Replimune Group, Inc.

Good morning and welcome to the RepliMuun 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 RepliMuun's website at replimuun.com and a recording will be available after the call. I would like to introduce Arlene Goldenberg from RepliMuun. Please go ahead.

Thank you, Operator, and good morning, everyone. Thank you for joining us today for a discussion of RepliMuun'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 Starkey, 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 for planned 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 10K and our Form 10Q file 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 risks and uncertainties that are described in the filings made with the SEC or other significant events occurring outside of Revenue'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. RepLemunes exclaims 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, RepLemunes' 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, we'll 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 IGNITE 3 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. RepLemunes was founded to pioneer the next generation of onclinic 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 meet 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 -PD1-filled melanoma. This would not have been possible without the efforts of the entire RepLemune 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 Purdue for date of July 22nd, 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 priority endpoint over all 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-PD1 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 and advanced melanoma, we are equally excited about our pipeline developments, 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 immunoncology 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 buildout of our customer-facing organization. Now, let me turn the call over to Chris Sarkey, Chief Commercial Officer of Refinu to discuss the RP1 launch in more detail. Chris.

Thanks, Sush. Before I get into our commercial plans, perhaps a brief introduction for those of you on the call who I haven't yet had the opportunity to meet. I joined RepliMu about two and a half years ago to help lead our commercial organization. Prior to joining RepliMu, I helped spearhead the launch of LibTio as a new standard of care for the treatment of cutaneous squamous cell carcinoma. Upon approval, the successful launch of RP1 will be my 10th oncology product launch that I've had the opportunity to be a part of, and now I look forward to helping to build RepliMu into a leading oncology company. Our team is really excited and ready to launch RP1 for a broad range of patients upon approval. We believe RP1 will be well positioned for most patients who progress on a PD-1 containing regimen based on the deep and durable response rates as well as the safety profile demonstrated in our night registrational trial. With our PDUFA date fast approaching, our primary focus has been on the commercial preparations. We have a deep understanding of the market landscape, prescriber adoption and referral patterns, and an established launch plan that's optimized for intertumoral delivery across all customer segments. The commercial opportunity for RP1 to help improve the lives of those with advanced melanoma is considerable. We estimate approximately 13,000 patients progress on or after PD-1 treatment annually in the U.S., and about 80% of these patients would be eligible for RP1 distributed evenly across hospital and non-hospital settings. Importantly, RP1 is administered in the outpatient setting and doesn't require hospitalization. For community-based oncology, we believe the introduction of RP1 will allow providers to maintain treatment continuity for their patients within their practice for the full course of RP1 as well as the Nebulumab for up to two years. For superficial injections, we anticipate administration will most often take place in the patient exam room, and while medical oncologists may be some of the early injectors, the primary injector over time will likely be advanced practice providers. We expect that this approach will help support the broad and rapid adoption of RP1 into clinical practice. From our research, we know that for patients in the advanced melanoma setting who would be candidates for RP1, about eight in 10 will have deep lesions or a combination of both superficial and deep. In these cases, interventional radiologists will work closely with the oncologist and play a key role using image guidance. Interventional radiologists are excited that RP1 may afford them the opportunity to play an even greater role in actively treating patients. Both oncologists as well as interventional radiologists are impressed with the data showing the systemic activity of RP1 plus Nebulumab in non-injected visceral lesions, which provides them with added confidence in selecting tumors for injections. Interventional radiologists have also expressed that administering RP1 is straightforward and can be readily adopted into practice upon approval. Importantly, procedural codes already exist to support RP1 deep and superficial injections, with a routine RP1 drug -and-build reimbursement process that further minimizes barriers to access across all settings. The geographic distribution of patients with advanced melanoma allows us to be very focused and targeted in our launch efforts. Even more importantly, there's a high and overlapping concentration of providers, primarily interventional radiologists and medical oncologists, who treat most melanoma patients. We've identified roughly 350 key accounts that we believe treat half of the melanoma population. Beyond that, we know that nearly all of these patients are being treated in healthcare settings that have interventional radiology on site or readily accessible through existing referral processes, further supporting our belief in the broad and rapid adoption of RP1. Our comprehensive understanding of the market drove how we've built our commercial organization, which we believe will accelerate the launch of RP1. We recently completed the buildout of our commercial infrastructure. The customer-facing team has been trained and comprised of approximately 60 people with half-focused on demand generation and their main drone supporting pull-through. The new and differentiated role we've created is the interventional radiology oncology coordinator, or IROC. This team has a significant level of experience working in the interventional radiology space. Their focus will be coordination between medical oncology and interventional radiology, ensuring that we're able to connect the dots between these functions while supporting RP1 image guided administration. We also have a team of oncology nurse educators who provide guidance on superficial administration, drive positive early experiences with RP1, and work across the medical oncology multidisciplinary team. Our national accounts team is actively engaged with payers, and our field reimbursement specialists, regional marketers, and strategic account managers round out our customer-facing teams. Our distribution model is now complete with specialty distributor agreements and key state licenses in place, which will support next-day delivery to accounts across the country. At launch, our patient support hub, RepLemune Connect Plus, will provide critical services to patients and caregivers to ensure a positive treatment experience. You may have noticed several programs already in market. Our HCP unbranded awareness effort, the Oncolytic Frontier, which highlights the importance of collaboration across multidisciplinary treatment teams, is live online now. A few months ago, we also launched a program called Melanoma Path, focused on unbranded disease education featuring real advanced melanoma patients and caregivers. Much of this content was created with the support of our Advanced Melanoma Patient Steering Committee. We've been actively engaged with the melanoma community through the support of many key organizations, including the Melanoma Research Foundation. We're excited to be one of two presenting sponsors at their annual breakthrough consortium meeting this year at ASCO, the consortium of 30 cancer centers of excellence, collaborating to develop the most promising therapies in melanoma. As you can hear, we're excited with our progress to date and looking forward to hitting the ground running. Of course, ultimately our goal is to ensure that no patient is left behind and all appropriate patients for our P1 are offered this valuable treatment once available. Our team is confident in the plans we put in place to help deliver on this important goal. With that update, I'll turn the call over to Emily to discuss our financial results. Emily?

Thank you, Chris. I'm going to start today with an update on the investor relations front. We are excited to be in the process of planning an upcoming investor day for June 24. During investor day, you will be able to hear from our management team and leading key opinion leaders on the current melanoma landscape and the opportunity to deliver onclinic immunotherapy to patients and our RP1 roadmap for commercial success upon approval and anti-PD1 failed melanoma. Our KOL panel includes expert interventional radiologists, medical oncologists, and pharmacists in the melanoma space. We will also share more about our future development of RP2, including our registration-directed trial reveal, new reveal melanoma, and our study in hepatocellular carcinoma. Finally, we will discuss our strategy for RPX long-term pipeline development. Now turning to our financial results for the fiscal year and quarter ended March 31, 2025. We ended the fiscal year with cash and cash equivalents totaling $483.8 million as compared to $420.7 million as the fiscal year ended March 31, 2024. Based on the current operating plan, the company believes that existing cash, cash equivalents, and short-term investments as of March 31, 2025 will enable the company to fund operations into the fourth quarter of 2026, which includes scale-up for the potential commercialization of RP1 and skin cancers and for working capital and general corporate purposes. This current cash runway excludes any potential revenue expected. Research and development expenses were $54 million for the fiscal fourth quarter and $189.4 million for the fiscal year ended March 31, 2025 as compared to $42.6 million for the fiscal fourth quarter and $175 million for the fiscal year ended March 31, 2024. This increase is primarily due to an increase in personnel-related costs as we scaled operations in preparation for commercial launch as well as consulting and facility-related costs. Research and development expenses included $4.5 million in stock-based compensation expenses for the fiscal fourth quarter and $18.4 million for the fiscal year ended March 31, 2025. Selling, general, and administrative expenses were $25.4 million for the fiscal fourth quarter and $72.2 million for the fiscal year ended March 31, 2025 as compared to $16.2 million for the fourth quarter and $59.8 million for the fiscal year ended March 31, 2024. Selling, general, and administrative expenses included $3.8 million in stock-based compensation expenses for the fiscal fourth quarter and $16.6 million for the fiscal year ended March 31, 2025. The company's net loss was $74.1 million for the fiscal fourth quarter and $247.3 million for the fiscal year ended March 25, 2025 as compared to a net loss of $55.1 million for the fiscal fourth quarter and $215.8 million for the fiscal year ended March 31, 2024. I will now turn the call over to the operator to open our question and answer session. Operator?

Thank you. If you'd like to ask a question, please press star 11. If your question has been answered and you'd like to remove yourself from queue, please press star 11 again. Our first question comes from Anupam Rama with JP Morgan. Your line is open.

Hey guys, thanks so much for taking the question. With the Padoopher around the corner, what sort of medical education work are you going to be doing at ASCO ahead of the launch of RP-1? I noticed that you guys had a couple of posters at the conference. Thanks so much.

Morning, Anupam. Thanks for the question. Yeah, we've got a busy ASCO coming up. We have a couple of important posters, as you mentioned, including the data that we presented previously on Ignite, showing systemic and visceral activity, including in non-injected liver and lung metastases. What we'll be doing at ASCO is actually sharing what the response rate looks like when you inject superficial lesions versus a combination of superficial visceral lesions versus visceral only lesions such as lung and liver metastases. I think that data is going to show that there's going to be a strong rationale for physicians to want to inject deeper lesions to maximize outcomes for patients. We also have a bio-distribution and safety poster, which is going to show that you can use routine cleaning using disinfectants that are routinely available for physicians in their practices and that RP-1 is neutralized very rapidly. Then also that patients don't see infections or their close contacts. So we're excited about that data, and I think it's going to build on the evidence of the data we've previously presented with the Ignite data.

Thanks so much for taking our question.

Thank you. Our next question comes from Roger Song with Jeffries. Your line is open.

Great. Thanks for that, Ben, for taking our question. So maybe given the dynamic for the launch between the oncologists and interventional radiologists, can you just give us some color around your expectations for the launch trajectory, considering some of them are superficial only, the lesion, and then some of them are mixed, and then some of them are visceral only. Thank you.

Thanks, Roger. This is Chris. So we are anticipating broad and rapid adoption across hospitals and communities, really with a heavier lift initially within the hospital setting. We've identified, as you heard, around 350 of our top accounts across the country. We, by the time of the launch, expect that roughly 150 of these accounts will have experience with intramural injections or have been trained on that by the time we get approved. The vast majority of these accounts will have access to interventional radiology within their centers. We've done a lot of research, as you can imagine, across the space between medical oncologists and interventional radiologists, and over 90% of the folks we've spoken to are willing to utilize RP-1 routinely upon approval. And so when you think about this level of excitement, the familiarity, and experience, this really does support broad and rapid adoption of RP-1 post-approval.

Got it. Thank you. If I can have a follow-up question, assuming you will get approval for the PD-1 serotonin monoloma in the upcoming day, what would be your NCC listing strategy to maybe potentially expand to some other subgroup and then also maybe beyond the monoloma like a PHTC? Thank you.

Thank you for the question, Roger. In terms of the IGNITE data, obviously, we'll be able to get approval straight away when we get the FDA approval for -1-filled melanoma. And yes, we would, though, still submit that data once we have the publication, which we're hoping to have around the time of the PDUFA date, which will, again, just further sort of solidify our position in NCCN, although it's not necessary as we will have FDA approval. As we think about future indications, I think what we're going to do is obviously see what the data looks like from those different indications, whether that's non-melanoma skin cancers such as SUPASS or the ARTICUS data in solid organ transplant. We'll be publishing the data and then determining the best path to provide access for patients,

Roger. Yeah. In addition to that, Roger, upon approval, we'll be immediately submitting our information to the drug compendium so that hospitals can download this into the system. What we've done is to make sure that we have rapid adoption within the electronic medical record system as quickly as we can. On day one, we'll be submitting a package to the companies that represent roughly 85% of all the electronic medical records databases in the country. And we put in place sort of a reactive mode as well so that for those that don't readily adopt into their EMR system, our customer-facing teams will have an app they can go to right away, reach out and let the third party group we're working with know where those haven't taken place yet. And we'll resolve those issues very, very quickly to ensure we minimize barriers to access, as Sush was saying.

Excellent. Thanks for the comment. Congrats.

Thank you. Our next question comes from Jonathan Chang with Learing Partners. Your line is open.

Hi, guys. Good morning. Thanks for taking the questions. Congrats on the progress and for hosting what I believe is your first earnings call. First question, can you discuss the impact you're seeing from the recent regulatory changes and provide any color on recent FDA interactions? And then on second question, on Ignite, can you discuss the translation of response rate into metrics like PFS and OS? And what benchmarks are you pointing to for PFS and OS in the -PD-1 field melanoma setting? Thank you.

Thanks, Jonathan. This is Emily. I'll take the first segment of your question. So just as a reminder for those on the call, we received breakthrough designation late last year and then submitted our BLA for RP-1 and PD-1 field melanoma. Our BLA was accepted in January with a priority review. And since that, since January, we've been responding to information requests from the FDA in a timely and thorough manner. We're very grateful to have seen committed and consistent engagement from our review team. We haven't seen any changes to the guidance of that commitment. Having recently completed both our late cycle meeting with the FDA and our manufacturing inspections, we're very pleased with the outcome of those interactions. And we believe there are no impediments. We're on track for our July 22nd PDU

process. And then Jonathan, just to address your second question, and yes, you're right, this is after school, which we're very excited about. So in terms of the data that we've seen for IGNITE, just as a reminder, we've seen around a third of patients achieve durable responses, which you look at median duration response of more than 20 months. This is a single arm study, as you're aware. And so obviously there are some limitations of PFS and OS in this study. However, we've seen a PFS around four months and an overall survival, which I think is actually very impressive where we've seen more than about 55% of patients still alive at three years. And so we think that can be very meaningful relative to other options in this space. You asked about the benchmarks we should be using. And I think it is important to remember that the IGNITE did use a very strict criteria for -PD-1 failure. And there isn't exact apples to apples comparisons. But if you think about some of the other studies and assets or molecules used in this space, such as ipinivo or op-duo lag, having failed either ipinivo or op-duo lag in the frontline setting, you see about a 12% response rate. And typically physicians and KRLs will tell you would not expect to see median overall survival of more than 12 months. So I think that's a reasonable benchmark that most people use. Further checkpoint inhibition after failure of prior checkpoint inhibition really only results in a response rate of 6% or 7% with very modest overall survival

benefits.

Understood. Thanks for taking my

questions.

Thank you. Our next question comes from Allison Bratzel with Piper Sandler. Your line is open.

Hey, good morning. Thanks, guys, for taking the question. Just on the confirmatory IGNITE 3 trial, I think you initiated dosing of patients last summer. So could you just talk to your experience to date with that trial and what you're seeing in terms of enrollment, opening of trial sites, and things like that, and just expectations on a timeline for completing enrollment? Any color there would be helpful. And second, could you talk to your expectations on the potential label or label discussions for RP-1 and just what gives you confidence in a broad label and achieving broad access? Thank you.

Good morning, Allison. Thanks for those questions. So just in terms of IGNITE or RP-3, just as a reminder for people, this is a large randomized study confirmatory phase 3 trial with 400 patients where we're combining RP-1 with Nivolumab versus limited dealers choice, which includes Opgio, ALAG, chemotherapy, or single agent checkpoint inhibition. This is a trial that's going to have more than 100 sites globally. And as you can imagine, we've been providing the agency the updates on the timelines for the overall study and enrollment updates on a regular basis. We expect the trial to take a couple of years to complete enrollment given the study population and size of the study. But as you can imagine, right now, we're intentionally focusing on enrolling in US sites given the upcoming PDUFA. And we realize that at approval, patients will not want to be randomized onto the control arm. So given that, we're really focusing our efforts and driving enrollment in the US. It's going very well. There's a lot of excitement around the trial. And what we're actually now doing is spending a lot of time on the rest of world expansion so that at PDUFA, we would continue to see enrollment in that study in countries such as the UK, Australia, and Europe. And again, there's equally high level excitement from ex-US investigators around the trial. We look forward to speaking to many of them at the upcoming ASCA meeting. And then you asked the second question, I believe, on a broad label, is that correct? Yeah. Just as a reminder, Ignite really enrolled a real world population, which included really pretty much every type of -1-filled presentation. We saw consistent benefit across all the subgroups. So we would expect the label, and as you know, now that we've finished the late cycle meeting, we'll be going into labeling discussions to very much reflect the study population that we investigated in the Ignite trial would expect a label to reflect

that broad population.

Thank you.

Thank you. Our next question comes from Evan Seigerman with BMO Capital Markets. Your line is open.

This is Connor on for Evan. Thanks for taking our question. Head of the potential commercial launch, can you maybe talk a little bit about how you're planning for manufacturing resiliency, including second sites to provide RP-1 product? And then I also believe you have an attractive cost of goods profile with RP-1. Can you maybe remind us what drivers are there? Thank you.

Yeah. So just in terms of the manufacturing, and again, as a reminder, we're manufacturing our own product at our facility that was designed specifically for the manufacture of RPX in Framingham in the US. And yes, you're right. We have an attractive cost of goods. It was one of the strategic reasons that we actually invested in the manufacturing early. And we do anticipate to have an -the-shelf product that positions that are utilized or used the next day. We'll have sufficient inventory for rapid and broad support at launch and also have sufficient supply to ensure that we have mid to long-term supply for expansion of RP-1. In terms of the capacity, again, we have a lot of redundancy within the facility to produce sufficient supply way beyond the initial launch. And we're also looking to produce other products, including RP-2 and RP-3 at the facility in

the future.

Great. Thank you.

To ask a question, please press star 11. Our next question comes from Peter Lawson with Barclays. Your line is open.

Great. Thank you so much. I wonder if you've just talked through any of the gating factors that exist between now and the future date, especially around CMC, and then your thoughts around enlightened learnings from the two launches, how you're thinking about giving revenue guidance, and thinking about market penetration. Thank

you. Yes. I'll just take the first question. As I mentioned earlier, we did complete our late cycle meeting, and we did complete our factoring inspections both at our Milton Park facility, which does our process validation analytical methods, and then the main manufacturing facility in Framingham. So we feel we're well positioned there. And as you would imagine, there was discussions on CMC and other clinical questions at the late cycle meeting, and we remain on track.

In terms of revenue guidance, I anticipate that we'll be providing metrics for you to track the launch, including ultimately patient numbers and payers, and we'll hold off on revenue guidance until further into the launch.

Thank you. Is there any kind of formal or informal feedback you've got from the FDA regarding, I guess, manufacturing or any other components there?

Yeah. I mean, of course, we are under an active BLA review. We have completed the inspections, and so there is formal feedback associated with those inspections, and none of that formal feedback should provide a bottleneck towards our July 22nd PDUFA.

Peter, thank you for the second question. While there have been significant advances in the treatment of advanced melanoma in recent years, there still remains a pretty significant unmet need when it comes to either deep responses, durable responses, or safety profiles. And so we know that today, when patients progress on a PD-1, they start on a PD-1 therapy in the frontline setting, half of them are going to progress within six months. And so for these patients, they don't have oftentimes six, eight, or 10 weeks for the next treatment option to be employed. When we talk to physicians and the community of melanoma experts around the country, when they start a patient on a treatment and it's working well, and it's tolerated well, they will rarely remove that patient from treatment. And so our position is that our PD-1 will be positioned as a first-line option for patients who progress on PD-1 therapy based upon our deep and durable response rates, our safety profile, and our next-date distribution off the SHELC families of convenience, which again, really helps to support broad and rapid adoption once approved.

Thank you.

Thank you. I'm showing no further questions at this time. I'd like to turn the call back over to Shashil Patel for closing remarks.

Thank you. So in summary, it's been a productive few months and we're at a very exciting inflection point as we prepare for our first approval and commercial launch with RP-1. We look forward to our upcoming milestones, including data updates on our deep and visceral activity and safety at ASCO and our upcoming investor day and potential approval announcement. Finally, I just want to acknowledge everyone at RepVid. I'm proud of the efforts of our team and want to thank them for their dedication as we work to deliver important treatment options to patients in need. Thank you for joining our call today.

Thank you for your participation. This does conclude the program and you may now disconnect. Everyone have a great day.