NFL Biosciences: Green Light for Tonic, Cash Runway Brought Forward to Mid-2027
NFL Biosciences published half-year accounts on October 22, 2026, marking the transition from a preparation phase to a clinical execution phase. The biopharmaceutical company, based in the Montpellier region, obtained authorizations from the ANSM and the Committee for the Protection of Persons for its phase 2 TONIC trial dedicated to NFL-102. First inclusions are scheduled for November 2026. This launch has a direct financial translation: the company integrated part A study expenses into its forecasts, thereby advancing its cash runway. As of June 30, 2026, its shareholders' equity stands at -926 k€, compared to 1.820 M€ a year earlier. Its financial debt reaches 3.27 M€, compared to 30 k€ on June 30, 2025, following two financing operations carried out in spring.
Operating Loss of 1.99 M€, Slightly Reduced Year-on-Year
With no revenue during the period, NFL Biosciences recorded an operating result of -1,988 k€ in the first half of 2026, compared to -2,121 k€ in the first half of 2025. The financial result stands at -8 k€, compared to -2 k€ a year earlier. Net income is -1,527 k€, compared to -1,804 k€.
Research tax credit, raised to 470 k€ compared to 320 k€ in the first half of 2025, helps offset the net loss relative to the operating loss. The accounts, prepared in accordance with French accounting standards, were subject to a limited review by the statutory auditor.
According to the company, expenses notably covered supplementary analyses of the CESTO II phase 2 study, characterization of drug candidates, industrial development of NFL-102, and preparation of TONIC. The clinical batch of NFL-102, manufactured in accordance with good pharmaceutical manufacturing practices (GMP), was deemed compliant with specifications upon inspection.
Financial Visibility Brought Forward to End of First Half 2027
As of June 30, 2026, available funds amounted to 2.48 M€, compared to 2.93 M€ on June 30, 2025. On this basis, NFL Biosciences estimates it can finance its operations through the end of the first half of 2027, compared to a previously announced horizon of the third quarter of 2027.
The company explains this revision by the integration of expenses for implementing part A of the TONIC study, which are added to preparation expenses already accounted for (finalization of the clinical batch, submission of authorization request). The new horizon thus covers financing of this part A, whose initial results are expected in April 2027.
The semester was financed by two operations. In March, the company obtained a 0.5 M€ loan from Bpifrance, with a 36-month repayment deferral. In April, it issued convertible bonds with a nominal amount of 2.6 M€ to European investors, including Vester Finance; subscribed at 92% of par value, they raised 2.392 M€.
Going forward, NFL Biosciences states it is seeking strategic and financial partners to ensure part B of TONIC and the launch of the phase 3 of NFL-101. The company specifies that it will favor a strategic partner to finance phase 3.
Biomarker to be Confirmed for NFL-101, First TONIC Data in April 2027
For NFL-101, post-hoc analyses of CESTO II identified a population defined by an initial IgG1-specific antibody rate below 200 ng/mL, representing 57.2% of the 306 participants whose samples could be analyzed. In this subgroup, at the 100 µg dose, the rate of continuous four-week abstinence reached 29.5% under treatment compared to 12.1% under placebo (p = 0.016). The company specifies that the predictive nature of the biomarker will need to be confirmed prospectively.
NFL Biosciences intends to seek FDA and EMA feedback on a phase 3 plan incorporating this biomarker, with regulatory exchanges scheduled between January and April 2027. The program is intended to be the subject of a licensing agreement. A manuscript on these results is to be submitted to a peer-reviewed journal in October 2026.
The TONIC study plans to enroll 310 smokers in France, in a randomized double-blind placebo-controlled trial, with an adaptive design starting from three doses. Part A will involve 40 participants and allow one dose to be eliminated; part B will enroll 270 additional participants. In parallel, a preclinical study in mice conducted by McLean Hospital / Harvard Medical School delivered initial results deemed positive by the company in late September, and the portfolio now comprises five patent families.
The analysis of the first 40 TONIC participants, scheduled for April 2027, occurs before the end of the first half of 2027, the deadline of the cash runway announced by the company.
