NFL Biosciences: Progress Update Ahead of Upcoming Value-Creating Milestones for Its Two Clinical Programs in Smoking Cessation

MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News:

NFL BIOSCIENCES (Euronext Growth Paris – FR0014003XT0 – ALNFL), a biopharmaceutical company developing immunotherapies for smoking and nicotine cessation, provides an update on progress with NFL-101 and NFL-102 and outlines the timeline for their upcoming scientific and clinical milestones.

Scientific publication on NFL-101 in preparation to support licensing discussions

The post-hoc analysis of CESTO2 study data concerning the biomarker predictive of efficacy has been completed. A group of authors including experts from McLean Hospital / Harvard Medical School in Boston, the Centre for Addiction and Mental Health (CAMH) in Toronto and the Georges Pompidou European Hospital in Paris is finalizing a manuscript, with submission to an international peer-reviewed scientific journal planned in the coming days.

Publication of these results, following independent peer review, will broaden their scientific visibility and support licensing discussions with pharmaceutical companies.

Regulatory decision on the initiation of the Phase 2 TONIC study evaluating NFL-102 expected in November 2026

The application for authorization of the Phase 2 TONIC study evaluating NFL-102 was submitted in late July 2026. As part of the standard application review process, the French National Agency for Medicines and Health Products Safety (ANSM) and the Committee for the Protection of Human Subjects (CPP) sent questions to NFL Biosciences. The Company has responded and, provided no further questions are raised, expects a decision in November 2026.

As a reminder, the TONIC study is expected to enroll 310 smokers to evaluate the safety and efficacy of NFL-102 and determine its optimal dose. An initial analysis will cover the first 40 participants as soon as their data become available.

Mechanisms of action: CEA publication in preparation and initial positive results at McLean/Harvard

The CEA is finalizing a manuscript presenting brain imaging and proteomics results, with submission to an international peer-reviewed scientific journal planned in October. Publication of these results, following independent peer review, could increase their visibility within the scientific community.

Complementing the CEA’s studies on brain activity and the biological pathways involved, McLean Hospital / Harvard Medical School is conducting a preclinical microdialysis study in mice. This technique measures neurotransmitters released in different brain regions to better understand the effects of the immunotherapies developed by NFL Biosciences. The Company received positive initial results in late September. The work is ongoing, and a dedicated announcement will be issued once the results have been consolidated.

About NFL Biosciences: www.nflbiosciences.com

NFL Biosciences is a biopharmaceutical company based in the Montpellier region (France) that is developing a portfolio of innovative immunotherapies for smoking cessation and nicotine dependence. The Company is developing two drug candidates derived from tobacco leaves, NFL-101 and NFL-102, which target complementary complementary biological mechanisms involved in addiction. NFL-101, whose efficacy and safety have been evaluated in a Phase 2 trial, is being developed using a precision medicine approach based on a biomarker that identifies patients most likely to respond to treatment. It is currently preparing for a Phase 3 trial and is intended to be the subject of a licensing agreement. NFL-102 represents a second immunotherapeutic approach and enters Phase 2 to evaluate its efficacy, select the optimal dose, and characterize responders. Both treatments are designed to be administered as just two subcutaneous injections one week apart.

NFL Biosciences shares are listed on Euronext Growth Paris (FR0014003XT0 - ALNFL).