NFL Biosciences Reports Its 2025 Half-Year Results and Provides an Update on Its Development

Regulatory News:

NFL BIOSCIENCES (Euronext Growth Paris – FR0014003XT0 – ALNFL), a biopharmaceutical company developing innovative botanical drugs for the treatment of addictions, today announces its half-year results for the period ended June 30, 2025, as approved by the Board of Directors on October 16, 2025, and provides an update on its clinical, industrial and financial developments.

Bruno Lafont, Chief Executive Officer and co-founder of NFL Biosciences, states: “September 2025 marked a major milestone for NFL Biosciences, with the publication of the full results of the Phase 2 CESTO II trial in Nicotine & Tobacco Research, the official journal of the Society for Research on Nicotine and Tobacco (SRNT). This peer-reviewed publication, which validates the methodological robustness and relevance of our results, confirms NFL-101’s position as an innovative treatment for smoking cessation and highlights its unique approach based on a specific immunological response. We have strengthened our Scientific Advisory Board by welcoming internationally recognized experts and initiated a scientific collaboration with McLean Hospital, affiliated with Harvard Medical School. We now await the final feedback from the scientific advice procedures conducted with several European regulatory agencies and the U.S. FDA, which will enable us to finalize our development plan.”

Update on first-half 2025 activity

Clinical progress

NFL-101, first-in-class treatment for smoking cessation

Positive results from an additional preclinical program confirming the excellent safety profile of NFL-101

NFL Biosciences conducted an extended toxicity program designed to assess the administration of higher doses of NFL-101, with daily administrations compared to the weekly administrations used in the previous program conducted prior to the start of clinical trials. The program also included genotoxicity and mutagenicity tests, performed at the maximum doses authorized by these tests. The toxicity study evaluated daily subcutaneous administration of increasing doses of NFL-101 in Sprague Dawley rats for 14 days. The maximum cumulative dose tested was 630 times higher than the cumulative dose administered to humans and did not induce any signs of systemic or local toxicity.