2022 first half business and earnings

NFL Biosciences: 2022 First Half Business and Earnings

A Phase II/III clinical trial for smoking cessation drug candidate NFL-101 continues to move forward, with eight clinical centers in France participating.

Intellectual property is extended. NFL Biosciences patents are registered in China and South Korea

Collaboration with Themis Medicare to develop NFL-101 in India

Collaboration with Athena Pharmaceuticals for the global development of NFL-301

Hiring a finance director

NFL BIOSCIENCES (Euronext Growth Paris – FR0014003XT0 – ANLFL), a biopharmaceutical company developing herbal medicines for the treatment of addictions, is reporting its results for the first half of 2022, which were approved by its Board of Directors on October 24, 2022. Half-year financial statements as if On June 30, 2022, a limited review was conducted by the company’s statutory auditors. NFL Biosciences is listed on the stock market Since July 2021, It continues to do so. development in NFL-101 Development of a Drug Candidate for Smoking Cessation.

NFL-101 phase II/III clinical trial continuesE To go forward with the participation of eight clinical centers in France

In recent months, the CESTO II phase II/III clinical trial evaluating the efficacy and dosage of the drug candidate NFL-101 has been distributed across eight clinical centers in France: the CHU teaching hospital centers in Bordeaux, Clermont-Ferrand, Dijon, Marseille, Montpellier, Poitiers and Rennes, and The Eurofins-Optimized Research Institute in Grenoble, which is the contract research organization (CRO) of the study.

The clinical trial targets men or women aged 18 to 70 who smoke more than 11 cigarettes a day and are committed to quitting. The trial included three arms (two dose arms and one placebo arm) and monitored patients over 12 months. The primary objectives of CESTO II are to select the optimal dose and evaluate the efficacy of NFL-101 and placebo. The primary evaluation criterion was the subject’s continued abstinence for four weeks (US Food and Drug Administration (FDA) criteria). The main secondary criterion for evaluation was the subjects’ continuous abstinence for six months (European Medicines Agency (EMA) criteria). Many other secondary variables are also assessed, including number of cigarettes smoked, withdrawal symptoms, and level of craving. Biomarkers used to confirm abstinence are carbon monoxide and urine cotinine excretion.

Subject recruitment is expected to be completed in the first half of 2023, assuming the recruitment rate of the eight clinical centers and, barring events beyond the Company’s control or related to economic and geopolitical developments.

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

In the year In February 2022, NFL Biosciences entered into a joint development agreement with ATHENA Pharmaceutiques, a market leader in the development and manufacture of oral drugs for NFL-301, a natural drug candidate. NFL-301 is indicated for reducing alcohol consumption.

In the year Development of the script, which started in the first quarter of 2022, is still ongoing. The company is in discussions with European and American regulatory agencies (EMA and FDA) for the clinical development of the product.

Intellectual property extended by NFL Biosciences patent registered in China and South Korea

NFL Biosciences continues to move forward with its knowledge management and protection strategy. This led to the registration of two patent families, giving exclusive rights to the drug candidate NFL-101. This product patent, originally registered and approved in France, concerns the “water extraction of tobacco leaves and its use in the treatment of addiction.” The invention based on NFL-101 is protected until 2036 in France, the United States and now China (300 million smokers) from April 2022 and South Korea (9 million smokers) from May 2022.

National registration applications are still open in the following regions and countries: Japan, Canada, Australia, Europe, Brazil, India, Indonesia, Philippines, Saudi Arabia, United Arab Emirates and Nigeria.

Collaboration with Themis Medicare to develop NFL-101 in India

In October 2022, NFL Biosciences formed a partnership with Themis Medicare Ltd to develop NFL-101 for the Indian market. Themis Medicare, a Mumbai-headquartered pharmaceutical company with over 50 years of experience in providing new treatment options to patients, has submitted an Investigational New Drug (IND) application for a phase II/3 clinical trial to the Central Drug Regulatory Organization (CDSCO), India’s national regulatory authority. (NRA).

India has about 267 million smokers, and their options to quit smoking are very limited. After the study is approved, the clinical trial will be conducted in India, targeting 334 smokers. The cost of the procedure, from the time of presentation to completion of the study, will be paid by Themis Medicare. Themis purchases the active pharmaceutical ingredient (API) of NFL-101 from NFL Biosciences. NFL Biosciences receives double-digit royalties on sales.

Recruitment of Director of Finance

In the first half of 2022, the company further strengthened its team by recruiting a finance director. Guillaume Audema spent six years with an audit firm, where he became a manager. He joined NFL Biosciences after gaining initial experience as a finance director at another company.

Earnings for the first half of 2022 (January 1 to June 30, 2022)

The accounts for the first half of 2022, prepared in accordance with French GAAP, were approved by the Board of Directors at its meeting on October 24, 2022. A limited review of the half-year financial statements has been completed and the financial report for the first half of 2022 will be available on October 26, 2022. It can be consulted at www.nflbiosciences.com under “Investors” and “Documents”.

The initial public offering in July 2022 on Euro Continuity Paris raised an issue premium of €4,960,724.34, grossing €5m (€4.2m net). Since then, NFL Biosciences has aligned its business plan with the strategy presented at the time of the IPO, consolidating the company’s development of herbal drug candidates for the treatment of addiction, and specifically NFL-101.

First-half EBIT totaled €(1,301)k, compared to €(978)k in 2022, including the costs incurred for the CESTO II clinical trial, consolidation of the teams from the third quarter of 2021, ingredients for the production of active compounds, intellectual property costs and payments to various CROs. . Following the decision to recruit patients in France, the subsidiary in Australia will be wound up in the second half of this year. This decision to recruit all patients in France was made thanks to: (i) the good recruitment rate in different French CHU centers and (ii) the cost of clinical trials in France is much lower compared to Australia.

The increase in the clinical trial is reflected in an increase in accounts payable to €534K in the first half of this year, compared to €120K at December 31, 2021, mainly including accrued receivables. The company still has a government-backed loan of €85K to be repaid quarterly starting in 2023. The previous financing line is based on the success of the NFL-101 Phase I trial, registered as quasi-equity, currently payable quarterly at €18K and fully repaid in December 2023.

Cash and cash equivalents on June 30, 2022 totaled 2,044,267 euros and do not include the study tax credit, 100,670 euros for the first half of this year and 159,447 euros for 2021, which has not yet been received by the company until June 30, 2022.

NFL Biosciences operates with very low fixed costs and overhead costs, outsourcing activities to various industrial firms. This strategic choice allows greater flexibility in deploying its financial resources to advance its development programs. Most of the free money is earmarked for the clinical programs.

Grant requests submitted to BPI France are currently at an advanced evaluation stage, with payment for the success of the projects: (i) €1.8m request for the CESTO2 study, for a total of €1.3m, revised upwards; The decision to recruit patients only in France, therefore increases the level of eligible costs; (ii) A request for €245K relating to the formulation and clinical trial approval of NFL-301, a drug candidate to reduce alcohol consumption. The applications are currently being evaluated by BPI France, with a response expected in the coming weeks.

The company is continuously looking at different financing options available in France and other countries, opting for uncomplicated financing.

Outlook for 2022

Dr. Ignacio Faus, CEO of NFL Biosciences: “In addition to developing NFL-201 (Cannabis Addiction) and NFL-301 (Reducing Alcohol Consumption), NFL Biosciences continues to conduct Phase II/III clinical trials for NFL-101 (Smoking Cessation). Controlling manufacturing expertise as a key component in the NFL-101 value chain Production of GMP batches is underway and clinical Ready Collection is expected in 2023. We continue to look for partners for NFL-101 Outside of Europe and America, Low or middle income Countries. First partnership established in India.

Product development of NFL-301, the second pillar of the company’s global strategy, is moving forward in collaboration with France’s Athena Pharmaceuticals. NFL Biosciences hopes to have a formula ready for use as early as 2023.

In accordance with its global growth strategy, NFL Biosciences will advance initiatives that enable the development of NFL-101 and NFL-301 in the United States and other countries. Within this framework, various meetings are scheduled with the US FDA, mainly focused on the development plan for drug candidates and ensuring that future clinical trials are approved by the FDA in the US.

About NFL Bioscience

NFL Biosciences is a Montpelier-based biopharmaceutical company that develops drug candidates for addiction treatment. NFL Biosciences’ ambition is to bring new, natural, safer and more effective medical solutions to the entire world’s population, including low- and middle-income countries. Its most advanced product, called NFL-101, is a standardized, nicotine-free tobacco leaf protected by two patent families. NFL Biosciences aims to provide smokers who want to quit with a natural, safe, easy-to-administer and personalized alternative. NFL Biosciences is also developing NFL-301, a natural drug candidate to reduce alcohol consumption, and has a drug development project to treat cannabis use disorders.

Shares of NFL Biosciences are listed on Euronext Growth Paris (FR0014003XT0 – ANLFL). Find out more at www.nflbiosciences.com

Contacts

Bruno Lafont – info@nflbiosciences.com – +33 4 11 93 76 67 Calyptus Agency – nflbio@calyptus.net – +33 1 53 65 68 68

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