NFL Biosciences Announces the Successful Manufacturing of a GMP Clinical Batch of NFL-102 and Validates Its Industrial Production Chain

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MONTPELLIER, France, June 30, 2026--(BUSINESS WIRE)--Regulatory News: NFL BIOSCIENCES (Euronext Growth Paris – FR0014003XT0 – ALNFL), a biopharmaceutical company developing innovative botanical drugs for the treatment of addictions, announces today the successful manufacturing of a GMP (Good Manufacturing Practice) clinical batch of NFL-102, a new drug candidate for smoking cessation. The analytical controls performed on this batch confirmed its compliance with the expected specifications. This achievement enables the Company to continue preparing the Phase 2 clinical trial TONIC and marks the completion of an industrial development program initiated several years ago. Beyond the availability of the clinical material required for the TONIC trial, this manufacturing validates the entire production chain for NFL-102 in a pharmaceutical environment compliant with international standards. This step covers the production of the tobacco extract, purification and quality control operations, as well as sterilization, aseptic vial filling, lyophilization and pharmaceutical release of the finished drug product. Mastering these different steps is a key element in the development of a drug candidate. Potential pharmaceutical partners expect a biotechnology company to demonstrate not only the clinical potential of its products, but also its ability to manufacture them using robust and reproducible processes compatible with the requirements of international development and future commercialization. NFL Biosciences has therefore structured its industrial organization at a very early stage in order to anticipate these requirements. The tobacco extract is produced by Fareva, a major international player in pharmaceutical outsourcing. The finished drug product manufacturing operations are carried out by Meribel Pharma Solutions, a recognized specialist in sterile injectable dosage forms. The key analytical tests are performed by Eurofins, a global leader in its field. The sterilization, aseptic filling and lyophilization operations for the batch announced today were carried out on industrial production lines used for the manufacturing of drugs intended for commercialization. This approach enables NFL Biosciences to rely on an established industrial infrastructure, already compatible with future clinical development phases and potential production scale-up.

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