Q4 2019 Earnings Call

Ladies and gentlemen piece Terry I, Yeah, I <unk>, I guess therapeutics fourth quarter 2018 financial results will begin momentarily be again peace time by your conference calls I'll begin momentarily. Thank you.

Operator: Ladies and gentlemen, please stand by. Your Iovance Biotherapeutics 4th quarter 2018 financial results will begin momentarily. Again, please stand by. Your conference call will begin momentarily. Thank you.

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Operator: Good afternoon, and welcome to the Iovance Biotherapeutics fourth quarter and year-end 2019 financial results conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session, and instructions will follow at that time. If anyone should require assistance during the conference, please press star then zero on your touchtone telephone. Please be advised that the call is being recorded at the company's request. Now, I would like to turn the call over to Sara Pellegrino, Vice President, Investor, and Public Relations at Iovance. Please go ahead.

Good afternoon, and welcome to the I O Vance bio therapeutics fourth quarter and year end 2019 financial results Conference call. At this time all participants are in listen only mode. Later, we will conduct a question and answer session and instructions will follow.

Well at that time, if anyone should require assistance during the conference.

Press Star then zero on your Touchtone telephone please be advised that the call is being recorded at the company's request now I would like to try to call over to Sara Pellegrino, Vice President Investor and public Relations I O. Vance. Please go ahead.

Sara Pellegrino: Thank you, Laurie. Good afternoon, everyone, and thank you for joining us.

Sara Pellegrino: Speaking on today's call will be Maria Fardis, our President and Chief Executive Officer, Frederick Finckenstein, our Chief Medical Officer, and Tim Morris, our Chief Financial Officer. This afternoon, we issued a press release, which can be found on our website at iovance.com, which includes the financial results for the fourth quarter and year-ended December 31, 2019, as well as a corporate update. Before we start, I would like to remind everyone that statements made during this conference call will include forward-looking statements regarding Iovance's goals, business focus, business plans, free commercial activities, clinical trial plans and results, potential future applications of our technologies, manufacturing capabilities, regulatory feedback and guidance, licensing and collaboration agreements, and future updates. Such 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 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'll pass the call over to Maria.

Thank you Laurie good afternoon, everyone and thank you for joining US speaking on today's call will be Maria as part of our President and Chief Executive Officer, Frederic thinking Stein, our Chief Medical Officer, and Tim first Chief Financial Officer.

This afternoon, we issued a press release found on our website at <unk> Dot Com, which includes the financial results for the fourth quarter and your ended December 31st 2019, as well as the corporate update.

Before we start I would like to remind everyone that statements made during this conference call will include forward looking statements regarding Iran to schools business focused business plan Precommercial activities clinical trial plans and result potential future applications of our technologies manufacturing capabilities regulatory fees.

Back in garden licensing in collaboration agreements and future update forward looking statements are subject to numerous risks and uncertainties many of which are beyond our control, including the risks and uncertainties described from time to time in our FCC filing our results may differ materially from those projected during today's call we undertake no.

No obligation to publicly update any forward looking statements with that I'll pass the call over to Maria.

Maria Fardis: Thank you, Sara, and good afternoon, everyone. I am pleased to lead today's conference call to summarize the tremendous progress made at Iovance during 2019 and highlight recent updates and important milestones to come in 2020. I will also comment on our progress toward a planned Biologics License Application, or BLA, submission for LIFE-ELUSO and LN145 this year, as well as preparation for a commercial launch in 2021. In 2019, we continued to advance our TIL tumor-infiltrating lymphocyte therapy in pivotal programs in melanoma and cervical cancers. We also initiated Phase II clinical studies for multiple indications in solid tumors. In addition, we introduced our very first Peripheral Blood Lymphocyte Therapy, or PBL, into the clinic as a new approach for blood cancer. I'd like to begin with an update on our loose-till therapy, filusol, and metastatic melanoma. As a reminder, melanoma is a common type of skin cancer, accounting for approximately 96,000 patients diagnosed annually and 7,200 deaths each year in the United States.

Thank you Sarah and good afternoon, everyone [laughter] I am pleased to meet these conference call to summarize this progress made at I. events during 2019 and highlight recent updates unimportant much supposed to come in 2020.

We'll also comment on our progress toward a planned biologics license application or B L. A submission for life healing Seoul, and OLED 145, this year as well that's preparation for commercial launch and 2021.

In 2019 be continued to advance our till tumor infiltrating lymphocytes therapy in pivotal programs in melanoma cervical cancers.

Also initiated phase two clinical studies for multiple indications in solid tumors.

In addition, we have introduced our very first peripheral blood implicitly therapy or PD L into clinic as a new approach for blood cancers.

I'd love to begin with an update [laughter] til therapy like to loosen in metastatic melanoma.

As a reminder, melanoma is a common type of skin cancer accounting for approximately 96000 patients diagnosed annually and 7200 deaths each year in the United States.

We announced last month that'd be have completed patient dosing ahead of schedule in the pivotal cohort for an hour see one for 40 to one study of like feeling. So this pivotal cohort was initiated in March of 29 team with a target enrollment of 75 patients.

Maria Fardis: We announced last month that we have completed patient dosing ahead of schedule in Pivotal Cohort 4 in our C14401 study of Leif-E-Lusso. This pivotal cohort was initiated in March of 2019 with a target enrollment of 75 patients. We currently plan on allowing all patients from Ward 4 to be followed for six months before data is cut for inclusion in the BLA. We have started the process of assembling documents to be used for the BLA.

We currently plan on allowing all patients import for to be followed for six months before data cards for inclusion into BLE.

We have started the process of assembling documents to be used for to be really be plan to meet with F.D.A. unexpectedly submit to be a late and lead to 2020.

Maria Fardis: We plan to meet with FDA and expectedly submit the BLA in late 2020. As a reminder, Lifeluthal has received both Fast-Track and Regenerative Medicine Advanced Therapy, or RMAT, designations from the US FDA, which was supported by the clinical data from Cohort 2 in the melanoma study. The protocol for cohort 4 was designed to enroll the same patient population as cohort 2.

As a reminder, like the diesel has received both fast track on regenerative medicine advanced therapy or Ormat designation from the U.S.S.T.A., which was supported by the clinical data from poor to into melanoma study.

The protocol for Cold for was designed to enroll the same patient population of core to be presented data from core too and the melanoma study several times over the last year.

Maria Fardis: We have presented data from cohort 2 in the melanoma study several times over the last year. The most recent update on overall response rate, or ORR, was presented in November at the Society for Immunotherapy of Cancer, or SIDS, annual meeting. We reported a 36.4% ORR in 66 patients who were heavily pre-treated. As assessed by investigators, the duration of response, or DOR, for COVID-2 has not been reached at the time of CIDC presentation. In a recent Iovance corporate update in January 2020, DOR was still not reached at 15.5 months of median study follow-up. Published data shows median overall survival in late-stage melanoma patients may reach seven to eight months, so the results with Lifelucid are highly encouraging.

The most recent update on overall response rate or or or what's presented in November at the society for immunotherapy of cancer or sit see annual meeting.

We reported at 36.4% or or in 66 patients who were heavily pre treated.

As assessed by investigators the duration of response or deal or for core to has not been reached at the time of 50 presentation.

In a recent islands corporate update in January 2020, you are was still not reached 15.5 months of median study follow up.

Published data shows median overall survival and late stage melanoma patients may reach 78 months. So the results would like to loose or highly encouraging.

Maria Fardis: We continue to monitor the patients in this study and hope to provide additional updates from Corps II in 2020. Iovance as an organization is very focused on the advancement of this program toward preparation for the BLA. Our second pivotal study is LN145 in patients with metastatic cervical cancer. We continue enrolling patients in the C14504 study and remain on track to complete dosing approximately mid-year 2020 in the pivotal part of this study. Target enrollment is 75 patients. We are still planning to submit a BLA later this year, following dialogue with the FDA. The submission of the two BLAs is not dependent on each other, and each indication may be submitted separately.

We continue to monitor to patients and just study and hope to provide additional updates from core to in 2020.

I have asked as an organization is very focused on the advancement of this program toward preparation for to be alike.

Our second pivotal studies, Ellen one four or five in patients with metastatic cervical cancer be continue enrolling and to see one four or 504 study and remain on track to complete dosing approximately mid year 2020 and to pivot all part of this study.

Target enrollment is 75 patients we are still planning to submit it delayed later this year following a dialogue with the FDA submission of the to be lays or not dependent on each other and he syndication maybe submitted separately.

Maria Fardis: During 2019, LN145 received Breakthrough Therapy designation, or BTD, as well as Fast Track designation from the FDA. These designations were supported by compelling data demonstrating a 44% ORR from 27 patients in the ongoing study, which was presented at the American Society of Clinical Oncology, or ASCO, annual meeting in June of 2019. We also successfully completed an end-of-phase II meeting with the FDA in 2019. Following the meeting, we increased target enrollment for the pivotal part of this study to 75 patients in order to support registration of LN145. We also added new cohorts in earlier and later lines of cervical cancer patients in anticipation of the changing landscape in this indication. This specifically includes a cohort that allows for treatments with LN145 in combination with pembrolizumab and a cohort with patients who have failed prior anti-PD-1 therapy.

During 2019, and then one four or five received breakthrough therapy designation or BTD as well that fast track designation from the FDA.

Designations were supported by compelling data, demonstrating a 44% or or from 27 patients in the ongoing study, which was presented at the American society of clinical oncology or ASCO annual meeting in June of 2019.

We also successfully completed an interface to meeting with the F.D.A. and 2019th.

Following the meeting to be increase target enrollment for the pivotal part of the study to 75 patients in order to support registration up and then one four or five.

We also added new cohorts in earlier and later lines of cervical cancer patients in anticipation of changing landscape into syndication.

Specifically includes a cohort that allows for treatments with Elon, one four or five in combination with pembrolizumab and a cohort of patients who have failed prior anti PD one therapy.

During 2019 be dose more than 150 patients in our clinical program, our second generation or Gen. Two til therapy manufacturing process continues to be a robust one and with a demonstrated success rate of little over 90% and approximately 300 patients.

Maria Fardis: During 2019, we dosed more than 150 patients in our clinical program. Our second generation or Gen 2 Tilt Therapy manufacturing process continues to be a robust one, with a demonstrated success rate of well over 90% in approximately 300 patients. In parallel with the pivotal trials for melanoma and cervical, we are already building our international and internal manufacturing capacity. Specifically, for launch, the initial commercial supply will come from our CMO partner, WUJI AptX Philadelphia facility, as we continue to build our internal Iovance manufacturing capability. Construction of the Iovance Commercial Facility started in June of 2019 aiming to build a state-of-the-art 136,000 square foot commercial scale production facility in Philadelphia. The new facility is expected to be operational by year-end 2020-2021 to support commercial supply in 2022. The expected capacity is planned to meet demand for thousands of patients.

In parallel with the pivotal trials for melanoma cervical we are already building, our international and internal manufacturing capacity.

Typically for launch the initial commercial supply will come from our CMO partner, who she optics Philadelphia facility as we continue to build our internal I last manufacturing kept capability.

Construction of the ideal that's commercial facilities started in June of 2019, aiming to build a state of the art hundred 36000 square foot commercial scale production facility in Philadelphia continues.

The new facility is expected to be operational by yearend 2020, 2021 to support commercial supply in 2022.

They expected capacity its plans to meet demand for thousands of patients.

[laughter] and anticipation of launch of life in Nuseal and one for five to be continue expanding our commercial and medical affairs infrastructure.

Maria Fardis: In anticipation of the launch of Lifey-Luthel and LN145, we continue expanding our commercial and medical affairs infrastructure. Our main area of focus remains ensuring a positive patient experience at Life Relief Center. Toward that end, we are working on the following items. Clinical Site Engagement in Preparation for Commercial Launch Development of a Close Collaboration with Healthcare Professionals, or HCPs, who will be handling and administering our products. Operational excellence by Iovance in the provision of the product and communication with payers. In the United States, we currently work with over 20 clinical sites for melanoma and approximately the same number of sites for cervical. We anticipate that centers with prior tele-experience and those with key opinion leaders in melanoma and cervical cancers will be the initial targets for the launch of LIFELUSO and LN145 subsequent to approval.

Our main area of focus remains ensuring a positive patients experienced the life at liesl towards that you're working on the following item.

Clinical site engagement in preparation for commercial launch development of a close collaboration with health care professionals or H.C. piece will be handling and administering our product.

[laughter] operational excellence Biovance in provision of the product and communication with payers.

In the United States. We currently work with over 20 clinical sites for melanoma and approximately the same number of sites for cervical we anticipate that sensors, a with prior till experience and those with key opinion leaders in melanoma cervical cancers will be initial target for the launch of likes to do so and then one four or five subsequent approval.

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Maria Fardis: Our medical affairs team is in place to work with a network of treating HCPs and patient advocacy groups to assure that information about TIL is available to interested organizations. We also continue optimizing our logistics and infrastructure to assure a patient-focused organization is in place not only for our clinical program but also for commercialization. We have made great progress in the identification of centers that we work with in the clinical program and expect to collaborate with them in commercializing TIL. On the patient access and reimbursement front, we have initiated discussions with private payers and CMS to ensure timely access to tilt therapy for patients. And under a patient-centric model, we intend to support the patient at every step of the way in the process from initial resection to infusion. As our market research and commercial preparation continue, we look forward to providing updates on our launch plan throughout the year. I would now like to ask our Chief Medical Officer, Frederick Finckenstein, to provide an update about our other clinical programs and ongoing research at Iovance.

Our medical affairs team is in place to work with a network of treating HCP and patient advocacy group test short that information about till its available to interested organization.

We also continue optimizing our logistics on infrastructure to assure a patient focused organization is in place not only for clinical program, but also for commercialization.

We have made great progress than identification of centers stuff. He worked with in the clinical program and expect to collaborate with them into commercial commercializing till.

On the patient access and reimbursement front, we have initiated discussions with private payors and CMS to ensure timely access to til therapy for patients.

Under a patient centric model, we intend to support the patient at every step of the way and the process from initial reception to infusion.

So market research on commercial preparation continues to be look forward to providing updates on our launch plan throughout the year I would like to US Canal, our Chief Medical Officer, Frederic Finkelstein to provide an update about or other clinical programs on ongoing research I dialed up.

Pretty good.

Friedrich Graf Finckenstein: Thank you, Maria. I would like to begin with the expansion of our ongoing C14503 clinical study in head and neck cancer, which remains an important indication for Iovance. We continue to enroll patients in our CE 14503 study and recently added new cohorts to this study. Patients in the first new cohort will be treated with LN145, manufactured with our new proprietary 16-day, third-generation chill therapy process, which we call Gen3. The second new cohort will evaluate a selected TIL product, PD1Select, designated as LM145S1.

Thank you Maria.

I'd like to begin with the expansion of our ongoing see one four or five all three clinical study in head and neck cancer, which remains an important indication for all of them.

We continue to enroll patients in our see wonderful twice or three stones and recently new cohorts to this study.

Patients in the first nucor will be treated with other than the one for flight manufactured with a new proprietary 16 day third generation til therapy process, which we call Gen three.

The second new cohort well evaluate it sounds like the tool product PD, one so like designated as Alan one for voice as well.

We presented preclinical information on PD wants to look the tool. It's it's in November 2018, which demonstrated improved tumor cell killing properties for this product.

Friedrich Graf Finckenstein: We presented preclinical information on PD-1-selected TIL at CIDC in November 2018, which demonstrated improved tumor cell killing properties for this product. This cohort is the first time we are testing selected TIL in the clinic. We have also made significant progress in evaluating the broader potential for TIL treatment in earlier lines of therapy for checkpoint-naive melanoma, head and neck, and non-small cell lung cancer. Patient dosing in the IOV-COM-202 clinical study, which we also refer to as our basket study, was initiated in May 2019. The three cohorts will evaluate TIL plus pembrolizumab in patients who are immune checkpoint inhibitor naive with melanoma, squamous cell carcinoma of the head and neck, and non-small cell lung cancer. In the fourth cohort, LN145 monotherapy is offered to relapsed refractory non-small cell lung cancer patients.

This cohort is the first time, we are testing select until in the clinic and we look forward to enrolling patients and these new cool.

We've also made significant progress in evaluating the broader potential for two treatment in earlier lines of therapy, So checkpoints naive melanoma hidden Nick and non small cell lung cancer.

Patient dosing in the are you will be come too old to clinical study, which we also referred to as a basket study was initiated in May 2019.

Three cohorts will evaluate two plus pembrolizumab in patients who are immune checkpoint inhibitor naive with melanoma squamous cell carcinoma, all the head of Nick and non small cell lung cancer.

And the fourth cohort and then 145 monotherapy is offered to relapsed refractory non small cell lung cancer patients.

Enrollment across all Florals. These schools is proceeding well and we have plans to assist cohort to investigate honest elected to and then one full five it's.

No no more patients who have received prior anti PD, one and be Russell will be rough make it indicated.

This is the same so like the to the product that we have introduced into the headwind next study.

Friedrich Graf Finckenstein: Enrollment across all four of these cohorts is proceeding well, and we have plans to add a fifth cohort to investigate our selected TILs, LN145S1, in melanoma patients who have received prior anti-PD1, and BRAF or BRAF-MEC, if indicated. These are the same selected two products that we have introduced into the head and neck study. The additional cohort will also increase the overall target enrollment in the background.

The additional Gord will also increase the overall target enrollment in the basket study.

Moving on to all peripheral blood lymphocyte therapy or P.O. therapy.

Very excited to be and connect with our very first I owe them cell therapy for blood cancers.

I'm happy to report that last week, we dosed the first patient in the clinical study of oral PBL therapy, which we have designated you will be 2001.

The phase one two study you named O V C and Oh, one is currently enrolling patients with relapsed or refractory CLL or small lymphocytic lymphoma itself well into the phase one dose escalation portion.

Friedrich Graf Finckenstein: Moving on to our peripheral blood lymphocyte therapy, or PBL therapy, we are very excited to be in clinic with our very first Iovance cell therapy for blood cancer. I am happy to report that last week we dosed the first patient in the clinical study of our PBL therapy, which we have designated IOV2001. The Phase I-II study, named IOV-CLL01, is currently enrolling patients with relapsed or refractory CLL or small lymphocytic lymphoma, SLL, into the Phase I dose escalation portion.

We generated polyclonal population of P. deal for therapeutic use from 50 minute years old blog, using a nine day T cell manufacturing process.

You bet on from Oh, I O V 2001, PBL therapy as a result of internal research and development efforts at all you're about to translate O experience with killed in solid tumors.

We think this study will provide important proof of concept floral P.B.L. approach and look forward to enrolling additional patients in the study.

[noise] before I turn the call to Tim I would like to briefly mention our audio states research and development efforts.

Friedrich Graf Finckenstein: We generate a polyclonal population of PBL for therapeutic use from 50 milliliters of blood using a 9-day T cell manufacturing process. Development of IOV-2001 PBL therapy is a result of internal research and development efforts at Iovance to translate our experience with Tylenol in solid tumors. We think this study will provide important proof of concept for our PBL approach and look forward to enrolling additional patients in this study.

As announced in January we have obtains a license from novartis to develop and commercialize an anti bodies cytokine engrafted protein referred to as I O V 3001, as a talk with it and so that just oil to analog.

It was too is a major component of all treatment.

Well the development of a proprietary oil to analog there's a valuable opportunity to further optimize the beneficial properties of the oil to through improving pharmacokinetic and pharmacodynamic properties as compared to currently available oil too.

[laughter].

We're also exploring genetically modified to what's the potential to create an even more potent tool.

Unnamed: [inaudible]

Friedrich Graf Finckenstein: Before I turn the call over to Tim, I would like to briefly mention our earlier stage research and development efforts. As announced in January, we have obtained a license from Novartis to develop and commercialize an antibody-cytokine engrafted protein, referred to as IOV3001, as a targeted and selective IL-2 analog. IL-2 is a major component of our treatment, so the development of a proprietary IL-2 analog is a valuable opportunity to further optimize the beneficial properties of IL-2 through improving its pharmacokinetic and pharmacodynamic properties as compared to currently available IL-2. We are also exploring genetically modified pills with the potential to create an even more potent pill. Under research collaboration and an exclusive worldwide license agreement with Selective, we have licensed certain talent technology to develop genetically edited pills in several cancer indications. The worldwide exclusive license enables us to use TALENT technology to address multiple gene targets to modify TIL for therapeutic use. I will now hand the call over to Tim to discuss our financial results.

Although research collaboration and exclusive worldwide license agreement with like this we have license certain talent technology to develop genetically editing tool in several cancer indications.

The worldwide exclusive license enables us to use talent technology to address multiple disease targets to modify tool for therapeutic use.

I will now hand, the call over to Tim to discuss all financial results.

Thank you Frederick My remarks will address the high level financial results from our fourth quarter and full year 2019 additional details can be found in the press release, we distributed earlier as well as our annual report on form 10-K to be filed shortly with the FCC.

Net loss for the fourth quarter ended 2019 was $63.6 million or 50 cents per share this compared to a net loss of $32.6 million or 27 cents per share for the fourth quarter 2018.

Net loss for the full year, 2019 was $197.6 million or $1.59 cents per share compared to a net loss of $123.6 million or $1.27 cents per share for 2018.

Research and development expenses were $54.2 million for the fourth quarter 2019, an increase of $26.8 million compared to the $27.4 million for the fourth quarter 2018.

Tim Morris: Thank you, Frederick. My remarks will address the high-level financial results from our fourth quarter and full year 2019. Additional details can be found in the press release that we distributed earlier, as well as in our annual report on Form 10-K, to be filed shortly with the SEC. The net loss for the fourth quarter ended 2019 was $63.6 million, or $0.50 per share. This compared to a net loss of $32.6 million, or $0.27 per share, for the fourth quarter of 2018. The net loss for the full year 2019 was $197.6 million, or $1.59 per share, compared to a net loss of $123.6 million, or $1.27 per share, for 2018.

Research and development expenses were $166 million for the full year 2019, an increase of $66.2 million when compared to $99.8 million for the prior year the increases in the fourth quarter and the full year over the prior periods were probably.

Barely attributable to an increase in costs associated with manufacturing activities and increased capacity.

Clinical trials due to higher enrollment and the growth at the internal research and development team.

General and administrative expenses were $10.9 million for the fourth quarter 2019, an increase of $3.4 million when compared to $7.5 million for the fourth quarter 2018.

General and administrative expenses were $40.8 million for the full year, 2019, and increase a $12.4 million compared to $28.4 million for 2018.

Increases in the fourth quarter and the full year.

Tim Morris: Research and development expenses were $54.2 million for the fourth quarter 2019, an increase of $26.8 million compared to $27.4 million for the fourth quarter 2018. Research and development expenses were $166 million for the full year 2019, an increase of $66.2 million when compared to $99.8 million for the prior year. The increases in the fourth quarter and the full year over the prior periods were primarily attributable to an increase in costs associated with manufacturing activities and increased clinical trials due to higher enrollment and the growth of the internal research and development team. General and administrative expenses were $10.9 million for the fourth quarter of 2019, an increase of $3.4 million when compared to $7.5 million for the fourth quarter 2018. The general and administrative expenses were $40.8 million for the full year 2019, an increase of $12.4 million compared to $28.4 million for 2018. Increases in the fourth quarter and the full year over 2018 were primarily attributable to the growth of the internal general and administrative team, as well as higher IP legal costs and market research activities in preparation for commercialization.

Over 2018 were primarily attributable to the growth of internal.

General and administrative team.

As well as higher IP legal costs and market research activities in preparation for commercialization.

At December 31, 2019, we held $312 million and cash cash equivalents short term investments unrestricted cash compared to $468.5 million at December 31, 2018.

In addition, as Maria mentioned, we're building our own I have asked manufacturing facility.

We expect to invest approximately $85 million over three years for equipment. It construction.

I'll now hand, the call back to Maria to review upcoming milestones and to kick off the QNX session.

Good Tim.

Thank you all for attending to call today, we look forward to an exciting and productive 2020.

Closing anticipated milestones for this year included last fission to be dose and the pivotal program for Ellen one four or five for cervical cancer.

CBLI meetings with U.S.S.T.A. melanoma topline pivotal data and be any sufficient.

Before we begin to Q when a session I would like to remind everyone that I have asked us not comment on speculation in the media and will not answer questions related to any articles circulating in the press.

I will now turn to call over to operator for any questions operator.

Hi, ladies and gentlemen, if you have a question at this time. Please press Star then the number one on your Touchtone telephone. If your question has been answered are you wish to you we moved yourself from the Q. Please press the pound.

Tim Morris: By December 31, 2019, we held $312 million in cash, cash equivalents, short-term investments, and restricted cash, compared to $468.5 million at December 31, 2018. In addition, as Maria mentioned, we are building our own Iovance manufacturing facility. We expect to invest approximately $85 million over three years for equipment and construction. I will now hand the call back to Maria to review upcoming milestones and to kick off the Q&A session.

We have a question from the line of Chan breaking off from Wells Fargo. Please ask your question.

Hi, guys. Congratulations on all the progress I guess thinking it led to the commercial opportunity just wondering if you're thinking about the 7200 patients.

The die each year melanoma, and if you thought about the addressable population that could benefit in cervical cancer could you talk about the initial target population of 20 plus centers for each and what capacity they have to treat these patients and then I guess the second part of it is one of the gating items.

Maria Fardis: Thank you, Jim. Thank you all for attending the call today. We look forward to an exciting and productive 2020. In closing, our anticipated milestones for this year include the last patient to be dosed in the Pivotal Program for LN145 for cervical cancer, pre-BLA meetings with USFDA, melanoma top-line Pivotal data, and BLA submission. Before we begin the Q&A session, I would like to remind everyone that Iovance does not comment on speculation in the media and will not answer questions related to any articles circulating in the press. I will now turn the call over to the operator for any questions.

To really making this more broadly available and how you're going to go about.

Accessing that.

Sure Hi, Jim. Thank you for the question from a commercial opportunity perspective, although unfortunately 7200 patients die in the melanoma landscape and one can consider till certainly I'm an option for these patients we are actually thinking about second and third line and that patient population.

As a broader than 7200 that is currently reported so that's that's how we're thinking about sort of positioning the product and that's the patient population that our current protocol allows.

In terms of the centers I, just want to make sure that I'm clear or you're not targeting just 20 centers. The comment I made was we start with the sites that have been participating in a clinical program and those have been around 24 melanoma in cervical be certainly intend to expand that Buddy time, you're getting ready to kick off the price.

In the commercial landscape.

And I guess the question Murray I just to follow up when you think about those initial centers that have had the most experienced until therapies give a sense.

Operator: Operator.

Operator: Operator. All right, and ladies and gentlemen, if you have a question at this time, please press star, then the number one on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. We have a question from the line of Jim Birkenoff from Wells Fargo; please ask your question.

Portion of the melanoma patients they treat and how many more sensors and you think you need to.

Gain to gain experience to get more broad access to that second third wine opportunity.

Yeah, we do know exactly what is the distribution of patience in terms of I'm aware that the bulk of them are Oh, we certainly have an internal map reconsider where they typically go to received their care I don't know if I'm quite ready to speak about that specific plan will be we certainly think about it in the same way as youre approach.

Jim Birkenoff: Hi guys, congratulations on all the progress. I guess thinking ahead to the commercial opportunity, just wondering if you think about the 7,200 patients that die each year from melanoma, and if you think about the addressable population that could benefit from the treatment for cervical cancer, could you talk about the initial target population of 20 plus centers for each and what capacity they have to treat these patients? And then I guess the second part of it is, you know, what are the gating items to really making this more broadly available, and how are you going to go about accessing that?

And get.

And just a quick one is the cervical.

Filing the I won 145 filing.

Do you expect to get done in 2020 or does that really depend on when mid year, you close out enrollment and could that slip into 2021.

Right you recognize that the timing of cervical in melanoma <unk> like the apart I would crafty continue to plan for cervical submission by yearend and you're correct that at some of that would depend on exactly when cervical enrollment will complete as well as a dialogue with FDA, but the current plans remain to go ahead and submit.

Maria Fardis: Sure. Hi Jim.

Maria Fardis: Thank you for the question. From a commercial opportunity perspective, although unfortunately, 7,200 patients die in the melanoma landscape, and one can consider TILS certainly an option for these patients, we are actually thinking about second and third line therapy. And that patient population is wider than 7,200 that is currently reported. So that's how we are thinking about sort of positioning the product. In terms of the centers, I just want to make sure that I'm clear. We are not targeting just 20 centers. The comment I made was we start with the sites that have been participating in our clinical program, and those have been around 20 for melanoma and cervical. We certainly intend to expand that by the time we are getting ready to kick off the product in the commercial landscape.

Assuming of course all of the milestones are met around a later part of 2020 as of now.

Great. Thanks, Thanks for taking the questions and congrats again on the progress. Thank you Jim.

Your next question comes from the line Ben Bernanke from Stifel. Please ask your question.

Great. Thanks, so much.

Question on the E com two to the basket trial looking at till plus Pembro.

As well as the fourth cohort monotherapy I guess you have a an expectation when we might get data for these first four cohorts.

Hi, Ben Thank you for the question I'm, just sort of patient dosing in May of 2019, given that this study is a basket study the patients may be distributed between the cohorts be really would love to make sure. We have a handful of patients in each cohort before we can report them. So we have not committed to specific timing for dataflow.

From this study yet.

Okay, Okay understood.

Thank you if I could just one more on the.

The regarding the recent Novartis collaboration can you talk more about the non T. T. Reg activating aisle to antibody. This being developed I guess, how is the antibody Ben grafted in and I guess, what makes this a more selective.

Maria Fardis: And I guess the question, Maria, just to follow up, when you think about those initial centers that have had the most experience with TIL therapy, do you have a sense of what proportion of the melanoma patients they treat, and how many more centers do you think you need to gain experience to get more broad access to that second, third line opportunity?

Thank you.

Sure, Yes of course, so as that you might know aisle to bind to three different sub units also beat on gamma sub units under various T cells. The beta gamma sub units is what we are interested in the alpha sub unit is more prevalent and binding toward T. Reg, we're trying to rule that finding out.

Maria Fardis: Yeah, we do know exactly what the distribution of patients is in terms of where the bulk of them are. We certainly have an internal map. We consider where they typically go to receive their care. I don't know if I'm quite ready to speak about that specific plan, but we certainly think about it in the same way as you're approaching it.

So the CDR that'd be how does not allow for this particular aisle to bind to the alpha sabean. It. It in fact focus is it better on to beat again most of you know that's that's why the expected to be better.

Okay, and I guess at this point can you comment on just kind of to the architecture of.

How big antibodies engrafted or is that <unk> at this point is that proprietary.

Maria Fardis: And just a quick one, Maria: is the cervical filing, the LN145 filing, something you expect to get done in 2020, or does that really depend on when you close out enrollment mid-year, and could that slip into 2021?

It's certainly proprietary and thank you for understanding.

Okay. Okay makes sense. Thanks, so much thank you.

Your next question comes from the line of a joke packaging is from H.C. Wainwright. Please ask your question.

Maria Fardis: Right. We recognize that the timing of cervical and melanoma is slightly apart. We currently continue to plan for cervical submission by year-end, and you're correct that some of that would depend on exactly when cervical enrollment will complete, as well as a dialogue with FDA. But the current plans remain to go ahead and submit, assuming, of course, all of the milestones are met around the later part of 2020, as of now.

Everyone. Good afternoon, thanks for taking the question.

Just curious if you could provide a little more detail with regarding your strategy for the evolution of your manufacturing facilities. As you mentioned in your prepared comments you have she right now and looking to have your new facility come online in 2022, how do you look to sort of share responsibilities between these two facilities and also.

And your facility comes on line do you anticipate that that will start off with Gen. Three.

Jim Birkenoff: Great, well, thanks for taking the questions and congrats again on the progress.

George <unk> [noise].

Give me just to correct. Your statement it would start off with Gen. II correct is that what you said you're right. Thank you and when it would evolve to Gen. Three sorry, yeah right right. So we currently our commercial plan is very much locked and loaded for Gen. Two this facility is very much designed around gen. Two of course, it can support other manufacturing processes.

Maria Fardis: Thank you, Jim.

Operator: Your next question comes from the line of Ben Burnett from Stifel. Please ask your question.

Benjamin Jay Burnett: Great, thanks so much. I have a question on the

Maria Fardis: Com 202, the basket trial looking at TIL plus PEMBRO, as well as the fourth cohort monotherapy. I guess, do you have an expectation as to when we might get data for these first four cohorts?

Would there be a need for them, but right now we very much or planning on our commercialization, but gen. Two process in terms of roles and responsibilities you already have started building your team I'm out in Philadelphia.

Maria Fardis: Hi Ben, thank you for the question. We started patient dosing in May of 2019, and given that this study is a basket study, the patients may be distributed between the cohorts, we really would like to make sure we have a handful of patients in each cohort before we can report them. So we have not committed to a specific timetable for data flow from this study yet.

Certainly did that building of the building itself requires a number of staff who are familiar with the process. We have great expertise in house I'm, starting from engineering team as well as people who are very familiar with the process and in terms of process development and optimization. So we already have a team that is slowly ramping up to what is going to be need.

Good [laughter] why did time to commercial activities roll out a in addition to their local team members in Philadelphia be however, additional team members as quality or otherwise and Suncor those who are supporting the activities for for the facility. So I don't foresee a sort of is switched on where everybody. Then you know 100.

Benjamin Jay Burnett: Okay, understood. If I could just ask one more question regarding the recent Novartis collaboration, can you talk more about the non-Treg activating IL-2 antibody that's being developed? I guess, how has the antibody been engrafted, and I guess what makes this a more selective IL-2 antibody? Thank you.

But our hired and they go into the facility I see a roll out on the rollout has already been started.

No. That's really helpful. Thank you and if I could just asking a quick follow up on your research.

Maria Fardis: Sure. Yes, of course.

With regard to the PBL program, obviously, it's exciting that it's a much shorter process and how you can.

Maria Fardis: So, as you might know, IL-2 binds to three different subunits, alpha, beta, and gamma subunits on various T-cells. The beta and gamma subunits are what we are interested in. The alpha subunit is more prevalent in binding toward Treg, so we are trying to rule that binding out. So the CDR that we have does not allow for this particular IL-2 to bind to the alpha subunit. It, in fact, focuses it better on the beta and gamma subunits. That's why we expect it to be better.

So just curious is there any major difference once you.

Extract T cells from the blood are there any major differences between Gen two and its Phil identification process before you expand them in the PBL versus Gen. Two.

We haven't very different process that'd be used for PD L.

There is and again, it's some of that is proprietary in a bulk of it has not been sort of shared already so yes. There is rather significant differences the cells. The T cells that be usually harvest from tumor or not in a very high concentration in blood, they're already familiar with that'd be noted that there are difficult to find so.

Maria Fardis: And I guess at this point, can you comment on just kind of the architecture of how the antibody is engrafted, or is that...

Maria Fardis: And at this point, is that proprietary?

We had to implement different procedures in order to fish T cells out nvvault very successful obviously in doing so but yes, there's differences in how we get the cells from to source, one being a tumor one being blood.

Maria Fardis: It's certainly proprietary, and thank you for understanding.

That's great. Thanks.

Benjamin Jay Burnett: Okay, okay. It makes sense. Thanks so much.

Thank you Jeff.

Your next question comes from the line of Mark Breidenbach from Oppenheimer. Please ask your question.

Operator: Thank you. Your next question comes from the line of Joel Pankinis from HC Wainwright. Please ask your question.

Joel Pankinis: Hi everyone. Good afternoon.

Hey, guys. Thanks for taking my questions on it and congrats on the progress.

Maria Fardis: Thanks for taking the question. Maria, I was just curious if you could provide a little more detail regarding your strategy for the evolution of your manufacturing facilities. As you mentioned in your prepared comments, you have WuXi right now and are looking to have your new facility come online in 2022. How do you look to sort of share the responsibilities between these two facilities? And also, when your facility comes online, do you anticipate that it will start off with Gen 3?

I noticed that the.

Oh cohort in melanoma enrolled a little bit faster than maybe you had an initially projected and the pivotal cohort in cervical maybe more or less on the timeline. You had initially projected I'm. Just wondering if you can put any specific factors that are contributing to that discrepancy and also.

Is it safe to assume we would want a minimum of six month follow up a one the pivotal cervical cancer completes enrollment before we did see topline data from that.

Maria Fardis: Joe, to correct your statement, it would start off with Gen 2, correct? Is that what you said? Yes. Thank you. Yes. Right, right.

Thank you for Mark for the question, Yes, you're correct monoamine grows faster than we expected and I think that definitely shows a clear unmet medical need the cyclical landscape is definitely changing as you're aware. There's earlier line Keytruda studies are coming into this space.

Maria Fardis: So currently, our commercial plan is very much locked and loaded for Gen 2. The facility is very much designed around Gen 2. But, of course, it can support other manufacturing processes, should there be a need for them.

Both in terms of clinical trials as when I was just the commercial use and so the patients have you ever and rolling into our core one is certainly that that the nature of the patients that are out there is changing so it's really due to the change in landscape and they'll be anticipated that this is going to happen and I made a comment about it get added to older cohorts into our.

Maria Fardis: But right now, we are very much planning our commercializations with the Gen 2 process. In terms of roles and responsibilities, we have already started building our team out in Philadelphia. Certainly, the building itself requires a number of staff who are familiar with the process. We have great expertise in-house, starting from our engineering team as well as people who are very familiar with the process in terms of process development and optimization. So we already have a team that is slowly ramping up to what is going to be needed by the time the commercial activities roll out. In addition to the local team members in Philadelphia, we have additional team members such as Quality or Otherwise in San Carlos who are supporting the activities for the facility. So I don't foresee a sort of switch on where everybody then, you know, 100 people are hired, and they go into the facility. I see a rollout, and the rollout has already been started.

And then one four or five study for cervical and anticipation, but the change in landscape. So be you have thought through this and be have some alternative strategies a if this continues.

And your second question in terms of the six months a follow up we thought about a six month a follow up for melanoma, just because enrollment closed so early and it allows us to do a six month a follow up there has not been really a request either from agency or otherwise for a certain amount a follow up I think that this is really a subject to discussion with you.

58 in terms of how much follow up there might be asking for.

What I do want to note that the six months is a <unk> event.

Suppose all in demolish the case.

Understood and maybe just a quick follow up on the Gen. Three process I I'm curious why this is.

Really initially being focused in head and neck, maybe you could elaborate a little bit on why it's important to have a fannie faster manufacturing timeline in head and neck and I'm also curious with regard to that PD. One select version of Phil what is that what was the impact of that on manufacturing high minded.

Maria Fardis: Now that's really helpful, thank you. And if I could just ask a quick follow-up on your research front. With regard to the PBL program, obviously, it's exciting that it's a much shorter process and you know how you can identify these TILs. Just curious, is there any major difference once you extract T cells from the blood? Are there any major differences between Gen 2 and the TIL identification process before you expand them in the PBL versus Gen 2?

At several days and process.

Okay. Thank you.

Yes, we had recognized earlier on that the patients in head and neck in a cancer have fairly short survival. Unfortunately, so be felt that is shorter manufacturing process really could benefit a patient population that doesn't many times. They don't make it through the first assessment or second assessment. So that's why.

The implemented that initially into the head and neck study.

Maria Fardis: We have a very different process that we use for PDLs, and again, some of that is proprietary, and the bulk of it has not been sort of shared already. So yes, there are rather significant differences. The T cells that we usually harvest from tumors are not in a very high concentration in blood. We are already familiar with that. We know that they're difficult to find. So we had to implement different procedures in order to fish these cells out, and we were very successful, obviously, in doing so. But yes, there are differences in how we get the cells from the source, one being a tumor, and one being blood.

Their PD one selected process does not add additional days to the manufacturing process. It is in fact, we have optimize that process. So that it is not longer than our gen. Too. So it's it's the same duration as our gen two process.

Okay understood.

Alright, Thank you for answering the question congrats again.

Got you Mark.

Your next question comes from the line of Ren Benjamin from JP JMP Securities. Your line is now open.

Great. Thanks for taking my questions and congratulations on the progress.

Can you.

Just talk a little bit about how many patients.

I think are required.

Before you feel pretty comfortable with disclosing results not just from the basket, but maybe some of your other studies and you mentioned duration.

Maria Fardis: That's great. Thanks, Maria.

Joel Pankinis: Thank you, Joe.

Operator: Your next question comes from the line of Mark Breidenbach from Oppenheimer.

The answer to Mark's question, but what other kind of gating items needs to be discussed with the FDA prior to filing.

Mark Alan Breidenbach: Hey guys, thanks for taking the questions and congrats on the progress. Maria, I noticed that the pivotal cohort in melanoma enrolled a little bit faster than maybe you had initially projected, and the pivotal cohort in cervical is maybe more or less on the timeline you had initially projected. I'm just wondering if you can point to any specific factors that are contributing to that discrepancy and also, is it safe to assume we would want a minimum of six months of follow-up once the pivotal cervical cancer trial completes enrollment before we would see top-line data from that?

Right.

Thank you Ben.

Can I don't think there's a magical number for us to disclose but I prefer fear for example at these five patients before it would be kind a nice to talk about but there's not a magical number I think it depends on what we see but that's my mental note. If you asked me what is your mental number no somewhere between 4567 would be really good numbers, but again.

I do emphasize there's not a magical number by which we want to disclose something you know the data for that for that study.

In terms of did you ask about the duration can you repeat your question on what you're asking on the duration front.

Oh, sorry, just a in regards to your discussions with the FDA pardon.

Maria Fardis: Thank you Mark for the question. Yes, you're correct.

Maria Fardis: Melanoma enrollment is faster than we expected, and I think that definitely shows a clear unmet medical need. The cervical landscape is definitely changing. As we are aware, there are earlier Keytruda studies coming into this space, both in terms of clinical trials as well as just commercial use. And so the patients that we are enrolling into our Cohort 1, the nature of the patients that are out there is changing. So it's really due to the change in landscape. Now we anticipated that this was going to happen, and I made a comment about it.

I think you mentioned you know duration would be one of the things that you'll be talking about.

Particular mandate, but what are other items like that.

Discussion prior to filing.

Sure.

So just to make sure that I I clarified a question.

Specific item that'd be would be asking the agencies duration a follow up another duration of response the duration of response to the property of the product, but the duration of follow up that they would like to see is typically a subject to discussion as part of the DNA that dialogue.

That being a pre meeting typically has a component of a logistics involved in it. It usually has a component of how you're going to build you'll be L.A.B. and he's a very large document exactly where to find something and then theres. Other components of the ask questions about it's it's a bit of in logistics meeting as well as.

Maria Fardis: We had added two other cohorts to our LN145 study for cervical cancer in anticipation of the change in landscape. So we have thought through this, and we have some alternative strategies if this continues. In terms of the six months of follow-up, we thought about a six months of follow-up for melanoma just because enrollment closed so early and it allows us to do six months of follow-up. There has not really been a request either from the agency or otherwise for a certain amount of follow-up. So I think that this is really a subject for discussion with USFDA in terms of how much follow-up they might be asking for. But I do want to note that the six months is an Iovance proposal in the melanoma case.

Guidelines for next step sometimes the other topics scientific topics also Paul Paul I won't go into too much detail obviously that.

Something thats proprietary teach company as to what they discuss at at the previously meeting.

Got it and I guess, just one final question from US is really that the cadence of.

Data it seems like it will be primarily second half focus from kind of all the programs that are running are we thinking about that correctly.

Lease kinda topline data for melanoma.

Maria Fardis: And maybe just a quick follow-up on the Gen 3 process. I'm curious why this is really initially being focused on the head and neck. Maybe you could elaborate a little bit on why it's important to have a faster manufacturing timeline for the head and neck. And I'm also curious with regard to the PD-1 select version of TIL; what was the impact of that on the manufacturing timeline? Does that add several days to the process?

Filing and then kind of full data sometime in 21 is that how we should be thinking about it.

Different cadence.

Right.

I wouldn't rule out any any specific patterns in any shape or form just specifically talking about the melanoma topline data that we I'm thinking about it right now is possibly just disclosing very high level topline data and then submission to FDA and may be disclosing more information at a medical conference. That's that's sort of how you're thinking about it right.

Now.

Perfect. Thank you again congrats on the progress. Thank you then.

Maria Fardis: Okay, thank you. Yes, we had recognized earlier on that patients with head and neck cancer have a fairly short life expectancy, unfortunately. So we felt that a shorter manufacturing process really could benefit a patient population that doesn't, many times, don't make it to the first assessment or a second assessment. So that's why we implemented that initially into the head and neck study.

Your next question comes from the line of Latin for wire from Baird. Please ask your question.

Hi, great. Thanks for taking our question. So I guess, our first one is what do you see.

Yes regulatory.

And all that stuff.

Sure. Thanks, I do we do have plans to initiate a broader dialogue with F. <unk> email health authorities call teach and Pea.

Potentially in later part of 2020, its not that there has been no dialogue. We obviously have a number of clinical sites that are active in E U and as part of that'd be submitted what is called the clinical trial authorizations as it has the summit and preliminary dialogue has been had been local hassle, sorry will be do intend on starting a sort of them.

Maria Fardis: The PD-1 selected process does not add additional days to the manufacturing process. It is, in fact, we have optimized that process so that it is not longer than our Gen 2. So it's the same duration as our Gen 2 process.

I have a centralized procedure later part of the year in 2020.

Mark Alan Breidenbach: Okay, understood. All right, thank you for answering the questions, and congrats again. Thank you, Mark.

Okay and get them more practical question about the PD one combination studies. So you all give the kills do the aisle to treatment and then is there like a washout period, where you start PD one like how much a gap is there between that killed procedure and the beginning of PD, One administration and the combination studies.

Operator: Your next question comes from the line of Ren Benjamin from JMP Securities. Your line is now open.

Reni John Benjamin: Great, thanks for taking the questions and congratulations on the progress. Rhea, can you just talk a little bit about how many patients you think are required per cohort before you feel pretty comfortable with disclosing the results, not just from the basket, but maybe some of your other studies? You mentioned duration in an answer to Mark's question, but what other kind of gating items need to be discussed with the FDA prior to filing?

So the PD one is administered at prior to two.

And that information to the degree I can speak to is available on clinical trials, the golf, but it won't be able to go into details of this study designed to do.

Okay. Thanks.

[noise]. Your next question comes from the line of Gary and then from Jefferies. Please ask your question.

Yeah, Hi, guys. Thanks for taking my questions and it was great to see you earlier today, So Maria with the melanoma cohort for a fully enrolled <unk>. How do you think about the baseline characteristics of this cohort compared to cohort to in terms of.

Maria Fardis: Right. Thank you, Ben.

Maria Fardis: You know, I don't think there's a magical number for us to disclose, but I prefer if you're, for example, at least five patients or four, it would be kind of nice to talk about, but there's not a magical number. I think it depends on what we see, but that's my mental note. If you ask me what your mental number is, you know, somewhere between four, five, six, and seven would be really good numbers. But again, I do emphasize there's not a magical number by which we want to disclose something, you know, the data for that study. In terms of, did you ask about the duration? Can you repeat your question on what you're asking about the duration?

Median prior lines as well as in terms of PD, one refractory status. Thanks.

Hi, Ben Thank you for your question.

Have not been analyzing cohort four we actually have a data integrity document in place, where we don't be don't compiled the data for quote for so I won't be able to speak to the patient population and core for I did a news that we designed the protocol the same way the patient population definition.

Maria Fardis: Now, sorry, just in regards to your discussions with the FDA prior to filing, I think you mentioned that duration would be one of the things that you'll be talking about since they don't have a particular mandate, but what are other items that you think are worthy of discussion prior to filing?

Is the same between courts, two and four and be tried to keep the participating sites to the degree because control at the same.

Okay, and then can you just talk a little <unk> about the PD one selected till what are you hoping to gain from this program in terms of activity.

Maria Fardis: Sure. So just to make sure that I clarify the question, the specific item that we would be asking the agency is the duration of follow-up, not the duration of response. The duration of response is a property of the product, but the duration of follow-up that they would like to see is typically a subject to discussion as part of a BLA dialogue. The BLA pre-meeting typically has a component of logistics involved in it. It usually has a component of how you're going to build your BLA. A BLA is a very large document, exactly where to find something.

And I guess, what do you currently seeing I'm, the head and neck cohort, which tend to that you know allowed you to decide to move forward with not just the gen three but the PD one selected till.

Sure.

So some of the data for PD. One selected Hill was presented at I think it was 52018 did the criteria for that program was there was some preliminary data around a T cells that are ultimately recognized the tumor because they have seen the PD L. One of the tumor so it's building.

Maria Fardis: And then there's other components that we ask questions about. It's a bit of a logistic meeting as well as guidelines for next steps. Sometimes other topics, scientific topics, also pop up. I won't go into too much detail. Obviously, that's something that's proprietary to each company as to what they discuss at the pre-BLA meeting.

Resting PD, one hi, they recognize the tumor not only beyond what till initially identified but they have literally touched a tumor the tumor cell.

So that was idea around the selection process and again there was literature showing that these are more potent till they have better activity and cell killing capability. One you presented this at CES seen 2018, we showed in fact that the other the that till that or PD, one selected have enhanced autologous melanoma.

Maria Fardis: Got it. And I guess just one final question from us. Really, the cadence of data, seems like it will be primarily second-half focused on kind of all the programs that are running. Are we thinking about that correctly? Would you release kind of top-line data for melanoma, then a filing, and then, you know, kind of full data sometime in the future? Is that how we should be thinking about it? Or is there a different way of reporting the results?

What's cell, killing capability and a it was quite remarkable so we decided to move that product into clinic.

In terms of what the bar would be the had disclosed for gen. Two in a very very preliminary set of data back maybe a couple of years ago now that it median deal or was around you know two to seven months for our head and neck patients. So we're looking to try and elongate the median deal or that would be our our goal for the additional costs.

<unk>.

Got it and then maybe for the last question were Maria in terms of the landscape pills and how you think about neo antigens do you view this as a competitive approach or complimentary approach because it seems there's some pharma companies that are investing in this and do you feel that some of these cuts.

Maria Fardis: I wouldn't rule out any specific patterns in any shape or form. Just specifically talking about the melanoma top-line data, the way I'm thinking about it right now is possibly just disclosing very high-level top-line data and then submitting it to FDA and maybe disclosing more information at a medical conference. That's sort of how we're thinking about it right now.

Actually be synergistic to pills.

Thank you for that question I think they may cover let you defend landscapes in my opinion wouldn't be have diseases that are high mutational load as such as possibly mono love Your thinking you know head and neck longer.

Reni John Benjamin: Terrific. Well, thank you again, and congrats on the progress.

Maria Fardis: Thank you, Ben.

Operator: Your next question comes from the line of Madhu Kumar from Baird. Please ask your question.

These are diseases that there's multiple targets on there there needs to be multiple cells that would hit those targets. So the challenge with them would be identifying that specific neoantigen that a T cell could I could target and if you don't have that then it's really hard to hit them. So I do think that they would occupied different spaces I think neoantigen targeted.

Madhu Sudhan Kumar: Hi, great. Thanks for taking our questions. So I guess our first one is, what is the XUS regulatory path in melanoma and cervical cancer?

Maria Fardis: Sure. Thanks, Madhu. We do have plans to initiate a broader dialogue with EMA health authorities called the CHMP, potentially in the latter part of 2020. It's not that there has been no dialogue. We obviously have a number of clinical sites that are active in the EU, and as part of that, we submit what is called a clinical trial authorization, so a CTA has been submitted, and preliminary dialogue has been had with local health authorities. But we do intend on starting a sort of a more of a centralized procedure later part of the year in 2020.

Therapies would could be beneficial for lower mutational load, while still are maybe more beneficial for high end mutational load and this would last as long as we don't know exactly what targets are trying to hit a with a with various cell therapies. So, yes, I guess I see them complimentary maybe.

So are there any pharma companies that you think complement pills.

[laughter] I did I don't know if I can address that there's a number of companies who are interested in that particular landscape and.

I'm really well of course monitor them very closely.

Great. Thank you.

Thank you Karen.

Your next question comes from the line of gel Catherines Arrow from Piper Sandler Your line is now open.

Madhu Sudhan Kumar: Okay, and just a more practical question about the PD-1 combination studies. So you give the tills, do the IL-2 treatment, and then is there like a washout period before you start PD-1? Like how much of a gap is there between the till procedure and the beginning of PD-1 administration in the combination studies?

Hey, guys just maybe one quick one for me some Maria you had mentioned that as part of your commercial preparation clinical site engagement is the main area of focus now that cohort for melanoma is close what are the opportunities from now until potential approval to continue to mean maintain and expand that clinical site engage.

Maria Fardis: So the PD-1 is administered prior to tilt, and that information, to the degree I can speak to, is available on clinicaltrials.gov. But I won't be able to go into details of the study design, Madhu. Okay, thank you.

Into the the current ongoing studies allow you to do that would you potentially expect an expanded access program that would allow you to do that how are you thinking about that.

Madhu Sudhan Kumar: Sure.

Operator: Your next question comes from the line of Baron Amin from Jeffries. Please ask your question.

Yeah, great. Thank you Joe as a matter of fact that is something that is very much front of mind. This is why and Frederick commented about this for the I overcome too old to study we are adding he cohort into that study that will and enroll melanoma patients with the selected till product to one four or five is one that's exactly the.

Baron Amin: Hi guys, thanks for taking my questions and it was great to see you earlier today. Maria, with melanoma cohort 4 fully enrolled, how do you think about the baseline characteristics of this cohort compared to cohort 2 in terms of median prior lines as well as PD-1 refractory status? Thanks.

Purpose to allow access to till product wise, we are bringing this the ellen wonderful for like to do so to market.

Maria Fardis: Hi Biren. Thank you for your question. We have not been analyzing Cohort 4. We actually have a data integrity document in place where we don't compile the data for Cohort 4. So I won't be able to speak to the patient population in Cohort 4. But I did note that we designed the protocol the same way. The patient population definition is the same between Cohorts 2 and 4, and we try to keep the participating sites the same to the degree we can control them.

Okay, Great. That's all I have thanks for taking them my questions are not congrats on the progress. Thank so much.

There are no further questions at this time I will now turn the call over back to know yeah for her closing remarks.

Thank you all favor overall I'm very pleased with the progress the of beef and our prospects are becoming the leader and until development manufacturing and commercialization. Indeed in just four years, we have gone from our first accretion in the clinic to preparing our first regulatory submission for approval, we have the potential to impact lives of.

Baron Amin: Okay, and then can you just talk a little bit about the PD-1 Selected-TIL? What are you hoping to gain from this program in terms of activity? And I guess what are you currently seeing in the head and neck cohort with Gen 2 that's, you know, allowed you to decide to move forward with not just the Gen 3, but the PD-1 Selected-TIL?

Dozens of patients had melanoma cervical cancers, who have exhausted current treatment options. Our work is possible. Thanks to the valuable contribution of many individuals including committed shareholders hard working employees clinical investigators collaboration partners on patients on patient families, who motivate us we look forward to realizing this shared vision for the surprise.

Product with a the individuals that are need of therapy. Thank you.

Maria Fardis: So, some of the data for PD-1 selected TIL was presented at, I think it was 50, 2018. The criteria for that program were there was some preliminary data around T cells that ultimately recognized the tumor because they had seen the PD-L1 of the tumor. So, a TIL that is expressing PD-1 high, they recognize the tumor not only beyond what TIL initially identified, but they have literally touched the tumor, the tumor cell. So that was the idea around the selection process. And again, there was literature showing that these are more potent TILs. They have better activity and cell-killing capability. When we presented this at CITSE in 2018, we showed, in fact, that the TILs that are PD-1 selected have enhanced autologous melanoma cell-killing capability.

This concludes the call today you may now disconnect.

[music].

Maria Fardis: And It was quite remarkable, so we decided to move that product into clinics. In terms of what the bar would be, we disclosed for Gen 2 in a very, very preliminary set of data back maybe a couple of years ago now that its median DOR was around, you know, two to seven months for our head and neck patients. So we are looking to try and extend that median DOR. That would be our goal for the additional cohorts.

Baron Amin: Got it. And then maybe the last question, Maria, in terms of the landscape of TILS and how you think about neoantigens, do you view this as a competitive approach or a complementary approach? Because it seems there are some pharma companies that are investing in this, and do you feel that some of these could potentially be synergistic to TILS?

Maria Fardis: Thank you for that question. I think they may cover slightly different landscapes. In my opinion, when we have diseases that have a high mutational load, such as possibly melanoma, we think, you know, head and neck, lung, these are diseases where there are multiple targets, and there needs to be multiple cells that would hit those targets. So the challenge with them would be identifying that specific new antigen that a T cell could target. And if you don't have that, it's really hard to hit them.

Maria Fardis: So I do think that they would occupy different spaces. I think new antigen-targeted therapies would be beneficial for lower mutational load, while TIL is maybe more beneficial for higher mutational load. And this would last as long as we don't know exactly what targets we're trying to hit with various cell therapies. So yes, I guess I see them as complementary, maybe.

Baron Amin: So are there any pharma companies that you think complement TILS?

Maria Fardis: Thank you. Thank you. Thank you.

Baron Amin: I don't know if I can address that. There are a number of companies who are interested in that particular landscape, and we, of course, monitor them very closely.

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Maria Fardis: Great. Thank you.

Baron Amin: Thank you, Biren.

Operator: Thank you very much. Your next question comes from the line of Joe Catanzaro from Piper Sandler. Your line is now open.

Joseph Michael Catanzaro: Hey guys, just maybe one quick one for me. So Maria, you had mentioned that as part of your commercial preparation, clinical site engagement is the main area of focus. You know, now that Cohort 4 of melanoma is closed, you know, what are the opportunities from now until potential approval to continue to maintain and expand that clinical site engagement? Do the current ongoing studies allow you to do that? Would you potentially expect an expanded access program that would allow you to do that? How are you thinking about that?

Maria Fardis: Yeah, great. Thank you, Joe. As a matter of fact, that is something that is very much front and center. This is why Frederick commented on this. For the Iovacom 202 study, we are adding a cohort into that study that will enroll melanoma patients with the selected TIL product, 145S1. That's exactly the purpose, to allow access to TIL products while we're bringing the LN144 Lifelucel to market.

Joseph Michael Catanzaro: Okay, great. That's all I have. Thanks for taking my questions and congrats on the progress.

Maria Fardis: Thank you so much.

Operator: There are no further questions at this time. I will now turn the call over back to Maria for her closing remarks. Thank you all very much.

Maria Fardis: Overall, I'm very pleased with the progress we have made and our prospects of becoming a leader in TILT development, manufacturing, and commercialization. Indeed, in just four years, we have gone from our first patient in the clinic to preparing our first regulatory submission for approval. We have the potential to impact the lives of thousands of patients with melanoma and cervical cancer who have exhausted current treatment options. Our work is possible thanks to the valuable contribution of many individuals, including committed shareholders, hardworking employees, clinical investigators, collaboration partners, and patients and patient families who motivate us. We look forward to realizing this shared vision for this product with individuals that are in need of therapy. Thank you. This concludes the call today.

Operator: This concludes the call today. You may now disconnect.

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