Q2 2022 Iovance Biotherapeutics Inc Earnings Call

August 4, 2022

Okay.

Welcome to the Iovance Biotherapeutics second quarter and first half 2022 financial results and corporate updates conference call.

Welcome to the Io vans Biotherapeutics second quarter, and first half 2022 financial results and corporate update conference call.

The conference will begin shortly. , Music, Welcome to the Iovance Biotherapeutics Second Quarter and First Half 2022 Financial Results and Corporate Updates Conference Call.

My name is Andrew and I will be your operator, for today's call.

My name is Andrew, and I will be your operator for today's call.

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.

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

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

Later, we will conduct a question and answer session.

Later, we will conduct a question-and-answer session.

Later, we will conduct a question and answer session.

During the question and answer session, if you have a question, please press star one one on your telephone.

During the question-and-answer session, if you have a question, please press star-one-one on your telephone.

During the question and answer session. If you have a question. Please press star one one on your telephone. Please note that this conference is being recorded I will now turn the call over to Sara Pellegrino.

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 at Iovance.

Senior Vice President Investor Relations and corporate communications at <unk>, Sir you may begin.

Sara, you may begin.

Thank you, operator.

Thank you operator, good afternoon, and thank you for joining us.

Good afternoon and thank you for joining us.

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 Volinsky, our Chief Operating Officer, James Ziegler, our Executive Vice President Commercial, Dr. Frederick Finkenstein, our Chief Medical Officer, and Jean-Marc Bellamy, our Chief Financial Officer.

Speaking of today's call, we have Dr. Fred Vogt, our Interim President and Chief Executive Officer.

It's not today's call we have Dr. Fred though our interim President and Chief Executive Officer, Dr. <unk> <unk>, our Chief operating Officer, Jim Ziegler, Our executive Vice President commercial.

Dr. Igor Volinsky, our Chief Operating Officer.

Jim Ziegler, our Executive Vice President, Commercial.

Dr. Friedrich Finckenstein, our Chief Medical Officer.

Dr. Frederic Finkelstein, our Chief Medical Officer, John Martin, Our Chief Financial Officer.

And Jean-Marc Bellamy, our Chief Financial Officer.

Dr. Madan Jagadzia, our Executive Vice President, Medical Affairs, and Dr. Raj Puri, our Executive Vice President, Regulatory Strategy and Translational Medicine, are also available for the Q&A session.

Dr. Madan Jagazia, our Executive Vice President, Medical Affairs.

Doctor Mcdonald's It gave you our executive Vice President of Medical Affairs, and Dr. Raj <unk>, our executive Vice President regulatory strategy and translational medicine are also available for the Q&A session.

And Dr. Raj Puri, our Executive Vice President, Regulatory Strategy and Translational Medicine, are also available for the Q&A session.

This afternoon, we issued a press release, that can be found on our corporate website at iovance.com, which includes the financial results for the three and six months ended on June 30th, 2022, as well as recent corporate updates.

This afternoon, we issued a press release that can be found on our corporate website at iovance.com, which includes the financial results for the three and six months ended on June 30, 2022, as well as recent corporate updates.

This afternoon, we issued a press release that can be found on our corporate website.

<unk> Dot com, which includes the financial results for the three and six months ended June 32020, Q as well as recent corporate update.

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 results, regulatory interactions, plans and strategies, research and pre-clinical activities, potential future applications of our technology, manufacturing capabilities, regulatory feedback and guidance, payer interactions, licenses and collaboration, cash position and expense guidance, and future updates.

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 results, regulatory interactions, plans and strategies, research and preclinical activities, potential future applications of our technology, manufacturing capabilities, regulatory feedback and guidance, payer interactions, licenses and collaboration, cash position and expense guidance, and future updates.

Let me start I would like to remind everyone.

During this conference call.

We will include forward looking statements regarding either back to school business focused business plan pre commercial activities clinical trials and results.

Inventory interaction plans and strategy research and preclinical activity potential future applications of our technology manufacturing capabilities regulatory feedback and guidance payer interactions licensing and collaboration cash position and expense guidance and future outlook.

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.

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.

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.

Finally.

Our results may differ materially, from those projected during today's call.

Our results may differ materially from those projected during today's call.

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

We undertake no obligation to publicly update, any forward-looking statement.

We undertake no obligation to publicly update any forward-looking statements.

With that, I will turn the call over to Fred.

With that I will turn the call over to Fred.

Thank you, Sarah.

Thank you Sarah and good afternoon, everyone I'm pleased to highlight our significant year to date progress.

Good afternoon, everyone.

I'm pleased to highlight our significant, year-to-date progress at Iovance.

I'm pleased to highlight our significant year-to-date progress at Iovance.

I'll begin with our first planned, biologics license application, or BLA, for our lead-till therapy, lipoleucel and metastatic melanoma. This is our number one priority on behalf of patients, who are eager to see lipoleucel approved. We successfully completed a pre-BLA meeting, with the FDA in July, and we are on track to begin the BLA submission this month. The FDA provided favorable feedback, on the clinical efficacy data from cohorts two and four of the C.1.144.01 clinical trial, including duration of follow-up, as opposed to the assay matrix.

I'll begin with our first planned biologics license application, or BLA, for our lead-till therapy, lipoleucel and metastatic melanoma. This is our number one priority on behalf of patients who are eager to see lipoleucel approved. We successfully completed a pre-BLA meeting with the FDA in July, and we are on track to begin the BLA submission this month. The FDA provided favorable feedback on the clinical efficacy data from cohorts 2 and 4 of the C.1.144.01 clinical trial, including duration of follow-up and the photosynthesis assay matrix. The FDA also agreed that the clinical and safety data set was sufficient for a BLA review, and provided valuable feedback and advice regarding various parts of the planned BLA submission.

I'll begin with our first planned biologics license application or BLA for our lead til therapies like we'll do so in metastatic melanoma.

The FDA also agreed that the clinical and safety data, that was sufficient for a BLA review would provide valuable feedback and advice regarding various parts of the plan, plan BLA.

This is our number one priority on behalf of patients who are eager to see life loose law group.

We successfully completed a pre BLA meeting with the FDA in July we are on track to begin to BLA submission. This month.

The FDA provided favorable feedback on the clinical efficacy data from cohorts, two and four of the Civil War.

One clinical trial include duration of follow up.

And the potency assay matrix.

CA also grades with the clinical and safety data set with sufficient for BLA review and provided valuable feedback and advice regarding various parts of the planet and BLA submission.

Following the pre-VLA meeting, we will commence the rolling VLA submission this month. The rolling VLA submission is a benefit available under our Regenerative Medicine Advanced Therapy, or RMAT designation. The rolling VLA allows us to submit sections of the VLA to the FDA on an ongoing basis. This process enables the FDA to begin review of submission documents as early as possible as they are received, potentially allowing for earlier approval.

Following the pre-VLA meeting, we will commence the rolling VLA submission this month. The rolling VLA submission is a benefit available under our Regenerative Medicine Advanced Therapy, or RMAT, designation. The rolling VLA allows us to submit sections of the VLA to the FDA on an ongoing basis. This process enables the FDA to begin review of submission documents as early as possible as they are received, potentially allowing for earlier approval.

Following the pre BLA meeting, we will commence the rolling BLA submission this month.

The rolling BLA submission is the benefit available under a regenerative medicine advanced therapy for our mat designation.

Our rolling BLA allows us to submit sections of the BLA to the FDA on an ongoing basis.

This process enables the FDA to begin review of submission documents as early as possible as they are received actually aligned earlier approval.

We expect to complete the rolling VLA submission during the fourth quarter of this year. We are pleased with the outcome of the pre-VLA meeting, which multiple members of the FDA's Senior Management Team attended.

We expect to complete the mobile late submission during the fourth quarter of this year.

We are pleased with the outcome of the pre BLA meeting, which multiple members of <unk> Senior management team attended.

The FDA is engaged and supportive of the VLA for Lifelucel, and we look forward to continuing this level of collaboration throughout the submission and review process.

Yes, they are engaged and supportive of the BLA for <unk> and we look forward to continuing this level of collaboration throughout the submission and review process.

In parallel with the VLA-related activities, we are actively preparing to launch Lifelucel. Key pre-commercial activities include medical education, treatment center onboarding, payer engagement, commercial manufacturing readiness, and near and long-term capacity planning.

In parallel with the VLA-related activities, we are actively preparing to launch Lifelucel. Key pre-commercial activities including medical education, treatment center onboarding, payer engagement, commercial manufacturing readiness, and near and long-term capacity planning.

In parallel with the BLA related activities, we are actively preparing to launch late leucyl.

Key pre commercial activities, including medical education treatment Center, Onboarding payer engagement commercial manufacturing readiness near and long term capacity planning.

We aim to successfully deliver TILT therapy to cancer patients and create value for our shareholders.

We aim to successfully deliver TIL therapy to cancer patients and create value for our shareholders.

We aim to successfully deliver til therapy to cancer patients and create value for our shareholders.

We are also excited about the advancement of our TILT settle therapy pipeline. We are recruiting patients across five Iovance clinical trials, including the recently initiated trial of our first genetically modified TILT therapy.

We are also excited about the advancement of our TIL-settled therapy pipeline. We are recruiting patients across five Iovance clinical trials, including the recently initiated trial of our first genetically modified TIL therapy.

We're also excited about the advancement of our cell therapy pipeline, we're recruiting patients across five Ivan trials, including the recent recently initiated trial of our first genetically modified til therapy.

Six cohorts of non-small cell lung cancer patients are part of three of these active trials, reflecting our focus on that indication.

Six cohorts of non small cell lung cancer patients are part of a three of these active trials, reflecting our focus on that indication.

We are also on track to initiate a phase three trial of Lifelucel in combination with Pembrolizumab and frontline melanoma towards the end of the year.

We are also on track to initiate a phase III trial of Iclusig in combination with Loopnet in frontline melanoma towards the end of the year.

As noted in this afternoon's press release, we are expecting our C14504 study to support a VLA submission for Lifelucel in cervical cancer, which Frederick will highlight further. This updated registration strategy reflects FDA discussions and feedback that address the shift from frontline standard of care in cervical cancer.

As noted in this afternoon's press release, we are expecting our C. One for 501.

Sorry, So you wont for 504 study to support a BLA submission for <unk>, one cervical cancer, which Frederic will highlight this further.

This updated registration strategy reflects FDA discussions and feedback that address the shift from frontline standard of care in cervical cancer as.

As we prepare to launch the first one-time cell therapy for solid tumors, we are growing the organization to advance our mission of innovating, developing, and delivering TILT therapies. Today we have nearly 450 employees that bring deep expertise and successful track record in oncology and cell therapy development and commercialization.

As we prepare to launch the first one-time cell therapy for solid tumors, we are growing the organization to advance our mission of innovating, developing, and delivering TIL therapies.

As we prepare to launch the first onetime cell therapy solid tumors.

We're growing the organization to advance our mission of innovating developing and delivering til therapies. Today, we have nearly 450 employees bring deep expertise and successful track record of oncology and cell therapy development and commercialization.

Today, we have nearly 450 employees that bring deep expertise and successful track work as oncology and cell therapy development and commercialization.

The strength within our organization reflects tremendous enthusiasm for Iovance TILT therapies and our global leadership within the field.

The strength within our organization reflects tremendous enthusiasm for Iovance TIL therapies and our global leadership within the field.

The strength within our organization reflects tremendous enthusiasm for our advanced cell therapies, and our global leadership in the field.

I look forward to addressing your questions later during this call and will now ask Igor to discuss manufacturing updates.

I look forward to addressing your questions later during this call, we'll now ask Igor to discuss manufacturing methods.

Thank you, Fred.

Thank you Fred.

Our manufacturing network is dedicated the patient needs and operational excellence with a consistent til manufacturing success rate of more than 90% and more than 500 patients treated with either til therapy to date.

<unk> cell therapy center or ICC is all 136000 square foot internal manufacturing facility in the Philadelphia Navy yard.

We custom designed ICTC and in just two and a half years constructed it from dirt on the ground to an operational facility supplying Iovance clinical studies.

Our manufacturing network is dedicated to patient needs and operational excellence, with a consistent TIL manufacturing success rate of more than 90% in more than 500 patients treated with Iovance TIL therapy to date.

<unk> custom designed by CDC and in just two five years constructed from birth on the ground to an operational facility supplying <unk> clinical studies.

Manufacturing is critical for any commercial launch, particularly for autologous cell therapies, so our top priority is to prepare ICTC for DLA submission and commercial supply.

The Iovance Cell Therapy Center, or ICTC, is our 136,000 square foot internal manufacturing facility in the Philadelphia Navy Yard. We custom designed ICTC and, in just two and a half years, constructed it from dirt on the ground to an operational facility supplying Iovance clinical studies.

Any picturing is critical for any commercial loan.

Particularly for autologous cell therapies, so our top priority is to prepare ITC for BLA submission and commercial supply.

Today, the ICTC is operating flood suites for clinical manufacturing and conducting DLA readiness activities in the course of the Iovance TILT program.

Manufacturing is critical for any commercial launch, particularly for autologous cell therapies, so our top priority is to prepare ICTC for DLA submission and commercial supply.

Today, the ICD cease operating fleets.

Our clinical manufacturing and conducting BLA readiness activities in the core suites. In addition, we are on track in preparing the ICD.

In addition, we are on track in preparing the ICD-C and our contract manufacturers facility, for FDA pre-approval inspections. The ICD-C is expected to supply most of the commercial TIL therapies upon approval with, flexibility to use contract manufacturing to optimally manage capacity and fully meet patient demand.

Today, the ICTC is operating flood suites for clinical manufacturing and conducting DLA readiness activities in the course of the Iovance Therapy Center.

Our contract manufacturing facility for FDA pre approval inspections.

Icd's fleet is expected to supply most of the commercial til therapy upon approval with flexibility to use contract manufacturing to optimally manage capacity and fully meet patient demand.

As we look to establish TIL as the next paradigm-shifting class of cancer therapy, we are also planning, for our future capacity needs.

As we look to establish <unk> as the next paradigm shift in class of cancer therapy. We are also planning for our future capacity needs.

As currently constructed, the ICD-C includes 12 core suites and 4 flex suites with projected, capacity to treat more than 2,000 patients per year. Within the existing structure at ICD-C, the available shelf space allows us to double, the number of core suites and increase annual capacity to provide TIL for more than 5,000 patients annually.

As currently constructed, the ICD-C includes 12 core suites and 4 flex suites with projected, capacity to treat more than 2,000 patients per year. Within the existing structure at ICD-C, the available shell space allows us to double, the number of core suites and increase annual capacity to provide TIL for more than 5,000 patients annually.

As currently constructed.

ITC includes 12 core suites, and four flex suites with projected capacity to treat more than 2000 patients per year.

Within the existing structure at ITC the available shelf space allows us to double the number of core suite.

And increase annual capacity to provide for more than 5000 patients annually.

Longer term to reach til manufacturing capacity for more than 10000 patients annually. Our technology plans include streamlining and automating manufacturing processes, while adding new facilities.

In the longer term, to reach TIL manufacturing capacity for more than 10,000 patients annually, our technology plans include streamlining and automating manufacturing processes while adding new facilities. These new facilities potentially include an adjacent lot in the Philadelphia Navy Yard, where we have an option to build under similar terms as ICD-C. To support and protect our proprietary manufacturing processes and know-how, and to further solidify, our leadership in TIL therapy, we are growing our intellectual property, or IT, portfolio. We currently own more than 50 granted or allowed U.S. and international patents, including, Gen 2 patent rights that are expected to provide exclusivity into 2038.

In the near term, to reach TIL manufacturing capacity for more than 10,000 patients annually, our technology plans include streamlining and automating manufacturing processes while adding new facilities.

These new facilities potentially include an adjacent lot in the Philadelphia Navy Yard, where we have an option to build under similar terms as ICD-C. To support and protect our proprietary manufacturing processes and know-how, and to further solidify, our leadership in TIL therapy, we are growing our intellectual property, or IT, portfolio.

These new facilities potentially includes an adjacent Walt in the Philadelphia Navy yard.

We have an option to build under similar terms as our CTC.

To support and protect our proprietary manufacturing processes and Knowhow and to further solidify our leadership in til therapy, we are growing our intellectual property or by deeper folio.

We currently own more than 50 granted or allowed U.S. and international patents, including, Gen 2 patent rights that are expected to provide exclusivity into 2038.

We currently own more than 50 granted or allowed U S and special patents, including Gen. Two patent rights that I expect it to provide exclusivity into 2038.

I would now like to hand the call to Jim Ziegler to highlight our commercial launch preparations.

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

Thank you, Igor.

Thank you Igor leadership positions in key roles are currently in place for commercial and other important functions supporting the launch of <unk> for metastatic melanoma patients.

Certificate positions and key roles are currently in place for commercial and other important, functions supporting the launch of lipolysis for metastatic melanoma patients.

Accurate positions and key roles are currently in place for commercial and other important, functions supporting the launch of lipoleucel for metastatic melanoma patients. Our cross-functional team has built the foundation to scale rapidly and efficiently as we accelerate, launch preparations based upon key regulatory milestones.

Our cross-functional team has built a foundation to scale rapidly and efficiently as we accelerate, launch preparations based upon key regulatory milestones.

Our cross functional team has built the foundation to scale rapidly and efficiently as we accelerate launch preparations based upon key regulatory milestones.

We continue to collaborate with our top targets to become authorized treatment centers, or, ATCs.

We continue to collaborate with our top targets to become authorized treatment centers or ATC.

We are prioritizing leading cancer centers to treat patients as soon as possible after, approval.

We are prioritizing leading cancer centers to treat patients as soon as possible. After approval. Our goal is to onboard and train at least 40 atc's within the first 90 days of launch.

Our goal is to onboard and train at least 40 ATCs within the first 90 days of launch. From our analysis of CAR-T claims data, we anticipate a patient concentration for lipolysal, similar to the CAR-T market, where approximately 50% of CAR-T patients are treated in the top, 10 centers, and approximately 80% of CAR-T patients are treated in the top 40 centers.

Our goal is to onboard and train at least 40 ATCs within the first 90 days of launch. From our analysis of CAR-T claims data, we anticipate a patient concentration for lipoleucel, similar to the CAR-T market, where approximately 50 percent of CAR-T patients are treated in the top 10 centers and approximately 80 percent of CAR-T patients are treated in the top 40 centers.

From our analysis of car T claims data, we anticipate a patient concentration for LIFO leucyl similar to the car T market, where approximately 50% of car T patients are treated in the top 10 centers.

And approximately 80% of car T patients are treated in the top 40 centers.

Through structured interactions with the ATCs, we are efficiently facilitating the development, of new workflows that are unique to TIL cell therapy, while leveraging existing workflows within prevalent cell therapy service lines at the ATCs.

Through structured interactions with the ATCs, we are efficiently facilitating the development, of new workflows that are unique to TIL cell therapy while leveraging existing workflows within prevalent cell therapy service lines at the ATCs.

Through structured interactions with the ATC, we are efficiently facilitating the development of new workflows that are unique to <unk> cell therapy, while leveraging existing workflows within prevalent cell therapy service lines at the ATC.

We designed our customer-centric approach to meet ATC training needs and ensure just-in-time, preparation for each center.

We designed our customer centric approach to meet ATC training needs and ensure just in time preparation for each center.

In addition to onboarding the ATCs, we plan to target high-volume community practices, to increase awareness and encourage referrals to the ATCs.

In addition to Onboarding to Atc's, we plan to target high volume community practices to increase awareness and encourage referrals to the ATC.

We foresee a strong collaboration between the ATCs and community medical oncologists, because we expect referred patients to receive one-time treatment with Lifelucel at the ATCs and then transition back to the community for ongoing monitoring and care.

We foresee a strong collaboration between the ADC and community medical oncologists, because we expect referred patients to receive one time treatment with LIFO Russo at the ATC.

And then transitioned back to the community for ongoing monitoring and care.

Moving to our reimbursement strategies, we are focused on securing coding coverage and payment.

Moving to our reimbursement strategies, we are focused on securing coding, coverage, and payment.

Our market access team continues to engage the key national and regional payers to support, appropriate and timely access to Lifelucel upon approval.

Our market access team continues to engage the key national and regional Payors to support appropriate and timely access to LIFO lusso upon approval.

As a reminder, Lifelucel will be administered on an inpatient basis with reimbursement from, payers to hospitals generally falling under a case rate for commercial patients and the, DRG or Diagnostic Related Group for Medicare patients. This means all care, treatment, services, and hospitalization are generally reimbursed, under one bundled payment.

As a reminder, LIFO litho will be administered on an inpatient basis with reimbursement from payers to hospitals generally falling under a case rate for commercial patient.

And the DRG or diagnostic related group for Medicare patients.

This means all care treatment services and hospitalization are generally reimbursed under one bundled payment.

Finally, our proprietary Iovance CARES program is on track to assist healthcare providers, and patients through their TIL journey as a best-in-class cell ordering, chain of identity, chain of custody, and patient support program for launch.

Finally, our proprietary Iovance CARES program is on track to assist healthcare providers, and patients through their TILJ journey as a best-in-class cell ordering, chain of identity, chain of custody, and patient support program for launch.

Finally, our proprietary <unk> program is on track to assist health care providers and patients through their <unk> journey as a best in class cell ordering.

Chain of identity chain of custody and patient support program for launch.

As we prepare for commercialization, I want to acknowledge the strong and sustained effort, by our core cross-functional teams who have built the foundation for launch.

As we prepare for commercialization I want to acknowledge the strong and sustained effort by our core cross functional teams, who have built the foundation for a launch.

I will now pass the call to Frederick Finkenstein, our Chief Medical Officer, to highlight the, clinical progress.

I will now pass the call Dr. Frederic Benkenstein, our chief Medical officer to highlight the clinical progress.

Thank you, Jim.

Thank you Jim today, I would like to share recent clinical and research program update that reflects the evolution of our pipelines to incorporate additional treatment modalities next generation technologies to address more cancer patients new tumor types at various stages.

Today, I would like to share recent clinical and research program updates that reflect, the evolution of our pipeline to incorporate additional treatment modalities and next-generation technologies to address more cancer patients and new tumor types at various stages of disease.

First, I will briefly summarize the positive top-line clinical data from 153 patients across, cohorts 2 and 4 in the C14401 trial in metastatic melanoma. We previously reviewed these results in detail in our data press release and conference call, in May. Patients in both cohorts 2 and 4 met the same primary eligibility criteria, had the same, study assessment, and received the same treatment regimen and glycolytol that was produced using the same Gen 2 cryopreserved TIL manufacturing process. Our pivotal cohort 4 met the pre-specified primary endpoint, which was ORR assessed by, IRC.

First, I will briefly summarize the positive top-line clinical data from 153 patients across, cohorts 2 and 4 in the C14401 trial in metastatic melanoma. We previously reviewed these results in detail in our data press release and conference call, in May. Patients in both cohorts 2 and 4 met the same primary eligibility criteria, had the same, study assessment, and received the same treatment regimen and glycolutrile that was produced using the same Gen 2 cryopreserved cell manufacturing process. Our pivotal cohort 4 met the pre-specified primary endpoint, which was ORR assessed by, IRC.

First I will briefly summarize the positive topline clinical data from 153 patients across cohorts, two and four and the C 14401 trial in metastatic melanoma.

We previously reviewed these results in detail and our data press release and conference call in May.

Patients in both cohorts two and four met the same primary and its ability criteria at the same study assessment and received the same treatment regimen and I'd like to look at whats produced using the same just to Cryopreserved til manufacturing process.

Our pivotal cohort four met the pre specified primary endpoint, which was all our offices.

ORR, as well as various measures of durability for cohorts 2 and 4, represent meaningful, improvements over available care for our clinical trial population.

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As well as various measures of durability for cohorts, two and four represent meaningful improvement over available care for clinical trial population.

We look forward to announcing more detailed data from the C14401 trial at a medical meeting, later this year.

We look forward to announcing more detailed data from the <unk> 1401 trial at a medical meeting later this year.

We also continue to develop TIL in combination with pembrolizumab in checkpoint inhibitor, naive patients with various tumor types to expand upon the initial opportunity for lisalutel monotherapy after anti-PD-1 therapy.

We also continue to develop TIL in combination with Pembrolizumab in checkpoint inhibitor, naïve patients with various tumor types to expand upon the initial opportunity for glycolutrile monotherapy after anti-PD-1 therapy.

We also continued to develop til in combination with temporary.

And checkpoint inhibitor naive patients with various tumor types that expands upon the initial opportunity for likelihood for monotherapy after anti PD one therapy.

We are committed to starting a phase 3 study in frontline melanoma later this year, which, is also designed to serve as a confirmatory study.

We are committed to starting a phase 3 study in front-line melanoma later this year, which, is also designed to serve as a confirmatory study.

We are committed to starting a phase III study in frontline melanoma. Later this year, which is also designed to serve as the confirmatory study.

As Fred mentioned, during the second quarter, we also began site activation and patient, recruitment for the IOV-GM1-201 First in Human Study of IOV-4001. IOV-4001 is a PD-1 inactivated TIL therapy that incorporates the TALEN gene editing technology, license from Selective.

As Philip mentioned during the second quarter. We also began site activation and patient recruitment for the <unk>. One 201 first in human study of <unk> 4001.

<unk> 4001 is the PD, one and activate the til therapy that is corporate talent gene editing technology licensed from connected.

IOV-4001 may leverage the combination of TIL and interruption of PD-1 signaling within, a single therapy. In a murine model of melanoma, the antitumor activity of IOV-4001 was superior to non-edited, TIL products, whether alone or in combination with an anti-PD-1 antibody.

IOV-4001 may leverage the combination of TIL and interruption of PD-1 signaling within, a single therapy. In a murine model of melanoma, the anti-tumor activity of IOV-4001 was superior to non-edited, TIL products, whether alone or in combination with an anti-PD-1 antibody.

<unk> 4001 may leverage the combination of til and.

Interruption of PD, one signaling within a single therapy.

In a murine model of melanoma, the anti tumor activity of <unk> 4001 was superior to non <unk> product with a known on combination with an anti PD one antibody.

The IOV-GM1-201 study includes two patient cohorts. The first cohort includes advanced melanoma patients who were previously treated with, anti-PD-1 therapy, similar to the patient population in our C14401 study. The second cohort in IOV-GM1-201 is recruiting metastatic non-small cell lung cancer patients, whose disease has progressed after up to three lines of prior therapy, including anti-PD-1 therapy, and will also include patients with tumors with EGFR-ALK or ROS-activating mutations.

<unk> 201 study in Q2 patient cohorts.

The first cohort includes advanced melanoma patients who were previously treated with anti PD one therapy similar to the patient population in our CE one warranty robust study.

The second cohort in <unk> 201 is recruiting metastatic non small cell lung cancer patients.

This has progressed after up to three lines of prior therapy, including anti PD one therapy.

Also include patients with tumors with Egfr.

Activating mutations.

Data from unmodified TIL clinical trials in comparable patient populations provide, appropriate benchmarks for potential differentiation of IOV-4001.

Data from unmodified <unk> clinical trials and comparable patient populations provide appropriate benchmarks for potential differentiation of annual it'd be 4001.

We look forward to dosing the first patient in this study in the second half of this year.

Continuing onto our non small cell lung cancer, we have multiple shots on goal with a total of six cohorts across three Ireland is now enrolling patients at various stages of disease and using multiple treatment modality.

Continuing on to our non-small cell lung cancer pipeline, we have multiple shots on goal with, a total of six cohorts across three IOM studies now enrolling patients at various stages of disease and using multiple treatment modalities. One cohort, which I just mentioned, will receive our genetically modified TIL therapy, IOV-4001.

One cohort, which I just mentioned will receive Alex genetically modified til therapy <unk>.

Yes.

Three cohorts are being treated with TIL monotherapy, LN145, for metastatic non-small cell lung, cancer after progression on chemo and anti-PD-1 in our IOV-LUM202 clinical study.

Three cohorts are being treated with <unk> monotherapy and that's wonderful for.

<unk> for metastatic non small cell lung cancer after progression on chemo and anti PD, one and <unk> 202 clinical studies.

Two additional cohorts are receiving combination treatment in our basket study, IOV-COM202, TIL plus pamprolizumab in anti-PD-1 naive patients and TIL plus ipilimumab, nivolumab, in patients who progress after anti-PD-1 monotherapy.

Two additional cohorts are receiving combination treatment in our basket study, IOV-COM202, TIL plus pembrolizumab in anti-PD-1 naive patients and TIL plus ipilimumab, nivolumab, in patients who progress after anti-PD-1 monotherapy.

Two additional cohorts are receiving combination treatments in our basket study <unk> com 202 to relive them up and anti PD, one naive patients and to deliver new volume up in patients who progressed after anti PD one monotherapy.

As Fred mentioned, we plan to enroll additional cervical cancer patients who have progressed, on anti-PD-1 therapy into cohort two of our C14544 study. Currently active sites are expected to begin recruitment in the coming weeks.

As Fred mentioned, we plan to enroll additional cervical cancer patients who have progressed, on anti-PD-1 therapy into cohort two of our C14504 study. Currently active sites are expected to begin recruitment in the coming weeks.

As mentioned, we have constant enroll additional cervical cancer patients who have progressed on anti PD one therapy into cohort two of our <unk> five <unk> study.

Existing active sites are expected to begin recruitment in the coming weeks.

TIL therapy with lipoleucel has the potential to offer an entirely new class of treatment, to address a significant unmet need for cervical cancer patients who progress after anti-PD-1 therapy.

TIL therapy with lifalutil has the potential to offer an entirely new class of treatment, to address the significant unmet need for cervical cancer patients who progress after anti-PD-1 therapy.

Til therapy with <unk>.

Potential to offer an entirely new class of treatment to address the significant unmet need for cervical cancer patients who progressed after anti PD one therapy.

Available care in this setting is chemotherapy with ORR ranging from 3.4% to 15% and median, duration of response is 4.41.

Available care in this setting is chemotherapy with ORR ranging from 3.4% to 15% and median, duration of response is 4.4 months.

Available care in this setting is chemotherapy with or are ranging from three 4% to 15% and median duration of response for one month.

Cohort two is intended to be pivotal to support regulatory submissions for the treatment of, cervical cancer after chemotherapy and immune checkpoint inhibitor therapy. The pre-specified primary endpoint for COHA2 is Objective Response Rate, or ORR, as assessed, by Independent Review Committee, or IRC, using RESIST 1.1.

Cohort two is intended to be pivotal to support regulatory submissions for the treatment of, cervical cancer after chemotherapy and immune checkpoint inhibitor therapy. The pre-specified primary endpoint for COHORT-2 is Objective Response Rate, or ORR, as assessed, by Independent Review Committee, or IRC, using RESIST-1.1.

Cohort two is intended to be pivotal to support regulatory submissions for the treatment of cervical cancer after chemotherapy and immune checkpoint inhibitor therapy.

The pre specified primary endpoint for cohort two is objective response rate or <unk> as assessed by independent review committee or IRC using with one quick one on the CMC side, we plan to leverage our knowhow.

On the CMC side, we plan to leverage our know-how from the potent CFA matrix for diselute melanoma.

CSA matrix product melanoma.

We also have a robust research pipeline advancing towards the clinic. Following the success of IOB4001, several targets for genetic modification are in pre-clinical studies using the Gene Editing Talent Technology, licensed from Selective, including double genetic knockout programs.

We also have a robust research pipeline advancing towards the clinic.

We also have a robust research pipeline in SaaS and towards the clinic.

Following the success of IOB-4001, several targets for genetic modification are in preclinical studies using the Gene Editing Talent Technology, licensed from Selective, including double genetic knockout programs.

Following the success of <unk> 4001, several targets for genetic modification in preclinical studies using the gene editing talent technology licensed from selected including double genetic knockout programs using additional technologies, our research and preclinical studies.

Using additional technologies, our research in pre-clinical studies include approaches to increase till potency using CD3969 double negative tills, and gene knock-in targets, as well as IND-enabling studies of our novel interleukin-2 analog.

Using additional technologies, our research in preclinical studies include approaches to increase pill potency using CD3969 double negative pills, and gene knock-in targets, as well as IND-enabling studies of our novel interleukin-2 analog.

Which is to increase took ultimately using TV 39, 69, double negative, Phil and Jim and targets as well as.

IMD, enabling studies of our novel interleukin two analog.

I am available to provide additional details during the question and answer session.

I am available to provide additional detail during the question and answer session.

For now, I will hand the call over to Jean-Marc to discuss our second quarter and first half 2022 financial results.

Now I will hand, the call over to Jean Marc to discuss our second quarter and first half 2022 financial results.

Thank you, Frederic.

Thank you Mike.

My comments will reflect the high-level financial results of our second quarter and first half 2022. Additional details can be found in this afternoon's press release, as well as in our SEC findings.

My comments will reflect the high level financial results of our second quarter and first half of.

2022.

Details can be found in this afternoons press release.

Well as <unk> filings.

I will begin with the strength of our cash position. As of June 30, 2022, Iovant held $430.9 million in cash, cash equivalents, investment, and restricted cash, compared to $602.1 million on December 31, 2021. Our cash usage from operations during the second quarter included significant one-time retention-related payments.

I will begin with the strength of our cash position.

As of June 30, Principal Institute, <unk>, Florida, driven through two 9 million.

Cash cash equivalents.

<unk> and.

The restricted cash compared to $602 1 million.

On December 31st 2021.

Our cash usage from operations during the second quarter included significant one time retention related payments.

As a late-stage oncology company approaching potential commercialization, we continue to make prudent investments in commercial launch preparation, internal manufacturing, and pipeline expansion.

As a late-stage oncology company approaching potential commercialization, we continue to make prudent investments in commercial loan preparation, internal manufacturing, and pipeline expansion. We maintain prior guidance that our cash position is sufficient to advance these activities and our overall operating plan into 2024.

As of late stage oncology company approaching potential commercialization, we continue to make prudent investments and commercial launch preparation internal manufacturing and pipeline expansion.

We maintain prior guidance that our cash position is sufficient to advance these activities and our overall operating plan into 2024.

We maintain our prior guidance that our cash position is sufficient to advance this activity and our overall operating plan into 2024.

Moving to the income statement, our net loss for the second quarter under June 30, 2022, was $99.3 million, or $0.63 per share. This compared to a net loss of $81.4 million, or $0.53 per share, for the second quarter under June 30, 2021.

Moving to the income statement.

Net loss for the second quarter ended June 32022.

Was $99 3 million.

All $6 <unk> per share.

This compared to a net loss of $81 4 million or <unk> <unk> per share for the second quarter ended June 32021.

Net loss for the six months under June 30, 2022, was $191 million, or $1.21 per share, compared to a net loss of $156.8 million, or $1.04 per share, for the first half of 2021. Research and development expenses were $73.4 million for the second quarter under June 30, 2022, an increase of $11.3 million, compared to $62.1 million for the second quarter under June 30, 2021. Research and development expenses were $141.7 million for the six months and the June 30, 2022, an increase of $23.6 million compared to $118.1 million for the first half of 2021.

Net loss for the six months ended.

At June 32022.

191 million.

One golar in 21 per share.

Firstly, a net loss of $166 8 million or one.

Im going on <unk> per share for the first half of 2021.

Research and development expenses were $73 4 million.

For the second quarter ended June 32022, and <unk>.

<unk> of $11 3 million.

Compared to $62 1 million for the second quarter ended June 32021.

Research and development expenses were $141.7 million for the six months and the June 30, 2023, an increase of $23.6 million compared to $118.1 million for the first half of 2021. The increase in research and development expenses over the prior three and six months period, was primarily attributable to the growth of the internal research and development team, including stock-based competition expense to support our ongoing and planned pipeline activities, as well as increased facility-related and internal research program costs.

Research and development expenses were $141 7 million.

For the six months ended June 32023.

Increase of $22 6 million compared to $118 1 million.

For the first half of 2021.

The increase in research and development expenses over the prior three and six months periods, was primarily attributable to the growth of the internal research and development team, including stock-based competition expense, to support our ongoing and planned pipeline activities, as well as increased facility-related and internal research program costs.

The increase in research and development expenses over the prior three and six months periods was primarily attributable to the growth of internal research and development team, including stock based compensation expense.

Both are ongoing and planned pipeline activity.

Well as increased facility related and internal research program costs.

These higher costs were partially offset by lower clinical and manufacturing costs in, the first half of 2022, driven by completion of enrollment in pivotal clinical trials.

You saw your costs were partially offset by lower clinical and manufacturing costs in the first half of 2022, driven by completion of enrollment in two clinical trials.

General and administrative expenses were $26 3 million for the second quarter ended June 32022, an increase of 7 million compared to $19 3 million for the second quarter ended June 32021.

General and administrative expenses were $26.3 million for the second quarter and the June, 30, 2022, an increase of $7 million compared to $19.3 million for the second quarter and the June 30, 2021.

General and administrative expenses were $26.3 million for the second quarter and the June 30, 2022, an increase of $7 million compared to $19.3 million for the second quarter and the June 30, 2021.

General and administrative expenses were $49.7 million for the six months and the June 30, 2022, an increase of $10.8 million compared to $38.9 million for the first half of 2021. The increase in general and administrative expenses compared to the prior three and six, months periods was primarily attributable to the growth of the internal general and administrative and commercial teams, including stock-based competition expense, as well as costs associated with the build-out of the new corporate headquarter and pre-commercial and launch readiness activity, as well as our overall growth.

General and administrative expenses were $49.7 million for the six months and the June 30, 2022, an increase of $10.8 million compared to $38.9 million for the first half of 2021. The increase in general and administrative expenses compared to the prior three and six, months period was primarily attributable to the growth of the internal general and administrative and commercial teams, including stock-based competition expense, as well as costs associated with the build-out of the new corporate headquarter and pre-commercial and launch readiness activity, as well as our overall growth.

General and administrative expenses.

Were $49 7 million.

For the six months ended June 32022.

<unk> of 10 8 million.

Baird.

The $8 9 million.

For the first half of 2021.

The increase in general and administrative expenses compared to the prior of three and six months periods was primarily attributable to the growth of the intermodal general and administrative and commercial teams, including stock based compensation expense.

As well as <unk>.

Shape, because the build out of the new co fourth quarter, and pre commercial and launch readiness activities as well as our overall growth.

As of June 30, 2022, there were approximately 157.8 million common shares outstanding. With the strength of our balance sheet and by continuing to align our spending with our, corporate priorities, we are well positioned to execute our operating plan into commercial launch and beyond.

As of June 32000 to Institute.

Were approximately 167 8 million common shares outstanding.

With the strength of our balance sheet and by continuing to align our spending resort corporate priorities, we are well positioned to reduce.

Our operating plan and the true commercial launch of MBM.

I will now hand the call back to the operator to kick off the Q&A session.

I will now turn the call back to the operator to kick off the Q&A session.

Thank you.

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

As a reminder, to ask a question, you will need to press star 11 on your telephone.

As a reminder, to ask a question, you will need to press star 1 1 on your telephone.

Please stand by while we compile the Q&A roster.

Please standby, while we compile the Q&A roster.

And our first question comes from the line of Peter Lawson with Barclays.

Great.

Thanks for the update.

Great. Thanks for their pacings, so taking the questions.

Thanks for taking the questions.

I guess during the pre-BLA meeting, was there any discussion around the confirmation retrial, that's required?

I guess during the, pre-BLA meeting, was there any discussion around the confirmatory trial that's required, and then any commentary around the alignment around the potency assay would be great.

During the pre BLA meeting was there any discussion around that.

Confirmation trial Thats required.

And then any commentary around the alignment around the potency assay would be great.

Any commentary around alignment around the potency assay would be great. Thank you.

Thank you.

Thanks, Peter.

Yes.

Okay. Thanks Peter.

As part of the pre-BLA meeting, confirmatory trials did come up, and we did get some favorable, commentary on what we're currently planning.

Yes, as part of the pre-BLA meeting, confirmatory trials did come up, and we did get some favorable commentary on what we're currently planning.

Yes. This is part of the pre BLA meeting confirmatory trials didn't come up and we did get some favorable commentary on.

We're currently planning we don't have any update to the street just yet on that but there is as you know we're planning frontline melanoma study later this year and the FDA did provide at least some commentary that we read as being favorable towards over proposing that trial.

We don't have any updates to the street just yet on that.

We don't have any updates to the street just yet on that, but there is, as you know, we're planning a front-line melanoma study later this year, and the FDA did provide at least some commentary that we read as being favorable towards what we're proposing in that trial.

But there is, as you know, we're planning a front-line melanoma study later this year, and the FDA did provide at least some commentary that we read as being favorable towards what we're proposing in that trial.

And to your second question on the potency assay matrix situation, that really wasn't, a major topic at the meeting, and so we really don't see any change in our prior discussions of that topic come out.

And to your second question on the potency assay matrix situation, that really wasn't a major topic at the meeting, and so we really don't see any change in our prior discussions of that topic come out.

So your second question on the potency assay matrix situation that really wasn't a major topic at the meeting so we really don't see any change in our prior discussions of that topic come out.

Gotcha.

Got you I guess a final question around the pre BLA.

Part of the question would just be around.

And I guess a final question around the pre-BLA and my final question would just be around, the read-through from that meeting and how it could help inform filings for also cervical cancer and lung cancer.

The read through from that meeting and how it could help in full.

Sure.

Filings for cervical cancer and lung cancer.

Ah, it's an interesting question.

Ah, very interesting question.

Interesting question.

I think what we learned a lot of that meeting about what it's going to take break now with FCA to get cell therapies approved so I think in general it gave us some insight we're not going to share all of that publicly because I think it's competitively valuable, but we do know quite a bit now having gone to a pre BLA meeting over this but I think it's going to be helpful.

I think, look, we learned a lot at that meeting about what it's, going to take right now with FDA to get cell therapies approved, so I think in general it gave us some insight.

I think, look, we learned a lot at that meeting about what it's, going to take right now with FDA to get cell therapies approved.

We're not going to share all that publicly because I think it's competitively valuable, but we do know quite a bit now having gone to a pre-BLA meeting over this that I think is going to be helpful.

So I think in general, it gave us some insight.

We're not going to share all that publicly because I think it's competitively valuable, but we do know quite a bit now having gone to a pre-BLA meeting over this that I think is going to be helpful.

There is nothing specific that I think we've learned there that we didn't already know that would impact cervical or long right now, but there is general some jumbo information that we got out of the meeting and we think it's helpful. As to how you get these drugs approved.

There's nothing specific that I think we've learned there that we didn't already know that would impact cervical or lung right now, but there is general, some general information that we got out of the meeting that we think is helpful as to how you get these drugs approved, so we will certainly take advantage of that.

So we'll certainly take advantage of that.

Well certainly take advantage of that.

Great.

Great. Thanks, so much.

Thank you so much.

Thanks so much.

Thank you.

Our next question comes from the line of Michael Yee.

With Jefferies.

Thank you.

Hi, This is Dennis on for Mike. Thanks, So much for taking our questions.

Two questions from us.

And our next question comes from the line of Michael Yee with Jeffries.

One can you please talk about.

What were the issues discussed at the pre BLA meeting was there anything that the FDA asked that may have been unexpected and I guess what were their comments on durability. After sandy cohort four data and then my second question is.

Hi, this is Dennis on for Mike.

Thanks so much for taking our questions.

Around what specific gating factors to you.

Two questions from, us, please.

Two questions from us, please.

Taking a walk through to actually submit the BLA.

It's a rolling BLA now, two apparently which which was sprint.

Scenario for for most investors I think so talk about the decision to do that as well. Thank you.

One, can you please talk about what were the issues discussed at the pre-BLA meeting?

One, can you please talk about what were the issues discussed, at the pre-BLA meeting?

Sure so on the first point.

Was SBA commented very favorably about the clinical data that includes the durability of this all of the data.

They saw the data the second we will be talking about medical conference. Later this year and there was a favorable commentary you had mentioned that in our press release, we think they are there.

Supporters of the product from a clinical perspective.

Based on based on what the confidence to me.

So I don't think there was anything specific there or nor would I say there was anything unexpected at the meeting in terms of.

Was there anything the FDA asked that may have been unexpected?

And I guess what were their, comments on durability after seeing the cohort 4 data?

And I guess, what were their comments on durability after seeing the cohort 4 data?

Things that came out of left field that we were not planning for it one way or another now going into your the second part of your question second part of your question Rolling BLA is something that we are obviously announcing here.

And then my second question is around, you know, what specific gating factors do you guys need to work through to actually submit the BLA?

And then my second question is around what specific gating factors do you guys need to, work through to actually submit the BLA?

It's a rolling BLA now, too, apparently, which wasn't a scenario for most investors, I think.

It's a rolling BLA now too, apparently, which wasn't a scenario for most investors, I think.

The rolling BLA is something that gives us some advantages allows us to be able to start looking at our following first.

So, talk about the decision to do that as well.

So talk about the decision to do that as well.

Thank you.

Start to potentially.

Get comfortable work work through some of the models, while we finish up on a few secondary tasks and get those.

So that's really the story behind the rolling BLA submission.

Got it thank you.

Sure.

Thank you Andrew.

Our next question comes from the line of Tyler Van Buren with Cowen.

So on the first point, there was, FDA commented very favorably about the clinical data, and that includes the durability. They saw all the data.

So on the first point, there was, FDA commented very favorably about the clinical, data, and that includes the durability. They saw all the data.

Hey, guys. Good afternoon. Thank you very much for taking the questions.

I just had a follow up on the pre BLA meeting of course, specifically what feedback are they giving you regarding the potential for cohort two data to get into the label and the second question is just a point of clarification for the C. One towards zero, one data being presented at a medical meeting by year end.

They saw the data that effectively we'll be talking about at medical conference later this year, and there was favorable commentary. We mentioned that in our press release. We think they're supporters of the product from a clinical perspective based on what they commented at the meeting.

They saw the data that effectively we'll be talking about at Medical Conference later this year. And there was favorable commentary.

So I don't think there was anything specific there, nor would I say there was anything unexpected at the meeting in terms of, you know, things that came out of left field that we were not planning for in one way or another.

We even mentioned that in our press release.

We think they're supporters of the product from a, clinical perspective based on what they commented at the meeting.

So I don't think there was anything specific there, nor would I say there was anything unexpected at the meeting in terms of things that came out of left field that we were not planning for in one way or another.

Will it include the pooled analysis of cohort two and for any additional color there will be helpful.

Yeah, Let me take a member versus order in the second part, yes, we'll definitely be talking about the pooled analysis of cohorts going forward, we think thats. The most relevant to the medical community as we said before we cannot.

I can have other members of the team follow up and tell you more about that we haven't announced the conference yet but that is our.

That is our intention is to focus on that data because thats really the same patient population with the same unmet medical need the same thing that's.

It's out there.

Back to cohort two being supported the FDA has reiterated the supportive thats a cohort so.

As mentioned in fact hold.

I will cover two in four it could be supportive as well so we don't know anything more.

And the fact that Dave said that many times now and we think Thats what.

We're thinking of it didn't have any anything negative to say about cohort two at the meeting.

Alright. Thanks.

Thank you.

And our next question comes from the line of Reni Benjamin with JMP Securities.

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

Just starting off again with the.

<unk> meeting.

Total package, Fred how many patients worth of safety data.

Included is it is it just those from the Q1 floor 401 study or can you pool others.

Others together.

And when.

In your discussions with them what are there any review issues or do you think there might be a potential for Kodak panel.

Now, going into the second part of your question, second big part of your question, rolling BLA is something that we are obviously announcing here.

Let me take the second part of that first for any then I'll ask fredrik to answer the first part because I actually don't know the exact number of others. This full side of the safety 70, Explants again, we didnt hear anything at the meeting I want to note.

Panel that changes what we said previously we think we.

We don't think it's something that is going to happen here, but we are preparing in case. There is no direct parallel as you always have to prepare so we're going to be well prepared if that does happen.

There was nothing at the meeting on that topic.

It gave us.

That would be the case.

To answer any question about the the total size of the safety data set.

Yes, I don't think that we share the exact number of patients that are going into safety said, what we have shared with the full analysis set with the 153 patients from.

66 patients from cohort two in 87 patients from cohort four so those are the patients that will drive the efficacy there are some additional patients.

That could be considered as part of our review of safety data.

We will certainly do that.

Got it and then just as a follow up just based on your FDA discussions regarding the cervical study can you.

Maybe just provide some color as to as to how.

Those discussions went how many patients actually remain.

On the study because youre going to be re expanding a reopening cohort two I'm just wondering if there's a chance for.

Let's say a data update.

For people, who had remained on the study.

Versus the new patients that you plan on enrolling and about how many patients are you planning on enrolling for the new expanded cohort two.

Yes, so we havent disclosed how many patients remain on study and we are.

Well, we have what we think is a sufficient amount of data that is always can we put out some data potentially on that this is a pivotal study this week.

We have to be careful about doing that.

At this point fully fully finalized the total patient number here, but.

Think of the sample size here as being similar to what we looked at for melanoma.

And we're taking that feedback to account so.

Slightly higher a lot of it will have to figure that out as we go here, but.

The sample size I would broadly say is consistent with what we did with melanoma.

Great. Thanks for taking the questions.

Thank you.

And the line of Mark Breidenbach with Oppenheimer.

Hey, good afternoon, guys. Thanks for taking our questions and glad to hear the pre BLA meeting went relatively smoothly.

Now, going into the second part of your question, second big part of your question, rolling BLA is something that we are obviously announcing here.

Just one for Fred.

I was wondering if you can kind of offer.

The rolling BLA is something that gives us some advantages. It allows FDA to start looking at our following first and start to potentially get comfortable and work, you know, work through some of the modules while we finish up on a few secondary tasks and get those submitted.

The rolling BLA is something that gives us some advantages, allows FDA to start looking at our following first and start to potentially get comfortable and work through some of the modules while we finish up one or few secondary tasks and get those submitted. So that's really the story behind the rolling BLA solution.

Any more granularity around.

The steps of the rolling BLA submission and kind of like what's giving you the confidence that the process will be completed in the fourth quarter, and then kind of an addendum on the previous question with regard to the.

So that's really the story behind the rolling BLA submission.

Got it.

Thank you.

And our next question comes from the line of Tyler Van Buren with Cowen.

Cervical cancer cohort.

Hey guys, good afternoon.

Opening for enrollment.

Thank you very much for taking the questions.

I know you can't tell me how much how many patients are you planning to enroll but but does the FDA kind of indicate why they want more patients or is it more to satisfy safety database requirement.

I just had a follow-up, on the pre-BLA meeting, of course.

Specifically, what feedback did they give you regarding the potential for Cohort 2 data to get into the label?

And the second question is just a point of clarification for the G14401 data being presented at a medical meeting by year end.

Whereas this request for more patients coming from thanks for taking the questions.

Will it include the pooled analysis of Cohort 2 and 4?

Any additional color there will be helpful.

Sure I'll take a member versus orders.

Yeah, let me take them in reverse order.

On cervical it's obviously so much I'm sure safety is part of what they're thinking, but it's just we need to we need to size of a patient.

On the second part, yes, we'll definitely be talking about the pooled analysis of Cohort 2 and 4.

We think that's the most relevant to the medical community, as we said before.

I can have other members of the team follow up and tell you more about that.

We haven't announced the conference yet, but that is our intention is to focus on that data because that's really the same patient population with the same amount of medical need.

It would be the same thing for the investigators out there.

We need a size similar to whats been accepted a statistically meaningful for other cell therapies, including our own so with 20 plus patients in that study thats buckets, if I could do it at the patient population. We're interested in so but just asking us for the efficacy set first and foremost to increase side.

Back to Cohort 2 being supportive, the FDA has reiterated the support of Cohort, 2. They did mention that, in fact, pooled Cohort 2 and 4 could be supportive as well.

So we don't know anything more beyond the fact that they've said that many times now, and we think that's what they're thinking.

Great, thanks.

They didn't have anything negative to say about Cohort 2 at the meeting.

Thank you.

And our next question comes from the line of Rennie Benjamin with JMP Securities.

That will inform safety as well, although we've got well north of 500 patients worth of safety data across our co programs.

Hey, good afternoon, guys.

One the rolling BLA and a little bit more granularity.

Thanks for taking the questions.

We're primarily going to be submitting supportive information during the rolling period.

Such as manufacturing capacity demonstration information and things like that these things are not super complicated.

Things that we can.

We can get done fairly quickly, which is why we've got confidence in that fourth quarter.

As early as possible.

Maybe just starting off again, with the pre-VLA meeting.

<unk> of the volume below it.

Alright Thats helpful. Thanks, Thanks for taking the question Glenn Congrats.

Thank you and our next question comes from the line of Mara Goldstein with Mizuho.

Thank you.

The total package, Fred, how many patients' worth of safety data will be included?

Great. Thanks for taking my question.

I have a question on manufacturing and at the time of launch.

Is it just those from the C14401 study, or can you pool others together?

I know you have annualized capacity of about 2000 patients.

What do you think about for sort of steady state. If you will for the initial few months of Watson and how much capacity do you need to read back.

Nicole trial requirements.

And then I'm just curious about.

Okay.

Possibility of improvement on a margin basis.

Where you will be at launch to where you will be when you get to steady state.

Thanks, Laura would you be able to answer.

And in your discussions with them, were there any review issues, or do you think there might, be a potential for an ODAC panel?

Happy to Mara Thanks for your question. So I guess, it's a two fold question. So its launch we have very detailed plans, we're not disclosing the exact numbers, but for flooding obviously.

For meeting the commercial demand, we anticipate an unparallel of course, we continue clinical trials.

And all of that's included in the capacity that we're planning to have it.

ICT seed.

That's cell therapy center in the Navy yard and also supplemented by additional capacity is needed at our contract manufacturer.

The cost of goods, there's a lot of focus on the margins, obviously and that's the team's working on that and yes when does it.

As we scale up.

The cost of goods, we have more control over those by having their own facility and we expect that to improve over time to time.

Okay, and then just on the rolling BLA.

What's the statutory if you will timeframe for FDA decision time.

From completion of that Rolling BLA, you like how should we think about that.

So are they.

From the completion of the Rolling BLA.

Eight eight months.

Date, however, because youre submitting a rolling BLA the benefit as they get to look at it early so you can you have a higher chance to early approval.

Okay, but at the outset I see what.

Youre thinking yes, that's the way they calculate it but again the benefit of rolling BLA is to is to get in front of it.

To get them early so that it can beat that.

Okay. Thanks, so much I appreciate it.

And our next question comes from the line of Tyler Van Buren with Cowan.

Thank you.

Our next question comes from the line of James Chin with Wells Fargo.

Hey guys, good afternoon.

Hey, guys. Thanks for taking the question for the frontline melanoma study in PD, one naive patients can you disclose disclose if you'll take into account the number of baseline tumor lesions in LDH levels.

Cohort four.

It's a different patient population, we're talking about there are further if you want to maybe talk about how we're thinking about that patient population from that perspective.

Yes. Good question no I don't I don't think that we would.

Try to match cohort four because again.

I just said, it's a different patient population.

Much earlier treatment setting remember.

Median number of prior lines of therapy.

On a quarter two and quarter three many patients had more lines of therapy. These are quite a bit are still frontline therapy naive patient.

So the distribution of all numbers.

Other prognostic factors and it's very likely to be different.

We will certainly not match tied to match the link line population.

There are though some steps that you need to take.

<unk> population.

There are some steps that you need to take when you run a randomized trial and that means you need to stratify or non prognostic factors certainly going to.

Through all of the standard measures that we use.

So I think if I like that.

Thank you very much for taking the questions.

I appreciate it thanks guys.

Thank you.

And our next question comes from the line of SDK grew more dean with truest.

I just had a follow-up, on the pre-BLA meeting, of course.

Hi, This is Joe on for Africa.

Couple of questions for you guys wondering how much would it cost you to increase your capacity from 2005 thousand and then how much more additional to increase of 10000 patients.

Patients per year.

Yes.

Uh huh.

It's a complicated question, but let me let me give you some yardsticks and then feel free to feel free to chime in so the total capital investment we had in Philadelphia to get us to where we are right now is about $85 million of tenant improvement.

Thats all shelf space now that includes a lot of <unk>.

Support services as well and with the ability is built so we can just expand the shelf space.

For manufacturing so it would not be anywhere near 85 billion to expand that space that will get us up to the <unk>.

Ultimately 5000 patients a year.

To go to.

Higher than 5000, a year to go to the next level.

We're talking about another building.

That's something.

Against you can do a comparison to what we've done in Philadelphia, but it depends on where you could do that we do have a very favorable financially favorable optional land here in Philadelphia to expand a lot too, but we could also do it elsewhere.

And it would be something like the investment that we've made at this facility in terms of the lease plus the $5 million just adjusted for inflation.

The change in the real estate market, you want to add anything to that.

Fred I think you covered it again.

And to understand that the first expansion would be within the existing building says within the existing shell.

We can add additional looking at 12 core suites to double the course with capacity.

Beyond that as Fred mentioned it depends on the options we're considering several.

Where to expand likely.

Likely to be Greenfield, but there are several location options that could be on the table and we will talk about that in due time its premature to comment on that today.

Great.

I guess when is the soonest, you think you'd get a green light for <unk> as a registrational studies.

We noted that you had a distinct populations within that study, namely PDL, one 1% to 49% and PDL one.

Do you feel confident that one of those subpopulations with lower benchmark profile ability.

Let me take the second part of that first, Rennie, and then I'll ask Frederick to answer the first part because I actually don't know, the exact number of this full size of the safety set, but he can explain that to you.

We didn't hear anything at the meeting on an ODAC panel that changes what we said previously, we think.

In terms of it let me take the first part and then Fredrik to speak to the PDL one status.

Specifically, what feedback did they give you regarding the potential for Cohort 2 data to get into the label?

We're still in the <unk>.

We've been seeking FDA feedback on you went through it too as a registrational study.

We don't think it's something that is going to happen here, but we're preparing in case there is an ODAC panel, and you always have to prepare, so we're going to be well prepared if that does happen.

We don't have anything to update you on right now.

But there was nothing at the meeting on that topic that gave us any indication that that would be the case.

Both vessels cannot study to see how the earlier line of treatment.

<unk>.

Works for til therapy for those patients.

And the second question is just a point of clarification for the G14401 data being presented at a medical meeting by year end.

Frederick, do you want to answer Rennie's question about the total size of the safety data set?

If you want to comment on the PDL one status to cohorts.

Will it include the pooled analysis of Cohort 2 and 4?

Any additional color there will be helpful.

Yes, I don't think that we've shared the exact number of the patients that are going in the safety set.

Yep.

Two I think.

That is the discussion so.

Remember the PDL one status that we're defining for this cohort for PDL one status prior to first line therapy.

Yeah, let me take them in reverse order.

What we have shared is the full analysis set, which is 153 patients from 66 patients from Cohort 2 and 87 patients from Cohort 4.

That is the PDL one.

On the second part, yes, we'll definitely be talking about the pooled analysis of Cohort 2 and 4.

So those are the patients that will drive the efficacy.

Before they start the chemo checkpoint inhibitor therapy, we have.

Separated these cohort like that because we thought that there is a chance that the treatment course under a first line on first line therapy might be different and because of that these patients might go into cell therapy slightly differently not because we think the PDL one status.

We think that's the most relevant to the medical community, as we said before.

There are some additional patients that could be considered as part of the review of the safety data, and FDA will certainly do that.

Got it.

That's part of cell therapy necessarily would be driving treatment outcome.

That is obviously something that we that we will have to explore and demonstrate it.

We are not seeing differences there.

Good status that we put simply collapse and.

And be able to look at this as a single population.

Hope that makes sense.

I can have other members of the team follow up and tell you more about that.

And then just as a follow-up, just based on your FDA discussions regarding the cervical study, can you maybe just provide some color as to how those discussions went?

We haven't announced the conference yet, but that is our intention is to focus on that data because that's really the same patient population with the same amount of medical need.

Clear thank you so much.

Thank you and our.

Next question comes from the line of Ben Burnett with Stifel.

It would be the same thing for the investigators out there.

How many patients actually remain on the study?

Alright, Thank you very much.

I have a question around the release criteria for life <unk> Lusso.

Understanding that the assays themselves have been established an agreed upon I guess can you could you talk about the release margins or release criteria is to what extent are they release margins established an agreed upon with the FDA.

Or is this something that could potentially get ironed out during the review.

Is this something that can get ironed out during the review and we would that's pretty sensitive stuff for us to release our product specifications.

But it's basically a big topic during the review we think we have a pretty good idea of where we stand in that area right now but.

Probably we're going to stay very little even after we get a degree those what those are.

Unless we have to.

Okay. Okay.

Understood and then if I could ask one other question I think previously you had mentioned that cohorts. So so the melanoma cohort.

Back to Cohort 2 being supportive, the FDA has reiterated the support of Cohort, 2. They did mention that, in fact, pooled Cohort 2 and 4 could be supportive as well.

Because now you're going to be re-expanding or reopening Cohort 2.

I'm just wondering if there's a chance for, let's say, a data update, for people who had remained on the study versus the new patients that you plan on enrolling.

Two and four when they were combined have a median Dr that hasnt yet been reached I guess can you comment is that still the case today.

So we don't know anything more beyond the fact that they've said that many times now, and we think that's what they're thinking.

They didn't have anything negative to say about Cohort 2 at the meeting.

Great, thanks.

We will all I can say there is stay tuned for our presentation.

Yes.

The conference later on this year.

Okay. Okay understood. Thank you very much.

Thank you.

And about how many patients are you planning on enrolling, for the new expanded cohort too?

Thank you.

And our next question comes from the line of choline Cucina with Baird.

And our next question comes from the line of Rennie Benjamin with JMP Securities.

Yeah, so we haven't disclosed how many patients, remain on study and we're looking, what we have, what we think is a sufficient amount of data as always, we would put out some data potentially on that.

Hi, good afternoon, thanks for taking our questions I know you've said previously you're targeting 40 centers that launch can you remind us roughly how that compares to what the car keys had at launch and then within those 40 centers. What do you expect the average capacity will be do you think about that as patients per month their beds at a time or just understand.

How many patients might fit into that 40 launch hi, Colin it's Jim here. Thanks for that so we've done a lot of benchmarking.

Hey, good afternoon, guys.

It is a pivotal study that we have to be careful, about doing that.

We're not at this point fully finalized, on the total patient number here, but you should think of the sample size here as being similar to what we looked at for melanoma.

And we're taking that feedback into account, so it could be slightly higher, we'll have to figure that out as we go here.

But the sample size, I would broadly say it's consistent, with what we did with melanoma.

Thanks for taking the questions.

Great, thanks for taking the questions.

The car T market when we look specifically at claims data over about a four year period and what we found is the top 10 centers drive about 50% of all of the car T treated patients in the top 40 centers account for 80%. So based upon those insights and the centers of excellence that have been.

Maybe just starting off again, with the Pre-VLA meeting.

Thank you.

The total package, Fred, how many patients' worth of safety data will be included?

The line of Mark Bradenbach with Oppenheimer.

Is it just those from the C14401 study, or can you pool others together?

Hey, good afternoon guys.

Established in the car T market, that's how we are targeting the 40.

Centers, the top 40 centers within the first 90 days after approval.

And then just staying on.

On a capacity within those.

Yes.

I think the way, we think about capacity with them is what is their bed capacity where are they.

Ducting, the cell therapy treatment and follow up and so it's going to vary site by site, but we have an idea of how many there are in the ICU, how many beds there on the.

General oncology Ward, and we will be working with each site specifically to ensure that.

We really understand their capacity our capacity and make sure that we're able to treat patients appropriately.

Got it. Thank you and then just wondering if there's any guidance that we could expect any updates for the lung programs either PD, one combo or additional monotherapy data this year.

Not right now, but thats something thats.

I mentioned earlier during the early earnings.

We're point there one is really important to us. So that's something that we'll be looking to do as soon as we can.

With that many cohorts open and we hope to billions more data out there.

Great. Thank you.

Thank you and our next question comes from the line of Joe Kattan Zero with Piper Sandler.

And in your discussions with them, were there any review issues, or do you think there might, be a potential for an ODAC panel?

Let me take the second part of that first, Rennie, and then I'll ask Frederick to answer the first part because I actually don't know the exact, number of this full size of the safety set, but he can explain that to you.

Hey, guys. Thanks for the update thanks for taking my questions wondering first if you could clarify whether the decision to move to a rolling BLA submission was driven by any of the feedback you received during the pre BLA meeting or was that decision.

We didn't hear anything at the meeting on an ODAC panel that changes what we said previously, we think.

Thanks for taking our questions, and glad to hear the pre-BLA meeting went relatively smoothly.

We don't think it's something that is going to happen here, but we're preparing in case there is an ODAC panel, and you always have to prepare, so we're going to be well prepared if that does happen.

Just one for Fred, I was wondering if you can kind of offer, any more granularity around the steps of the rolling BLA submission and kind of like what's giving you the confidence that the process will be completed in the fourth quarter.

A wholly independent of that and then second question, maybe perhaps a bit speculative but wondering if.

And then kind of an addendum on the previous question, with regard to the cervical cancer cohort that's reopening for enrollment.

The impact of duration of prior PD, one that you've observed in melanoma is something you expect to extrapolate into other settings, and I guess I'm asking that in the context of post PD, one cervical now being the emphasis in that indication.

But there was nothing at the meeting on that topic that gave us any indication that would, be the case.

I know you can't tell me how many patients, you're planning to enroll, but does the FDA kind of indicate why they want more patients?

So let me let me take the first one that maybe you can take the second question.

Frederick, do you want to answer Rennie's question about the total size of safety data set?

Is it more to satisfy safety database requirement, or where is this request for more patients coming from?

During this pre BLA meeting I think.

Abided us with some context for.

Our submission as a whole and I think as a result of that we just basically came to conclusion that a rolling BLA submission was the best approach here.

Yes, I don't think that we shared the exact number of patients that are going in the safety set.

What we have shared is the full analysis set, which is 153 patients from, 66 patients from Cohort 2 and 87 patients from Cohort 4.

Really I don't want to.

So I want to say anymore.

About how that went down but it's basically a full picture of what happened led us to conclude.

Including the Rolling BLA was the best approach to assess the product and we think FDA very supportive of it.

I understand all that.

But if you answer the second part of the question.

Okay.

Yes sure good question.

So.

I don't think that we have sufficient information at this point yet either either based on clinical data that we've generated more already fully understanding.

What's the mechanism of action is that PD prior pretty one therapy Mike.

Volume.

Good day, and some of the differences that have been.

Observed.

Mainly in melanoma really.

<unk> patients that were previously treated with checkpoint inhibitors, such as the patients in cohort two and four and our Q1 was your own study.

Ah patients that are checkpoint inhibitor naive.

There are a couple of hypotheses out there and there.

There is some recent publications coming out of the Rosenberg group.

It also visiting some of that whether that translates into other indications those tumor types I think that needs to be shown clinically. We have presented initial data on combinations of Liza neutral with.

September isn't up.

In checkpoint naive patients.

In patients with head and neck cancer cervical cancer, we are seeing.

Encouragingly high response rates that are clearly higher than what.

<unk> with temporary law.

So we might be seeing that difference as well, but I think we need to generate more data for cervical cancer. However, the unmet medical need certainly is in the post PD one setting there is really nothing good out. Therefore this patient this is an underserved population of patients.

With therapy.

Terribly inefficient after failure of frontline doublet chemo.

And.

Til therapy as a real opportunity for these patients and that's what we are focusing on currently.

Okay, great. Thanks for taking my question.

Thank you.

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

Hi, This is Omar so we have two questions first how should we think about the objective response rate that will be necessary for approval.

And post PD, one cervical cancer and then two on.

Post PD one in melanoma beyond call. It four can we expect.

Any additional data disclosures from the pipeline in 2022.

All we can say.

On your second question I missed what from what study and a second question beyond cohort core from the Asa.

Sure.

Can we expect any additional data disclosure from the pipeline got it okay.

But the first question there is no right now there is no approved therapy post PD one cervical patients.

There is available care out there and be able to look at assets chemotherapy with very.

Poor results and maybe Fredrick do you want to add a little bit to that but yes.

These are things that we don't view as huge barriers to a successful study.

Anything thats available care for surplus we won several patients.

Yes, there is there's limited data on on late line.

Nightline outcomes of cervical cancer patients with with chemotherapy, which is really the main main therapeutic options.

These patients have or ours are ranging somewhere between three and 15% with chemo that includes additional doublets.

Toxic.

<unk>.

And the duration of.

Responses.

Last time I looked.

During the quarter between four and five months.

So that bar is relatively low.

There is no there is no experience with chemo after failure of PD, one checkpoint inhibitors.

The FDA, usually when when you're when you're looking at.

What would be required for an approval says that they are going to look at the totality of the data at the time of approval in the context of available care.

There is not much activity in that field. So maybe maybe these additional these initial number could you give me a rough idea.

And to answer the second part of your question you want to think about data flow beyond.

The melanoma cohort two cohort four data flows that we already talked about.

The way, we're thinking about at least as long as non small cell lung is one of our priority areas of small and we'd like to get some data out soon.

I haven't given any specific guidance from the App is high on our list and then after that the other indications.

Yeah.

Alright, thank you.

Thank you I'm showing no further questions so with that I'll hand, the call back over to <unk> interim President and CEO , Fred Boehler for any closing remarks.

Yes.

Thank you operator.

Thank you again for joining the <unk> biotherapeutics second quarter and first half financial results Conference call is an exciting time to be part of <unk> I would like to recognize the patients physicians and regulators who have collaborated with us throughout the journey.

Til therapy, as well as our employees and cross functional teams for their hard work in arriving at this point.

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

Please feel free to reach out nations team, if you wish to follow up and follow up.

Thank you.

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

So those are the patients that will, drive the efficacy.

Thanks for taking the questions.

The conference will begin shortly to raise your hand during Q&A you can dial one one.

There are some additional patients that could be considered as part of review of the safety data, and FDA will certainly do that.

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Yes.

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Yes.

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Got it.

Sure, I'll take them in reverse order.

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And then just as a follow-up, just based on your FDA discussions regarding the cervical study, can you maybe just provide some color as to how, you know, those discussions went?

On cervical, it's not really so much, I'm sure safety is part of what they're thinking, but it's just, we need a size of a patient.

Welcome to the Io vans Biotherapeutics second quarter, and first half 2022 financial results and corporate update conference call.

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. Later, we will conduct a question and answer session.

How many patients actually remain, you know, on the study?

We need a size similar to what's been accepted, as statistically meaningful for other cell therapies, including our own.

Senior Vice President Investor Relations and corporate communications at <unk>, Sir you may begin.

Because now you're going to be re-expanding or reopening Cohort 2.

So with 20 plus patients in that study, that's not gonna do it as a patient population we're interested in.

Thank you operator, good afternoon, and thank you for joining us.

I'm just wondering if there's a chance for, let's say, a data update, for people who had remained on the study versus the new patients that you plan on enrolling.

So they're just asking us for the efficacy set, first and foremost to increase the size.

Today's call we have Dr. Fred, though our interim President and Chief Executive Officer, Dr. Igor Glenn <unk>, our Chief operating Officer, Jim Ziegler, Our executive Vice President commercial Dr. Frederic Finkelstein, our Chief Medical Officer, John Martin, Our Chief Financial Officer.

And about how many patients are you planning on enrolling, for the new expanded cohort too?

And of course that will inform safety as well.

Although we've got well, 100 to 500 patients, for the safety data across our programs.

Doctor Mcdonald's or gave you our executive Vice President of Medical Affairs and Dr. Robert Gerry Our executive Vice President regulatory strategy and translational medicine are also available for the Q&A session.

This afternoon, we issued a press release that can be found on our corporate website at <unk> Dot Com, which includes the financial results for the three and six months ended June 32020, Q as well as recent corporate update.

It is a pivotal study, though, so we have to be careful about doing that.

Before we start I would like to remind everyone that statements made during this conference call.

We will include forward looking statements regarding either back to school business focused business plan pre commercial activities clinical trials and results.

Inventory interaction plan and strategy research and preclinical activity potential future applications of our technologies manufacturing capabilities regulatory feedback and guidance payer interaction licenses and collaboration cash position and expense guidance and future update.

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

Alright.

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 Fred.

We're not at this point fully finalized, on the total patient number here, but you should think of the sample size here as being similar to what we looked at for melanoma. And we're taking that feedback into account, so it could be slightly higher.

On to the rolling BLA and a little bit more granularity, we're primarily gonna be submitting supportive information during the rolling period, such as manufacturing capacity demonstration information and things like that.

Thank you Sarah and good afternoon, everyone I'm pleased to highlight our significant year to date progress side of it.

We'll have to figure that out as we go here.

These things are not super complicated.

But the sample size, I would broadly say, it's consistent with what we did with melanoma.

They're the things that we can, we think we can get done fairly quickly, which is why we've got confidence in that quarter and hopefully as early as possible on completion of the rolling BLA.

I'll begin with our first planned biologics license application or BLA for our lead til therapy playful leucyl in metastatic melanoma.

Great, thanks for taking the questions.

All right, that's helpful.

This is our number one priority on behalf of patients who are eager to see life loose La Cruz <unk>.

Thank you.

Thanks for taking the questions and congrats.

The line of Mark Bradenbach with Oppenheimer.

We successfully completed a pre BLA meeting with the FDA in July we are on track to begin to BLA submission. This month.

Hey, good afternoon, guys.

Thank you.

The FDA provided favorable feedback on the clinical efficacy data from cohorts, two and four of the C level one support.

One clinical trial include duration of follow up.

Thanks for taking our questions, and glad to hear the pre-BLA meeting went relatively smoothly.

And our next question comes from the line, of Mara Goldstein with Mizzouho.

And the potency assay of matrix.

Just one for Fred, I was wondering, if you can kind of offer any more granularity around the steps of the rolling BLA submission and kind of like what's giving you the confidence that the process will be completed in the fourth quarter.

Great, thanks for taking that question.

<unk> also great clinical safety data set was sufficient for BLA review and provided valuable feedback and advice regarding various parts of the planet and BLA submission.

Following the pre BLA meeting will commence the rolling BLA submission this month.

The rolling BLA submission is the benefit available under a regenerative medicine advanced therapy arm that designation.

Our rolling BLA allows us to submit sections of the BLA to the FDA on an ongoing basis. This.

This process enables the FDA to begin a review of submission documents as early as possible as they are received potentially allowing for earlier approval.

We expect to complete the rolling BLA submission during the fourth quarter of this year.

We are pleased with the outcome of the pre BLA meeting, which multiple members of senior management team attended.

The FDA has engaged and supportive of the BLA for <unk> and we look forward to continue this level of collaborations throughout the submission and review process.

I have a question on manufacturing, and at the time of launch, I know you have annualized capacity of about 2000 patients, but what do we think about for sort of steady state, if you will, for those initial few months of launching and how much capacity do you need to leave back to fulfill clinical trial requirements?

In parallel with the BLA related activities, we are actively preparing to launch late leucyl.

Key pre commercial activities, including medical education treatment Center, Onboarding payer engagement commercial manufacturing readiness newer long term capacity planning.

We aim to successfully deliver til therapy to cancer patients and create value for our shareholders.

We're also excited about the advancement of our until cell therapy pipeline, we are recruiting patients across five I've been home trials, including the recent recently initiated trial of our first genetically modified til therapy.

Six cohorts of non small cell lung cancer patients in part a of three of these active trials, reflecting our focus on that indication.

We're also on track to initiate a phase III trial of Iclusig in combination with <unk> in frontline melanoma towards the end of the year.

And then kind of an addendum on the previous question, with regard to the cervical cancer cohort that's reopening for enrollment.

As noted in this afternoon's press release, we are expecting our C won't for 501.

Sorry, one for 504 study to support a BLA submission for <unk> cervical cancer would trigger for islands further.

I know you can't tell me how many patients, you're planning to enroll, but does the FDA kind of indicate why they want more patients?

This updated registration strategy reflects FDA discussions and feedback that address the shifting frontline standard of care in cervical cancer as.

Is it more to satisfy a safety database requirement?

And I'm just curious about the, possibility of improvement on a margin basis from where you will be at launch to where you will be when you get to steady state.

As we prepare to launch the first onetime cell therapy solid tumors.

We're growing the organization to advance our mission of innovating developing and delivering til therapies. Today, we have nearly 450 employees the brake deep expertise and successful track record of oncology and cell therapy development and commercialization.

Where is this request for more patients coming from?

Thanks, Mara.

Thanks for taking the questions.

The strength within our organization reflects tremendous enthusiasm for <unk> cell therapies, and our global leadership in the field.

Sure, I'll take them in reverse order.

Igor, would you be able to answer that one?

On cervical, it's not really so much, I'm sure safety is part of what they're thinking, but it's just, we need a size of a patient.

I look forward to addressing your questions later during this call, we'll now ask Igor to discuss manufacturing methods.

We need a size similar to what's been accepted, as statistically meaningful for other cell therapies, including our own.

Happy to.

Thank you Fred.

So with 20 plus patients in that study, that's not gonna do it as a patient population we're interested in.

So they're just asking us for the efficacy set, first and foremost to increase the size.

Mara, thanks for your question.

And of course, that will inform safety as well.

So I guess it's a twofold question.

<unk> cell therapy center or ICC is our 136000 square foot internal manufacturing facility in the Philadelphia Navy yard.

So at launch, we have very detailed plans.

<unk> custom designed ICT and.

And in just two five years constructed from dirt on the ground to an operational facility supplying <unk> clinical studies.

We're not disclosing the exact numbers, but we're planning obviously for meeting the commercial demand that we anticipate and in parallel, of course, we'll continue clinical trials.

Manufacturing is critical for any commercial look, particularly for autologous cell therapies. So our top priority is to prepare ITC.

Late submission and commercial supply.

Today, the ICD cease operating flood suites for clinical manufacturing and conducting BLA readiness activities in the core suites. In addition, we are on track in preparing the ITC and our contract manufacturers facility or FDA pre approval inspections.

Icd's fleet is expected to supply most of the commercial til therapies upon approval.

Look the ability to use contract manufacturing to optimally manage capacity and fully meet patient demand.

As we look to establish <unk> as the next paradigm shifting cluster of cancer therapy.

We are also planning for our future capacity needs.

And all of that's included in the capacity that we're planning to have at ICTC, at the Iovance Cell Therapy Center in the Navy Yard, and also supplemented by additional capacity as needed at our contract manufacturer.

The cost of goods, there's a lot of focus on the margins, obviously, and that's the, team's working on that. And yes, we anticipate as we scale up the cost of goods, we have more control over that by having our own facility, and we expect that to improve over time.

Currently constructed the ICC includes 12 core suites, and four flex suites with projected capacity to treat more than 2000 patients per year.

Okay.

Within the existing structure CDC the available shelf space allows us to double the number of core suite.

An increased annual capacity to provide for.

For more than 5000 patients annually.

Longer term to reach to manufacturing capacity for more than 10000 patients annually. Our technology plans include streamlining and automating manufacturing processes, while adding new facilities.

These new facilities potentially includes an adjacent Walt in the Philadelphia Navy yard.

We have an option to build under similar terms as high CTC.

To support and protect our <unk>.

Primary manufacturing processes, and Knowhow and through further solidify our leadership in til therapy, we are growing our intellectual property or IP portfolio.

We currently own more than 50 granted or allowed us and special patents, including Gen. Two patent rights that I expect it to provide exclusivity into 2038.

And just on the rolling BLA, what's the statutory, if you will, time frame for FDA, decision time from completion of that rolling BLA?

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

How should we think about that?

Thank you Igor leadership positions in key roles are currently in place for commercial and other important functions supporting the launch of <unk> for metastatic melanoma patients.

Our cross functional team has built the foundation to scale rapidly inefficiently as we accelerate launch preparations based upon key regulatory milestones.

We continue to collaborate with our top targets to become authorized treatment centers or ATC we.

We are prioritizing leading cancer centers to treat patients as soon as possible. After approval. Our goal is to onboard and train at least 40 atc's within the first 90 days of launch.

From the completion of the rolling BLA, they calculate eight months to the PDUVA date.

From our analysis of car T claims data, we anticipate a patient concentration for LIFO leucyl similar to the car T market, where approximately 50% of car T patients are treated in the top 10 centers.

And approximately 80% of car T patients are treated in the top 40 centers.

Through structured interactions with the ATC, we are efficiently facilitating the development of new workflows that are unique to <unk> cell therapy, while leveraging existing workloads within prevalent cell therapy service lines at the ATC.

We designed our customer centric approach to meet ATC training needs and ensure just in time preparation for each center.

In addition to Onboarding the ATC, we plan to target high volume community practices to increase awareness and encourage referrals to the ATC.

We foresee a strong collaboration between the ADC and community medical oncologists, because we expect preferred patients to receive one time treatment with LIFO lethal at the ATC.

And then transition back to the community for ongoing monitoring and care.

Moving to our reimbursement strategies, we are focused on securing coding coverage and payment.

However, because you're submitting a rolling BLA, the benefit is they get to look at it early, so you have a higher chance of early approval before the PDUVA date.

Okay.

But at the outset, it's eight months.

Our market access team continues to engage the key national and regional Payors to support appropriate and timely access to LIFO lusso upon approval.

As a reminder, LIFO litho will be administered on an inpatient basis with reimbursement from payers to hospitals generally falling under a case rate for commercial patient.

And the DRG or diagnostic related group for Medicare patients.

This means all care treatment services and hospitalization are generally reimbursed under one bundled payment.

That's what you're thinking?

Finally, our proprietary <unk> program is on track to assist health care providers and patients through their <unk> journey as a best in class cell ordering chain.

Yes, that's the way they calculate it.

Chain of identity chain of custody and patient support program for launch.

But again, the benefit of rolling BLA is to get in front of, it, to get them early so that they can beat that date.

As we prepare for commercialization I want to acknowledge the strong and sustained effort by our core cross functional teams, who have built the foundation for launch I.

Okay.

I will now pass the call Dr. Frederic Benkenstein, our chief Medical officer to highlight the clinical progress.

Thank you Jim today, I would like to share recent clinical and research program update that reflect the evolution of our pipelines and incorporate additional treatment modality and next generation technologies to address more capture patients new tumor types at various stages of disease.

Although we've got well, 100 to 500 patients, for the safety data across our programs.

Thanks so much.

On to the enrolling PLA and a little bit more granularity.

We're primarily gonna be submitting supportive information, during the enrolling period, such as manufacturing capacity demonstration information and things like that.

These things are not super complicated.

I appreciate it.

First I will briefly summarize the positive topline clinical data from 153 patients across cohorts, two and four and the C 14401 trial in metastatic melanoma.

They're the things that we can, we think we can get done fairly quickly, which is why we've got confidence in that quarter and hopefully as early as possible on completion of the enrolling PLA.

All right, that's helpful.

Thank you.

Thanks for taking the questions and congrats.

And our next question comes from the line of James Chin with Wells Fargo.

We previously reviewed these results in detail and our data press release and conference call in May.

Thank you.

Hey, guys.

And our next question comes from the line, of Mayor Goldstein with Mizzouho.

Thanks for taking the question.

Great, thanks for taking that question.

Patients in both cohorts two and four met the same primary and its ability criteria at the same study assessment and received the same treatment regimen and then like the local network using the same gen II cryo preserve fuel manufacturing process.

I have a question on manufacturing, and at the time of launch, I know you have the annualized capacity, of about 2000 patients, but what do we think about for sort of steady state, if you will, for those initial few months of launching and how much capacity do you need to leave back to fulfill clinical trial requirements?

And I'm just curious about the.., possibility of improvement on a margin basis from where you will be at launch to where you will be when you get to steady state.

Thanks, Mara.

Igor, would you be able to answer that one?

Happy to.

Mara, thanks for your question.

Our pivotal cohort four met the pre specified primary endpoint, which was all our business.

So I guess it's a twofold question.

So at launch, we have very detailed plans.

We're not disclosing the exact numbers, but we're planning obviously for meeting the commercial demand that we anticipate.

<unk>.

As well as various measure durability for cohorts, two and four represent meaningful improvement over available care for clinical trial population.

And in parallel, of course, we continue clinical trials. And all of that's included in the capacity that we're planning to have at ICTC, at the Iovance Cell Therapy Center in the Navy Yard, and also supplemented by additional capacity as needed at our contract manufacturer.

The cost of goods, there's a lot of focus on the margins, obviously, and the team's working on that. And yes, we're anticipating as we scale up the cost of goods, we have more control over that by having our own facility, and we expect that to improve over time.

Okay.

We look forward to announcing more detailed data from the <unk> trial at a medical meeting later this year.

We also continued to develop til in combination with <unk>.

And checkpoint inhibitor naive patients with various tumor types and expand upon the initial opportunity for likelihood for monotherapy after anti PD one therapy.

For the frontline melanoma study in PD-1 naive, patients, can you disclose if you will take into account the number of baseline tumor lesions and LDH levels, what match cohort 4?

We are committed to starting a phase III study in frontline melanoma. Later this year, which is also designed to serve as the confirmatory study.

And just on the rolling BLA, what's the statutory, if you will, time frame for FDA decision time from completion of that rolling BLA?

It's a different patient population we're, talking about there.

As Philip mentioned during the second quarter. We also began site activation and patient recruitment for the <unk> B GM. One 201 first in human study of <unk> 4001.

How should we think about that?

Frederick, do you want to maybe talk about how we're thinking about that patient population from that perspective?

Mara, from the completion of the rolling BLA, they calculate eight months to the PDUVA date.

Yeah, good question.

No, I don't think that we would try to match cohort 4 because, again, as Fred just said, it's a different patient population.

<unk> 4001 is the PD one an estimate of til therapy that is corporate talent gene editing technology licensed from connected.

However, because you're submitting a rolling BLA, the benefit is they get to look at it early, so you have a higher chance of early approval before the PDUVA date.

It's a much earlier treatment setting.

Okay.

<unk> 4001 may leverage the combination of til and.

Interruption of PD, one signaling within a single therapy.

A mirroring model of melanoma, the anti tumor activity of <unk> 4001 was superior to non enters into a product with alone or in combination with an anti PD one antibody.

But at the outset, it's eight months.

Remember, median number of prior lines of therapy, on cohort 2 and cohort 4 was three. Many patients had more lines of therapy.

The <unk> 201 study in Q2 patient cohorts.

That's what you're thinking.

These are checkpoint inhibitors, so frontline therapy naive patients.

The first cohort includes advanced melanoma patients who were previously treated with anti PD one therapy similar to the patient population in our CE one warranty robust study.

Yes, that's the way they calculate it.

So the distribution of numbers and other prognostic factors is very likely to be different, and we will certainly not match – try to match the late-line population.

But again, the benefit of rolling BLA is to get in front of, it, to get them early so that they can beat that date.

There are, though, some steps that you need to take when you run a randomized trial, and that means you need to stratify for known prognostic factors.

The second cohort in <unk> 201 is recruiting metastatic non small cell lung cancer patients.

Okay.

We're certainly going to do all the standard measures that you'll usually do in a study design like that.

This has progressed after up to three lines of prior therapy, including anti PD, one therapy and will also include patients with tumors with Egfr.

Thanks so much.

Appreciate it.

Activating mutations.

I appreciate it.

Thanks guys.

Data from unmodified til clinical trials with comparable patient populations provide appropriate benchmarks for potential differentiation of annual would be four one.

Thank you.

We look forward to dosing the first patient in this study in the second half of this year.

Continuing on to our non small cell lung cancer, we have multiple shots on goal with a total of six cohorts across three Ireland is now enrolling patients in various stages of disease and using multiple treatment modality.

And our next question comes from the line of James Chin with Wells Fargo.

And our next question comes from the line of Asthika Goonewardene with Truist.

Hey, guys.

Hi, this is Gil on for Astika.

Thanks for taking the question.

For the frontline melanoma study in PD-1, naive patients, can you disclose if you will take into account the number of baseline tumor lesions and LDH levels, what match cohort four?

It's a different patient population we're talking about there.

We had a couple questions for you guys.

One cohort, which I just mentioned will receive our genetically modified til therapy <unk> for closing remarks.

Frederick, do you want to maybe talk about how we're thinking about the patient population from that perspective?

We're wondering how much, would it cost for you to increase your capacity from 2000 to 5000?

Three cohorts are being treated with <unk> monotherapy in at 105 for metastatic non small cell lung cancer after progression on chemo and anti PD, one and our <unk> 202 clinical studies.

Yeah, good question.

And then how much more additional to increase to 10,000 patients per year?

No, I don't think that we would try to match cohort four because again, as Fred just said, it's a different patient population.

Yeah.

Two additional cohorts are receiving combination treatment in our basket study <unk> come to a two tiered test parallelism up an anti PD one naive patients.

It's a much earlier treatment setting.

It's a complicated question, but let me give you some yardstick and then Igor, feel free to, chime in.

So the total capital investment we had in Philadelphia to get us to where we are right now is about 85 million of tenant improvement and that built shell space.

If the level the volume up in patients who progressed after anti PD one monotherapy.

Remember, median number of prior lines of therapy on cohort two and cohort four was three. Many patients had more lines of therapy.

Now that includes a lot of support services as well.

And the building is built so we can just expand the shell space for manufacturing. So it would not be anywhere near 85 million to expand that space.

These are checkpoint, but also frontline therapy naive patients.

And that would get us up to the approximately 5,000 patients a year.

As Phil mentioned, we pass it enrolled additional cervical cancer patients who have progressed on anti PD one therapy into cohort two of our key one for Scott.

To go to higher than 5,000 a year to go to the next level, we're talking about another building and that's something, again, you can do a comparison to what we've done in Philadelphia, but it depends on where you do that.

We do have a very financially favorable option on land here in Philadelphia to expand onto, but we could also do it elsewhere. And it would be something like the investment that we made in this facility in terms of the lease plus 85 million, just adjusted for inflation and the things that have changed in the real estate market.

So the distribution of numbers, other prognostic factors is very likely to be different.

Igor, do you want to add anything to that?

And we will certainly not match, try to match the late-line population.

Existing active sites.

There are, though, some steps that you need to take. There are, though, some steps that you need to take when you run a randomized trial, and that means you need to stratify core known prognostic factors.

Fred, I think you covered it again.

And it's important to understand that the first expansion, would be within the existing building. So it's within the existing shell.

To begin recruitment in the coming weeks.

We're certainly going to do all the standard measures that you'll usually do in a study design like that.

We can add additional, we can add 12 core suites to double the core suite capacity.

Til therapy with like the neutral.

Retention to offer an entirely new class of treatment to address the significant unmet need for cervical cancer patients who progressed after anti PD one therapy.

Thank you.

Beyond that, as Fred mentioned, it depends on the options.

And our next question comes from the line of Asthika Goonewardene with Truist.

We're considering several, where to expand, likely to be Greenfield, but there are several location options that could be on the table.

Hi, this is Gil on for Astika.

Available care in this setting is chemotherapy with or are ranging from three 4% to 15% and medium duration of responses for one month.

We had a couple questions for you guys.

We're wondering how, much would it cost for you to increase your capacity from 2000 to 5000?

Cohort two is intended to be pivotal to support regulatory submission for the treatment of cervical cancer after chemotherapy and immune checkpoint inhibitor therapy.

The pre specified primary endpoint for cohort two is objective response rate or <unk> as assessed by independent review committee or IRC using resist one one on the CMC side, we plan to leverage our knowhow from the potency assay matrix for that.

Sure.

We also have a robust research pipeline in SaaS and towards the clinic.

Following the success of <unk> 4001, several targets for genetic modification in preclinical studies using the gene editing talent technology licensed from selected.

Excluding double genetic knockout programs using additional technologies, our research and preclinical targets include approaches to increase took ultimately using TV 39, 69, Dublin negative pill and gene knocked in target.

IMD, enabling studies of our novel interleukin two analog.

And we'll talk about that in due time.

I am available to provide additional details during the question and answer session for now I will hand, the call over to Jean Marc to discuss our second quarter and first half 2022 financial results.

And then how much more additional to increase to 10,000 patients per year?

It's premature to comment on that today.

It's a complicated question, but let me let me give you some yardsticks and then you feel free, to feel free to chime in.

Great.

Thank you Michael.

So the total capital investment we had in Philadelphia to get us to where we are right now is about $85 million of tenant improvement at that shelf space. Now, that includes a lot of support services as well. And the building is built so we can just expand the shelf space for manufacturing.

My comments will reflect the high level financial results of our second quarter and first half 2000 to Institute.

Additional details can be found in this afternoons press release.

As well as in our SEC filings.

So it would not be anywhere near $85 million to expand that space. And that would get us up to the approximately 5000 patients a year.

And I guess, when is the soonest you think you'd get a green light for LUN202 as a, registrational study?

I will begin with the strength of our cash position.

To go to higher than 5000 a year to go to the next level, we're talking about another building.

And that's something, again, you can do a comparison to what we've done in Philadelphia.

And we noted that you had distinct populations within that study, namely PDL1, 1 to 49% and PDL1, 0%.

As of June 32022 <unk>.

<unk> four driven through $2 9 million.

Cash cash equivalents and investment.

Restricted cash compared to $602 1 million on December 31st 2021.

Our cash usage from operations during the second quarter included significant one time retention related payments.

But it depends on where you do that.

Do you feel confident that one of those subpopulations would have a lower benchmark profilability?

As of late stage oncology company approaching potential commercialization, we continue to make prudent investments in commercial loans preparation internal manufacturing and pipeline expansion.

We do have a very favorable, financially favorable option on land here in Philadelphia to expand onto, but we could also do it elsewhere. And it would be something like the investment that we made in this facility in terms of the lease plus $85 million just adjusted for inflation and the things that have changed in the real estate market.

Igor, do you want to add anything to that?

Let me take the first part and then ask Fredrick to speak to the PDL1 status.

We've been seeking FDA feedback on LUN202 as a registrational study.

We don't have anything to update you on right now.

All we can say is we're continuing to enroll as fast as we can in that study to see how the earlier line of treatment works with total therapy for those patients.

Fredrick, do you want to comment on the PDL1 status and those two cohorts?

Fred, I think you covered it again.

Happy to.

We maintain our prior guidance that our cash position is sufficient to advance this activity and our overall operating plan into 2024.

And it's important to understand that the first expansion would be within the existing building. So it's within the existing shell. We can add additional, we can add 12 core suites to double the core suite capacity.

That's beyond that, as Fred mentioned, it depends on the options.

We're considering several, where to expand, likely to be greenfield, but there are several location options that could be on the table.

And we'll talk about that in due time.

It's premature to comment on that today.

Great.

I think that deserves discussion.

Moving to the income statement.

So, remember, the PD-L1 status that we're, defining for these cohorts is the PD-L1 status prior to first-line therapy. So that is the PD-L1 status before they start the chemo checkpoint inhibitor therapy.

We have separated these, cohorts like that because we thought that there is a chance that the treatment course under first-line, on first-line therapy might be different.

And because of that, these patients might go into cell therapy slightly differently, not because we think that the PD-L1 status at the start of cell therapy necessarily would be driving treatment outcomes.

Loss for the second quarter ended June 32000 to Institute was $99 3 million.

So that is obviously something that we will have to explore and demonstrate.

If we are not seeing differences, there is a very good chance that we would simply collapse and be able to look at this as a single population.

All $6 <unk> per share.

I hope that makes sense.

As compared to a net loss of $81 4 million or <unk>.

<unk> per share for the second quarter ended June <unk> 2021.

Clear.

Net loss for the six months ended.

<unk> 2022 was 191 million.

A one going on in 'twenty, one per share compared to a net loss of $166 8 million.

Thank you so much.

Yes.

<unk> and <unk> <unk> per share for the first half of 2021.

Thank you.

Research and development expenses were $73 4 million for the second quarter ended June 32022.

And our next question comes from, the line of Ben Burnett with Stiefel.

The increase of $11 3 million.

Compared to $62 1 million for the second quarter ended June 32021.

Hi, thank you very much.

Research and development expenses were $141 7 million.

For the six months ended June 32020.

I have a question around the release criteria for Lifelucel.

Understanding that the assays themselves have been established and agreed upon, I guess, can you talk about the release margins or release criteria?

The increase of <unk> two.

<unk> 6 million compared to $118 1 million.

For the first half of 2021.

To what extent are the release margins established and agreed upon with the, FDA?

Both are ongoing and planned pipeline activity as well as increased <unk> related to the internal research program costs.

These higher costs were partially offset by lower clinical and manufacturing costs in the first half of 2022.

Given by the completion of enrollment in pivotal clinical trials.

General and administrative expenses were $26 3 million for the second quarter ended June 32022.

The increase of $7 million compared to $19 3 million for the second quarter ended June 32021.

General and administrative expenses were $49 7 million.

For the six months ended June 32022, an increase of $10 8 million.

Compared to $38 9 million for the first half of 2021.

The increase in general and administrative expenses.

Third through the prior of three and six months periods was primarily attributable to the growth of the intermodal general and administrative and commercial teams.

Stock based compensation expense as well as costs associated with the build out of the new co fourth quarter and pre commercial and launch readiness activities.

As well as our overall growth.

As of June 32000 to Institute there were approximately 167 8 million common shares outstanding.

Or is this something that could potentially get ironed out during the review?

With the strength of our balance sheet and by continuing to align our spending with our corporate priorities.

This is something that can get ironed out during the review.

We're well positioned to execute.

Do you plan to commercially launch and beyond.

We would, that is pretty, sensitive stuff for us to release our product specifications, but it is basically a big topic during the review.

We think we have a pretty good idea where we stand in that area right now, but publicly we are going to say very little even after we get it agreed as to what those are, unless we have to.

I will now hand, the call back to the operator to kick off the Q&A session.

Okay.

Thank you.

A reminder to ask a question you will need to press star one one on your telephone please.

Understood.

Please standby, while we compile the Q&A roster.

And then if I could ask one other question.

And our first question comes from the line of Peter Lawson with Barclays.

I think previously you had mentioned that cohorts, so the melanoma cohorts two and four when they were combined have a median DOR that has not yet been reached.

Great. Thanks for the update thanks for taking the questions I guess during the pre BLA meeting was there any discussion around the <unk>.

Confirmation trial that's required.

And then any commentary around alignment around the CSA would be great. Thank you.

Yes.

And I guess, can you comment, is that still the case today?

Yeah. Thanks Peter.

Yes, it's part of the pre BLA meeting confirmatory trials didn't come up and we did get some favorable commentary on <unk>.

Currently planning, we don't have any update to the street just yet on that but there is as you know we're planning.

We will, all I can say there is stay tuned for our presentation at a medical conference, later on this year.

Study later this year and the FDA did.

At least some commentary that we read as being favorable towards <unk>.

We're proposing that trial.

So your second question on the potency assay matrix situation that really wasn't a major topic at the meeting and so we really.

Don't see any change in our prior discussions of that topic come out.

Got you and then I guess a final question around the pre BLA.

My other question would just be around.

The read through from that meeting and how it could help inform.

Filings for cervical cancer and lung cancer.

Interesting question.

Yes.

I think look we learned a lot of that meeting about what it's going to take a break now with FCA to get cell therapies approved so I think in general it gave us some insight we're not going to share all of that publicly because I think it's competitively valuable, but we do know quite a bit now having gone to a pre BLA meeting over this I think is going to be helpful.

There is nothing specific that I think we've learned there that we didn't already know that would impact cervical or long right now, but there is generally some general information that we got out of the meeting and we think it's helpful. As to how you get these drugs approved.

Well certainly take advantage of that.

Great. Thanks, so much.

Okay.

Thank you.

Our next question comes from the line of Michael Yee.

With Jefferies.

Okay.

Hi, This is Dennis on for Mike. Thanks, So much for taking our questions.

Understood.

Two questions from us.

One can you please talk about.

What were the issues discussed at the pre BLA meeting was there anything that the FDA asked that may have been unexpected and I guess lowered their comments on on durability. After seeing the cohort four data and then my second question is.

And I guess, when is the soonest you think you'd get a green light for LUN202 as a, registrational study?

And we noted that you had distinct populations within that study, namely PDL1, 1 to 49% and PDL1, 0%.

Around what specific gating factors to you.

Walk through to actually submit the BLA.

It's a rolling BLA, now, two apparently which which wasn't a.

Scenario for most investors I think so talk about the decision to do that as well. Thank you.

Do you feel confident that one of those subpopulations would have a lower benchmark profilability?

Thank you very much.

Sure so on the first point.

Was SBA commented very favorably about the clinical data and that includes the durability of this all of the data.

They saw the data the second we will be talking about medical conference. Later this year and there was favorable commentary you had mentioned that in our press release, we think they are there.

Supporters of the product from a clinical perspective.

Based on based on what the covenant at the meeting.

So I don't think there was anything specific there or nor would I would say there was anything unexpected at the meeting in terms of.

Let me take the first part and then ask Frederick to speak to the PDL1 status.

Thank you.

We've been seeking FDA feedback on LUN202 as a registrational study.

We don't have anything to update you on right now.

All we can say is we're continuing to enroll as, best as we can in that study to see how the earlier line of treatment works for, you know, teletherapy for those patients.

Frederick, do you want to comment on the PDL1 status in those two cohorts, what the expectations might be?

The rolling BLA is something that gives us some advantages allows us to start looking at our following firstly and start to essentially.

Get comfortable and work worked through some of the modules, while we finish up on a few secondary tasks and get those.

So that's really the story behind the rolling BLA submission.

Got it thank you.

Happy to.

And our next question comes from the line of Colleen Coosey with Baird.

Thank you Andrew.

Our next question comes from the line of Tyler Van Buren with Cowen.

I think that deserves discussion.

Hi, good afternoon.

We have separated these, cohorts like that because we thought that there is a chance that the treatment course under first-line, on first-line therapy might be different.

Hey, guys. Good afternoon. Thank you very much for taking the questions.

I just had a follow up on the pre BLA meeting of course, specifically what feedback did they give you regarding the potential for cohort two data to get into the label and the second question is just a point of clarification for the C. One portfolio zero, one data being presented at a medical meeting by year end.

So that is obviously something that we will have to explore and demonstrate.

If we are not seeing differences, there is a very good chance that we would simply collapse and be able to look at this as a single population.

Will it include the pooled analysis of cohort two for any additional color there will be helpful.

Yes, let me take a member versus order in the second part, yes, we will definitely be talking about the pooled analysis of cohort going forward, we think thats. The most relevant to the medical community as we said before we cannot.

I can have other members of the team follow up and tell you more about that we haven't announced the conference yet.

That is our intention is to focus on that data because thats really the same patient population with the same unmet medical need that same thing investing in yourself.

There.

Back to cohort two being supported the FDA has reiterated the supportive that's a cohort. So they didnt mentioned is in fact hold holdco two in four it could be supportive as well. So we don't know anything more.

And the fact that Dave they've said that many times now and we think thats.

But they are thinking of it didn't have any anything negative to say about cohort two at the meeting.

Great. Thanks.

I hope that makes sense.

Thanks for taking our questions.

Thank you.

And our next question comes from the line of Reni Benjamin with JMP Securities.

Clear.

I know you said previously you, are targeting 40 centers at launch.

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

Maybe just starting off again with the with the pre BLA meeting.

Thank you so much.

Can you remind us roughly how that compares to what the CAR T's had at launch?

Thank you.

Total package Fred how many patients worth of safety data will be included as it is it just those from the C. One floor 401 study or can you pool.

Others together.

And then within those 40 centers, what do you expect the average capacity will be?

Do you think about that as patients per month or beds at a time or just understanding how many patients might fit into that 40 launch?

And when.

In your discussions with them, where there any review issues or do you think there might be a potential for Kodak panel.

Hi, Colleen.

Let me take the second part of that first part and then I'll ask Roger to answer the first part because I actually don't know the exact number of is this full size of the safety 76 last year, we didn't hear anything at the meeting I want to note.

It's Jim here.

Thanks for that.

So we've done a lot of benchmarking of the, CAR T market and we look specifically at claims data over about a four-year period. And what we found is the top 10 centers drive about 50% of all the CAR T treated patients and the top 40 centers account for 80%.

So based upon those insights and the centers of excellence that have been established in the CAR T market, that's how we are targeting the 40 centers, the top 40 centers within the first 90 days after approval.

And anything on kind of capacity within those?

Panel.

Yeah, so I think the way we think about capacity with them is, you know, what is their bed, capacity?

<unk>, what we said previously we think.

Where are they conducting the cell therapy treatment and follow up?

And so it's going to vary site by site.

But we have an idea of how many beds there are in the ICU, how many beds there on the, oncology ward.

We don't think it's something that is going to happen here, but we are preparing in case. There is no duck paddling as you always have to prepare so we're going to be well prepared if that does happen.

And we'll be working with each site specifically to ensure that, you know, we really understand, their capacity, our capacity, and make sure that we're able to treat patients appropriately.

There was nothing at the meeting on that topic.

Gave us any indication that that would be the case.

To answer a question about the the total size of the safety data set.

Yes, I don't think that we share the exact number of patients.

Going into the safety said, what we have shared with the full analysis set with this one.

153 patients.

66 patients from cohort 287 patients from cohort four so those are the patients that will drive the efficacy there are some additional patients.

That could be considered as part of our review of safety data.

They will certainly do that.

Got it and then just as a follow up just based on your FDA discussions regarding the cervical study can you.

Maybe just provide some color as to as to how.

Those discussions went how many patients actually remain.

The study because you know you're going to be re expanding a reopening cohort two I'm just wondering if there's a chance for.

Let's say a data update.

For people, who have remained on the study.

Versus the new patients that you plan on enrolling and about how many patients are you planning on enrolling for the new expanded cohort two.

Yes, so we havent disclosed how many patients remain on study and we are.

What we have what we think is a sufficient amount of data that is always going to put out some data potentially on that as a pivotal study that we have.

You have to be careful about doing that.

At this point fully fully finalized so the total patient number here, but you should think of the sample size here as being similar to what we've looked at for melanoma.

And we're taking that feedback to account so it could be slightly higher.

I have to figure that out as we go here, but.

The sample size I would broadly say is consistent with what we did with melanoma.

Great. Thanks for taking the questions.

Thank you.

Got it.

And the line of Mark Breidenbach with Oppenheimer.

Thank you.

Hey, good afternoon, guys. Thanks for taking our questions and glad to hear the pre BLA meeting went relatively smoothly.

And then just wondering if there's any guidance that we could expect any updates for the lung, programs, either PD-1 combo or additional telemonotherapy data this year?

Just one for Fred.

I was wondering if you can kind of offer any.

Any more granularity around that.

With regard to the cervical cancer cohort that's reopening for enrollment.

I know you can't tell me how many how many patients you are planning to enroll but what does the FDA kind of indicate why they want more patients or is it more to satisfy safety database requirement.

Whereas this request for more patients coming from thanks for taking the questions.

Sure I'll take a member versus orders.

Cervical it's not really so much I'm sure safety is part of what they're thinking, but it's just we need to we need to size of the patient.

We need a size similar to whats been accepted a statistically meaningful for other cell therapies, including our own.

With 20, plus patients in that study thats not going to do it at the patient population. We're interested in so they're just asking us for the efficacy set first and foremost to increase the size.

Savings as well, although we've got well north of 500 patients worth of safety data across our programs.

One the rolling BLA and a little bit more granularity.

We're primarily going to be submitting supportive information during the rolling period.

Such as manufacturing capacity demonstration information and things like that these things are not super complicated there are the.

Things that we can.

We can get done fairly quickly, which is why we've got confidence in that fourth quarter.

As early as possible.

Felicia the rolling BLA.

Alright Thats helpful. Thanks, Thanks for taking my questions and congrats.

Thank you.

And our next question comes from, the line of Ben Burnett with Stiefel.

Not right now.

Our next question comes from the line of Mara Goldstein with Mizuho.

But that's something that's, as I mentioned earlier during the early earnings report there, you know, lung is really important to us.

Hi, thank you very much.

Great. Thanks for taking the question.

I have a question around the release criteria for Lifelucel.

I have a question on manufacturing and at the time of launch I know you have annualized capacity of about 2000 patients but.

So that's something that we'll be looking to do as soon as we can with that many cohorts, open.

What do you think about for sort of steady state. If you will for the initial few months of Watson and how much capacity do you need to read back.

So clinical trial requirements.

And then I'm just curious about.

Okay.

Possibility of improvement on a margin basis.

Where you will be at launch to where you will be when you get to steady state.

Thanks, Bob would you be able to answer that one.

Sure.

Understanding that the assays themselves have been established and agreed upon, I guess, can you talk about the release margins or release criteria?

We hope to be able to get some more data out soon.

Happy to Mara Thanks for your question. So I guess, it's a twofold question. So its launch we have very detailed plans, we're not disclosing the exact numbers, but for flooding obviously.

Great.

Thank you.

For meeting the commercial demand that we anticipate an unparallel of course, we continue clinical trials.

And all of that's included in the capacity of those were planning to have it.

ICT seed.

Then cell therapy center in the Navy yard and also supplemented by additional capacity is needed at our contract manufacturer.

The cost of goods, there's a lot of focus on the margins, obviously and that's the team's working on that and yes when does it.

As we scale up.

The cost of goods, we have more control over those by having their own facility and we expect that to improve over time to time.

Okay, and then just on the rolling BLA.

What's the statutory if you will timeframe for FDA decision time.

From completion of that rolling BLA and like how should we think about that.

So.

From the completion of the Rolling BLA.

Eight months.

Date, however, because youre submitting a rolling BLA benefit as they get to look at it early so you can you have a higher chance of early approval.

Okay, but at the outset, Mark you're thinking yes, that's the way they calculate it but again the benefit of rolling BLA is to is to get in front of us.

To get them right. So that it can beat that date.

Okay. Thanks, so much I appreciate it.

And our next question comes from the line of Joe Catanzaro with Piper Sandler.

Thank you.

Our next question comes from the line of James Chin with Wells Fargo.

Hey, guys.

It's a different patient population, we're talking about they are further if you want to maybe talk about how we're thinking about the patient population from that perspective.

Thanks for the update.

Thanks for taking my questions.

Wondering first if you could clarify whether the decision to move to a rolling BLA submission, was driven by any of the feedback you received during the pre-BLA meeting, or was that decision wholly independent of that?

Yes. Good question no I don't I don't think that we want.

Try to match cohort four because again.

I just said, it's a different patient population.

Much earlier treatment setting remember.

Median number of prior lines of therapy on cohort two cohort three many patients had more lines of therapy. These are quite a bit are still frontline therapy.

<unk>.

So the distribution of all nominees.

Other prognostic factor and we are starting to likely to be different.

And we will not match tied to match the late line population.

There are though.

Some steps that you need to take.

Biden population.

Hey, Glenn.

I think if I like that.

And then second question, maybe perhaps a bit speculative, but wondering if the impact, of duration of prior PD-1 that you've observed in melanoma is something you expect to extrapolate into other settings?

Thank you.

And I guess I'm asking that in the context of post-PD-1 cervical now being the emphasis, in that indication.

Hi, This is Joe on for Africa, We had a couple of questions for you guys wondering how much would it cost you to increase your capacity from 2005 thousand and then how much more additional to increase it.

Thanks.

Let me take the first one, and Frederick, maybe you can take the second question.

Patients per year.

Yes.

During the pre-BLA meeting, I think, provided us with some context for our submission as, a whole.

That the shelf space now that includes a lot of support services as well and when the building is built so we can just expand the shelf space for.

Factoring so it would not be anywhere near 85 billion to expand that space that will get us up to the approximately 5000 patients a year.

We're talking about another building.

Again, you can do a comparison to what we've done in Philadelphia, but it depends on where you do that we do have a very favorable financially favorable optional land here in Philadelphia to expand a lot too, but we could also do it elsewhere.

And it would be something like the investment that we've made in this facility in terms of the lease plus the $5 million just adjusted for inflation and other things that have changed in the real estate market or do you want to add anything to that.

Fred I think you covered it again, it's important to understand the first expansion would be within the existing building sits within the existing shell.

We can add additional looking at 12 core suites to double the course, we have capacity.

That's b beyond that as Fred mentioned it depends on the options, we're considering several where to expand.

Likely to be Greenfield, but there are several location options that could be on the table and we will talk about that in due time its premature to comment on that today.

Great.

I guess when is the soonest, you think you'd get a green light for <unk> to grow to as a Registrational studies and we've noted that you had a distinct populations within that study, mainly PDL, one 1% to 49% and PD L 1% how.

Do you feel confident that one of those subpopulations with lower benchmark profile ability.

In terms of the puts and take the first part and then give frederic to speak to the PDL one status.

We're still on that.

We have been seeking FDA feedback on our <unk> as a registrational study.

We don't have anything to update you on right now.

Both vessels again that study to see.

The earlier line of treatment.

Works for til therapy for those patients.

You want to comment on the PDL one status two cohorts.

Please go ahead.

That'd be too I think.

That is us discussing so remember the PDL one status that we're defining for this cohort with the PDL one status prior to first line therapy. So that is the PDL one status before they start the chemo checkpoint inhibitor therapy.

Therapy, we have.

Separated these cohorts like the because we thought that there is a chance that the treatment course under a first line on first line therapy might be different and because of that these patients might go into cell therapy slightly differently.

Not because we think the pea.

One status.

Lot of cell therapy necessarily would be driving treatment outcome.

So that is obviously something that we that we will have to explore and demonstrate.

We are not seeing differences there.

Good SaaS that we simply collapse and.

And be able to look at this as a single population.

Hope that makes sense.

Clear thank you so much.

Thank you and our next.

Next question comes from the line of Ben Burnett with Stifel.

Alright, Thank you very much.

To what extent are the release margins established and agreed upon with the, FDA?

I have a question around the release criteria for life of Lusso.

Understanding that the assays themselves have been established an agreed upon I guess can you could you talk about the release margins or at least criteria is to what extent are the release margins established an agreed upon with the FDA.

Or is this something that could potentially get ironed out during the review?

Or is this something that could potentially get ironed out during the review.

This is something that can get ironed out during the review.

This is something that can get ironed out during the review and we would that's pretty sensitive stuff for us to release our product specifications.

We would, that is pretty, sensitive stuff for us to release our product specifications, but it is basically a big topic during the review.

It's basically a big topic during the review.

We think we have a pretty good idea where we stand in that area right now, but publicly we are going to say very little even after we get it agreed as to what those are, unless we have to.

I think we have a pretty good idea of where we stand in that area right now but.

Probably we're going to stay very little even after we get an agreed as what those are.

Unless we have to.

Okay.

Understood and then if I could ask one other question I think previously you had mentioned that cohorts. So the melanoma cohort two.

And for when they were combined have a median D var that hasnt yet been reached I guess can you comment is that still the case today.

We will all I can say there is stay tuned for our presentation.

Medical Conference later on this year.

Okay. Okay understood. Thank you very much.

Okay.

Thank you.

Our next question comes from the line of Colleen <unk> with Baird.

Understood.

Hi, good afternoon. Thanks for taking our questions. I know you said previously you're targeting 40 centers that launch can you remind us roughly how that compares to what the car keys had at launch and then within those 40 centers. What do you expect the average capacity will be do you think about that as patients per month their beds at a time I guess understanding.

How many patients might set into that support the launch.

And then if I could ask one other question.

I think previously you had mentioned that cohorts, so the melanoma cohorts two and four when they were combined have a median DOR that has not yet been reached.

<unk>, it's Jim here.

And I guess, can you comment, is that still the case today?

We will, all I can say there is stay tuned for our presentation at a medical conference, later on this year.

So we've done a lot of benchmarking the car T market. When we look specifically at claims data over about a four year period.

Okay.

And what we found is the top 10 centers drive about 50% of all of the car T treated patients in the top 40 centers account for 80%. So based upon those insights and the centers of excellence that have been established in the car T market. That's how we are targeting the 40.

Understood.

Thank you very much.

Thank you.

Centers, the top 40 centers within the first 90 days after approval.

And our next question comes from the line of Colleen Kosey with Baird.

And then just staying on kind of capacity within those.

Yes, I think the way we think about capacity.

What is their bed capacity where are they.

In the cell therapy treatment and follow up and so it's going to vary site by site, but we have an idea of how many there are in the ICU, how many beds there on the.

General oncology Ward and we'll be working with each site specifically to ensure that.

We really understand their capacity our capacity and make sure that we're able to treat patients appropriately.

Got it. Thank you and then just wondering if there was any guidance that we can expect any updates for the lung programs either PD, one combo or additional monotherapy data this year.

Not right now, but that's something it's.

I mentioned earlier during the early earnings.

Point, there one is really important to us so that's something that we'll be looking to do as soon as we can.

That many cohorts open we hope to billions more data out soon.

Great. Thank you.

Thank you and our next question comes from the line of Joe Kattan Zero with Piper Sandler.

And I think as a result of that, we just basically came to the conclusion that a rolling BLA, submission was the best approach here. And really, I don't want to say any more about how that went down, but it's basically a full, picture of what happened led us to the conclusion that the rolling BLA was the best approach for the success of the product, and we think FDA is very supportive and understands all that.

Wholly independent of that and then second question, maybe perhaps a bit speculative but wondering if.

The impact of duration of prior PD, one that you've observed.

Melanoma is something you expect to extrapolate into other settings, and I guess I'm asking that in the context of post PD, one cervical now being the emphasis in that indication.

Frederick, do you want to answer the second part of the question?

So let me let me take the first one and then maybe you can take the second question.

During the pre BLA meeting I think provide us with some context for.

Our submission as a whole and I think as a result of that we just basically came to conclusion that a rolling BLA submission was the best approach here.

Really I don't want to.

I don't want to say anymore.

About how that went down but it's basically a full picture of what happened led us to conclude.

<unk> was the best approaches and Thats the product that we think FDA very supportive.

I understand all that.

But if you want to answer the second part of the question.

Okay.

Yeah, sure.

Good question.

Yeah sure good question.

So I don't think that we have sufficient information at this point yet, either based on clinical, data that we generated, nor on really fully understanding what the mechanism of action is that prior PD-1 therapy might drive that explains some of the differences that have been observed, mainly in melanoma, really, between patients that were previously treated with checked inhibitors, such as the patients in core 2 and 4 in our C14401 study versus patients that are checked inhibitor-naive.

So.

I don't think that we have sufficient information at this point yet either either based on clinical data that we've generated nor on really fully understanding.

What's the mechanism of action is that PD.

<unk> one therapy.

Right.

Volume.

I think some of the differences that have been.

Observed.

Mainly in melanoma really between patients that were previously treated with checkpoint inhibitors, such as the patients in cohort two and four and I'll ask one for their own study versus Ah patients that are checkpoint inhibitor naive.

There are a couple of hypotheses out there, and there are some recent publications coming, out of the Rosenberg group that are elucidating some of that.

There are a couple of hypotheses out there.

There is some recent publications coming out of the Rosenberg group that are elucidating some of that whether that translates into other indications or tumor types I think that needs to be shown clinically. We have presented initial data on combinations of light to move forward with.

Whether that translates into other indications or tumor types, I think that needs to be shown, clinically.

We have presented initial data on combinations of Lysolucel with Pembrolizumab in checkpoint, of a naive patient, namely in patients with head and neck cancer, with cervical cancer. We are seeing encouragingly high response rates that are clearly higher than what you, would be expecting with Pembrolizumab.

September listen up.

In checkpoint naive patients.

In patients with head and neck cancer cervical cancer, we are seeing.

Encouragingly high response rates that are clearly higher than what you would expect.

<unk> with temporary law.

So we might be seeing that difference as well, but I think we need to generate more data.

So we might be seeing that difference as well, but I think we need to generate more data plus cervical cancer. However, the unmet medical need certainly is in the post PD one setting there's really nothing good out. Therefore this patient this is an underserved population of patients.

For cervical cancer, however, the unmet medical need certainly is in the post-PD-1 setting.

There's really nothing good out there for this patient.

This is an underserved population of patients.

Chemotherapy.

Tilt therapy is terribly inefficient after failure of frontline doublet chemo, and tilt, therapy is a real opportunity for these patients, and that's what we are focusing on currently.

Terribly inefficient after failure of frontline doublet chemo.

And.

Til therapy as a real opportunity for these patients and Thats, what we are focusing on currently.

Okay, great.

Okay, great. Thanks for taking my question.

Okay.

Thank you.

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

Thanks for taking my question.

Hi, This is omar.

Thank you.

So we have two questions first how should we think about the objective response rate that will be necessary.

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

Sure.

This will in post PD, one cervical cancer and then too.

Hi, this is Omari from Madhu.

Post PD one in melanoma beyond call. It four can we expect.

Any additional data disclosure from the pipeline 2022.

All we can say.

On your second question I missed what for which study and a second question beyond cohort core from the Opco.

Okay I'll caveat. So can we expect any additional data disclosure from the pipeline got it okay.

Well. The first question there is no right now there is no.

No proof therapy post PD, one cervical patients.

Theres available care out. There then you have to be able to look at assets chemotherapy with very.

Poor results and maybe Fredrick, if you want to add a little bit to that but.

These are things that we don't view as huge barriers to a successful study.

Anything about the available care for surplus we won several patients.

Yes. There is there is limited data on on late line.

Line outcomes of cervical cancer patients with with chemotherapy, which is really the main main therapeutic options.

Patients have or ours are ranging somewhere between three and 15% with chemo that includes additional doublets is quite toxic.

No.

And the duration of.

If responses.

Last time I looked at historical quarter between 405 months.

So that bar is relatively low.

There is no there is no experience with chemo after failure of PD, one checkpoint inhibitors.

The FDA, usually when when you're when you're looking at.

What would be required for an approval says that they were going to look at the totality of the data at the time of approval in the context of available care.

There is not much activity in that field. So maybe maybe these conditions. These initial number could you give me a rough idea.

And to answer the second part of your question do you want to talk about data flow beyond.

The melanoma cohort two cohort four data flows that we already talked about.

The way, we're thinking about it leases lump has not as well so long as one of our priority areas Thats model, we'd like to get some data out soon.

We haven't given any specific guidance on the App is high on our list and then after that the other indications.

Alright, thank you.

Thank you I'm showing no further questions so with that I'll hand, the call back over to <unk> interim President and CEO Fred Boehler for.

For any closing remarks.

Yes.

Hi, good afternoon.

So we have two questions.

Thank you operator.

Sure.

Thank you again for joining the <unk> biotherapeutics second quarter and first half financial results conference call. It's an exciting time to be part of <unk> I would like to recognize the patients physicians and regulators who have collaborated with us throughout the journey to develop til therapy as well as our employees and cross functional teams for their hard work.

Thanks for taking our questions.

First, how should we think about the objective response rate that will be necessary for accelerated recovery of glycolysis and post-PD-1 cervical cancer?

I know you said previously you, are targeting 40 centers at launch.

And then two, on post-PD-1 melanoma, beyond cohort four, can we expect any additional data disclosures from the pipeline in 2022?

Can you remind us roughly how that compares to what the CAR T's had at launch?

And then within those 40 centers, what do you expect the average capacity will be?

Wait, can you say from which?

Do you think about that as patients per month or beds at a time or just understanding how many patients might fit into that 40 launch?

Hi, Colleen.

It's Jim here.

Thanks for that.

Oh, your second question, I missed.

From which study?

In arriving at this point.

And anything on kind of capacity within those?

The second question, beyond cohort four from post-PD-1.

Yeah, so I think the way we think about capacity with them is, you know, what is their bed, capacity?

Beyond cohort, four.

I'd also like to thank our shareholders and covering analysts for their support.

Were they conducting the cell therapy treatment and follow up?

Okay, I'm sorry.

And so it's going to vary site by site, but we have an idea of how many beds there are, in the ICU, how many beds there are on the general oncology ward, and we'll be working with each site specifically to ensure that, you know, we really understand their capacity, our capacity, and make sure that we're able to treat patients appropriately.

Got it.

Beyond cohort four, can we expect any additional data disclosures from the pipeline?

Feel free to reach out nations team, if you wish to follow up and follow up.

Got it, okay.

Thank you.

And then just wondering if there's any guidance that we could expect any updates for the lung, programs, either PD-1 combo or additional telemonotherapy data this year?

Ladies and gentlemen, this concludes today's conference call.

On the first question, there is no, right now, there's no proof of therapy in post-PD-1 cervical patients.

Ladies and gentlemen, this concludes today's conference call.

Not right now, but that's something that I mentioned earlier during the early earnings, report there.

There's available care out there that the FDA would look at.

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

You know, lung is really important to us, so that's something that we'll be looking to, do as soon as we can.

It's chemotherapy with very poor results.

With that many cohorts open, we hope to be able to get some more data out soon.

And maybe Friedrich, if you want to add a little bit to that.

Thank you for participating and you may now disconnect.

Great.

But, you know, these are things that, we don't view as huge barriers to a successful study.

Thank you.

Friedrich, do you want to add anything about the available care for post-PD-1 cervical patients?

And our next question comes from the line of Joe Catanzaro with Piper Sandler.

Yeah, there is limited data on late-line outcomes of cervical cancer patients with chemotherapy, which is really the main therapeutic option these patients have.

Hey, guys.

ORRs are ranging somewhere between 3 and 15 percent with chemo. That includes additional doublets, so it's quite toxic.

Thanks for the update.

So, that's, and the duration, of responses, last time I looked in the historical cohort, it's been four and five months.

Thanks for taking my questions.

So, that bar is relatively low.

There is no experience with chemo after a failure of PD-1 tick planiviters.

The FDA usually, when you're looking at what would be required for an approval, says that, they were going to look at the totality of the data at the time of approval in the context of available care.

And I guess I'm asking that in the context of post-PD-1 cervical now being the emphasis, in that indication.

There is not much activity in that field, so maybe these initial numbers give you a rough idea.

Thanks.

And to answer the second part of your question, you want to think about data flow beyond the melanoma cohort 2, cohort 4 data flow that we already talked about.

Let me take the first one, and maybe you can take the second question.

The way we're thinking about it, at least, is, you know, lung has, non-tumoral lung is one of our priority areas.

During the pre-BLA meeting, I think, provided us with some context for our submission as, a whole.

That's the one we would like to get some data out on soon.

We haven't given any specific guidance on that.

And we think FDA is very supportive in understanding all that.

That's high on our list, and then after that, the other indications.

Frederick, do you want to answer the second part of the question?

All right, thank you.

Yeah, sure.

Thank you.

Good question.

I'm showing no further questions.

So I don't think that we have sufficient information at this point yet, either based on clinical, data that we generated, nor on really fully understanding what the mechanism of action is that prior PD-1 therapy might drive that explains some of the differences that have been observed, mainly in melanoma, really, between patients that were previously treated with check point inhibitors, such as the patients in core 2 and 4 in our C14401 study, versus patients that are check point inhibitor naive.

So with that, I'll hand the call back over to Interim President and CEO, Fred Vogt, for any closing remarks.

There are a couple of hypotheses out there, and there are some recent publications coming, out of the Rosenberg group that are elucidating some of that.

Thank you, Operator.

Whether that translates into other indications or tumor types, I think that needs to be shown, clinically.

Thank you again for joining the IVANS Biotherapeutics second quarter and first half financial results conference call.

We have presented initial data on combinations of Lysolucel with Pembrolizumab in check point, of a naive patient, namely in patients with head and neck cancer, with cervical cancer. We are seeing encouragingly high response rates that are clearly higher than what you, would be expecting with Pembrolizumab.

It is an exciting time to be part of IVANS.

So we might be seeing that difference as well, but I think we need to generate more data.

I would like to recognize the patients, physicians, and regulators who have collaborated with us throughout the journey to develop pill therapy, as well as our employees and cross-functional teams for their hard work in arriving at this point.

For cervical cancer, however, the unmet medical need certainly is in the post PD-1 setting.

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

There is really nothing good out there for this patient.

Please feel free to reach out to H&S teams if you wish to follow up.

This is an underserved population of patients.

Thank you.

Chemotherapy is terribly inefficient after failure of frontline doublet chemo.

Till therapy is a real opportunity for these patients, and that's what we are focusing on currently.

Okay, great.

Thanks for taking my question.

Thank you.

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

Hi, this is Omar from Madhu.

So we have two questions.

First, how should we think about the objective response rate that will be necessary for expiry approval of glycolysis and post PD-1 cervical cancer?

And then two, on post PD-1 melanoma, beyond cohort 4, can we expect any additional data disclosures from the pipeline, 2022?

Wait, can you say from which?

Oh, your second question, I missed.

From which study?

The second question, beyond cohort 4 from post PD-1.

Beyond cohort 4.

Okay, I'm sorry.

Yeah, beyond cohort 4, can we expect any additional data disclosures from the pipeline this year?

On the first question, there is no, right now, there's no proof of therapy in post PD-1, cervical patients.

There's available care out there that the FDA would look at.

It's chemotherapy with very poor results.

And maybe, Friedrich, if you want to add a little bit to that.

But, you know, these are things that we don't view as huge barriers to a successful study.

Friedrich, do you want to add anything about the available care for post PD-1 cervical patients?

Yeah, there's limited data on late-line outcomes of cervical cancer patients with chemotherapy, which is really the main therapeutic option that these patients have. ORs are ranging somewhere between 3 and 15% with chemo.

That includes additional doublets, so it's quite toxic.

So, that's, and the duration of responses, last time I looked in the historical cohort, it's been 4 and 5 months.

So, that bar is relatively low.

There is no experience with chemo after failure of PD-1 tick planiviters.

The FDA usually, when you're looking at what would be required for an approval, says that they are going to look at the totality of the data at the time of approval in the context of available care.

There is not much activity in that field, so maybe these initial numbers give you a rough idea.

And to answer the second part of your question, you want to think about data flow beyond, the melanoma cohort 2, cohort 4 data flow that we already talked about.

The way we're thinking about it, at least, is, you know, lung has, non-small-cell lung is one, of our priority areas.

That's the one we would like to get some data out on soon.

We haven't given any specific guidance on that, but it's high on our list, and then after that, the other indications.

All right, thank you.

Thank you.

I'm showing no further questions, so with that, I'll hand the call back over to Interim President and CEO, Fred Vogt, for any closing remarks.

Thank you, Operator.

Thank you again for joining the IVANS Biotherapeutics second quarter and first half, financial results conference call.

It is an exciting time to be part of IVANS.

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

Please feel free to reach out to the nation's team if you wish to follow up.

Thank you.

Q2 2022 Iovance Biotherapeutics Inc Earnings Call

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