{"success":true,"data":{"pressRelease":{"id":"161195","rtpr_id":"nBw2Mwq6Ha-20261006","ticker":"ALNFL","exchange":"Euronext Paris","all_tickers":["ALNFL"],"title":"NFL Biosciences: Progress Update Ahead of Upcoming Value-Creating Milestones for Its Two Clinical Programs in Smoking Cessation","author":"Business Wire","published_at":"2026-10-06T06:00:00.098Z","article_body":"NFL Biosciences: Progress Update Ahead of Upcoming Value-Creating Milestones\nfor Its Two Clinical Programs in Smoking Cessation\n\nRegulatory News:\n\nNFL BIOSCIENCES (Euronext Growth Paris – FR0014003XT0 – ALNFL), a\nbiopharmaceutical company developing immunotherapies for smoking and nicotine\ncessation, provides an update on progress with NFL-101 and NFL-102 and\noutlines the timeline for their upcoming scientific and clinical milestones.\n\nScientific publication on NFL-101 in preparation to support licensing\ndiscussions\n\nThe post-hoc analysis of CESTO2 study data concerning the biomarker predictive\nof efficacy has been completed. A group of authors including experts from\nMcLean Hospital / Harvard Medical School in Boston, the Centre for Addiction\nand Mental Health (CAMH) in Toronto and the Georges Pompidou European Hospital\nin Paris is finalizing a manuscript, with submission to an international\npeer-reviewed scientific journal planned in the coming days.\n\nPublication of these results, following independent peer review, will broaden\ntheir scientific visibility and support licensing discussions with\npharmaceutical companies.\n\nRegulatory decision on the initiation of the Phase 2 TONIC study evaluating\nNFL-102 expected in November 2026\n\nThe application for authorization of the Phase 2 TONIC study evaluating\nNFL-102 was submitted in late July 2026. As part of the standard application\nreview process, the French National Agency for Medicines and Health Products\nSafety (ANSM) and the Committee for the Protection of Human Subjects (CPP)\nsent questions to NFL Biosciences. The Company has responded and, provided no\nfurther questions are raised, expects a decision in November 2026.\n\nAs a reminder, the TONIC study is expected to enroll 310 smokers to evaluate\nthe safety and efficacy of NFL-102 and determine its optimal dose. An initial\nanalysis will cover the first 40 participants as soon as their data become\navailable.\n\nMechanisms of action: CEA publication in preparation and initial positive\nresults at McLean/Harvard\n\nThe CEA is finalizing a manuscript presenting brain imaging and proteomics\nresults, with submission to an international peer-reviewed scientific journal\nplanned in October. Publication of these results, following independent peer\nreview, could increase their visibility within the scientific community.\n\nComplementing the CEA’s studies on brain activity and the biological\npathways involved, McLean Hospital / Harvard Medical School is conducting a\npreclinical microdialysis study in mice. This technique measures\nneurotransmitters released in different brain regions to better understand the\neffects of the immunotherapies developed by NFL Biosciences. The Company\nreceived positive initial results in late September. The work is ongoing, and\na dedicated announcement will be issued once the results have been\nconsolidated.\n\nAbout NFL Biosciences: www.nflbiosciences.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.nflbiosciences.com&esheet=54616391&newsitemid=20261005969891&lan=en-US&anchor=www.nflbiosciences.com&index=1&md5=7e8a3cfd652365c478d52c5d254aa111)\n\nNFL Biosciences is a biopharmaceutical company based in the Montpellier region\n(France) that is developing a portfolio of innovative immunotherapies for\nsmoking cessation and nicotine dependence. The Company is developing two drug\ncandidates derived from tobacco leaves, NFL-101 and NFL-102, which target\ncomplementary complementary biological mechanisms involved in addiction.\nNFL-101, whose efficacy and safety have been evaluated in a Phase 2 trial, is\nbeing developed using a precision medicine approach based on a biomarker that\nidentifies patients most likely to respond to treatment. It is currently\npreparing for a Phase 3 trial and is intended to be the subject of a licensing\nagreement. NFL-102 represents a second immunotherapeutic approach and enters\nPhase 2 to evaluate its efficacy, select the optimal dose, and characterize\nresponders. Both treatments are designed to be administered as just two\nsubcutaneous injections one week apart.\n\nNFL Biosciences shares are listed on Euronext Growth Paris (FR0014003XT0 -\nALNFL).\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20261005969891/en/\n(https://www.businesswire.com/news/home/20261005969891/en/)\n\nNewCap \n\nInvestor Relations / Media Relations\n\nMathilde Bohin / Jérémy Digel\n\nTel.: 01 44 71 94 94\n\nE-mail : nfl@newcap.eu (mailto:nfl@newcap.eu)\n\nNFL Biosciences \n\nBruno Lafont\n\nTél.: 04 11 93 76 67\n\nE-mail : info@nflbiosciences.com (mailto:info@nflbiosciences.com)\n\n\nCopyright Business Wire 2026","article_body_html":"","raw_payload":{"data":{"id":"nBw2Mwq6Ha-20261006","title":"NFL Biosciences: Progress Update Ahead of Upcoming Value-Creating Milestones for Its Two Clinical Programs in Smoking Cessation","author":"Business Wire","ticker":"ALNFL","created":"2026-10-06T06:00:00.098Z","tickers":["ALNFL"],"exchange":"Euronext Paris","article_body":"NFL Biosciences: Progress Update Ahead of Upcoming Value-Creating Milestones\nfor Its Two Clinical Programs in Smoking Cessation\n\nRegulatory News:\n\nNFL BIOSCIENCES (Euronext Growth Paris – FR0014003XT0 – ALNFL), a\nbiopharmaceutical company developing immunotherapies for smoking and nicotine\ncessation, provides an update on progress with NFL-101 and NFL-102 and\noutlines the timeline for their upcoming scientific and clinical milestones.\n\nScientific publication on NFL-101 in preparation to support licensing\ndiscussions\n\nThe post-hoc analysis of CESTO2 study data concerning the biomarker predictive\nof efficacy has been completed. A group of authors including experts from\nMcLean Hospital / Harvard Medical School in Boston, the Centre for Addiction\nand Mental Health (CAMH) in Toronto and the Georges Pompidou European Hospital\nin Paris is finalizing a manuscript, with submission to an international\npeer-reviewed scientific journal planned in the coming days.\n\nPublication of these results, following independent peer review, will broaden\ntheir scientific visibility and support licensing discussions with\npharmaceutical companies.\n\nRegulatory decision on the initiation of the Phase 2 TONIC study evaluating\nNFL-102 expected in November 2026\n\nThe application for authorization of the Phase 2 TONIC study evaluating\nNFL-102 was submitted in late July 2026. As part of the standard application\nreview process, the French National Agency for Medicines and Health Products\nSafety (ANSM) and the Committee for the Protection of Human Subjects (CPP)\nsent questions to NFL Biosciences. The Company has responded and, provided no\nfurther questions are raised, expects a decision in November 2026.\n\nAs a reminder, the TONIC study is expected to enroll 310 smokers to evaluate\nthe safety and efficacy of NFL-102 and determine its optimal dose. An initial\nanalysis will cover the first 40 participants as soon as their data become\navailable.\n\nMechanisms of action: CEA publication in preparation and initial positive\nresults at McLean/Harvard\n\nThe CEA is finalizing a manuscript presenting brain imaging and proteomics\nresults, with submission to an international peer-reviewed scientific journal\nplanned in October. Publication of these results, following independent peer\nreview, could increase their visibility within the scientific community.\n\nComplementing the CEA’s studies on brain activity and the biological\npathways involved, McLean Hospital / Harvard Medical School is conducting a\npreclinical microdialysis study in mice. This technique measures\nneurotransmitters released in different brain regions to better understand the\neffects of the immunotherapies developed by NFL Biosciences. The Company\nreceived positive initial results in late September. The work is ongoing, and\na dedicated announcement will be issued once the results have been\nconsolidated.\n\nAbout NFL Biosciences: www.nflbiosciences.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.nflbiosciences.com&esheet=54616391&newsitemid=20261005969891&lan=en-US&anchor=www.nflbiosciences.com&index=1&md5=7e8a3cfd652365c478d52c5d254aa111)\n\nNFL Biosciences is a biopharmaceutical company based in the Montpellier region\n(France) that is developing a portfolio of innovative immunotherapies for\nsmoking cessation and nicotine dependence. The Company is developing two drug\ncandidates derived from tobacco leaves, NFL-101 and NFL-102, which target\ncomplementary complementary biological mechanisms involved in addiction.\nNFL-101, whose efficacy and safety have been evaluated in a Phase 2 trial, is\nbeing developed using a precision medicine approach based on a biomarker that\nidentifies patients most likely to respond to treatment. It is currently\npreparing for a Phase 3 trial and is intended to be the subject of a licensing\nagreement. NFL-102 represents a second immunotherapeutic approach and enters\nPhase 2 to evaluate its efficacy, select the optimal dose, and characterize\nresponders. Both treatments are designed to be administered as just two\nsubcutaneous injections one week apart.\n\nNFL Biosciences shares are listed on Euronext Growth Paris (FR0014003XT0 -\nALNFL).\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20261005969891/en/\n(https://www.businesswire.com/news/home/20261005969891/en/)\n\nNewCap \n\nInvestor Relations / Media Relations\n\nMathilde Bohin / Jérémy Digel\n\nTel.: 01 44 71 94 94\n\nE-mail : nfl@newcap.eu (mailto:nfl@newcap.eu)\n\nNFL Biosciences \n\nBruno Lafont\n\nTél.: 04 11 93 76 67\n\nE-mail : info@nflbiosciences.com (mailto:info@nflbiosciences.com)\n\n\nCopyright Business Wire 2026"},"type":"article","timestamp":"2026-10-06T06:00:00.149409039Z","server_sent_at_ms":1791266400149},"received_at":"2026-10-06T06:00:00.200Z","source_url":"https://www.businesswire.com/news/home/20261005969891/en/"},"analysis":{"id":"149750","press_release_id":"161195","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":["no new clinical data disclosed; milestone dates could slip pending further regulator questions"],"eventType":"clinical_trial","narrative":"NFL Biosciences provided a progress update on its two smoking-cessation immunotherapy candidates, NFL-101 and NFL-102, ahead of upcoming milestones.\n\nA post-hoc analysis of the CESTO2 biomarker study is complete, and a manuscript authored with experts from McLean Hospital/Harvard, CAMH Toronto, and Georges Pompidou Hospital is being submitted to a peer-reviewed journal to support licensing discussions for NFL-101.\n\nFor NFL-102, the company responded to ANSM and ethics committee questions on its Phase 2 TONIC study application and expects a regulatory decision in November 2026; the trial plans to enroll 310 smokers with an initial analysis of the first 40 participants.\n\nAdditional mechanism-of-action publications from the CEA and positive initial preclinical microdialysis results from McLean/Harvard round out the update, though none contain new efficacy data.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"Pipeline housekeeping for a micro-cap biotech — the real catalyst is the November 2026 ANSM decision on the TONIC Phase 2 study."},"keyFigures":{"drugName":"NFL-101; NFL-102","phaseOfTrial":"Phase 2 (TONIC study for NFL-102)","customDimensions":{"tonic_planned_enrollment":310,"regulatory_decision_expected":"November 2026","interim_analysis_participants":40}},"namedEntities":{"people":[{"name":"Bruno Lafont","role":"NFL Biosciences contact"},{"name":"Mathilde Bohin","role":"NewCap Investor Relations"},{"name":"Jérémy Digel","role":"NewCap Media Relations"}],"products":["NFL-101","NFL-102"],"companies":[{"name":"NFL Biosciences","ticker":"ALNFL","relationship":"filer"},{"name":"McLean Hospital / Harvard Medical School","relationship":"research collaborator"},{"name":"Centre for Addiction and Mental Health (CAMH)","relationship":"research collaborator"},{"name":"Georges Pompidou European Hospital","relationship":"research collaborator"},{"name":"French National Agency for Medicines and Health Products Safety (ANSM)","relationship":"regulator"},{"name":"Commissariat à l'énergie atomique (CEA)","relationship":"research collaborator"},{"name":"NewCap","relationship":"investor relations agency"}],"dollarAmounts":[]},"materialImpact":{"score":2,"reasoning":"Routine pipeline progress update: completed post-hoc biomarker analysis, manuscript submissions planned, and a Phase 2 regulatory decision expected November 2026. No new data, no binary outcome, and no clinical results disclosed."},"tickerRelevance":{"others":[],"primary":"ALNFL"},"globalImportance":15,"audienceRelevance":10,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"micro-cap (Euronext Growth)","eventGravity":"routine pipeline update without new data","sectorWeight":"biotech milestone catalysts matter but none imminent with data","issuerAuthored":true}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":2,"narrative":"NFL Biosciences provided a progress update on its two smoking-cessation immunotherapy candidates, NFL-101 and NFL-102, ahead of upcoming milestones.\n\nA post-hoc analysis of the CESTO2 biomarker study is complete, and a manuscript authored with experts from McLean Hospital/Harvard, CAMH Toronto, and Georges Pompidou Hospital is being submitted to a peer-reviewed journal to support licensing discussions for NFL-101.\n\nFor NFL-102, the company responded to ANSM and ethics committee questions on its Phase 2 TONIC study application and expects a regulatory decision in November 2026; the trial plans to enroll 310 smokers with an initial analysis of the first 40 participants.\n\nAdditional mechanism-of-action publications from the CEA and positive initial preclinical microdialysis results from McLean/Harvard round out the update, though none contain new efficacy data.","key_figures":{"drugName":"NFL-101; NFL-102","phaseOfTrial":"Phase 2 (TONIC study for NFL-102)","customDimensions":{"tonic_planned_enrollment":310,"regulatory_decision_expected":"November 2026","interim_analysis_participants":40}},"named_entities":{"people":[{"name":"Bruno Lafont","role":"NFL Biosciences contact"},{"name":"Mathilde Bohin","role":"NewCap Investor Relations"},{"name":"Jérémy Digel","role":"NewCap Media Relations"}],"products":["NFL-101","NFL-102"],"companies":[{"name":"NFL Biosciences","ticker":"ALNFL","relationship":"filer"},{"name":"McLean Hospital / Harvard Medical School","relationship":"research collaborator"},{"name":"Centre for Addiction and Mental Health (CAMH)","relationship":"research collaborator"},{"name":"Georges Pompidou European Hospital","relationship":"research collaborator"},{"name":"French National Agency for Medicines and Health Products Safety (ANSM)","relationship":"regulator"},{"name":"Commissariat à l'énergie atomique (CEA)","relationship":"research collaborator"},{"name":"NewCap","relationship":"investor relations agency"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-06T06:00:07.249Z","global_importance":15,"audience_relevance":10,"importance_components":{"tickerTier":"micro-cap (Euronext Growth)","eventGravity":"routine pipeline update without new data","sectorWeight":"biotech milestone catalysts matter but none imminent with data","issuerAuthored":true}},"durationMs":6936,"modelName":"glm-5.3-flashx"}}