Genelux (GNLX) Corporate presentation summary

Clinical program and pipeline advancement

• Olvi-Vec is in late-stage clinical development, focusing on platinum resensitization in ovarian and lung cancers, with ongoing pivotal Phase 3 and Phase 2/1b trials in ovarian, NSCLC, and SCLC indications.

• FDA alignment could allow traditional approval for ovarian cancer without a confirmatory trial; topline Phase 3 results expected in 2H 2026.

• Systemic administration shows promise for first-in-class delivery across multiple tumor types, overcoming limitations of first-generation oncolytic viruses.

• Olvi-Vec demonstrates robust immune activation, tumor selectivity, and potential as a backbone for combination therapies.

• The CHOICE platform includes a diverse library of over 500 vaccinia strains and 110+ transgenes for future pipeline expansion.

Clinical trial results and efficacy

• Phase 2 in platinum-resistant/refractory ovarian cancer showed a 54% ORR, mPFS of 11 months, and mOS of 15.7 months, with durable responses and reversal of platinum resistance.

• Tumor shrinkage was observed in 86% of patients, with deep and durable responses, including in platinum-refractory cases.

• Olvi-Vec primed immunochemotherapy led to PFS and OS exceeding prior lines, with 20% long-term survivors in heavily pretreated patients.

• Systemic administration in solid tumors and lung cancers demonstrated dose-dependent OS benefit and disease control, with well-tolerated safety profiles.

• Interim data in SCLC and NSCLC trials show disease control rates of 66% and 60%, respectively, with ongoing dose escalation.

Commercial strategy and partnerships

• US launch is planned for ovarian cancer, with strategic partnerships for ex-US rights, including a validating partnership with Newsoara Biopharma for Greater China.

• Newsoara has paid $11M to date, with additional milestone and royalty payments possible.

• Large-scale proprietary CGMP manufacturing in San Diego supports clinical and commercial needs, with attractive COGS and production scalability.

• The addressable market for advanced recurrent ovarian cancer is projected to grow to $5.5 billion by 2032.