Zymeworks(ZYME) - 2024 Q4 - Annual Results

FDA Approvals and Clinical Trials - Zymeworks achieved FDA approval for zanidatamab, marking a significant milestone in 2024[3] - Phase 3 results for Ziihera® (zanidatamab-hrii) in HER2-positive gastroesophageal adenocarcinoma are expected in 2Q-2025, with potential sBLA submission later in 2025[5][12] - Zymeworks initiated first-in-human studies for ZW171 and ZW191, targeting solid tumors[6] Research and Development Pipeline - IND applications for ZW220 and ZW251 are anticipated in 2025, with additional IND applications for ZW209 and ZW1528 expected in 2026[5] - The company plans to nominate ZW209 as the fifth product in its '5 by 5' R&D program, with an IND application planned for 1H-2026[8] - The company aims to complete all five IND applications under the '5 by 5' R&D program by the end of 1H-2026[8] - Zymeworks is expanding its R&D pipeline into autoimmune and inflammatory diseases and hematological cancers[5] Financial Performance - The company reported cash, cash equivalents, and marketable securities of approximately $324 million as of December 31, 2024, providing a cash runway into 2H-2027[5][9] - The company successfully completed$30 million in share repurchases under its Share Repurchase Program announced in August 2024[8] Upcoming Events - Zymeworks will present at the J.P. Morgan Annual Healthcare Conference on January 16, 2024[10]