{"success":true,"data":{"pressRelease":{"id":"111072","rtpr_id":"nGNX6J02hs","ticker":"IOVA","exchange":"NASDAQ","all_tickers":["IOVA"],"title":"Iovance Biotherapeutics Reports Record Second Quarter 2026 Revenue of ~$99M, Business Achievements, and Corporate Updates","author":"Globe Newswire","published_at":"2026-08-06T11:01:00.260Z","article_body":"U.S. Amtagvi Revenue Reaches ~$91M and Total Revenue Increased 66%\nYear-over-Year\n\nGross Margin Increased to 56%\n\nFast Track Designation (FTD) Granted by the FDA for Lifileucel in Soft Tissue\nSarcomas\n\nSAN CARLOS, Calif., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics,\nInc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating,\ndeveloping, and delivering novel polyclonal tumor infiltrating lymphocyte\n(TIL) therapies for patients with cancer, today reported second quarter 2026\nfinancial results, business achievements, and corporate updates.\n\n“Second-quarter revenue reached a record $99.3 million with gross margin of\n56%, driven by continued U.S. Amtagvi demand,” said Frederick Vogt, Ph.D.,\nJ.D., Interim President and Chief Executive Officer. “Based on our\nsecond-quarter performance and strong demand trends, we are reviewing our\npreviously issued 2026 revenue guidance of $350 million to $370 million and\nwill provide an update during the third quarter. Additionally, we continue to\nbe excited by our clinical pipeline as lifileucel advances across other solid\ntumor indications including metastatic non-squamous non-small-cell lung cancer\n(NSCLC), the new registrational SARATOGA trial in undifferentiated pleomorphic\nsarcoma (UPS) and dedifferentiated liposarcoma (DDLPS), and metastatic serous\nendometrial cancer. Continued manufacturing and operating efficiencies support\nour sustainable growth, accelerate progress toward profitability, and advance\nour clinical pipeline with first-in-class, novel products in new solid tumor\nindications.”\n\nSecond Quarter 2026 Financial Highlights \nRecord Revenue and Improving Margin Supported by Cost Discipline\n* Total product revenue was ~$99 million, an increase of 66% from ~$60 million\nin 2Q25 and 39% from ~$71 million in 1Q26.\n* U.S. Amtagvi revenue was ~$91 million, up 40% from 4Q25. Global Proleukin\nrevenue was ~$9 million and is expected to grow during the remainder of 2026.\n* Gross margin was 56%(1), reflecting higher Amtagvi sales volume, continued\ncost optimization, and maturing internal manufacturing efficiencies.\n* Research and Development (R&D) expenses decreased by ~6% compared to 1Q26,\ndriven by continued operational efficiencies during the fourth straight\nquarter of improvements.\nFull Year 2026 Outlook\nSecond Quarter Performance and Demand Growth\n* Based on strong second-quarter sales and current demand trends, Iovance is\nreviewing its FY26 total revenue guidance of $350 million to $370 million. An\nupdate will be provided during the third quarter.\n* Improvements in gross margin are expected to continue, excluding occasional\none-time items.\nAmtagvi Commercial Business\nSignificant U.S. Commercial Business Growth and Progress in Global Expansion\n* Demand and awareness: Record Amtagvi demand, catalyzed by a new marketing\ncampaign (https://www.amtagvi.com/hcp) and an expanded sales team, is driving\nincreased adoption across a growing ATC network and referrals toward earlier\ntreatment. Unaided physician awareness of Amtagvi has nearly tripled during\nthe last year.\n* Authorized treatment center (ATC) network: The network has grown to more\nthan 95 U.S., Canadian, and Australian ATCs, with at least 110 ATCs expected\nto be active by the end of 2026. Community ATCs now represent a third of the\nnetwork and are expected to increase significantly over the next several\nquarters.\n* Real-world experience: Multiple real-world studies\n(https://www.iovance.com/scientific-publications-presentations/) by Iovance\nand ATCs using commercial Amtagvi continue to advance, supporting broader\nadoption of Amtagvi and earlier patient referrals and access. These studies\nhighlight objective response rates (ORRs) of 50% or greater and address\nidentification of tumor harvest sites, accelerated institutional workflows,\nand improved patient care.\n* Manufacturing turnaround time: Amtagvi turnaround time is 31 days or less\nusing the only scaled, centralized commercial manufacturing process approved\nby FDA for TIL therapy.\n* Australia: The marketing authorization application (MAA) for Amtagvi in\nAustralia was approved\n(https://ir.iovance.com/news-releases/news-release-details/iovances-amtagvir-lifileucel-granted-approval-treatment-advanced)\nby the Therapeutic Goods Administration (TGA), marking the third approval of\nAmtagvi by global health authorities to date. A high incidence of advanced\nmelanoma in Australia causes more than 1,500 annual deaths. Australian ATCs\nare currently progressing through the authorization process in parallel with\ndiscussions for national reimbursement.\n* United Kingdom (UK): The MAA for Amtagvi in the UK was resubmitted in early\nJuly and is undergoing expedited review by the Medicines and Healthcare\nproducts Regulatory Agency (MHRA) for potential approval later in 2026.\nAdvanced melanoma causes more than 2,500 deaths annually in the UK.\n* Switzerland: Potential approval of the MAA in Switzerland is expected in\n1H27, opening a second market opportunity in Europe with the potential for\nmedical tourism. Switzerland’s domestic melanoma burden causes several\nhundred deaths annually.\n* Other markets and indications: An MAA resubmission for Amtagvi in advanced\nmelanoma to the European Medicines Agency is on track for 2027. Other\nregulatory submissions are planned in international markets with a high\nprevalence of advanced melanoma, NSCLC, and soft tissue sarcomas.\nClinical and Regulatory Pipeline Updates \nProgress Across a Deep Pipeline of Registrational Programs\n* IOV-LUN-202\n(https://www.tilcelltherapy.com/clinical-trials/iov-lun-202-non-small-cell-lung-cancer-nsclc/):\nInitial results\n(https://ir.iovance.com/news-releases/news-release-details/iovance-biotherapeutics-reports-potential-best-class-clinical)\nin previously treated metastatic non-squamous NSCLC supported FDA FTD\n(https://ir.iovance.com/news-releases/news-release-details/iovance-biotherapeutics-highlights-strong-fourth-quarter-and).\nEnrollment is nearly complete in the pivotal cohorts and program updates are\nexpected in 4Q26. A supplemental Biologics License Application (sBLA)\nsubmission is planned in 2027. The U.S. market opportunity in metastatic\nnon-squamous NSCLC is about seven times that of advanced melanoma.\n* SARATOGA (IOV-SAR-201)\n(https://www.tilcelltherapy.com/clinical-trials/saratoga/): The registrational\ntrial in UPS and DDLPS is underway, driven by positive early data\n(https://ir.iovance.com/news-releases/news-release-details/iovance-announces-positive-results-first-clinical-trial-til-cell)\nwith an ORR by RECIST v1.1 of 50% in the first six evaluable patients. Based\non the strength of this early data, FDA granted FTD for UPS and DDLPS. Results\nwill be highlighted in an oral presentation (abstract #3725RO) at the European\nSociety for Medical Oncology (ESMO) meeting in Madrid, Spain, from October\n23–27, 2026.\n* TILVANCE-301\n(https://www.tilcelltherapy.com/clinical-trials/tilvance-301-advanced-melanoma/):\nA Phase 3 randomized trial of lifileucel and pembrolizumab is enrolling\npatients with frontline advanced melanoma across a broad global footprint. The\nTILVANCE-301 trial includes an early interim analysis based on ORR for a\npotential sBLA for frontline advanced melanoma. The trial also serves as the\nconfirmatory study for the accelerated approval of lifileucel in second-line\nadvanced melanoma. Results supporting the combination of lifileucel and\npembrolizumab as a potential best-in-class option for frontline advanced\nmelanoma were accepted (abstract #2072O) for an oral presentation at the ESMO\nannual meeting.\n* IOV-END-201\n(https://www.tilcelltherapy.com/clinical-trials/iov-end-201-endometrial-cancer/):\nPositive initial data\n(https://ir.iovance.com/news-releases/news-release-details/iovance-biotherapeutics-highlights-positive-first-quarter-2026)\nin previously treated metastatic serous endometrial cancer using a biomarker\nstrategy based on histology were recently reported. A protocol amendment is\nbeing submitted and engagement with FDA is underway on an expedited approval\npathway to focus on this population.\nNext-Generation Pipeline Updates \nFirst-in-Class Immuno-Oncology Technologies Target New Indications\n* IOV-GM1-201 (https://www.iovance.com/clinical-trials/): A Phase 1/2 trial\ninvestigating IOV-4001, a PD-1 inactivated TIL therapy, is enrolling patients\nwith previously treated metastatic melanoma and NSCLC. IOV-4001 is engineered\nto resist inhibitory signals and enhance the ability of TIL therapies to fight\nand kill cancer in the tumor microenvironment (TME).\n* IOV-GE1-201\n(https://www.tilcelltherapy.com/clinical-trials/iov-ge1-201-advanced-solid-tumors/):\nA Phase 1/2 trial is underway using IOV-5001, a second-generation IL-12\ntethered TIL therapy designed to remodel the suppressive TME and activate\nimmunologically “cold tumors” to support TIL responses and boost response\nrates.(2) Cohorts include metastatic colorectal cancer, triple-negative and\nestrogen receptor low breast cancers, and other solid tumors causing more than\n100,000 annual U.S. deaths.(3)\n* IOV-IL2-101 (https://clinicaltrials.gov/study/NCT06940739): A Phase 1 safety\ncohort is advancing through multiple dose levels in the Phase 1/2 trial of\nIOV-3001, our second-generation modified IL-2 analog for the TIL treatment\nregimen. IOV-3001 selectively expands effector T cells while avoiding\nactivation of regulatory T cells with the potential for a lower dose IL-2\nregimen with reduced adverse events. IOV-3001 is expected to be superior to\nProleukin as a component of future TIL regimens.\n* Investigator-sponsored trials (ISTs): Iovance is advancing several\nlifileucel ISTs in new indications. Multiple patients have been treated for\ncutaneous squamous cell carcinoma (CSCC) and Merkel cell carcinoma (MCC) with\ninitial data expected in 1H27. To date, early clinical activity has been\nreported. With no approved therapies after failure of checkpoint inhibitors,\nlifileucel could address a large CSCC and MCC market with several thousand\nannual deaths in the U.S.\nCorporate Updates\n* Iovance is deploying and advancing artificial intelligence (AI) tools to\ndrive significant future cost efficiencies and new product pipeline insights.\n* Iovance currently owns or licenses more than 400 granted or allowed U.S. and\ninternational patents and patent rights\n(https://www.iovance.com/intellectual-property/) for Amtagvi and other\nTIL-related technologies and has filed more than 1,000 additional patent\napplications worldwide. This broad patent portfolio is expected to provide\npatent exclusivity through at least 2042 and beyond.\n* As of June 30, 2026, Iovance’s cash position was ~$304 million(4) and\ncurrent cash is expected to fund operations into 2H28.\nWebcast and Conference Call \n\nManagement will host a conference call and live audio webcast to discuss these\nresults and provide a corporate update today at 8:30 a.m. ET. To listen to the\nlive or archived audio webcast, please register at\nhttps://edge.media-server.com/mmc/p/3f4w9ts7/. The live and archived webcast\ncan be accessed in the Investors section of the Company’s website,\nIR.Iovance.com, for one year.\n\n(1. Excludes depreciation and amortization)\n(2. Zhang L, Rosenberg SA, et al., Clin Cancer Res 2015;21(10):2278–2288.)\n(3. Surveillance, Epidemiology, and End Results Program Cancer Stat Facts\n(accessed April 2026).)\n(4. Cash, cash equivalents, short-term investments, and restricted cash as of\nJune 30, 2026.)\n\nAbout Iovance Biotherapeutics, Inc. \n\nIovance Biotherapeutics, Inc. is the global leader in innovating, developing,\nand delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients\nwith solid tumors. Amtagvi® (lifileucel) is the first FDA-approved, one-time\ntreatment for previously treated advanced melanoma, now approved in three\nglobal markets and available at more than 95 authorized treatment centers.\nThe Iovance TIL platform\n(https://www.iovance.com/our-science/til-platform/) spans registrational\ntrials and next-generation programs in additional solid tumors, including\ngene-edited and IL-12 tethered TIL therapies, next-generation IL-2, and\nprecision immuno-oncology approaches. As the first and only company to take\nTIL therapy from concept to a broadly accessible commercial treatment, Iovance\noperates as an end-to-end cell therapy company, anchored by fully owned,\ncentralized U.S.-based manufacturing that is scaled to serve thousands of\ncancer patients worldwide each year. For more information, please\nvisit www.iovance.com.\n\nAmtagvi® and its accompanying design marks, Proleukin(®), Iovance(®), and\nIovanceCares™ are trademarks and registered trademarks of Iovance\nBiotherapeutics, Inc. or its subsidiaries. All other trademarks and\nregistered trademarks are the property of their respective owners.\n\nInformation on Iovance’s broad, industry-leading patent portfolio is\navailable on the Intellectual Property page on www.iovance.com.\n\nForward-Looking Statements\n\nCertain matters discussed in this press release are “forward-looking\nstatements” of Iovance Biotherapeutics, Inc. (hereinafter referred to as the\n“Company,” “we,” “us,” or “our”) within the meaning of the\nPrivate Securities Litigation Reform Act of 1995 (the “PSLRA”). Without\nlimiting the foregoing, we may, in some cases, use terms such as\n“predicts,” “believes,” “potential,” “continue,”\n“estimates,” “anticipates,” “expects,” “plans,” “intends,”\n“forecast,” “guidance,” “outlook,” “may,” “can,”\n“could,” “might,” “will,” “should,” or other words that convey\nuncertainty of future events or outcomes and are intended to identify\nforward-looking statements. Forward-looking statements are based on\nassumptions and assessments made in light of management’s experience and\nperception of historical trends, current conditions, expected future\ndevelopments, and other factors believed to be appropriate. Forward-looking\nstatements in this press release are made as of the date of this press\nrelease, and we undertake no duty to update or revise any such statements,\nwhether as a result of new information, future events, or otherwise.\nForward-looking statements are not guarantees of future performance and are\nsubject to risks, uncertainties, and other factors, many of which are outside\nof our control, that may cause actual results, levels of activity,\nperformance, achievements, and developments to be materially different from\nthose expressed in or implied by these forward-looking statements. Important\nfactors that could cause actual results, developments, and business decisions\nto differ materially from forward-looking statements are described in the\nsections titled “Risk Factors” in our filings with the U.S. Securities and\nExchange Commission, including our most recent Annual Report on Form 10-K and\nQuarterly Reports on Form 10-Q, and include, but are not limited to, the\nfollowing substantial known and unknown risks and uncertainties inherent in\nour business: the risks related to our ability to successfully commercialize\nour products; the acceptance by the market of our products and product\ncandidates, if approved, and their potential pricing and/or reimbursement by\npayors, and whether such acceptance is sufficient to support continued\ncommercialization or development of our products or product candidates; the\nrisk regarding our ability to manufacture our therapies at our iCTC facility,\nincluding the risk that our ability to increase manufacturing capacity at our\nfacility may adversely affect our commercial launch; the risks related to our\nability to obtain, maintain and enforce patent and other intellectual property\nprotection for our products and product candidates; the risk that the\nsuccessful development or commercialization of our products may not generate\nsufficient revenue from product sales, and we may not become profitable in the\nnear term, or at all; the risks related to the timing of and our ability to\nsuccessfully develop, submit, obtain, or maintain regulatory authority\napproval of our product candidates; whether clinical trial results from our\npivotal studies and cohorts, and meetings with regulatory authorities may\nsupport registrational studies and subsequent approvals by regulatory\nauthorities, including the risk that the planned registrational trial in\nadvanced sarcomas may not support approval; preliminary and interim clinical\nresults, which may include efficacy and safety results, from ongoing clinical\ntrials or cohorts may not be reflected in the final analyses of our ongoing\nclinical trials or subgroups within these trials or in other prior trials or\ncohorts; the risk that we may be required to conduct additional clinical\ntrials or modify ongoing or future clinical trials based on feedback from\nregulatory authorities; the risk that our interpretation of the results of our\nclinical trials or communications with regulatory authorities may differ from\nthe interpretation of such results or communications by such regulatory\nauthorities; the risk that clinical data from ongoing clinical trials of\nAmtagvi will not continue or be repeated in ongoing or planned clinical trials\nor may not support regulatory approval or renewal of authorization; the risk\nthat unanticipated expenses may decrease our estimated cash balances and\nforecasts and increase our estimated capital requirements; the risk that we\nmay not be able to recognize revenue for our products; the risk that Proleukin\nrevenues, and other factors such as the number of ATCs, may not serve as a\nleading indicator for Amtagvi revenues; the risks regarding our anticipated\noperating and financial performance, including our financial guidance and\nprojections; the effects of global and domestic geopolitical factors or public\nhealth events; and other factors, including general economic conditions and\nregulatory developments, not within our control. Any financial guidance\nprovided in this press release assumes the following: no material change in\nour ability to manufacture our products; no material change in payor coverage;\nno material change in revenue recognition policies; no new business\ndevelopment transactions not completed as of the period covered by this press\nrelease; and no material fluctuation in exchange rates.\n\n\n\n IOVANCE BIOTHERAPEUTICS, INC. Selected Condensed Consolidated Balance Sheets (in thousands) \n                                                                                      \n                                                                                      \n                                            June 30, 2026       December 31, 2025     \n                                            (unaudited)                               \n Cash, cash equivalents, and investments    $        297,674    $          296,980    \n Restricted cash                            $        6,005      $          5,980      \n Total assets                               $        915,531    $          913,170    \n Stockholders’ equity                       $        736,045    $          698,583    \n\n\n\n                                                                                                                                                                                             \n Condensed Consolidated Statements of Operations (unaudited; in thousands, except per share information)                                                                                     \n                                                                                                                                                                                             \n                                                                                        For the Three Months Ended                         For the Six Months Ended                          \n                                                                                        June 30,                                           June 30,                                          \n                                                                                        2026                       2025                    2026                        2025                  \n Revenue                                                                                                                                                                                     \n Product revenue, net                                                                   $     99,313               $     59,952            $     170,743               $     109,276         \n Total revenue                                                                                99,313                     59,952                  170,743                     109,276         \n                                                                                                                                                                                             \n Costs and expenses*                                                                                                                                                                         \n Cost of sales **                                                                       $     43,595               $     48,881            $     86,093                $     91,595          \n Research and development **                                                                  58,851                     77,928                  121,338                     153,895         \n Selling, general, and administrative **                                                      39,272                     37,567                  78,221                      81,366          \n Depreciation and amortization                                                                9,500                      9,350                   18,039                      17,415          \n Total costs and expenses                                                                     151,218                    173,726                 303,691                     344,271         \n Loss from operations                                                                         (51,905  )                 (113,774  )             (132,948  )                 (234,995  )     \n Other income                                                                                                                                                                                \n Interest and other income, net                                                               3,217                      4,104                   4,550                       7,324           \n Net Loss before income taxes                                                                 (48,688  )                 (109,670  )             (128,398  )                 (227,671  )     \n Income tax benefit (expense)                                                                 1,373                      (1,988    )             2,038                       (150      )     \n Net Loss                                                                               $     (47,315  )           $     (111,658  )       $     (126,360  )           $     (227,821  )     \n Net Loss Per Share of Common Stock, Basic and Diluted                                  $     (0.11    )           $     (0.33     )       $     (0.29     )           $     (0.69     )     \n Weighted Average Shares of Common Stock Outstanding, Basic and Diluted                       450,189                    334,511                 434,437                     328,721         \n                                                                                                                                                                                             \n *Non-cash stock-based compensation included in cost of sales and operating expenses                                                                                                         \n Cost of sales                                                                          $     1,536                $     2,149             $     2,555                 $     4,569           \n Research and development                                                                     5,078                      6,359                   10,195                      16,276          \n Selling, general, and administrative                                                         5,119                      6,435                   10,252                      17,013          \n                                                                                        $     11,733               $     14,943            $     23,002                $     37,858          \n                                                                                                                                                                                             \n ** Excludes depreciation and amortization                                                                                                                                                   \n\nCONTACTS \n\nInvestors\nIR@iovance.com\n650-260-7120 ext. 150\n\nMedia\nPR@iovance.com \n650-260-7120 ext. 150\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/d0986bd6-4603-4e31-8ed1-f23b3e123605)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX6J02hs","title":"Iovance Biotherapeutics Reports Record Second Quarter 2026 Revenue of ~$99M, Business Achievements, and Corporate Updates","author":"Globe Newswire","ticker":"IOVA","created":"2026-08-06T11:01:00.260Z","tickers":["IOVA"],"exchange":"NASDAQ","article_body":"U.S. Amtagvi Revenue Reaches ~$91M and Total Revenue Increased 66%\nYear-over-Year\n\nGross Margin Increased to 56%\n\nFast Track Designation (FTD) Granted by the FDA for Lifileucel in Soft Tissue\nSarcomas\n\nSAN CARLOS, Calif., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics,\nInc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating,\ndeveloping, and delivering novel polyclonal tumor infiltrating lymphocyte\n(TIL) therapies for patients with cancer, today reported second quarter 2026\nfinancial results, business achievements, and corporate updates.\n\n“Second-quarter revenue reached a record $99.3 million with gross margin of\n56%, driven by continued U.S. Amtagvi demand,” said Frederick Vogt, Ph.D.,\nJ.D., Interim President and Chief Executive Officer. “Based on our\nsecond-quarter performance and strong demand trends, we are reviewing our\npreviously issued 2026 revenue guidance of $350 million to $370 million and\nwill provide an update during the third quarter. Additionally, we continue to\nbe excited by our clinical pipeline as lifileucel advances across other solid\ntumor indications including metastatic non-squamous non-small-cell lung cancer\n(NSCLC), the new registrational SARATOGA trial in undifferentiated pleomorphic\nsarcoma (UPS) and dedifferentiated liposarcoma (DDLPS), and metastatic serous\nendometrial cancer. Continued manufacturing and operating efficiencies support\nour sustainable growth, accelerate progress toward profitability, and advance\nour clinical pipeline with first-in-class, novel products in new solid tumor\nindications.”\n\nSecond Quarter 2026 Financial Highlights \nRecord Revenue and Improving Margin Supported by Cost Discipline\n* Total product revenue was ~$99 million, an increase of 66% from ~$60 million\nin 2Q25 and 39% from ~$71 million in 1Q26.\n* U.S. Amtagvi revenue was ~$91 million, up 40% from 4Q25. Global Proleukin\nrevenue was ~$9 million and is expected to grow during the remainder of 2026.\n* Gross margin was 56%(1), reflecting higher Amtagvi sales volume, continued\ncost optimization, and maturing internal manufacturing efficiencies.\n* Research and Development (R&D) expenses decreased by ~6% compared to 1Q26,\ndriven by continued operational efficiencies during the fourth straight\nquarter of improvements.\nFull Year 2026 Outlook\nSecond Quarter Performance and Demand Growth\n* Based on strong second-quarter sales and current demand trends, Iovance is\nreviewing its FY26 total revenue guidance of $350 million to $370 million. An\nupdate will be provided during the third quarter.\n* Improvements in gross margin are expected to continue, excluding occasional\none-time items.\nAmtagvi Commercial Business\nSignificant U.S. Commercial Business Growth and Progress in Global Expansion\n* Demand and awareness: Record Amtagvi demand, catalyzed by a new marketing\ncampaign (https://www.amtagvi.com/hcp) and an expanded sales team, is driving\nincreased adoption across a growing ATC network and referrals toward earlier\ntreatment. Unaided physician awareness of Amtagvi has nearly tripled during\nthe last year.\n* Authorized treatment center (ATC) network: The network has grown to more\nthan 95 U.S., Canadian, and Australian ATCs, with at least 110 ATCs expected\nto be active by the end of 2026. Community ATCs now represent a third of the\nnetwork and are expected to increase significantly over the next several\nquarters.\n* Real-world experience: Multiple real-world studies\n(https://www.iovance.com/scientific-publications-presentations/) by Iovance\nand ATCs using commercial Amtagvi continue to advance, supporting broader\nadoption of Amtagvi and earlier patient referrals and access. These studies\nhighlight objective response rates (ORRs) of 50% or greater and address\nidentification of tumor harvest sites, accelerated institutional workflows,\nand improved patient care.\n* Manufacturing turnaround time: Amtagvi turnaround time is 31 days or less\nusing the only scaled, centralized commercial manufacturing process approved\nby FDA for TIL therapy.\n* Australia: The marketing authorization application (MAA) for Amtagvi in\nAustralia was approved\n(https://ir.iovance.com/news-releases/news-release-details/iovances-amtagvir-lifileucel-granted-approval-treatment-advanced)\nby the Therapeutic Goods Administration (TGA), marking the third approval of\nAmtagvi by global health authorities to date. A high incidence of advanced\nmelanoma in Australia causes more than 1,500 annual deaths. Australian ATCs\nare currently progressing through the authorization process in parallel with\ndiscussions for national reimbursement.\n* United Kingdom (UK): The MAA for Amtagvi in the UK was resubmitted in early\nJuly and is undergoing expedited review by the Medicines and Healthcare\nproducts Regulatory Agency (MHRA) for potential approval later in 2026.\nAdvanced melanoma causes more than 2,500 deaths annually in the UK.\n* Switzerland: Potential approval of the MAA in Switzerland is expected in\n1H27, opening a second market opportunity in Europe with the potential for\nmedical tourism. Switzerland’s domestic melanoma burden causes several\nhundred deaths annually.\n* Other markets and indications: An MAA resubmission for Amtagvi in advanced\nmelanoma to the European Medicines Agency is on track for 2027. Other\nregulatory submissions are planned in international markets with a high\nprevalence of advanced melanoma, NSCLC, and soft tissue sarcomas.\nClinical and Regulatory Pipeline Updates \nProgress Across a Deep Pipeline of Registrational Programs\n* IOV-LUN-202\n(https://www.tilcelltherapy.com/clinical-trials/iov-lun-202-non-small-cell-lung-cancer-nsclc/):\nInitial results\n(https://ir.iovance.com/news-releases/news-release-details/iovance-biotherapeutics-reports-potential-best-class-clinical)\nin previously treated metastatic non-squamous NSCLC supported FDA FTD\n(https://ir.iovance.com/news-releases/news-release-details/iovance-biotherapeutics-highlights-strong-fourth-quarter-and).\nEnrollment is nearly complete in the pivotal cohorts and program updates are\nexpected in 4Q26. A supplemental Biologics License Application (sBLA)\nsubmission is planned in 2027. The U.S. market opportunity in metastatic\nnon-squamous NSCLC is about seven times that of advanced melanoma.\n* SARATOGA (IOV-SAR-201)\n(https://www.tilcelltherapy.com/clinical-trials/saratoga/): The registrational\ntrial in UPS and DDLPS is underway, driven by positive early data\n(https://ir.iovance.com/news-releases/news-release-details/iovance-announces-positive-results-first-clinical-trial-til-cell)\nwith an ORR by RECIST v1.1 of 50% in the first six evaluable patients. Based\non the strength of this early data, FDA granted FTD for UPS and DDLPS. Results\nwill be highlighted in an oral presentation (abstract #3725RO) at the European\nSociety for Medical Oncology (ESMO) meeting in Madrid, Spain, from October\n23–27, 2026.\n* TILVANCE-301\n(https://www.tilcelltherapy.com/clinical-trials/tilvance-301-advanced-melanoma/):\nA Phase 3 randomized trial of lifileucel and pembrolizumab is enrolling\npatients with frontline advanced melanoma across a broad global footprint. The\nTILVANCE-301 trial includes an early interim analysis based on ORR for a\npotential sBLA for frontline advanced melanoma. The trial also serves as the\nconfirmatory study for the accelerated approval of lifileucel in second-line\nadvanced melanoma. Results supporting the combination of lifileucel and\npembrolizumab as a potential best-in-class option for frontline advanced\nmelanoma were accepted (abstract #2072O) for an oral presentation at the ESMO\nannual meeting.\n* IOV-END-201\n(https://www.tilcelltherapy.com/clinical-trials/iov-end-201-endometrial-cancer/):\nPositive initial data\n(https://ir.iovance.com/news-releases/news-release-details/iovance-biotherapeutics-highlights-positive-first-quarter-2026)\nin previously treated metastatic serous endometrial cancer using a biomarker\nstrategy based on histology were recently reported. A protocol amendment is\nbeing submitted and engagement with FDA is underway on an expedited approval\npathway to focus on this population.\nNext-Generation Pipeline Updates \nFirst-in-Class Immuno-Oncology Technologies Target New Indications\n* IOV-GM1-201 (https://www.iovance.com/clinical-trials/): A Phase 1/2 trial\ninvestigating IOV-4001, a PD-1 inactivated TIL therapy, is enrolling patients\nwith previously treated metastatic melanoma and NSCLC. IOV-4001 is engineered\nto resist inhibitory signals and enhance the ability of TIL therapies to fight\nand kill cancer in the tumor microenvironment (TME).\n* IOV-GE1-201\n(https://www.tilcelltherapy.com/clinical-trials/iov-ge1-201-advanced-solid-tumors/):\nA Phase 1/2 trial is underway using IOV-5001, a second-generation IL-12\ntethered TIL therapy designed to remodel the suppressive TME and activate\nimmunologically “cold tumors” to support TIL responses and boost response\nrates.(2) Cohorts include metastatic colorectal cancer, triple-negative and\nestrogen receptor low breast cancers, and other solid tumors causing more than\n100,000 annual U.S. deaths.(3)\n* IOV-IL2-101 (https://clinicaltrials.gov/study/NCT06940739): A Phase 1 safety\ncohort is advancing through multiple dose levels in the Phase 1/2 trial of\nIOV-3001, our second-generation modified IL-2 analog for the TIL treatment\nregimen. IOV-3001 selectively expands effector T cells while avoiding\nactivation of regulatory T cells with the potential for a lower dose IL-2\nregimen with reduced adverse events. IOV-3001 is expected to be superior to\nProleukin as a component of future TIL regimens.\n* Investigator-sponsored trials (ISTs): Iovance is advancing several\nlifileucel ISTs in new indications. Multiple patients have been treated for\ncutaneous squamous cell carcinoma (CSCC) and Merkel cell carcinoma (MCC) with\ninitial data expected in 1H27. To date, early clinical activity has been\nreported. With no approved therapies after failure of checkpoint inhibitors,\nlifileucel could address a large CSCC and MCC market with several thousand\nannual deaths in the U.S.\nCorporate Updates\n* Iovance is deploying and advancing artificial intelligence (AI) tools to\ndrive significant future cost efficiencies and new product pipeline insights.\n* Iovance currently owns or licenses more than 400 granted or allowed U.S. and\ninternational patents and patent rights\n(https://www.iovance.com/intellectual-property/) for Amtagvi and other\nTIL-related technologies and has filed more than 1,000 additional patent\napplications worldwide. This broad patent portfolio is expected to provide\npatent exclusivity through at least 2042 and beyond.\n* As of June 30, 2026, Iovance’s cash position was ~$304 million(4) and\ncurrent cash is expected to fund operations into 2H28.\nWebcast and Conference Call \n\nManagement will host a conference call and live audio webcast to discuss these\nresults and provide a corporate update today at 8:30 a.m. ET. To listen to the\nlive or archived audio webcast, please register at\nhttps://edge.media-server.com/mmc/p/3f4w9ts7/. The live and archived webcast\ncan be accessed in the Investors section of the Company’s website,\nIR.Iovance.com, for one year.\n\n(1. Excludes depreciation and amortization)\n(2. Zhang L, Rosenberg SA, et al., Clin Cancer Res 2015;21(10):2278–2288.)\n(3. Surveillance, Epidemiology, and End Results Program Cancer Stat Facts\n(accessed April 2026).)\n(4. Cash, cash equivalents, short-term investments, and restricted cash as of\nJune 30, 2026.)\n\nAbout Iovance Biotherapeutics, Inc. \n\nIovance Biotherapeutics, Inc. is the global leader in innovating, developing,\nand delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients\nwith solid tumors. Amtagvi® (lifileucel) is the first FDA-approved, one-time\ntreatment for previously treated advanced melanoma, now approved in three\nglobal markets and available at more than 95 authorized treatment centers.\nThe Iovance TIL platform\n(https://www.iovance.com/our-science/til-platform/) spans registrational\ntrials and next-generation programs in additional solid tumors, including\ngene-edited and IL-12 tethered TIL therapies, next-generation IL-2, and\nprecision immuno-oncology approaches. As the first and only company to take\nTIL therapy from concept to a broadly accessible commercial treatment, Iovance\noperates as an end-to-end cell therapy company, anchored by fully owned,\ncentralized U.S.-based manufacturing that is scaled to serve thousands of\ncancer patients worldwide each year. For more information, please\nvisit www.iovance.com.\n\nAmtagvi® and its accompanying design marks, Proleukin(®), Iovance(®), and\nIovanceCares™ are trademarks and registered trademarks of Iovance\nBiotherapeutics, Inc. or its subsidiaries. All other trademarks and\nregistered trademarks are the property of their respective owners.\n\nInformation on Iovance’s broad, industry-leading patent portfolio is\navailable on the Intellectual Property page on www.iovance.com.\n\nForward-Looking Statements\n\nCertain matters discussed in this press release are “forward-looking\nstatements” of Iovance Biotherapeutics, Inc. (hereinafter referred to as the\n“Company,” “we,” “us,” or “our”) within the meaning of the\nPrivate Securities Litigation Reform Act of 1995 (the “PSLRA”). Without\nlimiting the foregoing, we may, in some cases, use terms such as\n“predicts,” “believes,” “potential,” “continue,”\n“estimates,” “anticipates,” “expects,” “plans,” “intends,”\n“forecast,” “guidance,” “outlook,” “may,” “can,”\n“could,” “might,” “will,” “should,” or other words that convey\nuncertainty of future events or outcomes and are intended to identify\nforward-looking statements. Forward-looking statements are based on\nassumptions and assessments made in light of management’s experience and\nperception of historical trends, current conditions, expected future\ndevelopments, and other factors believed to be appropriate. Forward-looking\nstatements in this press release are made as of the date of this press\nrelease, and we undertake no duty to update or revise any such statements,\nwhether as a result of new information, future events, or otherwise.\nForward-looking statements are not guarantees of future performance and are\nsubject to risks, uncertainties, and other factors, many of which are outside\nof our control, that may cause actual results, levels of activity,\nperformance, achievements, and developments to be materially different from\nthose expressed in or implied by these forward-looking statements. Important\nfactors that could cause actual results, developments, and business decisions\nto differ materially from forward-looking statements are described in the\nsections titled “Risk Factors” in our filings with the U.S. Securities and\nExchange Commission, including our most recent Annual Report on Form 10-K and\nQuarterly Reports on Form 10-Q, and include, but are not limited to, the\nfollowing substantial known and unknown risks and uncertainties inherent in\nour business: the risks related to our ability to successfully commercialize\nour products; the acceptance by the market of our products and product\ncandidates, if approved, and their potential pricing and/or reimbursement by\npayors, and whether such acceptance is sufficient to support continued\ncommercialization or development of our products or product candidates; the\nrisk regarding our ability to manufacture our therapies at our iCTC facility,\nincluding the risk that our ability to increase manufacturing capacity at our\nfacility may adversely affect our commercial launch; the risks related to our\nability to obtain, maintain and enforce patent and other intellectual property\nprotection for our products and product candidates; the risk that the\nsuccessful development or commercialization of our products may not generate\nsufficient revenue from product sales, and we may not become profitable in the\nnear term, or at all; the risks related to the timing of and our ability to\nsuccessfully develop, submit, obtain, or maintain regulatory authority\napproval of our product candidates; whether clinical trial results from our\npivotal studies and cohorts, and meetings with regulatory authorities may\nsupport registrational studies and subsequent approvals by regulatory\nauthorities, including the risk that the planned registrational trial in\nadvanced sarcomas may not support approval; preliminary and interim clinical\nresults, which may include efficacy and safety results, from ongoing clinical\ntrials or cohorts may not be reflected in the final analyses of our ongoing\nclinical trials or subgroups within these trials or in other prior trials or\ncohorts; the risk that we may be required to conduct additional clinical\ntrials or modify ongoing or future clinical trials based on feedback from\nregulatory authorities; the risk that our interpretation of the results of our\nclinical trials or communications with regulatory authorities may differ from\nthe interpretation of such results or communications by such regulatory\nauthorities; the risk that clinical data from ongoing clinical trials of\nAmtagvi will not continue or be repeated in ongoing or planned clinical trials\nor may not support regulatory approval or renewal of authorization; the risk\nthat unanticipated expenses may decrease our estimated cash balances and\nforecasts and increase our estimated capital requirements; the risk that we\nmay not be able to recognize revenue for our products; the risk that Proleukin\nrevenues, and other factors such as the number of ATCs, may not serve as a\nleading indicator for Amtagvi revenues; the risks regarding our anticipated\noperating and financial performance, including our financial guidance and\nprojections; the effects of global and domestic geopolitical factors or public\nhealth events; and other factors, including general economic conditions and\nregulatory developments, not within our control. Any financial guidance\nprovided in this press release assumes the following: no material change in\nour ability to manufacture our products; no material change in payor coverage;\nno material change in revenue recognition policies; no new business\ndevelopment transactions not completed as of the period covered by this press\nrelease; and no material fluctuation in exchange rates.\n\n\n\n IOVANCE BIOTHERAPEUTICS, INC. Selected Condensed Consolidated Balance Sheets (in thousands) \n                                                                                      \n                                                                                      \n                                            June 30, 2026       December 31, 2025     \n                                            (unaudited)                               \n Cash, cash equivalents, and investments    $        297,674    $          296,980    \n Restricted cash                            $        6,005      $          5,980      \n Total assets                               $        915,531    $          913,170    \n Stockholders’ equity                       $        736,045    $          698,583    \n\n\n\n                                                                                                                                                                                             \n Condensed Consolidated Statements of Operations (unaudited; in thousands, except per share information)                                                                                     \n                                                                                                                                                                                             \n                                                                                        For the Three Months Ended                         For the Six Months Ended                          \n                                                                                        June 30,                                           June 30,                                          \n                                                                                        2026                       2025                    2026                        2025                  \n Revenue                                                                                                                                                                                     \n Product revenue, net                                                                   $     99,313               $     59,952            $     170,743               $     109,276         \n Total revenue                                                                                99,313                     59,952                  170,743                     109,276         \n                                                                                                                                                                                             \n Costs and expenses*                                                                                                                                                                         \n Cost of sales **                                                                       $     43,595               $     48,881            $     86,093                $     91,595          \n Research and development **                                                                  58,851                     77,928                  121,338                     153,895         \n Selling, general, and administrative **                                                      39,272                     37,567                  78,221                      81,366          \n Depreciation and amortization                                                                9,500                      9,350                   18,039                      17,415          \n Total costs and expenses                                                                     151,218                    173,726                 303,691                     344,271         \n Loss from operations                                                                         (51,905  )                 (113,774  )             (132,948  )                 (234,995  )     \n Other income                                                                                                                                                                                \n Interest and other income, net                                                               3,217                      4,104                   4,550                       7,324           \n Net Loss before income taxes                                                                 (48,688  )                 (109,670  )             (128,398  )                 (227,671  )     \n Income tax benefit (expense)                                                                 1,373                      (1,988    )             2,038                       (150      )     \n Net Loss                                                                               $     (47,315  )           $     (111,658  )       $     (126,360  )           $     (227,821  )     \n Net Loss Per Share of Common Stock, Basic and Diluted                                  $     (0.11    )           $     (0.33     )       $     (0.29     )           $     (0.69     )     \n Weighted Average Shares of Common Stock Outstanding, Basic and Diluted                       450,189                    334,511                 434,437                     328,721         \n                                                                                                                                                                                             \n *Non-cash stock-based compensation included in cost of sales and operating expenses                                                                                                         \n Cost of sales                                                                          $     1,536                $     2,149             $     2,555                 $     4,569           \n Research and development                                                                     5,078                      6,359                   10,195                      16,276          \n Selling, general, and administrative                                                         5,119                      6,435                   10,252                      17,013          \n                                                                                        $     11,733               $     14,943            $     23,002                $     37,858          \n                                                                                                                                                                                             \n ** Excludes depreciation and amortization                                                                                                                                                   \n\nCONTACTS \n\nInvestors\nIR@iovance.com\n650-260-7120 ext. 150\n\nMedia\nPR@iovance.com \n650-260-7120 ext. 150\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/d0986bd6-4603-4e31-8ed1-f23b3e123605)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-08-06T11:01:00.471665833Z","server_sent_at_ms":1786014060471},"received_at":"2026-08-06T11:01:00.806Z","source_url":"https://www.globenewswire.com/news-release/2026/08/06/3340124/0/en/iovance-biotherapeutics-reports-record-second-quarter-2026-revenue-of-99m-business-achievements-and-corporate-updates.html"},"analysis":{"id":"100075","press_release_id":"111072","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":["Guidance is under review rather than formally raised","Company continues to operate at a net loss, though losses narrowed year-over-year"],"eventType":"earnings","narrative":"Iovance reported Q2 revenue of $99.3 million, up 66% year-over-year, driven by strong demand for Amtagvi which contributed $91 million in sales.\n\nGross margin expanded to 56% due to volume leverage and manufacturing efficiencies, prompting the company to review its FY26 revenue guidance of $350 million to $370 million.\n\nRegulatory progress included a Fast Track designation for lifileucel in soft tissue sarcomas and approval of Amtagvi in Australia, while the cash position remains robust at approximately $304 million.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Commercial ramp accelerates with 66% revenue growth and margin expansion, driving potential guidance raise."},"keyFigures":{"revenue":99313000,"guidance":"Reviewing FY26 revenue guidance of $350M to $370M","revenueYoy":"66%","customDimensions":{"rd_expenses":58851000,"gross_margin":"56%","amtagvi_revenue":91000000}},"quotedText":"Second-quarter revenue reached a record $99.3 million with gross margin of 56%, driven by continued U.S. Amtagvi demand","namedEntities":{"people":[{"name":"Frederick Vogt","role":"Interim President and Chief Executive 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The company also secured a key regulatory Fast Track designation for soft tissue sarcomas and received approval in Australia, validating the global commercial strategy."},"tickerRelevance":{"others":[],"primary":"IOVA"},"globalImportance":40,"audienceRelevance":55,"eventTypeSecondary":["regulatory","operations_update"],"importanceComponents":{"tickerTier":"mid-cap","eventGravity":"earnings_beat_and_regulatory_win","sectorWeight":"biotech","retailFavoriteBoost":"moderate"}},"event_type":"earnings","event_type_secondary":["regulatory","operations_update"],"sentiment":"bullish","material_impact_score":4,"narrative":"Iovance reported Q2 revenue of $99.3 million, up 66% year-over-year, driven by strong demand for Amtagvi which contributed $91 million in sales.\n\nGross margin expanded to 56% due to volume leverage and manufacturing efficiencies, prompting the company to review its FY26 revenue guidance of $350 million to $370 million.\n\nRegulatory progress included a Fast Track designation for lifileucel in soft tissue sarcomas and approval of Amtagvi in Australia, while the cash position remains robust at approximately $304 million.","key_figures":{"revenue":99313000,"guidance":"Reviewing FY26 revenue guidance of $350M to $370M","revenueYoy":"66%","customDimensions":{"rd_expenses":58851000,"gross_margin":"56%","amtagvi_revenue":91000000}},"named_entities":{"people":[{"name":"Frederick Vogt","role":"Interim President and Chief Executive Officer"}],"products":["Amtagvi","lifileucel","Proleukin","IOV-4001","IOV-5001","IOV-3001"],"companies":[{"name":"Iovance Biotherapeutics, Inc.","ticker":"IOVA"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"},{"name":"Therapeutic Goods Administration","relationship":"regulator"},{"name":"Medicines and Healthcare products Regulatory Agency","relationship":"regulator"},{"name":"European Medicines Agency","relationship":"regulator"}],"dollarAmounts":[{"amount":"~$99.3 million","context":"Q2 2026 total revenue"},{"amount":"~$91 million","context":"Q2 2026 U.S. Amtagvi revenue"},{"amount":"~$9 million","context":"Q2 2026 Global Proleukin revenue"},{"amount":"$350 million to $370 million","context":"FY26 revenue guidance under review"},{"amount":"~$304 million","context":"Cash position as of June 30, 2026"}]},"model_name":"glm-4.7","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-08-06T16:42:21.364Z","global_importance":40,"audience_relevance":55,"importance_components":{"tickerTier":"mid-cap","eventGravity":"earnings_beat_and_regulatory_win","sectorWeight":"biotech","retailFavoriteBoost":"moderate"}},"durationMs":220770,"modelName":"glm-4.7"}}