Genelux Corporation Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update

Core Insights - Genelux Corporation has reached alignment with the U.S. FDA on key elements of the approval pathway for Olvi-Vec in treating platinum-resistant/refractory ovarian cancer [1][4] - The company reported a net loss of $29.9 million for the year ending December 31, 2024, compared to a net loss of $28.3 million in 2023 [15][21] - Genelux has strengthened its management team and balance sheet, positioning itself for future growth and clinical development [2][7] Pipeline Highlights - The ongoing Phase 3 OnPrime/GOG-3076 trial is focused on platinum-resistant/refractory ovarian cancer, with a primary endpoint of progression-free survival (PFS) [3] - The FDA indicated that an interim analysis of overall survival (OS) should be planned alongside the primary PFS analysis, which could support traditional approval if a meaningful PFS advantage is demonstrated [4] - The trial aims to enroll enough patients to achieve 127 events, with topline data expected in the first half of 2026 [5] Clinical Trials Updates - Preliminary data from the Phase 1b/2 Olvi-Vec-SCLC-202 trial showed a 71% disease control rate in patients with extensive small cell lung cancer [11] - The Phase 2 VIRO-25 trial is actively enrolling patients with recurrent non-small cell lung cancer, with interim data anticipated in the second half of 2025 [6] Financial Overview - The company closed an underwritten offering of 3 million shares at $3.50 per share, raising approximately $10.5 million for working capital and clinical development [8][10] - As of December 31, 2024, cash, cash equivalents, and short-term investments totaled $30.9 million, providing a runway into the first quarter of 2026 [12] - Research and development expenses increased to $19.0 million in 2024 from $12.8 million in 2023, primarily due to higher clinical trial costs [13] Management Changes - Matt Pulisic has joined Genelux as the new Chief Financial Officer, bringing over 19 years of experience in the biopharmaceutical industry [7]