Nivolumab

TUDRIQEV™ in combination with nivolumab receives FDA accelerated approval and will launch within 60 days Michelle DiNapoli appointed as Chief Commercial Officer Recently completed financing extends cash runway to support commercial launch and confirmatory trial WOBURN, Mass., Aug. 14, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a commercial stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced financial results for the fiscal first quarter ended June 30, 2026 and provided a business update. On August 6, 2026, the Company announced the U.S. Food and Drug Administration (FDA) has approved TUDRIQEV (vusolimogene oderparepvec-wtpg), previously referred to as RP1, in combination with nivolumab for the treatment of adults with unresectable advanced cutaneous melanoma who experienced disease progression with a PD-1 antibody-based regimen. The Company has begun launch preparations in the U.S. and anticipates having product in the market within 60 days. Replimune also recently completed a $150 million financing to support commercial launch and the ongoing IGNYTE-3 confirmatory trial. The Company also announced today the appointment of Michelle DiNapoli as Chief Commercial Officer, effective August 18, 2026. Ms. DiNapoli brings more than 25 years of biopharmaceutical experience commercializing innovative oncology therapies and building high-performing commercial organizations. She joins Replimune after a seven-year tenure at Deciphera Pharmaceuticals. At Deciphera, she built the U.S. sales force, led the U.S. Commercial organization, and scaled infrastructure to drive launch execution as the company grew from a single product to a multi-product organization. Prior to Deciphera, Ms. DiNapoli spent 16 years at Genentech in commercial leadership roles spanning breast, lung, and colorectal cancer franchises as well as cancer immunotherapy, developing deep expertise in market access, lifecycle management, and cross-functional execution. “The FDA’s approval of TUDRIQEV is a defining milestone for Replimune and, more importantly, for the patients facing advanced melanoma, where the need for safe and effective treatment options remains significant,” said Sushil Patel, Ph.D., CEO of Replimune. “With this approval, we are now a fully integrated biotechnology company. We are completing the build out of our commercial infrastructure to enable a successful launch and bring TUDRIQEV to patients as quickly as possible.” Program Highlights & Milestones RP1 (vusolimogene oderparepvec) IGNYTE-3 Confirmatory Study: The global Phase 3 trial assessing RP1 in combination with nivolumab versus physician's choice in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for anti-CTLA-4 treatment is actively enrolling. The primary endpoint, expected to readout in 2030, is overall survival, and key secondary endpoints are progression free survival and overall response rate. RP2 REVEAL Study: The registration-directed Phase 2/3 trial of RP2 in metastatic uveal melanoma is actively enrolling. The trial is evaluating RP2 in combination with nivolumab versus ipilimumab in combination with nivolumab in approximately 280 patients. The primary endpoints of the trial are overall survival and progression free survival, and key secondary endpoints are overall response rate and disease control rate. Phase 2/3 transition is expected in Q1 2027. Financial Highlights Cash Position : As of June 30, 2026, cash, cash equivalents and short-term investments were $195.3 million, as compared to $268.9 million as of fiscal year ended March 31, 2026. The decrease in cash balance was a result of cash burn related to operating activities in advancing the company’s clinical development plans. Based on our current operating plan, we expect that our existing cash and cash equivalents and short-term investments, as of June 30, 2026, in addition to the $141.0 million of net proceeds from the issuance of our common stock in August 2026, will enable us to fund operations for greater than twelve months from the issuance of the condensed consolidated financial statements, which includes scale up for the commercialization of TUDRIQEV in advanced melanoma and for working capital and general corporate purposes. R&D Expenses: Research and development expenses were $49.3 million for the fiscal first quarter and $57.8 million for the fiscal first quarter ended June 30, 2025. This decrease was primarily due to a decrease in personnel related and other costs, as well as a decrease in direct research costs relating to the IGNYTE, ARTACUS and CERPASS studies. Research and development expenses included $3.6 million in stock-based compensation expenses for the fiscal first quarter ended June 30, 2026. S,G&A Expenses: Selling, general and administrative expenses were $19.0 million for the fiscal first quarter ended June 30, 2026, as compared to $32.6 million for the fiscal first quarter ended June 30, 2025. Selling, general and administrative expenses included $4.1 million in stock-based compensation expenses for the fiscal first quarter ended June 30, 2026. Net Loss: Net loss was $69.8 million for the fiscal first quarter ended June 30, 2026 and $86.7 million for the fiscal first quarter ended June 30, 2025. About TUDRIQEV™ (vusolimogene oderparepvec-wtpg) TUDRIQEV (vusolimogene oderparepvec-wtpg) is a genetically modified herpes simplex virus, type 1 (HSV-1) oncolytic viral therapy that encodes a fusogenic glycoprotein derived from gibbon ape leukemia virus with the R sequence deleted (GALV-GP-R–) and human granulocyte macrophage colony-stimulating factor (GM-CSF). The genes encoding the HSV-1 neurovirulence factor ICP34.5 and the transporter associated with antigen presentation inhibitor ICP47 are deleted from TUDRIQEV. TUDRIQEV preferentially replicates within the tumor leading to tumor lysis, release of tumor and viral antigens, proinflammatory molecules, and infiltration of T cells. The GALV-GP-R– expressed by TUDRIQEV increases direct tumor killing and the GM-CSF expressed by TUDRIQEV is intended to activate and mature dendritic cells and monocytes. In the anti-PD-1 resistant setting, TUDRIQEV and nivolumab in combination may promote anti-tumor immune response. INDICATION TUDRIQEV™ is indicated in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). IMPORTANT SAFETY INFORMATION Warnings and Precautions Accidental exposure of TUDRIQEV: Healthcare providers, caregivers, close contacts, pregnant women, newborns, and patients should avoid direct contact with injected tumors, dressings, or bodily fluids of patients. Herpetic infection or reactivation: Patients with suspected herpetic infections should contact their healthcare provider for assessment and antiviral treatment of the suspected herpetic infection as clinically warranted. Injection procedure complications: Complications related to injection procedure have occurred, including hemorrhage, infection, and visceral injury. Patients should be monitored for signs and symptoms of visceral injury (eg, pneumothorax) during and after TUDRIQEV administration and managed according to clinical practice. Immune-mediated events: In clinical studies, immune-mediated events, including colitis, hepatitis, myocarditis, neuropathy, capillary leak syndrome, dermatitis, and vitiligo have been reported in patients treated with TUDRIQEV and nivolumab. Adverse Reactions Most common non-laboratory adverse reactions reported in more than 10% of patients were fatigue, pyrexia, infections, chills, musculoskeletal pain, nausea, diarrhea, injection site reaction, headache, cough, influenza like illness, rash, vomiting, pruritus, arthralgia, constipation, decreased appetite, dizziness, dyspnea, hemorrhage, edema, and abdominal pain. Serious adverse reactions occurring in >1% patients include pleural effusion (n=3), acute kidney injury (n=2), arthralgia (n=2), atrial fibrillation (n=2), atrial flutter (n=2), cancer pain (n=2), hypophysitis (n=2), immune-mediated enterocolitis (n=2), pyrexia (n=2), sepsis (n=2), urinary tract infection (n=2), and myocardial infarction (n=2). Serious adverse reactions leading to death include myocardial infarction (n=1) and multiple organ dysfunction (n=1). Drug Interactions Patients receiving systemic antiviral treatment for herpetic infection should delay TUDRIQEV treatment for 72 hours after completion of antiviral therapy. Special Populations Advise females and males of reproductive potential to use effective contraception during treatment with TUDRIQEV and for 90 days after the last dose. About RP1 RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response. About RP2 RP2 is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response. RP2 additionally expresses an anti-CTLA-4 antibody-like molecule, as well as GALV-GP R- and GM-CSF. RP2 is intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic-immune-based efficacy on tumors and limiting off-target toxicity. About Replimune Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of novel oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is intended to ignite local activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to then activate a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit Forward Looking Statements This press 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, including statements regarding clinical trials, clinical studies and other clinical work (including the funding therefor, anticipated patient enrollment, safety data, study data, trial outcomes, timing or associated costs, sufficiency of any resulting data), regulatory applications and related submission contents and timelines, the timelines or outcomes related to litigation, including any rehearings or appeals of decisions in any such proceedings, and our ability to execute on our strategic or financial initiatives, our estimates regarding future expenses, capital requirements and needs for additional financing, and potential commercial viability, and potential reimbursement and utilization of TUDRIQEV involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein. Our ability to maintain TUDRIQEV’s accelerated approval and to continue commercialization of TUDRIQEV may be contingent on verification of clinical benefit in a confirmatory trial(s). Other forward looking statements may be identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited experience in commercializing products for sale, our ability to successfully verify the clinical benefit of TUDRIQEV in our ongoing confirmatory Phase 3 trial, IGNYTE-3, our ability to meet our product manufacturing goal, the timing and scope of future regulatory approvals, the availability of combination therapies needed to conduct our clinical trials, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, the impact of political and global macro factors and military conflicts, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements. Investor Inquiries Chris Brinzey ICR Healthcare 339.970.2843 chris.brinzey@icrhealthcare.com Media Inquiries Arleen Goldenberg Replimune 917.548.1582 media@replimune.com Replimune Group, Inc. Condensed Consolidated Statements of Operations (Amounts in thousands, except share and per share amounts) (Unaudited) Three Months Ended June 30, 2026 2025 Operating expenses: Research and development $ 49,277 $ 57,843 Selling, general and administrative 18,970 32,579 Total operating expenses 68,247 90,422 Loss from operations (68,247 ) (90,422 ) Other income (expense): Research and development incentives 296 420 Investment income 1,960 4,714 Interest expense on finance lease liability (506 ) (521 ) Interest expense on debt obligations (2,581 ) (1,475 ) Other (expense) income, net (688 ) 591 Total other (expense) income, net (1,519 ) 3,729 Net loss $ (69,766 ) $ (86,693 ) Net loss per common share, basic and diluted $ (0.72 ) $ (0.95 ) Weighted average common shares outstanding, basic and diluted 96,864,452 91,516,199 Replimune Group, Inc. Condensed Consolidated Balance Sheets (Amounts In thousands, except share and per share amounts) (Unaudited) June 30, 2026 March 31, 2026 (in thousands) Consolidated Balance Sheet Data: Cash, cash equivalents and short-term investments $ 195,328 $ 268,889 Working capital 162,395 220,891 Total assets 252,447 332,388 Total stockholders' equity 105,645 166,160

2026 年 8 月 6 日，致力于开发新型溶瘤免疫疗法的 Replimune 宣布 TUDRIQEV（vusolimogene oderparepvec-wtpg，原 RP1）已获得 FDA 加速批准，与 nivolumab 联合用于治疗接受含抗 PD-1 抗体方案后，疾病进展的不可切除晚期皮肤黑色素瘤成人患者。TUDRIQEV 是 Replimune 的首款获批产品，也是继 2015 年 Imlygic（T-VEC） 后FDA批准的第二款溶瘤病毒疗法。 FDA 加速批准溶瘤病毒 TUDRIQEV 联合 Nivolumab 治疗晚期黑色素瘤 by TiPLab 木桃 Replimune 于 2015 年由原 BioVex 团队成员创立，BioVex 后来被 Amgen 收购并开发出 T-VEC。 Replimune 的专有 RPx 平台基于强效的 HSV-1 骨架，旨在最大限度地提高免疫原性细胞死亡并诱导全身性抗肿瘤免疫反应。RPx 经瘤内注射后，可直接选择性地通过病毒介导杀伤肿瘤细胞，从而释放肿瘤来源的抗原，改变肿瘤微环境。当与免疫检查点抑制剂联合使用时，RPx 可激发全身性抗肿瘤免疫反应。除了RP1之外，另一个在研管线RP2在RP1基础上额外增加了编码抗 CTLA-4 抗体样分子的表达元件。 TUDRIQEV是一个经多重工程改造、可复制的 1 型单纯疱疹病毒（HSV-1）溶瘤病毒，核心结构为：HSV-1 backbone + ΔICP34.5 + ΔICP47 + GALV-GP-R− + human GM-CSF，其中，GALV-GP-R− 是 RP1 相对于 T-VEC 最核心的差异化组件。 参见：Replimune, TUDRIQEV (RP1) BLA 125827 FDA 咨询委员会会议，申办方简报材料 TUDRIQEV 通过瘤内直接注射给药，适用于浅表、深部和/或内脏病变。对于深部/内脏肿瘤，给药需在影像引导下进行。 TUDRIQEV 的推荐剂量取决于肿瘤大小。 TUDRIQEV 优先在肿瘤内复制，导致肿瘤裂解，释放肿瘤抗原、病毒抗原及促炎分子，并诱导T细胞浸润。在抗 PD-1 耐药的情况下，TUDRIQEV 和 nivolumab 联合使用可能促进抗肿瘤免疫反应。 IGNYTE（NCT03767348，支持获批的关键研究）是一项开放标签、多中心 1/2 期单臂研究，旨在评估 RP1 作为单药疗法或与 nivolumab 联合治疗晚期实体瘤成年患者的安全性和有效性。IGNYTE 试验的临床结果表明，在疗效评估人群中（即，至少存在一个未注射病灶的 91 例患者），RP1 联合nivolumab的客观缓解率（ORR）为 24.2%，中位缓解持续时间为 14.1 个月。治疗耐受性良好，不良事件多为轻度至中度。 晚期黑色素瘤的治疗选择有限，超过半数的患者在使用抗 PD-1 疗法等免疫检查点抑制剂治疗后六个月内病情进展。这些患者预后不良，病情进展后的中位总生存期不足一年。 此前，RP1上市审批过程中收到FDA的两次完整回复函（CRL），Replimune 在解决主要问题之后获得了加速批准，不过FDA明确要求完成 IGNYTE-3 (NCT06264180) Phase III 作为上市后确证研究以证实其临床获益。 CRL中提出瘤内注射本身可能影响被注射病灶的影像评价，并要求分别分析注射与未注射病灶，以支持系统性抗肿瘤免疫效果。因此，最终审批时只选择有未注射病灶的患者作为评估人群。 基于同样的三件优先权，Replimune于同日递交了四个PCT申请（PCT/GB2017/050036、PCT/GB2017/050037、PCT/GB2017/050038和PCT/GB2017/050039），分别涉及RP1核心结构设计、RH018A等HSV-1病毒株、RP2核心结构设计和溶瘤病毒联合免疫调节剂的癌症治疗用途。 PCT/GB2017/050036和PCT/GB2017/050037在中美欧均获得授权，在欧洲和美国均有一件授权专利，在美国有4件授权成员。 从保护主题来看，以溶瘤病毒设计和不同的HSV-1病毒株为主，也有药物组合物和用途等权利要求。 从保护范围上来讲，中国的范围明显最窄，欧洲和美国的范围相对宽泛（包括较多功能性限定特征），且美国衍生的多个授权成员划定了多个不同的保护范围。 有多个授权专利直接对应上市的RP1产品，比如，授权专利US12458696B2保护一种癌症治疗方法，包括使用含有融合蛋白基因和免疫刺激分子基因的溶瘤 HSV与 PD-1 抑制剂分别给药；CN109415703B限定编码 GALV-R− + GM-CSF、ICP47删除以及HSV-1衍生自 RH018A，非常接近RP1具体产品构型。 在FTO方面，Amgen 的授权专利 US10,034,938涉及一种治疗IIIB–IV期黑色素瘤的方法，包括施用抗 PD-1 抗体/抗 CTLA-4 抗体和HSV（包含ICP34.5功能缺失 + ICP47功能缺失＋编码human GM-CSF）。从这些限定特征上看，即使 RP1 多了GALV-GP-R− 编码基因，也大概率会落入’938 专利的保护范围。 Replimune 选择在RP1进入关键临床数据读出阶段提前启动专利无效：2022 年 11 月，Replimune向 PTAB 提起 IPR试图无效 ’938 专利的部分权利要求，后于2023年与Amgen和解并取得许可。 * 以上文字仅为促进讨论与交流，不构成法律意见或咨询建议。 © 作为一家专业服务公司，TiPLab坚持原创的系统的研究，注重系统性知识积累与专业影响力。欢迎读者个人分享转发，各专业平台媒体如需转载请联系TiPLab获得授权。  TiPLab提供基于研究的核心知识产权服务 FTO：技术商业化实施的侵权风险防范 TiPLab通过对细分技术领域内核心技术和重要专利的长期研究，结合自身在数据检索和分析方面的专长，致力于帮助客户深入了解、积极应对潜在的专利侵权风险。 Due Diligence：商业活动中的知识产权尽职调查 在企业许可交易、融资、并购、上市等过程中，TiPLab帮助企业和投资方了解目标技术/产品的专利保护强度及产品商业化过程中潜在的专利侵权风险，从而为商业谈判和决策提供支持依据。 Patenting：全球范围内高价值专利资产的创设 TiPLab熟知全球主要国家和地区的法律实践和细分领域内的前沿技术进展情况，通过前瞻性的专利布局策略，帮助客户通过创设有价值的专利资产而获取、保持和巩固独特的竞争优势。