Aldesleukin

创新药五大风口2026：谁在改变游戏规则？ 从ADC到AI制药，从GLP-1到细胞治疗，中国生物医药正在经历一场前所未有的价值跃迁。 ADCGLP-1AI制药细胞治疗出海 2026年上半年，中国创新药对外授权交易总额突破1100亿美元——这是2024年全年的两倍。在全球医药交易Top10中，中国药企占据八席。 但真正值得关注的不是数字本身，而是数字背后的结构性变化：五个技术赛道正在同步爆发，中国企业的角色正在从"跟随者"变成"规则制定者"。 本文导览： ADC：从跟随到领跑，中国企业重新定义全球格局 GLP-1：从注射到口服，从减重到"万能药" AI制药：第一个AI设计的药物进入III期，但挑战才刚开始 细胞与基因治疗：实体瘤的城墙正在被攻破 创新药出海：从"卖管线"到"共创价值"01 ADC：从跟随到领跑，中国企业重新定义全球格局 2026年ASCO年会上，共有15款ADC首次披露临床试验数据。其中12款来自中国企业。 这不是偶然。 过去十年，中国ADC企业从靶点筛选、连接子设计到载荷优化，已经建立起完整的技术体系。2026年ASCO上，靶向Claudin18.2、AXL、CD46、FRα、GPC3等新兴靶点的ADC管线集中亮相，覆盖胃癌、卵巢癌、胰腺癌等难治性实体瘤。ADC靶点格局正在打破HER2、TROP2少数靶点垄断的局面。 更值得关注的，是技术路线的升级。双抗ADC：从"单靶点导弹"到"多靶点精确制导" 百利天恒的Iza-bren（BL-B01D1）是全球首创的EGFR×HER3双抗ADC。它的设计思路很清晰：同时识别肿瘤细胞表面的两个靶点，双重阻断生长信号通路，有效克服单靶点ADC易产生耐药性的痛点。 2025年10月ESMO年会上，Iza-bren的关键III期临床研究入选Late-breaking Abstract，并同步发表于《柳叶刀》主刊。数据显示：确认ORR达到54.6%，较化疗组27.0%实现翻倍；中位缓解持续时间8.5个月 vs 4.8个月，同样翻倍。 而在AACR 2026上，更多此前从未公开的双抗ADC靶点组合涌现：百奥赛图的TROP-2×MUC1、EpCAM×HER3，海思科的FRα×CDH6。正大天晴的TQB6411是全球首个公布人体临床数据的EGFR/c-Met双抗ADC，在≥4 mg/kg剂量下ORR达50%，DCR达100%。 案例：科伦博泰SKB264——"IO+ADC"的标杆 SKB264（芦康沙妥珠单抗）是靶向TROP-2的ADC。其核心突破不在于单药数据，而在于与帕博利珠单抗（K药）的联合应用——将"IO+ADC"联合疗法从理论推向大规模临床验证。 OptiTROP-Lung05 III期数据显示：联合用药用于PD-L1阳性NSCLC一线治疗，疾病进展或死亡风险下降65%，ORR达70.2%，显著优于K药单药42%。 这意味着ADC已从末线挽救治疗，全面渗透到一线治疗场景。新靶点突破：填补全球空白 企业 药物 突破恒瑞医药 SHR-A2009 全球首个HER3 ADC III期成功，打破HER3"不可成药"魔咒，预计2027年获批乐普生物 MRG006A 全球首创GPC3 ADC，剑指肝癌，DAR值8设计，填补肝癌ADC空白 复宏汉霖的HLX43则是另一个值得关注的创新——靶向PD-L1的ADC，实现了"免疫治疗+靶向杀伤"的协同效应。2025年ASCO公布的数据显示，在NSCLC患者中ORR达38.1%，其中胸腺鳞状细胞癌亚组ORR高达75%，脑转移患者DCR达100%。 中国已成为全球ADC研发的创新中心。从靶点多元化到双抗ADC、双载荷等创新技术落地，行业正由同质化竞争走向差异化创新。02 GLP-1：从注射到口服，从减重到"万能药" 2026年4月1日，礼来宣布其口服小分子GLP-1受体激动剂orforglipron获FDA批准，用于肥胖或超重人群的体重管理。 这是全球首个口服小分子、非肽类GLP-1减重药。它的意义不在于减重效果最强——最高剂量平均减重12.4%，低于注射剂型——而在于可及性。 orforglipron可以随时服用，没有饮食和饮水限制。相比之下，诺和诺德的口服司美格鲁肽片（2025年12月获批减重适应症）需要空腹服用，服药后至少等待30分钟才能进食。 为什么口服剂型如此重要？ 因为目前GLP-1类药物在肥胖症中的渗透率仅约2%。注射剂的依从性、冷链运输和储存要求，严重限制了可及性。口服剂型是破局的关键。 企业 减重幅度 特点诺和诺德 16.6% 口服司美格鲁肽25mg，64周平均体重降幅，近1/3患者减重超20%礼来 12.4% orforglipron最高剂量，无饮食饮水限制，小分子易规模化生产中国企业的口服竞速 国内十余家药企已布局口服减重药。恒瑞医药的HRS-7535片正在开展III期临床，II期数据显示180mg剂量组26周体重下降9.36%。HRS9531口服制剂II期数据显示25mg和50mg组体重均下降12.1%。闻肽医药的小分子GLP-1受体激动剂减重III期已接近完成，华东医药的口服小分子GLP-1处于国内III期阶段。适应症扩展：从减重到"一药多用" GLP-1类药物的价值远不止减重。 2025年12月，国家药监局批准司美格鲁肽注射液心血管适应症上市。2026年1月，一款口服小分子GLP-1获批临床，适应症为高血压合并超重或肥胖。GLP-1与银屑病关节炎联用的III期研究也取得积极结果。 从糖尿病管理，到体重管理，再到心血管保护、肝脏保护、肾脏保护、阻塞性睡眠呼吸暂停——GLP-1正在成为跨越代谢、心血管、免疫多个领域的"平台型药物"。 北京大学人民医院纪立农教授指出："GLP-1受体激动剂对许多疾病的治疗作用是独立于体重下降的。"这意味着，这个药物的作用机制比我们想象的更复杂、更深远。 信达生物的玛仕度肽（GLP-1/GCG双靶点）在《自然》同日发表两项临床研究，能在抑制食欲的同时增加脂肪消耗，24周约64%的患者体重下降超过5%。礼来已布局三靶点减重药，在降低食欲、增加消耗的同时进一步优化代谢。03 AI制药：第一个AI设计的药物进入III期，但挑战才刚开始 2026年7月，Insilico Medicine启动了一项III期临床试验——320名特发性肺纤维化（IPF）患者，47个中心，随机双盲安慰剂对照。 这本身不算大新闻。IPF的III期试验每年都有几项。 但这个药物叫rentosertib（INS018_055），它是全球首个由AI从零设计、并进入确证性III期试验的小分子药物。AI到底改变了什么？ 对比维度 传统药物研发 AI驱动研发靶点到IND周期 3-6年 18个月合成化合物数量 5000-10000个 <80个 截至2026年初，全球已有超过173个AI发现的候选药物进入临床试验。I期成功率80-90%，远高于传统的40-65%。 看起来很美好。但真正的考验在II期。失败案例同样真实 Recursion Pharmaceuticals的REC-994在SYCAMORE II期试验中未达到主要疗效终点。REC-2282在POPLAR II/III期中数据模糊。两个项目均被终止。 Exscientia的DSP-1181（2020年号称最早的"AI设计分子进入临床"之一）在I期完成后被搁置，从未进入II期。 AI加速了药物发现的"漏斗前门"，但漏斗中段——临床试验——仍由人类生物学决定。AI设计的分子在II期的成功率，与传统药物一样，仍然面临约60%的失败率。大药企的态度转变 2025-2026年，大药企从"观望"转向"真金白银"。 Isomorphic Labs（DeepMind旗下，基于AlphaFold 3）与诺华达成12亿美元、与礼来达成17亿美元合作，2026年5月完成21亿美元B轮融资。Insilico Medicine与施维雅达成8.88亿美元多年合作，与齐鲁制药达成近1.2亿美元合作，2025年12月在港交所上市，成为2025年最大港股生物科技IPO。 辉瑞与Boltz合作蛋白质结构预测AI，拜耳采用Cradle的蛋白质设计AI，礼来与NVIDIA联合建设AI制药算力工厂。Recursion在2025年收购Exscientia，整合了AI分子设计与表型筛选两大能力。 值得关注的下一个里程碑：Isomorphic Labs的首个候选药物预计2026年底进入临床试验。Schrödinger平台的zasocitinib（TYK2抑制剂）已进入III期。04 细胞与基因治疗：实体瘤的城墙正在被攻破 实体瘤占恶性肿瘤90%以上。长期以来，CAR-T细胞疗法在血液瘤中屡创佳绩，但在实体瘤面前，始终面临三道城墙：异质性强、肿瘤微环境免疫抑制、细胞浸润难。 2026年，这道城墙正在出现裂缝。全球首款实体瘤CAR-T，申报上市 科济药业的CT041（舒瑞基奥仑赛注射液）——靶向Claudin18.2的自体CAR-T，2025年6月NDA获CDE受理，被纳入突破性治疗及优先审评。有望成为全球首款获批上市的实体瘤CAR-T。 确证性II期临床结果显示：在所有随机人群中，舒瑞基奥仑赛较标准治疗显著延长无进展生存期（mPFS 3.25个月 vs 1.77个月，HR 0.366），疾病进展/死亡风险下降63%。在实际用药人群中，mPFS达4.37个月（HR 0.304），风险下降70%。 这不是个例。2025年全年，中国免疫细胞领域共获批近60项IND，覆盖CAR-T、TCR-T、TIL、CAR-NK、Treg、iNKT等多条技术路径。TIL疗法：用肿瘤自己的"叛徒"打回去 TIL（肿瘤浸润淋巴细胞）疗法的逻辑不同于CAR-T。它不从外部安装靶向受体，而是直接从患者肿瘤组织中提取已经浸润进去的T细胞——这些细胞天然表达多克隆TCR，能识别多个肿瘤新抗原，解决了肿瘤异质性问题。 国内已有三款TIL治疗黑色素瘤进入关键临床试验。君赛生物的GC101是全球首款"免清淋、免IL-2注射"TIL疗法，预计2026年提交上市申请。华赛伯曼HS-IT101在I期试验中ORR达50%、CRR 20%、DCR 100%。蓝马医疗LM103成为国内首个同时拥有两个II期临床的TIL产品。 适应症已超越黑色素瘤：沙砾生物GT101在宫颈癌I期试验中ORR达45.5%。百吉生物启动了全球首个针对肝癌的TIL注册临床研究。从肿瘤到自免：细胞治疗的疆域扩张 细胞治疗的边界正在从肿瘤向自身免疫性疾病扩展。 西比曼生物的C-CAR168先后在国际系统性红斑狼疮大会和美国风湿病学会年会上公布积极数据，2025年获FDA再生医学先进疗法（RMAT）认定。 而更前沿的方向是体内CAR-T（in vivo CAR-T）——通过单次静脉注射将CAR基因直接递送至患者体内，在体内完成T细胞改造，跳过传统CAR-T繁琐的体外制造环节。礼来四个月内连下两城，阿斯利康、艾伯维、BMS群雄逐鹿。可及性：从"天价"到"可负担" 案例：华道生物——CAR-T价格体系的"破坏性创新者" 华道生物依托"全产业链自主创新国产化"与"全自动、全封闭、无人化生产系统"，开发了预计售价仅20余万元的CAR-T细胞治疗药物，2025年12月已向CDE递交上市申请。 同期，首版《商业健康保险创新药品目录》中已有5款CAR-T药物入选。复星凯瑞推出"按疗效价值支付计划"——若患者未达完全缓解，最高可获60万元返还。 技术迭代与支付创新双轮驱动，正推动细胞治疗从"天价"走向"可及"。 西比曼与阿斯利康的合作则代表了中国CGT"走出去"的典型路径。GPC3靶向CAR-T C-CAR031登顶《Nature》正刊，阿斯利康以最高6.3亿美元获得全球权益。05 创新药出海：从"卖管线"到"共创价值" 2026年上半年，中国创新药完成81笔对外授权交易，合同潜在总金额约1100亿美元。 这个数字是2024年全年的两倍多，是2025年全年的80%。2025年全年交易157笔、总额1356.55亿美元、首付款70亿美元。 但比数字更重要的是结构的变化。三笔交易，三个阶段 阶段一：石药集团 × 阿斯利康——185亿美元 2026年1月。8个创新长效多肽药物项目，依托石药专有的缓释给药技术平台及AI多肽发现平台。创全球历史第二高单笔交易。首付款12亿美元。 这不是卖一个分子，是卖一个技术平台。 阶段二：恒瑞医药 × BMS——152亿美元 2026年5月。13款早期项目覆盖肿瘤、血液和免疫三大领域。关键变化：恒瑞保留共同开发与共同商业化选择权。 这意味着中国企业从"授权方"升级为"联合开发者"。 阶段三：迪哲医药 × 阿斯利康——15亿美元 2026年7月。自主研发的小分子新药舒沃哲全球权益授权。首付款6亿美元，创下国产小分子新药出海交易首付款纪录。 一家小型Biotech，凭借一个分子，拿到了6亿美元首付款。从"规模出海"到"价值出海" 2026年以来，中国创新药BD交易出现三个显著变化。 第一，交易结构在变。 传统单向License-out仍占主流，但"共同开发+共同商业化"（Co-Co）模式正在落地。信达生物与辉瑞105亿美元合作中，4个核心项目采用全球联合开发模式，欧美市场利润共享。 第二，资产类型在变。 从早期管线的低价出让，到平台级技术合作、多管线"打包"交易。石药的AI多肽平台、信达的12个肿瘤项目"打包"，卖的不只是分子，是体系能力。 第三，首付款在变。 2026年BD交易平均首付款0.6亿美元，同比增长38%；平均交易金额10.6亿美元，同比增长22%。首付款比总金额更能说明MNC对中国资产的刚性需求——他们愿意现在就掏真金白银。 2025年中国BD交易首付款占全球比重高达49.5%。中国创新资产已从"可选项"变为"必选项"。结语 回看这五个赛道，有一个共同特征： 中国企业正在从"做出来"走向"做得好"，从"卖给谁"走向"一起做"。 ADC领域，中国企业已成为全球创新中心，靶点多元化和技术路线升级同步推进。GLP-1领域，口服剂型的突破正在打开百亿级别的可及性市场。AI制药领域，rentosertib进入III期是一个里程碑，但真正的考验在II期临床数据。细胞治疗领域，实体瘤CAR-T和TIL疗法正在改写"不可治"的定义，可及性问题也在通过技术和支付创新双线突破。创新药出海领域，从License-out到Co-Co模式，中国企业正在从全球分工底端向上攀升。 2026年是中国创新药从"量变"到"质变"的关键一年。 五个风口同时爆发，这不是周期的轮回，而是结构的跃迁。 接下来要关注的不是"有多少交易"，而是"有多少能在II期、III期活下来"。 因为最终改变游戏规则的，不是PPT上的交易金额，而是患者的临床获益。 —END—

U.S. Amtagvi Revenue Reaches ~$91M and Total Revenue Increased 66% Year-over-Year Gross Margin Increased to 56% Fast Track Designation (FTD) Granted by the FDA for Li in Soft Tissue Sarcomas SAN CARLOS, Calif., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today reported second quarter 2026 financial results, business achievements, and corporate updates. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); “Second-quarter revenue reached a record $99.3 million with gross margin of 56%, driven by continued U.S. Amtagvi demand,” said Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer. “Based on our second-quarter performance and strong demand trends, we are reviewing our previously issued 2026 revenue guidance of $350 million to $370 million and will provide an update during the third quarter. Additionally, we continue to be excited by our clinical pipeline as li advances across other solid tumor indications including metastatic non-squamous non-small-cell lung cancer (NSCLC), the new registrational SARATOGA trial in undifferentiated pleomorphic sarcoma (UPS) and dedifferentiated liposarcoma (DDLPS), and metastatic serous endometrial cancer. Continued manufacturing and operating efficiencies support our sustainable growth, accelerate progress toward profitability, and advance our clinical pipeline with first-in-class, novel products in new solid tumor indications.” Second Quarter 2026 Financial Highlights Record Revenue and Improving Margin Supported by Cost Discipline Total product revenue was ~$99 million, an increase of 66% from ~$60 million in 2Q25 and 39% from ~$71 million in 1Q26. U.S. Amtagvi revenue was ~$91 million, up 40% from 4Q25. Global Proleukin revenue was ~$9 million and is expected to grow during the remainder of 2026. Gross margin was 56% 1 , reflecting higher Amtagvi sales volume, continued cost optimization, and maturing internal manufacturing efficiencies. Research and Development (R&D) expenses decreased by ~6% compared to 1Q26, driven by continued operational efficiencies during the fourth straight quarter of improvements. Full Year 2026 Outlook Second Quarter Performance and Demand Growth Based on strong second-quarter sales and current demand trends, Iovance is reviewing its FY26 total revenue guidance of $350 million to $370 million. An update will be provided during the third quarter. Improvements in gross margin are expected to continue, excluding occasional one-time items. Amtagvi Commercial Business Significant U.S. Commercial Business Growth and Progress in Global Expansion Demand and awareness: Record Amtagvi demand, catalyzed by a new marketing campaign and an expanded sales team, is driving increased adoption across a growing ATC network and referrals toward earlier treatment. Unaided physician awareness of Amtagvi has nearly tripled during the last year. Authorized treatment center (ATC) network: The network has grown to more than 95 U.S., Canadian, and Australian ATCs, with at least 110 ATCs expected to be active by the end of 2026. Community ATCs now represent a third of the network and are expected to increase significantly over the next several quarters. Real-world experience: Multiple real-world studies by Iovance and ATCs using commercial Amtagvi continue to advance, supporting broader adoption of Amtagvi and earlier patient referrals and access. These studies highlight objective response rates (ORRs) of 50% or greater and address identification of tumor harvest sites, accelerated institutional workflows, and improved patient care. Manufacturing turnaround time: Amtagvi turnaround time is 31 days or less using the only scaled, centralized commercial manufacturing process approved by FDA for TIL therapy. Australia : The marketing authorization application (MAA) for Amtagvi in Australia was approved by the Therapeutic Goods Administration (TGA), marking the third approval of Amtagvi by global health authorities to date. A high incidence of advanced melanoma in Australia causes more than 1,500 annual deaths. Australian ATCs are currently progressing through the authorization process in parallel with discussions for national reimbursement. United Kingdom (UK): The MAA for Amtagvi in the UK was resubmitted in early July and is undergoing expedited review by the Medicines and Healthcare products Regulatory Agency (MHRA) for potential approval later in 2026. Advanced melanoma causes more than 2,500 deaths annually in the UK. Switzerland: Potential approval of the MAA in Switzerland is expected in 1H27, opening a second market opportunity in Europe with the potential for medical tourism. Switzerland’s domestic melanoma burden causes several hundred deaths annually. Other markets and indications: An MAA resubmission for Amtagvi in advanced melanoma to the European Medicines Agency is on track for 2027. Other regulatory submissions are planned in international markets with a high prevalence of advanced melanoma, NSCLC, and soft tissue sarcomas. Clinical and Regulatory Pipeline Updates Progress Across a Deep Pipeline of Registrational Programs IOV-LUN-202 : Initial results in previously treated metastatic non-squamous NSCLC supported FDA FTD . Enrollment is nearly complete in the pivotal cohorts and program updates are expected in 4Q26. A supplemental Biologics License Application (sBLA) submission is planned in 2027. The U.S. market opportunity in metastatic non-squamous NSCLC is about seven times that of advanced melanoma. SARATOGA (IOV-SAR-201) : The registrational trial in UPS and DDLPS is underway, driven by positive early data with an ORR by RECIST v1.1 of 50% in the first six evaluable patients. Based on the strength of this early data, FDA granted FTD for UPS and DDLPS. Results will be highlighted in an oral presentation (abstract #3725RO) at the European Society for Medical Oncology (ESMO) meeting in Madrid, Spain, from October 23–27, 2026. TILVANCE-301 : A Phase 3 randomized trial of li and pembrolizumab is enrolling patients with frontline advanced melanoma across a broad global footprint. The TILVANCE-301 trial includes an early interim analysis based on ORR for a potential sBLA for frontline advanced melanoma. The trial also serves as the confirmatory study for the accelerated approval of li in second-line advanced melanoma. Results supporting the combination of li and pembrolizumab as a potential best-in-class option for frontline advanced melanoma were accepted (abstract #2072O) for an oral presentation at the ESMO annual meeting. IOV-END-201 : Positive initial data in previously treated metastatic serous endometrial cancer using a biomarker strategy based on histology were recently reported. A protocol amendment is being submitted and engagement with FDA is underway on an expedited approval pathway to focus on this population. Next-Generation Pipeline Updates First-in-Class Immuno-Oncology Technologies Target New Indications IOV-GM1-201 : A Phase 1/2 trial investigating IOV-4001, a PD-1 inactivated TIL therapy, is enrolling patients with previously treated metastatic melanoma and NSCLC. IOV-4001 is engineered to resist inhibitory signals and enhance the ability of TIL therapies to fight and kill cancer in the tumor microenvironment (TME). IOV-GE1-201 : A Phase 1/2 trial is underway using IOV-5001, a second-generation IL-12 tethered TIL therapy designed to remodel the suppressive TME and activate immunologically “cold tumors” to support TIL responses and boost response rates. 2 Cohorts include metastatic colorectal cancer, triple-negative and estrogen receptor low breast cancers, and other solid tumors causing more than 100,000 annual U.S. deaths. 3 IOV-IL2-101 : A Phase 1 safety cohort is advancing through multiple dose levels in the Phase 1/2 trial of IOV-3001, our second-generation modified IL-2 analog for the TIL treatment regimen. IOV-3001 selectively expands effector T cells while avoiding activation of regulatory T cells with the potential for a lower dose IL-2 regimen with reduced adverse events. IOV-3001 is expected to be superior to Proleukin as a component of future TIL regimens. Investigator-sponsored trials (ISTs): Iovance is advancing several li ISTs in new indications. Multiple patients have been treated for cutaneous squamous cell carcinoma (CSCC) and Merkel cell carcinoma (MCC) with initial data expected in 1H27. To date, early clinical activity has been reported. With no approved therapies after failure of checkpoint inhibitors, li could address a large CSCC and MCC market with several thousand annual deaths in the U.S. Corporate Updates Iovance is deploying and advancing artificial intelligence (AI) tools to drive significant future cost efficiencies and new product pipeline insights. Iovance currently owns or licenses more than 400 granted or allowed U.S. and international patents and patent rights for Amtagvi and other TIL-related technologies and has filed more than 1,000 additional patent applications worldwide. This broad patent portfolio is expected to provide patent exclusivity through at least 2042 and beyond. As of June 30, 2026, Iovance’s cash position was ~$304 million 4 and current cash is expected to fund operations into 2H28. Webcast and Conference Call Management will host a conference call and live audio webcast to discuss these results and provide a corporate update today at 8:30 a.m. ET. To listen to the live or archived audio webcast, please register at . The live and archived webcast can be accessed in the Investors section of the Company’s website , IR.Iovance.com, for one year. 1. Excludes depreciation and amortization 2. Zhang L, Rosenberg SA, et al., Clin Cancer Res 2015;21(10):2278–2288. 3. Surveillance, Epidemiology, and End Results Program Cancer Stat Facts (accessed April 2026). 4. Cash, cash equivalents, short-term investments, and restricted cash as of June 30, 2026. About Iovance Biotherapeutics, Inc. Iovance Biotherapeutics, Inc. is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. Amtagvi® (li ) is the first FDA-approved, one-time treatment for previously treated advanced melanoma, now approved in three global markets and available at more than 95 authorized treatment centers. The Iovance TIL platform spans registrational trials and next-generation programs in additional solid tumors, including gene-edited and IL-12 tethered TIL therapies, next-generation IL-2, and precision immuno-oncology approaches. As the first and only company to take TIL therapy from concept to a broadly accessible commercial treatment, Iovance operates as an end-to-end cell therapy company, anchored by fully owned, centralized U.S.-based manufacturing that is scaled to serve thousands of cancer patients worldwide each year. For more information, please visit . Amtagvi® and its accompanying design marks, Proleukin ® , Iovance ® , and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners. Information on Iovance’s broad, industry-leading patent portfolio is available on the Intellectual Property page on . Forward-Looking Statements Certain matters discussed in this press release are “forward-looking statements” of Iovance Biotherapeutics, Inc. (hereinafter referred to as the “Company,” “we,” “us,” or “our”) within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Without limiting the foregoing, we may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “forecast,” “guidance,” “outlook,” “may,” “can,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments, and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events, or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements, and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the sections titled “Risk Factors” in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and include, but are not limited to, the following substantial known and unknown risks and uncertainties inherent in our business: the risks related to our ability to successfully commercialize our products; the acceptance by the market of our products and product candidates, if approved, and their potential pricing and/or reimbursement by payors, and whether such acceptance is sufficient to support continued commercialization or development of our products or product candidates; the risk regarding our ability to manufacture our therapies at our i CTC facility, including the risk that our ability to increase manufacturing capacity at our facility may adversely affect our commercial launch; the risks related to our ability to obtain, maintain and enforce patent and other intellectual property protection for our products and product candidates; the risk that the successful development or commercialization of our products may not generate sufficient revenue from product sales, and we may not become profitable in the near term, or at all; the risks related to the timing of and our ability to successfully develop, submit, obtain, or maintain regulatory authority approval of our product candidates; whether clinical trial results from our pivotal studies and cohorts, and meetings with regulatory authorities may support registrational studies and subsequent approvals by regulatory authorities, including the risk that the planned registrational trial in advanced sarcomas may not support approval; preliminary and interim clinical results, which may include efficacy and safety results, from ongoing clinical trials or cohorts may not be reflected in the final analyses of our ongoing clinical trials or subgroups within these trials or in other prior trials or cohorts; the risk that we may be required to conduct additional clinical trials or modify ongoing or future clinical trials based on feedback from regulatory authorities; the risk that our interpretation of the results of our clinical trials or communications with regulatory authorities may differ from the interpretation of such results or communications by such regulatory authorities; the risk that clinical data from ongoing clinical trials of Amtagvi will not continue or be repeated in ongoing or planned clinical trials or may not support regulatory approval or renewal of authorization; the risk that unanticipated expenses may decrease our estimated cash balances and forecasts and increase our estimated capital requirements; the risk that we may not be able to recognize revenue for our products; the risk that Proleukin revenues, and other factors such as the number of ATCs, may not serve as a leading indicator for Amtagvi revenues; the risks regarding our anticipated operating and financial performance, including our financial guidance and projections; the effects of global and domestic geopolitical factors or public health events; and other factors, including general economic conditions and regulatory developments, not within our control. Any financial guidance provided in this press release assumes the following: no material change in our ability to manufacture our products; no material change in payor coverage; no material change in revenue recognition policies; no new business development transactions not completed as of the period covered by this press release; and no material fluctuation in exchange rates. IOVANCE BIOTHERAPEUTICS, INC. Selected Condensed Consolidated Balance Sheets (in thousands) June 30, 2026 December 31, 2025 (unaudited) Cash, cash equivalents, and investments $ 297,674 $ 296,980 Restricted cash $ 6,005 $ 5,980 Total assets $ 915,531 $ 913,170 Stockholders’ equity $ 736,045 $ 698,583 Condensed Consolidated Statements of Operations (unaudited; in thousands, except per share information) For the Three Months Ended For the Six Months Ended June 30, June 30, 2026 2025 2026 2025 Revenue Product revenue, net $ 99,313 $ 59,952 $ 170,743 $ 109,276 Total revenue 99,313 59,952 170,743 109,276 Costs and expenses* Cost of sales ** $ 43,595 $ 48,881 $ 86,093 $ 91,595 Research and development ** 58,851 77,928 121,338 153,895 Selling, general, and administrative ** 39,272 37,567 78,221 81,366 Depreciation and amortization 9,500 9,350 18,039 17,415 Total costs and expenses 151,218 173,726 303,691 344,271 Loss from operations (51,905 ) (113,774 ) (132,948 ) (234,995 ) Other income Interest and other income, net 3,217 4,104 4,550 7,324 Net Loss before income taxes (48,688 ) (109,670 ) (128,398 ) (227,671 ) Income tax benefit (expense) 1,373 (1,988 ) 2,038 (150 ) Net Loss $ (47,315 ) $ (111,658 ) $ (126,360 ) $ (227,821 ) Net Loss Per Share of Common Stock, Basic and Diluted $ (0.11 ) $ (0.33 ) $ (0.29 ) $ (0.69 ) Weighted Average Shares of Common Stock Outstanding, Basic and Diluted 450,189 334,511 434,437 328,721 *Non-cash stock-based compensation included in cost of sales and operating expenses Cost of sales $ 1,536 $ 2,149 $ 2,555 $ 4,569 Research and development 5,078 6,359 10,195 16,276 Selling, general, and administrative 5,119 6,435 10,252 17,013 $ 11,733 $ 14,943 $ 23,002 $ 37,858 ** Excludes depreciation and amortization CONTACTS Investors IR@iovance.com 650-260-7120 ext. 150 Media PR@iovance.com 650-260-7120 ext. 150