Data from the IGNYTE primary analysis shows clinically meaningful activity across all subgroups, including those who had received prior anti-PD1 and anti-CTLA-4 or had primary resistance to anti-PD1 Injected and non-injected lesions responded with similar frequency, depth, duration and kinetics WOBURN, Mass., Sept. 15, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that data ...

WOBURN, Mass., Aug. 13, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced that the first patient has been randomized and dosed in the IGNYTE-3 study – a global Phase 3 clinical trial assessing the efficacy and safety of RP1 (vusolimogene oderparepvec) plus nivolumab in patients with advanced melanoma who have progressed on anti-PD1 and anti-CTLA-4 drugs or are ineligi ...

临床试验进展 - 公司正在开展多项RP1、RP2和RP3的临床试验，包括作为单药和联合治疗[136,137,138,139,140,141,142,145,146] - RP1联合nivolumab治疗既往接受过抗PD-1治疗的黑色素瘤患者的总体反应率为33.6%[140] - RP1联合nivolumab治疗非黑色素瘤皮肤癌患者的总体反应率为30%[141] - RP2单药和联合nivolumab治疗转移性眼黑色素瘤患者的总体反应率为29.4%[145,146] - 公司已开始启动RP2治疗转移性眼黑色素瘤的注册临床试验[146] - 公司与BMS和Regeneron建立了临床试验合作关系，共同开展产品候选药物的联合临床试验[205][206][209][210] - 公司与罗氏达成主临床试验合作和供应协议,共同开展结直肠癌和肝细胞癌的临床试验[213] - 公司与Incyte公司达成临床试验合作和供应协议,共同开展鳞状细胞癌的临床试验,但Incyte后续终止了该口服PD-L1抑制剂的开发[214] 监管进展 - 公司已完成与FDA的CMC计划沟通,计划于2024年下半年提交RP1联合nivolumab治疗既往接受过抗PD-1治疗的黑色素瘤的生物制品许可申请[140] 财务状况 - 公司已完成约9.457亿美元的股权融资,为研发活动提供资金支持[150] - 公司预计未来几年内将持续发生运营亏损[151,152,153,154] - 公司截至2024年6月30日的现金及现金等价物和短期投资为4.691亿美元[156] - 公司目前尚未产生任何产品销售收入，未来也不会在短期内产生任何产品销售收入[157] - 研发费用将持续增加,主要是由于后期临床试验规模和周期较长,成本较高[165,167] - 销售及管理费用将继续增加,主要是为了支持公司的研发和准备商业化工作[168,169] - 公司目前处于亏损状态,未来能否实现盈利存在不确定性[155] - 公司在英国子公司享受研发税收优惠,可获得最高14.5%的研发支出补贴[170,171] - 公司在美国和英国均存在累计亏损,暂不确认递延所得税资产[173,174,175] - 2024年第一季度研发费用同比增加2.535百万美元,主要是由于人员成本增加[178,181] - 2024年第一季度销售及管理费用同比减少816万美元,主要是由于人员成本下降[183] - 公司自成立以来一直未产生任何产品销售收入，并持续产生运营亏损和负现金流[186][187] - 公司主要通过股权融资和部分债务融资获得资金支持，截至2024年6月30日共获得9.457亿美元的净融资[188] - 截至2024年6月30日，公司拥有4.691亿美元的现金及现金等价物和短期投资[188] - 公司预计现有现金及现金等价物和短期投资可支持运营至2026年下半年[198] - 公司2024年第二季度净亏损5380万美元，主要由于研发和管理费用增加[190][191] - 公司2024年第二季度经营活动净现金流出4917万美元[189] - 公司2024年第二季度投资活动净现金流入2976万美元，主要为出售和到期的短期投资[192][193] - 公司2024年第二季度筹资活动净现金流入9664万美元，主要为6月份的PIPE融资[194][195] 关键会计政策和内部控制 - 公司的关键会计政策和估计包括应计研发费用和股份支付费用的确认[215][216][217][218][219][220][221][222] - 公司在2024年6月30日评估了披露控制和程序的有效性,认为是有效的[224][225] - 公司在2024年6月30日季度内部控制未发生重大变化[226] 未来资本需求 - 公司未来资本需求取决于产品研发进度、是否建立商业化渠道等诸多不确定因素[199][200][201][202][203]

临床试验进展 - 公司计划于2H 2024提交RP1生物制品许可申请(BLA)[1,2] - RP1联合Opdivo(nivolumab)治疗anti-PD1失败的黑色素瘤,12个月总体反应率为33.6%[5] - 公司计划于2024年第三季度开始RP1 III期确证性试验的首例患者入组[7] - RP2单药或联合nivolumab治疗眼部黑色素瘤的客观反应率为29.4%,疾病控制率为58.8%[9] - 公司已完成RP2在转移性眼部黑色素瘤的注册性试验方案设计并开始启动试验[10] 财务状况 - 公司完成9670万美元PIPE融资,用于RP1商业化准备及一般运营[12] - 截至2024年6月30日,公司现金及现金等价物为4.691亿美元,预计可支持运营至2026年下半年[13,14] - 研发费用同比增加6.3%至4300万美元,主要由于人员费用和股份支付增加[15] - 销售及管理费用同比下降5.3%至1440万美元,其中包括520万美元股份支付[16] - 净亏损同比增加8.5%至5380万美元[17]

WOBURN, Mass., July 30, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ:REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced that members from the Replimune management team will host investor meetings at the following two conferences: BTIG Virtual Biotechnology Conference Dates: August 5-6, 2024 2024 Wedbush PacGrow Healthcare Conference Date: Tuesday, August 13, 2024 About Replimune Replimune Group, Inc., headquartere ...

- Led by a life-sciences focused institutional investor, with participation from Redmile Group, RTW Investments, Boxer Capital and other institutional investors - - Financing follows strong primary analysis data from the RP1 IGNYTE clinical trial in anti-PD1 failed melanoma; BLA filing expected in 2H 2024 - - Proceeds enable full commercial scale up to support a potential launch in 2H 2025 - WOBURN, Mass., June 13, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ:REPL), a clinical stage biotechnology ...

Replimune Group, Inc. (REPL) announced positive top-line results from the primary analysis of the IGNYTE study on lead pipeline candidate RP1, in combination with Bristol Myers’ (BMY) blockbuster immuno- oncology drug Opdivo (nivolumab), in patients with anti-PD1 failed melanoma. The analysis was conducted by an independent central review. RP1 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 tumo ...

WOBURN, Mass., June 07, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ:REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced that Sushil Patel, Chief Executive Officer of Replimune, will present at the Goldman Sachs 45th Annual Global Healthcare Conference on Tuesday, June 11, 2024 at 2:00 PM ET. A simultaneous webcast will be available in the Investors section of Replimune's website at www.replimune.com. A replay will ...

WOBURN, Mass., June 07, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ:REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced that Sushil Patel, Chief Executive Officer of Replimune, will present at the Goldman Sachs 45th Annual Global Healthcare Conference on Tuesday, June 11, 2024 at 2:00 PM ET. A simultaneous webcast will be available in the Investors section of Replimune's website at www.replimune.com. A replay will ...

Primary endpoint data shows 12-month overall response rate (ORR) of 33.6% Biologics license application (BLA) submission intended for 2H 2024; first patient expected to be enrolled in IGNYTE-3 confirmatory trial in Q3 2024 Company to host conference call and webcast today at 8:00 a.m. ET WOBURN, Mass., June 06, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced the top ...