Sensorion (ALSEN) Investor Update summary

Strategic focus and partnerships

• Advancing gene therapy programs for hearing restoration, post-loss treatment, and prevention, with strong collaborations including Institut Pasteur and Hôpital Necker-Enfants Malades.

• Raised €100 million over the past 18 months from specialized healthcare investors to support product portfolio development.

• Partnerships with industry leaders like Cochlear and Sonova enhance diagnostic and patient pathway understanding.

Pipeline and clinical progress

• SENS-501 gene therapy is in phase 1-2, with first cohort completed and second cohort recruitment to finish by mid-year; initial efficacy data to be communicated soon.

• GJB2 gene therapy program progressing, with toxicology studies and clinical batch production underway; clinical trial application planned for early next year.

• SENS-401 small molecule program completed recruitment for ototoxicity prevention; main results expected by year-end.

Competitive positioning and regulatory strategy

• SENS-501 study design targets very young children to maximize language acquisition, differentiating from competitors who include older or already implanted children.

• Regulatory discussions with FDA and European authorities have been positive, allowing for inclusion of younger patients in the US trial protocol.

• Orphan drug and pediatric designations secured in the US and Europe for SENS-501, with pediatric plan approved in Europe.