Announcement • 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.

CEO salary percentage	n/a
CEO tenure	less than a year
CEO ownership	n/a
Management average tenure	2.7yrs
Board average tenure	5.9yrs

Name	Position	Tenure	Compensation	Ownership
Frederic Chereau	Chief Executive Officer	less than a year	no data	no data
Laurene Danon	Chief Financial Officer	2.1yrs	no data	no data
Bernd Schmidt	Chief Technical Officer	2.6yrs	no data	no data
Christine Bec	Head of CMC Gene Therapy	6.4yrs	no data	no data
Stephanie Filipe	Head of Business Operations & Portfolio Management	5.1yrs	no data	no data
Laurent Desire	Head of Preclinical Development	3.5yrs	no data	no data
Rachel Cooper	Head of Audiology	2.7yrs	no data	no data

Name	Position	Tenure	Compensation	Ownership
Robert Dow	Member of Scientific Advisory Board	5.9yrs	no data	no data
Khalil Barrage	Director	7yrs	no data	no data
Cédric Moreau	Representative Director	7yrs	no data	no data
Amit Munshi	Independent Chairman	1.3yrs	no data	no data
Alain Fischer	Member of Scientific Advisory Board	5.9yrs	no data	no data
Julien Miara	Director	7yrs	no data	no data
Eric de La Fortelle	Independent Director	14.4yrs	no data	no data
Aniz Girach	Independent Director	4.5yrs	no data	no data
Christine Petit	Chair of Scientific Advisory Board	8.2yrs	no data	no data
Hernán López-Schier	Member of Scientific Advisory Board	5.9yrs	no data	no data
Paul Avan	Member of Scientific Advisory Board	5.9yrs	no data	no data
Diane Lazard	Member of Scientific Advisory Board	5.9yrs	no data	no data

Data	Last Updated (UTC time)
Company Analysis	2026/07/06 21:02
End of Day Share Price	2026/07/06 00:00
Earnings	2025/12/31
Annual Earnings	2025/12/31

Package	Data	Timeframe	Example US Source ^*
Company Financials	10 years	Income statement Cash flow statement Balance sheet	SEC Form 10-K SEC Form 10-Q
Analyst Consensus Estimates	+3 years	Forecast financials Analyst price targets	Analyst Research Reports Blue Matrix
Market Prices	30 years	Stock prices Dividends, Splits and Actions	ICE Market Data SEC Form S-1
Ownership	10 years	Top shareholders Insider trading	SEC Form 4 SEC Form 13D
Management	10 years	Leadership team Board of directors	SEC Form 10-K SEC Form DEF 14A
Key Developments	10 years	Company announcements	SEC Form 8-K

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

Sensorion Management

Management criteria checks 2/4

Key information

Recent management updates

Sensorion SA Announces Chief Executive Officer Changes

Sensorion SA, Annual General Meeting, May 11, 2026

Sensorion Sa Announces Stepping Down of Nawal Ouzren as Director on the Board

Sensorion SA, Annual General Meeting, May 12, 2025

Sensorion Announces Board Changes

Sensorion Announces Appointment of Laurene Danon as Chief Financial Officer

Recent updates

Sensorion Achieves Key Regulatory Milestones for Sens-601 for Gjb2-Related Hearing Loss and Selects Program as Lead Gene Therapy Candidate

Consensus EPS estimates upgraded to €0.015 loss

Sensorion SA Announces Chief Executive Officer Changes

Sensorion SA, Annual General Meeting, May 11, 2026

New major risk - Revenue and earnings growth

No longer forecast to breakeven

New major risk - Revenue and earnings growth

Price target decreased by 23% to €1.30

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

New minor risk - Profitability

Forecast to breakeven in 2026

Consensus revenue estimates fall by 57%

New major risk - Revenue and earnings growth

Sensorion Sa Announces Stepping Down of Nawal Ouzren as Director on the Board

New major risk - Share price stability

New minor risk - Profitability

Forecast to breakeven in 2026

Sensorion SA has filed a Follow-on Equity Offering in the amount of €60 million.

New minor risk - Market cap size

Sensorion Reports Independent Data Monitoring Committee Raises No Safety Concerns and Agrees to Continue SENS-501'S Audiogene Phase 1/2 Trial

Consensus revenue estimates increase by 22%

Price target increased by 12% to €2.38

Sensorion Completes Patient Enrollment of the Second Cohort in Audiogene Phase 1/2 Gene Therapy Clinical Trial

Sensorion Announces Preliminary Positive Data from the First Cohort of the Audiogene Phase 1/2 Gene Therapy Clinical Trial

New minor risk - Market cap size

Consensus revenue estimates increase by 49%

Sensorion SA, Annual General Meeting, May 12, 2025

Sensorion Announces Board Changes

New minor risk - Share price stability

Consensus revenue estimates increase by 26%

Sensorion Announces the End of Patient Inclusion in NOTOXIS Phase 2a Clinical Trial of Sens-401 for the Prevention of Cisplatin-Induced Ototoxicity

Sensorion Receives Positive Recommendation from Data Monitoring Committee of Sens-501’S Audiogene Phase 1/2 Clinical Trial

Price target increased by 7.1% to €2.50

Sensorion Announces Completion of Enrollment of the First Cohort of the Audiogene Phase 1/2 Gene Therapy Clinical Trial

Sensorion Reports Data in the Audiogene Phase 1/2 Gene Therapy Clinical Trial

Does Sensorion (EPA:ALSEN) Have A Healthy Balance Sheet?

Consensus revenue estimates increase by 13%

First half 2024 earnings released

Sensorion Announces Positive Recommendation From the Data Safety Monitoring Board (DSMB) Regarding the Continuation of NOTOXIS, its Phase 2a Clinical Trial of SENS-401 in Cisplatin-Induced Ototoxicity

Sensorion Announces New Positive Secondary Efficacy Endpoints Data from Sens-401 Phase 2A Clinical Trial for the Preservation of Residual Hearing Loss

Sensorion Announces Appointment of Laurene Danon as Chief Financial Officer

New major risk - Revenue and earnings growth

Sensorion SA, Annual General Meeting, May 29, 2024

Sensorion SA has completed a Follow-on Equity Offering in the amount of €15.482057 million.

Sensorion Meets Primary Endpoint for Sens-401 Phase 2A Clinical Study for Residual Hearing Preservation

Sensorion SA to Report Fiscal Year 2023 Results on Mar 14, 2024

Sensorion Announces the Completion of Patient Inclusion in Phase 2A Clinical Trial of Sens-401 for Residual Hearing Preservation After Cochlear Implantation

Sensorion Appoints Federico Mingozzi as Non-Executive Director to the Board of Directors

Sensorion Announces Approval to Initiate Lead Gene Therapy Candidate Sens-501 into a Phase 1/2 Clinical Trial in Some European Countries

Consensus revenue estimates increase by 15%

Sensorion SA Appoints Bernd Schmidt as New Chief Technical Officer

Sensorion SA, Annual General Meeting, Dec 20, 2023

New minor risk - Market cap size

Consensus revenue estimates increase by 242%

Sensorion SA announced that it has received €33.214286 million in funding from Sofimac Innovation SAS, The Invus Group, LLC, Redmile Group, LLC

Price target decreased by 14% to €2.33

New major risk - Revenue and earnings growth

New major risk - Share price stability

New major risk - Shareholder dilution

New major risk - Revenue and earnings growth

Sensorion Submits Clinical Trial Application for OTOF-GT, its Lead Gene Therapy Candidate, in Europe

Sensorion Sa Submits Clinical Trial Application for Lead Gene Therapy Candidate Otof-Gt in the Uk

Sensorion Reports Positive Efficacy Data from SENS-401 Phase 2a Clinical Study

Price target decreased by 33% to €1.80

Sensorion SA Announces First Patient Enrolled in Phase 2a Proof of Concept Clinical Trial of SENS-401 in Cisplatin-Induced Ototoxicity

Less than half of directors are independent

Price target increased to €3.90

Companies Like Sensorion (EPA:ALSEN) Are In A Position To Invest In Growth

Price target increased to €5.15