TMS Co., Ltd.
4891・Growth Market・Pharmaceuticals
Business
TIMS Co., Ltd. is a drug discovery biotech venture established in 2005, originating from pharmaceutical seeds developed at Tokyo University of Agriculture and Technology. Centered on the SMTP compound group, which targets soluble epoxide hydrolase (sEH), the company advances clinical development across multiple high unmet medical need areas, including acute ischemic stroke (TMS-007/JX10), acute kidney injury and cancer cachexia (TMS-008), treatment-resistant hypertension (JX09), and spinal cord injury (TMS-010). The company handles research through early clinical stages in-house, and adopts a business model in which it partners with global pharmaceutical companies for late-stage development onward to earn milestone and royalty income. It listed on the Tokyo Stock Exchange Growth Market in November 2022, and is currently in a pre-revenue investment phase.
Business Model
The company handles the research stage through early clinical stages (up to Phase II) in-house, and grants development, manufacturing, and marketing rights to domestic and overseas pharmaceutical companies for late-stage clinical development onward. In return, it receives upfront payments, development milestones, sales milestones, and royalties. For TMS-007, under the agreement with Biogen (now CORXEL), the company has already received $22 million, and holds rights to receive up to an additional $367.5 million in milestones and royalties going forward. Currently there are no sales track records, and fundraising is mainly through capital increases and exercise of stock acquisition rights.
Company Strengths
In the prior Phase II clinical trial of TMS-007 (90 subjects), the 90-day mRS 0-1 outcome rate was 40.4% in the TMS-007 group versus 18.4% in the placebo group, achieving a statistically significant difference (P value <0.05, adjusted odds ratio 3.34). Symptomatic intracranial hemorrhage occurred in 0% (0/52 subjects) of the TMS-007 group, also suggesting favorable safety, which formed the basis for progression to the global Phase II/III trial "ORION".
Following the conclusion of an option agreement with Biogen (2018) and the exercise of the option right (2021), the company currently holds, under an agreement with CORXEL, rights to receive up to $12.5 million in development milestones, up to $355 million in sales milestones, and tiered royalties (high single digits to low teens percent). Amounts already received total $22 million ($4 million contract fee plus $18 million option exercise fee).
Through patent assignment and license agreements with Tokyo University of Agriculture and Technology, Hokkaido University, Showa University of Medicine, Tohoku University, and others, the company holds TMS-007/008/009/010, JX09, resolvin analogs, and multiple clinical and preclinical pipeline assets. In November 2025, the company newly introduced a novel stable resolvin analog, a bioactive lipid, from Hokkaido University, continuing to expand its pipeline.
ENVALITH's Perspective
Performance Trend
In 1Q FY2026 (December 2026) (January-March 2026), operating revenue was zero, with an operating loss of ¥203 million, an ordinary loss of ¥203 million, and a quarterly net loss of ¥204 million. Past annual results showed continuing losses: FY2023 ¥-520 million, FY2024 ¥-943 million, and FY2025 ¥-908 million (all operating income/loss figures). The narrowing of the 1Q loss is largely attributable to the timing of research and development expense execution, and for the full year, total expenses of ¥900 million to ¥1,300 million are expected, comprising research and development expenses of ¥600 million to ¥900 million and other expenses of ¥300 million to ¥400 million. In terms of the external environment, unmet medical needs in acute cerebral infarction treatment remain substantial, and this market environment serves as a backdrop supporting the value of the lead pipeline.
Growth Strategy
Global clinical advancement of the lead pipeline and pipeline expansion through academic collaboration and AI-driven drug discovery
Subject enrollment is progressing steadily in the ORION trial, a global Phase II/III clinical trial led by CORXEL. The first dosing in Japan took place in February 2026, with the Company participating as the clinical trial sponsor in Japan. The greatest value-realization event will be the acquisition of milestone revenue upon trial completion and filing for approval.
In preparation for conducting an early-phase Phase II clinical trial targeting cardiac surgery-associated acute kidney injury (CSA-AKI), the Company received preliminary consultation from the PMDA in February 2026 and is preparing for a face-to-face consultation. This is an area of high unmet medical need, and initiation and progress of the trial will contribute to expanding pipeline value. The possibility of indication expansion is also under consideration following the start of joint research with Kyushu University.
A spinal cord injury treatment candidate acquired through a licensing agreement with Hokkaido University (July 2024). Pharmacological efficacy studies were conducted in Q1, and the formulation was determined. Neuroprotective effects through prevention of blood-spinal cord barrier disruption are expected, and development is proceeding in an area lacking effective therapeutics.
Novel sEH inhibitor candidates were acquired through AI-driven compound generation and natural product library screening, with efficacy confirmed in multiple disease animal models. Examination of potential indications for the novel stable resolvin analogs introduced from Hokkaido University also continues. Pipeline diversification is being advanced along two axes, in-house and external.
Last updated: July 17, 2026