Iovance Biotherapeutics, Inc. (NASDAQ:IOVA) Q1 2024 Earnings Call Transcript

Iovance Biotherapeutics, Inc. (NASDAQ:IOVA) Q1 2024 Earnings Call Transcript May 9, 2024

Iovance Biotherapeutics, Inc. isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).

Operator: Welcome to the Iovance Biotherapeutics Conference Call to discuss the First Quarter 2024 Results and recent Corporate Updates. My name is Livia, and I’ll be your operator for today’s call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Please note that this conference is being recorded. I will now hand the conference call over to Sara Pellegrino, Senior Vice President, Investor Relations and Corporate Communications at Iovance. Sarah, you may begin.

Sara Pellegrino: Thank you, operator. Good afternoon and thank you for joining this conference call and webcast to discuss our first quarter 2024 results and recent corporate update. Dr. Fred Vogt, our Interim President and Chief Executive Officer will provide an introduction and summarize key updates on our U.S. Commercial launch of Amtagvi and our pipeline program. Jim Ziegler, EVP Commercial, will highlight our initial insights for the U.S. commercial launch of Amtagvi, in advanced melanoma. Dr. Igor Bilinsky, COO, will highlight commercial manufacturing and capacity expansion plans. Jean-Marc Bellemin, CFO will review our financial results. And Dr. Friedrich Finckenstein, Chief Medical Officer, will review key pipeline update including upcoming clinical data presentations at ASCO and new next generation approaches.

Dr. Brian Gastman, Executive Vice President, Medical Affairs; and Dr. Raj Puri, Executive Vice President, Regulatory Strategy are also on the call and available for the Q&A session. Earlier this afternoon, we issued a press release that can be found on our corporate website at iovance.com. 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 and transactions, revenue, commercial activities, clinical trials and results, regulatory approvals and interactions, plans and strategies, research and preclinical activities, potential future applications of our technologies, manufacturing capabilities, regulatory feedback and guidance, payer interactions, licenses and collaboration, cash position and expense guidance, and future updates.

Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time-to-time in our SEC filings. Our results may differ materially from those projected during today’s call. We undertake no obligation to publicly update any forward-looking statements. With that, I will turn the call over to Fred.

Dr. Fred Vogt: Thank you, Sarah and good afternoon everyone. I’m pleased to host our first quarter 2024 results conference call. This has been a decisive year for Iovance following our first FDA approval and strong start to the U.S. launch of Amtagvi for patients with advanced melanoma. We expect the positive momentum at Iovance will continue to build throughout 2024 as we ramp up the U.S. launch and execute across our broad clinical pipeline. To begin, we are very pleased that the high initial demand for Amtagvi continues to accelerate. Demand has increased month over month since approval and expected to grow further throughout the year. As of today, more than 100 patients are already enrolled for Amtagvi therapy and most are expected to be ready for infusion across the second and early third quarters of 2024.

In addition, more than 60 additional patients have been identified at ATCs and are expected to enroll soon. As existing and new ATCs continue to build experience, we expect patient enrollments to steadily increase throughout the year, supporting our expectations for sustained growth. As we anticipated, interest is very high on ATCs and they are demonstrating that they have the training, infrastructure and capabilities to treat patients with the Amtagvi, which Jim will further highlight. We remain on track to have 50 total ATCs by the end of this month. We also set a new goal of at least 70 ATCs by the end of this year, representing the largest ever number of ATCs for a cell therapy launch. We are pleased to see positive reimbursement trends, which is a key indicator for success and adoption.

Positive reimbursement decisions are supported by our clinical data and the recent addition of Amtagvi as the preferred second line or subsequent therapy in the National Comprehensive Cancer Network or NCCN guidelines. The time to treatment will accelerate as ATC has established a solid foundation for broad market access and reimbursement which will add to momentum. Jim will describe this in more detail. In terms of commercial manufacturing, we have two FDA approved manufacturing sites and sufficient capacity to meet near-term demand at launch setting a new bar for cell therapy launches. Our commercial manufacturing experience is very positive and is consistent with our prior clinical experience. We have successfully manufactured and delivered Amtagvi within our target turnaround time of 34 days.

ATC has observed sufficient availability of manufacturing slots and reported positive experience in the scheduling process, which is critical for broader utilization. We expect to have ample capacity to meet the anticipated ramp up in demand this year. Finally, long-term expansions are underway to more than double our currently built capacity for future growth. In addition to the U.S. launch, we are working to enter new markets that can more than double the total addressable advanced melanoma patient population for Amtagvi. Regulatory submissions remain on track this year in the EU, UK and Canada where we have the potential to begin driving significant additional revenue by the end of 2025. We also continue to advance and expand our robust and exciting pipeline including two registrational programs as well as new next generation approaches that Frederick will highlight on this call.

As a fully integrated company is executing the U.S. launch and developing a broad pipeline, Iovance is well positioned to remain a global leader in innovating, developing and delivering TIL Cell Therapy for patients with cancer. I’ll now hand over to Jim, our Executive Vice President of Commercial who will speak in more detail about our launch metrics.

Jim Ziegler: Thank you, Fred. We are excited about the potential for Amtagvi to transform the treatment paradigm in advanced melanoma. My objectives today are to highlight initial U.S. launch metrics, which are supported by robust demand among ATCs and patients as well as progress with payers. ATCs are the key driver of demand and patient enrollments for Amtagvi. Launching with 30 ATCs was a testament to the significant unmet need in advanced melanoma and each center’s high level of commitment to offer Amtagvi for their patients. Today, there are more than 40 ATCs and we remain on track to meet our goal of 50 total ATCs by the end of May. Due to increasing interest by hospitals that offer Amtagvi, we are now targeting at least 70 total ATCs by the end of the year.

As Fred mentioned earlier, ATCs have enrolled more than 100 patients for Amtagvi treatment. A patient enrollment is defined as an Amtagvi treatment decision by the provider and patient. The patient enrollment is followed by commercial payer, prior authorization and a scheduled tumor procurement for manufacturing. Based on the patient journey timeline Amtagvi infusion for currently enrolled patients would likely occur across the second quarter and early third quarter. In addition, existing ATCs are screening an increasing number of patients for treatment eligibility. With more than 60 patients currently in screening today, we expect a high conversion of additional patients to Amtagvi patient enrollment in the near-term for potential infusion in the third quarter.

We are observing month over month growth and we anticipate sustained growth throughout the year as the number of ATCs expand and there is broader utilization of Amtagvi. In the short time since approval, favorable reimbursement trends and medical coverage policies have set us up for success and broad access for patients. Early launch data indicates that more than 75% of patients enrolled for Amtagvi are commercially insured which aligns with our expectations. Thus far payers responsible for more than 200 million lives have approved at least one patient for Amtagvi treatment and notably 13 payers responsible for approximately 90 million covered lives have already published medical coverage policies that are consistent with label, clinical trials and the recently updated NCCN guidelines.

We expect the remaining payers to issue similar favorable medical coverage policies and that timelines for financial clearance will accelerate as more payers, issue coverage policies. In summary, we are extremely pleased with the early launch progress and we expect steady growth as ATCs gain treatment experience, our ATC network expands and community referrals increase over time. I look forward to providing future updates on these important ATC reimbursement and performance metrics. I would like to acknowledge the very talented cross functional teamwork at Iovance. I’m even more pleased in the deep partnerships our team has established with ATCs. Collectively, our goal is to broaden and accelerate patient access to Amtagvi. I will now pass the call to Igor Bilinsky, our Chief Operating Officer to highlight our manufacturing progress.

Dr. Igor Bilinsky: Thank you, Jim. Today, I’d like to highlight our current manufacturing capabilities, experience with the Amtagvi U.S. launch, as well as our capacity expansion plans to support significant further growth in demand that we anticipate in the U.S. from geographic expansion and from our exciting clinical pipeline. Manufacturing is a core competency for us at Iovance and we built our own manufacturing facility, Iovance Cell Therapy Center or ICTC in Philadelphia. ICTC is one of the largest cell therapy manufacturing facilities in the world and the only one specifically designed for TIL manufacturing. ICTC is now FDA approved for commercial manufacturing of Amtagvi for the U.S. market and continues to serve patients in our clinical trials in melanoma, lung cancer and other indications in the U.S., Europe, Australia and other geographies.

ICTC has been responsible for most of the commercial and tagging manufacturing volume to date. In addition to ICTC, the FDA approved our contract manufacturer site for commercial manufacturing of Amtagvi. Having two approved facilities provides us with additional flexibility and capacity for both commercial and clinical patients. Overall, we believe that our manufacturing capabilities and capacity are setting a new bar for cell therapy launches and we’re strategically planning ahead for anticipated demand in future. Turning to our early experience with commercial launch, we’re executing as planned. The commercial manufacturing experience to date is consistent with prior clinical experience. Turnaround time has been on target with initial launch expectations of approximately 34 days from receipt of tumor tissue to return shipment of Amtagvi to the ATC, which is then followed by lymphodepletion and infusion.

We are confident in our capacity to meet the current and projected demands of the U.S. launch in our clinical trials, as well as to support Iovance’s planned future growth. ICTC as built today has the capacity to provide TIL therapies for more than 2,000 patients per year. A competent manufacturing team is important in biotech and cell therapy in particular. Right now we are staffed appropriately for launch and we are continuing to add headcounts to meet the demand for commercial Amtagvi as well as for our clinical trials. To fulfill our staffing needs, the ICTC Philadelphia location provides access to talent with cell therapy and gene therapy experience at other companies in the region, as well as the next generation of talent through the local schools and resources.

In preparation for increasing commercial demand in the U.S. and additional geographies and in support of our advancing clinical pipeline, further capacity expansion is now underway at ICTC and is expected to be completed in a few years. Building out the existing shelf space of the facility is expected to enable ICTC to supply TIL therapies for more than 5,000 patients annually. Longer term, our vision is to supply TIL for over 10,000 patients annually from the ICTC accounts. We’ve an option to construct another building of the ICTC campus and plan to drive additional efficiencies by incorporating increased automation in our manufacturing process. In summary, our team is excited to provide Amtagvi and our investigational TIL therapies for patients with cancer.

We are laser focused on the quality of the manufacturing process in the spirit of doing everything right first time at every step from incoming receipt of tumor sample through manufacturing and product release to outbound shipment of Amtagvi to the commercial ATCs and investigational tools to clinical trial sites. I’m available to answer additional questions during the Q&A. And I will now hand the call over to Jean-Marc, our Chief Financial Officer.

Jean-Marc Bellemin: Thanks Igor. Today, I will review our current cash position as well as our results for the quarter ended on March 31, 2024. I will also highlight our 2024 outlook. As of March 31, 2024, Iovance had cash, cash equivalents, investments and restricted cash of approximately $362.6 million. The current cash position and anticipated revenue from Amtagvi and Proleukin are expected to be sufficient to fund current and planned operation well into the second half of 2025. Shifting to our first quarter financial results. Net loss for the first quarter ended March 31, 2024, was $113 million or $0.42 per share, compared to a net loss of $107.4 million or $0.50 per share for the first quarter ended March 31, 2023. The net loss for the first quarter of 2024 includes amortization of intangible assets acquired as part of the Proleukin transaction.

Revenue for the first quarter ended March 31, 2024 was $715,000 and comprised of sales of Proleukin in licensed market outside of the U.S. Cost of sales for the first quarter ended March 31, 2024 was $7.3 million primarily related to inventoriable cost associated with sales of Proleukin and non-cash amortization expense for the acquired intangible asset for developed technology. There was no revenue or cost of sales in the first quarter ended March 31, 2023. Research and development expenses were $79.8 million for the first quarter ended March 31, 2024, a decrease of $2.9 million compared to $82.7 million for the same period ended March 31, 2023. The decrease was primarily attributable to the transition to commercial Amtagvi remanufacturing in the most recent quarter, partially offset by increased cost associated with the purchase of raw materials, clinical trials driven primarily by the Phase 3 TILVANCE-301 clinical trial and the planned EU regulatory submissions for lifileucel.

Selling, general and administrative expenses were $31.4 million for the first quarter ended March 31, 2024, an increase of $3.3 million compared to $28.1 million for the same period ended March 31, 2023. The increase was primarily attributable to increases in headcount and related costs, including stock-based compensation to support the growth in their whole business and related corporate infrastructure as well as cost incurred to support the commercialization of Amtagvi and Proleukin, partially offset by a decrease in legal costs. Regarding our outlook for this year, we continue to guide towards full year 2024 cash burn in the range of $320 million to $340 million excluding onetime expenses, and we’ll continue to leverage opportunities to optimize spending.

The U.S. launch of Amtagvi as well as the sales of Proleukin used in conjunction with the Amtagvi treatment regimen are expected to drive significant revenue in the second half of 2024 and into 2025 and beyond. As a reminder, revenue recognition for Amtagvi occurs upon infusion like other cell therapies, so we expect to begin recognizing and reporting significant revenue in the second quarter of this year. For additional information, please see this afternoon’s press release and our Form 10-Q to be filed later today. I will now hand the call to Frederick, our Chief Medical Officer to discuss our clinical pipeline.

Dr. Friedrich Finckenstein: Thank you, Jean-Marc. I am pleased to speak today about our key clinical pipeline highlights in solid tumors, which as you all know, represent more than 90% of all diagnosed cancers in the U.S. One of our key priorities is expanding the label for Amtagvi to address the need of patients with advanced melanoma in the frontline treatment setting. Our registrational Phase 3 TILVANCE-301 is well underway and on track to support accelerated and full approvals of Amtagvi in combination with pembrolizumab in frontline advanced melanoma as well as regular approval of Amtagvi in post anti-PD-1 melanoma. Global site activation and patient enrollment continue with strong momentum in the U.S., Europe, Australia, Canada and additional countries.

Our frontline advanced melanoma strategy is supported by Cohort 1A in our IOV-COM-202 trial in solid tumors and previously published data on TIL therapy in the pre immune checkpoint inhibitor era. We look forward to an oral presentation of updated clinical data from Cohort 1A, which continue to strongly support our frontline development plans at the American Society of Clinical Oncology or ASCO Annual Meeting on May 31, 2024. Shifting to our program in non-small cell lung cancer, we reported positive updates for our single arm registrational Phase 2 trial, IOV-LUN-202 in post anti-PD-1 non-small cell lung cancer. We resumed enrollment for new patients within a very short time after the U.S. FDA lifted our partial clinical trial hold in the first quarter.

IOV-LUN-202 includes clinical sites in the U.S., Canada and Europe with plans to include additional regions with strong track record for enrollment in lung cancer studies over the next few months. Enrollment has restarted with high demand, which is driven by encouraging data and further augmented by excitement from the approval of Amtagvi. We expect the registrational cohorts to be fully enrolled in 2025. Current data from IOV-LUN-202 and the FDA interactions regarding our regulatory pathway continue to be positive and support our confidence in the opportunity for TIL cell therapy in lung cancer. The FDA has provided positive regulatory feedback on the proposed potency matrix for lifileucel in non-small cell lung cancer during a recent Type D meeting and as previously announced that the design of the single arm IOV-LUN-202 trial may be acceptable for approval of lifileucel in post-anti-PD-1 non-small cell lung cancer.

In other tumor types, we are starting a Phase 2 trial of lifileucel in post-anti-PD-1 endometrial cancer, which is a significant opportunity for TIL cell therapy. Our Phase 2 trial will include patients with advanced endometrial cancer, who progress after platinum based chemotherapy and anti-PD-1 therapy regardless of mismatch repair status of the tumor. Our rationale is supported by the TIL mechanism of action, which may benefit both patient populations as well as preclinical and manufacturing success data that we plan to report later this year. There is a significant unmet medical need and no currently approved treatment options for the vast majority of patients with endometrial cancer in the post-anti-PD-1 treatment setting. Given this unmet medical need and the enthusiasm we’ve received from gynecological oncologists, we expect to enroll quickly and we look forward to seeing first data soon.

As the leader in TIL cell therapy, Iovance is at the forefront of next generation approaches that have the potential to address unmet need for patients and solidify our long-term leadership in the space. We reached an important milestone for our genetically modified TIL cell therapy, IOV-4001, in the first in human GM1-201 trial in previously treated advanced melanoma or non-small cell lung cancer patients. The Phase 1 safety portion concluded successfully and we are progressing into the multicenter Phase 2 efficacy stage of the trial. IOV-4001 utilizes the TALEN technology license from Cellectis to inactivate PD-1 during the TIL manufacturing process. We also have options to continue to develop other investigational gene edited TIL cell therapies with multiple knockout targets to potentially improve efficacy.

We are also making great strides to advance additional next generation programs towards the clinic. In the third quarter of 2024, we plan to submit an investigational new drug application or IND for a Phase 1/2 clinical trial of IOV-3001, a modified interleukin-2 or IL-2 fusion protein. At ASCO 2024, a poster will highlight preclinical data that supports the potential for improved safety with robust defector T cell expansion with IOV-3001. Lastly, on today’s call, we are introducing IOV-5001, a new next generation program. IOV-5001 is a genetically engineered TIL cell therapy with inducible and tethered IL-12. The addition of IL-12 has augmented TIL antitumor activity in vitro. IOV-5001 also builds on the improved efficacy of a prior generation IL-12 TIL therapy that was observed in a clinical trial at the National Cancer Institute or NCI.

IOV-5001 is currently in IND enabling studies. We plan to discuss IOV-5001 with the FDA at an INTERACT meeting in the third quarter of 2024 and anticipate an IND submission in early 2025. I’m happy to address questions about these programs and additional trials during the Q&A session. I’ll now turn the call over to the operator to begin the question-and-answer session.

Operator: [Operator Instructions] And our first question coming from the line of Michael Yee with Jefferies. Your line is open.

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Q&A Session

Michael Yee: We have maybe a two part question. You gave some really great metrics around the indications of interest in the enrollment numbers. Can you maybe just describe sort of the journey of time from enrolling and then getting reimbursed and then I think sort of the 34 days to then inbound to get treated? I’m just trying to think about how many of the 100 people who’ve enrolled are likely to get treated in this quarter and thinking about the consensus number and then thinking about how many of those would get treated in the third quarter? Maybe just talk a little bit about the journey and how you think about those 100 patients getting treated? Thank you.

Dr. Fred Vogt: Yes, I can give you a little color on that. So the patients right now that are being enrolled right now could be, in theory, treated in the second quarter or, so when I say treated I mean infused revenue recognized in the second quarter or early in the third quarter. That’s because as we mentioned it takes some time to do the financial clearance of the patients that come in and then they get resected and then there is a target right now which we’re meeting of 34 days from the time we start manufacturing all the way through to completing the quality control testing and then the patient is lymphodepleted and infused after that. It’s a little different than the clinical trial. The clinical trial will move faster because the patients who are on bridging therapy, in many cases now they are on bridging therapy and we have to do it this way with the commercial product.

Michael Yee: So just to be clear, patients have been treated in April and then some of those patients as you are going through it would be treated in May and June as part of those 100?

Dr. Fred Vogt: Correct. And July and so on.

Operator: And our next question coming from the line of Andrea Tan with Goldman Sachs. Your line is open.

Andrea Tan: Maybe a follow-up there. Just wondering if you’re able to provide some numbers around those comments. Just of the 100 plus that have been enrolled, how many specifically have had their tumor resected thus far and how many have received an infusion?

Dr. Fred Vogt: We can’t give you the detail, otherwise you would actually have revenues at that point, but what we can tell you is that right now many of those patients have resected. We’re moving through the process with them. I want to stress the importance of the patients that enrolled. Some of them will be infused. Obviously over that large time period that we just mentioned with Mike’s question. We also have a few dropouts in OS stuff like that to account for as well. So, it’s very difficult for us to predict all that stuff. When we finally report revenues, we’ll be able to say a little bit more about how that actually played out in the transition from enrolled numbers to revenues.

Andrea Tan: And the nature of the dropout if you’re able to share a little bit more there?

Dr. Fred Vogt: Most of the time the dropouts are caused by patient health issues and sadly some of the patients passed away by the way for therapy and we’ve actually had that happen. It’s an unfortunate consequence of the stage, the disease stage these patients are in. That’s usually what the issue is, the patient declines in health and is put on hospice or is test on the way before Amtagvi can be fully manufactured and tested for them. That’s the driver of dropout rate for us.

Operator: And our next question coming from the line of Peter Lawson with Barclays. Your line is open.

Peter Lawson: Fred, just maybe you could provide any some more granularity around the 100 plus patients that have enrolled for TIL therapy, if you could what percentage actually have insurance in place and then the number of ATCs that have actually resected patients? Thank you.

Jim Ziegler: Hi, Peter, it’s Jim Ziegler here. Virtually all of the 100 plus patients have insurance or have cash, so that’s not been an issue right now. And by definition enrolled patient basically means there’s the treatment decision followed soon there by commercial payer prior authorization and the scheduled surgery.

Peter Lawson: And then the ATCs that have actually resected a patient number?

Dr. Fred Vogt: Yes, we can’t tell you exactly that Peter right now, but it’s a substantial number. Let’s call it that. It’s increasing daily or at least weekly and it’s getting up to the point where hopefully all or almost all of them will be resected the patient in the not-too-distant future.

Peter Lawson: Just final question, you mentioned about cash, what percentage of patients are paying in cash?

Dr. Fred Vogt: We haven’t disclosed that. It’s a low number.

Operator: And our next question coming from the line of Tyler Van Buren with TD Cowen. Your line is open.

Tyler Van Buren: Congrats on the progress. Shockingly, I have another question regarding the launch. Just regarding the dropouts for enrolled patients that you mentioned, can you discuss what the attrition rate for enrolled patients has looked like so far based upon the dropouts and or manufacturing success? And then, how that attrition rate might differ for patients that are in screening as we think about the 60 patients you mentioned?

Dr. Fred Vogt: Yes. Right now, Tyler, it’s in line with our expectations. There’s been a few dropouts as well as manufacturing aspects, not many and based on our experience we feel like it’s playing out the way we had expected. We’re only going to get better at this. The patients that are dropping out sometimes were the ones waiting for Amtagvi therapy and obviously that will be less of an issue as we go forward with the launch here. So, I can’t give you any quantitative numbers on that right now. Obviously, it’s very early for this, but it’s in line with what we anticipated and we’re able to handle.

Operator: And our next question coming from the line of Yanan Zhu with Wells Fargo Securities. Your line is open.

Yanan Zhu: Thanks for taking our questions and congrats on the progress. Just wondering, for dropouts, Fred, could you comment on whether we could look at maybe perhaps clinical trials experience and historically to get a sense of what might be the percentage of patients who couldn’t wait for the duration of the manufacturing and perhaps also insurance approval in this case period? And then wondering about how evenly are the, more than 100 enrolled patients are distributed across the 40 plus centers? And lastly, I think I heard a comment Jim made about month over month growth, are, still expected going forward, in the number of enrolled patients. Just want to make sure, I get the get the right. And, could that, if that’s correct, could the increase, other than driven by obviously increased ATCs, could that still be driven in part by increased number of patients from the already enrolled started ATCs?

Dr. Fred Vogt: Hey, Yanan, the comparison between the dropout rate in the clinical trial and commercial is a little bit different. In a clinical trial we don’t have the financial clearance issues, we don’t have any of that kind of thing and the patients are basically being raised through the therapy. We had — as you know, we had a very advanced patient population in the trial late line and they were not being bridged and nothing was being done. They had to we couldn’t do that because of the trial. So it’s a very different experience than treating a patient now where we do have the financial clearance too. It takes a little bit of time to resolve, but we’ve been making progress on that. Obviously, it’s going quite well right now for us.

But also we’re bridging in many cases, we’re bridging those patients and those patients are not necessarily as far along in the treatment journey as they were in the clinical trial. So I don’t think you compare dropout between the two. I don’t think it’s a very good comparison at all. Your second question was how many patients can wait for treatment. I don’t really have a good estimate for you right now on that. That’s something we’ll have to see. But as the launch goes, I think we we’ll have some indication of what number of patients really currently because we’ll see the dropout rate and we’ll understand that. And finally, regarding month over month growth like Jim mentioned, it could be driven just by the number of patients. So, we have centers.

Right now that are enrolling at high capacity and many of the analysts are out there calling those centers and getting information from them and you know all about that. And they’re saying things like right now we’re rolling X a month and six months from now we’ll be rolling X plus five a month or X plus three a month or whatever it is. So, we expect that to be the case across many of our centers even without the addition of ATCs we expect the number of patients to go up.

Yanan Zhu: Those are great color. Could you, sorry, touch on the second point about how evenly are the currently enrolled patients distributed across the centers?

Dr. Fred Vogt: We missed that one. Jim, you want to get that one?

Jim Ziegler: Sure, I can take that. Hi, Yanan, it’s Jim here. Like other cell therapy launches and in fact oncology launches, most launches don’t have even distribution of adoption across the centers. And what we will expect over time is all centers will gain experience and increase utilization within each of the centers, but it is not normally distributed for any of the other launches out there.

Operator: And our next question coming from the line of Colleen Kusy with Baird. Your line is open.

Colleen Kusy: Can you comment on, if there’s any anecdotal feedback on the experience with IL-2 so far and how often that would come up as a potential reason not to pursue a treatment with Amtagvi? And then can you also comment on the profile of the average patient in process right now? I think you mentioned there have been patient deaths in this waiting period. Are you getting a lot later line patients or are you getting some earlier line patients too? Thanks.

Dr. Brian Gastman: Hi, this is Brian Gastman, I’m happy to answer that. We have not seen really any pushback for use of IL-2 and in fact some of the cell therapists who are getting involved in this beyond the medical oncologist who start with the patients have actually commented how IL-2 is not a rate limiting issue for them and even mentioned to me personally how it’s self-limiting reversible toxicities. That is absolutely not been an issue. And I would add that one thing that we’ve noted was our education to this authorized treatment centers has paid off. The patient selection overall has been pretty good, if I have to say for myself, not knowing what we would have expected. The actual drop off because of progression is rather low. What happens is it’s rare enough that it raises an eyebrow, but it’s not a very common event at all. It’s just something that’s happened at least once. But it’s definitely no more maybe even less than what we were expecting.

Colleen Kusy: And one follow-up if I can, just on the, you said about 60 patients are in screening right now. What would be kind of common reasons that a patient would fail that screen to not pursue treatment?

Dr. Fred Vogt: Well, they have to go through the financial clearance. They may not be eligible. They may not be on label effectively. They may not have melanoma in some cases. There can be all sorts of things that can disqualify patients with normal medical screening of patients for prescription.

Jim Ziegler: Yes. Just like the enrolled patients that we currently have, we expect a high conversion because these treating physicians understand the unmet need and are choosing and as much as possible the right patients balancing the unmet need.

Operator: And our next question coming from the line of Asthika Goonewardene from Truist. Your line is open.

Asthika Goonewardene: Thanks for taking my questions and also my congrats on the quarter here and the update. I know this question variations of this have been asked, but let me try it this way. Can you of the 100 patients who have been enrolled? Can you tell us how many have been resected so far?

Dr. Fred Vogt: Not yet, Asthika, but there is a very large number that have been resected, I can tell you that.

Asthika Goonewardene: And then, Fred, when talking about getting financial clearance, can you give us some sort of an idea from enrollment how many days does it take on average to get financial clearance? I understand it’s very early in the launch, but so far what are you seeing?

Dr. Fred Vogt: It is very early in the launch and it’s very consistent with what we seeing with other cell therapy launches by our authorization team about three days and single case agreements vary. It ranges anywhere between two to six weeks with an average of three to four.

Asthika Goonewardene: And then lastly, about how many on average vials of IL-2 do you anticipate being used per patient? I know it could be up to 18, but what are you seeing so far in the patients that have been dosed?

Dr. Fred Vogt: I don’t have anything new to add there except that I can say in the trial was six the average was for the median bar I think whatever it was 16 and I would expect something similar in real practice, but I don’t think I would want to quote a stat view right now. It’s close to 18 per patient and that’s the way it should be.

Operator: And our next question coming from the line of Joe Catanzaro with Piper Sandler. Your line is open.

Joe Catanzaro: Hey guys, appreciate you taking my questions here. Maybe similarly some sort of same question in a different vein as we think about the cadence and rate of the 100 patients ultimately being fused. At the end of February, you said there were about 20 patients in progress, we’re now about two months past that, I guess. So, can you say or give any sort of additional comments on how many of those 20 patients were ultimately infused? And then my second question is on the early sort of experience or feedback you’re seeing on the use of bridging therapy, are physicians using that and then stopping once they receive Amtagvi and ready to go? Are they sort of receiving the cell shipment and sort of continuing bridging therapy for a prolonged period of time if the patient is benefiting and tolerating that? Thanks.

Dr. Fred Vogt: Yes, Joe, I can take the first part and then I’ll have Brian answer the second part. Of the 20 patients back then that number obviously has become more than 160 today and I can’t tell you exactly how many is going to move through. I really don’t know, but I would think the vast majority of them move through to actual at least be in the treatment process, I’m not sure if they’ve all been infused. We don’t have that information just yet. But importantly, what we reported is 10 and 20 on February 28th is now more than 100 and more than 160. So, you can see the off swing there is pretty significant. Brian, can you talk a little bit about the bridging?

Dr. Brian Gastman: Yes. I think it’s important to note that we don’t have clear line of sight on every patient. The way they get entered into our system, there’s a certain level of assumption that the physician has a background in treating the patient. Where we get the information is when a peer-to-peer or our response [Technical Difficulties] and when that happens, we get good, we really get good engagement with the sites, the physicians treating the patients. We offer them obviously scientific exchange when needed. And that’s where we found out about maybe bridging patients. Interestingly, sometimes the bridging therapy is literally done not because the patient is progressing or can’t make it to the therapy, but sometimes the patients themselves want to sort of dictate when the therapy is being given.

So bridging therapy really affords a lot of latitude for these physicians, but how often is actually being used, we probably won’t know until some real-world evidence comes out.

Operator: And our next question coming from the line of Reni Benjamin with JMP Securities. Your line is open.

Reni Benjamin: I’m kind of curious about whether there’s the potential for a backlog at the manufacturing site and how you might handle that? With the number of patients and surgeries that are happening, how do samples kind of wait, I guess, before they’re getting processed? How many samples can you handle in a month? That’d be my first question. And then second, just switching gears to the Type D meeting you had for non-small cell lung cancer, it looks like you got positive feedback on a proposed potency matrix. And I thought we were kind of all done with discussions regarding potency matrix. So, I’d love to get some ideas to what’s happening there?

Dr. Fred Vogt: Igor, are you able to comment on the manufacturing question?

Dr. Igor Bilinsky: I can comment on that. So thanks for the question, it’s Igor Bilinsky. So right now, as I mentioned, we have sufficient capacity at our manufacturing facility and contract manufacturer for launch. So, the capacity is sufficient to meet demand from the commercial on target patients as well as the clinical trial and we actually continue hiring additional staff because we anticipate demand to be growing into the remainder of ’24 and beyond. So, I think I hope that answers your question the capacity is right now certainly adequate for the demand we’re seeing.

Dr. Fred Vogt: And then on the Type D question, is Raj available? Raj, can you take that question? We may be a little, we may have a breakdown here, Reni, in the audio, I will take it for you. We have to have regulatory meetings with the FDA for each indication for potency assays right now. Now ultimately, we may be able to take a platform approach. I’m sure you’ve seen Peter, Marks talking lately about platforms and this kind of thing. But as of today, what we’re doing is we’re going to the FDA with each of our indications and talking to them about the specifics of the potency assay for that indication and that’s what we successfully did recently for non-small cell lung, which is a very important step in getting towards a BLA submission for non-small cell lung cancer with lifileucel.

Reni Benjamin: And as we think about timing, Fred, like can we at least assume that since you it took pretty a decent amount of time to get that discussion lead and for everyone to be on the same page. We say that that’s kind of 80%, 90% there already with non-small cell lung cancer and so things should go by a lot quicker or are we kind of back to the drawing board with each indication?

Dr. Fred Vogt: No, no, we’re definitely not back to the drawing board. What we’re doing now is we’re doing it what we think is the right way. We’re getting in front of the FDA at the right point in our clinical development program for non-small cell lung. You can see we’re still enrolling for that study. We’ve got enough data now from enough patients that we can actually show them what we think is a viable potency matrix proposal with data from the actual pivotal patients which is very important. While we’re early enough in the study to be able to make adjustments should they have questions or have things they want to change. As opposed to what we did the last time with melanoma, it was effectively do that all after the fact or largely after the fact if the study was already complete.

So what we’re doing now we think is the right way to develop polyclonal T cell therapies and this should actually accelerate our process, so that when we finish non-small cell lung, we go straight to a pre BLA meeting and straight to a submission.

Operator: And our last questioner coming from the line Ben Burnett with Stifel. Your line is open.

Ben Burnett: I was wondering if you could maybe just talk about the patient flow within the hospital. Are you seeing any bottlenecks popping up, like for example, are there any, have there been any learnings that have needed to happen sort of efficiently coordinate with the surgeon or anything like that?

Dr. Fred Vogt: Yes. Actually, I would say the opposite. We’ve really seen a tremendous enthusiasm from the surgeon all the way through the cell therapists and the nurses that treat these patients. We’ve seen a hospital bend over backwards to find operator in time, space in the hospital. We really haven’t experienced any of the potential bottlenecking even as we increase. Most of the things that we encounter are really just sort of small questions on details, but not the big issues like having a time or place to treat a patient.

Ben Burnett: And if you could also just comment on just the quality of tumor sample coming in for manufacturing, I guess, how is like kind of the specifications around those tumor samples compared to like what you saw in clinical trials?

Dr. Fred Vogt: I can take that or Igor if you would like.

Dr. Igor Bilinsky: I’d be happy to. Good question. So far, the experience has been very consistent with our clinical experience, including the quality and the size and the quality of the tumor samples for manufacturing.

Operator: Thank you. And ladies and gentlemen, that’s all the time we have for our Q&A session. I will now turn the call back over to Dr. Fred Vogt for any closing remarks.

Dr. Fred Vogt: Thank you again for joining the Iovance Biotherapeutics’ First Quarter 2024 Financial Results and Corporate Update Conference Call. As we’ve shared on this call, we are very pleased with the strength of the Amtagvi launch and excited to see accelerated growth throughout the rest of 2024. Thank you to those in the patient, healthcare and advocacy communities, our partners and our exceptional Iovance team. I would also like to thank our shareholders and covering analysts for their support. We look forward to presenting data at ASCO and lifileucel and frontline melanoma and we’ll host an Analyst and Investor event on May 31st. Please feel free to reach out to our Investor Relations team for follow-up. Thank you.

Operator: Ladies and gentlemen, that does not conference call for today. Thank you for your participation. You may now disconnect.