Q4 2025 Replimune Group Inc Earnings Call
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Okay.
Good morning, and welcome to the reps immune fiscal year fourth quarter 2025 financial results and corporate update conference call.
Operator: Currently, all participants are in listen-only mode.
All participants are in listen only mode. This call is being webcast live on the investors and media section of Webster.
Operator: This call is being webcast live on the Investors & Media section of Replimune's website at Replimune.com and a recording will be available after the call.
Website.
Com and a recording will be available after the call.
Arlene Goldenberg: I would like to introduce Arlene Goldenberg from Replimune. Please go ahead. Thank you, operator and good morning, everyone.
Speaker Change: I'd like to introduce Arlene Goldenberg firmed up the ma'am. Please go ahead.
Speaker Change: Thank you operator, and good morning, everyone. Thank you for joining us today for a discussion of rapidly in fiscal year fourth quarter of 2025.
Arlene Goldenberg: Thank you for joining us today for a discussion of Replimune's fiscal year fourth quarter 2025 business highlights and financial results.
Speaker Change: <unk> financial results.
Arlene Goldenberg: 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.
Speaker Change: Leading the call today will be the shale Patel, our chief Executive Officer.
Chris <unk>: He will be joined by Chris <unk>, Our Chief commercial Officer, and Emily Hill, our Chief Financial Officer.
Arlene Goldenberg: After our prepared remarks, we will open the call for Q and A.
Chris <unk>: After our prepared remarks, we will open the call for Q&A.
Unknown Executive: 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 processes. 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 file today.
Chris <unk>: 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.
Chris <unk>: 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.
Chris <unk>: Our anticipated cash runway and our future expectations plans partnership and prospect.
Chris <unk>: These statements are subject to various risks such as changes in market conditions and difficulties associated with research and development and regulatory approval process.
Chris <unk>: These and other risk factors are described in our filings made with the SEC, including our annual report on Form 10-K, and our Form 10-Q filed today.
Unknown Executive: 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 Replimune's normal course of business.
Chris <unk>: Forward looking statements are based on the assumption opinions and estimates of management at the date the statements were made.
Chris <unk>: <unk> the non occurrence of the risks and uncertainties that are described in our filings made with the SEC or other significant event occurring outside of rapidly as normal course of business.
Unknown Executive: You are cautioned not to place undue reliance on these forward-looking statements, which are made as of today, May 22nd, 2025.
You are cautioned not to place undue reliance on these forward looking statements, which are made as of today may 22nd 2025.
Unknown Executive: Replimune disclaims any obligation to update such statements, even if management's views change, except as required by law.
Chris <unk>: <unk> disclaims any obligation to update such statements, even if management's views change except as required by law.
Sushil Patel: 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, 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 III trial, pipeline developments for RP2, and our financial position as we prepare for commercial registration.
Sushi: With that let me turn the call over to Sushi, Alcatel Reprimands, Chief Executive Officer.
Speaker Change: Thank you Holly and welcome everyone to todays earnings call we.
Speaker Change: We appreciate you joining us as we review our fiscal fourth quarter and full year 2025 results.
Speaker Change: Today, we will highlight the significant progress we've made across regulatory clinical and commercial as we approach the potential approval and launch of <unk>.
Speaker Change: You'll also hear updates on our confirmatory phase three trial.
Speaker Change: Developments for all P too and their financial position as we prepare for commercial readiness.
Sushil Patel: I'll begin with a strategic overview before turning the call over to Chris to walk through launch preparation and Emily to cover our financial. Replimune 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.
Speaker Change: I'll begin with a strategic overview before turning the call over to Chris to walk through launch preparation and Emily to cover financials.
Speaker Change: Revenue was founded to pioneer the next generation of OLED convenient therapy and is now poised to realize that comes with.
Speaker Change: With a substantial body of evidence supporting our mission in.
Speaker Change: In particular data from the ignite study shows that roughly one third of patients are able to achieve durable response.
Speaker Change: High unmet need searching with few options.
Sushil Patel: 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 Replimune 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 inspection. The IGNITE-3 confirmatory study is underway and has a priory endpoint overall survival.
Speaker Change: 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 of anti PD one in melanoma.
Speaker Change: This would not have been possible without the efforts of the entire community.
Speaker Change: Over the past year, we have made significant regulatory progress, resulting in a recognition of all people wanted to breakthrough therapy with priority review and a <unk> date of July 22nd 2025.
Speaker Change: We remain actively engaged with the FDA.
Speaker Change: And recently completed the late cycle meeting and manufacturing inspections.
Speaker Change: Ignite three confirmatory study is underway and has a primary endpoint overall survival.
Sushil Patel: 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 containment.
Speaker Change: In the U S is on track with over 100 sites plan globally.
Speaker Change: While we have seen important advances in the melanoma treatment landscape. The unmet need remains significant we believe upon FDA approval, all Q1 will be well positioned to be the first choice for advanced melanoma patients who have previously received an anti PD one containing regimen.
Sushil Patel: 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 Building upon the strong systemic and visceral activity we've seen with RP-1 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.
Speaker Change: This is based on a combination of compelling safety and efficacy data.
Speaker Change: Comprehensive understanding of the patient population and prescriber base and launch model optimized to unlock the potential of intra tumoral injection.
Speaker Change: Building upon the strong systemic and visceral activity, we've seen with <unk> in advanced melanoma, we are equally excited about our pipeline development.
Speaker Change: Our focus on the potential Legion injections with RPX to benefit patients beyond skin cancer.
Speaker Change: We look forward to establishing our RPX platform, making new intervention or immuno oncology treatment paradigm, which we believe will be enabled through the collaboration between oncology and interventional radiologists.
Sushil Patel: Our U.S. manufacturing facility has produced commercial inventory to support the RP-1 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.
Speaker Change: Our U S manufacturing facility has produced commercial inventory to support the <unk> launch with capacity to support long term global demand.
Speaker Change: We are well capitalized to execute on our commercialization plans and have recently completed the build out of that customer facing organization.
Chris Starkey: Now, let me turn the call over to Chris Sarkey, Chief Commercial Officer of Replimune, to discuss the RP1 launch in more detail. Chris. Thanks, Sush.
Speaker Change: Now, let me turn the call over to Chris <unk>, Chief Commercial Officer, Brett could you discuss the <unk> launch in more detail.
Speaker Change: Great.
Chris Starkey: Before I get into our commercial plans, perhaps a brief introduction for those of you in the call who I haven't yet had the opportunity. I joined Replimune about two and a half years ago to help lead our commercial organization. Prior to joining Replimune, 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 Replimune into a leading oncology.
Brett: Thanks, Steve.
Speaker Change: 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.
Speaker Change: I joined grapple immune about two and a half years ago helped lead our commercial organization.
Speaker Change: Prior to joining revenue helped spearhead the launch of lip tie it was a new standard of care for the treatment of cutaneous squamous cell carcinoma.
Speaker Change: Upon approval.
Speaker Change: Full launch of our <unk>, one will be might tempt oncology product launch that I've had the opportunity to be a part of and now I look forward to helping to build rapidly into a leading oncology company.
Chris Starkey: 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 IGNITE registrational trial.
Speaker Change: Our team is really excited and ready to launch our <unk> one for a broad range of patients upon approval.
Speaker Change: We believe our people want to be well positioned for most patients who progressed on a PD one containing regimen based on a deep and durable response rates as well as the safety profile demonstrated in our Registrational trial.
Chris Starkey: With our PDUFA date fast approaching, our primary focus has been on the commercial preparation. We have a deep understanding of the market landscape, prescriber adoption and referral patterns, and an established launch plan that's optimized for inter-tumoral 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 annual in the US, 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.
Speaker Change: But after you predict 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 intra tumoral delivery across all customer segments.
Speaker Change: The commercial opportunity for our <unk> one to help improve the lives of those with advanced melanoma is considerable we estimate approximately 13000 patients progress on or after PD, one treatment annually in the U S and about 80% of these patients would be eligible for RP, one distributed evenly across hospital and non hospital settings.
Speaker Change: Importantly, <unk> is administered in the outpatient setting it doesn't require hospitalization.
Chris Starkey: 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 nivolumab 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 8 in 10 will have deep lesions or a combination of both superficial and deep.
Speaker Change: For community based oncology do you believe the introduction of <unk> will allow providers to maintain treatment continuity for their patients within their practice for the full course of our PD, one as well as nivola map or up to two years.
Speaker Change: For superficial injections, we anticipate administration will most often take place in the patient exam room, and while medical oncologists, maybe some of the early injectors. The primary injector over time, we'll likely be advanced practice providers.
Speaker Change: We expect that this approach will help support the broad and rapid adoption of our <unk> one into clinical practice.
Speaker Change: From our research, we know that for patients in the advanced melanoma, setting who would be candidates for our Q1 about eight in 10 will have deep lesions or a combination of both superficial Andy.
Chris Starkey: 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 nivolumab in non-injected visceral lesions, which provides them with added confidence in selecting tumors for injection. 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 buy and bill reimbursement process that further minimizes barriers to access across all settings.
Speaker Change: In these cases, interventional radiologists, who work closely with the oncologist and play a key role using image guidance interventional.
Speaker Change: Radiologists are excited that RP, one may afford them the opportunity to play an even greater role in actively treating patients both on.
Speaker Change: Oncologists as well as interventional radiologists are impressed with the data showing the systemic activity of <unk> plus <unk> in non injected visceral lesions, which provides them with added confidence in selecting tumors for injections.
Speaker Change: Interventional radiologists have also expressed that administering RP one is straightforward and can be readily adapted into practice upon approval.
Speaker Change: Importantly, procedural codes already exists to support our <unk> deep and superficial injections with a routine RP, one drug buy and bill reimbursement process that further minimizes barriers to access across all settings.
Chris Starkey: The geographic distribution of patients with advanced melanoma allows us to be very focused and targeted in our launch effort. 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 to existing referral processes, further supporting our belief in the broad and rapid adoption of RP1.
Speaker Change: The geographic distribution of patients with advanced melanoma allows us to be very focused and targeted in our launch efforts even.
Speaker Change: Even more importantly, there is a high end overlapping concentration to providers, primarily interventional radiologist and medical oncologists.
Speaker Change: We treat most melanoma patients.
Speaker Change: We've identified roughly 350 key accounts that we believe treat half of the melanoma population.
Speaker Change: Beyond that we know that nearly all of these patients are being treated in health care settings to have interventional radiology on site are readily accessible through existing referral processes.
Speaker Change: They're supporting our belief in the broad and rapid adoption of our <unk>.
Chris Starkey: Our comprehensive understanding of the market drove how we built our commercial organization, which we believe will accelerate the launch of RP1. We recently completed the build out of our commercial infrastructure. The customer facing team has been trained and comprised of approximately 60 people with half focused on demand generation and the remainder on supporting pull. A 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 our P1 image-guided administration.
Speaker Change: Our comprehensive understanding of the market drove how we've built our commercial organization, which we believe will accelerate the launch of <unk> one.
Speaker Change: We recently completed the Buildout of our commercial infrastructure, our customer facing team has been trained and comprised of approximately 60 people have focused on demand generation and the remainder in supporting appropriate.
Speaker Change: A new and differentiated what we've created is the interventional radiology oncology coordinator or Iraq.
Speaker Change: 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 RP one image guided administration.
Chris Starkey: 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. Our national accounts team is actively engaged with payers, and our field reimbursement specialists, regional marketers, and strategic account managers round out our customer face Our distribution model is now complete with specially distributor agreements and key state licenses in place, which will support next day delivery to accounts across the country.
Speaker Change: We also have a team of oncology nurse educators, who will provide guidance on superficial administration.
Speaker Change: Drive positive early experiences with <unk>, one and work across the medical oncology multidisciplinary team.
Speaker Change: 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.
Speaker Change: Our distribution model is now complete with specialty distributor agreements in key state licenses in place, which will support next day delivery to accounts across the country.
Chris Starkey: At launch, our patient support hub, Replimune 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 care. Much of this content was created with the support of our Advanced Melanoma Patient Steering We've been actively engaged with the melanoma community for the support of many key organizations, including the Melanoma Research Foundation.
Speaker Change: At launch our patient support hub rep immune connect plus will provide critical services to patients and caregivers to ensure a positive treatment experience.
Speaker Change: You may have noticed several programs already in market.
Speaker Change: Our HCP unbranded awareness effort, the oncologic frontier, which highlights the importance of collaboration across multi disciplinary treatment pool is live online now.
Speaker Change: A few months ago. We also launched a program called melanoma path focused on unbranded disease education, featuring real advanced melanoma patients and caregivers.
Speaker Change: Much of this content was created with the support of our advanced melanoma patients steering Committee.
Speaker Change: We've been actively engaged with the melanoma community because it's supported many key organizations, including the melanoma Research Foundation.
Chris Starkey: We're excited to be one of two presenting sponsors at their annual breakthrough consortium meeting later this year at ASCO, the consortium of 30 cancer centers of excellence, collaborating to develop the most promising therapies in melanoma.
Speaker Change: We're excited to be one or two presenting sponsors at their annual breakthrough consortium meeting later this year at <unk>, a consortium of 30 cancer centers of excellence collaborating to develop the most promising therapies in melanoma.
Chris Starkey: 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 RP1 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.
Speaker Change: 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 has left behind and all appropriate patients for our people and our operators valuable treatment once available.
Speaker Change: Our team is confident in the plans we put in place to help deliver on this important goal for.
Emily Hill: For that update, I'll turn the call over to Emily to discuss our financial results, Emily. Thank you, Chris.
Speaker Change: With that update I'll turn the call over to Emily to discuss our financial results Emily.
Emily Hill: 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 oncolytic immunotherapy to patients and our RP1 roadmap for commercial success upon approval in anti-PD-1 failed melanoma. Our KOL panel includes expert interventional radiologists, medical oncologists, and pharmacists in the melanoma state. We will also share more about our future development of RP2, including our registration-directed trial reveal in uveal melanoma and our study in hepatocellular carcinoma.
Emily: Thank you, Chris I'm going to start today with an update on the Investor Relations front, we are.
Speaker Change: We're excited to be in the process of planning an upcoming Investor day for June 24.
Speaker Change: 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 on political immunotherapy to patients and the RP one roadmap for commercial success upon approval and anti PD one failed melanoma.
Speaker Change: Our Kols panel includes expert interventional radiologists medical oncologists and pharmacists in the melanoma space.
Speaker Change: We will also share more about our future development of RP too, including our registration directed trial reveal you beyond melanoma and our study in hepatic cellular carcinoma.
Emily Hill: 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 31st, 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 31st, 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.
Speaker Change: Finally, we will discuss our strategy for RPX long term pipeline development.
Speaker Change: 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 $427 million as the fiscal year ended March 31 2024.
Speaker Change: Based on the current operating plan the company believes that existing cash cash equivalents and short term investments as of March 31, 2025, we will enable the company to fund operations into the fourth quarter of 2026, which includes scale up for the potential commercialization of <unk>, one and skin cancers and <unk>.
Speaker Change: For working capital and general corporate purposes.
Emily Hill: This current cash runway excludes any potential revenue expected. Research and development expenses for $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.
Speaker Change: Current cash runway excludes any potential revenue expected.
Speaker Change: 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.
Speaker Change: This increase was 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.
Speaker Change: Research and development expenses included $4 5 million in stock based compensation expenses for the fiscal fourth quarter at $18 4 million for the fiscal year ended March 31 2025.
Emily Hill: 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 fiscal 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 31, 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.
Speaker Change: 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 fiscal fourth quarter and $59 8 million for the fiscal year ended March.
Speaker Change: 31 2024.
Speaker Change: 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.
Speaker Change: The year ended March 31 2025.
Speaker Change: 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.
Operator: 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 one one. If your question has been answered and you'd like to remove yourself from the queue, please press star one one again.
Speaker Change: I will now turn the call over to the operator to open a question and answer session operator.
Speaker Change: Thank you if you'd like to ask a question. Please press star one one.
Speaker Change: If your question has been answered and you'd like to remove yourself from the queue. Please press star one again.
Anupam Rama: Our first question comes from Anupam Rama with J.P. Morgan. Your line is open. Hey guys, thanks so much for taking the question. With the PDUFA around the corner, what sort of medical education work are you going to be doing at ASCO ahead of the launch of RP1? I noticed that you guys had a couple of posters at the conference. Thanks so much.
Speaker Change: First question comes from <unk> Rama with Jpmorgan. Your line is open.
Speaker Change: Hey, guys. Thanks, so much for taking the question.
Speaker Change: With the particular around the corner, what sort of medical education work or are you going to be doing it as go ahead of the launch of RP. One I noticed that you guys had a couple of posters at the conference. Thanks.
Chris Starkey: 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. We've built a 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 and visceral lesions versus visceral only lesions such as lung and liver metastases. And I think that data is going to show that there's going to be a strong rationale for physicians to want to inject deep lesions to maximize outcomes for patients.
Speaker Change: Thanks, so much.
Speaker Change: Jonathan Thanks for the question, Yes, we got the <unk> coming up we had a couple of important posters as you mentioned we.
Speaker Change: Build a data that we presented previously on ignite showing.
Speaker Change: In vitro activity, including a non injected.
Speaker Change: And lung metastasis.
Speaker Change: Perhaps disease would be doing at Astro was actually sharing what the response rate looks like when you inject superficial lesions versus a culmination of superficial visceral lesions.
Speaker Change: Visual only lesions such as lung and liver metastases and I think that data is finished.
Speaker Change: To be a strong rationale for physicians to want to inject depletions to maximize outcomes to patients. We also have a biomarker.
Chris Starkey: We also have a biodistribution 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 RP1 is neutralized very rapidly, and then that 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 previously presented with IGNITE. Thanks so much for taking our question. Thank you.
Speaker Change: Distributions safety poster, which is going to show that you can use routine cleaning.
Speaker Change: Using disinfectants routinely available for physicians and their practices and <unk>.
Speaker Change: One is neutralized very rapidly and then that also that.
Speaker Change: Patients don't see infections or they close complex. So we're excited about that data and I think it's going to build on the evidence of the data we previously presented data.
Speaker Change: Thanks, so much for taking my question.
Roger Song: Our next question comes from Roger Song with Jeffries. Your line is open. Great. Thanks for that and taking our questions.
Speaker Change: Thank you. Our next question comes from Roger song with Jefferies. Your line is open.
Speaker Change: Great.
Speaker Change: Thanks for that question.
Chris Starkey: So maybe given this dynamic for the launch between the oncologist and the interventional radiologist, can you just give us some color on your expectation for the launch trajectory? You know, 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.
Speaker Change: Question.
Speaker Change: So maybe given this dynamic for the launch.
Speaker Change: Between the oncologists and.
Speaker Change: As I mentioned all the geologist can you just give us some color on your expectation for the launch trajectory.
Speaker Change: Considering some of the demand.
Speaker Change: Thank you Ole.
Speaker Change: Some of the mix and then some.
Speaker Change: Goodbye.
Speaker Change: Thank you.
Chris Starkey: This is this is Chris. So we're anticipating a 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 intuminal 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. You know, we've done a lot of research, as you can imagine, across the space between medical oncologists and interventional radiologists.
Chris <unk>: Thanks. Roger This is this is Chris so we are anticipating a broad and rapid adoption across hospitals and communities.
Speaker Change: Really.
Speaker Change: A heavier lift initially within the hospital setting we've identified identified as you heard around 350 of our top accounts across the country.
Speaker Change: By the time of launch expects debt of roughly 150 of these accounts will have experience within a two mile injections are being trained on that by the time, we get approved the vast majority of these accounts will have access to interventional radiology within their centers.
Speaker Change: <unk> 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 <unk> one routinely upon approval and so when you think about this level of excitement that familiarity and experience. This really does support broad and rapid adopt.
Roger Song: And over 90% of the folks we've spoken to are willing to utilize RP1 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 RP1 post-injection. Got it. Thank you.
Speaker Change: <unk> of our <unk>, one post approval.
Speaker Change: Got it. Thank you if I can have a follow up question.
Chris Starkey: If I can have a follow-up question, assuming you will get approval for the PD-1 cell, the melanoma, in the upcoming PDUFA day, what will be your NCCM listing strategy to maybe potentially expand to some other subgroup, and then also maybe beyond the melanoma, like a CACC? Thank you. Thank you for the question, Roger. Well, in terms of the IGNITE data, obviously, we'll be able to get approval straight away when we get the FDA approval for anti-PD-1-filled melanoma. And yes, we would 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.
Speaker Change: Assuming you will get approval.
Speaker Change: For the PD one alone.
Speaker Change: In the upcoming packages a day.
Speaker Change: Yes.
Speaker Change: <unk> strategy to maybe potentially expense with some others.
Speaker Change: The subgroup and then also maybe beyond the melanoma lack of CFCC. Thank.
Speaker Change: Thank you.
Roger Song: Thank you for your question Roger.
Roger Song: Terms of the ignite data, obviously will be able to get approval straight away when we get the FDA approval for anti PD, one field in melanoma and yes, we would still submit that data once we have the publication, which we're hoping to add around the time of the Paducah date.
Speaker Change: Which will again just further solidify our positioning in <unk> that was not necessarily 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 the POS will be article states are in solid organ transplant will be put.
Chris Starkey: 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 SURPASS 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. 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 making is to make sure that we have rapid adoption within the electronic medical record system as quick as we can.
Speaker Change: <unk> seen to date, and then determining the best path to provide access to patients.
Speaker Change: In addition to that Roger upon approval will be immediately submitting our information to the drug compendium. So that hospitals can download this into the system. What we've done is making is to make sure that we have rapid adoption within the electronic medical record systems as quick as we can on day, one we will be submitting a package to the companies.
Chris Starkey: 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.
Speaker Change: That represent roughly 85% of all the electronic medical records database in the country and we put in place sort of reactive mode as well so that for those that don't readily adopt into their EMR system.
Speaker Change: 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 will resolve those issues very very quickly to ensure we minimize barriers to access decision was saying.
Sushil Patel: Sushil Patel, Anupam Rama, Sushil Patel, Kostas Xynos, Replimune Group Inc Excellent. Thanks for the comment. Congrats. Thank you.
Speaker Change: Excellent thanks for the comments congrats.
Jonathan Chang: Our next question comes from Jonathan Chang with Lyrinc Partners. Your line is open. Hi, guys. Good morning. Thanks for taking the question.
Speaker Change: Thank you. Our next question comes from Jonathan Chang with Leerink Partners. Your line is open.
Jonathan Chang: Hi, guys. Good morning, Thanks for taking my questions. Congrats on the progress for hosting what I believe is your first earnings call.
Jonathan Chang: 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 can you provide any color on recent FDA interactions?
Speaker Change: First question can you discuss the impact you're seeing from the recent regulatory changes. Thank you provide any color on recent FDA interactions.
Emily Hill: And then our 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 anti-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 RP1 and PD1 failed melanoma. Our BLA was accepted in January with a priority review. And since that January, we've been responding to information requests from the FDA in a timely and thorough manner.
Speaker Change: And then on second question on ignite can discuss the translation of response rate and to metrics that PFS and OS.
Speaker Change: And what benchmarks are pointing to for PFS and OS and the anti PD one field melanoma setting. Thank you.
Speaker Change: 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 one in PD, one field melanoma.
Speaker Change: Our BLA was accepted in January with a priority review and since that.
Speaker Change: In January we've been responding to information requests from the FDA and timely and thorough manner.
Emily Hill: We're very grateful to have seen committed and consistent engagement from our review team. We haven't seen any changes to the cadence 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.
Speaker Change: Very grateful to have seen committed and consistent engagement from my review team, we haven't seen any changes to the cadence of that.
Speaker Change: Commitment.
Speaker Change: Having recently completed both our late cycle meeting with the FDA and our manufacturing inspections.
Speaker Change: Pleased with the outcome of those interactions and we believe there are no impediments were on track for July 22nd with you.
Emily Hill: We're on track for our July 22 And Jonathan, just to address your second question, and yes, you're right, this is our first call, 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 our overall survival, which I think is actually very impressive, where we've seen more than about 55 percent of patients still alive at three years.
Speaker Change: And Jonathan just to address your second question, Yes, you are right after school, which we're very excited about.
Speaker Change: So in terms of the <unk>.
Speaker Change: Data that we've seen for ignite.
Speaker Change: Just as a reminder, we've seen around a third patient instead of patients achieve durable responses, which you look at median duration response in more than 20 months. This is a single arm study as Youre aware and so obviously there is some limitations of PFS and OS in this study. However, we have seen a PFS around four months and overall survival, which I think is actually very impressive.
Speaker Change: Where we've seen more than about 55% of patients still alive at three years and so we think thats 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 could use a very strict criteria for anti PD, one failure and there is an exact apples to apples comparison.
Emily Hill: 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, you know, the IGNITE did use a very strict criteria for anti-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 ipinevo or OpDuoLAG, having failed either ipinevo or OpDuoLAG in the frontline setting, you see about a 12 percent response rate. And typically physicians and KRLs will tell you you would not expect to see median overall survival of more than 12 months.
Speaker Change: But if you think about some of the other studies.
Speaker Change: The assets of molecules used in this space, such as <unk> or opt your lag having failed either <unk> lagging the frontline setting you see about a 12% response rate and typically.
Speaker Change: <unk> and Kols and so you would not expect to see median overall survival of more than 12 months. So I think thats a reasonable benchmark that most people use further checkpoint inhibition after failure of prior checkpoint inhibition results in a response rate of six 7% with very modest cycles survival benefits.
Emily Hill: 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 six or seven percent with very modest overall survival benefits. Understood. Thanks for taking my question. Thank you.
Speaker Change: Understood. Thanks for taking my questions.
Allison Bratzel: 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 IGNITE3 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.
Allison Brussel: Thank you. Our next question comes from Allison Brussel with Piper Sandler Your line is open.
Allison Brussel: Hey, good morning, Thanks, guys for taking my question.
Speaker Change: Just on the confirmatory ignite three trial I think you indicated dosing.
Speaker Change: Patients last summer. So could you just talk to your experience to date with that trial and what Youre seeing in terms of enrollment opening of trial sites.
Speaker Change: And things like that and just expectations on.
Speaker Change: A timeline for completing enrollment any color there would be helpful and second could you talk to your expectations.
Emily Hill: And second, could you talk to your expectations on the potential label or label discussions for RP1 and just what gives you confidence in a broad label and achieving broad access? Thank you. Good morning, Alison. Thanks for those questions. So just in terms of IGNITE or RP1, just as a reminder for people, this is a large, randomised study, a confirmatory phase 3 trial with 400 patients, where we're combining RP1 with Nivolumab versus a limited dealers choice, which includes OcteoLAG, chemotherapy, or single-agent checkpoint inhibition. This is a trial that's going to have more than 100 sites globally.
Speaker Change: On the potential label or label discussions for our Purion in gist.
Speaker Change: As you confidence.
Speaker Change: Broad label and achieving products us thank you.
Speaker Change: Good morning, guys and thanks for those questions. So just in terms of ignite three.
Speaker Change: Three is I think it just as a reminder for people. This is a large randomized.
Speaker Change: Randomized study.
Speaker Change: XOMA three phase III trials with 400 patients, where we're combining <unk> with the volume out of the six limited.
Speaker Change: Limited dealer's choice, which includes opt your lag chemotherapy.
Speaker Change: Single agent checkpoint inhibition.
Speaker Change: 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.
Emily Hill: And as you can imagine, we've been providing the agency the updates on the timelines for the overall study and enrolment updates on a regular basis. We expect the trial to take a couple of years to complete enrolment, 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 realise that at approval, patients will not want to be randomised onto the control arm. So given that, we're really focusing our efforts and driving enrolment in the US. It's going very well.
Speaker Change: We expect the trial to take a couple of years to complete enrollment given the study population.
Speaker Change: Size of the study.
Speaker Change: And as you can imagine right now we are intensely focusing on enrolling in U S sites given the upcoming producers.
Speaker Change: Realize that at approval.
Speaker Change: Will it be randomized onto the control arm. So given that we're really focusing our efforts in driving enrollment in the U S is going very well, there's a lot of excitement around the trial and what we are actually now doing is spending a lot of time on the rest of world expansion so that activity.
Emily Hill: 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 enrolment 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 AFSCO. And then you asked the second question, I believe. on a broad label, is that correct? Just as a reminder, IGNITE really enrolled a real-world population, which included really pretty much every type of anti-PD-1-filled presentation, and we saw a consistent benefit across all the subgroups.
Speaker Change: We would continue to see enrollment in that study.
Speaker Change: Countries, such as the UK, Australia and Europe.
Speaker Change: And again, there's equally high level excitement from ex U S. Investigators around the trial, we look forward to speaking to many of the upcoming Astro meeting.
Speaker Change: And then you asked the second question.
Speaker Change: Okay.
Speaker Change: On the broad label is that correct.
Speaker Change: Alright.
Speaker Change: Yes, just so just isn't right.
Speaker Change: Ignite William wrote a real world population, which included really pretty much every type of anti PD. One presentation, we saw consistent benefit across all the subgroups. So we would expect the label as you know now that we finished the late cycle meeting, we'll be getting into labeling discussions to very much reflect the study population that we.
Emily Hill: 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 and would expect a label to reflect that broad population. Thank you.
Speaker Change: We investigated in nitrile, we'd expect the label to reflect that broad population.
Speaker Change: Thank you.
Speaker Change: Okay.
Evan Segerman: Our next question comes from Evan Segerman with BMO Capital Markets. Your line is open. This is Conor on Fredman. Thanks for taking our question.
Speaker Change: Thank you. Our next question comes from Evan <unk> with BMO capital markets. Your line is open.
Connor: This is connor on for Adam and thanks for taking our question.
Sushil Patel: Ahead 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 our P1 product? And then I also believe you have an attractive cost of goods profile with our P1. Can you maybe remind us what the drivers are there? Thank you.
Speaker Change: How does the potential commercial launch can you maybe talk a little bit about how you are planning for manufacturing resiliency.
Speaker Change: Including second sites to provide our <unk> product and then I also believe you have an attractive cost of goods profile with our Q1 can you maybe remind us what the drivers are there. Thank you.
Sushil Patel: Yeah, so just in terms of the manufacturing, and again, as a reminder, we're manufacturing our own product to that facility that was was designed specifically for the manufacture of RPX in Framingham in the US. And yes, you're right, we have a 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 a off-the-shelf product that positions or that utilize order and use the next day. We'll have sufficient inventory for, you know, rapid and broad support at launch, and also have sufficient supply to ensure that we have mid to long term supply for expansion of RP1.
Speaker Change: Yes, so just in terms of the manufacturing and again as a reminder, we're manufacturing our own product to that facility that was designed specifically for the manufacture of RPX and framing them in the U S. And yes, you are right. We have an attractive cost of goods. It was one of the strategic reasons that we actually invested in the manufacturing.
Speaker Change: Ali.
Speaker Change: And we do anticipate to have a off the shelf product positions.
Speaker Change: Utilized.
Speaker Change: Or use the next day.
Speaker Change: We will have sufficient inventory for.
Speaker Change: Rapid and broad.
Speaker Change: Supported launch and also have sufficient supply to <unk>.
Speaker Change: Sure that we have mid to long term.
Speaker Change: Supply for expansion above Q1.
Sushil Patel: In terms of the capacity, we again, we have a lot of redundancy within the facility to, you know, produce sufficient supply way beyond the initial launch.
Speaker Change: In terms of the capacity.
Speaker Change: Again, we have a lot of redundancy within the facility.
Speaker Change: Produce sufficient supply way beyond the initial launch and we're also looking to produce other.
Sushil Patel: And we're also looking to produce other product including RP2 and RP3 at the facility in the future.
Speaker Change: Products, including <unk> and <unk> in the future.
Unknown Executive: Great, thank you.
Speaker Change: Great. Thank you.
Speaker Change: Okay.
Speaker Change: Yes.
Operator: To ask a question, please press star 1 1.
Speaker Change: To ask a question. Please press star one one our next question comes from Peter Lawson with Barclays. Your line is open.
Peter Lawson: Our next question comes from Peter Lawson with Barclays. Your line is open. Great, thank you so much.
Sushil Patel: I wonder if you just talked through any of the gating factors that Sushil Patel, Kostas Xynos, Replimune Group Inc In terms of revenue guidance, I anticipate that we'll be providing metrics for you to track the success of the launch, including ultimately patient numbers and payers and we'll hold off on revenue guidance until further in into the law. Thank you.
Peter Lawson: Great. Thank you so much wonder if you could just talk through any of the gating factors that.
Peter Lawson: Just between now and the producer date, especially at CFC.
Peter Lawson: And then kind of your thoughts around.
Peter Lawson: Kind of learnings.
Peter Lawson: Earnings from skin care launches.
Peter Lawson: Thinking about.
Peter Lawson: Given our revenue guidance.
Peter Lawson: Thinking about market penetration. Thank you.
Peter Lawson: Yes, so I'll just take the first question as I mentioned earlier, we did complete our late cycle meeting and we did complete a factoring inspections, both a terminal facility, which does add process validation to analytical message and then the main message.
Peter Lawson: Manufacturing facility in framing them. So we feel we're well positioned there.
Peter Lawson: As you would imagine there was discussions on CMC and clinical questions at the late cycle meeting and we remain on track.
Peter Lawson: Yes.
Peter Lawson: In terms of revenue guidance I anticipate that we will be providing metrics for you to track that success the launch, including ultimately patient numbers on payers.
Peter Lawson: Hold off on revenue guidance until further into the launch.
Sushil Patel: 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.
Peter Lawson: Got it thank you.
Speaker Change: Kind of formal or informal feedback you've got from the FDA regarding I guess the manufacturing any other components there.
Speaker Change: Yes of course, we are under an active BLA review, we have completed the inspections and so there is a formal feedback associated with those inspections and none of that formal feedback should provide a bottleneck.
Sushil Patel: And none of that formal feedback should provide a bottleneck towards our July 22 to do Peter, thank you for the second question. You know, while there's been, you know, 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, 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.
Peter Lawson: Towards our July 22nd Party.
Peter Lawson: Yes.
Peter Lawson: Okay.
Peter Lawson: Okay. 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.
Peter Lawson: We know that today when patients progressed on a PD one let me start with PD, one therapy in frontline setting for them, they're 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.
Sushil Patel: When we talk to physicians in the community, 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 RP-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-day distribution off the shelf use of convenience, which again, really helps to support broad and rapid adoption once approved. Thank you.
Peter Lawson: When we talk to physicians in the community melanoma experts around the country when.
Peter Lawson: When they start up or start a patient on treatment and it's working well and its tolerated.
Peter Lawson: Tolerated well.
Peter Lawson: It will rarely remove that patient from treatment and so our position is that <unk> will be positioned as a first line option for patients who progressed on PD one therapy based upon our deep and durable response rates or safety profile and our next date distribution or off the shelf familiar ease of convenience, which again really helps to support broad in rapid <unk>.
Peter Lawson: Option once approved.
Peter Lawson: Thank you.
Peter Lawson: Yes.
Operator: I'm showing no further questions at this time.
Patel: Thank you I'm showing no further questions at this time I'd like to turn the call back over to <unk> Patel for closing remarks.
Sushil Patel: I'd like to turn the call back over to Sushil Patel for closing remarks. Thank you. So in summary, it's been a productive few months and with a very exciting inflection point as we prepare for our first approval and commercial launch with RP1. 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.
Peter Lawson: Thank you.
Peter Lawson: So in summary, it's been a productive few months and would a very exciting inflection point as we prepare for our first approval and commercial launch without people.
Peter Lawson: We look forward to our upcoming milestones, including data updates on that deep in vitro activity and safety of <unk>.
Peter Lawson: At our upcoming Investor day, and potential approval announcement.
Operator: Finally, I just want to acknowledge everyone at Replimune. 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. 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.
Speaker Change: Finally, I just want to acknowledge everyone at reputation 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.
Speaker Change: Thank you for joining our call today.
Speaker Change: Thank you for your participation. This does conclude the program and you may now disconnect everyone have a great day.
Speaker Change: Okay.
Speaker Change: [music].
Unknown Executive: Thank you for watching!