Replimune Group, Inc.

Good morning and welcome to the REPLIMUNE fiscal year fourth quarter 2025 financial results and corporate update conference call. Currently, all participants are on listen-only mode. This call is being webcast live on the investors and media section of REPLIMUNE's website at REPLIMUNE.com, and a recording will be available after the call. I would like to introduce Arlene Goldenberg from REPLIMUNE. Please go ahead.

Thank you, operator, and good morning, everyone. Thank you for joining us today for a discussion of Replicant's fiscal year fourth quarter 2025 business highlights and financial results. Leading the call today will be Sushil Patel, our Chief Executive Officer. He will be joined by Chris Sarkey, our Chief Commercial Officer, and Emily Hill, our Chief Financial Officer. After our prepared remarks, we will open the call for Q&A. An audio recording and webcast replay for today's conference call will also be available online as detailed in the press release announcement for this call. During today's call, we will be making certain forward-looking statements, including, without limitation, statements about the potential safety, efficacy, and regulatory and clinical progress of our product candidates, our anticipated cash runway, and our future expectations plans, partnerships, and prospects. These statements are subject to various risks, such as changes in market conditions and difficulties associated with research and development and regulatory approval processes. These and other risk factors are described in the filings made with the SEC, including our annual report on Form 10-K and our Form 10-Q filed today. Forward-looking statements are based on the assumptions, opinions, and estimates of management at the date the statements are made, including the non-occurrence of the risk and uncertainties that are described in the filings made with the SEC or other significant events occurring outside of Replenium's normal course of business. You are cautioned not to place undue reliance on these forward-looking statements, which are made as of today, May 22, 2025. RepLimune disclaims any obligation to update such statements even if management's views change, except as required by law. With that, let me turn the call over to Sushil Patel, RepLimune's Chief Executive Officer.

Thank you, Arlene, and welcome everyone to today's earnings call. We appreciate you joining us as we review our fiscal fourth quarter and full year 2025 results. Today, will highlight the significant progress we've made across regulatory, clinical, and commercial as we approach the potential approval and launch of RP1. You'll also hear updates on our confirmatory IGNITE3 trial, pipeline developments for RP2, and our financial position as we prepare for commercial readiness. I'll begin with a strategic overview before turning the call over to Chris to walk through launch preparation and Emily to cover our financials. RepImmune was founded to pioneer the next generation of oncolytic immunotherapy and is now poised to realize that promise with a substantial body of evidence supporting our mission. In particular, data from the IGNITE study shows that roughly one third of patients are able to achieve durable response in a high unmet need setting with few options. I am delighted with the tremendous organizational advances we've made, allowing us, if approved, to be ready for a strong, commercial launch of our first therapy in anti-PD-1-filled melanoma. This would not have been possible without the efforts of the entire RepliMe team. Over the past year, we have made significant regulatory progress, resulting in a recognition of RP1 as a breakthrough therapy with priority review and a PDUFA date of July 22, 2025. We remain actively engaged with the FDA and recently completed the late cycle meeting and manufacturing inspections. The IGNITE-3 confirmatory study is underway and has a primary endpoint to overall survival. Enrollment in the U.S. is on track with over 100 sites planned globally. While we have seen important advances in the melanoma treatment landscape, the unmet need remains significant. We believe, upon FDA approval, RP1 will be well-positioned to be the first choice for advanced melanoma patients who have previously received an anti-PD-1 containing regimen. This is based on a combination of compelling safety and efficacy data, a comprehensive understanding of the patient population and prescriber base, and a launch model optimized to unlock the potential of intratumoral injections. Building upon the strong systemic and visceral activity we've seen with RP1 in advanced melanoma, we are equally excited about our pipeline development, which are focused on the potential of deep lesion injections with RPX to benefit patients beyond skin cancer. We look forward to establishing our RPX platform as a new interventional immuno-oncology treatment paradigm, which we believe will be enabled through the collaboration between oncologists and interventional radiologists. Our U.S. manufacturing facility has produced commercial inventory to support the RP1 launch with capacity to support long-term global demand. We are well capitalized to execute on our commercialization plans and have recently completed the build-out of our customer-facing organization. Now, let me turn the call over to Chris Salke, Chief Commercial Officer of RepLimune, to discuss the RP1 launch in more detail. Chris.