Why NFL Biosciences (Smoking Cessation) Goes Public

NFL Biosciences is a biotechnology company that develops prescription botanical drugs for the treatment of addictions. Founded near Montpellier, it initially claims to revolutionize smoking cessation therapies thanks to a botanical drug candidate. Called NFL-101, this natural product, extracted from standardized tobacco leaves and without nicotine, is protected by two families of patents and ready to enter clinical phase II / III.

On June 16, the leaders of NFL Biosciences, Joël Besse (Chairman of the Board of Directors), Ignacio Faus (CEO) and Bruno Lafont (Founder and Deputy CEO) announced the launch of its IPO on Euronext Growth Paris® .

“A strong reduction in the desire to smoke”

The future development strategy of this innovative therapy will be international so that it can reach the 780 million smokers who the WHO has said they want to quit, says NFL Biosciences. According to the French Observatory for Drugs and Drug Addiction, in 2019, France had 36 million smokers, including 13 million daily users …

According to the company, “ the drug candidate NFL-101, an innovation of natural origin, has been the subject of preclinical studies and a Phase I which has demonstrated a strong reduction in the desire to smoke, successful long-term quit attempts, or a strong reduction in daily consumption, without presenting any toxicity ».

« We are aiming for an almost immediate reduction in the desire to smoke after a first subcutaneous injection, which corresponds to the first fifteen days, the most difficult period for smokers, consolidated by a second to a week apart, explains Bruno Lafont to The gallery. But we also offer a personalization of the treatment, which current treatments do not allow (nicotine replacement treatments, patch or chewing gum, and Chantix, Editor’s note). Two catch-up injections are available after three and six months. The two current treatments target the nicotine receptor and treat withdrawal symptoms, when ours reduces the desire to smoke. NFL-101 could be given in combination with these existing treatments. “

A study of 318 smokers in Australia

Approved at the end of May 2021, the Phase II / III study will be conducted in Australia, a country spared by the Covid-19 pandemic ” and recognized for the quality of its clinical research ». Selon NFL Biosciences, « Thanks to the alignment of the regulatory approaches of the Australian Therapeutic Goods Administration with those of the main international agencies, the data collected could be used with the EMA (European Medicines Agency) and the FDA (Food & Drug Administration, United States ) ».

“We would also like to be able, by amending the protocol, to carry out a study in France where we have hospitals which are good partners, such as the CHU de Poitiers …”, indicates Bruno Lafont.

The Phase II / III clinical trial (multicenter, randomized, double-blind versus placebo) will have 318 smokers, aged 18 and over. Main objectives: to select the best dose and to evaluate the effectiveness of NFL-101 compared to placebo, for immediate cessation of smoking and also for gradual cessation. Secondary endpoints will also be assessed, such as the number of cigarettes smoked, withdrawal symptoms and craving, as well as the potential for personalization of treatment.

« We aim to do a parallel and shorter study on 100 patients to show the effectiveness of the product in combinations with existing nicotine substitutes ”, explains Bruno Lafont.

Raise up to 8 million euros

The IPO of NFL Biosciences is open until June 30, for a global offer of 5.26 million euros that the company hopes to push to 8 million euros. The operation ” benefits from subscription commitments for a total amount of 2.46 million euros (803,000 euros of subscription commitments received from the historical shareholders of the company, natural persons, including 525,000 euros by its directors Ignacio Faus, Bruno Lafont and Joël Besse; € 561,000 in subscription commitments received from other individual investors; € 1.1 million in subscription commitments received from institutional investors and European investment funds, including 800,000 euros by Nyenburgh Partners) ».

Why this choice to go public?

“Addiction concerns everyone and we have a product that can be easily understood, replies Bruno Lafont. Going public allows us to gain notoriety. “

The funds raised will enable NFL Biosciences to finance the conduct of the Phase II / III study of its drug candidate NFL-101, and to recruit.

« We plan to recruit three people: a head of clinical studies, a clinical researcher and a person for product manufacturing, which we will need in industrial quantities and which will be manufactured with a partner for plant extraction and a other for bottling “, explains Bruno Lafont.

The phase II / III study is expected to run until mid-2023. It will be followed by a phase III study for two years, which could lead to the marketing of the drug NFL-101 in 2026 in Europe and the United States.

« India and China have great potential, but local authorities will require clinical studies on their respective populations, underlines the leader. We are in negotiations with two Indian laboratories to sign licensing and co-development agreements, which could allow marketing earlier, in 2024. “

But also alcohol and cannabis

The IPO will also support the development of the NFL-201 and NFL-301 programs, for the treatment of cannabis and alcohol addiction.

“For NFL-201, it will be the same process as for tobacco, but with a mixed tobacco / cannabis extract. We are at the very beginning, a patent has been filed, and we have to do the 1st preclinical tests … Regarding NFL-301, for the treatment of alcohol dependence, nWe are working on a plant derived from traditional Chinese medicine, widely used for alcohol reduction as a food supplement. An American company (whose name he is, Editor’s note) worked for years on a drug project and invested $ 10 million. But it lacks the expertise to go further and industrialize. We signed an agreement with her to work on this project and reposition it with a new form of delivery. “