Sensorion 2024 H1 Results and Recent Updates

Sensorion, a clinical-stage biotechnology company based in Montpellier, France, has announced its half-year results for the period ending June 30, 2024, alongside its outlook for the remainder of the year. The company, which focuses on developing therapies for hearing loss disorders, has made significant strides in its research and clinical trials.

Chief Executive Officer Nawal Ouzren highlighted the progress made in the first half of 2024, particularly with Sensorion's gene therapy program SENS-501. The company received regulatory approval from European authorities in January, and the first patient has been enrolled and treated in the study. Sensorion plans to provide further updates on this program in the coming months.

The company is also advancing its SENS-401 program, which is in Phase 2a clinical trials. Sensorion released new positive efficacy data for SENS-401 in preventing residual hearing loss after cochlear implantation, with full data to be presented at the World Congress of Audiology later in the month. Additionally, Sensorion is continuing to recruit participants for the NOTOXIS study, which is investigating SENS-401 in the context of Cisplatin-Induced Ototoxicity.

Financially, Sensorion has been successful in securing new investments, raising over €65 million through private placements in February and April. This funding ensures the company is well-capitalized through the end of 2025.

In the realm of gene therapies, Sensorion is working on several programs developed in collaboration with the Institut Pasteur. The collaboration was extended for an additional five years starting in January 2024. The lead gene therapy program, SENS-501, targets hereditary monogenic hearing loss caused by mutations in the OTOF gene. The therapy aims to restore hearing in patients suffering from severe sensorineural hearing loss. The European Medicines Agency approved a Pediatric Investigation Plan for SENS-501, ensuring necessary data is collected for marketing authorization in the pediatric population.

Sensorion’s GJB2-GT gene therapy program, also developed with the Institut Pasteur, addresses three forms of hearing loss related to GJB2 mutations. The program is progressing towards Clinical Trial Application submissions planned for the second half of 2025.

For its small molecule therapy SENS-401, Sensorion is investigating its efficacy in three different indications. The company has made notable progress in the prevention of hearing loss after cochlear implantation. Data from a Phase 2a clinical trial has shown that SENS-401 can reduce hearing loss post-surgery. Sensorion will present the final results at the World Congress of Audiology. Additionally, the NOTOXIS Phase 2a trial is evaluating SENS-401's ability to prevent ototoxicity in patients undergoing cisplatin-based chemotherapy, with preliminary safety and efficacy data expected to be reported at the same congress.

Financially, Sensorion reported an increase in research and development expenses from €12.3 million to €14.7 million, attributed mainly to the growth in its gene therapy programs. General and administrative expenses also rose from €2.6 million to €3.8 million. The company's net loss for the first half of 2024 was €13.9 million, up from €12.3 million in the same period the previous year. As of June 30, 2024, Sensorion had cash and cash equivalents amounting to €87.3 million, compared to €37.0 million at the end of 2023.

Sensorion’s financial outlook remains optimistic, with sufficient funds projected to support operations until the end of 2025. The company's Board of Directors has approved the half-year financial statements, and the statutory auditors are in the process of issuing an unqualified report.

Overall, Sensorion continues to make substantial progress in its mission to develop innovative therapies for hearing loss, supported by a strong financial position and ongoing clinical and regulatory achievements.