Replimune Group (REPL) 2025 Conference June 05, 2025 04:20 PM ET Speaker0 Well, these guys in the back, they turn it on for you. Okay. The middle, please. Speaker1 I was gonna take this one. Speaker2 This is Speaker1 on a mic. Speaker0 This Okay. Speaker1 You can take a wee bit. Speaker0 Would you like to be in the middle? Nope. K. Speaker2 Rose between two thorns. K. Well said. Alright. Okay. Alright. Welcome everyone to Jefferies twenty twenty five Healthcare Global Conference. My name is Roger Song, one ...

Core Insights - Replimune Group, Inc. presented data on RP1 plus nivolumab at the 2025 ASCO Annual Meeting, highlighting robust responses in both injected and non-injected lesions, with deep injections showing higher response rates compared to superficial injections [1][2][4] Group 1: Clinical Trial Findings - The IGNYTE clinical trial involved 140 anti-PD-1 failed melanoma patients, showing an objective response rate (ORR) of 32.9% and a complete response rate of 15.0% [4] - Landmark overall survival (OS) rates at 1, 2, and 3 years were reported as 75.3%, 63.3%, and 54.8% respectively, with median OS not yet reached [4] - Deep injections resulted in higher ORR: 29.8% for superficial injections, 42.9% for deep/visceral plus superficial injections, and 40.9% for deep/visceral injections only [4] Group 2: Safety and Tolerability - RP1 injections into the liver and lung were generally well tolerated, with few organ-specific adverse events [4] - No bleeding events were reported after liver injections, and lung injections had low rates of pneumothorax, typically of low grade and manageable [4] - Standard disinfection procedures were confirmed sufficient for RP1 clean-up, with no transmission of RP1 reported to date [10] Group 3: Product Information - RP1 is Replimune's lead product candidate, engineered from a proprietary strain of herpes simplex virus, designed to maximize tumor killing potency and activate a systemic anti-tumor immune response [6][8] - The RPx platform aims to induce a strong and durable systemic response while being synergistic with various cancer treatment modalities [8]

WOBURN, Mass., May 29, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that members of the Replimune management team will present in a fireside chat at the 2025 Jefferies Global Healthcare Conference on Thursday, June 5, 2025 at 4:20 PM ET. A simultaneous webcast will be available in the Investors section of Replimune’s website at replimune.com. A replay will be available for ...

Financial Performance and Projections - The company has not generated any revenue from product sales and may never be profitable[168] - The company has incurred net losses since inception and anticipates continuing substantial losses in the foreseeable future, with no products approved for commercial sale to date[243] - For the years ended March 31, 2025 and 2024, the company reported net losses of $247.3 million and $215.8 million, respectively, with an accumulated deficit of $948.6 million as of March 31, 2025[244] - The company anticipates continuing to incur significant losses in the foreseeable future, particularly as it continues research and development for RP1 and other product candidates[244] - Future capital requirements will depend on various factors, including the costs of research and development, obtaining marketing approvals, and commercialization activities[250] - The company may need to expand its internal manufacturing, marketing, and sales capabilities as operations grow, which could impose significant responsibilities on management[228] - Future reimbursement for approved product candidates may be less than projected, impacting net revenue and profitability[238] - The potential market for the company's product candidates is difficult to estimate, and actual markets may be smaller than projected due to reliance on various assumptions[239] Product Development and Regulatory Risks - The FDA has accepted and granted priority review for the company's lead product candidate, RP1[170] - The company faces risks related to product development, including the potential for negative or inconclusive results from clinical trials[171] - The company’s ability to commercialize product candidates is contingent on successful clinical trials demonstrating safety and efficacy[171] - The regulatory approval process is lengthy and unpredictable, potentially impacting the ability to generate revenue[190] - The company may experience delays in testing or approvals, impacting development costs and timelines[176] - The company’s product candidates are in various stages of development and are not approved for commercial sale[168] - The company may require additional financing to achieve its goals due to a history of losses and the likelihood of incurring substantial future losses[168] - The company faces intense competition from other biopharmaceutical and biotechnology companies, which may hinder its ability to commercialize products successfully[219] Collaboration and Supply Chain Challenges - The company has entered into agreements with BMS and Regeneron for the supply of anti-PD-1 therapies for ongoing clinical trials[178] - The company relies on third-party suppliers like BMS and Regeneron for anti-PD-1 therapies, and any failure in these relationships could delay the development and commercialization of its product candidates[270] - Collaboration agreements with partners may not be successful, potentially affecting the company's ability to develop and commercialize its product candidates[271] - The company relies on third-party manufacturers for raw materials and product candidates, which may lead to delays in clinical development and commercialization if performance failures occur[285] - The company has only one in-house manufacturing site, and lacks long-term commitments from suppliers, which could result in supply limitations and potential revenue losses[286] Legal and Compliance Risks - The company faces risks related to intellectual property, including potential infringement claims from third parties and the need to maintain and protect its intellectual property rights[253] - The company may incur substantial costs and face delays if it needs to replace third-party service providers due to performance issues[282] - The company is subject to various healthcare laws, and violations could result in significant penalties and adversely affect financial results[304] - The company is exposed to risks of employee misconduct, which could lead to significant fines or sanctions affecting its financial condition[310] - The company faces potential liabilities under environmental, health, and safety laws, which could result in substantial costs and impact business success[311] Market and Economic Conditions - The stock price of the company has been volatile, influenced by factors such as clinical trial results, regulatory developments, and competition in the biopharmaceutical sector[341] - Unfavorable market conditions could adversely affect the company's ability to raise capital and strain suppliers, impacting overall business performance[359] - Global financial markets are experiencing extreme disruption, leading to volatility in securities prices and potential adverse economic conditions affecting the company's liquidity[360] - Unfavorable global economic conditions and geopolitical events, including military conflicts and trade disputes, could adversely impact the company's operations and objectives[364] Internal Control and Governance - The company has identified material weaknesses in its internal control over financial reporting, which could lead to misstatements in financial statements[330] - The company is implementing comprehensive control protocols to address identified weaknesses in internal controls over financial reporting[334] - Ineffective internal control could increase the risk of financial reporting fraud and misappropriation of assets, potentially leading to regulatory investigations and civil or criminal sanctions[336] - The company did not maintain effective IT general controls relevant to financial statement preparation, increasing the risk of misstatements[332] Environmental and Regulatory Compliance - Compliance with FDA regulations is critical; failure to meet these standards could result in delays in product approvals and commercialization[291] - Legislative and regulatory changes in healthcare could increase compliance costs and adversely affect the ability to market products and achieve profitability[307] - Compliance with the Drug Supply Chain Security Act (DSCSA) may increase operational expenses and impose significant administrative burdens[309] - The company is subject to stringent data privacy and security obligations, with potential penalties for non-compliance that could adversely affect financial condition[313]

Replimune Group (REPL) Q4 2025 Earnings Call May 22, 2025 08:00 AM ET Company Participants Arleen Goldenberg - VP - CommunicationsSushil Patel - CEO & DirectorChris Sarchi - CCOEmily Hill - Chief Financial OfficerJonathan Chang - Senior Managing Director Conference Call Participants Anupam Rama - AnalystRoger Song - AnalystAllison Bratzel - Senior Research AnalystNone - AnalystPeter Lawson - Analyst Operator Good morning and welcome to the RepliMune Fiscal Year Fourth Quarter twenty twenty five Financial Re ...

Financial Data and Key Metrics Changes - The company ended the fiscal year with cash and cash equivalents totaling $483.8 million, an increase from $420.7 million at the end of the previous fiscal year [21] - Research and development expenses for the fiscal fourth quarter were $54 million, compared to $42.6 million in the same quarter of the previous year, reflecting increased personnel and consulting costs [22] - The net loss for the fiscal fourth quarter was $74.1 million, compared to a net loss of $55.1 million in the same quarter of the previous year [23] Business Line Data and Key Metrics Changes - The company is preparing for the potential approval and launch of RP-one, which is positioned as a first choice for advanced melanoma patients who have previously received anti PD-one therapy [6][7] - The IGNITE study data indicates that approximately one-third of patients achieve durable responses, highlighting the potential of RP-one in a high unmet need setting [6] Market Data and Key Metrics Changes - The company estimates that approximately 13,000 patients progress on or after PD-one treatment annually in the US, with about 80% eligible for RP-one [12] - The geographic distribution of patients with advanced melanoma allows for targeted launch efforts, focusing on around 350 key accounts that treat half of the melanoma population [15] Company Strategy and Development Direction - The company aims to establish RPX as a new interventional immuno-oncology treatment paradigm, expanding beyond skin cancer [8] - The commercial organization has been built out to support the launch of RP-one, with a focus on interventional radiology and oncology collaboration [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming PDUFA date of July 22, 2025, and the potential for RP-one to address significant unmet needs in advanced melanoma treatment [6][41] - The company is actively engaged with the FDA and has completed necessary inspections, indicating no impediments to the approval process [42] Other Important Information - The company plans to host an Investor Day on June 24, where it will discuss the current melanoma landscape and the RP-one roadmap for commercial success [20] - The company has developed a patient support hub, Replimmune Connect Plus, to enhance the treatment experience for patients and caregivers [18] Q&A Session Summary Question: What sort of medical education work are you going to be doing at ASCO ahead of the launch of RP-one? - The company will present important data at ASCO, including response rates for different lesion types and safety data, to build physician confidence in RP-one [26] Question: Can you give us some color around your expectation for the launch trajectory? - The company anticipates broad and rapid adoption of RP-one, with significant training and experience among key accounts by the time of launch [33] Question: Can you discuss the impact you're seeing from the recent regulatory changes? - The company has received breakthrough designation and is on track for the July 22 PDUFA, with consistent engagement from the FDA [41] Question: Can you talk to your expectations on the potential label for RP-one? - The company expects the label to reflect the broad population studied in the IGNITE trial, which included various anti PD-one failed presentations [52]

Financial Performance - As of March 31, 2025, cash, cash equivalents, and short-term investments were $483.8 million, up from $420.7 million as of March 31, 2024, primarily due to a public offering in November 2024[9] - Research and development expenses for the fiscal fourth quarter were $54.0 million, compared to $42.6 million for the same period in 2024, and $189.4 million for the fiscal year, up from $175.0 million in 2024[14] - Selling, general and administrative expenses were $25.4 million for the fiscal fourth quarter, compared to $16.2 million in the same quarter of 2024, and $72.2 million for the fiscal year, up from $59.8 million in 2024[14] - The net loss for the fiscal fourth quarter was $74.1 million, compared to a net loss of $55.1 million for the same period in 2024, and the total net loss for the fiscal year was $247.3 million, up from $215.8 million in 2024[14] - The company believes existing cash will fund operations into the fourth quarter of 2026, excluding any potential revenue[9] Clinical Trials and Research - The company estimates approximately 13,000 patients progress on or after PD-1 treatment annually in the U.S., with about 80% eligible for treatment with RP1[3] - The confirmatory Phase 3 trial, IGNYTE-3, is expected to enroll 400 patients globally, assessing RP1 in combination with nivolumab in patients with advanced melanoma[7] - The registration-directed REVEAL trial of RP2 in metastatic uveal melanoma is currently enrolling approximately 280 patients[5] - The Phase 2 clinical trial of RP2 combined with atezolizumab and bevacizumab in hepatocellular carcinoma is expected to enroll 30 patients[6] Regulatory Updates - The FDA has indicated no advisory committee is planned for the biologics license application, which remains on schedule ahead of the July 22, 2025 PDUFA date[7]

•  BLA priority review of RP1 plus nivolumab in advanced melanoma proceeding on schedule; manufacturing inspections and late cycle review meeting complete •  Full commercial infrastructure for launch in place ahead of July 22nd PDUFA date •  Conference call today at 8:00 AM ET WOBURN, Mass., May 22, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced financial results for the fisc ...

Core Insights - The article discusses the Biotech Analysis Central service, which provides in-depth analysis of pharmaceutical companies and investment opportunities in the biotech sector [1][2]. Group 1 - The service offers a library of over 600 biotech investing articles, a model portfolio of more than 10 small and mid-cap stocks, and live chat features for investors [2]. - A promotional offer is available for new subscribers, including a two-week free trial and a discounted annual subscription price of $399, which represents a 33.50% discount compared to the monthly rate [1]. - The author emphasizes that the analysis is independent and not influenced by any business relationships with the companies mentioned [3].

Company Overview - Replimune Group, Inc. is a clinical stage biotechnology company focused on developing novel oncolytic immunotherapies to transform cancer treatment [4] - The company was founded in 2015 and is headquartered in Woburn, MA [4] - Replimune's proprietary RPx platform utilizes a potent HSV-1 backbone to maximize immunogenic cell death and induce a systemic anti-tumor immune response [4] Inducement Equity Awards - The company granted inducement equity awards to 10 newly hired non-executive employees as a material inducement for their employment [2] - The inducement awards consist of non-qualified stock options to purchase a total of 11,085 shares and restricted stock units representing 22,225 shares of common stock [2] - Each option has an exercise price of $12.29 per share, equal to the closing price on March 5, 2025, and has a 10-year term with vesting over four years [2][3] Vesting Schedule - 25% of the underlying shares from the options will vest on the one-year anniversary of the grant date, with the remainder vesting in monthly installments over the next three years [2] - The restricted stock units will vest in approximately four equal annual installments starting on February 15, 2026 [2] Compliance and Approval - The inducement awards were approved by the compensation committee of the company's board of directors under Nasdaq Listing Rule 5635(c)(4) [3] - Although granted outside of the company's 2018 Equity Incentive Plan, the terms and conditions of the awards are consistent with that plan [3]