Q3 2023 Iovance Biotherapeutics Inc Earnings Call

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Speaker 1: Welcome to the I-OVANCE Biotherapeutics third quarter and year-to-date 2023 financial results and corporate updates conference call. My name is Abigail and I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later we'll conduct a question and answer session. To ask a question, you will need to press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised.

Welcome to the Io vans, biotherapeutics third quarter and year to date, 'twenty 'twenty financial results and corporate update conference call.

My name is Abigail and I will be your operator for today's call. At this time all participants are in a listen only mode. Later, we'll conduct a question and answer session to ask a question you will need to press star one on your telephone you will then hear an automated message advising your hand is raised.

Speaker 1: Please note that this conference is being recorded. I will now turn the call over to Sarah Pellegrino, Senior Vice President in investor relations and corporate communications at IOVANTS. Sarah, you may begin.

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.

Speaker 2: Thank you, Operators. Good afternoon and thank you for joining us.

Sir you may begin.

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

Speaker 2: Speaking of today's call, we have Dr. Fred Vot our interim president and chief executive officer, Dr. Ihor Balinsky, our chief operating officer, Jim Zeebler, executive vice president commercial, Dr. Fryberg-Sinkinstein, our chief medical officer, and John Mark Bellamen, our chief financial officer.

Speaking on today's call, we have doctor friend vote, our interim President and Chief Executive Officer Doctor Yorba, Linda <unk>, Our Chief operating Officer, Jim Ziegler Executive Vice President commercial Doctor Fragrance Stein, our Chief Medical Officer, and John Mark Sullivan, Our Chief Financial Officer.

Speaker 2: Dr. Brian Gasson, Executive Vice President Medical Affairs, and Dr. Raj Prairie, our Executive Vice President, regulatory strategy and translational medicine are available for the Q&A session.

Brian Johnson Executive Vice President Medical Affairs, and Dr. Raj Gray, our executive Vice President regulatory strategy and translational medicine are available for the Q&A session.

Speaker 2: This afternoon, we issued a press release that could be found at our corporate website at bioband.com, which includes the financial results for the three and nine months ended on September 30th, 2023, as well as recent corporate updates.

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

Dot Com, which includes the financial results for the three and nine months.

2023.

As well as recent corporate updates.

Speaker 2: Before we start, I would like to remind everyone that statements made during this conference call will include forward-looking statements regarding IOMAP's goals, business focus, business plans and transactions, revenue, pre-commercial activities, clinical trials and results.

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

Forward looking statements regarding I hope that this goal is still good business plans and transaction revenue pre commercial activities clinical trials in adult.

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

Regulatory interaction plans and strategies research and preclinical activities.

Future applications of our technologies manufacturing capabilities regulatory feedback and guidance Payor interactions.

Since it then collaboration cash position on expense guidance and future updates.

Speaker 2: Forward-looking statements are subject to numerous risk-synun-certainties, many of which are beyond our control, including the risk-synun-certainties 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 and SEC filings.

Speaker 2: Our results may differ materially from those projected during today's call. We undertake no obligation to publicly update any forward-looking statements. With that, I will turn the call to the next speaker.

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.

Speaker 3: Thank you, Sarah, and good afternoon, everyone. I'm pleased to highlight several recent important milestones was describe.

Thank you Sarah and good afternoon, everyone I'm pleased to highlight some recent important milestones Robbins.

Speaker 3: continue to make significant progress towards US commercialization while pursuing opportunities for atill therapies and additional geographies in solid tumor cancer.

We continue to make significant progress towards U S commercialization, while pursuing opportunities for our til therapies in additional geographies and it's all through.

Speaker 3: Our top priority is to secure FGA approval on launch light for loose on the US to new class of treatment for advanced non-owned patients with limited options.

Our top priority is to secure FDA approval and launched like for loose on the U S. A new class of treatment for advanced melanoma patients with limited options.

Speaker 3: Overall, the BLA process continues on the priority review with several positive stats.

Overall, the BLA process continues under priority review with several positive status updates.

Speaker 3: We remain engaged with the FDA to complete the review as efficiently as possible.

We remain engaged with the FDA to complete the review as efficiently as possible.

Speaker 3: As a reminder, the FDA reiterated in September that there are no major review issues and no plans to hold an advisory committee meeting.

Minor the FDA reiterated in September that there are no major review issues and no plans to hold an advisory Committee meeting.

Speaker 3: In addition, all pre-approval inspections of all clinical sites and internal and external manufacturing and testing facilities have been successfully completed.

In addition, all pre approval inspections of all clinical sites and internal and external manufacturing and testing facilities have been successfully completed.

Speaker 3: The FDA is also engaged and has no concerns of the status of the Tillbance 301 confirmatory trial, which remains on track to be well underway by the producer.

The FDA has also engaged has no concerns with the status of the Covance deal one confirmatory trial, which remains on track to be blown away by the producer.

Speaker 3: We appreciate the FDA review team's efforts to expedite the remaining review. We are confident in the potential for life of Lusol to redefine the treatment paradigm for these patients who have no approved options after current standard of care.

We appreciate the FDA team's efforts tax rates are meeting review, we're confident in the potential for life of Leucyl to redefine the treatment paradigm for these patients who have no approved options after current standard of care.

Speaker 3: The strength of our clinical data, manufacturing capabilities, and commercial readiness efforts, I have an instance ready to rapidly serve the US Milano and the community, and really following an approval, including the potential scenario for approval earlier than the February 24th, 2024.

With the strength of our clinical data and manufacturing capabilities and commercial readiness efforts.

Have answers ready to rapidly sharp U S melanoma community immediately following approval, including the potential scenario for approval earlier than the February 24th 2015 for PPD.

Speaker 3: Beyond the US, we plan to submit additional marketing applications for Lake Flucile in Europe and other GeoGer.

Beyond the U S. We plan to submit additional marketing applications for <unk> Lusso in Europe and other geographies.

Speaker 3: Based on positive feedback for the European Medicine Agency on codes 2 and 4, the C-1 for 401 clinical trial, we plan to submit a marketing authorization application at the first half of 2024 with a potential European launch in 2025.

Based on positive feedback from the European Medicines agency in cohorts, two and four seat one full floor of one clinical trial, we plan to submit a marketing authorization application in the first half of 2020 for a potential European launch in 2025.

Speaker 3: We're also engaged with regulatory authorities in the United Kingdom and Canada.

We're also engaged with regulatory authorities in the United Kingdom and Canada.

Speaker 3: plan to submit marketing applications in both countries in the second half of next year, again with potential launches in 2025. Key markets such as Germany, France, and the UK have mechanisms for early access and reimbursement that can begin to drive significant additional near-term revenue by the end of 2025.

We plan to submit marketing applications in both countries in the second half of next year again with the potential launches in 2025.

Key markets, such as Germany, France, and the UK have mechanisms for early access and reimbursement. It can begin to drive significant additional near term revenue by the end of 2025.

Speaker 3: Next year we expect to have additional regulatory updates about our expansion plans for LIFEL in Australia and other countries with a significant number of advanced melanoma patients.

Next year, we expect to have additional regulatory updates about our expansion plans for life looser, Australia and other countries.

Difficult number number of advanced melanoma patients.

Speaker 3: Collectively, the advanced non-o-population in Germany, France, the UK, Canada, and Sludley-Large, and the US patient population with the same unmet medical need. Our geographic expansion, when complete, can more than double the total address-hole patient population for life-illusional and advanced non-o.

Collectively the advanced melanoma population of Germany, France, UK, and Canada is slightly larger than the U S patient population with the same unmet medical need.

Our geographic expansion when complete more than double the total addressable patient population for <unk> in advanced melanoma.

Speaker 3: We plan to leverage existing resources to serve the Melanoma community in these new geographies without incurring significant additional expense.

We plan to leverage existing resources to serve the melanoma community in these new geographies without incurring significant additional expenses for.

Speaker 3: For example, our IBAN self-therapy center or ICTC has sufficient capacity for these new countries. We already have an existing office name, so they have a field medical support in the region.

For example, our advanced cell therapies in our ICT C has sufficient capacity for these new countries.

<unk> already has existing Sam Samad field medical support in the region.

Speaker 3: As we prepare the launch light, Volusil, we are also upgrading ProLukein, apparently marketed aisle two product uses part of the Tilt Therapy Reg.

Yeah.

As we prepare to launch like Melissa. We're also integrating proleukin currently marketed our two product used as part of til therapy regimen.

Speaker 3: By owning pre-luchin we can offer it alongside light blue so it can have full control of the IL-2 supply chain.

By owning <unk>, we can offer alongside light blue solid have full control of the IL two supply chain.

Speaker 3: We also expect to lower clinical trial expenses and future costs of goods for life will lose.

We also expect to lower clinical trial expenses and future cost of goods for life Leucyl.

Speaker 3: The honor regulatory commercial ratings activities are robust tilt therapy pipeline continues to advance with seven active clinical trials.

Beyond our regulatory commercial readiness activities are robust cell therapy pipeline continues to advance with seven active clinical trials.

Speaker 3: These include two registration trials. I have an, or sorry, to be in 301 in front of my melanoma. And LUN202, and previously treated advanced lung cancer, which Frederick will highlight in a moment.

These include two Registrational trials.

Sorry, Tobey in 301 frontline melanoma.

202 in previously treated advanced lung cancer, which Frederic will highlight in a moment.

Speaker 3: Completing enrollment in OUN 202 in 2024 is a top priority towards a potential supplemental BLA file.

Completing enrollment I know you went to a two and 2024 is a top priority towards potential supplemental BLA filings.

Speaker 3: Additional clinical trials include the IOP, come to a two trial and fellow tumors, and our first in human trial, originally modified self therapy, IOP 4,0001.

Additional clinical trials include the Iowa E com to a two trial in solid tumors.

Our first in human trial of our genetically modified til therapy IV 4001.

Speaker 3: Lastly, we are excited to introduce a new IVANS Tilt Therapy program in Endometrial.

Lastly, we are excited to introduce a new Ibs til therapy program in endometrial cancer.

Speaker 3: Checkpoint inhibitors are moving into earlier why the therapy leaving an unmet medical need for patients to progress before or after a meet-a-thera being chemothera.

Check point inhibitors or moving into earlier lines of therapy, leaving an unmet medical need for patients who progressed on or after immunotherapy and chemotherapy.

Speaker 3: Frederick will provide more details on this new program later in this call.

Fredrik will provide more details on this on this program later in this call.

Speaker 3: Turning to our organization, we have more than 500 people with experience in developing and commercializing oncology and cell and gene therapy products.

Turning to our organization, we have more than 500 people with experience in developing and commercializing oncology and cell and gene therapy products.

Speaker 3: They are ready for our initial US launch, XUS expansion, and ongoing pipeline development.

We're ready for our initial U S launch ex U S expansion and ongoing pipeline developments.

Speaker 3: We have recently completed headcount for it's a significant one-time investment, six commercial manufacturing readiness activities to prepare for launch and expand our pipeline.

We have recently completed a head count for US a significant one time investments in commercial manufacturing readiness activities to prepare for launch and expand our pipeline.

Speaker 3: Following these one-time investments in strategic portfolio prioritization, we can reduce quarterly and annual operating expenses in the remainder of 2023 and full year 2024 while continuing low key clinical programs in internal manufacturing capability.

Following these one time investments in strategic portfolio prioritization.

We can reduce quarterly and annual operating expenses in the remainder of 2023 and full year 2024, while continuing while key clinical programs and internal manufacturing capabilities.

Speaker 3: In addition, our September 30th cash position of roughly $420 million is expected to fund our operating plan into 2025.

In addition, our September 30 cash position of roughly $428 million is expected to fund our operating plan into 2025.

Speaker 3: John Mark will provide additional color on the expense guide and to catch runway assumptions on today's call.

Mark will provide additional color on the expense guidance and cash runway assumptions on today's call.

Speaker 3: We're excited about the near-term future at I-Vance as we advance and broaden our mission to be the global leader in innovating, developing and delivering tilt therapies for people with cancer across multiple tall tumours.

We're excited about the near term future and I've answered as we advance and broaden our mission to be the global leader in innovating developing and delivering til therapies for people with cancer across multiple solid tumors.

Speaker 3: I look forward to addressing your questions later in this call, and we'll now ask you to present our manufacturing updates.

I look forward to addressing your questions later on this call I will now ask you go to present, our manufacturing updates.

Speaker 4: We are connected to operational excellence and today have provided tilt therapy to more than 600 patients with a consistent manufacturing success rate of more than 90%.

Thank you Brad.

We are committed to operational excellence.

To date has provided til therapy to more than 600 patients with a consistent manufacturing success rate of more than 90%.

Speaker 4: As part of the BLA review process, the FDA completed successful pre-licensed inspections of our I-AVAN cell therapy center facility, or ICDC, and our contract manufacturer's facility.

As part of the BLA review process. The FDA completed successful pre licensing sections of our <unk> cell therapy center facility or ICD.

And our contract manufacturers facility.

Speaker 4: Both sites are prepared with sufficient capacity and staffing to supply or commercial lunch and clinical trials.

Both sites are prepared with sufficient capacity and staffing to supply or commercial launch and clinical trials.

Speaker 4: Our manufacturing network strategy supports our vision to establish TIL therapy as the next paradigm shifting class of cancer therapy in the US and beyond.

Our manufacturing network strategy supports our vision to establish til therapy as the next paradigm shifting cost of cancer therapy in the U S and beyond.

Speaker 4: The ICDC is currently built to supply two products for more than 2000 patients annually in the US and our plan-jerk traffic expense.

The ITC is currently built to supply two products for more than 2000 patients annually in the U S and our planned geographic expansion.

Speaker 4: By building out additional existing shell space, ICDC may ultimately supply two products for more than 5000 patients annually.

By building out additional existing shelf space ICD CMA ultimately supply tube products for more than 5000 patients annually.

Speaker 4: Longer term, our vision is to build capacity for more than 10,000 patients annually by adding new facilities as well as streamlining and automating manufacturing.

Longer term, our vision is to build capacity for more than 10000 patients annually by adding new facilities as well as streamlining and automating manufacturing processes.

Speaker 4: Intellectual property or IP is also a critical component at iVents. We currently own at least 60 granted or allowed US and international patents, including Gen 2 patent rights that we expect to provide exclusivity into 2038.

Intellectual property or IP is also critical components that we currently own 60 granted or allowed U S and international Athens, including Gen. Two patent rights that we expect to provide exclusivity into 2038.

Speaker 4: extensive detail on ION's own IP is available on our corporate website and within our annual report on Fountain.

Extensive detail on <unk> owned IP is available on our corporate website and within our annual report on Form 10-K.

Speaker 4: I would now like to hand the call to Jim Ziegler to highlight our commercial launch preparations. Jim?

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

Speaker 5: Thank you, Igor. At Iovance, we have the potential to transform the practice of medicine in advanced melanoma and additional solid tumors. In the U.S., approximately 8,000 people die of melanoma annually, and the World Health Organization reports higher mortality in Europe .

Thank you Igor I events, we have the potential to transform the practice of medicine and advanced melanoma in additional solid tumors.

In the U S. Approximately 8000 people die of melanoma annually and the World Health organization reports higher mortality in Europe.

Speaker 5: LIPLUSAL has the potential to be standard of care for patients who have no currently approved treatment options after standard of care frontline therapy.

<unk> has the potential to be standard of care for patients who have no currently approved treatment options after standard of care frontline therapy.

Speaker 5: We have a sense of urgency to deliver Lifelucel to these advanced melanoma patients upon approval.

We have a sense of urgency to deliver LIFO lethal to these advanced melanoma patients upon approval or.

Speaker 5: Our commercial and cross-functional teams are on track as we approach our Purdue for date. Today, I will highlight onboarding for authorized treatment centers or ATCs, payer engagement and commercial operational readiness activities.

Our commercial and cross functional teams are on track as we approach our <unk> date today I will highlight onboarding for our authorized treatment centers or atc's payer engagement and commercial operational readiness activities.

Speaker 5: Onboarding is a strong indication of ATC commitment and life-alucal demand. Today's press release provided our first status update on ATC onboarding.

First on.

Onboarding is a strong indication of ATC commitment and LIFO leucyl demand today.

Today's press release provided our first status update on ATC Onboarding.

Speaker 5: Approximately 30 centers have completed pre-approval onboarding steps to establish their TIL service line capability.

Proximately 30 centers have completed pre approval onboarding steps to establish their til service line capabilities.

Speaker 5: These centers are educated in all aspects of the lipoleucel treatment regimen with staff and processes to begin treating patients pending the approval.

These centers are educated in all aspects of the LIFO lethal treatment regimen with staff and processes to begin treating patients pending the approval.

Speaker 5: Previously, we shared our gold on board 40 ATCs within 90 days of the Padufa day.

Previously we shared our goal to onboard 40, Atc's within 90 days of the <unk> date.

Speaker 5: Based on our onboarding progress, we now expect to onboard approximately 50 centers within 90 days of the Padoe Vidae. We are also planning a disciplined approach to organize and schedule each HEC for their first treatments with full Iovan support.

Based on our Onboarding progress, we now expect to onboard approximately 50 centers within 90 days of the Paducah date.

We are also planning a disciplined approach to organize and schedule each ATC for their first treatment with full <unk> support.

Speaker 5: We believe a positive initial experience will drive long-term success and peak revenue.

We believe a positive initial experience will drive long term success and peak revenues.

Speaker 5: Reimbursement is also essential for patient access and provider adoption.

Reimbursement is also essential for patient access and provider adoption.

Speaker 5: Our market access team continues to engage the key national and regional payers to accelerate timely access and appropriate reimbursement for life elusal upon approval.

Our market access team continues to engage the key national and regional payers to accelerate timely access and appropriate reimbursement for LIFO lusso upon approval.

Speaker 5: We believe payers appreciate the high and met need, lack of treatment options.

We believe payers appreciate the high unmet need and lack of treatment options.

Speaker 5: and clinical value of life elucid when advanced melanomes.

And clinical value of LIFO LIFO in advanced melanoma.

Speaker 5: We expect strong reimbursement for life elusal. With the pair mix that includes a favorable, commercially-insured population.

We expect strong reimbursement for like the looser with the payer mix that includes a favorable commercially insured population.

Speaker 5: More than three-quarters of advanced melanoma patients are currently insured through commercial, Medicare Advantage, and Medicare IPPS Exempt Sagnets.

More than three quarters of advanced melanoma patients are currently insured through commercial Medicare advantage and Medicare PPS exempt segment.

Speaker 5: Based on our payer interactions, we expect coverage similar to CAR keys required prior authorization with coverage consistent with label. Medical coverage policies issued within about 90 to 180 days and single case agreements for commercially insured patients.

Based on our payer interactions, we expect coverage similar to car T requiring prior authorization with coverage consistent with label medical coverage policies issued within about 90 to 180 days and single case agreements for commercially insured patients.

Speaker 5: Although pricing will be disclosed after approval, we believe the lipoleucel value proposition supports pricing in the higher range of CAR T cell therapy.

Although pricing will be disclosed after approval, we believe the LIFO looser value proposition supports pricing and the higher range of car T cell therapies. The car T prices range from 424000 to 508000 based on current and reported price increases.

Speaker 5: The CAR T prices range from $424,000 to $508,000 based on current and reported price increases with additional price increases expected in early 2024.

With additional price increases expected in early 2024.

Speaker 5: In addition to lifalucel, we will receive incremental revenue from the sales of proleucin for each patient.

In addition to LIFO Luzon, we will receive incremental revenue from the sales of Proleukin for each patient.

Speaker 5: As a reminder, revenue recognition for life-illusal occurs upon infusion, like other felt-bear.

As a reminder, revenue recognition for LIFO lusso occurs upon infusion like other cell therapies.

Speaker 5: As we approach the U.S. launch, I would like to highlight the extensive cross-functional launch preparations underweath. Our commercial and cross-functional teams are on track as we approach our pedophadies and we remain confident in our ability to deliver a successful launch.

As we approached the U S launch I would like to highlight the extensive cross functional launch preparations underway.

Our commercial and cross functional teams are on track as we approach our <unk> date, and we remain confident in our ability to deliver a successful launch.

Speaker 5: I will now pass the call to Friedrich Finkins, I'm our Chief Medical Officer to highlight our clinical progress.

I will now pass the call Dr. Friedrich Finkelstein, our Chief Medical officer to highlight our clinical progress.

Speaker 6: Thank you, Jim. This afternoon's press release highlighted several pipeline updates. On the call today, I would like to focus on our recent data presentations, which are available on our corporate website, as well as selected registrational programs in frontline advanced melanoma and non-small cell lung cancer. I will also discuss our new TIL program in endometrial cancer.

Thank you Tim this.

This afternoon's press release highlighted several pipeline update.

On the call today, I would like to focus on our recent data presentations, which are available on our corporate website.

Well the selected Registrational programs in frontline advanced melanoma, and non small cell lung cancer.

I will also discuss our utility program in endometrial cancer.

Speaker 6: We are pleased that several recent posters and presentations from our C14401 trial continue to support the potential benefit of lifelucid as a one-time treatment that is differentiated from other immunotherapies for advanced melanoma.

Okay.

We are pleased that several recent posters and presentations from RSC 14401 trial continued to support the potential benefits of life a lot of that's a onetime treatment that is differentiated from other immunotherapies for advanced melanoma.

Speaker 6: In October , during the European Society for Medical Oncology, or ESMO, Congress and at this week's Society for Melanoma Research, or SMR, we highlight clinically meaningful and durable activities for life elusive from a subgroup analysis of patients with the rare and difficult-to-treat mucosal melanoma subtype.

October during the European Society for medical oncology or ESMO Congress and at this week's society for melanoma research or at the Mark we highlight clinically meaningful and durable activity for life Luther from a subgroup analysis of patients with the rare and difficult to treat mucosal melanoma subtypes.

Speaker 6: During the Society of the Immunotherapy of Cancer R, SATC Annual Meeting last week, we highlighted the durable efficacy shown in a now four-year analysis of COHOT 2 and 4 of the C14401 trial. Our poster reported the longest follow-up data on life-illusal treatment outcomes in the largest population of patients with anti-PD1 refractory advanced melanoma treated with TOTAR.

During the society of immunotherapy of cancer or <unk> annual meeting last week, we highlighted the durable efficacy. So now four year analysis of cohort two and four of the E. One four for the <unk> trial.

Our poster reported a longer follow up data on like the little treatment outcome and the largest population of patients with anti PD, one refractory melanoma treated with til therapy.

Speaker 6: Our registrational trials continue to advance an additional indication.

Our business traditional trial continue to advance in additional indications.

Speaker 6: TILVANS-301 is designed to support accelerated and full approvals of Loyfilusol in combination with Tembrelizumab in front line advanced melanoma. This randomized trial remains on track to be well underway at the time of potential approval and is designed as the confirmatory trial to support full approval for Loyfilusol in post anti-PD-1 ducting melanoma.

Till then 301 is designed to support accelerated and full approval of <unk> in combination with timberlands them up in frontline advanced melanoma.

It's randomized trial remains on track to be well underway at the time of potential approval and is designed is the confirmatory trial to support full approval for life and hopeful and post anti PD one in melanoma.

Speaker 6: We continue to randomize patients and activate global threats in the Stodans 3A1 in key geographies with a large presence of melanoma patients and the potential for strong involvement. We recently activated new threats in the US and the first site in Australia. We also have regulatory clearances to open sites in the United Kingdom and Canada.

We continue to randomize patients and activate global price and still bank's Korean won and key geographies with a large presence of melanoma patients and the potential for strong enrolment.

We recently activated new sites in the U S and the first site in Australia. We also have regulatory clearances to open sites in the United Kingdom and Canada.

In non small cell lung cancer. We have also made significant progress with our Registrational strategy.

Speaker 6: IOV, LUN, 202 with our registration single arm phase 2 trial in post-antipity 1 long cam.

I L. B L. U N 202, with our Registrational single arm phase two trial in post anti PD, one lung cancer.

Speaker 6: Following the positive preliminary data analysis from LUN202, physician interest and momentum for center participation is strong and remain actively activated with the site.

Following the positive preliminary data analysis from Ellie went to a two physician interest and momentum for front of participation are strong and remain accurately activated.

Speaker 6: We also have FDA regulatory feedback that the trial design may be acceptable for an accelerated approval of TIL therapy and post-antipedioinox mausulanca.

Right.

We also have FDA regulatory feedback that the trial design may be acceptable from accelerated approval of til therapy and post anti PD, one non small cell lung cancer.

Speaker 6: The preliminary analysis ensued the data from the registration of population in courts one and two, which enrolled EGFR Roth or alt mutation negative patients who have progressed on or after chemotherapy and anti-PD one third.

The preliminary analysis until the data from the Registrational population in cohorts, one and two which enrolled Egfr Russ are out mutation negative patients who have progressed on our out of chemotherapy and anti PD. One therapy six patients had a confirmed objective response, representing an O R. R of $26 one.

Speaker 6: Six patients had a confirmed objective response, representing an ORR of 26.1%.

Speaker 6: All six responses, including one complete response and five partial responses, remained ongoing at the time of the data analysis and ranged from 1.4 plus to 9.7 last month.

All six responses, including one complete response and five partial responses remains ongoing at the time of the data analysis and range from one four plus 497 months.

Speaker 6: We remain on track to complete enrollment in LU-212 and the second half of 2024. Based on this trial, we intend to submit a supplemental DLA for a US-excelluated approval in post-antipity-1 non-small-fail-on-cancer. We are proposing a Phase III Registrationals trial in front-line-line-lancer, which is intended to serve as the confirmatory trial for full approval in the post-antipity-1 setting, and to support an approval in front-line treatment setting.

We remain on track to complete enrollment and you want to or two in the second half of 2024.

Based on this trial, we intend to submit a supplemental BLA for U S accelerated approval and post anti PD, one non small cell lung cancer, we are proposing a phase III registrational trial in frontline lung cancer, which is intended to serve as the confirmatory trial for full approval.

Did you want setting and to support an approval in frontline treatment setting.

Speaker 6: We plan to meet with FDA early next year to discuss the phase three registrational trial where our goal is to improve front-line on small cell and cancer therapy by adding to therapy to standard of care, panberalism, and maintenance therapy administered after completion of the initial chemo immunotherapy.

Plan to meet with FDA early next year to discuss the phase III Registrational trial, where our goal is to improve frontline non small cell lung cancer therapy by adding til therapy to standard of care Pembina maintenance therapy administered after completion of the initial chemo immunotherapy.

Speaker 6: Our confidence in this frontline trial design is supported by the encouraging responses and response durations that we have observed with the TIL-pembrolizumab combination compared to standard of care benchmarks, even without chemotherapy.

Our confidence in the frontline trial design is supported by the encouraging responses.

Duration that we have observed with the til tamper lithium combination compared to standard of care benchmarks either without chemotherapy.

Turning toward our new program in endometrial cancer.

Speaker 6: As Fred mentioned, we are starting an IOMAN Philtherative Programme and the Metriole Cancer. The standard of care frontline treatment is shifting and there is a lack of approved treatment options for patients who progress on or after immune checkpoints that are containing treatment regimen.

As Rick mentioned, we are starting in Ireland til therapy program in endometrial cancer. The standard of care frontline treatment is shifting and there is a lack of approved treatment options for patients who progressed on or after immune checkpoint inhibitor containing treatment regimen.

Speaker 6: Analogous to other tumor types, our one-time TIL therapy may offer benefit in this setting. Based on the TIL mechanism of action, the benefit of TIL therapy is likely to extend across patients with tumors that are mismatch repair mechanism deficient and proficient, and our clinical program will include patients from both subgroups.

Analogous to other tumor types, our onetime til therapy may offer benefit in the Sydney.

Based on the mechanism of action the benefit of til therapy is likely to extend across patients with tumors that have mismatch repair mechanism deficient and profession and our clinical program will include patients from both subgroups.

Speaker 6: We look forward to providing more details as we work towards initiating the study in the first half of 2024. I am available

Look forward to providing more details as we work towards initiating the study in the first half of 2024.

I'm available during the question and after session.

Speaker 6: For now, I will hand the call over to Zomark to discuss our year-to-date 2023 financial results.

For now I will hand, the call over to Mark to discuss our year to date 2023 financial results.

Thank you for that.

Speaker 7: I will summarize the high-level financial results for the three and nine months ended on September 3, 2020.

I will summarize the high level financial results for the three and nine months ended September 32000.

Speaker 7: More details can be found in the softening press release as well as in our SEC file.

More details can be found in this afternoon's press release as well as in our eyes.

The SEC filings.

Speaker 7: Beginning with the balance sheet, Iovance had $427.8 million in cash, cash equivalents, investment and restricted cash as of September 30, 2023.

Beginning with the balance sheet.

$427 8 million.

Cash cash equivalents investments and restricted cash as of September 32023.

Speaker 7: Compared to $478.8 million as of December 31, 2020.

<unk> $478 3 million as of December 31st question for instance.

Speaker 7: The current cash position includes approximately $200 and $3.2 million in combined net proceeds from our public offering in July 2020.

The current cash position includes approximately room to run through them $3 2 million daus in <unk>.

Combined net proceeds from our public offering in July 2023.

Speaker 7: and the other market equity facility financing facility.

The other market equity financing.

Speaker 7: We expect our cash position and anticipated 2024 moving you from life, all those all and for looking to be sufficient to found current and land operation into 2025.

We expect our cash position and anticipated 2020 for revenue from local and southern cooking to be sufficient to fund current and planned operations into towards the 25.

Speaker 7: As Fred described earlier, we continue to internally prioritize and optimize our operations and completed many one-time investments.

As Fred described earlier, we continue to internally prioritize and optimize our operation and completed the menu one time investments.

Speaker 7: As we carefully manager operating expenses, we are guiding towards 2024 cash burn in the range of 320 to 340 million dollars, including one time expenses.

As we carefully manage our operating expenses we.

We are guiding towards 2020 forecast burn in the range of 320 to 314 million.

Excluding onetime expenses.

Speaker 7: and will continue to look for opportunities to further streamline spending and driver

And we'll continue to look for opportunities to further streamline spending on driver of them.

Speaker 7: Transitioning to financial results, net loss for the third quarter and September 30, 2023 was $113.8 million, or 46 cents per share, compared to a net loss of $99.6 million, or 63 cents per share, for the third quarter and September 30, 2023.

Transitioning to financial results.

Net loss for the third quarter ended September 32023 was $113 8 million.

46 cents per share compared to a net loss of $99 6 million or <unk>.

<unk> 63 per share for the third quarter ended September 32000 probes.

Speaker 7: Net loss for the 9 months and the September 30, 2023 was $327.7 million or $1.44 per share compared to a net loss of $290.6 million or $1.80 per share from the same period and the September 30, 2020.

Net loss for the nine months ended September 32023 was 227 $7 million or $1.44 per share.

Compared to a net loss of $290 6 million.

One the law and that 80 cents per share from the same period ended September 32.

2022.

Speaker 7: We began recording revenue from product sales following the Polukin acquisition in May 2023 and anticipate significant revenue after the launch of LIFON.

We began recording revenue from product sales following the polluting acquisition in mid 2023, and anticipate significant revenue after the launch of LIFO himself.

Speaker 7: Revenue for the third quarter and nine months ended September 30, 2023 was $469,000 and $777,000 on This note only headed for the third quarter, did you see the enclosure in 2016?

Revenue for the third quarter and nine months ended.

So Tom referred to 2023 was $469000 and 707000 got all respectively.

Speaker 7: There were no revenue for the third quarter and nine months under September 13, 2020.

There were no revenue for the third quarter and nine months ended September 32022.

Speaker 7: Corporate sales for the third quarter, and nine months and the September 30, 2022, 23, sorry, was $4.3 million, and $6.4 million respect.

Cost of sales for the third quarter and nine months ended September 32022.

I am sorry was $4 3 million Doyle and $6 $4 million respectively.

Speaker 7: The cost of sales includes cost of inventory associated with sales of polluting as well as 4 million dollars and 5.9 million dollars respectively of non-cash amortization expenses of the required intangible assets for developed technology in the three and nine months period and the September 30, 2020.

The cost of sales includes the cost of inventory associated with sales of Proleukin as well as $4 million and $5 9 million, respectively of noncash amortization expenses of the acquired intangible assets for the block technology and the three and nine months periods ended September 30.

And towards the tried and true.

Speaker 7: There was no cost of revenues for the third quarter and nine months under September 30, 2021.

There was no cost of revenues for the third quarter and nine months ended September 32022.

Speaker 7: Research and development expenses were $87.5 million for the third quarter of the September 30, 20, 23.

Research and development expenses were $7 5 million or.

For the third quarter ended September 32023.

Speaker 7: An increase of $15 million compared to $72.5 million for the same period as September 30, 2020.

An increase of $15 million compared to $72 $5 million over the same period ended September.

2022.

Speaker 7: Research and development expenses were of $256.6 million for the nine months under the hadn't written the deal inahi Cover and ended.

Research and development expenses were up 250 to $6 6 million for the nine months ended September <unk> 2023.

Speaker 7: An increase of 42.4 million dollars compared to 214.2 million dollars for the same period than the September 13, 2020.

Crude of $42.4 million compared to $214.2 million for the same period ended September 32022.

Speaker 7: The increases in research and development expenses in the third quarter and the nine months ended September 30, 2023, over the prior year of failures were primarily attributable to growth of the internal research and development team, as well as higher cost related to facilities and the initiation of new clinical tries, including the phase three Tio Dance Drive, which were partially off-site by a decrease in study-based composition.

The increases in research and development expenses in the third quarter and the nine months ended September 32023 over the prior year, our Europe failures were primarily attributable to growth of the internal research and development team as well as the iron costs related to <unk> and the initiation of new clinical trials.

Including the phase III chosen strong which were partially offset by a decrease in stock based compensation expense.

Speaker 7: Selling general and administrative expenses were $27.0 million for the third quarter of the September 30, 2020.

Selling general and administrative expenses were up 27.0 million for the third quarter ended September 32020.

Speaker 7: a decrease of 0.9 million dollars compared to 27.9 million dollars for the same period and the September 30, 2020.

A decrease of zero point $9 million compared to $27 $9 million for the center and at September 32022.

Speaker 7: Selin General and administrative expenses were $77.0 million for the nine months and the September 30, 2023. The decrease of $0.6 million compared to $77.6 million for the same period and the September 30, 2020.

Selling general and administrative expenses were 70 701 million for the nine months ended September 32023, a decrease of zero point $6 million compared to $77 6 million for the same period ended September 32000.

Speaker 7: The decrease in selling general and administrative expenses in the third quarter and the nine months ended at 10th of 13th, 23, compared to prior your periods was primarily attributable to the decrease in stock-based compensation expenses and other costs related to the timing of spend compared to the prior your period, including marketing advertising and legal costs, partially offset by cost associated with the growth in their role being.

The decrease in selling general and administrative expenses in the third quarter and the nine months ended September 30 to 23 compared to prior they were failures.

It was primarily attributable to the decrease in stock based compensation expenses and other costs related to the timing of spend compared to the prior to our European Europe, including marketing advertising and Angola costs, partially offset by costs associated with the growth in their overall business.

Speaker 7: As of September 30, 2023, there were approximately 255.8 million common share outstanding. Before I...

As of September 32023, there were approximately 265 8 million common share outstanding.

Before handing the call back to the operator to kick off the Q&A session.

Speaker 7: pick up the QNN station. I want to reiterate a 2024 cash run guidance in the range of 320 to 340 million dollar excluding one time expensive

I want to reiterate our 'twenty to 'twenty forecast of <unk> guidance in the range of 320 to 314 million Doyle.

Speaker 7: as we will carefully manage your operating expenses in the coming months and quarters.

<unk> onetime expenses as.

As we will carefully manage all periods in your expenses and becoming months and quarters.

Operator, which a mouth public Q&A session.

Speaker 1: Thank you. At this time, we'll conduct the question and answer session. As a reminder to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. One moment will be compiled at Q&A roster.

Thank you at this time, we will conduct a question and answer session. As a reminder to ask a question you will need to press star one on your telephone and wait for your name to be announced to withdraw your question. Please press star one again.

That will be compile the Q&A roster.

Speaker 1: Our first question comes from Peter Lawson with Barclays. Please read the question once your line is open.

Our first question comes from Peter Lawson with Barclays. Your line is open.

Speaker 8: Great, thank you so much. Thanks for taking my questions. Does he think about a potential EU filing? If you can talk about the impact of a single arms study on a EU approval and if that kind of changes the way you think about reimbursement, there's one in the EU, and then I've got to follow up the thing.

Great. Thank you George Thanks for taking my questions just as we think about a potential EU. Currently if you can talk about that.

<unk>.

<unk> study on the <unk>.

Year approval, and if that kind of changes the way you think about reimbursement as well.

<unk>.

Speaker 3: Sure Peter, yes, you're thinking of the CART products and what they did to get approval there. And obviously we have the Tullman 301 study already running, which could provide us that randomized control trial that we could use to, and it will read out right around the time, and potentially where we could use it to drive reimbursement in Europe .

Thank you.

Sure Peter Yes, Youre thinking of the car T products and what they did to get approval there and obviously, we Havent told me in 301 study up and running which could provide us that randomized controlled trial that we could use to.

Read out right around the time potentially where we could use it to drive reimbursement in Europe. So yes. That's correct. We think as you know there's early access programs in all the major countries.

Speaker 3: So yes, that's correct. We think, as you know, there's early access programs in all the major countries, the synalarm data should be good enough for that. The AMA seems fine with the synalarm data. And then you get through the early access program and then till Vance is reading out and potentially you're on to work longer term public, Ramburra, some programs in Europe .

The single arm data should be good enough for that Macy's filing single arm data and then you get through the early access program and until the answers reading out and potentially youre on to work.

Longer term public reimbursement programs in Europe.

Great. Thank you and then.

Sure.

Yes.

Speaker 8: And I had to follow up just around the number of authorized treatment centers that do to increase and just curious about what drew that increase with a kind of demand driven essentially or if it was the benefit of the FDA delay.

And I had a follow up just around the number.

Authorized treatment centers.

Seem to increase I'm, just curious about what drove that increase whether it was kind of a demand driven essentially.

Better.

But the FDA delay.

Jim do you want to take this.

Speaker 5: Hi Peter, it's Jim. Yes, it's a combination of both. There's a high sense of urgency and demand from our treatment centers. So we've had a few extra weeks, months to prepare and we're just increasing the number. We're very confident to share that number publicly because the demand is so high right now for these centers to be able to offer like a Lucille. Great. Thank you.

Hi, Peter its Jim Yes, it's a combination of both.

There's a high sense of urgency and demand from our <unk>.

Treatment centers. So we've had a few extra weeks months to prepare and we're just increasing the number.

We're very confident to share that number publicly because.

The demand is so high right now for these centers to be able to offer like lusso.

Great.

Thank you.

For Q.

One moment our next question.

Okay.

Speaker 1: Our next question comes from calling Kizzi with Barrett. Your line is open.

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

Hi, Good afternoon can you hear me okay.

Speaker 9: Hello? Can you hear me, okay? Oh, and we can hear you. Okay, great. So thanks for the question, congrats on all the progress and on the launch prep. So, clarifying question, on the 30 centers who have completed the ATC preparation, theoretically, if a life loop will were approved today, could those centers start preparing to dose a patient today or kind of what else needs to be done for those patients to start using life loop will once it's approved, once they're through the training.

Hello.

Can you hear me okay.

Can hear you okay great.

Thanks for the question Congrats on all the progress on the launch prep.

Clarifying question on the 30 centers, who have completed the.

The ATC preparation theoretically LIFO muscle we're approved today could those centers start preparing to dose a patient today or kind of what else needs to be done for those patients who start using like was that once its approved once they're through the training.

Speaker 3: Yeah, Jim can answer this in more detail, Colleen, but yes, basically these guys are ready to go. Jim, do you want to give us a little bit more detail here?

Yes, Jim can answer this in more detail Colin but yes, basically these guys are ready to go and Jim do you want to give a little bit more detail here sure.

Speaker 5: Sure. Thanks, Colleen. Just real quickly, what we've done to date on the pre-approval onboarding is

Thanks Colleen.

Just real quickly what we've done to date on the Preapproval Onboarding is we work with the centers to develop their <unk> service line, which includes the clinical end to end education and training with metal surgeons' cell therapy.

Speaker 5: You know, we've worked with the centers to develop their TEL service line, which includes

Speaker 5: the clinical and education and training with metarch surgeons, cell therapy. We've operationalized the tumor journey in terms of building out workflows, SOPs, coordination and procedures on all of the logistics from OR, chain of identity, chain of custody to product handling and logistics.

We've operationalized the tumor journey in terms.

Building out workflows Sop.

Coordination and procedures.

All of the logistics from or chain of identity chain of custody to product Candellin in logistics and we've worked extensively on the reimbursement front. So when we say that the centers are ready to go they're ready to go at the last step in all of this will be for us to use the final label make sure that all of them.

Speaker 5: And we've worked extensively on the reimbursement front. So when we say that these centers are ready to go, they're ready to go. The last step in all of this will be for us to use the final label, make sure that all of our training and initiatives are consistent with label. And then we'll roll out a very abbreviated update based upon the label. And centers will be ready to enroll their first patient.

Our training and initiatives are consistent with label and then we will roll out a very abbreviated Ah.

Based upon the label and centers will be ready to enroll their first patients.

Speaker 9: Great, that's really helpful. Thank you. And you had some commentary around the size and the mortality rate of the XUS territories. Can you just talk a little bit more about the differences in the cell therapy market as you see it in Europe versus the US and talk about what the manufacturing plans would be in those?

Yeah.

Great. That's really helpful. Thank you and you had some commentary around the size and the mortality rates in the ex U S. Territories can you just talk a little bit more about the differences in the cell therapy market as you see it in Europe versus the U S and talk about what the manufacturing plants would be in those regions.

Speaker 3: Sure, the manufacturing plan we mentioned earlier, we're going to use our ICT facility there, so

Sure the manufacturing plan, we mentioned earlier, we're going to use our MCT facility there so.

Speaker 3: Want to make it absolutely clear we're not talking about building a new facility there right now or focus on using our existing facility that's already built out Make fish use for a castle

I wanted to get absolutely clear, we're not talking about building a new facility. There right now we're focused on using our existing facility that's already built out.

So she use of our capital.

Speaker 3: The CARP launch is in Europe , provided pretty good in your respect for what's available there and what can be done in Europe . You can see from there's six CARP products that have been approved in Europe at this point in different jurisdictions, then you've seen sales figures, you've seen.

<unk> launches in Europe provide a pretty good yardstick for what's available there and what can be done in Europe.

You can see from there is there are six car T products have been approved in Europe at this point in different jurisdictions and you see sales figures you see.

Speaker 4: from the European sales, and these things that range anywhere from tens of millions up into the low, hundreds of millions at this point. So we see this is a pretty good upside opportunity here. Again, it increases the market significantly. We've got more than 3000 patients a year and Germany dying from melanoma right now. And equally bad numbers in France and the UK and elsewhere. And then we've also got Canada in play here. And we're gonna look at Australia as well as we've mentioned too, where, yep, well, a 1000 patients a year dying.

From the European sales are these things that range anywhere from tens of millions up into the low hundreds of millions at this point. So we see this as a pretty good upside opportunity here again, it increases the market significantly more than 3000 patients a year in Germany from melanoma right now.

Equally bad numbers in France, the UK and elsewhere.

And then we've also got kind of in play here and we're going to look at Australia as well as we've mentioned to wear.

Yes Oliver.

1000 patients who are dying in Australia of melanoma the demand for til therapy. In these jurisdictions is very high we have clinical sites there.

Speaker 4: The demand for tilt therapy in these jurisdictions is very high. We have clinical sites there. We know the physicians very well and we're very comfortable with launching the product there. We think it can be successful just at the Carties Arc. Great.

Physicians very well and we're very comfortable with launching the product. There. We think it can be successful just like the car Ts.

Great. Thanks for taking my questions.

One moment our next question.

Speaker 1: Our next question comes from Yan and Sue with Wells Fargo. Your line is open.

Our next question comes from Yanan, Zhu with Wells Fargo. Your line is open.

Speaker 10: Great, thanks for taking our questions. Could you give us a sense of how the review is going? Have you had the late cycle meeting? Have you had any labeled in discussion? And also, could you talk about your perception of the agency's resource? The resources allocated to the review and whether the previous constraint has improved? And then I have a follow-up. Thanks. You're going to be finding the maintainer of the industry and purchasing the products.

Great. Thanks for taking our questions.

Could you give us a sense of how the review is going.

Have you had the late cycle meeting have you had any label labeling discussion.

Also could you talk about your perception of the agency's resource.

The resources allocated to the review and whether the previous constraint has improved.

And then I have a follow up thanks.

Brian would you like to take John's question.

Speaker 6: and projects on the line. Yeah, no, I'll take that question. Thank you, Jan, and thank you for the question. The review is coming along very well. We have been getting IRs and providing all the responses to the agency.

I think rational one.

I'll take that question Craig. Thanks, Thank you Jan and thank you for that by the question that it really is coming along very well.

We have been getting IRS and providing all the responses to the to the agency.

Speaker 11: Our late cycle meeting is planned. We will announce when that has happened. There are no other additional issues currently that the resource issues seem to be have been under control, and we are expecting that our

Our lead titled meeting as planned we will announce when that has happened.

There's no other additional issues currently that at.

That <unk> seem to be had.

The under control and.

We are expecting that our BLA would be approved.

Speaker 11: BLA would be approved perhaps before the Purdue Fudduke Update in January . Sometimes in January , the Purdue Fudduke is February 20, 2024.

Perhaps.

Before the Purdue high beta in January some.

Times generally.

The Purdue Friday It is February 2024.

Speaker 10: Great. Great. And could you elaborate on the estimate of January ? Is there anything for us to further understand here?

Great.

Great and could you elaborate on the estimate of January is there.

Anything for us to to further.

I understand here.

Speaker 11: Yeah, so the FDA likes to approve products with their unmet medical needs at least four to six weeks prior to Padufa date as they have done with all??

Yes, so the.

FDA likes to accrue.

Products for unmet medical need.

At least four to six weeks prior to Baidu hard date as they have done, but all car T cell products.

Speaker 11: and other products as well. So with that, keeping that in mind, FDA will like to, they like to approve the product sooner before the pollupa date. So we are expecting.

And other products as well so that that keeping that in mind, the FDA relate to that.

They like to approve the product sooner before the coupon rate. So if we are expecting the same for the light flu season.

Speaker 10: Got it. That's very, very helpful. And then my follow up is about the number of centers and manufacturing capacity. So great to hear that you have 30 centers virtually ready to go. And by the time of approval, I assume you might have additional centers ready to go.

Got it that's very helpful. And then my follow up is about.

The number of centers and manufacturing capacity.

So great to hear that you have a 30 centers virtually ready to go.

And by the time of approval I assume you might have additional centers ready to go.

Speaker 10: And the question is, would you have any capacity limit that you might place a cap on the number of manufacturing swans at each of these early centers?

And the question is.

Would you have any capacity limit that you might.

Placed a cap on the number of manufacturing slots at each of these.

Speaker 10: Um, and my other question is, uh, whether you can foresee that you might on board more than 50 by the time by 90 days after the approval, and would you all capacity allow that? Thank you. Yeah, let me start.

Early centers.

And my other question is whether you can foresee that you might onboard more than 50 by the time by 90 days after the approval and what's your capacity allow that thank you.

Yes, let me start and then maybe you can help out here.

Speaker 3: Yes, obviously you're aware of our facility. It's a very large facility. And the gut capacity is built today for the 2000 plus patient.

Yes, we obviously are aware of our facility. It's a very large facility. That's got capacity is built today for the 2000 plus patients.

Speaker 3: FDA is the final insider capacity with self-divocal polygousel therapies so we can't really say what's going on to us. I have to feedback from FDA as far as the approval process at the very end. We'll find out more about that. We did announce as you saw that we anticipate 50 EATCs within nine days of the new state. If possible, we can go beyond that. We have to see. Right now, that's a pretty large launch.

FDA is the final decider of capacity with sort of a ballpark to cell therapy. So we can't really say, what's going on until we got.

The feedback from FDA as part of the approval process at the very end, we will find out more about that we did announced as you saw that we anticipate 50 etc's within 90 days of the date as possible.

That we have to see right now that is a pretty large launch.

Speaker 3: in these largest launch error for cell therapy. So it's pretty progressive. But let me turn over to you or for just...

It'd be the largest launch ever for cell therapy, So it's pretty pretty aggressive, but let me let me turn over to you for just.

Speaker 3: So comments on the capacity and our ability to scale up between our own facilities as well as our contract manufacturer.

Some comments on the on the capacity and our ability to scale up between our our own facility as well as our contract manufacturer.

Speaker 4: Yeah, thanks for the question. So, first of all, as I mentioned earlier, the VA completed pre-license inspections at both sites, at our ICTC facility and contract manufacturing facility, both

Yes, thanks, Jonathan Thanks for the question so.

So first of all as I mentioned earlier.

VA completed pre license inspections at both sites at our ICT C facility on contract manufacturing facility both.

Speaker 4: went very, very well. And so both were successful. So both sites, our ICDC site and the contract manufacturer's site are preparing for the launch and also producing clinical material.

Went very very well.

And so both were successful so both sites ours, our Icd's you cite in the contract manufacturing site.

Preparing for the launch and also producing clinical materials.

Speaker 4: The exact capacity, as Fred mentioned, will be determined by what capacity VFD allows. We've been hiring and training the personnel, well, we have been and our contract manufacturing partner has been as well, in preparation for launch. But again, the exact capacity of launch we'll know hopefully in the next several weeks as we get to approval.

The exact capacity as Fred mentioned, we will determine will be determined by what.

<unk>.

We've been hiring and training the personnel what we have been at our contract manufacturing partner has been as well in preparation for launch, but again the exact capacity with lunch will know.

Hopefully in the next several weeks as we get to approval.

Speaker 10: Great, super helpful. Thank you for all the comments.

Great Super helpful. Thank you for all the color.

One moment for our next question.

Speaker 1: Our next question comes from Michael Yee with Jefferies, your line is open.

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

Hi, Thanks for the question. This is Dana on for Mike Congrats.

Speaker 12: Congrats on all the progress. I just wanted to ask about lung. I know that there was a previous disclosure about.

Congrats on all the progress I just wanted to ask about lung I know that there was a previous disclosure about potentially seeing from second line updated lung data maybe at a medical conference.

Speaker 12: line, updated lung data, maybe in a medical conference that's coming up by year end. Is that still on track, or what are you guys thinking about the lung strategy?

That's coming up by year end is that still on track or or what are you guys thinking about the lung strategy. Thank you.

Speaker 4: Yes, you know, we're looking to put data out along when we think we have meaningful additional numbers available. So we would really like to see more patients, I think, in the study, and then we would get that to a medical meeting. I don't know if we're going to get up by the end of the year at this point or next year, but it's important also to have that data be more significant once we have more patients in the study. Remember, we put out data with 23 patients, so that's 26.1% RR with good signs of durability. So it could use dose of additional patients here to help foster the case.

Yes, we're looking to put data out on long and we think we have meaningful additional numbers available. So we would really like to see more patients I think in the study and then we will get that to a medical meeting I don't know if were going to get it by the end of the year at this point or it could be next year.

But it is important to us.

That data will be more significant once we have more patients in the study remember we put out 23 patients who had a 26, 1% of our with good signs of durability. So it could use dose.

Additional patients here to help.

Speaker 3: Meanwhile, we're just executing on a study right now, running hard to make sure we can complete enrollment in 2024.

Cost per case.

While we're just executing on our study right now running hard to make sure we can complete enrollment by 'twenty four.

Perfect. Thank you so much.

Our next question.

Speaker 1: Our next question comes from Ronnie Benjamin with JMP Securities Your Line Isle.

Our next question comes from Reni, Benjamin with JMP Securities. Your line is open.

Speaker 13: Hey, good afternoon, guys. Thanks for taking the questions and congratulations on all the progress and a very informative call. A couple of quick ones. You mentioned following a strategic portfolio prioritization.

Hey, good afternoon, guys. Thanks for taking the questions and congratulations on all the progress on a very informative call.

Couple of quick ones, you mentioned following a strategic portfolio prioritization.

Speaker 13: I typically think, you know, anytime that's mentioned, there have been programs that have been backburnered. Are there any programs that have been backburnered? Because you mentioned that there's 7 clinical studies that are still ongoing. And as part of that, can you just give us an update as to what's happening with the ovarian study? Or do you think the endometrial 1 that you're going to start? We'll kind of take that 1 over.

Typically you think.

Thats mentioned there have been programs that have been backward are there any programs that have been backburner. Because you mentioned that there are seven clinical studies that are still ongoing.

And as part of that can you just give us an update as to what's happening with the ovarian study or do you think the endometrial one that you're going to start what kind of take that one over.

Speaker 3: You know, I think you're referring to servicemen, I think it's the well-variant, right? I said, we don't have an ovarian program.

Yes, Brian I think youre, referring to cervical I think instead of ovarian right.

We don't have an ovarian program events.

Speaker 3: Oh, sorry. Yeah, cervical. Thank you. Yeah, so all those studies continue to run, and we actually think we can continue to run these studies as the budget we're on. We say prioritization, we may focus more when enrolling one particular study and putting our efforts on.

Oh, sorry, yes cervical.

So all of those studies continue to run and we actually think we can continue to run. These studies as the budget were one we say prioritization, we may focus more on enrolling one particular study we're putting our efforts on for example, how you enter two study where we need to enroll fast that doesn't mean, we're closing the cervical study by the end of.

Speaker 3: For example, the A-1-2 study where we need to enroll fast, that doesn't mean we're closing the cervical study. The end of the mutual study when it does hit, we'll hit later and so we don't proceed in the near-term impact on cash.

Mutual study when it does hit will hit later and so we don't foresee a near term impact on cash.

Speaker 4: we could always re-evaluate the programs at that point. What we're basically saying, though, is we're focusing on particular studies that are of high importance, like LUN-202 and TILVAN-301, as well as VLA approvals and the XUS filings at this point so we can drive revenue.

We can always reevaluate programs at that point, what we're basically saying, though is we're focusing on particular studies are of high importance like how you want to go too until we had 301 as well BLA approvals in the ex U S bonds at this point so we can drive revenues.

Speaker 13: Got it. Okay. When just switching gears to the Esmo data that for your convention.

Got it Okay and then just.

Switching gears to the asthma data that you mentioned.

Speaker 13: Um, you know, the, as of the, the, the latest long term follow up, can you talk a little bit.

You know the as of the latest long term follow up can you talk a little bit I guess about the PFS for the pooled cohorts.

Speaker 13: I guess about the PFS for the pooled cohorts of, you know, two and four.

Speaker 13: What kind of, can you just remind us, what kind of subsequent therapies these patients got? And if I'm remembering right, correct?

Tuned for what kind of can you just remind us what kind of subsequent therapies. These patients Scott.

And if I'm remembering right correct me if I'm wrong.

Speaker 13: The 26% of patients that are surviving four years.

The 26% of patients that are surviving for years right. There overall survival.

Speaker 13: Right, they're overall survival is 26% of patients are out four years.

Twice as percent of patients are out four years does that suggest that patients who have been treated with LIFO leucyl are not in any way detrimentally impacted by any post therapies or is there another way to look at that data.

Speaker 13: Does that, you know, suggest that patients who have been treated with Lifelucel are not in any way detrimentally impacted by any post therapies or is there another?

Yeah.

Speaker 6: Really, I can take this one. So, as you know, collecting data, collecting subsequent data is always something that you have to take. With the grain of salt, we haven't put out a comprehensive summary of what we are seeing in the study. But again, I think what you are seeing in these long-term follow-up data is...

Randy I can I can I can take this one.

So as you know.

<unk> data collecting subsequent data is always something that you have to take with a grain of salt we haven't put out.

A comprehensive summary of what we are seeing in the study, but again I think what youre seeing in the long.

Long term follow up data.

Speaker 6: The promise that whatLFRP has.

Really the promise that till cell therapy has.

Speaker 6: For patients treated with an inner setting where there's really no no visible care right so I don't actually think there's going to be a pattern here in regards to what these patients would be seeing after we don't certainly don't see any signals for detriment.

For patients treated with intercept.

Where there is really no.

All right.

I don't actually think there's going to be.

Eight a pattern here in regards to what these patients what are you seeing after a week.

Certainly don't see any signals or four detriment.

Speaker 6: What we think is really fascinating in this data is the fact it's the long-term durability.

What we think is really fascinating and this data is the fact is the long term durability. The fact that we now have patients who have completed the study income in the response.

Speaker 6: the fact that we now have patients who have completed the study, income in response, meaning a five-year.

Speaker 6: which equals to cure. And that we see late, late deepening of responses and conversions to complete response, which is speaking to the mechanism of action.

Meaning a five year follow up which equals to cure and that we see late Nate deepening of responses and conversions to complete response, which is sticky.

Speaker 6: of a living drug. That I think is the importance of this data.

<unk> two to the mechanism of action of <unk>.

Thank God.

If you put yourself this data.

Speaker 13: Yep, not fair enough. I guess this one final question regarding the label. Is there any possibility of a blue sky sort of scenario for a labeling discussion where you get more than what you want? Or really when we're looking at this data, accelerated approval and the like, you think the base case scenario can be based on the trial results from code four is the best that we can...

Yes fair enough I guess, just one final question regarding the label.

Is there is there any possibility of a blue sky sort of scenario for a labeling discussion where you got more than what you want or really when we're when we're looking at this data accelerated approval and the like do you think the base case scenario kind of based on the on the trial results.

From cohort two and called for is the best that we can hope for.

Speaker 3: No, I think it's, well, actually, let me say something, Rajen, that you can add in because we didn't answer Yanam on this fully either. But on the label front, if we get cohort 4 followed by pool cohort 2 plus 4, which is what we think FDA is leaning towards right now based on our conversations, we think that's the.

No.

Okay.

Actually let me say something Brian that you can add it because we didnt answer your on them on this fully either but.

On the label front, if we get cohort four followed by pool cohort two plus four which is what we think FCA has leaned towards right now based on our conversations we think thats the.

Speaker 3: the best option because that allows.

The home run the best option.

Does that allows.

Speaker 3: Motion on the back of both the core four data the triple data as well as the 150 patient data set with

Ocean on the back of both the core four data the pivotal data as well as the 150 patient dataset with.

Speaker 3: With them, they are not reached. The Lawrence dataset gives you a lot of different promotional opportunities for the product. The Rods can tell you more about the deep reading of the details of when the timing for labels and that kind of discussion comes up.

With MBR not reached the large dataset just gives you a lot of different promotional opportunities for the product. Roger can tell you more about sort of the nitty gritty of the details of when the timing for label.

Speaker 14: Yeah, I think some of Fred covered pretty well. Some of the labeling discussion actually has begun. We have received a few IRs and we have responded to them. So as I be concerned that the labeling has started and we have more discussions regarding that in next couple of weeks. So first guys.

The question comes up as well.

I think Tom covered.

Some of the labeling discussing actually has begun.

Received a few hours and we have responded to them. So.

Consented, enabling has started.

Does that have more smaller discussions regarding that.

Next couple of weeks ago.

Perfect guys. Thanks for taking the questions and good luck.

One moment our next question.

Speaker 1: Our next question comes from Mary Goldstein with Mizzou. Your line is open.

Our next question comes from Mara Goldstein with Mizuho. Your line is open.

Speaker 15: Great, thank you so much for taking on my question. I could just return to the strategic portfolio prioritization as well as the completion of a number of activities. You mentioned that that is likely to reduce the quarterly and annual operating expenses. So, I'm wondering if you can provide us with some guidance at least directly as to what that is. And then on the ATM program, how much capacity is left there? Yeah.

Great. Thank you so much for taking my question, if I could just return to the to the.

The strategic portfolio prioritization as well.

The completion of a number of activities you mentioned that that is likely to reduce the quarterly and annual operating expenses.

Wondering if you can provide us with some guidance at least directionally as to what that is and then on the ATM program how much capacity is left there.

Mark you want to take that.

Speaker 7: Yes, definitely. Thank you, Ma'am, for the questions. So I'm not going to be really specific, but you can imagine that this year as we are preparing for launch.

Yes definitely thank you Marc for the question, so I'm not going to be really specific but you can you can imagine that this year as we were preparing for launch.

Speaker 7: There was a lot of one-time expenses related to manufacturing readiness, even on the CAPEX and OPEX front. Also, ramping up on the commercial, all the activities, and medical. So there was a lot of spend that occurred in 2023 that will be considered again one time and not happen next year.

There was a lot of onetime expenses related to manufacturing readiness.

Capex and Opex from also ramping up on the commercial all the all the activities.

In medical so there is a lot of.

<unk> 2023 that will be drops of darrow again, onetime and not up in the mix that mixture. So prioritization means also managing investment overtime and that's why we're confident about our ability.

Speaker 7: So prioritization means also managing investment over time. And that's why we're confident about our ability to reduce our spend both quarterly and annually as we announced during the COVID-19 pandemic.

To reduce our spend both of our quarter OEM in Europe.

We announced during that during the call.

Speaker 10: And yeah, so on the ATM, we still have a large amount available because we have a 500 million ATM on which we only do a partial amount in the in-culture. All right, thank you very much.

And.

Jim Yes.

We are we still have a large amount of available because we have a 500 million with Jim on which we own okay.

Partially Malta in Q3.

Alright, Thank you very much.

One moment our next question.

Speaker 1: next question comes from Asika Gnoordin, the truest your line is open.

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

Speaker 16: Hi, this is Karina. I had a question. If you could share some color on the manifesto success rate, whether you had any discussions with the FDA on this and the potential prospects to be tighter in the commercial setting as has been previously seen with other parties. Thank you.

Hi, this is Kurt.

I had a question if you could share some color on the manufacturing success rate.

Have you had any discussions with <unk>.

And that's kind of potential prospects can be tighter in the commercial setting as has been previously seen with other crises.

Yes.

You Gotta do you want to get that.

Speaker 6: And I'm sorry, when you did the question, please, my audio person is broken up.

And I'm.

I'm sorry could you repeat the question. Please my audio prison broken out.

Speaker 16: So in the manufacturing success rate, whether you have any discussions with the FDA and for the potential for the spec to be tighter in the commercial setting.

So on the manufacturing success rate, whether you had any discussions with the FDA and quite a potential for the specs can be tighter in the commercial setting.

Yes so.

As you know in case of car T. We've seen that happen.

Some cases to an extreme extent.

In our case with heads of manufacturing success rate maintained in the clinic.

More than 90% consistently and then the pivotal cohorts it was 94, 7%.

Speaker 14: The final specs will be set very late at approval. So we cannot comment on the final specs right now, but that's certainly being part of the discussions with the agency and part of the information requests that have been ongoing. But we don't expect, I mean, right now, we don't expect anything as anywhere close, as draconian, as you've seen in some cases of CARTIE in terms of tightening the specs.

The final specs will discuss very late.

Its approval so we cannot comment on the final specs right now, but that's certainly been part of the discussions with the agency and part of the information requests that have been ongoing.

But we don't expect I mean, right now we don't expect anything is anywhere close as draconian as you've seen in some cases of carty in terms of tightening the specs.

Does that answer your question.

One moment for our next question.

Speaker 1: Our next question comes from Ben Burnett with the stiff-full your line is open.

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

Speaker 17: Hey, great, thanks so much. I wanted to go back and ask another question about just the capacity. I understand that the FDA will sort of help define the capacity at launch, just in terms of the number of slots that are available for commercial use. But I guess, can you frame for us just maybe like an upper limit of the capacity that you feel like you can handle now?

Hey, great. Thanks, so much I wanted to go back and ask another question about the just the the capacity.

Understand that the FDA will sort of help to find the capacity.

At launches just in terms of the number of slots that are available.

For commercial use but I guess can you frame for us maybe like an upper limit of the capacity that you feel like you can handle now.

Speaker 3: Yeah, Ben, at the facility right now, it's actually constructed to go even beyond 2,000 patients a year at our facility. And then on top of that, we have our CDMO who she that has considerable capacity to we haven't disclosed exactly what that is, but it's quite large. It could represent a good portion of our capacity.

Yes, Ben at the facility right now it's actually constructed to go even beyond 2000 patients a year at our facility and then on top of that we have our CMO Wuxi that has considerable capacity until we haven't disclosed the capital that has been quite large.

And could represent a good portion of our capacity at launch so that's the really the Max that we've got constructed today without the need for additional capital.

Speaker 3: So that's really the max that we've got constructed today without the need for additional cap.

Speaker 17: OK, that's helpful. And is that does that include like the personnel required to to sort of run that type of capacity at that level?

Okay. That's helpful and does that does that include like the personnel required to sort of run that type of capacity at that level.

Speaker 3: Yeah, the majority of that personnel is in place and the rest of it can be put in place very quickly. Obviously, we don't just sit the personnel there as a fixed cost, we don't need to, but we are very well skilled in bringing on manufacturing and QC personnel quickly, and know how to do that in both events in the North.

Yes, the majority of that personnel is in place and the rest of it can be put in place very quickly. Obviously, we don't we don't just sit the personnel there.

Fixed costs, we don't need to us, but we are very.

Very well skilled in bringing on manufacturing and QC personnel quickly and know how to do that both <unk> and our CMO.

Speaker 17: Okay, that's great. And then maybe just one other question. Just, I guess, can you frame for us when one would expect the labeling discussions to start? Would this be something at the late segment meeting? That has been the first ever sort of until a privilege to any color you can provide on that.

Okay. That's great and then maybe just one other question just on <unk>.

I guess could you frame for us when one would expect the labeling discussions to start would this be something at the late cycle.

Our meeting.

That's been the first servicer until till approval just any color you can provide on that.

Speaker 11: Yeah, as I mentioned earlier, thanks for asking this question, that labeling discussion had actually begun. We have received a couple IRs, clarifying things in the in the label. So I'm going to continue until they perhaps are earlier approval date.

Yes, as I mentioned earlier, thanks for asking this question.

Leveling discuss and had actually begun we have received.

Couple of IRS.

Clarifying things in the in the label so it's going to continue.

Until the perhaps Alere approval date, so it's a good news files that we have already engaged with agency delivering discussion.

Speaker 11: It's a good news for us that we have already engaged with agency the labeling discussion. Okay, that's great.

Okay. That's great. Thanks, so much.

One moment for our next question.

Speaker 1: As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. Our next question comes from Kelsey Goodwin with Guggenheim, your line is open.

As a reminder to ask a question you will need to press star one on your telephone and wait for your name to be announced our next question comes from Kelsey Goodwin with Guggenheim. Your line is open.

Speaker 18: Oh, hey, thanks for taking my question. Just a couple quick ones from me. I guess maybe just on XUS, is this still something that you're looking to pursue on your own? And I guess is there any appetite to maybe partner or in specific regions or just more broadly XUS? And then moving on to the endometrial cancer trial, I guess maybe because you just remind us what kind of the efficacy benchmark is in the post PD1 setting here. Thank you.

Oh, Hey, Thanks for taking my question just a couple quick ones from me I guess, maybe just on ex U S is this still something that you're looking to pursue on your own and I guess is there any appetite to maybe partner in specific regions or just more broadly ex U S. And then moving on to the.

Endometrial cancer trial, I guess, maybe could you just remind us what kind of efficacy benchmark is in the post PD one setting here. Thank you.

Speaker 3: Yeah, I can't say the first one is Kelsey and then Frederick can just handle the second part of the individual benchmarks.

Yes, I can answer the first one and then Fredrik can jump in on the second part I only endometrial benchmarks.

Speaker 3: So we're always looking for opportunities, and yes, we would consider things like partnership, strategic alliances and things like that. But right now, we do have the ability to go into these jurisdictions ourselves as needed, and we can do that with...

We're always looking for opportunities and yes, we would consider things like partnerships strategic alliances and things like that but right now we do have the ability to go into these jurisdictions ourselves as needed and we can do that with minimal capital investments right now.

Speaker 3: medical capital investments right now, as we discussed on the earlier part of the call, we don't need to build a facility there, we don't need to.

As we discussed on the earlier part of the call we don't need to build a facility. There we don't need to go into a whole lot of hiring there we can get in there and generate revenues relatively quickly now if it turns out there is a partnership that would be.

Speaker 3: We're going to do a whole lot of hiring there. We can get in there and generate revenue as well, till it's quickly. Now if it turns out there's a partnership, it would be...

Speaker 3: value to our shareholders, certainly we would consider that in those jurisdictions. But right now we're looking to do it ourselves as well.

Our value to our shareholders certainly we would consider that in those jurisdictions, but right now we're looking to do it ourselves as well.

Speaker 6: And then Fred, are you answering the individual benchmark question? Yeah, really good question. And I love getting a question or a major program. Thank you.

And then Fredrik you answered the endometrial benchmark question, Yes, really good question and I Love getting his question I would say no material program. Thank you.

Speaker 6: So as you know, what we're seeing happening right now with the checkpoint editors moving from a second line treatment setting into frontline, the data on what's being used and efficacy after use of checkpoint editors is really not available. So I think probably the best benchmark, the best starting point of what you can look at.

So as you know what we're seeing happening right now with the checkpoint inhibitors moving from second line treatment setting into frontline.

The data on on what's being used in efficacy after use.

Or is this is really not available so I think probably the best benchmark the best starting point of what you can what you can look at.

Speaker 6: as a potential benchmark would be data that have been used when Pembrold and Lendana was brought into the second line setting. There the control arm of study, a keynote 775 was investigators choice Dr. Paxi Rubin, I'll pack the text on monotherapy.

As a as a potential benchmark would be data that have been used when Pam broadband.

It was brought into the second line setting there the the control arm all study.

35 was investigator choice doxorubicin Paclitaxel monotherapy.

Speaker 6: And those showed an ORR of about 15%.

And also in our off about 15%.

Speaker 6: median duration of response of 5.7 months in patients with MMR proficient tumors. The results in DMMR patients were a little lower with ORR of 12% and medium DOR of 4.1 months. So I think that's probably where you can start.

Median duration of response of five seven months in patients with MMR proficient tumors.

Without in DMR patients were a little lower with or off 12% medium deal RF for one month. So I think that's probably where you can start given that.

Speaker 6: given that we would be exploring populations that have seen both chemo, frontline chemo, which was the prior therapy for patients in this study and keynote since M5, but also either concomitant or sequential checkpoint of the therapy, I think it's fair to say that we would beat, we would choose to beat an ORR of about 10 to 15 percent. Thank you.

We will be exploring populations that have seen both chemo frontline chemo, which was the prior therapy for patients in this study.

Hum.

Also either concomitant or sequential checkpoint inhibitor therapy, I think it's fair to say that we would be the Cleveland should beat or of about 10% to 15%.

Okay, great. Thank you so much.

Speaker 1: It includes the question and answer session. At this time, I would like to try to call back to Fried's vote for closing remarks.

<unk> concludes the question and answer session. At this time I would like to turn the call back to Fred for closing remarks.

Speaker 3: Thank you again for joining the I-Advanced Biocerapeutics Third Quarter 2023 Financial Results and Corporate Updates Conference Call.

Thank you again for joining the <unk> Biotherapeutics third quarter 2023 financial results and corporate corporate update conference call.

Speaker 3: We've had a productive year to date with the priority review of the BLA and closed with the Proleucon Transaction and Port Mopsons and lung cancer.

We've had a productive year to date with the priority review of the BLA and closer to the Proleukin transaction important milestone to lung cancer.

Speaker 3: and delivering on our key regulatory, commercial, manufacturing, and pipeline activities. I am grateful for the patients, physicians, and regulators.

And delivering on our key regulatory commercial manufacturing and pipeline activities I am grateful for the patients physicians and regulators.

Speaker 3: as well as for our employees and cross-functional teams who have collaborated on our PLA submission while advancing our mission to be the global leader until therapy. I'd also like to thank our shareholders and covering analysts for their support. Please feel free to reach out to our Invest Relations team for follow-up. Thank you.

As well as for our employees and cross functional teams have collaborated on our BLA submission, while advancing our mission to be the global leader in til therapy I would also like to thank our shareholders and covering analysts for their support please feel free to reach out to our Investor relations team for follow up thank you.

Speaker 1: you for your participation in today's conference. This does conclude the program. You may now disconnect.

Thank you for your participation in today's conference. This does conclude the program you may now disconnect.

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