Iovance Biotherapeutics, Inc. (IOVA) Q4 2019 Earnings Call Transcript

Iovance Biotherapeutics, Inc. (IOVA -2.34%)
Q4 2019 Earnings Call
Feb 25, 2020, 4:30 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good afternoon, and welcome to the Iovance Biotherapeutics fourth-quarter and year-end 2019 financial results conference call. [Operator instructions] Please be advised that the call is being recorded at the company's request. Now I would like to turn the call over to Sara Pellegrino, vice president, investor, and public relations at Iovance. Please go ahead.

Sara Pellegrino -- Vice President, Investor, and Public Relations

Thank you, Laurie. Good afternoon, everyone, and thank you for joining us. Speaking on today's call will be Maria Fardis, our president and chief executive officer; Friedrich Finckenstein, our chief medical officer; and Tim Morris, chief financial 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 fourth quarter and year ended December 31, 2019, as well as a corporate update.

Before we start, I would like to remind everyone that statements made during this conference call will include forward-looking statements regarding Iovance's goals, business focus, business plans, pre-commercial activities, clinical trial plans and results, potential future applications of our technologies, manufacturing capabilities, regulatory feedback and guidance, licensing and collaboration agreements and future updates. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time to time in our SEC filings. Our results may differ materially from those projected during today's call. We undertake no obligation to publicly update any forward-looking statements.

With that, I'll pass the call over to Maria.

Maria Fardis -- President and Chief Executive Officer

Thank you, Sara, and good afternoon, everyone. I am pleased to lead today's conference call to summarize the business progress made at Iovance during 2019 and highlight recent updates and important milestones to come in 2020. I will also comment on our progress toward a planned biologics license application or BLA submission for lifileucel and LN-145 this year, as well as preparation for a commercial launch in 2021. In 2019, we continued to advance our TIL, tumor-infiltrating lymphocyte therapy in pivotal programs in melanoma and cervical cancers.

We also initiated Phase 2 clinical studies for multiple indications in solid tumors. In addition, we have introduced our very first peripheral blood lymphocyte therapy, or PBL, into clinic as a new approach for blood cancers. I'd like to begin with an update on our lead TIL therapy, lifileucel, in metastatic melanoma. As a reminder, melanoma is a common type of skin cancer, accounting for approximately 96,000 patients diagnosed annually and 7,200 deaths each year in the United States.

We announced last month that we have completed patient dosing ahead of schedule in the pivotal Cohort 4 and our C-144-01 study of lifileucel. This pivotal cohort was initiated in March of 2019, with a target enrollment of 75 patients. We currently plan on allowing all patients from Cohort 4 to be followed for six months before data cuts for inclusion in the BLA. We have started process of assembling documents to be used for the BLA.

We plan to meet with FDA and expect to at least submit the BLA in late 2020. As a reminder, lifileucel has received both fast-track and regenerative medicine advanced therapy or RMAT designations from the U.S. FDA, which was supported by the clinical data from Cohort 2 in the melanoma study. The protocol for Cohort 4 was designed to enroll the same patient population of Cohort 2.

We presented data from Cohort 2 in the melanoma study several times over the last year. The most recent update on overall response rate, or ORR, was presented in November at the Society for Immunotherapy of Cancer or SITC annual meeting. We reported a 36.4% ORR in 66 patients who were heavily pretreated. As assessed by investigators, the duration of response, or DOR, for Cohort 2 has not been reached at the time of SITC presentation.

In a recent Iovance corporate update in January 2020, DOR was still not reached at 15.5 months of median study follow-up. Published data shows median overall survival in late-stage melanoma patients may reach seven to eight months, so the results of lifileucel are highly encouraging. We continue to monitor the patients in this study and hope to provide additional updates from quarter two in 2020. Iovance as an organization is very focused on the advancement of this program toward preparation for the BLA.

Our second pivotal study is LN-145 in patients with metastatic cervical cancer. We continue enrolling in the C-145-04 study and remain on track to complete dosing approximately midyear 2020 in the pivotal part of the study. Target enrollment is 75 patients. We are still planning to submit a BLA later this year, following a dialogue with the FDA.

Submission of the two BLAs are not dependent on each other, and each indication may be submitted separately. During 2019, LN-145 received breakthrough therapy designation or BTD, as well as fast-track designation from the FDA. These designations were supported by compelling data demonstrating a 44% ORR from 27 patients in the ongoing study, which was presented at the American Society of Clinical Oncology or ASCO Annual Meeting in June of 2019. We also successfully completed an end of Phase 2 meeting with the FDA in 2019.

Following the meeting, we increased target enrollment for the pivotal part of the study to 75 patients in order to support registration of LN-145. We also added new cohorts in earlier and later lines of cervical cancer patients in anticipation of changing landscape in this indication. This specifically includes a cohort that allows for treatment with LN-145 in combination with pembrolizumab and a cohort with patients who have failed prior anti-PD-1 therapy. During 2019, we dosed more than 150 patients in our clinical program.

Our second-generation or Gen 2 TIL therapy manufacturing process continues to be a robust one and with a demonstrated success rate of well over 90% and approximately 300 patients. In parallel with the pivotal trials for melanoma and cervical, we are already building our international and internal manufacturing capacity. Specifically for launch, the initial commercial supply will come from our CMO partner, WuXi AppTec Philadelphia facility as we continue to build our internal Iovance manufacturing capability. Construction of the Iovance commercial facility started in June of 2019, aiming to build a state-of-the-art 136,000 square foot commercial scale production facility in Philadelphia continues.

The new facility is expected to be operational by year-end 2020, 2021 to support commercial supply in 2022. The expected capacity is planned to meet demand for thousands of patients. In anticipation of launch of lifileucel and LN-145, we continue expanding our commercial and medical affairs infrastructure. Our main area of focus remains ensuring a positive patient experience with lifileucel.

Towards that, we are working on the following items: clinical site engagement in preparation for commercial launch; development of a close collaboration with healthcare professionals or HCPs, who will be handling and administering our product; operational excellence by Iovance in provision of the product; and communication with payers. In the U.S. space, we currently work with over 20 clinical sites for melanoma and approximately the same number of sites for cervical. We anticipate that centers with prior TIL experience and those with key opinion leaders in melanoma and cervical cancers will be initial target for the launch of lifileucel and LN-145 subsequent to approval.

Our medical affairs team is in place to work with a network of treating HCPs and patient advocacy groups to assure that information about TIL is available to interested organizations. We also continue optimizing our logistics and infrastructure to assure a patient-focused organization is in place, not only for our clinical program, but also for commercialization. We have made great progress in identification of centers that we work with in the clinical program and expect to collaborate with them in commercializing TIL. On the patient access and reimbursement front, we have initiated discussions with private payers and CMS to ensure timely access to TIL therapy for patients.

And under a patient-centric model, we intend to support the patient at every step of the way in the process from initial resection to infusion. As our market research and commercial preparation continues, we look forward to providing updates on our launch plan throughout the year. I would like to ask now our Chief Medical Officer, Friedrich Finckenstein, to provide an update about our other clinical programs and ongoing research at Iovance. Friedrich?

Friedrich Finckenstein -- Chief Medical Officer

Thank you, Maria. I would like to begin with the expansion of our ongoing C-145-03 clinical study in head and neck cancer, which remains an important indication for Iovance. We continue to enroll patients in our C-145-03 study and recently added new cohorts to the study. Patients in the first new cohort will be treated with LN-145, manufactured with our new proprietary 16-day third-generation TIL therapy process, which we call Gen 3.

The second new cohort will evaluate a selected TIL product, PD-1 Select, designated as LN-145-S1. We presented preclinical information on PD-1 selected TIL at SITC in November 2018, which demonstrated improved tumor cell-killing properties for this product. This cohort is the first time we are testing selected TIL in clinic, and we look forward to enrolling patients in these new cohortS. We have also made significant progress in evaluating the broader potential for TIL treatment in earlier lines of therapy for checkpoint-naive melanoma, head and neck and non-small cell lung cancer.

Patient dosing in the IOV-COM-202 clinical study, which we also refer to as our basket study, was initiated in May 2019. Three cohorts will evaluate TIL plus pembrolizumab in patients who are immune checkpoint inhibitor naive with melanoma, squamous cell carcinoma of the head and neck and non-small cell lung cancer. In the fourth cohort, LN-145 monotherapy is offered to relapse/refractory non-small cell lung cancer patients. Enrollment across all four of these cohorts is proceeding well, and we have plans to add a fifth cohort to investigate our selected TIL, LN-145-S1 in melanoma patients who have received prior anti-PD-1 and BRAF or BRAF/MEK as indicated.

This is the same selected TIL products that we have introduced into the head and neck study. The additional cohort will also increase the overall target enrollment in the basket study. Moving on to our peripheral-blood lymphocyte therapy or PBL therapy, we are very excited to be in clinic with our very first Iovance cell therapy for blood cancers. I am happy to report that last week, we dosed the first patient in the clinical study of our PBL therapy, which we have designated IOV-2001.

The Phase 1/2 study named IOV-CLL-01 is currently enrolling patients with relapsed or refractory CLL or small lymphocytic lymphoma, SLL, into the Phase 1 dose escalation portion. We generate a polyclonal population of PBL for therapeutic use from 50 milliliters of blood using a nine-day T cell manufacturing process. Development of IOV-2001 PBL therapy is a result of internal research and development efforts at Iovance to translate our experience with TIL in solid tumors. We think the study will provide important proof-of-concept for our PBL approach and look forward to enrolling additional patients in this study.

Before I turn the call to Tim, I would like to briefly mention our earlier-stage research and development efforts. As announced in January, we have obtained a license from Novartis to develop and commercialize an antibody cytokine engrafted protein referred to as IOV-3001 as a targeted and selective IL-2 analog. IL-2 is a major component of our treatment. So the development of a proprietary IL-2 analog is a valuable opportunity to further optimize the beneficial properties of the IL-2 through improving pharmacokinetic and pharmacodynamic properties as compared to currently available IL-2.

We are also exploring genetically modified TIL with the potential to create an even more potent TIL. Under a research collaboration and exclusive worldwide license agreement with Cellectis, we have licensed certain TALEN technology to develop genetically edited TIL in several cancer indications. The worldwide exclusive license enables us to use TALEN technology to address multiple gene targets to modify TIL for therapeutic use. I will now hand the call over to Tim to discuss our financial results.

Tim Morris -- Chief Financial Officer

Thank you, Friedrich. My remarks will address the high-level financial results from our fourth-quarter and full-year 2019. Additional details can be found in the press release that we distributed earlier, as well as our annual report on Form 10-K to be filed shortly with the SEC. Net loss for the fourth quarter ended 2019 was $63.6 million or $0.50 per share.

This compared to a net loss of $32.6 million or $0.27 per share for the fourth-quarter 2018. Net loss for the full-year 2019 was $197.6 million or $1.59 per share, compared to a net loss of $123.6 million or $1.27 per share for 2018. Research and development expenses were $54.2 million for the fourth-quarter 2019, an increase of $26.8 million, compared to the $27.4 million for the fourth-quarter 2018. Research and development expenses were $166 million for the full-year 2019, an increase of $66.2 million, when compared to $99.8 million for the prior year.

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

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

Maria Fardis -- President and Chief Executive Officer

Thank you, Tim. Thank you, all, for attending the call today. We look forward to an exciting and productive 2020. In closing, our anticipated milestones for this year include last patient to be dosed in the pivotal program for LN-145 for cervical cancer, pre-BLA meeting with U.S.

FDA, melanoma top-line pivotal data and BLA submission. Before we begin the Q&A session, I would like to remind everyone that Iovance does not comment on speculation in the media and will not answer questions related to any articles circulating in the press. I will now turn the call over to the operator for any questions. Operator?

Questions & Answers:

Operator

[Operator instructions] We have a question from the line of Jim Birchenough from Wells Fargo. Please ask your question.

Jim Birchenough -- Wells Fargo Securities -- Analyst

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

Maria Fardis -- President and Chief Executive Officer

Sure. Hi, Jim, thank you for the question. From a commercial opportunity perspective, although unfortunately, 7,200 patients die in the melanoma landscape, and one can consider TIL certainly an option for these patients, we are actually thinking about second and third line. And that patient population is broader than 7,200 that is currently reported.

So that's how we are thinking about sort of positioning the product, and that's the patient population that our current protocol allows. In terms of the centers, I just want to make sure that I'm clear. We are not targeting just 20 centers. The comment I made was, we start with the sites that have been participating in our clinical program, and those have been around 20 for melanoma and cervical.

We certainly intend to expand that by the time we're getting ready to take off the product in the commercial landscape.

Jim Birchenough -- Wells Fargo Securities -- Analyst

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

Maria Fardis -- President and Chief Executive Officer

Yeah. We do know exactly what is the distribution of patients in terms of where the bulk of them are. We certainly have an internal map. We consider where they typically go to receive their care.

I don't know if I'm quite ready to speak about that specific plan. Well, we certainly think about it in the same way as you are approaching it.

Jim Birchenough -- Wells Fargo Securities -- Analyst

And just a quick one, Maria. Is the cervical filing, the LN-145 filing something you expect to get done in 2020? Or does that really depend on when midyear you closed out enrollment? And could that slip into 2021?

Maria Fardis -- President and Chief Executive Officer

Right. We recognize that the timing of cervical and melanoma are slightly apart. We currently continue to plan for cervical submission by year-end. And you're correct that some of that would depend on exactly when cervical enrollment will complete, as well as a dialogue with FDA.

But the current plans remain to go ahead and submit, assuming, of course, all of the milestones are met around later part of 2020 as of now.

Jim Birchenough -- Wells Fargo Securities -- Analyst

Great. Well, thanks for taking the questions, and congrats again on the progress.

Maria Fardis -- President and Chief Executive Officer

Thank you, Jim.

Operator

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

Ben Burnett -- Stifel Financial Corp. -- Analyst

Great. Thanks so much I had a question on the IOV-COM-202, the basket trial. Looking at TIL plus pembro, as well as the fourth cohort monotherapy, I guess do you have an expectation as to when we might get data for these first four cohorts?

Maria Fardis -- President and Chief Executive Officer

Hi, Ben, thank you for the question. We started patient dosing in May of 2019. Given that the study is a basket study, the patients may be distributed between the cohorts. We really would like to make sure we have a handful of patients in each cohort before we can report them.

So we have not committed to a specific timing for data flow from this study yet.

Ben Burnett -- Stifel Financial Corp. -- Analyst

OK, OK, understood. If I could just ask one more regarding the recent Novartis collaboration. Can you talk more about the non T reg activating IL-2 antibody that's being developed? I guess how has the antibody been engrafted. And I guess what makes us a more selective IL-2?

Maria Fardis -- President and Chief Executive Officer

Sure. Yeah, of course. So as you might know, IL-2 binds to three different subunits, alpha, beta and gamma subunits on various T cells. The beta gamma subunits is what we are interested in.

The alpha subunit is more prevalent in binding toward T reg. We are trying to rule that binding out. So the CDR that we have does not allow for this particular IL-2 to bind at the alpha sub unit. It, in fact, focuses it better on the beta gamma subunits.

That's why we expect it to be better.

Ben Burnett -- Stifel Financial Corp. -- Analyst

OK. And I guess, at this point, can you comment on just kind of the architecture of how the antibody is engrafted? Or at this point, is that proprietary?

Maria Fardis -- President and Chief Executive Officer

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

Ben Burnett -- Stifel Financial Corp. -- Analyst

OK. OK. Makes sense. Thanks so much.

Maria Fardis -- President and Chief Executive Officer

Thank you.

Operator

Your next question comes from the line of Joe Pantginis from H.C. Wainwright. Please ask your question.

Joe Pantginis -- H.C. Wainwright and Company -- Analyst

Hi, everyone. Good afternoon. Thanks for taking the question. Maria, I was just curious if you could provide a little more detail with regarding your strategy for the evolution of your manufacturing facilities.

As you mentioned in your prepared comments, you have WuXi right now and looking to have your new facility come online in 2022. How do you look to sort of share the responsibilities between these two facilities? And also, when your facility comes online, do you anticipate that that will start off with Gen 3?

Maria Fardis -- President and Chief Executive Officer

Joe, just to correct your statement, it will start off with Gen 2, correct? Is that what you said?

Joe Pantginis -- H.C. Wainwright and Company -- Analyst

Right. Yeah. And when it would evolve to Gen 3, sorry. Yeah.

Maria Fardis -- President and Chief Executive Officer

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

But right now, we very much are planning on our commercialization with Gen 2 process. In terms of roles and responsibilities, we already have started building our team out in Philadelphia. Certainly, the building itself requires a number of staff who are familiar with the process. We have great expertise in health, starting from our engineering team, as well as people who are very familiar with the process, and in terms of process development and optimization.

So we already have a team that is slowly ramping up to what is going to be needed by the time the commercial activities roll out. In addition to the local team members in Philadelphia, we have additional team members such as quality or otherwise in San Carlos, who are supporting the activities for the facility. So I don't foresee a sort of a switch on where everybody then -- 100 people are hired, and they go into the facility. I see a rollout, and the rollout has already been started.

Joe Pantginis -- H.C. Wainwright and Company -- Analyst

No, that's really helpful. And if I could just ask a quick follow-up on your research front. With regard to the PBL program, obviously, it's exciting that it's a much shorter process and how you can identify these TILs. Just curious, is there any major difference -- once you extract T cells from the blood, are there any major differences between Gen 2 and the TIL identification process before you expand them in the PBL versus Gen 2?

Maria Fardis -- President and Chief Executive Officer

We have a very different process that we use for PDLs. There is, and again, some of that is proprietary and bulk of it has not been sort of shared already. So yes, there's rather significant differences. The cells, the T cells that we usually harvest from tumor are not in a very high concentration in blood.

We are already familiar with that. We know that they're difficult to find. So we had to implement different procedures in order to fish these cells out, and we were very successful, obviously, in doing so. But yes, there's differences in how we get the cells from the source, one being a tumor, one being blood.

Joe Pantginis -- H.C. Wainwright and Company -- Analyst

That's great. Thanks, Maria.

Maria Fardis -- President and Chief Executive Officer

Thank you, Joe.

Operator

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

Mark Breidenbach -- Oppenheimer -- Analyst

Hey, guys. Thanks for taking the questions, and congrats on the progress. Maria, I noticed that the pivotal cohort in melanoma enrolled a little bit faster than maybe you had initially projected. And the pivotal cohort in cervical is maybe more or less on the time line you had initially projected.

I'm just wondering if you can point to any specific factors that are contributing to that discrepancy. And also, is it safe to assume we would want a minimum of six months follow-up once the pivotal cervical cancer completes enrollment before we would see top-line data from that?

Maria Fardis -- President and Chief Executive Officer

Thank you, Mark, for the question. Yeah, you're correct. Melanoma enrolled faster than we expected. And I think that definitely shows a clear unmet medical need.

The cervical landscape is definitely changing. As you are aware, there's earlier line KEYTRUDA studies coming into this space, both in terms of clinical trials, as well as just the commercial use. And so the patients that we are enrolling into our Cohort 1 is certainly -- the nature of the patients that are out there is changing. So it's really due to the change in landscape.

Now we anticipated that this is going to happen. And I made a comment about it, we had added two other cohorts into our LN-145 study for cervical in anticipation with the change in landscape. So we have thought through this, and we have some alternative strategies if this continues. And your second question in terms of the six months of follow-up, we thought about a six months of follow-up from melanoma just because the enrollment closed so early, and it allows us to do a six months of follow-up.

There has not been really a request either from agency or otherwise for a certain amount of follow-up. So I think that this is really a subject to discussion with U.S. FDA in terms of how much follow-up they might be asking for. But I do want to note that the six months is a Iovance proposal in the melanoma case.

Mark Breidenbach -- Oppenheimer -- Analyst

Understood. And maybe just a quick follow-up on the Gen 3 process. I'm curious why this is really initially being focused in head and neck. Maybe you could elaborate a little bit on why it's important to have a faster manufacturing time line in head and neck.

And I'm also curious with regard to the PD-1 Select version of TIL, what was the impact of that on manufacturing time line? Does that add several days to the process?

Maria Fardis -- President and Chief Executive Officer

OK. Thank you. Yeah, we had recognized earlier on that the patients in head and neck cancer have a fairly short revival, unfortunately. So we felt that a shorter manufacturing process really could benefit a patient population that doesn't -- many times, they don't make it to the first assessment or a second assessment.

So that's why we implemented that initially into the head and neck study. The PD-1 selected process does not add additional days to the manufacturing process. In fact, we have optimized that process so that it is not longer than our Gen 2. So it's the same duration as our Gen 2 process.

Mark Breidenbach -- Oppenheimer -- Analyst

OK, understood. All right. Thank you for answering questions, and congrats again.

Maria Fardis -- President and Chief Executive Officer

Thank you, Mark.

Operator

Your next question comes from the line of Ren Benjamin from JMP Securities. Please ask your question.

Ren Benjamin -- JMP Securities --Analyst

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

Maria Fardis -- President and Chief Executive Officer

Right. Thank you, Ren. I don't think there's a magical number for us to disclose, but I prefer, for example, at least five patients per cohort would be kind of nice to talk about. But there's not a magical number.

I think it depends on what we see. But that's my mental note. If you ask me, what is your mental number? Somewhere between four, five, six, seven would be really good numbers. But again, I do emphasize there's not a magical number by which we want to disclose something, the data for that study.

Did you ask about the duration? Can you repeat your question on what you are asking on the duration front?

Ren Benjamin -- JMP Securities --Analyst

No, sorry. Just in regards to your discussions with the FDA prior to filing, I think you mentioned duration would be one of the things that you'll be talking about since they don't have a particular mandate. But what are other items that you think are worthy of discussion prior to filing?

Maria Fardis -- President and Chief Executive Officer

Sure. So just to make sure that I clarified the question. The specific item that we would be asking the agency is duration of follow-up, not the duration of response, the duration of response is the property of the product. But the duration of follow-up that they would like to see is typically a subject of discussion as part of the BLA dialogue.

The BLA pre-meeting typically has a component of logistics involved in it. It usually has a component of how you're going to build your BLA. BLA is a very large document, exactly where to find something. And then there's other components that we ask questions about.

It's a bit of a logistics meeting, as well as guideline for next steps. Sometimes other topic, scientific topics also pop up. I won't go into too much detail. Obviously, that's something that's proprietary to each company as to what they discuss at the pre-BLA meeting.

Ren Benjamin -- JMP Securities --Analyst

Got it. And I guess just one final question from us is really the cadence of data. It seems like it will be primarily second half focused from kind of all the programs that are running. Are we thinking about that correctly? Would you release kind of top-line data for melanoma, then a filing and then kind of full data sometime in '21? Is that how we should be thinking about it? Or is there a different cadence of results reporting that?

Maria Fardis -- President and Chief Executive Officer

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

Ren Benjamin -- JMP Securities --Analyst

Terrific. Well, thank you again, and congrats on the progress.

Maria Fardis -- President and Chief Executive Officer

Thank you, Ben.

Operator

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

Madhu Kumar -- Baird -- Analyst

Hi, great. Thanks for taking our questions. So I guess, our first one is what is the ex U.S. regulatory task in melanoma and cervical cancer?

Maria Fardis -- President and Chief Executive Officer

Sure. Thanks, Madhu. We do have plans to initiate a broader dialogue with EMA health authorities called CHMP, potentially in later part of 2020. It's not that there has been no dialogue.

We obviously have a number of clinical sites that are active in EU. And as part of that, we submit what is called the clinical trial authorization, a CTA has been submitted, and preliminary dialogue has been had with local health authorities. But we do intend on starting a sort of a more of a centralized procedure in later part of the year in 2020.

Madhu Kumar -- Baird -- Analyst

OK. And just a more practical question about the PD-1 combination studies. So you all give the TIL, do the IL-2 treatment, and then is there like a wash-out period before you start PD-1? Like how much of a gap is there between the TIL procedure and the beginning of PD-1 administration in the combination studies?

Maria Fardis -- President and Chief Executive Officer

So the PD-1 is administered prior to TIL. And that information, to the degree I can speak to, is available on clinicaltrials.gov. But I won't be able to go into details of the study design, Madhu.

Madhu Kumar -- Baird -- Analyst

OK. Thanks.

Operator

Your next question comes from the line of Biren Amin from Jefferies. Please ask your question.

Biren Amin -- Jefferies -- Analyst

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

Maria Fardis -- President and Chief Executive Officer

Biren, thank you for your question. We have not been analyzing Cohort 4. We actually have a data integrity document in place where we don't compile the data for Cohort 4. So I won't be able to speak to the patient population in Cohort 4.

I did note that we designed the protocol the same way. The patient population definition is the same between Cohorts 2 and 4, and we try to keep the participating sites to the degree we could control it the same.

Biren Amin -- Jefferies -- Analyst

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

Maria Fardis -- President and Chief Executive Officer

Sure. So some of the data for PD-1 selected TIL was presented at, I think it was SITC 2018. The criteria for that program was there were some preliminary data around T cells that are ultimately recognized the tumor because they have seen the PD-L1 of the tumor. So a TIL that is expressing PD-1 high, they recognize the tumor not only beyond what TIL initially identified, but they have literally touched the tumor, the tumor cell.

So that was the idea around the selection process. And again, there was literature showing that these are more potent TILs. They have better activity and cell-killing capability. When we presented this at SITC 2018, we showed in fact that the TIL that are PD-1 selected have enhanced autologous melanoma cell-killing capability, and it was quite remarkable.

So we decided to move that product into clinic. In terms of where the bar would be, we have disclosed for Gen 2 in a very, very preliminary set of data back maybe a couple of years ago now,that a median DOR was around two to seven months for our head and neck patients. So we are looking to try and elongate the median DOR. That would be our goal for the [Inaudible] cohort.

Biren Amin -- Jefferies -- Analyst

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

Maria Fardis -- President and Chief Executive Officer

Thank you for that question. I think they may cover slightly different landscapes. In my opinion, when we have diseases that are high mutational load just possibly melanoma, we are thinking head and neck, lung, these are diseases that there are multiple targets and there needs to be multiple cells that would hit those targets. So the challenge with them would be identifying that specific new antigen that a T cell could target.

And if you don't have that, then it's really hard to hit them. So I do think that they would occupy different spaces. I think new antigen-targeted therapies could be beneficial for lower mutational load while TIL are maybe more beneficial for high mutational load. And this would last as long as we don't know exactly what targets you're trying to hit with various cell therapies.

So yeah, I guess I see them complementary maybe.

Biren Amin -- Jefferies -- Analyst

So are there any pharma companies that you think complement TILs?

Maria Fardis -- President and Chief Executive Officer

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

Biren Amin -- Jefferies -- Analyst

Great. Thank you.

Maria Fardis -- President and Chief Executive Officer

Thank you, Biren.

Operator

Your next question comes from the line of Joe Catanzaro from Piper Sandler. Please ask your question.

Joe Catanzaro -- Piper Sandler -- Analyst

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

Maria Fardis -- President and Chief Executive Officer

Yeah, great. Thank you, Joe. As a matter of fact, that is something that is very much front of mind. This is why, and Friedrich commented about this, for the IOV-COM-202 study, we're adding a cohort into that study that will enroll melanoma patients with a selected TIL product.

145 is one. That's exactly the purpose to allow access to TIL products, while we're bringing the LN-144 lifileucel to market.

Joe Catanzaro -- Piper Sandler -- Analyst

OK. Great. That's all I have. Thanks for taking my questions, and congrats on the progress.

Maria Fardis -- President and Chief Executive Officer

Thank you so much, Joe.

Operator

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

Maria Fardis -- President and Chief Executive Officer

Thank you, operator. Overall, I'm very pleased with the progress we have based on our prospects of becoming the leader in the TIL development, manufacturing and commercialization. Indeed, in just four years, we have gone from our first patient in the clinic to preparing our first regulatory submission for approval. We have the potential to impact lives of thousands of patients with melanoma and cervical cancers who have exhausted current treatment options.

Our work is possible, thanks to the valuable contribution of many individuals, including committed shareholders, hard working employees, clinical investigators, collaboration partners and patients and patient families who motivate us. We look forward to realizing this shared vision for this product with the individuals that are in need of therapy. Thank you.

Operator

[Operator signoff]

Duration: 51 minutes

Call participants:

Sara Pellegrino -- Vice President, Investor, and Public Relations

Maria Fardis -- President and Chief Executive Officer

Friedrich Finckenstein -- Chief Medical Officer

Tim Morris -- Chief Financial Officer

Jim Birchenough -- Wells Fargo Securities -- Analyst

Ben Burnett -- Stifel Financial Corp. -- Analyst

Joe Pantginis -- H.C. Wainwright and Company -- Analyst

Mark Breidenbach -- Oppenheimer -- Analyst

Ren Benjamin -- JMP Securities --Analyst

Madhu Kumar -- Baird -- Analyst

Biren Amin -- Jefferies -- Analyst

Joe Catanzaro -- Piper Sandler -- Analyst

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