NFL BIOSCIENCES: Activities and results for the first half of 2021


NFL Biosciences: Activities and Results of the 1er semester 2021

Admission to Euronext Growth Paris: € 5 million raised from institutional, historical and individual investors (July 2021)

Approval of the Phase II / III clinical study, entitled CESTO II, in Australia (May 2021) and in France (September 2021)

Strengthening of the clinical team

US Patent Grant Agreement (September 2021)

« Innovative company » qualification for innovation mutual funds

NFL BIOSCIENCES (Euronext Growth Paris – FR0014003XT0 – ALNFL), biopharmaceutical company who develope botanical medicines for the treatment of addictions and addictions, announcement its results from 1er semester 2021 and takes stock of its activities following its admission to Euronext Growth Paris beginning of July 2021.

Admission to Euronext Growth Paris: € 5 million raised

NFL Biosciences shares have been listed on Euronext Growth Paris since July 5, 2021 on the occasion of a capital increase of € 5 million gross for a price per share set at € 3.80 per share. The operation benefited from subscriptions from historical shareholders, institutional investors and individual investors, aware of the potential global impact on public health of the development of innovative treatments in the field of dependencies and addictions. These resources allow NFL Biosciences to accelerate its development through:

  • the completion of the Phase II / III study of its drug candidate NFL-101 to aid in smoking cessation;
  • recruiting seasoned experts to strengthen the organization;
  • the initiation of the NFL-201 and NFL-301 programs, for the treatment of cannabis addiction and the reduction of alcohol consumption.

Over the past several months, NFL Biosciences has conducted its operations in accordance with its goals and business plan.

THE’clinical study of Phase II/ III by NFL-101 validated by regulatory authorities in Australia in May and in France in September

In line with its business plan presented during its fundraising, the Phase II / III clinical study authorized in Australia1 end of May 2021 – a country targeted for the quality of its clinical trials and the availability of a competitive research tax credit, was also approved by the ANSM2 and received the favorable opinion of a CPP (Committee for the Protection of Persons) in France in September 2021.

The Phase II / III clinical trial, titled CESTO II, will include 318 smokers, aged 18 and over. The trial will be international, multicenter, randomized, double-blind against placebo. It will include 3 arms (two dose arms and one placebo arm) and patient follow-up will be 12 months. The main objectives of CESTO II are to select the best dose and to assess the effectiveness of NFL-101 compared to placebo, for immediate cessation of smoking and also for gradual cessation. The main endpoints are continuous abstinence for 4 weeks (FDA criterion, Food & Drug Administration, United States) and 6 months (EMA criterion, European Medicines Agency). The biomarkers used to confirm abstinence are exhaled carbon monoxide and urinary cotinine. Many secondary endpoints will also be assessed, such as the number of cigarettes smoked, withdrawal symptoms and craving.

The clinical centers, in which the first patients will be recruited in the coming weeks, are: in Australia, the clinical centers of the University of Tasmania (UTAS) in Hobart and Launceston, and subsequently, in France: the Centers of Clinical investigation (CIC) of the hospitals of Poitiers, Bordeaux and Rennes.

Two recruitments dedicated to carrying out the CESTO II clinical study

In line with its capital increase, NFL Biosciences has recruited its Director of Medical Operations (“ Medical Operations Director ”) To pilot the CESTO II clinical study and future clinical studies. Violaine Desort-Henin has more than 12 years of experience in the implementation of clinical projects for biotechnology companies and pharmaceutical groups. Her expertise was supplemented by the recruitment of a Senior Clinical Project Manager ( » Senior Clinical Project Leader « ), allowing NFL Biosciences to be in operational capacity to follow the progress of CESTO II. Marie-Laure Fraisse has 15 years of experience in managing international and multicenter clinical projects at different stages of maturity.

Registration d‘a NFL Biosciences patent in the USA

On September 21, 2021, the United States Patent and Trademark Office (USPTO) issued product patent number 11,123,395 for NFL-101, a botanical drug candidate composed of natural proteins extracted from tobacco leaves, devoid of nicotine, and primarily intended for smoking cessation. The addition of cannabis proteins to the extract is covered by one of the claims with a view to potential future application in cannabis withdrawal. This patent protects the innovation on which NFL-101 is based until 2036 in the United States. This patent is also registered until 2036 in France. National registration applications are under consideration in the following regions and countries: China, Japan, Canada, South Korea, Australia, Brazil, India, Indonesia, Israel, Mexico, Philippines, Eurasia, Saudi Arabia, Arab Emirates United, Nigeria.

Results of 1er semester 2021 (1er January – June 30, 2021)

The 2021 half-year accounts, drawn up in accordance with French accounting standards, were approved by the Board of Directors at its meeting on September 30, 2021. They were subject to a limited review by the statutory auditors. The accounts for the period do not include the results of the capital increase, the settlement of which took place on July 2, 2021.

Social accounts in euros June 30, 2021
(6 months)
December 31, 2020
(12 months)
Net sales
Total of exploitation products
Operating result (221,051) (318,028)
bottom line (354)
exceptional result 4,984
Accounting net income (221,405) (261,500)
Equity (71,380) 150,025
Intangible assets (patents) 120,566 108,946
Debts 1,247,447 174,613
Availabilities 175,972 310 201
Total assets 1 428,067 576,638

Qualification « Innovative Company » by BPIfrance

The « Innovative Company » qualification allows an Innovation Mutual Fund (FCPI) to account for its possible participation in NFL Biosciences in the mandatory part of its investment in innovative companies, as defined in I of article L 214-41 of the Monetary and Financial Code.

Outlook

Dr Ignacio Faus, CEO of NFL Biosciences said: “ The need for smoking cessation has increased as a result of the the Covid-19 while treatments pharmacological available are unchanged, relatively ineffective To long term, little well-off To to follow and sometimes topics Has Side effects limiting. NFL Biosciences has set up a clinical team that will collaborate with our CROs Eurofins Optimed and InClin, with the five clinical centers in France and Australia or patients, smokers willing to performr a new attempt, will be recruitedés and traités in the coming quarters. We are also working on the evaluation of other country so to be in a position to complete the recruitment as soon as possible. « 

In the coming months NFL Biosciences will continue to strengthen its operations and governance.

The evaluation of projects for the treatment of cannabis (NFL-201) and alcohol (NFL-301) addictions will continue.

About NFL Biosciences

NFL Biosciences is a biopharmaceutical company based in the Montpellier region whose most advanced botanical drug candidate is a smoking cessation aid. Called NFL-101, this natural product, extracted from standardized tobacco leaves and devoid of nicotine, is protected by two families of patents. NFL Biosciences intends to offer smokers who wish to quit a natural, safe, long-term effective, short administration and personalized alternative.

Beyond NFL-101, NFL Biosciences has plans to develop botanical drugs for the treatment of cannabis use disorders and alcoholism.

NFL Biosciences shares are listed on Euronext Growth Paris (FR0014003XT0 – ALNFL). The company is qualified as an “Innovative Company” eligible for investment by FCPIs.

More information on www.nflbiosciences.com

Contacts

Bruno Lafont – info@nflbiosciences.com – 04 11 93 76 67

Calyptus Agency – nflbiosciences@calyptus.net – 01 53 65 68 68


1 Approved by the Ethics Committee for Research on Humans (HREC) of Bellberry and the University of Tasmania (UTAS)
2 National Agency for the Safety of Medicines and Health Products


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