France-based hearing loss biotech Sensorion (Euronext: ALSEN) has confidentially submitted a draft registration statement on Form F-1 to the US Securities and Exchange Commission (SEC), a preliminary step toward a potential US initial public offering of American Depositary Shares (ADSs) on a US national exchange. No offering size, price range, exchange, or underwriters have been disclosed at this stage.
The move to access US capital markets comes as Sensorion pivots its pipeline around SENS-601 (GJB2-GT), an adeno-associated virus (AAV)-based gene therapy targeting hearing loss caused by mutations in the GJB2 gene — the most common cause of genetic congenital deafness. In June 2026, Sensorion filed clinical trial applications for SENS-601 in Canada and France, with the French medicines agency (ANSM) granting Fast Track designation. The company said IND submission with the FDA and a submission in Australia are targeted by year-end 2026.
The company extended its cash runway to end-2027 following the selection of SENS-601 as its lead program and a strategic decision to discontinue its prior lead program, SENS-501 (OTOF-GT), an otoferlin gene therapy that had been in the Phase I/II Audiogene trial. Sensorion said concentrating resources on SENS-601 reflected the larger addressable patient population in GJB2-related hearing loss relative to the ultra-rare otoferlin indication, where a competing therapy had demonstrated clinical efficacy.
Sensorion's pipeline also includes SENS-401 (arazasetron), an oral small molecule otoprotective agent that has completed three Phase II proof-of-concept studies: in sudden sensorineural hearing loss (SSNHL), in residual hearing preservation ahead of cochlear implantation in collaboration with Cochlear Limited (ASX: COH), and in cisplatin-induced ototoxicity (CIO), with CIO analysis from the NOTOXIS study completed in Q1 2026. SENS-401 holds Orphan Drug Designation from the FDA for prevention of platinum-induced ototoxicity in pediatric patients and from the European Medicines Agency (EMA) for treatment of SSNHL.