아이오반스(IOVA) 2026년 3분기 실적 발표: 매출 80% 증가, 가이던스 재확인

핵심 요약

• 2026년 3분기 매출은 전년 동기 대비 80%, 전분기 대비 22% 증가한 약 1억 2,200만 달러로 사상 최고치를 기록했다.
• 암탁비(Amtagvi) 매출은 약 1억 200만 달러로 전년 동기 대비 77%, 전분기 대비 12% 증가했다. 출시 이후 1,000명 이상의 상업 치료 환자가 치료를 받았다.
• 매출총이익률은 약 60%로 사상 최고 수준으로 상승한 반면, R&D 비용은 전분기 대비 16% 감소한 약 4,900만 달러를 기록했고 판관비는 약 3,900만 달러로 전분기와 비슷한 수준을 유지했다.
• 아이오반스는 2026년 연간 매출 가이던스로 4억 1,000만~4억 2,000만 달러를 재확인했다. 경영진은 보유 현금 자원과 매출을 바탕으로 2029년까지 안정적으로 운영 자금을 충당할 수 있을 것으로 예상하고 있다.
• Lung 202 임상시험에서 리필류셀(lifileucel)은 이전에 치료받은 비편평 전이성 비소세포폐암 환자 69명을 대상으로 24.6%의 객관적 반응률을 기록했다. 아이오반스는 2027년에 sBLA(생물학적제제 품목허가 변경신청)를 제출할 계획이다.
• 바이오마커 기반의 Lung 202 하위 그룹에서는 59.1%의 반응률을 달성했다. 전향적으로 정의된 포지티비티(Positivity) 코호트는 환자 80명을 목표로 하며, 2026년 11월에 등록을 시작할 예정이었다.

주요 재무 데이터

사업 및 운영 실적

암탁비는 주요 성장 동력의 위치를 유지했다. 경영진은 의사들이 해당 치료법을 선택하는 주된 이유로 치료 지속성을 꼽았으며, 자체 시장 조사에서 대상 의사의 80% 이상이 지속성을 높게 평가했다고 밝혔다.

아이오반스는 이번 분기를 100개 이상의 공인 치료 센터(ATC)로 마감했으며, 연말까지 최소 110개에 도달할 것으로 순조롭게 전망된다. 지역 사회 의료기관이 전체 네트워크의 3분의 1 이상을 차지했다. 현재 투여의 약 3분의 2는 대학병원에서, 3분의 1은 지역 사회 의료기관에서 이루어지고 있으나 경영진은 궁극적으로 지역 사회 의료기관이 절반 이상을 차지할 것으로 예상하고 있다.

대부분의 로트에서 제조 소요 시간은 30일 이하였다. 또한 경영진은 모듈식 제조 방식으로 전환함에 따라 과거 설비 유지보수로 인한 영향이 더 이상 운영에 지장을 주지 않을 것으로 예상된다고 밝혔다.

해외 시장의 경우 암탁비는 이전에 치료받은 적이 있는 흑색종을 적응증으로 캐나다와 호주에서 승인받았다. 캐나다에서는 초기 ATC가 준비되었고 호주에서는 도입이 진행 중이나, 폭넓은 접근성은 공적 급여 적용 여부에 달려 있다. 경영진은 2027년 1분기까지 영국과 스위스에서 승인을 받을 가능성이 있다고 언급했다. 아이오반스는 또한 2027년에 브라질 품목허가 신청과 유럽연합(EU) 재신청을 계획하고 있다.

파이프라인 업데이트

Lung 202 임상시험에서 이전에 치료받은 비편평 전이성 비소세포폐암 환자 69명 중 17명이 부분 반응 또는 완전 반응을 달성해 약 25%의 객관적 반응률을 나타냈다. 반응을 보인 환자의 약 절반은 반응이 지속 중이었다. 경영진은 림프구 고갈 요법의 용량을 줄임으로써 유사한 반응률과 지속성 프로파일을 유지하는 동시에 안전성을 개선했다고 밝혔다.

코호트 1과 2의 환자 등록은 목표치인 약 80명에 근접하고 있다. 아이오반스는 2027년 예정된 sBLA 제출을 앞두고 독립적 검토 평가, FDA와의 논의 및 기타 사전 제출 작업을 진행 중이다.

회사는 정밀 TIL 전략도 추진하고 있다. 바이오마커 기반의 Lung 202 하위 그룹은 21개월과 49개월 시점에 지속 중인 2건의 완전 반응을 포함해 59.1%의 반응률을 달성했다. 아이오반스는 80명 규모의 포지티비티 코호트에서 이 집단을 전향적으로 평가할 계획이며, 2027년에 1차 치료 임상인 OPAL-1 시험에서 해당 환자군을 연구할 예정이다.

난치성 미분화 다형성 육종 및 탈분화 지방육종 환자를 대상으로 한 연구에서 리필류셀은 환자 9명 중 5명(약 56%)에게서 확인된 반응을 이끌어냈다. 이 중 2건의 반응은 1년 이상 지속되고 있다. 허가용 임상시험인 사라토가(Saratoga) 연구는 각 코호트당 40명의 환자를 등록 중이며, 2028년 또는 2029년에 잠재적인 sBLA 제출을 계획하고 있다.

진행성 흑색종 1차 치료에서 리필류셀과 펨브롤리주맙 병용요법은 62.5%의 반응률과 29.2%의 완전 반응률을 나타냈다. 4년 이상의 추적 관찰 기간 후에도 전체 생존기간 중앙값에는 도달하지 않았다. 현재 3상 임상인 TILVANCE-301 시험은 80개 이상의 기관에서 환자를 모집하고 있다.

차세대 프로그램으로는 IL-12 테더링(tethered) TIL 치료제인 IOV-5001, PD-1 비활성화 TIL 치료제인 IOV-4001, 변형 IL-2 유사체인 IOV-3001 등이 포함된다. 이들 모두 초기 임상 개발 단계에 있다.

경영진 가이던스

아이오반스는 2026년 연간 매출 가이던스로 4억 1,000만~4억 2,000만 달러를 재확인했다. 중간값 기준으로 이는 전년 대비 약 60% 성장에 해당한다. 경영진은 회사가 해당 범위 달성을 향해 나아가고 있으며 4분기에도 전분기 대비 성장을 목표로 하고 있다고 밝혔다.

회사는 운영 효율성과 투자 규율을 통해 향후 매출총이익률이 더욱 확대될 것으로 기대하고 있다. 경영진은 구체적인 흑자 전환 시점을 제시하지는 않았으나, 매출 성장과 규율 있는 지출 관리가 지속된다면 폐암 또는 육종 치료제의 출시 이전에 흑자 전환을 달성할 수 있을 것이라고 밝혔다.

약 3억 8,200만 달러의 현금 및 투자자산, 매출 성장, 자본 배분 계획을 바탕으로 경영진은 가용 자원이 2029년까지 운영 자금을 충분히 뒷받침할 것으로 예상하고 있다.

위험 및 주요 점검 사항

• Lung 202의 반응 지속 기간 데이터는 여전히 미성숙한 상태이며, 경영진은 2027년에 업데이트된 데이터가 발표될 때에도 반응 지속 기간 중앙값에 여전히 도달하지 못할 수 있다고 밝혔다.
• 폐암 대상 sBLA 제출 계획은 환자 등록 완료, FDA와의 논의, 독립적 검토 및 기타 사전 제출 작업의 결과에 따라 달라질 수 있다.
• 해외 시장 도입은 급여 진행 상황, 특히 캐나다와 호주에서의 공적 급여 적용 여부에 부분적으로 달려 있다.
• 아이오반스는 영업손실을 지속적으로 기록하고 있으며, 경영진은 흑자 전환 일정을 제시하지 않았다.
• 파이프라인 확장은 임상적 지속성, 규제 당국의 심사, 다수의 허가용 임상시험 전반의 성공적인 환자 등록에 달려 있다.

애널리스트 Q&A 주요 내용

경영진은 연례 시설 유지보수가 생산이나 분기 실적에 더 이상 영향을 미치지 않을 것으로 예상된다고 밝혔다. 회사는 최근 발표한 연간 가이던스를 유지하면서 전분기 대비 매출 성장을 계속 목표로 하고 있다.

프로류킨 주문은 암탁비 수요에 맞춰 재조정되었다. 경영진은 이번 분기 프로류킨이 관련 수요의 약 16%를 차지했으며, 병원의 투여 수요를 실시간으로 지원할 수 있도록 도매업체 주문이 조율되었다고 설명했다.

Lung 202와 관련하여 경영진은 해당 임상이 조만간 약 80명의 환자에 도달할 것이며 업데이트된 데이터는 2027년에 나올 것으로 예상된다고 밝혔다. 경영진은 FDA와의 논의가 생산적이었다고 평가하고 해당 데이터 세트가 품목허가를 뒷받침할 수 있다는 자신감을 재확인하는 한편, 신청서 제출이 2027년으로 계획되어 있음을 확인했다.

상업적 확장에 대해 경영진은 지역 사회 ATC에서 환자 치료 개시가 더 빠르게 이루어지고 있다고 언급했다. 여전히 대학병원이 투여의 약 3분의 2를 차지하고 있으나, 회사는 시간이 지남에 따라 지역 사회 의료기관이 더 큰 비중을 차지하게 될 것으로 기대하고 있다.

실적 발표 콘퍼런스콜 전문

전체 실적 발표 컨퍼런스 콜 녹취록

경영진 발표

Unknown Speaker

Thank you. 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 flow, and more. in 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 Boat, Interim CEO and President.

Unknown Speaker

Thank you, Jen. Good morning, everyone. Our third quarter delivered outstanding record setting results for EyePoint. 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. Empaveli 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 Vyvgart 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 to $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. The 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 Lung 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 Lung 202 is consistent with our lifileucel experience to date across our clinical trials of multiple solid tumors. Encouragingly, the safety profile on Lung 202 improved using the updated reduced dose lymphodepletion regimen. efficacy, including durability, remains comparable and consistent in Lung 202 before and after the change to reduced dose lymphodepletion. We will provide more details on Lung 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 S-B-L-A, 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 Lung 202 update, we launched an innovative precision tilt strategy. We identified a biomarker-enriched subgroup of non-squamous, non-small cell lung cancer patients in Lung 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 POSITY, 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 Lung 202 site footprint to speed enrollment is part of a planned transition. In 2027, we are also planning our OPAL-1 trial to investigate this population in the frontline setting. Together, these biomarkers selected front and second line settings representing 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 Leifelusel 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%. 25.6%, 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 lete-leucel experience to date across our clinical trials of 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 more approvals for lete-lucel. After failing chemotherapy, second-line response rates are typically below 5%. Median survival is about 9 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 two cohort, frontline advanced melanoma, 62.5% of patients responded, including complete responses in 29.2% of patients where tumors disappeared completely and did not 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 design 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'm 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. Jean-Marc Roche, our Chief Financial Officer, will now highlight our financial results.

Unknown Speaker

Thanks, Fred, and good morning, everyone. The third quarter was another record quarter for Iovance, combining strong revenue, record margin, and disciplined spending.

Corleen Roche

Revenue is up 80% that's 80 year-over-year. Margin is at an all-time high of 60% 60 and operating expenses reflected discipline, intentional allocation of capital to our highest return priorities and now our cash run way 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 one hundred and and $2 million represent 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%. Intacct 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 a reduced R&D expense. 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 to $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, 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. And behind these record results are the patients we serve.

For more on how we are reaching them, here's Dan Kirby, our Chief Commercial Officer, to review our commercial progress in more detail.

Unknown Speaker

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 Filspari sales of approximately $20 million, we are confident in achieving our updated full year guidance of $410 to $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'll 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 mTAGV 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, Patty Garcee, who is experiencing a long-term durable response to MTAG-D after a single infusion two years ago. Patient stories like Patty'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 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. only scaled centralized commercial manufacturing process approved by the FDA for TIL therapy. Iovance's manufacturing capabilities are faster and more reliable than any till 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 mTAG-B 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 US 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, international, 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 UK 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 mTagV. 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'll now hand the call off to Noah, who will cover our pipeline in further detail. 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 TILT 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 1 and 2 in our Lung 202 trials. We believe the data compare quite favorably to docetaxel monotherapy, the disappointing standard of care in this treatment setting, with a published study in the National Institute response rate of under 13%. In our registrational patient population from cohorts 1 and 2, 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 of 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 pre-pandemic responses. 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 positivity in the LUN202 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 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 to 10 months, and there are no approved immunotherapies.

In oral session at ESMO Congress highlighted the pilot trial led by 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% five of nine patients is 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 registration at major US 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 Let's shift gears for a moment and highlight our next generation approaches. Let's start with IOV 5001, our IL-12 tethered till therapy. We know that IL-12 engineered tills have previously demonstrated differentiated efficacy with a new mechanism of action. Based on that prior experience, we believe that IOV5001 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 IOV5001, 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 IOV4001, 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 one 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.

Daniel Kirby

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.

질의응답

Lin Tsai

Our first question comes from Andrew Tsai with Jefferies. Your line is open. Hi there. Good morning. Great execution. Thanks for the updates. My question is about the commercial franchise right now. So traditionally, you guys have seen some impacts due to maintenance of your facility around the December and January time frame, I think. This time around, is it fair to assume everything will be smooth and good to go because you switched to the modular manufacturing early in the year. And if that's the case, you know 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.

Unknown Speaker

Yes, thanks Andrew for the question. You're correct, the maintenance is no longer an issue. We don't, that will not affect our earnings going forward. That was primarily affecting us in Q1 in the first quarter of each year, and that effect has gone away. We just issued this guidance five weeks ago, and so yes, obviously, We would like to have growth quarter over quarter, and we expect that, and that's something we would aim to do. But just keep in mind that the guidance really just came out five weeks ago. Right now, we're tracking to achieve it.

And of course, of course, of course, if we can beat our guidance, we're very happy to do so. as we just did. Great, thank you.

Daniel Kirby

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

Etzer Darout

Great, thanks for taking a question. I guess you know with quarterly operating loss of about 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 break-even given the momentum we're seeing in second-line melanoma alone?.

Corleen Roche

Thank you. The answer is yes. So, I mean, if you look at the EPS, it's only 5 cents loss, and that's the best it's ever been. 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.

Daniel Kirby

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

Yanan Zhu

Hi, thanks for taking our questions. This is Kuan-Nan for Yonan, and congrats on another strong quarter. For Perlucan, the sales increased from 9 million to 20 million, and you mentioned the ordering patterns are realigning with MTAGV demand. So can you share with us a little bit about the sales growth? How much does that reflect the expected use of mTAC-V? And is there an estimation on the average delay between Perlucan sales and the use for mTAC-V? Thank you.

Unknown Speaker

Thank you, Quan. Great question with it. ProLucan is in line with mTAC-V demand. So we had said before about 16% of the demand was represented by ProLucan. That is what this quarter represented. We're seeing the orders in line. One of the things that the teams are doing to ensure that their supply is a wholesaler is we're 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 mTAC-V infusions.

Yanan Zhu

Got it. And a quick question on Lung 002. When do you think we may see a mature median DOR data from this study? Thank you.

Unknown Speaker

Well, it's possible that when we complete this study, we may be not reached, so that we may have matured but not reached like we did with some other reports that we've done, so just bear that in mind. But 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'll 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, median DOR, but just don't be surprised if it's not reached at that point with a lot of follow-up.

Daniel Kirby

Got it. Thank you for all the color. Thank you. Our next question comes from Nick LaRusso with TD Cowen. Your line is open.

Unknown Speaker

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?.

Unknown Speaker

Sure, great question Nick. So we are focused, we've been focused for over a year now on opening community hospitals and ATCs to serve What we're seeing is in general we've gotten better at opening accounts, so as I mentioned in the prepared comments, we're seeing a quicker activation of first patient treated, so we are seeing the ramps come up. Our business still is concentrated mostly in the academics, but the community ATCs are growing over time with this. 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 Thanks very much for the call.

Daniel Kirby

Thank you. And our final question comes from Joe Pantginis with HC Wainwright. Your line is open.

Unknown Speaker

Hi, this is Josh on for Joe. Thanks for taking our question. So, I just wanted to follow up on LUN202, if there's any additional color you can provide with your, with the discussions you've been having with the FDA about the sBLA submission.

Unknown Speaker

Yes, 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. And we believe that this data set 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.

Raj Puri

comments on this as well. He's our head of Chief Regulatory Officer. Yes, I agree with Fred's comment that the FDA, we are on track to get BLA submission at the end of Q4 and based on our data, we are confident that FDA will consider for that is under prior approvals in this space with about 80 subjects trial.

Unknown Speaker

And just to clarify, we're planning to submit that BLA in 2027. Perfect. Thank you so much.

Daniel Kirby

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

Unknown Speaker

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 advocacy 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 TIL cell therapies for patients with cancer.

Daniel Kirby

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

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