GNLX

-- Topline data from randomized Phase 3 OnPrime/GOG-3076 ovarian cancer registrational trial of Olvi-Vec expected in 2H26 -- -- Systemic lung cancer programs advancing with additional updates expected throughout 2026 -- -- $26.3 million in cash, cash equivalents, marketable securities and restricted cash as of March 31, 2026; expected to fund operations into 1Q27 -- WESTLAKE VILLAGE, Calif., May 07, 2026 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today announced financial results for the first quarter of 2026 and provided general business updates. “As we build on our momentum entering 2026, we remain focused on disciplined execution of our registrational program. The randomized Phase 3 OnPrime/GOG-3076 trial remains on track for topline data in the second half of 2026. It is designed to generate robust, controlled clinical evidence intended to support filing for regulatory approval by demonstrating the efficacy of Olvi-Vec-primed immunochemotherapy relative to the active comparator arm,” said Thomas Zindrick, President, CEO and Chairman of Genelux. “In addition, we continue to advance our systemic lung cancer programs as we evaluate Olvi-Vec’s potential to resensitize tumors to platinum-based chemotherapy and expand beyond ovarian cancer.” “In parallel, we are making steady progress in advancing our manufacturing and operational capabilities to support the continued development of Olvi-Vec and position the Company for potential commercial readiness. Our focus remains on establishing the necessary supply, quality, and organizational infrastructure as our registration-directed programs advance,” concluded Mr. Zindrick. Clinical Program Highlights Olvi-Vec in Platinum-Resistant/Refractory Ovarian Cancer: Genelux continues to advance Olvi-Vec toward potential registration in platinum-resistant/refractory ovarian cancer (PRROC), where patients have limited treatment options and poor outcomes. Ovarian cancer is the 5th leading cause of cancer-related death among women. Approximately 243,572 women in the United States are diagnosed with ovarian cancer, and it is estimated that more than 70% will not respond to or will relapse after frontline platinum-based therapy (NIH Ovarian Cancer Fact Sheet 2022). Olvi-Vec’s intraperitoneal administration enables high, localized dosing within the peritoneal cavity and...

-- Topline data from Phase 3 OnPrime/GOG-3076 ovarian cancer registrational trial of Olvi-Vec expected in 2H26 -- -- Interim systemic lung cancer data with Olvi-Vec demonstrated partial responses in relapsed small cell lung cancer (SCLC) and early signs of anti-tumor activity in non-small cell lung cancer (NSCLC); additional updates expected throughout 2026 -- -- Appointed Jason Litten, M.D., as Chief Medical Officer to lead clinical development strategy -- -- $33.1 million in pro forma cash, cash equivalents, marketable securities and restricted cash as of December 31, 2025, including $18.5 million in net proceeds from underwritten offering of common stock in January 2026; expected to support operations into 1Q27-- WESTLAKE VILLAGE, Calif., March 19, 2026 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today announced fourth quarter and full year 2025 financial results and business updates. “Looking ahead in 2026, Genelux is entering a pivotal period of key clinical readouts for Olvi-Vec and defining milestones for the Company. With the Phase 3 OnPrime/GOG-3076 registrational trial expected to yield topline data in the second half of the year, we are focused on continued disciplined execution. Our productive interactions with the FDA, most recently in January 2026, have informed our next steps and strengthen our conviction in the development of Olvi-Vec for cancer patients with limited alternatives,” said Thomas Zindrick, President, CEO and Chairman of Genelux. “Encouraging interim data reported in January 2026 from our systemic lung cancer programs provided additional insight into the potential of Olvi-Vec. In platinum-relapsed or refractory advanced SCLC, systemically delivered Olvi‑Vec demonstrated partial responses, and in advanced or metastatic recurrent NSCLC, early signals of anti-tumor activity were observed. Collectively, these findings further support our strategy of developing Olvi-Vec as a potential platinum resensitizing agent across multiple platinum-treated solid tumors.” “In parallel, we are advancing our manufacturing and operational capabilities to support the long-term development of Olvi-Vec and lay the groundwork for potential commercial readiness following successful registration, if obtained. These efforts are intended to ensure appropriate supply, quality systems, and organizatio...

-- Lung cancer programs progressing with interim data updates expected in Q4 2025 -- -- Topline data from OnPrime Phase 3 ovarian cancer registrational trial expected in the second half of 2026 -- -- Cash, cash equivalents, short-term investments and restricted cash of $21.0 million as of September 30, 2025 -- WESTLAKE VILLAGE, Calif., Nov. 05, 2025 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today announced financial results for the third quarter of 2025 and provided general business updates. “In the third quarter, we continued to progress Olvi-Vec’s development across multiple solid tumor indications, positioning the program for meaningful clinical milestones and key catalysts in the coming year in indications that, together, represent a multi-billion-dollar market opportunity. Olvi-Vec’s differentiated mechanism of action is designed to directly kill cancer cells, stimulate a tumor-specific immune response, and alter the tumor microenvironment, with the potential to resensitize tumors to frontline platinum-based chemotherapy,” said Thomas Zindrick, President, CEO and Chairman of Genelux. “Enrollment in our Phase 3 ovarian cancer trial remains active across U.S. sites, and we are pleased to see strong engagement from investigators. Given the complexities inherent to running rigorous, randomized studies that can enable streamlined regulatory review, we now expect data in the second half of 2026. We look forward to sharing topline results from the Phase 3 ovarian cancer trial next year, and remain well-positioned to execute on our clinical and regulatory priorities.” “Looking ahead, we are also excited about our lung cancer studies, where Olvi-Vec is being delivered via systemic (intravenous) delivery, a physician-preferred route of administration that could support broader commercial opportunities across other solid tumors. We expect to share additional interim data from our systemic lung cancer programs in the fourth quarter of 2025, where ongoing studies aim to further validate our oncolytic immunotherapy platform. A positive signal in lung cancer could mark a pivotal inflection point for our pipeline and position the Company for the next phase of growth,” concluded Mr. Zindrick. Clinical Program Highlights Olvi-Vec in Platinum-Resistant/Refractory Ovarian Cancer: Genelux continues to advance Olvi...

WESTLAKE VILLAGE, Calif., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today announced financial results for the second quarter of 2025 and provided general business updates. Momentum continued to build across the Company, as it looks forward to a series of key clinical readouts over the next year. These readouts are intended to further demonstrate the ability of Olvi-Vec to resensitize tumors to frontline platinum-based regimens. Genelux continues to advance Olvi-Vec toward potential registration in platinum-resistant/refractory ovarian cancer (PRROC) with topline data expected in the first half of 2026. Earlier this year, the Company achieved alignment with the U.S. Food and Drug Administration (FDA) regarding OnPrime/GOG-3076 and its randomized trial design, which could potentially support traditional approval without the need for a confirmatory trial. Additionally, the FDA encouraged Genelux to request a meeting prior to filing a Biologics License Application with topline data upon study completion. The upcoming data updates expected from the small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) trials later this year will be important milestones as they hold the potential to anchor the systemic route of delivery program. In July 2025, the Company strengthened its executive leadership team with the appointment of Eric Groen as General Counsel, Corporate Secretary, Chief Compliance Officer, and Head of Business Development. “With important data milestones on the horizon, Olvi-Vec holds the potential to redefine the treatment paradigms of recurrent tumors in multiple indications, as well as the broader field of oncolytic immunotherapy,” said Thomas Zindrick, President, CEO and Chairman of Genelux. “We are entering an exciting phase of growth as we work to advance a potentially transformative therapy for patients with limited treatment options. The recent addition of Eric, who brings deep industry expertise and strategic acumen, further enhances our leadership talent to scale our operations and maximize the potential of Olvi-Vec.” Pipeline Highlights Genelux remains on track with its Phase 3 OnPrime/GOG-3076 registrational trial (NCT05281471) evaluating Olvi-Vec in platinum-resistant/refractory ovarian cancer (PRROC), aiming for topline data in the first half of 2026. In...

WESTLAKE VILLAGE, Calif., May 06, 2025 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today announced financial results for the first quarter of 2025 and provided general business updates. “The first quarter of 2025 has been highly productive and sets a strong foundation for the year ahead. We are well positioned to advance Olvi-Vec across multiple high-need cancer indications, with encouraging regulatory feedback from the FDA on our OnPrime Phase 3 registrational trial in resistant/refractory ovarian cancer, promising early lung cancer clinical data from our ongoing Phase 1b/2 study, and increasing patient enrollment in our U.S. Phase 2 lung cancer trial” said Thomas Zindrick, President, CEO and Chairman of Genelux. “We are energized by our momentum and look forward to advancing our strategic initiatives through key upcoming value inflection points this year and into 2026.” Pipeline Highlights Earlier this quarter, the completion of a productive Type D meeting with the U.S. Food and Drug Administration (FDA) regarding Olvi-Vec for the treatment of platinum-resistant/refractory ovarian cancer was announced. The FDA stated that data from the ongoing OnPrime/GOG-3076 Phase 3 registrational trial (NCT05281471) could potentially support traditional approval if a clinically meaningful progression-free survival advantage is demonstrated without a decrement in overall survival. The FDA also recommended that Genelux request a pre-BLA meeting with topline safety and efficacy data following study completion to discuss next steps. The trial is expected to readout in 1H 2026 for topline data. The company also announced preliminary safety and anti-tumor activity data from the Phase 1b dose escalation portion of their ongoing Phase 1b/2 trial (OLVI-VEC-SCLC-202) of Olvi-Vec immunochemotherapy in patients with platinum-relapsed or platinum-refractory extensive small cell lung cancer. Systemic administration of Olvi-Vec in the initial dose escalation cohorts achieved a 71% disease control rate (5/7 evaluable participants), with (i) two of the five exhibiting partial responses and (ii) all five showing consistent reductions across all target lesions, including a tumor reduction of approximately 79% in one participant. Three participants, including one heavily pretreated individual, achieved stable disease with tumor siz...

Net loss: US$29.9m (loss widened by 5.6% from FY 2023). Net loss: US$29.9m (loss widened by 5.6% from FY 2023). US$0.95 loss per share. US$0.95 loss per share. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue exceeded analyst estimates by 67%. Earnings per share (EPS) missed analyst estimates by 8.6%. Looking ahead, revenue is forecast to grow 64% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. Performance of the American Biotechs industry. The company's shares are down 22% from a week ago. Be aware that Genelux is showing 4 warning signs in our investment analysis and 2 of those are a bit concerning... Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

– Alignment reached with U.S. Food and Drug Administration on key elements of the approval pathway for Olvi-Vec in Platinum Resistant/Refractory Ovarian Cancer – – Positive Preliminary Phase 1b/2 Data of Olvi-Vec in Advanced Small-Cell Lung Cancer – – Matt Pulisic joined the company as its new Chief Financial Officer – – Closing of $10.5 Million Underwritten Offering of Common Stock – – $30.9 million in cash, cash equivalents and short-term investments – WESTLAKE VILLAGE, Calif., March 28, 2025 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, reported fourth quarter and full year 2024 financial results and business updates. "Our progress in the fourth quarter of 2024 and into 2025 marks a pivotal period for patients, our company, and our investors,” said Thomas Zindrick, President, CEO and Chairman of Genelux. “We 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." Pipeline Highlights OnPrime/GOG-3076 Phase 3 Registrational Trial Update 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), and continues to have productive discussions with the U.S. Food and Drug Administration (FDA). 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’s guidance on their expectations regarding a confirmatory trial using the ongoing Phase 3 trial results, the FDA responded that “As 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.” 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 potentiall...