Aelis Farma Advances on Dual Fronts with Stronger Finances

BORDEAUX, France – March 30, 2026 – Clinical-stage biopharmaceutical company Aelis Farma has signaled a period of focused execution, reporting improved 2025 financial results while making significant strides in the clinical development of its two leading drug candidates. The company confirmed it has secured a financial runway until at least early 2028, positioning it to advance its novel treatments for cannabis use disorder and cognitive impairments associated with Down syndrome.

In a comprehensive annual update, the French firm detailed a reduced net loss, the successful launch of a pivotal international study, and promising new analyses of its lead drug programs. These developments, coupled with a strategic consolidation of its operations, paint a picture of a company methodically advancing its innovative science while maintaining fiscal discipline.

A New Chapter for Neurological Therapies

Aelis Farma’s clinical pipeline is centered on two first-in-class assets targeting the brain's CB1 receptor with a unique mechanism. The company's latest results provide a clearer picture of the potential for both programs.

For AEF0117, a treatment for cannabis use disorder (CUD), the final analysis of its Phase 2b study has provided crucial data that could pave the way for new partnerships. While preliminary results in 2024 did not meet primary endpoints in the overall study population, a more detailed final analysis revealed a statistically significant impact in a key patient subgroup. According to the company, AEF0117 demonstrated a significant ability to reduce the number of days of cannabis use per week in patients with a strong motivation to quit. These patients also spent significantly less money on cannabis.

This finding is particularly relevant in a field with a substantial unmet need; there are currently no FDA-approved medications specifically for CUD. The market, estimated at over $1.7 billion in 2025, is primarily served by behavioral therapies with limited efficacy. Aelis Farma's drug, which confirmed an excellent safety and tolerability profile, could represent a breakthrough. The company now plans to leverage these new results to re-engage in partnership discussions, aiming to secure the resources needed for the next phase of development.

Simultaneously, Aelis Farma’s second candidate, AEF0217, has achieved a major milestone with the launch of a multicenter Phase 2b trial in December 2025. The study targets cognitive and behavioral impairments in individuals with Down syndrome (Trisomy 21), another area lacking any approved pharmacological treatments. The international trial will enroll 188 participants across France, Spain, and Italy.

This advancement follows a promising Phase 1/2 study where AEF0217 not only showed a favorable safety profile but also led to statistically significant improvements in adaptive behaviors, including communication and daily living skills. The program's credibility was further bolstered in January 2026 when the European Medicines Agency's (EMA) Pediatric Committee issued a favorable opinion on the drug’s Pediatric Investigation Plan (PIP), securing a key part of its European regulatory pathway.

Fortifying the Foundation: Financial Health and Strategic Focus

Underpinning these clinical advancements is a strengthened financial and operational posture. Aelis Farma reported a net loss of €6.434 million for 2025, an improvement from the €7.456 million loss recorded in 2024. This was largely driven by a 42% decrease in research and development costs as the expensive Phase 2b trial for AEF0117 concluded.

The company ended the year with a solid cash position of €9.058 million, bolstered by €2 million in non-dilutive financing secured in 2025. Critically, Aelis Farma stated this cash reserve is sufficient to fund its development plans until at least the beginning of 2028, providing stability as it pursues its next value-creation milestones.

In a notable strategic shift, the company also announced it will transition its financial reporting from International Financial Reporting Standards (IFRS) to French accounting standards beginning January 1, 2026. While IFRS is standard for most publicly traded companies in Europe to ensure cross-border comparability, the move to French GAAP may simplify reporting and reduce costs. The company, which has no subsidiaries, is not required to use IFRS, and this change aligns its public reporting with its statutory requirements. To further streamline operations, Aelis Farma will also consolidate all its staff and laboratories into a new registered office in Pessac, France, by mid-April 2026.

A Platform for the Future: The Science of Selective Inhibition

At the core of Aelis Farma's strategy is its proprietary drug discovery platform centered on Signaling Specific inhibitors of the CB1 receptor (CB1-SSi). This technology represents a significant evolution from previous attempts to modulate the endocannabinoid system. Earlier CB1 antagonists failed due to severe psychiatric side effects, as they blocked all activity of the receptor.

Aelis Farma's approach, developed from discoveries made at INSERM in Bordeaux, is more nuanced. Its CB1-SSi drugs are designed to mimic a natural brain mechanism that selectively inhibits only the excessive, disease-related signaling of the CB1 receptor without disrupting its normal physiological functions. This selectivity is the key to the favorable safety profile observed in its clinical trials.

Pier Vincenzo Piazza, CEO of Aelis Farma, expressed confidence in this approach. “Backed by the skills of our teams, we are confident of achieving these objectives, and of becoming a leading player in the development of innovative treatments for cerebral and peripheral diseases,” he stated.

The company is already looking beyond its two lead candidates. Its research platform has identified new families of CB1-SSi compounds with distinct properties, potentially opening doors to treating a wider range of diseases associated with CB1 dysregulation, including peripheral organ conditions. These efforts ensure a pipeline of future therapies that are not substitutable, each targeting different aspects of CB1 receptor dysfunction. With its lead programs at critical junctures and its financial future secured for the medium term, Aelis Farma is poised to continue its pioneering work in one of modern medicine’s most complex and promising fields.