NFL Biosciences receives a joint grant from the French Government and the Occitanie Region for its PRECESTO clinical trial

NFL Biosciences receives a joint grant from the French Government and the Occitanie Region for its PRECESTO clinical trial

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 received a €200,000 grant, awarded jointly by the French Government and the Occitanie Region, for its PRECESTO clinical trial.

NFL Biosciences has been awarded a €200,000 grant under Programme d’Investissement d’Avenir 4 (Future Investment Program 4) as part of the France 2030 plan. This nonrefundable grant is intended to support projects helping drive the sustainable transformation of key sectors in the French economy through technological innovation. Two other funding requests for a total of 1.5 million euros are currently being examined by Bpifrance. A response is expected during the first quarter of 2023.

The PRECESTO Phase IIa clinical trial aims primarily to validate the complementarity of NFL-101 with other smoking cessation treatments and particularly nicotine replacement therapies (NRTs) with a view to developing an innovative treatment method by associating NFL-101 with other smoking cessation methods (see press release from November 8, 2022).

Ignacio Faus, NFL Biosciences’ Chief Executive Officer: “For nicotine addiction research, the cost of clinical trials is relatively low compared with other indications, particularly because patients are monitored on an outpatient basis, yet smoking cessation offers a very strong level of commercial potential on account of the number of smokers and the limitations involved with current treatments. As we maintain a very low fixed cost structure, the vast majority of the funds are allocated to financing clinical trials and therefore serve to increase the potential value of NFL Biosciences’ projects. We would like to warmly thank our partners on this operation, and particularly BPI Occitanie”.

PRECESTO: a clinical trial that will be launched at the start of 2023 with a view to explore the complementarity of NFL-101 with other smoking cessation drugs

PRECESTO is a proof-of-concept clinical trial with the primary objective to validate the complementarity of NFL-101 with other smoking cessation treatments and particularly nicotine replacement therapies (transdermal patches, tablets, chewing gums, inhalers and nicotine sprays) with a view to developing an innovative treatment method by associating NFL-101 with other smoking cessation methods. The PRECESTO trial will compare against a placebo the ability of NFL-101 to reduce smoking satisfaction and cravings among 34 smokers with a cross-over design. Each participant will be his or her own control and will receive, on a random and alternating basis, either NFL-101 or the placebo at the start of each of the two periods during which they will assess smoking satisfaction and desire to smoke using standardized international questionnaires. The trial will be carried out at the Eurofins-Optimed research institute in Grenoble, with the first recruitments scheduled for the start of 2023 and the results expected for the third quarter of 2023.

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 – [email protected] – +33 4 11 93 76 67         Agence Calyptus – [email protected] – +33 1 53 65 68 68

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