Iovance (IOVA) Q3 2026 Earnings Call Transcript

DATE

Thursday, Nov. 5, 2026

CALL PARTICIPANTS

• Senior Director, Investor Relations and Corporate Communications - Jen Saunders
• Interim Chief Executive Officer and President - Fred Vogt
• Chief Financial Officer - Corleen Roche
• Chief Commercial Officer - Dan Kirby
• Chief Medical Officer - Noah Berkowitz
• Chief Regulatory Officer - Raj Puri

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TAKEAWAYS

• Total Revenue -- $121.5 million, growing 80% over the third quarter of 2025 due to increased adoption of AMTAGVI.
• AMTAGVI Revenue -- $101.5 million, increasing 77% year over year and 12% sequentially, reflecting strong patient demand.
• Proleukin Revenue -- $19.9 million, more than doubling from the second quarter of 2026 as wholesaler ordering patterns realigned with AMTAGVI demand.
• Gross Margin -- 60%, reaching an all-time high for the second consecutive quarter driven by sales volume and cost optimization programs.
• Full-Year Revenue Guidance -- $410 million to $420 million, which management reaffirmed based on year-to-date performance of $292 million.
• Commercial Patient Infusions -- 1,000 patients, passing a milestone for total commercial infusions in the U.S. since the launch of AMTAGVI.
• Authorized Treatment Centers -- 100 locations, with the network on track to reach at least 110 active centers by the end of 2026.
• R&D Expenses -- $49.3 million, decreasing 16% sequentially and marking the fifth consecutive quarter of reduced spending through operational efficiencies.
• SG&A Expenses -- $38.6 million, remaining flat sequentially even as total revenue grew 22% during the same period.
• Cash Position -- $382.3 million as of Sept. 30, 2026, which is expected to fund operations into 2029.
• IOV-LUN-202 Objective Response Rate -- 24.6% in 69 patients, demonstrating efficacy in the nonsmall cell lung cancer population with nonsquamous histology.
• Biomarker-Enriched Lung Subgroup -- 59.1% response rate, identified among current or former smokers without actionable driver mutations in the IOV-LUN-202 trial.
• Sarcoma Objective Response Rate -- 55.6% in nine patients, based on updated clinical data for refractory undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma.
• Frontline Melanoma Phase 2 Results -- 62.5% response rate, including a 29.2% complete response rate and median overall survival not reached after four years of follow-up.
• Manufacturing Turnaround Time -- 30 days or less for the majority of lots, utilizing a centralized commercial manufacturing process.
• U.K. and Swiss Regulatory Timelines -- Potential approvals expected in the first quarter of 2027, with the U.K. application currently under expedited review.
• Net Loss -- $22.3 million, or $0.05 per share, representing a significant reduction from the $91.3 million loss in the prior-year period.
• Community ATC Composition -- 33% of the active network, with management expecting community centers to eventually represent more than half of all infusions.
• IOV-LUN-202 sBLA Target -- 80 patients, with enrollment in cohorts one and two nearing completion to support a planned submission in 2027.

SUMMARY

Iovance Biotherapeutics, Inc. (NASDAQ:IOVA) reported record quarterly revenue and its highest gross margin to date, driven by the expansion of the commercial AMTAGVI launch. Management confirmed that the company has treated more than 1,000 commercial patients since the therapy's introduction and expects its authorized treatment center network to reach at least 110 locations by the end of the year. The company is advancing several registrational programs across multiple solid tumor indications, including nonsmall cell lung cancer and soft tissue sarcoma, with plans for supplemental license applications in 2027. Management stated that the current cash position is sufficient to fund operations into 2029 while supporting international expansion and next-generation pipeline development.

• The company plans to submit regulatory applications in Brazil and resubmit to the European Union in 2027, following potential approvals in the U.K. and Switzerland expected in the first quarter of 2027.
• Management is advancing next-generation therapies including IOV-5001, an IL-12 tethered TIL therapy, and IOV-3001, a modified IL-2 analog designed to selectively expand effector T cells while reducing adverse events.
• Interim CEO Vogt stated that facility maintenance will no longer impact quarterly results, as the company has transitioned to modular manufacturing processes that eliminate previous first-quarter downtime.
• Chief Commercial Officer Kirby noted that Proleukin sales are tracking in line with demand for AMTAGVI, representing approximately 16% of demand this quarter as ordering patterns at wholesalers realigned.
• The new POSITILITY trial will utilize the existing IOV-LUN-202 site footprint to evaluate a biomarker-enriched cohort of nonsmall cell lung cancer patients, aiming for 80 patients with registrational intent.
• Chief Medical Officer Berkowitz indicated that the company is planning discussions with the FDA for an expedited approval pathway for the ENDURANCE trial in metastatic serous endometrial cancer.

INDUSTRY GLOSSARY

• AMTAGVI: The first FDA-approved, one-time tumor infiltrating lymphocyte (TIL) therapy for previously treated advanced melanoma.
• TIL (Tumor Infiltrating Lymphocyte): A type of immune cell that recognizes and attacks cancer cells from within a tumor.
• ATC (Authorized Treatment Center): A specialized hospital or clinic authorized and trained to administer Iovance's cell therapies.
• sBLA (Supplemental Biologics License Application): A request to the FDA to allow a previously approved drug to be marketed for a new indication.
• ORR (Objective Response Rate): The percentage of patients in a trial whose cancer shrinks or disappears after treatment.
• RECIST 1.1: A standardized set of rules used to measure whether tumors shrink, stay the same, or grow during clinical trials.
• DDLPS (Dedifferentiated Liposarcoma): A rare and aggressive type of soft tissue sarcoma that begins in fat cells.
• UPS (Undifferentiated Pleomorphic Sarcoma): A type of cancer that begins in the soft tissues and can occur anywhere in the body.
• MAA (Marketing Authorization Application): The application submitted to international regulatory agencies to market a new drug.
• IL-2 (Interleukin-2): A type of cytokine used in cell therapy regimens to promote the growth and activity of T cells.
• Proleukin: A commercial brand of IL-2 used as part of the AMTAGVI treatment regimen.

Full Conference Call Transcript

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

Jen Saunders: Thank you, Daniel. Good morning, and welcome to the Iovance webcast to discuss our third quarter 2026 financial results, business achievements, and corporate updates. This morning, we issued a press release that is available on our corporate website at iovance.com. This conference call will include forward-looking statements regarding Iovance's goals, business focus, business plans and transactions, revenue and revenue guidance, commercial activities, clinical trials and results, regulatory approvals, submissions, feedback and guidance, plans and strategies, research and preclinical activities, potential future applications of our technologies, manufacturing capabilities, payer interactions, licenses and collaborations, cash position, and future updates.

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

Fred Vogt: Thank you, Jen. Good morning, everyone. Our third quarter delivered outstanding record-setting results for Iovance, with our highest ever revenue and margin and strong financial performance across the board. Total revenue of about $122 million surged 80% over the prior year. U.S. AMTAGVI revenue increased 77% over the prior year and crossed $100 million in a single quarter for the first time. We also passed an important landmark this quarter, with more than 1,000 commercial AMTAGVI patients now infused in the U.S. since launch. Based on this strong performance, we remain on track to achieve our full-year revenue guidance of $410 million-$420 million.

Our authorized treatment center, or ATC network, continues to expand rapidly, and we fully expect to reach 110 or more authorized treatment centers by year-end. Third quarter margin of about 60% also set a new all-time high for the second consecutive quarter, and we expect it to expand further over time. Our cash runway is now expected to fund operations well into 2029. This strong performance reflects the financial health of Iovance and the strong platform that we can build upon for upcoming launches. The third quarter and recent updates also reflect major progress across our TIL platform and pipeline programs. In metastatic non-small cell lung cancer, lifileucel continues to demonstrate a potentially best-in-class clinical profile.

Earlier this year, the FDA granted fast-track designation based on the strength of our data and the high unmet need. Last week, we reported positive updated results from our registrational IOV-LUN-202 trial that included 69 patients with previously treated non-squamous metastatic non-small cell lung cancer. The objective response rate, or ORR, by RECIST 1.1 was 24.6%, consistent with our prior results in 39 patients. Durability, while still maturing, was also consistent with our prior results and has already greatly surpassed the current standard of care, docetaxel, which has a response rate of only 12.8%, short durability of 5.6 months, and median overall survival of just 12.3 months.

Safety in IOV-LUN-202 is consistent with our lifileucel experience to date across our clinical trials in multiple solid tumors. Encouragingly, the safety profile in IOV-LUN-202 improved using the updated reduced-dose lymphodepletion regimen. Efficacy, including durability, remains comparable and consistent in IOV-LUN-202 before and after the change to reduced-dose lymphodepletion. We will provide more details on IOV-LUN-202 as the study completes, with potential presentations at medical meetings in 2027. Looking ahead, we are confident in our plans to submit a supplemental Biologics License Application, or sBLA, in 2027. We are completing enrollment in cohorts one and two with a target of approximately 80 patients for the sBLA.

In parallel, we are advancing independent review committee assessments, FDA discussions, and other pre-submission activities, including preparation for a confirmatory trial. Alongside our latest IOV-LUN-202 update, we launched an innovative precision TIL strategy. We identified a biomarker-enriched subgroup of non-squamous non-small cell lung cancer patients in IOV-LUN-202 that demonstrated a remarkable 59.1% response rate. Nearly six in 10 patients showed a deep and durable response. These results are the foundation for POSITILITY, a first-in-class prospectively defined biomarker-enriched cohort with registrational intent that we will pursue in addition to our initial sBLA in 2027 in non-squamous non-small cell lung cancer.

POSITILITY is targeting 80 patients and will begin enrollment this month, utilizing the existing IOV-LUN-202 site footprint to speed enrollment as part of a planned transition. In 2027, we are also planning our OPTILISM trial to investigate this population in the frontline setting. Together, these biomarker-selected front and second-line settings represent a U.S. opportunity about 10 times the size of advanced melanoma. At the ESMO Congress in late October, two oral presentations showcased the broader potential for lifileucel to demonstrate deep, durable responses in soft tissue sarcomas and frontline advanced melanoma. Following one of the oral sessions at ESMO, this morning's press release included our most recent updates in soft tissue sarcoma.

The confirmed ORR by RECIST 1.1 for lifileucel in refractory undifferentiated pleomorphic sarcoma, or UPS, and dedifferentiated liposarcoma, or DDLPS, has climbed to 55.6%, five of nine patients. Multiple durable responses have already been observed, including two ongoing more than a year from infusion. Safety in the sarcoma trial is consistent with our lifileucel experience to date across our clinical trials in multiple solid tumors. These powerful results in heavily pretreated patients are the basis for SARATOGA, our registrational trial that is actively enrolling to support two approvals for lifileucel. After failing chemotherapy, second-line response rates are typically below 5%. Median survival is about nine to 10 months, and there are no approved immunotherapies.

In recognition of this unmet need, as well as our initial results, the FDA granted fast-track designation in both UPS and DDLPS. In addition, we have aligned with the agency on the design and a potential accelerated approval pathway based on the SARATOGA trial, with 40 patients expected in each cohort and sBLA submissions planned for 2028 or 2029. In our second oral session at ESMO, we focused on frontline advanced melanoma, where about half of patients do not achieve long-term benefit with today's standard combination checkpoint inhibitors. In our phase II cohort of frontline advanced melanoma, 62.5% of patients responded, including complete responses in 29.2% of patients where tumors disappeared completely and did not return.

Median overall survival was not reached after more than four years of follow-up. Safety was consistent with the known safety profiles of one-time lifileucel and pembrolizumab. These results reinforce TILVANCE-301, our phase III trial enrolling in more than 80 sites and expanding, designed to support both the frontline approval and serve as the confirmatory trial for full U.S. approval of AMTAGVI. In summary, Iovance is focused on growing revenue, expanding into new indications and markets, and broadening TIL therapy into solid tumor indications, including biomarker-selective populations that collectively represent tens of thousands of cancer patients with poor prognosis and limited available options. I am also thrilled to welcome our new Chief Medical Officer, Dr.

Noah Berkowitz, to his first quarterly call at Iovance to discuss additional details about our pipeline. His valuable expertise in global drug development across cancer and blood disorders led to approvals for the CAR T-cell therapies Abecma and Breyanzi while at Bristol Myers Squibb. As the first and only company in the world to take TIL therapy from concept to commercial treatment, we are forging ahead with tremendous momentum toward profitability and long-term value for patients and shareholders alike. Corleen Roche, our Chief Financial Officer, will now highlight our financial results.

Corleen Roche: Thanks, Fred, and good morning, everyone. The third quarter was another record quarter for Iovance, combining strong revenue, record margin, and disciplined spending. Revenue is up 80% year over year. Margin is at an all-time high of 60%, and operating expenses reflected disciplined, intentional allocation of capital to our highest return priorities. Our cash runway is expected to fund operations well into 2029. Total revenue once again achieved a new quarterly record of about $122 million, up 80% year over year, as I mentioned, and 22% sequentially. AMTAGVI powered that revenue growth by reaching more patients than ever before.

AMTAGVI sales of around $102 million represent a 77% increase year over year and a 12% increase sequentially, reflecting strong patient demand and broad adoption. Proleukin revenue contributed approximately $20 million in the third quarter, more than double the second quarter level as wholesaler ordering patterns are realigning with AMTAGVI demand. As expected, the quality of our revenue remains high, with gross to net deductions around 1%, consistent with prior quarters. That high-quality revenue is flowing through to margin, which reached an all-time high for the second consecutive quarter of approximately 60%, up sequentially from our previous record of 56%, and that brings our year-to-date margin to 54%.

AMTAGVI growth, operational efficiencies, and investment discipline contributed to this margin gain and remain powerful levers for continued expansion as we drive further efficiencies across the company. Turning to operating expenses. Third quarter R&D expenses were down approximately 16% sequentially to about $49 million, marking the fifth consecutive quarter of reduced R&D spend. This trend reflects efficiency of our operations, including clinical and manufacturing, which allows us to advance multiple registrational programs at greater scale and much less cost than any TIL competitor. Total selling, general, and administrative expenses held flat at about $39 million sequentially, even as revenue grew about 22%. We continue to make targeted investments in revenue-generating activities that drive the greatest commercial return.

We are reaffirming our recently updated full-year revenue guidance range of $410 million-$420 million. At the midpoint, that is nearly 60% growth over last year. Through the first three quarters of 2026, we have already delivered $292 million of revenue, expanded margin, and controlled operating expenses. We end the quarter in a strong financial position with approximately $382 million in cash equivalents, short-term investments, and restricted cash on September 30th. Together, with robust revenue and careful capital allocation, this cash position is now expected to fund operations well into 2029, giving us the runway to execute on our growth plan from a position of strength. In closing, we again delivered strong revenue, improved margin, and intentional capital allocation this quarter.

With a strong balance sheet supporting us, we are well-positioned as we build a valuable, self-sustaining business that delivers lasting value for patients and our shareholders. Behind these record results are the patients we serve. For more on how we are reaching them, here is Dan Kirby, our Chief Commercial Officer, to review our commercial progress in more detail.

Dan Kirby: Thank you, Corleen. Third quarter was the strongest quarter of the AMTAGVI launch. AMTAGVI revenue surpassed $100 million for the first time, and we treated more patients than in any prior quarter. Together with Proleukin sales of approximately $20 million, we are confident in achieving our updated full-year guidance of $410 million-$420 million. We also achieved two milestones this quarter. We have now treated more than 1,000 commercial patients, and we have more than 100 ATCs. Access is expanding, and more patients are able to receive a one-time cell therapy that can deliver long-term durable responses. I will cover how we got here through our three priorities: physician awareness, growing our ATC network, and clinical data. First, physician awareness.

Our latest market research shows durability of response is the leading reason physicians choose AMTAGVI over other treatments. Durability was rated highly by more than 80% of our target physicians and was cited by nearly two-thirds as the key driver for the decision to treat. Durability with Amtagvi is measured in years, with over three years median duration, while other options, both on the market and in trials, measure durability in weeks and months. Last week, Fox News covered a story about one of our patients, Paty Garcini, who is experiencing a long-term durable response to Amtagvi after a single infusion two years ago.

Patient stories like Paty's are increasingly being featured across media outlets and continue to reinforce the promise of our TIL therapy. Also, our expanded sales force returned clear value on investment as they logged more customer interactions than in any quarter since launch, which translated into more patients treated than ever. Second, our ATC network. We now have more than 100 ATCs and are on track to reach at least 110 by the end of the year. Most of the centers we onboarded in Q3 were community-based, and community ATCs represent over a third of our network. New centers are also getting started faster as the time between authorization and first patient treatment continues to shorten.

Behind these numbers is reliable delivery to patients. For the majority of lots, turnaround time is 30 days or less, using the only scaled, centralized commercial manufacturing process approved by the FDA for TIL therapy. Iovance's manufacturing capabilities are faster and more reliable than any TIL therapy in development. Third, clinical data. Real-world studies show response rates of 50% or greater in second-line patients, supported by five-year durable responses after a one-time Amtagvi treatment. These results are the standard in second-line plus metastatic melanoma, where patients get better and more durable responses with Amtagvi than any other option.

At ESMO, a new indirect comparison suggested that lifileucel may approximately double four-year overall survival compared with standard of care in anti-PD-1-resistant advanced melanoma. Our teams also met with U.S. and international thought leaders at ESMO, who were excited about the data and what it means for their patients. Turning to Proleukin, third-quarter sales were about $20 million, driven by Amtagvi demand. We expect that trend to continue in Q4. Now, internationally, Amtagvi is approved in Canada and Australia for previously treated melanoma, with our first ATCs ready in Canada and onboarding in Australia. We are progressing reimbursement discussions in both countries.

These ATCs will initially treat private pay patients while we work towards public reimbursement, which is key to broad access. The U.K. application is under expedited review, and the Swissmedic process is moving smoothly, with potential approvals in both markets by the first quarter of 2027. Also in 2027, we plan to submit an application in Brazil, where expedited review is available, and to resubmit our application in the European Union. Finally, looking beyond today's indication. In frontline advanced melanoma, the population is more than twice the size of the previously treated population we serve today.

In metastatic non-small cell lung cancer with KRAS wild type, the first and second line addressable market is at least 10 times that of Amtagvi's current indication. In soft tissue sarcomas, the U.S. market opportunity in UPS and DDLPS is approximately the same as the current second-line metastatic melanoma opportunity for Amtagvi. Across indications, these patients are concentrated at centers of excellence that are already ATCs, which we believe positions us well to quickly reach and treat patients upon approval. To close, we had a record third quarter, approximately $122 million in total revenue, including more than $100 million in AMTAGVI revenue, reaching more patients than ever.

We are on track to reach at least 110 ATCs, with community centers and faster onboarding driving growth. Finally, we are on track to achieve all of our commercial goals for 2026. I will now hand the call off to Noah, who will cover our pipeline in further detail.

Noah Berkowitz: Thank you, Dan, and hello, everyone. My name is Noah Berkowitz. Having joined the company a month ago, this is my first Iovance earnings call, and I am incredibly happy to be here. I joined Iovance because TIL is the first single administration cell therapy that achieves deep and lasting responses in a significant proportion of patients with advanced melanoma. This success is being replicated across our robust clinical pipeline, with translational medicine and early development programs aimed at optimizing outcomes in patient populations that may derive the greatest benefit from TIL therapy. Today, I am pleased to talk more about our exciting pipeline.

To begin, we are looking forward to our upcoming sBLA submission for lifileucel in previously treated non-squamous metastatic non-small cell lung cancer. Our enthusiasm for this submission is driven by the strength of the response rates and the durability of responses in cohorts one and two in our IOV-LUN-202 trial. We believe the data compare quite favorably to docetaxel monotherapy, the disappointing standard of care in this treatment setting, with a published response rate of under 13%. In our registrational patient population from cohorts one and two, 17 out of 69 patients, or about 25%, experienced a PR or CR, as well as durable responses, including many patients treated with reduced dose lymphodepletion regimen.

Impressively, about half of the responders remain ongoing in the study. As you may recall, to manage toxicity, the trial included a reduced lymphodepletion preconditioning dose that became a trial requirement for all patients after mid-2024. We have observed improved safety and are maintaining a similar ORR, including long, durable responses. In parallel, we are aggressively advancing our precision TIL strategy following our identification of a biomarker-enriched subgroup with a response rate of 59.1%, including two ongoing complete responses at 21 and 49 months. This subgroup includes current or former smokers without actionable driver mutations, patients with significant unmet medical need, and no targeted therapy options available.

This novel biomarker-enriched subgroup will be evaluated prospectively in cohort five for POSITILITY in the IOV-LUN-202 trial. This is a precision opportunity that we will advance alongside and not far behind our planned sBLA based on cohorts one and two. Our biomarker-enriched frontline strategy in metastatic non-small cell lung cancer is also moving forward after six out of seven, or nearly 86% of patients from this subgroup, responded. For patients with UPS and DDLPS, poor prognosis variants of soft tissue sarcoma, second-line response rates are typically below 5% after failing chemotherapy. Median survival is about 9-10 months, and there are no approved immunotherapies.

An oral session at ESMO Congress highlighted the pilot trial led by a Memorial Sloan Kettering investigator and included a 50% confirmed ORR among the first eight evaluable patients. As Fred mentioned, we included the recent results in today's press release, with a 56% ORR in five of nine patients, this being updated data. Multiple durable responses have already been observed, including two ongoing more than a year from infusion. The data are available in our corporate slide deck in the investor section of iovance.com. We are currently enrolling patients in the SARATOGA registrational trial at major U.S. cancer centers. As you may recall, we reported positive initial data in the first quarter of 2026 in the ENDURANCE trial.

Here, we focused on previously treated metastatic serous endometrial cancer using a biomarker strategy based on histology. Among the first five evaluable patients, we observed a 40% confirmed objective response rate and 100% disease control rate. We are planning discussions with the FDA on an expedited approval pathway and expect to increase enrollment based on this patient population. I'd like to shift gears for a moment and highlight our next-generation approaches. Let's start with IOV-5001, our IL-12 tethered TIL therapy. We know that IL-12 engineered TILs have previously demonstrated differentiated efficacy with a new mechanism of action.

Based on that prior experience, we believe that IOV-5001 is designed to remodel the suppressive tumor microenvironment and activate immunologically cold tumors, supporting TIL responses and boosting response rates. POTENTIL, a first-in-human trial of IOV-5001, is currently enrolling patients with metastatic colorectal cancer, triple-negative and estrogen receptor-low breast cancer, and other solid tumors that represent more than 100,000 U.S. cancer deaths annually. We're also investigating IOV-4001, a PD-1 inactivated TIL therapy engineered to resist inhibitory signals in a first-in-human trial where we continue to enroll patients with previously treated metastatic non-small cell lung cancer.

And finally, we have a phase I safety cohort investigating multiple dose levels of IOV-3001, a second-generation modified IL-2 analog designed to selectively expand effector T cells while avoiding activation of regulatory T cells. IOV-3001 is a potential component of future TIL regimens with a lower dose IL-2 regimen and fewer adverse events. I'm energized by the work ahead at Iovance to develop the current and future TIL pipeline. My priority is rigorous execution, close collaboration with regulators, and letting the data speak for itself. I will now hand the call back to the operator to begin the Q&A session.

Operator: To ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. In the interest of time, we ask that you please limit yourself to one question. Please stand by while we compile the Q&A roster. Our first question comes from Andrew Tsai with Jefferies. Your line is open.

Andrew Tsai: Hi there. Good morning. Great execution. Thanks for the updates. My question is about the commercial franchise right now. Traditionally, you guys have seen some impacts due to maintenance of your facility around the December and January timeframe, I think. This time around, is it fair to assume everything will be smooth and good to go because you've switched to the modular manufacturing early in the year? If that's the case, the guidance implies maybe a flattish to slightly up quarter-over-quarter growth for Q4. Is that really going to be the case? Can you maybe then talk about any other potential headwinds we should think about for Q4 as it relates to your guidance? Thank you.

Fred Vogt: Yeah, thanks, Andrew, for the question. You're correct. The maintenance is no longer an issue. That will not affect our earnings going forwards. That was primarily affecting us in Q1 and the first quarter of each year, and that effect has gone away. We just issued this guidance five weeks ago, and yes, obviously, we would like to have growth quarter-over-quarter, and we expect that, and that's something we've been able to do. Just keep in mind that the guidance really just came out five weeks ago, and right now, we're tracking to achieve it. Of course, of course, of course, if we can beat our guidance, we're very happy to do so, as we just did.

Andrew Tsai: Great. Thank you.

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

Etzer Darout: Great. Thanks for taking the question. I guess, with quarterly operating loss of approximately $24 million, I guess, is profitability achievable before launches in lung cancer or sarcoma? And I guess, what remaining revenue scale or gross margin improvements do you think are needed to reach operating cash flow breakeven given the momentum we're seeing in second-line melanoma alone? Thank you.

Corleen Roche: Hey, Etzer. The answer is yes. I mean, if you look at the EPS, it's only $0.05 loss, and that's the best it's ever been, and so we are on our way to profitability. I'm not guiding when, but if we continue on this path of revenue growth and disciplined investments, we'll get there.

Etzer Darout: Great. Thank you.

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

Quanang: Hi. Thanks for taking our questions. This is Quanang for Yanan. And congrats on another strong quarter. For Proleukin, the sales increased from $9 million to $20 million, and you mentioned the ordering patterns are realigning with AMTAGVI demand. Can you share how much does that reflect the expected use of AMTAGVI, and is there an estimation on the average delay between Proleukin sales and the use for AMTAGVI? Thank you.

Dan Kirby: Thank you, Quanang. Great question. Proleukin is in line with AMTAGVI demand. We had said before about 16% of the demand would be represented by Proleukin. That is what this quarter represented. We are seeing the orders in line. One of the things that the teams are doing to ensure that there is supply at the wholesaler is we are communicating planned orders at the hospitals that pull from that wholesaler. So, we are tracking in line with demand in real time with the wholesalers ensuring the hospitals have supply to support the AMTAGVI infusions.

Quanang: Got it. And a quick question on IOV-LUN-202. When do you think we may see a mature median DOR data from this study? Thank you.

Fred Vogt: Well, it is possible that when we complete this study, we may be not reached, so that we may have mature but not reached like we did with some other reports that we have done, so just bear that in mind. As we mentioned a couple times now, we expect to finish the study imminently at 80 patients. We will report, as I mentioned in the prepared remarks, we will report data on that at some point next year. And then at that point, you should see what you might, I think what you mean by mature, meaning DOR, but just do not be surprised if it is not reached at that point with a lot of follow-up.

Quanang: Got it. Thank you for all the colors.

Operator: Thank you. Our next question comes from Nick Lorusso with TD Cowen. Your line is open.

Nick Lorusso: Hey, guys. Thanks for taking my question. You noted that community ATCs represent about a third of the current network, which is impressive. Can you discuss the current prescribing patterns, and maybe the proportion of patients coming from the community versus academic centers, and how we should think about this ramping over time? Thanks.

Dan Kirby: Sure. Great question, Nick. We are focused, and we've been focused for over a year now on opening community hospitals and ATCs to service AMTAGVI. What we're seeing is, in general, we've gotten better at opening accounts. As I mentioned in the prepared comments, we're seeing a quicker activation to first patient treated, so we are seeing the ramp come up. Our business still is concentrated mostly in the academics, but the community ATCs are growing over time with it. So it's about a little over a third of our ATC world, but it's going to represent in the future probably more than half of our infusions.

Right now, it's still about two-thirds in the academic world, a third in the community world, but we do expect that to grow as we continue to open more community ATCs.

Nick Lorusso: Thanks very much for the call.

Operator: Thank you. Our final question comes from Joe Pantginis with H.C. Wainwright. Your line is open.

Josh: Hi, this is Josh on for Joe. Thanks for taking our question. I just wanted to follow up on IOV-LUN-202, if there's any additional color you can provide with the discussions you've been having with the FDA about the sBLA submission.

Fred Vogt: Yeah, I'm happy to provide that. We're very focused right now on those discussions with the FDA, and we're having productive discussions right now. We believe that this dataset that we have right now should be registrational and should be approvable. I'll ask Raj Puri here, who's with me, to make some comments on this as well. He's our Chief Regulatory Officer.

Raj Puri: Yeah, I agree with Fred's comment that the FDA, we are on track to get BLA submission in 2027. Based on our data, we are confident that FDA will consider that accelerated approval based on the prior approvals in this space with about 80 subjects filed.

Fred Vogt: Yeah, just to clarify, we are planning to submit that BLA in 2027.

Speaker 10: All right, perfect. Thank you so much.

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

Fred Vogt: Thank you for joining us. This is another record-breaking quarter, and our pipeline is advancing rapidly. We remain deeply grateful to the patients, partners, healthcare professionals, and advocates in communities we serve. Finally, I want to thank our exceptional Iovance team, our dedicated long-term shareholders, and our covering analysts for their continued support. We remain committed to our mission to innovate, develop, and deliver current and next-generation T-cell therapies for patients with cancer. Thank you.

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

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