NFL Biosciences Presents the Agenda for Results Expected by Regulatory Agencies and Potential Pharmaceutical Partners

12 Nov 2025 08:00 CET

Regulatory News:

NFL Biosciences SA (Euronext Growth Paris – FR0014003XT0 – ALNFL), a biopharmaceutical company developing innovative botanical drugs for the treatment of addiction, today presents the communication agenda for the initial results of the work requested by regulatory agencies and awaited by pharmaceutical companies interested in licensing NFL-101, its first-in-class drug candidate for smoking cessation.

Regulatory agencies have emphasized the uniqueness and originality of the NFL-101 approach. The forthcoming results, aimed at confirming this distinctive scientific positioning, are of particular importance to interested pharmaceutical companies.

Upcoming scientific milestones

• Mechanism of action (MOA) in January 2026: preliminary results from a proteomic analysis aimed to identify neural and immune signalling markers induced by NFL-101, to compare them with those involved in tobacco dependence to further elucidate its MOA and demonstrate that these original characteristics clearly and meaningfully distinguish NFL-101 from all existing smoking cessation products.

• In-depth characterisation in December 2025: first results from additional analyses of the composition of NFL-101, designed to further characterize the extracts and confirm inter-batch reproducibility.

Context

These studies are part of the roadmap announced on October 20, 2025, which includes additional work on the composition and mechanism of action of NFL-101.

About NFL Biosciences: www.nflbiosciences.com

NFL Biosciences is a biopharmaceutical company based in the Montpellier region of France, developing plant-based drug candidates for the treatment of addictions. NFL Biosciences' ambition is to bring new, safer and more effective natural therapeutic solutions to the entire world population, including low- and middle-income countries. Its most advanced product, NFL-101, is a standardized tobacco leaf extract protected by three patent families. NFL Biosciences intends to offer smokers wishing to quit a natural, safe, easy-to-administer and personalized alternative. NFL Biosciences is also developing NFL-301, a natural drug candidate for the reduction of alcohol consumption and has a drug development project for the treatment of cannabis use disorders.

NFL Biosciences shares are listed on Euronext Growth Paris (FR0014003XT0 - ALNFL). The company is qualified as an “Innovative Company” eligible for FCPI investment. More information on www.nflbiosciences.com

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NewCap
Investor Relations / Media Relations
Mathilde Bohin / Arthur Rouillé
Tel.: 01 44 71 94 94
E-mail : nfl@newcap.eu

NFL Biosciences
Bruno Lafont
Tél.: 04 11 93 76 67
E-mail : info@nflbiosciences.com