TYK Medicines 2025 Net Loss Narrows 21% to RMB 305.97 Million; NDA for Core Drug TY-9591 Enters Priority Review

Bulletin Express03-30

TYK Medicines, Inc. reported a consolidated net loss of RMB 305.97 million for 2025, an improvement of 21.1% versus 2024. Loss per share narrowed to RMB 0.80 from RMB 1.15.

R&D AND EXPENSES • Research and development outlays edged up 3.7% to RMB 244.06 million, driven mainly by a milestone payment related to core asset TY-9591. • Administrative expenses fell 27.6% to RMB 78.48 million, primarily due to a reduction in listing-related costs booked in 2024.

OTHER INCOME Other income and gains rose 23.1% to RMB 37.61 million, reflecting higher government interest-free financing support and a RMB 4.92 million gain on the disposal of a subsidiary.

BALANCE SHEET AND LIQUIDITY • Cash and bank balances stood at RMB 367.29 million, down from RMB 460.46 million a year earlier, after RMB 215.77 million net operating cash outflow and RMB 35.95 million net investing outflow. • Short-term bank borrowings totaled RMB 134.12 million; the gearing ratio (total liabilities/total assets) rose to 63.2% from 48.4%. • Net assets declined to RMB 286.61 million (2024: RMB 472.56 million).

CAPITAL MOVEMENTS • In August 2025 the company placed 9.23 million new H shares, raising net proceeds of approximately RMB 135.02 million. • During the year, 1.41 million H shares were repurchased for RMB 17.67 million to fund the share incentive plan.

PIPELINE PROGRESS • Core Product TY-9591 (third-generation EGFR-TKI): Pivotal Phase II enrollment of 224 patients with EGFR-mutant NSCLC brain metastases completed in November 2024. The NDA was filed in Q4 2025 and accepted with priority review by the CDE in February 2026. A registrational Phase III trial in EGFR L858R-mutant NSCLC had enrolled 541 patients by July 2025; full enrollment is expected in Q4 2026 with NDA submission targeted for 2028. • TY-302 (CDK4/6 inhibitor): Ongoing Phase II trial in breast cancer; Phase II combo study with abiraterone in first-line prostate cancer approved in July 2025. • TY-2136b (ROS1/NTRK inhibitor): U.S. Phase I study under way; product holds FDA orphan-drug designation. • TY-2699a (CDK7 inhibitor), TY-0540 (CDK2/4 inhibitor) and TY-1054 (YAP-TEAD inhibitor) advanced through Phase I programs; additional pre-clinical candidates in CDK4, EGFR/FAK PROTAC, PI3Kα and GLP-1 pathways are progressing toward IND submissions.

CORPORATE DEVELOPMENTS • The company received a Drug Production License in January 2026, enabling future commercial manufacturing. • A new solid-formulation facility targeting 150 million tablets/capsules annual capacity is slated for GMP certification in 2026. • The board proposes amendments to the Articles of Association to align with updated PRC Company Law and Hong Kong Listing Rules, including provisions for hybrid shareholder meetings and expanded committee terms of reference.

OUTLOOK Management plans to intensify R&D investment, integrate artificial-intelligence-driven drug design, and adopt a phased commercialisation strategy combining external partnerships with in-house capabilities. No final dividend was declared for 2025.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

We need your insight to fill this gap
Leave a comment