THX Pharma: 16M€ cash position end September, Batten-1 Phase 3 preparation underway
The cash position published on October 22, 2026 by THX Pharma (formerly Theranexus) is linked to the Batten-1 timeline. According to the company, third-quarter cash consumption reflects operational preparation of the international Phase 3 pivot trial for this candidate, as well as repayment of bank loan maturities. However, Batten-1 clinical development costs are entirely financed by Biocodex.
The Lyon-based biotech explains this situation by the timing difference between costs incurred and their recharging, which can lead to variations in its cash position from quarter to quarter. Over the same period, the company filed trial authorization requests in the United States and Europe and obtained a European patent protecting Batten-1 until 2041.
Cash position of 16.0M€ at September 30, compared to 17.5M€ end June
At September 30, 2026, THX Pharma's cash and cash equivalents amounted to 16.0 million euros, compared to 17.5 million euros at June 30, 2026. The company attributes this consumption to two items: preparation of the Phase 3 trial for Batten-1 and repayment of bank loan maturities.
This update comes less than a month after the publication of half-year results on September 29, 2026. These showed revenue of 3.2M€ in the first half of 2026, the first in the company's history since its creation in 2013. This revenue stems from the licensing agreement concluded with Biocodex.
The half-year net loss had been reduced to 0.1M€, compared to 1.1M€ in the first half of 2025. On September 30, 2026, the share had declined more than 5% and had fallen back below the 3.50€ threshold.
Batten-1 trial: authorization requests filed in the United States, United Kingdom and Europe; patent protection until 2041
On September 1, 2026, THX Pharma, the Beyond Batten Disease Foundation (BBDF) and Biocodex submitted authorization requests for the Batten-1-02 trial to the American Food and Drug Administration (FDA), the British medicines agency (MHRA) and, via the European CTIS system, to six European Union Member States: France, Germany, the Netherlands, Denmark, Sweden and Italy.
This multicenter, open-label trial is to be conducted at 10 reference centers in the United States and Europe. It plans to include approximately 27 patients aged 4 to 17 years with juvenile Batten disease (CLN3), with visual acuity as the primary evaluation criterion.
In terms of intellectual property, the European Patent Office has granted patent no. EP 4 188 371. This protects the use of miglustat, the active ingredient in Batten-1, in the treatment of the juvenile form of Batten disease until July 30, 2041, in 38 contracting states. THX Pharma holds an exclusive worldwide license to this patent, granted by the BBDF. This protection is in addition to the commercial exclusivities linked to orphan drug designations obtained in the United States and the European Union.
First patients expected by end of 2026
THX Pharma now has two advanced assets: TX01, intended for the treatment of Gaucher disease and Niemann-Pick disease type C, and Batten-1. Commenting on this cash position, Mathieu Charvériat, Chief Executive Officer, stated: "Our cash position of 16.0M€, combined with the full financing of Batten-1 clinical development by Biocodex, allows us to pursue our roadmap".
The executive has set two priorities: the launch of the Phase 3 pivot trial for Batten-1, subject to regulatory approvals, and preparation, with Exeltis, of the marketing authorization application for TX01 in Europe under the PUMA procedure. The next financial publication, dedicated to cash position at December 31, 2026, is scheduled for February 18, 2027.
Subject to clearance from the solicited authorities, the company plans to include the first patients in the Batten-1-02 trial by the end of 2026.