Q4 2023 Iovance Biotherapeutics Inc Earnings Call

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Okay.

Operator: Welcome to the Iovance Biotherapeutics Conference call to discuss the full year 2023 results and recent corporate updates. My name is Kevin and I'll be your operator for today's call. At this time, all participants are in a listen-only mode.

Kevin: Welcome to the Isle Dance about Therapeutics conference call to discuss the full year 2023 results and recent corporate updates my name is Kevin and I'll be your operator for today's call. At this time all participants are in a listen only mode. Later, we will conduct a question and answer session. Please note that this conference is being recorded I will now turn the call over to Sara Pellegrino Senior Vice President Investor Relations.

Operator: Later, we will conduct a question and answer session. Please note that this conference is being recorded. I will now turn the call over to Sara Pellegrino, Senior Vice President, Investor Relations and Corporate Communications, Iovance. Sara, you may begin.

Sara Pellegrino: And corporate communications.

Sara Pellegrino: Sir you may begin.

Sara Pellegrino: Thank you, Operator. Good afternoon, and thank you for joining our conference call and webcast to discuss full year 2023 results and recent corporate updates. Dr. Fred Vogt, our Interim President and Chief Executive Officer, will provide a brief introduction. Jim Ziegler, CBB Commercial, will highlight our initial insights for the U.S. commercial launch of Amtagby following the recent U.S. Food and Drug Administration, or FDA, approval in advanced melanoma, Igor Bilinsky, Chief Operating Officer, will highlight commercial manufacturing and capacity expansion plans. Frederick Graf Finkenstein, our Chief Medical Officer, will summarize key clinical pipeline highlights, and Jean-Marc Bellarmine, Chief Financial Officer, will review our financial results. Dr. Brian Gastman, EVP Medical Affairs, and Raj Puri, EVP Regulatory Strategy and Translational Medicine, are also on the call and available for the Q&A session.

Sara Pellegrino: Thank you operator, good afternoon, and thank you for joining our conference call and webcast to discuss all your 2020, even though.

Speaker Change: Corporate update Dr.

Sara Pellegrino: Doctor friends, though our interim President and Chief Executive Officer will provide a brief introduction.

Sara Pellegrino: Jim dealer EVP commercial well highlight our initial insights for the U S commercial launch of damn happy.

Sara Pellegrino: The recent U S drug administration.

Sara Pellegrino: We will in advanced melanoma.

Sara Pellegrino: Igor Gonzales G Chief operating officer will highlight commercial manufacturing capacity expansion plan.

Sara Pellegrino: Her grasp at this time.

Sara Pellegrino: Our Chief Medical Officer will summarize the key clinical pipeline highlight Angie.

Speaker Change: John Marc Baumann, Chief Financial Officer, Who'll review, our financial results Dr.

Speaker Change: Dr. Brian Johnson, EVP Medical Affairs, and Roger Perry EVP regulatory strategy and translational medicine are also on the call and available for the Q&A session.

Speaker Change: Okay.

Sara Pellegrino: Before we start, I would like to remind everyone that statements made during this 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 capabilities, regulatory feedback and guidance, payer interactions, licenses and collaboration, cash position and expense guidance, and future updates. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time to time in our SEC filing. Our results may differ materially from those projected during today's call. We undertake no obligation to publicly update any forward-looking statements.

Speaker Change: Before we start I would like to remind everyone that statements made during this call will include forward looking statements regarding <unk> goals business focus is at Plaza transaction revenue commercial activities clinical trials and results regulatory approvals and interaction landed strat.

Speaker Change: G research and preclinical activity potential future applications of our technologies manufacturing capabilities regulatory feedback and guidance here interaction licenses the collaboration cash position an expense guidance and future update.

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

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

Frederick G. Vogt: With that, I will turn the call over to Fred. Thank you, Sara, and good afternoon, everyone. I'm pleased to host our 2023 full-year results conference call. Throughout last year, we executed toward our first approval of commercial lawns while advancing our pipeline.

Speaker Change: With that I will turn the call over to Fred.

Fred: Thank you Sarah and good afternoon, everyone I'm pleased to host our 2023 full year results conference call.

Last year, we executed toward our first approval and commercial launch while advancing our pipeline.

Frederick G. Vogt: On today's call, we have a variety of exciting topics to cover on the heels of the US FDA's recent approval of Ibtagvi, the first one-time T-cell therapy for a solid tumor. And tagging this label allows it to become the first treatment option for advanced melanoma patients after anti-PD-1 and targeted therapy. The strength of this label also reflects a best-case scenario with strong efficacy data from Pueblo cohort 4 as well as pooled cohorts 2 and 3. In the first few days of US launch, we were seeing strong demand and momentum for MPEG. Consequently, we also expect increased demand for proleucin.

Please call me up a variety of the same topics to cover on the heels of U S. Fda's recent approval of <unk> IV.

Fred: The first one time T cell therapy for solid tumor.

Fred: Obviously, it will allow us to become the first treatment option for advanced melanoma patients.

Fred: PD one targeted salary.

Fred: This label also reflects the best case scenario with strong efficacy data.

Fred: I work for as well as cold cohorts towards war.

Fred: And the first few days of U S launch, we are seeing strong demand and momentum for Empire.

Fred: Consequently, we also expect increased demand for ILUVIEN.

Frederick G. Vogt: 30 authorized treatment centers or ATCs were ready for approval, and nearly all have identified a patient, who will provide more detail later in the call. The first tumor resection occurred on the first business day after approval, and commercial manufacturing began the following day at our Iovance Cell Therapy Center, or ICTC. This is a testament to the high unmet medical need and the great excitement around this new therapy, as well as our commercial manufacturing readiness. Igor will talk today about our capacity to serve our near-term commercial launch, clinical trials, and ongoing expansion. In addition to the U.S. launch, our near-term expansion plans for Amtagby are focused on addressing many balance of additional patients by entering new geographies, broadening the label to include frontline advanced melanoma, as well as other indications. For example, our planned global expansion has the potential to double the total number of addressable patients for Amtagby and post-anti-P1 melanoma. We remain on track to submit regulatory dossiers this year in the European Union in the first half of the year, followed by the United Kingdom and Canada in the second half.

Fred: 30 authorized treatment centers <unk>, we're ready for approval and nearly all of the identified a patient.

Fred: Joe will provide more detail later in the call.

Fred: First tumor resection occurred in the first business day after approval and commercial manufacturing began the following data there Ivy and cell therapy center or ICC.

Fred: This is a testament to the high unmet medical need is a great excitement around this new therapy as well as our commercial manufacturing readiness.

Fred: We'll talk today about our capacity to serve our near term commercial launch clinical trials and ongoing expansion plans.

Fred: In addition to the U S launch of our near term expansion plans from Tankier focused on addressing many thousands.

Fred: Patients by entering new geographies broadening the label to include frontline advanced melanoma as well as other indications.

Fred: For example, our global expansion has doubled.

Fred: Double the total number of addressable patients for MTBE.

Fred: Yes.

Fred: Uh huh.

Fred: We remain on track to submit regulatory dossiers this year.

Fred: And in the first half of the year.

Fred: The United Kingdom, and Canada in the second half.

Frederick G. Vogt: In addition, our Phase 3 TILVAD 301 trial continues with strong momentum in several countries. We support regulatory submissions and frontline advanced melanoma. We are also pleased with the progress with our robust development pipeline across all tumor cancer. Frederick will speak later about some key highlights in our ongoing clinical trial program. Today Iovance is a fully integrated company and is now the first company to commercialize a T-cell therapy for cell tumor indication.

In addition, our phase III <unk> trial continues with strong momentum in several countries to support regulatory submissions in frontline advanced melanoma.

Fred: We're also pleased with the progress with our robust development pipeline across all tumor cancers.

Fred: Eric will speak later about some key highlights and on our ongoing clinical trial programs.

Fred: So in diabetes.

Fred: The company is now the first company to commercialize the T cell therapy for solid tumor indications.

James Ziegler: We are well positioned to execute on our regulatory pipeline, manufacturing, commercial launch activities to remain the global leader until self there. Jim will now describe the ongoing activities related to our U.S. launch. Thank you, Fred. Each year, approximately 8,000 people in the U.S. die from melanoma.

We are well positioned to execute on our regulatory pipeline manufacturing commercial launch activities to remain the global leader until sell there Joel.

Fred: Jim will now describe the ongoing activities related to our U S launch.

Jim: Thank you Fred each year, approximately 8000 people in the U S guide for melanoma.

James Ziegler: Until now, there have been no FDA-approved treatment options for patients with advanced melanoma whose disease progressed following an immune checkpoint inhibitor and, if appropriate, a targeted therapy. For these patients, MTagV ushers in a new era for the melanoma treatment landscape as a one-time cell therapy that is manufactured specifically for each patient to address a significant unmet need. Today, I will highlight our launch activities, ATC onboarding, as well as access and reimbursement. There is strong level of ATC commitment with 30 on board today. These on boarded ATCs are engaged in various stages of the process, including patient identification, reimbursement, authorization, scheduling and tumor tissue procurement and manufacturing.

Jim: Now there have been no FDA approved treatment options for patients with advanced melanoma.

Jim: Disease progressed, following an immune checkpoint inhibitor and if appropriate a targeted therapy for these patients and tag be ushers in a new era for the melanoma treatment landscape as a onetime cell therapy that is manufactured specifically for each patient to address a significant unmet need.

Jim: Today, I will highlight our launch activities.

<unk> onboarding as well as access and reimbursement.

Jim: There is strong level of ATC commitment with 30 onboard today. These onboarding atc's are engaged in various stages of the process, including patient identification reimbursement authorization scheduling and tumor tissue procurement.

James Ziegler: In the less than two weeks following approval, the majority of our activated ATCs have at least one identified patient and are in the process of establishing financial clearance for reimbursement, including prior authorizations and single case agreement. There are at least 20 patients in the process, which includes 10 patients with scheduled or pending manufacturing slots. The number of ATCs engaged in this process reflects the high unmet need and a sense of urgency to offer mTagV for their advanced melanoma patients. In addition, we continue to onboard and remain on track to have approximately 50 active ATCs in total by the end of May. We are also pleased with the initial market access and inpatient reimbursement trends for MTAG. These are consistent with approved CAR T products with the benefit of increased speed resulting from both our preparation and the ATC's experience.

Manufacturing in.

Jim: In the less than two weeks following approval the majority of our activated atc's have at least one identified patient and are in the process of establishing financial clearance for reimbursement, including prior authorizations and single case agreements.

Jim: There are at least 20 patients and the process, which includes 10 patients with scheduled are pending manufacturing slots. The number of Atc's engaged in this process reflects the high unmet need and a sense of urgency to offer and tag beat it for their advanced melanoma patients in.

Jim: In addition, we continue to onboard and remain on track to have approximately 50 active atc's in total by the end of May.

Jim: We are also pleased with the initial market access and patient reimbursement trends for AMETEK right. These are consistent with the approved car T products with the benefit of increased speed, resulting from both our preparation and the Atc's experience.

James Ziegler: We continue to anticipate prior authorizations to include coverage consistent with label, medical coverage policies within about 90 to 180 days, and single case agreements for, commercially insured patients. I want to acknowledge our strong cross-functional teams who have worked tirelessly to ensure our launch readiness and execution. We are confident in our ability to deliver a successful commercial launch. I will now turn the call over to Igor, who will highlight our manufacturing readiness and capability. Thank you, Jim. Antagony, as well as our investigational till still therapies are manufactured using our proprietary process. To collect the patient's still cells from a portion of the tumor, multiply them into billions, and return them back to the patients to fight cancer. The U.S. FDA has approved commercial manufacturing at our internal facility, the Iovance Cell Therapy Center, or ICTC, as well as at a nearby contract manufacturer. These facilities are built to support up to several thousand patients annually.

Jim: We continue to anticipate prior authorizations to include coverage consistent with label medical coverage policies within about 90 to 180 days and single case agreements work.

Jim: Commercially insured patients.

Jim: I want to acknowledge our strong cross functional teams, who have worked tirelessly to ensure our launch readiness and execution. We are confident in our ability to deliver a successful commercial launch I will now turn the call over to Igor who will highlight our manufacturing readiness and capabilities.

Igor Gonzales: Thank you Tim.

And Doug as.

Igor Gonzales: As well as our investigational cell therapies are manufactured using a proprietary process to collect the patients still sells from a portion of the tumor both deploy them into billions and return them back to the patients to fight cancer.

Igor Gonzales: The U S. FDA has approved commercial manufacturing at our internal facility.

Igor Gonzales: Cell therapy center, or <unk> as well as at the nearby contract manufacturer.

Igor Gonzales: These facilities are built to support up to several thousand patients annually.

Igor P. Bilinsky: As Fred mentioned, the first tumour resection occurred on the first business day after approval and commercial manufacturing of Ontagvi is officially underway. We are currently staffed to meet the anticipated needs of our U.S. launch as well as our ongoing and planned clinical trials. In the BLA submission form, we have included the capacity demonstration study higher than our immediate need.

Igor Gonzales: As Fred mentioned, the first tumor resection occurred on the first business day after approval and.

Igor Gonzales: Commercial manufacturing of <unk> is officially underway.

Igor Gonzales: We're currently staffed to meet the anticipated needs of our U S launch as well as our ongoing and planned clinical trials.

Igor Gonzales: In the BLA submission for <unk>, we haven't quoted the capacity demonstration study.

Igor Gonzales: Higher than our immediate needs. This means that we can increase near term capacity through increased staffing without requiring additional capacity authorizations.

Igor P. Bilinsky: This means that we can increase near-term capacity through increased staffing without requiring additional capacity authorization. In addition, we're building further capacity to align with our near-term and long-term manufacturing needs. As we prepare to expand and tag into new markets and indications and advance our solid tumor pipeline, expansion within the ICTC facility is already starting, build out of additional clean rooms within the existing shelf space at ICD-C can significantly increase capacity to over 5,000 patients annually over the next few years. Longer term, our future expansion plans may bring our manufacturing capacity above 10,000 patients annually. In summary, our team is excited to provide Antagvi to patients in need. We're laser focused on the quality of the manufacturing process in the spirit of doing everything right first time at every step from incoming receipt of the tumor sample through the manufacturing and product release process to outbound shipment of the final Antagvi product to the ATCs and to patients. I'm available to answer additional questions during the Q&A and I will now hand the call over to Friedrich. Thank you, Igor.

Igor Gonzales: In addition, we're building further capacity to align with our near term and long term manufacturing needs as.

Igor Gonzales: As we prepare to extend them taghavi into new markets and indications in advance so solid tumor pipeline extension within the ICC facility is already starting.

Igor Gonzales: The build out of additional clean rooms within the existing shelf space at ICD C can significantly increase capacity to over 5000 patients annually over the next few years.

Igor Gonzales: Longer term, our future expansion plans may bring our manufacturing capacity about 10000 patients annually.

Igor Gonzales: In summary, our team is excited to provide them tied with the patients in need.

Igor Gonzales: Our laser focus on the quality of the manufacturing process in the spirit of doing everything right first time at every step from incoming receipt of the tumor sample through the manufacturing and product release process to outbound shipment of the final integrity product to the hec them to patients I'm.

I'm available to answer additional questions during the Q&A and I will now hand, the call over to Frederic.

Igor Gonzales: Okay.

Igor Gonzales: Yeah.

Frederic: Thank you Igor.

Friedrich Graf Finckenstein: I'm pleased to speak today about the key highlights within our clinical pipeline in solid tumors, which as you know represent more than 90% of all diagnosed cancers in the U.S. I'll begin with PILOBAN's 301, our registrational phase 3 trial in frontline advanced melanoma. SILVAN301 is well underway to support accelerated and full approval of Antagli in combination with Pembrolizumab and frontline advanced melanoma. Global site activation and patient enrollment continue with strong momentum in the U.S., Europe, Australia, Canada, and additional countries. STILVANS 301 is also the confirmatory trial to support full approval of TACVN post-anti-PD-1 advanced melanoma. Shifting to our program in non-small cell lung cancer and our single arm registrational phase two trial, IOV-LUM202 in post-antipedy-1 non-small cell lung cancer.

Frederic: Pleased to speak today about the key highlights within our clinical pipeline and solid tumors.

Frederic: Which says hey, now represent more than 90% of all diagnosed cancer in the U S.

Speaker Change: I'll begin with telephones, three or one hour a registrational phase III trial in frontline melanoma.

Speaker Change: One is well under way to support accelerated and full approval of <unk> in combination with embolism in frontline melanoma.

Speaker Change: Global site activation and patient enrollment continue with strong momentum in the U S Europe, Australia, Canada and additional countries.

Speaker Change: For you. One is also the confirmatory trial to support full approval of Pac Van post anti PD, one adopt an anomaly.

Speaker Change: Shifting to our program in non small cell lung cancer in our single arm Registrational phase II trial of <unk> and post anti PD, one non small cell lung cancer enrollment in the Registrational cohort is estimated to compete.

Friedrich Graf Finckenstein: Enrollment in the registrational cohorts is estimated to complete in 2025. Following the partial clinical hold for new patients, we are working collaboratively with the US FDA and believe we have provided all the necessary information to resume new patient enrollment in the near future. We are also preparing to start up a new phase 2 trial in post-anti-PD-1 endometrial cancer which is expected to include patient populations who are deficient and proficient in mismatch repair. Tilt-cell therapy based on its mechanism of action may benefit both of these patient populations.

Speaker Change: Following the partial clinical hold for new patients. We are working collaboratively with U S. FDA and believe we have provided all the necessary information to resume new patient enrollment in the near future.

Speaker Change: We are also preparing to start up a new phase II trial in post anti PD, one endometrial cancer, which is expected to put patient populations, who are efficient and proficient and mismatch repair.

Speaker Change: <unk> cell therapy based on its mechanism of action may benefit both of these patient populations.

Friedrich Graf Finckenstein: We look forward to providing more details in advancing this trial this year. Iovance is the leader in tilt-cell therapy, including next generation approaches that have the potential to optimize outcomes for patients. We continue to investigate our genetically modified PD-1 inactivated TIL therapy IOV4001 in the GM1-201 trial.

Speaker Change: Forward to providing more detail and advancing this trial this year.

Speaker Change: <unk> is the leader in cell cell therapy, including next generation approaches that have the potential to optimize outcomes for patients.

Speaker Change: We continue to investigate our genetically modified PD one inactivate it til therapy will be 4000, Guam and the G. M. One 201 trial. This is a first in human trial in previously treated adopt melanoma or non small cell lung cancer patients.

Friedrich Graf Finckenstein: This is the first in-human trial in previously treated advanced melanoma or non-small cell lung cancer patients. This was just a snapshot of the many activities in progress across our follow-tumor pipeline, and I'm happy to address questions about these programs and additional trials during the Q&A session. I will now hand the call to Jean-Marc. Jean-Marc?

Speaker Change: This was just a snapshot of M&A activities and progress across our solid tumor pipeline and I'm happy to address questions about these programs and additional trial during the Q&A session.

Speaker Change: I'll hand, the call to Zama zama.

Jean-Marc Bellarmine: Thank you, Fred. Today, I will review our current cash position, as well as our four-year results for the year ended on December 31st, 2023. I will also highlight 2024.

Zama: Thank you.

Zama: Today, I will review, our current cash position as well as our full year results for the year ended on December 31st 2000 <unk>.

Zama: I would also highlight our pretzel currency for our group.

Jean-Marc Bellarmine: As of February 22nd, 2024, our unedited cash position is approximately $485.2 million, which includes net proceeds of approximately $197.1 million net of underwriting and other offering expenses from a follow on equity financing in February of 2020. The current cast position and anticipated revenue from both TAVV and Forlooking are expected to be sufficient to fund current and planned operations well into the second half of 2021. Shifting to a four-year financial result. Net loss for the fourth quarter under December 31st 2023 was $116.4 million or 45 cents per share compared to a net loss of $105.3 million or 64 cents per share for the fourth quarter under December 31st 2022.

Zama: As of February 22nd 2020 for our allergy to cash position is approximately $485 $2 million, which includes net proceeds of approximately $197 $1 million net of otherwise seeing another offering.

Zama: Fences from our follow on equity financing in February of 2020.

Zama: The current cash position and anticipated revenue from both in Calgary and currently are expected to be sufficient to fund current and paying the operation well into the second half of 2025.

Zama: Shifting to our pool of zero financial results.

Zama: Net loss for the fourth quarter ended December 31st 2021.

Zama: $116 4 million or 45 per share.

Zama: And perhaps to a net loss of $105 3 million or 64 cents per share for the fourth quarter ended December 31st 2012.

Jean-Marc Bellarmine: Net loss for the year ended December 31st, 2023 was $444 million or $1.89 per share compared to a net loss of $395.9 million or $2.49 per share for the year ended December 31st, 2021, The net loss for the year ended December 31st, 2023 includes amortization of intangible assets acquired as part of the forlooking transact. Revenue from the fourth quarter and year ended December 31, 2023, was $482,000 and $1,000,000 respectively, and comprised of product sales of Polukin following the acquisition in May 2020. There were no revenue for the fourth quarter and year ended December 31st, 2021. Cost of sales for the fourth quarter and year-end, December 31st, 2023, was $4.4 million and $10.8 million, respectively, and comprised of cost of inventory associated with sales of polluting, as well as $3.9 million and $9.7 million, respectively, of non-cash amortization expenses for the required intangible assets for developed technologies.

Zama: Net loss for the year ended December 31st 2023 was $444 million.

Zama: One girl I'm 89 cents per share compared to a net loss of $395 9 million Daus, all $2 49 per share for the year ended December FTSE post 'twenty two.

Zama: The net loss for the year ended December 31st prototypes and three includes amortization of intangible assets acquired as part of the <unk> transaction.

Zama: Revenue from the fourth quarter on Euro ended December 31st 2023.

Zama: Was 410 to $2000 and $1 million.

Zama: Aspect.

Zama: Comprised of product sales of <unk> following the acquisition in mid 2023.

There were no revenue for the fourth quarter and year ended December 31st Party.

Zama: Cost of sales for the fourth quarter in Europe.

Zama: At December 31st 2012.

Was $4 4 million and $10 8 million respectively.

Zama: Comprised of.

Comprised of cost of inventory associated with sales of Proleukin.

Zama: As well as $3 9 million.

Zama: $9 7 million, respectively of non cash amortization expenses for the acquired intangible assets for the block technology.

Jean-Marc Bellarmine: There was no cost of revenue for the fourth quarter and year ended this August 31st, 2021. Research and development expenses were $87.5 million for the fourth quarter and the December 31st, 2023, an increase of $6.9 million compared to $80.6 million for the same period and the December 31st, 2023. Research and development expenses were $344.1 million for the year ended December 31st, 2023, an increase of $49.3 million compared to $294.8 million for the same period ended December 31st, 2023. The increases in research and development expenses in the fourth quarter and the year ended December 21, 2023, over the prior year periods, were primarily attributable to increases in headcount and related costs to support increased production capacity and commercial manufacturing readiness and clinical trial costs driven primarily by the initiation of our Phase III-301 clinical trials.

Zama: There were no cost of revenue for the fourth quarter.

Zama: Thats the first parts of 2002.

Research and development expenses were $7 5 million for the fourth quarter ended December 31st 2023, an increase of $6 $9 million compared.

Zama: $6 million over the same period ended December 31st 2020.

Zama: Research and development expenses were $344 1 million for the Europe ended December 31st towards the 2003.

An increase of $49 3 million.

Zama: Compared to $294 million for the same carrier ended December 31st 2012.

Zama: The increases in research and development expenses in the fourth quarter under Neuro ended December 31st two.

<unk> thousand trips in three or four of the prior neuro failures were primarily attributable to increases in the Taliban related costs to support.

Zama: <unk> increased production capacity and commercial manufacturing readiness and clinical trial costs, driven primarily by the initiation of our phase III program.

Zama: 301 clinical trial.

Jean-Marc Bellarmine: Selling General and Administrative Expenses were at $29.9 million for the fourth quarter and December 31st, 2023, an increase of $3.4 million compared to $26.5 million for the same period on December 31st, 2023. Selling General and Administrative Expenses were $106.9 million for the year ended December 31, 2023, an increase of $2.8 million compared to $104.1 million for the same period ended December 31, 2023. The increase in selling general and administrative expenses in the fourth quarter and the year ended December 31st, 2023 compared to the prior year periods was primarily attributable to increase in net count and related costs to support the growth in the overall business and related corporate infrastructure, professional fees and travel costs, as well as costs associated with prolonging integration activities. This increase was partially offset by an increase in stock-based compensation expenses, illegal and other costs.

Zama: Selling general and administrative expenses were $29 9 million for the fourth quarter ended December 31st months of 2000, and an increase of $3 4 million compared to $26 5 million for.

For the same period under December 31st 2012.

Zama: Selling general and administrative expenses were $106 9 million. Although there are hundreds of December 31st 2023, an increase of $2 $8 million compared to $104 1 million for the same period ended December 31 2012.

Zama: The increase in selling general and administrative expenses in the fourth quarter ended.

Zama: December 31, 2020 compared to the prior year periods was primarily attributable to increasing the talent and related costs to support the growth of the overall business and our royalty co parts infrastructure professional fees and travel costs as well as cost associated with Proleukin integration activities.

Zama: This increase was partially offset by a decrease in stock based compensation expenses legal and other costs.

Jean-Marc Bellarmine: For additional information, please see this afternoon's press release and our annual report on Form 10-K to be filed later today. Regarding our outlook for this year, we continue to guide towards full year 2024 cash burn in the range of 320 to 340 million dollars, excluding one time expenses, and we will continue to leverage opportunities to optimize spending. The U.S. launch of M-TAG-V, as well as the sales of Perukin, used in conjunction with the M-TAG-V treatment regimen, are expected to drive significant revenue in the second half of 2024 and into 2025 and beyond. We have a new recognition for anti-V oxides upon infusion, like other cell therapy.

Zama: For additional information. Please see this afternoon's press release and our annual report on Form 10-K to be filed later today.

Zama: Regarding our outlook for this year, we continue to guide towards full year 2020 forecast growth in the range of $320 million to $314 million.

Zama: Excluding onetime expenses.

Zama: And we will continue to leverage opportunities to optimize spending.

Zama: The U S launch of <unk> as well as the sales of polluting used in conjunction with the 500 treatment regimen.

Zama: I expect it to drive significant revenue in the second half of 2024 and into 2025 and beyond.

Zama: Revenue recognition for <unk> upon intrusion like.

Operator: So we expect to begin recognizing and reporting significant revenue in the second quarter of the year. I will now turn the call over to the operator to begin the question and answer session. Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question hasn't been answered and you wish to unmute yourself from the queue, please press star 11 again.

Zama: <unk> cell therapies. So we expect to begin recognizing are reporting significant progress through the second quarter of this year.

Speaker Change: I will now turn the call over to the operator to begin the question and answer session.

Speaker Change: Thank you ladies and gentlemen, if you have a question or a comment at this time. Please press star one on your telephone. If your question has been answered already we're sticking with yourself from the queue. Please press star one again, we will pause for a moment, while we compile the Q&A roster.

Yanan Zhu: We'll pause for a moment while we compile our Q&A round. Our first question comes from Yanan Zhu with Wells Fargo. Your line is open.

Speaker Change: Our first question comes from Robyn <unk> with Wells Fargo. Your line is open.

Speaker Change: Great.

Robyn: Thanks for taking our questions and.

Yanan Zhu: Great. Thanks for taking our questions and congrats on this initial momentum. Just curious about the 10 patients.

Robyn: <unk> on this.

Robyn: Initial momentum.

Robyn: Just curious about the 10 patients sounds like you have 10 patients that are already at the stage of <unk>.

Yanan Zhu: Sounds like you have 10 patients that are already at the stage of scheduling manufacturing slot. Wondering how long did these patients' reimbursement process, Cook. Does that give you any updated thinking, a way of thinking of the average time from patient identification to tumor resection?

Robyn: Scheduling manufacturing slot.

Robyn: Wondering how long did these patients.

Robyn: Reimbursement.

Robyn: The process.

Robyn: Took.

Robyn: Does that give you any.

Robyn: David thinking our way of thinking of the average time from patient identification to tumor resection and also we see the word.

Frederick G. Vogt: And also, we see the word, you know, some of these 10 patients are pending for manufacturing slots, just wondering what does that mean? And, you know, what's behind the word pending? Thank you. Hi Yanan, it's Fred.

Robyn: Some of these 10 patients that are pending.

Robyn: For manufacturing slots just wondering.

Robyn: What does that room and.

Speaker Change: Whats behind the work pending thank you.

Speaker Change: Yes, Hi, Ana it's Fred.

Frederick G. Vogt: It obviously moved very quickly for the centers that we're able to schedule these patients, the 10 patients that are there that are either scheduled for a slot or soon to schedule for a slot. We're all moving through the process much more quickly. Some centers move fast, some centers move slow.

Fred: Yeah, obviously move very quickly for the centers that we're able to schedule. These patients 10 patients.

Speaker Change: Already there are scheduled for a slot or so in the schedule first slot.

Speaker Change: Moving through the process much more quickly some centers grew fast I'm sorry has been slow.

Frederick G. Vogt: What we're seeing here, I think, is some pent-up demand and real excitement for the NPAGV launch. I'll let Jim add. Jim, do you want to add any comments to that? Thanks, Fred. I think, Yanan, it's still too early to tell.

Speaker Change: What we're seeing here I think of some pent up demand and real excitement for the impact of the launch.

Speaker Change: Let Jim add Jim do you want to add any comments to that.

Speaker Change: Brad.

Jim: I think it's still too early to tell what we've guided before based upon our experience in cell therapy approval is it takes a couple of days for prior authorization and a couple of weeks for single case agreement as Greg pointed out there has been some quick movement because.

James Ziegler: What we've guided before, based upon our experience in cell therapy approvals, is it takes a couple of days for prior authorization and a couple of weeks for single case agreement. As Fred pointed out, there has been some quick movement because of the sense of urgency at these ATCs. To further define what pending means, ATCs basically will schedule a slot once they know they have successful reimbursement. Pending is that they're registered, they're ready to go, but they're not quite ready to pull the trigger on that slot.

Jim: <unk> of urgency at these adcs to.

Jim: To further define what pending means.

Jim: ATC basically we will schedule a slot once they know they have successful reimbursement. So pending is that they are registered there ready to go but they are not quite ready to act.

Jim: I pulled the trigger on that slot yet.

James Ziegler: Great. If I can have a very quick follow up. Namely, you mentioned, you know, manufacturing could be conducted at ICTC or the CDMO. Just wondering, how are you distributing the flow to these two facilities?

Speaker Change: Alright, if I had to have a very quick follow up.

Speaker Change: Namely you mentioned.

Speaker Change: Manufacturing could be conducted.

Speaker Change: CTC or the.

The CDM al just wondering how are you distributing the flow to these two facilities and if you like.

Yanan Zhu: And if you might, if you wouldn't mind commenting on the margin for the CDMO. Thank you very much. Yeah, we can't really say what their margin is.

Speaker Change: If you wouldn't mind.

Our commentary on the margin for the CMO. Thank you very much.

Speaker Change: Yes, we cant really say what their margin is they know that obviously thats their business. We think is competitive with what we do so we employ a make versus buy strategy and I've answered we constantly look at.

Frederick G. Vogt: They know that, obviously, that's their business. We think it's competitive with what we do. So we employ a make versus buy strategy at Iovance. And we constantly look at internal manufacture versus external that keeps everything in tight competition.

Speaker Change: Internal manufacturer versus external that keeps everything and high competition, and we think thats the way the best way to run our business.

Frederick G. Vogt: And we think that's the way, the best way to run a business. Does that answer your question? Right. How would you distribute the flow to ITCGC versus CMO?

Speaker Change: Does that answer your question.

Speaker Change: Right.

Would you distribute it the flow.

Frederick G. Vogt: Yeah, so we have internal algorithms for doing that, and I can't share the full details, but we distribute the flow, somewhat evenly across the two sites. And as we expand and as we grow, I think we'll be able to manage that even more tightly as we learn a little bit more right now about how the sites perform and who's doing the best here. But we run them as an internally competitive process. And I will... Great. Again, just to make sure it's really clear, there is no real issue at all with capacity between the two. We have tons of capacity right now for this launch. Great. Thanks for all the prior and congrats on the progress. Thank you. One moment for our next question. Our next question comes from Tyler Van Buren with PD Cowan. Your line is open. Great. Hey, guys.

Speaker Change: ITC proceed versus CMO so.

Speaker Change: So we have we have internal algorithms for doing that and I can't share the full details, but we distribute the flow.

Speaker Change: Somewhat evenly across the two sites and as we expand as we grow I think we'll be able to manage that and even more tightly as we learn a little bit more right now, but how the site to perform.

And who is who is doing the best here, but we run the business internally competitive process.

Speaker Change: Thanks, Paul.

Paul: Just maybe just to make sure. It's really clear there is no real issue at all with capacity between until we have the capacity right now for this launch.

Speaker Change: Great. Thanks for all the color and congrats on the progress.

Speaker Change: One moment for our next question.

Speaker Change: Okay.

Speaker Change: Okay.

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

Tyler Martin Van Buren: Thanks for taking the question. The patients in process for MTAG-V is a very encouraging update, given that we're just a week and a half in. But as we think about the 20 MTAG-V patients in process, does this constitute the majority of the initial bolus in the 30 ATCs with the majority of sites having at least one patient, as you noted? Or would you be more likely to characterize it as a fraction?

Speaker Change: Great Hey, guys. Thanks for taking the question the patients and process for <unk> is very encouraging update given that we're just a week and a half and but as we think about the 20 <unk> patients in process does this constitute the majority of the initial bolus and the 30 <unk> with the majority of sites, having at least one patient as you noted.

Speaker Change: Would you be more likely to characterize it as a fraction and just as a quick second question with the MAA to be submitted in the first half and other ex U S submissions.

Frederick G. Vogt: And just as a quick second question, with the MAA to be submitted in the first half and other XUS submissions, will Iovance be launching Life Loose Hold abroad, or do you expect to partner? Yeah, Tyler, that's a tiny fraction we think of the patients out there. It's not the initial bolus.

Speaker Change: <unk> launching life loophole abroad, or do you expect to partner.

Speaker Change: Yeah, Tyler that's a tiny fraction, we think of the patients out there it's not the initial bolus the bolus, it's going to go on for quite some time and our sales team is out there and they've got a lot of information and it looks like this is going to be sustainable for quite some time on the MAA front.

Frederick G. Vogt: The bolus is going to go on for quite some time. And our sales team is out there and they've got a lot of information. And it looks like this is going to be sustainable for quite some time. On the MAA front, we intend to do that ourselves. We're not looking for a partner right now to do that. We think that could potentially dilute the value of our assets.

Speaker Change: We intend to do that ourselves.

Speaker Change: We're not looking for a partner right now to do that we think that could potentially dilute the value of our assets.

Frederick G. Vogt: Thank you. One moment for our next question. Our next question comes from Peter Lawson with Barclays. Your line is open.

Speaker Change: Thank you.

Speaker Change: Okay.

One moment for our next question.

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

Peter Richard Lawson: Great, thank you. Thanks for taking the question. I wonder if you kind of talk through how you're thinking about how revenue gets bought, and The Impact. Iraj Kaif, Are you on that.

Peter Richard Lawson: Great. Thank you thanks for taking the questions.

Peter Richard Lawson: That's on the progress.

Peter Richard Lawson: Just wondering if you could kind of talk through how you're thinking about how revenue gets broken.

And the impact of the patients on the <unk> program and kind of how are you.

Peter Richard Lawson: Patients coming in on that program is not on that program.

Peter Richard Lawson: If Peter, in the press release we talk about Iovance Cares, we're talking about the, the system that we use to register patients. Iovance Cares also includes patient assistance services. Right now, we're seeing commercial patients come through that are financially able to pay the full amount for lethal, for tag B, but don't confuse the two. Iovance Cares, when we say they're registered in the system, that's our system that all the patients track through, no matter what they all do. Does that help? Thank you. And then how should we think about how long it would take to kind of... I'm going to start booking revenues. Is that a kind of a 30?

Speaker Change: Yes, Peter in the press release, we talked about Ibs carriers were talking about the <unk>.

Speaker Change: System that we used to register patients <unk> also includes patient assistant services right now, we're seeing commercial patients come through that are.

Speaker Change: Financially.

Speaker Change: Pay the full amount for let's look for TB.

But don't confuse the two <unk> when we say the registered in the system. That's our system that all the patients tractor with no matter, what the element versus that helpful.

Perfect. Thank you and then.

Speaker Change: How should we think about how long it would take to kind of.

Speaker Change: Stop booking revenues is that a kind of at 30 40 days.

Frederick G. Vogt: about that. Long. Thank you. So we recognize revenue at the time of infusion. Jean-Marc was talking about that earlier, and we talked about that last year, too.

Speaker Change: Period before we can think about that or is it longer or is it kind of beginning of <unk> versus.

Speaker Change: <unk>.

Speaker Change: So we recognize revenue at the time of infusion John Mark was talking about that earlier and we talked about that last year too just like the other cell therapies, we recognize revenue when we actually infuse impacting into the arms of the patient. So obviously, if we just commenced manufacturing you can add some type of manufacturing we released the product and then the infusions Volcker and Youll see us accrued revenue at that point.

Frederick G. Vogt: Just like the other self-therapies, we recognize revenue when we actually infuse the antagony into the arm of the patient. So obviously, if we just commence manufacturing, you gotta have some time for manufacturing and release of the product, and then the infusions will occur, and you'll see us accrue revenue at that point. It's not very far away.

Frederick G. Vogt: We're talking weeks now until that starts to happen. But there is a time lag, and that's why we've been talking about first quarter versus second quarter versus third quarter revenues here. Don't mind if I add anything to that. No, I think you characterized it properly.

Speaker Change: It's not very far away, we're talking weeks now until that starts to happen.

Speaker Change: But it does there is there is a time lag and that's why we've been talking about first.

Speaker Change: <unk> first quarter versus second quarter versus third quarter revenues here.

Speaker Change: No Martin.

Martin: Anything to that.

No nothing to characterize it appropriately so we will have the first infusion coming out some.

Jean-Marc Bellarmine: So we will have the first infusion coming, you know, sometimes after all the manufacturing process, the release will happen and then we'll book the revenue. Now it's a question of several weeks. Anything you can say about the, who have already been selected, later line, earlier line, Yeah, Jim, could you get this? Yes, it's probably not appropriate to comment too much other than this patient had been identified and was ready to go. The center that we're talking about had worked them up and as soon as we got approval, moved literally within hours.

Sometimes after all the manufacturing process that will happen and then the revenue now it's a question of several weeks till.

Martin: Anything you can say about the patients that have already been selected.

Martin: Do they kind of.

Martin: Later line airline any any details around that would be great. Thank you.

Speaker Change: Yes, Jim could you get us.

Martin: Yes.

Jim: Yes, it's probably not appropriate to comment too much I didn't in this patient has had been identified and waste ready to go.

Jim: The salary that we're talking about had work them up and as soon as we got approval moved.

Colleen Margaret Kusy: Great, thanks. One moment for our next question. Our next question comes from Colleen Kusy with Baird. Your line is open. Great, thanks. Good afternoon.

Speaker Change: Literally within hours.

Speaker Change: Okay.

Speaker Change: Great. Thanks, so much.

Speaker Change: One moment for our next question.

Speaker Change: Yes.

Our next question comes from Colin <unk> with Baird. Your line is open.

Colleen Margaret Kusy: Congrats on the progress. And thanks for taking our questions. On the example of the tumor resection that happened the next business day, did that patient have reimbursement lined up already?

Great. Thanks, Good afternoon, congrats on the progress and thanks for taking my questions on the example of the jurisdiction that happened. The next business day does that patient have reimbursement lineup already or does that speak to the confidence of the center and eventually getting reimbursement.

Colleen Margaret Kusy: Or does that speak to the confidence of the center and eventually getting reimbursement? And as an add on to that, can you just speak to the early reimbursement success rates? Yeah, Colleen, you got partially cut off there for the first question, but I think you're asking whether the first patient had had their financial clearance already worked up. Is that what you're saying? Yeah, exactly. Yeah, so that that center, Jim, Jim can comment more, but that center basically wanted to get ahead so fast that they are doing it in parallel.

Colin: Add on to that can you just speak to the early reimbursement success rate so far.

Speaker Change: Yes, Colin partially.

Speaker Change: Partially cut off there for the first question, but you are asking whether the first patient.

Speaker Change: Ed.

Speaker Change: There are financial clearance already worked up is that what you're saying.

Speaker Change: Yes exactly.

Speaker Change: Yes so.

Centered Jim Jim can comment more but that center basically wanted to get ahead. So fast that they are doing it in parallel essentially.

Frederick G. Vogt: And again, do you want to comment on Colleen's second question about how the financial clearance is going overall? Yeah, Colleen, it's still a bit too early to tell, but what I would say is the payers appreciate the unmet need, understand the clinical value of MTagV. And to date, we haven't had any issues, but I would provide the disclaimer that we are very, very early on. Just going back to that first patient and having a very competent, experienced team, when this particular ATC reached out to the payer, the payer reached out to our account manager, connected the dots, and everything moved very smoothly and very quickly in this particular situation. Great, that's really helpful.

Speaker Change: And then Jim do you want to comment on.

Second question about the health financial crisis is going overall.

Speaker Change: Yes.

Jim: It's still a bit too early to tell but what I would say is the payers.

Jim: I appreciate the unmet need understand the clinical value.

Speaker Change: <unk> and to date, we haven't had any issues.

Speaker Change: Sure.

Speaker Change: Provide the disclaimer that we are very very early on just going back to that first patient and having a very competent and experienced team.

Speaker Change: When this particular ATC reached out to the payer the payer reached out to our account manager connected the dots and everything moved very smoothly and very quickly.

Speaker Change: In this particular situation.

Colleen Margaret Kusy: Thank you. And one quick follow on, if I can, on Europe, can you just remind us, have EU regulators historically approached this review similar to US regulators? Is there anything unique about this filing versus the US filing?

Speaker Change: Great. That's really helpful. Thank you and one quick follow on if I can on Europe can you just remind us how to have EU regulators has historically approached this review similar to the U S. Regulators is there anything unique about this filing versus the U S filing and just remind us what time lines would be in Europe. Please.

Frederick G. Vogt: And just remind us what timelines would be in Europe. Raj, do you want to take that one? Raj is unavailable, I can't answer it. The accelerated approval in Europe as well, we won't know that until we actually get further in the MAA process, and it can be a level on versus a 14-month review period. We will obviously aim for the fastest review as we can possibly get with the MAA. The EMA has been very cooperative and very interested in getting this drug to European patients. Great, thanks for taking our questions and congrats again. One moment for our next question. Our next question comes from Michael Yee with Jefferies, your line is open. Hi, this is Dina on from.

Speaker Change: Raj do you want to take that one.

Raj: Rogers and available to answer.

Raj: The accelerated.

Raj: Accelerated approval like thing in Europe, as well, we won't know that until we actually get further in the MAA process and it can be 11 offers a 14 month review period.

We will obviously aimed for the fastest overview as we can possibly get with the MAA MAA as a very cooperative and very interested in getting this drug to European patients.

Speaker Change: Great. Thanks for taking my questions and congrats again.

Speaker Change: One moment for our next question.

Speaker Change: Our next question comes from Michael Yee with Jefferies. Your line is open.

Michael Jonathan Yee: Congrats again on the approval and, today. Just a quick question on how we should think about the cadence of how patients would be treated, for the coming months. I know we've been busy. I'm sure you've all been busy.

Speaker Change: Hi, This is neena on for Mike just wanted to say congrats again on the approval and thanks for the update today just a quick question on how we should think about the cadence of how patients would be treated in the coming months. I know you mentioned that you had the 20 patients sort of in process.

Michael Jonathan Yee: And I hope you guys have a great day. Thanks so much for being here. Thanks for joining us. We'll see you guys in a few hours.

Michael Jonathan Yee: Bye! Bye! Bye! Bye! Bye! Bye! Bye! Bye! Bye! Bye! Bye! Bye! Bye! Bye! Bye! Bye! Bye! Bye! Bye! Bye! Bye! Bye! 20 patients sort of in process. But how can we sort of think about the bolus and the cadence of how?

Speaker Change: <unk>, how can we sort of think about the bolus and the cadence of how many new patients as we identified.

Speaker Change: Per site in the next coming minus.

Speaker Change: And just quickly on the slots and capacity.

Speaker Change: How much how many slots for actually approved by the FDA and is the manufacturing success rate likely to be in spec of at least 80% or how should we model and assume that thank you.

Frederick G. Vogt: I think that's all I have to say. Thank you, and just quickly on the slots and capacity. How many slots were actually approved by the FDA and is the manufacturing success rate likely? I'm so glad to be here. Thank you. Thank you. Thank you for watching!

Frederick G. Vogt: Yeah, so on the cadence of treatment, we expect essentially a large bullet to go through. Just as you can see from all the banks and the analysts getting KOL calls and stuff like that, there's a lot of patients waiting for MTAGV, so we think we're going to be really busy here for the next couple of months. And then after that, we think we're going to continue to be busy, as you can see from those same KOL interactions. Most of the sites have several patients a month, and when you average that all out across 30, moving to 50 APCs, that's a very large number of patients every month for us to contend with. So we expect the cadence to eventually be at bullets and then move to a steady state.

Speaker Change: Yes, so on the cadence of treatment.

Speaker Change: We expect to essentially a large bolus to go through just as you can see from all the banks and the analysts getting calls and stuff like that there's a lot of patients waiting for him tanks that we think we're going to be really busy here for the next couple of months and then after that we think we're going to continue to be busy as you can see from the same okay.

Speaker Change: Well interactions both of those sites have several patients a month that when you average it all out across 30 moving to <unk>.

Speaker Change: Yes.

Speaker Change: A large number of patients every month for us to contend with.

Speaker Change: We expect the cadence specifics you'd be a bolus and then move to a steady state that's helpful.

Frederick G. Vogt: That's helpful. On slots and capacity, we haven't actually publicly disclosed the total amount of slots that we've got between Mushi and our ITTC facility, but it's enormous. And I think we'll be able to handle any load that comes in with what we got. And we're very happy with the fact that the FDA gave us a lot of space to be able to manufacture.

Speaker Change: All sorts of capacity, we haven't actually publicly disclosed the total amount of slots we've got between Wuxi.

Speaker Change: Alrighty Tc facility creates enormous and I think we'll be able to handle any load that comes in.

Speaker Change: We got and we're very happy with the fact that the FDA gave us a lot of space to build manufacturer and then regarding the success rate. We don't really we can't really disclose at this point with the percentages and what's happening we don't really know yet we're still working on that still testing, we think it's going to be quite high.

Frederick G. Vogt: And then regarding the success rate, we don't really, we can't really disclose at this point what the percentage is and what's happening. We don't really know yet. We're still working on that, still testing. We think it's going to be quite high. We will be successful in manufacturing in the vast majority of cases. But again, we're only 12, literally 12 days into launch right now.

Speaker Change: We will be successful manufacturing and the vast majority of cases, but again, we're only 12 literally 12 days of the launch right now so we still need time to figure that out.

Joseph Michael Catanzaro: So we still need a little bit more time to figure that out. Got it. One moment for our next question. Our next question comes from Joseph Catanzaro with Piper Stanley. Your line is open. Hey guys, appreciate you taking my questions here. I wanted to maybe follow up on manufacturing capacity, but as it is slightly different.

Speaker Change: Got it thank you.

Speaker Change: One moment for our next question.

Speaker Change: Our next question comes from Joseph Catanzaro with Piper Sandler Your line is open.

Joseph Michael Catanzaro: Hey, guys I appreciate you taking my questions here I wanted to maybe follow up on on manufacturing capacity, but asset it in a slightly different way.

Joseph Michael Catanzaro: So as we think about the dynamic of Ebola and the early indicators of demand you just mentioned today, to what extent, if at all, will you have to stagger receipt of tumor samples? Meaning, you know, are the ATTs going to have to dictate the timing of their resection based on your ability to provide a slot, or are ATTs able to resect? Sample pretty much at their choosing. And then sort of my second question, I know it's still the early days, but with the 50 ATCs planned to be on boarded by the end of May, are there any plans to add ATCs beyond? So, you know, to what extent and...

Joseph Michael Catanzaro: So as we think about the dynamic of a bullet in the early indicators of demand you just mentioned today to what extent if at all will you have to stagger receipt of tumor samples meaning.

Joseph Michael Catanzaro: The ADC is going to have to dictate the timing of their resection based on your ability to provide a slot or ACC is able to reset and then sample pretty much out there at their choosing and then sort of my second question I know its still the early days.

Joseph Michael Catanzaro: But with the 50 ATC is planned to be on boarded by the end of May are there any plans to add <unk> beyond that and if so to what extent and what's the timing around that thanks.

Joseph Michael Catanzaro: I'm, Thank you. Yeah, Igor, do you want to take the first part? Maybe, Jim, we can talk a little bit about the plan PAST-50, too. Yes. Yes.

Joseph Michael Catanzaro: Yes.

Speaker Change: Yes, do you want to take the first part maybe Jim we could talk a little bit about the planned pit 52, yes, yes, great. Joe. Thanks for the question. So we have as I mentioned, we have ample capacity to support launch as well as the clinical trials and the way we design no capacity part of it was extensive research understanding the prefs.

Igor P. Bilinsky: Great. Joe, Joe, thanks for the question. So we have, as I mentioned, we have ample capacity to support launch, as well as the clinical trials and the way we design our capacity. Part of that was extensive research, understanding the preferences of each and every ATC about the typical surgery dates.

Jim: Prince's hope each and every ADC above that typical surgery dates and all of this accounted for in our plan. So we expect to accommodate basically be completely flexible just towards adcs need to do and provide all the capacity that they need to treat all the patients who are in the queue right now.

Igor P. Bilinsky: And all of that's accounted for in our plan. So we expect to accommodate, basically be completely flexible as to what ATCs need to do and provide all the capacity they need to treat all the patients who are in the queue right now. And as additional ATCs on board, we plan to do the same. And also, as I mentioned, the capacity authorization enables us to hire additional staff and increase capacity without conducting additional filings with the agency. Joe, this is Jim.

Joseph Michael Catanzaro: Additional ADC is onboard we plan to do the same.

Joseph Michael Catanzaro: And also as I mentioned the.

Joseph Michael Catanzaro: Capacity authorization enables us to hire additional staff.

Joseph Michael Catanzaro: And increase capacity without conducting additional filings with the agency.

James Ziegler: The 50 ATCs that we identified by the end of May is going to pick up the significant portion of the treated patients in the country. We will continue to monitor the need to expand from that point. But what we want to do is make sure that, With these top centers, we reinforce success, we build their service line, and make sure that they're successful in the treatment. And just a reminder, what I had mentioned before, like the CAR-T market, there's a concentration of care at the top centers. We expect the top 40 to do about 80% of all the treatments for MTAG.

Joseph Michael Catanzaro: Joe This is Jim 50, 86 that we identified by the end of May is going to pick up.

Joseph Michael Catanzaro: The significant portion of the treated patients in the country. We will continue to monitor the need to expand from that point, but what we wanted to do is make sure that.

Joseph Michael Catanzaro: With these top centers, we reinforced success, we build their service line and <unk>.

Joseph Michael Catanzaro: Make sure that they're successful in the treatment and just a reminder.

Joseph Michael Catanzaro: I had mentioned before like the car T market. There is a concentration of care at the top centers, we expect the top 40 to do about 80% of all the treatments for amtech.

James Ziegler: Okay, got it. Thanks. That's helpful and appreciate it. One moment for our next question. Our next question comes from Asthika Goonewardene with Truist Securities. Your line is open. Hey guys. I just want to maybe ask a little bit more about insurance coverage. Could you tell us a bit about what proportion of lives in the U.S. have some degree of coverage right now and what proportion have preferential coverage right now? I know it's only day 12 or 13 up since approval, but just want to get an idea of where you are right now. And then if you can also maybe look down into the year, where do you plan on getting that to in the next, Great. This is Jim.

Speaker Change: Okay got it. Thanks, that's helpful and I appreciate you taking my question.

Speaker Change: One moment for our next question.

Speaker Change: Our next question comes from Sneaker going to war entity with true Securities. Your line is open.

Sneaker: Hey, guys I just wanted to.

Speaker Change: Maybe.

Sneaker: Asked a little bit more about insurance coverage, maybe could you tell us a bit about what proportion of lives in the U S. At some degree up coverage right now and what proportion has.

Speaker Change: <unk> coverage right now I know it's early days.

Speaker Change: $12 13 up since.

Speaker Change: Since approval, but just want to get and I have way are right now and then if you can also maybe to look down.

Speaker Change: I look down.

Speaker Change: Where do you plan on getting that to in the next six months.

Asthika Sarith Goonewardene: I'll just remind you that in the corporate deck, we have our payer mix. About three quarters of our payer mix has strong coverage and reimbursement. This includes 55% commercial, and in Medicare, 4% are IPPS exempt, where these centers are reimbursed at cost, and 70% are Medicare Advantage. So I would say that we have a lot of tailwinds in terms of coverage.

Speaker Change: Great.

Speaker Change: As Jim I'll, just remind you that in the corporate deck, we have our payer mix about three quarters of our payer mix has.

Speaker Change: Strong coverage and reimbursement this includes 55% commercial.

Speaker Change: And in Medicare, 4%, our Ips exempt where the centers are reimbursed at cost.

Speaker Change: And 70% are Medicare advantage, so I would say that.

Speaker Change: We have a lot of tailwind in terms of coverage and right now initial indications granted we're very very early on and launch is that.

James Ziegler: And right now, initial indications, granted we're very, very early on in launch, is that coverage seems to be appropriate and payers are ensuring access at this moment. Great, thanks for taking my question. One moment for our next question. Our next question comes from Reni Benjamin with Citizens JMP. Your line is open.

Speaker Change: Coverage seems to be appropriate and payors.

Speaker Change: Our insurance access at this moment.

Speaker Change: Great. Thanks for taking my questions.

Speaker Change: One moment for our next question.

Reni John Benjamin: Our next question comes from Reni, Benjamin with citizens JMP. Your line is open.

Reni John Benjamin: Very great, guys. Thanks for taking the questions. Maybe just to start off, are you seeing multiple patients.., potentially getting treated this early in the launch from you know the same ATC or do you think this early on you know maybe it's more of a you know once the reimbursement and infusion takes place the next patient will get online just trying to understand, How do you see that developing? And then maybe one for Friedrich, you know, you have the cohort 1A data expected at a medical meeting. I would love to know, you know, should we just be expecting longer follow-up, will we have more patients, you know, and.., for that update. And related to that, you guys have other trials that are ongoing. Could we be, could we get additional clinical data from either 4001 or, you know, one of the other studies that's ongoing? So, Reni, we had a technical issue here. We couldn't hear most of the first question.

Reni John Benjamin: Okay, great guys. Thanks for taking the questions.

Reni John Benjamin: Maybe just to start off are you seeing multiple patients.

Reni John Benjamin: Potentially getting treated this early in the launch from the same ATC or where do you think this early on maybe it's more of a.

Reni John Benjamin: Once reimbursement and infusion takes place the next patient will get online just trying to understand.

Reni John Benjamin: How you see that developing and then maybe one for Friedrich.

Speaker Change: You have the core cohort one data expected at a medical meeting.

Speaker Change: I would love to know should we just be expecting longer follow up will we have more patients in.

Speaker Change: For that update and related to that you guys have other trials that are ongoing could we be could we get additional clinical data from either 4001 or one of the other studies that's ongoing this year.

Speaker Change: Yes.

Speaker Change: So we had a technical issue here, we couldnt hear most of the first question can you just heard the part the clinical question, we get that but what was the first question again, yes. So so I'm just trying to understand from a Pcs that are on board.

Frederick G. Vogt: Can you just, we heard the part of the clinical question when you asked that, but what was the first question again? Yeah, so I'm just trying to understand from the ATCs that are on board, are they, like, you know, you have patients going through the process. Is each ATC pretty much putting one patient on, and then they're kind of going to wait until an infusion takes place before they bring another patient on? Or are you seeing ATCs, like, putting, you know, two or three patients on, and they've... Go ahead and ramp it right away. They're ramping right away. That's the easy question. They're ramping right away. They're not limited in any way by that.

Speaker Change: Are they like.

Speaker Change: Patients going through the process.

Speaker Change: As each ATC pretty much putting one patient on and then they are kind of going to wait until an infusion takes place before they bring another patient on or are you seeing adcs like putting.

Speaker Change: Two or three patients on and they've just go ahead.

Speaker Change: Ramping right away Youre ramping right away. That's easy question. They are ramping very way Theyre not limited in any way by that and then I guess the second part of your question Frederick could you.

Frederick G. Vogt: And then I guess the second part of the question, Frederick, could you, that one came through clearly, at least here. Can you hear, can you take that one? Yeah, I heard that.

Speaker Change: Completely at least here if you get you take that one yes.

Friedrich Graf Finckenstein: So thanks, Reni. So your question was about the CORD1A data. So as a reminder for everyone, that's the cohort and study IOPCOM202 that's involving checkpoint and very naive patients with advanced melanoma to be treated with TILT plus PEMBRO. So that's our kind of proof of concept to part of study for TILVAN. And you were asking, is it more patients or more follow-up? It's both.

Frederick: Got that.

Frederick: So thanks Amit.

Frederick: So your question was about the <unk> data as a reminder for everyone that a coupon.

Frederick: <unk> come to two that's enrolling.

Frederick: Checkpoint inhibitor naive patients with advanced melanoma to be treated with til plus <unk>. So that's our proof of concept study for till then.

Frederick: And you were asking is is it more patients on my follow up.

Friedrich Graf Finckenstein: And it's obviously great to bring out some more data here in the context of us having TILVANs enrolling. We haven't really said anything about additional publications at this time. So stay posted on that. Okay. Can I just ask a follow-up for both those questions again? Do you see any, you know, at any point in the process, do you see an area where there could be a potential bottleneck? And then from the clinical trial perspective, is there any color you can provide just regarding the FDA hold? You know, Friedrich, I think you mentioned.

Frederick: And it's obviously great to bring out some more data here in the context of us having having until thats been hauling.

Frederick: Haven't really said anything about additional applications at this time, so stay posted on that.

Speaker Change: Okay can I just ask a follow up.

Speaker Change: For both those questions again do you see any.

Speaker Change: At any point in the process do you see an area, where there could be a potential bottleneck.

Speaker Change: And then from the clinical trial perspective is there any color you can provide just regarding the FDA hold.

Friedrich Graf Finckenstein: You've already replied to the FDA, correct me if I'm wrong, do you expect there to be back and forth or do you feel like it was pretty straightforward? the whole should be listening. Jim, do you want to go first, and then I take the question while you go to it too?

Speaker Change: I think you mentioned, you've you've already replied to the FDA correct me if I'm wrong do you expect there to be back and forth or do you feel like it was pretty straightforward and you should be the hold should be lifted pretty soon.

Speaker Change: Yeah.

Speaker Change: Tim do you want to go first and then I'll take the question.

James Ziegler: Sure. Reni, just to circle back on your question about multiple patients, it's still very early on, but we are seeing multiple patients from centers, even, you know, multiple patients on a given day, you know, in the scheduling calendar. So I think you should expect that as we ramp up, and ATCs become more comfortable, that you'll see demand with multiple patients from ATCs, you know going forward. And on your question regarding the LUM222 studies, we're confident that we gave them what they needed, them being the FDA in this case, in order to see what our plans are, and we're expecting a response soon and to start enrolling fairly soon as well. Perfect, thanks. Thanks for the question. Yeah, this is Raj Puri.

Speaker Change: Sure.

Tim: Randy just to circle back on your question about multiple patients.

Tim: It's still very early on but we are seeing multiple patients from saturday's event.

Tim: Multiple patients on a given day.

Tim: In the scheduling calendar. So I think you should expect that as we ramp up and atc's become more comfortable that youll see.

Tim: Demand with multiple patients from ATC.

Tim: Going forward.

Tim: And on your question regarding regarding the are you into two studies.

Tim: But confident that we that we gave them, but what they needed them being the <unk> in this case in order to see what our plans are.

Tim: We're expecting a response to that.

Tim: Two to start enrolling fairly soon as well.

Speaker Change: Perfect. Thanks.

Speaker Change: Yes.

Raj K. Puri: Can I also add that to Frederick's comment regarding the clinical hold? As Frederick mentioned that FDA has everything they need to lift the clinical hold and we are actually expecting really soon the resolution of this hold to begin enrolling the patients again. Thanks for taking the questions. One moment for our next question. Our next question comes from Andrea Tan with Goldman Sachs. Your line is open. Good afternoon.

Speaker Change: So add that to critics comment regarding the clinical hold.

Speaker Change: <expletive> mentioned that FDA has everything they need to lift the clinical hold and we are actually expecting really soon David.

Speaker Change: Listen at this this hold to begin enrolling the patients again.

Speaker Change: Thanks for taking the questions.

Speaker Change: One moment for our next question.

Speaker Change: Our next question comes from Andrew <unk> with Goldman Sachs. Your line is open.

Andrea Tan: Thanks for taking our questions. Frederick, maybe a follow up to the last question there, but just wanted to confirm if you could share any more details on the basis of the partial clinical hold, if it was any different from your initial thoughts back in December. That would be helpful. Thank you. No, sorry.

Andrew: Good afternoon. Thanks for taking our question for you Doug maybe a follow up the last question there, but just wanted to confirm if you could share any more details on the basis of the partial clinical hold.

Andrew: If there was any different from your initial thoughts.

Andrew: Back in December that would be helpful. Thank you.

Speaker Change: No.

Friedrich Graf Finckenstein: And there's nothing, there's no information on it, no new aspects that we would have learned in the meantime from our interactions with the FDA. So the basis, we discussed in quite a bit of detail in December, we've been working on addressing that, and as we said, we have addressed in our exciting response about the involvement of new patients. And just as a reminder, this was a partial hold, right?

Speaker Change: There's nothing there's no information on a non U S. So we would have learned in the meantime for Maui precedence with the FDA.

Speaker Change: So the the basis.

Speaker Change: We discussed it quite a bit of detail in December we've been working on addressing that as we said we have addressed them.

Speaker Change: Our thoughts about the enrollment of new patients.

Speaker Change: Ken.

Speaker Change: Just as a just as a reminder, this partial hold right. So we are we are in agreement with the FDA to be able to offer a therapy.

Friedrich Graf Finckenstein: So we are in agreement with the FDA to be able to offer this therapy to patients who were already involved and who had available products, so that also hasn't changed. So again, no new information, nothing unexpected or new that we didn't know back then. Thank you. One moment for our next question. Our next question comes from Kelsey Goodwin with the Guggenheim. Your line is open. Oh hey, good afternoon. I guess just to build a bit on some of the prior questions. First, for the average... Why am I hearing Kelsey?

Speaker Change: Therapy to patients who were already enrolled.

Speaker Change: Available product. So that also hasnt changed so again no non UN Commission no nothing unexpected about that.

Speaker Change: Did the mailbox.

Dan McGill: Dan Mcgill.

Speaker Change: One moment for our next question.

Speaker Change: Yes.

Speaker Change: Yeah.

Speaker Change: Yeah.

Speaker Change: Our next question comes from Kelsey Goodwin with Guggenheim Your line is open.

Kelsey Beatrice Goodwin: Oh, Hey, good afternoon.

Kelsey Beatrice Goodwin: But.

Kelsey Beatrice Goodwin: I guess just to build a bit on some prior questions first for the App, we're unable to hear you Kelsey.

Kelsey Beatrice Goodwin: Oh, okay. Can you hear me better now? Operator, we're unable to hear Kelsey's question. Can you hear us? One moment.

Kelsey Beatrice Goodwin: Okay.

Kelsey Beatrice Goodwin: You hear me better now.

Kelsey Beatrice Goodwin: Okay.

Kelsey Beatrice Goodwin: Now operator, we are unable to hear Chelsea's question, Paris, one moment.

Kelsey Beatrice Goodwin: Yeah.

Operator: [inaudible] We'll move on to the next question and come back to Kelsey one moment. Can you guys still hear me? Yeah, Operator, we can hear you. We're just having a difficult time hearing the analysts.

Speaker Change: Yes.

Speaker Change: Well move on to the next question will come back to the calcium involvement.

Speaker Change: Yes.

Speaker Change: Can you guys hear me.

Speaker Change: Yes, operator, we can hear you just having a difficult time hearing the Alice Alright, one moment.

Speaker Change: Okay.

Speaker Change: Okay.

Benjamin Jay Burnett: Our next question comes from Ben Burnett with Stiefel. Your line is open. Sorry, thank you very much. I just had just a question to help with the model Can you talk about the price of Proleucan and just how much incremental revenue per patient this will be? And I guess it's sort of a follow-up to that. Is this handled the same regardless if the patient has commercial insurance versus government insurance?

Speaker Change: Our next question comes from Ben Burnett with Stifel. Your line is open.

Benjamin Jay Burnett: Great. Thank you very much I just had just a question on <unk>.

Benjamin Jay Burnett: But the model could you talk about the price of Proleukin and just how much incremental revenue per patient this will be.

Benjamin Jay Burnett: I guess as sort of a follow up to that is this handled the same regardless of if it's if the patient is commercial insurance versus.

James Ziegler: Could you repeat the question, please? The first part of the question was cut off. Apologies. I wanted to ask about Proleucin and how much incremental revenue per patient you might expect on top of the MTagV price tag, and then sort of the follow-up to that was would that be handled the same regardless of commercial insurances involved versus government insurance? Sure, why don't I take the first part and then, John, Mark, you can jump in. So as you know, for the MTAGV regimen, Proleucin would be used six doses on average, 18 vials per dose at a WAC of 5,551.

Benjamin Jay Burnett: Versus government insurance.

Dan McGill: And this is Dan.

Dan McGill: Could you repeat the question. Please the first part of the question was cut off.

Dan McGill: Apologies.

Speaker Change: I wanted to ask about Proleukin and how much incremental revenue per patient you might expect.

Dan McGill: Top of the <unk> and tagged price tag.

Dan McGill: And then sort of the follow up to that was would that be handled the same regardless of commercial insurance is involved versus government insurance.

Speaker Change: Sure why don't I take the first part and then John Mark you can jump in so as you know.

Speaker Change: For the <unk> regimen.

Speaker Change: And China's production would be you six doses on average.

Speaker Change: 18 vials per dose at a whack a 5551.

James Ziegler: What I would share is that the cost would be the same, the reimbursement would be the same, whether you are commercial or government at this point, with the exception of mandatory discounts for government sectors. I see. Okay, that's helpful. Thank you. And just maybe one question for Jean-Marc, to what extent is the cash runway assumption that you mentioned earlier, incorporate a revenue estimate for MTAG? Hello, this is John Mark. Are you there?

Speaker Change: I would share is that the.

John Mark: The cost would be the same the reimbursement would be the same whether you're a commercial or government at this point with the exception.

John Mark: Mandatory discounts for government sectors.

Speaker Change: I see okay. That's helpful. Thank you.

Speaker Change: Maybe one question for John Mark to what extent does the cash runway assumption that you mentioned earlier incorporate a revenue estimate for <unk>.

Speaker Change: Yeah.

Speaker Change: Right.

Speaker Change: Yeah.

Benjamin Jay Burnett: Could you repeat that question one more time, Ben? Certainly. I was just curious, to what extent is the cash runway assumption that was mentioned earlier in the prepared remarks, I guess, a corporate revenue estimate for MTAG-B?

Speaker Change: Hello, John Mark are you there.

Speaker Change: Okay.

John Mark: Could you repeat that question one more time Ben.

John Mark: Certainly.

John Mark: I was just curious to what extent does the cash runway assumption that was mentioned earlier in the prepared remarks, I guess incorporate a revenue estimate for <unk> curious if you could maybe speak to that estimate.

Benjamin Jay Burnett: I'm curious if you could maybe speak to that. Can you hear me now? Yes, we can hear you now. Okay, sorry, we're having some technical difficulties there. So, thank you for the question, Ben. So, yes, we do have to take into account some revenue from the entire degree and looking into a cash runway, but of course, obviously, we have been very conservative in the way we have taken those revenues.

Speaker Change: Can you hear me now.

Speaker Change: Yes, we can hear you now okay. As a result, we are having some technical difficulties. So thank you for the question Ben So yes, we do have taken.

Benjamin Jay Burnett: Taking into account some revenue from <unk>.

Speaker Change: Total Canadian mature cash runway, but of course, obviously, we have been very conservative in the way we have taken those revenues are not disclosing more.

Jean-Marc Bellarmine: So, I'm not disclosing more, but again, conservatively on the revenue side, we have enough cash well into second half of 2025. Understood. Thanks so much. Ladies and gentlemen, this concludes today's presentation. I would now like to turn the call back over to Fred for any closing remarks. Operator, can you confirm that you can hear me just because of the technical difficulties? Yes, I can hear you.

Speaker Change: Ken called sovereignty really on the revenue side, we have enough cash went into the second half of consequences.

Speaker Change: Understood. Thanks, so much.

Speaker Change: Ladies and gentlemen, this does conclude today's presentation.

Jean-Marc Bellarmine: I would now like to turn the call back over to Fred for any closing remarks, and operator can you confirm that you can hear me just because of the technical difficulties, yes, I can hear you.

Frederick G. Vogt: Thank you again for joining the Iovance Biotherapeutics fourth quarter and full year 2023 financial results and corporate updates conference call. 2024 is already off to an incredible start for Iovance. Our mission is to remain the global leader in innovating, developing and delivering tilt therapies. And we've now planted a firm stake in the ground as the pioneers of the first commercial tilt therapy. This is also a momentous occasion for the oncology community that has been advancing research in cell therapy for solid tumors for decades. We're thankful to all the scientists, researchers, healthcare providers, and institutions who have contributed to the field, to the patients and their loved ones who have participated in teletherapy clinical trials. It takes a large and coordinated effort to deliver this type of first-in-class category therapy to patients, and this achievement is a testament to the unwavering commitment, expertise, and collaborative efforts of many.

Fred: Thank you again for joining the <unk> therapeutics fourth quarter and full year 2023 financial results and corporate update conference call 'twenty 'twenty four is already off to an incredible start <unk>. Our mission is to remain the global leader in innovating developing and delivering til therapies and we have now plan of the firm stake in the ground. The pioneers the first commercial til therapy.

Speaker Change: It is also a momentous occasion for the oncology community has been advancing research cell therapy for solid tumors for decades.

Speaker Change: Thanks for all the scientists researchers health care providers and institutions have contributed to the field to the patients and their loved ones, who have participated in until therapy clinical trials. It takes a larger coordinated effort to deliver this type of first in class category therapy patients and this achievement is a testament to the unwavering commitment expertise and collaborative efforts.

Frederick G. Vogt: Thank you to those in the healthcare advocacy and patient communities, as well as the regulators, our partners in the local communities in Philadelphia, San Carlos, and Tampa that made this U.S. approval possible. I would also like to thank our shareholders and covering analysts for their support. And lastly, I want to thank our exceptional Iovance team. We could not be here without their cross-functional efforts and our collective, steadfast commitment to following the science.

Speaker Change: Thank you to those need healthcare advocacy and patient communities as well as the regulators are partners in the local communities in Philadelphia, San Carlos in Tampa that made this U S approval popular possible I would also like to thank our shareholders and covering analysts for the support and lastly, I want to thank our exceptional I've asked Steve we cannot be here without their cross functional efforts and our collective steadfast commitment.

Frederick G. Vogt: We look forward to providing further updates on the ANTAGV launch and our pipeline on the first quarter 2024 conference call in May. Please feel free to reach out to our investors relations team for follow-up and apologies for the technical difficulties today. Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect. Thank you for watching!

Speaker Change: Following the science, we look forward to providing further updates on the <unk> launch and our pipeline on the first quarter 2024 conference call May Please feel free to reach out to our investors relation team for follow up and apologies for the technical difficulties today. Thank you.

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

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: Yes.

Frederick G. Vogt: [music].