Q1 2022 Iovance Biotherapeutics Inc Earnings Call

Welcome to the <unk> Biotherapeutics first quarter 2022 financial results. My name is Andrew and I'll be your operator for today's call. At this time all participants are in a listen only mode.

Operator: Welcome to Iovance Biotherapeutics' first quarter 2022 financial results. My name is Andrew, and I will be your operator for today's call. At this time, all participants are in a listen-only mode.

Operator: Later, we'll conduct a question and answer session. During the question and answer session, if you have a question, please press star and then one on your touchtone phone. Please note that this conference is being recorded. I will now turn the call over to Sara Pellegrino, Vice President, Investor and Public Relations at Iovance. Sara, you may begin.

Later, we will conduct a question and answer session.

During the question and answer session. If you have a question. Please press Star then one on your Touchtone phone.

Please note that this conference is being recorded.

I will now turn the call over to Sara Pellegrino, Vice President Investor and public relations at <unk>, Sir you may begin.

Thank you operator, good afternoon, and thank you for joining US speaking on today's call. We have Dr. Fred boat, our interim President and Chief Executive Officer, Dr. Igor Bolinsky, our Chief operating officer.

Sara Pellegrino: Thank you, Operator. Good afternoon, and thank you for joining us. Speaking on today's call, we have Dr. Fred Vogt, our Interim President and Chief Executive Officer, Dr. Igor Bilinsky, our Chief Operating Officer, Jim Ziegler, our Senior Vice President, Commercial, Dr. Frederick Finckenstein, our Chief Medical Officer, Dr. Madan Jagazia, our Senior Vice President, Medical Affairs, and Jean-Marc Bellamy, our Chief Financial Officer. Dr. Raj Puri, This afternoon, we issued a press release that can be found on our website at iovance.com, which includes the financial results for the three months ended March 31st, 2022, as well as recent corporate updates.

Ziegler, our senior Vice President commercial.

Dr. Roderick Lincoln Stein, our Chief Medical Officer Dr.

Dr. <unk> <unk>, our senior Vice President Medical Affairs, and John Marc <unk>, Our Chief Financial Officer, Dr. Raj <unk>, our executive Vice President regulatory strategy and translational Medicine is also on the call to participate in the question and answer session.

Afternoon, we issued a press release that can be found on our website at <unk> Dot Com, which includes the financial results for the three months ended on March 31, 2022, as well as recent corporate updates before we start I would like to remind everyone that statements made during this conference call will include forward looking.

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, pre-commercial activities, clinical trials, and regulatory plans and results. Research and Preclinical Activities, Potential Future Applications of our Technologies, Manufacturing Capabilities, Regulatory Feedback and Guidance, Payer Interaction, 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 filings. Our results may differ materially from those projected during today's call. We undertake no obligation to publicly update any forward-looking statements.

Statements regarding <unk> goals business focus business plan pre commercial activities clinical trials and regulatory plans and results.

Research and preclinical or potential future applications of our technologies manufacturing capabilities regulatory feedback and guidance payer interaction collaboration cash position that 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 the call over to Brett.

Fred Vogt: With that, I will turn the call over to Fred. Thank you, Sara. Good afternoon, everyone.

Thank you Sir good afternoon, everyone I'm pleased to highlight our positive start to the year and I have answered during today's conference call first.

Fred Vogt: I am pleased to highlight our positive start to the year at Iovance during today's conference call. First and foremost, we are moving rapidly towards our first ever BLA submission for our lead pill therapy, glyphylucel, and metastatic melanoma. This is our top priority at IOM. As we announced last month, we received positive feedback from the FDA regarding our potency assays and assay matrix for Lifeluce. For next steps, we intend to hold a pre-BLA meeting in July 2022 and submit the BLA in August 2022.

First and foremost we are moving rapidly towards our first ever BLA submission for our lead til therapy likes leucyl in metastatic melanoma.

This is our top priority as.

As we announced last month, we received positive feedback from the FDA regarding a potency assay and assay matrix for LIFO Leucyl.

For next steps, we intend to hold a pre BLA meeting in July 2022, and submit the BLA in August 2022.

In addition, we continue discussions with the FDA about our registrational strategies in cervical cancer and non small cell lung cancer.

Fred Vogt: In addition, we continue discussions with the FDA about our registrational strategies in cervical cancer and non-small cell lung cancer so that we may offer TIL therapy to patients with significant unmet need in these additional tumor types. As we prepare to launch Lifelucid, we are also making progress in our commercial readiness and internal manufacturing capabilities at the Iovance Cell Therapy Center, or ICTC, in Philadelphia. Our organization is growing to further our mission of innovating, developing, and delivering pill therapy.

So that we may offered til therapy to patients with significant unmet need in these additional tumor types.

As we prepare to launch late Leucyl, we're also making progress on our commercial readiness and internal manufacturing capabilities at the <unk> cell therapy center or <unk> in Philadelphia.

Our organization is growing to further our mission of innovating developing and delivering til therapies.

We now have nearly 400 employees at the company who has on average over the four years of cell therapy experience.

Fred Vogt: We now have nearly 400 employees at the company who have, on average, more than four years of cell therapy experience. The talent within our organization is a testament to the potential of our Iovance pill therapy and our global leadership within the field. We're excited about the momentum for our glaring-tail pipeline.

Talent within our organization is a testament to the potential of til therapy, and a global leadership within the field.

We're excited about the momentum for our growing sales pipeline, we continue to enroll patients across four IV and sponsored clinical trials and plan to initiate two additional trials this year.

Fred Vogt: We continue to enroll patients across four Iovance-sponsored clinical trials and plan to initiate two additional trials this year. The FDA has allowed an IND to proceed for a clinical trial of our PD-1 inactivated gene-edited TIL therapy, IV4001. We also plan to conduct a phase three trial of pill in combination with Pembrolizumab and frontline melanoma, where clinical data demonstrated the potential to improve patient outcomes compared to pembrolizumab alone in patients who are naive to immune checkpoint inhibitors.

CA has allowed <unk> to proceed.

Our clinical trial of our PD, one and activated gene edited til therapy IV 4001, we.

We also plan to conduct a phase III trial of <unk> in combination with <unk> in frontline melanoma, where.

Our clinical data demonstrated the potential to improve patient outcomes compared to <unk> alone in patients who are naive to immune checkpoint inhibitors.

Fred Vogt: As we prepare to launch the first one-time cell therapy in solid tumors, we believe that our TIL platform, clinical data, and people set a strong foundation to establish Iovance TIL therapy as the next class of paradigm-shifting therapies for people with cancer.

As we prepare to launch the first onetime cell therapy in solid tumors, we believe that our til platform clinical data and people set a strong foundation to establish its til therapy as the next class a paradigm shifting therapy for people with cancer.

Manufacturing and managing demand for our new cell therapy is key to our success.

Igor Bilinsky: Manufacturing and managing demand for a new cell therapy is key to our success, so I'll ask Igor to talk more about our progress in these areas. Thank you, friends.

So if you could talk more about our progress in these areas.

Thank you Brian .

Igor Bilinsky: Across our manufacturing network, we continue to focus on patient needs and operational excellence, maintaining a till manufacturing success rate of more than 90% in more than 500 patients treated with Iovance till therapy. Today, I will summarize key activities at the Iovance Cell Therapy Center, or ICTC, which is our 136,000 square foot cell therapy manufacturing facility. Recently, Iovance was honored by the International Society for Pharmaceutical Engineering with a 2022 Facility of the Year Category Award for ICTC, a remarkable reflection of what we have accomplished since the initial groundbreaking of this facility only three years ago. As for CDC, the main priority remains preparation for the DLA and commercial loans.

Cross sell manufacturing network, we continue to focus on patient needs has operational excellence maintaining until many texturing success rate of more than 90% and more than 500 patients treated with either dual therapy.

Today, I will summarize Q activities of the OIBDA fell 30%. Therefore, as you can see which is our 136000 square foot cell therapy manufacturing facility.

Recently <unk> was honored by the International Society for pharmaceutical engineering with the 'twenty to 'twenty two facility of the year category Award for ITC.

Probably a reflection of what we have accomplished since the initial groundbreaking of this facility only three years ago.

Did you see the main priority remains preparation for the BLA.

The commercial launch.

Igor Bilinsky: We designed ICTC to have the capacity to provide commercial and clinical trial supply for thousands of patients per year. We expect ITTC to handle most of our commercial demand at launch, with the added flexibility to use contract manufacturing to optimally manage capacity and address patient demand. We are performing numerous activities to support the BLA submission at ICTC in parallel with clinical manufacturing, which began at ICTC last year. In addition, we are on track in preparing ICTC and our contract manufacturer's facility for BLA for FDA pre-approval inspections, which we expect to occur as part of the BLA review process. In addition to manufacturing, we have established a strong quality control or QC group at ICR.

Design ICT seem to have the capacity to provide commercial and clinical tools applied for thousands of patients per year.

We expect TTC to handle most of our commercial demand. This launch with the added flexibility to use contract manufacturing to optimally manage capacity and address patient demand.

We're performing numerous activities to support the BLA submission by the CDC in parallel with clinical manufacturing, which began with the CDC last year in.

In addition, we are on track in preparing the ITC and our contract manufacturing facility.

BLA for FDA pre approval inspections, which we expect to occur as part of the BLA review process.

In addition to manufacturing we have established a strong quality control or do you see group, but by the CDC.

Igor Bilinsky: The QC team performs release testing of two products, which will include commercial release testing of Lifelucil upon potential. In collaboration with our analytical development group, our QC team has been completing BLA-related activities needed for our TIL potency assays and assay matrix, including our new potency co-culture assay. Turning to our intellectual property or IP, we continue to build our robust and growing IP portfolio to support our proprietary manufacturing processes, as well as our know-how surrounding till therapy. We currently own more than 40 granted or allowed US and international patents.

<unk> performance release testing on tube products, which will include commercial release testing uplift upon potential approval.

In collaboration with our analytical development.

Our QC team has been completing BLA related activities needed for both <unk> and SMA, including our new potency co culture.

Turning to our intellectual property or IP, we continue to build a robust and growing our portfolio to support our proprietary manufacturing processes as well as our knowhow surrounding til therapy.

We currently own more than 40 granted or allowed U S and international events.

This IP covers compositions and methods of treatment in manufacturing in a broad range of cancers, including Gen. Two patent rights that I expect it to provide exclusivity into 2038.

James Ziegler: This IP covers two compositions and methods of treatment and manufacturing in a broad range of cancers, including Gen 2 patent rights that are expected to provide exclusivity into 2038. I would now like to hand the call to James Ziegler to highlight our commercial launch preparations.

I would now like to hand, the call to Jim Ziegler to highlight all commercial launch preparations overdue Jim.

Thank you Igor our cross functional team has built the foundation to scale rapidly and efficiently from BLA submission and the launch and commercialization we.

James Ziegler: Thank you, Igor. Our cross-functional team has built the foundation to scale rapidly and efficiently from BLA submission to launch and commercialization. We are partnering with the leading U.S. cancer centers to develop their kill service line capabilities, and we aim to have at least 40 authorized treatment centers or ATCs for the lines. The key onboarding and training activities are also aligned with the BLA-related milestones to ensure just-in-time training and readiness at our ATCs.

We are partnering with a leading U S cancer centers to develop their kill service line capabilities and we aim to have at least 40 authorized treatment centers or atc's for launch.

Key Onboarding and training activities are also aligned with the BLA related milestones to ensure just in time training and readiness at our ATC.

Our market access team continues to engage commercial state and federal Payors, such as the centers for Medicare and Medicaid services or CMS to ensure patients have appropriate and timely access to LIFO lusso.

James Ziegler: Our market access team continues to engage commercial, state, and federal payers, such as the Centers for Medicare and Medicaid Services, or CMS, to ensure patients have appropriate and timely access to Lifelucel. CMS released the Fiscal Year 2023 Inpatient Prospective Payment, or IPPS, proposed rules as part of their annual process in April. In this draft rule, CMS proposes to continue policies that were finalized in the fiscal year 2022 rulemaking cycle, which expanded DRG 18 for CAR T's and other immunotherapies, including Lifelucel. This means hospitals will have more appropriate payment for Medicare beneficiaries upon life insurance approval.

CMS released the fiscal year 2023, inpatient prospective payment our Ips proposed rules as part of their annual process in April .

In this graph rule.

CMS proposes to continue policies that were finalized in the fiscal year, 2022, rulemaking cycle, which expanded DRG for.

<unk> for car T and other immunotherapies, including LIFO Lusso.

Hospitals will have more appropriate payment for Medicare beneficiaries upon LIFO leucyl approval.

And the rule CMS also summarizes the new technology add on payment or <unk> applications, including LIFO Leucyl.

Friedrich Finckenstein: In the rule, CMS also summarizes the new technology add-on payment or NTAP applications, including Lifelucel. With the anticipated BLA timelines, we plan to submit our NTAP application in the next fiscal cycle. We appreciate the positive steps CMS has taken to improve Medicare patient access to cell therapies, and we look forward to working with CMS and other key stakeholders to ensure access to this emerging class of cell therapies. In addition to supporting access, we are also developing our proprietary Iovance CARES program to assist health care providers and patients through every step of their TIL journey.

With the anticipated BLA timelines, we plan to submit our application in the next fiscal cycle.

We appreciate the positive step CMS has taken to improving Medicare patient access to cell therapies, and we look forward to working with CMS and other key stakeholders to ensure access for the emerging class of cell therapies.

In addition to supporting access we are also developing our proprietary <unk> cares program to assist health care providers and patients through every step of their toe journey.

Our goal is to deliver a best in class cell ordering change of identity.

Friedrich Finckenstein: Our goal is to deliver a best-in-class cell ordering, chain of identity, chain of custody, and patient support program for long. I will now pass the call to Friedrich Finckenstein, our Chief Medical Officer, to highlight our clinical progress. Thank you, Jim.

Custody and patient support program for launch.

I will now pass the call to redirect Finkelstein, our chief Medical officer to highlight our clinical progress.

Thank you Jim.

Friedrich Finckenstein: Today I would like to share recent updates for our TILT clinical program. We have made great strides in evolving our TILT technology platform to incorporate additional therapies and technologies to address more cancer patients and new tumor types and indications. The important proof of concept for TIL in combination with pembrolizumab in multiple solid tumors, as well as our IND-enabling work to proceed to a clinical trial with IOV4001 are two prime examples of our platform expansion and commitment to TIL innovation.

I would like to share a recent updates for our <unk> clinical program.

We have made great strides, enabling our <unk> technology platform to incorporate additional therapies and technologies to address more cancer patients and youll tumor types and indications.

Important proof of concept fulfilled in combination with Pemberton amount in multiple solid tumors as well as our IMD, enabling works to proceed to a clinical trial with <unk> 4001 onto Prime example.

On his passion and commitment to innovation.

Our strategy for <unk> in combination with <unk>.

Friedrich Finckenstein: Our strategy for TILT in combination with Tembolizumab in checkpoint inhibitor nave patients expands upon the initial opportunity for light to act as monotherapy after checkpoint inhibitor therapy. In an April 2022 press release, we announced updated clinical data for Lifelucid in combination with Pembrolizumab from cohort 1A in our IOV-COM-202 trial. In melanoma patients who are now on yeast immune checkpoint inhibitor therapy, the overall response rate was 67%.

Each patient expands upon the initial opportunity for like a neutral monotherapy after checkpoint inhibitor therapy.

And in April 22 press release, we announced updated clinical data for likelihood for a combination with $10 amount from cohort one.

Our IRB come to trial.

In melanoma patients who are not used to immune checkpoint inhibitor therapy. The overall response rate was 67% eight.

Eight out of 12 patients had a confirmed objective response.

Friedrich Finckenstein: Eight out of 12 patients had a confirmed objective response, including three complete responses and five partial responses. Overall and complete response rates for this combination were above published response rates for PEMBRO alone in frontline melanoma. Based on these promising clinical data and to offer possible benefit from pill therapy to more melanoma patients, we are working with our internal teams and key opinion leaders to finalize the design for a phase 3 trial.

<unk> three complete responses and partial responses.

Overall and complete response rates for this combination, whereas the published response rate for <unk> alone in frontline melanoma.

Based on the promising clinical data and to offer possible benefit from til therapy to more melanoma patients. We are working with our internal team and key opinion leaders to finalize the design for our phase III trial.

Friedrich Finckenstein: We currently expect this trial to begin at the end of this year and look forward to providing updates as available. In addition, we are advancing our first genetically modified cell therapy candidate, IOV4001, into the clinic. During the first quarter, the FDA allowed our IND to proceed for IOV4001, a PD-1 inactivated TIL therapy that incorporates the TALEN gene editing technology licensed from Selective. Preclinical results for IOV4001 were recently presented in a poster at the American Association for Cancer Research Annual Meeting. In the murine model of melanoma, the anti-tumor activity of IOV4001 was superior to the non-edited TIL product, whether alone or in combination with an anti-PD-1 antibody.

Okay.

File to begin at the end of this year and look forward to providing updates that's available.

In addition, we are advancing.

First genetically modified til therapy candidate <unk> 4001 into the clinic.

During the first quarter the FDA allowed our IMG to proceed for ILD.

On previously treated advanced melanoma, metastatic non small cell lung cancer.

<unk>, one is with PD, one and excavator til therapy that incorporates the current gene editing technology licensed from <unk>.

Preclinical results for <unk> 4001 were recently presented in a poster at the American Association for cancer Research annual meeting or ACR.

The mirror in models of melanoma, the anti tumor activity of <unk>. One was superior to non ended until kind of alone or in combination with an anti PD one antibody.

Friedrich Finckenstein: We are excited about the potential for IOV4001 to deliver TIL and PD-1 inhibition within a single therapy and look forward to starting a first-in-human study with IOV4001 later this year. Turning to our strategy for children with small cell lung cancer, we are currently enrolling second-line non-small cell lung cancer patients in the IOV Lung 202 trial at Dirty Cycle. We recently amended the trial protocol to broaden the patient population in reflection of real world practice and the unmet need in small telemedicine.

We're excited about the potential for <unk> 4001 to deliver and PD one inhibition within a single therapy and look forward to starting our first in human study with <unk>.

Later this year.

Turning to our strategy for Trimble and non small cell lung cancer. We are currently enrolling second line non small cell lung cancer patients in the ILB Lum 202 trial at 30 sites.

We recently amended the trial protocol to broaden the patient population a reflection of real world practice, and the unmet need in non small cell lung cancer.

This amended protocol also provide flexibility around the timing of tumor harbor.

Friedrich Finckenstein: This amended protocol also provides flexibility around the timing of tumor harvests, as well as around therapy prior to tumor infusion, which may inform new practices for patients across solid tumors. To elaborate on our medical education and outreach efforts, I will hand the call to Madan to discuss. Thank you, Friedrich.

As around therapy prior to infusion, which may inform new practices for patients across solid tumors.

Our medical education, and outreach efforts I will hand, the call coming down to discuss.

Thank you Friedrich our medical Affairs team has a depth of experience in oncology with long standing relationships with many of our key opinion leaders for.

Madan Jagazia: Our medical affairs team has a depth of experience in oncology and longstanding relationships with many of our key opinion leaders. Over the past three years, our medical affairs team has been active in engaging centers and physicians about Iovance pill therapy. These interactions include scientific exchange at individual and small group meetings or during medical conferences. In total, the team has interacted with approximately 500 healthcare providers, or HCPs. Among these ACPs, 70% are dedicated to hematology-oncology, 20% are cell therapy specialists, and the remaining 10% are surgeons.

For the past three years, our medical affairs team has been active in engaging centers and physicians about <unk> therapy.

These interactions into scientific exchange at individual and small group meetings argued medical conferences.

In total the team has interacted with approximately 500 health care providers are HCP.

Among these hcp's, 70% dedicated to hematology oncology, 20%, that's cell therapy specialists and the remaining 10% decision.

Our medical Affairs team also lead to publication and scientific communication strategy and execution of diagram.

Madan Jagazia: Our Medical Affairs team also leads the publication and scientific communication strategy and execution at Iovance. Our goal is to present and publish clinical data and engage with physicians so that we can attract top centers to participate in our clinical trials, increase scientific awareness, drive patient recruitment, and increase share of voice for Iovance still therapy within the oncology and cell therapy community. In 2021 alone, our clinical trial data presentations represented 136 patients across four tumor types.

Goal is to present and publish clinical data and engage with physicians. So that we can attract top centers to participate in our <unk>.

Let me take trials.

<unk> scientific awareness.

Patient recruitment and increased share of voice for IV <unk> therapy within the oncology and cell therapy communities.

In 2021 alone are clinical trial data presentation represented 136 patients across four tumor types.

Madan Jagazia: The venues included three major medical meetings, AACR, ASCO, and CITSI, and one manuscript, which was a melanoma cohort to data in the Journal of Clinical Oncology. In addition, our Iovance medical affairs team has interacted with more than 100 centers as we work cross-functionally to facilitate onboarding activities at the authorized treatment centers. Among these centers, 60% are designated cancer centers by the National Cancer Institute and or member institutions of the National Comprehensive Cancer Center Network. The remaining 40% are a mix of academic and large community networks.

Venues included three major medical meetings.

<unk> and <unk>.

One manuscript, which was melanoma cohort two data in the journal of clinical oncology.

In addition, our islands Medical Affairs team has interacted with more than 100 centers as we will cross functionally to facilitate ongoing activities at the authorized treatment centers among.

Among the centers, 60% designated cancer centers or the National Cancer Institute and our member institutions of the National Comprehensive Cancer Center network.

The remaining 40% are a mix of academic and large community networks.

I will now hand, the call over to John Mark to discuss our first quarter 2022 financial results.

Jean-Marc Bellamy: I will now hand the call over to Jean-Marc to discuss our first quarter 2022 financial results. Thank you, Madam. My comments will reflect the high-level financial results from our first quarter of 2022. Additional details can be found in this afternoon's press release, as well as in our SEC filing. I will begin with the strengths of our cash position. As of March 31, 2022, Iovance held $516 million in cash, cash equivalents, and restricted cash, compared to $62.1 million on December 31, 2021. Cash usage from operations included certain annual payments totaling $16 million.

Thank you Michael.

Jean-Marc Bellamy: We maintain prior guidance that our cash position is sufficient to advance our operating plan into 2024, including pipeline development and expansion, commercial manufacturing readiness, and launch preparation. Moving to the income statement, our net loss for the first quarter and March 31st, 2022 was $91.6 million or 58 cents per share, compared to a net loss of $75.4 million or $0.51 per share for the first quarter and March 31, 2021. Research and development expenses were $68.3 million for the first quarter and March 31, 2022.

My comments will reflect the high level financial results from our first quarter of 2020.

Additional details can be found in this afternoon's press release as well as <unk>.

The SEC filings.

I will begin with the strength of our cash position.

As of March 31st 2022.

Jean-Marc Bellamy: An increase of $12.4 million compared to $55.9 million for the first quarter ended March 31, 2020. The increase in research and development expenses over the prior year period was primarily attributable to the growth of the internal research and development team, including stock-based compensation expense, to support our ongoing and planned pipeline activities, as well as increased facility-related expenses. General and administrative expenses were $23.4 million for the first quarter and March 31, 2022, an increase of $3.8 million compared to $19.6 million for the first quarter and March 31, 2021.

$516 million in cash cash equivalent investments and restricted cash compared to $602 1 million on December 31 2021.

Our cash usage from operations included certain unusual business totaled $16 million.

We maintain our prior guidance that our cash position is sufficient to advance our operating plan into 2024, including pipeline development and expansion commercial manufacturing readiness and launch preparation.

Moving to the income statement, our net loss for the first quarter ended March 31st 2022 was $91 6 million Daus, all 58 per share.

This compared to a net loss of $75 4 million.

<unk> 51 per share for the first quarter on those March 31st 2021.

Research and development expenses were $68 3 million for the first quarter ended March 31st 2022.

An increase of $12 4 million.

Both through $55 9 million for the first quarter ended March 31st 2021.

The increase in research and development expenses over the prior year was primarily attributable to the growth of the intermodal research and development team, including stock based compensation expense to support our ongoing and planned pipeline activities as well as increased facility related costs.

General and administrative expenses were $23 4 million for the first quarter on March 31st 2022.

Jean-Marc Bellamy: The increase in general and administrative expenses compared to the prior year period was primarily attributable to the growth of the internal general and administrative team, including stock-based compensation expense, an increase in marketing, intellectual property, and legal expenses, as well as the build-out of our new corporate headquarters, office, and information technology infrastructures to support pre-commercialization, launch readiness, and our overall growth. As of March 31, 2022, there were approximately 157.2 million common shares outstanding.

An increase of $3 8 million.

<unk> to $19 6 million.

For the first quarter ended March 31 2021.

The increase in general and administrative expenses compared to the prior year period.

It was primarily attributable to the growth of the internal general and administrative team, including stock based compensation expense and increased marketing intellectual property.

<unk> expenses as well as the build out of our new Gulfport headquarter office and information technology infrastructure to support pre commercialization launch readiness and their overall growth.

As of March 31st 2020, there were approximately.

One of the GTE $7 2 million common shares outstanding.

So is the strength of our balance sheet and by managing our focused investments across the pipeline launch readiness and internal manufacturing, we are well positioned to execute our operating plan, while continuing to align our spending with our corporate priorities.

Operator: With the strength of our balance sheet and by managing our focused investments across the pipeline, launch readiness, and internal manufacturing, we are well positioned to execute our operating plan while continuing to align our spending with our corporate priorities. I will now hand the call back to the operator to kick off the Q&A session. Thank you. As a reminder, to ask a question, you will need to press star 1 on your telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key.

I'll now hand, the call back to the operator.

The Q&A session.

Thank you as a reminder to ask a question you will need to press star one on your telephone.

If your question has been answered or you wish to remove yourself from the queue. Please press the pound key.

And our first question comes from the line of Madhu Kumar with Goldman Sachs.

Madhu Kumar: And our first question comes from the line of Madhu Kumar with Goldman Sachs. Yeah, everyone, thanks for taking our questions. I guess our first one is, again, kind of a simple one of looking at the calendar.

Yes, Brian Thanks for taking our questions. So I guess the first one is again kind of a simple one of looking at the calendar how should we think about the cadence of events in terms of the release of cohort for topline data.

Unknown Executive: How should we think about the cadence of events in terms of the release of cohort 4 toppling data vis-a-vis the July pre-BLA meeting and the August BLA submission? It's going to be part of that process. We can't really give any more guidance on that, but effectively, it's part of that process, you know, we're trying to get the BLA in, and we're trying to talk more about CORA 4 and have completed the process of filing the BLA at the same time. So really, I wouldn't think about it as any particular cadence; it should, it should come.

The July pre BLA meeting and August BLA submission.

And then do it.

Part of that process, we can't really give any more guidance as to that but effectively as part of that process.

We're trying to get to BLA in and we're trying to talk more about <unk>.

Complete the process of filing the BLA at the same time, so I wouldn't think about it is there any particular cadence to should it should come in.

As soon as we're able to do it.

Unknown Executive: As soon as we're able to do it. Okay, and then on non-small cell and cervical cancer, how should we, you mentioned you were planning to have regulatory interactions to discuss kind of making registrational cohorts. In both indications, what do you see as the effective population for unmet need where either TIL monotherapy or TIL plus PD-1 blockade kind of makes sense as a line of therapy for whom you could have a registrational cohort?

Okay, and then on <unk>.

Small cell and cervical cancer, how should we you mentioned, you're kind of regulatory interactions discuss kind of making registrational cohorts.

And those indications what do you see as the effective population for unmet need where either <unk> monotherapy or <unk> plus PD, one blockade kind of makes sense as a line of therapy for him you could have a registrational cohort.

While both of occasions, you have the post checkpoint population available where there is significant unmet medical need today.

Unknown Executive: Well, on both occasions, you have the post-checkpoint population available where there's significant medical need today. So that's sort of the short answer to your question. There are obviously many finer points, and we can talk more about the details of each study. And hopefully, after getting our strategy together and regulatory input, and sorting out our plans here.

So that's that's sort of the short answer to your question. There is obviously a much finer points and we can talk more about the details of each study.

Hopefully after after getting our strategy together and regulatory input.

Sorting out our plans here, we can talk more about this but that's the general approach and then of course, we've got frontline studies running in combination with umbrella both as well to look at earlier lines of therapy is as you normally do in oncology drug development.

Unknown Executive: We can talk more about this, but that's the general approach. And then, of course, you know, we've got frontline studies running in combination with PEMBRO and both as well to look at earlier lines of therapy as you normally do in oncology drug development. Okay, one last question I have is maybe a scientific slash philosophical one. How do you think about PD-1 knockout TILs as compared to TILs plus PD-1 as a kind of therapeutic avenue?

Okay. One last question on kind of maybe scientific slash philosophical one how do you think about PD, one knockout tells as compared to <unk> plus PD, one as a kind of a.

Therapy that Gavin is like Westwood, one PD, one monoclonal antibody combination make more sense or with a PD one knockout kearl population makes more sense in Vegas, which raises the question.

Unknown Executive: Where would one, the PD-1 monoclonal antibody combination, make more sense? Or would a PD-1 knockout TIL population make more sense? And I guess kind of, which raises the question, how much of TIL efficacy is from the initial TIL product versus the kind of epitope spread?

How much.

Efficacy is from the initial <unk> product versus kind of epitope spreading.

Well.

Unknown Executive: Well, guys, let me take the first part of your question. And we can talk a little more about telepathy as we go here. Madonna, Frederick can jump in as well. It's untested as of today, but we do believe that knocking down the gene within the T cell may lead to a more efficacious treatment for PD-1, PD-L1 Block A. There are a number of reasons for this.

So let me take the first part of your question, if we could talk a little about til efficacy as we go here.

Donna project can jump in as well as needed.

It is untested as of today, but we do believe that knocking down the gene within the T cells may lead to a more efficacious til in a more efficacious MLA for PD, one PDL one blockade.

There's a number of reasons for this.

Unknown Executive: And there are a number of advantages to knocking down the gene as opposed to giving the patient an antibody. For example, better penetration of the TILs into a tumor. Stromal Layers in the Microenvironment, as opposed to an antibody, and separately, that's an efficacy side argument, but on a toxicity side argument, you could argue that there are fewer off-target effects from the pill having a knockout versus the antibody being systemically delivered, on the idea, on the question of where the tele-efficacy comes from.

Theres, a number of advantages to knocking down the gene as opposed to giving the patient antibody for example, better penetration of the <unk> into a.

Tumor.

Stroma layers in the microenvironment.

As opposed to an antibody.

And separately you could.

The efficacy side argument.

On the toxicity side argument you could argue that less off target.

<unk> from the still having a knockout versus the antibody being systemically delivered.

On the idea on the question of where the til efficacy comes from.

Steve Rosenberg's lab has published a lot illness.

Unknown Executive: Steve Rosenberg's lab has published a lot on this, and it's generally believed that the efficacy of TIL therapies occurs in the early period after administration, although obviously, we see... From a clinical perspective, we see responses that can originate later, after some time. You can have an ST convert to a PR and that kind of thing. But Rosenberg's imaging studies from back, you know, 20-plus years ago now show tiltrafficking rapidly to the lungs and then to the tumor, and then generally show, you know, where the signs of tumor clearance early in the process. Madonna-Frederick, do you want to add anything to that?

And it's generally believed that the efficacy of til therapies occur in.

In the early periods after administration, although obviously we see.

Clinical perspective, we see responses that can originate later after some time you could have an SPE convert to a PR and that kind of thing.

But rosenberg's imaging studies from the back.

20, plus years ago, now show till trafficking rapidly the lungs, and then to the tumor.

And then generally show.

Signs of tumor clearance early in the process.

The data further if you want to add anything to that yes. This.

Madan Jagazia: Yeah, this is Taimoor, and this is Madan. Just a comment, I think even in the post-till infusion TCR persistence, right, in a non-genetically edited till, the TCR, the clonotypes that are persisting, have the potential to get exhausted with repeated antigenic stimulation. But once you knock out the PD-1, the immune surveillance capability of these genetically edited tills may hypothetically be much superior to the current tills that we have. Again, as Fred said, it's untested, and we have to get into the clinic to test all these hypotheses. All right, great. Thanks, everyone.

This is a time window.

Just to comment I think even in the post til infusion TCR persistence right in a non genetically edited til. The TCR. The prototypes that are persisting or have the potential of getting exhausted with repeated antigenic stimulation, but once you knock out the PD one immune surveillance.

Ability off these genetically edited til may hypothetically be much more superior to the current tools that we have again as Fred said, it's untested and we have to get into the clinic.

Test all of these hypotheses.

Yes.

Alright, great. Thanks, everyone.

As you probably saw Madhu, we are about to get into the clinical in that so thats something thats imminent.

Unknown Executive: As you probably saw him do, we're about to get into the clinical net. So that's something that's imminent. You know, our clinicaltrials.gov posting went up yesterday. Cool, thanks. Thank you. And our next question comes from the line for Michael Yee with Jeffries. Hi, this is Dennis Peng on for Mike. Thanks for taking the questions. Two for me, one on the BLA.

Our trials Gov, posting went up yesterday.

Cool thanks.

Thank you.

And our next question comes from the line of Michael <unk> with Jefferies.

Hi, This is that we're staying on for Mike.

Thanks for taking the questions.

Michael Yee: Can you discuss any other gating factors we should be thinking about, like AFE validation or perhaps even CMC? What else needs to happen between now and when you submit your application, and not? And then my second question is on second-line lung cancer. You know, you talked about using the LUN-202 study as a registrational trial. Do you need to include a dosotaxel arm or, you know, can you get approval on just ORR, or do you think you need PFS? Thank you very much. Sure, why don't I take the first one, and Frederick, could you take the second one?

Two for me one on the BLA can you discuss any other gating factors, we should be thinking about like assay validation or perhaps even CMC what else needs to happen between now and when you submit in August .

And then my second question is on second line lung cancer, you talked about using the <unk>.

<unk> 202 study as a registrational.

You need to include a docetaxel arm or can.

Can you get approval on just <unk> or do you think any PFS. Thank you very much.

Sure why don't I take the first one and Fredrik can you.

The second one.

On the validation.

Unknown Executive: On validation, on activities like validation, and anything else we do in the CMC sphere to get ready for the BLA. We're not talking about the details of this publicly, but you can assume that a lot of that's happening has already happened, and we're making great progress.

Activities like validation and anything else, we do in the CMC sphere to get ready for the BLA.

Talking about the details of this publicly you can assume that a lot of that's happening or has already happened.

And we're making great progress we have already completed most of those tasks.

Unknown Executive: We've already completed most of those tasks. There is a tremendous amount of work to be done here, but nothing that rises to the level of the potency assay situation that we were in before where there were, or other affiliates. Produced by the U.S. Embassy for the Korean Peninsula. So, you know, the teams at Iovance, the employees at Iovance, and all our partners are working really hard to get all these things done

There is a tremendous amount of work to be done here, but nothing that rises to the level of the potency assay situation that we were in before where there was.

A gating item type of thing there that we had to resolve.

So the teams that I've asked employees that <unk> and our partners are working really hard to get all these things done, yes, theres tons of validation there's tons of them.

Unknown Executive: Yes, there's tons of validations, there's tons of... PPQs and comparability and all the stuff that needs to be run and succeeded, but that's stuff that we think we can handle. Frederick, do you want to talk a little bit more about WN202 and then use TACS as a comparator and make a study registrational? Yeah, sure. Good question.

PV cues and comparability and all the stuff that needs to be run and succeed but that's stuff that we think we can handle it.

Further do you want talk a little bit more about how you want to have to docetaxel as a comparator in Registrational study a registrational.

Yes sure.

Friedrich Finckenstein: So one thing to keep in mind here is that the FDA is happy to review single-arm data. It looks at single-arm clinical trial data in a somewhat different way than randomized studies, and both have preferences for where they would prefer which type of data, but when they are looking at single-arm data, they are looking at those data in the context of risk-benefit. Assessed by the totality of the data, which does include available therapy at that time.

And so one thing too.

So keep in mind here.

The SBA is is.

Happy to review single arm data.

It looks in single arm clinical trial data.

And then somewhat different way then randomized studies in bolthouse preferences for or where they would prefer which type of data, but they are looking at single arm data, they're looking at those data in the context of Av.

Risks benefit.

Assess.

<unk> of the data which does include.

Available therapy at that time.

But they are they are they are generally happy to look at that data.

Friedrich Finckenstein: But what they are, they are, they are generally happy to look at that data. Keep in mind, docetaxel itself is not a great drug. It's not popular with non-cancer doctors. It has low response rates, short durability, a lot of proxicity.

Keep in mind Docetaxel.

<unk> is another great job is not done.

Hence our doctors has lower funds raised short durability and a lot of toxicity.

So there certainly is an unmet medical need in that.

Friedrich Finckenstein: So there certainly is an unmet medical need, and that would certainly support bringing single-arm data forward. And the FDA generally will look at that. Got it. Thank you. Let me just add one more time.

Certainly support bringing single order data forwarder USDA generally look at that.

Got it thank you.

Unknown Executive: The other point to add is we're not, we're not, this is not combination therapy, right? In combination therapy, that then gets a little more complicated because the FDA usually likes to look at data that bulk, identify, and pinpoint the contribution of components. Our therapy is a monotherapy that you can compare with historical historical data from available therapy.

Ed.

Let me just add one more time the other point to add is.

We're not this is not combination therapy.

And then combination therapy doesn't get complicated because they usually like to.

Look at data that well.

Identify and pinpoint the contribution of components.

There is a monotherapy that you can compare with historical historical data from available therapy.

Thank you and our.

Unknown Executive: Thank you. Our next question comes from the line of Peter Lawson with Barclays. Great. Thank you so much.

Our next question comes from the line of Peter Lawson with Barclays.

Great. Thank you so much.

Peter Lawson: I'm just kind of curious about just going back to the kind of sequence of events for the BLA submission. When will we get the first feedback from the FDA regarding that, and when will we be able to see that? Peter, probably the first real feedback comes at the time of acceptance of the BLA, which is 60 days after submission. Would there be any commentary around the alignment around the potency assay?

Just kind of curious on.

Just going back to the kind of sequence of events for the BLA submission when would we get the first feedback from FDA regarding that.

When we can we can see that.

Peter probably the first real feedback comes at the time of acceptance of the BLA, which is 60 days after submission.

And would there be any commentary around the alignment.

The potency assay.

I can't say for sure what FDA is going to say at that stage, but.

Unknown Executive: I can't say for sure what FDA is going to say at that stage, but, you know, typically, at that stage, they're going to tell you that, you know, you're going to have to wait a little, The BLA has been accepted, and then later during the review process, they may... They typically make requests where they could ask for more details about all sorts of things, including assay information. Now, we think we've addressed all that up front, and our goal is to address all that up front, with the idea that any requests that come in are simple and easily dealt with. Okay. And then,

Typically at that stage youre going to tell you that.

BLA has been accepted and then later during the during the review process. They may.

They typically make requests where they could ask for more details about all sorts of things, including assay information and we think we've addressed all of that upfront and our goal is to address all of that upfront.

With the idea that any request to come out are simple and easily dealt with.

Got it and then.

As that communication kind of unfolds.

Unknown Executive: As that communication unfolds, you'll keep us in the loop on how that communication is evolving, whether you need additional questions. Is that the plan? I think we'll probably get a lot of questions about that period, Peter, as you can imagine, but we'll do our best to keep everybody informed. I don't think companies typically do a blow-by-blow as everything comes in from the FDA, but I'm sure you'll hear us talk about this as people check in.

You will keep us in the loop of like how that communication is evolving.

Evolving.

Do you need additional questions et cetera.

Is that the plan.

I think we will probably get a lot of questions about that period, Peter as you can imagine, but we will do our best to keep everybody informed.

Companies typically do a blow by blow as everything comes in from the FDA, but I'm sure you'll hear US talk about this as people check and let's say it's.

Unknown Executive: Let's say it's... November on the earnings call; people are checking in on how things are going, and we'll hopefully be able to give some updates then as to how we see the BLA review progressing at that stage. And then just the final question, just around when the BLA is submitted, will we get kind of more information around the potency assay, and will we see... IP filings as well around the podium. Ultimately, you will see IP filings. I can't tell you exactly when because it's a little sensitive right now. But, as you probably know, patent filings eventually become public, typically around 18 months or greater after the first priority date.

November earnings call and people are checking out on how things are going and what will hopefully be able to give some updates then as to as to how we see the BLA.

Our review progressing at that stage.

And then just final question just around when.

The BLA submitted will be get kind of more information around the potency assay and we see I guess IP filings as well around the potency assay.

Ultimately you will see IP filings I can't tell you exactly when because it's a little a little sensitive right now but.

Probably no patent filings eventually become public typically around 18 months or greater after the first priority date. So there's there's some there could be information out there of some level I don't think.

Right.

Caution analysts to think that we're going to put detailed out on some of this stuff. It is.

<unk> sensitive and I think we'll probably continue to talk about at the local culture.

Okay. Thank you so much thanks for taking the questions.

Thank you.

Unknown Executive: So there could be information out there at some level. I've tried to caution analysts to think that we're going to put details out on some of this stuff. It is competitively sensitive, and I think we'll probably continue to talk about it in the local culture. Okay, thank you so much. Thanks for taking the time. Thank you. And our next question comes from the line of Colleen Kusy with Baird. Hi, good afternoon, and thanks for taking our questions. Have you received confirmation of the scheduling of the July meeting? Or what is the likelihood that that might slip and could further delay your BLA filing?

Question comes from the line of Colleen <unk> with Baird.

Yeah.

Hi, good afternoon, and thanks for taking our questions.

Have you received confirmation of the scheduling of the July meeting or what is the likelihood that that might slip and could further delay your BLA filing.

Probably we don't.

Colleen Kusy: Colleen, we don't we, you know, we did a pre-billing meeting is a type B meeting. So they're requested 60 days in advance. We're not, we're not putting out details about exactly what's going on there. But right now, the July timing was, you know, we just Reannounced it. So we're very comfortable with that time.

A pre BLA meeting is a type b meeting so they requested 60 days in advance we're not we're not put out details exactly and what's going on there, but right now that July timing as we just.

We announced it so we're very comfortable with that timing.

Okay. That's helpful. Thank you and what is your latest understanding on whether the BLA submission and lately melanoma would support accelerated or full approval.

Unknown Executive: Okay, that's helpful. Thank you. And what is your latest understanding on whether the BLA submission and late-line melanoma would support an accelerated or full approval? We don't know for sure. We think that with the size of the data set we're coming in with, with COER4 and COER2, there's a good chance of full approval. We've spoken about that a few times on calls recently.

We don't know for sure.

We think that with the size of the data set we're coming in with with cohort four and cohort two.

There's a good chance of full approval and we've spoken about that a few times on calls recently.

Unknown Executive: We do have the option of the phase 3 study that we've been talking about also serving as a confirmatory trial should the need be there, so we're planning for every scenario. Okay, great. Thank you. And one more follow-up question if I can. The comments on the call around potentially using a CMO if needed upon launch; would you expect that would be driven more by limited capacity at the ICTC early on or more due to any sort of indication you're seeing of High Demand at Launch? Probably a demand at launch issue first.

We do we do have the option of the phase III study that we've been talking about also serve as a confirmatory trial should that need to be there. So we're planning for every every scenario.

Okay, great. Thank you and one more follow up if I can.

The comments on the call around potentially using a CMO if needed upon launch would you expect that that would be driven more by limited capacity at the ITC early on or more.

Any sort of indication youre seeing.

High demand at launch.

It's probably a demand at launch issue first.

Unknown Executive: We're trying to learn as much as we can from the launches of the two BCMA Partis right now and just make sure we've got a really, really flexible footing when we go to launch. So the ICTC obviously bears the brunt of the capacity, but having the CMO available to help will allow us to potentially do better than what happened with some of the two BTMA products, certainly with the Beck. Okay, great.

Trying to learn as much as we can from the launches of the <unk> parties right now and just make sure we've got a really really flexible footing.

When we go to launch the ICC, obviously bears the brunt of the capacity, but having the CMO available to help us kind of just.

Allow us to potentially do better than what happened with some of the <unk> PMA products certainly with the Beckman.

Okay, great. Thanks for taking my question.

Thank you and our next question comes from the line of Tyler Van Buren with Cowen.

Colleen Kusy: Thanks for taking our questions. Thank you. Our next question comes from the line of Tyler Van Buren with Cowan. Good afternoon.

Good afternoon, thanks for taking the questions. The first one.

Tyler Van Buren: Thanks for taking the questions. The first one, Dr. Puri, great to have you on board and congratulations on the new role. I'd love to hear why you decided to join Iovance at this stage in your career and the confidence you have in LifeLucil receiving approval. And then the second question is related to LN 145 and lung cancer. When should we expect to get the next data update for earlier stage second line patients? Could we get an update later in the year? Sure, why don't I, why don't I take the second one first? Go ahead, Raj, go ahead. Why don't you take the first one?

Dr pretty great to have you onboard and congratulations on the new role.

To hear why you decided to join <unk> at this stage in your career and the confidence you have in life Leucyl receiving approval and then the second question is related to <unk> $1 five in lung cancer. When should we expect to get the next data update with earlier stage second line patients could we get an update later in the year.

Sure why don't I wanted to ask the second one first.

Raj go ahead, why don't you take the first one and I'll come back around and you went to it too.

Yes.

Raj Puri: I'll come back around. You went through it too. Yeah, I just want to say after a significant number of years at the FDA, 19, as Division Director, I was interested in career goals and I see that T cells, TILs, have a great potential for solid cancer compared to other modalities such as, you know, checkpoint inhibitors or CAR T cells, which only works in the hematological malignancies and checkpoint inhibitors have limited effect in 15 to 20 percent of the cases, so vast majority of the patients with solid cancer has no other option and TIL cells, the broad reactive T cells, CD4, CD8 cells have a great potential in the solid cancer.

Just trying to stay up.

A significant number of years at the FDA 19 as dividend to.

They are interested in.

The cardio.

<unk> goes and.

And I see that T cells pills.

Have a great potential for solid cancer can compare to.

That modality such as.

Checkpoint inhibitors car T cell over to Tony who works in the Hematological malignancies.

Check point inhibitors have limited effect in 2015% to 20% of the cases, so vast majority of the patients with solid cancer has no other option and telesat broadly active T cell <unk> for CDA cells have a great potential to in the solid cancer.

Raj Puri: So I think that was one of the main goals, to join a company, and Iovance is an important friend of this therapy, so that's the reason I joined Iovance. And then, with respect to LUN22 and data, possibly later this year, we haven't said specifically. Obviously, we're trying to optimize enrollment in that trial and get more data there to bolster what we think is a clean efficacy signal until therapy and not for so long.

That doesn't mean, we're not the.

Maine.

Go to joining the company in Ireland.

And this type of so that's the reason I joined the iOS.

And then with respect to <unk> data.

Data, possibly later this year, we haven't said, specifically, obviously, we're trying to optimize enrollment in that trial and get more data there too to bolster what we think of the clean efficacy signal in til therapy in non small cell lung and if we get some data that we think is worth putting out I think we would try to put that out.

Raj Puri: And if we get some data that we think is worth putting out, I think we will try to put that out as soon as we can. We tried to do that specifically with Lung last year. So all I can say there is just hang tight and let us continue to enroll and generate data. Thanks very much.

As soon as we can we've tried to do that specifically.

With one last year. So I all I can say there is just hang hang tight and let us let us continue to enroll in general.

Generate data.

Thanks very much.

Thank you and our next.

Unknown Executive: Thank you. And our next question comes from the line of Mark Bradenbach with Oppenheimer. Hey, good afternoon.

Question comes from the line of Mark Breidenbach with Oppenheimer.

Hey, good afternoon, thanks for taking the question.

Mark Bradenbach: Thanks for taking the question. Just a quick one for me with respect to the new trial of IOV-4001. Can you just remind us why the protocol is focused on melanoma and non-small cell lung cancer only, and is not inclusive of some of the other tumor types you've investigated, till therapy, and also, will this trial kind of be competing at all with the LUN-202 trial in terms of trying to enroll the same types of lung cancer patients, or are they more or less distinct populations? Thanks. Frederick, do you want to take this one?

Just a quick one for me with respect to be.

The new trial.

<unk> four or one.

Can you just remind us why the protocol is focused on melanoma and non small cell lung cancer only.

It is not inclusive.

The other tumor types you investigated til therapy in and also will this trial.

Competing at all with with.

Yes.

Two trial in terms of trying to enroll the same types of lung cancer patients are are they.

More or less distinct populations. Thanks.

Fredrick do you want to take this one.

Yes sure.

Friedrich Finckenstein: Yeah, sure. Um, good, good question. Thanks. Number one, the cohort on that that enrolls melanoma patients is, is an opportunity to enroll and generate clinical data fast because we know there's a demand for, for access to TIL therapy. This is, this is an attractive, an attractive new approach.

Good good question. Thanks.

Theres really two strategies here in the same trial number one.

The cohort.

Yes.

<unk> melanoma patients.

As an opportunity to enroll and generate clinical data fast because we know there is there is.

Demand for access to til therapy. This is this is an attractive and objective.

Early promising based on the preclinical data and the rationale of that.

Friedrich Finckenstein: Um, really promising based on the preclinical data and the rationale that, uh, Fred and Madan spoke about earlier. So we'll be able to generate data in a population that we know very well based on our own data and the academic data, which then allows us to, um, compare and draw some conclusions as soon as possible. So that's really the strategy for melanoma here. Non-small cell lung cancer is a really important indication and somatite for us. We have generated data in COVID-3B that indicate activity in osteotherapy in non-small cell lung cancer.

But Don spoke about earlier, so we will be able to generate data in a population that we know very well.

On our own data.

They make data, which then allows us to.

Compare.

Some conclusions.

Possible. So that's really the strategy for melanoma here.

Non small cell lung cancer is is is a really important indication and so on.

For us we have generated data in cohort three.

That indicate activity.

In til therapy in non small cell lung cancer, we hope that with the technological approach.

Friedrich Finckenstein: We hope that with the technological approach of PD-1 knockout, we're improving both response rates and durations. In addition, if you look at the populations, we are going to a broader patient population than the population we're targeting and LUN202 both in regards to allowed numbers of prior therapy as well as driver mutations in the patient's tumor. So there's really an opportunity to go and take another shot at those late-line patients and start an exploring activity and drive a mutation positive.

Any one knockout.

Improving on both response rates and duration.

In addition, if you look at the populations. We are we are going to a broader patient population.

The population of that targeting and are related to the true both in regards to allow us numbers.

As well.

The driver mutations in the patient's tumor so there is really an opportunity.

And.

Take care.

Take another shot at those late line patients.

Start exploring activity doesn't mutation positive patients.

Friedrich Finckenstein: So that speaks to your question about overlap with existing studies. For melanoma, we do think that because we are going to enroll rather quickly, there's little risk of overlap with other efforts in melanoma that we are currently taking. Okay. All right. Thanks for the detailed answer.

Around that.

A question about overlap with existing study.

Our melanoma, we do think that because the ethylene to enroll rather safety there is very.

Little digital risk.

Overlap with other efforts in melanoma.

King.

Understood Alright, thanks for the.

Detailed answer.

Okay. Thank you.

And our next question comes from the line of Mara Goldstein with Mizuho Securities.

Unknown Executive: Thank you. And our next question comes from the line of Mara Goldstein with Mizuho Securities. Hi guys, this is Jerry on behalf of Mara Goldstein.

Hi, guys. This is Jerry <unk> Goldstein and thanks for taking our questions.

Mara Goldstein: Thanks for taking our questions. So our first is also on IOV4001. How do you anticipate prioritizing the two malnomial NSCLC cohorts? How do we anticipate prioritizing?

So first is also on ILD four O one.

How do you anticipate prioritizing the two melanoma.

CLC cohorts.

How do we anticipate prioritizing the work can be open at the same time and there are different patient populations.

Unknown Executive: They're both gonna be open at the same time, and they have different patient populations and different investigators. So I kind of view them as equal priorities, but Frederick just mentioned a little bit earlier that we do expect melanoma to spread rapidly because of the demand in that area right now. So I can't tell you for sure exactly how enrollment will go at one versus the other, but Melnick should enroll faster, I would think.

Different investigators so we.

I kind of view them as equal priority, but Frederic just mentioned little bit earlier that we do expect melanoma.

We'll rapidly because of the demand in that area right now so.

So I can't tell you for sure exactly how enrollment will go in one versus the other but melanoma should enroll faster I would think.

Unknown Executive: That doesn't mean we're prioritizing. You're correct. These two cohorts are open simultaneously. They're expecting different enrollment rates, but there's really no overlap or competition.

That doesn't mean, we're prioritizing.

Reality.

These two cohorts are open simultaneously very expecting different enrollment rate.

There is no.

I'll open it up on our competition.

Certainly not held back by having limited manufacturing slots or anything like that so we don't do we don't have to decide which patients does next because those any sort of concerns around have been strong for these patients. So there is no need to prioritize based on that.

Unknown Executive: We're certainly not held back by having limited manufacturing slots or anything like that. So we don't have to decide which patient is next because of any sort of concerns around having slots for these patients. So there's no need to prioritize based on that. Gotcha. Thanks for that, Connor.

Got you. Thanks for that color next one is on <unk> and $1 45.

Unknown Executive: Next one is on LN145. With the slight, you know, trial protocol change, do you expect a similar strategy to be applicable for other tumor types as well? Are you talking about LUN202?

With the slight trial protocol change.

Do you expect a similar strategy to be Apple for other tumor types as well.

So you're talking about how you want to it too.

Yes.

Unknown Executive: Yes, yes, yes, there is going to be potential for that. Yes. Gotcha. Okay. Well, thanks for taking our questions. Thank you. Thank you. Our next question comes from the line of Ben Burnett with Stiefel.

Yes, yes, there is going to be potential for that yes.

Gotcha Okay.

Taking my questions.

Thank you.

Thank you and our next question comes from the line of Ben Burnett with Stifel.

Alright. Thank you very much just a couple of commercial questions. I guess first is there any color you can provide at this point in terms of securing IL. Two just commercially it will just be procured kind of on an as needed basis in real time or.

Benjamin Burnett: Hey, thank you very much. Just a couple commercial questions. I guess the first is, is there any color you can provide just at this point in terms of securing IL-2? Just commercially, will this be procured kind of on an as-needed basis in real time or otherwise? And, I guess, how confident are you that your IL-2 supplier can handle the initial commercial demand? Hi, this is Jim Ziegler.

Or otherwise and I guess, how confident are you that your IL two supplier can handle the initial commercial demand.

Hi, This is Jim in particular, we've met with the.

James Ziegler: We've met with the folks from Clinigen that supply IL-2 in the past. As you know, they're going through a transition right now. We'll be working with them as we approach our BLA and coordinating forecast needs with them to ensure that we have adequate supply across the board. We have looked at all of the potential ATCs that we're working with, and all of them basically have the ability to order IL-2 at their current wholesale prices. Okay, so they would order IL-2 on their own; you wouldn't be ordering IL-2 and then supplying it yourselves.

Folks from Clinton Gin net supply IL two in the past as you know they're going through a transition right now.

Working with them as we approach our BLA and coordinating.

Forecast needs with them to ensure that we have supply adequate supply across the board. We have look at all of the potential ATC that we're working with and all of them basically have the ability to.

Order IL two with their current wholesalers.

Okay. So they would order IL two on their own you wouldn't be ordering IL two in and supplying it yourselves.

James Ziegler: Correct. Okay. Okay. And then, if I could just ask another question, really, I guess, just on the sort of patient journey that you're expecting if lifelucille is approved. I guess, like specifically, are you expecting cardiac and pulmonary functions to need to be verified? And if so, does that happen?

Correct, Okay. Okay, and then if I could just just another question really I guess just on the.

Sort of the patient journey that youre expecting a playful lusso is approved.

Madan Jagazia: Does it happen after the biopsy is taken? Yes, this is Madan Jagesh. It's a very valid question. So in the conduct of the clinical trial, patients obviously have to meet eligibility criteria prior to the tumor harvest. I suspect that will be the same pattern of practice. Once we are in the commercial landscape, healthcare professionals will need to ensure that patients have adequate cardiopulmonary reserve before they go in for a tumor harvest, which then subsequently leads to TILT cell therapy.

Madan Jagazia: So that's a pretty standard practice in the world of stem cell therapy. In the world of cardiac cell therapy as well today.

Benjamin Burnett: Okay. And would they, I guess, would they go through those tests again after the manufacturing process when when it's ready, when telefusion is ready? Not necessarily. Obviously, if they have had any further cytotoxic therapy, which may influence their cardiac or pulmonary reserve, which is highly unlikely, given the agents that are in use for metastatic melanoma.

Madan Jagazia: So typically, it is done once, and unless the clinical situation changes, it's typically not repeated. Okay, super helpful. Thank you very much. Thank you. Our next question comes from the line of Asthika Goonewardene with Truist.

It is done once and unless the clinical situation changes, it's typically not repeated.

Okay Super helpful. Thank you very much.

Cause it.

Thank you your.

Your next question comes from the line of S Speaker Leloir D with truest.

Hello. This is a non Sean Roth because of that.

Asthika Goonewardene: Hello, this is Yanan, Sean for Asthika today. Just one question on lung and then one on cervical. So on the 202 study protocol amendment, if you gather resections for a patient and they haven't yet progressed, how do you determine when to manufacture a TIL product? And will you guys have TILs manufactured and stored somewhere until needed? Yes, this is Miran.

Just one question on long and then one on cervical so on the two O. Two study protocol Amendment, if you gathered resections for patient and they haven't yet progressed, how do you determine on the manufacturer itself product and will he guys have pills manufactured and stored somewhere until needed.

Thanks.

Madan Jagazia: Good question. So, I think what you're referring to is what we allude to as a pre-progression resection. So, yes, the patients will have their, you know, tumor resected and the tooth manufactured. But we expect most of these patients to eventually progress because the chance that a patient is going to, quote, unquote, respond for perpetuity with a non-small cell lung cancer is very small. So, we do expect most of these patients to progress, but based on their frontline therapy, and does the probability of using the tools that have been developed approaches a very, very high number? And would that be a gating factor from presenting data from the study? And any other gating factors you could mention in terms of just presenting the data would be very helpful as well.

Yes. This is <unk>.

Good question, So I think what you're referring to is what we allude to as a pre progression resection. So yeah. The patients will have there are.

Tumor resected and the tooth manufactured.

We expect most of these patients to eventually progress because the chance that a patient is going to quote unquote respond for perpetually in a non small cell lung cancer was very small so we do expect most of these patients who progress on the frontline therapy and does the probability of using the tools that have been manufactured.

Approach that are very very high number.

Mmm.

Would that be a gating factor from presenting data from the study and any other dating package that you could mention in terms of just presenting the data would be very helpful as well.

Nah that should not be a gating factor for data from this study we view that is actually something that we think will lead to improved enrollment.

Unknown Executive: Now, that should not be a gating factor for data from this study. We view that as actually something that we think will lead to improved enrollment and more flexibility, and it could be something that we explore, like I said earlier, in other indications. Okay, great. And then on cervical cancer, when can we expect an update on the regulatory discussions that you've been having with the FDA? It seems like, based on the cadence of these earnings releases, you've been talking to them for somewhere between like two to five months.

More flexibility and it could be something that we explore like I said earlier and other indications too.

Okay, Great and then on cervical cancer when can we expect an update just on the regulatory discussions that you've been having with the FDA. If it seems like it's based on the kittens. These earnings releases that you can talk to them for somewhere between like two to five months.

Unknown Executive: And yeah, just when can we get an update on that? Bear in mind that the announcement with Pembalism as approval came at the very end of last year. So yes, it's been a few months, but it does take some time to get the regulator, and then also build a strategy.

And yeah, just one can we get an update on that.

Bear in mind that.

The announcement with symbolism as approval came at the very end of last year. So yes, it's been a few months, but it does it does take some time to get in.

In front of the regulator and that also build a strategy. So we we haven't guided to a specific date year, because we don't have one yet.

Unknown Executive: So we haven't guided to a specific date yet because we don't have one yet, but we are working hard on Cervical, and hopefully, we'll be back with more information. Final one. Would you expect a similar sort of timeline? What's longer?

But we are working hard to on cervical and hopefully we'll be back with more information soon.

The final one would you expect a similar sort of timeline.

Unknown Executive: Is there anything different there versus your conversations on cervical cancer? There are separate conversations. And so I can't say the timeline will be the same, but it's similar in the sense that we're having those discussions separately with the FDA and setting the strategy for those things. Other than that, I can't really elaborate.

Longer is there anything different there.

First your conversations on cervical.

They're separate conversations and so I can't say the timeline to be the same but.

Ah.

Similar in a sense that we're having those discussions separately, which FDA and setting the strategy for those things other than that I can't really liked him.

Okay. Thank you so much.

Thank you.

Unknown Executive: Okay, thank you so much. Thank you. And our next question comes from the line of Ren Benjamin with JMP Security. Hey, good afternoon, guys.

And our next question comes from the line over in Benjamin with JMP Securities.

Hey, good afternoon, guys. Thanks for taking the questions.

Reni Benjamin: Thanks for taking the questions. Fred, I think I heard this right, but I'm not sure. In the prepared remarks, I believe you said that there'd be data at ASCO and CITSI. If I did hear that right, can you give us an idea as to what are the most likely trials that might be updated at those conferences? This is Madan.

Right I think I heard this right I'm not sure in the prepared remarks, I believe you said that they would be data <unk>, but I did hear that right can you give us an idea as to what are the most likely trials that might be updated at those conferences.

This is Ah and so I think what we mentioned in the prepared statement as our data that we had presented in 2021.

Madan Jagazia: So I think what we mentioned in the prepared statement is our data that we presented in 2021 at ASCO, CIDC, and AACR on 136 patients across four tumor indications. And we do have a title up for ASCO coming this year, which you can see, but we can't really say much more about that right now. Okay. And then I'm, you know, with the potency assays. I'm just kind of curious, are those assays already integrated into the new ISTC facility?

<unk> on the 136 patients across four tumor indications.

Now we've got it all up for for ASKO come in this year, which you can say, but we can't really say much more about that right now.

Okay.

And then.

With the with the potency assay is I'm just kind of curious are those essays already integrated into the new IFC iced tea seat facility or is that something that's done.

Madan Jagazia: Or is that something that's done, you know, sort of outside the facility? Now, that's something that we do at our facility, and we can do it elsewhere as well, but that's something that, you know, the facility... Reni, I can't remember if you joined us for any of our open houses, but if you have come and seen it, you'll see it's fully integrated in terms of QC. And that includes the ability to do the potency matrix that we talk about a lot.

Sort of outside the facility.

Now that's.

That's something that we do at our facility or we can do it elsewhere as well, but that's something that the facility.

Randy I can't remember if you joined us for any of our open houses, but if you have come and seen it you'll see it's fully integrated in terms of QC and that includes the ability to do that.

Matrix that we talk about a lot.

Unknown Executive: Yep, got it. Okay, that makes sense. And then just a couple of other ones. I don't know if you've mentioned this in the past, but how are you thinking about a potential sales force? And how big could it or small could it possibly be?

Yep got it okay that makes sense.

And then just.

Couple of other ones I don't know if you've mentioned this in the past, but how are you thinking about a potential salesforce and how how big could it or small could it possibly be.

Unknown Executive: I think you can think of it on a comparison basis to the existing cell therapy field forces for the other CAR Ts. You know, the way that we'll be operating is through the potential authorized treatment centers. There's a pretty high concentration of care, and then community referrals will come in through the ATCs. So I would say if you benchmark the current CAR T field forces, you're right in the ballpark.

I think you can think of it on a comparison basis to the existing cell therapy field forces for the other car teeth.

Way that will be operating is through the potential authorized treatment centers is a pretty high concentration of care and then the community referrals will come in through the ATC. So I would say the benchmark. The current car key field forces you are right in the ballpark.

Okay.

Unknown Executive: Okay. I guess one final one for me. In your discussions with the regulatory agencies, have they brought up anything in particular that could be a review issue? Or do you think that, you know, since this is the first time that Attila is going through this, it's most definite that you'll have an ODAC panel? We don't know that for sure, but it's possible because it is the first therapy in this class that we could get on a committee, an advisory committee, but TILT therapy is also very well known, and it's well known, you know, from NIH and NTI experience as well as plenty of other academic centers' experience.

Just one final one for me.

As in your discussions with the regulatory agencies that they brought up any.

Anything in particular that could be.

A review issue.

You think that.

Since this is the first time that a total is going through that most definitely that you'll have another attack now.

We don't know that for sure. It's it's.

Possible because it is the first therapy in this class that we could get in a committee Advisory Committee.

But.

Until therapy is also very well known as.

It's well known from from NIH NCI experience as well as plenty of other academics centres experience and we've got tons of data that I dance too. So that doesn't mean, we have to get in.

Unknown Executive: We've got tons of data at Iovance, too, so that doesn't mean we have to get on the Advisory Committee. We may not get one.

Advisory Committee, we may not get one.

To your to the bigger part of your question basically are there any other things no right now we feel pretty comfortable with her timings in every all the things we're doing.

Unknown Executive: To the bigger part of your question, basically, are there any other things? No, right now, we feel pretty comfortable with our timings and all the things we're doing. We have to, obviously, for biotech, it's a big thing to file its first BLA, so we have to execute on that, but other than that, we think we're in good shape. Terrific. Thanks for taking the questions. Thank you. And I'm showing no further questions.

You have to obviously, it's for biotech it's a big thing the phosphorus BLA. So we have to execute on that but other than that we think we're in good shape.

Perfect. Thanks for taking my questions.

Thank you and I'm showing no further questions. So with that I'll turn the call back over to interim President and CEO frayed vote for any closing remarks.

Fred Vogt: So with that, I'll turn the call back over to Interim President and CEO Fred Vogt for any closing remarks. Thank you again for joining the Iovance Biotherapeutics first quarter 2022 financial results conference call. It's an exciting time to be part of Iovance as we move towards our first BLA submission, continue our ongoing clinical trials, and expand our growing field pipeline into new clinical trials, including the clinical trial of IV4001 that just posted to clinicaltrials.gov yesterday.

Thank you again for joining the <unk> advanced Biotherapeutics first quarter of 2022 financial results Conference call.

Fred Vogt: I would like to recognize the patients and physicians who are participating in our clinical studies as well as our employees and cross-functional teams for their hard work in moving pill therapy forward. I would also like to thank our shareholders and covering analysts for their support. Please feel free to reach out to our investor relations teams if you wish to follow up. Ladies and gentlemen, this concludes today's conference call. Thank you for participating, and you may now disconnect.

It's an exciting time, the part of I advanced as we move towards our first BLA submission continue ongoing clinical trials and expand our growing until pipeline and a new clinical trials, including the clinical trial about every 4001 that just posted the clinical trials dot Gov yesterday.

I would like to recognize the patients and physicians who are participating in a clinical studies as well as our employees and cross functional teams for their hard work and moving until therapy forwards.

I would also like to thank our shareholders and covering analysts for the support.

Please feel free to reach out to Investor Relations teams, if you wish to follow up.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating and you may now disconnect.

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