NFL BIOSCIENCES 
05 Oct 2023 19:00 CEST
NFL BIOSCIENCES S.A.
Promising results for the PRECESTO Phase 2a exploratory study: detailed analysis CESTO II clinical trial (phase 2b, underway) for the drug candidate NFL-101 for smoking cessation: results to be released in July 2024 Co-development of NFL-301, a drug candidate to reduce alcohol consumption. New formulation developed and patent application filed €3m fundraising round in January 2023 and up to €1.9m of non-dilutive financing secured in February 2023 (Bpifrance, France Relance 2030 stimulus plan) Cash position: €3.6m as of September 30, 2023. Cash horizon secured through to the end of 2024. NFL BIOSCIENCES (Euronext Growth Paris - FR0014003XT0 - ALNFL), a biopharmaceutical company developing botanical drugs for the treatment of addictions, is reporting its results for the first half of 2023, approved by the Board of Directors on October 5, 2023. On this occasion, NFL Biosciences looks back on its recent progress, including the promising results of the PRECESTO exploratory study, and confirms that the strategy for reporting the CESTO II results will make it possible to take into account the entire study, which will remain double blind through to 12 months of monitoring, with the results of this Phase 2b study expected in July 2024. October 12, 2023 at 2:30 pm CET - Webinar for shareholders and investors NFL Biosciences will discuss the promising results of the Phase 2a PRECESTO exploratory study, which demonstrated a clinically relevant effect of NFL-101 on the reduction of satisfaction with cigarettes, and the development strategy of CESTO II, its Phase 2b clinical study to evaluate the efficacy of NFL-101, currently underway on 318 smokers in 8 clinical investigation centers. NFL Biosciences executives will also discuss the development of NFL-301, a drug candidate to reduce alcohol consumption. >> Click here to register1. Promising results for the PRECESTO clinical trial PRECESTO is the second study after CESTO which highlights the effect of NFL-101 in terms of reducing smoking satisfaction. The clinically relevant effect is also more prolonged than expected. These results confirm the therapeutic interest of NFL-101 administered on its own or in combination with nicotine replacement therapies, which reduce withdrawal symptoms. They corroborate the results of the patent application filed in the United States in October 2022, increasing the probability of a patent being issued that would offer protection through to 2042 as a minimum. A detailed presentation of the results is appended. Optimization of the strategy for reporting on the CESTO II clinical trial Reminder: What is the CESTO II study? CESTO II is a multicentric, randomized, double blind and placebo-controlled phase 2b clinical trial. The trial is being conducted as follows: • Three arms (two dose arms and one placebo arm); • 318 smokers, aged 18 and over; • Monitoring over 12 months (CESTO2, NCT04571216); 1 Or type this webpage address in your browser: https://www.boursedirect.fr/fr/formations#webinaires 2 • The subjects receive two initial subcutaneous injections one week apart. Additional follow-up injections could be provided after three and six months for subjects who have not stopped smoking by these dates. This study's primary objectives are to select the best dose and assess the efficacy of NFL-101 versus placebo. The main criterion is continued abstinence for four weeks and the key secondary criterion is continued abstinence for six months, measured from 15 days after the first administration and confirmed by measuring exhaled CO. Other secondary criteria are also being studied, including continued abstinence for three months, nine months and 12 months, continued abstinence at the end of the treatment for three months and six months, and continued abstinence during the last three months of the study. A number of exploratory criteria will then be analyzed. The recruitment of subjects started in January 2022, gradually mobilizing a total of eight Clinical Investigation Centers (CIC) at CHU university hospital centers (Bordeaux, Clermont-Ferrand, Dijon, Lorient, Marseille, Montpellier, Poitiers and Rennes), as well as the Eurofins-Optimed research institute (Grenoble). The final and 318th randomization was carried out at the start of May 2023. Data analysis and strategy for reporting the results An analysis of the results had been announced after reaching six months of monitoring for the 318th subject. Under this reporting strategy, the analysis of continued abstinence rates based on the data for the first six months monitored involved unblinding the study. This limited the opportunities to capitalize on the data collected between the 6th and 12th months, which would be considered as open data. Maintaining the blind during the planned 12 months of monitoring would make it possible to maximize the use of all the data collected during the CESTO II study. The observation of a more prolonged effect than expected during the PRECESTO study calls for a certain level of caution concerning an early review of the results leading to an unblinding before the end of the planned 12- month monitoring period. If an immune response is triggered by the administration of NFL-101, this could, in addition to an immediate effect that would support the success of an attempt to stop smoking, result in a longerterm effect in terms of preventing or managing relapses. The CESTO II study includes a hierarchy within the criteria for analysis: there is one primary criterion, then one key secondary criterion, six secondary criteria and a number of exploratory criteria. Each of the secondary criteria has a high level of clinical relevance. Maintaining the blind during the 12 months of monitoring will then make it possible to fully capitalize on the results obtained concerning these secondary criteria. For these three reasons, and because the CESTO II study has been the focus of the majority of the Company's resources for a total of around €8m, the decision has been taken to maximize the use of the data generated. This involves maintaining the blind through to the end of the planned observation period. The provisional schedule is as follows: • Final visit for the final subject included: start of May 2024 • Completion of the audits of the centers and review of the data collected: end-June 2024 • Unblinding and transfer of data for statistical analysis: mid-July 2024 • Reporting of results for the primary criterion, the key secondary criterion and the secondary criteria: end-July 2024 It is important to remember that the Company continues to be subject to the blind condition, in the same way as the subjects, the clinical centers and the Eurofins Optimed CRO. Collaboration with the CEA to study the mechanism of action of NFL-101 In February 2023, NFL Biosciences set up a research partnership with the French Alternative Energies and Atomic Energy Commission (CEA) to study the mechanism of action of its drug candidate NFL-101. This study is being led by the CEA's Paris-Saclay Pharmacological Neuroimaging team. It will focus on following, by positron emission tomography (PET) imaging, the modifications in the cerebral function associated with the development of tobacco addiction in mice, in order to highlight the central effects of NFL-101 treatment. The results are expected before the end of the first quarter of 2024. 3 Co-development of NFL-301, a drug candidate to reduce alcohol consumption Under the co-development agreement set up at the start of 2022, NFL Biosciences and its industrial partner Athena Pharmaceutiques have developed a prolonged-release form of kudzu plant extracts in microgranule form, NFL-301. NFL Biosciences aims to develop the first oral delivery drug based on kudzu extracts to tackle excessive alcohol consumption. NFL is preparing a pre-IND in the United States, which is expected to be submitted before the end of the fourth quarter of 2023, with a view to obtaining FDA approval for the manufacturing process, product quality and development strategy through to the MA. There are no plans for any significant spending on the development of NFL-301 over the next nine months. The current work primarily concerns regulatory and consultation aspects. Extension of intellectual property NFL Biosciences has continued moving forward with its intellectual property protection strategy for NFL-101 and NFL-301. Patent application for NFL-301: a patent application has been filed in the United States for the formulation of NFL-301 with a commitment to extending this globally. This first patent application for NFL-301 aims to protect prolonged-release formulations of extracts of kudzu, a plant used in traditional Chinese medicine, as well as their uses for the treatment of alcohol consumption reduction. Patent approval on NFL-101: NFL Biosciences has three patent families granting it extensive international protection for its drug candidate NFL-101, including Europe, the United States, China and Japan. Partnership strategy Looking beyond the studies underway (CESTO-II and the collaboration with CEA-Saclay), NFL BIOSCIENCES will focus on continuing to develop NFL-101 in partnership with pharmaceutical companies that are interested in the addiction field. As part of its normal business operations, the Company has already had discussions with several international pharmaceutical companies. Considering the positive results seen with PRECESTO, these discussions could be ramped up. Regarding the partnership with THEMIS PHARMACEUTICALS in India, the development strategy in this country is also being reassessed following the results of the PRECESTO clinical trial. NFL Biosciences has been invited to attend two major business conferences over the coming months, where its discussions with pharmaceutical companies and institutional investors will continue: • Jefferies Healthcare annual conference (London, November 14-16, 2023) • JP Morgan Healthcare annual conference (San Francisco, January 8-11, 2024) Diversified sources of financing set up at the start of 2023: cash runway to the fourth quarter of 2024 At the start of 2023, NFL Biosciences successfully rolled out its financing strategy by applying for various grants and advances, and calling on the financial markets. In total, €4.2m were received during the first quarter of 2023 and €0.7m are still to be received as findings are generated confirming the success of the trials, representing a total secured amount of €4.9m (€3m through a capital increase and €1.9m of repayable advances or grants). This has enabled NFL Biosciences to secure financing to drive progress with its priority projects, and it has a cash horizon that now runs through to the fourth quarter of 2024. NFL Biosciences will continue to benefit from an organization with limited fixed costs. Looking further ahead, NFL Biosciences will need additional financing which, independently or combined, may come from (1) capital increases, (2) non-dilutive financing and (3) partnerships with pharmaceutical companies. Governance changes On February 27, 2023, the Board of Directors appointed Dr Ignacio Faus, the Company's Chief Executive Officer, as Chairman of the Board of Directors for a period that will not exceed his term of office as a director, i.e. through to the end of the Ordinary General Shareholders' Meeting held in 2024 to approve the financial statements for the year ending December 31, 2023. 4 On June 27, 2023, the shareholders approved the appointment of Ms Dominique Côté as an independent director. Her three-year term of office will expire at the end of the Ordinary General Shareholders' Meeting held in 2026 to approve the financial statements for the year ending December 31, 2025. 2023 first-half earnings The financial statements for the first half of 2023 (January 1, 2023 - June 30, 2023), prepared in accordance with French GAAP, were approved by the Board of Directors during its meeting on October 5, 2023. The accounts have been subject to a limited review by the statutory auditors and the HY financial report will be published on October 6, 2023 after the market closing. Corporate accounts (€) Jun 30, 2023 (6 months) Jun 30, 2022 (6 months) Dec 31, 2022 (12 months) Net revenues - - - Total operating income 94,777 5 22 EBIT (2,382,387) (1,300,816) (3,083,170) Financial income (expense) 71,388 107,829 182,831 Non-recurring income (expense) - - 39,025 Corporate income tax (200,349) (121,632) (417,829) Net income (2,110,650) (1,071,354) (2,443,484) Shareholders' equity 1,907,772 2,216,127 843,996 Intangible assets (patents) 122,785 139,577 135,784 Liabilities - Of which financial liabilities - Of which operating liabilities - Of which prepaid income 2,461,532 72,727 2,283,580 105,225 736,661 85,007 651,654 1,478,510 83,256 1,395,254 Cash and cash equivalents 3,359,459 2,044,267 1,053,581 Balance sheet total 5,578,281 3,043,765 2,395,484 During the first half of 2023, NFL Biosciences recorded €94K of operating income. This amount corresponds to part of the operating grant awarded by Bpifrance (total amount of €200K). Still in the clinical trials development stage, NFL Biosciences did not record any revenues during the last two years. In line with the resources allocated to drive progress with the programs presented above, and the Company's operations, EBIT came to €(2.4)m for the first half of 2023, compared with €(1.3)m for the same period in 2022. Payroll and social security contributions totaled €307K for four people at June 30, 2023, compared with €254K for three people at June 30, 2022. During the first half of 2023, NFL Biosciences recorded a research tax credit (CIR) of €203K, compared with €101K for the first half of 2022, with this change reflecting the ramping up of its research programs. Over the period, NFL Biosciences received €161K of prefinancing from the research tax credit reported in 2022, which totaled €397K. Financial income and expenses for the first half of 2023, which came to €71K, compared with €108K one year earlier, take into account the remuneration from investments of cash surpluses for €32K and the reversal of depreciation concerning the liquidity agreement for €39K. As a result, NFL Biosciences recorded €(2.1)m of net income over the period, compared with €(1.1)m at June 30, 2022. At June 30, 2023, the Company had €1.9m of shareholders' equity and €3.4m of available cash. Cash and cash equivalents reflect the capital increase carried out at the end of January 2023 (€3.0m), as well as the advances granted by Bpifrance for the NFL-101 and NFL-301 clinical trials (€1.1m). In the third quarter of 2023, the Company received €550K of proceeds from the exercising of the BSA and BSPCE warrants from end-June and July 2023 for a total of €550K, as well as the first installment of the grant for the PRECESTO study for €140K. 5 Outlook for 2023 Dr Ignacio Faus, NFL Biosciences Chairman of the Board and CEO: "We are very satisfied with the progress made in the past few months. We carried out the PRECESTO Phase 2a clinical trial while respecting the budget and timeframes that were set. The results achieved with PRECESTO, which are presented in detail in this press release, are very promising. PRECESTO is the first placebo-controlled clinical trial for NFL-101. We have shown that NFL-101 has a greater effect than placebo on reducing smoking satisfaction. For CESTO II, we also aim to complete this clinical trial on budget and on time. After reviewing the PRECESTO results, the Board of Directors decided to modify the schedule for reporting the CESTO-II results with a view to maximizing the study's potential. With regard to NFL-301, our product for reducing alcohol consumption, we have made progress with developing a new product formulation. Over the next nine months our development will continue moving forward. As we have already mentioned, NFL Biosciences has a very robust approach in place for managing fixed costs. We use the funds that are allocated to us with the greatest care and we focus them primarily on funding scientific studies. Thanks to this, the Company's cash horizon can be extended through to the end of 2024. Given the small size of the company, we will prioritize partnerships for the development of NFL-101 beyond the studies that are underway. Discussions have been started with major American and European pharmaceutical companies and, considering the positive results achieved with PRECESTO, they could now be accelerated".
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NFL BIOSCIENCES
Euronext
NFL BIOSCIENCES S.A.
FR0014003XT0
ALNFL
Euronext Growth
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NFL Biosciences SA published this content on 05 October 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 05 October 2023 17:11:20 UTC.
