patients with Cannabis Use Disorder (CUD") (SICA2) (SICA2).1 Participants were recruited across eleven clinical centres throughout the United States. Three hundred thirty-three treatment-seeking participants with moderate To severe CUD were treated once daily for 12 weeks, with either 1.0mg, 0.3mg, and 0.1mg of AEF0117 or placebo. By mimicking this natural mechanism, CB1-SSi appear to selectively inhibit the disease-related activity of the CB1 receptor without disrupting its normal physiological activity.2 CB1-SSi have subsequently the potential to provide new safe treatments for several brain diseases. Aelis Farma is currently developing two first-in-class clinical-stage drug candidates: AEF0117 for the treatment of cannabis related disorders, that has just completed a Phase 2B study in the United States in CUD, and AEF0217 for cognitive disorders, including those of Down Syndrome (Trisomy 21), currently in a Phase 1/2 study in Spain in people with Down syndrome, which results are expected in Q4-2024. The Company also has a portfolio of new innovative CB1-SSi for the treatment of other disorders associated with a dysregulation of the activity of the CB receptor. The different drugs developed by the company belong to the same general pharmacological class, the CB1-SSi, but have distinct functional effects allowing to target different types of dysregulations of the CB receptor. Announcement • Apr 19
Aelis Farma SA Announces the Last Patient, Last Visit in its Clinical Phase 2b Trial with AEF0117 for the Treatment of Cannabis Use Disorder Aelis Farma SA announced a significant milestone in the clinical development of AEF0117: the last patient visit in the clinical phase 2b study, which included 333 individuals seeking treatment for cannabis use disorder (CUD), has been completed. AEF0117 represents a novel class of drugs developed by Aelis Farma, the Signaling-Specific inhibitor of the CB1 receptor ("CB1-SSi"). This phase 2b multicenter study aims to demonstrate the efficacy and safety of this "first-in-class" compound in treating cannabis addiction, currently defined as CUD in the DSM-5, the reference diagnostic manual of mental disorders. This significant advancement marks the conclusion of clinical data collection and the start of in-depth analysis. The company confirms its intention to announce the study results in the third quarter of this year. Pr. Finally, the productive toxicology studies show that AEF0117 does not modify embryonic and embryofetal development. The successful early completion of the toxicity studies described above and of additional non-clinical development studies, positions AEF0117 to enter phase 3 clinical trials for the treatment of CUD upon positive results of the present phase 2b clinical trial and regulatory agreement of the phase 3 protocol. To reach this goal, the company plans to request an end-of-phase 2 (EOP2) meeting with the FDA in the fourth quarter of this year. Phase 2b clinical study with AEF0117 for the treatment of cannabis addiction. Under the coordination of Professor Frances Levin at Columbia University (New York) and of Aelis Farma clinical team, recruitment and randomization of the 333 patients for the phase 2b trial of AEF0117 at 11 clinical centers in the United States were completed in December 2023. The last visit for the last patient was completed mid-April 2024. These secondary endpoints, if positive, could potentially serve as alternative primary objectives for the future phase 3 trials. The Phase 2b study is part of the clinical program for AEF0117, which received $7.8 million of total funding from the National Institutes of Health (NIH), with $4.5 million allocated in late 2021 for the current development phase, aiming to ready the compound to enter phase 3. The remaining $3.3 million were previously dedicated to help financing phase 1 and a Phase 2a study with AEF0117. Within three months following the end of phase 2 meeting with the FDA, Indivior will be able to exercise its license option, trigger the payment of a $100 million license fee, up to an additional $340 million in milestone payments involving upon the achievement of development, regulatory, and commercial milestones, as well as royalties on net sales of AEF0117 ranging from 12% to 20%. Aelis Farma is currently developing two first-in-class drugs developed by AelisFarma, the Signaling- Specific inhibitor of the CB1 receptor (CB1-SSi). This Phase 2b multicenter study aims for the treatment of cannabis addiction, which is expected to be in the second quarter of this year. Reported Earnings • Apr 03
Full year 2023 earnings released Full year 2023 results: Revenue: €12.4m (up 48% from FY 2022). Net loss: €5.08m (loss narrowed 65% from FY 2022). Revenue is expected to decline by 34% p.a. on average during the next 3 years, while revenues in the Biotechs industry in France are expected to grow by 36%. Announcement • Jan 18
Aelis Farma Announces the Appointment of Arsène Guekam as Chief Corporate Development Officer Aelis Farma announced the reinforcement of its leadership team with the appointment of Arsène Guekam as Chief Corporate Development Officer. With over 15 years of experience in the Healthcare (biotech/medtech) and financial sectors, Arsène Guekam brings an unvaluable expertise to Aelis Farma in these fields. Graduate in Pharmacy and from the EM Lyon's Programme Grandes Ecoles (finance option), Arsène held key positions as a financial analyst in several renowned brokers such as Oddo BHF, CM-CIC Securities, or Crédit Lyonnais Small Caps. Before joining Aelis Farma, Arsène served as Senior Analyst, Head of Biotech Research at Kepler Cheuvreux, and later as Co-Head of Healthcare Research. His extensive experience in financial markets and trend analysis, combined with a profound understanding of the challenges in the biotechnology industry, makes him an exceptional asset for Aelis Farma. As Chief Corporate Development Officer, Arsène will be responsible for steering and overseeing the Company’s development strategy, including identifying and evaluating new growth opportunities, fostering strategic partnerships, and strengthening relationships with investors. Announcement • Jan 10
Aelis Farma Announces Completion of Patient Randomization for Phase 2B Study with Aef0117 for the Treatment of Cannabis Addiction Aelis Farma announced to have reached a key milestone by successfully completing the recruitment of 333 patients suffering from cannabis addiction in its Phase 2b clinical study with AEF0117. AEF0117 is the first of a new class of proprietary drugs developed by Aelis Farma, the Signaling Specific inhibitors of the CB1 receptor of the endocannabinoid system (CB1-SSi). The ongoing multicenter Phase 2b study aims to demonstrate the effectiveness of this "first-in-class" compound in treating cannabis addiction, currently defined as CUD (Cannabis Use Disorder) in the DSM-5, the reference diagnostic manual of mental disorders. The recruitment and randomization of the 333 study patients were accomplished across 11 clinical centers in the United States, under the coordination of Pr. Frances Levin from Columbia University (New York). The double-blind, placebo-controlled trial involves the administration of either placebo or one of the three tested doses of AEF0117 (0.1 mg, 0.3 mg, and 1 mg) once daily for 3 months. The primary objective of the study is to assess whether AEF0117 reduces cannabis consumption by demonstrating an increase in the proportion of subjects consuming cannabis =1 day per week compared to the placebo. The proportion of patients achieving other levels of reduced consumption, along with the potential improvement in their quality of life, will also be examined as secondary endpoint. Initial results are expected in line with the timeline previously announced for the second quarter of 2024. To ensure a smooth transition of AEF0117 to the Phase 3 study after a positive Phase 2b, Aelis Farma initiated, in parallel with the Phase 2b, a series of toxicology studies required by the regulatory authorities. Announced last November, the favourable safety profile observed in this context validates the positive observations of the independent Data Safety Monitoring Board (DSMB) for the initial 115 patients in the Phase 2b study, confirming the good tolerance of AEF0117 in individuals with cannabis addiction. Thanks to the completion of these non-clinical developments ahead of schedule, AEF0117 will be ready to enter the Phase 3 clinical study for cannabis addiction at the end of a positive Phase 2b, subject to regulatory approval of the Phase 3 design. The Phase 2b study is an integral part of the clinical program for AEF0117, which received USD 7.8 million of total funding from the National Institutes of Health (NIH), with USD 4.5 million allocated in late 2021 for the current development phase. Previously, a Phase 2a study, conducted by Pr. Margaret Haney (Columbia University, NY) in volunteers with cannabis addiction, provided initial evidence of the efficacy of AEF0117 with a favourable safety profile. Based on encouraging Phase 2a results, Aelis Farma entered into an exclusive option and license agreement in 2021 with Indivior PLC, a leading pharmaceutical group in addiction treatment, for the development and commercialization of AEF0117 as a treatment for disorders due to excessive cannabis use. As part of this agreement, Aelis Farma has received already USD 30 million (option payment). If Indivior exercises the license option at the end of the Phase 2b (H2 2024), Aelis Farma will receive a USD 100 million license fee and up to USD 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%. Following the exercise of the option, all development, registration, and commercialization costs of AEF0117 will be borne by Indivior. Announcement • Nov 08
Aelis Farma Announces Positive Results of Non-Clinical Studies Required by Regulatory Agencies to Enter Its First Cb1-SSI, AEF0117, in Phase 3 Clinical Trial for the Treatment of Cannabis Use Disorder Aelis Farma announced that it has successfully completed all the regulatory non-clinical studies necessary to enter in phase 3 clinical trials AEF0117, the Company's most advanced signaling specific inhibitor of the CB1 receptor of the endocannabinoid system. AEF0117 is currently tested in a large phase 2b study in people with cannabis use disorder (CUD). CUD is the current definition of cannabis abuse and dependence in the DSM5, the reference diagnostic manual for psychiatric diseases. Recruitment is on track and results are expected in second quarter 2024. Thanks to the successful completion of the non-clinical development ahead of schedule, AEF0117 will be prepared to enter pivotal phase 3 clinical trials for CUD upon successful completion of the present phase 2b clinical study and regulatory clearance of the phase 3 protocol. Both compounds have a favorable safety profile and no effect on normal behavior perse. Aelis Farma, using its proprietary screening platform, has also identified new families of CB1 compounds, chemically and functionally differentiated from the first two, but sharing the core mechanism of action. The development of AEF0117, for the treatment of cannabis use disorder is progressing according to plan. AEF0117 is current in a phase 2b study conducted in 11 clinical centers in the US and coordinated by Pr. Frances Levin (Columbia University, New York). The study, that aims to enroll up to 330 patients, progresses according to plan with recruitment expected to be finalized by fourth quarter 2023. The first results should be available in second quarter 2024. To ensure a smooth transition of AEF0117 to the phase 3 study after a positive phase 2b, Aelis Farma initiated, in parallel with the phase 2b clinical studies, a series of toxicology studies required by the regulatory authorities. These confirmed the very favorable therapeutic index >13,000 time the active dose. CB1-SSi have consequently the potential to provide new treatments for several brain diseases. Aelis Farma is currently developing two first-in-class clinical-stage drug candidates: AEF0117 is currently in a phase 2b study completed in 11 clinical centers in the U.S and coordinated by Pr.Frances Levin (Columbia University, New York). New Risk • Oct 06
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 5.2% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. This is currently the only risk that has been identified for the company. Reported Earnings • Sep 28
First half 2023 earnings released First half 2023 results: Revenue: €5.70m (up 34% from 1H 2022). Net loss: €1.63m (loss narrowed 84% from 1H 2022). Revenue is forecast to grow 25% p.a. on average during the next 3 years, compared to a 26% growth forecast for the Biotechs industry in France. Announcement • Jul 06
Aelis Farma Receives a Positive Recommendation From the DSMB to Continue, With No Modification to the Protocol, the Phase 2b Clinical Study With AEF0117 in Cannabis Addiction Aelis Farma announced that it has received a unanimous positive recommendation from the Data Safety Monitoring Board (DSMB) to continue, without modifying the protocol, the phase 2b clinical study with AEF0117 for the treatment of cannabis addiction. A DSMB is a committee of independent experts, specialized in clinical research, that reviews studies’ data with a particular emphasis on tolerability and safety. The DSMB that analyzed the data from the phase 2b study with AEF0117 met to assess the safety and tolerability data on the first 115 patients treated for at least 4 weeks with AEF0117. Following the meeting, the committee observed no serious adverse events or significant events associated with the treatment and recommended that the study be continued without any modifications to the protocol. The phase 2b study with AEF0117, currently being undertaken in 11 clinical centers in the United States, aims to demonstrate the efficacy of AEF0117 in treating cannabis use disorder, the modern medical definition of cannabis addiction. This double-blind placebo-controlled study should include a total of around 330 patients who will be administered either a placebo or one of the three test doses of AEF0117 (0.1 mg, 0.3 mg and 1 mg) once daily for 3 months. The primary objective of this study is to evaluate whether AEF0117 reduces cannabis use, measured by the increase in the proportion of subjects who use cannabis =1 day a week compared to the placebo. The proportion of patients achieving other levels of reduction of their use and a potential improvement in their quality of life will also be investigated. Enrollment in the study is continuing at a sustained pace, enabling the first results to be anticipated in mid-2024, as expected. Major Estimate Revision • Jun 18
Consensus EPS estimates upgraded to €1.36 loss The consensus outlook for fiscal year 2023 has been updated. 2023 losses forecast to reduce from -€1.89 to -€1.36 per share. Revenue forecast unchanged from €8.90m at last update. Biotechs industry in France expected to see average net income growth of 0.3% next year. Consensus price target of €21.50 unchanged from last update. Share price was steady at €14.00 over the past week. Announcement • Jun 12
Aelis Farma Announces the Presentation of New Preclinical Data on its Drug Candidate AEF0217 at the 2nd European Conference on Phelan-McDermid Syndrome Aelis Farma announced the presentation of new preclinical data on its drug candidate AEF0217 at the 2nd European Conference on Phelan-McDermid Syndrome, which was held from June 9 to 11, 2023 at CEU San Pablo University in Madrid. Phelan-McD Germid Syndrome (PMS), which is caused by the deletion of chromosome 22q13 including the SHANK3 gene or by a sequence variation in this gene, is one of the most frequently observed genetic mutations in autism. It is an orphan disease for which there is currently no treatment. In affected people, these mutations can lead to development delays in multiple areas, in particular delayed speech, intellectual disability and often autism spectrum disorder. Dr. Pier Vincenzo Piazza, CEO of Aelis Farma, alongside Flavio Tomasi, PhD student in Dr. Catalina Betancur’s INSERM/CNRS laboratory at the Sorbonne university, gave an oral communication entitled: “Inhibition of the cannabinoid CB1 receptor rescues deficits in a mouse model of Phelan-McDermid syndrome” at the 2ndEuropean Conference on Phelan-McDermid Syndrome, organized by the Spanish Phelan-McDermid Syndrome Association. The presented data was obtained within the context of a collaboration between several laboratories coordinated by Dr. Betancur. The results showed the ability of AEF0217 to statistically significantly reverse behavioral, cognitive and motor deficits observed in a genetic mouse model of Phelan-McDermid Syndrome. In these mice, ARF0217 also reversed a neurological alteration (cortical hyperactivity), considered as a neurobiological marker of autism. Based on these promising results Aelis will now analyze the feasibility to develop of AEF0217 in this indication and more generally in autism spectrum disorder. AEF0217 is the second drug candidate developed by Aelis Farma. It belongs to a new generation of drugs discovered by the Company, the Signaling-Specific inhibitors of the CB1 receptor of the endocannabinoid system (CB1-SSi). The CB1 is one of the most expressed neurotransmitter receptors in the brain implicated in many diseases. AEF0217 is currently being developed for the treatment of cognitive disorders in people with Down syndrome (trisomy 21) and evaluated in a phase 1/2 study in this population. Reported Earnings • Apr 08
Full year 2022 earnings released Full year 2022 results: Revenue: €8.36m (down 22% from FY 2021). Net loss: €14.3m (down €14.9m from profit in FY 2021). Products in clinical trials Phase I: 1 Phase II: 1 Revenue is forecast to grow 28% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in France. Board Change • Nov 16
High number of new directors There are 6 new directors who have joined the board in the last 3 years. Censor Francois Thomas was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Reported Earnings • Sep 26
First half 2022 earnings released First half 2022 results: Revenue: €4.25m (down 49% from 1H 2021). Net loss: €10.4m (down 374% from profit in 1H 2021). Revenue is forecast to grow 114% p.a. on average during the next 3 years, compared to a 32% growth forecast for the Biotechs industry in France. Board Change • Apr 27
High number of new directors There are 6 new directors who have joined the board in the last 3 years. Censor Francois Thomas was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Reported Earnings • Apr 06
Full year 2021 earnings released Full year 2021 results: Revenue: €10.8m (up €9.63m from FY 2020). Net income: €574.0k (up €2.66m from FY 2020). Profit margin: 5.3% (up from net loss in FY 2020). The move to profitability was driven by higher revenue. Over the next year, revenue is expected to shrink by 86% compared to a 268% growth forecast for the pharmaceuticals industry in France. 