Tillkännagivande • Mar 23

Sensorion Reports Six-Month Update from the Audiogene Phase 1/2 Trial of SENS-501 and Advances GJB2-GT (SENS-601) Toward First-In-Human Clinical Development

Sensorion reported updated six-month efficacy data from Cohort 2 of the Audiogene Phase 1/2 clinical trial evaluating SENS-501, its gene therapy for the treatment of otoferlin-mediated congenital deafness, and provided a timeline update on the advancement of its GJB2-GT (SENS-601) gene therapy program toward clinical development in Europe and in the U.S. The early directional improvements in pure-tone audiometry reported at Month 3 in two of three patients treated with the higher dose of SENS-501 (Cohort 2) were sustained at the six-month follow-up assessment. These findings build on observations from Cohort 1, where initial signs of auditory pathway activation were reported at a lower dose level, and are consistent with a dose-response relationship across the two cohorts. Across all six patients treated in the dose-escalation phase, the surgical procedure and intra-cochlear administration of SENS-501 continued to be well tolerated, with no serious adverse events or serious side effects reported. Based on the dose-response signal observed across the first two cohorts, the Company is considering a third dose level within the Audiogene trial framework and will consult with regulatory authorities as part of this evaluation, while continuing to monitor the evolving regulatory and competitive landscape for gene therapies in the hearing loss space. The gene therapy for patients suffering from otoferlin deficiency has been developed in the framework of RHU AUDINNOVE, a consortium composed of Sensorion with the Necker Enfants Malades Hospital, the Institut Pasteur, and the Fondation pour l’Audition. The project is partially financed by the French National Research Agency, through the “investing for the future” program (ref: ANR-18-RHUS-0007). The OTOF gene targeted by the Audiogene trial was discovered in 1999 at the Institut Pasteur, by Prof. Christine Petit's team (Institut reConnect, Institut de l'Audition, Pasteur Institute), who also unravelled the pathophysiology of the corresponding deafness (DFNB9). The Company intends to provide regular updates on the GJB2-GT (SENS-601) program as it advances toward the clinic, and will present preclinical safety, biodistribution and efficacy data for SENS-601 in a poster entitled "Safety, biodistribution and efficacy of SENS-601, an AAV-based gene therapy treatment candidate for the autosomal recessive non-syndromic deafness 1A (DFNB1A)" at the American Society of Gene & Cell Therapy (ASGCT) annual meeting in May 2026 in Boston, USA. GJB2 mutations represent the most common cause of genetic congenital deafness, responsible for approximately 50% of autosomal recessive non-syndromic hearing loss. Sensorion's SENS-601 program, developed in collaboration with the Institut Pasteur, targets this significant unmet need with an AAV-based gene therapy approach. CTA-enabling studies are progressing well, and the program remains on track for CTA submission in First Half 2026 and IND submission is targeted by year-end 2026. With a dual CTA/IND strategy targeting both European and U.S. regulatory pathways, SENS-601 is positioned to be the first gene therapy to enter clinical development for GJB2-related hearing loss. SENS-501 (OTOF-GT) is an innovative gene therapy program developed to treat a specific form of congenital deafness linked to mutations in the OTOF (otoferlin) gene. This gene plays a key role in the transmission of auditory signals between the hair cells of the inner ear and the auditory nerve. When this gene is defective, affected individuals are born with severe to profound hearing loss. The aim of SENS-501 (OTOF-GT) is to restore hearing by introducing a functional copy of the OTOF gene directly into hair cells via viral vector technology (AAV). This therapy aims to restore the normal process of converting sound into electrical signals, enabling patients to regain their hearing ability. Currently in the clinical research phase, this gene therapy program represents significant hope for families affected by this rare form of genetic deafness. SENS-501 (OTOF-GT) embodies a commitment to scientific innovation in the field of hearing, with the potential to dramatically improve the quality of life of patients suffering from genetic deafness. This gene therapy for patients suffering from otoferlin deficiency has been developed in the framework of RHU AUDINNOVE, a consortium composed of Sensorion with the Necker Enfants Malades Hospital, the Institut Pasteur, and the Fondation pour l’Audition. The project is partially financed by the French National Research Agency, through the “investing for the future” program (ref: ANR-18-RHUS-0007). The OTOF gene targeted by the Audiogene trial was discovered in 1999 at the Institut Pasteur, by Prof. Christine Petit's team (Institut reConnect, Institut de l'Audition, Pasteur Institute), who also unravelled the pathophysiology of the corresponding deafness (DFNB9). Audiogene aims to evaluate the safety, tolerability and efficacy of intra-cochlear injection of SENS-501 for the treatment of OTOF gene-mediated hearing loss in infants and toddlers aged 6 to 31 months at the time of gene therapy treatment. By targeting the first years of life, when brain plasticity is optimal, the chances of these young children with pre-linguistic hearing loss acquiring normal speech and language are maximized. The study comprises two cohorts of two doses followed by an expansion cohort at the selected dose. While safety will be the primary endpoint of the first part of the dose escalation study, auditory brainstem response (ABR) will be the primary efficacy endpoint of the second part of the expansion. Audiogene will also evaluate the clinical safety, performance and ease-of-use of the delivery system developed by Sensorion. GJB2-GT (SENS-601) is an innovative AAV-based gene therapy program developed in collaboration with the Institut Pasteur to treat hearing loss linked to mutations in the GJB2 gene, which plays a critical role in maintaining the ionic balance necessary for sound transduction in the inner ear. GJB2 mutations represent the most common cause of genetic congenital deafness, responsible for approximately 50% of autosomal recessive non-syndromic hearing loss. Recent research has also established that GJB2 mutations are found in early onset forms of severe presbycusis in adults, which appear to be monogenic potentially treatable by gene therapy. As such, GJB2-GT has the potential to address three distinct pathologies: paediatric congenital deafness, progressive forms of hearing loss in children, and early onset of presbycusis in adults. With no approved gene therapy currently available for GJB2-related hearing loss, SENS-601 has the potential to be the first-in-human gene therapy addressing GJB2 mutations. CTA-enabling studies are progressing well and the program is on track for CTA submission during First Half 2026.

VD-lön i procent	n/a
Anställning som VD	less than a year
Ägande av VD	n/a
Ledningens genomsnittliga anställningstid	2.5yrs
Styrelsens genomsnittliga mandatperiod	5.8yrs

Namn	Position	Anställning	Kompensation	Ägarskap
Amit Munshi	Chairman & Interim CEO	less than a year	inga uppgifter	inga uppgifter
Laurene Danon	Chief Financial Officer	1.9yrs	inga uppgifter	inga uppgifter
Bernd Schmidt	Chief Technical Officer	2.4yrs	inga uppgifter	inga uppgifter
Christine Bec	Head of CMC Gene Therapy	6.3yrs	inga uppgifter	inga uppgifter
Stephanie Filipe	Head of Business Operations & Portfolio Management	4.9yrs	inga uppgifter	inga uppgifter
Laurent Desire	Head of Preclinical Development	3.3yrs	inga uppgifter	inga uppgifter
Rachel Cooper	Head of Audiology	2.5yrs	inga uppgifter	inga uppgifter

Namn	Position	Anställning	Kompensation	Ägarskap
Amit Munshi	Chairman & Interim CEO	1.1yrs	inga uppgifter	inga uppgifter
Robert Dow	Member of Scientific Advisory Board	5.8yrs	inga uppgifter	inga uppgifter
Khalil Barrage	Director	6.8yrs	inga uppgifter	inga uppgifter
Cédric Moreau	Director	6.8yrs	inga uppgifter	inga uppgifter
Alain Fischer	Member of Scientific Advisory Board	5.8yrs	inga uppgifter	inga uppgifter
Julien Miara	Director	6.8yrs	inga uppgifter	inga uppgifter
Eric de La Fortelle	Independent Director	no data	inga uppgifter	inga uppgifter
Aniz Girach	Independent Director	4.3yrs	inga uppgifter	inga uppgifter
Christine Petit	Chair of Scientific Advisory Board	8yrs	inga uppgifter	inga uppgifter
Hernán López-Schier	Member of Scientific Advisory Board	5.8yrs	inga uppgifter	inga uppgifter
Paul Avan	Member of Scientific Advisory Board	5.8yrs	inga uppgifter	inga uppgifter
Diane Lazard	Member of Scientific Advisory Board	5.8yrs	inga uppgifter	inga uppgifter

Uppgifter	Senast uppdaterad (UTC-tid)
Analys av företag	2026/05/22 12:56
Aktiekurs vid dagens slut	2026/05/22 00:00
Intäkter	2025/12/31
Årlig intjäning	2025/12/31

Paket	Uppgifter	Tidsram	Exempel US-källa
Företagets finansiella ställning	10 år	Resultaträkning Kassaflödesanalys Balansräkning	SEC Form 10-K SEC Form 10-Q
Analytikernas konsensusuppskattningar	+3 år	Prognos för finansiella poster Analytikernas prismål	Rapporter från analytiker Blue Matrix
Marknadspriser	30 år	Aktiekurser Utdelningar, splittar och åtgärder	ICE Marknadsdata SEC Form S-1
Ägarskap	10 år	Största aktieägare Insiderhandel	SEC Formulär 4 SEC Formulär 13D
Förvaltning	10 år	Ledningsgrupp Styrelse och verkställande direktörer	SEC Form 10-K SEC Form DEF 14A
Viktiga utvecklingstendenser	10 år	Företagsmeddelanden	SEC Formulär 8-K

Analytiker	Institution
Jack Allen	Baird
Janani Sundararajan	Chardan Capital Markets, LLC
Yevgeniya Livshits	Chardan Capital Markets, LLC

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