Iovance Biotherapeutics Q2 2026 Earnings Call Transcript

Quartr
Provided by Quartr
August 6, 2026

Key Takeaways

  • Positive Sentiment: Record second-quarter performance: Revenue reached $99.3 million, up 66% year over year and 39% sequentially, led by approximately $91 million in Amtagvi sales that exceeded guidance. Gross margin rose to a record 56% as manufacturing volume and in-house efficiencies improved.
  • Positive Sentiment: Commercial adoption continues to broaden. Iovance reported more than 95 Authorized Treatment Centers, including a growing community-based presence, and expects at least 110 centers by year-end; management said demand remained strong entering the third quarter.
  • Positive Sentiment: Pipeline milestones advanced: Enrollment is nearly complete in the pivotal lung cancer trial, with an update expected in the fourth quarter and a potential supplemental filing targeted for 2027. Lifileucel also received FDA Fast Track designation in two soft-tissue sarcoma indications, while early endometrial and serous cancer data supported a protocol amendment aimed at an expedited approval pathway.
  • Positive Sentiment: Financial flexibility improved. Cash, cash equivalents, and short-term investments totaled approximately $304 million at June 30, which management expects to fund operations into the second half of 2028; research and development expenses declined for the fourth consecutive quarter.
  • Neutral Sentiment: The company is reviewing its 2026 total revenue guidance of $350 million to $370 million and expects to issue an update during the third quarter. Management characterized the revision as driven by improved visibility into demand, but the updated outlook and timing remain unspecified.
AI Generated. May Contain Errors.
Earnings Conference Call
Iovance Biotherapeutics Q2 2026
00:00 / 00:00

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Operator

Welcome to the Iovance Biotherapeutics Second Quarter 2026 Conference Call. My name is Daniel, and I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session. Please note that this conference call is being recorded. I will now turn the call over to Sara Pellegrino, Senior Vice President, Investor Relations and Corporate Communications at Iovance. Sara, you may begin.

Sara Pellegrino
Sara Pellegrino
SVP of Investor Relations and Corporate Communications at Iovance Biotherapeutics

Thank you, operator. Good morning and welcome to the Iovance webcast to discuss our second 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 Iovance's 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 collaborations, cash position, 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.

Sara Pellegrino
Sara Pellegrino
SVP of Investor Relations and Corporate Communications at Iovance Biotherapeutics

I will turn the call over now to Dr. Fred Vogt, Interim CEO and President.

Fred Vogt
Fred Vogt
Interim CEO and President at Iovance Biotherapeutics

Thank you, Sara. Iovance is the global leader in innovating, developing, and delivering TIL therapy for solid tumors, today and for the next generation. The second quarter of 2026 was our strongest yet. We delivered record revenue and margin, advanced our pipeline, and secured important new regulatory approvals and designations. I'll start by highlighting a few notable achievements. First, our commercial launch reached new heights in the second quarter while our foundation for growth expanded. More Authorized Treatment Centers, or ATCs, are activating, enrolling, and infusing patients than ever before. We reported $99.3 million in revenue, driven by record Amtagvi demand. We also greatly exceeded both our Amtagvi and total revenue guidance ranges for the second quarter. Second quarter margin also reached an all-time high of 56%. We expect margin to keep expanding as we increase revenue, fine-tune execution, and gain efficiency at scale.

Fred Vogt
Fred Vogt
Interim CEO and President at Iovance Biotherapeutics

Looking ahead, we maintain our peak assumptions for Amtagvi and Proleukin of more than $1 billion in U.S. sales from advanced melanoma alone. The opportunity in other indications is significantly larger. Our third quarter performance to date is very strong. Once we fully assess increasing growth trends, we expect to provide an update to our full-year guidance during the third quarter. We are now providing commercial Amtagvi to more than 50 patients a month on top of increasing numbers of clinical patients, which demonstrates both our manufacturing scale and how broadly accessible our cell therapies have become. We are not choosing between growth and discipline. This quarter, we delivered both. Research and development expenses improved for the fourth consecutive quarter, even as every lead program advanced and our pipeline grew.

Fred Vogt
Fred Vogt
Interim CEO and President at Iovance Biotherapeutics

We are closing in on our pursuit of the largest opportunities for cancer patients who have the greatest unmet need. Our technology platform is scaling quickly. Recent regulatory and clinical milestones bring TIL therapy forward for more patients in the U.S., as well as new markets and additional solid tumor indications. Nearly 2,000 patients have received Iovance TIL therapies in commercial and clinical settings across hundreds of centers in the U.S. and in 30 countries. Over the coming years, our vision is to reach tens of thousands of patients. In our registrational trials, enrollment is nearly complete in our IOV-LUN-202 trial in the pivotal cohorts in non-squamous, non-small cell lung cancer. This indication represents a blockbuster opportunity that is roughly 7 times that of advanced melanoma. We look forward to providing program updates in the fourth quarter as we work toward a supplemental Biologics License Application in 2027.

Fred Vogt
Fred Vogt
Interim CEO and President at Iovance Biotherapeutics

We're moving quickly with our registrational SARATOGA trial for IOV-SAR-201 in two advanced soft tissue sarcomas. As we announced today, the U.S. FDA granted Fast Track designation in undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma, validating the promise of the initial clinical data for lifileucel, as well as the substantial unmet medical need in both indications. In a pilot study with one-time lifileucel therapy, the objective response rate was an unprecedented 50% in the first six evaluable patients, compared with abysmal response rates of less than 5% using current standard of care in these refractory treatment settings. Our translational data and state-of-the-art technologies are uncovering the next frontier in TIL therapy. We are now able to identify highly responsive patient populations across solid tumor indications that comprise more than 90% of all cancers.

Fred Vogt
Fred Vogt
Interim CEO and President at Iovance Biotherapeutics

For example, a histology-based biomarker strategy produced striking early Phase II data in the first five evaluable patients with metastatic serous and endometrial cancer. In our N-201 trial, we reported a 40% confirmed objective response rate and a 100% disease control rate. We are submitting a protocol amendment engaging with the FDA on an expedited approval pathway based on this patient population. Our leadership in TIL therapy includes continuous investment in next generation programs. A new trial known as G1TIL1 is using IOV-5001, our next generation IL-12 tethered TIL therapy. This Phase I/II basket trial will run across prevalent solid tumors representing more than 100,000 U.S. deaths annually, including metastatic colorectal, triple-negative breast, and estrogen receptor-low breast cancers. We expect to provide more updates this year. Today, profitability is in sight, and with it, lasting value for patients and shareholders alike.

Fred Vogt
Fred Vogt
Interim CEO and President at Iovance Biotherapeutics

Iovance is the first and only company in the world to take cell therapy from concept to commercial treatment for patients, supported by our scalable manufacturing infrastructure, clinical breadth, commercial experience, and operational discipline. With healthy commercial momentum, a broadening pipeline, and solid execution, Iovance has never been better positioned for long-term success. I'll now ask Corleen Roche, our Chief Financial Officer, to detail our financial results.

Corleen Roche
Corleen Roche
CFO at Iovance Biotherapeutics

Thanks, Fred, and good morning, everyone. Our highest ever quarterly revenue and margin clearly demonstrate our commitment to top-line growth, operational excellence, and financial discipline as we build a sustainable self-funded business. Second quarter total revenue was more than $99 million. That is up 66% year-over-year and 39% sequentially from the first quarter, which have included one-time non-recurring impacts from our internal manufacturing upgrades. Amtagvi was the key growth driver, reaching a new high of approximately $91 million in the quarter. We exceeded our second quarter Amtagvi guidance range of $79 million-$81 million. Second quarter Amtagvi revenue increased roughly 51% over the first quarter of 2026 and 68% year-over-year, reflecting a robust increase in patient demand and adoption. Proleukin contributed about $9 million in the second quarter, slightly down from $11 million in the prior quarter due to timing of wholesaler inventory stocking.

Corleen Roche
Corleen Roche
CFO at Iovance Biotherapeutics

For the full year of 2026, we anticipate that Proleukin as a percentage of total revenue will be in line with 2025. Consistent with the prior quarters, overall gross-to-net impact remains minimal at less than 2%. Margin increased to approximately 56%, up from 41% in the first quarter and above our previous all-time high of 50% in the fourth quarter of 2025. With the year-to-date 2026 margin of 50%, the second quarter benefited from higher Amtagvi volume, continued cost optimization, and maturing internal efficiencies during our first full quarter of manufacturing exclusively in-house. We are also deploying and advancing artificial intelligence tools to drive significant future cost efficiencies and new product pipeline insights. As we expand our business as well as our development pipeline, we are very closely managing operating expenses.

Corleen Roche
Corleen Roche
CFO at Iovance Biotherapeutics

Research and development expenses were about $59 million, down from $62 million in the prior quarter, reflecting ongoing efficiency gains as we progress all of our programs. This marks the fourth consecutive quarter of cost savings through R&D optimization. Selling general and administrative expenses held essentially flat at about $39 million, even as revenue grew roughly 39%. With clear operating leverage from our commercial infrastructure, we expect to gain further efficiency with targeted investment across the business. I will now cover our outlook for the rest of the year. Based on strong second quarter sales, we are reviewing our previously issued full year 2026 total revenue guidance of $350 million-$370 million and plan to share more detail in the third quarter. We are well capitalized to fund both the launch and our pipeline.

Corleen Roche
Corleen Roche
CFO at Iovance Biotherapeutics

As of June 30th, 2026, we had approximately $304 million in cash equivalents, and short-term investments. This cash position is now expected to fund operations into the second half of 2028. When I joined Iovance, the priorities were clear: grow revenue, expand margins, and manage spend to reach profitability as quickly as possible. On my one-year anniversary, I am pleased to highlight that all three of these priorities are translating into positive results and lasting value for patients and our shareholders. I will now turn the call to Dan Kirby, our Chief Commercial Officer, to review our commercial progress.

Dan Kirby
Dan Kirby
Chief Commercial Officer at Iovance Biotherapeutics

Thank you, Corleen. As mentioned, Amtagvi generated record revenue with more patients treated than in any prior quarter. This commercial momentum is carrying into the third quarter. Adoption isn't just growing, it's broadening into new ATCs and earlier lines of treatment. Today, I will highlight three commercial priorities powering that trajectory for Amtagvi growth, which are rising physician awareness, continued expansion of our ATC network, and a deepening body of clinical evidence. The first priority is to continue to increase awareness of Amtagvi among both treating and referring physicians. Unaided awareness has increased nearly threefold over the past year, driven by two factors. One, a new marketing campaign unveiled at ASCO. Two, improvement in sales force effectiveness, measured by meaningful growth in both number of treaters and referrers. The second priority is increasing our footprint across both academic and community settings.

Dan Kirby
Dan Kirby
Chief Commercial Officer at Iovance Biotherapeutics

With more than 95 total ATCs today, we are on track to reach at least 110 by year's end. Community ATCs now represent a third of our network and are expected to increase significantly over the next several quarters. Each new ATC is widening our commercial reach to the patients who need it. The third priority is the continued expansion of our already deep industry-leading clinical evidence. The published five-year durability data and real-world response rates of greater than 50% in patients with two or fewer lines of therapy are convincing physicians to adopt Amtagvi earlier. In addition, at ASCO, we released a new survival analysis from our clinical trial. This analysis estimated that the Amtagvi 10-year overall survival for responders would be 46.7%, or almost half. Independently, a growing number of our ATCs are publishing their own real-world experience.

Dan Kirby
Dan Kirby
Chief Commercial Officer at Iovance Biotherapeutics

Across these studies, response rates and patient outcomes consistently meet or exceed what we observed in our clinical trials, which support the emerging practice pattern of treating patients with Amtagvi as soon as possible after checkpoint inhibitor therapy. These aggregated real-world evidence data are being deployed across our sales force in conversations with ATCs and physicians. This information can be found on the publications page of our website at iovance.com for those interested. Underpinning all three priorities is ensuring coverage and access. Amtagvi has strong payer coverage. More than 75% of Amtagvi patients are covered by private payers. Payers and plans that cover more than 250 million lives have added Amtagvi to their policies. Our U.S. ATCs are strategically located in proximity to most addressable patients. More than 95% of patients live within 200 miles, and 80% of patients live within 100 miles of an ATC.

Dan Kirby
Dan Kirby
Chief Commercial Officer at Iovance Biotherapeutics

With our rapidly expanding ATC network and increased community presence, we expect even broader access to Amtagvi throughout 2026. Importantly, we are also proving we can deliver on our promise to patients. With a turnaround time of 31 days or less using the only scaled centralized commercial manufacturing process approved by the FDA for TIL therapy. Demand for Proleukin, our second product, remains strong. All three wholesalers have sold through their previous stocking inventory in the second quarter and are currently ordering in line with Amtagvi demand. For the rest of the year, we expect quarter-on-quarter Proleukin growth tied to Amtagvi growth on a steady basis of approximately 16% of total revenue. Outside of the U.S., with two approvals of Amtagvi in Canada and Australia, we are continuing to expand into new markets for previously treated melanoma patients, a globally addressable population of more than 30,000 patients annually.

Dan Kirby
Dan Kirby
Chief Commercial Officer at Iovance Biotherapeutics

Our first ATC in Canada is ready to support international private pay patients while we work toward public reimbursement. In Australia, I recently visited several of our onboarding ATCs as we collaborate to raise awareness and expand access to Amtagvi. Australia has the highest rate of melanoma in the world. We are opening our first ATCs for private pay patients while we work with the government on pricing. Looking ahead, regulatory approvals are pending in the United Kingdom and Switzerland. Elsewhere, we continue to work closely with health authorities in the European Union towards resubmission. Together, these foundational international markets augment our growing U.S. franchise for Amtagvi. In summary, demand for Amtagvi is strong and continues to grow. Rising physician awareness is accelerating referrals. A growing network of ATCs is broadening access that is converting into more patients treated, and the deepening clinical evidence is expanding the addressable patient population.

Dan Kirby
Dan Kirby
Chief Commercial Officer at Iovance Biotherapeutics

Iovance is committed to serving patients with a one-time cell therapy that delivers meaningful, validated systemic clinical benefits. I will now hand the call back to the operator to begin question and answer session.

Operator

To ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from Andrew Tsai with Jefferies. Your line is open.

Andrew Tsai
Andrew Tsai
Analyst at Jefferies

Good morning. Thanks. Congrats on a great quarter. Can you talk about this large upswing in Q2 that even came out well ahead of your guidance? Was it purely due to underlying demand, or was there any one-off in the timing of shipments maybe being more favorable in Q2? Just wanted to check the box on that. Secondly, on the lung update later in Q4, just wanted to clarify on the cadence of events we can expect here. Is it fair to assume you would first need to complete enrollment in this pivotal cohort first and then generate follow-up data on every enrolled patient before you top-line the data? Or can the top-line data be on the majority of patients, not necessarily all patients with follow-up? Thank you.

Dan Kirby
Dan Kirby
Chief Commercial Officer at Iovance Biotherapeutics

I'll take the first part on demand. It's a great question. What we saw in demand was, as I said on the call script, we saw that awareness is increasing among our physician base, both treaters and referrers. We are expanding our ATC network, and then the clinical data is evidence of Amtagvi's efficacy. One thing that did happen in the first quarter that helped us in the second quarter was we had the manuscript published on our real-world evidence data that showed over 50% of the patients with two or fewer lines of therapy were responding. That data helped propel our sales force and our commercial efforts to raise awareness further and encourage more patients to be treated. We expect this to continue, and we are seeing this into the third quarter.

Fred Vogt
Fred Vogt
Interim CEO and President at Iovance Biotherapeutics

I'll add to Dan, to be very clear, Andrew, this is not a timing issue or anything. This is organic demand for the product that's looking very good right now based on all the factors that Dan described and more that we really do expect that demand is going to continue to increase significantly for Amtagvi throughout the coming quarters. On your question about the lung two-out-of-two update. Yes, I think it's fair to assume we're going to complete enrollment very soon, and we would want to finish that process before we put any kind of material update out. Obviously, for FDA purposes, we want to do that. I don't think it's fair to assume that we would wait for every single patient to become evaluable.

Fred Vogt
Fred Vogt
Interim CEO and President at Iovance Biotherapeutics

We really want to make sure the integrity of the trial is clean, and we have all the patients in before we put some data out. Some of the patients may still be coming for their first evaluation, that kind of thing, when we put that out, or maybe not, depends on the timing and how the data looks. Just stay tuned. The lung is looking very positive right now. We feel very good about where we stand with the study. We will have a lot, I think, to say about that. I know that's a very key thing for investors, and I really urge everybody to watch carefully as we talk about that, and maybe even more than what people are expecting in this space.

Andrew Tsai
Andrew Tsai
Analyst at Jefferies

Thanks so much. Congratulations.

Operator

Thank you. Our next question comes from Yanan Zhu with Wells Fargo. Your line is open.

Yanan Zhu
Yanan Zhu
Analyst at Wells Fargo

Great. I'll add my congrats on a very strong quarter. Maybe from Fred's comment, it sounds like, for the next two quarters, you expect the demand to further build upon the current demand level or the second quarter demand level. Just want to see if that's the correct interpretation. In terms of given your visibility into the third quarter and perhaps also into the first quarter, can you talk about your expectation and also the guidance sounds like it's going to come during the third quarter, is that the case, rather than at the next quarter's earnings call? Perhaps also a question on TILVANCE-301. Can you give an update on where you are? Sounds like you have a presentation at ESMO. Can you talk about what can we expect the data there? Thanks.

Fred Vogt
Fred Vogt
Interim CEO and President at Iovance Biotherapeutics

Sure. Let me cover the first two and then Dan can comment, and then I'll come back to TILVANCE at the end. Yes, I think you heard correctly. Demand trends are very positive right now for the Amtagvi product, and we expect increasing demand Q3 to Q4. We're obviously seeing quite a bit of Q3 right now. We want to just evaluate the whole situation because we really focus on long-term guidance here, and we want to make sure we can give good guidance for the full year, before we announce it. You are correct. We are intending to make a separate announcement of guidance. One morning, you'll wake up to some hopefully very positive news, I think, from Iovance on the guidance as we get that visibility. Can't tell you exactly when, but obviously sometime in the third quarter. Yes, that's very strong.

Fred Vogt
Fred Vogt
Interim CEO and President at Iovance Biotherapeutics

Amtagvi is strong. As we pointed out, for Proleukin, demand is very strong. Dan, do you want to comment and add some detail to that?

Dan Kirby
Dan Kirby
Chief Commercial Officer at Iovance Biotherapeutics

Sure. For Q3 right now, as you mentioned, Yanan, we have pretty good insight into Q3 and what's going on right now. The demand continues to grow, so we're very confident that Q3 will build upon the success in Q2. Then of Q4, of course, following from that. We've expanded our sales force. We continue to evaluate putting promotional activities in place, such as new campaigns, et cetera, to continue that growth driving not only through 2026, but 2027, too.

Fred Vogt
Fred Vogt
Interim CEO and President at Iovance Biotherapeutics

I'll come back and answer your question about TILVANCE-301. That study continues to run well. We're very happy with the performance of the study. At ESMO, we're going to, again, in an oral session there, highlight some of the compelling clinical characteristics of Amtagvi plus pembrolizumab in the frontline setting, including the fact that almost a third of patients go into a complete response. We have a very rapid velocity of response, meaning we can drive patients into a response much faster than other alternative therapies, we think. We'll show much more insight, I think, from the predecessor phase II study. Obviously, TILVANCE is a randomized trial that we can't look at right now. It's blinded. We'll read that at the interim point, hopefully relatively soon, although these trials take a long time to run, as you know.

Fred Vogt
Fred Vogt
Interim CEO and President at Iovance Biotherapeutics

We're going to show the compelling clinical characteristics. I think it's going to be a very important output for people in the field, especially since some of the excitement around LAG-3 has faded, especially post ASCO with Regeneron's results. Opdualag is still, in some cases, being questioned as whether it's the right combination in the frontline setting. There really is an extremely large need for some alternative to ipi/nivo in the frontline setting for these patients. We think lifileucel's characteristics are perfect for this with the one-time therapy combined with what may end up being fairly limited pembro dosing. The fact that we can drive a large percentage of patients into what's effectively a cure.

Yanan Zhu
Yanan Zhu
Analyst at Wells Fargo

Great. Thanks for the update.

Operator

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

Etzer Darout
Etzer Darout
Analyst at Barclays

Great. Thanks for taking the question and congrats on the strong second quarter. One question on margins and then one on lung. You had a meaningful step-up, obviously, in gross margin in the second quarter. Maybe if you could talk about the remaining opportunities to improve margins further, relative to current levels and where you think mature commercial margins could ultimately trend to over time, that would be great. Then on lung Obviously, the durability exceeds historical benchmarks from what you've previously shown. Is the internal goal there to replicate earlier data from an efficacy and durability standpoint? Also with enrollment nearly complete, have you continued to enroll patients with similar baseline characteristics from the prior update? Thank you.

Corleen Roche
Corleen Roche
CFO at Iovance Biotherapeutics

Hi, Etzer. It's Corleen. I'll answer your margin question. The driver is a number of things, and as you know, we've been focusing on this internally, and we've been talking about it. Obviously, higher volume, which you can see, but we have all of our manufacturing in-house, and those efficiencies are also helping margin, as well as these projects that we have where we're continuing to focus on margin improvement and operational efficiencies within the plant. I would think about that in terms of process, automation, things like that.

Fred Vogt
Fred Vogt
Interim CEO and President at Iovance Biotherapeutics

Yeah. One other point I'll just add to what Corleen said is, as Dan and others pointed out here already, with Proleukin now normalizing and then Proleukin sales expected to increase this year and then stabilize at the right percentage going forwards. Proleukin is a very high-margin product, so you can expect a little bit of tailwind there as well. On lung 202, you asked two questions there, Etzer. One was, is our internal goal to replicate the durability? It's to actually exceed the durability because when we reported the durability earlier, we had a shorter follow-up. I think what we're seeing right now, although we're not going to pre-release the results here, obviously, right now, we're seeing very strong durability. I think very similar in overall outcome to what we saw in melanoma. It's effectively the same type of product.

Fred Vogt
Fred Vogt
Interim CEO and President at Iovance Biotherapeutics

When we get a response, it's usually pretty durable. Whether it ends up being two years, three years, whatever it's going to be, we'll find that out when we do the ultimate stats analysis at the end, but it looks pretty good. I think any of those options are going to be successful in the marketplace in terms of a product that will attract a lot of prescribers and patients to a one-time therapy like that. You mentioned, with enrollment nearly complete, you asked about the baseline characteristics of the patients. I think we are seeing similar baseline through it. We don't have a lot of heterogeneity in our population. We're very comfortable with how we enroll these studies. We've spent a lot of time on our protocols to make sure we get things right.

Fred Vogt
Fred Vogt
Interim CEO and President at Iovance Biotherapeutics

Yes, I think we're seeing similar patients come through right now than we were throughout the study. Obviously, we changed our lymphodepletion to make it a little less burdensome on patients, and we're seeing really good results with that right now in terms of the safety profile and the overall risk-benefit profile of the product.

Etzer Darout
Etzer Darout
Analyst at Barclays

Great. Thanks for the color, congrats again.

Operator

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

Reni Benjamin
Reni Benjamin
Analyst at Citizens

Hey, good morning, guys. Thanks for taking the questions and congratulations on an amazing quarter. Just two questions from us. One regarding the outlook, and the fact that you're reviewing guidance. Related to that, does Replimune's recent positive FDA advisory committee feedback and maybe even the Obsidian going public, does that kind of impact guidance? If not, what are your thoughts regarding at least Replimune's agent coming into the marketplace? Just as a final question, the endometrial study, Fred, you had mentioned, histology-based patient selection and that there are protocol amendments going on right now. Can you talk a little bit or provide some color regarding the protocol amendments and how that study will ultimately reach conclusion? Thanks.

Fred Vogt
Fred Vogt
Interim CEO and President at Iovance Biotherapeutics

Yeah, let me take the last one first, Reni, because it's fast. It's a protocol amendment to focus on the serous subtype, and it really links up with the disclosure we had last quarter about the response rate that we're seeing and that precise approach to how we deliver TIL therapy to certain histological subpopulations in our studies. Well, we have a lot more to say about that across all the indications soon. On the guidance, what we're doing with the guidance internally is we're going to make sure we understand Q3, but really we want to understand the full year. We're not looking to give guidance that is just sort of short-term. We're really focused on long-term guidance to show the strength of the product overall.

Fred Vogt
Fred Vogt
Interim CEO and President at Iovance Biotherapeutics

Obviously, we cater to long investors, long holders of the stock, and we want to make sure they have the information they need to understand the overall trajectory. What we're going to do is make sure we have our demand understood fully. Obviously, it's very good, and then we will come back out at some point, which I can't tell you exactly when it's going to be during the third quarter, and we will announce something that I think everybody will find very positive and persuasive. On the competitor front, obviously, there's a lot of noise out there. I just want to stress that we stay out of this. This is not our situation. Other people have their drama that's going on with the FDA. Obviously, that product could get approved or not get approved. We don't really know.

Fred Vogt
Fred Vogt
Interim CEO and President at Iovance Biotherapeutics

If it does get approved, we view it as primarily competitive with T-VEC, which is the product that's on the market today that's also an oncolytic virus very similar to that product, as well as products like Opdualag that are being recycled in the community right now. It has a lot of barriers like T-VEC did, obviously, when a company goes to launch a product, they have to perform, we expect Amtagvi as a much more compelling option, I think, for patients with its one-time profile and really fantastic efficacy and tons of real-world experience now. We think that'll be good. With the other company, Obsidian, that's a TIL competitor, I think people should look very hard and carefully at how far ahead Iovance is in this space

Fred Vogt
Fred Vogt
Interim CEO and President at Iovance Biotherapeutics

The infrastructure Iovance has and the strength that we have and the experience that we have in this area before they just randomly assume that some other TIL company's going to come out of nowhere and somehow conquer the world here. Just bear that in mind, that there's reality to all these things. Many investors have visited us and seen the scale of what we do and can see the power of what we do and how much hard work and experience and intellect went into this whole thing. It's not easy to reproduce, there's a giant moat around Iovance that's, I think, very helpful for investors.

Reni Benjamin
Reni Benjamin
Analyst at Citizens

Great. Thanks for taking the questions.

Operator

Thank you. Our next question comes from David Dai with UBS. Your line is open.

David Dai
David Dai
Analyst at UBS

Thanks for taking my questions and also my congratulations on a great quarter. I have two questions. On the topic of demand, can you just talk more about the demand across different ATCs? Do you see more demand concentrating in large ATCs, or do you see increased demand in smaller and newly activated ATCs? I have a follow-up.

Dan Kirby
Dan Kirby
Chief Commercial Officer at Iovance Biotherapeutics

Thanks for the question. What we saw and what we are seeing right now is the ATCs that we originally opened in 2024 are starting to grow based on patient type and based on the information that we have that's been published recently. The ATCs that we onboarded last year in 2025, those are continuing to accelerate. Some of them are hitting their stride, so to speak, and getting mature and treating their patients. In the first half of this year, we've been opening ATCs at a pretty substantial pace, and those are starting to contribute now. We do see there's a few months between an ATC activation to them starting to treat patients, and then comfort level goes up. We are seeing growth across the different segments.

Dan Kirby
Dan Kirby
Chief Commercial Officer at Iovance Biotherapeutics

In regard to larger ATCs and whether they're contributing to more, I think our larger ATCs are still growing. We still haven't had an ATC that we can say has reached complete peak because they keep looking for new patients and patient types then. We are seeing across our subset of ATCs, all of them.

David Dai
David Dai
Analyst at UBS

Great. Thanks for the color. On community ATCs, which now represent roughly one-third of the network, how does patient volume, refer behavior, and reimbursement experience differ between community and academic centers?

Dan Kirby
Dan Kirby
Chief Commercial Officer at Iovance Biotherapeutics

Great question. For patient volume, they have the patients there, and it's really not the number of patients, it's what time we're getting these patients. As we said in the real-world data that got published earlier this year, is that patients that are on two or fewer lines of therapy have an over 50% response rate. Those patients reside primarily in the community setting before referred to the academics. We see referral barriers go down. The volume of patients are there, and they're there earlier. We do see the community ATCs are having learning curves similar to what we saw in the academics. Again, it takes a little while for them to ramp up. They're doing so now. Most of the community ATCs we started to onboard in the second half of last year.

Dan Kirby
Dan Kirby
Chief Commercial Officer at Iovance Biotherapeutics

I joined in the first half, that was one of the things that we said would be a focus. We've come through on that focus, now a third of our ATCs. We do see that they can have a higher ceiling than the academics because, again, it's organic referral patterns within network, which are much easier to maximize than referring to the academic centers.

David Dai
David Dai
Analyst at UBS

Got it. Thank you so much.

Operator

Thank you. Our next question comes from Colleen Kusy with Baird. Your line is open.

Analyst at Baird

Hey, everyone. It's Nick on for Colleen. Thanks for taking the question. Congrats on the quarter. Just wondering if you could provide any color on how the conversion rate from referrals of treated patients has changed over the last few quarters. Also just on growth bottlenecks like patient identification referrals, et cetera, what do you expect to be the biggest constraint on growth going forward, and just wondering if you could talk about how you plan on addressing that. Thank you.

Dan Kirby
Dan Kirby
Chief Commercial Officer at Iovance Biotherapeutics

Sure. As we look at this, the conversion to referrals, what we do see is earlier patients coming in. We're using that data in both non-personal media as well as in face-to-face with our field forces to get that word out. Again, we are seeing the referrals come in earlier, which means we have time to treat the patients. That is the change in the referral pattern to the earlier patient. That gets into patient ID as well. We have gone after, I've mentioned in previous calls, the BRAF mutated patients because that is a very important patient type, 40% of our market that we were having trouble accessing before. We're getting tumor tissue earlier. That is helping us ID these patients earlier to get tissue so we can manufacture for infusion at the right time.

Dan Kirby
Dan Kirby
Chief Commercial Officer at Iovance Biotherapeutics

As far as constraints with it, the constraints that we're working on is really more penetration into the larger community networks, and we see that as an opportunity. We've made a lot of strides over the last six to eight months with other entities, Florida Cancers, et cetera, where we're getting the referral pattern up while we're looking to establish ATCs within their own networks. We've got some up right now in those areas. We're looking to get more up. Fred, did you have anything to add?

Fred Vogt
Fred Vogt
Interim CEO and President at Iovance Biotherapeutics

No. I think that's pretty accurate.

Operator

Thank you. This concludes the question and answer session. I would now like to turn it back to Fred Vogt for closing remarks.

Fred Vogt
Fred Vogt
Interim CEO and President at Iovance Biotherapeutics

Thank you for joining us. This was a record quarter for revenue, infusions, and margin. Our pipeline is advancing rapidly with new registrational trials, next-generation clinical programs, and new approvals outside the United States. We are energized by the growing number of patient stories that show the power of our TIL therapies. We remain deeply grateful to the patients, partners, healthcare professionals, and advocacy communities we serve. Finally, I want to thank our exceptional Iovance team, our dedicated shareholders, and our covering analysts for their continued support. We remain committed to our mission to innovate, develop, and deliver current and next-generation TIL cell therapies for patients with cancer. Thank you.

Operator

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

Executives
    • Sara Pellegrino
      Sara Pellegrino
      SVP of Investor Relations and Corporate Communications
    • Fred Vogt
      Fred Vogt
      Interim CEO and President
    • Corleen Roche
      Corleen Roche
      CFO
    • Dan Kirby
      Dan Kirby
      Chief Commercial Officer
Analysts
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