Signet Therapeutics completes 80 million Series A financing to accelerate global clinical development of its "Organoids + AI" innovative drug pipelines

Signet Therapeutics, a global pioneer in the "organoids + AI"-enabled innovative targeted drug R&D model, announced the completion of an 80 million Series A financing round. This round was jointly invested by XtalPi, Green Pine Capital Partners, Zhisheng Synergy, Yael Capital, and Blue Ocean Capital Group. The funds will primarily be used to advance Signet Therapeutics' lead pipeline, SIGX1094, into global Phase II clinical trials, as well as to support the IND application and Phase I clinical trials for its second pipeline, SIGX2649, further expanding Signet Therapeutics' strategic focus in targeted therapies for malignant metastatic solid tumors. Beyond pipeline development, the financing will also drive the expansion of Signet Therapeutics' organoid platform to empower innovative drug discovery and development initiatives.

Since its establishment at the end of 2020, Signet Therapeutics has centered its efforts around a forward-looking "organoids + AI" drug R&D platform, dedicated to addressing the major unmet clinical needs of malignant metastatic cancers such as diffuse gastric cancer, liver cancer, and lung cancer. The founding team of Signet Therapeutics comprises senior experts from globally top-tier research institutions such as the Dana-Farber Cancer Institute at Harvard University and the Broad Institute of MIT and Harvard, as well as from renowned pharmaceutical companies. By establishing proprietary organoid disease models, the team deeply integrates the real genomic characteristics of cancer patients with functional biology, aiming to resolve key issues that may arise during clinical stages at the preclinical stage, thereby systematically enhancing the efficiency and success rate of new drug development.

Based on this organoid platform, Signet Therapeutics has successfully discovered novel therapeutic targets for various cancers. Building on this foundation, Signet Therapeutics has entered into an in-depth strategic collaboration with XtalPi (2228.HK), a pioneer in "AI + Robotics," to jointly develop innovative targeted drugs.

Signet Therapeutics' lead pipeline, SIGX1094, progressed from target discovery to entering Phase I clinical trials in less than four years. It has successively obtained Investigational New Drug (IND) approvals from the U.S. FDA (June 2024) and China's NMPA (September 2024), and has received Orphan Drug Designation (ODD, November 2024) and Fast Track Designation (FTD, February 2025) from the FDA. The second pipeline, SIGX2649, is an innovative small-molecule inhibitor targeting TEAD, a key transcription factor in the Hippo pathway, and holds potential for treating various solid tumors such as mesothelioma, liver cancer, and lung cancer. It has currently completed preclinical development and is preparing for the simultaneous submission of IND applications to regulatory agencies in China and the United States.

Signet Therapeutics' innovative "organoids + AI" drug R&D paradigm has gained authoritative recognition both domestically and internationally. Not only was Signet Therapeutics featured in a homepage report by the globally renowned biotech media Fierce Biotech as early as 2021, where it was described as "the next-generation paradigm for cancer drug development," but its technological approach also aligns closely with the 2025 FDA policy statement supporting the use of organoid and AI technologies as alternatives to traditional animal testing.

Furthermore, based on patients' genomic characteristics and gene-editing-induced carcinogenesis, Signet Therapeutics has constructed a variety of standardized tumor organoid models to enable feasibility in early-stage drug development screening. For example, Signet Therapeutics' independently developed cardiac organoid model, which features atrial and ventricular structures, has significantly improved the prediction accuracy for drug-induced cardiotoxicity to approximately 85%. The traditional gold standard for cardiotoxicity testing, "hERG," only reflects potassium channel function, with a prediction accuracy of about 45%. 

To address this limitation, the Signet Therapeutics team systematically analyzed cardiotoxicity data from over 120 drugs and constructed a beating 3D cardiac organoid model in vitro. By integrating AI technology for intelligent analysis of organoid beating imagery, the prediction accuracy for cardiotoxicity was increased to approximately 85%, providing a more reliable and physiologically relevant solution for preclinical safety assessment of drugs. Currently, as the only corporate participant, Signet Therapeutics is involved in formulating organoid standards with the National Medical Products Administration and the National Institutes for Food and Drug Control, continuously promoting industry standardization.