Genelux (GNLX) investor relations material

Strategic focus and pipeline advancement

• Olvi-Vec is in late-stage clinical development, targeting platinum-resistant/refractory ovarian cancer with a pivotal Phase 3 trial and additional trials in lung cancers, aiming for systemic administration across multiple tumor types.

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

• The CHOICE platform supports a broad discovery engine with over 500 vaccinia strains and 110+ transgenes, enabling a diverse pipeline.

• Strategic partnerships, notably with Newsoara Biopharma for Greater China, have generated $11M to date, with potential for $160.5M in milestones and mid-double-digit royalties.

• US commercial launch is planned for ovarian cancer, with ex-US rights pursued through partnerships.

Clinical data and therapeutic potential

• Olvi-Vec demonstrated strong overall response rates, progression-free survival, and overall survival in heavily pretreated ovarian cancer patients, including those with platinum-refractory disease.

• Phase 2 data showed a 54% ORR and median PFS of 11 months, with durable responses and reversal of platinum resistance.

• Systemic administration in solid tumors and lung cancers showed dose-dependent overall survival benefits and favorable safety profiles.

• Combination with chemotherapy and immune checkpoint inhibitors is supported by preclinical and clinical data, positioning Olvi-Vec as an ideal backbone for combination therapy.

• Olvi-Vec induces robust immune activation, converting immunologically 'cold' tumors to 'hot' and enhancing T-cell infiltration and anti-tumor immunity.

Financials, manufacturing, and commercialization

• Cash position as of June 30, 2026, is ~$19M, with a quarterly operating cash burn up to ~$6M and a runway into Q1 2027.

• Commercial manufacturing upgrades in San Diego are expected to be completed in 2026 to support launch.

• No entrenched competitor exists in 4th line PRROC, and the US market opportunity is significant, with 243,572 ovarian cancer patients and global revenues projected to more than double by 2032.

• Proprietary CGMP manufacturing enables attractive cost of goods and scalable production.

• Integrated capabilities in Southern California support clinical, translational, and commercial operations.