Earnings Call: Q2 2021

Aug 5, 2021

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. 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. 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 Balinski, our Chief Operating Officer Jim Ziegler, our Senior Vice President, Commercial Doctor. Fred Wittstein, our Chief Medical Officer and Jean Marc Bellamy, our Chief Financial Officer. Doctor. Madan Jagatia, 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 3 6 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 technology, 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. Thank you, Sarah, and good afternoon, everyone. I'm pleased to highlight our progress in the Q2 and first half of twenty twenty one at iVance during today's conference call. During this year, we have continued to advance our tumor infiltrating lymphocyte or Till pipeline. We've reported clinical data across our metastatic melanoma program, including our first clinical data in early line melanoma as well as the new indications such as metastatic non small cell lung cancer. For our lead Till product candidate, 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 are confident in our ability to address FDA's 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 BLA submission in the first half of twenty twenty two as guided. Resolution of the potency updates. We now have clinical data showing the promise to Till therapy in 4 different solid tumors types across various treatment settings, furthering our confidence until it's a broad platform in next class of cancer treatment. Frederic will summarize the key updates in a moment, but overall, we are really excited about 3 key takeaways. First, our initial data in metastatic non small cell lung cancer demonstrated 21.4% overall response rate in a heavily pretreated patient population, all of them have progressed from prior immune checkpoint inhibitor or ICI therapy, which represents significant unmet need to patient population in non small cell lung cancer. Next, lifileucelain post anti PD-one melanoma continues to show increasing long term durability. And third, the initial results for lifoleucilone combination with pembrolizumab showed an 86% overall response rate, including a 43% complete response rate in anti PD-one naive melanoma patients and supports our broader strategy to combine Iovance Till with available therapies and move into earlier treatment settings to solid tumors. On the research side, we are bringing the next generation of Till and supporting therapies into the clinic. As we noted in today's press release, we are advancing Till to genetically modify the knockout PD-one, which we have designated IOV 4,001 as well as our novel IL-two analog, IOV-three thousand and one. Both IOV-four thousand and one and IOV-three thousand and and one are progressing through IND enabling studies and are moving towards the clinic. In summary, we continue to execute all development, manufacturing activities and furthering our commitment to address the critical needs of cancer patients. I'm very 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 270 employees, who on average have more than 3.5 years of cell 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 Balinski. Thank you, Fred. I'm pleased to speak today about the progress of Iovance 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 still with a continuing manufacturing success rate above 90%. Iovance has transformed Till manufacturing from a lengthy single center academic process to a shorter scalable centralized GMP process yielding a cryopreserved product for shipment back to the sites where the patients are treated. Our current Gen 2 process is 22 days. We are also continuing to advance our Till leadership position. We are already investigating in the clinic our GEN-three process, which is 16 days, to further improve Iovance Till manufacturing efficiencies and deliver Iovance Till to patients even sooner. We believe that our Gen 3 16 day Till 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 iCPC in the near future to supply investigational IVAN stool therapies to cancer patients enrolled in our clinical trials. In addition, we're now moving to commercial manufacturing readiness activities for IVM still at ICBC. 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 Iovance steel manufacturing capabilities and pipeline, we have been sharply focused on building our robust and growing intellectual property or IT portfolio. Our Gen 2 IP portfolio is covered by more than 25 granted or allowed U. S. And international patents with expected exclusivity through 2,038. In total, we have more than 700 patents and patent applications filed globally across major pharmaceutical markets and other key geographies. Our events is 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 pregnant 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 cell 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? 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 twenty twenty two. 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 association and partners with patient advocacy groups to increase awareness for Iovance pill and lipo 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 Till 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 Till cell therapy. Specifically, this week, the Centers For Medicare and Medicaid Services, or CMS, finalized its proposal to expand the existing MS DRG18 to include lipo leucil and other cell therapies. With this significant change, we expect that our Till centers will experience a much more stable and predictable Medicare inpatient reimbursement landscape at Lonnie. In turn, we anticipate that Medicare patients will have timely access to lifileucel. We thank key stakeholders 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 to ensure patients with private insurance will have timely and appropriate access to lifileucel. 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 Care 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. Thank you, Jim. I am pleased to highlight recent clinical data updates as well as the status of our 4 ongoing clinical studies. Our drug development strategy focuses on cancer populations with high unmet need with substantial opportunities for Till 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 liso leucine advanced melanoma patients who had progressed on anti PD-one therapy. And at ASCO, our first set of clinical data for lizolelizolelizolelizumab in an earlier treatment setting with melanoma patients who are not used to anti PD-one therapy. In post anti PD-one patients from Cohort 2 in our CE-one hundred and forty four-one 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 analysis suggest that early intervention with lifileutal at the time of initial progression on anti PD-one therapy may maximize benefit. So the post anti PD-one patient population enrolled in Cohort 2, chemotherapy is the only currently available option and offers a 4% to 10% response rate and overall survival of only 7 to 8 months. We as well as KOLs continue to be very enthusiastic about the durability of response following one time treatment with lisolestal in these very difficult to treat metastatic melanoma patients. We are very excited about the high impact publication of our Cohort 2 data in JCO in May 2021 with an accompanying editorial that outlines the transformative potential of Till 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 7 anti PD-one therapy naive melanoma patients in Cohort 1a of the IOV COM two zero two study suggests that the response rate for lifedilutin combination with pembrolizumab may be additive. 6 of the 7 patients had a confirmed objective response, representing an 86% ORR, including 2 complete responses or CR, 1 unconfirmed CR or hue CR in the patient who had not yet reached the confirmatory CR assessment but remained in follow-up, 3 partial responses or PR and one best response of stable disease. Responses deepened over time and the CR and new CR rate was 43%. We are very excited about these data and look forward to seeing longer follow-up as well as data and additional patients. There's a need to increase overall response rate and deepen responses with more complete responses in anti PD-one 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 ICI. For our non small cell lung cancer program, we provided corporate update with clinical data for our Till therapy LN-one hundred and forty five 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 percent including all responders had received 2 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 0.4%, including 1 confirmed complete response and 5 confirmed partial responses, a 64.3% disease control rate and median duration of response that have not been reached at 8.2 months of median study follow-up. Historically, ORRs of approximately 20% were reported with ICI 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 always received prior anti PD-one 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 4 clinical trials with Iovance Till. In our potentially registration supporting IOV LUN202 study in second line lung cancer, we have dosed the first patient and now activated a total of more than 15 sites. We believe that the patient population in the 3 IOV LUN202 cohort, including a cohort using core biopsies, as well as the 3 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 IOB COM202 basket study of Iovance Till and Till plus ICI combinations across melanoma, head and neck and non small cell lung cancers. In our C-one hundred and forty five 4 clinical study in advanced cervical cancer, we continue to recruit a cohort of patients not previously treated with systemic chemotherapy or anti PD-one to receive Iovance TAL plus pembrolizumab. We are also actively enrolling in our IOV CLL-one 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 2021 financial results. Thank you, Frederic. My comments will reflect the high level financial results from the Q2 of 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 June 30, 2021, Iovance held $708,700,000 in cash, cash equivalents, investments and restricted cash compared to $635,000,000 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 preparations. Moving on to the income statement. Our net loss for the Q2 ended June 30, 2021 was $81,400,000 or $0.53 per share compared to a net loss of $63,000,000 or $0.47 per share for the Q2 ended June 30, 2020. Net loss for the 6 months ended June 30, 2021 was $156,800,000 or $1.04 per share compared to a net loss of $132,600,000 or $1.02 per share for the same period ended June 30, 2020. Research and development expenses were $62,100,000 for the Q2 ended June 30, 2021, an increase of $12,800,000 compared to $49,200,000 for the 2nd quarter ended June 30, 2020. Research and development expenses were $118,100,000 for the 6 months ended June 30, 2021, an increase of $11,800,000 compared to $106,200,000 for the same period ended June 30, 2020. The increase in research and development expenses in the Q2 2021 over the prior year period was primarily attributable to growth of the internal research and development team and increasing cost related to manufacturing and our internal ICTC facility. The increase in research and development expenses in the first half of twenty twenty one 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 our 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 $19,200,000 for the Q2 ended June 30, 2021, an increase of $5,000,000 compared to $14,400,000 for the Q2 ended June 30, 2020. General and administrative expenses were $38,900,000 for the 6 months ended June 30, 2021, an increase of $10,700,000 compared to $28,200,000 for the same period ended June 30, 2020. The increase in general and administrative expenses in the 2nd quarter and first half of twenty twenty one compared to the prior 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 155,000,000 common shares outstanding. We continue to focus on investments in 4 key areas, as outlined previously, to ensure the growth and strength of our value creation, which are advancement and expansion of Norfolk Clinical pipeline, launch readiness, the 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 and A session. Thank you. Our first question comes from Michael Yee with Jefferies. You may proceed with your question. 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 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. Michael, it's Fred. I can answer that for you. It's the FDA interaction It's 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 post a meeting, for example, for Type A meeting, it's 30 days. For 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 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 twenty twenty one, which we're in right now. So please stay tuned and we'll as soon as we can get some information that we think is significant and we can communicate, we'll certainly be communicating it. 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 2021. So if I just do math on that, a calendar 'twenty two. Is that a fair conclusion? No, I don't think that's fair. It very well could be and our intention is to have interactions in 'twenty one and we very well could be communicating in 'twenty one. We just don't know right now. Our next question comes from Mark Breidenbach with Oppenheimer. You may proceed with your question. 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 guided 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 and your 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? Hi, Mark. It's Fred. 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 do hope to present more on the Cohort 3b data in non small cell lung this year. But yes, we are looking we're all trying to we're always trying to take 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 ICC? Yes, happy to. Hey, Mark, thanks for your question. So 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 are also getting ready for commercial manufacturing in 2022 that could support multiple indications and potentially thousands of patients commercially. And the importance of having our own in house manufacturing 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, that in house facility can allow us to achieve lower COGS than outsourcing. Thank you. Our next question comes from Ben Burnett with Stifel. You may proceed with your question. Hi, 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? Should we therefore be thinking about sort of a single BLA covering both indications? Hi, Ben. This is Fred. I don't know if you would want to think about a single BLA. We haven't guided at 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. 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 from melanoma. 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? Yes. Well, when we get close to the BLA submission, that would be around the time where we would typically want to do an IRC read, a more formal cut plus the IRC read of the data. And so at that point, it's fairly typical for companies to disclose something. I can't commit to anything at this point given where we are, the regulatory process, but you could foresee strategies where we might have that available not long before filing, for example. All right. Okay. Makes sense. Thank you. I appreciate it. Thank you. Our next question comes from Madhu Kumar with Goldman Sachs. You may proceed with your question. 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? 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? 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? 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 the sort of the details of the assays, while we're still in the conversation with FDA about which assay or assays we would use to evaluate potency. So 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 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? Yes, for sure. That answered my question. Thanks so much. Thank you. Our next question comes from Boris Peaker with Cowen. You may proceed with your question. Operator, I can't hear anything. We'll go to our next question from Mara Goldstein with Mizuho. You may proceed with your question. Hi. This is Sabo for Mara. Thank you for taking the questions. I have the questions around the next generation tail that was discussed, ILV-three thousand and one and 4,001. 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. Sure. IV-three thousand and one is a monoclonal antibody product that's designed to offer an alternative to all deflukin. So don't think of that as a Till product. It's part of a Till regimen. IV-four thousand is in fact a Till product. That's a Till that has a genetic knockout or silencing of the PD-one gene that we think will help we hope will help improve efficacy because it will cells will carry a bit of an immunity, if you will, to an inventory mechanism in the tumor microenvironment. Okay. Thank you. Thank you. Our next question comes from Nick Abbott with Wells Fargo. You may proceed with your question. Good afternoon. Thank you for taking my questions. First one is, 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 seen at ASCO, what are the next steps in the frontline and perhaps more broadly, the lifecycle management, you could be doing a second line trial, for example? And then I have a follow on. Thank you. Yes. Nick, in the frontline melanoma data 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 a 6% CR rate. So that's these are things that are really, really interesting to us. We do view the future of Till therapy as transitioning to frontline or early line therapy. However, of course, 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. Okay. Thanks. And then we mentioned 4,001 just a minute ago. Can you talk about how that electroporation step is being integrated into the manufacturing process? Gen 3 type process? Or Gen 3 type process or a Gen 2? Just what does that overall timeline look like for 3,001 I'm sorry, Yes. 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 a 20 22 approximately 22 day manufacturing cycle. So that's this is something we're focused on. We'll hopefully provide more detail on 4,001 in a future meeting. Okay. Thank you. Thank you. Our next question comes from Aspika Boonwarden with Tuohy Securities. You may proceed with your question. Hi, this is Bill on for Asthika. You guys are giving 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. I really appreciate that. But are there any new anecdotes or takeaways that you can share at this time? Look, FDA, what 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 what they're either saying roughly 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 statement on this whole potency assay situation in Celgene and the industry. I don't have any new anecdotes for you or anything that I can tell you specifically. We're 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 in FDA, 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. Thank you. Appreciate it. Thank you. Our next question comes from Colleen Cusi with Baird. You may proceed with your question. 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 Collin, I can give you some thoughts on this. I mean, it's a little early to say exactly how this will 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 our COGS and make Till manufacturing as efficient as possible we 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 IV 4000 and one where we achieve some additional feature that has been integrated into the manufacturing process. But all these things are on the table. Genic Engineering is obviously something that's we're very interested in. And 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 sort of thing. I don't know if that helps to answer your question, but it's something that we're heavily invested in and we've already launched the first that 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 going to be right now. Great. That's helpful. Thank you. And for the retreatment arm in the Basket study, how long will the interval be between pill dosing and re dosing? And would patients have received any other anticancer therapy in that window? For the retreatment in the Basket study, we don't do you mean in LUN202? Yes, sorry. Thank you. Madan, do you happen to have that information? Yes, 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 re resection and that may or may not involve interim therapy before they can get ready for the 2nd treatment with the tip. So that's really it's a very case by case and depending upon the PI's treatment recommendation. Great. Thanks for taking our questions. Thank you. 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. Thank you, operator. Thank you again for joining the Iovance second quarter and first half twenty twenty one 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 Till cell therapy for cancer patients. I think it's an exciting time in the company and we are unwavering in our commitment to advance and expand the Till pipeline towards potential approval. Please feel free to reach out to our Investor Relations team if you wish to follow-up. Thank you. Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.