GNLX
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Earnings documents stored for GNLX.
Investor releaseQuarter not tagged2026-08-13Genelux Corporation Reports Second Quarter Financial Results and Provides Business Updates
GlobeNewswire
Genelux Corporation Reports Second Quarter Financial Results and Provides Business Updates
-- 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 5th 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 F…Read full documentShow less
-- 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 5th 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 MurtaghPrecision [email protected] Media Contact Ashley MurphyPrecision [email protected] Source: Genelux Corporation
Investor releaseQuarter not tagged2026-05-08Genelux Corporation Reports First Quarter Financial Results and Provides Business Updates
GlobeNewswire
Genelux Corporation Reports First Quarter Financial Results and Provides Business Updates
-- 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…Read full documentShow less
-- 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 is designed 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 the safety and efficacy of Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab compared to the active comparator arm of physician's choice of chemotherapy and bevacizumab in women with PRROC (including fallopian tube and primary peritoneal cancers). As of its most recent assessment in February 2026, the Independent Data Monitoring Committee recommended continuation of the trial without modification. Olvi-Vec in Lung Cancer: Genelux is advancing two ongoing lung cancer trials of systemically delivered Olvi-Vec to evaluate its potential beyond intraperitoneal delivery and into a broader range of solid tumor types. These studies also support the Company’s strategy to resensitize multiple tumor types to platinum-based chemotherapy and to optimize a systemic dosing regimen for the advancement of future registration-path development in lung cancer. 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, including frontline platinum and etoposide chemotherapy. The trial is being conducted by the Company’s licensing partner, Newsoara HYK Biopharmaceuticals Co., Ltd., in China. Data from dose-escalation cohorts are expected to inform selection of a systemic dose for Phase 2 and subsequent development. 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. Together, these studies are intended to inform the potential for broader systemic use of Olvi-Vec across additional solid tumor types. First Quarter 2026 Financial Results Cash, cash equivalents, marketable securities and restricted cash were $26.3 million as of March 31, 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 $5.8 million and $4.7 million for the three months ended March 31, 2026 and 2025, respectively, an increase of $1.1 million. The increase was primarily driven by clinical and regulatory expenses relating to increased clinical trial costs associated with our Phase 3 On Prime/GOG-3076 registration trial and employee compensation and related expenses. General and administrative (G&A) expenses were $3.4 million and $3.1 million for the three months ended March 31, 2026 and 2025, respectively, an increase of $0.3 million. The increase was primarily driven by higher employee compensation and related expenses. Net loss was $8.9 million or $0.20 per share for the three months ended March 31, 2026, as compared to $7.5 million or $0.21 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,” “progress,” “anticipated,” “continued,” “designed to,” “remains on track” 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, likelihood or 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 [email protected] Media Contact Ashley Murphy Precision AQ [email protected] Source: Genelux Corporation
Investor releaseQuarter not tagged2026-03-20Genelux Corporation Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Updates
GlobeNewswire
Genelux Corporation Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Updates
-- 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…Read full documentShow less
-- 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 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,” “will,” “believes,” “advancing,” “expected,” “anticipated,” “continued,” “designed to,” 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; expected use of proceeds from the January 2026 financing; the timing, likelihood or 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, 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 [email protected] Media Contact Ashley Murphy Precision AQ [email protected] Source: Genelux Corporation
Investor releaseQuarter not tagged2025-11-06Genelux Corporation Reports Third Quarter 2025 Financial Results and Provides General Business Updates
GlobeNewswire
Genelux Corporation Reports Third Quarter 2025 Financial Results and Provides General Business Updates
-- 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…Read full documentShow less
-- 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-Vec toward potential registration in platinum-resistant/refractory ovarian cancer (PRROC). Intraperitoneal administration of Olvi-Vec offers an attractive approach for high and condensed dosing in PRROC, where patients need options that can deliver anti-tumor activity and effectively reverse platinum resistance: The ongoing OnPrime Phase 3 registrational trial (NCT05281471) of Olvi-Vec in platinum-resistant/refractory ovarian cancer is enrolling patients at sites across the United States, with topline data now anticipated in the second half of 2026. The OnPrime study is a multi-center, randomized open-label phase 3 study evaluating the safety and efficacy of Olvi-Vec followed by 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). The Independent Data Monitoring Committee has regularly reviewed and recommended continuation of the trial without modifications. Based on a Type D meeting with the U.S. Food and Drug Administration, Genelux believes data from OnPrime could potentially support traditional regulatory approval if a clinically meaningful progression-free survival advantage is demonstrated without a decrement in overall survival. 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 2 study (NCT06463665) in recurrent non-small cell lung cancer (NSCLC) is assessing Olvi-Vec in combination with standard-of-care regimens, including platinum-based chemotherapy and an immune checkpoint inhibitor. The Phase 1b/2 study (OLVI-VEC-SCLC-202) in small-cell lung cancer (SCLC) is evaluating Olvi-Vec in combination with platinum and etoposide in patients with platinum-resistant or relapsed disease. We are continuing to enroll in the dose-escalation portion of these open-label lung cancer studies, which will support determination of a systemic dose for future trials. Further to SCLC data shared earlier this year, additional interim data from both trials are expected to be shared in the fourth quarter of 2025 and throughout 2026. Third Quarter 2025 Financial Results Cash, cash equivalents, short-term investments and restricted cash were $21.0 million as of September 30, 2025. The Company expects its existing cash, cash equivalents, short-term investments and restricted cash will provide runway into the third quarter of 2026. Research and development (R&D) expenses were $4.7 million and $4.1 million for the three months ended September 30, 2025 and 2024, respectively, an increase of $0.7 million. The increase was primarily driven by stock compensation and clinical and regulatory expenses relating to increased clinical trial costs associated with our Phase 3 On Prime registration trial. General and administrative (G&A) expenses were $3.5 million and $2.9 million for the three months ended September 30, 2025 and 2024, respectively, an increase of $0.6 million. The increase was primarily driven by stock compensation and salary and benefits, partially offset by a decrease in professional services. Net loss was $8.0 million for the third quarter of 2025 or a net loss per share of $0.21, as compared to a net loss of $6.5 million for the third quarter of 2024, or a net loss per share of $0.19. 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 Phase 1b 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 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 X @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 “potential,” “could,” “believe,” “positioning,” “expect,” “anticipated,” “look forward,” or “aim,” 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, likelihood or success of Genelux’s business strategy, as well as plans and objectives of management for future operations; the size of the market opportunity for Olvi-Vec; 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 frontline platinum therapy; the potential for the ongoing NSCLC and SCLC trials to support the systemic route of delivery program of Olvi-Vec, the potential for positive data from systemic administration lung cancer studies to further validate Genelux’s oncolytic immunotherapy platform and to mark an inflection for Genelux’s pipeline and to position Genelux for growth; 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. The accompanying notes are an integral part of these condensed financial statements. The accompanying notes are an integral part of these condensed financial statements. Investor Contact Austin Murtagh Precision AQ [email protected] Media Contact Ashley Murphy Precision AQ [email protected] Source: Genelux Corporation
Investor releaseQuarter not tagged2025-08-08Genelux Corporation Reports Second Quarter 2025 Financial Results and Provides General Business Updates
GlobeNewswire
Genelux Corporation Reports Second Quarter 2025 Financial Results and Provides General Business Updates
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…Read full documentShow less
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 parallel, the Company’s lung cancer trials intend to demonstrate the potential of Olvi-Vec to resensitize tumors to frontline platinum-based therapy and generate other clinical benefits across diverse solid tumor settings. In the ongoing Phase 1b/2 trial (OLVI-VEC-SCLC-202) of Olvi-Vec immunochemotherapy in platinum-relapsed or platinum-refractory extensive-stage small cell lung cancer, previously disclosed preliminary data showed a 71% disease control rate in initial dose escalation cohorts, with a favorable safety profile and no dose-limiting toxicities observed as of the February 19, 2025 data cutoff. Enrollment into dose escalation cohorts remains active, which will support determination of an intravenous dose for Phase 2. Updated interim results are expected in the second half of 2025. A Phase 2 trial (NCT06463665) in recurrent non-small cell lung cancer is also progressing. Interim data from this study are anticipated in the second half of 2025. Business Updates Mr. Groen brings over 20 years of experience in the life sciences industry and has held senior leadership roles across legal, compliance, and corporate development functions. Second Quarter 2025 Financial Results “We are very pleased with our quarterly performance, which reflects our commitment to capital-efficient innovation. We continued to advance towards our clinical, manufacturing and regulatory goals with relentless operational execution and disciplined resource allocation,” said Matt Pulisic, Chief Financial Officer of Genelux. Cash, cash equivalents and short-term investments were $28.1 million as of June 30, 2025. The Company expects its existing cash, cash equivalents and short-term investments will provide runway into the third quarter of 2026. Research and development (R&D) expenses were $4.8 million and $4.4 million for the three months ended June 30, 2025 and 2024, respectively, an increase of $0.3 million. The increase was primarily driven by clinical and regulatory expenses relating to increased clinical trial costs associated with our Phase 3 OnPrime registrational trial in 2025. General and administrative (G&A) expenses were $3.0 million and $2.5 million for the three months ended June 30, 2025 and 2024, respectively, an increase of $0.5 million. The increase was primarily driven by a $0.3 million increase in salary and benefits and $0.2 million in professional services. Net loss was $7.5 million for the second quarter of 2025 or a net loss per share of $0.20, as compared to a net loss of $6.6 million for the second quarter of 2024, or a net loss per share of $0.22. 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. The contents of Genelux’s website or social media shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended. 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,” “aiming,” “believes,” “anticipates,” “expect,” “may,” “plan,” “look forward,” “intended to” or “will”. 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, likelihood or success of Genelux’s business strategy, as well as plans and objectives of management for future operations; 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 patients to frontline platinum therapy and redefine treatment paradigms of recurrent tumors in multiple indications and in the field of oncolytic immunotherapy, the potential for the ongoing NSCLC and SCLC trials to support the systemic route of delivery program of Olvi-Vec, 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 and Media Contacts Ankit Bhargava, MD Allele Communications, LLC [email protected] Source: Genelux Corporation
Investor releaseQuarter not tagged2025-05-07Genelux Corporation Reports First Quarter 2025 Financial Results and Provides General Business Updates
GlobeNewswire
Genelux Corporation Reports First Quarter 2025 Financial Results and Provides General Business Updates
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…Read full documentShow less
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 size reductions of 24% to 29.2%. Olvi-Vec was generally well tolerated with a favorable safety profile, and no maximum tolerated dose had been reached at the time of data cutoff on February 19, 2025. Enrollment into dose escalation cohorts remained ongoing to further investigate safety and determine the recommended intravenous dose for the Phase 2 trial, with updated interim results anticipated in the second half of 2025. Patient enrollment has been increasing in the ongoing US based Phase 2 trial for the systemic administration of Olvi-Vec in recurrent non-small cell lung cancer, with an interim readout anticipated in the second half of 2025. Business Updates In February, the company announced that Matthew Pulisic joined as its new Chief Financial Officer, effective January 30, 2025. Mr. Pulisic brings over 19 years of finance and commercial experience in the biopharmaceutical industry, with a background spanning the United States, Europe, and Asia. Prior to joining Genelux, he served as Vice President of Finance at Arrowhead Pharmaceuticals, where he played a key role in shaping the company’s financial direction, establishing a commercial manufacturing facility, and driving operational improvements. He began his career at Amgen as a Research Associate before transitioning into finance, eventually holding senior roles including Finance Director of Amgen Worldwide and Head of Capital Finance. In March, the company completed an underwritten offering of 3,000,000 shares of its common stock at an offering price of $3.50 per share, raising approximately $10.5 million in gross proceeds. Titan Partners Group acted as the sole bookrunner for the offering. “This successful equity raise strengthens our balance sheet, extends our runway into the third quarter of 2026 and enables us to confidently advance our strategic priorities through key upcoming milestones, including the Phase 3 topline readout in resistant/refractory ovarian cancer”, said Matthew Pulisic, Chief Financial Officer of Genelux. First Quarter 2025 Financial Results Cash, cash equivalents and short-term investments were $35.1 million as of March 31, 2025. We expect our existing cash, cash equivalents, and short-term investments will provide runway into the third quarter of 2026. Research and development (R&D) expenses were $4.7 million and $4.0 million for the three months ended March 31, 2025 and 2024, respectively, an increase of $0.7 million. Significant variations between periods are primarily a result of a $1.4 million increase in clinical and regulatory expenses relating to increased clinical trial costs associated with our Phase 3 On Prime Registration trial in 2025, partially offset by a $0.6 million decrease in stock-related compensation in 2025, relating to the decreased cost of stock options and restricted stock units in 2025. General and administrative (G&A) expenses were $3.1 million and $4.1 million for the three months ended March 31, 2025 and 2024, respectively, a decrease of $1.0 million. Significant variations between periods are primarily a result of a $0.7 million decrease in stock compensation expense in 2025, relating to the decreased cost of stock options and restricted stock units in 2025. Net loss was $7.5 million for the first quarter of 2025, or a net loss per share of $0.21, as compared to net loss of $7.9 million for the first quarter of 2024, or a net loss per share of $0.29. 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, Genelux’s anticipated cash runway and the sufficiency of its resources to support its planned operations; the timing, likelihood or success of Genelux’s business strategy, as well as plans and objectives of management for future operations; 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 [email protected] Source: Genelux Corporation Genelux Corporation Condensed Balance Sheets (In thousands, except for share amounts and par value data) March 31, December 31, 2025 2024 (Unaudited) ASSETS Current Assets Cash and cash equivalents $ 16,206 $ 8,565 Short-term investments 18,896 22,330 Prepaid expenses and other current assets 843 653 Total Current Assets 35,945 31,548 Property and equipment, net 1,287 1,316 Right of use assets 1,680 1,760 Other assets 73 92 Total Other Assets 3,040 3,168 TOTAL ASSETS $ 38,985 $ 34,716 LIABILITIES AND SHAREHOLDERS' EQUITY Current Liabilities Accounts payable and accrued expenses $ 6,688 $ 5,570 Accrued payroll and payroll taxes 664 1,004 Lease liabilities, current portion 337 329 Total Current Liabilities 7,689 6,903 Lease liabilities, long-term portion 1,450 1,539 Total Liabilities 9,139 8,442 Commitments and Contingencies Shareholders' Equity Preferred stock, par value $0.001, 10,000,000 shares authorized; no shares issued and outstanding, respectively; - - Common stock, par value $0.001, 200,000,000 shares authorized; 37,733,140 and 34,728,140 shares issued and outstanding 38 35 Treasury stock, 433,333 shares, at cost (433 ) (433 ) Additional paid-in capital 289,097 278,001 Accumulated other comprehensive income 29 64 Accumulated deficit (258,885 ) (251,393 ) Total Shareholders' Equity 29,846 26,274 TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 38,985 $ 34,716 The accompanying notes are an integral part of these condensed financial statements. Genelux Corporation Condensed Statements of Operations (in thousands, except for share amounts and per share data) Three Months Ended March 31, 2025 2024 (Unaudited) Revenues $ - $ 8 Operating expenses: Research and development 4,698 4,010 General and administrative 3,118 4,113 Total operating expenses 7,816 8,123 Loss from operations (7,816 ) (8,115 ) Other income (expenses): Interest income 184 114 Bond Accretion Income 140 151 Total other income (expenses), net 324 265 NET LOSS $ (7,492 ) $ (7,850 ) LOSS PER COMMON SHARE - BASIC AND DILUTED $ (0.21 ) $ (0.29 ) WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING - BASIC AND DILUTED 34,926,075 26,849,737 The accompanying notes are an integral part of these condensed financial statements.
Investor releaseQuarter not tagged2025-03-30Genelux Full Year 2024 Earnings: Revenues Beat Expectations, EPS Lags
Simply Wall St.
Genelux Full Year 2024 Earnings: Revenues Beat Expectations, EPS Lags
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.
Investor releaseQuarter not tagged2025-03-29Genelux Corporation Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
GlobeNewswire
Genelux Corporation Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
– 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…Read full documentShow less
– 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%. 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%. 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. 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 [email protected] Source: Genelux Corporation Genelux Corporation Balance Sheets (In thousands, except for share amounts and par value data) December 31, 2024 2023 ASSETS Current Assets Cash and cash equivalents $ 8,565 $ 9,418 Short-term investments 22,330 13,773 Prepaid expenses and other current assets 653 1,012 Total Current Assets 31,548 24,203 Property and equipment, net 1,316 1,170 Right of use assets 1,760 2,428 Other assets 92 92 Total Other Assets 3,168 3,690 TOTAL ASSETS $ 34,716 $ 27,893 LIABILITIES AND SHAREHOLDERS' EQUITY Current Liabilities Accounts payable and accrued expenses $ 5,570 $ 3,784 Accrued payroll and payroll taxes 1,004 2,117 Lease liabilities, current portion 329 653 Total Current Liabilities 6,903 6,554 Lease liabilities, long-term portion 1,539 1,866 Total Liabilities 8,442 8,420 Commitments and Contingencies Shareholders' Equity Preferred stock, par value $0.001, 10,000,000 shares authorized; no shares issued and outstanding, respectively; - - Common stock, par value $0.001, 200,000,000 shares authorized; 34,728,140 and 26,788,986 shares issued and outstanding 35 27 Treasury stock, 433,333 shares, at cost (433 ) (433 ) Additional paid-in capital 278,001 241,389 Accumulated other comprehensive income 64 14 Accumulated deficit (251,393 ) (221,524 ) Total Shareholders' Equity 26,274 19,473 TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 34,716 $ 27,893 The accompanying notes are an integral part of these financial statements. Genelux Corporation Statements of Operations (in thousands, except for share amounts and per share data) Years Ended December 31, 2024 2023 Revenues $ 8 $ 170 Operating expenses: Research and development 18,998 12,767 General and administrative 12,706 11,568 Total operating expenses 31,704 24,335 Loss from operations (31,696 ) (24,165 ) Other income (expenses): Interest income 1,457 244 Gain on extinguishment of accounts payable 370 - Interest expense - (173 ) Debt discount amortization - (649 ) Financing costs - (3,152 ) Debt extinguishment costs (402 ) Total other income (expenses), net 1,827 (4,132 ) NET LOSS $ (29,869 ) $ (28,297 ) LOSS PER COMMON SHARE - BASIC AND DILUTED $ (0.95 ) $ (1.16 ) WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING - BASIC AND DILUTED 31,450,727 24,429,278 The accompanying notes are an integral part of these financial statements. Genelux Corporation Statements of Comprehensive Loss (in thousands) Years Ended December 31, 2024 2023 Net loss $ (29,869 ) $ (28,297 ) Other comprehensive loss: Net unrealized gain on short and long-term investments 50 12 Comprehensive loss $ (29,819 ) $ (28,285 ) The accompanying notes are an integral part of these financial statements. Genelux Corporation Statements of Shareholders' Equity (Deficit) (in thousands, except share amounts) Accumulated Other Preferred Stock Common Stock Treasury Stock Additional Comprehensive Accumulated Shares Amount Shares Amount Shares Amount Paid-in Capital Income (Loss) Deficit Total Balance, December 31, 2022 22,094,889 $ 22 9,126,726 $ 9 (433,333 ) $ (433 ) $ 154,401 $ 2 $ (189,784 ) $ (35,783 ) Stock compensation - - - - - - 2,515 - - 2,515 Unrealized gain on short-term investments - - - - - - - 12 - 12 Issuance of common shares upon the closing of the initial public offering, net of offering costs - - 2,653,000 3 - - 12,629 - - 12,632 Issuance of common shares upon the closing of private financings, net of offering costs - - 1,292,079 2 - - 25,140 - - 25,142 Issuance of common shares upon conversion of preferred stock (22,094,889 ) (22 ) 8,359,143 8 - - 14 - - - Issuance of common shares upon conversion of convertible notes payable, accrued interest and loan fees - - 4,137,760 4 - - 29,970 - - 29,974 Issuance of common shares upon conversion of preferred stock dividends payable - - 272,101 - - - 3,443 - (3,443 ) - Fair value of vested restricted stock units - - 113,500 - - - 940 - - 940 Cost of stock option repricing - - - - - - 2,689 - - 2,689 Reclassification of warrant liabilities upon the closing of the initial public offering - - - - - - 169 - - 169 Fair value of warrants issued in connection with the the conversion of convertible notes payable - - - - - - 3,152 - - 3,152 Conversion of notes payable-shareholders and accrued interest - - 73,134 - - - 1,865 - - 1,865 Issuance of common shares upon exercise of stock options - - 232,787 - - - 1,474 - - 1,474 Issuance of common shares upon exercise of stock warrants - - 528,756 1 - - 2,988 - - 2,989 Net loss during the year ended December 31, 2023 - - - - - - - - (28,297 ) (28,297 ) Balance, December 31, 2023 - - 26,788,986 27 (433,333 ) (433 ) 241,389 14 (221,524 ) 19,473 Stock compensation - - - - - - 5,738 - - 5,738 Unrealized gain on short and long-term investments - - - - - - - 50 - 50 Fair value of vested restricted stock units - - 303,389 - - - 2,044 - - 2,044 Cost of stock option modifications and repricing - - - - - - 332 - - 332 Issuance of common shares for cash and warrants, net of costs - - 7,505,460 8 - - 27,685 - - 27,693 Issuance of common shares in connection with the Company’s equity award programs - - 53,818 - - - 125 - - 125 Issuance of common shares upon exercise of stock warrants - - 76,487 - - - 688 - - 688 Net loss during the year ended December 31, 2024 - - - - - - - - (29,869 ) (29,869 ) Balance, December 31, 2024 - $ - 34,728,140 $ 35 (433,333 ) $ (433 ) $ 278,001 $ 64 $ (251,393 ) $ 26,274 The accompanying notes are an integral part of these financial statements. Genelux Corporation Statements of Cash Flows (In thousands) Years Ended December 31, 2024 2023 Cash Flows from Operating Activities Net loss $ (29,869 ) $ (28,297 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation expense 235 499 Net amortization of premiums and discounts on short-term investments (757 ) (62 ) Right-of-use asset 668 519 Amortization of debt discount - 649 Stock compensation 5,738 2,515 Fair value of restricted stock units 2,044 940 Cost of stock option modifications and repricing 332 2,689 Gain on extinguishment of accounts payable (370 ) - Debt extinguishment costs - 402 Fair value of warrants issued in connection with the conversion of convertible notes payable - 3,152 Changes in Assets and Liabilities (Increase) Decrease in: Prepaid expenses and other assets 359 483 (Decrease) Increase in: Accounts payable and accrued expenses 2,156 (2,358 ) Accrued payroll and payroll taxes (1,113 ) (735 ) Accrued interest payable - 22 Deferred revenue - (170 ) Lease liability (651 ) (523 ) Net cash used in operating activities (21,228 ) (20,275 ) Cash Flows from Investing Activities Purchases of property and equipment (381 ) (1,025 ) Purchase of short and long-term investments (29,000 ) (13,699 ) Proceeds from sales and maturities of short and long-term investments 21,250 - Net cash used in investing activities (8,131 ) (14,724 ) Cash Flows from Financing Activities Proceeds from notes payable - shareholders - 900 Repayment of notes payable - shareholders - (685 ) Payment of deferred offering costs - (303 ) Proceeds from common stock issued in connection with the Company’s equity award programs 125 - Proceeds from the exercise of stock options - 1,474 Proceeds from the exercise of stock warrants 688 2,989 Proceeds from common stock issued for cash in connection with the closing of the IPO - 14,503 Proceeds from common stock issued for cash in connection with the closing of private financings - 25,142 Proceeds from common stock issued for cash in connection with the closing of a second public offering 27,693 - Net cash provided by financing activities 28,506 44,020 Net increase (decrease) in cash and cash equivalents (853 ) 9,021 Cash and cash equivalents at the beginning of year 9,418 397 Cash and cash equivalents at the end of year $ 8,565 $ 9,418 Supplemental cash flows disclosures: Interest paid $ - $ 72 Taxes paid $ - $ - Supplemental non-cash financing disclosures: Effect of the extension of right-of-use asset and operating lease $ - $ 1,612 Reclassification of deferred offering costs to shareholders' equity $ - $ 1,871 Reclassification of warrant liabilities to shareholders' equity $ - $ 169 Conversion of convertible notes payable, accrued interest and loan fees to shareholders' equity $ - $ 29,974 Conversion of preferred stock to common stock $ - $ 22 Conversion of dividends payable to shareholders' equity $ - $ 3,443 Conversion of notes payable-shareholders and accrued interest to shareholders' equity $ - $ 1,463 Unrealized gain on investments $ 50 $ 12 The accompanying notes are an integral part of these financial statements.

