Latest news with #SENS-501
Business Wire
21 hours ago
- Business
- Business Wire
Sensorion Announces an Increase in Resources Allocated to the Liquidity Contract with Kepler Cheuvreux
MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News: Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company specializing in the development of novel therapies to restore, treat and prevent hearing loss disorders, today announces an increase in resources allocated to the liquidity contract entrusted to Kepler Cheuvreux. On 15 December 2017 Sensorion entered into a Liquidity Contract with Kepler Cheuvreux, modified by amendments dated 7 December 2018 and 15 July 2022 (the " Contract"). This Contract aims to promote the liquidity of the Shares of Sensorion on Euronext Paris. On 14 August 2025, in accordance with Article 4 of AMF Decision No. 2021-01 of 22 June 2021 renewing the establishment of liquidity contracts on equity securities as an accepted market practice, Sensorion increased the resources allocated to the liquidity contract by €60,000. Following this increase in resources, as of 14 August 2025, the following assets appear on the liquidity account: - 206,211 Sensorion Ordinary Shares - €66,965.21 About Sensorion Sensorion is a pioneering clinical-stage biotech company, which specializes in the development of novel therapies to restore, treat, and prevent hearing loss disorders, a significant global unmet medical need. Sensorion has built a unique R&D technology platform to expand its understanding of the pathophysiology and etiology of inner ear related diseases, enabling it to select the best targets and mechanisms of action for drug candidates. It has two gene therapy programs aimed at correcting hereditary monogenic forms of deafness, developed in the framework of its broad strategic collaboration focused on the genetics of hearing with the Institut Pasteur. SENS-501 (OTOF-GT) currently being developed in a Phase 1/2 clinical trial, targets deafness caused by mutations of the gene encoding for otoferlin and GJB2-GT targets hearing loss related to mutations in GJB2 gene to potentially address important hearing loss segments in adults and children. The Company is also working on the identification of biomarkers to improve diagnosis of these underserved illnesses. Sensorion's portfolio also comprises programs of a clinical-stage small molecule, SENS-401 (Arazasetron), for the treatment and prevention of hearing loss disorders. Sensorion's small molecule progresses in a Phase 2 proof of concept clinical study of SENS-401 in Cisplatin-Induced Ototoxicity (CIO) for the preservation of residual hearing. Sensorion, with partner Cochlear Limited, completed in 2024 a Phase 2a study of SENS-401 for the residual hearing preservation in patients scheduled for cochlear implantation. A Phase 2 study of SENS-401 was also completed in Sudden Sensorineural Hearing Loss (SSNHL) in January 2022. Disclaimer This press release contains certain forward-looking statements concerning Sensorion and its business. Such forward looking statements are based on assumptions that Sensorion considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the 2024 full year report published on March 14, 2025, and available on our website and to the development of economic conditions, financial markets and the markets in which Sensorion operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Sensorion or not currently considered material by Sensorion. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Sensorion to be materially different from such forward-looking statements. This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Sensorion shares in any country. The communication of this press release in certain countries may constitute a violation of local laws and regulations. Any recipient of this press release must inform oneself of any such local restrictions and comply therewith.
Business Wire
29-07-2025
- Business
- Business Wire
Sensorion Completes Patient Enrollment of the Second Cohort in Audiogene Phase 1/2 Gene Therapy Clinical Trial
MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News: Sensorion (FR0012596468 – ALSEN), a pioneering clinical-stage biotechnology company specializing in the development of novel therapies to restore, treat and prevent hearing loss disorders, today announced the completion of patient enrollment in the second cohort of its Phase 1/2 Audiogene clinical trial evaluating SENS-501, the Company's gene therapy candidate being developed to treat a specific form of congenital deafness linked to mutations in the OTOF (otoferlin) gene. Recruitment of the second cohort, composed of three patients aged between 6 and 31 months, was recently completed with the injection of the third patient. Patients in this second cohort were administered, unilaterally, a dose of d4.5 E 11 vg/vector/ear of SENS-501 which was higher than the dose in the 1 st cohort (1.5 E 11 vg/vector/ear). For all patients treated in the first and second cohorts, the surgical procedure was well tolerated: the intra-cochlear administration of the gene therapy product was uneventful. No serious adverse events and no serious side effects were reported. Early signs of hearing improvement have been observed in Patient 3, aged 11 months at the time of injection, three months after receiving the low dose. Nawal Ouzren, Chief Executive Officer of Sensorion, commented: "The completion of patient enrollment in the second cohort in Audiogene is an important milestone as it enables us to attest to the safety of the surgical approach, as no serious adverse events have been observed in all six patients injected, and of the good tolerability of SENS-501 to date. I look forward to advancing this innovative and unique program to its next steps, notably with the planned Data Monitoring Committee meeting, and to providing an update as soon as the data have sufficiently matured. On behalf of my colleagues, I would like to extend gratitude to the patients' families for their trust, as well as all the healthcare professionals involved in this clinical trial.' Professor Natalie Loundon, M.D., Director of the Center for Research in Pediatric Audiology, Pediatric Otolaryngologist and Head and Neck Surgeon, Necker Enfants Malades, AP-HP, in Paris, France, Principal Investigator of the Audiogene clinical study, added: 'I am thrilled we have successfully completed the patient enrollment of the second Cohort in Audiogene's Phase 1/2 gene therapy trial. The good tolerability of patients to SENS-501 so far and the preliminary positive data from the first cohort are very encouraging first steps for the continuation of this trial that has the potential to address a global significant unmet medical need. Once again, I would like to thank the patients' families for their trust.' Audiogene ( ID: NCT06370351) is the first gene therapy clinical trial addressing a unique homogeneous population of infants and toddlers (aged 6 to 31 months and naive of cochlear implants at the time of the injection, as per study protocol). Audiogene's clinical trial design has been intended to assess SENS-501 gene therapy product's safety and tolerability as well as its capacity not only to restore hearing but also to allow the infants and toddlers to acquire and develop normal speech. Moreover, Audiogene aims to evaluate the usability, the clinical and the technical performances of the injection system in development. About SENS-501 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 unraveled the pathophysiology of the corresponding deafness (DFNB9). About the Audiogene Trial 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. About Sensorion Sensorion is a pioneering clinical-stage biotech company, which specializes in the development of novel therapies to restore, treat, and prevent hearing loss disorders, a significant global unmet medical need. Sensorion has built a unique R&D technology platform to expand its understanding of the pathophysiology and etiology of inner ear related diseases, enabling it to select the best targets and mechanisms of action for drug candidates. It has two gene therapy programs aimed at correcting hereditary monogenic forms of deafness, developed in the framework of its broad strategic collaboration focused on the genetics of hearing with the Institut Pasteur. SENS-501 (OTOF-GT) currently being developed in a Phase 1/2 clinical trial, targets deafness caused by mutations of the gene encoding for otoferlin and GJB2-GT targets hearing loss related to mutations in GJB2 gene to potentially address important hearing loss segments in adults and children. The Company is also working on the identification of biomarkers to improve diagnosis of these underserved illnesses. Sensorion's portfolio also comprises programs of a clinical-stage small molecule, SENS-401 (Arazasetron), for the treatment and prevention of hearing loss disorders. Sensorion's small molecule progresses in a Phase 2 proof of concept clinical study of SENS-401 in Cisplatin-Induced Ototoxicity (CIO) for the preservation of residual hearing. Sensorion, with partner Cochlear Limited, completed in 2024 a Phase 2a study of SENS-401 for the residual hearing preservation in patients scheduled for cochlear implantation. A Phase 2 study of SENS-401 was also completed in Sudden Sensorineural Hearing Loss (SSNHL) in January 2022. Disclaimer This press release contains certain forward-looking statements concerning Sensorion and its business. Such forward looking statements are based on assumptions that Sensorion considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the 2024 full year report published on March 14, 2025, and available on our website and to the development of economic conditions, financial markets and the markets in which Sensorion operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Sensorion or not currently considered material by Sensorion. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Sensorion to be materially different from such forward-looking statements. This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Sensorion shares in any country. The communication of this press release in certain countries may constitute a violation of local laws and regulations. Any recipient of this press release must inform oneself of any such local restrictions and comply therewith.
Business Wire
01-07-2025
- Business
- Business Wire
Sensorion Announces Preliminary Positive Data from the First Cohort of the Audiogene Phase 1/2 Gene Therapy Clinical Trial
MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News: Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company specializing in the development of novel therapies to restore, treat and prevent hearing loss disorders, today announced preliminary positive data from the first cohort of the Phase 1/2 Audiogene clinical trial evaluating the low dose of SENS-501, the Company's gene therapy candidate being developed to treat a specific form of congenital deafness linked to mutations in the OTOF (otoferlin) gene. The second cohort at a higher dose is ongoing and recruitment is close to being completed. The results from all patients dosed to date (5) confirm that SENS-501 and the corresponding surgical procedure are well tolerated by all participating infants and toddlers (aged 6 to 31 months and naive of cochlear implants at the time of the injection, as per study protocol) having received a gene therapy injection. Intracochlear administration of SENS-501 was uneventful, and no serious adverse events or serious side effects were reported. Three patients were enrolled into Cohort 1 and received a low dose of SENS-501 of 1.5 E 11 vg/vector/ear, corresponding to the minimally effective dose in preclinical studies. The primary objective is to assess the safety and feasibility of the intra-cochlear administration of SENS-501. In Cohort 1, early signs of hearing improvement were observed in Patient 3, aged 11 months at the time of injection. The clinical response observed in Patient 3 was evaluated using standard hearing tests carried out by the investigators (Auditory Brainstem Response ABR, Pure Tone Audiometry PTA, and Patient (Parents) Reported Outcomes PROs). Three-month data from the Patient 3 include: Positive ABR responses at two frequencies, with the best frequency reaching 70 dB. Improvement of hearing levels across two speech frequencies with best frequency reaching 90 dB level, per PTA. Meaningful changes in responses to sounds and voices as reported by the parents with an IT-MAIS score increase of 16 points (145% relative improvement from baseline), and met expected auditory milestones based on an age-based parent questionnaire and according to the patient's age (LittlEARS). The recruitment in Cohort 2, utilizing a second and higher dose level, is nearly complete. The Company plans to provide the next update when Cohort 2 data have reached sufficient maturity to determine next steps for the program. Professor Catherine Birman, ENT surgeon, otolaryngologist, and Senior Staff Specialist at the Children's Hospital at Westmead, Australia, commented: "I'm thrilled to report the preliminary Cohort 1 data of SENS-501 in the first infants and toddlers treated with this highly innovative therapy. Treatment with SENS-501 had a good safety profile and the onset of early auditory responses observed in Patient 3 of the first cohort is very encouraging, especially given the very low dose of vector injected, which is primarily intended at assessing the safety of the therapeutic and of the intracochlear surgical procedure. I look forward to Patient 3's next visit and continuing the Audiogene study with the second cohort to assess a higher dose of SENS-501. Treating children under 31 months of age and naive of cochlear implants is a much-needed undertaking, as restoring hearing in the first three years of childhood has the potential to result in de-novo language acquisition. We thank Sensorion for their commitment to this patient population.' The Phase 1/2 clinical trial Audiogene ( ID: NCT06370351), developed in the frame of the strategic partnership with the Institut Pasteur and led by Professor Natalie Loundon, Coordinating Investigator, M.D., Director of the Center for Research in Pediatric Audiology, Pediatric Otolaryngologist and Head and Neck Surgeon, Necker Enfants Malades, AP-HP, in Paris, France, aims to evaluate the safety and efficacy of an intra-cochlear injection of SENS-501 for the treatment of OTOF gene-induced hearing loss in paediatric patients aged 6 to 31 months and naive of cochlear implants at the time of the gene therapy treatment. Audiogene consists of a dose-escalation part, comprising two cohorts of three patients each, assessing a low dose of SENS-501 in Cohort 1 (1.5 E 11 vg/vector/ear) and a higher dose of SENS-501 in Cohort 2 (4.5 E 11 vg/vector/ear). The dose-escalation part will be followed by a dose-expansion cohort at the selected dose. While safety is the primary endpoint of the dose escalation study, Auditory Brainstem Response, twelve months following the injection, will be the primary endpoint for the dose expansion part. Audiogene is the first gene therapy clinical trial addressing a unique homogeneous population of infants and toddlers (aged 6 to 31 months and naive of cochlear implants at the time of the gene therapy injection). Addressing this young patient population aims at maximizing the chances of these infants and toddlers to acquire language (below three years old, when brain plasticity is optimal). Furthermore, and uniquely to Audiogene's gene therapy program, all enrolled patients should not have current or previous cochlear implantation in the treated or contralateral ear, allowing to best document the contribution of the gene therapy in speech development. About SENS-501 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 unraveled the pathophysiology of the corresponding deafness (DFNB9). About Sensorion Sensorion is a pioneering clinical-stage biotech company, which specializes in the development of novel therapies to restore, treat, and prevent hearing loss disorders, a significant global unmet medical need. Sensorion has built a unique R&D technology platform to expand its understanding of the pathophysiology and etiology of inner ear related diseases, enabling it to select the best targets and mechanisms of action for drug candidates. It has two gene therapy programs aimed at correcting hereditary monogenic forms of deafness, developed in the framework of its broad strategic collaboration focused on the genetics of hearing with the Institut Pasteur. SENS-501 (OTOF-GT) currently being developed in a Phase 1/2 clinical trial, targets deafness caused by mutations of the gene encoding for otoferlin and GJB2-GT targets hearing loss related to mutations in GJB2 gene to potentially address important hearing loss segments in adults and children. The Company is also working on the identification of biomarkers to improve diagnosis of these underserved illnesses. Sensorion's portfolio also comprises programs of a clinical-stage small molecule, SENS-401 (Arazasetron), for the treatment and prevention of hearing loss disorders. Sensorion's small molecule progresses in a Phase 2 proof of concept clinical study of SENS-401 in Cisplatin-Induced Ototoxicity (CIO) for the preservation of residual hearing. Sensorion, with partner Cochlear Limited, completed in 2024 a Phase 2a study of SENS-401 for the residual hearing preservation in patients scheduled for cochlear implantation. A Phase 2 study of SENS-401 was also completed in Sudden Sensorineural Hearing Loss (SSNHL) in January 2022. Disclaimer This press release contains certain forward-looking statements concerning Sensorion and its business. Such forward looking statements are based on assumptions that Sensorion considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the 2024 full year report published on March 14, 2025, and available on our website and to the development of economic conditions, financial markets and the markets in which Sensorion operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Sensorion or not currently considered material by Sensorion. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Sensorion to be materially different from such forward-looking statements. This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Sensorion shares in any country. The communication of this press release in certain countries may constitute a violation of local laws and regulations. Any recipient of this press release must inform oneself of any such local restrictions and comply therewith.
Yahoo
13-05-2025
- Business
- Yahoo
Sensorion Publishes Results of Combined Shareholders' General Meeting Resolutions
MONTPELLIER, France, May 13, 2025--(BUSINESS WIRE)--Regulatory News: Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company specializing in the development of novel therapies to restore, treat and prevent hearing loss disorders, today announced the results of resolutions presented at its Combined General Meeting (CGM), held on May 12, 2025, and made them available on the dedicated section of its website. All resolutions recommended by the Board and submitted to the Combined General Meeting were adopted. 81.7% of the capital was present and represented. The results of the votes on all proposed resolutions can be found on Sensorion's website ( in the Investors section under the Governance tab. About Sensorion Sensorion is a pioneering clinical-stage biotech company, which specializes in the development of novel therapies to restore, treat, and prevent hearing loss disorders, a significant global unmet medical need. Sensorion has built a unique R&D technology platform to expand its understanding of the pathophysiology and etiology of inner ear related diseases, enabling it to select the best targets and mechanisms of action for drug candidates. It has two gene therapy programs aimed at correcting hereditary monogenic forms of deafness, developed in the framework of its broad strategic collaboration focused on the genetics of hearing with the Institut Pasteur. SENS-501 (OTOF-GT) currently being developed in a Phase 1/2 clinical trial, targets deafness caused by mutations of the gene encoding for otoferlin and GJB2-GT targets hearing loss related to mutations in GJB2 gene to potentially address important hearing loss segments in adults and children. The Company is also working on the identification of biomarkers to improve diagnosis of these underserved illnesses. Sensorion's portfolio also comprises programs of a clinical-stage small molecule, SENS-401 (Arazasetron), for the treatment and prevention of hearing loss disorders. Sensorion's small molecule progresses in a Phase 2 proof of concept clinical study of SENS-401 in Cisplatin-Induced Ototoxicity (CIO) for the preservation of residual hearing. Sensorion, with partner Cochlear Limited, completed in 2024 a Phase 2a study of SENS-401 for the residual hearing preservation in patients scheduled for cochlear implantation. A Phase 2 study of SENS-401 was also completed in Sudden Sensorineural Hearing Loss (SSNHL) in January 2022. Label: SENSORIONISIN: FR0012596468Mnemonic: ALSEN Disclaimer This press release contains certain forward-looking statements concerning Sensorion and its business. Such forward looking statements are based on assumptions that Sensorion considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the 2024 full year report published on March 14, 2025, and available on our website and to the development of economic conditions, financial markets and the markets in which Sensorion operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Sensorion or not currently considered material by Sensorion. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Sensorion to be materially different from such forward-looking statements. This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Sensorion shares in any country. The communication of this press release in certain countries may constitute a violation of local laws and regulations. Any recipient of this press release must inform oneself of any such local restrictions and comply therewith. View source version on Contacts Investor Relations Noémie Djokovic, Investor Relations and Communication Press Relations Ulysse CommunicationBruno Arabian / 00 33(0)6 87 88 47 26barabian@ Nicolas Entz / 00 33 (0)6 33 67 31 54nentz@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
06-05-2025
- Business
- Business Wire
Sensorion Announces its Participation in the American Society of Cell and Gene Therapy (ASGCT) Annual Meeting
MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News: Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company specializing in the development of novel therapies to restore, treat and prevent hearing loss disorders, today announced its participation at the 28 th Annual American Society of Cell and Gene Therapy Meeting (ASGCT), taking place on May 13-17, 2025, in New-Orleans, United States of America. On this occasion, Rafik Boudra, Preclinical Group Leader Technology & Innovation Platform at Sensorion, will present the 2 following posters on May 15, 2025: Poster N°1556 Title: Safety and efficacy of GJB2-GT, an adeno associated viral vector-based gene therapy treatment candidate for the autosomal recessive non-syndromic deafness 1A (DFNB1A) Poster N° 1559 Title: GJB2 gene therapy-response of two pre-clinical mouse models of the most frequent form of human deafness, DFNB1A This poster is presented in collaboration with the Auditory Therapies Innovation Laboratory headed by Professor Christine PETIT at Hearing Institute, research center of the Institut Pasteur Date: May 15, 2025 Time: 5.30 pm - 7.00 pm CT Room: Morial Convention Center, Poster Hall, Hall I2 About Sensorion Sensorion is a pioneering clinical-stage biotech company, which specializes in the development of novel therapies to restore, treat, and prevent hearing loss disorders, a significant global unmet medical need. Sensorion has built a unique R&D technology platform to expand its understanding of the pathophysiology and etiology of inner ear related diseases, enabling it to select the best targets and mechanisms of action for drug candidates. It has two gene therapy programs aimed at correcting hereditary monogenic forms of deafness, developed in the framework of its broad strategic collaboration focused on the genetics of hearing with the Institut Pasteur. SENS-501 (OTOF-GT) currently being developed in a Phase 1/2 clinical trial, targets deafness caused by mutations of the gene encoding for otoferlin and GJB2-GT targets hearing loss related to mutations in GJB2 gene to potentially address important hearing loss segments in adults and children. The Company is also working on the identification of biomarkers to improve diagnosis of these underserved illnesses. Sensorion's portfolio also comprises programs of a clinical-stage small molecule, SENS-401 (Arazasetron), for the treatment and prevention of hearing loss disorders. Sensorion's small molecule progresses in a Phase 2 proof of concept clinical study of SENS-401 in Cisplatin-Induced Ototoxicity (CIO) for the preservation of residual hearing. Sensorion, with partner Cochlear Limited, completed in 2024 a Phase 2a study of SENS-401 for the residual hearing preservation in patients scheduled for cochlear implantation. A Phase 2 study of SENS-401 was also completed in Sudden Sensorineural Hearing Loss (SSNHL) in January 2022. Disclaimer This press release contains certain forward-looking statements concerning Sensorion and its business. Such forward looking statements are based on assumptions that Sensorion considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the 2024 full year report published on March 14, 2025, and available on our website and to the development of economic conditions, financial markets and the markets in which Sensorion operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Sensorion or not currently considered material by Sensorion. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Sensorion to be materially different from such forward-looking statements. This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Sensorion shares in any country. The communication of this press release in certain countries may constitute a violation of local laws and regulations. Any recipient of this press release must inform oneself of any such local restrictions and comply therewith.
