-- 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 organizational infrastructure as we advance our registration-directed programs," 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). Intraperitoneal administration of Olvi-Vec enables high and condensed dosing in PRROC, where patients need options that can deliver anti-tumor activity and effectively reverse platinum resistance:
-- The ongoing Phase 3 OnPrime/GOG-3076 registrational trial (NCT05281471)
of Olvi-Vec in platinum-resistant/refractory ovarian cancer is being
conducted at sites across the United States, with topline data
anticipated in the second half of 2026.
-- The OnPrime/GOG-3076 study is a multi-center, randomized open-label phase
3 study evaluating the safety and efficacy of Olvi-Vec in combination
platinum-doublet chemotherapy and bevacizumab compared to the active
comparator arm with physician's choice of chemotherapy and bevacizumab in
women diagnosed with platinum-resistant/refractory ovarian cancer
(includes fallopian tube cancer and primary peritoneal cancer).
-- As of its most recent assessment in February 2026, the Independent Data
Monitoring Committee recommended study continuation without modification.
Olvi-Vec in Lung Cancer:
Genelux is advancing two ongoing trials of systemically delivered Olvi-Vec in lung cancer. These trials are designed to demonstrate that Olvi-Vec's oncolytic immunotherapy mechanism can extend beyond intraperitoneal delivery into a systemic setting across multiple solid tumor types and showcase Olvi-Vec's potential to resensitize tumors to platinum-based chemotherapy:
-- The Phase 1b/2 study (OLVI-VEC-SCLC-202) in 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 with platinum and etoposide
chemotherapy. The trial is being conducted by the Company's licensing
partner, Newsoara HYK Biopharmaceuticals Co., Ltd., in China. Data from
the dose escalation cohorts are expected to support determination of a
systemic dose for Phase 2. The following preliminary findings were
reported in January 2026:
-- Partial responses in 3 of 9 SCLC patients (33%), including two
responses in the highest dose cohort with 55% and 85% tumor
shrinkage from baseline.
-- The disease control rate was 67% (6/9 patients), with tumor
shrinkage ranging from 24--85% from baseline among patients
achieving disease control.
-- Durability signals were observed, including one patient with
ongoing progression--free survival $(PFS)$ of 12.1 months and
another patient with PFS of 7.7 months, the latter exceeding their
prior line of therapy by 5.8 months (PFS of 7.7 months vs. 1.9
months).
-- 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 NSCLC
who failed standard frontline treatment of platinum chemotherapy and an
ICI. The trial is being conducted in the United States.
-- In preliminary findings reported in January 2026, Olvi--Vec
demonstrated a 60% disease control rate (3/5 evaluable patients),
with tumor size changes of 8.9%, -18.9%, and -22.7% respectively,
as compared to baseline.
-- Olvi--Vec was generally well tolerated across the SCLC and NSCLC studies
as of their data review cutoff dates of December 23, 2025 and December
31, 2025, respectively.
Additional dose--finding updates from both the SCLC Phase 1b/2 and NSCLC Phase 2 VIRO--25 trials are expected throughout 2026, aligning with the Company's strategy to optimize a systemic dosing regimen to inform future registrational development.
Business Updates
Chief Medical Officer
Jason Litten, M.D., joined the Company as Chief Medical Officer in January 2026. Dr. Litten brings more than 20 years of experience across academia, large pharmaceutical organizations, and innovative biotechnology companies. He has led the design, execution, and interpretation of Phase 1-4 clinical trials in both liquid and solid tumors, with expertise across biologics, small molecules, and cellular therapies, and will oversee Genelux's clinical development strategy.
Underwritten Public Offering of Common Stock
In January 2026, the Company closed an underwritten follow-on public offering of 6,666,667 shares of common stock at a price of $3.00 per share, generating net proceeds of $18.5 million, after deducting underwriting discounts, commissions and offering expenses. Net proceeds are expected to be used for general corporate purposes, which may include research and development expenses, clinical trial expenses, capital expenditures, and working capital.
Fourth Quarter and 2025 Financial Results
Cash, cash equivalents, marketable securities and restricted cash were $14.6 million as of December 31, 2025. Subsequently, on January 8, 2026, the Company raised an additional $18.5 million in net proceeds through an underwritten offering of common stock, resulting in a pro forma balance of $33.1 million as of December 31, 2025. Based on its current operating plan, the Company expects the 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 $19.9 million and $19.0 million for the years ended December 31, 2025 and 2024, respectively, an increase of $0.9 million. The increase was primarily driven by increased clinical trial costs associated with the Company's Phase 3 On Prime/GOG-3076 registrational trial in 2025.
General and administrative (G&A) expenses were $13.4 million and $12.7 million for the years ended December 31, 2025 and 2024, respectively, an increase of $0.7 million. The increase was primarily driven by an increase in employee compensation due to the combination of annual salary increases and changes to headcount required to support the Company's operations, as partially offset by a decrease in consulting services.
Net loss was $32.1 million or $0.86 per share for the year ending December 31, 2025, as compared to $29.9 million or $0.95 for the year ended December 31, 2024.
About Genelux Corporation
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