Q1 2024 Iovance Biotherapeutics Inc Earnings Call

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Livia: Welcome to the Iovance Biotherapeutics conference call to discuss first quarter 2024 results and recent corporate updates. My name is Livia, and I'll be your operator for today's call. At this time, all participants are in listen-only mode. Later, we will conduct a question and answer session. Please note that this conference call is being recorded. I will now hand the conference call over to Sara Pellegrino, Senior Vice President, Business Relations, and Corporate Communications at Iovance. Sara, you may begin.

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<unk> Therapeutics conference call to discuss first quarter 'twenty 'twenty four results and recent corporate updates.

Livia: My name is living and I'll be your Alban you put today's call.

Livia: At this time, all participants on listen only mode.

Livia: Later, we will conduct a question and answer session. Please.

Livia: Please note that this conference is being recorded.

Livia: I will now hand, the conference call over to Sara Pellegrino Senior Vice President of Investor Relations, and corporate communications and power plants.

Livia: You may begin.

Sara Pellegrino: Thank you, Operator. Good afternoon, and thank you for joining this conference call and webcast to discuss our first quarter 2024 results and recent corporate updates. Dr. Fred Vogt, our Interim President and Chief Executive Officer, will provide an introduction and summarize key updates on our U.S. commercial launch of Amtasie and our pipeline program. Jim Ziegler, EVP Commercial, will highlight our initial success with the U.S. commercial launch of Amtavit, an advanced melanoma; Dr. Igor Bilinsky, COO, will comment on our commercial manufacturing experience and capacity expansion

Sara Pellegrino: Thank you operator, good afternoon, and thank you for joining this conference call and webcast to discuss our first quarter of 'twenty 'twenty four adult and read the corporate update.

Sara Pellegrino: Doctor friends.

Sara Pellegrino: Interim President and Chief Executive Officer, who will provide an introduction and summarize key updates on our U S commercial launch about appetite at.

Sara Pellegrino: At our pipeline program.

Sara Pellegrino: N D. R E V E commercial well highlight our initials picked up with the U S commercial launch.

Sara Pellegrino: We advanced melanoma Dr.

Sara Pellegrino: Doctor Ybarbo N G E L O will comment on our commercial manufacturing experience and capacity expansion plans.

Sara Pellegrino: Jean-Marc Bellarmine, CFO, will review our financial results, and Dr. Frederick Finckenstein, Chief Medical Officer, will review key pipeline updates, including upcoming clinical data presentations at ASCO and new Next Generation Approaches. Dr. Brian Gastman, Executive Vice President, Medical Affairs, and Dr. Raj Puri, Executive Vice President, Regulatory Affairs, are also on the call and available for the Q&A session. Earlier this afternoon, we issued a press release that can be found on our corporate website at iovance.com.

Sara Pellegrino: <unk> got I mean, yeah, Oh, well review, our financial results and.

Sara Pellegrino: Doctor Friedberg Finkelstein, Chief Medical Officer will review key pipeline updates.

Sara Pellegrino: <unk> upcoming clinical data presentations at <unk> and new next generation approaches.

Sara Pellegrino: Dr. Brian Johnson Executive Vice President Medical Affairs, and Dr. Raj Perry Executive Vice President Regulatory Affairs are also on the call and available for the Q&A session.

Sara Pellegrino: Earlier. This afternoon, we issued a press release that can be found on our corporate website at <unk> Dot com.

Sara Pellegrino: 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, commercial activities, clinical trials and results, regulatory approvals and interactions, plans and strategies, research and preclinical activities, potential future applications of our technologies, manufacturing usability, regulatory feedback and guidance, payer interactions, licenses and collaborations, 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 filings. 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 it over to Fred.

Sara Pellegrino: Before we start I would like to remind everyone that statements made during this conference call will include forward looking statements regarding idled at school business smoking is this plan to transaction revenue commercial activities clinical trials and results regulatory approvals and interaction plans and strategy.

Sara Pellegrino: <unk> research and preclinical activities potential future applications of our technologies manufacturing capabilities regulatory feedback and guidance payer interactions licenses in collaboration cash position, an expense guidance 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 a.

Fred: Our results may differ materially from those projected during today's call. We undertake no obligation to publicly update any forward looking statement.

Sara Pellegrino: With that I will turn it over to Fred.

Frederick G. Vogt: Thank you, Sara. Good afternoon, everyone.

Fred: Thank you Sarah and good afternoon, everyone.

Fred: I am pleased to host our first quarter 2024 results conference call.

Frederick G. Vogt: I'm pleased to host our first quarterly 2024 results conference call. This has been a decisive year for Iovance following our first FDA approval and a strong start to the U.S. launch of Antagony for patients with advanced melanoma. We expect the positive momentum at Iovance will continue to build throughout 2024 as we ramp up the U.S. launch and execute across our broad clinical pipeline. To begin, we are very pleased that the high initial demand for Antagony continues to accelerate. Demand has increased month over month since approval, and it is expected to grow further throughout the year.

Fred: This has been at the size of your prime installing their first FDA approval and strong start to the U S launch for.

Frederick G. Vogt: For patients with advanced melanoma.

Frederick G. Vogt: The positive momentum that will continue to build throughout 2024, as we ramp up U S launch and execute across a broad clinical pipeline.

Frederick G. Vogt: To begin we were very pleased with the high initial demand for <unk> continues to accelerate demand has increased month over month since approval and expect it to grow further throughout the year.

Frederick G. Vogt: As of today, more than 100 patients are already enrolled for antibiotic therapy, and most are expected to be ready for infusion across the second and early third quarters of 2024. In addition, more than 60 additional patients have been identified as ATCs and are expected to enroll soon. As existing and new ATCs continue to build experience, we expect patient enrollments to steadily increase throughout the year, supporting our expectations for sustained growth. As we anticipated, interest is very high in our ATCs, and they are demonstrating that they have the training, infrastructure, and capabilities to treat patients with amtagby, which Jim will further highlight. We remain on track to have 50 total ATCs by the end of this month.

Frederick G. Vogt: As of today, where the 100 patients who are already enrolled for impacted therapy and most are expected to be ready for infusion across the second and early third quarters of 2024.

Frederick G. Vogt: In addition, more than 60 additional patients have been identified at ACC and Theyre expected to enrol soon.

Frederick G. Vogt: As existing and new Atc's continued to build experience, we expect patient enrollment to slowly increase throughout the year supporting our expectations for sustained growth.

Frederick G. Vogt: As we anticipated interest is very high on our AC season, they are demonstrating that they have the training infrastructure and capabilities to treat patients with integrity, which Jim will further highlight.

Frederick G. Vogt: We remain on track to have 50 total atc's by the end of this month.

Frederick G. Vogt: We also set a new goal of at least 70 ATCs by the end of this year, representing the largest number of ADCs for a cell therapy launch. We're pleased to see positive reimbursement trends, which is a key indicator for success in adoption. Positive reimbursement decisions are supported by our clinical data and the recent addition of antagony as the preferred second line for subsequent therapy in the National Comprehensive Cancer Network, or NCCN, guidelines.

Frederick G. Vogt: We also set a new goal of at least 70 acc's by the end of this year.

Frederick G. Vogt: Representing the largest ever number of Atc's for cell therapy launch.

Frederick G. Vogt: We are pleased to see positive reimbursement trends trends, which is a key indicator for success and adoption.

Frederick G. Vogt: Positive reimbursement decisions are supported by our clinical data and the recent addition of impact as the preferred second line or subsequent therapy in the national comprehensive cancer network or <unk> guidelines.

Frederick G. Vogt: The time to treatment will accelerate as ATCs establish a solid foundation for broad market access and reimbursement, which will add to momentum, and we'll describe this in more detail. In terms of commercial manufacturing, we have two FDA-approved manufacturing sites in sufficient capacity to meet near-term demand at launch, setting a new bar for cell therapy launches. Our commercial manufacturing experience is very positive and is consistent with our prior clinical experience. We have successfully manufactured and delivered antibody within our target turnaround time of 34 days.

Frederick G. Vogt: Time to treatment will accelerate as ACC has established a solid foundation for broad market access and reimbursement, which will add the momentum Joe.

Frederick G. Vogt: Joe will describe this in more detail.

Frederick G. Vogt: In terms of commercial manufacturing, we have two FDA approved manufacturing site and sufficient capacity to meet near term demand at launch setting a new bar for cell therapy launches.

Frederick G. Vogt: Our commercial manufacturing experience is very positive is consistent with our prior clinical experience with.

Frederick G. Vogt: We have successfully manufactured and delivered in taxi within our target turnaround time of 34 days.

Frederick G. Vogt: ATCs observe sufficient availability of manufacturing slots and report a positive experience in the scheduling process, which is critical for broader utilization. We expect to have ample capacity to meet the anticipated ramp-up in demand this year. Finally, long-term expansions are underway to more than double our currently built capacity for future growth. In addition to the U.S. launch, we are working to enter new markets that can more than double the total addressable advanced melanoma patient population in APAC.

Frederick G. Vogt: <unk> observe sufficient availability of manufacturing spots.

Frederick G. Vogt: A positive experience with Goodman process, which is critical for broader utilization.

Frederick G. Vogt: We expect to have ample capacity to meet the anticipated ramp up in demand this year.

Frederick G. Vogt: Finally long term expansion is already underway to more than double our currently build capacity for future growth.

Frederick G. Vogt: In addition to the U S launch we are working to enter new markets that can more than double the total addressable advanced melanoma patient population.

Frederick G. Vogt: Registry submissions remain on track this year in the EU, UK, and Canada, where we have the potential to begin driving significant additional revenue by the end of 2025. We also continue to advance and expand our robust and exciting pipeline, including two registrational programs, as well as new next-generation approaches that Frederick will highlight on this call. As a fully integrated company that's executing a U.S. launch and developing a broad pipeline, Iovance is well-positioned to remain the global leader in innovating, developing, and delivering tilt-cell therapy for patients with cancer. I'll now hand it over to Jim, our Executive Vice President of Commercials, who will speak in more detail about our launch metrics.

Frederick G. Vogt: Regulatory submissions remain on track this year in the EU, UK and Canada, where we have the potential to begin driving significant additional revenue by the end of 2025.

Jim: We also continue to advance expand our robust exciting pipeline, including two registrational programs as well as new next generation approaches that Frederic will highlight on this call.

Jim: As a fully integrated company is executing a U S launch and developing a broad pipeline <unk> is well positioned to remain the global leader in innovating developing and delivering fuel cell therapy for patients with cancer.

Frederick G. Vogt: I'll now ill now handover to Jim <unk>, our executive Vice President of commercial who will speak in more detail about our launch metrics.

James Ziegler: Thank you, Fred. We are excited about the potential for MCAT-B to transform the treatment paradigm for advanced melanoma. My objectives today are to highlight initial U.S. launch metrics, which are supported by robust demand among ATCs and patients, as well as progress with payers. ATCs are the key driver of demand and patient enrollment for MCAT. Launching with 30 ATCs was a testament to the significant unmet need in advanced melanoma and each center's high level of commitment to Opram TagV for their patients. Today, there are more than 40 ATCs, and we remain on track to meet our goal of 50 total ATCs by the end of May.

Jim: Thank you Fred we are excited about the potential for <unk> to transform the treatment paradigm in advanced melanoma.

James Ziegler: Objectives today are to highlight initial U S launch metrics, which are supported by robust demand among <unk> patients as well as progress with payers.

James Ziegler: <unk> are the key driver of demand and patient enrollments for amtech and launching.

James Ziegler: Launching with 30 <unk> was a testament to the significant unmet need in advanced melanoma, and each center's high level of commitment to operating tag before their patients.

James Ziegler: Today, there are more than 40, Adcs and we remain on track to meet our goal of 50 total <unk> by the end of May.

James Ziegler: Due to increasing interest by hospitals that offer MCAGV, we are now targeting at least 70 total ATCs by the end of the year. As Fred mentioned earlier, ATCs have enrolled more than 100 patients where MCAGV treats. A patient enrollment is defined as an MTAGV treatment decision by the provider and patient. The patient enrollment is followed by commercial payer prior authorization and a scheduled tumor procurement for manufacturing. Based on the patient journey timeline, Amtagvi infusions for currently enrolled patients would likely occur in the second quarter and early third quarter.

James Ziegler: Due to increasing interest by hospitals offering we.

James Ziegler: We are now targeting at least 70 total atc's by the end of the year.

James Ziegler: Brian mentioned earlier.

James Ziegler: <unk> have enrolled more than 100 patients Graham KGB treatment.

James Ziegler: Patient enrollment is defined as a name tag the treatment decision by the provider and patient.

James Ziegler: Patient enrollment is followed by commercial Payor prior authorization and its scheduled tumor procurement for manufacturing.

James Ziegler: Based on the patient journey timeline and Taghavi infusions are currently enrolled patients would likely occur across the second quarter and early third quarter.

James Ziegler: In addition, existing ATCs are screening an increasing number of patients for treatment eligibility. With more than 60 patients currently in screening today, we expect a high conversion of additional patients to Amtagvi patient enrollment in the near term for potential infusions in the third quarter. We are observing month-over-month growth, and we anticipate sustained growth throughout the year as the number of ATCs expands and there is broader utilization of MTAC. In the short time since approval, favorable reimbursement trends and medical coverage policies have set us up for success and broad access for patients.

James Ziegler: In addition, existing ATC their screening and increasing number of patients for treatment eligibility.

James Ziegler: With more than 60 patients currently in screening today, we expect a high conversion of additional patients.

James Ziegler: In Calgary patient enrollment in the near term for potential infusion into third quarter.

James Ziegler: We are observing month over month growth and we anticipate sustained growth throughout the year as the number of ATC.

James Ziegler: <unk> expand and there is broader utilization of amtech.

James Ziegler: In the short time since approval favorable reimbursement trends in medical coverage policies.

James Ziegler: Let us up for success and broad access for patients.

James Ziegler: Early launch data indicates that more than 75% of patients enrolled for MTAG-V are commercially insured, which aligns with our expectations. Thus far, payers responsible for more than 200 million lives have approved at least one patient for antagony treatment. And notably, 13 payers responsible for approximately 90 million covered lives have already published medical coverage policies that are consistent with the label, clinical trials, and the recently updated NCCN guidelines.

James Ziegler: Early launch data indicates that more than 75% of patients enrolled per and <unk> are commercially insured, which aligns with our expectations. Thus.

James Ziegler: Thus far payers responsible for more than 200 million lives have improved at least one patient frame tagme treatment and notably 13 payers responsible for approximately 90 million covered lives have already published medical coverage policies that are consistent with label clinical trials and.

James Ziegler: We recently updated and CCM guideline.

James Ziegler: We expect the remaining payers to issue similar favorable medical coverage policies.

James Ziegler: Timelines for financial clearance will accelerate as more payers issue coverage policies.

James Ziegler: We expect the remaining payers to issue similar favorable medical coverage policies and that timelines for financial clearance will accelerate as more payers issue coverage policies. In summary, we are extremely pleased with the early launch progress, and we expect steady growth as ATCs gain treatment experience, our ATC network expands, and community referrals increase over time. I look forward to providing future updates on these important ATC reimbursement and performance metrics. Additionally, I would like to acknowledge the very talented cross-functional teamwork at Iovance.

James Ziegler: In summary, we are extremely pleased with the early launch progress and we expect steady growth at ADP has gained treatment experience.

James Ziegler: ACC network expands and community referrals increase overtime.

James Ziegler: I look forward to providing future updates on these important ADC reimbursement and performance metrics.

James Ziegler: I would like to acknowledge the very talented cross functional teamwork Nio man I.

James Ziegler: I'm even more pleased with the deep partnerships our team has established with ATCs. Collectively, our goal is to broaden and accelerate patient access to Antagony. I will now pass the call to Igor Bilinsky, our Chief Operating Officer, to highlight our manufacturing progress.

James Ziegler: I'm, even more pleased and the deep partnerships Archie Amendment established with Accs collectively our goal is to broaden and accelerate patient access to <unk>.

Igor P. Bilinsky: I will now pass the call to Igor Bolinsky, our chief operating officer to highlight our manufacturing progress.

Igor P. Bilinsky: Thank you, Jim. Today, I'd like to highlight our current manufacturing capabilities. Our experience with the M-TAG, the U.S. launch, as well as our capacity expansion plans to support significant product growth and demand that we anticipate in the U.S. from geographic expansion and from our exciting clinical pipeline. Manufacturing is a core competency for us at Iovance. And we built our own manufacturing facility, Iovance Cell Therapy Center, or ICTC, in Philadelphia. ICTC is one of the largest cell therapy manufacturing facilities in the world and the only one specifically designed for till manufacturing.

Igor P. Bilinsky: Thank you Jim today I'd like to highlight our current manufacturing capabilities experience will be outside of the U S launch as well as our capacity expansion plans to support significant further growth in demand that we anticipate in the U S from geographic expansion and promo exciting clinical.

Igor P. Bilinsky: Fine.

Igor P. Bilinsky: When you take <unk> as a core competency for us at <unk>.

Igor P. Bilinsky: We built our own manufacturing facility either in cell therapy center or ICC Philadelphia.

Igor P. Bilinsky: <unk> is one of the largest cell therapy manufacturing facilities in the world and the only one specifically designed with two manufacturing.

Igor P. Bilinsky: ICTC is now FDA-approved for commercial manufacturing of Antibody for the U.S. market and continues to serve patients in our clinical trials in melanoma, lung cancer, and other indications in the US, Europe, Australia, and other geographies. ICTC has been responsible for most of the commercial and tagging manufacturing volume.

Igor P. Bilinsky: ICD seasonal FDA approved for commercial manufacturing of <unk> for the U S market.

Igor P. Bilinsky: <unk> continues to serve patients in our clinical trials in melanoma lung cancer and other indications in the U S Europe, Australia and other geographies.

Igor P. Bilinsky: ICT has been responsible for most of the commercial uptitling manufacturing volume to date.

Igor P. Bilinsky: In addition to ICTC, the FDA approved our contract manufacturer site for commercial manufacturing of. Having two approved facilities provides us with additional flexibility and capacity for both commercial and clinical. Overall, we believe that our manufacturing capabilities and capacity are setting a new bar for self-therapy work, and we're strategically planning ahead for anticipated demand. Together, turning to our early experience with commercial lunch, we're executing as planned.

Igor P. Bilinsky: In addition to our CDC the FDA approved our contract manufacturer site for commercial manufacturing of uptime.

Igor P. Bilinsky: Having two approved facilities provides us with additional flexibility and capacity for both commercial and clinical patients.

Igor P. Bilinsky: Overall, we believe that our manufacturing capabilities and capacity of setting a new bar for cell therapy lunches and we're strategically planning ahead for anticipated demand in the future.

Igor P. Bilinsky: Together.

Igor P. Bilinsky: Turning to our early experience with commercial launch we're executing as planned.

Igor P. Bilinsky: The commercial manufacturing experience to date is consistent with prior clinical trials. Turnaround time has been on target with initial launch expectations of approximately 34 days from receipt of tumor tissue to return shipment of antibody to the ATC, which is then followed by lymphadepletion and infusion. We are confident in our capacity to meet the current and projected demands of the U.S. launch in our clinical trials, as well as to support Iovance's PlantFuture project.

Igor P. Bilinsky: The commercial manufacturing experience to date is consistent with prior clinical experience.

Igor P. Bilinsky: Turnaround time has been on targets with initial launch expectations to approximately 34 days from receipt of tumor tissue to return shipment of entitlement to the EDC, which is then followed by length of depletion in the future.

Igor P. Bilinsky: We are confident in our capacity to meet the current and projected demand of the U S launch in all clinical trials.

Igor P. Bilinsky: As well as to support <unk> future growth.

Igor P. Bilinsky: ICTC, as built today, has the capacity to provide two therapies for more than 2,000 patients per year. A competent manufacturing team is important in biotech and cell therapy, in particular. Right now, we are staffed appropriately for launch, and we are continuing to add headcounts to meet the demand for commercial antagonists, as well as for our clinical trials. To fulfill our staffing needs, the ICTC Philadelphia location provides access to talent with cell therapy and gene therapy experience at other companies in the region, as well as the next generation of talent through local schools and resources.

Igor P. Bilinsky: Icd's C is built today has the capacity to provide two therapies for more than.

Igor P. Bilinsky: 2000 patients per year.

Igor P. Bilinsky: Confidence manufacturing team is important biotech in cell therapy in particular.

Igor P. Bilinsky: Right now we're staffed appropriately for lunch.

Igor P. Bilinsky: And we're continuing to add headcount to meet the demand for commercial loan sizes as well as for clinical trials.

Igor P. Bilinsky: To fulfill our staffing needs the ICC Philadelphia location provides access to talent with cell therapy and gene therapy experience at other companies in the region as well as the next generation of talent through the local schools and resources.

Igor P. Bilinsky: In preparation for increasing commercial demand in the US and additional geographies and in support of our advancing clinical pipeline, capacity expansion is now underway at ICTC and is expected to be completed in a few years. Building out the existing shelf space of the facility is expected to enable ICD-C to supply tilt therapies for more than 5,000 patients annually. Longer term, our vision is to supply treatment for over 10,000 patients annually from the ICTC count.

Igor P. Bilinsky: In preparation for increasing commercial demand in the U S and additional geographies and in support of our advancing clinical pipeline.

Igor P. Bilinsky: For all the capacity expansion is now underway the ICC and is expected to be completed in a few years.

Igor P. Bilinsky: Building out the existing shelf space of the facility is expected to enable a CDC to supply two therapies for more than 5000 patients annually.

Igor P. Bilinsky: Longer term our vision is to supply its still for over 10000 patients annually from the ICC Kansas.

Igor P. Bilinsky: We have an option to construct another building at the ICTC campus and plan to drive additional efficiencies by incorporating increased automation. Phenomeni Faction, In summary, our team is excited to provide MTagV and our investigational tools therapies for patients with, We're laser focused on the quality of the manufacturing process, in the spirit of doing everything right the first time at every step, from incoming receipt of tumor samples, to manufacturing and product release, to outbound shipment of Antagvi to the commercial ATCs, and investigational devices to clinical trials. I'm available to answer additional questions during the Q&A, and I will now hand the call over to Jean-Marc, our Chief Financial Officer.

Igor P. Bilinsky: We have an option to construct another building at the ITC campus and plans to drive additional efficiencies by incorporating increased automation.

Jean-Marc: Any section process.

Jean-Marc: In summary, our team was excited to provide them Sotheby's and our investigational therapies for patients with cancer.

Jean-Marc: We're laser focused on the quality of the manufacturing process in the spirit of doing everything right first time every step from incoming receipt of tumor sample through manufacturing and product release to outbound shipment of on segments of the commercial atc's, an investigational tools to clinical trial sites.

Jean-Marc: Billable to answer additional questions during the Q&A and I will now hand, the call over to Mark our Chief Financial Officer.

Jean-Marc: Thank you Rocco.

Jean-Marc Bellarmine: Today, I will review our current cash position as well as our results for the quarter ended on March 31st, 2025. I will also highlight our 2024.

Jean-Marc: I will review, our current cash position as well as our results for the quarter ended on March 31st towards the principal.

Jean-Marc Bellarmine: I would also highlight of consequence before outlook.

Jean-Marc Bellarmine: As of March 31st, 2024, Iovance had cash, cash equivalents, investments, and restricted cash of approximately $362.6 million. The current cash position and anticipated revenue from Antavi and Coloquin are expected to be sufficient to fund current and planned operations well into the second half of 2025. Shifting to our first quarter financial results, the net loss for the first quarter and March 31st, 2024 was $113 million, or 42 cents per share, compared to a net loss of $107.4 million, or $0.50 per share, for the first quarter of March 31, 2021. The net loss for the first quarter of 2024 includes amortization of intangible assets acquired as part of the prolonged transaction.

Jean-Marc Bellarmine: As of March 31st 2024.

Jean-Marc Bellarmine: Cash cash equivalents investments and restricted cash of approximately $362 6 million.

Jean-Marc Bellarmine: The current cash position and anticipated revenue from <unk> and <unk>.

Jean-Marc Bellarmine: <unk> are expected to be sufficient to fund current and planned operation well through the second half of 2025.

Jean-Marc Bellarmine: Revenue for the first quarter under March 31st, 2024 was $715,000 and comprised of sales of Perlukin in licensed markets outside of the US. Cost of sales for the first quarter and the year ending March 31st, 2024 was $7.3 million primarily related to inventoryable costs associated with sales of Perloukin and non-cash amortization expense for the acquired intangible asset for developed technologies. There was no revenue or cost of sales in the first quarter until March 31st, 2020.

Jean-Marc Bellarmine: Shifting to our first quarter financial results.

Jean-Marc Bellarmine: Net loss for the first quarter ended March 31st 2024 was $113 million.

Jean-Marc Bellarmine: <unk> 42 per share.

Jean-Marc Bellarmine: Compared to a net loss of $107 4 million daus.

Jean-Marc Bellarmine: <unk> 50 per share for the first quarter ended March 31st 2020.

Jean-Marc Bellarmine: The net loss for the first quarter of 2024 includes amortization of intangible assets acquired as part of the <unk> transaction.

Jean-Marc Bellarmine: Revenue for the first quarter ended March 31st 2024 was $716000 and comprised of sales of polluting in license market outside of the U S.

Jean-Marc Bellarmine: Cost of sales for the first quarter ended March 31st 2024 was $7 3 million.

Jean-Marc Bellarmine: Primarily related to inventory costs associated with sales of Proleukin and noncash amortization expense for the acquired intangible assets for the <unk> technology.

Jean-Marc Bellarmine: There was no revenue or cost of sales in the first quarter ended March 31st 2022.

Jean-Marc Bellarmine: Research and development expenses were $79.8 million for the first quarter ended March 31st, 2024, a decrease of $2.9 million compared to $82.7 million for the same period ended March 31st, 2024. The decrease was primarily attributable to the transition to commercial and tax-free manufacturing in the most recent quarter, partially offset by increased costs associated with the purchase of raw materials, clinical trials driven primarily by the Phase 3-301 clinical trial, and the planned EU regulatory submissions for life-threatening diseases.

Jean-Marc Bellarmine: Research and development expenses were $79 8 million for.

Jean-Marc Bellarmine: For the first quarter ended March 31st 2024.

Jean-Marc Bellarmine: Decrease of $2 9 million compared.

Jean-Marc Bellarmine: Compared to $2 7 million for the same periods ended March 31st 2012.

Jean-Marc Bellarmine: The decrease was primarily attributable to the transition to commercial impact of the manufacturing the most for some quarter.

Jean-Marc Bellarmine: Partially offset by increased cost associated with the purchase of raw materials clinical trials, driven primarily by the phase III <unk>.

Jean-Marc Bellarmine: <unk> clinical trial and the plan you regulatory submissions for <unk>.

Jean-Marc Bellarmine: Selling general and administrative expenses were $31.4 million for the first quarter and on March 31st, 2024, an increase of $3.3 million compared to $28.1 million for the same period ended March 31, 2021. The increase was primarily attributable to increases in net count and related costs, including stock-based compensation, to support the growth in the overall business and related corporate infrastructure, as well as costs incurred to support the commercialization of MTAC-V and Proloquy, partially offset by a decrease in legal costs.

Jean-Marc Bellarmine: Selling general and administrative expenses were $31 4 million for the first quarter ended March 31st 2024.

Jean-Marc Bellarmine: The increase of $3 3 million.

Jean-Marc Bellarmine: Compared to $28 1 million for the same period ended March 31st 2020.

Jean-Marc Bellarmine: The increase was primarily attributable to increases in headcount and related costs, including stock based compensation.

Jean-Marc Bellarmine: The growth in their whole business unrelated to the gulfport infrastructure as well as cost material to support the commercialization of <unk>.

Jean-Marc Bellarmine: Partially offset by a decrease in legal costs.

Jean-Marc Bellarmine: Regarding our outlook for this year, we continue to guide towards full year 2024 cash burn in the range of $320 to $340 million, excluding one-time expenses, and we'll continue to leverage opportunities to optimize spending. The U.S. launch of Amtagvi, as well as the sales of Proloukine used in conjunction with the Amtagvi treatment regimen, are expected to drive significant revenue in the second half of 2024 and into 2025 and As a reminder, revenue recognition for Antagri occurs upon infusion, like other cell therapies.

Jean-Marc Bellarmine: Regarding your outlook for this year, we continue to get to guide towards the full year of 2020 forecast growth in the range of 322 trillion up $14 million.

Jean-Marc Bellarmine: Excluding onetime expenses and will continue to leverage opportunities to optimize spending.

Jean-Marc Bellarmine: The U S launch of <unk> as well as the sales of <unk> used in conjunction with the targeted treatment regimen.

Jean-Marc Bellarmine: I expected to drive significant progress during the second half of consequence, before and into 2025 and beyond.

Jean-Marc Bellarmine: As a reminder, revenue recognition from Dr. <unk> appointment.

Jean-Marc Bellarmine: Fusion like Aldo cell therapies. So we expect to begin recognizing in our reporting significant progress during the second quarter of this year.

Jean-Marc Bellarmine: So we expect to begin recognizing and reporting significant revenue in the second quarter of this year. For additional information, please see this afternoon's press release and our Forum 10 Q, to be filed later today. I will now hand the call to Frederick, our Chief Medical Officer, to discuss our clinical pipeline.

Frederick: For additional information please.

Frederick: Please see this afternoon's press release, and our Form 10-Q to be filed later today.

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

Frederick: Thank you so much.

Friedrich Graf Finckenstein: I am pleased to speak today about our key clinical pipeline highlights in solid tumors, which, as you all know, represent more than 90% of all diagnosed cancers in the U.S. One of our key priorities is expanding the label for mTagli to address the need for patients with advanced melanoma in frontline treatment. Our Registrational Phase III trial, TILBANS 301, is well underway and on track to support accelerated and full approvals of amtabian in combination with pembolizumab in frontline advanced melanoma, as well as regular approvals of amtabian in post-anti-PD-1 melanoma. Global site activation and patient enrollment continue with strong momentum in the U.S., Europe, Australia, Canada, and additional countries.

Frederick: I am pleased to speak today about our key clinical pipeline highlights in solid tumors.

Friedrich Graf Finckenstein: I'll now represents more than 90% of all diagnose cancers in the U S.

Friedrich Graf Finckenstein: One of our key priorities is expanding the label for <unk> to address the need of patients with advanced melanoma in the frontline treatment setting.

Friedrich Graf Finckenstein: Our Registrational phase III trial, <unk> 301 is well underway and on track to support accelerated and full approval of <unk> in combination with Campbellism up in frontline advanced melanoma as well as regulatory approvals towards the end post anti PD one in melanoma.

Friedrich Graf Finckenstein: Site activation and patient enrollment continue with strong momentum in the U S Europe, Australia, Canada and additional countries.

Friedrich Graf Finckenstein: Our frontline advanced melanoma strategy is supported by cohort 1A in our IOV-COM-202 trial in solid tumors and previously published data on TIL therapy in the pre-immune checkpoint inhibitor era. We look forward to an oral presentation of updated clinical data from cohort 1A, which continues to strongly support our frontline development plans, at the American Society of Clinical Oncology, or ASCO, annual meeting on May 31, 2024. Shifting to our program in non-small cell lung cancer, we reported positive updates for our single-arm registrational phase two trial, IOV-LUN202, in post-anti-PD-1 non-small cell lung cancer.

Friedrich Graf Finckenstein: Our frontline advanced melanoma strategy supported by cohort one and all.

Friedrich Graf Finckenstein: Our <unk> Com 202 trial in solid tumors.

Friedrich Graf Finckenstein: As previously published data on til therapy in the pre immune checkpoint inhibitor era.

Friedrich Graf Finckenstein: We look forward to an oral presentation of updated clinical data from cohort, one which continued to strongly support our frontline development plans at the American Society of clinical oncology or <unk> annual meeting on May 31, 2024.

Friedrich Graf Finckenstein: Shifting to our program in non small cell lung cancer, we reported positive updates for our single arm Registrational phase II trial IOP as you add 202 and post anti PD, one non small cell lung cancer.

Friedrich Graf Finckenstein: We resumed enrollment for new patients within a very short time after the U.S. FDA lifted our partial clinical trial hold in the first quarter. IOV-LUN202 includes clinical sites in the U.S., Canada, and Europe, with plans to include additional regions with strong track records for enrollment in lung cancer studies over the next few months. Enrollment has restarted with high demand, which is driven by encouraging data and further augmented by excitement from the approval of MTAG. We expect the registrational cohorts to be fully enrolled in 2025.

Friedrich Graf Finckenstein: We resumed enrollment for new patients within a very short time after the U S. FDA lifted off partially clinical trial hold in the first quarter.

Friedrich Graf Finckenstein: <unk> you want to have to include.

Friedrich Graf Finckenstein: Clinical sites in the U S, Canada and Europe with plans to include additional regions with strong track records for enrollment in lung cancer studies over the next few months.

Friedrich Graf Finckenstein: Enrollment has restarted with high demand, which is driven by encouraging data and further augmented by excitement from the approval of <unk>.

Friedrich Graf Finckenstein: We expect the registrational cohorts to be fully enrolled in 2025.

Friedrich Graf Finckenstein: Current data from IOV-RD1202 and FDA interactions regarding our regulatory pathway continue to be positive and support our confidence in the opportunity for TIL cell therapy in lung cancer. The FDA has provided positive regulatory feedback on the proposed post-C-MAT matrix for lifelucelin on small cell lung cancer during a recent Type D meeting and has previously announced that the design of the single-arm IOV-LUN202 trial may be acceptable for approval of lifelucelin post-anti-PD-1 in small cell lung cancer.

Friedrich Graf Finckenstein: Current data from <unk> <unk> to <unk> and the FDA interactions regarding our regulatory pathway continues to be positive and support our confidence in the opportunity for til cell therapy in lung cancer.

Friedrich Graf Finckenstein: <unk> has provided positive regulatory feedback on the proposed potency matrix for life of those for the non small cell lung cancer. During a recent type D meeting and as previously announced that the design of the single arm <unk> into two trials may be acceptable for approval.

Friedrich Graf Finckenstein: Anti PD, one non small cell lung cancer.

Friedrich Graf Finckenstein: In other tumor types, we are starting a phase 2 trial of lifelucelin in post-anti-PD-1 endometrial cancer, which is a significant opportunity for TILT cell therapy. Our Phase II trial will include patients with advanced endometrial cancer who progress after platinum-based chemotherapy and anti-PD-1 therapy, regardless of the mismatched repair status of the tumor. Our rationale is supported by the Till mechanism of action, which may benefit both patient populations, as well as preclinical and manufacturing success data that we plan to report later this year. There is a significant unmet medical need and no currently approved treatment options for the vast majority of patients with endometrial cancer in the post-anti-PD-1 treatment setting.

Friedrich Graf Finckenstein: In other tumor types, we are starting a phase II trial of likelihood and then post anti PD, one endometrial cancer, which is a significant opportunity for <unk> cell therapy.

Friedrich Graf Finckenstein: Our phase two trial will include patients with advanced endometrial cancer, who have progressed after platinum based chemotherapy and anti PD, one therapy, regardless of mismatch repair status of the tumor.

Friedrich Graf Finckenstein: Our rationale is supported by the <unk> mechanism of action, which may benefit both patient populations.

Friedrich Graf Finckenstein: Well as preclinical and manufacturing success data that we plan to report later this year.

Friedrich Graf Finckenstein: There is a significant unmet medical need and no currently approved treatment options for the vast majority of patients with endometrial cancer and the post anti PD one treatment setting.

Friedrich Graf Finckenstein: Given this unmet medical need and the enthusiasm we've received from gynecological oncologists, we expect to enroll quickly, and we look forward to seeing first data soon. As the leader in tilt-cell therapy, Iovance is at the forefront of next-generation approaches that have the potential to address unmet needs for patients and solidify our long-term leadership in them. We reached an important milestone for our Genetically Modified Tilt Cell Therapy, IOV4001, in the first-in-human GM1-201 trial in previously-treated advanced melanoma or non-small cell lung cancer patients.

Friedrich Graf Finckenstein: Given this unmet medical need and the enthusiasm we have received from gynecological oncologists, we expect to enroll quickly and we look forward to seeing first data soon.

Friedrich Graf Finckenstein: As the leader until cell therapy, I have asked us at the forefront of next generation approaches that have the potential to address unmet needs for patients and solidify our long term leadership in this space.

Friedrich Graf Finckenstein: We reached an important milestone for our genetically modified til cell therapy, <unk> 4001, and the first inhuman GM. One 201 trial in previously treated advanced melanoma, non small cell lung cancer patients.

Friedrich Graf Finckenstein: The phase one safety portion concluded successfully, and we are progressing into the multi-central phase two efficacy stage of the trial. ILV4001 utilizes the TALENT technology licensed from Selectus to inactivate PD-1 during the till manufacturing process. We also have options to continue to develop other gene-edited TILT cell therapies with multiple knockout targets to potentially improve efficacy. We are also making great strides to advance additional next-generation programs toward the clinic.

Friedrich Graf Finckenstein: A phase one safety portion concluded successfully and we are progressing into the multi center phase II efficacy stage of the trial.

Friedrich Graf Finckenstein: <unk> 4001 utilize the talent technology licensed from select us to and activate PD one during the til manufacturing process.

Friedrich Graf Finckenstein: We also have options to continue to develop other investigational gene edited til cell therapies with multiple knockout targets to potentially improve efficacy.

Friedrich Graf Finckenstein: We are also making great strides to advance additional next generation programs towards the clinic.

Friedrich Graf Finckenstein: In the third quarter of 2024, we plan to submit an Investigational New Drug Application, or IMD, for a Phase I-II clinical trial of IOV-3001; a modified interleukin-2 or IL-2 fusion protein. At ASCO 2024, the poster will highlight preclinical data that support the potential for improved safety with robust effector T cell expansion with IOV-3001. Lastly, on today's call, we are introducing IOV5001, a new next-generation program. IOV5001 is a genetically engineered tethered cell therapy with inducible and tethered IL-12.

Friedrich Graf Finckenstein: In the third quarter of 2024, we plan to submit an investigational new drug application or IMT.

Friedrich Graf Finckenstein: For our phase one two clinical trial of <unk> 3001, our modified interleukin two or IL two fusion protein.

Friedrich Graf Finckenstein: <unk> 2020 for a poster will highlight preclinical data that support the potential for improved safety with robust effector T cell expansion with IOP at 3001.

Friedrich Graf Finckenstein: The addition of IL-12 has augmented TIL anti-tumor activity in vitro. IOV-5001 also builds on the improved efficacy of a prior generation IL-12 TIL therapy that was observed in a clinical trial at the National Cancer Institute, or NCI. IOV5001 is currently an IND-enabling study. We plan to discuss IOV5001 with the FDA at an interactive meeting in the third quarter of 2024 and anticipate an IND submission in early 2025. I'm happy to address questions about these programs and additional trials during the Q&A session. I'll now turn the call over to the operator to begin the question and answer session.

Friedrich Graf Finckenstein: Lastly on today's call we are introducing <unk> 5001, our new next generation program.

Friedrich Graf Finckenstein: <unk> 5001 is a genetically engineered T cell therapy, with inducible and tethered IL 12.

Friedrich Graf Finckenstein: The addition of IL 12 has augmented till anti tumor activity in vitro.

Friedrich Graf Finckenstein: <unk> 5001 also builds on the improved efficacy of a prior generation of IL 12 til therapy that was observed in a clinical trial at the National Cancer Institute or NCI.

Friedrich Graf Finckenstein: <unk> Hi styles with one is currently in IND, enabling studies.

Friedrich Graf Finckenstein: We plan to discuss <unk> 5001, with the FDA at an interactive meeting in the third quarter of 2024 and anticipate an IND submission in early 2025.

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

Friedrich Graf Finckenstein: I'll now turn the call over to the operator to begin the question and answer session.

Speaker Change: Thank you, ladies and gentlemen to ask a question you will need to press star one on your telephone and we're planning to be announced.

Operator: Thank you. Ladies and gentlemen, to ask a question, you will need to press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, simply press star 1 1 again. Please stand by while we compile the CANI roster. Our first question comes from the line of Michael Yee with Jeffrey Thiel on his phone.

Operator: I'm showing a question simply press star one again.

Operator: I'm on the compounding Kenny roster.

Operator: First question coming from the line of Michael Yee with Jefferies. Your line is now open.

Michael Jonathan Yee: Hey guys, thanks. Congratulations on all the progress. We have a two part question.

Michael Jonathan Yee: Hey, guys. Thanks, Congrats on all the progress.

Michael Jonathan Yee: We have maybe a two part question.

Michael Jonathan Yee: You gave some really great metrics around the indications of interest in the enrollment numbers can you maybe just describe sort of the journey of time from.

Michael Jonathan Yee: Enrolling and then getting reimbursed and then I think sort of the 34 days than inbound to get treated I'm just trying to think about how many of the 100 people who've enrolled are likely to get treated and dose in this quarter and thinking about the consensus number and then thinking about how many of those would get treated in the third quarter maybe.

Michael Jonathan Yee: Just talk a little about the journey and how you think about those 100 patients getting treated thank you.

Michael Jonathan Yee: You gave some really great metrics around the indications of interest in the enrollment numbers. Can you maybe just describe sort of the journey of time from enrolling and then getting reimbursed? And then I think sort of the 34 days to then get treated? I'm just trying to think about how many of the 100 people who've enrolled are likely to get treated and go in this quarter and thinking about the consensus number and then thinking about how many of those would get treated in the third quarter. Maybe just talk a little about the journey and how you think about those 100 patients getting treated. Thank you.

Michael Jonathan Yee: Yes, I can.

Michael Jonathan Yee: Give me a little color on that so the patients right now that are being enrolled right now it could be in theory treated in the second quarter or sorry, when I say treated I mean infused that revenue recognized in the second quarter early in the third quarter, that's because as we've as we've mentioned it takes some time to do the financial clearance of the patients they come in and then they get Resected and then there is a target.

Frederick G. Vogt: Yeah, Mike, I can give you a little color on that. So the patients right now that are being enrolled right now could, in theory, be treated in the second quarter or—so when I say treated, I mean abused and revenue-recognized in the second quarter or early in the third quarter. That's because, as we've mentioned, it takes some time to do the financial clearance of the patients as they come in, and then they get resected, and then there's a target right now, which we're meeting, of 34 days from the time we start manufacturing all the way through to completing the quality control testing, and then the patient is liquid depleted and infused after that.

Frederick G. Vogt: Now, which we're meeting of 34 days from the time we.

Frederick G. Vogt: Start start manufacturing all with due to completing the quality control testing and then the patient is liquid depleted.

Frederick G. Vogt: It's a little different than the clinical trial. The clinical trial rate would move faster because the patients weren't on bridging therapy. But in many cases now, they are on bridging therapy, and we have to do it this way anyway with the commercial product.

Frederick G. Vogt: Infused after that it's a little different in the clinical trial.

Frederick G. Vogt: The trial it would move faster because the patients weren't on bridging therapy in many cases now they are on bridging therapy.

Frederick G. Vogt: And we have to do it this way with a commercial product.

Frederick G. Vogt: Okay, so just to be clear, patients have been treated in April, and then some of those patients, as you are going through this, would be treated in May and June as part of those hundreds.

Speaker Change: Okay. So just to be clear patients had been treated in April and then some of those patients as youre going through it would be treated in may and June as part of those hundreds.

Frederick G. Vogt: Correct, and you lie, and so on. Okay, I got it.

Frederick G. Vogt: Correct in July and so on.

Operator: Okay, got it. Thank you. Thank you. One moment for the next question. And our next question, coming from the line...

Speaker Change: Okay got it thank you.

Speaker Change: Thank you.

Operator: One moment for our next question. And our next question, coming from the line up, Andrea Tan with Goldman Sachs, your line is open. Good afternoon. Thanks for taking the question. Maybe a follow-up.

Speaker Change: My Mom is my next question.

Andrea R. Tan: Yeah, hi Andrea, we can't give you the details, otherwise you would actually have revenues at that point, but what we can tell you is that right now, many of those patients have been resected. We're moving through the process with them. We, you know, I want to stress the importance of the patients that enroll. Some of them will be infused, obviously, over that large time period that we just mentioned with Mike's question.

Andrea R. Tan: And our next question coming from the line of Andrea <unk> with Goldman Sachs. Your line is open good.

Andrea R. Tan: We also have a few dropouts and OLSs and stuff like that to account for as well, so it's very difficult for us to predict all that stuff. But when we finally report revenues, we'll be able to say a little bit more about how that actually played out, the transition from enrolled numbers to revenue.

Speaker Change: Good afternoon. Thanks for taking the question maybe a follow up there just wondering if you're able to provide some numbers around those comments just of the 100 plus that have been enrolled how many specifically have had their tumor resected, thus far and how many have are steeped in infusion.

Speaker Change: Yeah, Hi, Andrew we can't we can't give you the detail as you would actually have revenues at that point, but we can tell you is that.

Andrea R. Tan: Now many of those patients have been resected, we're moving through the process with them.

Andrea R. Tan: I wanted to stress the importance of the patients that enroll some of them will be infused obviously, where that large time period that we just mentioned, but mikes question. We also have a few dropouts.

Andrea R. Tan: It sounds like that's what counts were as well.

Andrea R. Tan: So it is very difficult for us to predict all that stuff. When we finally report revenues, we'll be able to say a little bit more about how that how that actually played out.

Andrea R. Tan: In addition from enrolled numbers to revenues.

Frederick G. Vogt: And the nature of the dropout, if you're able to share a little bit more there. Most of the time, dropouts are caused by patient health issues, and sadly, some patients pass away while they're waiting for therapy, and we've actually had that happen. It's an unfortunate consequence of the disease stage these patients are in. That's usually what the issue is. The patient declines in health and is put on hospice or is passed away before MPEG-B can be fully manufactured and tested. That's the driver of the dropout rate for us.

Speaker Change: Got it and just the nature of the dropouts, if youre able to share a little bit more there.

Frederick G. Vogt: Most of the time, the dropouts are caused by patient health issues and.

Frederick G. Vogt: Sadly some of the patients pass away whether way for therapy, and we've actually had that happened. It's an unfortunate consequence of the stage of disease States. These patients are in.

Frederick G. Vogt: Usually what the issue is the patient declines in health is put on hospice.

Frederick G. Vogt: Or is this the way before MTB can be fully manufacturing asset for them.

Frederick G. Vogt: That's the driver of dropout rate for us.

Speaker Change: Okay. Thank you.

Speaker Change: Thank you.

Frederick G. Vogt: And our next question comes from the line of... Peter Lawson with Barclays. Your line is open.

Speaker Change: And our next question coming from the line of.

Frederick G. Vogt: Peter Lawson with Barclays. Your line is open.

Peter Richard Lawson: Great. Thank you so much. Thanks for the details. Fred, maybe you could provide some more granularity around the hundred-plus patients that have enrolled for teletherapy, if you can, what percentage actually have insurance in place, and then the number of ATCs that have actually resected patients.

Peter Richard Lawson: Great. Thank you so much thanks, thanks for the details.

Peter Richard Lawson: Maybe you could provide any more granularity around.

Peter Richard Lawson: The 100 plus patients.

Peter Richard Lawson: Growth of til therapy.

Peter Richard Lawson: What percentage actually have insurance in place and then.

Peter Richard Lawson: Number of Atc's that eventually resected patients. Thank you.

James Ziegler: Hi Peter, it's Jim Ziegler here.

Peter Richard Lawson: Hi, Peter its Jim Ziegler here.

James Ziegler: Virtually all.

James Ziegler: The 100, plus patients have insurance or cash so that's not been an issue right now.

James Ziegler: Virtually all of the 100-plus patients have insurance or have cash, so that's not been an issue right now. And by definition, an enrolled patient basically means there's the treatment decision, followed soon by commercial payer prior authorization and the scheduled surgery.

James Ziegler: And by definition.

James Ziegler: Enrolled patients basically means the treatment decision.

James Ziegler: Followed soon thereby commercial payer prior authorization and is scheduled to be served.

James Ziegler: Surgery.

James Ziegler: Thank you. And then the ATCs that have actually resected the patient number.

James Ziegler: Thank you and then the ATC is the da Vinci.

James Ziegler: Patient number.

James Ziegler: Yeah, we can't tell you exactly that, Peter, right now, but it's a substantial number, let's call it that. It's increasing daily, or at least weekly, and it's getting up there to the point where, hopefully, all or almost all of them will have resected a patient.

Speaker Change: Yes, we can't we can't tell you exactly when Peter right now, but it's a substantial number let's let's call. It that is increasing daily.

James Ziegler: Or at least weekly and it's getting up there to the point where hopefully.

James Ziegler: All of our almost all of them of the receptor the patient in the not too distant future.

James Ziegler: Thank you. Just a final question. You mentioned cash. What percentage of patients... Payne and Keshe.

Speaker Change: Thank you then just final question, you mentioned that cash what percentage of patients.

James Ziegler: Paying in cash.

Speaker Change: We haven't disclosed that.

Speaker Change: Okay. Thank you so much its a low number.

Speaker Change: Thank you.

Operator: And our next question comes from the line-up: Tyler VanBuren with T.D. Cohen and Elon Isolfin.

Speaker Change: And our next question coming from the lineup.

Tyler Martin Van Buren: Tyler <unk> with Janney Cowen Your line is open.

Tyler Martin Van Buren: Hey guys, good afternoon. Congratulations on the progress. Shockingly, I have another question regarding the launch. Just regarding the dropouts for enrolled patients that you mentioned, can you discuss what the attrition rate for enrolled patients has looked like so far, based on the dropouts or manufacturing success? And then, you know, how that attrition rate might differ for patients that are in screening as we think about the 60 patients you mentioned? Yeah, right now, Tyler, it's in line with our expectations.

Tyler Martin Van Buren: Hey, guys. Good afternoon, congrats on the progress shockingly I have another question regarding the launch.

Tyler Martin Van Buren: Just regarding the dropouts for enrolled patients that you mentioned can you discuss what the attrition rate for enrolled patients has looked like so far based upon the dropouts.

Tyler Martin Van Buren: And we're manufacturing our success and then.

Tyler Martin Van Buren: How that attrition rate might differ for patients that are in screening as we think about the 60 patients you mentioned.

Frederick G. Vogt: Yeah, right now, Tyler, it's in line with our expectations. There have been a few dropouts, as well as manufacturing aspects, but not many. And based on our experience, we feel like it's playing out the way we expected. We're only going to get better at this. The patients that are dropping out sometimes were the ones waiting for antacid therapy.

Tyler Martin Van Buren: Yes, right now Tyler it's in line with our expectations. There has been a few drop outs as well as manufacturing.

Frederick G. Vogt: Thanks.

Frederick G. Vogt: Not many.

Frederick G. Vogt: Based on our experience we feel like it's playing out the way we had expected we are only going to get better at this the patients that are that are dropping out sometimes were ones waiting for integra therapy.

Frederick G. Vogt: And obviously, that'll be less of an issue as we go forward with the launch here. So I can't give you any quantitative numbers on that right now. It's very, very early for this, but it's in line with what we anticipated and we're able to handle.

Frederick G. Vogt: And obviously that will be less of an issue as we go forwards launch here. So I can't give you any quantitative numbers on that right. Now obviously, it's very very early for this but it's in line with what we anticipated and we're able to handle.

Frederick G. Vogt: Yes.

Speaker Change: Thank you.

Operator: And our next question comes from the line-up. Yanan Zhu with Wells Fargo Securities. Your line is open.

Speaker Change: And our next question coming from the lineup.

Yanan Zhu: Yeah, and then Sue with Wells Fargo Securities. Your line is open.

Yanan Zhu: Great, thanks for taking our questions and congratulations on the progress. Just wondering, for dropouts, Fred, could you comment on whether we could look at perhaps perhaps clinical trial experience and history to get a sense of what might be the percentage of patients who couldn't wait for the duration of the manufacturing and perhaps also insurance approval in this case. And then wondering about how evenly the more than 100 enrolled patients are distributed across the 40 plus centers.

Yanan Zhu: Great. Thanks for taking our questions and congrats on the progress.

Yanan Zhu: Just wondering for drop outs.

Speaker Change: Brad could you.

Yanan Zhu: Comment on whether we could look at maybe perhaps clinical trials experience and.

Yanan Zhu: Historically to get a sense of what might be the puts.

Yanan Zhu: Sensitive patients who couldnt.

Yanan Zhu: Wait for the duration of the manufacturing and perhaps also insurance approval in this case.

Yanan Zhu: Period.

Yanan Zhu: And then wondering about how evenly.

Yanan Zhu: More than 100 enrolled patients.

Yanan Zhu: And lastly, I think I heard a comment Jim made about month over month growth still being expected going forward in the number of enrolled patients. Just want to make sure I get that right. And could that, if that's correct, could the increased number of patients, other than driven by obviously increased ATCs, could that still be driven in part by increased numbers of patients from the already enrolled started ATCs? Thanks.

Yanan Zhu: Distributed across the four key plus centers.

Yanan Zhu: Lastly, I think I heard a comment Jim made about.

Yanan Zhu: Month over month growth are still expected going forward.

Yanan Zhu: The number of enrolled patients just want to make sure I get that.

Yanan Zhu: Right and.

Yanan Zhu: That if that's correct could the increase.

Yanan Zhu: Other than driven by obviously increased atc's could that still be driven.

Yanan Zhu: In part by increased number of patients from the already low.

Yanan Zhu: Started <unk>.

Yanan Zhu: Sure.

Frederick G. Vogt: Yeah, Yanan, the comparison between the dropout rate in the clinical trial and commercial is a little bit different. In a clinical trial, we don't have the financial clearance issues, we don't have any of that kind of thing, and the patients are basically being raced through to the therapy. We had, as you know, we had a very advanced patient population in the trial, late line, and they were not being bridged, nothing was being done. We couldn't do that because of the trial.

Speaker Change: Hey, John.

Yanan Zhu: Comparison between the dropout rate in the clinical trial and commercial enrollment different combo trial, we don't have the financial clearance issues. We don't have any of that kind of thing and the patients are basically being raised through the therapy. We had as you know we had a very advanced patient population in the trial late line and they were not being bridge nothing was being done.

Frederick G. Vogt: They had to do that because the trial. So it's a very different experience of treating a patient now where we do have the financial clearance.

Frederick G. Vogt: So it's a very different experience than treating a patient now, where we do have the financial It takes a little bit of time to resolve, but we've been making progress on that. Obviously, it's going quite well right now for us, but also, we're bridging, in many cases, we're bridging those patients, and those patients are not necessarily as far along in their treatment journey as they were in the clinical trial So I don't think you can compare dropout between the two. I don't think it's a very good comparison at all.

Frederick G. Vogt: Sure.

Frederick G. Vogt: It takes a little bit time to resolve but we've been making progress on that obviously this is going quite well right now for us, but also we're bridging that in many cases, we're bringing those patients and those patients are not necessarily as far along on a treatment journey as they were in the clinical trial. So I don't think you can compare dropout between the two I don't think it's a very good comparison at all.

Frederick G. Vogt: Your second question was how many patients can't wait for treatment. I don't really have a good estimate for you right now on that. That's something we'll have to see, but as the launch goes, I think we'll have some indication of that. And finally, regarding month-over-month growth, like Jim mentioned, it could be driven just by the number of patients. So we have centers right now that are enrolling at high capacity, and many of the analysts are out there calling those centers and getting information from them, and you know all about that.

Frederick G. Vogt: Your second question was how many patients could can't wait for treatment.

Frederick G. Vogt: I don't really have a good estimate for you right now on that that's something we'll have to see but as the launch goes I think we'll have we'll have some indication of.

Frederick G. Vogt: What number of patients really currently because we will see that we will see the dropout rate while understand that.

Frederick G. Vogt: Finally regarding month over month growth and Jim mentioned, it could be driven just by the number of patients. So we have centers right now that are enrolling at high capacity in many of the analysts are out there, calling those centers and getting information from them and you know about that.

Frederick G. Vogt: And they're saying things like, right now, we're enrolling X patients a month. Six months from now, we'll be rolling X plus 5 patients a month, or X plus 3 patients a month, or whatever. So we expect that to be the case across many of our centers. Even without the addition of ATCs, we expect the number of patients to go up.

Frederick G. Vogt: And they're saying things like right now, we're enrolling X amount.

Frederick G. Vogt: Those are great colors. Could you please touch on the second point about how evenly are the currently enrolled patients distributed across the centers?

Frederick G. Vogt: Six months from now we'll be Rolling X plus five a month for Xbox three a month or whatever it is so we expect that to be the case across many of our centers even without the addition of <unk>. We expect the number of patients would go up.

Frederick G. Vogt: Those are great color could you sorry touch on the second point about how evenly on the currently enrolled patients distributed across the centers.

James Ziegler: Oh, we missed that one. Jim, do you want to get that one?

Frederick G. Vogt: We missed that one Jim you want to get that sure I can take that hi on it it's Jim here.

James Ziegler: Sure, I can take that. Hi Yanan, it's Jim here.

Jim: Like other cell therapy launches in fact oncology launches most launches don't have even distribution of adoption across the us centers and what we will expect overtime.

Jim: All centers will gain experience and increased utilization within each of the centers, but it is not normally distributed for any of the other launches.

James Ziegler: Okay.

Jim: Very helpful. Thank you. Thanks.

Jim: Thank you.

James Ziegler: Like other cell therapy launches, in fact, oncology launches, most launches don't have an even distribution of adoption across centers. And what we will expect over time is all centers will gain experience and increase utilization within each of the centers, but it is not normally distributed for any of the other launches out there.

Speaker Change: And our next question coming from the lineup.

James Ziegler: Column, you can see with Baird. Your line is now open.

Speaker Change: Good afternoon, and thanks for taking our questions can you comment on if there's any anecdotal feedback on the experience with IL two so far and how often that would come up as a potential reason not to pursue a two month impact and then can you also comment on the profile of the average patient in process right now and I think you meant.

James Ziegler: There have been patient deaths in this waiting period or are you getting a lot. Later line patients are you getting some really LNP. Thanks, Hi, This is Brian gas, but I'm happy to answer that we have not seen really any pushback for use of IL. Two in fact, some of the cell therapies. So we're getting involved in this beyond the beyond the medical oncologists, who start with the patients have actually common.

Operator: And our next question, coming from the line of... Colleen Kusy with Bear Demon, is open.

James Ziegler: Very helpful. Thank you.

Colleen Margaret Kusy: Our IL two is not rate limiting issue for them and even mentioned to me personally.

Colleen Margaret Kusy: Self limiting reversible toxicity that is absolutely not been an issue that would all I would add that one thing that we've noted it was our education to the operators treatment centers has paid off.

Colleen Margaret Kusy: Patient selection overall has been pretty good.

Colleen Margaret Kusy: Save for myself, not knowing what we would've expected the actual drop off because of progression is rather low.

Colleen Margaret Kusy: When it happens.

Colleen Margaret Kusy: Fair enough.

Colleen Margaret Kusy: Raises an eyebrow, but it's not a very common event at all its just something thats happened at least once but.

Colleen Margaret Kusy: It's definitely.

Colleen Margaret Kusy: No more maybe even less than what we were expecting.

Colleen Margaret Kusy: Good afternoon. Thanks for taking our questions. Can you comment on whether there's any anecdotal feedback on the experience with IL-2 so far and how often that would come up as a potential reason not to pursue treatment with MTagV? And then can you also comment on the profile of the average patient in the process right now? I think you mentioned, you know, there have been patient deaths in this waiting period. Are you getting a lot of later line patients, or are you getting some earlier line patients? Hi, this is Brian Gastman.

Colleen Margaret Kusy: Great. Thank you and one follow up if I can.

Brian Gastman: Hi, this is Brian Gastman. I'm happy to answer any questions. We have not really seen any pushback for the use of IL-2. In fact, some of the self-therapists who are getting involved in this, beyond the medical oncologists who start with the patients, have actually commented how IL-2 is not a rate-limiting issue for them and even mentioned to me personally how it's self-limiting, reversible toxicities. That has absolutely not been an issue, and I would add that one thing that we've noted is that our education of the authorized treatment centers has paid off.

Brian Gastman: You said about 60 patients are in screening right now what would be kind of common reasons that a patient would fail that screen to not pursue treatment.

Brian Gastman: Well they have to go through the financial clearance. They may not be they may not be eligible it may not be on label effectively they may not.

Brian Gastman: Melanoma in some cases.

Brian Gastman: There can be all sorts of things that can.

Brian Gastman: Qualified patients.

Brian Gastman: <unk>.

Brian Gastman: And we've enrolled medical.

Brian Gastman: Bring in patients for <unk>.

Brian Gastman: The patient selection overall has been pretty good, if I have to say it for myself, not knowing what we would have expected. The actual drop-off because of progression is rather low. When it happens, it's rare enough that it raises an eyebrow, but it's not a very common event at all. It's just something that has happened at least once, but it's definitely no more, maybe even less, than what we were expecting.

Brian Gastman: Prescription yes.

Brian Gastman: Just like the enrolled patients that we currently have we expect a high conversion because these treating physicians understand the unmet need and are choosing and as much as possible the right patients balancing the unmet need.

Brian Gastman: Great, thank you. And one follow-up if I can. You said about 60 patients are in screening right now. What would be the common reasons that a patient would fail that screen and not proceed?

Brian Gastman: Well, they have to go through financial clearance. They may not be eligible, they may not be on label effectively, they may not have melanoma in some cases. There can be all sorts of things that, you know, can disqualify a patient. There's a normal medical screening of patients for a prescription.

Speaker Change: Great. Thanks for taking my questions Congrats on the progress.

Brian Gastman: Okay.

Speaker Change: Thank you.

Brian Gastman: Yeah, just like the enrolled patients that we currently have, we expect a high conversion rate because these treating physicians understand the unmet need and are choosing, in as much as possible, the right patients to balance the unmet need.

Speaker Change: And our next question coming from the line of Mr.

Speaker Change: Can you Martini commentary your line is now open.

Brian Gastman: Great. Thanks for taking our questions. Congratulations on the progress.

Speaker Change: Hey, guys. Thanks for taking my question.

Speaker Change: Congrats on the quarter here and the update.

Operator: Thank you. And our next question comes from the line of Asthika Goonewardene from Turris. Your line is open.

Speaker Change: I know this question variations of this have been asked but let me try it. This way can you after 100 patients who have.

Asthika Sarith Goonewardene: Hey guys, thanks for taking my questions and also my congratulations on the quarter here and the update. I know this question, variations of this have been asked, but let me try it this way. Can you, of the 100 patients who have been enrolled, tell us how many have been resected so far?

Asthika Sarith Goonewardene: Being enrolled can you tell us how many have been resected so far.

Frederick G. Vogt: Not yet, Asthika, but there is a very large number that have been resected already. I can tell you that.

Speaker Change: Not yet, but there is a very large number they are intersected I can tell you that.

Frederick G. Vogt: Got it. Okay. And then, Fred, when talking about getting financial clearance, can you give us some sort of an idea from enrollment, how many days does it take on average to get financial clearance? I understand this is very early in the launch, but so far, what are you seeing?

Speaker Change: Got it Okay and then.

Fred: We've been talking about.

Frederick G. Vogt: Getting financial clearance can you give us some sort of an idea from enrollment hanmi days taken.

Frederick G. Vogt: On average to get financial clearance I understand it's very early in the launch, but so far what are you seeing.

Frederick G. Vogt: It is very early in the launch, and it's very consistent with what we've seen with other cell therapy launches. Prior authorization takes about three days, and single case agreements vary. It ranges anywhere between two to six weeks, with an average of three to four.

Fred: It is very early in the launch and it's very consistent with what we've seen with other cell therapy largest prior authorizations take about three days and single case agreement bear it ranges anywhere between two to six weeks with an average of three to four.

Frederick G. Vogt: Got it. Okay. And then lastly, about how many vials of IL-2 do you anticipate being used per patient? I know it could be up to 18, but what do you think so far in the patients that have been dosed?

Frederick G. Vogt: Got it Okay, and then lastly about how many on average vials of IL two.

Frederick G. Vogt: Do you anticipate being used vacation I know it could be up to 18, but what are you seeing so far in the patients that have been dosed.

Frederick G. Vogt: I don't have anything new to add except that in the trial, it was six, the average was, or the median bio, I think whatever it was was, was 16, and I would expect something similar in real practice, but I don't think I would want to quote a stat to you right now. It's close to 18 now per patient, and that's the way it should be.

Frederick G. Vogt: I don't have anything new to add there except that I can say in the trial was six the average was for the medium box thing whatever it was 16 and I would expect something similar in real practice, but I don't think I wouldn't want to quota stat for you right now.

Frederick G. Vogt: It's close to 80 per patient and that's the way it should be.

Frederick G. Vogt: Got it. Great. Thanks, guys. Thanks for taking the questions.

Speaker Change: Got it great. Thanks, guys. Thanks for taking the questions.

Frederick G. Vogt: Yeah.

Operator: And our next question, coming from the line up: Joe Catanzaro with 5% lawyer Yolanda Solomon.

Speaker Change: And our next question coming from the line of.

Operator: Joe Catanzaro with Piper Sandler Your line is open.

Joseph Michael Catanzaro: Hey guys, appreciate you taking my questions here, maybe similarly sort of the same question in a different vein as we think about the cadence and rate of the 100 patients ultimately being fused. At the end of February, you said there were about 20 patients in progress. We're now about two months past that, I guess.

Joseph Michael Catanzaro: Hey, guys I appreciate you taking my questions here, maybe simulations sort of same question in a different vein as we think about the cadence in right at the 100 patients ultimately being used.

Frederick G. Vogt: So can you say or give any additional comments on how many of those 20 patients were ultimately infused? And then my second question is on the early sort of experience or feedback you're seeing on the use of bridging therapy. Are physicians using that and then stopping once they receive Togvi and it's ready to go? Or are they sort of receiving the cell shipment and sort of continuing bridging therapy for a prolonged period of time if the patient is benefiting from and tolerating that? Thanks.

Joseph Michael Catanzaro: At the end of February you said there were about 20 patients in progress were.

Frederick G. Vogt: Now about two months past that I guess, so can you say or give any additional comments on how many of those 20 patients where ultimately infused and then Mike.

Frederick G. Vogt: Second question is on the early sort of experience or feedback you're seeing on the use of bridging therapy are physician using that and then stopping once they receive I'm Todd V and ready to go or are they sort of receiving the cell shipment and sort of continuing bridging therapy for.

Frederick G. Vogt: Prolonged period of time that the patient is benefiting and tolerating that thanks.

Brian Gastman: Yeah, Joe, I can take the first part, and then I'll have Brian answer the second part. Of the 20 patients back then, that number obviously has become more than 160 today. And I can't tell you exactly how many of those 20 moved through. I really don't know, but I would think the vast majority of them moved through to actually at least be in the treatment process. I'm not sure if they've all been infused yet.

Speaker Change: Yes, I can take the first part and then I'll have Brian answer the second part.

Brian Gastman: Of the 20 patients back then that number obviously.

Brian Gastman: More than 160 <unk> today.

Brian Gastman: I can't tell you exactly how many.

Brian Gastman: I really don't know, but I would think the vast majority of them move through to actual.

Brian Gastman: <unk> in the treatment process I'm not sure if they've all been abused we don't we don't have that information just yet, but importantly, what we reported as 10 and 20 on February 28 is now more than 100 and more than.

Brian Gastman: We don't have that information just yet. Importantly, what we reported as 10 and 20 on February 28th is now more than 100 and more than 160. So you can see the upswing there is pretty significant. Brian, can you talk a little bit about the bridging? Yeah, I think it's important to note that we don't have a clear line of sight on every patient. The way they get entered into our system, there's a certain level of assumption that the physician has a background in treating the patient. Again, the information is when a peer-to-peer or a response came in. Yeah, right? Mm-hmm.

Brian Gastman: $160. So you can see the upswing sprague's designate Brian can you talk a little bit about the bridging yeah, Brian I think it's important to note that we don't have clear line of sight on every patient the way they get entered into our system. We theres a certain level of assumption that the physician has a background in treating the patient where we get the information has went up.

Brian Gastman: Year to Pierre.

Speaker Change: Our response.

Brian Gastman: Are you sleeping? No

Brian Gastman: Yes.

Brian Gastman: No.

Brian Gastman: Okay.

Brian Gastman: And when that happens, we really get good engagement with the sites, the physicians treating the patients, we offer them obviously scientific exchange when needed, and that's where we found out about bridging patients. Interestingly, sometimes bridging therapy is literally done not because the patient is progressing or can't make it to the therapy, but sometimes the patients themselves want to sort of dictate when the therapy is being given. So bridging therapy really affords a lot of latitude for these physicians, but how often it's actually being used, we probably won't know until some real-world evidence comes out.

Brian Gastman: And when that happens we get good we really get good engagement with the sites the physicians treating the patients.

Brian Gastman: We offer them, obviously scientific exchange win when needed and that's what we found out about maybe bridging patients interestingly, sometimes with the bridging therapy is literally doing not because the patients progressing or can't make it to the therapy, but sometimes to the patients themselves want to sort of dictate when the therapy is being given.

Brian Gastman: <unk> bridging therapy really affords a lot of latitude to these physicians, how often is actually being used we probably won't know until some real world evidence comes out.

Joseph Michael Catanzaro: Okay, great. That's all really helpful. Thanks for taking the time to answer my question.

Speaker Change: Okay great.

Speaker Change: Really helpful. Thanks for taking my question.

Operator: Thank you. And our next question coming from the line-up is from Reni Benjamin with JMP Securities. Your line is open. Hey guys, thanks for taking the questions and

Speaker Change: Thank you.

Speaker Change: And our next question coming from the lineup.

Reni John Benjamin: Many Benjamin with JMP Securities. Your line is open.

Reni John Benjamin: Hey guys, thanks for taking the questions and congratulations on the progress. I'm kind of curious about whether there's the potential for a backlog at the manufacturing site and how you might handle that. You know, with the number of patients and surgeries that are happening, how do samples kind of wait, I guess, before they're getting processed? How many samples can you handle in a month? That'd be my first question. And then, second, just switching gears to the type D meeting you had for non-small cell lung cancer, it looks like you got positive, you know, feedback on a proposed potency matrix. And I thought we were kind of all done with, you know, discussions regarding the potency matrix. So I'd love to get some ideas about what's happening there.

Reni John Benjamin: Hey, guys. Thanks for taking the questions and congratulations on the progress.

Reni John Benjamin: I'm kind of curious about whether there's the potential for a backlog at the manufacturing site and how you might handle that as well.

Reni John Benjamin: The number of patients and surgeries that are happening.

Reni John Benjamin: How does samples kind of wait I guess before theyre getting processed how many samples can you handle in a months that'd be my first question and then second just switching gears to the type D meeting you had for non small cell lung cancer. It looks like you got positive feedback on our proposed potency matrix and I thought we were.

Reni John Benjamin: All done with this.

Reni John Benjamin: <unk> regarding potency matrix, so I'd love to get some idea as to what's what's happening there.

Reni John Benjamin: Yes.

Reni John Benjamin: Are you able to comment on the manufacturing question? I think I can handle it.

Reni John Benjamin: If you're able to comment on the manufacturing question.

Igor P. Bilinsky: I can comment on that. Thanks for the question, Mr. Bilinsky. So right now, as I mentioned, we have sufficient capacity at our manufacturing facility and contract manufacturer for launch. So the capacity is sufficient to meet demand from the commercial market. I'm talking to patients as well as taking part in the clinical trial. And we actually continue hiring additional staff because we anticipate demand to be growing into the remainder of 24 and beyond. So I think, I hope that answers your question. The capacity is, right now, certainly adequate for the demand.

Speaker Change: I can comment on that Ryan. Thanks for the question on the <unk>. So right now as I mentioned, we have sufficient capacity at our manufacturing facility and the contract manufacturer for lunch.

Igor P. Bilinsky: So the capacity is sufficient to meet demand from the commercial.

Igor P. Bilinsky: Targeted patients as well as the clinical trial and we are sure to continue hiring additional staff, because we anticipate demand to be growing into the remainder of 2004 and beyond.

Igor P. Bilinsky: So I think I hope that answers your question the capacity is right now.

Igor P. Bilinsky: Adequate for from the Amendment.

Raj K. Puri: And then on the Type D quiz, Raj, are you available? Raj, can you take that question?

Igor P. Bilinsky: And then on the site.

Speaker Change: On a type D quite as Roger available Raj could you take that question.

Frederick G. Vogt: We may have a breakdown here, Reni, on the audio. I'll take it from here. We have to have regulatory meetings with the FDA for each indication for potency assays right now. Now, ultimately, we may be able to take a platform approach. I'm sure you've seen Peter Marks talking lately about platforms and this kind of thing. But as of today, what we're doing is going to the FDA with each of our indications and talking to them about the specifics of the potency assay for that indication. And that's what we successfully did recently for not-so-long, which is a very important step in getting towards a BLA submission for not-so-long.

Raj: We may be a little.

Speaker Change: They have a breakdown here Ronny on the audio all taken for you we have to have regulatory meetings with the FDA for each indication for potency assays right. Now now ultimately we may be able to take a platform approach I'm sure you keep your remarks talking lately about platforms in this kind of thing but as of today. What we're doing is we're going to the FDA with each of our indications.

Frederick G. Vogt: And talking to them about the specifics of the potency assay for that indication and Thats, what we successfully did.

Frederick G. Vogt: Recently for not also want which is a very important step in getting towards a BLA submission for non small cell lung cancer with like loosely.

Frederick G. Vogt: And as we think about, you know, timing, Fred, can we at least assume that since you, it took a pretty decent amount of time to have that discussion and for everyone to be on the same page? We say that that's kind of 80, 90% there already with non-small cell lung cancer, and so things should go by a lot quicker, or are we kind of back to the drawing board with each indication?

Frederick G. Vogt: Okay.

Frederick G. Vogt: And as we think about.

Frederick G. Vogt: Timing, so I'd like to can we at least assume that.

Frederick G. Vogt: Since you.

Frederick G. Vogt: It took a pretty decent amount of time to get that back discussion.

Frederick G. Vogt: And for everyone to be on the same page, we say that that's kind of 80, 90% there already with non small cell lung cancer and so things should.

Frederick G. Vogt: Go buy a lot quicker or are we kind of back to the drawing board with each indication.

Frederick G. Vogt: No, no, we're definitely not back to the drawing board. What we're doing now is we're doing it what we think is the right way. We're getting in front of the FDA at the right point in our clinical development program for non-small cell lung cancer. You can see we're still enrolling for that study, and we've got enough data now from enough patients that we can actually show them what we think is a viable potency matrix proposal with data from the actual pivotal patients, which is very important, while we're early enough in the study to be able to make adjustments should they have questions or have things they want to change, as opposed to what we did the last time with melanoma, which So what we're doing now, we think is the right way to develop polyclonal T-cells.

Fred: Definitely not back to the drawing board what we're doing now is we're doing it will be think is the right way, we're getting in front of the FDA at the right point in our clinical development program for non small cell lung you can see we are still enrolling for that study and we've got enough data now from enough patients that we can actually show them. What we think is a viable potency matrix proposal with data.

Frederick G. Vogt: Thank you very much.

Operator: Great. Thanks for taking the questions.

Operator: From the actual pivotal patients, which is very important while we're early in the study to be able to make adjustments should they have questions or have things that they want to change as opposed to what we did last time with melanoma was effectively do that all.

Operator: The facts are largely after the fact that this study was already complete so what we're doing now we think is the right way to develop pipeline T cell therapies and this should actually accelerate speed up their process. So that when we finish non small cell lung we go straight to mobile a pre BLA meeting and straight to a submission.

Speaker Change: Great. Thanks for taking my questions.

Speaker Change: Thank you.

Benjamin Jay Burnett: And our last questioner, coming from the line of... Ben Burnett with Stifo, Yelena Tsopin.

Speaker Change: Our next questionnaire coming from the lineup.

Benjamin Jay Burnett: Ben Burnett with Stifel. Your line is open.

Benjamin Jay Burnett: Hey, thank you so much. I was wondering if you could maybe just talk about patient flow within the hospital. Are you seeing any bottlenecks popping up? Like, for example, have there been any learnings that have needed to happen to sort of efficiently coordinate with the surgeon or anything like that?

Benjamin Jay Burnett: Hey, Thank you so much I wonder if you could maybe just talk about the patient flow within the hospital are you seeing any bottlenecks popping up like for example are there any have there been any learnings that are needed to happen sort of officially efficiently coordinate with the surgeon or anything like that.

Brian Gastman: Yeah, actually, I would say the opposite. We've really seen tremendous enthusiasm from the surgeon all the way through to the therapists and the nurses that treat these patients. We've seen a hospital bend over backwards to find operating room time and space in the hospital. But we really haven't experienced any of the potential bottlenecking, even as we increase. Most of the things that we encounter are really just sort of small questions on details, but not the big issues like having a time or place to treat a patient.

Speaker Change: Yes, actually I would say the opposite we've really seen a tremendous enthusiasm from the surgeon all the way through to the cell therapies in the nurses they treat these patients.

Brian Gastman: We've seen a household bend over backwards by an operating room time space in the hospital, we really haven't experienced any of the potential bottlenecking.

Brian Gastman: Even as we increase more.

Brian Gastman: Most of those things that we encounter a really just sort of small questions and details, but not the big issues like having a time or place to treat a patient.

Brian Gastman: Okay, that's excellent, and if you could also just comment on just the quality of tumor samples coming in for manufacturing and what the specifications are around those tumor samples compared to like what you saw in clinical trials.

Speaker Change: Okay that's excellent.

Brian Gastman: If you could also just comment on just the quality of tumor sample coming in for manufacturing.

Brian Gastman: How is it like kind of the specifications around those tumor samples compare it to like what you saw in clinical trials.

Igor P. Bilinsky: I could take that or Igor if you would like to.

Speaker Change: I can take that are eager if you if you would like.

Igor P. Bilinsky: I'm happy to. Good questions so far. The experience has been very consistent with our clinical experience, including the quality, the size, and the quality of the tumor samples for manufacturing.

Speaker Change: Got it.

Speaker Change: Two good questions so far.

Igor P. Bilinsky: Experience has been very consistent with our clinical experience.

Igor P. Bilinsky: Including the quality and the size and the quality of the tumor samples for manufacturing.

Benjamin Jay Burnett: Okay, I got it. Thank you.

Speaker Change: Okay got it thank you.

Speaker Change: Thank you.

Frederick G. Vogt: And ladies and gentlemen, that's all the time we have for our Q&A session. I will now turn the call back over to Dr. Fred Book for any closing remarks.

Dr. Frank: And ladies and gentlemen, that's all the time, we have for our Q&A session I will now turn the call back over to Dr. Frank <unk> for any closing remarks.

Frederick G. Vogt: Yeah.

Operator: Thank you again for joining the Iovance Biotherapeutics first quarter 2024 Financial Results and Corporate Updates conference call. As we shared on this call, we are very pleased with the strength of the impact we've launched and excited to see accelerated growth throughout the rest of 2024. Thank you to those in the patient, healthcare, and advocacy communities, our partners, and our exceptional Iovance team. I would also like to thank our shareholders and covering analysts for their support.

Speaker Change: Thank you again for joining the <unk> Biotherapeutics first quarter 2024 financial results and corporate update conference call as we've shared on this call. We are very pleased with the strength of the impact the launch and excited to see accelerated growth throughout the rest of 2024.

Operator: Thank you. Thank you to those in the patient 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 we look forward to presenting data at ESMO on less leucyl in frontline melanoma and will host an analyst and investor event on May 31.

Operator: We look forward to presenting data at ASCO and Lifelucil and Frontline Melanoma, and we'll host an analyst and investor event on May 31st. Please feel free to reach out to our investor relations team for follow-up. Thank you.

Operator: Please feel free to reach out to our Investor relations team for follow up thank you.

Operator: Ladies and gentlemen, this is the Tosca conference call for today. Thank you for your participation. You may now disconnect.

Speaker Change: Ladies and gentlemen that does call conference call for today. Thank you for your participation you may now disconnect.

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Operator: Okay.

Operator: Yes.

Operator: Yes.

Operator: Hum.

Operator: Yes.

Operator: Okay.

Operator: Okay.

Operator: Okay.

Operator: Yes.

Operator: Okay.

Operator: Okay.

Operator: Yes.

Operator: Okay.

Operator: Yes.

Operator: Yes.

Operator: Okay.

Operator: Right.

Operator: Yes.

Operator: [music].

Operator: Yes.

Operator: Yes.

Operator: Okay.

Operator: Okay.

Operator: Yes.

Operator: [music].

Operator: Thanks.

Operator: Okay.

Operator: Okay.

Operator: Okay.

Operator: Sure.

Operator: Okay.

Operator: Sure.

Operator: Okay.

Operator: Yes.

Operator: Okay.

Operator: Yes.

Operator: Yes.

Operator: Okay.

Operator: Yes.

Operator: Okay.

Operator: Okay.

Operator: Great.

Operator: Yes.

Operator: [music].

Operator: Yes.

Operator: Okay.

Operator: Okay.

Operator: Okay.

Operator: Yes.

Operator: Okay.

Operator: [music].

Operator: Hum.

Operator: Tom.

Operator: Yes.

Operator: Sure.

Operator: Okay.

Operator: Yes.

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Operator: Yes.

Operator: Yes.

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Operator: Thank you.

Operator: [music].

Operator: Okay.

Operator: Yes.

Operator: [music].

Operator: Okay.

Operator: [music].