Iovance Biotherapeutics Inc
NASDAQ:IOVA
If you don’t study any companies, you have the same success buying stocks as you do in a poker game if you bet without looking at your cards.
Utilize notes to systematically review your investment decisions. By reflecting on past outcomes, you can discern effective strategies and identify those that underperformed. This continuous feedback loop enables you to adapt and refine your approach, optimizing for future success.
Each note serves as a learning point, offering insights into your decision-making processes. Over time, you'll accumulate a personalized database of knowledge, enhancing your ability to make informed decisions quickly and effectively.
With a comprehensive record of your investment history at your fingertips, you can compare current opportunities against past experiences. This not only bolsters your confidence but also ensures that each decision is grounded in a well-documented rationale.
Do you really want to delete this note?
This action cannot be undone.
| 52 Week Range |
5.53
17.47
|
| Price Target |
|
We'll email you a reminder when the closing price reaches USD.
Choose the stock you wish to monitor with a price alert.
This alert will be permanently deleted.
Iovance Biotherapeutics Inc
You don't have any saved screeners yet
Welcome to the Iovance Biotherapeutics Third Quarter and Year-to-Date 2021 Financial Results. My name is Andrew, and I’ll be your operator for today’s call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. [Operator Instructions] Please note that today’s conference is being recorded.
I will now turn the call over to Sara Pellegrino, Vice President, Investor and Public Relations at Iovance. Sara, you may begin.
Thank you, operator. Good afternoon, and thank you for joining us. Speaking on today’s call, we have Fred Vogt, our Interim President and Chief Executive Officer; Igor Bilinsky, our Chief Operating Officer; Jim Ziegler, our Senior Vice President, Commercial; Dr. Friedrich Finckenstein, our Chief Medical Officer; and Jean-Marc Bellemin, our Chief Financial Officer. Dr. Madan Jagasia, our Senior Vice President, Medical Affairs; and Laurel Todd, Vice President of Policy are also on the call to participate in the Q&A session.
This afternoon, we issued a press release that can be found on our website at iovance.com, which includes the financial results for the three and nine months ended on September 30, 2021, 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 plans, pre-commercial activities, clinical trials and regulatory plans and results, potential future applications of our technologies, manufacturing capability, regulatory feedback and guidance, payer interactions, 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, I will turn the call over to Fred.
Thank you, Sara, and good afternoon, everyone. I am pleased to highlight our year-to-date progress of Iovance during today’s conference call. We have continued to advance our tumor-infiltrating lymphocyte, or TIL platform into new indications and earlier treatment settings throughout this year. For our lead TIL product candidate like lifileucel metastatic melanoma, our top priority remains our ongoing work to address FDA feedback regarding the potency assays for lifileucel to support our planned BLA submission.
We have continued ongoing work developing and validating our potency assays and have engaged in discussions with FDA during the second half of 2021. The anticipated BLA submission for lifileucel continues to be planned for the first half of 2022. We remain confident in our current guidance and timelines. Resolution of the potency assays for lifileucel is also an important next regulatory step for our cervical and non-small cell lung clinical programs.
Turning to our clinical pipeline. We now have clinical data showing the promise of TIL therapy in four different solid tumor types from first line to late-stage treatment settings, furthering our confidence until it’s a broad platform that may shift the treatment paradigm for patients with cancer. We continue to be excited about three key initiatives that have the potential to meaningfully impact patients while creating shareholder value.
First, lifileucel and post anti-PD-1 melanoma continues to show increasing long-term durability following onetime treatment, as demonstrated in our ASCO 2021 presentation where we showed median duration of response was not reached at 33 months of median study follow-up. Second, we continue to build on the potential for the combination of TIL with pembrolizumab, which supports our strategy to broaden access to TIL therapy for more patients in earlier treatment settings. We’re excited about presenting combination data and several advanced cancers at the upcoming SITC Annual Meeting.
As noted in this afternoon’s press release, the FDA granted Fast Track designation for lifileucel in combination with pemrolizumab for the treatment of metastatic melanoma based on the unmet medical need of potential advantages for this combination over available care. This Fast Track designation allows for potential accelerated approval and priority review as well as more frequent interactions with FDA.
Finally, our initial clinical data in metastatic non-small cell lung cancer demonstrated a 21.4% overall response rate in heavily pretreated patients, all of whom have progressed on prior immune checkpoint inhibitor therapy. This population represents a significant unmet need in non-small cell lung cancer. We provided a top line corporate announcement of the initial data earlier in the second quarter and look forward to presenting these data to a physician audience for the first time during the upcoming SITC meeting.
On the research side, we are bringing the next generation of TIL products and supportive therapies in the clinic. We are advancing a TIL product that is genetically modified to inactivate PD-1, which we have designated IOV-4001 as well as our novel IL-2 analog, IOV-3001. Both IOV-4001 and 3001 are progressing through IND-enabling studies and are moving towards the clinic.
In summary, we continue to execute all development, manufacturing and pre-commercial activities and furthering our commitment to address the critical needs of patients with cancer in multiple solid tumor cancers and treatment settings. I’m confident in the quality of our senior leadership as well as our full internal organization to deliver towards this mission. Today, we have more than 300 employees who on average have more than 3.5 years of cell therapy experience.
Members of our executive leadership team will now provide updates for the respective departments, beginning with our Chief Operating Officer, Igor Bilinsky.
Thank you, Fred. I’m pleased to speak today about our new manufacturing facility, the Iovance Cell Therapy Center, or iCTC, at the Navy Yard, Philadelphia. The iCTC is 136,000 square foot state-of-the-art LEED Gold Certified cell therapy manufacturing facility. In the third quarter at iCTC, we initiated manufacturing of investigational TIL therapies for patients enrolled in Iovance clinical trials, followed by an official opening ceremony at the end of September.
To date, more than 500 patients have received Iovance TIL with a continued manufacturing success rate above 90%. Iovance has transformed TIL manufacturing from a lengthy single-center academic process to a shorter scalable centralized GMP process. That yields a cryopreserved product for shipment back to clinical sites where the patients are treated.
Our current Gen 2 process is 22 days. We are also continuing to advance our TIL leadership position through our ongoing clinical studies to investigate a 16-day third-generation or Gen 3 process. Gen 3 may further improve Iovance TIL manufacturing efficiencies and deliver Iovance TIL to patients even sooner. We also believe that 16 days for TIL manufacturing is the fastest in the industry at this time.
In addition to commencing clinical manufacturing to supply investigational Iovance TIL therapies to patients with cancer enrolled in our clinical trials, we are advancing commercial manufacturing readiness activities for Iovance TIL at iCTC. Commercial supply remains on track for 2022 pending regulatory approval with ultimate capacity to meet the demand for up to thousands of patients in multiple indications.
Support of Iovance TIL manufacturing capabilities on the pipeline, we have been sharply focused on building our robust and growing intellectual property, or IP portfolio. Today, we have more than 30 granted and allowed U.S. and international patents and more than 700 patents and patent applications filed globally across major pharmaceutical markets and other key geographies.
In the past quarter, expansion to patent portfolio includes two new patents covering TIL compositions, repairs from tumor digest and methods of creating HPV – treating HPV positive cancers, including cervical and head and neck cancers. We believe that our internal manufacturing and IP position have firmly established our leadership in developing and delivering TIL therapies for unmet need patient populations with cancer.
I would now like to hand the call to Jim Ziegler, our Senior Vice President, Commercial, to highlight our commercial launch preparations. Jim?
Thanks, Igor. Throughout this year, including earlier this quarter at our ribbon-cutting event, we have been fortunate to meet several key opinion leaders, investigators, patients and family members who all understand the challenges of metastatic melanoma. The opportunities to hear their stories reinforce our commitment and our sense of urgency to bring lifileucel to market.
At Iovance, we have a mission to be the global leader in innovating, developing and delivering TIL cell therapy for patients with cancer. This is an obligation we all take personally. Our commercial team remains focused on customer and patient centricity to ensure a positive experience with lifileucel in three areas of operational excellence. First, we continue to enhance our partnership with the leading U.S. cancer centers to build their Iovance TIL service line capabilities. We are pleased with the partnership and engagement with these centers around a shared goal to ensure timely, appropriate access to lifileucel upon approval.
Our customer-centric onboarding program includes a training curriculum that ensures cross-disciplinary teams at each authorized treatment center can administer the lifileucel treatment regimen upon FDA approval. The planned timing and execution of key onboarding and training is also aligned to our BLA submission to ensure just-in-time training and readiness. Second, our market access team continues to engage commercial, Medicare and Medicaid payers to ensure patients have appropriate and timely access to lifileucel. We believe payers appreciate the unmet need and the clinical value of lifileucel.
And third, the development of IovanceCares, our own cell ordering and patient support platform, is on track for launch. IovanceCares is designed to be customer-centric in planning and coordinating patient care throughout the lifileucel journey. We have incorporated customer feedback in the design of IovanceCares throughout the process. The platform includes our proprietary chain of identity and chain of custody system, our fully integrated patient management approach and our integrated approach to quality. IovanceCares is patient-centric with dedicated Iovance case managers to handle the needs of HCPs and patients. The case managers will also provide reimbursement support for sites and patients at every step of the journey.
Demonstrating operational excellence across these three areas is expected to ensure patients have timely access to lifileucel upon approval. With the gated approach to commercial readiness, the commercial organization is well positioned to scale our efforts based upon internal milestones and time lines.
I will now pass the call to Friedrich to highlight our upcoming clinical presentations.
Thank you, Jim. I’m pleased to highlight upcoming clinical data updates as well as the status of our four ongoing clinical studies. Our drug development strategy focuses on cancer populations with high unmet need with substantial opportunity for TIL to make a meaningful impact. Since we have upcoming presentations as well as a conference call and webcast regarding the same, I will briefly touch upon the highlights.
As Fred mentioned, we are excited about the combination of TIL with pembrolizumab as an approach for earlier line treatment setting, primary resistance to immune checkpoint inhibitors is frequently observed in multiple tumor types. There’s a need to increase overall response rate and deepen responses with more complete responses in anti-PD-1 naïve patients. Previous results presented in head and neck cancer and melanoma patients demonstrated overall response rates that are significantly higher than pembrolizumab alone in patients who are naïve to immune checkpoint inhibitors.
Moving to our non-small cell lung cancer program, SITC will be the first medical meeting for us to share clinical data for our TIL therapy LN-145 in patients with metastatic non-small cell lung cancer who enrolled in Cohort 3B of the ongoing basket study, IOV-COM-202. As a reminder, Cohort 3B enrolled 28 patients that have progressed on prior immune checkpoint inhibitor therapy.
This was a heavily pretreated population for which there is a significant unmet need to increase response rate and prolonged survival. As previously reported in our top line corporate announcement, we were very pleased to see an overall response rate of 21.4%, and we look forward to providing additional details at SITC.
Turning to our ongoing clinical studies. We have four active clinical studies with Iovance TIL as follows: in our IOV-LUN-202 study in second-line lung cancer, which has more than 20 access sites in the U.S. and Canada; in our IOV-COM-202 basket study of Iovance TIL and TIL plus immune checkpoint inhibitor combinations, we have completed enrollment in the relapsed/refractory non-small cell lung cancer and head and neck cohorts. Recruitment continues in melanoma and with TIL combinations in non-small cell lung cancer.
In our C-145-04 clinical study in advanced cervical cancer, we continue to recruit a cohort of patients not previously treated with systemic therapy or anti-PD-1 to receive Iovance TIL plus pembrolizumab. We are also actively enrolling in our IOV-CLL-01 study in CLL, SLL patients, which is our first hematologic indication.
I will now hand the call over to Jean-Marc to discuss our third quarter 2021 financial results.
Thank you, Friedrich. My comments will reflect the high-level financial results for the third quarter and year-to-date 2021. Additional details can be found in this afternoon’s press release as well as in our SEC filings.
I will begin with our cash position. As of September 30, 2021, Iovance held $660.8 million in cash, cash equivalents, investments and restricted cash compared to $635 million on December 31, 2020. Our strong cash position is expected to be sufficient well into 2023 to advance our operating plan, including pipeline development, commercial manufacturing readiness and launch preparation with no immediate need to raise dilutive capital.
Moving on to the income statement. Our net loss for the third quarter ended September 30, 2021, was $86.1 million or $0.55 per share compared to a net loss of $58.6 million of $0.40 per share for the third quarter ended September 30, 2020. Net loss for the nine months ended September 30, 2021, was $242.9 million or $1.60 per share compared to a net loss of $191.2 million or $1.41 per share for the same period ended September 30, 2020.
Research and development expenses were $65.4 million for the third quarter ended September 30, 2021, an increase of $22.3 million compared to $43.1 million for the third quarter ended September 30, 2020. Research and development expenses were $183.4 million for the nine months ended September 30, 2021, an increase of $34.1 million compared to $149.3 million for the same period ended September 30, 2020.
The increase in research and development expenses in the third quarter 2021 over the prior year period was primarily attributable to an increase in cost associated with growth of the internal research and development team and increase in clinical trial costs and iCTC facility-related costs. The increasing research and development expenses in the first nine months of 2021 over the prior year period was primarily attributable to growth of the internal research and development team and an increase in iCTC facility-related costs. Following completion of the iCTC, we have concluded our initial $85 million investment in constructing the facility.
General and administrative expenses were $20.9 million for the third quarter ended September 30, 2021, an increase of $5 million compared to $15.9 million for the third quarter ended September 30, 2020. General and administrative expenses were $59.8 million for the nine months ended September 30, 2021, an increase of $15.7 million compared to $44.1 million for the same period ended September 30, 2020. The increase in general and administrative expenses in the third quarter and first nine months of 2021 compared to the prior year periods were primarily attributable to growth of the internal general and administrative team and higher stock-based compensation expenses.
As of September 30, 2021, there were approximately 156.7 million common shares outstanding. We continue to focus on investment in four key areas, as outlined previously, to ensure the growth and trends of our value creation. This advancement and the expansion of our clinical pipeline, launch readiness, a strong cash position and manufacturing at iCTC, which will provide new cost efficiencies as we are able to shift work currently being done through contract manufacturers to iCTC. I remain confident that by managing our investment across these priorities, we will continue to stay focused and align our spending with our corporate priorities.
I will now hand the call back to the operator to kick off the Q&A session.
Thank you. [Operator Instructions] Our first question comes from the line of Mara Goldstein with Mizuho.
Thanks very much for taking the question. So I just wanted to go back for a second to the question of the discussion with FDA, and I respect that there’s very little that you can say about it. But the press release makes reference to still being able to come up with a solution that will satisfy the agency. And so I’m wondering if you can maybe share with us where you are in the process in terms of the discussion level with them?
The original plan had been that you had some assays already on hand and that you also were pursuing a development track for new assays and would present those to the agencies. So maybe because we’re just about anniversarying this, maybe you can kind of walk us through exactly where things are at?
Sure, Mara. That was the plan as we discussed back in June, and that’s still the plan. We’re just – right now, we’re in the middle half when we’re having this communication with the FDA in those regulatory discussions.
Sorry, I didn’t mean to interrupt. I was going to say, is it fair to characterize that you’re still in the back and forth with the agency?
Yes, you could call – I mean, we would describe it as engagement, but yes, we’re in discussion with the FDA in kind of having that kind of level with them. And again, the anticipated BLA filing time line is still first half at this point.
Okay. And I know I appreciate the discussion around the activities as company is undertaking in advance of being able to submit and I’m speaking from a commercial perspective. But relative to the capital that the company raised ahead of being able to – ahead of launching and where you are now, I’m just curious about how much capital is being deployed while you are waiting that you would have otherwise not spent?
Well, we’re continuing to run our research and development program as we would normally have spent it. So we have all the clinical assets still progressing. We’re just running this in parallel. So I wouldn’t characterize it that way. I would basically say we’re continuing the development of the TIL platform as we intended. And at the same time, we’re working with FDA on moving forward on the potency assay situation, which is something that we think is a gating item across the TIL platform right now.
Okay. I really appreciate. I’ll pause and let others ask questions.
Thank you, Mara.
Thank you. And our next question comes from the line of Michael Yee with Jefferies.
Thanks and appreciate the question. My question is, if you feel that you can reiterate the filing guidance today, what are you specifically waiting for? Is it an official sign off on the assay? Is it meeting minutes? Do you have a good sense of what actually is going to be measured? Can you just give us a sense of the fact that you feel very good about that, and perhaps you’re just waiting for media minutes? I guess that’s question one. And then question two is, would you press release, this announcement, tell us what would happen and what would need to then happen after that to actually file? Thank you.
Sure. Thanks, Michael. Well, let me take them in reverse order. On the press release, we would – when we – material informations available to us, for example, responses from the FDA that are clear that we could put a press release out on the basis of, I think we would try to do that. We would very much like to update the market as soon as we can about the situation with FDA and our potency assays, of course.
Turning to your first question, it’s a very detailed long engagement that we’re in – it’s a six-month process here, and it could go beyond that, of course, into 2022. We never said we might have continuing stuff to TIL over in the early 2022 as we sort this out. But nevertheless, in the sort of the blow-by-blow of things with the FDA, yes, there are things like minutes. Yes, there are responses from the FDA and that sort of thing. We’re not particularly waiting on anything right now. We’ll update when we can based on the disclosures that we have available to us at the time.
Thank you.
Our next question comes from the line of Mark Breidenbach with Oppenheimer.
Hey, guys. It’s Matt on for Mark. Thanks for the question. Apologies if this has been asked before, but I’m just trying to think of worst-case scenarios here on the potency assay and pass. Have we ruled out FDA asking you for a randomized trial in order to support initial approval? Is that something that’s been discussed or is that completely out of the question in your view? Thanks.
Yes. Thanks. While we can never say what FDA truly might want at the end. Right now, FDA is not asking for that. So the way we’ve been treating this entire interaction with FDA is on the basis that we would be able to use the Cohort 4 pivotal study data that we’ve already generated.
Thanks.
Thank you. And our next question comes from the line of Asthika Goonewardene with Truist Securities.
Hi. This is Bill on for Asthika. We just had a couple of questions. We heard from some comments from another TIL company that the FDA has accepted their proposed potency assays, and we’re wondering if the FDA has given you any guidance as to what components of their assays were viewed favorably or any suggestions? And how does what you have in development compared to that in case you do have any guidance?
Yes. Good question. Yes, there’s been some comments by a competitor about this regarding a pre-IND meeting, and I believe a pre-IND meeting and then definitely an IND. At that stage of development, things are much, much more lightweight in terms of what you have with FDA. We’ve been engaged with the FDA for a long time on these things, and we’ve got a lot of detail from them about this.
We don’t really think there’s crossover between the two. FDA is not really supposed to tell you what other sponsors are doing anyway. But we think our assay technology, the most recent assay technology that we’ve developed does answer the question of how does potency of TIL therapy consistent with the mechanism of action of that therapy.
Great. Thanks. And I guess just one more on the LUN-202 study. Would you be able to contrast both the enrollment rate and the number of patients you have recruited so far based on PD-L1 expression level, so below 1% and above 1% to 49% in two cohorts?
Friedrich, do you want to answer that one?
Sure. This is Friedrich. Yes, thanks for the question. I don’t think that at this time we would be commenting on the number of enrolled patients. Remember, the study is designed to enroll patients who have failed one line of prior chemo immunotherapy combination in two different cohorts, Cohort 1 and Cohort 2. I would expect since the available care for these patients is similar that the distribution across the two cohorts would be reflective of the distribution of the PD-L1 status in the population, which you can assume is about one-third and two-third. But again, I don’t think that we’re going to comment on the exact enrollment number or distribution at this time.
Thanks.
Thank you. And our next question comes from the line of Madhu Kumar with Goldman Sachs.
Yes, thanks for taking our question. So as we think about kind of the potency assay situation, to what extent is this kind of a process of negotiation of kind of like sorting out your views on what are kind of relevant potency assays versus kind of their regulators take as compared to kind of just really testing hypotheses and really kind of sorting out what is a real metric of TIL cell potency?
I think it includes both of those components, Madhu. It’s a discussion about the mechanism of action of TILs and how potency assays can reflect that and then specifically how assays that we’ve developed work, and how they assess, we think accurately the potency of TIL therapy. FDA has issued guidance in 2011 on this, as you guys know, and a lot of the details of that guidance is wrapped up in these sort of discussions. We are at a pretty advanced state, in the sense that we’ve got these methods, and we’ve got data and we’ve got things we can talk about with FDA. So a lot of that’s part of the discussion as well.
Okay. And then how much lead time do you think you would need to actually get resolution of the potency assay before you could feel confident maintaining this first half 2022 guidance? Like if it’s March of next year and you guys haven’t reached resolution, would that be kind of like what’s the bond in which you would try to push back the timing potentially of BLA from first half 2022?
We don’t know exactly. We are able because a lot of the things we’re doing right now are enabling us to file a BLA to sort of do two things at once. We can engage with FDA on the potency assay and prepare everything for the BLA. At some point, obviously, that could slip, but it’s not something that I would worry about, at least not initially in the half of next year.
Okay, great. Thank you.
Thank you. And our next question comes from the line of Colleen Kusy with Baird.
Great. Thanks so much for taking my questions. So is it fair to assume that the third more novel potency assay is really the lead at this point that you’re discussing with the FDA? And when might we get more information on what that is?
Yes. Colleen, we haven’t disclosed the detail yet, although, obviously, when we talk about the potency assays, we talk often about the most recent assay or set of assay technologies that we’ve developed. I really can’t say what the lead is at this point. We’re – the new assay technology is something that we think is the right answer to FDA’s questions alone or perhaps in combination with other assessments that we’re already making.
I don’t know when we can disclose it. Remember that all these discussions are in confidence with FDA and the technology itself is proprietary. So immediately, we won’t be able to disclose it. I hope that we can disclose it sometime in the near to mid-future. And then certainly, we would want to put it out there so that we are more aware of how it works.
Great. Thanks. And then one more quick one on the upcoming presentation at SITC, just what tumor types will be included in that frontline pembro combo?
We haven’t disclosed that yet. The abstracts were under embargo right now. So that will – that should be available on November 9 in the morning. When the abstracts come out, you’ll be able to see more about that.
Great. Thank you.
Thank you. And our next question comes from the line of Ben Burnett with Stifel.
Hi this is Kailie Briza, on for Ben Burnett. Thanks for taking our questions. I just had one quick one. We were just wondering if you could give us any guidance or any details about when we might see some data for TIL using the Gen 3 manufacturing process for any of the indications that it’s been exploring? Thank you.
That’s something we’re looking at as soon as we can. Right now, I can’t say anything about that, but stay tuned on that. We are interested in trying to get that data out when we have something meaningful to report.
Okay. Thank you so much.
Thank you. And our next question comes from the line of Nick Abbott with Wells Fargo. Pardon me, Nick. Please check your mute button.
Sorry about that. Yes, thank you. Can you talk about the ongoing patient assessment for melanoma Cohort 2, and specifically will patients be called in for last stand to ensure inclusion of contemporary data with the BLA? And how does the timing for collection of that clinical data relate to resolution of this potency issue, given that we often hear it takes three months to read and clean clinical data through – under central review?
Yes. Nick, I think you’re referring to Cohort 4, right?
Oh, sorry. The melanoma BLA cohort. Yes, apologies.
Friedrich, could you answer that one please?
I completely unheard the question. Can you repeat that?
Yes, sure. So it’s about the ongoing patient assessment, efficacy assessment in melanoma Cohort 4. And specifically, will patients be called in for a last scan to ensure inclusion of contemporary data in the BLA? And how does the timing for collection of clinical data relate to resolution of potency given that we often hear it takes three months to read and clean data through central review?
Yes. Understood. Thanks. Yes. So this is going a little bit into the inner workings of preparing a data cut for a single arm response rate endpoint trial. We would not call patients in specifically for an assessment. This is not an overall survival trial where oftentimes you do an overall survival call as you’re getting closer to the data cut.
We are continuing to assess patients that are ongoing in the predefined assessment schedule for the CT scans. And then we’re defining a data cutoff date and everything up to that data cutoff date would be included in the analysis. And you usually choose that data cutoff date to allow for a sufficient time that then would allow you to clean the data prior to what we call the database lock. And that is still about two to three months’ time frame that you mentioned that can be shorter, it can be longer depending on what you think you need.
So that can be done without calling patients in specifically for an assessment, which would probably not be appropriate, because it would be asking for additional scans more frequently than predefined and what they agreed to in their content. Does that answer your question?
Yes, it does. And then I guess the question is then the timing of that, defining the cutoff date versus where you are in the potency issue – resolution of potency issue. Something has to be rate limiting. I guess you don’t want the clinical data to be rate limiting.
Yes, although – they can run in parallel to some extent, because we could be doing the IRC work while we’re resolving the potency assay issue and then sort of at the end of that process, as we’ve discussed on a lot of our calls, then go back and revisit the full analysis set. I suppose we get the information in hand.
Okay. Great. Thank you.
Thank you. [Operator Instructions] Our next question comes from the line of Peter Lawson with Barclays.
Great. Thanks for taking my questions. Just on the potency assay. Just I guess how many potency assays do you think you need? And do you have – and then what – how many of those do you think you could essentially have patent protection around that great – could preclude other users?
Yes. Good question, Peter. We have a lot. I don’t have an actual final number on them, because there are so many variations. It’s really a rather complicated environment. But we’ve shown multiple assays to the FDA and as most of you know, we’re on our third assay or set of assays that we’re showing them right now. Some of them, like the newer ones, do have IP associated with them that might create some barriers to entry for others, which we think is valuable. Others are more generic assays that have been out there for a while that may not provide as much protection, if you know what I mean.
Got you. And then you talked about three sets of assays, is this refinement as you go from Step 1 to Step 2 to Step 3? Or they’ve kind of reject all of them in Step 1, and you’ve had to kind of come back with Step 2 and then Step 3? How did that work?
Yes. I wouldn’t treat them as refinement. Some of them are completely new approaches, and that – one of the ones that we’re most focused on right now is what we were just talking about earlier with the question were really new technologies or new ways of looking at how TILs works, how the mechanism of action TIL can be reflected in no potency assay. So that’s more of the – I wouldn’t treat the misalignment at all really when you’re doing something like that. There are some of the earlier assays might be viewed as sort of variations of each other, but the new stuff that we’re doing is really fundamentally no.
Got you. And you feel kind of each step is kind of getting you closer with the FDA or has it accelerated recently? Or any kind of sense of speed of progress would be great?
So we feel like we’re making progress, and it’s good enough that we can continue to guide towards the first half of 2022 BLA filing, which is coming up fairly soon here. So we’re comfortable with where we are right now with FDA. There’s work to be done, and we’re still working. That’s – as things stand today, we’re standing by that guidance.
Great. Thanks so much. Thanks for the details.
Thank you. And I’m showing no further questions. So with that, I’ll turn the call back over to Fred for any closing remarks.
Thank you, again for joining the Iovance Biotherapeutics third quarter 2021 financial results conference call. I’d like to thank our investors, analysts, patients, collaborators and employees for their support. Please feel free to reach out to our Investor Relations team, if you wish to follow up. Thanks, everyone.
This concludes today’s meeting. Thank you for participating, and you may now disconnect.