Earnings Call Transcript - IOVA Q4 2020

Operator, Operator

Good afternoon, and welcome to the Iovance Fourth Quarter and Full Year 2020 Financial Results Conference Call. Now, I would like to turn the call over to Sara Pellegrino, Vice President of Investor and Public Relations at Iovance. Please go ahead.

Sara Pellegrino, Vice President, Investor and Public Relations

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; Friedrich Finckenstein, our Chief Medical Officer; and Jean-Marc Bellemin, our Chief Financial Officer. We are also joined by Jim Zigler, Senior Vice President, Commercial. This afternoon, we issued a press release that can be found on our website at iovance.com, which includes the financial results for the 3 and 12 months ended on December 31, 2020, 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 plans, 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 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 introduction, I will turn the call over to Maria.

Maria Fardis, President and CEO

Thank you, Sara, and good afternoon, everyone. I am pleased to highlight our 2020 progress as well as our 2021 priorities and all events during today's conference call. During 2020, we continued to advance and broaden our tumor-infiltrating lymphocytes (TIL) platform across multiple indications including metastatic melanoma, cervical, head and neck, and non-small cell lung cancers. For our product candidate like the metastatic melanoma, we reported new and updated data from our ongoing C14401 clinical study demonstrating durable responses and our core two for one time treatment. We initiated a dialogue with the FDA and learned that we need to continue refining the information from our potency assays. We continue our work to refine existing assays as well as to develop new assays in pursuit of our biologics license application (BLA), which is our top priority for 2021. Additionally, as we completed enrollment in two cohorts for advanced cervical cancer, we've reported the initial clinical data for TIL in combination with pembrolizumab in head and neck cancer and the activated site for the registration-directed study of LN-145 in non-small cell lung cancer. We believe that the growing body of clinical data across multiple late-stage cancers, coupled with the combination of TIL and checkpoint inhibitors in earlier stages of disease, validates the significance and broad potential for TIL. We also continue to execute toward all manufacturing and pre-commercial activities in furthering our commitment to address the critical needs of cancer patients. I am very confident in the strength of our employees to deliver on this mission. We have an impressive 76% of our nearly 250 employees who have at least a year of cell therapy experience. On the call today, I would like to spend a few minutes highlighting the main indication, and then I will let Frederick highlight our recent clinical study update. I will begin with our first pivotal program, lifileucel in advanced melanoma. Metastatic melanoma is a common skin cancer accounting for approximately 96,000 patients diagnosed and 7,000 deaths each year in the United States alone. We are focused on metastatic melanoma patients who have exhausted their most commonly used available care options and need alternative therapies. In early January of 2021, we provided a corporate update that the median duration of response has not been reached at 28.1 months of median follow-up for Cohort 2 from our C-14401 clinical study. We, as well as KOLs, continue to be very enthusiastic about the durability of response following one-time treatment. For the post-anti-PD1 patient population, similar to Cohort 2, chemotherapy is the only currently available option, offering a 4% to 10% response rate and an overall survival of only 7% to 8%. We intend to present the long-term follow-up data from Cohort 2 at an upcoming medical conference. As previously mentioned, reaching agreement with the FDA on the potency assays is a top priority for all events. Following a Type B meeting with the US FDA during the fourth quarter of last year, we reached agreement on the duration of clinical data follow-up for our pivotal cohort to support the BLA. We did not reach an agreement with the agency on the potency assays to define TIL and continue our work to refine existing potency assays while developing new assays. While the length of time until BLA submission depends on future dialogue with the agency, we continue staying prepared for a BLA submission in 2021. We plan to provide updates when available. Our second pivotal program is investigating LN-145, now also known as lifileucel, in the C-145-04 study to support BLA submission in metastatic cervical cancer. Enrollment in both Cohorts 1 and 2 of this study has been completed. Patients in our pivotal Cohort 1 are post-chemotherapy, while Cohort 2 includes post-anti-PD1 patients. We believe that inclusion of both cohorts in the BLA may strengthen the potential label and reflect the expected upcoming treatment landscape in cervical cancer. The resolution of the potency assay for lifileucel and melanoma is a key step toward our BLA submission plan in the cervical cancer indication. As a reminder, the FDA has previously granted both breakthrough therapy and fast track designation for lifileucel in cervical cancer. Turning to our manufacturing facility or advanced Cell Therapy Center, ICTC, the construction of clean rooms was completed in late 2020. Process equipment is now in place in the available clean rooms, and activities in support of clinical manufacturing are expected to initiate in the coming months. Commercial manufacturing remains on track for 2022 with capacity to meet the demand for up to thousands of patients. Iovance has transformed manufacturing from a lengthy academic process to a shorter, scalable, centralized GMP process, yielding a cryo-preserved product. Our Gen 2 process takes 22 days. To date, more than 400 patients have received Iovance TIL with a continuing success rate above 90%. We have also built and continued to augment our intellectual property, which is covered by more than 20 granted or allowed U.S. and international patents for compositions and methods of treatment in a broad range of cancers leading to the GEN 2 manufacturing process. Our Iovance IP portfolio includes patent applications and granted patents directed toward gently manufacturing selected TIL products, stable and fancy and genetic TIL modification, cryopreservation, and combination of TIL with checkpoint inhibitors. Turning to our commercial launch preparation, the advance team is currently focused on KOL engagement, site activation and training, TIL education and awareness, patient access, and other readiness activities. Our priority is to ensure launch success while taking a gated approach to commercial readiness, expenses, and headcount prior to BLA submission. Our medical affairs team works with a network of treating healthcare professionals (HCPs) and patient advocacy groups to ensure that the information about the tools available to interest that organization. A core commercial team continues to partner with the leading U.S. cancer centers to build their TIL service line capabilities and the intensive skill of training and onboarding upon submission. Our market access team continues to meet with private payers and the Centers for Medicare and Medicaid Services (CMS) to ensure patients have appropriate and timely access to lifileucel. We believe that CMS and payers recognize the unmet need and clinical value of lifileucel, as well as the potential benefits for patients with metastatic melanoma. We are also pleased with the development and progress of our patient access program. Our goal is to deliver a best-in-class cell ordering and patient support system that assists the patients at every step of the process. I will now pass the call to Frederick to outline our clinical study updates including enrollment status, as well as the introduction of new cohorts and treatment regimens into our existing studies.

Friedrich Finckenstein, Chief Medical Officer

Thank you, Maria. I am pleased to highlight today that we are currently recruiting patients for four clinical studies. Our drug development strategy focuses on cancer populations with high unmet need, with substantial opportunity to make a meaningful impact. Our C-145 clinical study in advanced cervical cancer has completed and closed enrollment in the first two cohorts while we continue to recruit a third cohort of anti-PD1-naive patients to receive TIL plus pembrolizumab. Recruitment also remains underway in our IOV-COM-202 study in solid tumors, the IOV-COM-202 study in second-line non-small cell lung cancer, and the IOV-CLL01 study in CLL/SLL. As we move ahead with TIL alone and in combination with approved treatments in different indications and various stages of cancer, the COVID-19 pandemic may impact the pace of enrollment, particularly across cohorts with earlier line patients, which may improve as COVID-19 abates. A lot for this call is focused on the activation of IOV-LUN-202 clinical studies. Today, I will highlight our current data and strategy in head and neck cancer, as well as the recent updates and inclusion of new cohorts in the IOV-COM-202 basket study. Head and neck cancer remains an important indication for Iovance, and we are particularly encouraged by the initial clinical data for TIL LN145 in combination with pembrolizumab, which was presented at the Society for the Immunotherapy of Cancer's annual meeting in November of 2020. We are also excited about the potential for combined therapy with pembrolizumab and other solid tumors. The study poster highlighted nine patients with head and neck squamous cell carcinoma from Cohort 2A in the IOV-COM-202 basket study. These patients had not previously received treatment with checkpoint inhibitors but may have received prior chemotherapy. Following LN-145 in combination with pembrolizumab, the overall response rate (ORR) was 44%, and the median duration of response has not been reached at 8.6 months of median study follow-up. As these are small patient numbers, we find the results to be very promising, as checkpoint inhibitor monotherapy and checkpoint combinations for head and neck cancer patient ranges from 15% to 18% in the literature. We look forward to gathering additional data to present at an upcoming conference in the future. Cohort 2A has now been expanded to include up to 19 patients. Regarding our C-145 clinical study of LN-145 alone in head and neck cancer, we achieved targeted enrollment and closed the study to enrollment. Before I hand the call to Jean-Marc, I would like to highlight additional updates in our IOV-COM-202 basket study, which now includes seven total cohorts across melanoma, head and neck, and non-small cell lung cancers. As Maria mentioned, we are very excited about the potential to offer an option for many different patient populations in multiple indications. In this basket study, early line patients in each indication received TIL plus pembrolizumab, while second line non-small cell lung cancer patients received TIL plus ipilimumab and nivolumab, and later lung cancer patients with melanoma and non-small cell lung cancer received TIL alone. Recent updates include the addition of new melanoma and lung cancer cohorts, and as mentioned previously, the expansion of the head and neck cancer cohort. Our newly added Cohort 1C will investigate LN-144 manufactured with our 16-day third-generation process in metastatic melanoma patients who have received one or more prior systemic therapies. Cohort 2A in head and neck cancer, which evaluates LN-145 in combination with pembrolizumab, was expanded to include up to 19 patients who have not previously used immune checkpoint inhibitors. Our new Cohort 3C will provide an alternative option to standard chemotherapy in non-small cell lung cancer, offering TIL plus pembrolizumab in non-small cell lung cancer patients who have received one prior systemic therapy. The three non-small cell lung cancer cohorts in this basket study, together with the second line patient population in our IOV-LUN-202 registration support study, allow us to cast a broad net to address the unmet needs of non-small cell lung cancer. I will now hand the call over to Jean-Marc to discuss our fourth quarter and full year 2020 financial results.

Jean-Marc Bellemin, Chief Financial Officer

Thank you, Friedrich. My comments will reflect the high-level financial results from the fourth quarter and full year 2020. Additional details can be found in this afternoon's press release, as well as in our annual report on Form 10-K filed with the SEC. I will begin with our cash position. As of December 31, 2020, Iovance held $635 million in cash, cash equivalents, short-term investments, and restricted cash compared to $312.5 million on December 31, 2019. This current cash position delivered on our commitment to end last year with at least $630 million in cash. Our current cash position includes net proceeds of $567 million from a June 2020 common stock public offering. Our financial strength is expected to be sufficient into 2023 to deliver on our pipeline programs. Moving to the income statement, our net loss for the fourth quarter ended December 31, 2020, was $68.4 million or $0.47 per share, compared to a net loss of $63.6 million or $0.50 per share for the fourth quarter ended December 31, 2019. Net loss for the 12 months ended December 31, 2020, was $259.6 million or $1.88 per share, compared to a net loss of $197.6 million or $1.59 per share for the 12 months ended December 31, 2019. Research and development expenses were $52.4 million for the fourth quarter ended December 31, 2020, a decrease of $1.8 million compared to $54.2 million for the fourth quarter ended December 31, 2019. Research and development expenses were $201.7 million for the full year ended December 31, 2020, an increase of $35.7 million compared to $166 million for the full year ended December 31, 2019. The decrease in research and development expenses in the fourth quarter of 2020 over the prior year period was primarily attributable to a decrease in manufacturing and clinical costs following the completion of enrollment in the pivotal cohorts for melanoma and cervical cancer. The increase in research and development expenses in the full year 2020 over the prior four-year period was primarily due to IR clinical costs, licensing fees, and growth of the internal research and development. General and administrative expenses were $16.1 million for the fourth quarter of 2020, an increase of $5.2 million compared to $10.9 million for the fourth quarter of 2019. General and administrative expenses were $16.2 million for the 12 months ended December 31, 2020, an increase of $19.3 million compared to $40.9 million for the 12 months ended December 31, 2019. The increases in general and administrative expenses in the fourth quarter and full year 2020 compared to the previous year periods were primarily attributable to the growth of the internal general and administrative team and our stock-based compensation expenses. As of December 31, 2020, there were approximately 146.9 million common shares outstanding. Looking ahead, we are open to opportunities to top off our cash balance while being mindful of dilution. As such, we have put an at-the-market (ATM) facility in place to raise up to $350 million. The ATM is a good housekeeping measure that may allow us to be opportunistic, in addition to an already strong balance sheet. I will now turn the call back to the operator to kick off the Q&A session.

Operator, Operator

First question is from Mark Breidenbach with Oppenheimer. Please go ahead with your question.

Mark Breidenbach, Analyst

Hey, thanks for taking the question and congrats on the progress this quarter. Maria, I was hoping you could clarify whether or not the first patient has been treated in the IOV-LUN-202 study? And can you offer any thoughts as to when we might see long cohort data from the basket trial?

Maria Fardis, President and CEO

Hi, Mark. Good afternoon. Thank you for the questions. We have not started patient dosing in LUN-202, although we do have a few sites that are activated. We have not committed to a data flow timeframe for our long data. If you recall, there are only two cohorts in our program that actually have patients in them. One is Cohort 3A, and one is Cohort 3B in the IOV-LUN-202 study; we have highlighted that in Cohort 3A, we have had challenges in patient enrollment, and in Cohort 3B, we are hoping to have additional patients with longer follow-up to be able to present the data, but we have not committed to a timeframe for data flow.

Mark Breidenbach, Analyst

Okay, but thanks, that's helpful. Just turning to the cervical program, obviously, there might be more focus on Cohort 2, given the evolving standard of care in frontline cervical cancer. Can you give us a sense of what you see as a meaningful efficacy bar that you'd need to clear for checkpoint-experienced patients in cervical and if we can expect to see data from the second cohort of this trial?

Maria Fardis, President and CEO

Sure. So, currently, the way we have designed the protocol for Cohort 2, we consider these patients as post-PD-1, expect that they would have received chemotherapy as a prior line because that's just available care for them. So if you think about third-line therapy, the best we are aware of—and there is no data that I'm aware of—this is for post-PD-1 patients; what I believe for chemo in third line, the bar is around a 3% response rate mark. In terms of the Cohort 2 data itself, we have blinded ourselves the same way as we have with our pivotal cohorts, and we have not read out that cohort since we have talked to the FDA. Frederick, I don't know if you want to add anything on the expected response rate for Cohort 2 patients with similar backgrounds.

Friedrich Finckenstein, Chief Medical Officer

No, that's correct. There is data for third-line treatment showing that 3% response rate is consistent across a number of different therapies, which are all chemotherapy-based.

Mark Breidenbach, Analyst

Okay, super helpful. Thanks for taking the question.

Operator, Operator

Our next question comes from Peter Lawson with Barclays. Your question, please.

Peter Lawson, Analyst

Hey, thanks for taking my questions. Maria, just on the FDA and the potency assay, what are the next steps, and are you asking for a more defined product?

Maria Fardis, President and CEO

Hi, Peter, thank you for your question. From the time we met with the agency, which was back in early October 2020, we have submitted a couple of packages to the agency. We have not received additional comments or questions from the FDA. We haven't received specific requests in any way. We continue with our validation work with additional assays, and we expect to be providing that information to the agency in the coming weeks or months. So we don't have anything new from the agency, and no additional questions have arrived.

Peter Lawson, Analyst

Okay, thank you. And then just with Gen 3 manufacturing, does that in any way generate a more refined product? And just a question around that as well as how many T-cell clones are there in most of your products?

Maria Fardis, President and CEO

Really good topic. Our Gen 3 is expected to be released under the same criteria as Gen 2. So from a clonotype diversity perspective, we don't expect it to be different than our Gen 2. In terms of how many approximant clones there are, we have released our repertoire data from our melanoma and cervical programs. On average, what we see is somewhere between 10,000 to 17,000 clonotypes per patient product.

Peter Lawson, Analyst

Okay, thank you.

Operator, Operator

Our next question is from Biren Amin with Jefferies. Your line is open.

Biren Amin, Analyst

Yes. Hi, guys. Thanks for taking my questions. On the cervical study across both Cohort 1 and 2, Maria, can you just talk about the lower bound on the 95% confidence interval that you need to exceed for regulatory purposes?

Maria Fardis, President and CEO

Thank you for the question. Biren, good afternoon. We haven't changed our statistical plans in any way, so we are still going with the existing plans that we had before. We haven’t changed anything. The only thing that we are basically communicating to investors is there is a possibility of using Cohort 2 in addition to Cohort 1. We stand ready, should that be a need from the agency. We are wondering whether that might be an ask because the landscape is expected to change with a potential chemo-immunotherapy becoming frontline therapy. So we haven't changed our statistical plan in any way.

Biren Amin, Analyst

So this statistical plan was based on Cohort 1, so is Cohort 2, then, I'm sure you've made some assumptions that you need to exceed a certain level of efficacy for cohort 2 as well. And given the patient populations, PD-1 experienced, there's probably differences in terms of what your assumptions are between Cohort 1 and 2. Is that accurate?

Maria Fardis, President and CEO

I can't speak to the data view. As noted, we are blinded to both Cohort 1 and Cohort 2 data. So it's hard for me to tell you what we are seeing. I can tell you that I've commented on this before; when we read out the 27 patients before we met with the agency and blinded ourselves, we did have patients who had prior checkpoint therapy, and we had responders in that group. That was on the slides presented at ASCO. But aside from that, we're not planning on changing our statistical approach in any way. We are just making sure that we are ready should the agency request cohort 2 to be added into the BLA—that's all we're saying.

Biren Amin, Analyst

Okay. And then maybe just one question on cohort 3C in the basket study where you're combining with another agent. What's the rationale with this combination, and is this a Phase 1 design? So is there a thought that you could develop this into a pivotal cohort if you're seeing encouraging data?

Maria Fardis, President and CEO

Just to make sure we are on the same page here, are you asking about the IOV-LUN-202 program or still the cervical program?

Biren Amin, Analyst

The IOV-COM-202, the basket study, combining with another agent.

Maria Fardis, President and CEO

Sure, I'm going to ask Friedrich to comment on this.

Friedrich Finckenstein, Chief Medical Officer

Sure. One thing to mention here is that the population in this cohort is non-overlapping with the IOV-LUN-202. I think that is one rationale here: we are broadening coverage for additional populations across the non-small cell lung cancer patient population. The further rationale for combining with another agent is that with this regimen, we're exploring priming of the tumor and T-cell infiltration by administering it prior to resection. So this is different from how we are doing this in the IOV-LUN-202, for example. Here, the dosing is a single dose of the combination prior to resection, and then after resection, we are continuing the both comparably to how we are doing this in the temporal combination studies. This is exploring a priming approach—that's the rationale for this.

Biren Amin, Analyst

Great, thank you.

Operator, Operator

Our next question comes from Reni Benjamin with JMP Securities. Your question, please.

Reni Benjamin, Analyst

Hey, good afternoon, guys. Thanks for taking the questions and congrats on the progress. Maria, I'd like to get a sense of the timing of the potential filings. I think before at least I had, I was thinking about both melanoma and cervical going in very close to each other. It seems to me, just kind of based on how things could unfold that melanoma could be a 2021 type of filing and cervical, kind of based on the work that needs to be done might be more of a 2022 submission. Am I thinking about that correctly, or is there another way to think about it?

Maria Fardis, President and CEO

Hi, Reni. Good afternoon. I don't know if I can necessarily deduct that. I think it really depends on resolution of the potency assay is a matter of the FDA. Given that we have completed enrollment into the cervical program, both cohorts 1 and 2, and cohort 1 was completed, if you recall, around the third quarter of 2020, we think we have a sufficient amount of follow-up possibly just for Cohort 1. If they asked for Cohort 2, of course, we would need additional follow-up, but I don't think I can rule out submission of potential BLAs for both indications in 2021.

Reni Benjamin, Analyst

Got it. Okay. And then, of course, it makes sense to combine studies with checkpoint therapies. But is there any other work being done to evaluate other combinations outside of checkpoints in these indications?

Maria Fardis, President and CEO

Yes, that's a great question. We've actually thought about a number of different alternative combinations and different settings and lines. Typically, we look to see where we can take the TIL product into earlier lines, looking at Steve Rosenberg's data in PD1-naive patients; this is highly encouraging. It showed us that it still has potential as an earlier line of therapy, and there may be additional responders and additional CRS that one can have. The initial thinking wasn't necessarily going into combination but going into an earlier line. Now once we decide we're going to use earlier lines, typically a regulatory path is offered for the patient available care in addition to TIL. Since in most of the diseases we are in, available care in frontline typically happens to be checkpoint inhibitors, we are combining with checkpoint inhibitors. But I do want to remind you that there has been data published in combining TIL plus other agents. TKIs come to mind regarding BRAF combinations that have been published. That data appears to have been possibly additive, although many of these studies are not statistically significant in terms of the number of patients. But there appears to be an additive effect.

Reni Benjamin, Analyst

Got it. I guess one final one for me in the melanoma study—you continue to not reach the median duration. Do you have any sort of sense as to what the patients who are progressing are moving on to, and have any of them ever been retreated with TIL?

Maria Fardis, President and CEO

Yes, we do collect that information as part of our database, certainly in certain cohorts. We also do have a retreatment cohort; you might recall it's called Cohort 3 in our melanoma program. So they do have the opportunity to be retreated should they choose to do that. So yes.

Reni Benjamin, Analyst

Okay. And we haven't seen any type of cohort—we haven't seen any data from those patients, or is there any sort of an update that we have from that cohort?

Maria Fardis, President and CEO

Yes, we haven't presented data from that cohort. Typically, we want to have a sufficient number of patients before we can present the data and have long enough follow-up. But yes, that Cohort 3 allows for retreatment of patients that may be coming from Cohorts 1, 2 and 4.

Operator, Operator

Our next question comes from Mara Goldstein with Mizuho. Please go ahead.

Mara Goldstein, Analyst

Hey, great. Thanks for taking the question. I think this kind of dovetails on the last question about earlier lines of therapy. In the non-small cell lung cancer study, the inclusion criteria really just specify that patients have a single line of systemic therapy that includes checkpoint and chemo. I'm just curious as to—is that your anticipation that you will essentially be looking at second-line patients, or are you taking patients who've had more than one prior line of therapy?

Maria Fardis, President and CEO

So, Mara, in the IOV-COM-202 study where chemo-immunotherapy is defined as prior line, we are asking patients to be second line. Does that answer your question?

Mara Goldstein, Analyst

Yes, no, I appreciate that. Thank you.

Operator, Operator

All right. And our last question comes from Nick Abbott with Wells Fargo. Your question please.

Nick Abbott, Analyst

Good afternoon. Thank you for taking my questions. First one, Maria, can I just confirm that the next sort of submission to the FDA on the potency assay would occur in this quarter? You said the next few weeks, so I'm not sure if that means this quarter?

Maria Fardis, President and CEO

Hi, Nick. Good afternoon. Yes, we have said that we are on track with completion of the validation work to provide the data to the agency. I have always said in the upcoming weeks, or months. So that's not an incorrect statement. Still, we are on target with our own internal activities.

Nick Abbott, Analyst

Okay. And then, in terms of the—you mentioned that you've been validating the assay. So by that, can it be concluded that you've tested all of the melanoma cohort for products without the assay? And I guess where I'm going with this is, what would be the timeline between an agreement with the FDA on the potency assay and the filing?

Maria Fardis, President and CEO

To clarify, the validation we’re talking about does not apply to our frontrunner assay; that assay had been validated a few years ago, and that data was provided to the agency. The clinical samples were, in fact, released based on that assay, so that work was completed. When we are talking about validation of additional assays, these are subsequent assays we are discussing with the agency. To answer the second question, yes, one would have to run the clinical samples with the validated assay and provide that to the agency. Depending on how many samples are asked, this is something that takes a few months to do. It shouldn't be a rate-limiting step or submission from the way we're thinking about it.

Nick Abbott, Analyst

So just to be clear, then you have run those clinical samples or you would be able to wait until you get agreement with the FDA that the assay is sufficient?

Maria Fardis, President and CEO

I don't know if I can disclose the details. There are ways of doing both at the same time. Not every single sample needs to be run in advance of getting some degree of agreement, but some samples can be run, and we do run them just to test the range of an assay.

Nick Abbott, Analyst

Okay. So that is, I'm sorry to belabor the point. So if we go ahead and we file in the next few weeks, then the FDA agrees. Some weeks after that, it's still possible you could file BLA before the middle of the year?

Maria Fardis, President and CEO

Without going into too much detail, because you’re right, it depends on what exactly the requests are and how clear they provide feedback. I do want to remind you that we still need to read our data by the Independent Review Committee; the clinical data still need to be read out by that committee. We have been waiting to ensure that the agency is comfortable with our approach and then read the clinical data by that committee.

Nick Abbott, Analyst

Okay. And then, just it's intriguing that you might be able to combine cervical data, Cohort 1 with, not just Cohort 2; melanoma, potentially. But am I right in assuming that the only Cohort 1, the breakthrough therapy designation only applies to Cohort 1? How do you combine submissions that have part of it being a breakthrough therapy and part of it not?

Maria Fardis, President and CEO

Really great question. Breakthrough therapy generally is a designation; it doesn't dictate your label. There's no direct correlation of whatever it is you receive breakthrough therapy has to be exactly your label. All it says is that the agency recognizes that this particular therapy for this patient population is an unmet need and they are willing to work with the sponsor to expedite the development program.

Operator, Operator

Thank you. And there are no further questions. I would like to turn the call back to Maria Fardis for your final remarks.

Maria Fardis, President and CEO

Thank you again for joining the Iovance fourth quarter and full year 2020 results conference call. Please feel free to reach out to our IR team if you wish to follow up. Have a great rest of the day.

Operator, Operator

And ladies and gentlemen, thank you for participating in today's program. You may now disconnect.