Sensorion Reports 2026 Half-Year Results, Provides Corporate Update and Announces Availability of Half-Year Report

- Clinical Trial Applications (CTAs) for SENS-601 (GJB2-GT), the Company’s lead gene therapy program for GJB2-related hearing loss were fíled in France and Canada, with Fast Track procedure granted in France; the Company subsequently received authorization from the French National Agency for Medicines and Health Products Safety (ANSM) to initiate the Phase I/II HearConnex clinical trial in France
- Investigational New Drug (IND) application in the United States and CTA in Australia expected to be submitted by year-end 2026
- Dosing of the írst patient in HearConnex targeted by early 2027
- Cash, cash equivalents and short-term deposits classified in current assets amounted to €88 million as of June 30, 2026, expected to fínance the Company until the end of 2027

MONTPELLIER, France & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Regulatory News: Sensorion (FR001401A9Z0 – ALSEN) (“the Company”) a pioneering clinical-stage biotechnology company focused on developing novel therapies to restore hearing and treat and prevent hearing loss disorders, today reported its half-year 2026 results, provided a corporate update and announced the availability of its half-year report.

“I am delighted to have joined Sensorion at such an exciting time, as SENS-601 enters the clinic” commented Fred Chereau, Sensorion’s Chief Executive Oficer. “Having filed Clinical Trial Applications in France and Canada, with the ANSM granting Fast Track procedure for assessment of the French CTA, we subsequently received authorization from the ANSM to initiate our Phase I/II HearConnex trial in France. We are backed by high-quality investors, including Sanofi, and remain well-funded to advance the clinical development of SENS-601. We look forward to reporting further progress toward our next milestones, including dosing the first patient in HearConnex by early 2027 and the IND submission in the United States and CTA filing in Australia, both planned by year-end 2026.”

Pipeline Highlights and Upcoming Milestones

Gene Therapies for Hereditary Monogenic Hearing Loss

In the first half of 2026, Sensorion advanced SENS-601, its lead gene therapy program developed in collaboration with the Institut Pasteur, Hearing Institute / Institut reConnect, filing CTAs in France and Canada with Fast Track procedure in France. In August 2026, the Company received authorization from the ANSM to initiate its Phase I/II clinical trial, HearConnex, in France. In June 2026, Sensorion also decided to discontinue further clinical development of SENS-501, its gene therapy program for otoferlin-mediated hearing loss, in order to concentrate resources on SENS-601.

SENS-601 (GJB2-GT): Gene therapy program to restore hearing in patients with GJB2-related hearing loss

SENS-601 is Sensorion's single-vector AAV-based gene therapy candidate designed to restore hearing in patients with hearing loss related to mutations in the GJB2 gene, one of the most common genetic causes of congenital sensorineural hearing loss, accounting for approximately a quarter of autosomal recessive non-syndromic hearing loss cases according to peer-reviewed published studies. SENS-601 is designed to address three non-syndromic forms of GJB2-related hearing loss: pediatric congenital deafness, childhood-onset progressive hearing loss, and early-onset age-related presbycusis in adults, with Sensorion's initial development focus on pediatric congenital deafness.

In June 2026, Sensorion filed CTAs for SENS-601 in France, where the ANSM granted Fast Track procedure for assessment of the CTA, and in Canada. In August 2026, the Company received authorization from the ANSM to initiate its Phase I/II clinical trial, HearConnex, in France. Dosing of the first patient in HearConnex is expected by early 2027. The Company also expects to submit an IND application in the United States and a CTA in Australia by year-end 2026. SENS-601 is designed to be administered via a single intracochlear injection using Sensorion’s internally developed injection system, which has already been evaluated in the Company’s SENS-501 clinical program.

HearConnex is designed as a two-part, open-label study. Part 1 will assess the safety and tolerability of SENS-601, following unilateral intra-cochlear injection across two ascending-dose cohorts. Part 2 will assess the eicacy of SENS-601 in an expansion cohort following bilateral intra-cochlear injection at the optimal dose. HearConnex will also assess the safety, tolerability, performance and usability of Sensorion’s injection system. HearConnex is designed as a multicenter trial, and its Coordinating Investigator is Dr. Sharon Cushing, Pediatric Otolaryngologist and Director of the Cochlear Implant Program at The Hospital for Sick Children (SickKids) in Toronto. Dr. Cushing will also serve as Principal Investigator for the Canadian site, subject to completion of the ongoing review.

In April 2026, the Company entered into a support agreement with Bpifrance for the GJB2-GT program, as part of the ‘France 2030’ investment plan (ConnexGene project). The financing covers the period from January 1, 2026 to January 1, 2030 and aid is granted in the form of a repayable advance. Payments are staggered as one initial advance and four milestone-based instalments for an aggregate amount of up to €10.3 million, subject to the satisfaction of the applicable conditions precedent. In May 2026, the Company received the initial advance of €2.6 million.

OTOCONEX, the Company’s ongoing Natural History Study, documents the natural course of disease progression in patients with GJB2-related hearing loss and supports patient identification and enrollment for HearConnex.

SENS-501 (OTOF-GT): Program discontinued

On June 10, 2026, Sensorion announced its decision to discontinue further clinical development of SENS-501 (OTOF-GT), its gene therapy program for otoferlin-mediated hearing loss, in light of the evolving competitive landscape in this ultra-rare indication, in order to focus its resources on SENS-601. In its Phase I/II Audiogene clinical trial, SENS-501 had shown a satisfactory safety profile, with no serious adverse events across the six infants and toddlers treated. The Company believes that the learnings from SENS-501’s clinical experience can be leveraged as it advances SENS-601 into clinical development.

SENS-401: Sensorion’s small molecule for the treatment and prevention of hearing loss

SENS-401 (Arazasetron) is an orally available small molecule that Sensorion has evaluated in three indications, for which proof-of-concept clinical studies have now been completed: (i) treatment of Sudden Sensorineural Hearing Loss (SSNHL, Phase 2b completed), (ii) preservation of residual hearing following cochlear implantation, in partnership with Cochlear Limited (Phase 2a completed), and (iii) prevention of Cisplatin-Induced Ototoxicity (Phase 2a completed). SENS-401 has been granted Orphan Drug Designation in Europe for the treatment of SSNHL, and in the U.S. for the prevention of Cisplatin-Induced Ototoxicity in the pediatric population. Sensorion's development resources are focused on SENS-601, and the Company is exploring partnering opportunities for SENS-401.

Change in Management and the Board of Directors

On February 17, 2026, Sensorion announced that Nawal Ouzren stepped down from her roles as Chief Executive Oicer and as a Director of the Company. Amit Munshi, Chairman of the Board since April 2025, assumed the role of Interim Chief Executive Oicer from February 2026 to May 2026.

opportunities for SENS-401.

Change in Management and the Board of Directors

On February 17, 2026, Sensorion announced that Nawal Ouzren stepped down from her roles as Chief Executive Oicer and as a Director of the Company. Amit Munshi, Chairman of the Board since April 2025, assumed the role of Interim Chief Executive Oicer from February 2026 to May 2026.

On May 18, 2026, the Company announced the appointment of Fred Chereau as Chief Executive Oicer, effective June 1, 2026. Mr. Chereau brings over 30 years of biotech leadership experience, most recently as Senior Vice President, Strategy and Business Development at Alexion AstraZeneca Rare Disease, following his tenure as President and Chief Executive Oicer of LogicBio Therapeutics, Inc. Mr. Munshi continues to serve as Chairman of the Board of Directors.

Post-Period Highlights

On July 29, 2026, the Company announced a reverse share split of its ordinary shares, exchanging every 50 existing shares with a nominal value of €0.10 each for one new share with a nominal value of €5.00 each. The reverse share split became effective on September 15, 2026, resulting in 10,312,972 ordinary shares with a nominal value of €5.00 each following the cancellation of the four treasury shares excluded from the reverse share split and had no material impact on the total value of shares held by each shareholder. Following the reverse share split, the Company's shares trade under a new ISIN code, FR001401A9Z0.

On September 3, 2026, the Company announced that it had received authorization from the ANSM to initiate HearConnex, its Phase I/II clinical trial of SENS-601 in France. On September 22, 2026, Sensorion hosted its first SENS-601 Program Day, an online scientific event featuring Prof. Christine Petit (Institut reConnect, Institut de l'Audition, Institut Pasteur, Inserm, CNRS) and Dr. Sharon Cushing (The Hospital for Sick Children, Toronto), alongside members of the Company's management team.

Subsequent to the reporting date, the Company informed its workers council of a proposed organizational restructuring to align resources with its focus on SENS-601. Consultation is ongoing, no formal plan has been approved, and the Company cannot yet estimate any financial impact.

Expected future milestones and estimated timelines:

• By year-end 2026: SENS-601 IND application submission in the United States
• By year-end 2026: SENS-601 CTA submission in Australia
• By early 2027: SENS-601 dosing of the first patient in HearConnex First-Half 2026 Financial Highlights
• Cash Position

Cash, cash equivalents, and short-term deposits classified in current assets, amounted to €88 million as of June 30, 2026, compared to €47.5 million as of December 31, 2025