Genelux Announces Publication of a Deep and Durable Response in a Platinum-relapsed Small Cell Lung Cancer Patient Following Systemically Delivered Olvi-Vec-Primed Immunochemotherapy

— A platinum-relapsed SCLC patient achieved 16.7 months progression-free survival following Olvi-Vec and platinum rechallenge, exceeding the PFS achieved following platinum-based first-line therapy —

— This patient also achieved 84.6% reduction in target lesion size, as previously reported by Genelux, exceeding the reduction achieved following first-line therapy —

— Findings support the potential of systemically administered Olvi-Vec to drive anti-tumor activity and enhance responsiveness to platinum-based chemotherapy in difficult-to-treat cancers —

— Enrollment ongoing in dose-escalation cohorts evaluating systemically administered Olvi-Vec in lung cancer trials —

WESTLAKE VILLAGE, Calif., Sept. 09, 2026 (GLOBE NEWSWIRE) — Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today announced the publication of a case report from the ongoing Phase 1b dose escalation portion of its Phase 1b/2 OLVI-VEC-202-SCLC trial (NCT07136285). The report was published in Frontiers in Oncology, a peer-reviewed journal published by Frontiers Media S.A., available here.

This is an open-label trial evaluating a single intravenous cycle with multiple doses of Olvi-Vec administered in combination with platinum and etoposide chemotherapy in patients with platinum-relapsed or platinum-refractory small cell lung cancer (SCLC) after failing previous first-line treatment with platinum and etoposide chemotherapy. The trial is being conducted by the Company’s licensing partner, Newsoara HYK Biopharmaceuticals Co. (Shanghai), Ltd. (Newsoara), in China.

“This compelling case published in Frontiers in Oncology provides clinically relevant evidence that strengthens our commitment to evaluating systemic (intravenous) administration of Olvi-Vec in combination with platinum-based chemotherapy and potentially other treatment regimens,” said Thomas Zindrick, President, CEO, and Chairman of Genelux. “We are encouraged by the consistency between our preclinical and clinical data with Olvi-Vec-primed immunochemotherapy which supports a mechanism of action by which Olvi-Vec-mediated changes to the tumor microenvironment may enhance responsiveness to therapies in both first-line and recurrent settings.”

In this case report, a 58-year-old woman was previously treated for extensive stage SCLC with four cycles of frontline standard treatment with platinum and etoposide, followed by radiotherapy to the lung and prophylactic brain radiotherapy resulting in a 14.3-month progression-free survival (PFS) and a duration of response (DOR) of 13.0 months.

After progressing from standard frontline therapy, the patient received a single course of systemically administered Olvi-Vec, which was well tolerated, and then was re-challenged with eight cycles of platinum and etoposide. The patient achieved a deep and durable partial objective response (84.6% reduction in target lesion size), a PFS of 16.7 months and a DOR of 14.3 months, exceeding those observed during her first-line platinum-based treatment.  Moreover, the patient achieved a deeper tumor reduction after 4 cycles of platinum re-challenge as compared to after 4 cycles of first-line treatment (-78.9% vs -67.8%), representing an absolute reduction of 22.0 mm (from a 27.9 mm baseline before initiation of 2nd line therapy) versus 11.6 mm (from a 17.1 mm baseline before initiation of 1st line therapy).

This patient’s experience exceeds historical outcomes reported with platinum rechallenge and support the hypothesis that Olvi-Vec-mediated changes in the tumor microenvironment may contribute to renewed sensitivity to platinum-based therapy.

“Small cell lung cancer is known for its aggressive nature and poor prognosis once it recurs after initial chemotherapy,” said Jason Litten, M.D., Chief Medical Officer of Genelux Corporation. “Although this case report reflects the outcome of a single patient and does not establish safety or efficacy or predict similar outcomes in other patients, the magnitude and duration of tumor regression are highly encouraging and align with our scientific rationale for combining Olvi-Vec with platinum-based therapy in various clinical settings.”

Patient enrollment is ongoing in the dose-escalation cohorts of OLVI-VEC-202-SCLC and in the VIRO-25 trial, a Phase 2 trial evaluating a single intravenous cycle with multiple doses of Olvi-Vec in combination with platinum chemotherapy and an immune checkpoint inhibitor (ICI) in patients with advanced or metastatic recurrent non-small-cell lung cancer (NSCLC) who failed standard first-line treatment of platinum chemotherapy and an ICI.  Additional dose‑finding updates from both the Phase 1b/2 SCLC trial and Phase 2 VIRO‑25 NSCLC trial are expected in 2026. Together, these dose‑finding studies are intended to inform the Company’s lung cancer development strategy and the potential for broader systemic use of Olvi-Vec across additional solid tumor types.

Pursuant to a license agreement entered into in September 2021, Genelux granted to Newsoara BioPharma Co. Ltd. an exclusive license to research, develop, commercialize or exploit Olvi-Vec in China, which includes mainland China, Taiwan, Hong Kong and Macau, for all human diagnostic, prophylactic and therapeutic uses. In October 2025, Newsoara BioPharma Co. Ltd. assigned all of its rights and obligations under the agreement to an affiliate, Newsoara HYK Biopharmaceuticals Co., Ltd.  Genelux and Newsoara co-sponsor the Olvi-Vec-SCLC-202 Phase 1b/2 study, which Newsoara is conducting in China.

About Olvi-Vec

Olvi-Vec (olvimulogene nanivacirepvec), Genelux’s lead investigational asset, is a proprietary, modified vaccinia virus being evaluated as an oncolytic immunotherapy. Olvi-Vec’s differentiated mechanism of action (MoA) is designed to directly kill cancer cells, stimulate a tumor-specific immune response, remodel the tumor microenvironment, and re-sensitize tumors to platinum-based chemotherapy with or without ICIs. Genelux is developing Olvi-Vec immunotherapy for multiple cancer types in a strategically integrated program based on robust preclinical data and clinical evidence of its differentiated MoA, feasibility of repeat dosing and a dose-dependent overall survival benefit in cancer patients with primary or metastatic lung diseases. To date, Olvi-Vec has been administered to more than 150 patients across seven completed clinical trials, where Olvi-Vec has been generally well tolerated and demonstrated clinically meaningful benefits. Genelux has granted Newsoara an exclusive license to develop and commercialize Olvi-Vec in greater China (i.e., Mainland China, Hong Kong, Macau and Taiwan). 

About Genelux Corporation

Genelux is a late clinical-stage biopharmaceutical company focused on developing next-generation oncolytic immunotherapies for patients with aggressive and/or difficult-to-treat tumor types. Olvi-Vec is currently 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. Additionally, Olvi-Vec is currently being evaluated for dose selection in VIRO-25, a multi-center open-label Phase 2 trial evaluating the efficacy and safety of Olvi-Vec & platinum-doublet + physician’s choice of immune checkpoint inhibitor in non-small-cell lung cancer and 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,” “intended,” “expected,” “may,” and “designed to.” Forward-looking statements in this release include, but are not limited to, statements related to Genelux’s future plans and prospects; the planned timing of Genelux’s data results and dose-selection in its ongoing clinical trials and continued development of Olvi-Vec; safety, tolerability, activity and efficacy of Olvi-Vec, including the potential synergy of Olvi-Vec with platinum-based therapy; the potential role of Olvi-Vec as a tumor-priming immunotherapy, the ability of Olvi-Vec to directly kill cancer cells, stimulate a tumor-specific immune response, remodel the tumor microenvironment, and re-sensitize tumors to platinum-based chemotherapy; Olvi-Vec’s potential to enhance responsiveness to therapies in first-line and recurrent settings; the potential for data from the lung cancer trials to inform the Company’s lung cancer development strategy, and the potential for systemic use of Olvi-Vec across clinical settings and tumor types. 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.

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Source: Genelux Corporation