Sensorion (ALSEN) H1 2025 earnings summary

Executive summary

• Expedited enrollment completed for first two cohorts in Phase 1/2 Audiogene trial evaluating SENS-501 gene therapy for OTOF-related congenital deafness, with positive initial safety profile in all six patients treated so far.

• Early signs of hearing improvement observed in Patient 3 at minimally effective dose; higher dose data from Cohort 2 being gathered, with Data Monitoring Committee review expected by end of H2 2025.

• GJB2-GT gene therapy program advancing toward first Clinical Trial Application (CTA) filing in Q1 2026, supported by regulatory discussions in Q3 2025.

• SENS-401 Phase 2a study in Cisplatin-Induced Ototoxicity completed enrollment, with topline data expected by end of H2 2025.

• Board strengthened with appointment of Amit Munshi as Chairman and Independent Director, bringing extensive biotech leadership experience.

Financial highlights

• Cash and short-term deposits totaled €57.1m as of June 30, 2025, down from €77.0m at December 31, 2024.

• R&D expenses increased 2% year-over-year to €15.0m; G&A expenses rose to €4.1m from €3.8m.

• Net loss widened to €16.0m for H1 2025, compared to €13.9m in H1 2024.

• Operating loss for H1 2025 was €16.8m, compared to €15.1m in H1 2024.

Outlook and guidance

• Cash position expected to finance operations into Q3 2026.

• Key milestones: SENS-501 Data Monitoring Committee review and SENS-401 topline results in H2 2025; GJB2-GT CTA filing in Q1 2026.