TMS Co., Ltd.

Business Details

TIMS Co., Ltd. is a drug discovery biotech venture whose core focus is the research and development of SMTP compounds targeting soluble epoxide hydrolase (sEH). It currently has no marketed products and handles research through early clinical stages in-house, adopting a business model in which it earns milestone payments and royalty income through partnerships with global pharmaceutical companies from the late clinical stage onward. Its lead pipeline candidate, TMS-007 (JX10), is undergoing the Phase II/III "ORION" trial under a global partnership with CORXEL. From FY2026 (ending December 2026), the company has transitioned to a normal 12-month fiscal period.

Recent Overview

Dosing began in the Japan portion of the ORION trial; PMDA preliminary meeting held for TMS-008 and preparations for the next-phase trial advanced

In the first quarter of 2026 (January to March), the first subject in Japan was dosed in February 2026 under the global Phase II/III "ORION" trial for TMS-007 (JX10), marking the start of subject enrollment in Japan. For TMS-008, in preparation for the prior Phase II trial targeting cardiac surgery-associated acute kidney injury (CSA-AKI), the company held a preliminary meeting with the PMDA in February 2026 and is preparing for a formal consultation. Total operating expenses were ¥203 million (R&D expenses of ¥121 million and other SG&A expenses of ¥81 million), resulting in a quarterly net loss of ¥204 million. Cash on hand was maintained at ¥2,633 million. There is no note regarding going concern assumptions.

Key Products

Growth Drivers

• Start of subject enrollment in the Japan portion of the TMS-007 (JX10) ORION trial (first dosing in February 2026) and expectations for achieving development milestones through steady overall enrollment progress
• Progress in preparing for a formal PMDA consultation ahead of the next-phase (prior Phase II) clinical trial for TMS-008, and potential indication expansion through the newly initiated joint research with Kyushu University
• Retention of rights to receive milestone payments and royalties for the global development and marketing of TMS-007 under the agreement with CORXEL
• Identification of novel sEH inhibitor candidates through AI-driven compound generation and natural product library screening, with confirmed efficacy in multiple disease animal models
• Pipeline expansion through collaboration with academia such as Hokkaido University (pharmacological efficacy studies and formulation determination for TMS-010, examination of applicability for resolvin analogs)
• Ensuring continuity of near-term R&D activities by maintaining cash on hand of ¥2,633 million

Risks

• The company continues to have zero operating revenue with no marketed products, and the timing of realization of milestone income and other revenue remains uncertain, making it difficult to disclose earnings forecasts
• Risk of clinical trial failure or delay: if the ORION trial or the next-phase TMS-008 trial does not proceed as planned, recovery of development costs may become difficult
• Dependence on CORXEL: the global development and marketing of TMS-007 is led by CORXEL, and changes in its strategy or financial condition would directly affect the company's revenue
• Cash consumption risk: against projected FY2026 (ending December 2026) R&D expenses of ¥600 million to ¥900 million and other SG&A expenses of ¥300 million to ¥400 million, a continuous decline in cash on hand of ¥2,633 million is expected
• Decline in net assets due to continued net losses (Q1 net loss of ¥204 million, cumulative retained earnings deficit of ¥(920) million)
• The next-phase clinical trial plan for JX09 remains undetermined at this time, leaving uncertainty regarding development progress