Olvimulogene nanivacirepvec

– 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 potentially avoid the need for conducting a separate confirmatory study. 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. Recurrent Lung Cancer Trials: Systemic Administration of Olvi-Vec Update 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). Systemic administration of Olvi-Vec in the initial dose escalation cohorts achieved a 71% disease control rate (5/7), with two partial responders. All participants with disease control experienced a reduction in all target lesions, with one participant achieving a tumor reduction of approximately 79%. Additionally, three participants, including one individual with three prior lines of treatment, achieved stable disease at lower dose cohorts, with tumor size reductions ranging between 24% to 29.2%. Olvi-Vec was generally well-tolerated with a favorable safety profile. Participant enrollment into dose escalation cohorts continues to investigate safety and the recommended intravenous dose of Olvi-Vec for Phase 2 portion of the trial, with updated interim results anticipated in the second half of 2025. Phase 2 VIRO-25 is actively enrolling recurrent non-small cell lung cancer (NSCLC) patients (NCT06463665), with interim data anticipated in second half of 2025. Business Updates Chief Financial Officer Matt Pulisic has joined the Company as its new Chief Financial Officer, effective January 30, 2025 . Mr. Pulisic is an accomplished, senior executive with over 19 years of finance and commercial experience in the biopharmaceutical industry, having worked across the United States , Europe , and Asia . He is recognized for his expertise in financial leadership, corporate strategy and operational execution. Underwritten Offering of Common Stock On March 26, 2025 , the Company closed an underwritten offering of 3,000,000 shares of its common stock at an offering price of $3.50 per share. The gross proceeds from the offering are expected to be $10.5 million , before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. The net proceeds from the offering are to be used for working capital and for general corporate purposes, including the continued clinical development of Olvi-Vec. Fourth Quarter and 2024 Financial Results Cash, cash equivalents and short-term investments were $30.9 million as of December 31, 2024 . The Company expects its cash, cash equivalents and short-term investments as of December 31, 2024 will provide runway into the first quarter of 2026. Research and development expenses were $19.0 million and $12.8 million for the years ended December 31, 2024 and 2023, respectively, an increase of approximately $6.2 million . Significant variations between periods are primarily a result of a $4.5 million increase in clinical and regulatory expenses relating to increased clinical trial costs associated with the Company’s Phase 3 On Prime Registration trial in 2024 and Phase 2 clinical trial for NSCLC, which the Company’s partner, Newsoara, is obligated to fully reimburse per the terms of their agreement; and a $1.2 million increase in employee compensation in 2024, primarily related to new employee hires in 2024. General and administrative expenses were $12.7 million and $11.6 million for the years ended December 31, 2024 and 2023, respectively, an increase of approximately $1.1 million . Significant variations between periods are primarily a result of a $0.2 million increase in employee compensation in 2024, a $0.8 million increase in stock compensation expense in 2024, due to the increase in the cost of stock options and restricted stock units in 2024, and a $0.4 million increase in consulting and contract labor expenses in 2024, primarily resulting from increased accounting and finance costs in 2024, partially offset by a $0.5 million decrease in professional services, primarily resulting from the decrease in legal expenses in 2024. Net loss was $29.9 million or $0.95 per share for the year ending December 31, 2024 , as compared to $28.3 million or $1.16 for the year ending December 31, 2023 . About Genelux Corporation Genelux is a late clinical-stage biopharmaceutical company focused on developing a pipeline of next-generation oncolytic immunotherapies for patients suffering from aggressive and/or difficult-to-treat solid 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 Ph1b 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 the Company has developed an extensive library of isolated and engineered oncolytic vaccinia virus immunotherapeutic product candidates, including Olvi-Vec. For more information, please visit www.genelux.com and follow us on Twitter @Genelux_Corp and on LinkedIn. 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 “believes,” “anticipates,” “expect,” “may,” “plan” or “will”. 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 in its ongoing clinical trials and continued development of Olvi-Vec, the potential capabilities advantages, safety and efficacy of Olvi-Vec and the potential regulatory 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 and Media Contacts Ankit Bhargava , MD Allele Communications, LLC genelux@allelecomms.com Source: Genelux Corporation Source: Genelux Corporation

–  Systemic administration of Olvi-Vec in the initial dose escalation cohorts achieved a 71% disease control rate (5/7) with two partial responders. All participants with disease control experienced a reduction in all target lesions, with one participant achieving a tumor reduction of approximately 79%. –  Additionally, three participants, including one individual with three prior lines of treatment, achieved stable disease at lower dose cohorts, with tumor size reductions ranging between 24% to 29.2%. –  Data are supportive of Olvi-Vec being a platinum resensitizing agent beyond ovarian cancer and, consistent with earlier studies, being systemically administered in multiple solid tumor types which underscore the current clinical development strategy. – Olvi-Vec was generally well-tolerated with a favorable safety profile. Participant enrollment into dose escalation cohorts continues to investigate safety and the recommended intravenous dose of Olvi-Vec for the Phase 2 trial. WESTLAKE VILLAGE, CA, USA I March 25, 2025 I Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, and Newsoara BioPharma Co., Ltd., a pre-commercial-stage biopharmaceutical company, today announced preliminary safety and anti-tumor activity data from the dose escalation Phase 1b portion of the companies’ co-sponsored ongoing Phase 1b/2 clinical trial (OLVI-VEC-SCLC-202) of Olvi-Vec immunochemotherapy in patients with platinum-relapsed or platinum-refractory extensive small cell lung cancer. “We are encouraged by the Phase 1b trial data which suggests preliminary anti-tumor activity. Consistent reductions in all individual target lesions in participants experiencing disease control (5/7), combined with encouraging anti-tumor activity of the first evaluable participant in the most recent dose-escalation cohort, highlights the potential of systemically administered Olvi-Vec to provide meaningful clinical benefit for patients with relapsed or refractory extensive small cell lung cancer,” said Thomas Zindrick, President, CEO, and Chairman of Genelux. “These results are consistent with our previous Phase 2 results in platinum-resistant/refractory ovarian cancer and, with further investigation in our ongoing trials in relapsed/refractory lung cancer, we anticipate demonstrating the potential of Olvi-Vec as a platinum resensitizing immunotherapeutic agent across multiple types of recurrent cancers with significant unmet medical needs.” Preliminary Dose Escalation Results Update The primary objectives of this trial are to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of systemically administered Olvi-Vec in the target population. The data cutoff for this announcement was February 19, 2025, with enrollment currently ongoing. Genelux anticipates providing updates on the trial’s progress as it continues to advance, whether through future publications or conference presentations. Key findings from the ongoing Phase 1b trial include: Favorable Safety and Tolerability Profile : Antitumor Activity : “The initial results are promising, especially considering the challenging and fragile nature of this patient population with extensive-stage disease and poor prognosis. What stands out is the anti-tumor responses in these participants, some who have been heavily pre-treated and have failed prior platinum-based therapy, which offers significant potential for Olvi-Vec to provide meaningful clinical benefits in small cell lung cancer, even in a patient population with complex and late-stage disease,” said Dr. Benny Li, CEO of Newsoara. “Ongoing evaluation of the Phase 1b results is consequentially informing the design elements of the Phase 2 portion of the clinical trial.” About the Olvi-Vec-SCLC-202 Trial Olvi-Vec-SCLC-202 is a Phase 1b/2, open-label, multicenter clinical trial evaluating the safety, tolerability, pharmacokinetics and efficacy of intravenously delivered Olvi-Vec combined with platinum and etoposide in the treatment of platinum-relapsed or platinum-refractory extensive small cell lung cancer patients. The Phase 1b trial is currently enrolling patients in China at Shanghai Chest Hospital, the lead clinical site, and Zhejiang Provincial People’s Hospital. Patients receive a single cycle of Olvi-Vec treatment for three consecutive days and, 21 days after the last dose of Olvi-Vec, receive platinum chemotherapy plus etoposide until disease progression or intolerable toxicity occurs. The dose escalation part of the trial is assessing the safety and tolerability of increasing doses of Olvi-Vec to determine the recommended dose and dosing regimen for Phase 2 expansion. Additionally, safety data may be evaluated to support the potential for Olvi-Vec to be safely combined with other agents, such as an immune checkpoint inhibitor, to further drive deep and durable responses in the Phase 2 portion of the trial. The Phase 2 portion of the trial is planned to follow and further evaluate the safety and tolerability as well as efficacy of Olvi-Vec at the recommended dose. About Olvi-Vec Olvi-Vec (olvimulogene nanivacirepvec), Genelux’s most advanced product candidate is a proprietary, modified oncolytic vaccinia virus, a stable DNA virus with a large engineering capacity. Genelux is developing Olvi-Vec for the treatment of multiple types of cancer based on the results of preclinical studies that suggest Olvi-Vec has the potential to infect and directly kill a wide range of tumor cell types in vitro and in vivo and produce an anti-tumor immune response. Genelux granted Newsoara an exclusive license to develop and commercialize Olvi-Vec in greater China (i.e., Mainland China, Hong Kong, Macau and Taiwan). To date, Olvi-Vec has been administered to more than 150 patients in seven completed clinical trials. In these trials, Olvi-Vec was observed to be generally well tolerated with data demonstrating clinical benefit. About Genelux Corporation Genelux is a late clinical-stage biopharmaceutical company focused on developing a pipeline of next-generation oncolytic immunotherapies for patients suffering from aggressive and/or difficult-to-treat solid tumor types. In addition to Olvi-Vec-SCLC-202, 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. The core of Genelux’s discovery and development efforts revolves around its’ proprietary CHOICE™ platform from which the Company has developed an extensive library of isolated and engineered oncolytic vaccinia virus immunotherapeutic product candidates, including Olvi-Vec. For more information, please visit www.genelux.com and follow us on Twitter @Genelux_Corp and on LinkedIn . About Newsoara Newsoara is a pre-commercial-stage biopharmaceutical company with a mission to develop and commercialize life changing medicines for cancer, autoimmune, metabolic and other major diseases to patients in China and around the world. Since its founding, Newsoara has developed a fully integrated platform which includes R&D, CMC and clinical development capabilities and built a robust and broad pipeline in major therapeutics areas. Newsoara has assembled a world-class management team with extensive experience in innovative drug development that is motivated to improve and impact human health worldwide. SOURCE: Genelux