Q1 2025 Iovance Biotherapeutics Inc Earnings Call

May 8, 2025

We are in a listen only mode. After the speaker's presentation, there will be a question and answer session.

I'll ask a question during the session you will press star one on your telephone you.

We'll then hear an automated message advising your hand is raised.

To withdraw your question. Please press star one again.

Operator: At this time, all participants are in a listen-only mode.

[music].

Operator: After the speaker's presentation, there will be a question-and-answer session. To ask a question during this session, you will press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To draw your question, please press star 1 1 again.

Please be advised that today's conference is being recorded.

Speaker Change: I'd now like to hand, the conference over to your Speaker today, Sara Pellegrino SVP of IR and corporate Communications. Please go ahead.

Speaker Change: Good afternoon, and thank you for joining the <unk> conference call and webcast to discuss our first quarter 2025 financial results as well as recent corporate updates.

Good day, and thank you for standing by and welcome to the Io Van Biotherapeutics first quarter 2025 financial results Conference call.

Sara Pellegrino: Please be advised that today's conference is being I would now like to hand the conference over to your speaker today, Sara Pellegrino, SVP, IR, and Corporate Communications. Please go ahead.

At this time all participants are in a listen only mode.

Good friend: Good friend, though our interim Chief Executive Officer, and President, who will provide an introduction and focus on the U S commercial launch at AMETEK, Inc.

After the speaker's presentation, there will be a question and answer session.

Sara Pellegrino: Good afternoon, and thank you for joining the Iovance conference call and webcast to discuss our first quarter 2025 financial results, as well as recent corporate updates.

Ask a question during the session you will depress star one on your telephone.

Speaker Change: Including revenue and revenue got it.

Speaker Change: Yeah, Dan Kirby Chief commercial officer will discuss the impact of the commercial launch Dr. Igor Balinsky, our Chief operating officer, who will provide a manufacturing update John Mark Benjamin Our CFO will review, our financial results, including revenue and revenue guidance gross margin and cash burn guidance and Dr.

We'll then hear an automated message advising their hand as rates.

To withdraw your question. Please press star one again.

Frederick Vogt: Dr. Fred Vogt, our Interim Chief Executive Officer and President, will provide an introduction and focus on the U.S. commercial launch of Amtagby, including revenue and revenue guidance. Dan Kirby, Chief Commercial Officer, will discuss the Amtagby commercial launch.

Please be advised that today's conference is being recorded.

Speaker Change: I would now like to hand, the conference over to your speaker today, Sara Pellegrino SVP of IR and corporate Communications. Please go ahead.

Speaker Change: Fredrik Finkelstein, our Chief Medical Officer will summarize key pipeline program.

Speaker Change: Good afternoon, and thank you for joining the <unk> conference call and webcast to discuss our first quarter 2025 financial results.

Igor Bilinsky: Dr. Igor Bilinsky, our Chief Operating Officer, will provide a manufacturing update.

Speaker Change: Additional members of our leadership team, including Dr. Raj Perry, our Chief Regulatory Officer, Dr. Bryan Johnson, our EVP of medical affairs will be available for the Q&A session.

John Mark Belliman: John Mark Belliman, our CFO, will review our financial results, including revenue and revenue guidance, gross margin and cash burn guidance.

Well as recent corporate updates.

Doctor Friends: Doctor Friends are <unk>, Chief Executive Officer and President.

Frederick Finckenstein: And Dr. Frederick Finckenstein, our Chief Medical Officer, will summarize key pipeline programs. Additional members of our leadership team, including Dr. Raj Puri, our Chief Regulatory Officer, Dr. Brian Gastman, our EVP of Medical Affairs, will be available for the Q&A session.

Doctor Friends: And introduction and focus on the U S commercial launch of Amazon, including revenues and revenue guidance.

Speaker Change: Earlier. This afternoon, we issued a press release it is available on our corporate website at <unk> Dot com.

Doctor Friends: Yeah, Dan Kirby Chief commercial officer.

Speaker Change: Before we start I would like to remind everyone that statements made during this conference call will include forward looking statements regarding IOM School business focus is this plant and transaction.

Doctor Friends: <unk> commercial launch.

Speaker Change: Dr. Igor Wolinsky, our Chief operating officer, who will provide manufacturing I E.

Speaker Change: John Marc Mehlman, CFO review, our financial results.

Sara Pellegrino: Earlier this afternoon, we issued a press release that is available on our corporate website at iovance.com. Before we start, I would like to remind everyone that statements made during this conference call will include forward-looking statements regarding Iovance's goals, business focus, business plans and transactions, revenue and revenue guidance, commercial activities, clinical trials and results, regulatory approvals and interactions, plans and strategies, research and preclinical activities, potential future applications of our technologies, manufacturing capabilities.

Speaker Change: <unk> revenue guidance commercial activities clinical trials and results regulatory approvals and interaction plans and strategies research and preclinical activity and potential future applications of our technologies manufacturing capabilities.

Speaker Change: Revenue gross margin and cash burn guidance.

Speaker Change: And Dr. Frederic Finkelstein, our Chief Medical Officer will summarize key pipeline programs.

Speaker Change: Additional members of our leadership team, including Dr. Raj Perry, our Chief Regulatory Officer, Dr. Brian Johnson, our EVP of medical affairs will be available for the Q&A session.

Speaker Change: Regulatory feedback and guidance payer interaction licenses in collaboration cash provision and expense guidance and future updates.

Speaker Change: Forward looking statements are subject to numerous risks and uncertainties many of which are beyond our control, including the risks and uncertainties described from time to time in our SEC filings.

Speaker Change: Earlier this afternoon.

Speaker Change: That release is available on our corporate website at <unk> Dot com.

Speaker Change: Before we start I would like to remind everyone that statements made during this conference call will include forward looking statements regarding island gold and this focus is this plant in transaction revenue and revenue guidance commercial activities clinical trials and results regulatory approvals and interaction plans in.

Sara Pellegrino: Regulatory Feedback and Guidance, Payer Interaction, Licenses and Collaboration, Cash Position and Expense Guidance, and Future Updates. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time to time in our SEC filing. Our results may differ materially from those projected during today's call.

Speaker Change: Our results may differ materially from those projected during today's call. We undertake no obligation to publicly update any forward looking statements with that I will turn the call over to Craig.

Craig: Thank you Sarah and welcome to the <unk> first quarter 2025 conference call.

Speaker Change: Strategies research and preclinical activity and potential future applications of our technologies manufacturing capabilities.

Craig: We're four quarters into our U S launch, we unpack the first FDA approved till cell therapy is the first treatment for patients with advanced melanoma.

Sara Pellegrino: We undertake no obligation to publicly update any forward-looking statement.

Frederick Vogt: With that, I will turn the call over to Fred. Thank you, Sara. Welcome to the Iovance first quarter 2025 conference. We are four quarters into our U.S. launch of EMPAGNY, the first FDA-approved tilt-cell therapy and the first treatment for patients with advanced melanoma who progress following anti-P1 treatment and, if appropriate, targeted therapy. In the first 12 months of our U.S. launch, we've executed towards our long-term goal Adoption Goals that generated more than $210 million in revenue. This includes infusions from nearly 300 Ampagni patients in the first launch year, starting with our first infusions in April of 2024.

Craig: Following anti PD, one treatment to have appropriate targeted therapy and the.

Speaker Change: Regulatory feedback and guidance payer interaction licenses in collaboration cash position, an expense guidance and future updates.

Craig: First 12 months of our U S launch, we execute towards our long term goal.

Craig: Adoption goal to generate more than $210 million in revenue.

Craig: This includes infusions from nearly 300 impact patients in the first launch here starting with our first infusions in April 2024.

Craig: Total first quarter product revenue was $49 $3 million, including $43 $6 million for more than 80 impact infusions.

Craig: With $7 million from public and sales.

Brad: Thank you Sarah and welcome to the <unk> first quarter 2025 conference call.

Craig: Following the steady growth throughout 2024 revenue was lower in the first quarter of this year drove by three key contributors.

We're four quarters into our U S launch, we unpack the first FDA approved cell therapy, and the first treatment for patients with advanced melanoma.

Frederick Vogt: Total first quarter product revenue is $49.3 million, including $43.6 million from more than 80 antibiotic infusions and $5.7 million from prolucent sales.

Craig: First our internal manufacturing facility the ICT Sea completed annual scheduled maintenance in December of last year as we previously discussed on last quarter's call.

Brad: Following anti PD, one treatment and if appropriate targeted therapy.

Frederick Vogt: Following steady growth throughout 2024, revenue was lower in the first quarter of this year, driven by three key contributors. First, our internal manufacturing facility, the ICTC, completed annual scheduled maintenance in December of last year, as we previously discussed on last quarter's call. As a result of limited production starts for multi-week end tagging manufacturing across our network, capacity was reduced by more than half for about one month. In addition, volume was impacted by higher rates of patient drop-offs and lower manufacturing success rates, but has since rebounded.

As a result of limited production starts from multi weekend pegged manufacturing across our network capacity was reduced by more than half for about one month.

Brad: The first 12 months of our U S launch, we execute towards our long term goal.

Brad: <unk> goal is to generate more than $210 million in revenue.

Craig: In addition volume was impacted by higher rates of patient drop off and lower manufacturing success rates, but has since rebounded.

Brad: This includes infusions from nearly 300 impact patients in the first launch years, starting with our first infusions in April 2024.

Craig: We are seeing healthy demand with a record number of production starts in the second quarter.

Brad: Total first quarter product revenue was $49 $3 million, including $43 $6 million for more than 80 Mpeg infusions.

Craig: Lower produce proleukin sales were the second factor contributing to the lower first quarter revenue.

Craig: We expect two of the three largest viewership our wholesalers to start replenishing proleukin in line with growing and highly demanded second quarter.

Brad: $7 million from Proleukin sales.

Brad: Following steady growth throughout 2024 revenue was lower in the first quarter of this year drove by three key contributors.

Frederick Vogt: Today we are seeing healthy demand with a record number of production starts in the second quarter. Lower Per Lucan sales are the second factor contributing to lower first quarter revenue. We expect two of the three largest U.S. ship wholesalers to start replenishing Prolucan in line with growing MTAVI demand in the second quarter. We're also growing other components of our franchise, including sales of Proluc in the third parties for use with manufacturing. The third contributor to the first quarter revenue was the variable pace at which ATCs began treating patients. has just differed from center to center.

Craig: We're also growing the other components of our franchise, including sales of Probuphine to third parties for use with manufacturing clinical research.

Brad: First our internal manufacturing facility the ICT Sea completed annual scheduled maintenance in December of last year as we previously discussed on last quarter's call.

Craig: There've been attributed in the first quarter revenue was the variable payout, which atc's began treating patients.

Brad: As a result of limited production starts for multi week impact manufacturing across our network.

Craig: This differs from center to center.

Craig: For context, 60% of Atc's are treated more than 10 patients.

Brad: <unk> was reduced by more than half for about one month.

Craig: The ACC to have ample room to grow and we anticipate near term contributions from Atc's that came online in the latter half of 2024 into 2025.

Brad: In addition volume was impacted by higher rates of patient drop off and lower manufacturing success rates, but has since rebounded.

Brad: Today, we are seeing healthy demand with a record number of production started in the second quarter.

Craig: We're also confident in our growth prospects under our new Chief Commercial Officer, Dan Kirby.

Brad: Lower produce proleukin sales were the second factor contributing to lower first quarter revenue.

Frederick Vogt: For context, 16% of ATCs have treated more than 10 patients.

Craig: Dan brings in valuable leadership experience in cell therapy commercial organization since the earliest developments in the field.

Frederick Vogt: Our ATCs have ample room to grow and we anticipate near-term contributions from ATCs that came online in the latter half of 2024 into 2025.

Brad: We expect two of the three largest U S wholesalers to start replenishing proleukin in line with growing and highly demanded second quarter.

Craig: Most of the three months data is already strengthening our commercial operations to drive EDC adoption and amplify earlier community referrals, where agency networks.

Brad: We're also growing the other components of our franchise, including sales of Probuphine to third parties for use with manufacturing and clinical research.

Frederick Vogt: We were also confident in our growth prospects under our new chief commercial officer Dan Kirby. Dan brings invaluable leadership experience in self-therapy commercial organizations since the earliest developments in the field. Less than three months, Dan is already strengthening our commercial operations to drive ADC adoption and amplify earlier community referrals to our ADC network. The commercial team is working aggressively to implement key learnings from the first year as we continue to execute our U.S. launch. We are also excited about upcoming milestones related to our X-U.S. launch expansion and pipeline development to lung cancer and beyond. We anticipate three potential approvals for Amtag via the United Kingdom, Canada and the European Union.

Craig: The commercial team is working aggressively to implement key learnings from the first year as we continue to execute our U S launch.

Brad: Certain attributed in the first quarter revenue was the variable piece of it which atc's began treating patients.

Craig: We're also excited about upcoming milestones related to our ex U S launch expansion and pipeline development for lung cancer and beyond.

Brad: This differs from center to center for.

Brad: For context, 60% of Atc's treated more than 10 patients.

Craig: We anticipate three potential approvals for <unk> in the United Kingdom, Canada, and the European Union and additional regulatory submissions are also underway in Australia and Switzerland.

Brad: Our adcs have ample room to grow and we anticipate near term contributions from ATC that came online in the latter half of 2024 into 2025.

Craig: We are on track to report updated data from our Registrational trial uplift Luzon previously treated advanced non small cell lung cancer and.

Brad: We're also confident in our growth prospects under our new Chief Commercial Officer, Dan Kirby.

Dan brings in valuable leadership experience in cell therapy commercial organization since the earliest development of the field.

Craig: The first clinical data in endometrial cancer.

Craig: And we continue to advance our robust pipeline of next generation wholesale therapies for patients with solid tumors.

Frederick Vogt: Additional regulatory submissions are also underway in Australia and Switzerland. We are on track to report updated data from our registrational trial of lipolysis on previously treated advanced non-small cell lung cancer and first clinical data in endometrial cancer. We continue to advance our robust pipeline of next generation toll cell therapies for patients with solitude.

Brad: Most of the three months data is already strengthening our commercial operations to drive EDC adoption and amplify earlier community referrals to our agency network.

Craig: Looking ahead I'll briefly comment on our revised full year revenue guidance of cash spend outlook.

Brad: The commercial team is working aggressively to implement key learnings from the first year as we continue to execute our U S launch.

Craig: We revised our guidance to between.

Craig: $250 and $300 million in total product revenue for the full year of 2025.

Brad: We're also excited about upcoming milestones related to our ex U S launch expansion and pipeline development to lung cancer and beyond.

Craig: We considered our experience with growth trajectories of Ptc's timelines for <unk> to begin treating their first patients.

Frederick Vogt: Looking ahead, I will briefly comment on our revised full-year revenue guidance and cash spend outlook. We revised our guidance to between $250 and $300 million in total product revenue for the full year 2025. We consider our experience with growth trajectories at the ATCs, timelines for new ATCs to begin treating their first patients. and expectations for large community practices and community referrals to drive momentum in the second half of 2025. These demand trends are consistent with the trajectory of other cell therapy launches moving from year one to year two. After aligning our manufacturing slot plans with our new demand forecast, we are maintaining our prior cash only guidance in the second half of 2020.

Brad: We anticipate three potential approvals for <unk> in the United Kingdom, Canada, and the European Union and additional regulatory submissions are also underway in Australia and Switzerland.

Craig: And expectations for larger community practice as a community referrals to drive momentum in the second half of 2025.

Craig: These demand trends are consistent with the trajectory of other cell therapy margins moving from your once a year or two.

Brad: We are on track to report updated data from our Registrational trial like Luzon previously treated advanced non small cell lung cancer.

Craig: After aligning our manufacturing slot plans with our new demand forecast, we are maintaining our prior cash runway guidance into the second half of 2026.

Brad: The first clinical data in endometrial cancer.

Brad: And we continue to advance our robust pipeline of next generation wholesale therapies for patients with solid tumors.

Craig: We remain confident in our peak sales opportunity of more than $1 billion in the U S and more than $2 billion globally for Mpeg we in the current approved indications.

Brad: Looking ahead I'll briefly comment on our revised full year revenue guidance of cash spend outlook.

We also continue to expect that gross margin can exceed 70% in the coming years.

Brad: We revised our guidance to between.

Brad: $250 and $300 million in total product revenue for the full year 2025.

Craig: And tagging and Proleukin are showing steady growth in the second quarter and will accelerate in the second half of the year <unk>.

Frederick Vogt: We remain confident in a peak sales opportunity of more than a billion dollars in the U.S. and more than two billion dollars globally for Ampeg being the current approved indication. We also continue to expect the gross margin can exceed 70% in the coming years. And Pagli and Perlucan are showing steady growth in the second quarter and will accelerate in the second half of the year. Her momentum is strong and we project between 100 and 110 commercial patient infusions in the second quarter. We're also motivated by positive feedback from key opinion leaders and patient success stories that reinforce the unmet medical need and value of MTAG.

Brad: We consider our experience with growth trajectory the accs timelines for new ATC is to begin treating their first patients.

Craig: Our momentum is strong and we project between 100 and 110 commercial patient infusions in the second quarter.

Brad: And expectations for large community practices the community referrals to drive momentum in the second half of 2025.

Craig: We're also motivated by positive feedback from key opinion leaders and patient success stories at reinvest reinforce the unmet medical need and value of impact.

Brad: These demand trends are consistent with the trajectory of other cell therapy margins moving from you for your once a year or two.

Craig: On a macro level of Zika will describe we are well prepared to supply ongoing demand delivered commercial impact as well as our investigational til products to patients around the world.

Brad: After aligning our manufacturing slot plans with our new demand forecast, we are maintaining our prior cash runway guidance into the second half of 2026.

Craig: <unk> is competitively positioned with a fully U S based patent portfolio and manufacturing network.

Brad: We remain confident in our peak sales opportunity of more than $1 billion in U S and more than $2 billion globally for Mpeg we in the current approved indications.

Craig: Actually I haven't minimal impact on Mpeg proleukin.

Igor Bilinsky: On a macro level, as Igor will describe, we are well prepared to supply ongoing demand to deliver commercial end-to-end media, as well as our investigational teleproducts to patients around the world.

Craig: I'm happy to go into more detail during the Q&A I will now turn the call to being perfect for a detailed commercial launch update.

Brad: We also continue to expect that gross margin can exceed 70% in the coming years.

Brad: And tagging and Proleukin are showing steady growth in the second quarter and will accelerate in the second half of the year <unk>.

Igor Bilinsky: Iovance is competitively positioned with a fully U.S.-based patent portfolio in manufacturing that Our show should have a minimal impact on antagony and proletarianism.

Speaker Change: Thank you Fred.

Speaker Change: My first 90 days of Iron Man I'm excited about the potential for <unk> to benefit patients around the world.

Brad: Our momentum is strong and we project between 100 and 110 commercial patient infusions in the second quarter.

Speaker Change: <unk> identified the strength of our launch as well as opportunities to optimize adoption and accelerate growth.

Dan Kirby: I'm happy to go into more detail during the Q&A and will now turn the call to Dan Kirby for a detailed commercial launch update. Thank you, Fred. Following my first 90 days at Ioman, I'm excited about the potential for antagony to benefit patients around the world. I've identified strengths of our launch, as well as opportunities to optimize adoption and accelerate growth. And Tag Me is a game-changer for patients who have failed first-line treatment in the and Peggy is also the first cell therapy for patients with solid tumor.

Brad: We're also motivated by positive feedback from key opinion leaders and patient success stories at reinvest reinforce the unmet medical need and value of impact.

Speaker Change: And <unk> is a game changer for patients who have failed first line treatment of melanoma.

Speaker Change: <unk> is also the first cell therapy for patients with solid tumor cancers.

Eager: On a macro level as eager will describe we are well prepared to supply ongoing demand deliberate commercial impact as well as our investigational til products to patients around the world.

Speaker Change: I'll begin with my observations of what it is going well.

Speaker Change: First I'm very impressed by our competent and dedicated commercial organization and cross functional teams. These teams has established.

Eager: <unk> is competitively positioned with a fully U S based patent portfolio and manufacturing network.

Speaker Change: Actually I haven't been oil and patent on Untagged and Proleukin.

Speaker Change: Let's foundation foreign tangy by building awareness of the unmet need in advanced melanoma and strong clinical profile of them Tagme.

Speaker Change: I'm happy to go into more detail during the Q&A I will now turn the call to <unk> for a detailed commercial launch update.

Dan Kirby: I'll begin with my observations of what is going well. First, I'm very impressed by our competent and dedicated commercial organization and cross-functional field. These teams have established a solid foundation for MTAGV by building awareness of the unmet need in advanced melanoma and strong clinical profile of MTAGV, activating our 70 ATCs within our treatment network and preparing for the next wave of new centers. Securing early inclusion in the NCCN guidelines and favorable reimbursement access for more than 95% of U.S. covered lines.

Speaker Change: Our 70% <unk> within our treatment network and preparing for the next wave of new centers.

Speaker Change: Thank you Fred.

Speaker Change: Following my first 90 days of Iron Man I'm excited about the potential for <unk> to benefit patients around the world.

Speaker Change: Securing early inclusion in the <unk> guidelines and favorable reimbursement access for more than 95% of U S covered lives.

Speaker Change: I have identified the strength of our launch as well as opportunities to optimize adoption and accelerate growth in.

Speaker Change: As a result of this execution and tight it's a successful cell therapy, the first of its kind and.

Speaker Change: <unk> is a game changer for patients who have failed first line treatment of melanoma.

Speaker Change: And <unk> is also the first cell therapy for patients with solid tumor cancers.

Speaker Change: In solid tumors.

Speaker Change: Today, I will discuss status in near term initiatives to improve our performance across three key areas.

I'll begin with my observations of what is going well.

Speaker Change: First I'm very impressed by our competent and dedicated commercial organization and cross functional teams. These teams has established a solid foundation for <unk> by building awareness of the unmet need in advanced melanoma and strong clinical profile of them Tagme.

Speaker Change: First our ATC network expansion and retention strategy to drive adoption.

Dan Kirby: As a result of this execution, M-Type B is a successful cell therapy, the first of its kind in cell tumors.

Speaker Change: A second area to address the plans to remap engagements with medical Oncologists to guide earlier consideration for Integra.

Dan Kirby: Today, I will discuss status and near-term initiatives to improve our performance across three key areas. First, our ATC network expansion and retention strategy to drive adoption. The second area is to address plans to revamp engagements with medical oncologists to guide earlier consideration for intact. And the third area is to further establish antagony within the U.S. community and policy. I'll start with our ATC strategy. In the first year of launch, we strategically prioritized 70 experienced cell therapy centers and most of the major cancer centers. nearly all currently treated melanoma patients and are within a two-hour drive of these ATCs.

Speaker Change: And the third area is to further establish that tagged within the U S community oncology networks.

Speaker Change: Activating our 70 atc's within our treatment network and preparing for the next wave of new centers.

Speaker Change: I'll start with our ATC strategies.

Speaker Change: Securing early inclusion in the NCC and guidelines and favorable reimbursement access for more than 95% of U S covered lives.

Speaker Change: In the first year of launch we strategically prioritize 70 experienced cell therapy centers and most of the major cancer centers.

Speaker Change: As a result of this execution and tight it's a successful cell therapy the <unk>.

Speaker Change: Nearly all currently treated melanoma patients that are within a two hour drive of these ATC.

Speaker Change: First of its kind and.

Speaker Change: In solid tumors.

Speaker Change: Current metrics amongst these 70 centers, demonstrating ample growth performance and potential for amtech.

Speaker Change: Today, I will discuss status in near term initiatives to improve our performance across three key areas.

Speaker Change: 79% or 56%.

Speaker Change: First our ATC network expansion and retention strategy to drive adoption.

Speaker Change: I've completed tumor resection, the starting material for til manufacturing.

Speaker Change: 69% or 48.

Speaker Change: A second area to address the plans to remap engagements with medical oncologists to guidance earlier consideration for amtech.

Speaker Change: Having to choose one or more patients.

Dan Kirby: Current metrics amongst these 70 centers demonstrate ample growth performance and potential for impact. 79% or 56%. have completed tumor resection, the starting material for tail manufacturing. 69% or 48 ADCs have infused one or more patients. and 16% or 11 ADCs have infused more than 10. ADC adoption is tracking in the right direction. We expect additional growth from the early launch centers with strong and steady patient Numerous centers, activated later in the launch, are currently contributing as they gain experience. For the next set of ATCs, we are currently in the process of activating more than ten select high quality centers, including those aligned to large community networks that have premier access to patients needing antigen as their second line treatment.

Speaker Change: And 16% or 11%.

Speaker Change: Infuse more than temptation.

Speaker Change: And the third area is to further establish that tagged within the U S community oncology networks.

Speaker Change: <unk> adoption is tracking in the right direction.

Speaker Change: We expect additional growth from the early launch centers with strong and steady patient volume.

Speaker Change: I'll start with our ATC strategies.

Speaker Change: In the first year of launch we strategically prioritize 70 experienced cell therapy centers and most of the major cancer centers.

Speaker Change: Newer centers activated later in the launch are currently contributing as they gain experience.

Speaker Change: For the next set of Atc's. We are currently in the process of activating more than 10 select high quality centers, including those aligned to large community networks that have premier access to patients meeting in Titan as their second line treatment.

Speaker Change: Nearly all currently treated melanoma patients and are within a two hour drive of these ATC.

Speaker Change: Current metrics amongst these 70 centers, demonstrating ample growth performance and potential franchisees.

Speaker Change: 79% or 56%.

Speaker Change: This next set of Atc's reflects lessons learned best practices and the characteristics of distinguish our top performing atc's, whilst specifically incorporating clinic referral patterns.

Speaker Change: I've completed tumor resection, starting material for til manufacturing.

Speaker Change: 89% or 48.

Speaker Change: Choose one or more patients and.

Speaker Change: 16% or eliminate having to use more than 10 patients.

Meanwhile, we continuously collaborate with all of our activities to support early referrals and best practices for procuring tumor samples.

Speaker Change: You see adoption is tracking in the right direction.

Dan Kirby: This next set of ADCs reflects lessons learned, best practices, and the characteristics that distinguish our top performing ADCs, while specifically incorporating clinic referral patterns. Meanwhile, we continuously collaborate with all of our active ATCs to support early referrals and best practices for procuring tumor samples.

Speaker Change: We expect additional growth from the early launch centers with strong and steady patient volume.

Speaker Change: As we prepare to commercialize <unk> beyond the U S.

Speaker Change: Newer centers activated later in the launch are currently contributing as they gain experience.

Speaker Change: 10 international treatment centers are in process to become a DTC for our planned launches in the United Kingdom, Canada and Europe.

Speaker Change: For the next set of <unk>. We are currently in the process of activating more than 10 select high quality centers, including those aligned to large community networks that have premier access to patients meeting in Titan as their second line treatment.

Speaker Change: We remain on track to onboard 15 international centers.

Speaker Change: <unk> by year end.

Dan Kirby: As we prepare to commercialize Intaki beyond the U.S. Ten international treatment centers are in process to become ATCs for our planned launches in the United Kingdom, Canada, and Europe. We remain on track to onboard 15 international centers as ATPs by year.

Speaker Change: Turning to the second area of focus we have made and our goal in the last three months to better understand our physicians and how they view antagonist and.

Speaker Change: This next set of Atc's reflects lessons learned best practices and the characteristics that distinguish our top performing <unk>.

Speaker Change: And the initial launch the team did a great job of educating the cell therapy community and key medical oncologists on the benefits of <unk>.

Speaker Change: While specifically incorporating clinic referral patterns.

Dan Kirby: Turning to the second area of focus, we have made it our goal in the last three months to better understand our physicians and how they view antibiotics. In the initial launch, the team did a great job of educating the cell therapy community and key medical oncologists on the benefits of Entagny. From our market research, we see that those physicians view Entagny as second-line treatment. We also saw that there is a disconnect in MTAGV treatment sequencing between our initial target physicians, who view MTAGV as a second-line treatment, and referring medical oncologists in the community who consider MTAGV as a third-liner later in therapy.

Speaker Change: Meanwhile, we continuously collaborate with all of our activities to support early referrals and best practices for procuring tumor samples.

Speaker Change: And from our market research, we see that those physicians viewing pagni as second line treatment.

Speaker Change: We also saw that there was a disconnect in NTIC treatment sequencing between our initial target physicians, who view <unk> as a second line treatment and referring medical oncologists in the community who consider amtech. This third line or later in therapy. This is a large market opportunity for <unk>.

Speaker Change: As we prepare to commercialize <unk> beyond the U S.

Speaker Change: 10 international treatment centers are in process to become a DTC for our planned launches in the United Kingdom, Canada and Europe.

Speaker Change: We remain on track to onboard 15 international centers.

Speaker Change: Our number one goal is to establish contact via a D preferred option for all appropriate patients.

Speaker Change: <unk> by year end.

Speaker Change: Turning to the second area of focus we have made it our goal in the last three months to better understand our physician and how they view antagonist.

Speaker Change: And we are educating referring medical oncologists to consider them tightening early and bring forward the promise of cell therapy within current solid tumor treatment practices.

Dan Kirby: This is a large market opportunity for MTAGV. Our number one goal is to establish Intaglia as the preferred option for all appropriate patients. To this end, we are educating and referring medical oncologists to consider MTAG-B early and bring forth the promise of cell therapy within current solid tumor treatment practices. We have a sizable patient population, and we have a tremendous potential to drive earlier patient referrals to our agency. For example, a portion of our ATC, a portion of patients who initiate the MTAGV journey die or enter hospice prior to surgery, shortly after committing to MTAGV.

Speaker Change: And the initial launch the team did a great job of educating the cell therapy community and key medical oncologists on the benefits of <unk>.

Speaker Change: We have a sizable patient population.

Speaker Change: And we have a tremendous potential to drive earlier patient referrals to our ATC.

From our market research, we see as those physicians viewing pagni as second line treatment.

Speaker Change: For example, a portion of our ATC unfortunate patients who initiated in Tagme journey dire Inter hospital prior to surgery. Shortly after committing to amtech. This is due to late referrals in the community.

Speaker Change: We also saw that there is a disconnect and in cagny treatment sequencing between our initial target physicians, who view anti via the second line treatment and referring medical oncologists in the community who consider anti bps third line or later this.

Speaker Change: This is a large market opportunity for <unk>.

Speaker Change: Our number one goal is to establish contact via a D preferred option for all appropriate patients.

Speaker Change: To do this we will educate practitioners on the benefits of durable responses with onetime cell therapy, like <unk> versus temporary responses and ongoing side effects seen with other treatments.

Dan Kirby: This is due to late referrals in the community. With our updated plans, we are doubling down on initiatives and medical education efforts with community medical oncologists so we can drive earlier patient referrals and shift the treatment sequence. To do this, we will educate practitioners on the benefits of durable responses with one-time cell therapies like mTagV versus temporary responses and ongoing side effects seen with other treatments. We will roll out new disease state educational efforts and amplify our presence at relevant medical meetings to provide a better understanding around till and cell therapy.

Speaker Change: And we are educating referring medical oncologists to consider him tightening early and bring forward the promise of cell therapy within current solid tumor treatment practices.

Speaker Change: We will rollout new disease state educational efforts and amplify our presence at relevant relevant medical meetings to provide a better understanding around <unk> and cell therapy.

Speaker Change: We have a sizable patient population.

Speaker Change: And we have a tremendous potential to drive earlier patient referrals to our ATC.

Speaker Change: For example, a portion of our ACC unfortunate patients who initiated in Tagme journey.

Speaker Change: For the first time in advanced melanoma, and solid tumors, a cell therapy may from a patients own immune cells has been shown to induce long term benefit with curative intent.

Speaker Change: And our hospice prior to surgery shortly after committing to amtech.

Speaker Change: This is due to late referrals in the community with.

Speaker Change: With our updated plans, we are doubling down on initiatives and medical education effort when community medical oncologists. So we can drive earlier patient referrals and shifts the treatment sequence.

Speaker Change: For the third area of focus we are building relationships within community oncology networks that treat our target <unk> patient.

Dan Kirby: For the first time in advanced melanoma and solid tumors, a cell therapy made from a patient's own immune cells has been shown to induce long-term benefit with curative intent. For the third area of focus, we are building relationships within community oncology networks that treat our target MTAG-B patients. We are expanding resources within our community field team to increase frequencies, speed, and overall timelines for referrals and to identify new ATC targets. Recently, we have seen increased momentum for patient referrals to current APCs and identified new APCs. Since my arrival, we've engaged with executive leadership in every major U.S.

Speaker Change: We're expanding resources within our community field team to increase frequency speed and overall timelines for referrals and to identify new ATC targets.

Speaker Change: To do this we will educate practitioners on the benefits of durable responses with onetime cell therapy, like MTV versus temporary responses and ongoing side effects seen with other treatments.

Speaker Change: Recently, we have seen increased momentum for patient referrals to current adcs.

Speaker Change: And identified new ATC.

Speaker Change: Since my arrival, we've engaged with executive leadership in every major U S community cancer network.

Speaker Change: We are now collaborating with the top U S community clinic networks to identify an onboard several preferred centers for amtech.

Speaker Change: For the first time in advanced melanoma, and solid tumors, a cell therapy may from a patients own immune cells has been shown to induce long term benefit with curative intent.

Speaker Change: We are also focused on breaking down any remaining access barriers to adoption for.

Speaker Change: For the third area of focus we are building relationships within community oncology networks that treat our target <unk> patient.

Speaker Change: For example, we are exploring alternative distribution channels that may offer flexibility and broader acceptance of onetime therapies like a technique, while maintaining our current pricing strength.

Dan Kirby: community cancer network. We are now collaborating with the top U.S. community clinic networks to identify and onboard several preferred centers for MTAG. We are also focused on breaking down any remaining access barriers to adopt. For example, we are exploring alternative distribution channels that may offer flexibility and broader acceptance of one-time therapies like entechni, while maintaining our current pricing strength.

Speaker Change: We are expanding resources within our community field team to increase frequency speed and overall timelines for referrals and to identify new ATC targets.

Speaker Change: In addition to impacting our commercial organization is dedicated to supporting Proleukin across three key business lines.

Speaker Change: Recently, we have seen increased momentum for patient referrals to current <unk>.

Speaker Change: Use within Taghavi used in manufacturing and clinical use.

Speaker Change: And identified new Whitney Pcs.

Speaker Change: Aside from the main business tied to impacting manufacturing and clinical use represented an existing base revenue for my.

Speaker Change: Since my arrival, we've engaged with executive leadership in every major U S community cancer network. We are now collaborating with a top U S community clinic networks to identify an onboard several preferred centers for amtech.

Dan Kirby: In addition to MTagVie, our commercial organization is dedicated to supporting ProLukin across three key business models. Use with the Antagony, Use in Manufacturing, and Clinical Use. Aside from the main business tied to OTAGV, manufacturing and clinical use represent an existing base revenue for ProLuca. My team is focusing on opportunities to increase sales growth in all three areas. As Fred mentioned, Strong Public and Sales on our main channel will resume throughout the remainder of 2025, including two distributors expected to reorder in the second quarter.

Speaker Change: My team is focusing on opportunities to increase sales growth in all three areas.

Speaker Change: As Fred mentioned strong <unk> sales in our main channel will resume throughout the remainder of 2025, including two distributors expecting to reorder in the second quarter.

Speaker Change: We are also focused on breaking down any remaining access barriers to adoption.

Speaker Change: In summary, I am.

Speaker Change: Energized to lead our commercial organization toward a bright future.

Speaker Change: Switching a first in class therapy entails a unique set of opportunities to make a fundamental difference.

Speaker Change: In addition to impacting our commercial organization is dedicated to supporting Proleukin across three key business lines used within taghavi used in manufacturing and clinical use.

Speaker Change: I'm deeply committed to the <unk> vision of pioneering a new treatment paradigm for physicians, who treat patients with solid tumors.

Dan Kirby: In summary, I am energized to lead our commercial organization toward a bright future. Launching a first in-class therapy entails a unique set of opportunities to make a fundamental difference. I am deeply committed to the Iovance vision of pioneering a new treatment paradigm for physicians who treat patients with solid tumors.

Speaker Change: We have barely scratched the surface of the protagonist potential globally address more than the 330000 melanoma patients.

Speaker Change: Aside from the main business tied to impacting manufacturing and clinical use represented an existing base revenue for <unk> My.

Speaker Change: And <unk> has tremendous promise in solid tumor cancers, which represent 90% of all cancers.

Speaker Change: My team is focusing on opportunities to increase sales growth in all three areas.

Speaker Change: I will now pass the call to Ibama Lynskey, our chief operating officer to highlight our manufacturing progress.

Dan Kirby: We have barely scratched the surface of this technique's potential to globally address more than 30,000 melanoma patients annually.

Speaker Change: Fred mentioned strong product sales in our main channel will resume throughout the remainder of 2025, including two distributors expected to reorder in the second quarter.

Ibama Lynskey: Thank you Don.

Speaker Change: Today, I will provide an update on our progress in many sectors.

Igor Bilinsky: And Tagge has tremendous promise in solid tumor cancers to represent 90% of all I will now pass the call to Igor Malinsky, our Chief Operating Officer, to highlight our manufacturing process. Thank you Dan. Today I will provide an update on our progress in manufacturing. Our Philadelphia-based manufacturing network consists of two FDA-approved facilities, our internal manufacturing facility, the Iovance Cell Therapy Center, or ICTC, and an American-owned contract manufacturer. This network serves commercial patients in the U.S. as well as clinical trial patients across Europe, Australia, and Asia. Our experience in supplying tilt-cell therapies to clinical patients around the world provides a strong foundation for delivering commercial products in the EU, UK and Canada in the near term.

Speaker Change: In summary, I am.

Speaker Change: Our Philadelphia based manufacturing network consists of two.

Speaker Change: Energized to lead our commercial organization toward a bright future.

Speaker Change: Facilities, our internal manufacturing facility.

Speaker Change: Launching a first in class therapy entails a unique set of opportunities to make a fundamental difference.

Speaker Change: Therapist, ICC and an American owned contract manufacture.

Speaker Change: I'm deeply committed to the <unk> vision of pioneering a new treatment paradigm for physicians, who treat patients with solid tumors.

Speaker Change: This network serves commercial patients in the U S as well as clinical trial patients across Europe, Australia and Asia.

Speaker Change: We have barely scratched the surface of the protagonist potential globally address more than the 330000 melanoma patients.

Speaker Change: While we experienced disappointing tilt cell therapies to clinical patients around the world provides a strong foundation, while delivering commercial product.

Speaker Change: And <unk> has tremendous promise in solid tumor cancers, which represent 90% of all cancers.

Speaker Change: UK and Canada in the near term.

Speaker Change: Today I'm pleased to report that a major step forward in the ongoing review of a marketing authorization application or MAA for the.

I will now pass the call to Ebore Malinski, our chief operating officer to highlight our manufacturing progress.

Ebore Malinski: Thank you Dan.

Speaker Change: European Union approval.

Speaker Change: Today, I will provide an update on our progress in manufacturing.

Speaker Change: Recently as part of the M&A process.

Speaker Change: Our Philadelphia based manufacturing network consists of two FDA approved facilities, our internal manufacturing facility OIBDA in cell therapy.

Speaker Change: Medicines agency or EMA inspected and confirmed the ICC coal contract manufacturer's facility are both GMP compliant.

Igor Bilinsky: Today, I'm pleased to report a major step forward in the ongoing review of our Marketing Authorization Application, or MAA, for the European Union approval of Amtagni. Recently, as part of the MAA process, the European Medicines Agency, or EMA, inspected and confirmed that the ICTC and our contract manufacturer facility are both GMT-compliant. These successful EMA inspections further validate our manufacturing network capabilities to meet regulatory standards from multiple health care authorities as we prepare to serve commercial patients in the European Union. As part of the ongoing launch, we steadily ramped up our staff manufacturing capacity to align with demand while tightly controlling expenses.

Speaker Change: CTC and an American Poland contract manufacture.

Speaker Change: These successful EMEA inspections further validates our manufacturing network capabilities to meet regulatory standards for multiple health care authorities as we prepare to serve commercial patients.

Network serves commercial patients in the U S as well as clinical trial patients across Europe, Australia and Asia.

Speaker Change: We experienced disappointing tilt cell therapies to clinical patients around the world provides a strong foundation, we're delivering commercial product.

Speaker Change: Sure.

Speaker Change: As part of the ongoing launch.

Speaker Change: It really ramped up our manufacturing capacity to align with demand while tightly controlling expenses.

Speaker Change: UK and Canada in the near term.

Speaker Change: Today I'm pleased to report the major step forward in the ongoing review of a marketing authorization application or MAA for the <unk>.

Speaker Change: As a result of our revised revenue guidance and updated demand forecast.

Speaker Change: Described we expect to realize additional cost savings by aligning our manufacturing capacity with.

Speaker Change: European Union approval.

Speaker Change: Recently as part of the MAA process, the European Medicines agency or EMA inspected and confirmed the ICC empower contract manufacturer's facility are both GMP compliant.

Speaker Change: With demand.

Speaker Change: Owning our own manufacturing facility provides us with tremendous flexibility to scale up efficiency when needed.

Igor Bilinsky: As a result of our revised revenue guidance and updated demand forecast, as Fred described, we expect to realize additional cost savings by aligning our manufacturing capacity growth plans with demand. Owning our own manufacturing facility provides us with tremendous flexibility to scale up efficiency when needed. As mentioned previously, ICDC conducted and successfully completed annual scheduled meetings. Given the three-week manufacturing process for M-Type-B, the network capacity was reduced by more than 50% for approximately one month in December 2024, thus lowering available capacity for Q1 M-Type-B integers. Following maintenance, production resumed successfully, with full capacity available for Q2 MTIB.

Speaker Change: As mentioned previously ITC conducted and successfully completed annual scheduled maintenance.

Speaker Change: Successful EMEA inspections further validates our manufacturing network capabilities to meet regulatory standards for multiple health care authorities as we prepare to serve commercial patients.

Speaker Change: Given the three week manufacturing process for them.

Speaker Change: Where capacity was reduced by more than 60% for approximately one month in December 2024, thus lowering available capacity for Q1 type institutions.

Speaker Change: As part of the ongoing launch we steadily ramped up our manufacturing capacity to align with demand.

Speaker Change: Following maintenance production resumed successfully with full capacity available for Q2.

Speaker Change: Tightly controlling expenses.

Speaker Change: As a result of our revised revenue guidance and updated demand forecast as Fred described we expect to realize additional cost savings by aligning our manufacturing capacity with.

Speaker Change: Yes.

Speaker Change: I will also comment on our manufacturing success rate in the first quarter.

Speaker Change: Delivering final product within defined specifications is critical for treating patients.

Speaker Change: With demand.

Speaker Change: Owning our own manufacturing facility provides us with tremendous flexibility to scale up efficiency when needed.

Speaker Change: The first nine months of the launch our commercial and manufacturing experience was consistent with prior clinical experience.

Speaker Change: As mentioned previously ICC conducted and successfully completed annual scheduled maintenance.

Igor Bilinsky: I will also comment on our manufacturing success rate in the first quarter. Delivering final product within defined specifications is critical for treating patients. Throughout the first nine months of the U.S. launch, our commercial manufacturing experience was consistent with prior clinical experience. The rate of patient drop-off and out-of-spec rate increased somewhat in the first quarter, thus impacting our cost-of-goods and gross margin, as shown marked below the display. Following Q1, manufacturing success rate has since rebounded. During this year, we also expect to shorten our manufacturing turnaround time, which is currently 34 days from receipt of cells at the manufacturing facility to the time they've been ready for return shipment to the agency.

Speaker Change: The rate of inflation drove halston spec rate increased somewhat from the first quarter, thus impacting our cost of goods and gross margin as mark will discuss.

Speaker Change: Given the three week manufacturing process for <unk> <unk>.

Speaker Change: Where capacity was reduced by more than 60% for approximately one month in December 2024, thus lowering available capacity for Q1.

Speaker Change: Following Q1 manufacturing success rate has since rebounded.

Speaker Change: During this year, we will expect the assortment co manufacturing turnaround time, which is currently at 34 days from receipt of cells of the manufacturing facility to be ready for it from shipments.

Speaker Change: Institutions.

Speaker Change: Following maintenance production resumed successfully with full capacity available for Q2.

Speaker Change: Sure.

Speaker Change: I will also comment on our manufacturing success rate in the first quarter.

Speaker Change: In addition, we continue to be laser focused on driving operational additional seats and economies of scale to optimize the cost of goods and improve gross margin over time.

Speaker Change: Delivering final product was into funds business vacation is critical for treating patients.

Speaker Change: The first nine months of the launch our commercial and manufacturing experience was consistent with prior clinical experience.

Speaker Change: Shifting to the current macroeconomic and geopolitical environment <unk> is operating at just strategic advantage within the Biopharma industry.

Igor Bilinsky: In addition, we continue to be in laser focus on driving operational efficiency and economies of scale to optimize the cost of goods and improve cross-marginalization.

Speaker Change: The rate of the patient drop offs, another spec rate increased somewhat from the first quarter.

We expect on time.

Speaker Change: Impacting our cost of goods and gross margin as Mark will discuss.

Speaker Change: To see minimal impact from tariffs.

Speaker Change: Yes.

Speaker Change: Our intellectual property for integrity and investigational therapies is domiciled in the U S and <unk>.

Speaker Change: Following Q1 manufacturing success rate has since rebounded.

Igor Bilinsky: Shifting to the current macroeconomic and geopolitical environment, Iovance is operating at a strategic advantage within the biopharma industry. We expect Antalya and Peloponnese to see minimal impact from Paris. Our Intellectual Property Forum, TAGWI, and Investigational Cell-Cell Therapists is domiciled in the U.S. Subtactic manufacturing is based in the U.S. Most of the Antarctic cost is U.S. based with direct materials procured from ex-U.S. vendors, currently representing less than 5% of the Antarctic cost. For Perlucan, we have also brought sufficient Perlucan inventory to the U.S. that we expect to be sufficient for meeting demand into 2027. Our TILT self-therapy expertise and manufacturing capabilities are protected by a robust patent estate domiciled in the U.S.

Speaker Change: During this year, we'll also expect to shorten co manufacturing turnaround time, which is currently at 34 days from receipt of ourselves at the manufacturing facility to <unk> being ready for a term shipments.

Speaker Change: Manufacturing is based in the U S.

Speaker Change: Most of them tied to cost as the U S base with direct materials procured from ex U S vendors currently representing less than 5%.

Speaker Change: In addition, we continue to be laser focused on driving operational efficiencies and economies of scale to optimize the cost of goods and improve gross margin over time.

Speaker Change: I'm talking to your customers.

Speaker Change: We have also grown sufficient for looking at inventory to the U S. We expect to be sufficient for meeting demand into 2027.

Speaker Change: Shifting to the current macroeconomic and geopolitical environment <unk> is operating as a strategic advantage within the Biopharma industry.

Speaker Change: Our total cell therapy expertise and manufacturing capabilities are protected by a robust at this stage some installed in the U S.

Speaker Change: We expect on time.

Speaker Change: One approximately 280 preempted allows U S and international.

Speaker Change: And to see minimal impact from tariffs.

Speaker Change: Our intellectual property for integrity investigational cell therapies is domiciled in the U S.

Speaker Change: Patent rights one category in other until it related technologies.

Speaker Change: We expect these investments to provide exclusivity through at least 2042.

Speaker Change: Our manufacturing is based in the U S.

Speaker Change: I am available density portion through the Q&A I will now have the colds, who show Mark what's your financial goals.

Speaker Change: Most of them temporary cost is U S based with direct materials procured from ex U S vendors currently representing less than 5% of them, Doug would be cost of goods.

Igor Bilinsky: We own approximately 280 granted or allowed U.S. and international patents and patent rights, one category and other TILT-related. We expect these patents to provide exclusivity through at least 2042.

Mark: Thank you Joe.

Mark: Today, I will review, our cash position and the results for the first quarter of 2025.

Speaker Change: We have also broken position for looking at inventory until the U S. We expect to be sufficient for meeting demand into 2027.

Mark: I will also highlight our financial outlook, including revenue explain geismar expense guidance and gross margin.

John Mark Belliman: I'm available to answer questions during the Q&A, and I will now end the call to Sean Mark, Deutsche Finance. Thank you, Igor. Today, I will review our cash position and results for the first quarter of 2025. I will also highlight our financial outlook, including revenue, expense guidance, and gross margin. As of March 31st, 2025, the cash position was approximately $366 million. Our current cash position is sufficient to fund current and planned operations, including manufacturing expansion into the second half of 2020.

Speaker Change: Our cell therapy expertise and manufacturing capabilities are protected by a robust state domiciled in the U S.

Mark: As of March 31st 2025, our cash position was approximately $366 million.

Speaker Change: We own approximately 280 preempted allows U S and international.

Our current cash position is sufficient to fund current and planned operations, including manufacturing expansion.

Speaker Change: One time up until related technologies, we expect these patents provide exclusivity through at least two points.

Mark: Through the second half of 2026.

Mark: We will now transition to our financial results.

Speaker Change: I am available density portion through the Q&A and I will now hand, the colds, who show Mark <unk> financials.

Mark: Net loss for the first quarter of 2025 was $116 2 million.

Speaker Change: Thank you Joe.

Mark: All sorts of six cents per share compared to a net loss of $113 million or <unk>.

Speaker Change: Today, I will review, our cash position and the results for the first quarter of 2025.

John Mark Belliman: I will now transition to our financial results. Net loss for the first quarter of 2025 was $116.2 million or $0.36 per shares compared to a net loss of $113 million or $0.42 per share for the first quarter of 2020. Total product revenue consists of antagonist fusion in the U.S. and prolonged sales. Total product revenue was $49.3 million for the first quarter of 2025, including $43.6 million for Antagby and $5.7 million for Prolucan, compared to total product revenue of $0.7 million for the first quarter of 2024. The U.S. commercial launch of MTAGV and ProLUKIN cells drove the revenue increase in the first quarter of this year over the prior year period.

Speaker Change: I will also highlight our financial outlook, including revenue explain geismar expense guidance and gross margin.

Mark: <unk> per share for the first quarter of 2024.

Mark: Total product revenue consists of an infusion in the U S and protein sales.

Speaker Change: As of March 31st 2025, our cash position was approximately $366 million.

Mark: Total product revenue was $49 3 million for the first quarter of 2025.

Speaker Change: Our current cash position is sufficient to fund current and planned operations, including manufacturing expansion into the second half of 2006.

Mark: <unk> for two to $3 6 million foreign Doug.

Mark: And $5 7 million small port looking compared to total product revenue of 0.7 million for the first quarter of 2024.

Speaker Change: I will now transition to our financial results.

Speaker Change: Net loss for the first quarter of 2025 was $116 2 million.

Mark: Portfolio.

Mark: The U S commercial launch of <unk> tags, Proleukin sales drove the revenue increase in the first quarter of this year or was it part of your program.

Speaker Change: All sorts of six cents per share compared to a net loss of $113 million or 42 per share for the first quarter of 2024.

Mark: I will now highlight.

Mark: Our cost of sales, which includes cost of inventory overhead and related cash and noncash expenses. That's all done.

Speaker Change: Total product revenue consist of infusion in the U S and protein sales.

Mark: Ricky associated with sales.

Speaker Change: Total product revenue was $49 3 million for the first quarter of 2025.

Mark: Proleukin as well as manufacturing cost for <unk>.

John Mark Belliman: I will now highlight our cost of sales, which includes cost of inventory, overhead and related cash and non-cash expenses that are directly associated with sales of untagged V&P as well as manufacturing costs for untagged V&P. Cost of sales for the first quarter of 2025 was $49.7 million, including $15 million in period costs associated with patient drop-off and manufacturing success rates, an increased quarter over quarter as Igor previously described. $5.4 million for non-cash expenses, including fair market value step up and intangible asset amortization and $1.3 million in royalties payable on products. During the first quarter of 2024, cost of sales was $7.3 million, primarily related to non-cash amortization for acquired intangible assets.

Mark: Cost of sales for the first quarter of 2025 was $49 $7 million, including <unk>.

Speaker Change: <unk> four to $3 6 million foreign Doug.

Speaker Change: And $5 7 million for forward looking.

Mark: 15 million.

Speaker Change: Compared to total product revenue of 0.7 million.

Mark: <unk> cost associated with vision drove both in manufacturing success rates and increased quarter over quarter. As you go previously described.

Speaker Change: The first quarter of 2024.

Speaker Change: Portfolio.

Speaker Change: The U S commercial launch of Proleukin sales drove the revenue increase in the first quarter of this year or was it part of your program.

Mark: $5 4 million for noncash expenses, including fair market value step up and intangible asset amortization our amortization.

Speaker Change: I will now highlight.

Mark: One $3 million in royalties payable on product sales.

Speaker Change: Our cost of sales, which includes cost of inventory overhead and related cash or non cash expenses.

Mark: During the first quarter of 2020 full cost of sales was $7 3 million.

Speaker Change: <unk> associated with sales of <unk>.

Mark: Primarily related to noncash amortization for acquired intangible assets.

Speaker Change: Proleukin as well as manufacturing cost for <unk>.

Speaker Change: Cost of sales for the first quarter of 2025 was $49 $7 million, including <unk>.

Mark: The increase in cost of sales in the first quarter of 2025 over the prior year period was primarily attributable to cash and non cash expenses associated with the <unk> product sales tied to the U S launch.

Speaker Change: 15 million.

Speaker Change: Cost associated revision dropoff in manufacturing success rates and increased quarter over quarter. As you go previously described.

Mark: Along with costs associated with sufficient drop off in manufacturing success rates.

John Mark Belliman: The increasing cost of sales in the first quarter of 2025 over the prior year period was primarily attributable to cash and non-cash expenses associated with Antigri product sales tied to the U.S. launch, along with period costs associated with patient drop-off and manufacturing success. Average standard gross margin is 32% for the first four launch crops. Standard gross margin for the first quarter of 2025 was 10% or $5 million compared to total product revenue of $49.3 million. First quarter was negatively impacted by lower revenue and higher cost of sales as previously described. As we increase volume and capacity utilization, we expect gross margin to surpass 70% in the coming year.

Speaker Change: $5 4 million for noncash expenses, including fair market value step up and intangible asset amortization our amortization.

Mark: I've already just send our gross margin.

Mark: So it's 2% for the first four launch quarters.

Mark: Our gross margin for the first quarter of 2025 was 10% or $5 million.

Speaker Change: One $3 million in royalties payable on product sales.

Speaker Change: During the first quarter of 2020 full cost of sales was $7 3 million.

Mark: Compared to total product revenue of $49 3 million daus.

Mark: First quarter was negatively impacted by lower revenue in your cost of sales as previously described.

Speaker Change: Primarily related to noncash amortization for acquired intangible assets.

Speaker Change: The increase in cost of sales in the first quarter of 2025 over the prior year period was primarily attributable to cash and non cash expenses associated with FW product sales.

Mark: As we increase volume and capacity utilization, we expect gross margin to surpass 70% in the coming years.

Mark: Our priorities are to drive revenue.

Mark: <unk>, our cost of sales with a corresponding gross margin as we expand our manufacturing coordinate and coaching Neurofocus I'll mentioned stengah instruments in training and realize efficiencies in manufacturing and related testing.

Speaker Change: The U S launch along with various costs associated with Fisher drop off in manufacturing success rate.

Speaker Change: Average gross margin.

Speaker Change: 32% for the first four launch quarters.

John Mark Belliman: Our priorities are to drive revenue while optimizing our cost of sales with a correspondingly higher gross margin, as we expand on manufacturing, coordinate and continue our focus on ATC engagement and training, and realize efficiencies in manufacturing and release testing.

Speaker Change: Our gross margin for the first quarter of 2025 was 10%.

Mark: I will now shift to our operating expenses.

Research and development expenses were $76 9 million for the first quarter of 2025, a decrease of 4% compared to $79 8 million.

Speaker Change: 5 million.

Speaker Change: Compared to total product revenue of $49 $3 million.

Speaker Change: First quarter was negatively impacted by lower revenue and cost of sales as previously described.

Mark: For the same period prior.

John Mark Belliman: I will now shift to our operating expansion. Research and development expenses were $76.9 million for the first quarter of 2025, a decrease of 4% compared to $79.8 million for the same prior year period. That was primarily attributable to the transition of MTAGRI from clinical to commercial manufacturing. This discrease was partially offset by higher headcount and related costs, including staff-based compensation and clinical trial costs resulting from continued enrollment in existing trials. Selling general and administrating expenses were $43.9 million for the first quarter of 2025, an increase of 40% compared to $31.4 million for the prior year period.

Mark: That was primarily attributable to the transition of <unk> from.

Speaker Change: As we increase volume and capacity utilization, we expect gross margin to surpass 70% in the coming years.

Mark: From clinical to commercial manufacturing.

Mark: This decrease was partially offset by higher headcount and related costs, including stock based compensation and clinical trial costs, resulting from continued enrollment in existing trials.

Speaker Change: Our priorities are to drive revenue, while optimizing our cost of sales with a corresponding gross margin as we can.

Speaker Change: Spend on manufacturing coordinate and continue our focus on the interest bearing instruments in training and realize efficiencies in manufacturing and related testing.

Mark: Selling general and administrative expenses were $43 9 million for the first quarter of 2025, an increase of 40% compared to $31 4 million for.

Speaker Change: I will now shift to our operating expenses.

Speaker Change: Research and development expenses were $76 9 million for the first quarter of 2025.

For the prior year period.

Mark: Selling general and administrative expenses were primarily attributable to increases net count and related costs, including stock based compensation to support the growth in the overall business and related corporate infrastructure marketing and legal cost and cost to support the commercialization of franchisees in Peru.

Speaker Change: <unk> or 4% compared to $79 million for.

Speaker Change: For the same period prior.

Speaker Change: <unk>.

Speaker Change: This was primarily attributable to the transition of <unk> from clinical to commercial manufacturing.

John Mark Belliman: Higher selling general and administrative expenses were primarily attributable to increases in headcount and related costs, including stock-based compensation, to support the growth in the overall business and related corporate infrastructure, marketing and legal costs, and costs to support the commercialization of MTAGV and Proloquium.

Speaker Change: This decrease was partially offset by higher head count and related costs, including stock based compensation and clinical trial costs, resulting from continued enrollment in existing trials.

Mark: Looking ahead we.

We revised our guidance to between 200, and 300 million and total product revenue for the full year approaching to Watson.

Mark: Right.

Speaker Change: Selling general and administrative expenses were $43 9 million for the first quarter of 2025, an increase of 40% compared to $31 4 million for.

Mark: After aligning your manufacturing slot expense from strategy with a new demand forecast, we are maintaining our program cash runway guidance into the second half of 2026.

John Mark Belliman: Looking ahead, we revised our guidance to between $250 and $300 million in total product revenue for the full year 2025. After aligning your manufacturing slot expansion strategy with our new demand forecast, we are maintaining our current cash runaway guidance into the second half of 2020. Cash burn for full year 2025 is expected to remain in line with prior guidance of less than $300 million, with a strong focus on optimizing spending and reducing expenses throughout the organization, including flat expenses related to MTAGV manufacturing account expansion for the latter half of 2025. As we grow revenue and as gross margin improves, we expect further reduction in our net cash spend, with ample flexibility to control both capital and operating expenses as we approach break-even.

Mark: Cash burn for full year 2025 is expected to remain in line with prior guidance of less than $300 million.

Speaker Change: For the prior year period.

Speaker Change: Selling general and administrative expenses were primarily attributable to increases net count and related costs, including stock based compensation to support the growth in the overall business and related to corporates infrastructure marketing and legal cost and cost to support the commercialization of <unk> in Peru.

Mark: With a strong focus on optimizing spending and reducing expenses throughout the organization, including flat expenses related to MTBE manufacturing head count expansion for the leather off of 2025.

Mark: As we grow revenue and thus gross margin improves we expect further reduction in our net cash spending with ample flexibility to control both capital and operating expenses as we approach breakeven.

Speaker Change: Looking ahead, we revised our guidance to between 200 to 300 million and total product revenue for the full year.

Speaker Change: Right.

Speaker Change: After our aligning our manufacturing slot expense from strategy. We are using them forecast, we are maintaining our program cash runway guidance into the second half of 2026.

Mark: For additional information please see the company's electric consolidated balance sheets and statements of operation in this afternoon's press release, and our Form 10-Q to be filed later today.

Speaker Change: Cash burn for full year 2025 is expected to remain in line with prior guidance of less than $300 million.

Frederick: I will now hand, the call to Frederick Chief Medical officer to discuss our clinical pipeline.

John Mark Belliman: For additional information, please see the company-selected consolidated balance sheet and statements of operation in this afternoon's press release and our form 10-Q to be filed later.

Speaker Change: With a strong focus on optimizing spending and reducing expenses throughout the organization.

Speaker Change: Thank you so much.

Speaker Change: Including flat expenses related to MTBE manufacturing account expansion for the leather.

Frederick: Building on the team's comments about them tagme the durability of responses. Following a onetime treatment is a key differentiator from other available and emerging therapies. We will present <unk> results from our <unk> trial at the American Society of clinical oncology or <unk> annual meeting on June <unk>.

Speaker Change: 2025.

Frederick Finckenstein: I will now end the call to Frederick, our Chief Medical Officer, to discuss our clinical pipe. Thank you so much. Building on the team's comments about MTAGV, the durability of responses following a one-time treatment is a key differentiator from other available and emerging therapies.

Speaker Change: As we grow revenue and gross margin improves we expect further reduction in our net cash spend with ample flexibility to control both capital and operating expenses as we approach breakeven.

Frederick: Compared to prior data updates these results show consistent trend for overall survival and durability over a five year period.

Speaker Change: For additional information please see the company's electric consolidated balance sheets and statements of operation in this afternoon's press release, and our Form 10-Q to be filed later today.

Frederick Finckenstein: We will present five-year results from our CE14401 trial at the American Society of Clinical Oncology, or ASCO, annual meeting on June 2nd. Compared to prior data, updates, these results show consistent trends for overall survival and durability over a five-year period.

Frederick: Our clinical program for <unk> next generation approaches are the next frontier for <unk> cell therapy in solid tumors, which represent more than 90% of all diagnosed cancer in the U S.

Speaker Change: I will now end the call to Frederick Chief Medical officer to discuss our clinical pipeline.

Speaker Change: Thank you so much.

Frederick: Future growth drivers include global label expense for Liza loosely into frontline about melanoma other solid tumor types, such as non small cell lung cancer and next generation therapies.

Speaker Change: Building on the team's comments about them tagme the durability of responses. Following a onetime treatment is a key differentiator from other available and emerging therapies. We will present <unk> results from our <unk> trial at the American Society of clinical oncology or <unk> annual meeting on June <unk>.

Frederick Finckenstein: Our clinical programs and next generation approaches are the next frontier for child cell therapy and solid tumors, which represent more than 90% of all diagnosed cancers in the U.S. Future growth drivers include global label expansion for lifelucid into frontline advanced melanoma, other solid tumor types such as non-small cell lung cancer, and next generation therapy.

Frederick: Today, I will summarize our pipeline update.

Frederick: First we are making progress towards the broader commercial opportunity for <unk> in frontline in.

Melanoma.

Speaker Change: Compared to prior data updates. These results showed consistent trends overall survival and durability over a five year period.

Frederick: A global Registrational phase III trial till them for me.

Frederick: <unk> remains on track to support accelerated and full approval to whom targeting in combination with <unk> in frontline that's on a nominal amount as well as regular approval of <unk>, our initial indication and potent anti PD one melanoma.

Frederick Finckenstein: Today I will summarize our latest pipeline update. First, we are making progress towards the broader commercial opportunity for MTAGV in frontline-advanced melanoma. Our global registrational phase 3 trial, TILBAN 301, remains on track to support accelerated and full approvals of MTAGV in combination with Pembrolizumab in frontline-advanced melanoma, as well as regular approval of MTAGV in our indication in post-anti-PD-1 melanoma. The proof-of-concept cohort is also investigating nifeluzumab in combination with nivolumab and rilazumab in the U.S. Our Registrational Program in Advancement of Small-Cell Lung Cancer, the Single-Arm Phase II IOV-LUN-202 Clinical Study, is designed to show efficacy and safety of lysoleuthral monotherapy in patients progressing after anti-PD-1 therapy.

Speaker Change: Our clinical program for <unk> next generation approaches are the next frontier for <unk> cell therapy in solid tumors, which may present more than 90% of all diagnosed cancer in the U S.

Frederick: The proof of concept cohort is also investigating <unk> in combination with new volume up in her lap them up in New York.

Speaker Change: Future growth drivers include global label expense for Liza loosely into frontline melanoma other solid tumor types, such as non small cell lung cancer and next generation therapies.

Frederick: Our Registrational program in non small cell lung cancer. The single arm phase II <unk> clinical study is designed to show efficacy and safety of license with a monotherapy in patients progressing app for anti PD one therapy.

Speaker Change: Today, I will summarize our pipeline update.

Speaker Change: First we are making progress towards the broader commercial opportunity for <unk> in frontline melanoma.

Speaker Change: Melanoma.

Speaker Change: Our global Registrational phase III trial till them.

Frederick: There is a significant unmet medical need is most patients progress.

Speaker Change: <unk> remains on track to support accelerated and full approval of <unk> in combination with <unk> in frontline melanoma as well as regular approval are intact and our initial indications and potent anti PD one melanoma approval.

Frederick: And chemotherapy the current standard of care in the treatment setting provides limited rate and duration of responses.

Frederick: We remain on track to share additional data from Iot and you went to a two in the second half of 2025.

Frederick Finckenstein: There is a significant unmet medical need as most patients progress in chemotherapy. The current standard of care in this treatment setting provides limited rate and duration of response. remain on track as planned to share additional data from IOV-LUN202 in the second half of 2025. The trial is designed with the potential to support a potential regulatory decision on U.S. accelerated approval in post-anti-PD-1 non-small cell lung cancer in 2027. In Frontline on Small Cell Lung Cancer, our strategy is to establish a new regimen consisting of lifelutel plus pembrolizumab following standard of care chemotherapy pembrolizumab. Multiple cohorts are investigating patients with EGFR wild-type non-small cell lung cancer who are the majority of patients with an unmet medical need in the state.

The proof of concept cohort is also investigating <unk> in combination with new volume up relapsing them up in New York.

Frederick: Trial is designed with the potential to support a potential regulatory decision on the U S accelerated approval and anti PD, one non small cell lung cancer in 2027.

Speaker Change: Yeah.

Speaker Change: Our Registrational program in advanced non small cell lung cancer. The single arm phase II <unk> clinical study is designed to show efficacy and safety of license with monotherapy in patients progressing app for anti PD one therapy.

Frederick: In frontline non small cell lung cancer.

Frederick: <unk> is to establish a new regimen, consisting of licensing and deliver map following standard of care chemotherapy turbulence in that month.

Speaker Change: There is a significant unmet medical need as patients progress and.

Speaker Change: Multiple cohorts.

Speaker Change: With patients with Egfr wild type non small cell lung cancer, who are the majority of patients with an unmet medical need in this treatment setting.

Speaker Change: In chemotherapy the current standard of care in the treatment setting provides limited rate and duration of responses.

Speaker Change: Turning to another significant opportunity advanced endometrial cancer, our <unk> hundred one clinical trial is investigating and license the frontline standard of care of chemotherapy and anti PD one.

Speaker Change: We remain on track to share additional data from Iot you went to a two in the second half of 2025.

Speaker Change: It's designed with the potential to support a potential regulatory decision on <unk>.

Speaker Change: We look forward to sharing initial data from <unk> hundred one in the second half.

Speaker Change: So related to approval and post anti PD, one non small cell lung cancer in 2027.

Frederick Finckenstein: Turning to another significant opportunity, advanced endometrial cancer, our IOV-END-201 clinical trial is investigating lysolucel after frontline standard of care of chemotherapy and anti-PD-1. We look forward to sharing initial data from END-201 in the second half of this year.

Speaker Change: As the leader until cell therapy I have asked this also per floor front of next generation approaches to optimize till until treatment regimen I'll briefly summarize our three lead next generation programs.

Speaker Change: In frontline non small cell lung cancer.

Speaker Change: <unk> is to establish a new regimen consisting of licensing.

Speaker Change: Following standard of care chemotherapy tempo there isn't that.

Speaker Change: Multiple cohort investigated in patients with Egfr wild type non small cell lung cancer, who are the majority of patients with an unmet medical need in this treatment setting.

Speaker Change: Our PD, one and activate until cell therapy, <unk> 4001 continues to enroll patients in the trial as previously treated.

Frederick Finckenstein: As the leader in TIL cell therapy, Iovance is also at the forefront of next-generation approaches to optimize TIL and TIL treatment regimens. I'll briefly summarize our three lead next-generation programs. Our PD-1 inactivated tilt cell therapy, IOV4001, continues to enroll patients in a trial that previously treated advanced melanoma or non-small cell lung cancer. Building on our successful PROLUGAN franchise, we are treating patients in a Phase I-II clinical trial of IOV-3001, a second-generation, modified IL-2 analog for use with a child self-therapy treatment regimen. And lastly, ILV5001 is a genetically engineered, inducible, and tethered IL-12 cell therapy with potential for enhanced activity, which could facilitate expansion into a wide range of common solid tumor cancers beyond our current pipeline with significant market opportunity.

Speaker Change: Noma or non small cell lung cancer.

Speaker Change: Turning to another significant opportunity advanced Metrial cancer, our <unk> 201 clinical trial is investigating and license the frontline standard of care of chemotherapy and anti PD one.

Speaker Change: Building on our successful Proleukin franchise, we are treating patients in the phase one two clinical trial of <unk> 3001 second generation modified IL two analog for use with the <unk> cell therapy treatment regimen.

Speaker Change: We look forward to sharing initial data from <unk> hundred one in the second half.

Speaker Change: And lastly, all of the 5001 as the genetically engineered inducible <unk> <unk> IL 12, 'til cell therapy with potential for enhanced activity, which could facilitate expansion into wide ranges of common solid tumor cancers beyond our current pipeline with significant market opportunity.

Speaker Change: Our PD, one inactivate until cell therapy, <unk> 4001 continues to enroll patients in the trial as previously treated melanoma or non small cell lung cancer.

Speaker Change: We plan to submit an investigational new drug application to FDA this year.

Speaker Change: I'm happy to address questions about these programs and additional trials in the Q&A session I'll now turn the call over to the operator to begin the question and answer session.

Frederick Finckenstein: We plan to submit an investigational new drug application to FDA this year for ILV5001.

Speaker Change: As a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced to withdraw your question. Please press star one again.

Frederick Finckenstein: I'm happy to address questions about these programs and additional trials during the Q&A session.

Speaker Change: And lastly, all of the 5001 is the genetically engineered inducible <unk> <unk> IL 12.

Operator: I now turn the call over to the operator to begin the question and answer session. As a reminder, to ask a question... Star, 1-1 on your telephone, and wait for your name to be announced. Withdraw your question, please press star 1 1 again. In the interest of time, we ask that you please limit yourself to one question, and you may rejoin the queue. Please stand by while we compile the Q&A roster.

Speaker Change: In the interest of time, we ask that you. Please limit yourself to one question and you may rejoin the queue. Please standby, while we compile the Q&A roster.

Speaker Change: With potential for enhanced activity, which could facilitate expansion into a wide range of common solid tumor cancers.

Speaker Change: Okay.

Speaker Change: Our first question comes from Andrew Tsai with Jefferies. Your line is open.

Speaker Change: Our current pipeline significant market opportunity.

Speaker Change: We plan to submit an investigational new drug application to FDA this year for <unk>.

Andrew Tsai: Hey, Thanks. Good afternoon. Thanks for taking my question I. Appreciate the update my question is around the line of sight.

Speaker Change: I'm happy to address questions about these programs and additional trials in the Q&A session I'll now turn the call over to the operator to begin the question and answer session.

Speaker Change: You are having.

Speaker Change: The revised guidance, presumably you do have some direct line of sight, maybe at least a month in advance into the number of patients who are waiting to get dosed in the queue can you confirm whether you are seeing are has seen a spike or in fact inflection in patient uptake as of today to give you the confidence.

Andrew Tsai: Our first question comes from Andrew Tsai with Jeffreys. Your line is open. Hey, thanks. Good afternoon. Thanks for taking my question. Appreciate the update.

Speaker Change: As a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced to withdraw your question. Please press star one again.

Dan Kirby: My question is around the line of sight you're having amidst the revised guidance. Presumably, you do have some direct line of sight, maybe at least a month in advance into the number of patients who are waiting to get dosed in the queue. Can you confirm whether you're seeing or have seen a spike or an inflection in patient uptake as of today to give you the confidence around your guidance of 100 to 110 patients for Q2? Thank you.

Speaker Change: In the interest of time, we ask that you. Please limit yourself to one question and you may rejoin the queue. Please standby, while we compile the Q&A roster.

Speaker Change: Around your guidance of 100 110 patients for keto. Thank you.

So Andrew this is Dan Thank you very much.

Speaker Change: Okay.

Speaker Change: Our first question comes from Andrew Tsai with Jefferies. Your line is open.

Speaker Change: Yes, we're confident in that number and we are seeing demand as we stated in the script.

Andrew Tsai: Hey, Thanks. Good afternoon. Thanks for taking my question I. Appreciate the update my question is around the line of sight you have.

Speaker Change: In quarter two.

Speaker Change: Sean.

Tyler Van Buren: So, Andrew, this is Dan. Thank you very much. Yes, we're confident in that number, and we are seeing demand, as we stated in the script, in quarter two be strong. Thank you.

Speaker Change: Thank you. Our next question comes from Tyler Van Buren with TD Cowen Your line is open.

Speaker Change: <unk>.

Speaker Change: The revised guidance, presumably you do have some direct line of sight, maybe at least a month in advance into the number of patients who are waiting.

Speaker Change: Hey, guys. Thanks, very much for all the information.

Speaker Change: So for the 11 Atc's that are infused more than 10 patients were most of them involved in the clinical program and it's just a matter of getting the other ones that werent up to speed.

Speaker Change: Who are waiting to get those in the queue? Can you confirm whether you're seeing or have seen a spike or an infection and patient uptake as of today to give you the constant around your guidance of 110 patients for Q2. Thank you.

Tyler Van Buren: Our next question comes from Tyler Van Buren with TD Cowan. Your line is open. Hey guys, thanks very much for all the information. So for the 11 ATCs that have infused more than 10 patients, or most of them involved in the clinical program, and it's just a matter of getting the other ones that weren't up to speed, you know, maybe you could discuss the barriers of the other 37 ATCs that have infused more than one patient but haven't infused 10 plus and what tactics you're employing to get them to increase their utilization. Yeah, Tyler, I'll start and I'll pass it over to Dan and give you a little bit more on the second part of that question.

Speaker Change: Maybe you could discuss the barriers of the other 37 agencies that have infused more than one patient, but have been infused 10, plus and what tactics you are employing to to get them to increase their utilization.

Speaker Change: So, Andrew, this is Dan. Thank you very much. Yes, we're confident in that number and we are seeing demand as we did in the script in order to be strong.

Speaker Change: Yes.

Speaker Change: I'll start and I'll pass over to Dan to give you a little bit more on the second part of that question on the trial only a few of those atc's, we're actually involved in the trial I'd say.

Speaker Change: Not necessarily.

and many more. Thank you. Thank you.

Speaker Change: A correlation between the clinical trial unit at a site and their experience with the site to a commercial impact.

Speaker Change: Thank you. Our next question comes from Tyler Buren with TD Calendar. Your line is open.

Speaker Change: Different people and we have to work closely with.

Speaker Change: Hey guys, thanks very much for all the information. So for the 11 ATTs that have been used more than 10 patients.

Frederick Vogt: On the trial, only a few of those ATCs were actually involved in the trial. It's a, it's not necessarily a correlation between the clinical trial unit of the site and their experience and what the site does with commercial antagony. A lot of times it's different people and we have to work closely with that unit at each ATC to get them up to speed. So there is some learning there, but we're able to overcome it. Obviously, we're learning quite a bit ourselves about how to do that and we're getting better and better all the time. And that's why we have confidence that many of those other ATCs are going to come along quickly.

Speaker Change: That unit any GCC to get them up to speed. So there is.

Speaker Change: Some learning there, but were able to overcome it obviously, we're learning quite a bit ourselves about how to do that and we're getting better and better all the time and Thats why we have confidence that many of those other ACC is going to come on quickly and in fact, we're seeing that today, but Dan you want to take the second part of the question sure and looking at just with cell therapy in general there is actually patients coming into tree and theirs.

Speaker Change: We're most of them involved in the clinical program and it's just a matter of getting the other ones that weren't up to speed. You know, maybe you could discuss.

Speaker Change: The barriers of the other 37-ATCs that have confused more than one patient, but have been infused 10 plus and what tactics you're employing to get them to increase their utilization.

Dan Kirby: Cell therapy.

Speaker Change: I'll start and I'll pass over to Dan and give you a little bit more on the second part of that question. On the trial, only a few of those ATC's were actually involved in the trial. It's not necessarily...

Dan Kirby: <unk> level at these centers. So what we'll say is that the larger centers that got off to a quicker start those are the ones with the infrastructure from various cell therapy launches that we're ready for <unk>.

Dan Kirby: In fact, we're seeing that today.

Dan Kirby: Dan, do you want to take the second part of the question? Sure. And looking at just with cell therapy in general, there's actually patients coming into TREAT and there's a cell therapy experience level at these centers. So what we'll say is that the larger centers that got off to a quicker start, those are the ones with the infrastructure from various cell therapy launches that were ready for antagony to enter in. The other ones are ramping up to speed. They're doing this with other cell therapies as well. But infrastructure such as billing mechanisms, cell therapy lab, et cetera, are coming online with that.

Dan Kirby: To answer it and the other ones are ramping up to speed. They are doing this with other cell therapies as well, but infrastructure such as billing mechanism cell therapy lab et cetera are coming online with that so we are seeing them increase their ramp a lot quicker once they get that infrastructure in place that answer your question.

Dan Kirby: Correlation between the clinical trial unit and the site and their experience and what the site does with the commercial impact. We've had a lot of times with different people and we have to work closely with that unit at each agency to get them out of the speed. So there is.

Speaker Change: Some learning there, but we're able to overcome it. Obviously, we're learning quite a bit ourselves about how to do that. We're getting better and better all the time. And that's why we have confidence that many of those other ATCs are going to come along quickly. In fact, we're seeing that today.

Dan Kirby: Yeah. Thank you. Thank you.

Speaker Change: Thank you. Our next question comes from Celine site with Mizuho. Your line is open.

Speaker Change: But Dan, you want to take the second part of the question? Sure. And looking at, just with cell therapy in general, there's actually patients coming into treat, and there's a cell therapy, um…

Tyler Van Buren: So we are seeing them increase their ramp a lot quicker once they get that infrastructure in place. Does that answer your question? Yep. Thank you.

Speaker Change: Great. Thanks for the question guys on the call today I guess on your on your guidance kind of going forward here for 25% if I'm doing my math correctly here and assuming something like <unk>.

Speaker Change: Experience level at these centers. So what we'll say is that the larger centers that got off to a quicker start those are the ones with the infrastructure from various self-therapy launches that were ready for MTAG-D.

Salim Saeed: Our next question comes from Salim Saeed with Mizuha. Your line is open. Great. Thanks for the question guys in the Colorado Day. I guess on your on your guidance kind of going forward here for for 25, if I'm doing my math correctly here and assuming something like 20% proleucin sort of backing into the balance of the year, you're going to have something like 250 or 325, 325 infusions. So roughly like 100. 100, 110, something like 100 per quarter, roughly.

Speaker Change: 20% Proleukin.

Sort of backing into that.

Speaker Change: Balance of the year Youre going to have something like 250 or 325.

Speaker Change: to enter in. The other ones are ramping up the speed. They're doing this with other cell therapies as well, but infrastructure such as billing, mechanism, cell therapy, lab, etc are coming online with that. So we are seeing them increase their ramp a lot quicker once they get that infrastructure. Is that answer your question?

Speaker Change: 325 infusions.

Speaker Change: So roughly call it 100.

100, 110, something like 100 100 per quarter roughly.

Speaker Change: Is that a correct way to sort of think about this which essentially apply.

Speaker Change: No growth versus.

Speaker Change: No growth versus like the <unk> number.

Speaker Change: No absolutely that's that's not how you want to think about it we're actually.

Speaker Change: Right now as you know, we did $164 million in revenue last year.

John Mark Belliman: Is that a correct way to sort of think about this, which is essentially apply, you know, no growth versus No growth versus like the two Q number Now, Colleen, that's that's not how you want to think about it. We're actually Right now, as you know, we did $164 million in revenue last year, including quite a bit of proleucin. And what we're projecting is $250 to $300 this year, which is some growth there, obviously, as fiscal year aligns. If you want to think of it as just infusions, though, you can look at the four quarters. We infused our first two patients back in April of 2024.

Speaker Change: Included quite a bit of Proleukin and what we're projecting is $2 50, and $2 50 to 300 this year, which is which is some growth there obviously.

Speaker Change: That's fiscal year aligned if you want to think of it as just infusion. So you can look at the four quarters, we infuse our first two patients back in April of 2024.

Speaker Change: The balance of the year youre going to have something like 250 or 325.

Speaker Change: 325 infusions.

Speaker Change: Through to the end of March we were about 280, some patients infused our guidance implies and this year, we'll probably get over 500 patients infused and that's in the four quarters of the fiscal year and of course there'll be another quarter into 2026 of the grocery store.

Speaker Change: So roughly call it 100.

Speaker Change: 100, 110, something like 100 100 per quarter roughly.

Speaker Change: Is that a correct way to sort of think about this which essentially apply.

Speaker Change: No growth versus.

Speaker Change: No growth versus like the <unk> number.

Dan Kirby: And through to the end of March, we were about 280 some patients infused. Our guidance implies that in this year, we'll probably get over 500 patients. And that's in the four quarters of the fiscal year. And of course, there'll be another quarter in 2026 that will grow even more. So you are looking at like a 50% or more growth rate there as you go through this time period year over year. And there's a lot of upside there as well.

Speaker Change: So you are looking at like 50% or more growth rate. There as you go through this time period year over year and Theres a lot of upside there as well.

Speaker Change: No absolutely that's not how you want to think about it we're actually.

Speaker Change: Right now as you know, we did a $164 million in revenue last year.

Speaker Change: I would add to that sure. So what I would say is the way you can look at this is that we expect continued growth throughout this year.

Speaker Change: Including quite a bit of Proleukin and what we're projecting is $2 50, and 250 to 300 this year, which is which is some growth there obviously.

Speaker Change: We will not be Flatlining will continue to grow that is driven by two factors one as we talked about the increase of adoption in our in our centers. Both the ones that started at the very beginning and the ones that wrapped up in 2024, and the addition of new Adcs that have enhanced referral networks within the community to get patients not only in quantity, but also quality meetings.

Speaker Change: That's fiscal year aligned if you want to think of it as just infusion. So you can look at the four quarters. We infuse our first two patients back in April of 2024 and through to the end of March we were about 280, some patients infused our guidance implies it and this year, we'll probably get over 500 patients infused and thats. It.

Dan Kirby: Dan, do you want to add to that? Sure. So what I would say is the way you can look at this is that we expect continued growth throughout this year. So it will not be flatline. It'll continue to grow. That's driven by two factors. One, as we talked about, the increase of adoption in our centers, both the ones that started at the very beginning and the ones that wrapped up through 2024, and the addition of new ATCs that have enhanced referral networks within the community to get patients not only in quantity, but also quality, meaning they're getting early referral.

Speaker Change: We're getting early referrals.

Speaker Change: Four quarters of the fiscal year and of course there'll be another quarter into 2026, it will grow even more so.

Speaker Change: Okay. Thank you so much.

Speaker Change: Thank you.

Speaker Change: Our next question comes from Andrea Newkirk with Goldman Sachs. Your line is open.

Speaker Change: You are looking at like 50% or more growth rate. There as you go through this time period year over year and Theres a lot of upside there as well.

Speaker Change: Good afternoon. Thanks for taking the question, maybe a follow up there Fred.

Speaker Change: And then you add to that sure. So what I would say is the way you can look at this is that we expect continued growth throughout this year.

Speaker Change: What your guidance is implying.

Operator: Okay, thank you so much.

Speaker Change: For infusions I, just want to make sure I understood that.

Andrea Newkirk: Thank Our next question comes from Andrea Newkirk with Goldman Sachs. Your line is open. Good afternoon. Thanks for taking the question. Maybe a follow up there, Fred, on what your guidance is implying per infusions. I just wanted to make sure I understood this, but are you suggesting that 500 infusions should be on top for 2025? And if that's the case, then what are you assuming for Proleucin through the remainder of this year, even after the uptick expected in 2Q? So if you just take the guidance we gave, subtract off a number like what Salim just gave you for proleucin, and divide that through by 550 or so, you're going to get something in the high 400s, close to 500, depending if you think there's some upside here, there could be some upside too on top.

Speaker Change: Are you, suggesting that 500 infusion should be on tap for 2025 and if that's the case then what are you assuming for proleukin through the remainder of this year, even after the uptick expected in QQ.

Speaker Change: We will not be Flatlining will continue to grow that is driven by two factors one as we talked about the increase of adoption in our in our centers. Both the ones that started at the very beginning and the ones that wrapped up through 2024, and the addition of new Adcs that have enhanced referral networks within the community to get patients not only in quantity, but also quality meetings.

Speaker Change: Yes.

Speaker Change: So if you just take the the guidance we gave subtract off a number of liquid Selim just gave you for proleukin and divide that through by $5 50, or so youre going to get something in the high <unk>.

Speaker Change: We're getting early referrals.

Speaker Change: Okay. Thank you so much.

Speaker Change: Four hundreds.

Speaker Change: Close to 500 dependent.

Speaker Change: Thank you.

Speaker Change: You saw some upside here that could be some upside to on top of that.

Speaker Change: Next question comes from Andrea Newkirk with Goldman Sachs. Your line is open.

Speaker Change: Does that answer the question.

Speaker Change: Afternoon. Thanks for taking the question, maybe a follow up there Fred.

Speaker Change: Okay.

Speaker Change: Thank you and then just really quickly eager could you just speak to what drove the higher patient roster lower manufacturing success in the quarter and what gives you the confidence that this will have on first on the far away.

Speaker Change: On what your guidance is implying.

Speaker Change: Per infusions I, just want to make sure I understood that.

Speaker Change: So.

Speaker Change: Some of this thanks for the question Andrew some of this or much of this was related to patient selection in the tumor procurement technique.

Andrea Newkirk: Does that answer the question? Okay, thank you.

Andrea Newkirk: And then just really quickly, Igor, could you just speak to what drove the higher patient draft or lower manufacturing success in the quarter and what gives you the confidence that this will reverse on the forward? So some of this, thanks for the question, Andrea, some of this or much of this is related to patient selection and the tumor procurement technique and as I mentioned, we're already saw the return to normal rebound in the Q2 so far. What gives us confidence is the success rate trend that we see among ATCs who've been up and running for a long time and the experience curve that they've been able to achieve, so that gives us confidence that it's teachable and can be translated to other ATCs across Thank you.

Speaker Change: And as I mentioned, where we just saw the return to normal rebound into Q2, so far what gives us confidence.

Speaker Change: So if you just take the guidance, we gave subtract off a number of liquids Selim just gave you for proleukin and divide that through by $5 50, or so youre going to get something in the high <unk>.

Speaker Change: The success rate trends that we see among Agc's group is up and running for a long time and the experience curve that they've been able to achieve so that gives us confidence that its tissue both of them can be translated to other adcs across to them.

Speaker Change: Four hundreds.

Speaker Change: Close to 500, depending if you did if you think there's some upside here that could be some upside to on top of that.

Speaker Change: Does that answer the question Okay.

Speaker Change: Okay.

Speaker Change: Thank you and then just really quickly <unk> could you just speak to what drove the higher patient roster lower manufacturing success in the quarter and what gives you the confidence that that is all of our first on the far right.

Speaker Change: Thank you. Our next question comes from Jan and Xu with Wells Fargo. Your line is open.

Jan: Thanks for taking our questions.

Speaker Change: First a clarifying question.

Speaker Change: So.

Speaker Change: Some of this thanks for the question Andrew some of this or much of this is related to patient selection in the tumor procurement.

Be missing something.

Speaker Change: So assuming each <unk> product is roughly <unk>.

Yanan Zhu: Our next question comes from Yanan Zhu with Wells Fargo. Your line is open. Thanks for taking our questions. First a clarifying question. I must be missing something. So, assuming each MTAGV product is roughly north of $500,000, that's half a million. And then if there's 500 patients infused this year, that alone will be $250 million, which is the lower bound of the guidance. So, if that's the case, then, you know, adding IL-2 on top of that, the lower bound of guidance should really be above $250. So, I'm trying to see if my assumption for per patient, you know, price, you know, off.

Speaker Change: And as I mentioned, where we just saw the return to normal rebound into Q2, so far what gives us confidence.

Speaker Change: $500000.

That's half a million and then if there is 500 patients in Houston. This year that alone will be 250 million, which is the lower bound of the guidance.

Speaker Change: The success rate trends that we see among agc's who've been up and running for a long time and the experience curve that they've been able to achieve so that gives us confidence that its tissue. Both apps can be translated to other adcs across the network.

Speaker Change: So if that's the case then adding.

Speaker Change: Adding our two on top of that to the lower bound of guidance should you really be above $2 50, So im trying to see if my assumption for patients.

Speaker Change: Thank you. Our next question comes from Giannis Zoom with Wells Fargo. Your line is open.

Speaker Change: Price.

Speaker Change: And.

Speaker Change: Right.

Speaker Change: Thank you for clarifying.

Giannis Zoom: Thanks for taking our questions.

Speaker Change: Question is on Cogs and can you talk about the.

Speaker Change: First a clarifying question.

Speaker Change: <unk>.

Speaker Change: Be missing something.

Speaker Change: It seems like the Cogs has.

Speaker Change: So assuming each <unk> product is roughly <unk>.

Speaker Change: Our ratio of revenue has increased over the last quarter.

Speaker Change: North of $500000.

Speaker Change: Just wanted to understand what proportion of them.

Yanan Zhu: And my – thank you for clarifying.

Speaker Change: That's half a million and then if there's 500 patients in fuel this year that alone will be 250 million, which is the lower bound of the guidance.

John Mark Belliman: My actual question is on COGS. And can you talk about the, you know, it seems like COGS has a, you know, ratio of revenue has increased over the last quarter. Just wanted to understand what proportion of the COGS is due to patient attrition, i.e., patient passing away, cannot get the product, or manufacturing failure. If you can, you know, give us some color there.

Speaker Change: This is due to <unk>.

Speaker Change: Patient nutrition, I E patient passing away cannot get the product.

Speaker Change: <unk> manufacturing failure, if you can give.

Speaker Change: Give us some color there. Thank you.

Speaker Change: So if that's the case then.

Speaker Change: Adding <unk> on top of that to the lower bound of guidance should you really be above $2 50.

Speaker Change: Yeah on the first part of our guidance, we consider this guidance to be fairly conservative.

Speaker Change: So as you go and do your math there there is going to be some upside to what we're giving you here.

Speaker Change: Trying to see if my assumption for patients.

Speaker Change: Price.

Speaker Change: If we get the 500 infusions it might be above three under all the upfront and Thats something that we really want to with this new guidance, we really want to show that we can actually exceed guidance here.

Speaker Change: Off and.

John Mark Belliman: Thank you. Yes, Yanan, on the first part, our guidance, we consider this guidance to be fairly conservative. So as you go and do your math there, there is going to be some upside of what we're giving you. If we get the 500 infusions, it might be above 300 on the upper end. And that's something that we really wanna, with this new guidance, we really wanna show that we can actually exceed guidance here and do well here with this launch. So it's not gonna work out exactly to where you might think. Maybe it's 450 patients if you wanna be more conservative.

Speaker Change: Thank you for clarifying that my actual question is on Cogs and can you talk about.

Speaker Change: The same.

Speaker Change: It seems like the Cogs has.

Speaker Change: Well here with this launch so it's not going to work out exactly to where you might think maybe it's 450 patients. If you want to be more conservative however, it's still growth.

Speaker Change: As the ratio of our revenue has increased over the last quarter.

Speaker Change: Just wanted to understand what proportion of them.

Speaker Change: Still growth over the first three quarters of the launch if you want to look at on a fiscal year basis or four quarters, you want to look at it on a launch year basis, but again the first four quarters of our launch we treated about 280 some patients.

Speaker Change: This is due to <unk>.

Speaker Change: Patient attrition I E patient passing away cannot get the product.

Speaker Change: Or manufacturing failure, if you can give.

Speaker Change: Give us some color there. Thank you.

Speaker Change: Yeah on the first part of our guidance, we consider this guidance to be fairly conservative.

Speaker Change: Now for the Cogs question, let me start.

John Mark Belliman: However, it's still growth. This slide shows the growth over the first 3 quarters of the launch. If you want to look at it on a fiscal year basis or 4 quarters, you want to look at it on a launch year basis. Again, the first 4 quarters of our launch, we treated about 280 some patients.

Speaker Change: And that's the ratio of scrapping.

Speaker Change: So as you go and do your math there there is going to be some upside to what we're giving you here.

Speaker Change: Mark maybe you might need to help out with that one can I just say one of the things.

Speaker Change: If we get the 500 infusions it might be above three under all the upfront.

I mean first the quarter, the $250 million and the 50% growth over 2020 for sale so revenue.

Speaker Change: And Thats something that we really want to with this new guidance, we really want to show that we can actually exceed guidance here.

John Mark Belliman: Now, for the COGS question, let me ask, and that's the ratio of scrap and Jean-Marc, and maybe Igor might need to help out with that one. Can I just say something? Sure, go ahead. So one of the things, I mean, first, the quarter, the $250 million is a 50% growth over 20 years. So I... So that is definitely a growth in the lower end for it. And yes, we would love to have upside to that. The second part, when you talk about patient health, I just want to clarify that statement. Those are patients who went to hospice or died prior to the manufacturing process start, meaning they went there before we had tumor procurement.

Speaker Change: So that is definitely a growth in the lower important and yes, there we would love to have upside to that.

Speaker Change: Well here with this launch so it's not going to work out exactly to where you might think maybe it's 450 patients. If you want to be more conservative. However, it's still growth it's too.

Speaker Change: The second part when you talk about patient our basement to clarify that statement. Those are patients who went to hospice or died prior to the manufacturing process start and they went there before we had tumor procurement. So therefore, they would not be affecting Cogs and <unk>.

Speaker Change: Growth over the first three quarters of the launch do you want to look at on a fiscal year basis or four quarters, you want to look at it in a launch year basis, but again the first four quarters of our launch we treated about 280 some patients.

Speaker Change: I think the Cogs question, you and you know I think job Mark maybe you can take that.

Speaker Change: Now for the Cogs question, let me ask.

I'm happy to take the <unk> question. So, yes, youre correct, we have an increase in there.

Speaker Change: And that's the ratio of scrap in the shop markets, maybe where maybe to help out with that one can I just say that when we get our strengths one of the things.

Speaker Change: Overall cost of sales together.

Igor Bilinsky: So therefore, they would not be affecting COGS.

Speaker Change: The.

Speaker Change: First the quarter, the $250 million and the 50% growth over 2020 for sale so revenue.

John Mark Belliman: And Igor, do you want to take the COGS question, you and Nohmar? I think John Mark may need to take that. Yeah, I'm happy to take the COGS question. So yes, you're correct. We had an increase in the overall cost of sales together. You know, as Igor mentioned during the script is that we see a spike in the out of spec on the first quarter that we know will improve over time, but you have to think of also relative to the overall revenue. So yes, the cost of goods and the cost of sales has increased in Q1, particularly related to revenue, but we know this will definitely improve in Q2.

Speaker Change: <unk> mentioned during the script is that we see here.

Speaker Change: Spike in there out of spec on the first quarter that renewal will improve over time, but you have to think of also relative to the overall revenue. So yes, the cost of goods and cost of sales has increased in Q1, particularly relative to revenue, but we knew just willing definitely improvement in Q2.

Speaker Change: So that is definitely a growth in the lower end point and yet there.

Speaker Change: Would love to have upside to that.

Speaker Change: The second part when you talk about patient based on the clarify that statement those are patients who went to hospice or died prior to the manufacturing process start and they went there before we had tumor procurement. So therefore, they would not be affecting cost.

Speaker Change: Our gross margin remained positive in Q1 as you are saying.

Speaker Change: I think the Cogs question, you and you know Mark I think job Mark maybe you can take that.

Speaker Change: Got it thanks for the color.

Speaker Change: Yes.

Speaker Change: I'm happy to take the <unk> question. So yes, you are correct, we have an increase in their overall cost of sales together.

Speaker Change: Thank you. Our next question comes from Colleen QC with Baird. Your line is open.

John Mark Belliman: And, you know, our standard gross margin remain positive in Q1, as you have been saying.

Colleen QC: Good afternoon, Thanks for taking my question.

Speaker Change: The.

Speaker Change: <unk> mentioned during the script is that we see here.

Colleen QC: So you report the patient dropout and honest about create together, but can we assume that that out of spec rate went up and if so what drove that was it anything to do with the email maintenance and then would we expect that same one month interruption going forward every year. Thank you.

John Mark Belliman: Got it.

Operator: Thanks for the call. Thank you.

Speaker Change: Spike in there out of spec on the first quarter that renewal.

Speaker Change: We will improve over time, but you have to think of also relative to the overall revenue. So yes, the cost of goods and cost of sales has increased in Q1.

Colleen Kusy: Our next question comes from Colleen Kusy with Baird. Your line is open. Good afternoon. Thanks for taking our questions. So you report that patient dropped on an out-of-spec rate together, but can we assume that that out-of-spec rate went up? And if so, what drove that? Was it anything to do with the annual maintenance?

Speaker Change: So Alicia thanks for the question so again regarding the patient drop offs in manufacturing success rate.

Speaker Change: Particularly relative to revenue, but we knew just willing definitely improvement in Q2.

Speaker Change: Yeah.

Speaker Change: Closely related to each agc's track record in patient selection in tumor tissue procurement.

Speaker Change: Our gross margin remained positive in Q1 is Europe Hussein.

Igor Bilinsky: And then would we expect that same one month interruption going forward every Colleen, thanks for the question. So, again, regarding the patient drop-offs and manufacturing success rate, these closely relate to each ATC's track record and patient selection and tumor tissue procurement. And, again, the increase we saw in Q1, we believe it to be transient. It's already normalized in Q2 to date. So that's what we believe is driving it. We have new ATCs, new surgeons, and some of that needs to be optimized over time, which our teams are working on.

Speaker Change: Got it thanks for the color.

Speaker Change: Again, the increase we saw in Q1, we believe transient it's already normalized in Q2 to date.

Speaker Change: Okay.

Speaker Change: Thank you. Our next question comes from Colleen QC with Baird. Your line is open.

Speaker Change: So that's what we believe is driving new Atc's new surgeons.

Colleen QC: Good afternoon. Thanks for taking my question. So you reported a decent drop on a spec create together, but can we assume that that out of spec rate went up and if so what drove that was it anything to do with the email maintenance and then would we expect that same one month interruption going forward every year. Thank you.

Speaker Change: Some of that needs to be optimized over time with which our teams are working on.

Speaker Change: Yes.

Speaker Change: What was the second part of the question.

Speaker Change: Just the annual maintenance, whether that will be a similar one months, 50% reduction.

Colleen QC: Colin Thanks for the question so again regarding the patient drop offs in manufacturing success rate.

Speaker Change: Annual maintenance. So we're now completing buildout of the shelf space at the ITC.

Igor Bilinsky: What was the second part of the question? Just the annual maintenance, whether that will be a similar one month, 50% reduction in capacity every year? Annual maintenance, so we are now completing build out of the shell space at ICTC. Once that shell space is operational, which will not be this year, but should be later on. Once that shell space is operational, then we don't need to... The maintenance will only affect part of the ICPC facility, not all. I don't have less impact, but yes, Colleen, it is an annual event, you have to do it, but for now, this year, we'll still need to do it, but in the subsequent years, once the ICTC is fully built out and fully up and running, we will not see that.

Colleen QC: Closely related to each agc's track record in patient selection in tumor tissue procurement.

Speaker Change: Once that shelf space is operational which will not be this year.

Speaker Change: B later on once that shelf space with operational that when we don't need to.

Colleen QC: Again, the increase we saw in Q1.

Colleen QC: Believe it to be transient it's already normalized in Q2 to date.

Speaker Change: The maintenance below net auto the ICC facility.

Speaker Change: So.

Colleen QC: So thats, what we believe is driving new atc's, new surgeons and some of that needs to be optimized over time with which our teams are working on.

Speaker Change: This doesn't happen it will have less impact.

Speaker Change: Yes, Kelly. This is it is an annual event that you have to do it but this year, we will still need to do it yet but in the subsequent years again once the ICC is fully built out and fully up and running almost see the.

Colleen QC: What was the second part of the question.

Colleen QC: Just the annual maintenance, whether that will be a similar one months, 50% reduction in.

Speaker Change: Helpful. Thank you.

Peter Lawson: Thank you. Our next question comes from Peter Lawson Barclays. Your line is open.

Colleen QC: Annual maintenance. So we're now completing buildout of the shelf space at the ITC.

Speaker Change: Great. Thank you so much.

Colleen QC: Once that shelf space is operational which will not be this year, but should be later on once that shelf space with operational that when we don't need to.

Peter Lawson: Just coming back to kind of manufacturing successes that returned back to.

Normal levels and was that also related to that.

Colleen Kusy: helpful. Thank you.

Peter Lawson: We've got a program in <unk> as well.

Peter Lawson: Our next question comes from Peter Lawson at Barclays. Your line is open. Great, thank you so much. Going back to kind of manufacturing success, has that returned back? Normal levels and was that also really We had a problem in 4Q as well, associated with the same thing.

Colleen QC: The maintenance below net auto the ICC facility.

Peter Lawson: But at the same things the same thing kind of spread into <unk> or a separate issue.

Colleen QC: So.

Colleen QC: So that will have less impact.

Peter Lawson: We don't know.

Speaker Change: Lithium segment, Yes. Kelly. This is it is an annual event that you have to do it but this year, we will still need to do it but.

Peter Lawson: <unk> traffic out there that's the important point is we didn't talk about that.

Colleen QC: But in the subsequent years to get once the ICC is fully built out and fully up and running well amongst us.

Peter Lawson: In Q last quarter at all.

Peter Lawson: When we did mentioned back then that there was going to be a shutdown and we were in the process of that.

Speaker Change: Helpful. Thank you.

Peter Lawson: Point actually shut down.

Frederick Vogt: We're not really sure, Peter, what you're asking out there. The important point is, we didn't talk about that in the last quarter at all. What we did mention back then is there was going to be a shutdown, and we were in the process of, at that point, actually hitting the shutdown. But no, we don't... That doesn't resonate. There was no issue with manufacturing success rate in Q4. No, Q4 was actually a good quarter. Now, the important thing to remember here, Peter, is it's rebounded already. Again, we think it has to do with individual activities in some of the ATCs and how they procure tumor, as well as some things that we can learn from throughout the entire process and how we can improve those things.

Speaker Change: Thank you. Our next question comes from Peter Lawson with Barclays. Your line is open.

Peter Lawson: But no we don't we don't.

Peter Lawson: That doesn't resonate there wasn't there was no issue with manufacturing since Australia, Q4, Q4 was actually a good quarter.

Speaker Change: Great. Thank you so much.

Speaker Change: Just going back to kind of manufacturing successes that returned back to.

Peter Lawson: Now the important thing to remember here Peter has rebounded already again, we think it has to do with individual activities and some of the accs in how they procure tumor as well as some some things that we can learn from throughout the entire process and how we can improve this thing it looks like it's already rebounded pretty well.

Speaker Change: Normal levels and was that also related to the.

Speaker Change: You had a program in <unk> as well associated with the same thing same thing kind of.

Speaker Change: Spread into <unk> or a separate issue.

Peter Lawson: Were in back end.

Speaker Change: We don't we're not really sure what youre asking under that's the important point is we didn't talk about that.

Peter Lawson: Back in the zone, where we think we were during the first part of the watch.

Peter Lawson: Yes.

Speaker Change: In Q last quarter at all.

Speaker Change: Got you. Thank you and is there any way of breaking out the revenue weakness you have lower guidance kind of how much is if that's due to.

Speaker Change: When we did mentioned back then there was going to be a shutdown and we were in the process of.

Frederick Vogt: And it looks like it's already rebounded pretty well. We're back in the zone where we think we were during the first part of the launch.

Speaker Change: At that point actually shut down.

Peter Lawson: Demand uncertainty.

Speaker Change: But no we don't we don't.

And all manufacturing uncertainty.

Speaker Change: That doesn't resonate there wasn't there was no issue with manufacturing since Australia, Q4, Q4 was actually a good quarter.

Peter Lawson: No I don't I don't really think there is a way of doing that.

Peter Lawson: Thank you. And is there any way of breaking out sort of the revenue weakness you have and lower guidance, kind of how much is of that? Now, I don't really think there's a way of doing that. Now, that would be very complicated to analyze that.

Peter Lawson: No.

Speaker Change: The important thing to remember here Peter has rebounded already again, we think it has to do with individual activities and some of the accs in how they procure tumor as well as some things that we can learn from throughout the entire process and how we can improve those things and it looks like it's already rebounded pretty well.

Speaker Change: It would be very helpful.

Peter Lawson: That I can't Dan or.

Peter Lawson: Yeah.

Peter Lawson: I mean, we see demand being consistent and growing now, especially with the new centers coming on with that nonetheless ramping up so demand is not an issue for that part of it with it and I think eager and addressing new manufacturing success rate trends over time from the beginning of March the success rates are improving and we expect to use this data.

Speaker Change: We're in back end.

Speaker Change: Back in the zone, where we think we were.

Frederick Vogt: I can't Dan or Peter. I mean, we see demand being consistent and growing, especially with the new centers coming on with it, not the ones ramping up. So demand is not an issue for that part of it, with it, and I think eager to address the manufacturing. And the manufacturing success rate, the trend over time from the beginning of launch, the success rates are improving, and we expect that to continue this year. Again, the guidance, Peter, is really driven by ATC launch dynamics more than anything. It's not really about uncertainty in those areas. Got you.

Speaker Change: During the first part of the watch.

Speaker Change: Got you. Thank you and is there any way of breaking out the revenue weakness you have lowered guidance kind of how much is if that's due to.

Speaker Change: Again, the guidance Peter is really driven by ATC launch dynamics more than anything it's not really about uncertainty in those areas.

Speaker Change: Demand uncertainty.

Peter Lawson: Yeah.

Peter Lawson: Got you okay. Thanks, so much.

Speaker Change: And all manufacturing uncertainty.

Peter Lawson: Sure.

Speaker Change: Thank you. Our next question comes from Reni Benjamin with citizens. Your line is open.

Speaker Change: No I don't really think there is a way of doing that.

Speaker Change: <unk>.

Speaker Change: No.

Speaker Change: Hey, guys. Thanks for taking the questions earlier, you had mentioned that.

Speaker Change: That would be very helpful.

Speaker Change: Dan are eager.

Speaker Change: These different adcs are doing things slightly different.

Speaker Change: I mean, we see demand being consistent and growing now, especially with the new centers coming on with that nonetheless ramping up so the demand is not an issue for that part of it with it and I think eager and addressing that.

Operator: Okay.

Kind of curious what are the strategies the different strategies that you guys are are employing right now to kind of get all these adcs rowing in the same direction to improve all of these.

Reni Benjamin: Thank you.

Brian Gastman: Our next question comes from Reni Benjamin with Citizens. Your line is open. Hey guys, thanks for taking the questions. Igor, you had mentioned that, you know, these different ATCs are doing things slightly different. I'm kind of curious, what are the strategies, the different strategies that you guys are, are employing right now, to kind of get all these ATCs rowing in the same direction to improve all these, you know, improve the various manufacturing. to help improve kind of the overall processes there.

Speaker Change: No manufacturing success rate trends over time from the beginning of the success rates of improvement again.

Speaker Change: Improve the various manufacturing things in.

Speaker Change: <unk> continues this year.

Speaker Change: Yeah.

Speaker Change: So again the guidance Peter is really driven by ATC launch dynamics more than anything it's not really about uncertainty in those areas.

Speaker Change: Help improve kind of the overall processes there and then just as a second question.

Speaker Change: Revised guidance I guess, we were all kind of surprised to begin with one last year you provided guidance for this year.

Speaker Change: Got you okay. Thanks, so much.

Speaker Change: Sure.

Speaker Change: Thank you. Our next question comes from Reni Benjamin with citizens. Your line is open.

Speaker Change: I'm kind of curious as to.

Speaker Change: I get being conservative now.

Speaker Change: <unk> provide guidance.

Speaker Change: Hey, guys. Thanks for taking the questions.

Frederick Vogt: And then just as a second question, it's revised guidance. I guess we were all kind of surprised to begin with when last year you provided guidance for this year. I'm kind of curious as to, you know, I get being conservative now. Why provide guidance for 2025 way back in 2024 to begin with?

Speaker Change: Guidance for 2025 way back in 2024 to begin with.

Speaker Change: You had mentioned that.

Speaker Change: Current <unk> are doing things slightly different.

Speaker Change: So the first part perhaps them can answer sure I can also throw it over to Brian for that one of the things were seeing from the tumor tissue procurement that's happening at the centers and replicating the success that we're seeing with the surgeons that are doing it better than others, we actually have our field teams out there now.

Speaker Change: Curious what are the strategies the different strategies that you guys are are employing right now to kind of get all of these adcs rowing in the same direction to improve all of these.

Speaker Change: Improve the various manufacturing things.

Brian Gastman: So the first part, perhaps Deb can answer. Sure, I can also throw over to Brian for that. One of the things we're seeing for the tumor tissue procurement that's happening at the centers and replicating the successes that we're seeing with the surgeons that are doing it better than others, we actually have our field teams out there now that are really focused and actually from the medical affairs side, so I'll hand to Brian. But Brian, can you talk about how your field teams are addressing that and the centers to replicate success? Yeah, I think one of the things that's happening is we recognize that these centers continue to grow internally.

Speaker Change: Yeah.

Speaker Change: Really focused and actually from the mountain medical affair side, So I'll hand to Brian, but Brian can you talk about how your field teams are addressing that.

Speaker Change: Improve kind of the overall processes there and then just as a second question. Its a revised guidance I guess, we were all kind of surprised to begin with one last year you provided guidance for this year.

Speaker Change: Okay.

Brian: Yes, I think one thing that's happening is we've recognized that these centers continue to grow internally to keep adding new members and what we've been doing really you can call. It a white glove service.

Speaker Change: I'm kind of curious as to.

Speaker Change: I get being conservative now.

Speaker Change: Why provide.

Speaker Change: Getting in there and actually.

Speaker Change: Guidance for 2025 way back in 2020 forward to begin with.

Speaker Change: Really for the newer surgeons to actually go from we call start programs start to finish program, where we actually go in and we'll walk through the surgery and beyond with them to try to make sure that every case is as successful as possible. We've had very good feedback and enjoying it especially that the new centers in the new surgeons and we are hoping to try to really.

Speaker Change: So the first part of the hip stem can answer sure I can also throw it over to Brian for that one of the things were seeing from the tumor tissue procurement that's happening at the centers.

Brian Gastman: They keep adding new members and what we've been doing really, we call it a white glove service where we're getting in there and actually, certainly for the newer surgeons that actually go from, we call it the start program or start to finish program where we actually go in and we'll walk through the surgery and be on with them to try to make sure that every case is as successful as possible. We've had very good feedback, they're enjoying it, especially the new centers and the new surgeons and we're hoping to try to really. Speak up those learning curves for our newest ADCs so that they can learn from the successes of our best ADCs that have been around a long time.

Speaker Change: And replicating the successes that we're seeing with the surgeons that are doing it better than others. We actually have our field teams out there now to really focus and actually from the mountain medical affair side, So I'll hand to Brian but.

Speaker Change: Speed up the learning curve for our newest atc's. So that they can learn from the successes of our best <unk> that have been around a long time.

Speaker Change: But Brian can you talk about how your field teams are addressing that.

Speaker Change: I guess I can get the second part of your question ready back in August we were trying to give investors our best line of sight to what we thought was going to happen.

Speaker Change: Okay.

Speaker Change: Yes, I think one thing that's happening is we've recognized that these centers continue to grow internally to keep adding new members and what we've been doing really you can call. It a white glove service, where we're getting in there and actually.

Speaker Change: At that point, we were very well aware of the high demand for the product and we were ramping up our manufacturing as finished goods. We built our model on the back of how many manufacturing slots, we would make available maximum ramp now as we've gone we've learned a lot about the launch.

Speaker Change: For the newer surgeons to actually go from recall start programs start to finish program. When we actually go in and we will work.

Frederick Vogt: I guess I can get the second part of your question, Reni. Back in August, we were trying to give investors our best line of sight to what we thought was going to happen. At that point, we were very well aware of the high demand for the product, and we were ramping up our manufacturing as fast as we could, so we built our model on the fact of how many manufacturing slots we would make available at maximum ramp. Now, as we've gone, we've learned a lot about the launch, especially recently as we've watched some of the dynamics of the ATCs, we looked at our experience with growth trajectories there, we looked at the timelines it takes for new ATCs to come on board and begin treating their first patients and how they work through their processes.

Speaker Change: The surgery and beyond with them to try to make sure that every case is as successful as possible. We've had very good feedback to enjoy especially that the new centers in the new surgeons and we're hoping to try to really.

Speaker Change: She recently as we watch some of the dynamics of the Accs, we looked at our experience with growth trajectory. There. We look at the timeline. It takes for new Atc's to come onboard and begin treating their first patients and how they work through their processes. We're onboarding. These large community practices, which takes some time and we're doing the CRO process, which takes a lot of time and as we looked at that we just decided that it was better.

Speaker Change: Speed up the learning curve for our newest ADC. So that they can learn from the successes of our best <unk> that have been around a long time.

Speaker Change: I guess I can get the second part of your question ready back in August we were trying to give investors our best line of sight to what we thought was going to happen.

Speaker Change: <unk> and more accurate for us to forecast guidance that we gave today.

Joe you that we can we can still make this product grow very very substantially but now we're going to do is we're just going to limit our manufacturing slots at the peak.

Frederick Vogt: We're onboarding these large community practices, which takes some time, and we're doing the community referral process, which takes a lot of time, too. And as we looked at that, we just decided that it was better and more accurate for us to forecast guidance that we gave today to show you that we can still make this product grow very, very substantially. But now what we're going to do is we're just going to limit our manufacturing slots. It ends up being potentially almost a neutral one with respect to how we use our cash, and we'll roll forward and we'll continue to succeed on the launch.

Speaker Change: At that point.

Speaker Change: We are very well aware of the high demand for the product and we were ramping up our manufacturing is finished because we built our model on the back of how many manufacturing slots, we would make available maximum ramp now as we've gone we've learned a lot about the launch.

Speaker Change: Almost a neutral with respect to how we use our cash.

Speaker Change: And we will roll forwards and we will continue to succeed with the launch, but we think we'll do it on terms that are I think a little bit more in line with what we actually see the seats.

Speaker Change: Especially recently is we've watched some of the dynamics of the accs, we looked at our experience with growth trajectory. There. We look at the timeline. It takes for new Adcs to come onboard and begin treating their first patients and how they work through their processes.

Speaker Change: Thank you. Our next question comes from Steve.

Gordon: Gordon with truth your line is open.

Speaker Change: These large community practices, which takes some time and we're doing the CRO process, which takes a long time too and as we looked at that we just decided that it was better and more accurate for us to forecast guidance that we gave today to show you that we can we can still make this product grow very very substantially but now we're going to do is we're just going to limit our manufacturing.

Frederick Vogt: But we think we'll do it on terms that are, I think, a little bit more in line with what we actually see at the ATCs. Thank you.

Speaker Change: Okay. That's great. Thanks for taking the question.

Speaker Change: What percentage of the product is currently being manufactured ICT versus contract manufacturer.

Speaker Change: And then also again, while our manufacturing success rate Todd the clinicians they noted that.

Karina: Our next question comes from Asthika Goonewardene with Truist. Your line is open. Hi, this is Karina for Asthika. Thanks for taking the questions.

Speaker Change: There is a need for a larger amount of tissue timber successor, I can't comment on that.

Speaker Change: Slots at the peak.

Igor Bilinsky: What percentage of the product is currently being manufactured at the ICT versus contract manufacturer? And then also, again, lower manufacturing success rates. Some of the clinicians, they noted that there's a need for a larger amount of tissue to improve success rate. Can you comment on that?

Speaker Change: Thanks.

Speaker Change: So I'll take the first part of <unk> internal manufacturing facility.

Speaker Change: Almost a neutral with respect to how we use our cash.

Speaker Change: We will roll forward that we will continue to succeed in the launch, but we think we'll do it on terms that are I think a little bit more in line with what we actually see the seats.

Speaker Change: Possible for most of the manufacturing volume and has significantly higher catastrophes, our contract manufacturer and then the second part, perhaps I'll turn it over to Brian.

Igor Bilinsky: So I'll take the first part of ITTC, our internal manufacturing facility is responsible for most of the manufacturing volume and has significantly higher capacity than our contract manufacturer.

Speaker Change: Thank you. Our next question comes from Stephen Gordon with tourists. Your line is open.

Brian: A lot of guidance changes in terms of best surgical practices. It goes from volume of tumor to handling of tumor in general and preparing before being sent.

Stephen Gordon: Okay. That's great. Thanks for taking the questions.

Speaker Change: Beyond this with you.

Stephen Gordon: What percentage of the product is currently being manufactured ICT versus contract manufacturer.

Brian Gastman: And then the second part, perhaps I'll turn it over to Brian. Yeah, I mean, we've made a lot of guidance changes in terms of best surgical practices. It goes from volume of tumor to handling of tumor in general and preparing it before it's being sent. To be honest with you, you know, do we need all the tumor that we get sent? Not always, but we generally guide towards what I would call the average ATC, the average surgeon, because, you know, the best surgeons probably don't need any guidance and probably the below average need a lot of guidance.

Speaker Change: Do we need to.

Brian: Two were that we get a sense not always but we generally.

Stephen Gordon: And then also again lower manufacturing success rate Todd the clinicians they noted that.

Brian: Guide towards what I would call the average ATC the average surgeon because the best surgeons, probably don't need any guidance in probably the below average deal on the guidance and so in general we do try and ask them for as much tumor that reasonably fits into our into the model that we give them.

Stephen Gordon: There is a need for a larger amount of tissue timber successor, I can't comment on that.

Stephen Gordon: Thanks.

Stephen Gordon: So I'll take the first part of <unk> internal manufacturing facility is responsible for most illuminate texturing volume is significantly higher than the cost that hit them all.

Yes.

Brian: Alright, thank you.

Brian Johnson: Manufacture and then the second part I'll turn it over to Brian.

Speaker Change: Thank you I'm showing no further questions at this time I would now like to turn it back to Fred vote interim President and CEO for closing remarks.

Operator: And so in general, we do try to ask them for as much tumor that reasonably fits into the vial that we give them. All right, thank you. Thank you. I'm showing no further questions at this time.

Speaker Change: A lot of guidance changes in terms of that surgical practices. It goes from volume of tumor to handling of tumor in general and preparing before things.

Speaker Change: Thank you again for joining the <unk> Biotherapeutics first quarter 2025 financial results and corporate update conference call.

Brian Johnson: The honest with you.

Brian Johnson: Do we need to.

Speaker Change: Look forward to providing future updates on our great commercial clinical portfolio, including our data presentation and investor event at the upcoming <unk> annual meeting in Chicago.

Brian Johnson: Two were that we get a sense not always but we generally.

Frederick Vogt: I would now like to turn it back to Fred Vogt, Interim President and CEO, for closing remarks. Thank you again for joining the Iovance Biotherapeutics First Quarter 2025 Financial Results and Corporate Updates conference call. We look forward to providing future updates on our growing commercial and clinical portfolio, including our data presentation and investor event at the upcoming ASCO annual meeting in Chicago. We are motivated by the stories we continue to hear about the patients who benefit from Iovance Health Cell Therapy during clinical trials in the commercial setting. I'm confident that Iovance will remain the global leader in innovating, developing, and delivering current and future generations of tilt-cell therapies for patients with cancer.

Brian Johnson: Guide towards what I would call they averaged ATC the average surgeon because the best surgeons, probably don't need any guidance in probably the below average deal on the guidance and so in general we do try and ask them for as much tumor that reasonably fits into our into the model that we give them.

Speaker Change: We are motivated by the stories, we continue to hear about the patients who benefit from my advanced cell therapies in a clinical trial and commercial settings.

Speaker Change: I'm confident that I've asked will remain the global leader in innovating developing and delivering current and future generations until cell therapies for patients with cancer.

Brian Johnson: Yes.

Speaker Change: As always we are thankful for the patients health care and advocacy communities, our partners and our exceptional <unk> team I would also like to thank our shareholders and covering analysts for their support thank you.

Brian Johnson: Alright, thank you.

Speaker Change: Thank you I'm showing no further questions at this time I would now like to turn it back to Fred the interim President and CEO for closing remarks.

Speaker Change: This concludes today's conference call. Thank you for participating you may now disconnect.

Brian Johnson: Thank you again for joining the <unk> Biotherapeutics first quarter 2025 financial results and corporate update conference call.

Operator: As always, we are thankful to the patients, healthcare and advocacy communities, our partners, and our exceptional Iovance team. I'd also like to thank our shareholders and covering analysts for their support. Thank you.

Brian Johnson: We look forward to providing future updates on our great commercial clinical portfolio, including our data presentation and investor event at the upcoming <unk> annual meeting in Chicago.

Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.

Brian Johnson: We are motivated by the stories, we continue to hear about the patients who benefit from Ivy Hill cell therapies in a clinical trial and commercial setting.

Brian Johnson: I am confident that I've asked will remain the global leader in innovating developing and delivering current and future generations until cell therapies for patients with cancer.

Brian Johnson: As always we are thankful for the patients health care and advocacy communities, our partners and our exceptional <unk> team.

Brian Johnson: I'd also like to thank our shareholders and covering analysts for their support thank you.

Brian Johnson: This concludes today's conference call. Thank you for participating you may now disconnect.

Brian Johnson: [music].

Brian Johnson: Okay.

Brian Johnson: [music].

Brian Johnson: Okay.

Brian Johnson: [music].

Brian Johnson: Yes.

Brian Johnson: [music].

Brian Johnson: Yes.

Brian Johnson: [music].

Brian Johnson: Sure.

Brian Johnson: [music].

Brian Johnson: Yes.

Brian Johnson: [music].

Brian Johnson: Yes.

Brian Johnson: [music].

Brian Johnson: Yes.

Brian Johnson: Okay.

Brian Johnson: [music].

Brian Johnson: Yes.

Brian Johnson: [music].

Brian Johnson: Yes.

Brian Johnson: [music].

Brian Johnson: Yes.

Brian Johnson: Sure.

Brian Johnson: [music].

Brian Johnson: Yes.

Brian Johnson: Okay.

Brian Johnson: Yes.

Brian Johnson: [music].

Brian Johnson: Okay.

Brian Johnson: [music].

Brian Johnson: Sure.

Brian Johnson: Yes.

Brian Johnson: [music].

Brian Johnson: Okay.

Brian Johnson: [music].

Brian Johnson: Okay.

Brian Johnson: Sure.

Brian Johnson: [music].

Brian Johnson: Yes.

Brian Johnson: [music].

Brian Johnson: Yes.

Brian Johnson: Sure.

Brian Johnson: Yes.

Brian Johnson: Okay.

Brian Johnson: Yes.

Brian Johnson: Okay.

Brian Johnson: [music].

Brian Johnson: Okay.

Brian Johnson: [music].

Brian Johnson: Yes.

Brian Johnson: [music].

Brian Johnson: Okay.

Brian Johnson: [music].

Brian Johnson: Yes.

Brian Johnson: Okay.

Brian Johnson: Sure.

Brian Johnson: Okay.

[music].

Brian Johnson: Okay.

Brian Johnson: [music].

Brian Johnson: Yes.

Brian Johnson: [music].

Brian Johnson: Okay.

Brian Johnson: [music].

Brian Johnson: Sure.

Brian Johnson: Thanks.

Brian Johnson: Yes.

Brian Johnson: Okay.

Brian Johnson: Yes.

Brian Johnson: Okay.

Brian Johnson: Yes.

Brian Johnson: Okay.

Brian Johnson: [music].

Brian Johnson: Okay.

Brian Johnson: Yes.

Brian Johnson: Thanks.

Brian Johnson: Okay.

Brian Johnson: Sure.

Brian Johnson: [music].

Brian Johnson: Okay.

Speaker Change: Good day, and thank you for standing by and welcome to the Io Vance Biotherapeutics first quarter 2025 financial results Conference call.

Speaker Change: At this time all participants are in a listen only mode.

Speaker Change: After the speaker's presentation, there will be a question and answer session.

Speaker Change: I ask a question during the session you will press star one on your telephone.

Speaker Change: We'll then hear an automated message advising your hand is raised to withdraw your question. Please press star one again.

Speaker Change: Please be advised that today's conference is being recorded.

Speaker Change: I'd now like to hand, the conference over to your Speaker today, Sara Pellegrino SVP of IR and corporate Communications. Please go ahead.

Speaker Change: Good afternoon, and thank you for joining the <unk> conference call and webcast to discuss our first quarter 2025 financial result, as well as recent corporate update Dr.

Speaker Change: <unk>, our interim Chief Executive Officer, and President, who will provide an introduction and focus on the U S.

Speaker Change: Commercial launch of <unk>, including revenues and revenue guidance.

Dan Kirby: Dan Kirby Chief commercial officer.

Dan Kirby: <unk> commercial launch Dr. Igor Bolinsky, our Chief operating officer will provide a manufacturing up eight.

Speaker Change: John and Mark <unk>, our CFO will review, our financial results, including revenue and revenue guided gross margin and cash burn guidance and Dr. Frederic Finkelstein, our Chief Medical Officer will summarize key pipeline program.

Speaker Change: Additional members of our leadership team, including Dr. Raj Perry, our Chief Regulatory Officer, Dr. Brian Gathman, our EVP of medical affairs will be available for the Q&A session.

Speaker Change: Earlier. This afternoon, we issued a press release it is available on our corporate website at <unk> Dot com.

Speaker Change: Before we start I would like to remind everyone that statements made during this conference call.

Speaker Change: Forward looking statements regarding island gold and <unk>.

Speaker Change: Is this plant in transaction revenue and revenue guidance commercial activity clinical trials and results regulatory approvals and interaction plans and strategy research and preclinical activity and potential future applications of our technology manufacturing capabilities.

Speaker Change: Regulatory feedback and guidance payer interaction licenses that collaboration cash position an expense guidance and future update forward looking statements are subject to numerous risks and uncertainties many of which are beyond our control, including the risks and uncertainties described from time to time in our SEC filings.

Speaker Change: Thank you Sarah and welcome to the <unk> first quarter 2025 conference call.

Speaker Change: We're four quarters into our U S launch, we unpack the first FDA approved cell therapy, and the first treatment for patients with advanced melanoma, we progressed following anti PD, one treatment as appropriate targeted therapy.

Speaker Change: In the first 12 months of our U S launch, we execute towards our long term goal adoption.

Speaker Change: Adoption goal to generate more than $210 million in revenue.

Speaker Change: This includes infusions from nearly 300 and Peggy patients in the first launch year, starting with our first infusions in April 2024.

Speaker Change: Total first quarter product revenue was $49 $3 million, including $43 $6 million for more than 80 Mpeg infusions.

Speaker Change: $5 $7 million from Proleukin sales.

Speaker Change: Following steady growth throughout 2024 revenue was lower in the first quarter of this year drove by three key contributors.

Speaker Change: First our internal manufacturing facility the ICT Sea completed annual scheduled maintenance in December of last year as we previously discussed on last quarter's call.

Speaker Change: As a result of limited production starts for multi weekend tank manufacturing across our network capacity was reduced by more than half for about one month.

Speaker Change: In addition volume was impacted by higher rates of patient drop off and lower manufacturing success rates, but has since rebounded.

Speaker Change: Today, we are seeing healthy demand with a record number of production started in the second quarter.

Speaker Change: Lower produce proleukin sales for the second factor contributing to lower first quarter revenue.

Speaker Change: We expect two of the three largest U S wholesalers to start replenishing proleukin in line with growing and highly demanded second quarter.

Speaker Change: We're also growing the other components of our franchise, including sales of Probuphine to third parties for use with manufacturing and clinical research.

Speaker Change: Certain attributed in the first quarter revenue was the variable payment, which atc's began treating patients.

Speaker Change: This differs from center to center for context, 60% of Atc's are treated more than 10 patients.

Speaker Change: The ACC to have ample room to grow and we anticipate near term contributions from ACC came online in the latter half of 2024 into 2025.

Speaker Change: We're also confident in our growth prospects under our new Chief Commercial Officer, Dan Kirby.

Dan Kirby: Dan brings in valuable leadership experience in cell therapy commercial organization since the earliest developments in the field.

Dan Kirby: Less than three months data is already strengthening our commercial operations to drive adoption.

Dan Kirby: Amplify earlier community referrals to our agency network.

Dan Kirby: The commercial team is working aggressively to implement key learnings from the first year as we continue to execute our U S launch.

Dan Kirby: We're also excited about upcoming milestones related to our ex U S launch expansion and pipeline development to lung cancer and beyond.

Dan Kirby: We anticipate three potential approvals for am Peggy the United Kingdom, Canada, and the European Union and additional regulatory submissions are also underway in Australia and Switzerland.

Dan Kirby: We are on track to report updated data from our Registrational trial uplift Luzon previously treated advanced non small cell lung cancer.

Dan Kirby: And first clinical data in endometrial cancer.

Dan Kirby: And we continue to advance our robust pipeline of next generation wholesale therapies for patients with solid tumors.

Dan Kirby: Looking ahead I will briefly comment on our revised full year revenue guidance of cash spend outlook.

Dan Kirby: Our guidance to between.

Dan Kirby: 250, and $300 million in total product revenue for the full year 2025.

Dan Kirby: We consider our experience with growth trajectory that the accs timelines for new ATC to begin treating their first patient in.

Dan Kirby: And expectations for large community practices in community referrals to drive momentum in the second half of 2025.

Dan Kirby: These demand trends are consistent with the trajectory of other cell therapy margins moving from your once a year or two.

Dan Kirby: After aligning our manufacturing slot plans as our new demand forecast, we are maintaining our prior cash runway guidance into the second half of 2026.

Dan Kirby: We remain confident in our peak sales opportunity of more than $1 billion in the U S and more than $2 billion globally for impact in the current approved indications.

Dan Kirby: We also continue to expect that gross margin can exceed 70% in the coming years.

Speaker Change: And tagging proleukin are showing.

Dan Kirby: Steady growth in the second quarter and will accelerate in the second half of the year <unk>.

Dan Kirby: Our momentum is strong and we project between 100 110 commercial patient infusions in the second quarter.

Dan Kirby: We're also motivated by positive feedback from key opinion leaders and patient success stories at reinvest reinforce the unmet medical need and value of impact.

On a macro level as Eagle will describe we are well prepared to supply ongoing demand delivered commercial impact as well as our investigational til products to patients around the world.

Dan Kirby: <unk> is competitively positioned with a fully U S based patent portfolio and manufacturing network.

Dan Kirby: Actually I haven't been oil and patent Tagmeme proleukin.

Dan Kirby: I'm happy to go into more detail during the Q&A I will now turn the call to Dan <unk> for a detailed commercial launch update.

Speaker Change: Thank you Fred.

Speaker Change: Blowing my first 90 days of Iron Man I'm excited about the potential for <unk> to benefit patients around the world.

Speaker Change: We've identified the strength of our launch as well as opportunities to optimize adoption and accelerate growth.

Speaker Change: And tightening the game changer for patients who have failed first line treatment of melanoma.

Speaker Change: <unk> is also the first cell therapy for patients with solid tumor cancers.

Speaker Change: I'll begin with my observations of what is going well first I'm very impressed by our confident in dedicated commercial organization and cross functional buildings. These teams has established.

Speaker Change: I would foundation foreign tangy by building awareness of the unmet need in advanced melanoma and strong clinical profile oven tagme activating.

Speaker Change: Activating our 70 atc's within our treatment network and preparing for the next wave of new centers.

Speaker Change: Securing early inclusion in the NCC and guidelines and favorable reimbursement access for more than 95% of U S covered lives.

Speaker Change: As a result of this execution and type B is a successful cell therapy.

Speaker Change: First of its kind.

Speaker Change: In solid tumors.

Speaker Change: Today, I will discuss status of near term initiatives to improve our performance across three key areas.

Speaker Change: First our Atg network expansion and retention strategy to drive adoption.

Speaker Change: A second area to address plans to revamp engagements with medical oncologists to guide earlier consideration for amtech.

Speaker Change: And the third area is further established tagme within the U S community oncology networks.

Speaker Change: I'll start with our ATC strategies.

Speaker Change: In the first year of launch we strategically prioritize 70 experienced cell therapy centers and most of the major cancer centers.

Speaker Change: Nearly all currently treated melanoma patients.

Speaker Change: In a two hour drive of these adcs.

Speaker Change: Current metrics amongst these 70 centers, demonstrating ample growth performance and potential franchisees.

Speaker Change: 79% or 56%.

Speaker Change: I've completed tumor resection, the starting material for tail manufacturer <unk>.

Speaker Change: 69% or 48.

Speaker Change: Having to use one or more patients.

Speaker Change: 16% or eliminate having to use more than 10 patients.

Speaker Change: AUC adoption is tracking in the right direction.

Speaker Change: We expect additional growth from the early launch centers with strong and steady patient volume.

Speaker Change: Newer centers activated later in the launch are currently contributing as they gain experience.

Speaker Change: This next set of ADC reflects lessons learned best practices and the characteristics that distinguish our top performing ADC while.

Speaker Change: Typically incorporating clinic referral patterns.

Speaker Change: Meanwhile, we continuously collaborate with all of our active ATC to support early referrals and best practices for procuring tumor samples.

Speaker Change: As we prepare to commercialize <unk> beyond the U S 10.

Speaker Change: Ken International treatment centers are in process to become Atc's for our planned launches in the United Kingdom, Canada and Europe.

Speaker Change: We remain on track to onboard 15 international centers.

Speaker Change: <unk> by year end.

Speaker Change: Turning to the second area of focus we have made and our goal in the last three months to better understand our physician and how they view antagonist.

Speaker Change: And the initial launch the team did a great job of educating the cell therapy community a key medical oncologists on the benefits of impact.

Speaker Change: And from our market research, we see as those physicians viewing pagni as second line treatment.

Speaker Change: We also saw that there was a disconnect in NTIC treatment sequencing between our initial target physicians, who view anti via the second line treatment and referring medical oncologists in the community who consider anti bps third minor later in therapy. This is a large market opportunity for <unk>.

Speaker Change: Our number one goal is to establish <unk> D preferred option for all appropriate patients.

Speaker Change: And we are educating referring medical oncologists to consider him tighten the urban and bring forward the promise of cell therapy within current solid tumor treatment practices.

Speaker Change: We have a sizable patient population.

Speaker Change: And we have a tremendous potential to drive earlier patient referrals to our ATC.

Speaker Change: For example, a portion of our ATC unfortunate patients who initiated in Tagme journey dire entered hospice prior to surgery. Shortly after committing to amtech. This is due to late referrals in the community.

Speaker Change: With our updated plans, we are doubling down on initiatives and medical education effort with community medical oncologists. So we can drive earlier patient referrals and shifts the treatment sequence to do this we will educate practitioners on the benefits of durable responses with onetime cell therapies like MTV versus temporary.

Speaker Change: Responses and ongoing side effects seen with other treatments.

Speaker Change: For the first time in advanced melanoma, and solid tumors with cell therapy may from a patients own immune cells has been shown to induce long term benefit with curative intent.

Speaker Change: For the third area of focus we are building relationships within community oncology networks that treat our target <unk> patient.

Speaker Change: We are expanding resources within our community field team to increase frequency speed and overall timelines for referrals and to identify new ATC targets.

Speaker Change: Recently, we have seen an increased momentum for patient referrals to current adcs and identified new Pcs.

Speaker Change: Since my arrival, we've engaged with executive leadership in every major U S community cancer network.

Speaker Change: We are now collaborating with a top U S community clinic networks to identify an onboard several preferred centers for amtech.

Speaker Change: We are also focused on breaking down any remaining access barriers to adoption.

Speaker Change: For example, we are exploring alternative distribution channels that may offer flexibility and broader acceptance of onetime therapies like <unk>, while maintaining our current pricing strength.

Speaker Change: In addition to impacting our commercial organization and dedicated to supporting Proleukin across three key business lines used within tabby used in manufacturing and clinical use.

Speaker Change: Aside from the main business tied to timing manufacturing and clinical use represented an existing base revenue for my.

Speaker Change: My team is focusing on opportunities to increase sales growth in all three areas.

Speaker Change: Fred mentioned strong product sales in our main channel resume throughout the remainder of 2025, including two distributors expected to reorder in the second quarter.

Speaker Change: In summary, I am.

Speaker Change: Energized to lead our commercial organization toward a bright future.

Speaker Change: Launching a first in class therapy entails a unique set of opportunities to make a fundamental difference.

Speaker Change: I'm deeply committed to the <unk> vision of pioneering a new treatment paradigm for physicians, who treat patients with solid tumors.

Speaker Change: We have barely scratched the surface of the protagonist potential globally address more than the 330000 melanoma patient value.

Speaker Change: And <unk> has tremendous promise and volunteer cancers, which represent 90% of all cancers.

Speaker Change: I will now pass the call to Ibama Lynskey, our chief operating officer to highlight our manufacturing progress.

Speaker Change: Thank you Tim.

Speaker Change: Today, I will provide an update on our progress in manufacturing.

Speaker Change: Our Philadelphia based manufacturing network consists of two FDA approved facilities, our internal manufacturing facility, the IBM cell therapy center, or ICC and an American owned contract manufacture.

Brooks serves commercial patients in the U S as well as clinical trial patients across Europe, Australia and Asia.

Speaker Change: We experienced disappointing tilt cell therapies to clinical patients around the world provides a strong foundation, while delivering commercial product you UK and Canada in the near term.

Speaker Change: Today I am pleased to report a major step forward in the ongoing review of our marketing authorization application or MAA for the European Union approval.

Speaker Change: Recently as part of the M&A process.

Speaker Change: European Medicines agency or EMA inspected and confirmed that the ITC empower contract manufacturer's facility are both GMP compliant. These.

Speaker Change: These successful EMEA inspections further validate our manufacturing network capabilities to meet regulatory standards for multiple health care authorities as we prepare to serve commercial patients in the European Union.

Speaker Change: Good.

Speaker Change: As part of the ongoing launch we steadily ramped up our manufacturing capacity to align with demand while tightly controlling expenses.

Speaker Change: As a result of our revised revenue guidance and updated demand forecast as Fred described we expect to realize additional cost savings by aligning our manufacturing capacity with.

Speaker Change: With demand.

Speaker Change: Owning our own manufacturing facility provides us with tremendous flexibility to scale up efficiency when needed.

Speaker Change: As mentioned previously ITC conduct business successfully completed annual scheduled maintenance.

Speaker Change: Given the three week manufacturing process from the.

Speaker Change: The network capacity was reduced by more than 50% for approximately one month in December 2020, or thus lowering available capacity for Q1 type institutions.

Speaker Change: Following maintenance production resumed successfully with full capacity available for Q2.

Speaker Change: Yes.

Speaker Change: I will also comment on our manufacturing success rate in the first quarter.

Speaker Change: Delivering final product within defined specifications is critical for treating patients.

Speaker Change: Throughout the first nine months of the launch our commercial and manufacturing experience was consistent with prior clinical experience.

Speaker Change: Innovation drove both in and out of spec rate increased somewhat from the first quarter.

Speaker Change: Impacting our cost of goods and gross margin as Mark will discuss.

Speaker Change: Following Q1 manufacturing success rate has since rebounded.

Speaker Change: During this year, we'll also expect to shorten or manufacturing turnaround time, which is currently at 34 days from receipt of ourselves of the manufacturing facility to <unk> going to be ready for a term shipments and as.

Speaker Change: We continue to be in laser focus on driving operational additional seats and economies of scale to optimize the cost of goods and improve gross margin over time.

Speaker Change: Shifting to the current macroeconomic and geopolitical environment.

Speaker Change: <unk> operating agenda strategic advantage within the Biopharma industry.

Speaker Change: We expect an.

Speaker Change: And to see minimal impact from tariffs.

Speaker Change: Our intellectual property for <unk> investigational therapies is domiciled in the U S.

Speaker Change: <unk> manufacturing is based in the U S.

Speaker Change: Most of them temporary cost is U S based with direct materials procured from ex U S vendors currently representing less than 5% of them talking to your customers.

Speaker Change: We are also broke positioned for looking at inventory until the U S. We expect that this addition for meeting demand into 2020.

Speaker Change: Our total cell therapy expertise and manufacturing capabilities are protected by a robust at this stage of installed in the U S.

Speaker Change: We own approximately 280 granted or allowed U S and international.

Speaker Change: One time up until related technologies, we expect these patents provide exclusivity through at least 2000 pointed to I'm.

Speaker Change: I'm available to answer questions. During the Q&A I will now have the colds, who show Mark <unk> financials.

Speaker Change: Thank you Joe.

Speaker Change: Today, I will review, our cash position and our results for the first quarter of 2025.

Speaker Change: I will also highlight our financial outlook, including revenue expanded geismar expense guidance and gross margin.

Speaker Change: As of March 31, 2025.

Speaker Change: Cash position was approximately 366 million.

Speaker Change: Our current cash position is sufficient to fund current and planned operations, including manufacturing expansion.

Speaker Change: The second half of 2026.

Speaker Change: We will now transition to our financial results.

Speaker Change: Net loss for the first quarter of 2025 was $116 2 million.

Speaker Change: All sorts of six cents per share compared to a net loss of $113 million.

Speaker Change: <unk> 42 per share for the first quarter of 2024.

Speaker Change: Total product revenue consisted of an <unk> infusion in the U S and protein sales.

Speaker Change: Total product revenue was $49 3 million for the first quarter of 2025.

Speaker Change: Including $43 6 million foreign Doug.

Speaker Change: $5 $7 million for port looking compared to total product revenue of 0.7 million for the first quarter of 2024.

Speaker Change: Portfolio the U S commercial launch of <unk> sales drove the revenue increase in the first quarter of this year over the prior year Europe very good.

Speaker Change: I will now highlight our cost of sales, which includes cost of inventory overhead and related cash and noncash expenses that are directly associated with sales of <unk> as well as manufacturing cost for <unk>.

Speaker Change: Cost of sales for the first quarter of 2025 was $49 7 million.

Speaker Change: Including $15 million in there.

Speaker Change: <unk> cost associated with patient drop off and manufacturing success rates and increased quarter over quarter. As we go previously described.

Speaker Change: $5 4 million for noncash expenses, including fair market value step up and intangible asset amortization our amortization.

Speaker Change: One $3 million in royalties payable on product sales.

During the first quarter of 2020 for cost of sales was $7 3 million.

Speaker Change: Primarily related to noncash amortization for acquired intangible assets.

Speaker Change: The increase in cost of sales in the first quarter of 2025 over the prior year period was primarily attributable to cash and non cash expenses associated with the <unk> product sales tied to the U S launch.

Speaker Change: Along with various cost associated risk patient drop off in manufacturing success rates.

Speaker Change: Average 10 to our gross margin is.

Speaker Change: So it's 2% for the first four launch quarters.

Speaker Change: Our gross margin for the first quarter of 2025 was 10% of $5 million.

Speaker Change: Compared to total product revenue of $49 3 million.

Speaker Change: First quarter was negatively impacted by lower revenue and higher cost of sales as previously described.

Speaker Change: As we increase volume and capacity utilization, we expect gross margin to surpass 70% in the coming years.

Speaker Change: Our priorities are to drive revenue, while optimizing our cost of sales with a correspondingly higher gross margin.

Speaker Change: We expand our manufacturing coordinate and continue our focus on interest and engagement and training and realize efficiencies in manufacturing and release system.

Speaker Change: I will now shift to our operating expenses.

Speaker Change: Research and development expenses were 7% to $6 9 million for the first quarter of 2025.

Speaker Change: Decrease of 4% compared to $79 8 million.

Speaker Change: For the same period.

Speaker Change: Prior year period.

Speaker Change: That was primarily attributable to the transition of <unk>.

Speaker Change: From clinical to commercial manufacturing.

Speaker Change: This decrease was partially offset by higher head count and related costs.

Speaker Change: <unk> stock based compensation and clinical trial costs, resulting from continued enrollment in existing trials.

Speaker Change: Selling general and administrative expenses were $43 9 million for the first quarter of 2025, an increase of 40% compared to $31 4 million for.

Speaker Change: For the prior year period.

Speaker Change: Higher selling general and administrative expenses were primarily attributable to increases net calvin related costs, including stock based compensation to support the growth in the overall business and related corporate infrastructure marketing and legal costs and costs to support the commercialization of franchisees in Peru.

Speaker Change: Looking ahead we.

Speaker Change: We revised our guidance to between 250 and 300 million in total product revenue for the full year 2000.

Speaker Change: All right.

Speaker Change: After our aligning our manufacturing slot expansion strategy without losing mental cost we are maintaining our program cash runway guidance into the second half of 2026.

Speaker Change: Cash burn for full year 2025 is expected to remain in line with prior guidance of less than $300 million.

Speaker Change: With a strong focus on optimizing spending and reducing expenses throughout the organization, including flat expenses related to MTBE manufacturing account expansion for the leather off of 2025.

Speaker Change: As we grow revenue and gross margin improves.

Speaker Change: We expect further reduction in our net cash spend with ample flexibility to control both capital and operating expenses as we approach breakeven.

Speaker Change: I will now end the call to Frederick Chief Medical officer to discuss our clinical pipeline.

Speaker Change: Okay.

Speaker Change: Thank you so much.

Speaker Change: Second.

Speaker Change: Compared to prior data updates.

Speaker Change: Results showed consistent trends for overall survival and durability over a five year period.

Speaker Change: Our clinical program for <unk> next generation approaches are the next frontier for <unk> cell therapy in solid tumors, which represent more than 90% of all diagnosed cancer in the U S.

Speaker Change: Future growth drivers include global label expense for Liza loosely into frontline about melanoma other solid tumor types, such as non small cell lung cancer and next generation therapies today, I will summarize our pipeline updates.

Speaker Change: First we are making progress towards the broader commercial opportunity for <unk> in frontline in melanoma.

Speaker Change: Melanoma.

Speaker Change: A global Registrational phase III trial till them.

Speaker Change: <unk> remains on track to support accelerated and full approval of <unk> in combination with <unk> in frontline advanced melanoma as well as regular approval of intact in our initial indications and post anti PD one melanoma approval.

Speaker Change: The proof of concept cohort is also investigating <unk> in combination with development rollout in the U S.

Speaker Change: Yes.

Speaker Change: Our Registrational program in advanced non small cell lung cancer. The single arm phase II <unk> clinical study is designed to show efficacy and safety of flight little monotherapy in patients progressing app for anti PD one therapy.

Speaker Change: There is a significant unmet medical need is most patients progress and.

Speaker Change: And chemotherapy the current standard of care in the treatment setting provide limited rate and duration of responses.

Speaker Change: We remain on track to share additional data from Iot you went to a two in the second half of 2025.

Speaker Change: Trial is designed with the potential to support a potential regulatory decision on U S accelerated approval and post anti PD, one non small cell lung cancer in 2027.

Speaker Change: In frontline non small cell lung cancer.

Speaker Change: <unk> is to establish a new regimen consisting of license.

Speaker Change: Following standard of care chemotherapy parallelism up.

Speaker Change: Multiple cohort investigate with patients with Egfr wild type non small cell lung cancer, who are the majority of patients with an unmet medical need in this treatment setting.

Speaker Change: Turning to another significant opportunity advanced endometrial cancer, our <unk> hundred one clinical trial is investigating license after frontline standard of care of chemotherapy and anti PD one.

Speaker Change: We look forward to sharing initial data from <unk> hundred one in the second half.

Speaker Change: Our PD, one inactivate until cell therapy, <unk> 4001 continues to enroll patients in the trial as previously treated melanoma or non small cell lung cancer.

Speaker Change: And lastly, all of the hype is the genetically engineered inducible tethered IL 12, total for RFP with potential for enhanced activity, which could facilitate expansion into a wide range of common solid tumor cancers beyond our current pipeline with significant market opportunity.

Speaker Change: We plan to submit an investigational new drug applications to the FDA. This year for <unk> 5000, a month.

Speaker Change: I'm happy to address questions about these programs and additional trials in the Q&A session I'll now turn the call over to the operator to begin the question and answer session.

Speaker Change: As a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced to withdraw your question. Please press star one again.

Speaker Change: In the interest of time, we ask that you. Please limit yourself to one question and you may rejoin the queue. Please standby, while we compile the Q&A roster.

Speaker Change: Okay.

Speaker Change: Our first question comes from Andrew Tsai with Jefferies. Your line is open.

Speaker Change: Hey, Thanks. Good afternoon. Thanks for taking my question I. Appreciate the update my question is around the line of sight you have.

Speaker Change: <unk>.

Speaker Change: The revised guidance, presumably you do have some direct line of sight, maybe at least a month in advance into the number of patients who are waiting.

Speaker Change: Get dosed in the queue can you confirm.

Speaker Change: Whether youre seeing or have seen a spike or in fact inflection in patient uptake as of today to give you the confidence.

Speaker Change: Around your guidance of 100 110 patients for Q2. Thank you.

Speaker Change: So Andrew this is Dan. Thank you very much yes, we're confident in that number and we are seeing demand as we stated in the script.

Speaker Change: And quarter to be strong.

Speaker Change: Thank you. Our next question comes from Tyler Van Buren with TD Cowen Your line is open.

Speaker Change: Hey, guys. Thanks, very much for all the information.

Speaker Change: Maybe you could discuss the barriers of the other 37 agencies that are infused more than one patient, but have been infused 10, plus and what tactics you are employing to to get them to increase their utilization.

Speaker Change: Yes.

Dan Kirby: I'll start and I'll pass over to Dan to give you a little bit more in the second part of that question on the trial only a few of those atc's, we're actually involved in the trial.

Speaker Change: Hey.

Speaker Change: It's not necessarily.

Speaker Change: Correlation between the clinical trial unit at a site in their experience on the site does with commercial impact.

Speaker Change: Different people and we have to work closely with that that unit any GCC to get them up to speed. So there is.

Speaker Change: Some learning there, but were able to overcome it obviously, we're learning quite a bit ourselves about how to do that and we're getting better and better all the time and Thats why we have confidence that many of those other ACC is going to come off quickly in fact, we're seeing that today, but Dan do you want to take the second part of the question sure and looking at just with cell therapy in general there is actually patients coming into tree and.

Dan Kirby: There is a cell therapy.

Dan Kirby: Experienced level at these centers. So what we will say is that the larger centers that got off to a quicker start.

Dan Kirby: Once with the infrastructure from various cell therapy launches that were ready for <unk>.

Dan Kirby: To enter it in the other ones are ramping up to speed. They are doing this with other cell therapies as well, but infrastructure such as billing mechanism cell therapy lab et cetera are coming online with that so we are seeing them increase their ramp a lot quicker once they get that infrastructure in place that answer your question.

Speaker Change: Yeah. Thank you. Thank you.

Speaker Change: Thank you. Our next question comes from Celine site with Mizuho. Your line is open.

Speaker Change: 20% Proleukin.

Speaker Change: Backing into that.

Speaker Change: Balance of the year Youre going to have something like 250 or 325.

Speaker Change: 325 infusions.

Speaker Change: So roughly call it 100.

Speaker Change: 110, something like 100 100 per quarter, roughly is that a correct way to sort of think about this which essentially apply.

Speaker Change: No growth versus.

Speaker Change: No growth versus like the <unk> number.

Speaker Change: No absolutely that's not how you want to think about it we're actually.

Speaker Change: Now as you know.

Speaker Change: We did a $164 million in revenue last year.

Speaker Change: <unk> quite a bit of a look at.

Speaker Change: And what we're projecting is $2 50, and 250 to 300 this year, which is which is some growth there obviously.

Speaker Change: Four quarters of the fiscal year and of course there'll be another quarter into 2026 at the grocery store.

So you are looking at like 50% or more growth rate. There as you go through this time period of year over year and Theres a lot of upside there as well.

Dan Kirby: Dan do you want to add to that sure. So what I would say is the way you can look at this is that we expect continued growth throughout this year and so it will not be flatlining will continue to grow that's driven by two factors one as we talked about the increase of adoption in our in our centers. Both the ones that started at the very beginning and the ones that wrapped up in 2024, and the addition of <unk>.

Dan Kirby: Seeds that have enhanced referral networks within the community.

Dan Kirby: Patients not only in quantity, but also quality, meaning we're getting earlier referrals.

Dan Kirby: Okay. Thank you so much.

Dan Kirby: Thank you art.

Speaker Change: Our next question comes from Andrea Newkirk with Goldman Sachs. Your line is open.

Speaker Change: Good afternoon. Thanks for taking the question, maybe a follow up there Fred.

Speaker Change: What your guidance is implying.

Speaker Change: Her infusions I, just want to make sure I understood.

Are you, suggesting that 500 infusion should be on tap for 2025 and if that's the case then what are you.

Speaker Change: Are you assuming for Proleukin through the remainder of this year, even after the uptick expected in QQ.

Speaker Change: So if you just take the guidance, we gave subtract off a number of liquids Selim just gave you for Proleukin and divide that grew by $5 50, or so youre going to get something in the high <unk>.

Speaker Change: 400.

Speaker Change: Close to 500, depending if you think there's some upside here that could be some upside on top of that.

Speaker Change: Does that answer the question okay. Thank.

Speaker Change: So some of this thanks for the question Andrew some of this or much of this is related to patient selection in the tumor procurement.

Speaker Change: And as I mentioned, where we just saw the return to normal rebound into Q2, so far.

Speaker Change: It gives us confidence.

Speaker Change: The success rate trends that we see among Agc's group is up and running for a long time and the experience curve that they've been able to achieve so that gives us confidence that its tissue. Both apps can be translated to other agencies across the network.

Speaker Change: Thank you. Our next question comes from Jan N Xu with Wells Fargo. Your line is open.

Speaker Change: Thanks for taking our questions.

Speaker Change: First a clarifying question.

Speaker Change: Be missing something.

Speaker Change: So assuming each <unk> product is roughly <unk>.

Speaker Change: $500000.

Speaker Change: That's half a million.

Speaker Change: If there is 500 patients in Houston this year that alone will be 215 million, which is the lower bound of the guidance.

Speaker Change: So if that's the case then.

Speaker Change: Adding <unk> on top of that to the lower bound of guidance should really be above $2 50, So im trying to see if my assumption for patients.

Speaker Change: Price.

Speaker Change: And.

Speaker Change: Hi.

Speaker Change: Thank you for clarifying that my actual question is on Cogs and can you talk about.

Speaker Change: <unk>.

Speaker Change: Seems like Cogs has.

Speaker Change: Our ratio of revenue has increased over the last quarter.

Speaker Change: Just wanted to understand what proportion of them.

Speaker Change: This is due to.

Speaker Change: Patient attrition I E patient passing away cannot get the product.

Speaker Change: Manufacturing failure.

Speaker Change: Give us some color there. Thank you.

Speaker Change: Yes on the first part of our guidance, we consider this guidance to be fairly conservative.

Speaker Change: So as you go and do your math there there is going to be some upside to what we're giving you here.

Speaker Change: If we get the 500 infusions it might be above three undrawn, the upfront and thats something that we really want to with this new guidance, we really want to show that we can actually exceed guidance here.

Speaker Change: Well here with this launch so it's not going to work out exactly to where you might think maybe it's 150 patients. If you want to be more conservative however, it's still growth.

Speaker Change: The growth over the first three quarters of launch do you want to look at on a fiscal year basis or four quarters, you want to look at it in a launch year basis, but again in the first four quarters of our launch we treated about 280 some patients.

Speaker Change: Now for the Cogs question, let me ask Scott.

Speaker Change: And that's the ratio of scrap in the job.

Speaker Change: Mark maybe you were maybe to help out with that one can I just take that one Brian.

Speaker Change: So one of the things.

Speaker Change: First the quarter the $250 million is that 50% growth over 2020 for sale so revenue.

Speaker Change: That is definitely a growth in the lower important and yes, we would love to have upside to that on the <unk>.

Speaker Change: Second part when you talk about patient our basement and clarify that statement those are patients who went to hospice or died prior to the manufacturing process start. They went there before we had tumor procurement. So therefore, they would not be affecting Cogs and <unk>.

Speaker Change: I think the question that you and you know Mark I think John Marc maybe to take that.

Speaker Change: I'm happy to take the <unk> question. So, yes, Youre correct, we had an increase in there.

Speaker Change: Overall cost of sales so together.

Speaker Change: The.

Speaker Change: Joe mentioned during the script is that we see here.

Speaker Change: Spike in there I'll go spec on the first quarter that we know where we will improve over time, but you have to think also relative to the overall revenue. So yes, the cost of goods and cost of sales has increased.

Speaker Change: One, particularly related to revenue, but we knew just willing definitely improvement in Q2.

Speaker Change: Yeah.

Speaker Change: Our gross margin remained positive in Q1 is Europe Hussein.

Speaker Change: Got it thanks for the color.

Speaker Change: Okay.

Colleen QC: Thank you. Our next question comes from Colleen QC with Baird. Your line is open.

Colleen QC: Good afternoon, thanks for taking our question.

Colleen QC: So you report the <unk> drop on a spec create together, but can we assume that that out of spec rate went up and if so what drove that was it anything to do with the email maintenance and then would we expect that same one month interruption going forward every year. Thank you.

Colin: Colin Thanks for the question so again regarding the patient drop offs in manufacturing success rate.

Colin: Closely related to each agc's track record in patient selection in tumor tissue procurement.

Colin: And again the increase we saw in Q1, we believe it to be transient it's already normalized in Q2 two days.

Colin: So thats, what we believe is driving new Atc's new surgeons.

Colin: That needs to be optimized over time with which our teams are working on.

Colin: What was the second part of the question.

Colin: Just the annual maintenance whether that will be.

Colin: <unk> one months, 50% reduction in annual maintenance. So we're now completing buildout of the shelf space at the ITC.

Colin: Once that shelf space is operational which will not be this year.

Colin: It should be later on once that shelf space with operational that when we don't need to.

Colin: The maintenance below net auto the CTC facility.

Colin: <unk>.

Colin: So.

Colin: That will have less impact.

Colin: Less impact, but yes. Kelly. This is it is an annual event, but you have to do it but for now this year, we will still need to do it.

Colin: In the subsequent years to get once.

Q1 2025 Iovance Biotherapeutics Inc Earnings Call

Request a DemoDemo

IOVA

Iovance

Earnings