ALNFL NFL Biosciences SA

NFL Biosciences receives €1.7 million in « Avance Innovation » funding from Bpifrance

NFL BIOSCIENCES (Euronext Growth Paris – FR0014003XT0 – ALNFL), a biopharmaceutical company developing botanical drugs for the treatment of addictions, and particularly NFL-101, its drug candidate for smoking cessation, is announcing that it has obtained financing for a total of €1.7 million, granted by Bpifrance and financed by the French government as part of the Programme d'Investissements d'Avenir.

Ignacio Faus, CEO of NFL Biosciences commented: “This is a very good start of the year for NFL Biosciences. Our cash flow horizon now extends to the end of Q3 2024. Following the success of our capital increase of approximately €3 million at the end of January and the granting by Bpifrance of an "Avance innovation" aid for a total of €1.7 million and financed by the French government within the framework of the "Programme d'Investissements d'Avenir", we have the appropriate resources to reach the key validation milestones of our two main clinical programs for NFL-101 in the third and fourth quarters of 2023. We will also advance the development of NFL-301. We would like to thank Bpifrance for its commitment to innovative companies and will continue to pay close attention to the efficient allocation of these resources.”

€1.5 million “Avance Récupérable” for the CESTO II study

To complete the CESTO II clinical study designed to evaluate the efficacy and safety of its NFL-101 treatment as a smoking cessation therapy, NFL Biosciences has been granted an innovation advance of €1,500,000 as part of the Programme d'Investissement d'Avenir 4 of the France 2030 plan. €1.05 million will be received upon signature of the final contract as a recoverable advance, and the balance upon request by NFL Biosciences upon completion of the study. The signature of the contract took place today.

At the end of the CESTO II clinical study, NFL Biosciences will have to provide Bpifrance with a technical and economic report, an account of its execution and results, and a summary of the expenses incurred. In case of success, NFL Biosciences will reimburse this aid as of the 4th quarter of 2025 at a rate of €75,000 per quarter, i.e. until the 3rd quarter of 2030. This aid does not give rise to the payment of interest. In the event that the project’s final report would lead to a request by the company to designate the project either a failure or a partial success, NFL Biosciences may, upon approval by Bpifrance, be released from 60% of its repayment obligations or the repayment conditions may be adapted by Bpifrance.

CESTO II is a Phase II/III clinical study which aims to include 318 smokers in order to demonstrate the efficacy of NFL-101 against a placebo and to choose the most effective dose. Nine clinical investigation centers are currently participating in the study: Bordeaux, Clermont-Ferrand, Dijon, Lorient, Marseille, Montpellier, Poitiers and Rennes University Hospitals, as well as the Eurofins-Optimed Research Institute in Grenoble.

€200,000 « Avance Récupérable » for NFL-301 to reduce alcohol consumption

For the advancement of the NFL-301 project, from product formulation to clinical trial authorization, NFL Biosciences has obtained an innovation advance of €200,000 within the framework of the Programme d'Investissement d'Avenir 4 of the France 2030 plan. €140,000 will be received upon signature of the aid contract as a recoverable advance, and the balance upon request by NFL Biosciences upon authorization of the first clinical trial of the product. Signature of this second contract also took place today. The same reimbursement conditions apply with a schedule of €10,000 per quarter starting from 1st quarter of 2026.

NFL-301 is a natural drug candidate for the reduction of alcohol consumption, which is the subject of a co-development agreement with ATHENA Pharmaceuticals since February 2022. Under the partnership, ATHENA Pharmaceuticals, a leading developer and manufacturer of oral drugs, is responsible for the development and production of NFL-301, and NFL Biosciences is responsible for the design and execution of the clinical program, which may be initiated in the United States in the coming months. NFL Biosciences will ensure the continued development of NFL-301 and the filing of a pre-IND application with the FDA (Food and Drug Administration) prior to a future clinical trial application. The partnership aims to develop NFL-301 at least to the point of demonstrating its efficacy against placebo in the indication of alcohol consumption reduction. NFL Biosciences and ATHENA Pharmaceuticals will jointly invest and share future revenues based on their respective investments. 

About NFL Biosciences

NFL Biosciences is a biopharmaceutical company based in the Montpellier area which develops botanical drug candidates for the treatment of addictions. NFL Biosciences' ambition is to bring new, natural, safer and more effective therapeutic solutions to the entire world population, including low- and middle-income countries. Its most advanced product, called NFL-101, is a standardized, nicotine free tobacco leaf extract protected by two patent families. NFL Biosciences intends to offer smokers who want 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. The shares of NFL Biosciences are listed on Euronext Growth Paris (FR0014003XT0 – ALNFL). Find out more at www.nflbiosciences.com

Contacts

Bruno Lafont – info@nflbiosciences.com - +33 4 11 93 76 67         Agence Calyptus – nflbio@calyptus.net - 1 53 65 68 68

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