Legend Biotech Corporation has commenced an underwritten public offering of $225 million of American Depositary Shares (ADSs), each representing two ordinary shares of the company. The offering aims to raise capital through the sale of these shares, with all ADSs being offered directly by Legend Biotech. The completion of the offering is subject to market conditions, and there is no assurance regarding the timing, size, or final terms of the transaction.

Underwriter Option

Legend Biotech intends to grant the underwriters involved in the offering a 30-day option to purchase up to an additional 15% of the ADSs sold. This additional purchase would be made at the public offering price, minus underwriting discounts and commissions. This provision allows underwriters to cover over-allotments, should there be sufficient demand from investors.

Offering Details

The following table outlines the key details of the public offering:

The company stated that the offering is contingent upon prevailing market conditions. Consequently, the actual size of the offering and the terms may vary, or the offering may not be completed at all.

Legend Biotech Corporation has established clinical proof-of-concept for LB2501, its investigational in vivo CD19/CD20 dual-targeting CAR-T cell therapy, demonstrating a 100% objective response rate (ORR) at a higher dose level in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL). The data, presented at the European Hematology Association (EHA) 2026 Congress, highlights the potential of LB2501 to generate CAR-T cells directly within the patient without lymphodepletion, offering a novel approach to treatment.

In the ongoing Phase 1 study, 12 patients with R/R B-NHL received LB2501 across two dose levels: DL1 (n=6) and DL2 (n=6). Patients had received a median of three prior lines of therapy, and 58.3% were refractory to their most recent treatment. The study evaluated safety, recommended Phase 2 dose, pharmacokinetics, and preliminary efficacy in adults with R/R B-NHL.

At DL2, LB2501 achieved a 100% ORR (6/6) and an 83.3% complete response rate (CR) (5/6), with responses observed across patients with diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), and follicular lymphoma (FL). Across both dose levels, the ORR was 50.0% (6/12), and the CR rate was 41.7% (5/12). All responses at DL2 were ongoing at the time of data cutoff.

LB2501 showed a favorable safety profile, with no dose-limiting toxicities (DLTs), serious adverse events (SAEs), immune effector cell-associated neurotoxicity syndrome (ICANS), or deaths reported. Infusion-related reactions (IRR) and cytokine release syndrome (CRS) were the most common adverse events of special interest and were all Grade 1–2. IRR occurred in 75.0% (9/12) of patients, with a median onset of 1.4 hours after infusion and a median recovery time of 18.6 hours. CRS occurred in 66.7% (8/12) of patients, with a median onset at Day 11 and a median duration of 4.5 days. No patients required glucocorticoids for CRS management, though four patients received tocilizumab.

Pharmacokinetic analyses showed dose-dependent in vivo CAR-T expansion in 100% (6/6) of patients at DL2 and 83% (5/6) of patients at DL1. CAR-T cells remained detectable in peripheral blood for up to 116 days. Viral copy number in peripheral blood peaked immediately after infusion and decreased to undetectable concentrations within 24 hours. Additional translational analyses revealed no evidence of non-specific transduction in NK cells or other non-T/B/NK lymphocyte populations, and vector integrations were highly polyclonal and diverse.

Key Efficacy and Safety Data

Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech, emphasized the significance of the results: "In vivo CAR-T represents a compelling frontier in cell therapy, enabling the generation of CAR-T cells directly within the patient, with the potential to simplify treatment and expand access over time. LB2501 is our step toward realizing that vision and reflects further progress toward our goal of leading the future of cell therapy."

Lei Fan, M.D., Ph.D., Professor and Administrative Director of the Hematology Department at Jiangsu Province Hospital, Nanjing, China, noted the encouraging nature of the findings in a heavily pretreated population. "The responses observed at the higher dose level achieved a 100% objective response rate, together with a favorable safety profile and the absence of lymphodepletion, support further investigation of LB2501 as a novel in vivo CAR-T approach," he said.