Lifileucel

New Guidance Represents an Increase of $55 Million at the Midpoint from the Prior Range of $350 to $370 Million Strong U.S. Demand for Amtagvi and Proleukin Drives Increased Outlook PHILADELPHIA, Sept. 29, 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 raised its full year 2026 total revenue guidance range to $410 to $420 million, driven by strong U.S. demand for Amtagvi® (li ) and Proleukin. The midpoint represents an increase of $55 million, or ~15%, over the previous guidance range of $350 to $370 million and implies nearly 60% annual growth in total revenue. “Our record second quarter and sustained demand for Amtagvi and Proleukin led us to raise our full year 2026 total revenue guidance by $55 million at the midpoint,” said Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer. “Increasing patient demand and our current manufacturing schedule provide strong visibility into our third and fourth quarter revenues. In addition, li continues to advance across our registrational programs in new solid tumor indications, while continued manufacturing and operating efficiencies accelerate our progress toward profitability.” Iovance most recently reported record second quarter 2026 total product revenue of $99.3 million, has grown its authorized treatment center (ATC) network to ~100 centers, and remains on track for expansion to at least 110 ATCs by year-end 2026. Iovance expects to report third quarter 2026 financial results in early November 2026. This update completes the guidance review announced with the Company’s second quarter 2026 results. 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 nearly 100 authorized treatment centers (ATCs). 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. Headquartered in Pennsylvania with offices and laboratories in California and Florida, Iovance serves patients at ATCs and clinical sites across almost the entire U.S. and in many countries around the world. 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 any of our planned registrational trials may not support approval; preliminary and interim clinical results, which may include efficacy and safety results, from ongoing clinical trials or cohorts may not be reflected in the final analyses of our ongoing clinical trials or subgroups within these trials or in other prior trials or cohorts; the risk that we may be required to conduct additional clinical trials or modify ongoing or future clinical trials based on feedback from regulatory authorities; the risk that our interpretation of the results of our clinical trials or communications with regulatory authorities may differ from the interpretation of such results or communications by such regulatory authorities; the risk that clinical data from ongoing clinical trials of Amtagvi will not continue or be repeated in ongoing or planned clinical trials or may not support regulatory approval or renewal of authorization; the risk that unanticipated expenses may decrease our estimated cash balances and forecasts and increase our estimated capital requirements; the risk that we may not be able to recognize revenue for our products; the risk that Proleukin revenues, and other factors such as the number of ATCs, may not serve as a leading indicator for Amtagvi revenues; the risks regarding our anticipated operating and financial performance, including our financial guidance and projections; the effects of global and domestic geopolitical factors or public health events; and other factors, including general economic conditions and regulatory developments, not within our control. Any financial guidance provided in this press release assumes the following: no material change in our ability to manufacture our products; no material change in payor coverage; no material change in revenue recognition policies; no new business development transactions not completed as of the period covered by this press release; and no material fluctuation in exchange rates. CONTACTS Investors IR@iovance.com 650-260-7120 ext. 150 Media PR@iovance.com 650-260-7120 ext. 150

– LNK001, an AND-gated CAR-T therapy targeting CAIX and ENPP3, is being evaluated in a Phase 1 study in advanced clear cell renal cell carcinoma at MD Anderson Cancer Center – – Jie D'Elia, Ph.D., joins as Chief Executive Officer and Friedrich Graf Finckenstein, M.D., as Chief Medical Officer; co-founder Brian Slingerland becomes Executive Chair – – Series A financing upsized from $60 million to $90 million to advance a second solid tumor program in colorectal cancer and expand the pipeline – SOUTH SAN FRANCISCO, Calif. and AUSTIN, Texas, Sept. 28, 2026 /PRNewswire/ -- Link Cell Therapies ("Link"), an oncology cell therapy company utilizing its proprietary logic-gating technology to develop next-generation CAR-T therapeutics for solid tumors and hematologic malignancies, today announced that it has initiated clinical dosing for its lead program, LNK001. The company also announced three additions to its executive leadership team and a $30 million expansion of its Series A financing. Initiated clinical dosing of LNK001 LNK001 is being evaluated in a Phase 1 study in patients with advanced or metastatic clear cell renal cell carcinoma ("RCC"). Clinical dosing has begun at MD Anderson Cancer Center. LNK001 requires the co-expression of two antigens, CAIX and ENPP3, which are both highly expressed in most RCC tumors. CAIX has long been among the most attractive targets in RCC, but conventional CAR-T cells directed against it have been limited by on-target, off-tumor toxicity in the biliary epithelium, where CAIX is also expressed. By gating CAR-T activity on both antigens, LNK001 is designed to preserve the antitumor potential of CAIX targeting while sparing the healthy tissue that has constrained single-antigen approaches. LNK001 is manufactured at CTMC, a joint venture between Resilience and The University of Texas MD Anderson Cancer Center. Additional clinical trial details are available at . Leadership additions Jie D'Elia, Ph.D., joins as Chief Executive Officer and a member of the Board of Directors. Dr. D'Elia was previously the CEO of SystImmune, Inc., a clinical-stage biopharmaceutical company focused on developing novel multi-specific antibodies and antibody-drug conjugates ("ADCs"). Before SystImmune, she spent eleven years at Bristol Myers Squibb ("BMS"), most recently as Senior Vice President of Business Development, Oncology, Hematology, and Cell Therapy. During her tenure at BMS, she made a significant impact to BMS's pipeline evolution through multiple strategic partnerships and acquisitions in therapeutic areas ranging from oncology, hematology, cardiovascular, virology, and cell therapy. Prior to BMS, Dr. D'Elia served as the Vice President and Global Head of Business Development at Simcere Pharmaceutical, and held roles at AstraZeneca, Boston Consulting Group and Baxter Healthcare. Over the course of her career, she has led more than $40 billion in strategic partnerships and acquisitions. Dr. D'Elia holds a Ph.D. from the College of Pharmacy at the University of Texas at Austin and an MBA from Columbia Business School. Brian Slingerland becomes Executive Chair. Brian co-founded Link in 2022 with Robbie Majzner, M.D., and Crystal Mackall, M.D., and has served on the Board of Directors. He previously co-founded and was the CEO of Stemcentrx, a next-generation ADC company that pursued novel targets with limited or no normal tissue expression, including DLL3 and SEZ6, and built the industry's first end-to-end ADC GMP manufacturing facility. Abbvie acquired Stemcentrx in 2016 for $6.2 billion, which at the time was the largest private acquisition of all time in biotechnology. Prior to founding Stemcentrx, Brian was a Founding Partner at Qatalyst Partners and Vice President at Goldman Sachs where he helped companies raise private venture capital, execute IPOs and other financings, advised on mergers and acquisitions, and gained valuable experience working with CEOs at various stages of development. Brian has held other biotechnology CEO roles, including of recently acquired Convergent Genomics, and Everest Detection, and served on the Boards of Directors and provided initial capital to multiple biotech companies including Enliven Therapeutics. Brian is a graduate of Virginia Tech. Friedrich Graf Finckenstein, M.D., joins as Chief Medical Officer. Dr Graf Finckenstein is a physician-scientist with decades of experience in clinical medicine, cancer research and drug development. Most recently, as Chief Medical Officer of Iovance Biotherapeutics he progressed the clinical portfolio of Tumor Infiltrating Lymphocyte (TIL) therapies across indications and next generation products and contributed to the approval of AMTAGVI® (lifileucel) in the US, Canada and Australia as the first approved cell therapy for a solid tumor. Before Iovance, he was Global Head of Oncology Translational Medicine at Roche Pharma Research and Early Development (pRED) in Basel, Switzerland. Earlier, he held clinical leadership roles at BMS, spanning early through late-stage development, including contributions to the approval of Opdivo® (nivolumab) in lung cancer. He holds a medical degree from the University of Hamburg, is a board-certified pediatrician and has conducted laboratory cancer research at the Ludwig Institute, San Diego Branch, the Children's Hospital Los Angeles and the University of Hamburg. "From the beginning, our vision has been to translate this breakthrough science into therapies that can make a profound difference for people impacted by cancer," said co-founder Robbie Majzner, M.D., of the Dana-Farber Cancer Institute and Harvard Medical School. "Bringing in leaders with the experience, commitment and passion to advance our technology and execute at scale gives me tremendous confidence that we can realize that vision." Abraham Bassan, Member of the Link Board of Directors and Partner at Samsara BioCapital, says "We are excited about the strength and depth of the leadership team at Link. Their broad experience and commitment to advancing our science puts the company in an excellent position to develop a new generation of impactful medicines for patients." Series A expansion to fund pipeline programs Link's previously announced $60 million Series A financing led by Johnson & Johnson, through its corporate venture capital organization, Johnson & Johnson Innovation – JJDC, Inc., with participation from founding investors Samsara BioCapital and Sheatree Capital, as well as Wing Venture Capital and new investors including BMS, Kyowa Kirin, Sherpa Healthcare Partners, Western Technology Investment and the MD Anderson Cancer Focus Fund, was upsized to $90 million. The additional capital will support clinical and preclinical development of additional logic gated CAR-T programs. Link's second solid tumor indication is colorectal cancer, where the company intends to begin a first-in-human trial in 2027 using a novel target pair co-expressed in the majority of colorectal tumors but absent from normal healthy tissues. Additional CAR-T programs in solid and hematologic cancers are in earlier development and will be advanced internally or through partnerships. "Link's logic-gate platform can make CAR-T broadly viable in solid tumors," said Dr. D'Elia. "A targeting approach that reliably distinguishes tumor from healthy tissue is what allows CAR-T to pursue in solid tumors the kind of deep and durable responses it has achieved in hematologic cancers. This financing lets us advance a pipeline built on that approach across additional tumor types." About Link Cell Therapies Link Cell Therapies ("Link") is a biotechnology company based in South San Francisco, California, founded in 2022 by Robbie Majzner, M.D., and Crystal Mackall, M.D. at Stanford University, biotech entrepreneur Brian Slingerland, and Samsara BioCapital. Link's proprietary logic-gating technology allows for safe targeting of multiple antigens that are co-expressed selectively on cancer cells, thereby reducing the risk of on-target, off-tumor toxicity. This enables discovery of an entirely new landscape of "clean" target pairs, and supports the development of next-generation CAR-T therapeutics for solid and hematologic cancers. Link's team features industry-leading scientists collaborating with top-tier advisors and life science financial and strategic investors committed to improving outcomes for cancer patients. To learn more, please visit . Media Contact Link Cell Therapies [email protected] SOURCE Link Cell Therapies 21% more press release views with Request a Demo