{"id":6726,"date":"2026-06-08T07:30:26","date_gmt":"2026-06-08T07:30:26","guid":{"rendered":"https:\/\/www.nflbiosciences.com\/?page_id=6726"},"modified":"2026-11-02T17:00:43","modified_gmt":"2026-11-02T17:00:43","slug":"faq-2026-eng","status":"publish","type":"page","link":"https:\/\/www.nflbiosciences.com\/en\/faq-2026-eng\/","title":{"rendered":"FAQ"},"content":{"rendered":"

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FAQ<\/span><\/span><\/h1><\/header>
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NFL BIOSCIENCES - Shareholders Q&A<\/span><\/span><\/h2><\/header><\/div><\/div><\/div><\/div><\/div>
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<\/p>\n
Update on the bond financing subscribed for by Vester Finance<\/strong><\/h5>\n

On April 15, 2026, NFL Biosciences implemented financing through the issuance of bonds convertible into shares, with a total nominal amount of \u20ac2.6 million, subscribed for by Vester Finance and certain family offices.<\/p>\n

Some shareholders have raised questions about the potential impact on the share price of sales of shares resulting from conversions.<\/p>\n

To provide factual information, Vester Finance has exceptionally agreed to allow us to disclose the following data for the period from the implementation of the financing through October 30, 2026:<\/p>\n

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  • \n

    Vester Finance\u2019s share sales accounted for only approximately one tenth of the trading volumes in NFL Biosciences shares.<\/p>\n<\/li>\n

  • \n

    During the eight trading sessions marked by sharp declines, its sales accounted for less than 5% of trading volumes: more than 95% of the shares traded on those days came from other sellers.<\/p>\n<\/li>\n<\/ul>\n

    Vester Finance is an investment firm specializing in financing solutions for listed companies with strong growth potential.<\/p>\n

    Vester Finance supports several listed companies in France and Europe and remains a significant shareholder in a number of them. In particular, Vester Finance is the largest shareholder and a financial partner of Mauna Kea Technologies and Adocia, as well as the second-largest shareholder of Crossject.<\/p>\n

    Vester Finance invests exclusively its own capital, ensuring complete independence in its investment decisions and advice, as well as the capacity to provide long-term support.<\/p>\n

    The positive stock market performance recorded by companies supported by Vester Finance has been the subject of an independent review engagement entrusted to Deloitte, covering the verification of the data and changes in the stock market valuations of the companies in this portfolio.<\/p>\n

    Over the past ten years, the financing solutions implemented by Vester Finance and its chief executive have helped support companies such as Exail Technologies, Soitec, Nanobiotix, Mersen and Abivax at pivotal moments in their development and stock market history.<\/p>\n

    \u00a0<\/h5>\n
    How could the next clinical phases be financed?<\/strong><\/h5>\n

    Based on its available cash and current forecasts, NFL Biosciences estimates that it can fund its operations through the end of the first half of 2027, including the conduct of Part A of the TONIC study.<\/p>\n

    The revision of this cash runway, previously announced as extending into the third quarter of 2027, reflects the inclusion of the costs of conducting Part A, in addition to the preparation costs already included in previous forecasts.<\/p>\n

    The Company is actively pursuing efforts to identify strategic and financial partners to support the continued development of NFL-102 through Part B of TONIC and the initiation of Phase 3 for NFL-101.<\/p>\n

    NFL Biosciences will prioritize a strategic partner to finance Phase 3 studies. Details of additional financing arrangements will be provided when they can be announced.<\/p>\n

    \u00a0<\/p>\n

    Where do discussions with potential industrial partners stand?<\/strong><\/h5>\n

    NFL Biosciences is seeking a partner to advance NFL-101 into Phase 3 through a licensing agreement. The results obtained in the biomarker-defined population and their anticipated scientific publication are intended to support these discussions.<\/p>\n

    The Company is also pursuing discussions with strategic and financial partners to support the development of Part B of TONIC with NFL-102.<\/p>\n

    These discussions remain confidential. No firm timeline for concluding an agreement or definitive agreement scope has been announced. The terms of any potential partnership will be assessed in the interests of the Company and its shareholders.<\/p>\n

    \u00a0<\/p>\n

    What is the role of the TONIC study?<\/strong><\/h5>\n

    TONIC is the Phase 2 study evaluating NFL-102 for smoking and nicotine cessation. It aims to confirm its safety profile, assess its efficacy and determine its optimal dose. The necessary approvals to initiate the study have been obtained from the French National Agency for Medicines and Health Products Safety (ANSM) and the Committee for the Protection of Human Subjects (CPP).<\/p>\n

    The multicenter, randomized, double-blind, placebo-controlled study plans to enroll 310 smokers in France. The primary endpoint is continuous abstinence for four weeks, confirmed by urinary cotinine.<\/p>\n

    Its adaptive design will allow for the progressive selection of one dose from three initial doses:<\/p>\n

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    • \n

      Part A<\/strong> will involve the first 40 participants, enrolled at Eurofins Optimed in Gi\u00e8res. One initial dose will be eliminated based on safety and efficacy data analyzed, after unblinding, by an Independent Data Monitoring Committee (IDMC) and the Company.<\/p>\n<\/li>\n

    • \n

      Part B<\/strong> will involve 270 additional participants. After 150 participants have been enrolled in Part B, an interim analysis conducted by the IDMC will identify the most effective dose, without unblinding the other parties involved in the study. The study will then continue with this dose versus placebo, with the enrollment of a further 120 participants.<\/p>\n<\/li>\n<\/ul>\n

      The first participants are expected to be enrolled in November 2026. Analysis and communication of the Part A results are expected in April 2027. Both milestones will be the subject of dedicated announcements.<\/p>\n

      \u00a0<\/p>\n

      When could Phase 3 begin?<\/strong><\/h5>\n

      For NFL-101, the next steps involve discussions with the FDA and EMA on the development plan incorporating the biomarker for patient selection. These discussions and preparation of the Phase 3 protocol are planned between January and April 2027. NFL Biosciences is seeking a partner to continue this development through a licensing agreement.<\/p>\n

      For NFL-102, the priority is to conduct the Phase 2 TONIC study. Initial results, covering the 40 participants in Part A, are expected in April 2027.<\/p>\n

      For each program, the actual start of Phase 3 will depend on the available clinical data, regulatory discussions and financing or partnership arrangements.<\/p>\n

      \u00a0<\/p>\n

      What is the difference between NFL-101 and NFL-102?<\/strong><\/h5>\n

      NFL-101 aims to reduce brain neuroinflammation. Post-hoc analyses of the Phase 2 CESTO2 study identified a population more likely to respond to treatment, defined by an immune biomarker. These results support a targeted development approach, with prospective confirmation of the biomarker\u2019s predictive value in a future clinical study.<\/p>\n

      NFL-102 aims to restore brain plasticity, which is involved in the lasting adaptations associated with addiction. Its clinical evaluation is based on the Phase 2 TONIC study.<\/p>\n

      Both candidates are derived from standardized tobacco leaf extracts, with the same protein profile and different concentrations of low-molecular-weight compounds. They are designed to be administered as two subcutaneous injections one week apart.<\/p>\n

      \u00a0<\/p>\n

      Is NFL-101 being replaced by NFL-102?<\/strong><\/h5>\n

      No. NFL-101 and NFL-102 are two distinct immunotherapies with different targets: NFL-101 targets the reduction of neuroinflammation, while NFL-102 targets the restoration of brain plasticity. Both are being developed in parallel through separate development programs.<\/p>\n

      NFL-101 follows a personalized medicine approach based on a biomarker designed to identify the smokers most likely to respond to treatment. NFL Biosciences is seeking a partner to advance its development into Phase 3 through a licensing agreement.<\/p>\n

      NFL-102 is being developed by the Company through clinical proof of concept with the Phase 2 TONIC study, which is designed to assess its safety, efficacy and optimal dose.<\/p>\n

      \u00a0<\/p>\n

      What do the new results on NFL-101 show?<\/strong><\/h5>\n

      NFL Biosciences presented new efficacy analyses from the Phase 2 CESTO2 study. These analyses identify a target population of patients more likely to respond to treatment, defined by baseline specific IgG1 levels below 200 ng\/mL. This population represents 57.2% of the patients analyzed.<\/p>\n

      In this target population, NFL-101 showed enhanced efficacy versus placebo. In other words, compared with the general population, efficacy in the target population is higher, the effect size versus placebo is greater, and statistical significance versus placebo is reached over the four-week period corresponding to the primary endpoint, using both confirmation methods: urinary cotinine and exhaled CO. These results support the continued development of NFL-101 through a personalized medicine approach, which will need to be prospectively confirmed in the next clinical study.<\/p>\n

      \u00a0<\/p>\n

      What are the main points to be confirmed?<\/strong><\/h5>\n

      The results presented strengthen the development strategy for NFL-101 and provide a solid basis for Phase 3 preparation. Discussions with regulatory agencies will focus in particular on the prospective validation of the biomarker, as well as the patient population to be enrolled and the study\u2019s sample size.<\/p>\n

      Other elements also remain to be clarified: the respective development pathways for NFL-101 and NFL-102, which will depend on the results of the TONIC study, and the financing arrangements for Phase 3 studies, linked to the potential conclusion of agreements with industrial partners. These elements are not weaknesses to be concealed; they represent the normal next steps in biotech clinical development.<\/p>\n

      \u00a0<\/p>\n

      Has the biomarker already been validated?<\/strong><\/h5>\n

      The four evaluation criteria are met in the available analyses: enhanced efficacy in biomarker-positive patients, comparable placebo response between subpopulations, limited effect in biomarker-negative patients, and biological consistency with the mechanism of action.<\/p>\n

      However, regulatory validation of a biomarker requires prospective confirmation. The most precise wording is therefore that the biomarker is supported by consistent and promising data from CESTO2, and that its prospective confirmation is planned in the next clinical study.<\/p>\n

      \u00a0<\/p>\n

      How could the biomarker test work in practice?<\/strong><\/h5>\n

      The process is based on a blood sample taken before treatment. The physician would prescribe a test measuring NFL-101-specific IgG1. If the result is below 200 ng\/mL, the patient would be considered biomarker-positive and potentially eligible for NFL-101.<\/p>\n

      This type of test could be performed in a community or hospital laboratory. Treatment with NFL-101 consists of two subcutaneous injections administered one week apart, on Day 1 and Day 8. This pathway remains subject to clinical development and will need to be confirmed as part of the next regulatory steps.<\/p>\n

      \u00a0<\/p>\n

      Why is it important to communicate the successful manufacture of a GMP clinical batch?<\/strong><\/h5>\n

      Manufacturing a GMP clinical batch is not only about producing the drug material intended for a clinical trial. It also demonstrates that the manufacturing process is controlled and meets regulatory requirements, an area known as CMC (Chemistry, Manufacturing and Controls), which represents one of the main risks in pharmaceutical development. In the smoking cessation field, Champix\u00ae was withdrawn from the market following manufacturing issues, while the approval of Achieve Life Sciences\u2019 cytisine is currently delayed due to manufacturing difficulties at a subcontractor. Successfully completing this step therefore reduces a major risk and strengthens the value of the NFL-102 development program.<\/p>\n

      \u00a0<\/p>\n

      What is the role of McLean Hospital?<\/strong><\/h5>\n

      McLean Hospital has a twofold role: first, McLean conducts additional research into the mechanism of action; second, Professor Scott Lukas plays a scientific key opinion leader role, particularly in supporting the dissemination of the results, publications and conference presentations.<\/p>\n

      \u00a0<\/p>\n

      What does the biomarker patent application change?<\/strong><\/h5>\n

      The patent application aims to protect the use of the predictive biomarker associated with NFL-101, particularly the use of specific IgG1 to identify a population of patients more likely to respond to treatment. It also covers the potential development of a test to identify biomarker-positive patients.<\/p>\n

      This patent application strengthens NFL Biosciences\u2019 intellectual property around its tobacco franchise. The Company now holds five patent families in smoking cessation based on tobacco extracts.<\/p>\n

      \u00a0<\/p>\n

      What is the biomarker-positive target population?<\/strong><\/h5>\n

      The target population consists of patients whose NFL-101-specific IgG1 levels are below 200 ng\/mL before treatment. In CESTO2, 306 of the 318 patient samples could be analyzed, and 57.2% of them showed this profile.<\/p>\n

      These patients have an immunological profile that is more receptive to the action of NFL-101. Conversely, biomarker-negative patients have a less receptive immunological profile. Efficacy in these patients was found to be comparable to that of placebo.<\/p>\n

      \u00a0<\/p>\n

      What is the difference between the general population and the target population?<\/strong><\/h5>\n

      The general population refers to all patients without prior biomarker-based selection. The target population refers to biomarker-positive patients, meaning those whose NFL-101-specific IgG1 levels are below 200 ng\/mL before treatment.<\/p>\n

      In CESTO2, NFL-101\u2019s efficacy is higher and the difference versus placebo is greater in this target population than in the general population. This observation has led NFL Biosciences to consider developing NFL-101 through a personalized medicine approach.<\/p>\n

      \u00a0<\/p>\n

      Why is this referred to as a post-hoc analysis?<\/strong><\/h5>\n

      It is referred to as a post-hoc analysis because the biomarker was not predefined in the initial CESTO2 protocol. Specific IgG1 were analyzed as part of the research into NFL-101\u2019s mechanism of action, and the 200 ng\/mL threshold was subsequently identified from the study data.<\/p>\n

      This does not make the analysis irrelevant. It simply means that the biomarker was identified during an exploratory phase aimed at improving biological understanding. To become a fully robust tool in clinical development, it will need to be prospectively confirmed in a future study, with its threshold and use defined in advance.<\/p>\n

      \u00a0<\/p>\n

      What does prospective confirmation of the biomarker mean?<\/strong><\/h5>\n

      Prospective confirmation means testing the biomarker in a new study designed from the outset to use it. In practical terms, the specific IgG1 threshold and patients\u2019 biomarker-positive status would be defined before patient enrollment and analysis.<\/p>\n

      NFL Biosciences plans to incorporate biomarker-positive patient status as an inclusion criterion in the protocol of the next NFL-101 clinical study. This step is important because it must confirm that the relationship observed in CESTO2 can be reproduced in a prespecified study.<\/p>\n

      \u00a0<\/p>\n

      How should the 4-week and 12-month results be interpreted?<\/strong><\/h5>\n

      When the protocol was designed, the number of patients to be enrolled was calculated based on efficacy assumptions for continuous abstinence over four weeks. This four-week abstinence period was defined as the study\u2019s primary endpoint, meaning the endpoint on which statistical significance must be demonstrated for the study to be considered successful. The other continuous abstinence measures, up to 12 months, are secondary endpoints intended to document the persistence of the treatment effect. Since the number of patients to be enrolled was not determined on the basis of these endpoints, statistical significance is not expected for them.<\/p>\n

      For both the four-week and 12-month endpoints, compared with the general population, efficacy in the target population is higher and the difference versus placebo is greater. In addition, for the four-week endpoint, statistical significance versus placebo is reached using both confirmation methods: urinary cotinine and exhaled CO.<\/p>\n

      \u00a0<\/p>\n

      Does the absence of statistical significance at 12 months call the results into question?<\/strong><\/h5>\n

      Not at all.<\/p>\n

      CESTO2 was designed to demonstrate efficacy on four-week continuous abstinence, which was the protocol\u2019s primary endpoint. Continuous abstinence at 12 months was a secondary endpoint. The number of patients, calculated for the primary endpoint, was insufficient to demonstrate a statistically significant difference at 12 months, as continuous abstinence naturally decreases over time.<\/p>\n

      For the 12-month endpoint, compared with the general population, efficacy in the target population is higher and the difference versus placebo is greater. Ultimately, an efficacy rate of 21.3% at 12 months and a 2.4-fold efficacy ratio versus placebo are excellent results that demonstrate the value of selecting this target population.<\/p>\n

      \u00a0<\/p>\n

      Why compare NFL-101 with Champix if the comparison is indirect?<\/strong><\/h5>\n

      Because, to date, an indirect comparison is the only way to assess the potential of NFL-101 relative to existing treatments. NFL Biosciences presents the comparison with the EAGLES study as an indirect comparison, intended to provide positioning information. It is not a direct comparative study between NFL-101 and Champix.<\/p>\n

      Nevertheless, this comparison makes it possible to put the results observed with NFL-101 into context against published results for reference treatments. NFL Biosciences particularly highlights the comparison at three months after the end of treatment, a period considered more relevant given the very different administration regimens. This interpretation should remain cautious and does not replace a direct comparative study.<\/p>\n

      \u00a0<\/p>\n

      What are IgG1 and specific IgG1?<\/strong><\/h5>\n

      IgG1 are a subclass of antibodies associated with acquired immune responses and immunological memory. NFL-101-specific IgG1 reflect the immune memory developed over time through chronic exposure to tobacco.<\/p>\n

      Since NFL-101 consists of tobacco leaf protein extracts, these antibodies indicate prior recognition of these antigens by the immune system. Their baseline levels therefore provide information about the patient\u2019s pre-existing immune status with regard to tobacco antigens.<\/p>\n

      \u00a0<\/p>\n

      What does the IgG1 < 200 ng\/mL threshold mean?<\/strong><\/h5>\n

      The 200 ng\/mL threshold is the concentration used to distinguish biomarker-positive patients from biomarker-negative patients. \u201cng\/mL\u201d means nanograms per milliliter, a unit of concentration used to measure antibody quantities in a biological sample.<\/p>\n

      Patients with low specific IgG1 levels may retain immune responsiveness that allows NFL-101 to exert its full effect. Conversely, patients with higher levels may already have an established or more tolerant immune response, associated with lower responsiveness to treatment.<\/p>\n

      \u00a0<\/p>\n

      I would like to quit smoking and participate in an NFL Biosciences clinical study. How can I participate?<\/strong><\/h5>\n

      TONIC is a Phase 2 study evaluating NFL-102 in smokers who wish to quit smoking permanently. The necessary approvals to initiate the study have been obtained from the ANSM and the Committee for the Protection of Human Subjects (CPP).<\/p>\n

      The first participants are expected to be enrolled in November 2026. The first 40 participants, corresponding to Part A, will be enrolled at the Eurofins Optimed clinical center in Gi\u00e8res, France (38610). For further information, you can contact the center at +33 (0)4 38 37 27 40.<\/p>\n

      Eligibility will be assessed by the medical teams according to the study criteria. Information on participation and study centers will be provided on the NFL Biosciences website and through its official communications.<\/p>\n

      The Phase 3 study of NFL-101 is not yet open for recruitment.<\/p>\n

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