Sensorion (FR0012596468 – ALSEN) has received authorization from the French National Agency for Medicines and Health Products Safety (ANSM) to initiate its Phase I/II clinical trial of SENS-601. The approval, granted on August 31, 2026, under the Fast Track assessment process, clears the path for the HearConnex study in France.

The company targets dosing the first patient by early 2027. Clinical data generation is expected to continue throughout 2027. HearConnex is designed as a two-part, open-label study. Part 1 will assess safety and tolerability following unilateral intra-cochlear administration across two ascending-dose cohorts. Part 2 will evaluate efficacy in an expansion cohort using bilateral administration at the selected dose.

Trial Design and Scope

HearConnex will also assess the safety, tolerability, performance, and usability of Sensorion’s injection system. The trial addresses GJB2-related hearing loss, a condition caused by pathogenic variants in the GJB2 gene, which accounts for approximately 50% of autosomal recessive non-syndromic hearing loss. No treatment addressing the underlying cause is currently approved.

Dr. Sharon Cushing, Pediatric Otolaryngologist at The Hospital for Sick Children (SickKids) in Toronto, serves as Coordinating Investigator and Principal Investigator for the Canadian site, subject to ongoing review completion. Professor Natalie Loundon of AP-HP in Paris leads the French site.

Global Regulatory Timeline

Sensorion is advancing regulatory submissions in multiple jurisdictions alongside the French launch. The review by Health Canada of the Clinical Trial Application (CTA) submitted in June 2026 remains on track. The company targets submitting a CTA in Australia and an Investigational New Drug (IND) application in the U.S. by year-end 2026.

What the Numbers Show

The reliance on the Fast Track assessment procedure indicates a streamlined regulatory pathway relative to standard reviews. This accelerated timeline supports the company’s objective to generate clinical data throughout 2027, compressing the typical early-stage development window for gene therapies targeting genetic deafness.

Upcoming Events

Sensorion will host an online SENS-601 Program Day on September 22, 2026. The event will feature Prof. Christine Petit from Institut Pasteur and Dr. Sharon Cushing, covering the underlying science, patient population, and trial design details.

Sensorion, a clinical-stage biotechnology company focused on hearing loss therapies, announced on July 29, 2026, that it will implement a reverse share split to streamline its capital structure. The move consolidates 50 existing shares with a par value of €0.10 into one new share with a par value of €5, reducing the total number of outstanding shares from 515,648,600 to approximately 10,312,972. This technical adjustment does not alter the total value of shareholders' holdings or the company's overall share capital but aims to improve marketability and compliance with listing requirements on Euronext Growth Paris.

The reverse share split was authorized by the Board of Directors on July 23, 2026, pursuant to the twelfth extraordinary resolution passed at the General Shareholders’ Meeting on May 11, 2026. The Chief Executive Officer finalized the implementation terms on July 27, 2026, and published the official notice in the Bulletin des Annonces Légales Obligatoires (BALO) on July 29, 2026. The process is governed by Articles L. 228-6-1 and R. 228-12 of the French Commercial Code.

Implementation Timeline

Shareholders must be aware of key dates surrounding the consolidation. The exchange period opens on August 13, 2026, allowing investors to adjust their holdings to avoid fractional shares. Trading in existing shares concludes on September 14, 2026, while the new shares begin trading on September 15, 2026.

Fractional Shares and Treasury Adjustments

Investors holding numbers of existing shares not divisible by 50 must purchase or sell fractional shares before September 14, 2026, to ensure full conversion. Those unable to do so will receive compensation from their financial intermediaries between September 17, 2026, and October 17, 2026, based on market sales of the fractional portions. Non-consolidated shares remaining after the deadline will lose voting rights and dividend entitlements.

To achieve a whole number of new shares, Sensorion waived the consolidation of four treasury shares, which were subsequently cancelled. This reduced the resources under its liquidity agreement with Kepler Cheuvreux, originally established on December 15, 2017, in accordance with AMF Decision No. 2021-01 dated June 22, 2021. As of July 27, 2026, the company holds 334,749 treasury shares with associated resources of €38,345,37.

What the Numbers Show

The reduction in share count from over 515 million to approximately 10.3 million represents a significant contraction in the float, likely aimed at meeting minimum price or liquidity thresholds required by European exchanges. While the par value increases fiftyfold to €5, the proportional ownership and economic value for each investor remain unchanged. The suspension of derivative exercise rights from August 14 to September 17, 2026, ensures no dilution or arbitrage opportunities arise during the transition period.