EX-99.1 2 a991earningsreleaseq32026.htm EX-99.1 Legend Biotech Reports Third Quarter 2026 Results and Recent Highlights • CARVYKTI ® (ciltacabtagene autoleucel; cilta-cel) net trade sales increased 36% versus third quarter of 2025 to approximately $710 million • Half of CARTITUDE-2 Cohort A patients remained alive and progression-free without further anti-myeloma treatment five years after a single CARVYKTI ® infusion, adding to growing long-term evidence supporting the curative potential of CARVYKTI in earlier-line RRMM • Updated NCCN Guidelines recommend that all patients with multiple myeloma be referred to a T-cell therapy capable center at first relapse for consideration of available therapies • Received U.S. FDA IND clearance for LB2501, an investigational CD19/CD20 dual-targeting in vivo CAR ‑ T therapy for relapsed or refractory B-cell malignancies • Appointed Ingrid Zhang as Chief Executive Officer • Cash and cash equivalents, and time deposits of approximately $853 million, as of September 30, 2026 Bridgewater, N.J.— November 10, 2026— Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today reported its third quarter 2026 unaudited financial results and recent highlights. "We made meaningful progress during the third quarter, expanding the reach of CARVYKTI and advancing our pipeline," said Ingrid Zhang, Chief Executive Officer of Legend Biotech. "Five-year CARTITUDE-2 Cohort A data added to the growing body of long-term evidence supporting the curative potential of CARVYKTI, especially in earlier-line multiple myeloma, demonstrating that half of the 20 patients remained alive and progression-free after a single infusion. Together, the promising early line data and updated NCCN guidelines preferring CAR-T ahead of other BCMA-directed therapies well positions CARVYKTI to potentially gain market share in the second- and third-line setting. We also achieved an important milestone for our next generation cell therapy pipeline with the IND clearance for LB2501. We remain focused on disciplined execution, expanding access to CARVYKTI worldwide, advancing our innovative pipeline, and delivering sustained profitability.” Recent Data Highlights Five-Year CARTITUDE-2 Cohort A Data Demonstrate Durable Outcomes Earlier-Line RRMM • Data from CARTITUDE-2 ( NCT04133636 ) Cohort A, which evaluated patients with relapsed or refractory multiple myeloma (RRMM) after one to three prior lines of therapy (n=20; median follow‑up, 60.7 months), were presented at the 23 rd International Myeloma Society (IMS) Annual Meeting in September. • With extended follow-up, patients continued to experience durable clinical benefit, with a median progression-free survival (PFS) of 60.5 months. • Median overall survival was not reached at the time of analysis, and 69.2% of patients were alive at five years. • With a median follow-up of 60.7 months, 10 of 20 patients (50%) remained alive and progression-free without further anti-myeloma treatment ≥5 years after a single CARVYKTI ® infusion. • The safety profile observed with longer follow-up was consistent with the known safety profile of CARVYKTI ® , with no new CAR-T-cell-related neurotoxicity reported. Since the previous analysis of CARTITUDE-2 Cohort A with a median follow-up of approximately 30 months [1] , one patient developed a new hematologic malignancy (acute myeloid leukemia) and two deaths occurred due to progressive disease and new cancer. • These findings build on five-year CARTITUDE-1 results presented at the 2025 ASCO Annual Meeting (Abstract #7505), in which 32 of 97 patients (33%) with more heavily pretreated RRMM remained progression-free for five years or more after a single infusion with no further myeloma therapy. Key Business Developments 1 Hillengass J, Cohen AD, Agha ME, et al. The Phase 2 CARTITUDE-2 trial: updated efficacy and safety of ciltacabtagene autoleucel in patients with multiple myeloma and 1-3 prior lines of therapy (Cohort A) and with early relapse after first line treatment (Cohort B). Blood. 2023;142(Suppl 1):1021. • Compared to the third quarter of 2025, CARVYKTI net trade sales increased 36% in the third quarter of 2026 to approximately $710 million, with U.S. net trade sales growth of 19% and ex-U.S. net trade sales growth of 86%. • CARVYKTI is now available across 373 treatment sites in 20 global markets. • National Comprehensive Cancer Network (NCCN) updated Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Multiple Myeloma. The updated NCCN Guidelines recommend that all patients with multiple myeloma be referred to a T-cell therapy capable center at first relapse for consideration of available therapies. The guidelines also state that when both BCMA CAR-T therapy and T-cell engagers (TCEs) are viable options, current data suggest that CAR-T is preferred, given the established efficacy of TCEs following CAR-T therapy failure, and that prior BCMA-directed therapies should be minimized in
