NFL Biosciences Obtains Complementary Characterization Results for NFL-101, its first-in-class Drug Candidate for Smoking Cessation, and Prepares a New Patent Application

08 Dec 2025 17:45 CET

• These results represent the first scientific milestone expected by regulatory agencies and potential pharmaceutical partners

• New patent application currently in preparation

• Results obtained in line with the announced timeline

Regulatory News:

NFL Biosciences SA (Euronext Growth Paris – FR0014003XT0 – ALNFL), a biopharmaceutical company developing innovative botanical drugs for the treatment of addiction, announces that it has obtained the expected results from the extended characterization program of NFL-101, in accordance with the guidance provided by several European regulatory agencies and the U.S. FDA.

These results strengthen intellectual property by consolidating undisclosed internal know-how, while potentially paving the way for additional formal protection, such as a new patent application.

NFL-101 is a standardized botanical extract derived from tobacco leaves, developed as a drug candidate for smoking cessation. As a natural product composed of a complex ensemble of constituents, it requires detailed characterization to accurately describe its composition, ensure lot-to-lot reproducibility, and meet the specific expectations of regulatory agencies regarding botanical products. This approach ensures robust analytical control in line with the standards required for this type of drug.

The work performed has enabled further refinement of the identification and quantification of NFL-101 constituents. These constituents were subsequently grouped into several chemical families representative of the botanical extract. Taken together, these data now provide a precise description of the constituent families present in NFL-101, and to control the reproducibility of the composition between batches.

These studies are fully aligned with the development roadmap, which anticipated the completion of characterization results by the end of 2025. NFL Biosciences is thereby continuing its strategy to strengthen the scientific and regulatory foundation of NFL-101, building on the guidance received from regulatory agencies. The results obtained support this approach and contribute to the preparation of the next steps of the program.

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