-- Topline data from Phase 3 OnPrime/GOG-3076 ovarian cancer registrational trial of Olvi-Vec expected in 2H26 --

-- Olvi-Vec systemic development programs continue to advance, with additional dose-escalation updates anticipated in 2026 --

-- Recently published Phase 1b/2 VIRO-15 translational analyses of heavily-pre-treated ovarian cancer patients support Olvi-Vec’s potential to overcome resistance biology and synergize with platinum chemotherapy --

-- $18.7 million in cash, cash equivalents, marketable securities and restricted cash as of June 30, 2026; expected to fund operations into 1Q27 --

WESTLAKE VILLAGE, Calif., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today announced financial results for the second quarter of 2026 and provided general business updates.

“During the second quarter, the Company continued to make meaningful clinical and operational progress. We look forward to reporting the upcoming topline data of our Phase 3 OnPrime/GOG-3076 registrational trial, as well as dose-finding updates from our systemic administration studies in lung cancer,” said Thomas Zindrick, President, CEO and Chairman of Genelux. “Recent translational findings further support Olvi-Vec’s tumor-priming immunotherapy mechanism and its potential to promote tumor sensitization to platinum-based chemotherapy, as well as strengthening the scientific foundation of our ongoing clinical development programs.”

“Alongside our clinical progress, we continue advancing our manufacturing and operational capabilities in preparation for the next stage of Olvi-Vec’s development. As our registration-directed programs mature, we remain focused on strengthening our organization, investing in our capabilities, and preparing for potential commercialization and future pipeline expansion,” concluded Mr. Zindrick.

Clinical Program Highlights

Olvi-Vec in Platinum-Resistant/Refractory Ovarian Cancer:
Genelux continues to advance Olvi-Vec toward potential registration for platinum-resistant/refractory ovarian cancer (PRROC), a setting defined by limited treatment options. Ovarian cancer is the 5^th leading cause of cancer-related death among women, and more than 70% of patients diagnosed with ovarian cancer in the United States will not respond to or will relapse after frontline platinum-based therapy (NIH Ovarian Cancer Fact Sheet 2022), underscoring the significant unmet medical need Olvi-Vec seeks to address.

Olvi-Vec’s intraperitoneal administration is designed to deliver high, localized dosing within the peritoneal cavity to drive anti-tumor activity and resensitize tumors to platinum-based chemotherapy. 

• OnPrime/GOG-3076 (NCT05281471) is an ongoing multi-center, randomized, open-label Phase 3 registrational trial being conducted at sites across the United States, with topline data anticipated in the second half of 2026.
• The trial is evaluating Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab against an active comparator arm of physician's choice of chemotherapy and bevacizumab in women with PRROC (including fallopian tube and primary peritoneal cancers). 
• In June 2026, Genelux announced the publication of translational analyses from the Phase 1b/2 VIRO-15 trial demonstrating immune activation, remodeling of tumor microenvironment, and gene expression changes consistent with platinum sensitization following treatment with Olvi-Vec. These data were presented in Gynecologic Oncology Reports, a peer-reviewed journal published by Elsevier, available here.
  
  

Olvi-Vec in Lung Cancer:
Genelux continues to advance two ongoing systemic Olvi-Vec lung cancer trials, expanding the platform beyond intraperitoneal delivery into a broader range of solid tumor types. Together, data from dose-escalation cohorts in these studies are designed to generate the clinical evidence to guide selection of a recommended systemic dose for subsequent development in lung cancer and for future development in additional systemic indications.

• The Phase 1b/2 study (OLVI-VEC-SCLC-202) in small-cell lung cancer (SCLC) (NCT07136285) is evaluating Olvi-Vec in combination with platinum and etoposide chemotherapy in SCLC patients with platinum-resistant or relapsed disease after failing previous treatment, including frontline platinum and etoposide chemotherapy. The trial is being conducted by the Company’s licensing partner, Newsoara HYK Biopharmaceuticals Co., Ltd., in China.
• The Phase 2 VIRO-25 study (NCT06463665) is assessing Olvi-Vec in combination with platinum-based chemotherapy and an immune checkpoint inhibitor (ICI) in patients with advanced or metastatic recurrent non-small-cell lung cancer (NSCLC) who failed standard frontline treatment of platinum chemotherapy and an ICI. The trial is being conducted in the United States and is designed to extend Olvi-Vec’s tumor-priming approach into NSCLC.
  
  

Additional dose‑finding updates from both the SCLC Phase 1b/2 and NSCLC Phase 2 VIRO‑25 trials are expected in 2026, aligning with the Company’s strategy to optimize a systemic dosing regimen and inform future registrational development.

Second Quarter 2026 Financial Results

Cash, cash equivalents, marketable securities and restricted cash were $18.7 million as of June 30, 2026. The Company expects that combined cash, cash equivalents, marketable securities and restricted cash will fund operations into the first quarter of 2027.

Research and development (R&D) expenses were $6.5 million and $4.8 million for the three months ended June 30, 2026 and 2025, respectively, an increase of $1.8 million. The increase was primarily driven by clinical and regulatory expenses relating to increased clinical trial costs associated with our Phase 3 OnPrime/GOG-3076 registration trial.

General and administrative (G&A) expenses were $3.1 million and $3.0 million for the three months ended June 30, 2026 and 2025, respectively, an increase of $0.1 million. The increase was primarily driven by an increase in stock compensation, partially offset by a reduction in professional services and other expenses.

Net loss was $9.5 million or $0.21 per share for the three months ended June 30, 2026, as compared to $7.5 million or $0.20 per share over the same period in 2025.

About Genelux Corporation

Genelux is a late clinical-stage biopharmaceutical company focused on developing next-generation oncolytic immunotherapies for patients suffering from aggressive and/or difficult-to-treat tumor types. Olvi-Vec currently is being evaluated in two U.S.-based clinical trials: OnPrime/GOG-3076, a multi-center, randomized, open-label Phase 3 registrational trial evaluating the efficacy and safety of Olvi-Vec in combination platinum-doublet + bevacizumab compared with physician's choice of chemotherapy and bevacizumab in patients with platinum-resistant/refractory ovarian cancer; and VIRO-25, a multi-center, randomized, open-label Phase 2 trial evaluating the efficacy and safety of Olvi-Vec & platinum-doublet + physician's choice of immune checkpoint inhibitor compared to docetaxel in non-small-cell lung cancer. Additionally, Olvi-Vec currently is being evaluated for dose selection in Olvi-Vec-SCLC-202, a China-based, multi-center, open label Phase 1b/2 trial evaluating the efficacy and safety of Olvi-Vec & platinum-doublet in recurrent small-cell lung cancer. The core of Genelux's discovery and development efforts revolves around its proprietary CHOICE™ platform from which Genelux has developed an extensive library of isolated and engineered oncolytic vaccinia virus immunotherapeutic product candidates, including Olvi-Vec.

Forward-Looking Statements

This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “potential,” “expected,” “look forward,” “anticipated,” “continued,” “designed to,” “remain” or “intended.” Forward-looking statements in this release include, but are not limited to, statements related to Genelux’s future plans and prospects, Genelux’s anticipated cash runway and the sufficiency of its resources to support its planned operations; the timing and likelihood of success of Genelux’s business strategy, as well as plans and objectives of management for future operations including advancing manufacturing and operational capabilities, organizational infrastructure and commercial readiness; the planned timing of Genelux’s data results in its ongoing clinical trials and continued development of Olvi-Vec; the potential capabilities advantages, safety and efficacy of Olvi-Vec, including the potential of Olvi-Vec to resensitize tumors to platinum therapy; the potential for the ongoing NSCLC and SCLC trials to support the systemic route of delivery program of Olvi-Vec and expansion of development into other solid tumor types; the potential for data from the lung cancer trials to enable the Company to optimize a systemic dosing regimen to inform future registrational development; and the potential regulatory requirements and approval pathway of Olvi-Vec. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements. These and other risks are identified under the caption “Risk Factors” in Genelux’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Genelux does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

Investor Contact

Austin Murtagh
Precision AQ
austin.murtagh@precisionaq.com

Media Contact

Ashley Murphy
Precision AQ
ashley.murphy@precisionaq.com

Source: Genelux Corporation