IOVA

Germany’s Ifo index has reached a one year high, which hints at a more confident backdrop for companies planning to grow earnings rather than just defend margins. That creates an interesting setting for investors looking for earnings momentum combined with balance sheet discipline. This article examines three stocks from the Healthy high growth potential screener and explains why this blend of growth and financial strength may be appealing at this point. The stocks covered below are only a first sample from this idea. The full screen surfaced 283 more companies with similarly strong growth expectations and balance sheet profiles that are not covered here. To go straight to the source, use the Healthy high growth potential screener to identify, analyze, and prioritize the highest conviction opportunities that fit your own criteria. Overview: Amylyx Pharmaceuticals is a clinical stage drug developer focused on treatments for rare endocrine and neurodegenerative diseases, with its Healthy high growth potential link coming from late stage programs like AMX0035 and avexitide that could move it from research focused spending to a commercial footing. The company is advancing a pipeline that includes AMX0035 for conditions such as Wolfram syndrome and progressive supranuclear palsy, as well as avexitide and other GLP 1 receptor antagonists for post bariatric hypoglycemia and related rare disorders. Market Cap: US$4.3b Investors looking at Amylyx Pharmaceuticals are getting exposure to a company whose growth story hinges on late stage trial assets that sit squarely in the Healthy high growth potential theme. The recent Phase 3 LUCIDITY success for avexitide in post bariatric hypoglycemia, with a reported 55% reduction in serious hypoglycemic events and a planned NDA filing by the end of 2026, provides a clearer line of sight to potential first commercial revenues. At the same time, Amylyx is still loss making, relies on external funding and has issued new equity to support commercialization and research, so dilution and execution risk are important considerations. The broader pipeline around AMX0035 and AMX0114 adds additional programs that could matter for earnings quality and durability depending on how future developments unfold. Amylyx Pharmaceuticals looks like a rare mix of high potential trial assets and real balance sheet questions that many investors may be glossing over. Before you lean into the story, review the 2 key rewards and 4 important warning signs (2 are major!) Overview: Oracle is a global enterprise software company best known for its cloud based applications and databases, with Oracle Fusion Cloud ERP, HCM, SCM and industry suites like NetSuite and Oracle Health giving it a strong link to the Healthy high growth potential theme as customers move from on premise software to subscription cloud services. Operations: Oracle generates the bulk of its revenue from Cloud and software at about US$58.5b, with smaller contributions from Services at about US$5.7b and Hardware at about US$3.1b. Market Cap: US$410.3b Oracle gives you exposure to two connected growth stories. Its cloud SaaS businesses in ERP, HCM and healthcare applications are central to analysts’ expectations for strong earnings and revenue growth over the next few years, and its AI ready Oracle Cloud Infrastructure and huge contracted backlog add another layer of potential. At the same time, this is a heavily leveraged balance sheet that leans on debt and planned capital raises to fund AI data centers, while free cash flow coverage of the dividend looks thin. For investors willing to accept execution and financing risk, the mix of high margin software, large AI contracts and a valuation that screens as attractive versus peers can be a compelling combination. Oracle’s accelerating cloud story can be easy to focus on, while the real swing factor may be hiding in how future cash flows match up with its debt load and dividend promises. Get the Oracle financial health report Overview: Iovance Biotherapeutics is a commercial stage biotech company focused on autologous tumor infiltrating lymphocyte cell therapies, led by Amtagvi for advanced melanoma and a late stage TIL pipeline that targets multiple solid tumors such as lung, cervical and endometrial cancers. This TIL platform is the clearest link to the Healthy high growth potential screener, as success in these indications is central to the company’s path to stronger earnings over the coming years. Operations: Iovance Biotherapeutics currently generates about US$325 million in revenue, all from its autologous TIL therapy business, with roughly US$321 million from the United States and about US$4 million from the rest of the world. Market Cap: US$3.7b Iovance Biotherapeutics gives you direct exposure to a commercial TIL therapy platform that already includes Amtagvi for advanced melanoma and a growing late stage pipeline. Analysts link this to rapid earnings growth and an expected move into profitability within 3 years. Recent quarters have highlighted strong Amtagvi driven revenue, improving margins and a fast expanding Authorized Treatment Center network, while analysts continue to raise targets as management reaffirms 2026 revenue guidance of US$350 to US$370 million. At the same time, the company still reports losses, relies on higher risk external funding and has diluted shareholders, so execution and financing risk remain central. For investors comfortable with biotech volatility, that mix of commercial traction, pipeline breadth and valuation sensitivity can be a compelling but high stakes proposition. Accelerating Amtagvi sales and a widening TIL pipeline make Iovance Biotherapeutics appear to be more than a high risk biotech swing. Get the full growth picture in the analyst forecasts for Iovance Biotherapeutics Fresh stock ideas can move from quiet to flying in a hurry. Use these curated screens before momentum gets fully caught by the crowd. Act now. Spot companies with steady fundamentals and low risk scores by running the 74 resilient stocks with low risk scores while they are still under the radar for now. Capture income opportunities that aim for durability by scanning the market with the 12 dividend fortresses before yields drop and attention surges. Explore potential moves in digital finance by checking the curated 20 cryptocurrency and blockchain stocks while the theme is still developing. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Have feedback on this article? Concerned about the content? Get in touch with us directly. 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Find your next quality investment with Simply Wall St's easy and powerful screener, trusted by over 7 million individual investors worldwide. Iovance Biotherapeutics (IOVA) is back on investor radars after its second quarter 2026 earnings. The company reported higher revenue and a reduced net loss, and it reaffirmed full year revenue guidance. The quarter was driven by Amtagvi and Proleukin sales, and by progress across Iovance Biotherapeutics pipeline programs, including new regulatory approvals and Fast Track designations for lifileucel in certain soft tissue sarcomas. Management also reiterated full year 2026 revenue guidance of US$350 million to US$370 million, with a further update indicated for the third quarter. See our latest analysis for Iovance Biotherapeutics. The latest earnings news arrives after a strong run in Iovance Biotherapeutics share price, with a 30 day share price return of 47.26%, a 90 day share price return of 102.32% and a year to date share price return of 176.98%. Over a longer horizon, the 1 year total shareholder return of 173.73% contrasts with a 5 year total shareholder return that is down 67.03%. This highlights how quickly sentiment around high risk biotech stocks can shift when revenue traction and clinical progress start to build. If you are looking for more ideas in the same space, now could be a good time to scan the market using our screener of 44 healthcare AI stocks. This can help you spot other healthcare stocks where AI and data driven approaches are starting to shape the growth story. After Iovance Biotherapeutics rapid share price move, the gap between the current US$6.98 price, analyst targets, and intrinsic value models is wide. Where does a reasonable fair value anchor sit in that spread? At a last close of $6.98 compared with a narrative fair value of $18.00, Iovance Biotherapeutics is framed as significantly undervalued, and the thesis leans heavily on product growth and pipeline optionality. Read the complete narrative. The narrative by Polip leans on strong revenue expansion, higher long term margins and a future earnings multiple that is more in line with larger oncology companies. Curious which specific growth path, profitability profile and valuation yardstick combine to support a fair value almost three times the current Iovance Biotherapeutics share price. Result: Fair Value of $18.00 (UNDERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, Iovance Biotherapeutics still faces real risks, including ongoing net losses of US$289.517 million and dependence on successful trials and approvals across a concentrated pipeline. Find out about the key risks to this Iovance Biotherapeutics narrative. The mix of optimism and concern around Iovance Biotherapeutics is clear, so move quickly to review both sides of the debate and shape your own conclusion. To weigh the full balance of potential upside and downside, take a closer look at the 2 key rewards and 2 important warning signs. If you are serious about building a stronger portfolio, do not stop at Iovance Biotherapeutics. Use the tools available now so you are not reacting after the fact. Target potential value opportunities early by scanning companies that screen as attractively priced on fundamentals with the 50 high quality undervalued stocks. Strengthen your portfolio’s foundation by focusing on companies with sturdy finances through the solid balance sheet and fundamentals stocks screener (50 results). Hunt for underfollowed opportunities that many investors may be overlooking by checking the screener containing 18 high quality undiscovered gems. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include IOVA. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

Image source: The Motley Fool. Thursday, Aug. 6, 2026 at 8:30 a.m. ET Senior Vice President, Investor Relations and Corporate Communications - Sara Pellegrino Interim CEO and President - Frederick Vogt Chief Financial Officer - Corleen Roche Chief Commercial Officer - Daniel Kirby Need a quote from a Motley Fool analyst? Email [email protected] 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. [Operator Instructions] 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: Thank you, operator. Good morning, and welcome to the Iovance webcast to discuss our second quarter 2026 financial results, business achievements, and corporate update. 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 activity 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. I will turn the call over now to Dr. Fred Vogt, Interim CEO and President. Frederick Vogt: 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. 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. 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 LUN-202 trial in the pivotal cohorts in non-squamous, non-small cell lung cancer. This indication represents a blockbuster opportunity that is roughly 7x that of advanced melanoma. We look forward to providing program updates in the fourth quarter as we work towards supplemental Biologics License Application in 2027. We're moving quickly with our registrational SARATOGA trial for SAR-201 in 2 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 6 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. For example, a histology-based biomarker strategy produced striking early Phase 2 data in the first 5 evaluable patients with metastatic serous endometrial cancer. In our END-201 trial, we reported a 40% confirmed objective response rate and a 100% disease control rate. We are submitting a protocol amendment and 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 GE1-201 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 positive 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. Iovance is the first and only company in the world to take TIL 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, 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: 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 a one-time non-recurring impact 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 to $81 million, and 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. 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%. Margins 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. 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 to $370 million and plan to share more detail in the third quarter. We are well capitalized to fund both the launch and our pipeline. As of June 30, 2026, we had approximately $304 million in cash, 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 3 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. Daniel Kirby: 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 3 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 2 factors. One, a new marketing campaign unveiled at ASCO, and 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. With more than 95 total ATCs today, we are on track to reach at least 110 by year's end. Community ATCs now represent 1/3 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 5-year durability data, and real-world response rates of greater than 50% in patients with 2 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. 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 3 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. 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 3 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 2 approvals of Amtagvi in Canada and Australia, we are continuing to expand in new markets for previously treated melanoma patients, a globally addressable population of more than 30,000 patients annually. 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 covering -- that is converting into more patients treated. And the deepening clinical evidence is expanding the addressable patient population. 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 the question-and-answer session. Operator: [Operator Instructions] Our first question comes from Andrew Tsai with Jefferies. Lin Tsai: Congrats on a great quarter. So 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 kind of any one-offs in the timing of shipments maybe being more favorable in Q2? Just wanted to check the box on that. And then 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 patients 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? Daniel Kirby: So 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, essentially 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 2 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. Frederick Vogt: I'll just to add to Dan, just to be very clear, Andrew, there's not a timing issue or anything. This is organic demand for the product. It'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 the lung -- your question about the LUN-202 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. But I don't think it's fair to assume that we would wait for every single patient to become evaluable. We really want to make sure the integrity of the trial is clean and we have all patients in before we put some data out. Some of the patients may still be coming for their first evaluation, that kind of thing. Will we put that out or maybe not? Depends on the timing and how the data looks. So just stay tuned. The LUN is looking very positive right now. We feel very good about where we stand with the study and 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. Operator: Our next question comes from Yanan Zhu with Wells Fargo. Yanan Zhu: Great. I'll add my congrats on a very strong quarter. Maybe from Fred's comment, it sounds like for the next 2 quarters, you expect the sales to -- or the demand to further build upon the current demand level or the second quarter demand level. Just wanted to see if that's the correct interpretation. And in terms of -- given your visibility into the third quarter and perhaps also into the fourth quarter, can you talk about your expectation? And also, the guidance sounds like it's going to come during the third quarter, is that's 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? And sounds like you have a presentation at ESMO. Yes, can you talk about what we can expect the data there? Frederick Vogt: Sure, yes. Let me cover the first 2, and then Dan can comment, and 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 in Q3 and 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. But you are correct, we are intending to make a separate announcement of guidance. So, one morning, you wake up with some hopefully very positive news, I think, from Iovance on the guidance as we get that visibility. I can't tell you exactly when, but obviously sometime in the third quarter. But yes, that's very strong. Amtagvi is strong, and as we pointed out, Proleukin demand is very strong. Dan, do you want to comment and add some detail to that? Daniel Kirby: Sure. For Q3 right now, as you mentioned, Yanan, we have pretty good sight into Q3 and what's going on right now. The demand continues to grow. And so we're very confident that Q3 will build upon the success in Q2, and then a 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 and beyond. Frederick Vogt: And then 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 1/3 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. And 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. But we're going to show the compelling clinical characteristics. And 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, and often LAG is still, in some cases, being questioned as whether it's the right combination in the frontline setting and there really is an extremely large need for something -- 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 pembrolizumab dosing and the fact that we can drive a large percentage of patients into what's effectively a cure. Operator: Our next question comes from Etzer Darout with Barclays. Etzer Darout: 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. And 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? And also, with enrollment nearly complete, have you continued to enroll patients with similar baseline characteristics from the prior update? Corleen Roche: Hi, Etzer. It's Corleen. So 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. Frederick Vogt: Yes. And one other point I'll just add to what Corleen said. 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 LUN-202, I just want to, you asked 2 questions there, Etzer, one was, is our internal goal to replicate the durability, is to actually exceed the durability, because when we reported the durability earlier, we had short follow-up and 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, and when we get a response, it's usually pretty durable. Whether it ends up being 2 years, 3 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. And then you mentioned with the enrollment nearly complete. You asked about the baseline characteristics of the patients. I think we are seeing similar baselines through. 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. And 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. Operator: Our next question comes from Reni Benjamin with Citizens. Reni Benjamin: Congratulations on an amazing quarter. Just 2 questions from us. I guess, one, regarding the outlook and the fact that you're reviewing guidance. Can you talk a little bit about what factors go into providing this reviewed outlook and kind of what prevents you from providing that guidance now? And 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? And if not, kind of, what are your thoughts regarding at least Replimune's agent coming into the marketplace? And just as a final question, the endometrial study, Fred, you had mentioned, you know, a 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? Frederick Vogt: Let me take the last one first, [ Frank ] 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 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. We really 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. So 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. But 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 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 and honestly when a company goes to launch a product, they have to perform. And we expect Amtagvi is a much more compelling option, I think, for patients with this one-time profile and really fantastic efficacy and tons of real-world experience now. And so we think that'll be good. And with the other company, Obsidian, it's a TIL competitor. I think people should look very hard and carefully at how far ahead Iovance is in this space and the infrastructure Iovance has and the strength that we have and the experience that we have in this area before they sort of just randomly assume that some other TIL company is going to come out of nowhere and somehow conquer the world here. So just bear that in mind that there's a reality of all these things. Many investors have visited us and see 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 replicate and there's a giant moat around Iovance, that's I think very, very helpful for investors. Operator: Our next question comes from David Dai with UBS. Xiaochuan Dai: I also add my congratulations on a great quarter. I have 2 questions. So on Amtagvi demand, can you just talk more about the demand across different ATCs? Do you see more demand concentrating on large ATCs, or do you see increased demand in smaller and newly activated ATCs? And I have a follow-up. Daniel Kirby: 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 in treating their patients. And then in the first half of this year, we've been opening ATCs at a pretty substantial pace. And those are starting to contribute now. So we do see there's a few months between an ATC activation to then starting to treat patients, and then comfort level goes up. So we are seeing growth across the different segments. 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 in. So we are seeing across our subset of ATCs, all of them. Xiaochuan Dai: Great, thanks for the color. And then on community ATCs, which now represent roughly 1/3 of the network, how does patient volume, referral behavior, and reimbursement experience differ between community and academic centers? Daniel Kirby: Great question. So 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. So as we said in the real-world data that got published earlier this year, is that patients that are on 2 or fewer lines of therapy have an over 50% response rate. Those patients reside primarily in the community setting before we refer to the academic. So 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. So 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. I joined in the first half and that was one of the things that we said would be a focus. We've come through on that focus and now 1/3 of our ATCs, and 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. Operator: Our next question comes from Colleen Kusy with Baird. Nick Quartapella: It's Nick on for Colleen. Congrats on the quarter. Just wondering if you could provide any color on how the conversion rate from referrals to treated patients has changed over the last few quarters. And then also just on growth bottlenecks like patient identification or 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. Daniel Kirby: Sure. So as we look at this, the conversion to referrals, what we do see is earlier patients and 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. So again, we are seeing the referrals come in earlier, which means we have time to treat the patients. So that is the change in the referral pattern of an earlier patient. And 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 tissues so we can manufacture for infusion at the right time. And then 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 6 to 8 months with other entities, Florida Cancer et cetera, where we're getting the referral pattern up where 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? Frederick Vogt: No, Dan, I think that's pretty accurate. Operator: This concludes the question-and-answer session. I would now like to turn it back to Fred Vogt for closing remarks. Frederick Vogt: 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 for the patients, partners, health care professionals, and advocacy communities we serve. Finally, I want to thank our exceptional Iovance team, our dedicated shareholders, 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. Before you buy stock in Iovance Biotherapeutics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Iovance Biotherapeutics wasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $400,209!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,375,393!* That performance is why people listen. With a track record of beating the S&P 500 by 4x, Stock Advisor offers a distinct advantage. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built for the long haul. See the 10 stocks » *Stock Advisor returns as of August 13, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has positions in and recommends Iovance Biotherapeutics. The Motley Fool has a disclosure policy. Iovance (IOVA) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Shares of biopharmaceutical company Iovance Biotherapeutics (NASDAQ: IOVA) have been skyrocketing lately. The California-based business reported earnings recently, which pleased investors, and that's putting it lightly, as the stock also hit a new 52-week high. What's gotten investors so bullish on the healthcare stock, and is now a good time to buy it? Missed Nvidia in 2009? This Rare Signal Is Flashing Again. In 2009, a "Double Down" signal flashed for a little-known chipmaker called Nvidia. For the first time in years, that same "Total Conviction" signal is flashing for a company 1/100th the size of Nvidia. Continue » On Aug. 6, Iovance released its second-quarter earnings numbers, which showed strong growth for its promising cancer treatment, Amtagvi (lifileucel). The company's revenue for the June quarter totaled $99.3 million, which was an increase of 66% from the prior-year period. The lion's share of the company's revenue comes from Amtagvi, which was responsible for $91 million. The Food and Drug Administration approved Amtagvi in early 2024 as a treatment for unresectable or metastatic melanoma. It has the potential to be a blockbuster for Iovance, as it may bring in more than $1 billion in revenue at its peak. However, how much it generates will depend on its approval for other indications. In addition to generating significant revenue growth this past quarter, the company also drastically reduced its losses during the period. Iovance's net loss came in at $47.3 million, which was less than half the $111.7 million loss it incurred in the same period last year. As Amtagvi continues to reach more patients and sales grow, there is hope that the business may have a path to profitability, which would make the stock a more attractive investment option for more risk-averse investors. Although Iovance's stock has been red hot of late, I think it can still rise higher. It's down more than 70% over the past five years, and now, with the business having an approved treatment and significant revenue to show for, it's not nearly as risky an investment as it was in the past. And with terrific margins, there's reason to be optimistic that it may get to breakeven in the future. The stock may even become an attractive acquisition target for a larger healthcare company, given its modest market cap of around $3 billion. There will inevitably be some risk with the stock because of its lack of profitability, but with some tremendous progress and positive signs around Iovance, I wouldn't be surprised if it were to rise a whole lot higher in the long run. This can be an excellent growth stock for investors who are comfortable taking on some risk and uncertainty. Before you buy stock in Iovance Biotherapeutics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Iovance Biotherapeutics wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $399,832!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,374,595!* Now, it’s worth noting Stock Advisor’s total average return is 968% — a market-crushing outperformance compared to 215% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of August 10, 2026. David Jagielski, CPA has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Iovance Biotherapeutics. The Motley Fool has a disclosure policy. Iovance Biotherapeutics Stock Soars After the Company Posts Strong Q2 Earnings. Is It Heading Even Higher? was originally published by The Motley Fool

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Record Q2 revenue of $99.3 million was driven by organic demand for Amtagvi, which reached approximately $91 million, reflecting a 51% sequential increase. Gross margins reached an all-time high of 56%, benefiting from higher volumes, cost optimization, and the first full quarter of exclusively in-house manufacturing. Management attributes commercial momentum to rising physician awareness, which has increased nearly threefold over the past year among treaters and referrers. The company is successfully shifting toward earlier-line treatment, supported by real-world evidence showing response rates over 50% in patients with two or fewer prior lines of therapy. Operational discipline is evidenced by a fourth consecutive quarter of declining R&D expenses even as lead programs in lung cancer and sarcoma advanced. Strategic expansion into community settings now accounts for one-third of the Authorized Treatment Center (ATC) network, facilitating easier access to patients earlier in their treatment journey. Management expects to provide an updated full-year 2026 revenue guidance during the third quarter once increasing growth trends are fully assessed. The company maintains a peak sales assumption of more than $1 billion for Amtagvi and Proleukin in advanced melanoma alone, with significantly larger opportunities in other indications. Cash runway is now projected to fund operations into the second half of 2028, reflecting a path toward self-funded profitability. Regulatory milestones include a planned supplemental Biologics License Application for non-small cell lung cancer in 2027 and ongoing engagement with the FDA for an expedited endometrial cancer pathway. International expansion is expected to accelerate with pending regulatory approvals in the United Kingdom and Switzerland, alongside active onboarding of ATCs in Canada and Australia. Proleukin revenue of $9 million was slightly lower than the prior quarter due to wholesaler inventory stocking timing, but is expected to stabilize at approximately 16% of total revenue. The company received FDA Fast Track designation for SAR-201 in soft tissue sarcomas, addressing a high unmet need where standard of care response rates are less than 5%. Management emphasized a 'giant moat' around their manufacturing infrastructure, downplaying competitive threats from newer TIL entrants by citing the complexity of scaling centralized cell therapy production. A protocol amendment for the END-201 trial will focus specifically on the serous endometrial cancer subtype following a 40% confirmed objective response rate in early data. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management confirmed the beat was driven by organic demand rather than timing issues or one-offs. Growth was propelled by the publication of real-world evidence showing high response rates in earlier-line patients, which encouraged broader physician adoption. Enrollment is nearly complete; management intends to provide a material update in Q4 2026. The update will not necessarily wait for every patient to be evaluable but will ensure trial integrity and sufficient follow-up to demonstrate durability. Management views potential competitors as primarily challenging existing therapies like T-VEC or Opdualag rather than Amtagvi. They highlighted their established infrastructure and real-world experience as significant barriers to entry for newer TIL competitors. Community centers provide access to patients earlier in their disease progression, which typically results in higher response rates. While community centers have a learning curve similar to academic centers, they may have a higher ceiling due to easier internal referral patterns.

Iovance Biotherapeutics IOVA incurred a second-quarter 2026 loss of 11 cents per share, narrower than the Zacks Consensus Estimate of a loss of 17 cents. In the year-ago quarter, the company reported a loss of 33 cents. Total revenues for the reported quarter rose 66% year over year to $99.3 million, generated entirely from the sales of the company’s two marketed drugs. The top line beat the Zacks Consensus Estimate of $87.3 million, as well as management's own guidance of $86-$88 million for the quarter. Iovance currently has two marketed drugs in its portfolio — the IL-2 product Proleukin and the TIL therapy Amtagvi. While Proleukin is approved to treat metastatic renal cell carcinoma and metastatic melanoma in adults, Amtagvi is approved for the advanced melanoma indication. The company recorded $90.7 million from Amtagvi sales during the second quarter, up 68% year over year and 51% sequentially.  The figure surpassed both the Zacks Consensus Estimate and our model estimate of $79 million. Amtagvi also outperformed the company's forecast of $79-$81 million. Proleukin sales rose 46% to $8.6 million, benefitting from its use alongside Amtagvi. The reported sales marginally beat the Zacks Consensus Estimate and our model estimate of $8.5 million. Management attributed the sequential decline from roughly $11 million in the previous quarter to the timing of wholesaler inventory stocking. Shares of Iovance jumped 43% yesterday to a 52-week high following the results, likely reflecting an encouraging investor response to Amtagvi's commercial momentum. Though the company did not immediately raise its revenue outlook, management said it is reviewing the guidance and will provide an update during the third quarter amid strong demand trends. Year to date, the stock has skyrocketed 127.5% compared with the industry’s 3.5% growth. Image Source: Zacks Investment Research Gross margin improved to 56% from 41% in the first quarter of 2026, marking a quarterly high. Higher Amtagvi volume, continued cost optimization and efficiencies from fully in-house manufacturing supported the improvement. Research and development expenses declined 24% year over year to $58.9 million. Selling, general and administrative expenses increased 5% to $39.3 million. Iovance ended the second quarter with approximately $304 million in cash and cash equivalents compared with $319 million in the previous quarter. Management expects the current cash position to fund operations into the second half of 2028, compared with its previous expectation of funding operations into 2028. The longer runway comes as Iovance continues to improve manufacturing efficiencies and control operating expenses while advancing its commercial launch and pipeline. Strong second-quarter sales prompted management to review its previously issued 2026 total revenue guidance of $350-$370 million. Iovance plans to provide an updated forecast during the third quarter after assessing current demand trends. Management expects Amtagvi's demand to increase in both the third and fourth quarters. Proleukin sales are also expected to grow alongside Amtagvi, with the product anticipated to represent approximately 16% of total revenues on a steady-state basis during the remainder of the year. Amtagvi recently secured approval in Australia for the melanoma indication. In the U.K., a regulatory filing for the therapy was resubmitted last month and is undergoing expedited review for potential approval before this year’s end. While a potential approval for Amtagvi in Switzerland is expected in the first half of 2027, Iovance is in discussions with the EMA to resubmit a regulatory filing for the therapy next year. Iovance continues to advance its development programs for Amtagvi. It is evaluating the drug in combination with Merck’s MRK Keytruda in the phase III TILVANCE-301 study as a potential treatment for frontline advanced melanoma. This study will serve as a confirmatory study seeking full approval for Amtagvi in the melanoma indication. Beyond melanoma, Iovance is developing Amtagvi for other cancer indications. Alongside the earnings results, the company reported that enrolment is nearly complete in the pivotal cohorts of the phase II IOV-LUN-202 study evaluating the therapy for previously treated metastatic non-squamous non-small cell lung cancer (NSCLC). An update is expected in the fourth quarter of 2026. The company intends to submit a regulatory filing seeking label expansion in 2027. Amtagvi is being evaluated in separate mid-stage studies for endometrial cancer and soft tissue sarcomas. Iovance currently carries a Zacks Rank #2 (Buy). Iovance Biotherapeutics, Inc. price | Iovance Biotherapeutics, Inc. Quote Some other top-ranked stocks in the biotech sector are Harmony Biosciences HRMY and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, earnings per share (EPS) estimates for Harmony Biosciences have risen from $3.20 to $3.33 for 2026. Over the same period, EPS estimates have increased from $3.64 to $3.87 for 2027. HRMY shares have risen about 4% year to date. Harmony Biosciences missed earnings in three of the trailing four quarters while meeting on one occasion, delivering an average negative surprise of 13.97%. Over the past 60 days, estimates for Liquidia’s 2026 EPS have increased to $3.02 from $2.97. Over the same period, EPS estimates for 2027 have risen from $4.81 to $5.31. LQDA shares have skyrocketed 159% so far this year. Liquidia’s earnings beat estimates in three of the trailing four quarters and missed on one occasion, with the average surprise being 54.40%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Iovance Biotherapeutics, Inc. (IOVA) : Free Stock Analysis Report Merck & Co., Inc. (MRK) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

This article first appeared on GuruFocus. Total Revenue: More than $99 million in Q2 2026, up 66% year-over-year and 39% sequentially. Amtagvi Revenue: Record approximately $91 million, up roughly 51% quarter-over-quarter and 68% year-over-year, exceeding guidance of $79 to $81 million. Proleukin Revenue: Approximately $9 million in Q2, slightly down from $11 million in the prior quarter due to wholesaler inventory timing. Gross Margin: Reached an all-time high of 56%, up from 41% in Q1 2026 and above the previous high of 50% in Q4 2025. Research and Development Expenses: Approximately $59 million, down from $62 million in the prior quarter, marking the fourth consecutive quarter of cost savings. Selling, General, and Administrative Expenses: Held essentially flat at about $39 million. Cash Position: Approximately $304 million in cash, cash equivalents, and short-term investments as of June 30, 2026, expected to fund operations into the second half of 2028. Full Year 2026 Revenue Guidance: Previously issued guidance of $350 to $370 million is under review, with an update expected in Q3. Warning! GuruFocus has detected 2 Warning Signs with IOVA. Is IOVA fairly valued? Test your thesis with our free DCF calculator. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Record Q2 2026 revenue of $99.3 million, driven by strong Amtagvi demand and exceeding guidance. Gross margin reached an all-time high of 56%, up from 41% in Q1, with expectations for further expansion. R&D expenses decreased for the fourth consecutive quarter, demonstrating operational discipline and efficiency gains. FDA granted Fast Track designation for lifileucel in two advanced soft tissue sarcomas, validating the program's potential. Early Phase 2 data in metastatic serous endometrial cancer showed a 40% confirmed objective response rate and 100% disease control rate. Expanding commercial footprint with over 95 ATCs, including a growing community presence, and strong payer coverage (75% private payers). Cash position of $304 million is expected to fund operations into the second half of 2028, supporting long-term growth. Proleukin revenue declined slightly in Q2 due to timing of wholesaler inventory stocking, though expected to stabilize. Full-year 2026 revenue guidance was not updated, with management only committing to a review during Q3, creating uncertainty. LUN-202 trial enrollment is nearly complete but not finished, and top-line data will not be available until Q4, with potential delays. Competitive threats from emerging therapies (e.g., Replimune's oncolytic virus) and other TIL developers could impact market share. International expansion is still in early stages, with approvals pending in the UK and Switzerland and EU resubmission ongoing. The company faces challenges in penetrating larger community networks, which may limit patient access and growth. Despite progress, the company is not yet profitable, and achieving profitability depends on continued revenue growth and cost management. Q: 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-offs in the timing of shipments? A: Dan Kirby (Chief Commercial Officer) confirmed the growth was driven by organic demand, citing increased physician awareness, an expanding ATC network, and the publication of real-world evidence showing over 50% response rates in patients with 2 or fewer lines of therapy. Fred Vogt (Interim CEO) added there were no timing issues, and demand is expected to continue increasing significantly in the coming quarters. Q: Can you provide an update on the LUN-202 trial in non-small cell lung cancer and the cadence of events we can expect for the Q4 update? A: Fred Vogt (Interim CEO) stated enrollment is nearly complete. While they will not wait for every patient to become evaluable, they want to ensure the integrity of the trial is clean before releasing data. He emphasized the study is looking "very positive" and expects to have "a lot to say" in Q4, potentially exceeding investor expectations. Q: Can you talk about the remaining opportunities to improve gross margins further and where mature commercial margins could ultimately trend? A: Corleen Roche (CFO) attributed the margin expansion to higher volume, in-house manufacturing efficiencies, and process automation. Fred Vogt added that Proleukin, a high-margin product, will provide a tailwind as sales normalize and grow. The company expects margins to keep expanding as they gain efficiency and scale. Q: What factors go into providing the reviewed guidance, and what prevents you from providing it now? Also, does Replimune's recent positive FDA advisory committee feedback impact your outlook? A: Fred Vogt (Interim CEO) explained they are focused on providing long-term guidance rather than short-term updates, ensuring they fully understand Q3 and full-year demand. Regarding competitors, he dismissed Replimune's product as primarily competitive with T-VEC, citing barriers to adoption. He also highlighted Iovance's significant "moat" in TIL therapy, including infrastructure and experience, which he believes protects against new entrants like Obsidian. Q: On Amtagvi demand, do you see more demand concentrating on large ATCs or increasing demand in smaller and newly activated ATCs? A: Dan Kirby (Chief Commercial Officer) noted growth across all segments. ATCs opened in 2024 are still growing, 2025 ATCs are accelerating, and new ATCs from the first half of 2026 are starting to contribute. He noted that no ATC has reached peak capacity yet, as they continue to find new patient types. Q: How does patient volume, referral behavior, and reimbursement experience differ between community and academic ATCs? A: Dan Kirby (Chief Commercial Officer) explained that community ATCs have access to earlier-line patients, which is crucial given the higher response rates in patients with 2 or fewer lines of therapy. While they have a learning curve similar to academics, they offer a higher ceiling due to organic referral patterns within their networks. Community ATCs now represent a third of the network and are expected to increase significantly. Q: Can you provide any color on how the conversion rate from referrals to treated patients has changed, and what do you expect to be the biggest constraint on growth going forward? A: Dan Kirby (Chief Commercial Officer) stated that referrals are coming in earlier, allowing more time to treat patients. They are focusing on identifying BRAF-mutated patients earlier by obtaining tumor tissue sooner. The biggest constraint is penetration into larger community networks, which they are addressing through partnerships with entities like Florida Cancer Specialists to establish more ATCs. Q: Can you give an update on TILVANCE-301 and what we can expect from the ESMO presentation? A: Fred Vogt (Interim CEO) said the study is running well. At ESMO, they will present compelling clinical characteristics of Amtagvi plus pembrolizumab in the frontline setting, including a near one-third complete response rate and rapid velocity of response. He highlighted the large unmet need for an alternative to ipi/nivo in the frontline setting, positioning lifileucel as a potential one-time therapy with durable outcomes. Q: Can you talk about the protocol amendments for the endometrial cancer study and how that study will ultimately reach conclusion? A: Fred Vogt (Interim CEO) explained the protocol amendment focuses on the serous subtype, linking to the high response rates seen in that histological subpopulation. The company is engaging with the FDA on an expedited approval pathway based on this patient population, with more details to be shared across all indications soon. Q: Can you provide more detail on the Q2 revenue beat and the outlook for Proleukin? A: Corleen Roche (CFO) reported Q2 total revenue of $99.3 million, up 66% year-over-year, with Amtagvi contributing approximately $91 million. Proleukin contributed about $9 million, slightly down due to wholesaler inventory timing, but all three wholesalers have sold through previous stocking inventory. For the rest of the year, Proleukin is expected to grow with Amtagvi, stabilizing at approximately 16% of total revenue. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

U.S. Amtagvi Revenue Reaches ~$91M and Total Revenue Increased 66% Year-over-Year Gross Margin Increased to 56% Fast Track Designation (FTD) Granted by the FDA for Lifileucel in Soft Tissue Sarcomas SAN CARLOS, Calif., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today reported second quarter 2026 financial results, business achievements, and corporate updates. “Second-quarter revenue reached a record $99.3 million with gross margin of 56%, driven by continued U.S. Amtagvi demand,” said Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer. “Based on our second-quarter performance and strong demand trends, we are reviewing our previously issued 2026 revenue guidance of $350 million to $370 million and will provide an update during the third quarter. Additionally, we continue to be excited by our clinical pipeline as lifileucel advances across other solid tumor indications including metastatic non-squamous non-small-cell lung cancer (NSCLC), the new registrational SARATOGA trial in undifferentiated pleomorphic sarcoma (UPS) and dedifferentiated liposarcoma (DDLPS), and metastatic serous endometrial cancer. Continued manufacturing and operating efficiencies support our sustainable growth, accelerate progress toward profitability, and advance our clinical pipeline with first-in-class, novel products in new solid tumor indications.” Second Quarter 2026 Financial Highlights Record Revenue and Improving Margin Supported by Cost Discipline Total product revenue was ~$99 million, an increase of 66% from ~$60 million in 2Q25 and 39% from ~$71 million in 1Q26. U.S. Amtagvi revenue was ~$91 million, up 40% from 4Q25. Global Proleukin revenue was ~$9 million and is expected to grow during the remainder of 2026. Gross margin was 56%1, reflecting higher Amtagvi sales volume, continued cost optimization, and maturing internal manufacturing efficiencies. Research and Development (R&D) expenses decreased by ~6% compared to 1Q26, driven by continued operational efficiencies during the fourth straight quarter of improvements. Full Year 2026 OutlookSecond Quarter Performance and Demand Growth Based on strong second-quarter sales and current demand trends, Iovance is reviewing its FY26 total revenue guidance of $350 million to $370 million. An update will be provided during the third quarter. Improvements in gross margin are expected to continue, excluding occasional one-time items. Amtagvi Commercial BusinessSignificant U.S. Commercial Business Growth and Progress in Global Expansion Demand and awareness: Record Amtagvi demand, catalyzed by a new marketing campaign and an expanded sales team, is driving increased adoption across a growing ATC network and referrals toward earlier treatment. Unaided physician awareness of Amtagvi has nearly tripled during the last year. Authorized treatment center (ATC) network: The network has grown to more than 95 U.S., Canadian, and Australian ATCs, with at least 110 ATCs expected to be active by the end of 2026. Community ATCs now represent a third of the network and are expected to increase significantly over the next several quarters. Real-world experience: Multiple real-world studies by Iovance and ATCs using commercial Amtagvi continue to advance, supporting broader adoption of Amtagvi and earlier patient referrals and access. These studies highlight objective response rates (ORRs) of 50% or greater and address identification of tumor harvest sites, accelerated institutional workflows, and improved patient care. Manufacturing turnaround time: Amtagvi turnaround time is 31 days or less using the only scaled, centralized commercial manufacturing process approved by FDA for TIL therapy. Australia: The marketing authorization application (MAA) for Amtagvi in Australia was approved by the Therapeutic Goods Administration (TGA), marking the third approval of Amtagvi by global health authorities to date. A high incidence of advanced melanoma in Australia causes more than 1,500 annual deaths. Australian ATCs are currently progressing through the authorization process in parallel with discussions for national reimbursement. United Kingdom (UK): The MAA for Amtagvi in the UK was resubmitted in early July and is undergoing expedited review by the Medicines and Healthcare products Regulatory Agency (MHRA) for potential approval later in 2026. Advanced melanoma causes more than 2,500 deaths annually in the UK. Switzerland: Potential approval of the MAA in Switzerland is expected in 1H27, opening a second market opportunity in Europe with the potential for medical tourism. Switzerland’s domestic melanoma burden causes several hundred deaths annually. Other markets and indications: An MAA resubmission for Amtagvi in advanced melanoma to the European Medicines Agency is on track for 2027. Other regulatory submissions are planned in international markets with a high prevalence of advanced melanoma, NSCLC, and soft tissue sarcomas. Clinical and Regulatory Pipeline Updates Progress Across a Deep Pipeline of Registrational Programs IOV-LUN-202: Initial results in previously treated metastatic non-squamous NSCLC supported FDA FTD. Enrollment is nearly complete in the pivotal cohorts and program updates are expected in 4Q26. A supplemental Biologics License Application (sBLA) submission is planned in 2027. The U.S. market opportunity in metastatic non-squamous NSCLC is about seven times that of advanced melanoma. SARATOGA (IOV-SAR-201): The registrational trial in UPS and DDLPS is underway, driven by positive early data with an ORR by RECIST v1.1 of 50% in the first six evaluable patients. Based on the strength of this early data, FDA granted FTD for UPS and DDLPS. Results will be highlighted in an oral presentation (abstract #3725RO) at the European Society for Medical Oncology (ESMO) meeting in Madrid, Spain, from October 23–27, 2026. TILVANCE-301: A Phase 3 randomized trial of lifileucel and pembrolizumab is enrolling patients with frontline advanced melanoma across a broad global footprint. The TILVANCE-301 trial includes an early interim analysis based on ORR for a potential sBLA for frontline advanced melanoma. The trial also serves as the confirmatory study for the accelerated approval of lifileucel in second-line advanced melanoma. Results supporting the combination of lifileucel and pembrolizumab as a potential best-in-class option for frontline advanced melanoma were accepted (abstract #2072O) for an oral presentation at the ESMO annual meeting. IOV-END-201: Positive initial data in previously treated metastatic serous endometrial cancer using a biomarker strategy based on histology were recently reported. A protocol amendment is being submitted and engagement with FDA is underway on an expedited approval pathway to focus on this population. Next-Generation Pipeline Updates First-in-Class Immuno-Oncology Technologies Target New Indications IOV-GM1-201: A Phase 1/2 trial investigating IOV-4001, a PD-1 inactivated TIL therapy, is enrolling patients with previously treated metastatic melanoma and NSCLC. IOV-4001 is engineered to resist inhibitory signals and enhance the ability of TIL therapies to fight and kill cancer in the tumor microenvironment (TME). IOV-GE1-201: A Phase 1/2 trial is underway using IOV-5001, a second-generation IL-12 tethered TIL therapy designed to remodel the suppressive TME and activate immunologically “cold tumors” to support TIL responses and boost response rates.2 Cohorts include metastatic colorectal cancer, triple-negative and estrogen receptor low breast cancers, and other solid tumors causing more than 100,000 annual U.S. deaths.3 IOV-IL2-101: A Phase 1 safety cohort is advancing through multiple dose levels in the Phase 1/2 trial of IOV-3001, our second-generation modified IL-2 analog for the TIL treatment regimen. IOV-3001 selectively expands effector T cells while avoiding activation of regulatory T cells with the potential for a lower dose IL-2 regimen with reduced adverse events. IOV-3001 is expected to be superior to Proleukin as a component of future TIL regimens. Investigator-sponsored trials (ISTs): Iovance is advancing several lifileucel ISTs in new indications. Multiple patients have been treated for cutaneous squamous cell carcinoma (CSCC) and Merkel cell carcinoma (MCC) with initial data expected in 1H27. To date, early clinical activity has been reported. With no approved therapies after failure of checkpoint inhibitors, lifileucel could address a large CSCC and MCC market with several thousand annual deaths in the U.S. Corporate Updates Iovance is deploying and advancing artificial intelligence (AI) tools to drive significant future cost efficiencies and new product pipeline insights. Iovance currently owns or licenses more than 400 granted or allowed U.S. and international patents and patent rights for Amtagvi and other TIL-related technologies and has filed more than 1,000 additional patent applications worldwide. This broad patent portfolio is expected to provide patent exclusivity through at least 2042 and beyond. As of June 30, 2026, Iovance’s cash position was ~$304 million4 and current cash is expected to fund operations into 2H28. Webcast and Conference Call Management will host a conference call and live audio webcast to discuss these results and provide a corporate update today at 8:30 a.m. ET. To listen to the live or archived audio webcast, please register at https://edge.media-server.com/mmc/p/3f4w9ts7/. The live and archived webcast can be accessed in the Investors section of the Company’s website, IR.Iovance.com, for one year. 1. Excludes depreciation and amortization2. Zhang L, Rosenberg SA, et al., Clin Cancer Res 2015;21(10):2278–2288.3. Surveillance, Epidemiology, and End Results Program Cancer Stat Facts (accessed April 2026).4. Cash, cash equivalents, short-term investments, and restricted cash as of June 30, 2026. About Iovance Biotherapeutics, Inc. Iovance Biotherapeutics, Inc. is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. Amtagvi® (lifileucel) is the first FDA-approved, one-time treatment for previously treated advanced melanoma, now approved in three global markets and available at more than 95 authorized treatment centers. The Iovance TIL platform spans registrational trials and next-generation programs in additional solid tumors, including gene-edited and IL-12 tethered TIL therapies, next-generation IL-2, and precision immuno-oncology approaches. As the first and only company to take TIL therapy from concept to a broadly accessible commercial treatment, Iovance operates as an end-to-end cell therapy company, anchored by fully owned, centralized U.S.-based manufacturing that is scaled to serve thousands of cancer patients worldwide each year. For more information, please visit www.iovance.com. Amtagvi® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners. Information on Iovance’s broad, industry-leading patent portfolio is available on the Intellectual Property page on www.iovance.com. Forward-Looking Statements Certain matters discussed in this press release are “forward-looking statements” of Iovance Biotherapeutics, Inc. (hereinafter referred to as the “Company,” “we,” “us,” or “our”) within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Without limiting the foregoing, we may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “forecast,” “guidance,” “outlook,” “may,” “can,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments, and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events, or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements, and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the sections titled “Risk Factors” in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and include, but are not limited to, the following substantial known and unknown risks and uncertainties inherent in our business: the risks related to our ability to successfully commercialize our products; the acceptance by the market of our products and product candidates, if approved, and their potential pricing and/or reimbursement by payors, and whether such acceptance is sufficient to support continued commercialization or development of our products or product candidates; the risk regarding our ability to manufacture our therapies at our iCTC facility, including the risk that our ability to increase manufacturing capacity at our facility may adversely affect our commercial launch; the risks related to our ability to obtain, maintain and enforce patent and other intellectual property protection for our products and product candidates; the risk that the successful development or commercialization of our products may not generate sufficient revenue from product sales, and we may not become profitable in the near term, or at all; the risks related to the timing of and our ability to successfully develop, submit, obtain, or maintain regulatory authority approval of our product candidates; whether clinical trial results from our pivotal studies and cohorts, and meetings with regulatory authorities may support registrational studies and subsequent approvals by regulatory authorities, including the risk that the planned registrational trial in advanced sarcomas may not support approval; preliminary and interim clinical results, which may include efficacy and safety results, from ongoing clinical trials or cohorts may not be reflected in the final analyses of our ongoing clinical trials or subgroups within these trials or in other prior trials or cohorts; the risk that we may be required to conduct additional clinical trials or modify ongoing or future clinical trials based on feedback from regulatory authorities; the risk that our interpretation of the results of our clinical trials or communications with regulatory authorities may differ from the interpretation of such results or communications by such regulatory authorities; the risk that clinical data from ongoing clinical trials of Amtagvi will not continue or be repeated in ongoing or planned clinical trials or may not support regulatory approval or renewal of authorization; the risk that unanticipated expenses may decrease our estimated cash balances and forecasts and increase our estimated capital requirements; the risk that we may not be able to recognize revenue for our products; the risk that Proleukin revenues, and other factors such as the number of ATCs, may not serve as a leading indicator for Amtagvi revenues; the risks regarding our anticipated operating and financial performance, including our financial guidance and projections; the effects of global and domestic geopolitical factors or public health events; and other factors, including general economic conditions and regulatory developments, not within our control. Any financial guidance provided in this press release assumes the following: no material change in our ability to manufacture our products; no material change in payor coverage; no material change in revenue recognition policies; no new business development transactions not completed as of the period covered by this press release; and no material fluctuation in exchange rates. CONTACTS [email protected] ext. 150 [email protected] 650-260-7120 ext. 150

Interested in Iovance Biotherapeutics, Inc.? Here are five stocks we like better. Record second-quarter performance: Revenue rose 66% year over year to $99.3 million, led by approximately $91 million from Amtagvi, while gross margin expanded to about 56%. Iovance is reviewing its 2026 revenue guidance of $350 million to $370 million after exceeding its quarterly forecast. Commercial expansion continues: Iovance had more than 95 authorized treatment centers and remains on track to reach at least 110 by year-end 2026. The company said demand is increasing, with more than 50 patients receiving commercial Amtagvi treatment monthly and insurance coverage expanding. Pipeline advances strengthen growth prospects: Enrollment is nearly complete in the lung-cancer IOV-LUN-202 trial, while lifileucel received FDA Fast Track designation in two sarcoma settings. Early studies also showed encouraging response rates in gynecologic cancers, supporting potential future approval pathways. Why 2 Small Biotechs May Hold the Key to New Cancer Treatments Iovance Biotherapeutics (NASDAQ:IOVA) reported record second-quarter revenue and gross margin, driven by demand for its Amtagvi tumor-infiltrating lymphocyte, or TIL, therapy, as the company expanded its treatment-center network and advanced clinical programs in lung cancer, sarcoma and gynecologic cancers. Total revenue reached $99.3 million in the second quarter of 2026, up 66% from a year earlier and 39% sequentially. Amtagvi generated approximately $91 million of revenue, exceeding the company’s prior quarterly guidance range of $79 million to $81 million. Proleukin contributed roughly $9 million, compared with $11 million in the first quarter, which Chief Financial Officer Corleen Roche attributed to the timing of wholesaler inventory stocking. → 3 Drone Stocks That Should Soar After the Summer Slump 3 Biotech Stocks to Watch: Iovance, Neurocrine & Viking “The second quarter of 2026 was our strongest yet,” Interim Chief Executive Officer and President Fred Vogt said. “We delivered record revenue and margin, advanced our pipeline, and secured important new regulatory approvals and designations.” Gross margin rose to approximately 56%, from 41% in the first quarter and above the company’s previous high of 50% in the fourth quarter of 2025. Roche said the improvement reflected higher Amtagvi volume, cost optimization and efficiencies from Iovance’s first full quarter of exclusively in-house manufacturing. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth The Top 5 Analysts Ranked by MarketBeat and Stocks They Cover Research and development expense declined to about $59 million from $62 million in the prior quarter, marking the fourth consecutive quarter of R&D cost reductions, according to Roche. Selling, general and administrative expense remained essentially flat at approximately $39 million even as revenue increased sequentially. The company had approximately $304 million in cash equivalents and short-term investments as of June 30 and said it expects that capital to fund operations into the second half of 2028. → Jersey Mike's Serves Fresh Gains After IPO Stumble Iovance is reviewing its existing full-year 2026 total revenue guidance of $350 million to $370 million following the stronger-than-expected second quarter. Vogt said the company expects to provide an update during the third quarter after evaluating demand trends further. “Demand trends are very positive right now for the Amtagvi product, and we expect increasing demand Q3 to Q4,” Vogt said during the question-and-answer session. Chief Commercial Officer Dan Kirby added that the company has sufficient visibility into the third quarter to be confident that performance will build on the second quarter. Kirby said Iovance had more than 95 authorized treatment centers, or ATCs, and remains on track to reach at least 110 by the end of 2026. Community sites account for about one-third of the network and are expected to expand further in coming quarters. According to Kirby, the company is providing commercial Amtagvi treatment to more than 50 patients per month. He said physician awareness has increased nearly threefold over the past year, supported by a marketing campaign introduced at the American Society of Clinical Oncology meeting, improved sales-force effectiveness and a growing body of clinical and real-world evidence. Iovance said more than 75% of Amtagvi patients have private insurance coverage, while payer policies covering more than 250 million lives include the treatment. The company also said more than 95% of addressable U.S. patients live within 200 miles of an ATC, and 80% live within 100 miles. The company reported a manufacturing turnaround time of 31 days or less through its centralized commercial manufacturing process. Kirby said all three Proleukin wholesalers sold through prior stocking inventory during the second quarter and are ordering in line with Amtagvi demand. Iovance expects Proleukin revenue to grow quarter over quarter and to represent approximately 16% of total revenue on a steady basis for the remainder of the year. Outside the U.S., Amtagvi has approvals in Canada and Australia. Iovance’s first Canadian ATC is prepared to support international private-pay patients while the company pursues public reimbursement, while Australian sites are being opened for private-pay patients as pricing discussions with the government continue. Regulatory decisions remain pending in the United Kingdom and Switzerland, and Iovance continues to work toward a European Union resubmission. Iovance said enrollment is nearly complete in pivotal cohorts of its IOV-LUN-202 registrational trial in non-squamous non-small cell lung cancer. Vogt said the company expects to provide a program update in the fourth quarter and continues to work toward a supplemental Biologics License Application in 2027. During the call, Vogt said Iovance intends to complete enrollment before issuing a material update, but may not wait for every patient to become evaluable. He said the company is seeing “very strong durability” in the study, without disclosing new data. The FDA granted Fast Track designation for lifileucel in undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma, two advanced soft tissue sarcoma settings being studied in the registrational SARATOGA trial. Vogt said a pilot study of one-time lifileucel treatment showed a 50% objective response rate among the first six evaluable patients, compared with response rates below 5% using current standard care in those refractory settings. In the company’s N-201 trial, Iovance reported a 40% confirmed objective response rate and 100% disease control rate among the first five evaluable patients with metastatic serous and endometrial cancer. The company said it is submitting a protocol amendment focused on the serous subtype and is engaging with the FDA regarding an expedited approval pathway. Iovance also highlighted G1TIL1, a Phase I/II basket trial studying IOV-5001, an IL-12 tethered next-generation TIL therapy, in metastatic colorectal cancer, triple-negative breast cancer and estrogen receptor-low breast cancer. Separately, Vogt said Iovance plans to present data at the European Society for Medical Oncology meeting from a predecessor Phase II study supporting TILVANCE-301, a blinded randomized trial of Amtagvi plus pembrolizumab in frontline melanoma. He said the presentation will include clinical characteristics such as complete responses in nearly one-third of patients and rapid response velocity, while noting that Iovance cannot evaluate the blinded randomized study at this stage. Iovance Biotherapeutics, Inc is a clinical‐stage biotechnology company specializing in the development and commercialization of tumor‐infiltrating lymphocyte (TIL) immunotherapies for the treatment of solid tumors. The company's lead product candidate, lifileucel (formerly LN‐144), is an autologous TIL therapy in late‐stage clinical development for patients with advanced melanoma. Iovance's pipeline also includes next‐generation TIL programs such as LN‐145 for cervical and other human papillomavirus (HPV)‐related cancers, as well as exploratory studies in head and neck, non‐small cell lung, gastric and other solid tumor indications. Iovance's TIL platform harnesses a patient's own immune system by isolating, expanding and reinfusing tumor‐reactive lymphocytes. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Iovance Biotherapeutics Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Arvinas, Inc. (ARVN) came out with quarterly earnings of $2.58 per share, beating the Zacks Consensus Estimate of a loss of $0.24 per share. This compares to a loss of $0.84 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +1,175.00%. A quarter ago, it was expected that this company would post a loss of $0.95 per share when it actually produced a loss of $0.9, delivering a surprise of +5.26%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Arvinas, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $249.7 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 562.56%. This compares to year-ago revenues of $22.4 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Arvinas shares have lost about 32% since the beginning of the year versus the S&P 500's gain of 11%. While Arvinas has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Arvinas was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.78 on $25.51 million in revenues for the coming quarter and -$2.82 on $103.17 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 42% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Iovance Biotherapeutics (IOVA), another stock in the same industry, has yet to report results for the quarter ended June 2026. The results are expected to be released on August 6. This biotechnology company is expected to post quarterly loss of $0.17 per share in its upcoming report, which represents a year-over-year change of +48.5%. The consensus EPS estimate for the quarter has been revised 6.1% higher over the last 30 days to the current level. Iovance Biotherapeutics' revenues are expected to be $87.33 million, up 45.7% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Arvinas, Inc. (ARVN) : Free Stock Analysis Report Iovance Biotherapeutics, Inc. (IOVA) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research