NFL Biosciences: H1 2022 Business and Earnings
The phase II/III clinical trial of the drug candidate NFL-101 for smoking cessation continues to advance, with the participation of 8 clinical centers in France
Intellectual property extension. NFL Biosciences patents registered in China and South Korea
Working with Themis Medicare to develop NFL-101 in India
NFL-301 in partnership with Athena Pharmaceutiques
Recruiting financial director
NFL BIOSCIENCES (Euronext Growth Paris – FR0014003XT0 – ANLFL), a biopharmaceutical company developing botanical medicines for the treatment of addiction, is reporting its results for the first half of 2022 and was appointed to the Board of Directors on October 24, 2022 approve.half year financial statement exist Limited review by the company’s statutory auditors on 30 June 2022. NFL Biosciences, publicly traded since July 2021, keep making progress exist Development of drug candidate NFL-101 for smoking cessation.
Phase II/III clinical trial of NFL-101 underwayes Moving 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 dose of its drug candidate NFL-101 has been launched at eight clinical centers in France: Bordeaux, Clermont-Ferrand, CHU Teaching Hospital Center in Dijon, Marseille, Montpellier, Poitiers and Rennes, as well as the Eurofins-Optimized Institute in Grenoble, which is also the contract research organization (CRO) for the study.
The clinical trial was conducted on men or women between the ages of 18 and 70 who smoked more than 11 cigarettes a day and were truly committed to quitting. The trial includes three arms (two doses and one placebo) and will monitor patients over 12 months. The primary goals of CESTO II are to select the optimal dose and evaluate the efficacy of NFL-101 versus placebo. The primary criterion for evaluation was the subject’s continued abstinence for 4 weeks (US Food and Drug Administration (FDA) criteria). The primary and secondary criterion for evaluation was the subject’s continued abstinence for six months (European Medicines Agency (EMA) criteria). A number of other secondary criteria will also be assessed, including the number of cigarettes smoked, withdrawal symptoms and craving levels. Biomarkers used to confirm abstinence were exhaled carbon monoxide and urinary cotinine.
Subject recruitment is expected to be completed in the first half of 2023 in the absence of events beyond the company’s control or related to economic and geopolitical developments, taking into account the recruitment rates at the eight clinical centers.
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 Pharmaceutiques, a market leader in the development and manufacture of orally administrable drugs, to co-develop and manufacture NFL Biosciences-derived natural drug candidate NFL-301. NFL-301 is used to reduce alcohol consumption.
Launched in the first quarter of 2022, the formula is still in development. The company will then establish a dialogue with European and US regulatory agencies (EMA and FDA) regarding the clinical development of the product.
Expansion of intellectual property through NFL Biosciences patents registered in China and Korea
NFL Biosciences continues to advance its knowledge management and conservation strategy. This led to the filing of two patent families granting exclusive rights to its drug candidate NFL-101. The product patent was originally registered and approved in France for “a water extract of tobacco leaves and its use in the treatment of dependence”. Thus, the innovations on which NFL-101 is based are now protected until 2036 in France, the United States, and in China (300 million smokers) from April 2022 and South Korea (9 million smokers) from May 2022.
National registration applications are still under review for the following regions and countries: Japan, Canada, Australia, Europe, Brazil, India, Indonesia, Philippines, Saudi Arabia, United Arab Emirates and Nigeria.
Working with Themis Medicare to develop NFL-101 in India
In October 2022, NFL Biosciences entered into a partnership with Themis Medicare Ltd to develop NFL-101 for the Indian market. Themis Medicare, a Mumbai-based pharmaceutical company with a more than 50-year tradition of providing patients with new treatment options, submitted an Investigational New Drug (IND) application for a Phase II/III clinical trial to the Central Medicines Standards Control Organization. CDSCO), National Regulatory Agency (NRA) of India.
There are approximately 267 million smokers in India who have very limited options to quit. Once the study is approved, the clinical trial will be conducted in India on 334 smokers. The process from submission to completion of the study will be covered by Themis Medicare. Themis will purchase the NFL-101 active pharmaceutical ingredient (API) from NFL Biosciences. NFL Biosciences will also receive double-digit sales royalties.
recruit one financial director
In the first half of 2022, the company will further strengthen team building by recruiting chief financial officer. Guillaume Audema worked for an audit firm for six years, where he was a manager. He joined NFL Biosciences after serving as financial director at another company.
Earnings for the first half of 2022 (January 1 – June 30, 2022)
The financial statements for the first half of 2022 have been prepared in accordance with French generally accepted accounting principles, and have been reviewed and approved at the meeting of the Board of Directors on October 24, 2022.Completed limited audit of semi-annual financial statements First half of 2022 to be listed on October 26, 2022; available at www.nflbiosciences.com under “Investors” and “Documents”
The July 2022 IPO of Euronext Growth Paris received an offering premium of EUR 4,960,724.34 and received a total of EUR 5 million (EUR 4.2 million net). Since then, NFL Biosciences has launched its business plan based on the strategy outlined at the time of the IPO, while further strengthening its organization to align with these new steps to develop botanical drug candidates for the treatment of addiction, and specifically NFL-101 .
Total EBIT in the first half of the year was (1,301)K EUR, compared to (978)K EUR in 2022, reflecting the costs incurred from CESTO II clinical trials, strengthening the team from Q3 2021, producing batch ingredients, knowledge Title cost and fees paid to different CROs. The Australian subsidiary will be disbanded in the second half of the year following a decision to recruit patients in France. The decision to recruit all patients in France was based on: (i) the rapid rate of recruitment at the various CHU centers in France, and (ii) the significantly lower cost of clinical trials in France compared to Australia.
The increase in clinical trials was reflected in an increase in accounts payable to EUR 534,000 in the first half of the year, compared to EUR 120,000 at 31 December 2021, mainly including accrued invoices. The company still has a government-backed loan of 85,000 euros, repayable on a quarterly basis, which will start in 2023. The previous financing amount, contingent on the success of the NFL-101 Phase 1 trial, is recorded as a quasi-equity and is currently repayable quarterly at €18,000 and will be fully repaid by December 2023.
Cash and cash equivalents as of June 30, 2022 totalled EUR 2,044,267, excluding research tax credits worth EUR 100,670 for the first half of this year and EUR 159,447 for 2021, which the company has not received as of June 30, 2022.
NFL Biosciences operates at very low fixed and overhead costs, outsourcing activities to various industrial companies. This strategic choice allows it to deploy its financial resources more flexibly to advance its growth plans. Most of the free cash is allocated to its clinical programs.
The funding application submitted to BPI France is currently in the advanced review stage and repayment is contingent on the success of the project: (i) EUR 1.8 million application for the CESTO2 study with an initial total of EUR 1.3 million followed by an upward revision decision to recruit patients only in France , thereby increasing eligible fee levels; (ii) EUR 245,000 request for formulation and clinical trial approval for NFL-301, a drug candidate for reducing alcohol consumption. BPI France is currently reviewing the applications and is expected to respond in the coming weeks.
The company is constantly researching the various financing options available in France and other countries, prioritizing non-dilutive financing.
| Company Account (€) | June 30, 2022 (6 months) |
December 31, 2021 (12 months) |
June 30, 2021 (6 months) |
| just income | – | – | – |
| total operating income | 5 | 39 | 0 |
| EBIT | (1,300,816) | (901,867) | (221,051) |
| Financial income (expenses) | 107,829 | (217,643) | (354) |
| Non-recurring income (expenses) | – | – | – |
| corporate income tax | -121,632 | -141,266 | – |
| net income | (1,071,354) | (978,243) | (221,405) |
| Shareholders’ Equity | 2,216,127 | 3,287,481 | (71,380) |
| Intangible assets (patents) | 139,577 | 124,034 | 120,566 |
| debt | 736,661 | 270,749 | 1,247,447 |
| Cash and cash equivalents | 2,044,267 | 3,039,570 | 175,972 |
| total balance sheet | 3,043,765 | 3,685,207 | 1,428,067 |
Outlook for 2022
Dr. Ignacio Faus, CEO of NFL Biosciences: “In addition to developing NFL-201 (marijuana addiction) and NFL-301 (drinking reduction), NFL Biosciences is continuing to launch Phase II/III clinical trials for NFL-101 (smoking cessation). As control over manufacturing technology is NFL -101 key elements in the value chain, GMP batch production of this product is in progress, clinical trials get ready Expected batch exist 2023. We will also continue to find partners for NFL-101 outside Europe and the United States, in low or middle income nation. India has established its first partnership”.
The NFL-301 product is the second pillar of the company’s global strategy and is progressing in partnership with French company Athena Pharmaceutiques. NFL Biosciences hopes to have the first available formulation in early 2023.
In accordance with its international growth strategy, NFL Biosciences will strengthen its initiatives to develop NFL-101 and NFL-301 in the United States and other countries. Within this framework, various meetings with the US FDA are being arranged, mainly focusing on ensuring that the drug candidate’s development plan and future clinical trials are accepted by the US FDA.
About NFL Biosciences
NFL Biosciences is a biopharmaceutical company based in the Montpellier region developing botanical drug candidates for the treatment of addiction. NFL Biosciences’ goal is to bring new, natural, safer and more effective therapeutic solutions to the world’s 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 aims to provide smokers who want to quit smoking a natural, safe, manageable and personalized alternative. NFL Biosciences is also developing NFL-301, a natural drug candidate for reducing alcohol consumption, and has a drug development program for the treatment of cannabis use disorder.
NFL Biosciences shares are listed on Euronext Growth Paris (FR0014003XT0 – ANLFL). For more information, visit www.nflbiosciences.com
contact
Bruno Lafont – info@nflbiosciences.com – +33 4 11 93 76 67 Agence Calyptus – nflbio@calyptus.net – +33 1 53 65 68 68
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