{"id":831252,"date":"2025-03-28T16:53:49","date_gmt":"2025-03-28T20:53:49","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/genelux-corporation-reports-fourth-quarter-and-full-year-2024-financial-results-and-provides-business-update\/"},"modified":"2025-03-28T16:53:49","modified_gmt":"2025-03-28T20:53:49","slug":"genelux-corporation-reports-fourth-quarter-and-full-year-2024-financial-results-and-provides-business-update","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/genelux-corporation-reports-fourth-quarter-and-full-year-2024-financial-results-and-provides-business-update\/","title":{"rendered":"Genelux Corporation Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update"},"content":{"rendered":"
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\u2013\u00a0Alignment reached with U.S. Food and Drug Administration on key elements of the approval pathway for Olvi-Vec in Platinum Resistant\/Refractory Ovarian Cancer \u2013<\/p>\n

\u2013\u00a0Positive Preliminary Phase 1b\/2 Data of Olvi-Vec in Advanced Small-Cell Lung Cancer \u2013<\/p>\n

\u2013\u00a0Matt Pulisic joined the company as its new Chief Financial Officer\u00a0\u2013<\/p>\n

\u2013\u00a0Closing of $10.5 Million Underwritten Offering of Common Stock\u00a0\u2013<\/p>\n

\u2013\u00a0$30.9 million in cash, cash equivalents and short-term investments\u00a0\u2013<\/p>\n

WESTLAKE VILLAGE, Calif., March 28, 2025 (GLOBE NEWSWIRE) — Genelux Corporation<\/a> (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, reported fourth quarter and full year 2024 financial results and business updates.<\/p>\n

“Our progress in the fourth quarter of 2024 and into 2025 marks a pivotal period for patients, our company, and our investors,\u201d said Thomas Zindrick, President, CEO and Chairman of Genelux. \u201cWe are pleased with the continued progress and promise of our clinical development program. The strengthening of our management team, with the addition of Matt, and of our balance sheet, with our recent financing, further positions the Company to execute on our mission to transform the lives of patients who need it most.”<\/p>\n

\n Pipeline Highlights<\/strong>\n <\/p>\n

\n OnPrime\/GOG-3076 Phase 3 Registrational Trial Update<\/em>\n <\/p>\n

The Company continues to enroll patients in the ongoing pivotal Phase 3 OnPrime\/GOG-3076 registration trial (Phase 3 trial) in platinum resistant\/refractory ovarian cancer (PRROC), with the primary endpoint of progression free survival (PFS) (Clinicaltrials.gov identifier NCT05281471<\/a>), and continues to have productive discussions with the U.S. Food and Drug Administration (FDA).<\/p>\n

The Company recently concluded a productive Type D meeting with the FDA for Olvi-Vec in the treatment of PRROC. In response to a question seeking the FDA\u2019s guidance on their expectations regarding a confirmatory trial using the ongoing Phase 3 trial results, the FDA responded that \u201cAs stated previously, an interim analysis of overall survival (OS) should be planned at the time of the primary PFS analysis. If a clinically meaningful PFS advantage is demonstrated in the absence of a decrement in OS, this could potentially support traditional approval.\u201d The FDA further recommended Genelux request a pre-BLA meeting with FDA with topline safety and efficacy data following completion of the study to discuss next steps. This could potentially avoid the need for conducting a separate confirmatory study.<\/p>\n

The trial will enroll a sufficient number of patients to achieve 127 events, with the primary endpoint of PFS and with secondary endpoints including OS. The Company anticipates reporting topline data in the first half of 2026.<\/p>\n

\n Recurrent Lung Cancer Trials: Systemic Administration of Olvi-Vec Update<\/em>\n <\/p>\n

Phase 1b\/2 Olvi-Vec-SCLC-202 has generated preliminary safety and anti-tumor activity data from the dose escalation Phase 1b portion of the ongoing Phase 1b\/2 clinical trial of Olvi-Vec immunochemotherapy in patients with platinum-relapsed or platinum-refractory extensive small cell lung cancer. The trial is co-sponsored by the Company and its licensing partner, Newsoara BioPharma Co., Ltd. (Newsoara).<\/p>\n