Activity and annual results 2021

NFL Biosciences: 2021 activity and results update

Deployment of the Phase II/III clinical trial of the drug candidate NFL-101 for smoking cessation: first patients recruited and ramp-up of recruitment capacities

Organization further strengthened and manufacturing partnership for active ingredients set up

Extensive intellectual property with an NFL Biosciences patent filed in the United States

Signing of a co-development agreement for the drug candidate NFL-301 to reduce alcohol consumption

NFL BIOSCIENCES (Euronext Growth Paris – FR0014003XT0 – ALNFL), a biopharmaceutical company that develops herbal medicines for the treatment of addictions, publishes its 2021 annual results, approved by the Board of Directors on March 24, 2022, in retrospect on its evolution following its listing on Euronext Growth Paris in early July 2021.

Phase II/III clinical trial deployed for NFL-101, drug candidate for smoking cessation: first patients recruited in France

Approved by the National Agency for the Safety of Medicines and Health Products (ANSM)¹, the Phase II/III clinical trial CESTO II received a favorable opinion from the Ethics Council (CPP) in September 2021. The recruitment of patients was launched in January 2022 in the Clinical Investigation Centers (CIC) of the university hospital centers of the CHU in Poitiers, Bordeaux and Rennes, managed by Eurofins-Optimed as Clinical Research Organization (CRO). Various initiatives are underway to add other clinical investigation centers.

In order to optimize the allocation of its resources, and given the positive evolution of the health context in France and more generally in Europe, NFL Biosciences has decided not to start recruiting patients in Australia and to focus on the opening of additional centers in France. This decision will allow it to reduce the overall cost of the clinical trial, simplify its management and accelerate the recruitment of patients.

The clinical trial targets male or female smokers between the ages of 18 and 70 who smoke more than 11 cigarettes a day and are truly determined to quit. The trial has three arms (two dose arms and one placebo arm) and will follow patients for 12 months. The main objectives of CESTO II are to select the best dose and to evaluate the efficacy of NFL-101 versus placebo, for immediate and progressive smoking cessation. The primary endpoints are a person’s continuous abstinence for four weeks (US Food & Drug Administration (FDA) criterion) and six months (European Medicines Agency (EMA) criterion). The biomarkers used to confirm abstinence are exhaled carbon monoxide and urinary cotinine. A range of secondary endpoints will also be assessed, including the number of cigarettes smoked, withdrawal symptoms and level of craving.

Further strengthened organization

In the third quarter of 2021, and aligned with the additional resources from the capital increase, NFL Biosciences has further strengthened its teams with a Director of Medical Operations and a Senior Clinical Project Manager, giving it the operational capacity necessary to continue moving forward. with CESTO II. In early 2022, NFL Biosciences also welcomed a part-time director of investor relations, while a chief financial officer is expected to arrive in late March.

Establishment of an active ingredient manufacturing partnership

In November 2021, NFL Biosciences selected Diverchim to manufacture the active ingredient of NFL-101 for use in additional clinical trials beyond the CESTO II study (Phase II/III). The developed development plan will also cover the preclinical development of the active ingredient of NFL-201, NFL Biosciences’ drug candidate for the treatment of cannabis addiction.

Thanks to this partnership, NFL Biosciences ensures control of the production of its botanical extracts in order to anticipate future development needs until its potential marketing.

Extensive intellectual property with an NFL Biosciences patent filed in the United States

On September 21, 2021, the United States Patent and Trademark Office (USPTO) granted product patent number 11,123,395 for NFL-101. The addition of cannabis protein to the extract is one of the claims for a possible future cannabis withdrawal application. This patent protects the innovation on which NFL-101 is based until 2040 in the United States. This patent is also filed in France until 2040. National registration applications are in the examination phase in the following regions and countries: China, Japan, Canada, South Korea, Australia, Brazil, India, Indonesia, Israel , Mexico, Philippines, Eurasia, Saudi Arabia, United Arab Emirates, Nigeria.

Co-development agreement for NFL-301, a drug candidate to reduce alcohol consumption

In February 2022, NFL Biosciences entered into a co-development agreement with ATHENA Pharmaceuticals, a market leader in the development and manufacturing of oral drugs, to develop and produce NFL-301, a natural drug candidate of NFL Biosciences aimed at reducing alcohol consumption. .

2021 annual results (January 1 – December 31, 2021)

The 2021 annual accounts, prepared in accordance with French standards, were approved by the Board of Directors during its meeting of March 24, 2022. The audit procedures for the annual accounts have been finalized. The auditors’ reports will be issued after the management report has been finalized, before the publication of the annual financial report.

The IPO on Euronext Growth Paris in July 2022 generated an issue premium of €4,960,724.34, with €3,287,481 in equity. The gross amount received is €5 million.

The EBIT amounts to (978K€), reflecting the costs incurred to set up the CESTO II clinical trial, including the reinforcement of the team from the third quarter of 2022, the manufacturing of the batches of assets and payments to CROs.

To optimize these resources, NFL Biosciences deploys various financial arrangements which result in a debt of €270.7 K and the research tax credit for €141.8 K. Various requests for additional public financing are in progress in France and in other countries.

Outlook for 2022

Dr. Ignacio Faus, CEO of NFL Biosciences, said, “NFL Biosciences continues to roll out the Phase II/III clinical trial for NFL-101 (smoking cessation), as well as the development of NFL-201 (addiction to cannabis) and NFL-301 (aimed at reducing alcohol consumption).

In line with its international development strategy, the company will intensify its initiatives enabling the development of NFL-101 and NFL-301 in the United States. In this context, various meetings are scheduled with the US FDA, aimed in particular at ensuring that the development plan for drug candidates and future clinical trials are acceptable to the FDA.

During the Covid-19 pandemic, tobacco and alcohol consumption increased dramatically in most countries. More than ever, there is a need for safe, effective and natural medicines that will have a lasting impact on the lives of the millions of people who wish to quit smoking and reduce their alcohol consumption”.

On NFL Biosciences

NFL Biosciences is a biopharmaceutical company based in the Montpellier region that develops plant drug candidates for the treatment of addictions. NFL Biosciences’ ambition is to bring new, safer and more effective natural 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 wish to quit smoking 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.

NFL Biosciences shares are listed on Euronext Growth Paris (FR0014003XT0 – ALNFL). Learn more at www.nflbiosciences.com

Contact

Bruno Lafont – info@nflbiosciences.com – +33 4 11 93 76 67

Calyptus Agency – nflbiosciences@calyptus.net – +33 1 53 65 68 68

1 National Agency for the Safety of Medicines and Health Products