Good day. Thank you for standing by. Welcome to the Iovance Corporate Update Call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one one on your telephone. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Sara Pellegrino, Senior Vice President of Investor Relations and Corporate Communications. Please go ahead. Thank you, Operator. Good morning, and thank you for joining our conference call to discuss the ongoing Biologic License Application or BLA submission for lifileucel, our lead cell therapy for patients with advanced melanoma. Earlier this morning, we issued a press release about the BLA submission that can also be found on our corporate website at iovance.com. On today's call, Dr. Frederick Vogt, our Interim President and Chief Executive Officer, will provide a brief introduction and summary. We will hold a question-and-answer session where several members of our executive leadership team are available to participate, Dr. Igor Bilinsky, our Chief Operating Officer, Dr. Raj K. Puri, our Executive Vice President, Regulatory Strategy and Translational Medicine, Jim Ziegler, our Executive Vice President, Commercial, Jean-Marc Bellemin, our Chief Financial Officer, Dr. Friedrich Graf Finckenstein, our Chief Medical Officer, and Dr. Madan Jagasia, our Executive Vice President, Medical Affairs. 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 results, regulatory interactions, plans and strategies, research and pre-clinical activities, potential future applications of our technologies, manufacturing capabilities, regulatory feedback and guidance, payer interactions, licenses and collaborations, 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 statement. With that, I will turn the call over to Fred. Thank you, Sara, and good morning, everyone. We continue to make significant progress towards completing our BLA submission to the U.S. FDA and are close to the finish line. As we announced in our press release today, the FDA has requested that we provide supplemental information on assay validation and comparability data for lifileucel. The FDA's feedback is related to an amendment that we submitted in the Q3 to the ongoing Investigational New Drug, or IND application for lifileucel at the FDA's request. We expect to address this feedback with requested supplemental information promptly. Our rolling BLA submission is planned for completion in the Q1 of next year after we address this updated feedback. Addressing the FDA's feedback allows us to work towards a smooth BLA review process. I would like to emphasize that this updated feedback to the IND application is valuable and specific, and the information they're asking for is limited to supplemental assay validation and site comparability information. Regarding the rolling BLA submission, the FDA remains supportive during the process and has not requested any additional information that we had not already planned to include in the submission, including our potency assay matrix, which has already received positive feedback. We also had a successful pre-BLA meeting in July, where the FDA provided favorable feedback on the clinical efficacy data from Cohorts 2 and 4 of our C-144-01 clinical trial, including duration of follow-up, and agreed that the clinical and safety data set was sufficient for BLA review. Lifileucel, if approved, may address a significant unmet medical need for melanoma patients who progress on or after anti-PD-1 therapy, for which there are no FDA-approved treatment options. The BLA submission for lifileucel is supported by positive clinical data from the C-144-01 clinical trial in patients with advanced melanoma. The detailed data set presented at SITC last week was extremely well received by the medical community. In addition, the phase three trial of lifileucel in combination with pembrolizumab in front-line advanced melanoma, on track to begin in late 2022, is intended to serve as a confirmatory study and is expected to be well underway at the time of a potential approval. With that, I'll hand the call back to the operator to kick off the Q&A session. Thank you. As a reminder, to ask a question, you will need to press star one one on your telephone. Please stand by while we compile the Q&A roster. Our first question comes from the line of Peter Lawson with Barclays. Your line is now open. Great. Thank you so much. Thanks for taking my question. Fred, thanks for the updated guidance around the completion of the submission. Just carry us around, you know, kind of what gives you the confidence around the 1Q completion timeline? Yeah, Peter. What they're asking for is relatively straightforward, short-term work that we can do rather quickly and get it done as early as possible in the Q1. Actually, doesn't take that long to do this sort of work. Since, you know, lifileucel is a first-in-class therapy, there's some details on what FDA gave us that I think, you know, has never been seen before and is new to the space. We're learning some things as they learn some things, and we think it's just supplemental validation really that's driving the whole thing and can do that fairly quickly. Got you. You mentioned about site comparability. Yeah. Tell us please. That has to do with the validation. They're tied together, basically. The FDA would like us to complete additional validation tasks so that they can then interpret the comparability between sites. That's one of the reasons we wanna get it done before the BLA filing so that we have a very smooth process once we do complete the rolling BLA submission. Thank you. Just a final question, and I know other people have got questions, but the potency assay, you already kind of got a sign-off from that. Any additional assay validation we should consider as almost minor additional data. I think that's a good way of saying it, Peter, yeah. It is, I think, relatively minor. The big picture is we think we're aligned with FDA. Actually, Raj Puri's on the call. Maybe Raj, you wanna add a little bit to my answer there for Peter? Yeah. FDA has already accepted the potency assay, the principles, and the mechanism of action. Basically we're just trying to do some validation of the assay in a specific way that the FDA would like to do. We are, you know, as Seth said, Peter, we're gonna continue to work on this, and should be done in the next two weeks, so we can go back and submit the amendment. Perfect. Thanks so much. Thanks for the time. Yeah, thanks, Peter. Thank you. Our next question comes from the line of Michael Yee with Jefferies. Your line is now open. Hi. Thanks. This is Yige Guo on for Michael Yee. Two questions. The first, what new comments did you receive on the assays? You know, given positive feedback originally, if you could provide some additional clarity on that would be really helpful. Second question, by comparability information, do you mean a validation that the product is comparable between CMO sites and iCTC? Could you clarify that, please? Thank you. Yeah. The new information they're looking for is best described as supplemental validation information. They, like Raj said, they want some specific things as part of the validation of some of the assay information we submitted, and that's pretty much all I can say. It's very technical in nature. As the first product of this class coming through, the way that we're validating it is kind of commercially sensitive as well. We really can't say a whole lot more, not that anybody would be able to understand it, given the level of complexity associated with it. It is routine and straightforward to do, and we can get this done in a very short period of time. On the comparability, we're just talking about comparability between manufacturing sites, and that is dependent on the assays, so that can be interpreted. You can think about it as the sites that we have involved in our network during the studies, as well as in the future. Got it. Thank you. Thank you. Our next question comes from the line of Madhu Kumar with Goldman Sachs. Your line is now open. Yeah, thanks for taking our questions. I guess kind of one follow-up here on the confirmatory study. You mentioned that you plan to have it well underway by the time of a potential approval. I guess kind of has the FDA given you explicit guidance as to what well underway means? If not, like, how does the team interpret what a well underway confirmatory study means? Yeah, Madhu, they don't give a definition of well underway. What they have done that's been very comforting to us is they seem to be very comfortable with our timelines for the study. In fact, we've gotten good feedback from them that we're on time and on track in that area. We know that we're not late for this, and we know that we're not gonna be one of these dog houses that they seem to be talking about right now for some of the other sponsors. They don't really tell you, though, exactly what that means. I don't know if you saw, but Kala from Richard Pazdur were out, I think it was yesterday, the day before, out speaking, and they've talked about just enrolling at the time of, you know, the study was enrolling at the time of accelerated approval. You know, that's one bit of guidance I've heard from them. With us, it's been very positive that we will have this with whatever they consider well underway to mean, we'll have that achieved at the time of approval. Okay, thank you. Thank you. Our next question comes from the line of Colleen Kusy with Baird. Your line is now open. Great. Thanks. Good morning, and thanks for taking our questions. Can you clarify if the group or division that you had previously received favorable feedback on the assay from is the same team that is now requesting additional data, or has this moved to some sort of different group at the FDA? Do you feel that the FDA cell therapy group will be satisfied with this last validation, or do you think there's still consensus building that needs to happen to get this over the goal line? It is, as far as I understand, the same group. There's many members of that group, and Raj actually could probably help with this answer a little bit. Maybe, Raj, did you wanna take the second part of that as well? Yeah. Colleen, good morning. Yes, it's the same group of reviewers. You know, the division has X number of people, so they don't have different various groups to review. I think as reviewers who have the history of this file, they continue to review till the end of the BLA. That's the answer to your question number one. Number two, when you were asking about. I missed that part, Colleen. Could you please state? Yeah, just I guess, how confident are you that this last validation will, you know, be sufficient to build consensus among the group? Do you think there's kind of further consensus building that needs to happen to get everybody comfortable with getting this over the goal line? No, I think they are very kind. They're very specific asking what something for the validation. As you know, that we can do validation in various different ways. We did that one way, and FDA wants it a different way. We can do that in the next only few weeks. We'll be done with that, and we'll send it back to the agency and also complete our submission. Great. Thanks for taking our questions. Thank you. Our next question comes from the line of Tyler Van Buren with Cowen. Your line is now open. Hey, guys. Good morning. Thanks for taking the question. Regarding the short-term work and validation, I guess, just to be clear, does this include more potency assay runs? Are you redoing this with samples that have already been analyzed, or are these samples that have not yet been analyzed? If so, is it related to Cohort 4 samples or Cohort 2 samples or both? No, it's just the validation, Tyler. It doesn't involve the samples. Okay, that's clear. What do you think caused the FDA, I guess, to change their stance on this validation or to ask you to do it a different way? I think fundamentally it's a new product. Everything's new about it. We're breaking new ground, and there's just alignment that needs to be gained. You know, the only precedent we have is really the CAR-T products, and things are done a little bit differently there. We've got a novel potency assay matrix. They, you know, as we progress through this filing, they just wanna see things a certain way, and we wanna work with them on it. Okay, thank you. Thank you. Our next question comes from the line of Mark Breidenbach with Oppenheimer. Your line is open. Hey, good morning, guys. Thanks for taking the question. Maybe just a quick one for Jean-Marc, actually. I was hoping you could comment on the potential impact of the delayed filing on your operational runway. I'm curious if this affects your previous cash guidance. Thank you. Yeah, thank you, Mark. Yeah, obviously we will be mindful about expenses and the additional delay. With the additional delay also in expenses. You know, our guidance is having sufficient cash in it into 2024. Actually the fact we have some delay, we work on tidying up our expenses, but it doesn't really impact any kind of operational readiness for commercialization. Our current plan will have just to be mindful again of this additional delay that, you know, will push some of the expenses at a later stage, actually. Same guidance in term of, you know, cash burn into 2024. Okay, thanks for clarifying. Thank you. Our next question comes from the line of Reni Benjamin with JMP Securities. Your line is open. Hey, good morning, guys. Thanks for taking the questions. Fred, I think you mentioned, you know, early on in your prepared remarks that the feedback was based on an amendment that you submitted. Can you just give us a little bit of clarity as to what the amendment was? Yeah. FDA had asked us to submit some information to the IND, which is something you can do even while you have a rolling BLA in process to get their feedback when you have an RMAT designation. We did that, and they provided very helpful feedback as part of that. That came in, you know, very quickly as opposed to going through the BLA review cycle and having it come much later. It's related to. Okay. The IND amendment was related to some of this validation and the feedback is related to the validations. Okay. When we talk about the supplemental validation assays, are we saying assay or assays? Is this like multiple things that you have to address? Not to be kind of like, you know, coy about it, but what stops the FDA from coming and asking for a supplemental validation to the supplemental validation? Like when does it kind of end? Well, there's multiple assays involved in our potency matrix. While we don't wanna talk about the details, you know, there's multiple factors at play here. However, all of them are, like Raj said, fairly straightforward. We're talking weeks here in terms of timelines to get the actual work done and turned around and submitted. What's stopping them from doing a supplement to a supplement? I guess nothing. We think, as Raj mentioned, the feedback that we got this time is very, very specific, and we think we can do exactly what they say. While the regulator has authority to do whatever it wants effectively in this area, we think we're gonna have the answers that they need in this round, and this should be the end of it for sure for these guys. Got it. Just one final one, just regarding the CEO search. You know, kind of where are we in the process? You know, is the filing maybe a gating item as well for anyone who's evaluating the company? I can't say for sure whether that's a gating item. Obviously, you know, the more progress the company makes, different CEO candidates may look at it differently. Right now, the board still continues their search, and it's active, and we're looking at candidates, and unfortunately, I don't have any updates for you today beyond that. All right. Thanks, guys, and good luck going forward. Thanks. Thank you. Our next question comes from the line of Mara Goldstein with Mizuho. Your line is open. Oh, great. Thanks for taking that question. Just can you maybe just confirm for us that once this is completed, that this is the last component of the BLA that needs to be submitted to be considered complete? Mara, we're not describing the details of our rolling BLA submission. We've said that many times now. Companies typically don't tell you exactly where they are in their submission. We told you we started in August, and we'll complete now in the Q1 of 2023. I don't wanna say this is the last component, but it is obviously, just because you can see the timeline shift, it's obviously a component that is towards the tail end of everything that we're doing here. If you're asking because you're worried there might be additional stuff that's gonna delay us further, no, we don't think so. We should be able to resolve it with this and then complete the submission. Okay. All right. Thanks a lot. I appreciate it. Thank you. Our next question comes from the line of Asthika Goonewardene with Truist. Your line is open. Hi, this is Karina for Asthika. I just have a question on the amendment to the IND. Does this have anything with the Cohort 4 data? Second question is update on your search for a CEO. Thank you. No, it doesn't have anything to do with the Cohort 4 data. It has to do with validation of the assays. We got a question, I think it was Tyler or Mark that asked me the question. You know, it doesn't require retesting or repeating sample work or anything like that. As I mentioned before in the CEO search, the board is actively looking for a CEO, and that work continues. Thank you. Thanks. Thank you. Our next question comes from the line of Joseph Catanzaro with Piper Sandler. Your line is now open. Hey, great. Thanks, guys, for taking my question. Maybe, Fred, you actually just answered this, but maybe not. I'm wondering with regards to comparability, whether there are any implications to how the clinical data are interpreted from study C-144, or is it more so related to sort of commercial product and being able to tie back your clinical data ultimately with the commercial product that you'll generate? Thanks. I think it's more the latter, Joe. Manufacturing site comparability is something you need to demonstrate that you've generated equivalent product at two different sites, whether they be two different clinical sites or two different manufacturing sites for the commercial marketplace. Ultimately, the latter is what really matters for us, and it's the most important. Really what it is, the way to think of the site comparability is if the validation works out as we expect, the site comparability will follow. The two are tied together in that manner. Okay. Got it. Thanks for taking the question. Thank you. Our next question comes from the line of Benjamin Burnett with Stifel. Your line is now open. Hey, thank you very much. Question about the potential, I guess, real commercial implications of this. Does this change the number of assays that would need to be done to release the product? Does this, in your view, change the release time? No, it doesn't, Ben. The matrix and the assays are already sort of on a timeline. It's already been developed. This is really, this is part of good manufacturing practice with GMP, a validation of how the assays, you know, are demonstrated to perform accurately and linearly and reproducibly across different conditions. Understood. Okay. Thank you. Not a change to the assay. Don't think of that as a change to the assay or assays. Got it. Okay. Thank you. Our next question comes from the line of Kelsey Goodwin with Guggenheim Partners. Your line's now open. Hey, thanks for taking my question. I guess maybe just to confirm one from the prepared remarks, did you say that this was data that you had already prepared or were preparing and planning to submit anyway, or it was additional data that they asked for? Secondly, I guess in terms of the variability and how the FDA sees it, I guess how do you kind of anticipate, you know, the specs once approved? Are they going to be narrower than what you used in the clinic and maybe implications there? Thanks so much. Kelsey, there is some additional data that we need to generate as part of this because it's a validation. It involves laboratory steps. As Raj kind of mentioned earlier, it's not a very long endeavor. It only takes a little bit, but there is some additional work that needs to be done. We don't really anticipate any impact on the release specifications coming from this. Okay, great. Thanks so much. Thank you. This concludes the question and answer session. I'd now like to hand the conference back over to Frederick Vogt for closing remarks. Okay. Thank you again for joining our update call. We are confident that we're close to completion of a rolling BLA submission in the Q1 of next year, and we look forward to advancing closer to potential approval. Please follow up with our Investor Relations team if you have questions or would like to talk. Thanks. Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.