Iovance Biotherapeutics, Inc.

Good day, and thank you for standing by. Welcome to the Iovance Biotherapeutics First Quarter 2026 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Sarah Pellegrino, SVP of Investor Relations and Corporate Communications. Please go ahead.

Thank you, Operator. Good morning, and welcome to the Iovance webcast to discuss our first quarter 2026 financial results, business achievements, and corporate updates. This morning, we issued a press release that is available on our corporate website at Iovance.com. This conference call will include forward-looking statements regarding IOVAMS' goals, business focus, business plans and transactions, revenue and revenue guidance, commercial activities, clinical trials and results, regulatory approvals, submissions, feedback, and guidance, plans and strategies, research and preclinical activities, potential future applications of our technologies, manufacturing capabilities, 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 filing. Our results may differ materially from those projected during today's call. We undertake no obligation to publicly update any forward-looking statements. I will now turn the call over to Dr. Fred Vose, our Interim Chief Executive Officer and President.

Thank you, Sarah. Iovance is the global leader in innovating, developing, and delivering current and future generations of TIL cell therapy in solid tumors. We are executing to maximize patient and shareholder value across four pillars, curative platform potential, commercial execution, technology extension, and fully-owned manufacturing. During the first quarter of 2026, we drove anti-antagony adoption, advanced our development pipeline, and streamlined costs and efficiencies. First quarter revenue grew approximately 45% year-over-year. Owning manufacturing is critical for our success. We navigated a temporary capacity reduction to complete maintenance upgrades at our internal manufacturing facility, the ICPC. Since resuming full production, Ampagni is now exclusively manufactured in-house and our modular facility can provide uninterrupted supply while supporting global demand and scale. Research and development expenses declined for the third consecutive quarter, helping to extend our cash run way into 2028. Looking ahead, MPAGNY enrollment and referral trends are at an all-time high in support of our second quarter and full year 2026 guidance issued today. Second quarter total revenue guidance is $86 million to $88 million. MPAGNY revenue is expected to grow to $79 million to $81 million in the second quarter, This is an increase of approximately 23% over our highest quarterly revenue to date in the fourth quarter of last year. For the full year of 2026, total revenue guidance for Ampagni and Prolucan is $350 to $370 million, predominantly fueled by Ampagni. Over time, we project a $1 billion plus peak out sales trajectory for Ampagni and Prolucan in the U.S. For the rest of 2026 and beyond, we expect gross margin to benefit from our financial discipline, in-house scale, and operational efficiencies. Shifting to our TIL platform, we're expanding the curative potential across solid tumors. This morning, we announced compelling and clinically differentiated early phase two data in metastatic serous endometrial cancer. The confirmed objective response rate was 40%, with a 100% disease control rate in the first five patients. Metastatic serous endometrial cancer is difficult to treat with an estimated 5,000 annual U.S. deaths. The second-line treatment setting represents a significant unmet medical need with response rates below 15%. We plan to engage with the U.S. FDA to pursue an expedited approval pathway. I will now highlight additional registrational trials for Leifelucel and new indications. To expand the Antagni's market potential into advanced frontline melanoma, we continue to execute our global TILBANS 301 trial. In previously treated non-squamous, non-small-cell lung cancer, Lypilosa received FDA Fast-Track designation following best-in-class unprecedented response rates and strong durability. This U.S. blockbuster market is about seven times larger than our peak opportunity in advanced melanoma. We plan to complete enrollment and provide a clinical update this year, targeting accelerated approval and U.S. launch in the second half of 2027. In advanced and difficult-to-treat soft tissue sarcomas, IFV SAR 201, our new registrational trial, is underway in refractory patients with advanced undifferentiated pleomorphic sarcoma and de-differentiated liposarcoma. The trial is beginning enrollment in the third quarter of 2026. We are building upon positive early clinical results with a 50% confirmed response rate in comparison to the abysmal response rates of less than 5% with current standard of care. We are actively engaging with FDA soon on a path to expedited approval. As the global leader in tilt cell therapy, we are making significant progress to our next generation programs. ILB5001 is our IL-12 tethered tilt therapy for highly prevalent solid tumors. A prior generation IL-12 tilt therapy at the National Cancer Institute improved clinical efficacy without IL-2 and informs how we optimize ILB5001 to enhance efficacy and safety. We recently submitted the investigational new drug, or IMD, application for a phase one slash two clinical trial, which includes indications that represent more than 15% of US cancer deaths annually. Among these indications are advanced colorectal cancer, as well as triple negative and estrogen receptor low breast cancers, adding large populations and massive commercial opportunities to our strategy. The trial is expected to begin in the second half of 2026. Our next-generation IL-2 product, IV3001, may optimize the tilt treatment regimen. A Phase I safety core using IV3001 is advancing to multiple dose levels in a Phase I-II trial. We continue to enroll in our clinical trial with our P1-inactivated tilt therapy, IV4001, which reduces inhibitory signals to enhance the ability of tilt therapies to fight and kill cancer. We are initially exploring melanoma and non-small cell lung cancer. We look forward to reporting data and updates soon. As we expand our clinical strategy in solid tumor cancers, we now have the opportunity and capability to identify enriched patient populations that are highly responsive to TILT therapy. We are identifying these enriched populations, such as the serious endometrial cancer population we highlighted today, and our selected populations within soft tissue comas and even within non-small cell lung cancer and other indications, which you will hear more about later this year. IVANS is well-positioned as the only company to have taken tilt therapy from concept to commercial scale. With the manufacturing infrastructure, clinical breadth, commercial experience, and operational discipline to back it up, we have momentum, a broadening pipeline, and an improving line of sight to profitability. The foundation is built, and as we continue to expand across indications, our ambition is clear, to extend our leadership not just in TILT therapy, but as the backbone of immuno-oncology in solid tumor cancers. As I conclude this pipeline update, I would like to extend my sincerest gratitude to Frederick Finckenstein, our chief medical officer, as he prepares to retire in June. During nearly seven years at Iovance, he was instrumental in leading us towards the FDA approval of the first ever TILT therapy, and our leadership position today. Frederick is available during today's question and answer session, and I wish him the best in his retirement. I will now turn the call over to Coraline Roche, our Chief Financial Officer, who will provide further updates on our first quarter financials and full year expectations. Coraline.

Thanks, Fred. And good morning, everyone. Our commitment to operational excellence, commercial growth, and financial discipline drove strong top-line year-over-year growth and meaningful cost containment in the first quarter. We transformed our internal manufacturing facility to meet demand growth and scale for the future without major additional capital investment. First quarter revenue of $71 million grew roughly 45% year-over-year, driven by strong antagony demand. Antagony revenue of $60 million increased by 38% year-over-year on strong demand growth, our second highest quarterly revenue for MTagV. We mitigated the first quarter impact from a temporary capacity reduction as we upgraded our facility. Moving to Prolucan, $11 million in first quarter revenue nearly doubled from the year-ago period on higher MTagV adoption. Importantly, gross to net impact remains extraordinary and consistent with past quarters at less than 2%. Our first quarter gross margin from cost of sales was about 41%, which absorbed one-time non-recurring costs related to our facility upgrades. Margin is expected to trend higher for the rest of 2026, excluding one-time items, as we operate our in-house capabilities more efficiently. we continue to manage operating expenses carefully, including optimizing research and development while expanding our pipeline. Notably, research and development expense declined for the third consecutive quarter, a reduction of 18% over the prior period and 12% over the prior quarter. Moving to our revenue outlook, after thorough analysis of demand trends and internal forecasts, we expect total revenue between $86 and $88 million for the second quarter, driven by strong and taggy demand. This momentum carries through into our full year 2026 guidance of $350 to $370 million for the full year. As of March 31st, we had approximately $319 million in cash and equivalents. Thanks to careful cost management and financial discipline, we expect to fund our operations into 2028. In closing, we are building momentum and focusing on operational excellence to grow revenue, manage expenses, and improve margins. We are on a clear path to profitability and remain committed to creating lasting value for our shareholders. I will now turn the call to Dan Kirby, our Chief Commercial Officer, to review our strong commercial progress.

Thank you, Corleen. Building on Corleen's comments, strong demand in the first quarter culminated in our second-highest quarter of antagony revenue. This performance was achieved with reduced capacity and yielded much better results compared to the first quarter of 2025. Demand continued to increase throughout the quarter, March was our largest month ever for reported MTAGV revenue. Second quarter is off to a very strong start, with projections supporting our guidance that this will be our best MTAGV quarter to date. In addition to generating demand, our three commercial priorities are further solidifying MTAGV as the choice for patients. First, our expanding ATC network of academic ATCs, together with new community ATCs, are creating more patients, establishing both a reliable base of business as well as driving additional growth in 2026. Second, patients are increasingly referred for MTAGI earlier in the treatment cycle. The recently published real-world evidence, combined with published five-year durability data, has been very impactful in educating physicians on the value of earlier referrals and optimal treatment with MTAGI. Our field teams are committed to educating our physicians while advocating for our patients. Third, antagonist awareness continues to build among our key target physicians. Our latest market research shows physician awareness increased to 70%, up from 50% over the last six months Earlier this year, we further expanded our field sales force with plans for additional increases in field staff as more ATCs onboard and demand continues to strengthen. ProLucan is seeing robust demand, driven primarily by its use alongside Amtaki. ProLucan sales were $11 million in the first quarter, down from the prior quarter due to wholesale buying patterns, but a substantial increase from the prior year as all three wholesalers ordered. We expect ProLuca to stabilize and grow throughout the year with increasing mTagV demand. Globally, we are making meaningful progress on XUS expansion. mTagV has the potential to reach more than 30,000 patients annually with previously treated advanced melanoma. Following mTagV approval in Canada, the first XUS treatment center is officially authorized to support international private pay patients. At the same time, we are advancing reimbursement discussions with the Canadian government. Regulatory decisions are anticipated in Australia in the first half of this year and in Switzerland next year. We continue making progress with regulatory submissions in other markets as well. Finally, May is Melanoma Awareness Month. We are collaborating with advocacy groups Yesterday, the Today Show posted an inspiring story highlighting Jennifer, a mother of three, who is back to enjoying her family after receiving MTAGV more than a year ago. Her story is one of many that represents the hope of MTAGV. Jennifer is now also featured on our website, mtagv.com. A growing network of patients are sharing how this one-time cell therapy has helped their own immune system fight cancer. I will now hand the call back to the operator to begin question and answers.

As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. In the interest of time, we ask that you please lend yourself to one question and one follow-up. Please stand by while we compile the Q&A roster.

Our first question comes from Andrew Tsai with Jefferies.

Your line is open.

Hey, guys. This is John on for Andrew. Congrats on all the progress. So for Q2, if you're in sales guidance of 79 to 81 million, how much can that improve gross margins quarter for quarter as well? And then can we assume that the Q2 gross margins will be better than the Q4 gross margins at 50%? Thanks.

Yeah, thanks, John. Well, obviously the margins we showed in Q4 of 25 were really where we aspire to be or above that. We can't say just yet where our margins are going to be exactly, but I would expect generally that they will trend upwards throughout the year. We're working very hard on that. It depends a lot on the product mix and a lot of other factors, but we really do want margins to be better throughout the year. And then, of course, the 27 and beyond, we're driving towards higher and higher margins all the time.

Yeah, just to emphasize, John, The margin was impacted, like I mentioned, from one-time non-recurring costs. That should not happen again. It will be non-recurring. So our margins should be continuing to grow, as I keep mentioning. We have a lot of efforts. We brought everything in-house, right? So we use the capacity of our own facility. We'll have economies of scale there. We also have targeted projects focused on operational excellence in the plant specifically. And as you see, as revenue grows, that also helps. Does that help you?

Yeah, definitely. And then also, maybe just a quick follow-up if I can. Is it fair to assume that the lung data would come at a major medical meeting in the second half of 2026 versus something like Q2 at ASCO? And then would you be inclined to press release the data before? Any timing granularity would be helpful. And maybe also just remind us your expectations on ORR and potentially even DOR. Thanks.

Yeah, as you can see, we released data in Lung only about six months ago that had excellent durability, which is typical of immuno-oncology approaches that work really well. So you can go back and look at our November press release. That's basically what we're looking at for this product and what we think is something that we can get approved. I can't really say much more about conference stuff, except that we've guided, obviously, to 2026 disclosure at a medical meeting, and we continue to plan to do that.

Thanks so much.

Thank you. Our next question comes from Renny Benjamin with Citizens. Your line is open.

Hey, good morning, guys. Thanks for taking the questions, and congrats on the progress. Maybe two questions. One, you know, as we think about the ATC network, they're now greater than 90. I think you're targeting 110 by the year end. Can you maybe talk to us a little bit about what the split will be between these academic ATCs and community ATCs? And what do you think will be the max capacity across these ATCs? And I think Pat maybe mentioned that the Salesforce is gonna be growing, throughout this year, can you give us an idea as to what the optimal number of that may be? That's the commercial question. One for Friedrich, because this will be the last time that we're speaking to him. Congratulations, Friedrich, on retirement. Kind of wanted to just get a sense as to the 40% confirmed ORR and endometrial, kind of your thoughts and any kind of details you can provide us in terms of depth of response or durability and how it compares to what's already out there. Thanks.

Thank you very much for the question. I'll start first and then hand to Frederick. In regard to the ATC network, we see ATCs now onboarding and starting to treat faster than they were last year. So the ones that onboarded the second half of the year are treating faster. Our academic and community mix is starting to get more balanced, whereas at the beginning we were mostly academic. Now we're going more into the community hospitals, getting closer to the patients where the opportunity is greater for us. So we do see that that is going to into a greater percentage of community entering, and because we do have the key academics already on board and treating. In regard to Salesforce, we did increase our Salesforce going into this year based on the second half ATCs entering into and tag the authorization. We did see and have seen and are seeing increased demand from those ATCs. The new reps are being very impactful in the field with it, and we have a in Q2 as well as looking at later this year based on the timing and pace of both demand in our current ETCs and onboarding new ETCs. Hopefully that answered your question. Thank you very much, Remy. I'll hand over to Frederick for the second half.

Yeah, thank you. Thanks for the question, Rene. Yeah, so this is a really, really exciting result that we're seeing there. As you know, In endometrial cancer, the checkpoint emitters have moved into frontline therapy. So standard of care or really available therapy, if you want, in second line is dire. Usually these patients are being treated with monotherapy, chemotherapy, and response rates are usually below 10%, 15% highest when you look at control arms of randomized trials. So that's not good enough. These patients have highly unmet medical needs. And seeing another immunotherapy come through with these response rates and typically durability that is differentiated from chemotherapy, that's really important. That's why we're planning on jumping on this and taking this further.

Thanks, guys, for taking the questions. Congrats.

Thank you. Our next question comes from with Barclays. Your line is open.

Great. Thanks for taking the question. Congrats on the quarter. Just looking again at your 2Q guide, just wondered how much of this rebound with the step-up from the first quarter, is maintenance disruption versus maybe underlying demand trends and what the key assumptions are behind the outlook there. And then maybe secondly on the pipeline, just as you think about the endometrial regulatory path, should we think about a potentially similar framework as you're employing for sarcoma in terms of the regulatory path to accelerated approval? Thank you.

Yeah, so let me take the second question first, actually, because, yes, correct, we are looking at a similar regulatory path for Cirrus Endometrial versus UPS and DLPS, and we'll come back soon after we have some interactions with FDA. We're going to try to optimize as much as we possibly can, so we'll know BLA filings and and possibly even combine stuff and work together to make sure that we can get these things approved as quickly as possible. The FDA says stay tuned for a lot more detail on that. We're very excited, obviously, about all three indications. We think they all significantly add to Ampag's potential, and we're currently built to launch all these indications quite quickly on the back of our commercial expertise manufacturing. On the Q2 guide, you were asking about maintenance versus demand. Demand trends are extremely strong, as Dan highlighted earlier. I really don't think about it as a maintenance issue. I think about it as something that we had to address. We fixed it. It's done. We won't talk about maintenance ever again. It's now built into our system, so we can do it without any kind of impact whatsoever. Demand is very, very, very strong for the product right now. So, Dan, do you want to emphasize again some of the points you made during the prepared remarks on demand trends?

We continue to see demand increase. This has happened through fourth quarter and first quarter and carried into second quarter. I mentioned before that March was our largest reported month to date. We continue to see a strong start to Q2, which is why we have the guidance set.

Thank you. Thank you.

Our next question comes from Colleen Cousy with Baird. Your line is open.

Hey guys, it's Nick on for Colleen. Thanks for taking the question and congrats on the progress. So with the new guidance, expecting $209 million in product sales in the back half of the year, can you just speak to your confidence in any of that goal and what else needs to be done to get there? Thanks.

Yeah, so right now, Nick, we're highly confident we can achieve that. We've obviously already done a lot of it and we have visibility right now in Q2 to essentially the entire quarter. That's why we're giving So strong guidance for Q2 AMTAG-B revenues as well as Prolucan. And then the back end of the year, we can see very clearly too. And when you look at the guidance that we gave today, it's easily achievable with some growth as we go from Q2 to Q3 to Q4 that we have line of sight and visibility to. We have a much better understanding of our ATCs and how they perform, how we can produce the product in every step of the process of getting AMTAG-B to a patient. And I think it's extremely responsible guidance that we've given It's guidance that we will do everything in our power to beat, of course, but it's guidance that we can stand by and live with, and it's quite strong compared to where we were last year.

And I would just add on to that, Nick, that This is our second full year on the market. We're over two years since launch. So variables such as seasonality, et cetera, we have a much better handle on. And we can project based on new ATCs coming and growth in the current ATCs where demand is picking up and where demand continues to increase. And that's why we look at the second half of the year as being extremely strong. This starts right now at the fourth quarter. We're seeing it right now in the demand and what's lining up from the centers.

Great. Thank you.

thank you as a reminder to ask a question please press star one one on your telephone again that is star one one to ask a question our next question comes from teller van buren with td cowan your line is open hey guys uh thanks very much for taking the question uh can you talk about the progress you made with the till events 301 enrollment uh

you know, where you are in terms of percent enrollment, and what's been working to enroll patients, and what are some of the hurdles that you've had to overcome, like sites in the U.S. using Nevo IPI in the front line?

Yeah, Tom, I can get that, and then maybe Frederick can add a little bit to it, too. We're seeing good enrollment until mid-year one. Obviously, we do a lot of it outside the United States because it's easier outside the United States with standard of care. But it's a study that we think is well-designed. We have very good FDA feedback on the design of the study. We're very focused on getting to the interim read where we can read ORR and have an early discussion with FDA about confirming MPAGV's approval as well as getting additional approval. You can go on clinicaltrials.gov and see the vast scope of sites that we're running right now. It's all over the place. Obviously, with any trial, there's things that you have to do to pound through it and succeed. Every company has to deal with this, and we're encountering and overcoming, I think, a lot of those right now with this trial. So we expect good things for TIL bands, and we think that TIL therapy in the frontline setting, especially combined with Pembrolizumab, can vastly improve the chances of a good overall survival outcome for patients. Our CONTO218 data shows that. You've seen that publicly. We'll talk about that more this year. But that's really what's driving the study right now. Frederick, do you want to add anything?

No, I think you said it. I think it's important to remind folks that pembrolizumab is standard of care, and there are some geographic differences around this, and not everyone believes that everyone should be getting frontline combination therapy. And then, Fred, you already highlighted the data from cohort 1a from COM2 to that is proof for the potential for durable, meaningful benefits for patients in that treatment setting from TIL therapy when used that early.

So I totally agree. Thank you.

Our next question comes from Salim Syed with Mizuho. Your line is open.

Great. Thanks for the question, guys. We'd love to ask more than two questions here, but I'll limit myself. Corleen, Fred, maybe just one. I'll limit myself to two here. On the ATM usage, this is now the fifth quarter you guys have access to ATM in a row. Four of the five quarters has been pretty heavy usage. Could you just outline for us just your financing plans here? I mean, this seems to be egregious at this point. beyond any biotech company that I'm aware of, of how much you've access to your ATM. Why don't you just do a more traditional sort of financing path here? Or what are your financing plans going forward? Should we expect this continued sort of practice? And then the second on guidance, could you just outline for us, please, how do you come up with your guidance now? Like, is it you have your sort of internal forecast and it's a plus minus when you get to that? Or is it Just a downside, just how conservative is this guidance? Thank you.

Yes, Lee, we don't think the ATM use is egregious at all. We dip on the ATM occasionally, and we use it as needed to sort of top up where we are, and we've been really, really disciplined in how we use it. We're really driving the cash-from-away extension, and now we've pushed the cash-from-away out two quarters, more than two quarters in this most recent. By the way, every single quarter we're pushing it out a quarter. So we're now all the way well into 2026, as you can see in the press release today. That's largely in the back of the cost discipline. And we're getting, internally, we're getting better and better at saving money when we run our trials, and we're obviously boosting margins, and we're making more revenue at the top line. Everything's coming together to really extend our runway, and we are already very focused on breakeven and ending dilutions for the shareholders. So yes, we do have to make use of the APM. We still explore non-dilutive options. We're still working on them right now, but we think the lowest cost of capital right now for the company is to do a little bit of equity here and there to make sure that we are getting closer and closer to that break-even every quarter. On the guidance, we think this guidance is responsible. We are in possession, of course, of the company of detailed information about each ATC, the performance of each ATC, performance of our manufacturing, every aspect of what we do with Amtag. much more detailed than we were when we launched the product in the beginning. Now we have all the information we need. The hands team is doing a great job identifying all the trends. As we onboard new ATCs, we have a much better understanding of what they're going to add to the picture. We know which ATCs to focus our sales teams on and which ATCs can produce for us reliably. Product that is the highest quality that we can make very reliably for them. And so we have internally, I would call them extremely sophisticated forecasts. that we are watching every day to make sure that they are accurate. So, for example, for Q2, practically every resection that we have for Q2 has already been performed. So we already have a very good understanding right now of what's going to happen for Q2. That's why we can give that guidance so tightly. And we're really, really comfortable in that guidance. That's why we're giving it. We know investors want it. And like I said earlier, we're going to do our absolute best to beat it.

So I'll just add on to that, Fred. Looking at that, I agree. The guidance, as we said, I've been here over a year, and really we've learned a lot about this market and how to forecast it and understanding it. So that's responsible, as Fred said. But I would also say that my teams are focused on beating that. That is our mission. That's what we're going to do, and our expectations are higher than that. But, again, the guidance is responsible. What we believe we're going to do based on the current information we have. But we will seek to onboard more ATCs than our goals. So hopefully that gives you an idea of the mindset from my teams on that, but also, too, what we issue publicly is what we believe is responsible and what we are going to do based on the information we have today.

Okay. I appreciate the call, guys. Thank you. Thank you.

Thank you. I'm showing no further questions at this time. I would now like to turn it back to Fred Vogt for closing remarks.

Thank you again for joining the IVANS Biotherapeutics first quarter 2026 conference call on the heels of record high demand for MTAGV, as well as significant progress across our pipeline. As we continue to work on therapies with curative potential in solid tumors, we are energized by the growing number of patient stories reflecting the impact of our health therapies, some benefiting upwards of six years and counting. We remain deeply grateful to the patients, partners, healthcare professionals, and advocacy communities we serve. Finally, I want to thank our exceptional advance team, our dedicated shareholders and covering analysts for their continued support and commitment to our mission to innovate, develop, and deliver current and next generation health cell therapies for patients with cancer. Thank you.

This concludes today's conference call. Thank you for participating. You may now disconnect.