Q2 2020 Iovance Biotherapeutics Inc Earnings Call

[music].

Ladies and gentlemen, please standby your conference calls we get momentarily once again, ladies gentlemen, please stay on both sides.

Operator: Ladies and gentlemen, please stand by. Your conference call will begin momentarily. Once again, ladies and gentlemen, please stay on the line. [inaudible] BF-WATCH TV 2021, Good afternoon, and welcome to the Iovance Second Quarter 2020 Financial Results Conference Call. At this time, all participants are in a listen-only mode.

[music].

Good afternoon walk into the heart and second quarter 2020 financial results Conference call. At this time all participants are in listen only mode. After the speakers presentation, there will be a question and answer session.

Operator: After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you need to press star 1 on your telephone. If you require further assistance, please press star then 0.

The question during the special due to press Star one on your telephone if your acquired further assistance. Please first starting with Europe now like turn the call at the Sara Pellegrino, Vice President Investor and public relations that Iran's. Please go ahead.

Sara Pellegrino: Now, I would like to turn the call over to Sara Pellegrino, Vice President and Investor in Public Relations at Iovance. Please go ahead. Thank you, Operator. Good afternoon, and thank you for joining us. Speaking on today's call, we have Maria Fardis, our President and Chief Executive Officer; Frederick Finckenstein, our Chief Medical Officer; and Michael Schwartzberg, Vice President of Finance and Principal Accounting Officer. This afternoon, we issued a press release that can be found on our website at iovance.com, which includes the financial results for the second quarter and first half ended on June 30, 2020, as well as corporate updates. Before we start, I would like to remind everyone that statements made during this conference call will include forward-looking statements regarding Iovance's goals, business focus, business plan, pre-commercial activities, clinical trial plans and results, potential future applications of Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time to time in our SEC filings.

Thank you operator good afternoon. Thank you for joining a speaking on today's call we have Maria target, our president and Chief Executive Officer.

Let me think inside our Chief Medical Officer, and Michaels work Swartzberg, Vice President Finance principal accounting officer.

This afternoon, we issued a press release it can be found on our website <unk> Dot com, which includes the financial results for the second quarter and first half ended on June Thirtyth 2020, as well 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 school business focused business plan Precommercial activities clinical trial plans and rebuild potential future applications of our technology manufacturing capability regulatory.

The feedback and guidance collaboration cash position and expense guidance and future updates.

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

Sara Pellegrino: Our results may differ materially from those projected during today's call. We undertake no obligation to publicly update any forward-looking statements. With that, I will turn the call over to Maria. Thank you, Sara, and good afternoon, everyone.

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

Undertake no obligation to publicly update any forward looking statement.

With that I will turn the call over to Maria.

Thank you Sarah and good afternoon, everyone I'm very pleased to lead today's conference call to summarize our achievements that I events during the second quarter and first half of 2020.

Maria Fardis: I am very pleased to lead today's conference call to summarize our achievements at Iovance during the second quarter and first half of 2020. We are moving closer toward commercializing Iovance as we continue to execute our key priorities, including clinical, manufacturing, and pre-commercial activities. We are driven because of our patience and by the dedication of internal team members and external partners.

We are moving closer towards commercializing I have until as you can teach execute our key priorities, including clinical manufacturing and pre commercial activities.

We are driven because of our patients and by the dedication of internal team members an external partners.

Maria Fardis: In the second quarter of 2020, we continued to advance our Tumor Infiltrating Lymphocyte Therapy, or TIL, in our lead pivotal programs in melanoma and cervical cancers. We reported updated cohort 2 data and early cohort 4 data in melanoma and recently completed enrollment in our Pivotal Cervical Program. We remain on track to submit our first planned biologics license application, or BLA, later this year, while preparing for potential commercial launch in 2021. Overall, we believe that the growing set of clinical data for TIL in advanced melanoma and cervical cancers, and more recently in lung cancer, further support TIL as a broad technology platform for cell therapies across solid tumors.

In the second quarter of 2020, we continue to advance our tumor infiltrating lymphocytes therapy or killed in our lead pivotal program in melanoma cervical cancers <unk>.

We reported updated cooler two data an early call. It 40 dot in melanoma and recently completed them Goldman in our pivotal surgical program.

Remain on track to submit our first plan to biologics license application or be in a later this year, while preparing for potential commercial launch and 2021.

Overall, we believe that the grueling set of clinical data for tilt in advanced melanoma, and cervical cancers and more recently in lung cancer further support till after brought technology platform a cell therapies across all the tumors.

Maria Fardis: With the successful completion of our June 2020 follow-on public offering, we are very well capitalized with approximately $777 million in cash to execute our initial commercial launch and expand our growing pipeline. We also continue to make great strides with our research efforts. We will be disclosing some of our research and bioinformatics data as part of three abstracts accepted as e-posters in the upcoming European Society for Medical Oncology, or ESMO, virtual scientific weekend to be held September 19th to 21st, 2020. They include data on persistence of TIL in cervical cancer patients, genetic modification of Iovance TIL using TALEN technology, and reinvigoration of Iovance T Further details of these posters are included in this afternoon's press release. I would like to take a few minutes to highlight the significant progress across our pivotal TIL programs, beginning with Lifelucel for advanced melanoma. Metastatic 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 alone.

With the successful completion of our June 2020 follow on public offering we are very well capitalized with approximately $777 million in cash to execute our initial commercial launch and expand our growing pipeline.

We also continue to make great strides without research efforts, we will be disclosing some of their research on bio informatics data as part of three abstracts accepted as E posters in the upcoming European Society for medical oncology or ESMO virtual scientific weekend to be held September 19th to 21st.

2020.

They include data on persistence of children cervical cancer patients genetic modification of I've asked hill using talent technology.

And reinvigoration of I have asked till during the Gen two manufacturing process.

Further details of these posters are included in this afternoon's press release.

I would like to take a few minutes to highlight the significant progress across our pivotal till program beginning with life and do so for advanced melanoma.

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

Maria Fardis: During the second quarter, we announced Early Pivotal Cohort 4 data and updated Cohort 2 data from our C14401 study of Lifelucil. We believe that the combined data from cohort 2 and 4 in our melanoma study continue to support the efficacy of Lifelucil to address a very significant medical need in metastatic melanoma. As a reminder, Lifelucel has also received both Fast-Track and Regenerative Medicine Advanced Therapy, or RMAT, designations from the U.S. FDA, which were supported by the clinical data from Cohort 2 in the melanoma study. Iovance, as an organization, is very focused on the advancement of this melanoma program. We anticipate meeting with FDA and expectedly submitting the BLA for lifelucid in late 2020. Our second pivotal program is investigating Lysalusol, formerly known as LN-145, in this C14504 study in patients with metastatic cervical cancer.

During the second quarter, we announced early pivotal quote for data an update is core to data from our C. One for 40 to one study of my feeling so.

We believe that it combined data from quarter, two and four in our melanoma study continue to support the efficacy of life and useful to address a very significant unmet medical need in metastatic melanoma.

As a reminder, they could do still has also received both fast track and regenerative medicine advanced therapy or Ormat designation from the U.S.F.D.A., which were supported by the clinical data from core too and the melanoma study.

I have asked as an organization is very focused on the advancement of this melanoma program, we anticipate to meet with hefty unexpectedly submit the BLE for life in new sold in late 2020.

Our second pivotal program is investigating lesser Lucille, formerly known and unknown as Alan one full five indicee, one four or five four study in patients with metastatic cervical cancer.

Maria Fardis: The United States Adopted Names or USAN Council has accepted and published the use of the name Life Illuso to describe Iovance tiltherapy for cervical cancer in addition to melanoma. We recently completed enrollment in Pivotal Cohort 1 of the Cervical Study, and we are scheduled to dose our last patient in the coming weeks. As a reminder, the FDA has previously granted both breakthrough therapy and fast-track designations for LN145, now referred to as Lifelucel. However, since we completed enrollment in our melanoma pivotal cohort approximately two and a half months ahead of schedule, the BLA submission for the two indications may be separate. We continue preparing for both submissions, with the BLA submission for melanoma anticipated later this year, and the BLA submission for cervical cancer most likely in the first half of 2021.

The United States adopted names or you send council has accepted and published the use of the name they fill diesel to describe I ever til therapy for cervical cancer. In addition to melanoma.

We recently completed enrollment into pivotal who would one of the cervical study and we are scheduled to dose our last patient becoming beach.

As a reminder, DFT has previously granted both breakthrough therapy and fast track designation for Ellen one four or five now refer to as like a diesel.

Since we completed enrollment in our melanoma pivotal cohort approximately two and a half months ahead of the plan. The BLE submission for the two indications maybe separate we continue preparing for both submission with the BLE submission for melanoma anticipated later this year and they'd be any submission for cervical most likely into first half of 2021.

[music].

Transitioning to our manufacturing capabilities, we have established a solid track record in manufacturing till four patients as we prepare to launch lately. So using our proprietary second generation or Gen. Two process. The gen. Two process protected by 12 granted U.S. pagans continues to be robust with a demonstrated.

Maria Fardis: Transitioning to our manufacturing capabilities, we have established a solid track record in manufacturing kills for patients as we prepare to launch Lifoleucel using our proprietary second generation or Gen 2 process. The Gen 2 process, protected by 12 granted U.S. patents, continues to be robust with a demonstrated success rate above 90% in over 300 patients. For launch, our CMO partner, Bougie App Tech's Philadelphia facility, will provide initial commercial supply of Lifelucel until we transfer to the Iovance Cell Therapy Center, now called ICTC. The ICTC is our own state-of-the-art 136,000 square foot facility at the Navy Yard in Philadelphia. The location of the ICTC near Philadelphia Airport also allows for shipment of tiltherapies to all states within the U.S. and throughout Europe if necessary.

Success rate above 90% in over 300 patients.

For launch our CMO partner Bougie optics, Philadelphia facility will provide initial commercial supply of liquidity. So until we transfer to the I have a cell therapy centered now called ICICI C.

I see TC is our own state of the our 236000 square foot facility at the Navy yard in Philadelphia.

The location of the I CTC near Philadelphia Airport also allows for shipment of till therapies to all states within the U.S. and throughout Europe if necessary.

We have been in active dialogue with the U.S.F.D.A. doing construction of the ice CTC facility.

In advance of a scheduled meeting with the division of manufacturing and product quality or DMP Q I am pleased to report that you reached full alignment with the division on commercial manufacturing facility design and capacity.

Maria Fardis: We have been in active dialogue with the U.S. FDA during construction of the ICTC facility. In advance of a scheduled meeting with the Division of Manufacturing and Product Quality, or DMPQ, I am pleased to report that we have reached full alignment with the Division on Commercial Manufacturing Facility Design and Capacity. Clean rooms at the ICTC are expected to be completed in late 2020, with clinical activities expected to begin in early 2021. Commercial manufacturing is on track for 2022 with capacity to meet the demand for thousands of patients. In anticipation of the launch of Lifelucel in melanoma and cervical cancers, we continue to build a strong team at Iovance with more than 200 employees across multiple locations, including a commercial team with extensive cell therapy experience. The commercial and medical affairs groups remain focused on ensuring a positive patient experience with Lifelucel during commercialization.

Clean rooms at the ICICI see are expected to be completed in late 2020 with clinical activity is expected to initiate an early 2021.

Commercial manufacturing is on track for 2022 with capacity to meet the demand for thousands of patients.

In anticipation of the launch of life for diesel in melanoma cervical cancers, we continue to build a strong team at i. events with more than 200 employees across multiple locations, including a commercial team, but extensive cell therapy experience.

The commercial and medical affairs groups remain focused on ensuring a positive patient experience with life will do so doing commercialization toward that you're working on the following areas of operational excellence.

Clinical site engagement in preparation for commercial launch development other close collaboration with health care professionals or a C piece, who will be administering life in soap.

Operational excellence, but I events in provision of life, Nuseal and communication with payers.

First we are partnering with the leading U.S. cancer centers to build their service line capabilities.

Among these centers, we anticipate that sites with prior till experience and those with key opinion leaders for melanoma cervical cancers will be the initial target for our launch.

Our comprehensive training program is designed to ensure cross disciplinary team can administer delightful nuseal a treatment regimen upon FDA approval.

Maria Fardis: Toward that end, we are working on the following areas of operational excellence: Clinical Site Engagement in Preparation for Commercial Launch. Development of a close collaboration with healthcare professionals, or ACPs, who will be administering life-healing salts. Operational excellence by Iovance in the provision of life and useful products and communication with payers. First, we are partnering with the leading U.S. cancer centers to build their service line capability. Among these centers, we anticipate that sites with prior TIL experience and those with key opinion leaders for melanoma and cervical cancers will be the initial targets for our launch. Our comprehensive training program is designed to ensure cross-disciplinary teams can administer the Lifelucid Treatment Regimen upon FDA approval. Iovance is targeting to train and onboard well over 40 sites at launch and expand over time.

I have asked a targeting to train and onboard well over 40 sites at launch and expand overtime.

Longer term goal is to bring on enough sites. So that most patients can be within a few hours drive twist sites offering life in diesel til therapy.

Based on our current market research, we estimate the addressable market for til therapy to be over 7000 post PD, one melanoma patients per year within us.

In addition, our medical affairs seem works with a network of treating a CP and patient advocacy groups to assure that information about hill is available to interest at organizations.

We have also continued discussions with private payors and sensors from Medicare and Medicaid reimbursement or CMS to ensure patients have appropriate and timely access to life and diesel.

Thus far we have met with or are scheduled to meet with commercial and Medicare payers responsible for approximately 50% of covered lives. We believe that CMS and payers appreciate the unmet need and clinical value of life into so I was what has the potential benefits for patients with metastatic melanoma and metastatic lung.

Maria Fardis: The longer-term goal is to bring on enough sites so that most patients can be within a few hours' drive of a site offering life-releasable tail therapy. Based on our current market research, we estimate the addressable market for TIL therapy to be over 7,000 post-P.E.1 melanoma patients per year within the U.S. In addition, our medical affairs team works with a network of treating HCPs and patient advocacy groups to assure that information about kill is available to interested organizations. We have also continued discussions with private payers and centers for Medicare and Medicaid reimbursement or CMS to ensure patients have appropriate and timely access to life-in-new-salt. Thus far, we have met with or are scheduled to meet with commercial and Medicare payers responsible for approximately 50% of covered lives.

Answers.

An under a patient centric model, we intend to support the patient at every step of the process from initial reception to infusion at iota being patient centric meas understanding anticipating and addressing our patient needs and removing barriers to treatment.

In today's press release, we introduced I events cares a program that reflects our commitment to provide individualized support for a personal life therapy.

I've asked cares will allow communication and coordination of patient care with a CPM throughout the life of diesel journey.

All elements of the system will be managed by dedicated I events case managers to handle the needs of a season patients.

Through I have asked cares AC piece can place order for life. If you sold while I events will monitor and track patient sell through manufacturing process until delivery to the hospitals.

The dedicated case managers will also provide reimbursement support for sites and patients.

As our market research on commercial preparation continues we look forward to providing updates on our launch plans throughout the year for you.

I wouldn't like to now ask our Chief Medical Officer, Frederic Frankenstein to summarize the recent data as well as our other clinical studies that I've asked Frederic.

Maria Fardis: We believe that CMS and payers appreciate the unmet need and clinical value of Lifelucil as well as the potential benefits for patients with metastatic melanoma and metastatic cervical cancer. And under a patient-centric model, we intend to support the patient at every step of the process from initial resection to infusion. At Iovance, being patient-centric means understanding, anticipating, and addressing our patients' needs and removing barriers to treatment. In today's press release, we introduce Iovance Cares, a program that reflects our commitment to provide individualized support for personalized therapy. Iovance Cares will allow communication and coordination of patient care with HCPs throughout the lifelucid journey. All elements of the system will be managed by dedicated Iovance case managers to handle the needs of ACPs and patients.

Thank you Mario.

I would like but some color walking for the most recent data from our C. One full four or one cynical W. Like the local or til therapy for metastatic melanoma.

They don't include an updated from cohort too early data from quarter four.

Both core and.

And for similar patient characteristics and that they are heavily pretreated with high baseline disease burden and significant unmet needs.

Chemotherapy the available carefully patients who have progressed on immune checkpoint inhibitors reported to offer this only affords the 10% response rate median overall survival of only seven put them all.

The updated cohort two data was presented at the school Twentytwenty virtual scientific meeting.

Following onetime treatment in.

Patients like Google show that 36.4 person or or at the original perform for go up reached at 18.7 months or medium 30 Pablo.

The new sensitivity analysis also showed the durable responses have been observed across a wide range in metastatic melanoma patients who layer receive cardio and positively for the rough target the treatment regardless of your reputation sub equally in patients with beauty or one high and low stuff.

Maria Fardis: Through Iovance Cares, HCPs can place orders for Lifelucel, while Iovance will monitor and track patients' cells through the manufacturing process until delivery to the hospital. The dedicated case managers will also provide reimbursement support for sites and patients. As our market research and commercial preparation continue, we look forward to providing updates on our launch plans throughout the year for you. I would now like to ask our Chief Medical Officer, Frederick Finckenstein, to summarize the recent data as well as our other clinical studies at Iovance. Frederick?

We believe abuse core to the further demonstrate durability of reforms.

Bill for all hub groups of patients as well as the value proposition for life in lieu of the one country necrotic melanoma.

Turning to called for we recently conducted the early data analysis as a reminder, primary endpoint for cohort four or our button independent review comedy and the key secondary endpoint is for ore body investigator.

Early analysis included an investigator assessments in 16 patients with COO available radiological assessments at the time before March Twentytwenty data cut off.

Friedrich Graf Finckenstein: Thank you, Maria. I would like to spend some time walking through the most recent data from our C14401 clinical study of lysolutel, our chill therapy for mendostatic melanoma. These new data sets include an update from cohort 2 and early data from cohort 4. Both cohorts 2 and 4 have similar patient characteristics in that they are heavily pretreated with a high baseline disease burden and significant unmet need. Chemotherapy is the available treatment for these patients who have progressed on immune checkpoint inhibitors reported to offer at best only a 4-10% response rate and median overall survival of only 7-8 months.

And these core more patients likely Luke will show that 32.4% or its 5.3 months of medium. So if you follow.

Overall, we were very pleased with these preliminary results such a significant improvement over vehicle careful this patient population as well as remarkable consistent with prior cohort two data that showed four or 33 person.

Oh median probably follow up.

Presented.

You see in 2018.

We will present, a detailed pivotal data for the future medical meetings and 20 could do you want.

Turning toward our development of Biovance sole therapy, 11, 140, probably in lung cancer. We continue to those two cohorts of non small cell lung cancer patients in our ongoing basket study, which we call it will be com tool to.

We were highly encouraged failed collaborator mosfets recent data up that they see our virtual meeting one which showed durable complete responses in non small lung cancer patients treated with mosfets too.

Friedrich Graf Finckenstein: The updated cohort 2 data was presented at the ASCO 2020 virtual scientific meeting. Following one-time treatment in 66 patients, results showed a 36.4% ORR, and duration of response was still not reached at 18.7 months of medium study follow-up. The new sensitivity analysis also showed that durable responses have been observed across a wide age range in metastatic melanoma patients who may have received prior anti-CTLA-4 and BRAF-targeted treatments, regardless of BRAF mutation status, and equally in patients with PADR1 high and low status.

The most with data provided the foundation of pool.

Just to get over on idle them pills in non small cell lung cancer and the two boxes or the cohort this world as a potentially registration, enabling studies, which we call it will be as do and Hello to.

Like our approach in both melanoma surgical we believe that the single arm study or kill therapy I loved 140 caused her for pencil.

<unk>, who in the well defined lung cancer patient population with significant unmet medical need.

We plan to begin the to the are you will be it was due in two or two studies for the and could be 20.

Moving onto our other studies, we continue to it I owe them. So based therapies that makes an additional indications as well as an earlier lines of therapy.

These studies include the are you will be com tool to clinical study, which we also referred to us or basket study.

Friedrich Graf Finckenstein: We believe that these cohort 2 data further demonstrate the durability of response to TIL for all subgroups of patients, as well as the value proposition for lifelucid as a one-time treatment in metastatic melanoma. Turning to Cohort 4, we recently conducted an early data analysis. As a reminder, the primary endpoint for Cohort 4 is ORR by independent review committee, and the key secondary endpoint is ORR by investigator. The early analysis included an investigator assessment in 68 patients with two available radiological assessments at the time of our March 2020 data cutoff. And these scored four patients' liposultal showed a 32.4% ORR at 5.3 months of median study follow-up.

Evaluates the broader pencil for till treatment in combination with Pembrolizumab in earlier lines of therapy for checkpoints not use melanoma, and then that non small cell lung cancer.

Furthermore, this study has two additional cohorts of loans and relapsed refractory melanoma and non small cell lung cancer.

The ongoing new one for five or preclinical study in head and neck cancer, which also introduces LM 145 manufactured with our new proprietary 16 days third generation on Gen. Three til therapy process as well as our proprietary PD wants to like the to the portal, which we call and then wonderful.

Replaced one.

We are also activating additional proceeds for the auditing.

Or one study of all peripheral abrupt lymphocyte or PBL therapy, and relapsed or refractory chronic lymphocytic leukemia, and small lymphocytic lymphoma, Hello Hello.

Friedrich Graf Finckenstein: Overall, we were very pleased that these preliminary results suggest significant improvement over available care for this patient population, as well as remarkable consistency with prior cohort 2 data that showed ORR of 33% at 6 months of median study follow-up, as presented at SITC in 2018. We will present the detailed pivotal data at a future medical meeting in 2021. Turning toward our development of Iovance Till Therapy LN145 in lung cancer, we continue to dose two cohorts of non-small cell lung cancer patients in our ongoing basket study, which we call IOVCOM202. We were highly encouraged by our collaborator Moffitt's recent data update at AACR Virtual Meeting 1, which showed durable complete responses in non-small cell lung cancer patients treated with Iovantil. The MOFFETT data provided the foundation for Like our approach in both melanoma and cervical, we believe that the single-arm study of oral kill therapy, LN145, has the potential to support approval in a well-defined lung cancer patient population with significant unmet medical needs.

I will now have the call over to Michael's to discuss our second quarter and first health Twentytwenty financial deals.

Thank you Frederick My comments will reflect the high level financial results from our second quarter and first half Twentytwenty.

Additional details can be found in this afternoon's press release as well as in our quarterly report on form 10-Q to be filed shortly with the SEC.

I'll begin with our cash position at June Thirtyth, Twentytwenty, Biovance held $777.4 million in cash cash equivalents short term investments and restricted cash compared to 312.5 million at December 30, Onest 2019.

Our current cash position includes net proceeds of 567.4 million from our June 2020, common stock at public offering.

We anticipate year end balances of cash cash equivalents short term investments unrestricted cash maybe over $630 million.

Moving to the income statement, our net loss for the second quarter ended June Thirtyth Twentytwenty was $63 million were 47 cents per share compared to a net loss of $47.6 million are 38 cents per share for the second quarter ended June Thirtyth 2019.

Net loss for the six month ended June Thirtyth, Twentytwenty was $132.6 million or one dollar two cents per share compared to a net loss of $84.5 million were 68 cents per share for the same period ended June Thirtyth 29 team.

Research and development expenses were $49.3 million for the second quarter ended June Thirtyth, Twentytwenty, an increase of $10 million compared to $39.3 million for the second quarter ended June thirtyth 2019th.

Research and development expenses were $106.2 million for the six months ended June Thirtyth Twentytwenty, an increase of $36 million compared to $70.2 million for the same period ended June Thirtyth 2019.

Friedrich Graf Finckenstein: We plan to begin the pivotal IOV-LUN-202 study by the end of 2020. Moving on to our other studies, we continue to advance iodine T cell-based therapies in the clinic in additional indications as well as in earlier lines of therapy. These studies include the IOV-COM-202 clinical study, which we also refer to as our basket study, to evaluate the broader potential for chill treatment in combination with pembrolizumab and earlier lines of therapy for checkpoint naive melanoma, head and neck, and non-small cell lung cancer. Furthermore, this study has two additional cohorts of TIL-alone and relapsed refractory melanoma and non-small cell lung cancer. The ongoing C14503 clinical study in head and neck cancer, which also introduces LN145 manufactured with our new proprietary 16-day third-generation or Gen 3 till therapy process, as well as our proprietary PD-1-selected tiller product, which we call LN145-S1. We are also activating additional sites for the IOV-CLL01 study of all-peripheral blood lymphocyte, or PBL, therapies in relapsed or refractory chronic lymphocytic leukemia and small lymphocytic lymphoma, CLL and SLL.

The increase in research and development expenses in the second quarter Twentytwenty over the prior year period was primarily attributable to an increase in cost associated with multiple clinical trials and growth of the internal research and development team.

The increase in research and development expenses in the first half of Twentytwenty over the prior year period was primarily attributable to the higher patient enrollment in clinical trials licensing fees and growth of the internal research and development team.

General and administrative expenses were $13.9 million for the second quarter Twentytwenty.

An increase of $4.8 million compared to $9.1 billion for the second quarter 2019.

The increase in the second quarter 2020 over the prior year period was primarily attributable to growth of the internal general and administrative team.

And higher stock based compensation expenses.

General and administrative expenses were $14.4 million for the second quarter ended June Thirtyth Twentytwenty, an increase of $3.5 million compared to $10.9 million for the second quarter ended June Thirtyth 2019.

General and administrative expenses were $20.2 million for the six months ended June Thirtyth Twentytwenty, an increase of $8.3 million compared to $19.9 million for the same period ended June Thirtyth 2019.

The increase in general administrative expenses in the first quarter and first half of Twentytwenty compared to the prior year periods were primarily attributable to the growth of the internal general administrative team and higher stock base compensation expenses.

Friedrich Graf Finckenstein: I will now hand the call over to Michael to discuss our second quarter and first half 2020 financial year. Thank you, Frederick. My comments will reflect the high-level financial results from our second quarter and first half of 2020. Additional details can be found in this afternoon's press release, as well as in our quarterly report on Form 10-Q, to be filed shortly with the SEC. I'll begin with our cash position. At June 30, 2020, Iovance held $777.4 million in cash, cash equivalents, short-term investments, and restricted cash, compared to $312.5 million at December 31, 2019. Our current cash position includes net proceeds of $567.4 million from our June 2020 Common Stock Public Offering. We anticipate year-end balances of cash, cash equivalents, short-term investments, and restricted cash may be over $630 million.

As of June Thirtyth Twentytwenty inclusive of the recent financing there were approximately 146 million common shares outstanding.

Looking ahead, we expect operating expenses in the second half of Twentytwenty to be in the same range as the first half of the year.

With a shift from certain clinical related expenses to commercial readiness expenses.

I will now hand, the call back to Maria to review upcoming milestones and kick off the Q in a session.

Thank you all for attending the call today, we have already achieved many of our 2020 milestones and we look forward to continued execution towards our PVA meeting BLE submission and remaining goals of the year, including initiation of a registration enabling studies in non small cell lung cancer overall on.

Very pleased with our progress and expanding our leadership until development manufacturing and commercialization.

I'll now turn to call overshoot operator for questions.

Operator.

Ladies and gentlemen, you have a question recombinant sorry, Please press the star <unk> warranty on your touched on telephone. If your question just minutes, where you were shorter softened acute please press the pound.

Our first question comes from Peter Lawson with Barclays.

Thanks for taking my questions very interested in lung cancer, how should we be thinking about subsets that you're targeting or whether its lines of therapy, where the where the tumors that case, how should we think about potential data from the whether it's from basket study all the.

Friedrich Graf Finckenstein: Moving to the income statement, our net loss for the second quarter ended June 30th, 2020 was $63 million, or 47 cents per share, compared to a net loss of $47.6 million, or 38 cents per share, for the second quarter ended June 30th, 2019. The net loss for the six months ending June 30, 2020 was $132.6 million or $1.02 per share compared to a net loss of $84.5 million or $0.68 per share for the same period ending June 30, 2019.

Pivotal study.

Thank you.

Yes of course I Peter Thank you for the question.

The has thought about the patient population and little bit differently for the L. UN tool to study.

When you're writing the basket study, we basically thought about relapse refractory patient population, while deepened we were thinking about El UN to a two study we are more thinking about a pivotal courts in a cohorts that can possibly support a registration. So that's the difference between the two programs. The one for you into two is better.

Michael Schwartzberg: Research and development expenses were $49.3 million for the second quarter ended June 30, 2020, an increase of $10 million compared to $39.3 million for the second quarter ended June 30, 2019. Research and Development expenses were $106.2 million for the six months ended June 30, 2020. An increase of $36 million compared to $70.2 million for the same period ended June 30, 2019. The increase in research and development expenses in the second quarter of 2020 over the prior year period was primarily attributable to an increase in costs associated with multiple clinical trials and growth of the internal research and development team; the increase in research and development expenses in the first half of 2020 over the prior year period was primarily attributable to higher patient enrollment in clinical trials, licensing fees, and growth of internal research and development.

Our defined towards registration.

Okay. Thank you and then.

Just a timing around the data from legacy the basket or the.

You have pivotal itself.

Right.

So the pivotal program is not expected to start until later part of the year and against registration supporting study.

And the basket study, we have not in are committed to a specific data flow for that program. I have noted that the started that program to basket study around a year ago. Although there was not a guarantee that the cohort for non small cell stored at the same time. So we wanted to make sure we have patients into that program to some degree of follow.

So we have a better understanding of I events Hill in non small cell lung cancer patient population. So we have not really committed to specific data flow I also.

Note that theres, not a particularly good venue and the remaining part of the year for solid tumor indications in a conference setting to be able to present. So I'm all of those considerations have gone into our decision to hold back until we have more data on the as a better venue to to present our data.

Thanks, and then just fundamental cervical cancer this seems a bit.

Michael Schwartzberg: General and administrative expenses were $13.9 million for the second quarter of 2020, an increase of $4.8 million compared to $9.1 million for the second quarter of 2019. The increase in the second quarter of 2020 over the prior year period was primarily attributable to growth of the internal general and administrative team and higher stock-based compensation expenses. General and administrative expenses were $14.4 million for the second quarter ended June 30, 2020, an increase of $3.5 million compared to $10.9 million for the second quarter ended June 30, 2019. General and administrative expenses were $28.2 million for the six months ended June 30, 2020.

<unk> potential to kind of west coast submit the ability with below the cervical cancer slowdown.

Hi, good related or was it just kind of better pacing driven by the FDA.

[noise] I think the always thought that our melanoma program is going to enroll it by around March timeframe and that program.

Sort of sped up I think that's what happened that program came in about two and a half months ahead of schedule.

The cervical program be always thought it would and to be around mid year and it has in fact consented our last.

Patient patient dosing always depends on the patients clinicals status.

So the difference between the two of them has to do more under melanoma being.

That up to a degree because we managed to get the enrollment.

Close and older patients got dose by around mid January.

Timing perspective, we have been sort of onpoint, saying that the to be delays could go together or they can be separate our best estimate at this point is possibly to a degree of follow up may be necessary for the cervical indication and given that we continue dosing patients enrolled our last patient, but we haven't dose or enough patients are best.

Michael Schwartzberg: An increase of $8.3 million compared to $19.9 million for the same period ended June 30, 2019. The increase in general administrative expenses in the first quarter and first half of 2020 compared to the prior year periods was primarily attributable to the growth of the internal general administrative team and higher stock-based compensation expenses. As of June 30, 2020, inclusive of the recent financing, there were approximately 146 million common shares outstanding.

Estimate was perhaps this submission is likely going into early part of 2021. So the gave that guidance today.

Perfect. Thank you as much.

Thank you Peter.

Our next question comes from Jim Burke dinner with Wells Fargo.

Yeah, Hi.

PNC and congrats on all the progress a couple of questions. Just first on a pre deal a meeting could you speak to what the focus of about meeting will be on what sort of areas you expect to touch on or do you feel like you already have agreement on most aspects of this filing.

Hi, Jim. Thank you for the question typical previously meetings has two components. They have a structural component discussion that the habit ft as to how we intend to compiled the document itself. It is a large document ended the second one is usually around data and amount of follow up so just kind of trying to answer your question.

Michael Schwartzberg: Looking ahead, we expect operating expenses in the second half of 2020 to be in the same range as the first half of the year, with a shift from certain clinical-related expenses to commercial readiness. I will now hand the call back to Maria to review upcoming milestones and kick off the Q&A session. Thank you all for attending the call today. We have already achieved many of our 2020 milestones, and we look forward to continued execution towards our pre-BLA meeting, BLA submission, and remaining goals of the year, including initiating a registration-enabling study in non-small cell lung cancer. Overall, I'm very pleased with our progress in expanding our leadership in research, development, manufacturing, and commercialization. I will now turn the call over to the operator for questions. Operator. Ladies and gentlemen, if you have a question or a comment at this time, please press the star and then the 1 key on your touch-tone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key.

As part of the second part so from a data perspective, usually there's at least three different sets of question Theres clinical questions or CMC questions and there is usually nonclinical and there there may be a bucket of regulatory questions that are usually yeah.

So all of those are part of the potential dialogue as part of the PBL EBITDA FDA.

And then Maria just in terms of.

Thank you, but the initial launch in the 40 sites that your initial targeting could you speak to what proportion of the late stage melanoma patients. Those 40 sites treat it's there's a number or a proportion.

Yes, absolutely I'm going ask our head of commercial Jim Ziegler Who's in the room with us to address that question, Jim Hi, Jim. Thank you very much for your question. Our first Rebased OCF Rebase the selection of our sites based upon prior clinical trial experience.

Okay, all while experience status of whether they have existing cell therapy service lines et cetera.

What Maria said earlier is that we plan to launch with at least 40 sites and based upon our estimates we think that walk will cover the majority of patients in the community but of course as we expand the number of sites overtime will look to include.

Maria Fardis: Our first question comes from Peter Lawson with Barclays. Thanks for taking my questions. Maria, just on lung cancer, how should we be thinking about the subset you target, you know, whether it's lines of therapy or where the tumor is located. And how should we think about potential data from that, whether it's from the basket study or the pivot? Yeah, of course. Hi Peter.

More geographies that allow greater access to care.

Great and maybe one final question just following up on Peter's question on non small cell lung cancer, what were your takeaways Maria from the market data and can you say, whether those learnings have been confirmed to some extent with the early experience in the basket study in and if Thats, what supporting the move to a registry.

One study.

Thank you Jim.

Maria Fardis: Thank you for the question. We have thought about the patient population a little bit differently for the LUN202 study. When we were writing the basket study, we basically thought about the relapsed refractory patient population. When we were thinking about the LUN202 study, we were more thinking about a pivotal, you know, cohorts that could possibly support a registration. So that's the difference between the two programs, and the one for LUN202 is better defined for registration. Roger, thank you. And then... Just the timing around the data from, I guess, either the basket or the pivot.

I think that the less than one of our strategies, maybe I'll step back to for a second one of our strategies has always been to look into new indications through collaborations with academic institutions as signal seeking and so we felt that the program be hard with this moffett was a great proof of concept signal seeking program, where it showed that till then.

Non small cell can be a very powerful potential therapy, not the patient population may or may not be representative of to these patients. The till from manufactured by Moffett may or may not be representative of I have asked his tail. So the purpose of our come to a two study is to do that too to get patients that are currently in.

You know community Orca academic institutions that are in seeking sort of clinical trials and we are trying to look at IHOP dances Gen. Two manufacturing process in the calm protocol. So I think that we learned a few things from that study what was remarkable was abroad patient population responded patients who might have had a biomarker therapy.

So they had received territories in kind of is it kind of his inhibitors followed by Nivolumab. They still respond and they were able to reach a CR as a matter of fact, we also noticed that patients that are PDL, one low or even zero percent has certainly an opportunity to respond to till so those are great lessons from us and this is how we define the patient population.

Maria Fardis: Right. So the Pivotal program is not expected to start until the later part of the year, and again, it's a registration supporting study. And the basket study, we have not, you know, committed to a specific data flow for that program.

And you and two or two based on the lessons that we learn from that study.

Maria Fardis: I have noted that we started that program, the basket study, around a year ago, although there was not a guarantee that the cohort for non-small cells would start at the same time. So we wanted to make sure we had some patients into that program with some degree of follow-up, so we have a better understanding of what's going on in that cohort. So we have not really committed to a specific data flow. I also note that there's not a particularly good venue in the remaining part of the year for solid tumor indications in a conference setting to be able to present.

Great. Thanks for taking the questions.

Thank you Jim.

Next question comes from Ben Bernanke Stifel.

Hi, Thank you so much.

Our just follow up on that and ask for just a little more color around the saw the spread just racial non small cell lung cancer study I guess, what are you thinking in terms of studies size and did I hear you right did you are you focusing on leveraging the gen two manufacturing process.

Hi, Ben Thank you for the question, yes, definitely using gen. Two going forward in most of our studies, although we have introduced other manufacturing methods into clinic as exploratory manufacturing methods, but given that we still are very much interested in gen. Two in a commercial landscape we will.

Maria Fardis: So all of those considerations have gone into our decision to hold back until we have more data and we have a better venue to present our data. And then, just finally, on cervical cancer, there seems a potential to kind of must co-submit a BLA with melanoma. Did cervical cancer slow down, or was that COVID related, or was it just kind of better pacing driven by the FDA? I think we always thought that our melanoma program was going to enroll by around the March time frame. That program sort of sped up, so I think that's what happened.

Continue with Gen two in and our El UN two or two study.

In terms of patient population, we really are looking at unmet medical need patient population, that's our strategy.

It does that answer your question do you have a further question in terms of the patient population for that study.

Well.

To the extent of your your prepared to disclose that I guess I was wondering you can probably any color on kind of the size of the study that would that would support registration here.

I think we will look to make sure that be first identified a patient population thats unmet need and we feel that we have done that and two we have always been interested in this stage programs such as assignments to stage program, where we explore a signal the strength of a signal in a certain population.

Maria Fardis: That program came in about two and a half months ahead of schedule. The cervical program, we always thought it would end by around mid-year, and it has, in fact, consented our last patient. Patient dosing always depends on the patient's clinical status, so the difference between the two has to do more with the melanoma being sped up to a degree because we managed to get the enrollment closed and all the patients got dosed by around mid-January. From a timing perspective, we have been sort of on point saying that the two BLAs could go together or they can be separate. Our best estimate at this point is possibly a degree of follow-up may be necessary for the cervical indication, and given that we continue to dosing patients, we have enrolled our last patient, but we haven't dosed our last patient, our best estimate was perhaps this submission is likely going into the early part of 2021, so we gave that guidance today. Thank you so much.

And then we can always expand.

I I believe that this study is very smartly designed and we think that there's a potential. If this strong signal is strong enough for registration, but our general strategy is find and define unmet medical need very well and ideally you the single arm strategy.

Okay, Okay, that's great understood.

And maybe just one follow up question on on the melanoma pivotal study.

So you provided an update on.

The secondary endpoint, the investigator assessment, which was.

Something like 60 locations do you plan on providing another update with a fuller dataset.

Indeed.

This year before we get the.

The primary endpoint.

I think what we're going to do Ben is to make sure that we have full agreement that Sta in terms of the size of the package.

And then ideally we always want to release our data at a medical conference. There wasn't a question earlier about this but there's not a lot of very good venues left in the year.

Where we have the data we can reach the timing of submission and then present and does medical conferences.

So I'm not committing necessarily to presenting the melanoma Registrational program and the and the 2020 timeframe. This likely would be a 2021 event, but it'd be read the data the full of the data make sure. We have agreement with FDA and then go to medical conference.

Maria Fardis: Thank you, Peter. Our next question comes from Jim Birchner with Wells Fargo. Hi Marie and team, congratulations on all the progress. A couple questions. First, at the pre-BLA meeting, could you speak to what the focus of that meeting will be on, what sort of areas you expect to touch on, or do you feel like you already have agreement on most aspects of this filing?

Okay very clear the before the sense. Thank you very much. Thank you Ben.

Our next question comes from Mara Goldstein with Mizuho.

Hey, Thanks, so much on <unk> question around.

On the manufacturing and when you are able to you are fully have the events, while therapy center up and running when it's fully operational.

Maria Fardis: Thank you for the question. Typical pre-BLA meetings have two components. They have a structural component discussion that we have with FDA as to how we intend to compile the document itself. It is a large document.

Little there'd be a perceptible change for you Sam I'll hop back yet.

And then I just kind of question around.

Capital allocation for the completion of manufacturing and your start up cost now that you've been.

Maria Fardis: And then the second one is usually around data and the amount of follow-up, so just kind of trying to answer your question as part of the second part. So from a data perspective, usually there are at least three different sets of questions.

Enable kind of top up your coffers and how should we think about.

You know cash spend over the next.

While 18 from pharma.

Sure sounds good. Thank you Laura Thanks area of course. Thank you, yes, we think that our manufacturing facility would offer the yield a lower cogs not because of necessarily raw material, but as part of Cogs. We certainly have a component of human capital on how much we pay for the time and.

Maria Fardis: There are clinical questions, there are CMC questions, and there are usually non-clinical questions. And there may be a bucket of regulatory questions that are usually asked. So all of those are part of the potential dialogue as part of the pre-BLA with FDA. And then, Maria, just in terms of thinking about the initial launch and the 40 sites that you're initially targeting, could you speak to what proportion of late-stage melanoma patients those 40 sites treat, if there's a number or a proportion? Yes, absolutely. I'm going to ask our Head of Commercial, Jim Ziegler, who's in the room with us, to address that question. Jim?

That's always something that you increase that payments when you're working with the CMO. So we think that once we have our own facility and then our own team, we should be able to further reduce our cogs.

I'm going ask Michel shortly to stick to their capital allocation Michael Yes. Thank you. So as we talk about spend I had mentioned that our operating expenses in the second half the or will look similar to the first half of here and we also mentioned that construction is ongoing for our I O van cell therapy Center.

Which the clean rooms are expected to be completed in 2020 and the rest as you imagine will continue ongoing as it relates to 20 to 21, we haven't given any guidance on that yet. We also stated that we believe our cash position of $777.4 million is sufficient for us to execute commercial launch and pipeline activities include.

James Ziegler: Hi Jim. Thank you very much for your question. First, we based the selection of our sites based upon prior clinical trial experience, KOL experience, the status of whether they have existing cell therapy, service lines, etc. What Maria said earlier is that we plan to launch with at least 40 sites. And based upon our estimates, we think that we'll cover the majority of patients in the community. But, of course, as we expand, the number of sites will, over time, look to include more geographies that allow greater access to care. Great

In our existing programs.

Thank you I appreciate that.

Thank you Laura.

Our next question comes from Mark Breidenbach Oppenheimer.

Hey, good afternoon, thanks for taking the questions and congrats on the progress.

Well since I I've heard you know a couple times, but you don't think there or any good venues left in the year for solid tumor data.

Just wondering if that implies that the other than its won't have much of a puzzle since you're at Citi.

[noise] I think that was in light of 'em. Thank you Mark It was in light of the pivotal program for melanoma and given that the timing of the abstract submission is literally the couple of weeks and you have to have read all the data on how the abstract Freddie I don't consider sisi good venue for for melanoma program.

Maria Fardis: And maybe one final question, just following up on Peter's question about non-small cell lung cancer. What were your takeaways, Maria, from the Moffitt data? And can you say whether, you know, those learnings have been confirmed to some extent with the early experience in the basket study, and if that's what's supporting the move to a registration study? Thank you, Jim.

It doesn't mean you will have nothing else I was just not committed to what that could be but from a pivotal data program.

I think we probably would look into 2021 for data release.

Okay and.

In terms of your your peripheral blood lymphocyte program I know that something that you've been working on for a while now is or terms with key our early data from that.

Maria Fardis: I think that the lesson, one of our strategies, maybe I'll step back for a second. One of our strategies has always been to look into new medications through collaborations with academic institutions as signal-seeking. And so we felt that the program we had with Moffitt was a great proof-of-concept signal-seeking program where it showed that TIL and non-small cell therapy could be a very powerful potential therapy. Now, the patient population may or may not be representative of today's patients. The TIL manufactured by Moffitt may or may not be representative of Iovance's TIL.

Yes later this year.

Thank you for the question our sites for Pvl, where in fact affected by coded and we are looking into expanding our additional sites to be able to expedite enrollment.

But our chances of being able to get data. This year is extremely low given the patients have to be enrolled the very first set of patients are typically safety and this is the a different study design in the sense that efficacy is pretty hard to see an early stages.

I'm going ask our chief Medical Officer, Fredriksen confined to speak to maybe just at a high level. The three design for the Pvl program. So you have an understanding and appreciation of when data may be available.

Yes, so thank you Larry Thanks for the question.

Maria Fardis: So the purpose of our COM202 study is to do that, to get patients that are currently in, you know, community or academic institutions that are seeking sort of clinical trials. And we are trying to look at Iovance's Gen 2 manufacturing process in the COM protocol. So I think that we learned a few things from that study. What was remarkable was that a broad patient population responded. Patients who might have had a biomarker therapy, so they had received their tyrosine kinase inhibitors, followed by nivolumab, still responded, and they were able to reach a CR as a matter of fact.

At very high level is thing.

Decision to to discuss the design as first a dose finding park, which is which is.

Really volume regimen.

A dose escalation design was small cohorts of patients being treated sequentially. After conformational to safety profile of that dose level. So by definition that goals basically small cohort by a small cohort and it takes a while to be done with that and to have a sufficient sampled sites that might.

Presenting the data and then it would be really mostly focus on safety maybe that gives you an idea around around the design and only one wind up is available would we be going into into an ex expansion at a at a dose level that we find appropriate than what you more focused on describing the efficacy profile.

Maria Fardis: We also noticed that patients that are PDL1 low or even 0% have an opportunity to respond to TIL. So those are great lessons for us, and this is how we define the patient population in LUN202 based on the lessons that we learned from that study. Great, thanks for taking the question. Thank you, Jim.

And probably most relevant for what we will be showing.

I will address the Chris.

Super helpful. Thanks for taking the questions.

Thanks Mark.

Our next question comes from where he brings more than with JMP securities.

Maria Fardis: Our next question comes from Ben Burnett, who the... Hey, thank you so much. I want to just follow up on that and ask for just a little bit more color around this registration for this non-small cell lung cancer study. I guess, what are you thinking in terms of study size? And did I hear you right?

Hi, This is adjusting walsh on for Randy.

Based on your agreement with the avid Bioscience Sciences with Aiotv three easier year. One I was wondering if you could comment on what you're trying to or what you're hoping to achieve with that.

How you're trying to improve over native aisle too.

Yeah absolutely.

Justin I don't know fuel seem will be had an earlier press release around.

I think it was the right around JP Morgan when we announced that we had taken a license from.

Maria Fardis: Are you focusing on leveraging the Gen 2 manufacturing process? Hi Ben. Thank you for the question. Yes, we are definitely using Gen 2 going forward in most of our studies, although we have introduced other manufacturing methods into the clinic as exploratory manufacturing methods. But given that we still are very much interested in Gen 2 in the commercial landscape, we will continue with Gen 2 in our LUN202 study. In terms of the patient population, we really are looking at that medically need patient population. That's our strategy. Does that answer your question? Do you have a further question in terms of the patient population for that study? Well, to the extent that you're prepared to disclose it, I guess I was wondering if you could provide any color on the kind of size of the study that would support registration here. Yeah,

Novartis to commercialize a novel I O. Two analog this was an idle to CDR grafted, which targets really I also receptor be regardless of units.

So as a novel I O two that we are pursuing and it's in a preclinical stage. So the agreement that avid was really to try and goes through their process development and manufacturing GLP as sort of GMP material for preclinical program that supports the idea enabling program.

Does that answer your question.

Yeah that makes sense. So how would you I guess you would in the preclinical xplore exploration you'd actually look at how you would consider incorporating that into your.

Your treatment programs.

Yeah.

So an ideal to analog, particularly discipline, which was the as I noted is the CDR graph. It allows for a better PK at has better CMC profile is certainly has.

Very.

Favorable IP characteristics.

Unexpectedly a differentiated safety profile compared to available aisle to the idea around this is to explore a potentially better product as we administer and core administer with til therapy, but there certainly are plenty of opportunities to develop something of this nature I'm on its own as well we have now committed one way or the other.

What I have committed as we expect to be an R&D, enabling program in 2021.

Maria Fardis: I think we will look to make sure that we first identify the patient population that is in need, and we feel that we have done that. And two, we have always been interested in a stage program, such as Assignments 2 stage program, where we explore a signal, the strength of a signal in a certain population, and then we can always expand. I believe that this study is very smartly designed, and we think that there is potential if the signal is strong enough for registration. But our general strategy is to find and define unmet medical need very well, and ideally use a single-arm strategy. Okay, okay, that's great, understood. And maybe just one follow-up question on the melanoma pivotal study. So you provided an update on the secondary endpoint, the investigator assessment, which was I think something like 68 patients. Do you plan on providing another update with a fuller data set this year before we get the primary endpoint?

Perfect. Thank you very much for taking the questions. Thank you Justin.

Our next question comes from would do Kumar with Baird.

Yeah. Thanks for taking our question. So all start micro and then go more macro and see all along so on a micro basis. So you completing enrollment in his cervical cord, that's 75 patients correct.

Approximately mid to high good afternoon, approximately typically when we close enrollment we don't always know exactly how many patients because there may be screen failures. So approximately 75 is what we had to find the protocol yes.

Okay, and then second question what is it going to take to get little lose so in melanoma in cervical approved in Europe.

I think it really depends on the dialogue with the European health authorities and the same way that we have been talking to F.D., we need to parallel that dialogue with the EU health authorities to make sure that they might be supportive of the existing program on the first trial are typically may do that I have.

With health authorities is due date I appreciate the unmet medical need and do the agreed with our definition and do day things that if the answer is yes, then do they agreed at a single arm can be supportive of registration it usually starts with that discussion and when and if they agree with those dialogues that I think is appropriate to talk about.

What is the size of the package what do they think is available care in that region what percent of responsibility to see and what could be a successful package for submission to you. So that entire dialogue needs to be hard with you health authorities, which was 150 for sometime now.

Maria Fardis: I think what we are going to do, Ben, is to make sure that we have full agreement with FDA in terms of the size of the package. And then, ideally, we always want to release our data at a medical conference. There was a question earlier about this, that there's not a lot of very good venues left in the year.

Does that answer your question I.

I mean, so I guess my question is when when you have those discussions given that you're pretty far along into the clinical development of lift to lose one both melanoma in cervical.

Maria Fardis: Where we have the data, we can reach the timing of submission and then present at those medical conferences. So I'm not necessarily committing to presenting the melanoma registrational program in the 2020 timeframe. This likely would be a 2021 event.

Yes.

So we have been planning on a potential interaction to get initiated later part of the year under our EU specific requirements and we are going through the list of items that we need to have on the ground in you to assure support of the program.

With assumption of success and that's enlisted every sponsor has to sort of review, particularly one that has not had a commercial product and you need to make sure that we have those in place before starting the dialogue with agency.

Maria Fardis: By the time you read the data, the full data, make sure we have an agreement with FDA and then go to a medical conference. Okay, very clear. That makes a lot of sense.

Okay, and then how are you thinking about moving off the line of therapy in both melanoma in cervical cancer, what's it going to take to try to get a clinical trial program started there really kind of in depth pursues either front line melanoma or on wide cervical cancer.

Maria Fardis: Thank you very much. Thank you, Ben. Our next question comes from Mara Goldstein with Zuha. Great, thanks so much.

Maria Fardis: So I have a question around manufacturing and when you are able to fully have the Iovance Cell Therapy Center up and running, when it's fully operational, will there be a perceptible change for you from a cost perspective? And then I just had a question around capital allocation for the completion of manufacturing and your startup costs now that you've been able to kind of top up your coffers, and how should we think about cash expenditure over the next 12, 18, 24 months? Sure, sounds good.

Yeah excellent question.

So in order to define go into earlier lines requires a couple of things one one has to understand the magnitude of the effect of the given product or less Russell and to their standard of care usually available for these patients. So typically the first step is to go on top of Thunder care, because the patients how the standard care available you.

Usually the sponsors have to add to it and once you see the magnitude of the affecting you might be able to peel off or and do a single agent and or go into registration study, where you have to randomize to see what is the magnitude of the effect. So the first step toward that is to run the combination in early line, which is exactly what we are.

Doing in our basket study for melanoma and in our own cervical study is our cohorts three is offering till plus pembrolizumab and early line patients. So so you are completed correct and we have already figured these steps in order to see what is the magnitude of the effect.

Maria Fardis: Thank you, Mara. Thank you, Maria. Of course. Thank you. Yes, we think that our manufacturing facility would also yield a lower COGS, not necessarily because of raw materials, but as part of COGS, we certainly have a component of human capital and how much we pay for the time.

In early line patients in combination with available care.

Okay and then finally, how are you thinking about combining tells with agents beyond PD one blockade like how would you want to pursue that how are you envisioning that in the next like say one to five years.

Maria Fardis: And that's always something you increase that payment when you're working with a CMO. So we think that once we have our own facility and then our own team, we should be able to further reduce our COGS. I'm going to ask Michael Schwartzbeck to speak to the capital allocation.

Yeah excellent question as well.

It is part of our strategy to think about what is in scope for our clinical development program and what is out of scope in our clinical development program, but it may be very well in scope for our investigators sponsored program. So when we think about some of these combinations which of course our of high interest I have asked the put those tip.

Michael Schwartzberg: Yes, thank you. So as we talk about spending, I mentioned that our operating expenses in the second half of the year will look similar to the first half of the year. And we also mentioned that construction is ongoing for our Iovance Cell Therapy Center, the clean rooms of which are expected to be completed in 2020. And the rest, as you imagine, will continue onwards. As relates to 2021, we haven't given any guidance on that yet. We also stated that we believe our cash position of $777.4 million is sufficient for us to execute commercial launch and pipeline activities, including our existing programs. Thank you; I appreciate that. Thank you, Mara. Our next question comes from Mark Breidenbach with Oppenheimer. Hey, good afternoon.

Typically an investigator sponsored studies as you might know we choose our resources very carefully and our focus typically is in new indications as well as a pivotal program. So things that may be non pivotal yet very relevant in the treatment landscape or part of our IC strategies.

So then kind of following on that how much of that could be on being just investigator sponsored trial.

Positioning beer business development positioning, where you say to look to collaborate with other companies that have interesting assets as compared to just having the investigator run a trial with drug day plus films.

Absolutely we are definitely open to that alternative as well the one consideration for that scenario as most of these drugs are out in the public market already and so if the collaboration ends up with I events, having to give up either a portion of its into intellectual property or anything of that sort or finance.

Mark Alan Breidenbach: Thanks for taking the questions and congratulations on the progress. Maria, since I've heard you say a couple times that you don't think there are any good venues left in the year for solid tumor data, I'm just wondering if that implies that Iovance won't have much of a presence this year at CITSE.

Actual I'm sort of commitments on our side, then I would rather we do an ice tea, if it's pure collaboration with with a if a sponsor who is bringing a product to market and.

It's a win win for everybody then we certainly very open to that but those considerations going to our decision, making as too we don't want to give up I have us IP, we certainly don't want to ideally have financial commitments to other sponsors, particularly if the drug is already a commercial product.

Maria Fardis: I think that was in light of, thank you Mark, it was in light of the pivotal program for melanoma and given that the timing of the abstract submission is literally in a couple of weeks and you have to have read all the data and have the abstract ready, I don't consider CITSE a good venue for the melanoma program. It doesn't mean we will have nothing else; I'm just not committed to what that could be. But from a pivotal data program, I think we probably would look into 2021 for data release. Okay. And, and, um, in terms of your peripheral blood lymphocyte program, I know that's something that you've been working on for a while now. Is there a chance we'll see early data from that at ASH later this year?

Okay, great. Thank you.

Sure thing Committee.

Our next question comes from Joker grow with Piper ceremony.

Hey, guys. Thanks, so much for taking my questions here, maybe just two quick ones from me. So in your pre BLA meeting later this year would you also look to receive alignment.

Around cervical cancer, and if so which would you need a data cut from from the pivotal cohort to frame that discussion.

Hi, Joe Good afternoon, an excellent question as well via Vin debating this and I don't know freak I can necessarily give you the best answer possible I think that it really would be dependent on what the division wants to discuss as part of the meeting however, just to kind of clarify the cervical program is under a different I Andy as this amount.

Friedrich Graf Finckenstein: Thank you for the question. Our sites for PBL were in fact affected by COVID, and we are looking into expanding our additional sites to be able to expedite enrollment. But the chances of being able to get data this year are extremely low, given that patients have to be enrolled.

No well program and therefore, the division that we usually request a meeting with is the division that is that I can be responsible to reveal that I. Andy. So the cervical team members may or may not be in the room. When we have a previously meeting so it's a little unclear whether it be whether this topic is going to come up is because the surgical review team may or may not.

Friedrich Graf Finckenstein: The very first set of patients are typically safety, and this is a different study design in the sense that efficacy is pretty hard to see in early stages. I'm going to ask our Chief Medical Officer, Frederick Finckenstein, to speak to, maybe just at a high level, this study design for the PBL program, so you have an understanding and appreciation of when data may be available. Yes, so thank you, Maria, and thanks for the question. At a very high level, I think it would describe the design as first a dose finding part, which is really by regimen a dose escalation design with small cohorts of patients that are being treated sequentially after confirmation of the safety profile at that dose level.

In the meeting.

Okay got it other than just one quick follow up how should we read into the fact that you're committing to a registration program in lung cancer, but not head and neck cancer, where you've seen an early 30% response rates and what that means about the kind of activity you're seeing in lung cancer or is this maybe more reflective of how you're thinking about had an.

Cancer.

Yeah.

I think that they're not necessarily opposing each other let's just take them one at a time.

And the non small cell and once the already to distribute and provide the study design, you'll see the study design, but assignments to stage allows for the sponsors to make a decision. While we are committing to the indication we certainly have the opportunity to make decisions along the way.

In head and neck, we have a slightly different landscape. While we had to response the duration of response has not been particularly something that we had we felt that we want to pursuing a very large way with gen. Two then head and neck be introduced to other products into clinic earlier part of the year be pretty heavy introduced a gen three which was a 16 days.

Friedrich Graf Finckenstein: So by definition, that goes basically, small cohort by small cohort, and it takes a while to be done with that and to have a sufficient sample size that might be worth presenting the data, and then it would be really mostly focused on safety. Maybe that gives you an idea of the design, and only when that is available would we be going into an expansion at a dose level that we find appropriate that then would be more focused on describing the efficacy profile, and that's probably most relevant for what we would do. I hope that, uh, that got... Very helpful. Thanks for taking the time to answer the question. Thanks, Mark. Our next question comes from Reni Benjamin with JMP Security. Hi, this is Justin Walsh on behalf of Reni.

Manufacturing process, and we introduced a PD one selected till which we thought based on literature should be a more potent product. So we're trying to solve slightly different problem for each one of them.

Does that make sense.

Yes, no that's helpful. While I'm wondering if we should read into [noise].

The fact that youre committing that if you've seen any responses in lung cancer that they've been durable.

I guess I'm, assuming you won't answer that.

I think that this sign from what we have seen from office study has been really promising from my perspective seem to see ours that have continued past 12 months NPR that went out 18 months.

Maria Fardis: Based on your agreement with Avid Biosciences regarding IOV3001, I was wondering if you could comment on what you're trying to do or what you're hoping to achieve with that and how you're trying to improve over native IL-2. Yeah, absolutely. Justin, I don't know if you have seen, but we had an earlier press release around, I think it was right around JP Morgan, when we announced that we had taken a license from Novartis to commercialize a novel IL-2 analog. This was an IL-2 CDR grafted, which targets really the IL-2 receptor beta gamma subunits.

It's really quite quite promising so not only we see an or are which is well above available care will be also CDR and that indication, which is well above available care and I think thats, maybe how we're thinking about it.

Okay got it thanks, so much for taking my questions. Thank you Joe.

Our next question comes from Breanna many projectors.

Hi, guys. Thanks for taking my questions and congrats on all the progress.

Maybe I'll start with a melanoma indication given the follow up from cohort two and the interim data from cohort four have you had discussions with payers regarding pricing for Lakos Hall.

Hi, there and let me ask Jim to speak to the pricing comment, yes, we have engaged payers for Darren.

While we have not set of price in order to assess the price for Michael and so as you know there are many factors to consider in establishing both price and value, which we will continue to evaluate until product approval.

Maria Fardis: So it's a novel IL-2 that we are pursuing, and it's in the preclinical stage. So the agreement with AVID was really to try and go through the process development and manufacturing GLP as well as GMP material for the preclinical program that supports the IND enabling program. Does that answer your question? Yeah, that makes sense.

As you know these potential indications are in areas of high unmet need for which there are no viable treatment and we believe that LIFO. So we'll support compelling value.

Okay, and then I guess on sort of recall I understood that you've had I guess or you're going to have a pre building meeting on the melanoma side, but.

Maria Fardis: So how would you, I guess you would, in the preclinical exploration, you would actually look at how you would consider incorporating that into your treatment program? Yeah, so an IL-2 analog, particularly this one, which, as I noted, is a CDR graph, it allows for a better PK, it has a better CMC profile, it certainly has very, you know, favorable IP characteristics, and expectedly a differentiated safety profile The idea around this is to explore a potentially better product as we administer and co-administer with teletherapy, but there certainly are plenty of opportunities to develop something of this nature on its own as well. We have not committed one way or the other.

Do you plan to have a separate second discussion with FDA regarding cervical and what type of follow up period. After you would like to see and is this driving the BLE submission early 2021, and I just want to clarify just from the cohort one cervical cancer is that data going to be away from 2021 or should we expect that kind of 2020.

Yeah.

I think a lot of that is dependent on the interactions with FDA completely correct.

So cervical as I noted earlier is under a different I, Andy and I think it depends on if the review division ends up participating in our melanoma discussions and we can have a potentially seminar dialogue around the follow up if they end up I'm staying in their own under their own I and didn't be absolutely need to separate meeting with them.

Which which then defines amount to follow all this is precisely why we thought it's safer to move the expected BLE timeline to early 2021, because by the time reduce the patients. The post agency the habit dialogue with the with them regarding to follow up chances are pretty good that it might be lane 2021.

Maria Fardis: What I have committed is that we expect to be an IND-enabling program in 2021. Perfect. Thank you very much for taking the time to answer the question. Thank you, Jeff.

Got it and then I'm just trying to be a couple more from a.

And we expect an additional update from offered at the C and.

Given the announcement regarding the posters at ESMO should we expect anything from late breakers at ESMO, I think we break or they're going to be out August 17.

Maria Fardis: Our next question comes from Madhu Kumar with Baird. Yeah, thanks for taking our questions. So I'll start micro and then go more macro as we go along. So on a micro basis, you've completed enrollment in a cervical cohort of 75 patients, correct? Approximately. Madhu, hi, good afternoon.

I am not aware, whether moffett is submitting something to sit C.

So I can't comment turned up.

I think from an ethanol perspective, let me now convent what might be in late breaking or not I think that we had not really committed to any clinical data flow for 2020 beyond will be already presented just want to remind ourselves.

Got it and then just on the with regards to the ESMO poster on in terms of the PD one knockout what's the difference between the PD, one knock out and that anyone silencing approach that you presented last year thats. It. Thank you use.

Maria Fardis: Approximately, typically when we close enrollment, we don't always know exactly how many patients because there may be screen failures. So, approximately 75 is what we had defined in the protocol, yes. Okay, and then the second question: what is it going to take to get Lipoluso and Melanoma and Cervical approved? I think that really depends on the dialogue with the European health authorities. The same way that we have been talking to FDA, we need to parallel that dialogue with the EU health authorities to make sure that they might be supportive of the existing program. The first dialogue typically, Madhu, that I have with health authorities is: do they appreciate the medical need and do they agree with our definition, and do they think that if the answer is yes, then do they agree that a single arm can be supportive of registration?

Ceos compounds ph Sevensix too.

Yeah.

There's a difference in the method of nothing something out the fire product was using and Arnie I technology and Thats a transient knockout. The one that is being expected to be presented at ESMO as a talen product, which is a permanent genetic knockout.

Got it thank you.

Thank you.

Our next question comes from journalists ships, which started.

Hi, Thanks to three questions and congrats on the Congress. So on maybe following up on the pricing question in regards to your discussions with payers and other stakeholders can you speak to how you might be thinking about pricing considerations for different indications I melanoma sort of go in particular, how that might relate to response durations in different settings potentially.

Yeah. Thanks, Glenn let me ask Jim to comment on the pricing Yep. Thanks. Thank you Maria there are many factors as we mentioned earlier that go into setting pricing and we're continuing to evaluate.

Maria Fardis: It usually starts with that discussion, and when and if they agree on those dialogues, then I think it's appropriate to talk about what the size of the package, what they think is available care in that region, what percent of response we need to see, and what could be a successful package for submission to the EU. So that entire dialogue needs to be had with EU health authorities, which we have had with the EU for some time now. Does that answer your question?

Pricing individually for both metastatic melanoma as well as metastatic cervical we're looking at the unmet need to clinical profile as you point out efficacy measures around our our deal are the safety profile. We're also considering other factors as well.

Our pricing decision and we look forward as we approach launch to having more dialogue with the specific we on pricing and value, but at this point, we're not prepared to talk about pricing.

Yes.

Got it and then just a follow up on maybe the the strategy for Europe.

Maria Fardis: Okay. I guess my question is, when will you have those discussions, given that you're pretty far along in the clinical development of lithalucelam, both melatonin, and so forth? Yes, so we have been planning on a potential interaction to get initiated later in the year. There are EU-specific requirements, and we are going through the list of items that we need to have on the ground in the EU to assure support of the program with the assumption of success.

I didn't really.

Thinking about that but in terms of what potential commercial launch planning and infrastructure do you envision assuming those needs to be similar is structured differently towards the strategy versus the strategy in the U.S.

Thank you Thats, a great question and one that the teams working on right now as we are evaluating both the best practices and approaches and the U.S. and what will be scalable in ex U.S.

Maria Fardis: And that's a list that every sponsor has to sort of review, particularly one that has not had a commercial product in the EU. We need to make sure that we have those in place before starting the dialogue with the Okay, and then how are you thinking about moving up the line of therapy in both melanoma and cervical cancer? What's it going to take to kind of get a clinical trial program started that really kind of in-depth pursues either frontline melanoma or frontline cervical cancer? Yeah, excellent question. So in order to define going to the earlier line, one has to understand the magnitude of the effect of the given product, life elusive. And two, there's a standard of care usually available for these patients.

We're considering as you might imagine.

Three real scenarios, one going it alone to potentially partnering our three outlicensing, but we're still very much early in the process and again, we'll look forward to yes.

Analyzing the assessment and making our go to market strategy based upon the data in the market dynamics.

Great. Thanks.

I'm not showing any for.

Sorry, I'm not showing any further questions from more turn the corporate over to Maria.

Thank you operator.

Thank you again for joining the I last quarter and call and first half of 2020, please feel free to reach out our IR team. If you wish to follow up on any items.

We look forward to effective second half of the year as we further solidify our leadership until develop and manufacturing and commercialization.

Maria Fardis: So typically, the first step is to go on top of the standard of care. Because patients have the standard of care available, usually, sponsors have to add to it. And once you see the magnitude of the effect, you might be able to peel off the block and do a single agent, or go into a registration study where you have to randomize to see what the magnitude of the effect is. So the first step toward that is to run the combination in early line, which is exactly what we are doing in our basket study for melanoma. And in our own cervical study, cohort three is offering TIL plus pembrolizumab in early line patients. So, you're completely correct.

Ladies and gentleman just conclude today's presentation. You may now disconnect have a wonderful there.

[noise].

Maria Fardis: And we have already triggered these steps in order to see what the magnitude of the effect is and in early line patients and in combination with available care. Okay, and then kind of finally, how are you thinking about combining TKIs with agents beyond the PD1 blockade? Like, how would you want to pursue that?

Maria Fardis: How are you envisioning that in the next like, say, one to five years? Yeah, excellent question as well. It is part of our strategy to think about what is in scope for our clinical development program and what is out of scope for our clinical development program, but it may be very well in scope for our investigator-sponsored program. So when we think about some of these combinations, which are, of course, of high interest to Iovance, we put those typically in investigator-sponsored studies. As you might know, we choose our resources very carefully, and our focus typically is on new indications as well as a pivotal program. So things that may be non-pivotal yet very relevant in the treatment landscape are part of our IST strategies.

Maria Fardis: So then kind of following from that, how much of that could, beyond being just an investigator-sponsored trial positioning, be a business development positioning where you say to look to collaborate with other companies that have interesting assets as compared to just having an investigator run a trial with the drug A plus, Absolutely. We're definitely open to that alternative as well. The one consideration for that scenario is that most of these drugs are out in the public market already. And so if the collaboration ends up with Iovance having to give up either a portion of its intellectual property or anything of that sort or financial commitments on our side, then I would rather we do an IST. If it's pure collaboration with a sponsor who is bringing a product to market, and it's a win-win for everybody, then we're certainly very open to that.

[music].

Maria Fardis: But those considerations go into our decision-making as to whether we don't want to give up Iovance IP. We certainly don't want to ideally have financial commitments to other sponsors, particularly if the drug is already a commercial product. Okay, great, thank you. Sure. Thank you, Madhu.

Maria Fardis: Our next question comes from Joe Catanzaro with Piper Sandler. Hey guys, thanks so much for taking my questions here; maybe just two quick ones from me. So in your pre-BLA meeting later this year, would you also look to get alignment around cervical cancer? And if so, would you need a data cut from the Pivotal cohort to frame that discussion? Hi Jo, good afternoon.

Maria Fardis: An excellent question as well. We have been debating this, and I don't know if I can necessarily give you the best answer possible. I think that it really would be dependent on what the division wants to discuss as part of the meeting. However, just to kind of clarify, the cervical program is under a different IND as is the melanoma program, and therefore, the division that we usually request a meeting with is the division that is responsible for the review of that IND. So the cervical team members may or may not be in the room when we have a pre-BLA meeting, so it's a little unclear whether this topic is going to come up. It's because the cervical review team may or may not be in the meeting. Okay, I got it.

Maria Fardis: And then just one quick follow-up question. How should we read into the fact that you're committing to a registration program in lung cancer but not head and neck cancer, where you've seen an early 30% response rate? And what does that mean about the kind of activity you're seeing in lung cancer? Or is this maybe more reflective of how you're thinking about head and neck cancer? Yeah, I think that they're not necessarily opposed to each other. Let's just take them one at a time.

Maria Fardis: In non-small cell, once we are ready to distribute and provide the study design, you'll see the study design, but the Assignments 2 stage allows for the sponsors to make a decision. While we are committing to the indication, we certainly have the opportunity to make decisions along the way. In head and neck, we have a slightly different landscape.

Maria Fardis: While we have a response, the duration of response has not been particularly something that we felt that we wanted to pursue in a very large way with Gen 2. In head and neck, we introduced two other products into clinic earlier in the year. We introduced the Gen 3, which had a 16-day manufacturing process, and we introduced the PD-1 Selected Till, which we thought, based on literature, should be a more potent product. So we are trying to solve slightly different problems for each one of them. Does that make sense?

Maria Fardis: Yeah, no, that's helpful. I'm wondering if we should read into the fact that you are committing that if you've seen any responses in lung cancer, they've been durable. But I guess I'm assuming you won't answer that.

Maria Fardis: I think that this sign from what we have seen from Moffitt's study has been really promising from my perspective. Seeing two CRs that have continued past 12 months and a PR that went out 18 months is really quite promising. So not only do we see an ORR which is well above available care, but we also see the DOR in that indication which is well above available care. And I think that's maybe how we are thinking about it.

Maria Fardis: Okay, I got it. Thanks so much for taking my questions. Thank you, Joe.

James Ziegler: Our next question comes from Breenam Linwood Jeffries. Hi guys, thanks for taking my questions and congratulations on all the progress. Maria, I'll start with the melanoma indication. Given the follow-up from Cohort 2 and the interim data from Cohort 4, have you had discussions with payers regarding pricing for leucalucel? Hi Biren, let me ask Jim to speak to the pricing comment. Yes, we have engaged payers, Biren, but we have not set a price, nor discussed a price, for Lifelucel.

James Ziegler: As you know, there are many factors to consider in establishing both price and value, which we will continue to evaluate until product approval. As you also know, these potential indications are in areas of high unmet need for which there are no viable treatments. And we believe that Lifelucel will support compelling value. And then I guess on cervical cancer. I understand that you've had, or you're going to have, a pre-BLA meeting on the melanoma side. But do you plan to have a separate second discussion with FDA regarding cervical cancer and what type of follow-up period FDA would like to see? And is this driving the BLA submission early in 2021? And I just want to clarify, I guess, from Cohort 1 cervical cancer data, is that data going to be released in 2021? Or can we expect that at the end of 2020?

Maria Fardis: Yeah. I think a lot of that is dependent on the interactions with FDA. You're completely correct.

[music].

Maria Fardis: So cervical, as I noted earlier, is under a different IND. And I think it depends on whether the review division ends up participating in our melanoma discussions; then we can have a potentially similar dialogue around the follow-up. If they end up staying under their own IND, then we absolutely need a separate meeting with them, which then defines the amount of follow-up.

Maria Fardis: This is precisely why we thought it was safer to move the expected BLA timeline to early 2021 because by the time we dose the patients, approach the agency, and have a dialogue with them regarding follow-up, chances are pretty good that it might be a BLA in 2021. Got it. And then maybe just a couple more for me.

Maria Fardis: Can we expect an additional update from Moffitt at SITC? And, you know, given the announcement regarding the posters at ESMO, should we expect anything from late breakers at ESMO? I think late breakers are going to be out on August 17th.

Maria Fardis: I am not aware whether Moffitt is submitting something to CITSI, so I can't comment on that. I think from an ESMO perspective, let me not comment on what might be in late-breaking or not. I think that we have not really committed to any clinical data flow for 2020 beyond what we have already presented. Just want to remind ourselves. And then just on the, with regard to the Esmo poster in terms of the PD-1 knockout, what's the difference between the PD-1 knockout and the PD-1 silencing approach that you presented last year? I think you used CEO's compound PH-762. Yeah, there's a difference in the method of knocking something out.

Maria Fardis: The file product was using an RNAi technology, and that's a transient knockout. The one that is being expected to be presented at ESMO is a Talon product, which is a permanent genetic knockout. Got it. Thank you. Thank you. Our next question comes from Gil Lischitz with Chardon.

Maria Fardis: Thanks for taking my questions and congratulations on the progress. So maybe following up on the pricing question, in regards to your discussion with payers and other stakeholders, can you speak to how you might be thinking about pricing considerations for different indications, i.e., melanoma and cervical, in particular, and how that might relate to response durations in different settings, potentially?

James Ziegler: Yeah. Thanks, Gula. Let me ask Jim to comment on the pricing.

James Ziegler: Thank you, Maria. There are many factors, as we mentioned earlier, that go into setting pricing, and we're continuing to evaluate pricing individually for both metastatic melanoma as well as metastatic cervical. We're looking at the unmet need, the clinical profile, as you point out, efficacy measures around ORR, DOR, and the safety profile. We're also considering other factors as well in our pricing decision, and we look forward, as we approach launch, to having more dialogue with you specifically on pricing and value, but at this point, we're not prepared to talk about pricing. And then just to follow up on maybe the strategy for Europe, it may be an early time to be thinking about that, but in terms of the potential commercial launch planning and infrastructure, do you anticipate some of those needs to be similar or structured differently towards the strategy versus the strategy in the U.S.? Thank you. That's a great question and one that the team's working on right now as we are evaluating both the best practices and approaches in the U.S. and what will be scalable in the ex-U.S. We're considering, as you might imagine, three real scenarios: one, going it alone, two, potentially partnering, or three, out licensing.

[music].

James Ziegler: But we're still very early in the process, and again, we'll look forward to finalizing the assessment and making our go-to-market strategy based upon the data and the market dynamics. Great. I'm not showing any purple.

Operator: Sorry, I'm not showing any server requests at this time. I'll turn the call back over to Maria. Thank you, Operator. Thank you again for joining the Iovance quarterly-end call and first half of 2020. Please feel free to reach out to our IR team if you wish to follow up on any items. We look forward to a productive second half of the year as we further solidify our leadership in development, manufacturing, and commercialization. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day. You can find this and many other recipes at www.mehr-als-rohkost.de. Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music