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spk07: Welcome to the Iovance Biotherapeutics second quarter 2021 financial results. My name is Josh, and I will 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. During the question and answer session, if you have a question, please press star, then the one on your touchstone telephone. Please note that this conference is being recorded. I will now turn the call over to Sarah Pellegrino, Vice President, Investor and Public Relations at Iovance. Sarah, you may begin.
spk00: 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 Belinsky, our Chief Operating Officer, Jim Ziegler, our Senior Vice President Commercial, Dr. Frederick Finkenstein, our Chief Medical Officer, and Jean-Marc Bellemeyne, our Chief Financial Officer. Dr. Madan Jagacia, our Senior Vice President of Medical Affairs, is also on the call to participate in the question and answer 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 six months ended on June 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 capabilities, regulatory feedback and guidance, payer interactions, 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 statements. With that, I will turn the call over to Fred.
spk16: Thank you, Sarah, and good afternoon, everyone. I'm pleased to highlight our progress in the second quarter and first half of 2021 at I-Advance during today's conference call. During this year, we have continued to advance our tumor infiltrating lymphocyte, or TIL, pipeline. We've reported clinical data across our metastatic melanoma program, including our first clinical data in early-line melanoma, as well as in new indications, such as metastatic non-small-cell lung cancer. For our lead TIL product candidate, life-loose-soul metastatic melanoma, Our top priority remains our ongoing work to address FDA feedback regarding the potency assays for lipoleucine to support our planned BLA submission. We are confident in our ability to address FDA feedback and complete our work on additional assays in a timely manner. We are engaged in an ongoing dialogue with the FDA that we plan to continue through the second half of the year to support a BLA submission in the first half of 2022 as guided. Resolution of the potency assays is also an important next step towards progress in our other late-stage clinical programs. Turning to our clinical pipeline updates, we now have clinical data showing the promise of TIL therapy in four different solid tumors pipes. Across various treatment settings, furthering our confidence in TIL as a broad platform and next class of cancer treatment. Frederick will summarize the key updates in a moment, but overall, we are really excited about three key takeaways. First, our initial data in metastatic non-small cell lung cancer demonstrated a 21.4% overall response rate in a heavily pre-treated patient population, all of whom have progressed on prior immune checkpoint inhibitor or ICI therapy, which represents a significant unmet need in the patient population in non-small cell lung cancer. Next, lipoleucine-imposed anti-PD-1 melanoma continues to show increasing long-term durability. And third, the initial results for lifolucelone combination with pembrolizumab showed an 86% overall response rate, including a 43% complete response rate in anti-P1 naive melanoma patients. And it supports our broader strategy to combine i-Advanced TIL with available therapies and move into earlier treatment settings in solid tumors. On the research side, we are bringing the next generation of TIL and supporting therapies into the clinic. As we noted in today's press release, we are advancing a pill that is genetically modified to knock out PD-1, which we have designated IOV-4001, as well as our novel IL-2 analog, IOV-3001. Both IOV-4001 and IOV-3001 are progressing through IMD-enabling studies and are moving towards the clinic. In summary, we continue to execute all development, manufacturing, and pre-commercial activities in furthering our commitment to address the critical needs of cancer patients. I am very confident in the quality of our senior leadership, as well as our whole internal organization, to deliver towards this mission. Today, we have more than 270 employees who, on average, have more than three and a half years of self-therapy experience. On the call today, I would like to ask the members of our executive leadership team to provide updates for their respective departments, beginning with our Chief Operating Officer, Igor Belinsky.
spk15: Thank you, Fred. I'm pleased to speak today about the progress of iAdvanced Manufacturing, and our in-house manufacturing facility, Iovance Cell Therapy Center, or ICTC, at the Navy Yard, Philadelphia. To date, nearly 500 patients have received Iovance TIL, with a continuing manufacturing success rate above 90%. Iovance has transformed TIL manufacturing from a lengthy, single-center academic process to a shorter, scalable, centralized GMP process, yielding a cryopreserved product for shipment back to the site's where the patients are treated. Our current Gen 2 process is 22 days. We are also continuing to advance our TIL leadership position. We are already investigating in the clinic our Gen 3 process, which is 16 days, to further improve eye events TIL manufacturing efficiencies and deliver eye events TIL to patients even sooner. We believe that our Gen 3 16-day TIL manufacturing process is the fastest in the industry at this time. We are excited to be completing the commissioning of our ICTC, where all activities are proceeding as planned. As noted in today's press release, we have received IND clearance and plan to commence clinical manufacturing at ICTC in the near future to supply investigational IVAN still therapies to cancer patients enrolled in our clinical trials. In addition, we are now moving to commercial manufacturing readiness activities for IVAN still at ICTC. Commercial supply remains on track for 2022, with capacity to meet the demand for up to thousands of patients in multiple indications. To support our advanced steel manufacturing capabilities and pipeline, we have been sharply focused on building our robust and growing intellectual property or IT portfolio. Our Gen 2 IT portfolio is covered by more than 25 granted or allowed U.S. and international patents, with expected exclusivity through 2038. In total, we have more than 700 patents and patent applications filed globally across major pharmaceutical markets and other key geographies. Our events as granted patents and patent applications include compositions and methods of treatment in a broad range of cancers relating to the Gen 2 manufacturing process, Gen 3 manufacturing, selected till products, till products produced from core biopsies, stable and transient genetic modifications of till, tumor digest and fragment compositions, and methods including cryopreservation, and combinations of till with checkpoint inhibitors. We believe that our internal manufacturing and IT position have firmly established our leadership in developing and delivering till therapies for patients with cancer. I would now like to hand the call to Jim Ziegler, our SVP commercial, to highlight our commercial launch preparations. Jim?
spk11: Thanks, Igor. We continue our launch preparations with U.S. cancer centers, payers, and other key stakeholders in anticipation of our first BLA submission in the first half of 2022. Our cross-functional team is focused on operational excellence to ensure a strong launch. The commercial organization maintains our gated approach to commercial readiness, and we are well positioned to scale our efforts based upon internal milestones and timelines. Our medical affairs team continues robust KOL and clinical site engagement in preparation for commercial launch through education and scientific communication activities that are essential to building a strong foundation for launch. This team works closely with leading medical associations and partners with patient advocacy groups to increase awareness for Iovans, TIL, and Lipoleucine. In addition, we have increased scientific communication through publication in high-impact journals and presentations at leading medical meetings that Friedrich will cover in more detail. Our commercial team is steeped in oncology and cell therapy experience. We are partnering with the leading U.S. cancer centers to build their TIL service line capabilities. We are also seeing a strong level of engagement and commitment by a significant number of sites. As we approach our BLA submission, we will ramp up our training and onboarding processes so these sites are ready to treat patients upon approval. I would like to recognize our public policy and market access teams who are working to ensure timely and appropriate access for TIL cell therapy. Specifically, this week, the Centers for Medicare and Medicaid Services, or CMS, finalized its proposal to expand the existing MS-DRG-18 to include lipolucel and other cell therapies. With this significant change, we expect that our TIL centers will experience a much more stable and predictable Medicare inpatient reimbursement landscape at long. In turn, we anticipate that, Medicare patients will have timely access to life-releasing. We thank key stakeholders who supported this approach and appreciate the steps CMS has taken to improve Medicare patient access to cell therapies. We look forward to working with CMS and other key stakeholders in the future as refinements may be needed for this emerging class of therapies. In addition to CMS, we continue to engage national and regional payers to ensure patients with private insurance, will have timely and appropriate access to life for Lucille. The team also remains on track to deliver Iovance Cares at launch, which includes our proprietary chain of identity and chain of custody system, our fully integrated patient management approach, and our integrated approach to quality. Our Iovance Cares cell ordering platform and patient support programs reinforce our commitment to customer and patient centricity, which means understanding, anticipating, and addressing their needs. I will now pass the call to Friedrich to outline our clinical updates.
spk09: Thank you, Jim. I am pleased to highlight recent 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 opportunities for Jill to make a meaningful impact. Since we have held recent conference calls to focus on the ASCO data and the non-small cell lung cancer data, I will briefly recap the highlights. First, as Fred mentioned, our clinical data updates and plenary presentations this year at AACR and ASCO included lysoleucine-advanced melanoma patients who had progressed on anti-PD-1 therapy. And at ASCO, our first set of clinical data for lysoleucine in combination with pembrolizumab in an earlier treatment setting with melanoma patients who were not used to anti-PD-1 therapy. In post-anti-PD-1 patients from cohort 2 in our C14401 study, the long-term follow-up data showed an overall response rate, or ORR, of 36.4%, and median duration of response was still not reached at 33.1 months of median study follow-up. Results from additional analyses suggest that early intervention with Lysolutil at the time of initial progression on anti-PD-1 therapy may maximize benefit. For the post-anti-PD-1 patient population in Walton Core 2, chemotherapy is the only currently available option and offers a 4% to 10% response rate and overall survival of only seven to eight months. We, as well as KOL, continue to be very enthusiastic about the durability of response following one-time treatment with Lysolucil in these very difficult-to-treat metastatic melanoma patients. We are very excited about a high-impact publication of our cohort 2 data in JCO in May 2021 with an accompanying editorial that outlines the transformative potential of TIL therapy. This publication will further help communicate our melanoma data to a broad international audience of oncologists. Also at ASCO, the initial clinical data from seven anti-PD-1 therapy naive melanoma patients in cohort 1A of the IOV-COM-202 study suggests that the response rate for Liferutin in combination with Pembrolizumab may be additive. Six of the seven patients had a confirmed objective response, representing an 86% ORR. including two complete responses, or CR, one unconfirmed CR, or UCR, in a patient who had not yet reached the confirmatory CR assessment but remained in follow-up, three partial responses, or PR, and one best response of stable disease. Responses deepened over time, and the CR and UCR rate was 43%. We are very excited about these data and look forward to seeing longer follow-up as well as data in additional patients. There is a need to increase overall response rates and deepen responses with more complete responses in anti-PD-1 naive metastatic melanoma, where pembrolizumab alone yields a 33% response rate with only 6% complete responses, and where 40% to 65% of patients have primary resistance to immune checkpoint inhibitors, or ICIs. For our non-small cell lung cancer program, we provided a corporate update with clinical data for our TIL therapy LN145 in patients with metastatic non-small cell lung cancer who enrolled in cohort 3B of the ongoing basket study IOV-COM202. Cohort 3B enrolled 28 patients that have progressed on prior immune checkpoint inhibitor or ICI therapy. It is important to note that this was a heavily pretreated population. 24 of the 28 patients, or 85.7%, including all responders, had received two or more prior lines of systemic therapies. There is a significant unmet need to increase response rate and prolong survival in this difficult-to-treat NSCLC population, so we were very pleased to see an ORR of 21.4%, including one confirmed complete response and five confirmed partial responses, a 64.3% disease control rate, and median duration of response that had not been reached at 8.2 months of median study follow-up. Historically, ORRs of approximately 20% were reported with ICIs as second-line therapy in ICI-naive patients who had progressed on frontline chemotherapy. So we are pleased to see a comparable ORR in sicker patients in cohort 3B, who have all received prior anti-PD-1 therapy, and we are confident in our non-small cell lung cancer development strategy. Turning to our ongoing clinical studies, we continue to recruit patients across four clinical trials with IOVAN skill. In our potentially registration-supporting IOV-LUN202 study in second-line lung cancer, we have dosed the first patients and now activated a total of more than 15 sites. We believe that the patient population in the three IOV LUN202 cohorts, including a cohort using core biopsies, as well as the three non-small cell lung cancer cohorts in the basket study, allow us to broadly address the unmet needs in non-small cell lung cancer. Recruitment also continues in our IOV COM202 basket study of IOVAMs TIL and TIL plus ICI combinations across melanoma, head and neck, and non-small cell lung cancers. In our C14504 clinical study in advanced cervical cancer, we continue to recruit a cohort of patients not previously treated with systemic chemotherapy or anti-PD-1 to receive ioventil plus pembrolizumab. We are also actively enrolling in our IOV-CLL01 study in CLL and SLL patients. We hope to be able to provide additional data from these studies at future medical meetings. I will now hand the call over to Jean-Marc to discuss our second quarter of 2021 financial results.
spk01: Thank you, Frédéric. My comments will reflect the high-level financial results from the second quarter of 2021. Additional details can be found in this afternoon's press release as well as in our SEC findings. I will begin with our cash position. As of June 30, 2021, Iovance held $708.7 million in cash, cash equivalents, investments, and restricted cash, compared to $635 million on December 31, 2020. A strong cash position is expected to be sufficient well into 2023 to advance our operating plan, including pipeline development, commercial manufacturing readiness, and launch preparations. Moving on to the income statement, our net loss for the second quarter under June 30, 2021 was $81.4 million of 53 cents per share compared to a net loss of $63 million of 47 cents per share for the second quarter under June 30, 2020. Net loss for the six months under June 30, 2021 was $156.8 million, or $1.04 per share, compared to net loss of $132.6 million, or $1.02 per share, for the same period under June 30, 2020. Research and development expenses were $62.1 million for the second quarter under June 30, 2021, an increase of $12.8 million compared to $49.2 million for the second quarter and the June 30, 2020. Research and development expenses were $118.1 million for the six months and the June 30, 2021, an increase of $11.8 million compared to $106.2 million for the same period and the June 30, 2020. The increase in research and development expenses in the second quarter of 2021 over the prior year period was primarily attributable to growth of the internal research and development team and increase in cost related to manufacturing and our internal ICTC facilities. The increase in research and development expenses in the first half of 2021 over the prior year period was primarily attributable to growth of the internal research and development team and costs related to the completion of construction at the ICTC facility, which were partially offset by lower manufacturing and clinical costs following the completion of enrollment in several cohorts of melanoma and cervical trials. General and administrative expenses were $19.3 million for the second quarter and the June 30, 2021, an increase of $5 million compared to $14.4 million for the second quarter and the June 30, 2020. General and administrative expenses were $38.9 million for the six months of the June 30, 2021, an increase of $10.7 million compared to $28.2 million for the same period and the June 30, 2020. The increase in general and administrative expenses in the second quarter and first half of 2021 compared to the premier year periods were primarily attributable to growth of the internal and general and administrative team and higher stock-based compensation expenses. As of June 30, 2021, there were approximately 155 million common shares outstanding. We continue to focus on investment in four key areas, as outlined previously, to ensure the growth and strength of our value creation, which are advancement and expansion of our clinical pipeline, launch readiness, a strong cash position, and our transition from construction to commencement of manufacturing at ICTC. I remain confident that by managing our investments 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.
spk07: Thank you. As a reminder, to ask a question, you'll need to press star 1 on your telephone. To withdraw your question, press the pound key. Please limit yourself to one question. Please stand by. We compile the Q&A roster. Our first question comes from Michael Yee with Jefferies. You may proceed with your question.
spk04: Hi guys, thank you. Congrats on the progress and thank you for the question. We had a question on clarifying the next steps on the potency assay. When you say you're going to submit data and meet with the FDA by the end of the year, can you walk through generally what you're focused on submitting and then when you submit it, Do you have to wait a certain number of days to get a meeting, and then you have to wait for the meeting minutes and then to update us, and therefore would that fall into actual calendar 2022? Maybe just walk through the chronology of how that works, because that would explain when you'd be able to come back to the street and tell us the next steps. Thank you.
spk16: Hi, Michael. It's Fred. I can answer that for you. The FDA interaction process is – we're not disclosing the details of what we're doing right now with the FDA, but in general, as you know, there's different types of meetings you can hold with the FDA. They have submission timelines, and then the FDA responds after those timelines, and you host a meeting. For example, for a type A meeting, it's 30 days. For a type B meeting, it's 60 days. You get feedback from the FDA ahead of the meeting. You have the meeting, and then typically 30 days later, you get a written response from FDA for most of these categories. We're not We're not disclosing any of the detail of exactly what we're doing right now with the FDA, but we are executing on the plan that we described earlier, which is to have these interactions in the second half of 2021, which we're in right now. So please stay tuned, and as soon as we can get some information that we think is significant and we can communicate, we'll certainly be communicating it.
spk04: But to clarify, you would probably not come back to the street on what the result of this stuff is, until after you've met with them and all of that, which you're saying is by end of 21. So if I just do math on that, that's a calendar 22. Is that a fair conclusion? No, I don't think that's fair.
spk16: It very well could be, and our intention is to have the interactions in 21, and we very well could be communicating in 21. We just don't know right now. Got it. Okay. Thank you.
spk07: Thank you. Our next question comes from Mark Breedenbach with Oppenheimer. You may proceed with your question.
spk02: Hey, guys. Congrats on the progress, and thanks for taking the question. Just wondering, aside from the more detailed lung data from the basket study that you've got to present later this year, should we be expecting any additional clinical presentations? And kind of a second part of the question is, do you see any sort of silver lining in the sense that your regulatory filings are kind of like syncing up with your in-house manufacturing capabilities? I guess I'm wondering how much of a COGS reduction we can expect from manufacturing once you translate the bulk of that to your own facility. Thanks for taking the questions.
spk16: I'm Mark. Why don't I take the first part, and then I'll ask Igor to answer the second part. On the first part, we're always looking for opportunities to communicate at medical meetings, and there's some coming up at the end of the year. We haven't guided towards anything specifically there beyond the fact that we We do hope to present more on the COVID-3B data in non-small cell lung this year. But yes, we are looking. We're always trying to take advantage of that. You've seen the history of the company. We've made major use of medical meetings wherever we possibly could. Igor, do you want to answer some questions about the availability of ICTC?
spk15: Yes, happy to. Hey, Mark, thanks for your question. As we mentioned on the call today, we are pleased that the IND has been accepted by the FDA, and we're getting ready to start clinical manufacturing at our ICDC facility in Philadelphia. We're also getting ready for commercial manufacturing in 2022 that could support multiple indications and potentially thousands of patients commercially. I mean, the importance of having our own in-house manufacturing is – is really threefold. We can control our capacity, which in the industry is short, so we're in control of our fate. We can reduce the cost of goods compared to what one could potentially achieve with contract manufacturing. And we believe we can also achieve higher quality by fully controlling the facility. So, Mark, I wouldn't be commenting specifically on the COGS percentages, but as you can imagine, an in-house facility can allow us to achieve lower COGS than outsourcing. All right. Thanks so much.
spk07: Thank you. Our next question comes from Ben Burnett with CFO. You may proceed with your question.
spk14: Hey, thank you very much. I was wondering if you could just talk about the regulatory strategy for cervical cancer, and I guess are we right to assume that the potency assays are rate limiting, and should we therefore be thinking about sort of a single BLA covering both indications?
spk16: Hi, Ben. It's Fred. I don't No, if you want to think about a single BLA, we haven't guided that, and that's something that could go either way. We talked a little bit before about this, I think. Right now, the potency assay is the gating item for all of our clinical programs, all of our registrational strategy. We think once we resolve the potency assay issue with FDA for melanoma, that should allow us to proceed with other clinical programs that However, we have multiple registrational programs now, and we'd have to evaluate exactly how to bring those in front of the FDA. Our first priority, above all, is getting the potency assay resolved for melanoma.
spk14: Okay, understood. And then I guess just one more question. Is there a chance that we could see the results of the pivotal, like, melanoma and cervical studies prior to the BLA submission?
spk16: Yeah, well, when we – When we get close to the BLA submission, that would be around the time where we would typically want to do an IRC read, you know, a more formal cut plus the IRC read of the data. And so at that point, you know, it's fairly typical for companies to disclose something. I can't commit to anything at this point given where we are in the regulatory process, but, you know, you could foresee strategies where we might have that available not long before filing, for example.
spk14: Okay. Okay. Makes sense. Thank you. I appreciate it.
spk07: Thank you. Our next question comes from Madhu Kumar with Goldman Sachs. You may proceed with your question.
spk12: Thanks. This is Rob on for Madhu. Just wondering, do you guys have any plans for updated potency assays? To what degree are points to address related to the actual assays to use versus the effect size or effect ranges for the current assays?
spk16: You got cut off partway through there, Rob. There was a big blank in your question there. Would you mind just repeating the first part of it?
spk12: Sure. So any updated plans for head and neck data? And then to what degree are the assays related to the actual assay to use versus the effect size of current assays?
spk16: The head and neck part got cut off, sorry. All right, so head and neck right now, we haven't indicated any plans on that right now. We're always looking for opportunities to do medical meetings where we can present that kind of data, so stay tuned on that. The effect sizes and sort of the details of the assays, well, we're still in the conversation with FDA about which assay or assays we would use to evaluate potency. So the The effect or whatever you're measuring in the assay, that could vary widely by choice of assay, depending on the detection method, what we actually look at, what we use to stimulate as a stimulation for the method. So that's still stuff that we would work out with FDA typically later in the process. Once we've got agreement on an assay, we start to talk about the performance of the assay in quantitative terms, including acceptance criteria, and I think that's what you're asking about. Is that right?
spk12: Yeah, for sure. That answers my question. Thanks so much.
spk07: Thank you. Our next question comes from Boris Peeker with Town. You may proceed with your question. If your line is on mute, please unmute, Boris. Operator, I can't hear anything. We'll go to our next question. from Mara Goldstein with Mizuho. You may proceed with your question.
spk13: Hi, this is from Mara. Thank you for taking the question. I have a question about the next generation that was discussed, ILV3001 and 4001. I was wondering about the status of that and how should we think about how they are differentiated from the current generations when translating into clinic? Thank you.
spk16: Sure. IV3001 is a monoclonal antibody product that's designed to offer an alternative to aldeflucan. So don't think of that as a TIL product. It's part of a TIL regimen. IV4001 is, in fact, a TIL product. That's a TIL that has a genetic knockout or silencing of the PD-1 gene that we think will help or we hope will help improve efficacy because it will the cells will carry a bit of an immunity, if you will, to an inhibitory mechanism in the tumor microenvironment.
spk13: Okay. Thank you.
spk07: Thank you. And as a reminder, to ask a question, you will need to press star 1 on your telephone. Our next question comes from Nick Abbott with Wells Fargo. You may proceed with your question.
spk05: Oh, good afternoon. Thank you for taking my questions. First one is, you know, and I think I know the answer to the first part, but I have to ask it anyways, when we might see more of the first-line melanoma data. But more importantly, if the data continue to support that scene at ASCO, what are the next steps in the front line and perhaps more broadly, you know, life cycle management? You could be doing a second-line trial, for example, and then I have a follow-on. Thank you.
spk16: Yeah, and the front-line melanoma, data that we reported at ASCO, we're always going to be looking for another conference to hopefully update that data and provide more information about how we're seeing things in that study. Obviously, the data was very promising with the 86% ORR right now and some really 43% CR rate, very significant numbers in a patient population that in checkpoint only gets 33% response rate with PEMBRO with the 6% CR rate. So these are things that are really, really interesting to us. We do view the future of tilt therapy as transitioning to frontline or early line therapy. However, of course, you know, our focus remains on the late line indications where we think we have faster approval routes, and then over time we can develop studies and work with the FDA on study designs that might allow us to economically bring forward the frontline indication.
spk05: Okay. Thanks. And then, You know, we mentioned 4001 just a minute ago. Can you talk about how that electroporation step is being integrated into the manufacturing process, where that's occurring, and is this being inserted into a Gen 3 type process or a Gen 2? Just what does that overall timeline look like for 3001? I'm sorry, 4001.
spk16: Yeah, we haven't disclosed the details of exactly what we're doing in that process yet. Hopefully we can do that at some point at a scientific conference. So don't assume it's electroporation. However, what we're doing there is we think is very similar in terms of timing to Gen 2. So we view Gen 2 as sort of the optimal commercial timing for a product these days with approximately a 22-day manufacturing cycle. So this is something we're focused on. We'll hopefully provide more detail on 4001 in a future meeting.
spk05: Okay. Thank you.
spk07: Thank you. Our next question comes from Astika Boonwaden with Truist Securities. He may proceed with your questions.
spk03: Hi, this is Bill. You guys have given us some good anecdotes and insights on your FDA discussions for potency assays. For example, you don't require antigen-specific reactivity, and also you don't need a new study, and we really appreciate that. But are there any new anecdotes or takeaways that you can share at this time?
spk16: Look, FDA, we're telling you when we have our meetings with all the analysts and all the investor community is what we're hearing from FDA as much as we possibly can, what they are either saying directly to us or what they've said in their guidance to industry, especially their cell and gene potency assay guidance that they put out about a decade ago now, which is effectively FDA's statement on this whole potency assay situation, cell and gene in the industry. I don't have any new anecdotes for you or anything that I can tell you specifically. All I can say is that we're engaged in A lot of discussions with them, and we think we can find a reasonable path to solution here on the potency assay situation, as we've been saying. And FDA, you know, when you collaborate with them, they tend to want to work with you. So we're looking forward to having that collaboration with them and moving this forward.
spk03: Thank you. Appreciate it.
spk07: Thank you. Our next question comes from Colleen Cusey with Baird. You may proceed with your question.
spk10: Hi, good afternoon. Thanks so much for taking our questions. So obviously work is well underway for Gen 3 manufacturing process. I guess, how do you see the manufacturing process continuing to evolve and get better? What could a hypothetical Gen 4 manufacturing process look like?
spk16: Colleen, I can give you some thoughts on this. I mean, it's a little early to say exactly how this would play out, but the idea behind Gen 3 was we're trying to shorten the process more than anything. We want to speed it up. We're also trying to lower COGS and make till manufacturing as efficient as we possibly can so that we can serve the maximum number of patients in the future. I don't know exactly what a Gen 4 would look like, whether it would be shorter or whether it would be something more like IV4001 where we would achieve some additional feature that has been integrated into the till manufacturing process, but All these things are on the table. Genetic engineering is obviously something that we're very interested in. You can see we've been licensing technology from NIH, as we announced recently, towards other modifications that we can make to till therapy and that sort of thing. I don't know if that helps answer your question, but it's something that we're heavily invested in, and we've already launched the first. Gen 2 really did change the game, and Gen 3 is continuing to change the game, so I do expect we'll have some more innovation here in the future, I'm just not sure exactly where it's gonna be right now.
spk10: Great, that's helpful, thank you. And for the re-treatment arm and the basket study, how long will the interval be between pill dosing and re-dosing? And would patients have received any other anti-cancer therapy in that window?
spk16: For the re-treatment and the basket study, we don't. Do you mean in LUN202?
spk10: Yeah, sorry, thank you.
spk16: Madan, do you happen to have that information?
spk06: Yeah, absolutely. So the retreatment strategy is really on a case-by-case basis. So initially patients should have had a response if they have subsequent progression. We definitely want the patient stabilized enough that they can do a resection, and that may or may not involve interim therapy before they can get ready for the second treatment with the tilt. So that's really, it's a very case-by-case and depending upon the PI's treatment recommendations.
spk10: Great. Thanks for taking our questions.
spk06: Thank you.
spk07: Thank you. And I'm not showing any further questions at this time. I would now like to turn the call back over to Fred Vogt for any further remarks.
spk16: Thank you, Operator. Thank you again for joining the Iovance second quarter and first half 2021 financial results conference call. I would like to thank our shareholders and covering analysts for their support, as well as Iovance employees for their hard work and contributions as we develop pill cell therapy for cancer patients. I think it's an exciting time at the company, and we are unwavering in our commitment to advance and expand the pill pipeline towards potential approval. Please feel free to reach out to our investor relations team if you wish to follow up. Thank you.
spk07: Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.
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