NFL Biosciences: Activities & 2021 Annual Results
Implementation of the Phase II/III clinical study of drug candidate NFL-101 for smoking cessation: first patients recruited and increase in recruitment capacity
Strengthening of the organization and establishment of a manufacturing partnership for active ingredients
Extension of intellectual property with the registration of an NFL Biosciences patent in the United States
Co-development agreement for drug candidate NFL 301 to reduce alcohol consumption
NFL BIOSCIENCES (Euronext Growth Paris – FR0014003XT0 – ALNFL), biopharmaceutical company who develope botanical medicines for the treatment of dependencies and addictions, present his results annual 2021 approved by the Board of Directors on March 24, 2022 and come back on his advancements following son admission sur Euronext Growth Paris beginning of July 2021.
Implementation of the’clinical study of Phase II/III the NFL 101drug candidate for smoking cessation : first patients recruited in France
ANSM approved1 in France, the Phase II/III clinical trial, entitled CESTO II, received the favorable opinion of a CPP (Committee for the Protection of Persons) in September 2021. The recruitment of patients began in January 2022 in the Centers of Clinical Investigation (CIC) of the University Hospital Centers (CHU) of Poitiers, Bordeaux and Rennes under the management of Eurofins Optimed which acts as CRO (Clinical Research Organisation). Initiatives are underway to add other CICs.
In order to optimize the allocation of its resources, and in view of the favorable evolution of the health context in France and more generally in Europe, NFL Biosciences has decided not to initiate the recruitment of patients in Australia and to favor the opening additional centers in France. This decision reduces the overall cost of the clinical study, simplifies its management and accelerates patient recruitment.
The clinical trial targets smokers, men or women aged 18 to 70, smoking more than 11 cigarettes a day and having a real desire to quit. The trial includes 3 arms (two dose arms and one placebo arm) and patient follow-up is 12 months. The main objectives of CESTO II are to select the best dose and to evaluate the effectiveness of NFL-101 compared to placebo, for immediate smoking cessation and also for gradual cessation. The primary endpoints are continuous abstinence for 4 weeks (FDA criteria, Food & Drug AdministrationUnited States) and 6 months (EMA criterion, European Medicines Agency). The biomarkers used to confirm abstinence are exhaled carbon monoxide and urinary cotinine. Many secondary criteria will also be assessed, such as the number of cigarettes smoked, withdrawal symptoms and cravings.
At 3th quarter of 2021, in line with the capital increase, NFL Biosciences has strengthened its teams with a Director of Medical Operations (” Medical Operations Director ”) and a Senior Clinical Project Manager (“ Senior Clinical Project Leader »), allowing it to be in operational capacity to follow the progress of CESTO II. At the beginning of 2022, NFL Biosciences also integrated a part-time director of investor relations and the entry into office of a financial director is scheduled for the end of March.
Mestablishment of a manufacturing partnership for active ingredients
In November 2021, NFL Biosciences selected Diverchim to produce the active ingredient of NFL-101 for use in additional clinical studies in the CESTO II study (Phase II/III). The development plan put in place will also be applied to 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 secures the control of the production of botanical extracts in order to anticipate future development needs until possible commercialization.
Extension of the property intellectual with patent registration from NFL Biosciences in the United States
On September 21, 2021, the United States Patent and Trademark Office (USPTO) issued product patent number 11,123,395 for NFL-101. The addition of cannabis proteins to the extract is covered by one of the claims in view of a potential future application in cannabis withdrawal. This patent protects the innovation on which NFL-101 is based until 2040 in the United States. This patent is also registered until 2040 in France. National registration applications are being examined in the following regions and countries: China, Japan, Canada, South Korea, Australia, Brazil, India, Indonesia, Israel, Mexico, Philippines, Eurasia, Saudi Arabia, United Arab Emirates United, Nigeria.
Co-development agreement the NFL-301, drug candidate to reduce alcohol consumption
In February 2022, NFL Biosciences entered into a co-development agreement with ATHENA Pharmaceuticals, a leading player in the development and production of oral drugs, for the development and production of NFL-301, a drug candidate natural product from NFL Biosciences targeting the reduction of alcohol consumption.
Results annual 2021 (1is January – December 31st 2021)
The 2021 annual accounts, prepared in accordance with French accounting standards, were approved by the Board of Directors at its meeting on March 24, 2022. The audit procedures on the annual accounts have been finalized. The Statutory Auditors’ Reports will be issued after finalization of the Management Report, prior to the publication of the Annual Financial Report.
The listing on Euronext Growth Paris in July 2022 resulted in the recording of an issue premium of 4,960,724.34 euros, and shareholders’ equity was increased to 3,287,481 euros. The gross amount collected is 5 M euros.
The operating profit, at (€978K), reflects the costs incurred to implement the CESTO II clinical study, with in particular the reinforcement of the teams from 3th quarter of 2022, the manufacture of batches of active ingredients, and payments to CROs.
In order to optimize these resources, NFL Biosciences mobilizes various financing mechanisms which are reflected in the debt of 270.7 K€ and the research tax credit for 141.8 K€. Various requests for additional public funding are in progress, in France and abroad.
|Corporate accounts in euros
||December 31, 2021
|December 31, 2020
|Total of exploitation products
|Accounting net income
||3 287 481
|Intangible assets (patents)
||3 039 570
|Total du bilan
||3 685 207
Dr. Ignacio Faus, Chief Executive Officer of NFL Biosciences, said: “NFL Biosciences continues to implement the Phase II / III clinical trial for NFL-101 (smoking cessation), as well as the development of NFL-201 (cannabis addiction) and NFL-301 (reduction of alcohol consumption). In line with our international development strategy, the company will intensify initiatives enabling the development of NFL-101 and NFL-301 in the United States -United. In this context, meetings are scheduled with the US FDA, with the main objective of 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 in the lives of millions of people who want to quit smoking and reduce their alcohol consumption. »
AT About NFL Biosciences
NFL Biosciences is a biopharmaceutical company based in the Montpellier region that develops botanical drug candidates for the treatment of addictions. NFL Biosciences aims to bring new therapeutic, natural, safer and more effective solutions to the entire world population, without forgetting countries with low or middle income levels. 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 a natural, safe, simplified and personalized administration 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). The company is qualified as an “Innovative Company” eligible for FCPI investment.
More information on www.nflbiosciences.com
Bruno Lafont – email@example.com – 04 11 93 76 67
Calyptus Agency – firstname.lastname@example.org – 01 53 65 68 68
1 National Agency for the Safety of Medicines and Health Products