您的浏览器禁用了JavaScript(一种计算机语言,用以实现您与网页的交互),请解除该禁用,或者联系我们。 [Jefferies]:瑞普利穆恩集团(REPL):ASCO25在7月PDUFA日期前,有意义的RP1数据提供了进一步支持 - 发现报告

瑞普利穆恩集团(REPL):ASCO25在7月PDUFA日期前,有意义的RP1数据提供了进一步支持

2025-06-02 Jefferies silence @^^@💗
报告封面

2025E2026E0.00.02.4NMNM(3.07)(3.43) 2027E39.621.8x20.7x(3.02) Roger Song, MD, CFA * | Equity Analyst(617) 342-7955 | rsong@jefferies.comCha Cha Yang, MS, MBA * | Equity Associate+1 (857) 330-5772 | cyang2@jefferies.comLiang Cheng, Ph.D. * | Equity Associate+1 (617) 342-7896 | lcheng1@jefferies.comFiona Jia, Ph.D. * | Equity Associate+1 (617) 342-7942 | fjia@jefferies.com Chart 1 - Efficacy by injection type by BICR using RECIST 1.1 (patient-level data).Source: Company reportsChart 2 - Responses in injected vs non-injected lesions from RECIST 1.1 responders (lesion-level data).Source: Company reportsPlease see important disclosure information on pages 6 - 11 of this report.This report is intended for Jefferies clients only. Unauthorized distribution is prohibited. Chart 3 - Responses in non-injected visceral lesions from RECIST 1.1 responders (lesion-level data).Source: Company reportsChart 4 - RP1 DNA Levels at Site of Injection, in Blood, and in Oral Mucosa/ Saliva.Source: Company reportsPlease see important disclosure information on pages 6 - 11 of this report.This report is intended for Jefferies clients only. Unauthorized distribution is prohibited. The Long View: Replimune GroupInvestment Thesis / Where We Differ•Replimune has developed a differentiated/ advantageous new-generationoncolytic virus therapy platform, with critical features increasing selectivity/safety, killing potency, and anti-tumor immunity.•Lead program RP1 has shown promising clinical profile in anti-PD1refractory melanoma, compared favorably to standard of care and compsin development. There is the potential for label expansion for CSCC. Wesee reasonable chance of success for clinical development and commercialadoption.•RP2 is designed to increase local/ systemic anti-tumor immune response;RP2showed encouraging single-agent activity across"cold"tumor,suggesting a broad applicability in nonskin solid tumors.Base Case,$31, +245%•Anti-PD1 refractory melanoma generates U.S.adjusted (80% POS) peak sales of ~$1.2B•CSCC generates U.S. adjusted (25% POS) peaksales of ~$500M•Platform value of $200M•No value outside the U.S.•DCF-based PT is $31Sustainability MattersTopMaterial Issue(s):1)Employee Engagement,Diversity,&Inclusion.Pharmaceutical andbiotechnology firms compete fiercely for workers. To create new goods, carry out clinical trials in diversepatient populations, handle regulatory regulations, and market new items, the sector needs highly qualifiedworkers. In light of a limited talent pool, if REPL can retain and recruit personnel, it may be betterpositioned to safeguard and grow shareholder value.2)Product Quality & Safety.Upon controlled clinicalstudies and regulatory approval, information on product safety might become available, which subjectscompanies such as REPL to the financial effects of recalls and other unfavorable occurrences.Company Target(s): 1)We found no targets set by REPL related to improving Employee Engagement,Diversity & Inclusion.2)We found no targets set by REPL related to improving Product Quality and Safety.Qs to Mgmt: 1)How does REPL ensure that employees comply with guidance procedures?2)How willyou adjust employee working conditions as we transition away from the pandemic?3)How diverse isthe REPL workforce?Please see important disclosure information on pages 6 - 11 of this report.This report is intended for Jefferies clients only. Unauthorized distribution is prohibited. Upside Scenario,$46, +412%•Anti-PD1 refractory melanoma succeeds andgenerates U.S. (100% POS) peak sales of ~$1.5B•CSCC generates U.S. adjusted (50% POS) peaksales of ~$1B•Platform value of $200M•No value outside the U.S.•DCF-based PT is $46 Risk/Reward - 12 Month View5045403530252015105020252024Downside Scenario,$3, -67%•CSCC fails•Anti-PD1 refractory melanoma fails•No platform value or value outside the U.S.•Cash-based PT is $3 (~50% of cash)Catalysts•July 22rd '25:PDUFA date for RP1 for aPD1-failed melanoma•Likely '25:Mature data from Ph2 pivotal RP1/cemiplimab in 1L CSCC•'26+:RP2 data updates for uveal melanoma 4 Company DescriptionReplimune GroupReplimune Group is a clinical-stage biotechnology company that develops oncolytic viral therapy for the treatment of cancers. The lead program isRP1, a modified clinical oncolytic HSV-1 in treating skin cancers, including melanoma and cutaneous squamous cell carcinoma (CSCC), as well asother solid tumors such as NSCLC. Other pipeline programs include RP2 and RP3, which incorporate transgene therapeutic proteins, increasing anti-tumor immune responses. The company is headquartered in Woburn, Massachusetts.Company Valuation/RisksReplimune GroupOur price target is DCF-based. Risks include clinical, regulatory, and commercial.Analyst Certification:I, Roger Song, MD, CFA, certify that all of the views expressed in this research report accurately reflect my personal views about the subject security(ies) andsubject company(ies). I also certify that no part of my compensation was, is, or will