Good day. Thank you for standing by, and welcome to the Iovance SITC Update Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. If anyone should require assistance during the conference, please press star then zero on your touchtone telephone. I would now like to turn the conference over to your host, Ms. Sara Pellegrino, Vice President, Investor and Public Relations at Iovance Biotherapeutics. Please go ahead, ma'am. Thank you, operator. Good afternoon, and thank you for joining our conference call to discuss the clinical data updates for Iovance TIL cell therapy in multiple solid tumors during SITC 2021. For today's agenda, our interim President and CEO, Fred Vogt, will do a brief introduction. Dr. Friedrich Graf Finckenstein, our Chief Medical Officer, will highlight the key takeaways for each data set in relation to our TIL development strategy. The highlight of today's call will be clinical data updates for Iovance TIL in metastatic non-small cell lung cancer and Iovance TIL in combination with pembrolizumab in early line cervical cancer, melanoma, and head and neck cancer. We are fortunate to welcome key opinion leaders and Iovance study investigators to summarize the clinical data they just presented at SITC. Dr. Adam J. Schoenfeld, Medical Oncologist at Memorial Sloan Kettering Cancer Center, will review clinical data for Iovance TIL in patients with metastatic non-small cell lung cancer in our IOV-COM-202 study, which was featured in a poster at SITC. We also welcome Dr. David M. O'Malley, Professor of Obstetrics and Gynecology at The Ohio State University College of Medicine and Director of the Division of Gynecologic Oncology at OSU CCC – Arthur G. James Cancer Hospital. He will summarize the data for Iovance TIL in combination with pembro in advanced solid tumors, which he just presented an hour ago during an oral presentation at SITC. Following the clinical data presentation, Dr. Madan Jagasia, our Senior Vice President, Medical Affairs, will lead a panel discussion with Dr. Schoenfeld and O'Malley as Dr. Omid Hamid, Chief, Translational Research & Immuno-Oncology at The Angeles Clinic and Research Institute and Iovance Clinical Study Investigator. Before we start, I would like to remind everyone that statements made during this conference call will include forward-looking statements regarding Iovance's clinical trial results, goals, business focus, business plans, clinical trials and regulatory plans and results, manufacturing capabilities, regulatory feedback and guidance, 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 evening, everyone. I'm pleased to host today's call to highlight our clinical updates at SITC. SITC annual meeting is always very important for Iovance. We're happy to be back in person to share our data and connect with the physician community. We are increasingly confident in the broad potential for TIL and new indications in earlier treatment settings, and I believe that the clinical data at SITC is further supportive of the development strategy for TIL in non-small cell lung cancer, as well as the platform potential for TIL combinations in earlier treatment settings. The Iovance team, in collaboration with Dr. Schoenfeld, O'Malley, Hamid, and our study investigators, did a terrific job in the abstract submissions for SITC. Our Cohort 3B and TIL combination abstracts ranked within the top 100 abstracts scored by the SITC review team. This is out of nearly 1,000 accepted abstracts and is a testament to the potential power of our TIL platform and the efforts of our team to publish the data. With that as a backdrop, I'd like to turn the call over to Friedrich for high-level key takeaways. Thank you, Fred. The data we presented at SITC this week further support our ongoing TIL development in non-small cell lung cancer in a diverse first set of 28 heavily treated patients, including eight patients who had best response of progressive disease on prior ICI therapy. It is also the first experience for TIL monotherapy to show clinical benefit in a multicenter study with a centralized manufacturing process. The ORR is 21.4% in the full analysis set of 28 patients, and 25% in the efficacy evaluable set of 24 patients. At the time of the data cutoff, one CR and one PR were ongoing at 20.7 months and three months respectively at a median study follow-up of 9.8 months. Both of these responses are also reported as ongoing as of today. Responses were observed following multiple prior therapies, including in tumors that were resistant to anti-PD-1 and across the range of PD-L1 expression levels, clinical characteristics, and molecular features. Also, the ongoing responders, for example, had best response of progressive disease on prior anti-PD-1 therapy and include a PD-L1 negative patient, as well as a patient with a KRAS mutation that is associated with more difficult to treat tumors. We believe these results validate the potential for TIL in non-small cell lung cancer and support the ongoing study IOV-LUN-202 in second-line metastatic non-small cell lung cancer patients. TIL may demonstrate increased overall responses and durability for patients with unmet medical needs, but with fewer prior lines of therapy in the LUN-202 study. Now I would like to introduce Dr. Adam J. Schoenfeld. Schoenfeld is a medical oncologist in the Thoracic Oncology Service and Cellular Therapeutic Service at Memorial Sloan Kettering Cancer Center and the Weill Cornell Medical College. Dr. Schoenfeld leads clinical and translational research efforts to develop novel immunotherapeutic and cellular treatment strategies for patients with lung cancer and other solid tumors. He is an investigator in the metastatic non-small cell lung cancer cohort from IOV-COM- 202 and IOV-LUN -202. Today, he will review the Cohort 3B. Great, thanks so much. Thanks for having me here to give me this opportunity to talk. I'll just review some of the highlights that I think were already briefly reviewed. Here you can see the first table shown is the baseline patient characteristics. It's pretty standard for non-small cell lung cancer cohort. There are a couple of things that I would like to highlight on the baseline characteristics of the patients. First, as is usually the case, most patients are former or current smokers, most commonly had adenocarcinoma as the primary histologic cell type, and PD-L1 expression ranged from negative to greater than 50%, with all patients having been in one of the categories of negative 1%-49% or greater than 50%. A couple of things to highlight here. I think that's important to note is that 35% or 36% of patients actually had prior brain metastases. Prior brain metastases can be a poor prognostic factor in lung cancer and can be a sign of more aggressive disease as well. That's just something to highlight in this cohort. All patients received prior immune checkpoint inhibition. TILs were most commonly harvested from lung metastases. This slide shows a table of treatment emergent adverse events that occurred in ≥30% of the full analysis set. Safety was primarily consistent with the underlying advanced disease and known safety profiles of the lymphodepletion in IL-2. Any grade tumor harvest-related AEs were reported for 41% of patients. Most commonly they were procedural pain followed by hypoxia, and the large majority of them were of the tumor harvested related AEs were grade one and two. I think this is an important figure to show as well that has been shown in other Iovance cohorts is that most AEs occurred prior to or within the first two weeks after TIL infusion. Since this is a one-time treatment, following that infusion period, patients are generally, you know, free from toxicity. Also, that the median number of doses for patients receiving IL-2 was 5.5, which is similar to the six doses that patients have received with melanoma, suggesting that patients can really tolerate the IL-2 in lung cancer. Here shown is the table of the efficacy data. I'll summarize the data both in the full analysis set and the efficacy evaluable set. The overall response rate was 21.4%. This includes six partial or complete responses. We had one patient with a complete metabolic response, five patients with partial responses, and there were 12 patients with stable disease. In the efficacy evaluable set, the patients who were able to undergo imaging and follow-up, the overall response rate was 25%, and the disease control rate was 75%. It's notable that, you know, all responders received 2 or greater prior lines of systemic therapy. The median time from resection to infusion was 35 days, and the median time from infusion to best overall response was 2.2 months. Here also highlights the best percentage change from baseline and target lesions in the sum of diameters and efficacy evaluable set. As you can see from this figure, most patients had some degree of shrinkage in their target lesions. Here shows more granular details of time to first response, duration of response, and time on efficacy assessment for confirmed responders who achieved PR or partial response or better. As you can see, most patients received two or greater lines of therapy. Three patients who had received prior checkpoint inhibition had progressive disease as their best response. PD-L1 expression ranged from 0 to greater than 50%, and two of our responders had PD-L1 negative, including the patient that had a response now ongoing past 20.7 months. One patient continues to have a duration of response at three months, which we'll talk more about on the next slide. Here tracks the patient's target lesions at each assessment. The patient I want to highlight is patient 17. As you can see, this patient has had a deepening response over time. Technically wasn't called a partial response until many weeks into treatment, but has clearly had clinical benefit for six plus months at this point in time. In summary, this is a signal-finding study which demonstrated feasibility of tumor harvest, TIL manufacturing, and TIL treatment in patients with advanced non-small cell lung cancer. The patients tolerated surgical resection, including pulmonary lesions. TIL manufacturing was feasible for most patients, and one-time treatment with LN-145 treatment with conditioning regimen was well-tolerated. Moving forward, we'll TIL cell therapy is a potentially viable treatment option for patients with advanced non-small cell lung cancer. The study IOV-LUN-202 was designed to enroll patients with lung cancer with an unmet medical need, but with fewer prior lines of therapy to maximize the potential for more sustained responses. Thank you very much, Dr. Schoenfeld. We are very encouraged by the Cohort 3B data and our advancement of TIL in non-small cell lung cancer. Right now, in the IOV-LUN-202 study, the design of which is shown on this slide, we have treated patients and plan to enroll approximately 95 patients. This is a second-line patient population that has received only one prior line of therapy with immune checkpoint inhibitor plus chemotherapy. We have excluded driver mutations. The two main cohorts in the study are further divided by PD-L1 high and low status prior to their first line of therapy. We have a third cohort that will receive TIL harvested from biopsy and manufactured our 16-day Gen 3 manufacturing process. Given this patient population has less prior treatment, we believe TIL has the potential to deliver more responses with longer durability. We also continue to enroll even earlier ICI-naive patients in our ongoing basket study to receive TIL plus pembrolizumab. Overall, we are confident and committed to advancing both TIL alone and TIL combinations to address multiple non-small cell lung cancer patient populations. Next, I would like to turn our attention towards the clinical data for TIL plus pembro in advanced solid tumors. We believe the clinical data validates the combination of checkpoint inhibition and TIL cell therapy as a potential platform in solid tumors. We know that novel early line combination therapies are needed for patients with solid tumors to improve rate and depth of responses with manageable long-term safety. In the ICI-naive setting, TIL and pembro produced encouraging efficacy with expected safety in patients with advanced melanoma, head and neck cancer, and cervical cancer. An ORR of 57% in cervical cancer, 60% in melanoma, and 39% in head and neck cancer represent a meaningful increase in responses versus pembrolizumab alone. Early line treatment with single-agent pembro achieved an overall response rate of 33% in patients with advanced melanoma and 17% in patients with head and neck cancer. Cervical cancer patients previously treated with standard of care chemotherapy achieved an ORR of 11%-14% with pembro monotherapy. Notably, the 30% CR rate in melanoma compares to 6% CR rate for pembro alone. We also note that one unconfirmed CR and two metabolic CRs have converted to three confirmed CRs per RECIST 1.1 in this data cut. Overall, these data support continued development of TIL combinations as earlier treatment in melanoma, head and neck, cervical, non-small cell lung, and other solid tumor cancers. Now I am pleased to welcome Dr. David O'Malley to summarize the data from his oral presentation at SITC. Dr. O'Malley is Professor of Obstetrics and Gynecology at the Ohio State University College of Medicine and the Division Director of Gynecologic Oncology within the Ohio State University Comprehensive Cancer Center, James Cancer Hospital and Solove Research Institute. During his tenure, he has developed the Gynecologic Oncology Division into one of the premier clinical research programs in the country. A talented surgeon and clinician, Dr. O'Malley has been a productive investigator, having published over 150 articles in the most prestigious medical and oncology-focused journals. He has served as principal investigator for multiple national and international trials, including the C-145-04 study in cervical cancer. Dr. O'Malley? Well, thank you, and thank you for that wonderful introduction. I just looked at that picture myself and remember when I used to have hair and my beard was black. With that, I wanna start with the background. Immune checkpoint inhibitors have become the standard care for treating patients with a variety of advanced cancers, as you know, including melanoma, head and neck cancer, and cervical cancer. Lifileucel and LN-145 are one-time autologous adoptive cell therapies using TIL that have demonstrated encouraging efficacy and acceptable safety as monotherapy in clinical trials of these patients in the post-checkpoint inhibitor setting. Earlier line treatment with a single-agent pembro has demonstrated about 33% objective response rate in patients with melanoma and 17% in patients with head and neck cancer. To provide an earlier line treatment option we explored TIL cell therapy with lifileucel or LN-145 combined with pembro in patients with checkpoint inhibitor naive advanced melanoma, head and neck cancer and cervix cancer. IOV-COM-202 and C-145-04 are ongoing phase II multi-center, multi-cohort, prospective open-label studies evaluating TIL cell therapy in patients with solid tumors. We report efficacy and safety from Cohorts 1A and 2A of study IOV-COM-202 and Cohort three of study C-145-04, which are enrolling patients with melanoma, head and neck cancer and cervical cancer respectively. Patient inclusion criteria and study endpoints are included in this slide. Both trials assess safety and efficacy. It is important to note that 1.5 cm resectable lesions need to be present in addition to the RECIST 1.1 measurable lesion. Here is the study schema. Treatment included tumor resection for TIL manufacturing, followed by one dose of pembro, then non-myeloablative lymphodepletion, followed by TIL infusion, up to six IL-2 doses given every 8-12 hours. After the patient has recovered from side effects, the pembro is continued for up to 24 months. As we move to the baseline demographics. At UC as of September 22, 2021, 10 patients with melanoma, 18 patients with head and neck cancer and 14 patients with cervical cancer were enrolled and treated in these cohorts. As shown in this table, patient characteristics at baseline were consistent with the requirement of checkpoint inhibitor naive disease for patients with melanoma and neck cancer, and the requirement for only chemoradiation or surgery for local regional disease for patients with cervical cancer. Despite relatively early line treatment, patients had a higher tumor burden at baseline, and all patients in the cervical cohort had distant metastases at the time of study entry. Here we see treatment emergent adverse events reporting greater than or equal to 30% of patients overall. Treatment emergent adverse events were consistent with the underlying advanced disease and known safety profiles of pembro and non-myeloablative lymphodepletion, as well as IL-2. five grade five events were reported. All were assessed as not related or not likely related to TIL or pembro therapy. Two were felt to be related to lymphodepletion, and one was related to lymphodepletion and IL-2. Two were felt to be unrelated to treatment. Here we see the frequency of adverse events over time separated by cohort. AEs were generally transient and temporally associated with pembro, lymphodepletion and IL-2 administration. Most events occurred prior to or within the first two weeks after the TIL infusion. The mean number of IL-2 doses was five or 5.5 in each cohort. In the full analysis set, which consisted of all patients who received TIL therapy and pembro, the objective response rate as assessed by investigator was 60% in the melanoma cohort, 39% in the head and neck cohort, and 57% in the cervical cohort. Of note, the complete response rate in the melanoma cohort was 30%. In the efficacy evaluable set seen on the bottom two rows, which includes only those patients who reached the first efficacy assessment at the time of the data cut, the objective response rates were 67%, 44% and 57% respectively. The median study follow-up was 11.5 months for melanoma, 7.8 for head and neck, and 7.6 months for cervical. The waterfall plot of best overall response by cohort demonstrates that nearly all of the efficacy evaluable patients had some degree of reduction from baseline tumor burden. The green bars represent patients achieving a complete response. Hash green denotes unconfirmed complete response. Blue indicates partial response, and hash blue indicates unconfirmed partial response. It's important to note that these unconfirmed responses were at the time of the data cut, meaning they had not yet had their confirmatory CAT scan. In this figure, we see timed response and duration response. The timing of pembro doses are indicated with blue circles. Time to response was typically by first assessment at around week six after TIL infusion, with several deepening over time as indicated by the blue and green triangle. Most responses were ongoing at the time of the data cut off, as you can see by the arrow. These spider plots show percent change from baseline in target lesions for each individual patient, colored according to their best response. Patient responses were durable and deepened over time for many patients. In conclusion, the combination of lifileucel or LN-145 plus pembro produced encouraging efficacy with expected safety in patients with advanced melanoma, head and neck cancer and cervical cancer in an early line setting. Notably, nearly all efficacy evaluable patients experienced a reduction in tumor burden. Very important to note, nearly all efficacy evaluable patients experienced reduction in tumor burden with objective responses per investigator assessed RECIST 1.1 observed in 39%-60% of patients. Rates that are similar to prior reports for the combination and that are somewhat unprecedented in some of these tumor types. This included a 30% complete response rate in the melanoma cohort. With these data, we now have support for the efficacy and safety of TIL cell therapy with lifileucel and LN-145 in multiple solid tumor types and lines of therapy, both as a monotherapy in combination with checkpoint inhibitors, strengthening the promise of this potentially best-in-class IO combination for patients with advanced cancer. The combination of TIL checkpoint inhibitor warrants continued investigation in patients with advanced cancer in the ongoing studies. Thank you for your attention. Thank you, Dr. O'Malley. Following the data summaries from SITC, I would like to ask Madan Jagasia, our Senior Vice President of Medical Affairs, to lead a panel with Drs. Schoenfeld and O'Malley, as well as Dr. Omid Hamid, who is here to offer his perspective on melanoma. Madan? Thank you, Friedrich. I'm pleased to moderate a brief panel today to hear further perspectives on unmet need and the potential for TIL to address some of these needs. As Friedrich mentioned, Drs. O'Malley and Schoenfeld will also be joined by Dr. Hamid. As the director of the Melanoma Center and phase 1 Immuno-Oncology program at The Angeles Clinic and Research Institute, Dr. Hamid has been instrumental in bringing new therapies from the investigational lab to the clinic for patient benefit, including immuno-oncology therapies such as PD-1 inhibitors and other checkpoint inhibitor therapies against tumor angiogenesis and targeted agents. He has presented research done at The Angeles Clinic at major national and international meetings and published manuscripts, abstracts, and reviews on immunotherapy, targeted therapy, and melanoma care in prestigious journals. Dr. Hamid has been a principal investigator in our C-144-01 clinical study and lead author on several other publications and presentations at medical meetings. I would first like to ask each of you what you believe are the most significant unmet needs in cervical, melanoma, and non-small cell lung cancer. Dr. O'Malley? The greatest unmet need is curing more patients, and particularly in those front-line patients with metastatic and recurrent disease. The first line setting, identifying patients who are going to benefit more and are cured of their disease, followed by post-IO treatment. For those who've been exposed and have already received IO therapy, then what are the next options for those patients? Thank you, Dr. O'Malley. Dr. Hamid? I would agree with what Dr. O'Malley has said, but in melanoma, we have a little bit more data to go on. I think in the refractory population, so those that don't ever respond to PD-1, we're having issues in finding the appropriate therapy. From the initial trials, in melanoma, we're seeing high response rates on patients whose best responses to PD-1 therapy were progressive disease. That's where I think, you know, the bright light of this therapy, it shines for melanoma. Additionally, we'd like to have therapies that, in the first line, bring us closer to a durable response. What we're learning in melanoma, understanding what types of therapies you get, is that those patients who get a complete response or a deep partial response that's negative on PET, those are the ones that do the best in the long term, and that's what we're seeing in the first-line combination trial. Additionally, we'd like to decrease toxicity. Unfortunately, the combination that's leading in melanoma, despite giving us high response rates and durability, is associated again with 55% grade three or four t oxicity. That's also important in melanoma, where chemotherapy is not the major therapy and targeted agents are being pushed further and further back. If you have a toxicity in your first-line therapy, that all but ensures that you are excluded from clinical trials moving forward. What we're seeing with this PD-1 Iovance trial in the first line is lower toxicity, higher response rate, higher complete response, and the hopes of durability. Thank you, Omid. Dr. Schoenfeld? Thank you. Yeah, I agree with the other two speakers here. I think there are trends that cross across tumor types. In lung cancer, if we look in the metastatic setting, immunotherapy with or without chemotherapy has really revolutionized the treatment of patients in the first-line setting. Most patients still really do not respond to treatment or they develop resistance over time. The objective response rate is less than 50%. It's worse for patients who are PD-L1 negative or PD-L1 low. The median duration of response is less than a year. In the second and later line setting, first we you know are resigned to single agent primarily single agent chemotherapies that have a really poor response rate and high toxicity. I think a great place that we need newer therapies is in the second line setting. There's been numerous trials of other immune modulation that unfortunately have not had success in lung cancer to date. I think this is an opportune time for innovation in lung cancer in that setting. Thank you, Adam. Given these unmet needs that you've described, as well as your experience with TIL, how do you believe TIL may fit into your practice? I will note that each of you is involved with a lot of clinical studies to investigate promising agents. For the purpose of today's call, I will ask you to speak specifically to TIL. Question to you, Dr. O'Malley, where do you believe TIL may fit into your practice? Yeah. You know, there's a lot of discussion after the oral today with some of the most recent data, KEYNOTE-826, and looking at the combination of platinum doublets with IO plus or minus bevacizumab. You know, and it's important to note that that indication was only on those PD-L1 positive patients. So clearly the first-line setting PD-L1 negative, but also the chronicity of therapy which is required is quite challenging, particularly in cervical cancer patients that are really under-resourced. So in some ways, a more intensive therapy that could be completed sooner may be quite beneficial to patients. Obviously, as I said earlier, the post-IO exposure, you look at those patients who go on to require systemic therapy, that about 80% of them had local regional disease to begin with. Those patients, if one of these several trials which are ongoing are positive for local regional disease, will all be exposed to IO therapy. Once again, that post-IO exposure is going to be so important, as Adam was saying, in that second line and greater, and to offer options. I mean, you know, I think Omid Hamid eloquently said with regards to our patients who don't have a response, we all see those in our practice across our solid tumors. Excellent. Omid, back to you. How do you believe TIL may fit into your practice? Well, it's not a belief. I've been told by my patients that TIL is fitting into my practice. They are voting with their feet. It's the durability of response, the high response rates post-failure of a PD-L1 containing regimen. The indications from our initial trials in patients who have seen anti-CTLA-4, anti-PD-1 and the targeted agent makes this a very viable option for patients and one they are looking for every day. Where it'll fit in our research program is that it will push other agents aside as we work together to find the optimal therapeutic regimens and combinations that will increase benefit and durability for patients. I love what Dr. O'Malley said, the ability to get a dose-dense regimen in and be done with it. The concern for our patients is that they will continue to have decremented performance status, and they understand that this type of therapy should be moved earlier in their therapeutic regimen. That's what they're telling us. Excellent. Thank you. Adam, where do you think TIL fits into your practice in lung cancer? Thanks. Yeah. I think the most obvious place to start in lung cancer would be after treatment with immunotherapy with or without chemotherapy. In the second line setting where our treatment options are incredibly limited. I think that would be a great place to start. But I honestly think there are multiple places that TIL therapy could be used. You know, lung cancer is a very heterogeneous disease, and there's multiple different subtypes. There's groups of lung cancer patients who have oncogene drivers such as EGFR, ALK mutations, who traditionally do not respond to checkpoint inhibition. There's also patients who are PD-L1 negative who traditionally do not respond to checkpoint inhibition. I think those are also great places to explore the use of TIL therapy. I think the early data really suggests that the traditional biomarkers of response to checkpoint inhibition may not translate to TIL therapy. I think all of those places are good places to start. Excellent. Thank you. We'll turn it over to the operator to read the Q&A instructions. Your first question comes from the line of Mark Breidenbach from Oppenheimer. Please go ahead, sir. Hey, good evening. Thanks for taking the question. Just a couple of quick ones for me. First of all, to Dr. O'Malley, I'm wondering, in the cervical trial, did the responses you saw depend on PD-L1 expression? You mentioned PD-L1 negativity as an area of potential unmet need, given recent changes in the landscape. A second question for me is, with regard to the lung cohort. There was a fairly high fraction of patients screened for enrollment but did not meet eligibility criteria. Then there was another drop off in patients who had tumor resected versus those who actually received treatment. Perhaps you know in Iovance or the panel can comment on the main reasons for screening failures as well as dropouts from the intent to treat population and how this level of attrition compares to what you've seen in other TIL trials. Trying to get a sense if it's very indication specific or not. Thank you. I'll start. David M. O'Malley. You know, I think as we look at this in a cervical cancer cohort when in the first line setting, there's only 14 patients. At this point we have not reported with regards to PD-L1 positive, negative and response rates. As you did see that there were patients included. To break those down right now I think would be premature with such small numbers in this initial cohort. Obviously in time, we'll report those in the larger cohorts and look forward to looking at that data in the future. Any comments from you, Frederick? Okay, good. Adam? Great, yeah. I can go through both the screen failures and then the patients, the 11 patients who do not receive treatment. The screen failures to me is not surprising. You know, it shows there's a demand for the study, and that the need for, you know, when we're first exploring TIL therapy in a new patient population, the need to abide by our inclusion and exclusion criteria. Patients didn't meet inclusion or exclusion criteria did not move forward with the study. I think that's just totally appropriate in this case and doesn't seem surprising to me. In terms of the 11 patients that did not receive TIL therapy among the 39, I think breaking it into separate categories is helpful. There were five patients, only five patients, who did not have TIL available. Among those patients, three had potentially low or very low TIL infiltrate. One was contaminated, and one was necrotic per the site, but the manufacturing was attempted, and no TIL was present. And then there were six other patients that did not receive TIL. Two had progressive disease. One passed away. And two decided, you know, for other reasons to not take part, and one patient had an adverse event. I think it's helpful to break it into those two separate kind of sub-cohorts of patients who didn't go on to TIL. Is that sort of representative or typical of other TIL therapy trials? You know, typically, I think the manufacturing rate's been, you know, 90 or 90%, and this is 87.5%, which in lung cancer I think is really good. I think it'll be interesting to see in IOV-LUN-202, if you have an earlier, you know, patients who are earlier on in their treatment, whether you might have a higher manufacturing success rate. I think exploring if there are any sites of disease that potentially could be associated with manufacturing failure. But what we really saw is that you can manufacture from lung sites in most patients. You know, I think the success, the manufacturing success rate was very high in my opinion, and on par with other studies. Thank you. Yeah, then the other question that you had was just, you know, other causes. Some patients are going to progress between the time of TIL and of resection and treatment. There were a few patients that happened to. Understood. Your next question comes from the line of Boris Peaker from TD Cowen. Please go ahead, sir. Great. I have two questions. Let's start with maybe Dr. O'Malley. Dr. O'Malley, in melanoma in Cohort 1A, we saw a response rate of 86% or six out of seven responders. That was back at ASCO. Now we're up to 10 patients, and there are still only six responses, which is why the response rate declined to 60%. I'm just curious, can you say whether the newly added patients had enough follow-up to confirm whether they are responses or not, or there was just not enough follow-up to make that assessment? Yeah. Go ahead. Yep. I think this is Frederick. I think so maybe I can answer that. So you are rightly pointing out what has changed from last time when we presented this data, and you're right. We added three patients to the study. In the meantime, with these three patients, we had reported an abstract at which we reported one additional responder with that one added patient. That additional responder did not confirm, so that's one of the stable disease patients. Then the other two patients that we added also are stable disease. You rightly point out these are most recently added just between the last time we presented and the time we published the abstract and now this presentation. There is room. We do see responders that happen over time, so we do need more follow-up here. Great. My next question is maybe broadly. You know, we always talk about partial responses and complete responses, and understandably, those are very meaningful results. There's a lot of patients that are getting stable disease here. I know in chemotherapy, stable disease maybe is not counted for a lot, but I'm just curious, in TIL therapy or immunotherapy in general, how valuable is a stable disease patient? How durable are these stable diseases across various tumor types? I'm not focused on any particular malignancy. Yeah, this is one thing that we struggle with all the time, is what to make of stable disease. There's probably a group that biologically is responding and a group that is biologically slowly progressing. How do you distinguish those two? What is the best criteria really to use in immunotherapy for measuring response? I think you know in lung cancer I can say that stable disease that over long periods of time is clinical benefit. You know patients who have some degree of tumor shrinkage and stability and maintain their performance status I consider that valuable clinical benefit the patients are having. I think it's really tricky in some of these cases to use, you know, duration of response as a surrogate for clinical benefit because, you know, as we saw with some of the patients in lung cancer, the responses can deepen over time, and so your duration of response is going to be more limited too. I would just like to point out that in the melanoma experience, we have extensive reviews to evaluate what stable disease, partial response, and complete response mean based on the KEYNOTE trials with anti-PD-1 that's been published and in the CheckMate trials with combination with anti-PD-1/CTLA-4. It really shows that those patients who have confirmed stability ongoing do worse in the long term than patients who have a good partial response. Again, the best are patients who have a complete response. What we have now are turning to is trying to get our patients, even those who are on a therapy with a stability of disease, into a deeper response and that may translate into greater benefit. The 30% CR rate here is important. The ability to bring TIL in heavily pretreated patients to get them to CR, as we've seen that in our trials, is important. Additionally, this trial initially looked at those patients who didn't achieve a radiographic CR and had a PET CR. In our experience, a PET CR is equivalent to a radiographic CR. That speaks to the benefit of this regimen and this combination therapy. The only thing I'd add to my esteemed colleagues is, you know, that question and one of the things I drew the attention to the waterfall plot, that the stability of disease, the patient with disease regression clearly is a clinical benefit. Ultimately, the duration and potentially impact on survival will be the gold standard factor. When you're seeing regression disease, you're seeing symptomatic improvement, and improvement in the quality of life that we know that if we shrink disease, patients have better quality of life, even though it doesn't meet that bar of 30% that the agency holds us to on the PR. It's a very good point. Ultimately, the clinical benefit in that, in a continued sustained stable disease can be important to impact. Walter, Friedrich has a comment on this as well. Friedrich? Yeah, I just wanted to point out two observations in our programs where I just wanted to pick up on something that Dr. Hamid said about metabolic CRs. We are now seeing examples where patients with initial metabolic CRs are converting to complete radiographic CRs as well. I think that is important to know. Obviously, one of the values of PET imaging and looking at metabolic responses that we're seeing things a little earlier, I think that's important background as you're looking at some of the data that we're generating with that modality too. Excellent. Thank you. Great. Thank you very much for taking my questions. Your next question comes from the line of Michael Yee from Jefferies. Please go ahead, sir. Hi. Thanks. Good evening. Question on lung cancer and then a question on melanoma. In lung cancer, maybe it's for Dr. Schoenfeld, could you comment about your thoughts around the second line data in the context of, for example, other alternatives such as chemo? How, you know, how do you expect second line to play out ultimately here if this data went to a pivotal study? Yeah. Then what is your read-through to first line, which is ongoing with PD-1, given all the data to date, how are you thinking about first line and the results from PD-1 combo? I'll follow up with melanoma. Yeah. Yes. This to me is really a proof of principle, a signal finding study, you know, in a really heavily pretreated patient population. You know, I can speak from my personal experience that I had patients that were extremely heavily pretreated and barely met the inclusion and exclusion criteria and were progressing quite quickly. One patient has, you know, an ongoing response for many months now off of any treatments, with the patient that's had the deepening response. Another patient who, you know, had a partial response for or PFS for essentially six months continues to have benefit. That's just not the type of benefit we see with chemotherapy. I'm really excited to see, you know, what will happen when we go into the second line study, the IOV-LUN-202. If we have a healthier patient population combined with a TIL product that's probably less exhausted and more of a stem or memory-like phenotype that maybe we'll get a higher response rate, more durable responses. But honestly, it's six patients, and to see this durable response greater than close to two years and another one that's ongoing, you know, patient now for nine to 10 months is really exciting to me. It's on par with what Ben Creelan saw in his Nature Medicine paper, where he saw two complete responses as well for greater than a year. I'm very excited about the second-line space here, and I think it could be a huge contribution to patients. For the first-line setting, it's a totally different story. I'm just interested to really see the dynamics of combination with PD-1 blockade, similar to what they've shown here in melanoma, cervical cancer. You know, potentially it can be synergistic, and you know, add benefit. You're additionally getting patients who are earlier on their treatment regimen and less treatment-exposed, and Ben Creelan's data in Nature Medicine, these are patients who are not PD-1-experienced, so you're getting that type of data as well. It'll be interesting to compare and look for in both settings. My question for the, for melanoma, and maybe it's for the company. Can you just remind us about the ongoing pivotal Cohort 4? What have you said about timing and guidance of finally releasing those results? I know you had disclosure back in the past. I know there's been some comments in the 10-Q filings as well about Cohort 4 versus Cohort 2. Because investors ask questions about it, could you just remind us how you think about Cohort 4 and when the data would come? Thank you so much. Sure, Michael, this is Fred. I can answer that one. That, that's tied to our IRC reads in the process of filing our BLA. The plan there is to basically commence that work and then at some point we'll have the IRC read Cohort four data set in a condition that we could put it out. Of course that'll be also the, you know, the play for the BLA. That's timed to our BLA timings, which are first half of next year. All we can say right now is stay tuned and we'll hopefully have more information pretty soon on that. Thank you. Your next question comes from the line of Reni Benjamin. Your line is open. Hey, good afternoon, guys. Thanks for taking the questions and congratulations on the data. A couple from me. You have several unconfirmed CRs and PRs as of the data cutoff. I just wanted to know, have they subsequently been confirmed? Number one. I know that you had talked to the panel about where, you know, TILs might ultimately find their way in each indication. I'm just kind of curious how the physicians might ultimately choose between either mono or combo, you know, as they evaluate, you know, kind of both within each therapeutic indication. Kind of finally, can you talk a little bit about the grade five events? What is happening there? Is there any learnings there that you might be able to. Anything you might be able to implement to mitigate that? All right. We have three questions. The first is, the unconfirmed PR, unconfirmed CR. I'm going to give that to Friedrich to try and tackle that. Yeah, we haven't cut the data. We haven't cut the data yet again, so I don't think that I can comment on this. Again, what you have to keep in mind as we are presenting data like this, we're cutting a live database. These patients are under observation. They are sometimes in for kind of their first assessment. We are following them. Many of these patients are confirming, but I can't comment on the data as we have them right now. Okay. The second question that was posed is, and I'll probably pass that over to Dr. Hamid for melanoma, is TIL monotherapy versus TIL as single therapy, how do you sort of compare and contrast? How would you be using that? I think at this point, TIL availability is how you will compare and contrast that and a discussion with patients. We're open to a clinical protocol that would allow us to do up front TIL therapy after an extensive discussion about options with patients. As you'll know, in melanoma, there are approved first line therapies and multiple clinical trials. It's an extensive discussion with patients and also in patients who are willing to have the resection and wait to begin. We've shown that we can turn it around within three weeks. We've shown that you can harvest from any site and get a viable TIL, and it is something that is in the forefront of their thoughts. I would say that it's only limited by the availability of the clinical protocols and the slots on trial at this point. Thank you, Omid. I can take, Michael, the Grade five event. I think their question is probably at the presentation on the TIL plus pembro. We had a total of five Grade five events. One Grade five event was in Cohort 1A, where it was attributed to sepsis, for sepsis to be related to cyclophosphamide, fludarabine, and IL-2, and not attributed to TIL or pembro. The four patients were in the head and neck cohort, Cohort 2A. These patients actually fall in sort of, you know, two sort of themes. There are two patients which have progressed beyond. Let me just back up a little bit. Our definition of treatment emergent adverse event varies by the protocol. In the single therapy arm, the definition of treatment emergent adverse event is from TIL infusion until day 30 post-TIL. In the combination arm, since the intervention starts with the pembro after harvest, the clock starts there. Since these patients continue on pembro after the TIL infusion, the time horizon continues. You've got more opportunities to quote-unquote, "be classified as a treatment emergent adverse event." Keeping that sort of context in mind, I think it's important to kind of keep that. In the head and neck, there were two events that were deemed related to Cy/Flu, but not TIL, pembro, or IL-2, and that there were two events that were unrelated to any study therapy that basically happened one at day 62 and the other at day 212. These were late events not attributed to the regimen at all and attributed just to the disease. Yeah. The only thing I would add to is that last point's important, which is two of the five seemed to be clearly related to disease, but with the way they're reported, they look like they're treatment related. That really leaves the three patients, as we said, you know, and we continue to move forward with supportive care in this technology, particularly on the IL-2. As we look at these patients, that is often where we have the toxicities. Additional knowledge as we move forward will be very important with regards to the management of toxicity of the IL-2. Got it. Just in the non-small cell lung cancer study, just a quick one. I think during the presentation you mentioned that some of the patients had brain metastases, you know, coming into the study. Do you have any sort of analysis or any thoughts regarding TIL's impact on brain metastases? Thanks. This is Madan Jagasia. I don't think we have the data currently in non-small cell lung cancer, but actually, at the presentation, Stephanie Goff presented just prior to Dr. David O'Malley and actually showed data that in melanoma there is documented in literature that brain metastases can regress after TIL therapy. We know that the TILs actually cross the blood-brain barrier and can quote-unquote "affect responses" intraparenchymal in the brain. That's been reported. That was really interesting because obviously that's a concern for us with regards to the crossing into blood-brain barriers. That's from a proof of principle standpoint is extremely important as we move forward. Perfect. Thanks for taking the question, guys. Your next question comes from the line of Peter Welford from Jefferies. Please go ahead. Hey, thank you so much. I guess a couple of questions on lung data. Just your thoughts on the initial durability and what you think could be impacting durability, if that's kind of the factor in late-stage patients and open up another follow-up. Let me restate the question, Peter, to make sure I got this right. The question is what are the factors that may impact durability? Adam, would you like to have that? I think one thing that potentially will impact durability is the number of prior lines of therapy the patient has had. You know, unlike in melanoma, these patients are typically treated with multiple chemotherapy regimens in addition to immunotherapy. By the time they were enrolled on the trial, their poor performance status could have been quite limited. I think that also could potentially affect the phenotype of the TIL product as well. I think earlier TIL resections could potentially have, you know, a more active TIL product as well. Additionally, you know, still with that, I thought the durability is actually quite impressive in some of the patients. They're, you know, looking at the patient with a complete metabolic response, who's had a response ongoing for 20-plus months. The other patient who's had the deepening response that's ongoing. If you really look at, I think a better thing to look at than even the duration of response is the progression-free survival at the time to the next treatment regimen. I think those are definitely better than what you would see with chemotherapy regimens. I just will add it. The same question could be asked, the data which I presented, and it's really important to keep in mind this is our median follow-up is quite short, with melanoma 11.5 months and 7.5, about 7.5 on head, neck, and cervix. Very, you know, preliminary data with regards to this earlier lines of therapy. We, as you can see in the swimmer plot, with the arrows, most patients with the PR or CR are ongoing at the time of this data cut. Great. Thanks much. Just, I guess, a follow-up just around tumor heterogeneity and the location of the tumor and if that impacts the TIL efficacy and if you think that's worse in whether it's lung or head, neck or melanoma. Any comment about that would be great. Yeah. Peter, I can take that. As we had reported at ASCO 2021, when we looked at Cohort 2 66 patients, we classified the anatomic site of resections to skin subcutaneous, lymph node, and visceral organs. The site of anatomic resection did not influence either the TIL dose, or the TIL dose did not affect the sum of diameter change. At least in that limited data set of melanomas where we've looked at this very systematically, we could not see an impact of the anatomic location on the TIL dose or efficacy. Obviously important question moving forward across, especially across tumor types, and we'll be able to learn from each other with regards to the heterogeneity as well as the best areas for resection moving forward. Excellent. Do you think that site of anatomical location is also important for lung cancers? I think it's definitely possible it could be. I think it's something worth, you know, looking into more deeply in the LUN-202 cohort. My feeling though is probably more exposure to prior therapy is a bigger component that was at play here. Omid has a comment. Go ahead. Yeah, I would agree with that. I think we've at Angeles harvested from multiple sites and had no issues and actually re-infused in a patient after progression on melanoma and reharvested a site after multiple- Mm-hmm. immuno-oncological and chemotherapeutic treatments. I have no doubt that we'll find more and more that as the patients are more heavily treated, that their T cells will be more exhausted and that it would be a difficult T cell Great. Thank you so much. Thanks for hosting the call. Your next question comes from the line of Benjamin Burnett from Stifel. Please go ahead, sir. Hey, thank you very much. I had a question for Dr. O'Malley on cervical cancer. Can you talk about the standard of care? I think your kind of alluded to this a little bit before the Q&A, but just the extent to which you use or plan to use chemo plus pembro. And then also for the company, is there an appetite to maybe look at a triplet of pembro chemo and TIL in cervical cancer? Well, as you know, the landscape in cervical cancer is changing rapidly, particularly the KEYNOTE-826, recent both leading to approval as well as the recent report in New England Journal of Medicine article. The upfront therapy with pembro is clearly going to be impactful in moving forward into where TIL therapy will fit. If that will fit to as an adjunct versus replace or an after IO therapy. That's obviously extremely important moving forward for positioning and patient selection. Friedrich's got a comment. Yeah. I can maybe comment on your question around the combination triplets. That would mean having to identify a rational sequence and a rational timing of the TIL regimen versus chemotherapy. That's something that we have not done yet. We would have to think about how to line this up, but I do think there are options that we could consider. Keep in mind what we have to do, thinking about the ability to harvest tumor, having T cells around that are not infected by the chemotherapy. It's something that we're considering and thinking about. Okay. Very helpful. Just one quick question, doctor, for Dr. Schoenfeld. I think this question was asked in regards to cervical cancer, but were there any trends in response or durability in the lung cancer cohort with PD-L1 status? You know, there were responses across PD-L1 status. There were two responses that were PD-L1 negative. There were responses that were PD-L1 low, and there was responses that were PD-L1 high. I think the biology of TIL therapy, that makes sense to me, that PD-L1 expression may not be a good marker, a predictive marker like it is for checkpoint inhibition. That would be consistent with our observations in melanoma, right? We have, I think now a very healthy data set there in which we show that PD-L1 status is in a way predictive for benefit from TIL therapy. Which speaks to TIL therapy being a differentiated immunotherapy mechanism of action. It works differently, and it doesn't have the same tendency as immune checkpoint inhibition. I would say it also speaks to the fact that these are going to be biomarkers that will identify patients who are going to be resistant, primarily resistant, and that will move TIL into the first line for patients with melanoma. It is somewhat the rationale for the study design of IOV-LUN-202, where we have divided the cohorts by PD-L1 status prior to their first-line regimen. We are not expecting impact on the ability on the activity of TIL directly, but rather indirectly, possibly by determining the course of the disease and the response to first-line chemo immunotherapy. Very interesting. Thank you. Your next question comes from the line of Colleen Kusy from Baird. Please go ahead. Hi. Good evening. Thanks for taking our questions and for all the updates today. Looking at the TCR repertoire data from the later line lung update, the unique TCR clones look to be a little bit lower in lung than what you reported in melanoma and cervical. Just curious if you have any thoughts on what might be driving that and what kind of impact you think that might be having? I have a follow-up. Yeah. I wouldn't make much of that, to be honest. I think, you know, TCR repertoire data is interesting to look at, and this clearly shows there's a polyclonal population of cells that are, you know, there's 4,000 plus. You know, when I think TCR repertoire data and diversity data gets particularly interesting is when you monitor it over time and you see changes in diversity, and whether there's clonal expansion. I think this is a good, you know, place to start just to show us the polyclonal repertoire as we've seen with other tumor types. Really, you know, there's a lot more translational work and analysis that can be done from there. Colleen, this is Madan. Statistically, they are actually you know, they are overlapping. Even if you look at the clonality and the entropy index and the median number of clones, and I think we sort of put the footnotes over there in the poster. We benchmarked it against the cervical and the melanoma data on TCR that we had published a couple of years ago. It's completely overlapping, so I wouldn't make a statement that that is you know, lower in lung cancer. Okay, great. Thank you. That's really helpful. I think it was reported that there was an average day of 35 for the manufacturing from resection to infusion in the later line lung. Just curious as to, kind of the difference there between the 22 days expected for Gen 2. Yeah. 22 days, right, is the timeline, not including what, you know, operational workflow the institution has. Whether there's a bed available, when they can admit the patient, if they're allowing for, You know, lymphodepletion prior or after receipt of the product. It involves, you know, every component up until the treatment with TIL. To me, 35 days sounds pretty good and pretty short with a 22-day manufacturing process. Great. Thanks so much for taking our questions. Your next question comes from the line of Madhu Kumar from Goldman Sachs. Please go ahead. Hey, everyone. Thanks for taking our questions. I have a couple bookkeeping questions to start out with and then a couple bigger picture questions. Bookkeeping questions for the company, what fraction of the head and neck cancer responders had prior platinum chemotherapy? Frederick, if you want to take that. I think we can go to the slide. I think it's in the slide set over here. Let me just I'll kind of rewind back and keep going back again. Back. Right there. Okay. Madhu, for the head and neck, I don't have specifically for the platinum. I'm assuming most of them are platinum-based chemotherapy. 12 out of the 18 patients, 66.7% got chemotherapy. nine out of 18, 50% got radiotherapy. Does that help? No. I'm asking how many of the responders had prior chemotherapy? This is the number of patients who had prior chemotherapy. Got it. How many of the responders had prior chemo? I do not have that information, but we can certainly get that to you. Okay, awesome. Next question. How many of the cervical cancer responders had prior chemo- rad- therapy? Yeah, we didn't break down the cohorts with a very small number. You're talking 14 patients here. With regards to breaking it down the responders, we did not do that at this point. Okay. Cool. Bigger picture questions. The first one is, so it seems like a common theme among the physicians' commentary earlier on in this call was about the desire for limited duration therapy, where you give a treatment, then you can discontinue treatment. Is there a thought kind of following that about running kind of going forward, a PD-1 plus TIL combination trial with kind of defined stopping rules for the PD-1 therapy? And kind of where do you think that a regulator might sit on that type of a combination trial? All right. That I think, I mean, go ahead. Yeah, I'll take that. I mean, I think most of our clinical trials in melanoma are looking at two years, so it's the first tumor that has a stop time. Then there's multiple trials going through, looking at, you know, complete metabolic response if you could stop at one year. KEYNOTE-001 allowed you to stop after two, one or two imaging if you had a complete response. So, there's indication there. Unfortunately, you know, melanoma is a highly immunogenic tumor. You can't really translate that to other tumor types. I think the question you ask is a field question, as we find more durable responders, we will be able to start to think about holding therapy there and amending the trials to do that. In order to do that, you would require the trials that have high CR rates, and this is what we're looking for in these combo studies, such as the combo PD-1 and TIL. You know, when I think about cervical cancer patients, it's a great question with regard to impact and resource management. But I have to be honest, when I think about single agent immune therapy, I don't think of that as a regimen. I think of that as almost a maintenance. In that regard, when we're giving triplet therapy, it's a set of toxic triplet therapy and prolonged exposure on that, the toxicity and the quality of life impact is real. No, it's a dichotomy in thought. I probably should really think about the impact of our patients every three to six weeks coming in for immune therapy. It's a great question. A lot of the comfort will come from evaluating patients who've come off for toxicity and have durability. There's patients like that in your melanoma cohort who has stopped being treated but is still having a durable response. Once we see more of those in the PRCR setting, there will be that comfort level. Okay. Last bigger picture question is thinking about the cervical cohort, is there a plan to try to focus future patients into the kind of PD-L1 negative population going forward? At this point, those decisions have not been made. Obviously, with the changing landscape, bringing that information in from an investigator standpoint, I'll let the company speak on that. You know, I think as we see these patients, particularly post-IO, both PD-L1-positive and PD-L1-negative patients are going to be very important to continue to evaluate this exciting technology investigational agent moving forward. I hope they don't. I hope they continue to evaluate in a PD-L1-positive population, especially in the post-IO exposure. Yeah. I don't think we know that yet. I think the landscape is changing. Patients are going to go into different available standard of care therapies, and that's, to a certain extent, also going to determine the population enrolling into clinical trials. I think we're going to have to follow that, but at this point we don't know how that's going to turn out. Okay, great. Thanks, everyone. Your last question comes from the line of Joseph Catanzaro from Piper Sandler. Please go ahead. Hey, guys. Thanks for squeezing me in here. I'll try and keep it pretty brief here. One for the company. Just following up on this idea of number of prior lines of therapy and impact on T-cell exhaustion and quality of final TIL product. The lung cohort had a range of prior therapies, as few as one, as many as six. You know, recognize numbers are small, but do you see any indication that, you know, one prior line has a better phenotype than two prior lines? Maybe you could take that question across your entire experience, not just considering lung. Thanks. Yeah, I can take that, Joe. I think the translational studies in lung are currently ongoing. Based at least on our melanoma experience, we have not seen any specific phenotypes that correlate with prior lines of therapy. That's not to say that we won't see that in lung because the prior lines of therapy in melanoma are not cytotoxic agents, whereas in lung they're predominantly cytotoxic agents. I think stay tuned. Those translational efforts are ongoing. We also shouldn't disregard the fact that what prior lines of therapy are not just affecting characteristics and capabilities of the product, but also the patient's tumor microenvironment, right? Once we put the cells back into the patient, they are going to encounter the tumor microenvironment, which is very likely to have been shaped by prior therapy. It's difficult to really unravel this, but that is an important factor as well. We might not be able to pick up the impact of prior lines of therapy just in our product. Yeah. Okay. Got it. That, that's helpful. Appreciate you guys squeezing me in. Thanks. These are all the questions we have for today. I would now like to turn the conference back to Mr. Fred Vogt. Please go ahead, sir. Thank you again for joining the Iovance Biotherapeutics SITC update call. I want to give special thanks to Dr. Omid Hamid, Dr. David O'Malley, and Dr. Adam J. Schoenfeld for joining us, and congratulations to the Iovance team in putting together the abstracts, poster, and presentation for this year's SITC. Please feel free to reach out to our investor relations team if you wish to follow up. Thanks, everyone, and have a good evening. This concludes today's conference call. Thank you all for your participation. You may now all disconnect. Have a great day.