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

• Validation of the entire GMP manufacturing chain for NFL-102, from extract production through to the lyophilized finished drug product

• Confirmation of NFL Biosciences’ industrial capacity to support future clinical development phases and production scale-up

• Preparation of the Phase 2 clinical trial TONIC, designed to confirm the safety of NFL-102, assess its efficacy and select the optimal dose

MONTPELLIER, France--(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.

This step also contributes to significantly reducing industrial risk by validating the key elements of its CMC (Chemistry, Manufacturing and Controls) strategy, an essential prerequisite for future partnership discussions and subsequent development stages.

The Phase 2 clinical trial TONIC, whose launch is currently in preparation, will aim to confirm the safety of NFL-102, assess its clinical efficacy and select the optimal dose for the continuation of its development.

Bruno Lafont, Chief Executive Officer and co-founder of NFL Biosciences, stated: “The manufacturing of this clinical batch represents much more than the production of the material required for the TONIC trial. It validates a complete industrial chain that we have been building for several years with leading pharmaceutical partners. We wanted to anticipate, at a very early stage, the industrial challenges associated with the development of our drug candidates in order to have robust and reproducible processes compatible with future scale-up. This achievement represents an important step and strengthens the credibility of the program with a view to future development and commercialization partnerships.”

NFL Biosciences now plans to complete the final preparatory steps for the TONIC trial, including the preparation of the regulatory dossier and the operational preparation of the clinical trial, in order to submit the clinical trial application to the ANSM as planned by mid-2026.

About NFL Biosciences: www.nflbiosciences.com

NFL Biosciences is a biopharmaceutical company based in the Montpellier region (France) developing botanical drug candidates for the treatment of addictions. NFL Biosciences’ ambition is to provide new natural therapeutic solutions that are safer and more effective for people worldwide, including in low- and middle-income countries. NFL-101 and NFL-102 are standardized tobacco leaf extracts protected by five patent families. NFL Biosciences aims to offer smokers who wish to quit a natural, safe, easy-to-administer and personalized alternative. NFL Biosciences is also developing NFL-301, a natural drug candidate intended to reduce alcohol consumption and has a drug development program targeting cannabis use disorders.

NFL Biosciences shares are listed on Euronext Growth Paris (FR0014003XT0 - ALNFL).