Bevacizumab

-- 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 Murtagh Precision AQ austin.murtagh@precisionaq.com Media Contact Ashley Murphy Precision AQ ashley.murphy@precisionaq.com Source: Genelux Corporation Source: Genelux Corporation

肝细胞癌（HCC）是我国高发恶性肿瘤之一，既往晚期患者长期面临治疗选择有限、生存获益不足和药物可及性不均衡等多重挑战。随着新药研发的不断发展，晚期HCC一线治疗已由传统TKI单药逐步迈入靶免、双免等多策略并行的新阶段。其中，纳武利尤单抗联合伊匹木单抗（O+Y方案）基于CheckMate 9DW研究显示出明确的显著生存获益（mOS 23.7个月）、高客观缓解率（ORR 36%）和持久应答（mDoR 34.3个月）特征[1]，为临床尤其是存在抗血管生成治疗顾虑的患者提供了差异化选择。与此同时，免疫相关不良反应（irAE）的规范化识别与管理，以及商业健康保险、区域性惠民保等创新支付方式的完善，正共同推动高质量治疗方案从循证证据走向真实临床获益。【肿瘤资讯】特邀辽宁省肿瘤医院王远鹤教授，围绕双免联合在晚期HCC一线治疗中的定位、irAE管理实践经验及创新支付模式对药物可及性的影响进行深入分享。王远鹤 教授主任医师，硕士研究生导师辽宁省肿瘤医院消化肿瘤内科副主任中国抗癌协会胰腺肿瘤整合康复专业委员会委员辽宁省抗癌协会靶向治疗专委会常委中国医促会神经内分泌肿瘤分会委员中国研究型医院学会分子肿瘤与免疫治疗专委会委员辽宁省细胞生物学学会MDT专委会常委辽宁省生命关怀协会营养专委会常委辽宁省抗癌协会肝癌委员会青年委员辽宁省预防医学会肿瘤防治专委会委员北京肿瘤防治研究会癌症早筛早诊早治分委会委员辽宁省细胞生物学学会肿瘤精准医疗与大数据管理专委会委员循证积淀与格局演进：双免联合在晚期肝癌一线治疗中的定位与价值王远鹤教授：我国是原发性肝癌的高发国家，每年新发及死亡病例数占全球超过40%，对高效系统治疗方案的需求迫切。回顾晚期HCC一线治疗的发展历程，早期阶段仅有口服TKI单药可供选择，包括最早获批的索拉非尼以及目前仍广泛使用的仑伐替尼[2]。随着肿瘤治疗步入免疫治疗时代，肝癌的系统治疗格局发生了深刻变革。IMbrave150研究证实了阿替利珠单抗联合贝伐珠单抗在HCC一线治疗中的生存优势，确立了靶免联合治疗在晚期HCC一线治疗中的基石地位。此后，以双艾组合（卡瑞利珠单抗联合阿帕替尼）和双安组合为代表的小分子TKI联合免疫治疗模式，亦通过III期临床研究证实了OS获益，相继获得晚期HCC一线治疗适应症。在靶免联合基础上，双免联合治疗策略的探索进一步拓展了晚期HCC一线治疗的维度。两项国际多中心III期临床研究（CheckMate 9DW和HIMALAYA）均证实了双免方案在晚期HCC一线治疗中的显著生存获益。CheckMate 9DW研究以索拉非尼和仑伐替尼作为对照组，充分体现了研究设计的严谨性与结果的说服力。纳武利尤单抗联合伊匹木单抗（O+Y方案）取得了显著生存获益：mOS达到23.7个月，显著优于对照组（20.6个月）；36个月OS率达39%，而对照组仅为25%；48个月OS率达31%（vs 对照组18%）。在缓解数据方面，ORR高达36%，中位持续缓解时间（DOR）达到34.3个月，较对照组（12.9个月）延长21.4个月[1]。这些数据充分体现了双免治疗在驱动深度应答的同时具备持续缓解的突出特征，为患者的长期生存奠定了基础。HIMALAYA研究同样证实了双免联合治疗的有效性，STRIDE方案对比索拉非尼取得了OS显著获益。最新的六年随访数据显示，STRIDE方案的6年OS率达17.1%[3]，为索拉非尼组的近2倍。这一长期生存结果在传统靶向治疗时代几乎难以实现，进一步印证了双免治疗在实现长期生存方面的价值。在治疗策略的选择层面，当前晚期HCC一线方案涵盖TKI单药、靶免联合及双免联合等多种模式，临床医生需根据患者的具体病情进行个体化决策。首先，应评估患者对抗血管生成治疗的耐受性：贝伐珠单抗或小分子TKI可能引起高血压、蛋白尿及出血等不良事件；使用贝伐珠单抗前需行胃镜检查，若存在严重食管胃底静脉曲张则为其使用禁忌症；对于肾功能不全或存在轻度肾功能异常的患者，抗血管生成药物的持续使用可能加重蛋白尿，导致长期用药受限。上述人群可考虑双免治疗。此外，不同临床研究的入排标准亦可作为人群选择的参考依据。例如，IMbrave150研究纳入了门静脉癌栓患者，因此合并门静脉癌栓的患者选择靶免联合模式更为适宜。综合而言，双免治疗的核心优势体现在安全性特征相对良好以及长期生存获益突出两方面，无论是OS率还是中位OS均展现了令人鼓舞的数据，为特定患者人群提供了优质的一线治疗选择。irAE规范化管理经验：熟识规律、强化教育、多学科联动王远鹤教授：随着免疫治疗时代的来临，免疫治疗药物在临床中的使用日益广泛，治疗期间出现的免疫相关不良反应（irAE）也成为临床实践中需要常规面对和规范管理的问题。以CheckMate 9DW研究为例，O+Y方案3-4级治疗相关不良反应（TRAE）的总体发生率为41%，而对照组（索拉非尼/仑伐替尼）为42%[1]，两组之间并无明显差异。在irAE的具体管理实践中，我认为需着重关注以下方面：第一，临床医生应充分熟悉irAE的常见临床表现及其发生时间规律。双免治疗中较常见的irAE包括：免疫相关性皮肤毒性（如免疫性皮炎），其次为免疫性肝炎，此外还包括免疫性肺炎、甲状腺相关毒性等。值得注意的是，双免治疗亦有引发免疫性心肌炎的可能，临床中需保持警觉。第二，应加强对患者及其家属的系统化教育。应使患者知晓irAE的常见表现及其对应的预警信号。例如，出现咳嗽可能提示免疫相关性肺炎，出现腹泻可能提示免疫性肠炎，出现皮疹可能提示免疫相关性皮肤毒性。通过有效的患者教育，促进患者在第一时间自我识别异常症状并及时就医，从而实现早期发现、早期识别和合理治疗。此外，多学科诊疗（MDT）是irAE识别与管理中不可或缺的重要环节。肿瘤科医生虽具备丰富的抗肿瘤治疗经验，但面对涉及多器官系统的irAE，仍需联合内分泌科、皮肤科、呼吸科、心内科等相关专科共同参与，更早为患者提供最适合的处理方案，从而实现更为有效的不良反应管理。创新支付赋能药物可及，让创新药物临床价值切实转化为患者获益王远鹤教授：抗肿瘤治疗的考量不仅限于疗效与安全性，亦与医疗卫生经济学密切相关。高质量创新药物的临床价值，最终需要通过药物可及性来实现落地转化。对于肝癌患者而言，国家基本医保之外的商业健康保险及城市惠民保等创新性支付方式，其核心作用可从以下几方面加以阐释。首先，在国家基本医保之外发挥重要的补充保障作用。国家医保局发布的《商业健康保险创新药品目录（2025年）》[4]及时回应了临床需求，已将纳武利尤单抗联合伊匹木单抗用于HCC一线治疗纳入其中，为符合适应症的患者提供了明确的支付保障，自2026年1月1日起已正式执行，标志着创新药物进入规范化支付通道的速度正在加快。其次，各地区域性惠民保同样发挥着有效的补充作用。以辽宁省的“惠辽保”为例，“惠辽保”作为辽宁省医疗保障局指导的普惠型商业健康保险[5]，与基本医疗保险形成良好衔接，进一步健全和完善了辽宁省多层次医疗保障体系，能够更好地满足患者群体多样化的保障需求，为全省人民的健康提供有力支撑。多层次支付体系的完善有效优化了临床决策。既往临床实践中，经济因素往往是影响治疗方案选择的重要制约。而在多种支付体系并存的当下，经济因素不再构成主要障碍，临床医生得以更好地回归循证医学证据，依据患者的个体化病情特征选择最为适合的治疗方案。从更深远的意义而言，创新支付模式的持续完善能够切实提升抗肿瘤药物的可及性和规范化使用，最终惠及广大患者，使更多肝癌患者获得长期生存的机会。参考文献[1]Galle PR, Sangro B, Decaens T, et al. Nivolumab plus ipilimumab vs lenvatinib or sorafenib as first-line treatment for unresectable hepatocellular carcinoma (HCC): 4-year follow-up of CheckMate 9DW. 2026 ASCO GI, Abstract LBA479.[2]2024《CSCO原发性肝癌诊疗指南》.[3]Bruno Sangro, Shukui Qin, Robin K. Kelley, et al. Pooled efficacy and safety outcomes with tremelimumab plus durvalumab in participants with unresectable hepatocellular carcinoma from the combined China extension and global cohorts in the Phase 3 HIMALAYA study. 2025 ESMO.[4]https://www.nhsa.gov.cn/art/2025/12/7/art_104_18970.html[5]https://ybj.ln.gov.cn/ybj/zwgk/mtbb/8F3EA037ECDE4F709BDBEC3B56EEC41F/index.shtml视频：7356-CN-2600177文稿：7356-CN-2600180