Q2 2026 Iovance Biotherapeutics Inc Earnings Call

August 6, 2026

Speaker #1: Welcome to the IOVANCE BIOTHERAPEUTICS Q2, 2026 conference call. My name is Daniel, and I will be your operator for today's call. At this time, all participants are in a listen-only mode.

Operator: Welcome to the Iovance Biotherapeutics Q2 2026 conference call. My name is Daniel, and I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session. Please note that this conference call is being recorded. I will now turn the call over to Sara Pellegrino, Senior Vice President, Investor Relations and Corporate Communications at Iovance. Sara, you may begin.

Operator: Welcome to the Iovance Biotherapeutics Q2 2026 Conference Call. My name is Daniel, and I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session. Please note that this conference call is being recorded. I will now turn the call over to Sara Pellegrino, Senior Vice President, Investor Relations and Corporate Communications at Iovance. Sara, you may begin.

Speaker #1: question-and-answer session. Please note that this conference call is being Later, we will conduct a recorded. I will now turn the call over to Sara Pellegrino, Senior Vice President, Investor Relations, and Corporate Communications at IOVANCE.

Speaker #1: Sara, you may begin.

Speaker #2: Thank you, operator. Good morning, and welcome to the IOVANCE webcast to discuss our second quarter 2026 financial results, business achievement, and corporate updates. This morning, we issued a press release that is available on our corporate website at iovance.com.

Sara Pellegrino: Thank you, operator. Good morning and welcome to the Iovance webcast to discuss our Q2 2026 financial results, business achievements, and corporate updates. This morning, we issued a press release that is available on our corporate website at iovance.com. 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, submissions, feedback and guidance, plans and strategies, research and preclinical activities, potential future applications of our technologies, manufacturing capabilities, payer interactions, licenses and collaborations, cash position, 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 filings. Our results may differ materially from those projected during today's call. We undertake no obligation to publicly update any forward-looking statements.

Speaker #2: This conference 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 #2: 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, submissions, feedback and guidance, plans and strategies, research and preclinical activities, potential future applications of our technologies, manufacturing capabilities, payer interactions, licenses and collaborations, cash position, and future updates.

Sara Pellegrino: 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. Our results may differ materially from those projected during today's call. We undertake no obligation to publicly update any forward-looking statements. I will turn the call over now to Dr. Fred Vogt, Interim CEO and President.

Speaker #2: Our results may differ materially from those projected during today's call. We undertake no obligation to publicly update any forward-looking statements. I will turn the call over now to Dr. Fred Vogt, Interim CEO and President.

Sara Pellegrino: I will turn the call over now to Dr. Fred Vogt, Interim CEO and President.

Speaker #3: Thank you, Sara. I have answered that we are the global leader in innovating, developing, and delivering TIL therapy for solid tumors—today, and for the next generation.

Fred G. Vogt: Thank you, Sara. Iovance is the global leader in innovating, developing, and delivering TIL therapy for solid tumors today and for the next generation. The Q2 2026 was our strongest yet. We delivered record revenue and margin, advanced our pipeline, and secured important new regulatory approvals and designations. I'll start by highlighting a few notable achievements. First, our commercial launch reached new heights in the Q2 while our foundation for growth expanded. More Authorized Treatment Centers, or ATCs, are activating, enrolling, and infusing patients than ever before. We reported $99.3 million in revenue, driven by record AMTAGVI demand. We also greatly exceeded both our AMTAGVI and total revenue guidance ranges for the Q2. Q2 margin also reached an all-time high of 56%. We expect margin to keep expanding as we increase revenue, fine-tune execution, and gain efficiency at scale.

Fred G. Vogt: Thank you, Sara. Iovance is the global leader in innovating, developing, and delivering TIL therapy for solid tumors today and for the next generation. The Q2 2026 was our strongest yet. We delivered record revenue and margin, advanced our pipeline, and secured important new regulatory approvals and designations. I'll start by highlighting a few notable achievements. First, our commercial launch reached new heights in Q2 while our foundation for growth expanded. More Authorized Treatment Centers, or ATCs, are activating, enrolling, and infusing patients than ever before. We reported $99.3 million in revenue, driven by record AMTAGVI demand. We also greatly exceeded both our AMTAGVI and total revenue guidance ranges for Q2. Q2 margin also reached an all-time high of 56%. We expect margin to keep expanding as we increase revenue, fine-tune execution, and gain efficiency at scale.

Speaker #3: The second quarter of 2026 was our strongest yet. We delivered record revenue and margin to advance our pipeline and secured important new regulatory approvals and designations.

Speaker #3: I'll start by highlighting a few notable achievements. First, our commercial launch reached new heights in the second quarter while our foundation for growth expanded.

Speaker #3: More authorized treatment centers, or ATCs, are activating and rolling and infusing patients than ever before. We reported 99.3 million dollars in revenue, driven by record antagonistic demand.

Speaker #3: We also greatly exceeded both our antagonistic and total revenue guidance ranges for the second quarter. The second quarter margin also reached an all-time high of 56%.

Speaker #3: We expect margin to keep expanding as we increase revenue, fine-tune execution, and gain efficiency and scale. Looking ahead, we maintain our peak assumptions for antagonistic and prolucent of more than $1 billion in U.S.

Fred G. Vogt: Looking ahead, we maintain our peak assumptions for AMTAGVI and Proleukin of more than $1 billion in US sales from advanced melanoma alone. The opportunity in other indications is significantly larger. Our Q3 performance to date is very strong. Once we fully assess increasing growth trends, we expect to provide an update to our full-year guidance during Q3. We are now providing commercial AMTAGVI to more than 50 patients a month on top of increasing numbers of clinical patients, which demonstrates both our manufacturing scale and how broadly accessible our cell therapies have become. We are not choosing between growth and discipline. This quarter, we delivered both. Research and development expenses improved for the fourth consecutive quarter, even as every lead program advanced and our pipeline grew.

Speaker #3: sales, from advanced melanoma alone. The opportunity in other indications is significantly larger. Our third quarter performance to date is very strong. Once we fully assess increasing growth trends, we expect to provide an update to our full-year guidance during the third quarter.

Speaker #3: We are now providing commercially antagonistic of more than 50 patients a month, on top of increasing numbers of clinical patients, which demonstrates both our manufacturing scale and how broadly accessible our cell therapies have become.

Speaker #3: We are not choosing between growth and discipline. This quarter, we delivered both. Research and development expenses improved for the fourth consecutive quarter, even as every lead program advanced in our pipeline grew.

Speaker #3: We are closing in on our pursuit of the largest opportunities for cancer patients who have the greatest unmet need. Our technology platform is scaling quickly, recent regulatory and clinical milestones bring TIL therapy forward for more patients in the U.S., as well as new markets and additional solid tumor indications.

Fred G. Vogt: We are closing in on our pursuit of the largest opportunities for cancer patients who have the greatest unmet need. Our technology platform is scaling quickly. Recent regulatory and clinical milestones bring TIL therapy forward for more patients in the US, as well as new markets and additional solid tumor indications. Nearly 2,000 patients have received Iovance TIL therapies in commercial and clinical settings across hundreds of centers in the US and in 30 countries. Over the coming years, our vision is to reach tens of thousands of patients. In our registrational trials, enrollment is nearly complete in our IOV-LUN-202 trial in the pivotal cohorts in non-squamous non-small cell lung cancer. This indication represents a blockbuster opportunity that is roughly seven times that of advanced melanoma. We look forward to providing program updates in Q4 as we work towards supplemental Biologics License Application in 2027.

Speaker #3: Nearly 2,000 patients have received IOVANCE TIL therapies in commercial and clinical settings, across hundreds of centers in the U.S. and in 30 countries. Over the coming years, our vision is to reach tens of thousands of patients.

Speaker #3: And our registrational trials, enrollment is nearly complete, and our lung 202 trial and the pivotal cohorts of non-squamous, non-small cell lung cancer. This indication represents a blockbuster opportunity that is roughly seven times that of advanced melanoma.

Speaker #3: We look forward to providing program updates in the fourth quarter as we work toward a supplemental biologics license application. In 2027. We are moving quickly with our registrational Saratoga trial, or SAR 201, and two advanced soft tissue sarcomas.

Fred G. Vogt: We are moving quickly with our registrational SARATOGA trial for IOV-SAR-201 in two advanced soft tissue sarcomas. As we announced today, the FDA granted Fast Track designation in undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma, validating the promise of the initial clinical data for lifileucel, as well as the substantial unmet medical need in both indications. In a pilot study with one-time lifileucel therapy, the objective response rate was an unprecedented 50% in the first six evaluable patients, compared with abysmal response rates of less than 5% using current standard of care in these refractory treatment settings. Our translational data and state-of-the-art technologies are uncovering the next frontier in TIL therapy. We are now able to identify highly responsive patient populations across solid tumor indications that comprise more than 90% of all cancers.

Yanan Zhu: We are moving quickly with our registrational SARATOGA trial for IOV-SAR-201 in two advanced soft tissue sarcomas. As we announced today, the FDA granted Fast Track designation in undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma, validating the promise of the initial clinical data for lifileucel, as well as the substantial unmet medical need in both indications. In a pilot study with one-time lifileucel therapy, the objective response rate was an unprecedented 50% in the first six evaluable patients, compared with abysmal response rates of less than 5% using current standard of care in these refractory treatment settings. Our translational data and state-of-the-art technologies are uncovering the next frontier in TIL therapy. We are now able to identify highly responsive patient populations across solid tumor indications that comprise more than 90% of all cancers.

Speaker #3: As we announce today, the U.S. FDA granted fast-track designation and undifferentiated pleomorphic sarcoma and de-differentiated liposarcoma, validating the promise of the initial clinical data for lipoleusal, as well as the substantial unmet medical need in both indications.

Speaker #3: In a pilot study with one-time lipoleusal therapy, the objective response rate was an unprecedented 50% in the first six valuable patients, compared with abysmal response rates of less than 5% using current standard of care in these refractory treatment settings.

Speaker #3: Our translational data and state-of-the-art technologies are uncovering the next frontier in TIL therapy. We are now able to identify highly responsive patient populations across solid tumor indications, and comprise more than 90% of all cancers.

Speaker #3: For example, a histology-based biomarker strategy produced striking early phase II data in the first five evaluable patients, with metastatic serous endometrial cancer. In our N201 trial, we reported a 40% confirmed objective response rate and a 100% disease control rate.

Fred G. Vogt: For example, a histology-based biomarker strategy produced striking early phase II data in the first five evaluable patients with metastatic serous and endometrial cancer. In our IOV-END-201 trial, we reported a 40% confirmed objective response rate and a 100% disease control rate. We are submitting a protocol amendment engaging with the FDA on an expedited approval pathway based on this patient population. Our leadership in TIL therapy includes continuous investment in next generation programs. A new trial known as IOV-GE1-201 is using IOV-5001, our next generation IL-12 tethered TIL therapy. This phase I/II basket trial will run across prevalent solid tumors representing more than 100,000 US deaths annually, including metastatic colorectal, triple-negative breast, and estrogen receptor-low breast cancers. We expect to provide more updates this year. Today, profitability is in sight, and with it, lasting value for patients and shareholders alike.

Speaker #3: We are submitting a protocol amendment, engaging with the FDA on an expedited approval pathway based on this patient population. Our leadership in TIL therapy includes continuous investment in next-generation programs.

Speaker #3: A new trial known as G1 201 is using IOV 5001, our next-generation IL-12 tethered TIL therapy. This phase I/II basket trial will run across prevalent solid tumors representing more than 100,000 U.S.

Speaker #3: deaths annually, including metastatic colorectal, triple-negative breast, and estrogen receptor low breast cancers. We expect to provide more updates this year. Today, profitability is in sight, and with it, lasting value for patients and shareholders alike.

Speaker #3: I have answered the first and only company in the world that takes TIL therapy from concept to commercial treatment for patients, supported by our scalable manufacturing infrastructure, clinical breadth, commercial experience, and operational discipline.

Fred G. Vogt: Iovance is the first and only company in the world to take TIL therapy from concept to commercial treatment for patients, supported by our scalable manufacturing infrastructure, clinical breadth, commercial experience, and operational discipline. With healthy commercial momentum, a broadening pipeline, and solid execution, Iovance has never been better positioned for long-term success. I'll now ask Corleen Roche, Chief Financial Officer, to detail our financial results.

Speaker #3: With healthy commercial momentum, a broadening pipeline, and solid execution, IOVANCE has never been better positioned for long-term success. I'll now ask Corleen Roche, our Chief Financial Officer, to detail our financial results.

Speaker #2: Thanks, Fred. And good morning, everyone. Our highest ever quarterly revenue and margin clearly demonstrate our commitment to top-line growth, operational excellence, and financial discipline as we build a sustainable, self-funded business.

Corleen Roche: Thanks, Fred, good morning, everyone. Our highest ever quarterly revenue and margin clearly demonstrate our commitment to top-line growth, operational excellence, and financial discipline as we build a sustainable self-funded business. Q2 total revenue was more than $99 million. That is up 66% year over year and 39% sequentially from Q1, which have included one-time non-recurring impacts from our internal manufacturing upgrades. AMTAGVI was the key growth driver, reaching a new high of approximately $91 million in the quarter. We exceeded our Q2 AMTAGVI guidance range of $79 to $81 million. Q2 AMTAGVI revenue increased roughly 51% over Q1 of 2026 and 68% year over year, reflecting a robust increase in patient demand and adoption. Proleukin contributed about $9 million in Q2, slightly down from $11 million in the prior quarter due to timing of wholesaler inventory stocking.

Speaker #2: Second quarter total revenue was more than $99 million, that is up 66% year over year, and 39% sequentially from the first quarter. Which have included one-time non-recurring impact from our internal manufacturing upgrades.

Speaker #2: Antagonistic was the key growth driver. Reaching a new high of approximately $91 million in the quarter. We exceeded our second quarter antagonistic guidance range of 79 to 81 million, and second quarter antagonistic revenue increased roughly 51% over the first quarter of 2026 and 68% year over year.

Speaker #2: Reflecting a robust increase in patient demand and adoption. Prolucent contributed about $9 million in the second quarter, slightly down from $11 million in the prior quarter, due to timing of full-sale or inventory stocking.

Speaker #2: For the full year 2026, we anticipate that prolucent as a percentage of total revenue will be in line with 2025. Consistent with the prior quarters, overall gross-to-net impact remains minimal at less than 2%.

Corleen Roche: For the full year 2026, we anticipate that Proleukin as a percentage of total revenue will be in line with 2025. Consistent with the prior quarters, overall gross to net impact remains minimal at less than 2%. Margin increased to approximately 56%, up from 41% in Q1, and above our previous all-time high of 50% in Q4 2025. With the year-to-date 2026 margin of 50%, Q2 benefited from higher AMTAGVI volume, continued cost optimization, and maturing internal efficiencies during our first full quarter of manufacturing exclusively in-house. We are also deploying and advancing artificial intelligence tools to drive significant future cost efficiencies and new product pipeline insights. As we expand our business as well as our development pipeline, we are very closely managing operating expenses.

Speaker #2: Margin increased to approximately 56%, up from 41% in the first quarter and above our previous all-time high of 50% in the fourth quarter of 2025.

Speaker #2: With the year-to-date 2026 margin of 50%, the second quarter benefited from higher antagonistic volumes, continued cost optimization, and maturing internal efficiencies during our first full quarter of manufacturing exclusively in-house.

Speaker #2: We are also deploying and advancing artificial intelligence tools to drive significant future cost efficiencies and new product pipeline insights. As we expand our business, as well as our development pipeline, we are very closely managing operating expenses.

Speaker #2: Research and development expenses were about $59 million, down from $62 million in the prior quarter, reflecting ongoing efficiency gains as we progress all of our programs.

Corleen Roche: Research and development expenses were about $59 million, down from $62 million in the prior quarter, reflecting ongoing efficiency gains as we progress all of our programs. This marks the fourth consecutive quarter of cost savings through R&D optimization. Selling, general, and administrative expenses held essentially flat at about $39 million, even as revenue grew roughly 39%. With clear operating leverage from our commercial infrastructure, we expect to gain further efficiency with targeted investment across the business. I will now cover our outlook for the rest of the year. Based on strong Q2 sales, we are reviewing our previously issued full year 2026 total revenue guidance of $350 to $370 million and plan to share more detail in Q3. We are well capitalized to fund both the launch and our pipeline.

Speaker #2: This marks the fourth consecutive quarter of cost savings through R&D optimization. Selling general and administrative expenses held essentially flat at about $39 million. Even as revenue grew roughly 39%.

Speaker #2: With clear operating leverage from our commercial infrastructure, we expect to gain further efficiency with targeted investment across the business. I will now cover our outlook for the rest of the year.

Speaker #2: Based on strong second quarter sales, we are reviewing our previously issued full year 2026 total revenue guidance of $350 to $370 million, and plan to share more detail in the third quarter.

Speaker #2: We are well-capitalized to fund both the launch and our pipelines. As of June 30, 2026, we had approximately $304 million in cash, cash equivalents, and short-term investments.

Corleen Roche: As of 30 June 2026, we had approximately $304 million in cash equivalents, and short-term investments. This cash position is now expected to fund operations into H2 2028. When I joined Iovance, the priorities were clear: grow revenue, expand margins, and manage spend to reach profitability as quickly as possible. On my 1-year anniversary, I am pleased to highlight that all three of these priorities are translating into positive results and lasting value for patients and our shareholders. I will now turn the call to Dan Kirby, our Chief Commercial Officer, to review our commercial progress.

Speaker #2: This cash position is now expected to fund operations into the second half of 2028. When I joined IOVANCE, the priorities were clear. Grow revenue, expand margins, and manage them to reach profitability as quickly as possible.

Speaker #2: On my one-year anniversary, I am pleased to highlight that all three of these priorities are translating

Speaker #1: Positive results and lasting value for patients and our shareholders . I will now turn the call to Dan Kerby , our chief commercial officer , to review our commercial progress .

Speaker #2: Thank you . Koleen As mentioned and tagged generated record revenue with more patients treated than in any prior quarter . This commercial momentum is carrying into the third quarter Adoption isn't just growing , it's broadening into new attacks .

Dan Kirby: Thank you, Corleen. As mentioned, AMTAGVI generated record revenue with more patients treated than in any prior quarter. This commercial momentum is carrying into Q3. Adoption isn't just growing, it's broadening into new ATCs and earlier lines of treatment. Today, I will highlight 3 commercial priorities powering that trajectory for AMTAGVI growth, which are rising physician awareness, continued expansion of our ATC network, and a deepening body of clinical evidence. The first priority is to continue to increase awareness of AMTAGVI among both treating and referring physicians. Unaided awareness has increased nearly threefold over the past year, driven by two factors. One, a new marketing campaign unveiled at ASCO, and two, improvement in sales force effectiveness measured by meaningful growth in both number of treaters and referrers. The second priority is increasing our footprint across both academic and community settings.

Speaker #2: And earlier lines of treatment Today , I will highlight three commercial priorities powering that trajectory for MTV growth , which are rising physician awareness , continued expansion of our ATC network , and a deepening of clinical evidence The first priority is to continue to increase awareness of Antagony among both treating and referring physicians .

Speaker #2: Unaided awareness has increased nearly threefold over the past year , driven by two factors . One , a new marketing campaign unveiled at Asco and two improvement in sales force effectiveness measured by meaningful growth in both number of treaters and referrers The second priority is increasing our footprint across both academic and community settings , with more than 95 total atcs today .

Dan Kirby: With more than 95 total ATCs today, we are on track to reach at least 110 by year's end. Community ATCs now represent a third of our network and are expected to increase significantly over the next several quarters. Each new ATC is widening our commercial reach to the patients who need it. The third priority is the continued expansion of our already deep industry-leading clinical evidence. The published 5-year durability data and real-world response rates of greater than 50% in patients with 2 or fewer lines of therapy are convincing physicians to adopt AMTAGVI earlier. In addition, at ASCO, we released a new survival analysis from our clinical trial. This analysis estimated that the AMTAGVI 10-year overall survival for responders would be 46.7%, or almost half. Independently, a growing number of our ATCs are publishing their own real-world experience.

Speaker #2: We are on track to reach at least 110 by year's end Community APCs now represent a third of our network and are expected to increase significantly over the next several quarters Each new APC is widening our commercial reach to the patients who need it The third priority is the continued expansion of our already deep industry leading clinical evidence .

Speaker #2: The published five year durability data and real world response rates of greater than 50% in patients with two or fewer lines of therapy are convincing physicians to adopt and tag the earlier .

Speaker #2: In addition , at Asco , we released a new survival analysis from our clinical trial This analysis estimated that the ten year overall survival for responders would be 46.7% , or almost half independently .

Speaker #2: A growing number of our ASCs are publishing their own real world experience across these studies Response rates and patient outcomes consistently meet or exceed what we observed in our clinical trials , which support the emerging practice pattern of treating patients with MTV .

Dan Kirby: Across these studies, response rates and patient outcomes consistently meet or exceed what we observed in our clinical trials, which support the emerging practice pattern of treating patients with AMTAGVI as soon as possible after checkpoint inhibitor therapy. These aggregated real-world evidence data are being deployed across our sales force in conversations with ATCs and physicians. This information can be found on the publications page of our website at iovance.com for those interested. Underpinning all 3 priorities is ensuring coverage and access. AMTAGVI has strong payer coverage. More than 75% of AMTAGVI patients are covered by private payers. Payers and plans that cover more than 250 million lives have added AMTAGVI to their policies. Our US ATCs are strategically located in proximity to most addressable patients. More than 95% of patients live within 200 miles, and 80% of patients live within 100 miles of an ATC.

Speaker #2: As soon as possible. After checkpoint inhibitor therapy, these aggregated real-world evidence data are being deployed across our sales force. In conversations with APCs and physicians, this information can be found on the publications page of our website at ir.com.

Speaker #2: For those interested Underpinning all three priorities is ensuring coverage and access and has strong payer coverage More than 75% of MTV patients are covered by private payers , payers , and plans that cover more than 250 million lives have added to their policies Our U.S.

Speaker #2: atcs are strategically located in proximity to most addressable patients . More than 95% of patients live within 200 miles , and 80% of patients live with 100 within 100 miles of an ATC With our rapidly expanding ATC network and increased community presence , we expect even broader access to MTV throughout 2026 .

Dan Kirby: With our rapidly expanding ATC network and increased community presence, we expect even broader access to AMTAGVI throughout 2026. Importantly, we are also proving we can deliver on our promise to patients, with a turnaround time of 31 days or less using the only scaled centralized commercial manufacturing process approved by the FDA for TIL therapy. Demand for Proleukin, our second product, remains strong. All three wholesalers have sold through their previous stocking inventory in Q2 and are currently ordering in line with AMTAGVI demand. For the rest of the year, we expect quarter-on-quarter Proleukin growth tied to AMTAGVI growth on a steady basis of approximately 16% of total revenue. Outside of the US, with two approvals of AMTAGVI in Canada and Australia, we are continuing to expand into new markets for previously treated melanoma patients, a globally addressable population of more than 30,000 patient deaths.

Speaker #2: Importantly , we are also proving we can deliver on our promise to patients with the turnaround time of 31 days or less , using the only scaled centralized commercial manufacturing process approved by the FDA for teletherapy Demand for Proleukin .

Speaker #2: Our second product remains strong All three wholesalers have sold through their previous stocking inventory . In the second quarter , and are currently ordering in line with demand for the rest of the year .

Speaker #2: We expect quarter on quarter proleukin growth tied to MTV growth on a steady basis of approximately 16% of total revenue Outside of the US , with two approvals of MTV Canada and Australia , we are continuing to expand into new markets for previously treated melanoma patients .

Speaker #2: A globally addressable population of more than 30,000 patients and our first ATC in Canada is ready to support international private pay patients while we work toward public reimbursement in Australia .

Dan Kirby: Our first ATC in Canada is ready to support international private pay patients while we work toward public reimbursement. In Australia, I recently visited several of our onboarding ATCs as we collaborate to raise awareness and expand access to AMTAGVI. Australia has the highest rate of melanoma in the world. We are opening our first ATCs for private pay patients while we work with the government on pricing. Looking ahead, regulatory approvals are pending in the United Kingdom and Switzerland. Elsewhere, we continue to work closely with health authorities in the European Union towards resubmission. Together, these foundational international markets augment our growing US franchise for AMTAGVI. In summary, demand for AMTAGVI is strong and continues to grow. Rising physician awareness is accelerating referrals. A growing network of ATCs is broadening access that is converting into more patients treated. The deepening clinical evidence is expanding the addressable patient population.

Speaker #2: I recently visited several of our onboarding atcs as we collaborate to raise awareness and expand access to MTV Australia has the highest rate of melanoma in the world .

Speaker #2: We are opening our first atcs for private pay patients while we work with the government on pricing Looking ahead , regulatory approvals are pending in the United Kingdom and Switzerland .

Speaker #2: Elsewhere , we continue to work closely with health authorities in the European Union towards resubmission Together , these foundational international markets augment our growing US franchise for MTV .

Speaker #2: In summary , demand for MTV is strong and continues to grow Rising physician awareness is accelerating referrals . A growing network of atcs is broadening access that is covering this , converting into more patients treated and the deepening clinical evidence is expanding the adjustable patient population Iovance is committed to serving patients with a one time cell therapy that delivers meaningful , validated , systemic clinical benefits .

Dan Kirby: Iovance is committed to serving patients with a one-time cell therapy that delivers meaningful, validated, systemic clinical benefits. I will now hand the call back to the operator to begin question and answer session.

Speaker #2: I will now hand the call back to the operator to begin . Question and answer session

Speaker #3: To ask a question, please press star one-one on your telephone and wait for your name to be announced. To withdraw your question, please press star one.

Operator: To ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from Andrew Tsai with Jefferies. Your line is open.

Speaker #3: One again , please stand by while we compile the Q&A roster Our first question comes from Andrew Tsai with Jefferies . Your line is open

Speaker #4: Hey , good morning . Thanks Congrats on a great quarter So can you talk about this large upswing in Q2 that even came out well ahead of your guidance ?

Andrew Tsai: Hey, good morning. Thanks. Congrats on a great quarter. Can you talk about this large upswing in Q2 that even came out well ahead of your guidance? Was it purely due to underlying demand, or was there any one-off in the timing of shipments maybe being more favorable in Q2? Just wanted to check the box on that. Secondly, on the lung update later in Q4, just wanted to clarify on the cadence of events we can expect here. Is it fair to assume you would first need to complete enrollment in this pivotal cohort first, and then generate follow-up data on every enrolled patient before you top-line the data? Or can the top-line data be on the majority of patients, not necessarily all patients with follow-up? Thank you.

Speaker #4: Was it purely due to underlying demand , or was there kind of any one offs ? And the timing of shipments maybe being more favorable in Q2 ?

Speaker #4: Just wanted to check the box on that and then secondly , on the lung update later in Q4 . , just wanted to clarify on the cadence of events we can expect here .

Speaker #4: Is it fair to assume you would first need to complete enrollment in this pivotal cohort first , and then generate follow up data on every enrolled patients before you topline the data or can the topline data be on the majority of patients ?

Speaker #4: Not necessarily . All patients with follow up . Thank you .

Speaker #2: So I'll take the first part on demand . It's a great question . What we saw in demand was , as I said , on the on the call script , essentially , we saw the awareness is increasing among our physician base , both treaters and referrers .

Dan Kirby: I'll take the first part on demand. It's a great question. What we saw in demand was, as I said on the call script, essentially, we saw that awareness is increasing among our physician base, both treaters and referrers. We are expanding our ATC network, the clinical data is evidence of AMTAGVI's efficacy. One thing that did happen in the first quarter that helped us in the second quarter was we had the manuscript published on our real-world evidence data that showed over 50% of the patients with two or fewer lines of therapy were responding. That data helped propel our sales force and our commercial efforts to raise awareness further and encourage more patients to be treated. We expect this to continue, and we are seeing this into the third quarter.

Speaker #2: We are expanding our agency network . And then the clinical data is evidence of efficacy . One thing that did happen in the first quarter that helped us in the second quarter was we had the manuscript published on our real world evidence data that showed over 50% of the patients with two or fewer lines of therapy were responding .

Speaker #2: That data helped propel our sales force and commercial efforts to raise awareness further and encourage more patients to be treated. We expect this to continue, and we are seeing this into the third quarter.

Fred G. Vogt: I'll just add to Dan, just to be very clear, Andrew, there's just not a timing issue or anything. This is organic demand for the product. It's looking very good right now based on all the factors that Dan described and more that we really do expect that demand is going to continue to increase significantly for AMTAGVI throughout the coming quarters. On your question about the lung 202 update. Yes, I think it's fair to assume we're going to complete enrollment very soon, and we would want to finish that process before we put any kind of material update out. Obviously, for FDA purposes, we want to do that. I don't think it's fair to assume that we would wait for every single patient to become evaluable.

Speaker #5: Now , I'll just add to Dan , just to be very clear , Andrew , there's just not a timing issue or anything .

Speaker #5: This is organic demand for the product . It's looking very good right now based on all the factors that Dan described and more that we really do expect that demand is going to continue to increase significantly for me throughout the coming quarters .

Speaker #5: On the lung . On your question about the lung , Q2 update yes , I think it's fair to assume we're going to complete enrollment very soon .

Speaker #5: And we would want to finish that process before we put any kind of , , material update out Obviously , for FDA purposes , we want to do that .

Speaker #5: But I don't think it's fair to assume that we would wait for every single patient to become a . We really want to make sure the integrity of the trials .

Fred G. Vogt: We really want to make sure the integrity of the trial is clean, and we have all the patients in before we put some data out. Some of the patients may still be coming for their first evaluation, that kind of thing. When we put that out, or maybe not, depends on the timing and how the data looks. Just stay tuned. The lung is looking very positive right now. We feel very good about where we stand with the study. We will have a lot, I think, to say about that. I know that's a very key thing for investors, and I really urge everybody to watch carefully as we talk about that, and maybe even more than what people are expecting in this space.

Speaker #5: And we have all the patients in . Before we put the . Put some data out . Some of the patients may still be coming for their first evaluation .

Speaker #5: That kind of thing . When we put that out . Or maybe not , depends on the timing and how the data looks .

Speaker #5: So just stay tuned . The lung is looking very positive right now . We feel very good about where we stand with the study , and we will have a lot , to say about that .

Speaker #5: I know that's a very key thing for investors , and I really urge everybody to watch carefully as we talk about that and maybe even even more than what people are expecting in this space .

Speaker #4: Thanks so much Congratulations

Andrew Tsai: Thanks so much. Congratulations.

Speaker #3: Thank you . Our next question comes from Yanan Zhu with Wells Fargo . Your line is open

Operator: Thank you. Our next question comes from Yanan Zhu with Wells Fargo. Your line is open.

Speaker #6: Great , great I'll add my congrats on a very strong quarter , maybe , , from Fred's comment , it sounds like , , for the next two quarters , you expect , , the , the sales to or the demand to further build upon , the current demand , the demand level or the second quarter demand level , just want to see if that's the correct interpretation .

Yanan Zhu: Great. I'll add my congrats on a very strong quarter. Maybe from Fred's comment, it sounds like for the next two quarters, you expect the demand to further build upon the current demand level or the Q2 demand level. Just want to see if that's the correct interpretation. In terms of given your visibility into the Q3 and perhaps also into the Q4, can you talk about your expectation and also the guidance sounds like it's going to come during the Q3. Is that the case rather than at the next quarter's earnings call? Perhaps also a question on TILVANCE-301. Can you give an update on where you are? Sounds like you have a presentation at ESMO. Can you talk about what can we expect the data there? Thanks.

Speaker #6: , and in terms of , , , you know , given your visibility into the third quarter and perhaps also into the fourth quarter , , can you talk about , , your expectation and also the guidance ?

Speaker #6: , sounds like it's going to come during the third quarter . Is that the case ? , rather than at the next quarter's earnings call , perhaps also a question on three over 301 .

Speaker #6: , can you give an update on where you are and sounds like you have a presentation at all . , yeah . Can you talk about what can we expect the data there ?

Speaker #6: Thanks .

Speaker #5: Sure . Yeah . Let me , let me cover the first two and then Dan can comment and I'll come back to Tilden's at the end .

Fred G. Vogt: Sure. Let me cover the first two, and then Dan can comment, and then I'll come back to TILVANCE at the end. Yes, I think you heard correctly. Demand trends are very positive right now for the AMTAGVI product, and we expect increasing demand Q3 and Q4. We're obviously seeing quite a bit of Q3 right now. We want to just evaluate the whole situation because we really focus on long-term guidance here, and we want to make sure we can give good guidance for the full year before we announce it. You are correct, we are intending to make a separate announcement of guidance. One morning, you'll wake up to some hopefully very positive news, I think, from Iovance on the guidance as we get that visibility. Can't tell you exactly when, but obviously sometime in the Q3. Yes, that's very strong.

Speaker #5: , yes . I think you heard correctly . We demand trends are very positive right now for the product . Product . And we expect increasing demand in Q3 and Q4 .

Speaker #5: We're obviously seeing quite a bit of Q3 right now , we want to just we want to just evaluate the whole situation because we really focus on long term guidance here .

Speaker #5: We want to make sure we can give good guidance for the full year before we announce it . But you are correct . We are intending to make a separate announcement of guidance .

Speaker #5: , so , you know , one morning , , you wake up to some hopefully very positive news , I think , from Iovance on the guidance as we , , get that visibility can tell you exactly when , but obviously sometime in the third quarter , , but yes , that's very strong and strong .

Fred G. Vogt: AMTAGVI is strong. As we pointed out, Proleukin demand is very strong. Dan, do you want to comment and add some detail to that?

Speaker #5: And as we pointed out , Proleukin demand is very strong . And do you want to comment and add some detail to that ?

Speaker #2: Sure . , for Q3 right now , as you mentioned , Jan , and we do have a pretty good site into Q3 and what's going on right now .

Dan Kirby: Sure. For Q3 right now, as you mentioned, Jan, we know it's pretty good insight into Q3 and what's going on right now. The demand continues to grow, we're very confident that Q3 will build upon the success in Q2, then a Q4 corresponding from that. We've expanded our sales force. We continue to evaluate putting promotional activities in place, such as new campaigns, et cetera, to continue that growth driving not only through 2026, but 2027.

Speaker #2: The demand continues to grow . And so we're very confident that Q3 will build upon the success in Q2 . And then of Q4 , of course , following from that , , you know , we've expanded our sales force .

Speaker #2: We continue to evaluate putting promotional activities in place , such as new campaigns , etc. , to continue that growth driving not only through 2026 , but 2027 and beyond .

Speaker #5: And then I'll come back and answer your question about that . Study continues to run well . We're very happy with the performance of the study .

Fred G. Vogt: I'll come back and answer your question about TILVANCE-301. That study continues to run well. We're very happy with the performance of the study. At ESMO, we're going to, again, in an oral session there, highlight some of the compelling clinical characteristics of AMTAGVI plus pembrolizumab in the frontline setting, including the fact that almost a third of patients go into a complete response. We have a very rapid velocity of response, meaning we can drive patients into a response much faster than other alternative therapies, we think. We'll show much more insight, I think, from the predecessor phase II study. Obviously, TILVANCE is a randomized trial that we can't look at right now. It's blinded. We'll read that at the interim point, hopefully relatively soon, although these trials take a long time to run, as you know.

Speaker #5: At ESMO . We're going to , again , in an oral session there , highlight some of the compelling clinical characteristics of Antagoni plus pembrolizumab in the frontline setting , including the fact that almost a third of patients go into a complete response We have a very rapid velocity of response , meaning we can drive patients into a response much faster than other alternative therapies .

Speaker #5: We think . And we'll show much more insight , I think , from the the predecessor phase two study , obviously , to a randomized trial that we can't look at right now .

Speaker #5: It's blinded . , we'll read that at the interim point . Hopefully , hopefully , , relatively soon , although these trials take a long time to run , as you know , but we're going to show the compelling clinical characteristics .

Fred G. Vogt: We're going to show the compelling clinical characteristics. I think it's going to be a very important output for people in this field, especially since some of the excitement around LAG-3 has faded, especially post ASCO with Regeneron's results. Opdualag is still, in some cases, being questioned as whether it's the right combination in the frontline setting, there really is an extremely large need for some alternative ipi/nivo in the frontline setting for these patients. We think lifileucel's characteristics are perfect for this with the one-time therapy combined with what may end up being fairly limited pembro dosing, the fact that we can drive a large percentage of patients into what's effectively a cure.

Speaker #5: And I think it's going to be a very important output for people in the field , especially since the some of the , , excitement around lag three has faded , especially post Asco with Regeneron's results .

Speaker #5: , and , you know , off the lag is still in some cases being questioned is whether it's the right combination in the frontline setting .

Speaker #5: And there really is an extremely large need for something, some alternative to Nivo in the frontline setting for these patients. We think those characteristics are perfect for this.

Speaker #5: With the one time therapy combined with , , what may end up being fairly limited . Pembro dosing , , and the fact that we can drive a large percentage of patients in the , what's effectively a cure

Speaker #6: Great . Thanks for the update

Yanan Zhu: Great. Thanks for the update.

Speaker #3: Thank you . Our next question comes from Edzard with Barclays . Your line is open .

Operator: Thank you. Our next question comes from Etzer Darout with Barclays. Your line is open.

Speaker #7: Great, thanks for taking the question. And congrats on the strong second quarter. One question on margins and then one on lung.

Etzer Darout: Great. Thanks for taking the question, and congrats on the strong Q2. One question on margins, and then one on lung. You had a meaningful step up, obviously, in gross margin in the Q2. Maybe if you could talk about the remaining opportunities to improve margins further, relative to current levels, and where you think mature commercial margins could ultimately trend to over time, that would be great. On lung, obviously the durability exceeds historical benchmarks from what you've previously shown. Is the internal goal there to replicate earlier data from an efficacy and durability standpoint? Also with enrollment nearly complete, have you continued to enroll patients with similar baseline characteristics from the prior update? Thank you.

Speaker #7: You had a meaningful step up obviously in gross margin in the second quarter . Maybe if you could talk about the remaining opportunities to improve margins further .

Speaker #7: , relative to current levels and where you think mature commercial margins could ultimately trend to over time , that would be great . And then on lung , obviously the durability exceeds historical benchmarks from what you've previously shown is the internal goal there to replicate earlier data from from an efficacy and durability standpoint , and also with enrollment nearly complete , have you continued to enroll patients with similar baseline characteristics from the prior update ?

Speaker #7: Thank you .

Speaker #8: Hi . It's Coraline . So I'll answer your margin question . , the driver is .

Corleen Roche: Hi, Etzer. It's Corleen. I'll answer your margin question. The driver is a number of things, and as you know, we've been focusing on this internally, and we've been talking about it. Obviously higher volume, which you can see. We have all of our manufacturing in-house, and those efficiencies are also helping margin, as well as these projects that we have where we're continuing to focus on margin improvement and operational efficiencies within the plant. I would think about that in terms of process, automation, things like that.

Speaker #1: A number of things . And as you know , we've been focusing on this internally and we've been talking about it obviously higher volume , which you can see , , but we have all of our manufacturing in house and those efficiencies are also helping margin as well as these projects that we have where we're continuing to focus on margin improvement and operational efficiencies within the plant .

Speaker #1: , I would think about that in terms of process automation , things like that .

Speaker #5: And one other point , I'll just add to what Cauleen said , as we , Dan and others pointed out here already with Proleukin .

Fred G. Vogt: Yeah, and one other point, and I'll just add to what Corleen said is, as Dan and others pointed out here already, with Proleukin now normalizing and then Proleukin sales expected to increase this year and then stabilize at the right percentage going forwards. Proleukin is a very high margin product, so you can expect a little bit of tailwind there as well. On lung, too, Etzer, you asked two questions there. One was, is our internal goal to replicate the durability? It's to actually exceed the durability because when we reported the durability earlier, we had a short follow-up. I think what we're seeing right now, although we're not going to pre-release results here, obviously, right now, we're seeing very strong durability. I think very similar in overall outcome to what we saw in melanoma. It's effectively the same type of product.

Speaker #5: Now normalizing and Proleukin sales expected to increase this year , and then stabilize at the right percentage going forward for Luca has a very high margin product .

Speaker #5: So you can expect a little bit of tailwind there as well . On Lung 202 I just want to ask two questions there .

Speaker #5: One was , , do we do we is our internal goal to , , to replicate the durability ? , it's to actually exceed the durability because when we reported the durability earlier , we had , , shorter follow up .

Speaker #5: And I think what we're seeing right now , although we're not going to pre-release the results here , obviously right now we're seeing very strong durability , I think very similar in , , in overall outcome to what we saw in melanoma .

Speaker #5: Its effectively the same type of product . And we get a response that's usually pretty durable , whether it ends up being two years , three years , whatever it's going to be , we'll find that out when we do the ultimate stats analysis at the end , but it looks pretty good .

Fred G. Vogt: When we get a response, it's usually pretty durable. Whether it ends up being two years, three years, whatever it's going to be, we'll find that out when we do the ultimate stats analysis at the end, but it looks pretty good. I think any of those options are going to be successful in the marketplace in terms of a product that will attract a lot of prescribers and patients to a one-time therapy like that. You mentioned, with enrollment nearly complete, you asked about the baseline characteristics of the patients. I think we are seeing similar baseline through it. We don't have a lot of heterogeneity in our population. We're very comfortable with how we enroll these studies. We've spent a lot of time on our protocol to make sure we get things right.

Speaker #5: I think any of those options are going to be , , successful in the marketplace in terms of a product that will , will attract a lot of prescribers and patients to a one time therapy like that .

Speaker #5: And then you mentioned , , with enrollment nearly complete , , you asked about the baseline characteristics of the patients . I think we are seeing similar baseline throughout .

Speaker #5: We don't have a lot of heterogeneity in our population . We're very comfortable with how we enroll these studies . We spent a lot of time on our protocols to make sure we get things right .

Speaker #5: And yes , I think we're seeing similar patients come through right now than we were throughout the study . Obviously , we changed our lymphodepletion to make it , , a little less burdensome on patients .

Fred G. Vogt: Yes, I think we're seeing similar patients come through right now than we were throughout the study. Obviously, we changed our lymphodepletion to make it a little less burdensome on patients, and we're seeing really good results with that right now in terms of the safety profile and the overall risk-benefit profile of the product.

Speaker #5: And we're seeing really good results with that right now, in terms of the safety profile and the overall risk-benefit profile of the product.

Speaker #7: Great . Thanks for the color and congrats again

Etzer Darout: Great. Thanks for the color and congrats again.

Speaker #3: Thank you . Our next question comes from Renee Benjamin with citizens . Your line is open .

Operator: Thank you. Our next question comes from Renny Benjamin with Citizens. Your line is open.

Speaker #9: Hey , good morning guys . Thanks for taking the questions and congratulations on an amazing quarter . , just two questions from us , I guess .

Reni Benjamin: Hey, good morning, guys. Thanks for taking the questions, and congratulations on an amazing quarter. Just two questions from us. I guess one regarding the outlook, and the fact that you're reviewing guidance. Can you talk a little bit about what factors go into providing this reviewed outlook and what prevents you from providing that guidance now? Related to that, does Replimune's recent positive FDA advisory committee feedback and maybe even the Obsidian going public, does that impact guidance? If not, what are your thoughts regarding at least Replimune's agent coming into the marketplace? Just as a final question, the endometrial study, Fred, you had mentioned, histology-based patient selection and that there are protocol amendments going on right now. Can you talk a little bit or provide some color regarding the protocol amendments and how that study will ultimately reach conclusion? Thanks.

Speaker #9: One , regarding the outlook and the fact that you're reviewing guidance . Can you talk a little bit about what factors go into providing this reviewed outlook and kind of what prevents you from providing that guidance ?

Speaker #9: Now ? And , and related to that , you know , does , does Replimune recent positive , you know , FDA advisory committee feedback and , and maybe even the obsidian , you know , going public , does that kind of impact guidance ?

Speaker #9: And if not kind of what are your , what are your thoughts regarding , , at least Replimune agent coming into the marketplace and , , and just as a , as a final question , the endometrial study , Fred , you had mentioned , you know , it's based patient selection and that their protocol amendments going on right now , can you talk a little bit or provide some color regarding the protocol amendments and , and you know , how that study will , will ultimately reach conclusion Thanks .

Speaker #5: Let me take the last one first , Renee , because it's fast . It's a protocol amendment to focus on the serious subtype and , , it really links up with the disclosure we had last quarter about the response rate that we're seeing and that , , precise approach to how we deliver therapy to certain histological subtype subpopulations in our studies , we have a lot more to say about that across all the indications .

Fred G. Vogt: Let me take the last one first, Renny, because it's fast. It's a protocol amendment to focus on the serous subtype, and it really links up with the disclosure we had last quarter about the response rate that we're seeing and that precise approach to how we deliver cell therapy to certain histological subpopulations in our studies. Well, we have a lot more to say about that across all the indications soon. On the guidance, what we're doing with the guidance internally is we're going to make sure we understand Q3, really, we want to understand the full year. We're not looking to give guidance that is just short term. We're really focused on long-term guidance to show the strength of the product overall.

Speaker #5: Soon , , on the guidance , what we're doing with the guidance internally is we're going to make sure we understand Q3 , really , we want to understand full year .

Speaker #5: We're not looking to give guidance . , that is just sort of short term . We're really focused on long term guidance to show the strength of the product overall .

Speaker #5: We really obviously , we cater to long investors , long owners of the stock , and we want to make sure they have the information they need to understand the overall trajectory .

Fred G. Vogt: Obviously, we cater to long investors, long holders of the stock, we want to make sure they have the information they need to understand the overall trajectory. What we're going to do is make sure we have our demand understood fully. Obviously, it's very good, then we will come back out at some point, which I can't tell you exactly when it's going to be during Q3, we will announce something that I think everybody will find very positive and persuasive. On the competitor front, obviously, there's a lot of noise out there. I just want to stress that we stay out of this. This is not our situation. Other people have their drama that's going on with the FDA. Obviously, that product could get approved or not get approved, we don't really know.

Speaker #5: So what we're going to do is make sure we have our demand understood fully . Obviously , it's very good . And then we will come back out at some point , which I can't tell you exactly when it's going to be .

Speaker #5: During the third quarter . And we will announce some something that I think everybody will find very positive . And persuasive on the competitor front .

Speaker #5: Obviously , there's a lot of noise out there . , I just want to stress that , you know , we we stay out of this .

Speaker #5: This is not our , our situation . Other people have their , their drama that's going on with , , with the FDA .

Speaker #5: Obviously , , that product could get approved or not get approved . We don't really know . , but if it does get approved , we view it as primarily competitive with Tvac , which is the product that's on the market today .

Fred G. Vogt: If it does get approved, we view it as primarily competitive with T-VEC, which is the product that's on the market today that's also an oncolytic virus very similar to that product, as well as products like Opdualag that are being recycled in the community right now. It has a lot of barriers like T-VEC did, obviously, when a company goes to launch a product, they have to perform, and we expect AMTAGVI as a much more compelling option, I think, for patients with its long time profile and really just fantastic efficacy and tons of real-world experience now. We think that'll be good.

Speaker #5: That's also not oncolytic virus , very similar to that product . , as well as , , products like the lag that are being recycled in the community right now .

Speaker #5: It has a lot of barriers . Like Tvec did . And honestly . , when a company goes to launch a product , they have to perform and we expect the impact is a much more compelling option , I think , for patients with its one time profile and really fantastic efficacy and tons of real world experience now .

Speaker #5: And so we think that'll be good . And with the other company , obsidian , it's a competitor . I think people should look very hard , carefully at how far ahead Iovance is in this space .

Fred G. Vogt: With the other company, Obsidian, that's a TIL competitor, I think people should look very hard carefully at how far ahead Iovance is in this space, the infrastructure Iovance has and the strength that we have and the experience that we have in this area before they just randomly assume that some other TIL company's going to come out of nowhere and somehow conquer the world here. Just bear that in mind that there's reality with all these things. Many investors have visited us and seen the scale of what we do and can see the power of what we do and how much hard work and experience and intellect went into this whole thing. It's not easy to replicate, and there's a giant moat around Iovance that's I think very helpful for investors.

Speaker #5: , and the infrastructure I has and the strength that we have and the , , experience that we have in this area before they sort of just randomly assume that , , some other company is going to come out of nowhere and , , somehow conquer the world here .

Speaker #5: So just bear that in mind that there's reality of all these things . Many investors have visited us and seen the scale of what we do and can see the power of what we do and how much hard work and experience and intellectual went into this whole thing .

Speaker #5: It's not easy to reproduce , and there's a giant moat around Eyevance that's , I think , very , very helpful for investors

Speaker #9: Great . Thanks for taking the questions

Reni Benjamin: Great. Thanks for taking the questions.

Speaker #3: Thank you . Our next question comes from David Dye with UBS . Your line is open .

Operator: Thank you. Our next question comes from David Dai with UBS. Your line is open.

Speaker #10: , great . Thanks for taking my questions . And also my congratulations on a great quarter . I have two questions . , so I'm happy , man .

David Dai: Great. Thanks for taking my questions and also my congratulations on a great quarter. I have 2 questions. On the topic of demand, can you just talk more about the demand you gave us across different ATCs? Do you see more demand concentrating in large ATCs, or do you see increased demand in smaller and newly activated ATCs? I have a follow-up.

Speaker #10: Can you just talk more about the demand varies across different attacks , but do you see more demand concentrating large pieces or do you see increasing demand smaller and newly activated APC ?

Speaker #10: I have a follow-up.

Speaker #2: Thanks for the question . What we saw and what we are seeing right now is the attacks that we originally opened in 2024 are starting to grow based on patient type and based on the information that we have that's been published recently , the atcs that we onboarded last year in 2025 , those are continuing to accelerate .

Fred G. Vogt: Thanks for the question. What we saw and what we are seeing right now is the ATCs that we originally opened in 2024 are starting to grow based on patient type and based on the information that we have that's been published recently. The ATCs that we onboarded last year in 2025, those are continuing to accelerate. Some of them are hitting their stride, so to speak, and getting mature and treating their patients. In H1 of this year, we've been opening ATCs at a pretty substantial pace, and those are starting to contribute now. We do see there's a few months between an ATC activation to them starting to treat patients, and then comfort level goes up. We are seeing growth across the different segments.

Speaker #2: Some of them are hitting their stride , so to speak . , and getting mature and treating their patients . And then in the first half of this year , we've been opening at a pretty substantial pace .

Speaker #2: And those are starting to contribute now . So we do see there's a few months between an ATC activation to them starting to treat patients .

Speaker #2: And then comfort level goes up. So we are seeing growth across the different segments in regards to larger ATCs, and whether they’re contributing to more.

Dan Kirby: In regard to larger ATCs and whether they're contributing to more, I think our larger ATCs are still growing. We still haven't had an ATC that we can say has reached complete peak because they keep looking for new patients and patient types then. We are seeing across our subset of ATCs, all of them.

Speaker #2: I think our larger atcs are still growing . We still haven't had an ATC , , that we can say has reached complete peak because they keep looking for new patients and patient types .

Speaker #2: , so we are seeing across our subset of attacks , all of them

Speaker #10: Great . That's the color . And then I'll community six , which now represent roughly one third of the network . , how does patient volume referral behavior and reimbursement experience differ between community and academic centers

David Dai: Great. Thanks for the color. On community ATCs, which now represent roughly one-third of the network, how does patient volume, referral behavior, and reimbursement experience differ between community and academic centers?

Speaker #2: Great question . So for patient volume , , they have the patients there and it's really not the number of patients . It's what time we're getting these patients .

Fred G. Vogt: Great question. For patient volume, they have the patients there, and it's really not the number of patients, it's what time we're getting these patients. As we said in the real-world data that got published earlier this year, patients that are on 2 or fewer lines of therapy have an over 50% response rate. Those patients reside primarily in the community setting before referred to the academics. We see referral barriers go down

Speaker #2: So as we said in the real world data that got published earlier this year is that patients that are on two or fewer lines of therapy have an over 50% response rate .

Speaker #2: Those patients reside primarily in the community setting before refer to the academics . So we see referral barriers go down . , the volume of patients are there and they're there earlier .

Dan Kirby: The volume of patients are there and they're there earlier. We do see the community ATCs are having learning curves similar to what we saw in the academics. Again, it takes a little while for them to ramp up. They're doing so now. Most of the community ATCs we started to onboard in H2 of last year. I joined in H1, and that was one of the things that we said would be a focus. We've come through on that focus and now a third of our ATCs. We do see that they can have a higher ceiling than the academics because again, it's organic referral patterns within network, which are much easier to maximize than referring to the academics.

Speaker #2: , we do see the , the community are having learning curves similar to what we saw in the academics . So again , it takes a little while for them to ramp up .

Speaker #2: They're doing so now . Most of the community attacks we started to onboard in the second half of last year . I joined in the first half , and that was one of the things that that would be a focus .

Speaker #2: We come through on that focus . And now a third of our atcs and we do see that they can have a higher ceiling than the academics because , again , it's organic referral patterns within network , which are much easier to maximize than referring it to the academic

David Dai: Got it. Thank you so much.

Speaker #10: Thank you so much

Speaker #3: Thank you . Our next question comes from Colleen QC with Baird . Your line is open

Operator: Thank you. Our next question comes from Corleen Roche with Baird. Your line is open.

Operator: Thank you. Our next question comes from Colleen Kusy with Baird. Your line is open.

Speaker #11: Hi , everyone . It's Nick on for Colleen . Thanks for taking the question . Congrats on the quarter . , just wondering if you could provide any color on how the conversion rate from referrals have treated patients has changed over the last few quarters .

[Analyst] (Baird): Hey, everyone. It's Nick on for Corleen. Thanks for taking the question. Congrats on the quarter. Just wondering if you could provide any color on how the conversion rate from referrals of treated patients has changed over the last few quarters. Also just on growth bottlenecks like patient identification referrals, et cetera, what do you expect to be the biggest constraint on growth going forward? Just wondering if you could talk about how you plan on addressing that. Thank you.

[Analyst] (Baird): Hey, everyone. It's Nick on for Colleen. Thanks for taking the question. Congrats on the quarter. Just wondering if you could provide any color on how the conversion rate from referrals of treated patients has changed over the last few quarters. Also just on growth bottlenecks like patient identification referrals, et cetera, what do you expect to be the biggest constraint on growth going forward? Just wondering if you could talk about how you plan on addressing that. Thank you.

Speaker #11: And then also just on , , just growth bottlenecks , like patient identification , referrals , etc. . What do you expect to be the biggest constraint on growth going forward ?

Speaker #11: And how just wondering if you could talk about how you plan on addressing that . Thank you

Speaker #12: Sure

Dan Kirby: Sure. As we look at this, the conversion to referrals, what we do see is earlier patients coming in. We're using that data in both non-personal media as well as in face-to-face with our field forces to get that word out. Again, we are seeing the referrals come in earlier, which means we have time to treat the patient. That is the change in the referral pattern with an earlier patient. That gets into patient ID as well. We have gone after, I've mentioned in previous calls, the BRAF mutated patients because that is a very important patient site, 40% of our market that we were having trouble accessing before. We're getting tumor tissue earlier. That is helping us ID these patients earlier to get tissue so we can manufacture for infusion at the right time.

Speaker #2: So as we look at this , the conversion to referrals , what we do see as earlier patients and earlier patients coming in , we're using that data in both , , non-personal media as well as in face to face with our with our field forces to get that word out .

Speaker #2: So again , we are seeing the referrals come in earlier , which means we have time to treat the patients . So that is the change in the referral patterns of an earlier patient .

Speaker #2: And that gets into patient ID as well . We have gone after I've mentioned in previous calls the Braf mutated patients because that is a very important patient type , 40% of our market that we were having trouble accessing before .

Speaker #2: We're getting tumor tissue earlier. That is helping us identify these patients earlier to get tissue so we can manufacture for infusion at the right time.

Speaker #2: , and then as far as constraints with the constraints that we're working on is really more penetration into the larger community networks . And we see that as an opportunity .

Dan Kirby: As far as constraints with it, the constraints that we're working on is really more penetration into the larger community networks. We see that as an opportunity. We've made a lot of strides over the last six to eight months with other entities for our cancers, et cetera, where we're getting the referral pattern up while we're looking to establish ATCs within their own networks. We've got some up right now in those areas. We're looking to get more up. Fred, did you have anything to add?

Speaker #2: We've made a lot of strides over the last 6 to 8 months . , with other entities . Florida cancers , etc. , where we're getting the referral patterns up while we're looking to establish a within their own networks , we've got some up right now in those areas .

Speaker #2: We're looking to get more up . Fred , did you have anything to add ?

Speaker #5: No , I think that's pretty accurate

Fred G. Vogt: No. Dan, I think that's pretty accurate.

Speaker #3: Thank you . This concludes the question and answer session . I would now like to turn it back to Fred Vogt for closing remarks .

Operator: Thank you. This concludes the question and answer session. I would now like to turn it back to Fred Vogt for closing remarks.

Speaker #5: Thank you for joining us . This was a record quarter for revenue and fusions , and margin Our pipeline is advancing rapidly with new Registrational trials , next generation clinical programs , and new approvals outside the United States .

Fred G. Vogt: Thank you for joining us. This was a record quarter for revenue, infusions, and margin. Our pipeline is advancing rapidly with new registrational trials, next-generation clinical programs, and new approvals outside the United States. We are energized by the growing number of patient stories that show the power of our cell therapies. We remain deeply grateful to the patients, partners, healthcare professionals, and advocacy communities we serve. Finally, I want to thank our exceptional Iovance team, our dedicated shareholders, and our covering analysts for their continued support. We remain committed to our mission to innovate, develop, and deliver current and next-generation cell therapies for patients with cancer. Thank you.

Speaker #5: We are energized by the growing number of patient stories that show the power of our cell therapies . We remain deeply grateful to the patients , partners , healthcare professionals , and advocacy communities we serve Finally , I want to thank our exceptional team , our dedicated shareholders are covering analysts for their continued support .

Speaker #5: We remain committed to our mission to innovate , develop and deliver current and next generation cell therapies for patients with cancer Thank you .

Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.

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