The first half of 2026 was marked by:
-- A positive opinion from the EMA Pediatric Committee on the Pediatric
Investigation Plan for AEF0217, securing the development plan for this
compound in Down syndrome;
-- The continuation of the international Phase 2b clinical trial (France,
Italy, Spain) with AEF0217 in people with Down syndrome, with recruitment
progressing on track and a positive recommendation from the independent
safety committee reviewing safety during the study;
-- Progress in the development of new CB1-SSi compounds from the Company's
proprietary platform, particularly in obesity and associated metabolic
diseases, supported by a EUR458,000 France 2030 grant; and
-- Rigorous cost management, resulting in a solid cash position of EUR6.6
million as of June 30, 2026, providing financial visibility through early
2028, which could be further extended through additional non-dilutive
funding.
BORDEAUX, France--(BUSINESS WIRE)--September 15, 2026--
Regulatory News:
Aelis Farma (ISIN: FR0014007ZB4 -- Ticker: AELIS), a clinical-stage biopharmaceutical company specializing in the development of treatments for brain and peripheral diseases involving the CB(1) receptor of the endocannabinoid system, today announces its financial results for the first half of 2026 and provides an update on its progress and development outlook.
Pier Vincenzo Piazza, CEO of Aelis Farma, stated: "The first half of 2026 was notably focused on executing our clinical priority: the international Phase 2b study with AEF0217, which aims to improve adaptive behavior and cognitive abilities in people with Down syndrome. Following regulatory approvals and the first participant's first visit in December 2025, recruitment continued in all three study countries -- France, Spain and Italy -- in line with our expectations. The positive opinion received in January 2026 on the Pediatric Investigation Plan for AEF0217 also represents an important regulatory milestone for the continued development of this drug candidate in pediatric populations.
For AEF0117, the final Phase 2b results confirmed the compound's pharmacological activity, its excellent safety profile and its potential in participants who are highly motivated to stop using cannabis. We are actively pursuing business development efforts to identify the most appropriate partner and development pathway to fully leverage these results.
At the same time, our proprietary research platform has enabled the advancement of new CB(1) -SSi with functional properties distinct from AEF0117 and AEF0217, opening the potential to address new brain diseases linked to CB(1) dysregulation as well as peripheral diseases such as obesity and associated metabolic disorders. The award, in April 2026, of a EUR458,000 grant under the France 2030 program in Nouvelle-Aquitaine region is an important recognition of the scientific quality and potential of our new compound development program.
Thanks to rigorous and optimized management of our resources and the non-dilutive funding secured, our cash position stood at EUR6.6 million as of June 30, 2026, providing financial visibility through early 2028 while preserving our ability to execute our priority programs and create value.
Our roadmap remains clear: continue executing the AEF0217 Phase 2b study, advance the discovery and development of new CB(1) -SSi compounds, and establish industry partnerships for AEF0117, AEF0217 and our platform.
We enter the second half of 2026 with confidence and the ambition to achieve further key milestones towards establishing Aelis Farma as a leading player in the development of innovative treatments for brain and peripheral diseases."
Half-year results 2026 (French GAAP)
Simplified income statement(1) (in EURK) 06/30/2026 06/30/2025 ----------------------------------------- ---------- ---------- Revenue from ordinary activities 449 343 ----------------------------------------- ---------- ---------- Operating expenses (3,157) (4,755) ----------------------------------------- ---------- ---------- Operating income (2,708) (4,411) ----------------------------------------- ---------- ---------- Financial result 17 (259) ----------------------------------------- ---------- ---------- Income taxes 279 565 ----------------------------------------- ---------- ---------- Net income (loss) (2,412) (4,105) ----------------------------------------- ---------- ----------
Since January 1, 2026, the Company has published its financial statements solely in accordance with French accounting standards. As the Company has no subsidiaries, it is not subject to the regulatory requirement to publish consolidated financial statements under IFRS.
In the first half of 2026, Aelis Farma recorded revenue from ordinary activities of EUR449,000, compared with EUR343,000 as of June 30, 2025, mainly corresponding to the portion of grants recognized over the period.
Operating expenses
In EURK 06/30/2026 06/30/2025 ------------------------- ---------- ---------- Personnel costs (1,048) (1,322) ------------------------- ---------- ---------- Other operating expenses (2,109) (3,433) ------------------------- ---------- ---------- Operating expenses (3,158) (4,755) ------------------------- ---------- ----------
Operating expenses amounted to EUR3.2 million in the first half of 2026, compared with EUR4.8 million in the first half of 2025. This 34% decrease mainly reflects the refocusing of activities on the AEF0217 Phase 2b clinical study, the completion of the main expenses related to previous clinical and non-clinical programs, and the continuation of the Company's cost-control plan.
R&D expenses incurred in the first half of 2026 mainly covered:
-- the conduct of the international Phase 2b clinical study of AEF0217,
initiated at the end of 2025 and currently recruiting in France, Spain
and Italy;
-- the continuation of activities on the proprietary research platform and
the early development of new CB1-SSi;
-- preclinical proof-of-concept work, particularly within the "metabolism"
program targeting obesity and associated metabolic diseases; and
-- patent and intellectual property maintenance costs.
Operating income showed a loss of EUR2,708,000 as of June 30, 2026, compared with a loss of EUR4,411,000 as of June 30, 2025, an improvement of EUR1,703,000.
Financial income amounted to EUR17,000 as of June 30, 2026, compared with a loss of EUR259,000 as of June 30, 2025. It mainly comprised interest on outstanding loans (-EUR122,000), income from cash investments (EUR120,000) and a positive foreign exchange result (EUR20,000). As of June 30, 2025, it mainly reflected a foreign exchange loss and interest on outstanding loans.
For the first half of 2026, net income was a loss of EUR2,412,000, compared with a loss of EUR4,105,000 for the same period in 2025.
Cash flow
Cash flow (in EURK) 06/30/2026 06/30/2025 ---------------------------------------- ---------- ---------- Cash flow from operating activities (1,970) (3,988) ---------------------------------------- ---------- ---------- Net cash flow from investing activities (2) (6) ---------------------------------------- ---------- ---------- Net cash flow from financing activities (483) 878 ---------------------------------------- ---------- ---------- Impact of exchange rate changes 18 (155) ---------------------------------------- ---------- ---------- Change in cash and cash equivalents (2,437) (3,271) ---------------------------------------- ---------- ---------- Opening cash position 9,054 14,051 ---------------------------------------- ---------- ---------- Closing cash position 6,616 10,791 ---------------------------------------- ---------- ----------
Financial structure
Financial structure (in EURK) 06/30/2026 12/31/2025 ------------------------------ ---- ---------- ---------- Liquid assets a 6,616 9,054 ------------------------------ ---- ---------- ---------- Gross financial debt b (4,375) (4,974) ------------------------------ ---- ---------- ---------- Net cash position a+b 2,241 4,080 ------------------------------ ---- ---------- ----------
Aelis Farma's financial structure remains solid, reflecting rigorous cost management and resulting in a cash position of EUR6.6 million as of June 30, 2026. Borrowings and financial debt amounted to EUR4.4 million, compared with EUR5.0 million as of December 31, 2025, resulting in a net cash position of EUR2.2 million.
During the period, the Company was awarded a EUR458,000 grant under the regional component of the France 2030 program in Nouvelle-Aquitaine, of which a first payment of EUR229,000 was received in June 2026.
Taking into account its cash position, the cost-control plan implemented and the non-dilutive funding secured, Aelis Farma believes it has the financial resources required to carry out its priority programs, with financial visibility through early 2028. At the same time, the Company continues to assess new financing and partnership opportunities that could further extend this visibility.
Highlights of the first half of 2026
Positive opinion from the EMA Pediatric Committee on the Pediatric Investigation Plan for AEF0217
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