Legend Bio Q2 updates

• A supplemental Biologics License Application (sBLA) was submitted to the U.S. Food and Drug Administration (FDA) and a Type II Variation Application was submitted to the European Medicines Agency (EMA) by Janssen, seeking approval of CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the earlier treatment of patients with relapsed or refractory multiple myeloma

• The FDA set the Prescription Drug User Fee Act target date for the CARVYKTI® sBLA to April 5, 2024

• The FDA granted Orphan Drug Designation for LB2102 (DLL-3) (NCT05680922), which is being evaluated for the treatment of small cell lung cancer. The US clinical trial is actively recruiting at two sites1

• On August 3, 2023, Legend Biotech received a payment in the amount of $15 million for the EMA’s acceptance of the Type II Variation Application for CARVYKTI®, in accordance with Legend Biotech’s license and collaboration agreement with Janssen (Janssen Agreement)

• On August 4, 2023, Legend Biotech earned a milestone payment of $20 million in connection with the FDA’s acceptance of the sBLA, in accordance with the Janssen Agreement

• New data from the CARTITUDE-4 study (NCT04181827) of cilta-cel were featured at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #LBA106) and European Hematology Association (EHA) 2023 Hybrid Congress (Abstract #S100); these data were also published in The New England Journal of Medicine2

• Long-term data from the cilta-cel CARTITUDE-1 (NCT03548207) and LEGEND-2 (NCT03090659) studies were also presented at ASCO (Abstract #8009, Abstract #8010) and EHA (Abstract #S202, Abstract #P874)

• Cash and cash equivalents, deposits and investments of $1.5 billion, as of June 30, 2023, extends Legend Biotech’s cash runway through 2025, strengthened by recently completed financings

• In April and May 2023, Legend Biotech entered into subscription agreements with certain institutional investors pursuant to which Legend Biotech sold an aggregate of 8,834,742 ordinary shares for aggregate gross proceeds of approximately $235 million

• In May 2023, Legend Biotech sold 5,468,750 American Depositary Shares (the "ADSs"), each representing two ordinary shares, to certain investors in a registered direct offering at a price of $64.00 per ADS for aggregate gross proceeds of $350 million

• In May 2023, an institutional investor exercised in full a warrant to purchase 10,000,000 ordinary shares of Legend Biotech at an exercise price of $20.00 per ordinary share for an aggregate exercise price of $200 million

Webcast/Conference Call Details:

Legend Biotech will host its quarterly earnings call and webcast today at 8:00am ET. To access the webcast, please visit this weblink.

A replay of the webcast will be available on Legend Biotech’s website at https://investors.legendbiotech.com/events-and-presentations.

https://finance.yahoo.com/news/legend-biotech-reports-second-quarter-100000475.html