ENVALITH
株式会社坪田ラボ logo

Tsubota Laboratory Incorporated

4890・Growth Market・Pharmaceuticals

Official website
株式会社坪田ラボ logo
Tsubota Laboratory Incorporated4890

Business

Tsubota Laboratory, Inc. is a venture company founded in 2012 originating from Keio University School of Medicine, guided by the purpose of "making the future kigen-ii (feel-good) through VISIONary INNOVATION." The company specializes in high unmet medical needs areas including myopia, dry eye, presbyopia, and brain diseases, and advances research and development through a unique approach fusing light science and medical science centered on violet light (wavelength 360–400nm) technology. Building on joint research with the Department of Ophthalmology at Keio University School of Medicine, the company operates a B2B-type research and development business as a single segment, transferring research outcomes to domestic and international partner companies such as Rohto Pharmaceutical, Maruho, JINS Holdings, and Laboratoires Théa.

Business Model

Under the proprietary Co-Creation Core (CCC) concept, research outcomes generated through co-creation with universities and research institutions are established as intellectual property, with upfront contract payments, milestones, and post-launch royalties earned through joint research and development agreements and licensing agreements with partner companies serving as revenue sources. The company employs a cyclical innovation model in which the resulting revenue is reinvested into new research and development. It pursues a T-shaped strategy that allocates approximately 70% of the research budget to deepening existing pipelines and approximately 30% to exploring new fields, aiming to balance short-term results with medium- to long-term growth.

Company Strengths

In 2017, the Department of Ophthalmology at Keio University School of Medicine discovered that violet light (360–400nm) is effective in suppressing myopia progression. The company elucidated the mechanism by which OPN5 mediates increased choroidal blood flow and has actively filed for and obtained related patents. In April 2025, it received the Commissioner's Award for Intellectual Property Achievement from the Japan Patent Office, having built a proprietary intellectual property foundation that is difficult for other companies to replicate in a short period.

The company has concluded licensing agreements with Rohto Pharmaceutical, Maruho, JINS Holdings, Laboratoires Théa, Shenyang Xingqi, and Beijing Yijie. Multiple pipeline candidates, including TLM-001 (Maruho), TLM-003 (Rohto, Théa), and TLG-001 (JINS and two Chinese companies), have progressed to the Phase II clinical trial stage, and the company has a track record of recognizing milestone revenue in stages.

The company has concluded a joint research agreement with the Department of Ophthalmology at Keio University School of Medicine through March 2027, continuing to advance the elucidation of the molecular mechanisms of myopia progression. It has also established its own research grant program, T-SBIR, building an academic network both domestically and internationally. Through collaboration with external researchers (contracted research fellows), the company has achieved an efficient R&D structure that enables a small organization to address multiple disease areas.

ENVALITH's Perspective

In FY2026 (ending March 2026), revenue fell sharply to ¥200 million (down 85.3% year on year), and the operating loss deteriorated sharply to ¥788 million. The main cause was the reversal effect from the large upfront payment recorded under a licensing-out agreement in the prior period (FY2025, ended March 2025), which once again exposed the revenue volatility risk inherent in the licensing model. Selling, general and administrative expenses were ¥919 million, roughly flat compared to the prior period (¥941 million), and the heavy fixed-cost burden widened the size of the loss. Investors should also note that this is disclosed as a material event related to the going-concern assumption.

The company forecasts revenue of ¥1,100–1,500 million, operating profit of ¥5–50 million, and net income of ¥45–90 million for FY2027 (ending March 2027), projecting a return to operating profitability. The plan anticipates that milestone income from already licensed-out projects and upfront payments from new licensing-out agreements will be the main sources of revenue, but the risk that the timing of recognition will fluctuate depending on the progress of clinical development is high. The company plans research and development investment of ¥400 million, and balancing cost control with revenue recognition will be key to achieving profitability.

Cash and cash equivalents at the end of FY2026 (ending March 2026) stood at ¥969 million (a decrease of ¥569 million from ¥1,539 million at the end of the prior period). The company states that it has secured the funds necessary to continue operations for the next year, but net assets decreased by approximately 45%, from ¥1,587 million to ¥864 million, and the accumulated deficit in retained earnings expanded to ¥809 million. Operating cash flow was an outflow of ¥577 million, and if losses continue into FY2027 (ending March 2027), the need for additional fundraising may arise.

Growth Strategy

Sustainable growth through clinical progress of existing pipelines, conclusion of new out-licensing agreements, and diversification of revenue sources

Maruho Co., Ltd. initiated a Phase IIa trial for TLM-001, targeting MGD, and milestone income was recognized in FY2026 (ending March 2026). Additional milestone income is expected to be recognized going forward in line with further trial progress.

For the myopia treatment TLM-003, a domestic Phase II clinical trial was initiated based on the long-term development agreement with Rohto Pharmaceutical, and a Phase II trial was also initiated by Théa, the European licensee. Milestone income is expected to be recognized in line with development progress.

The observation period of the confirmatory clinical trial for TLG-001, a medical device utilizing violet light technology, was completed, and the primary efficacy analysis was conducted. No discontinuations due to serious adverse events occurred, confirming a favorable safety profile. A statistically significant difference was confirmed in the subject group with shorter outdoor activity time. Future regulatory application and approval represent the most important catalyst in the near-to-medium term.

Multiple new pipelines have advanced to the clinical stage, including the initiation of specified clinical research for TLM-017 targeting corneal and conjunctival disorders, the initiation of specified clinical research for TLG-020 targeting retinitis pigmentosa at Keio University, and the implementation of specified clinical research for TLG-021 targeting menstrual irregularities, which confirmed the potential of a new intervention approach. These developments are expected to lead to future out-licensing opportunities.

The company concluded an exclusive domestic sales agreement for "aeonia," a basic skincare brand developed by U.S.-based Delavie Sciences based on research from Harvard University, and commenced sales. This is a new initiative aimed at moving away from dependence on license income and stabilizing revenue.

The company plans R&D investment of ¥400 million in the next fiscal year, promoting the strengthening of intellectual property and pipeline expansion through enhanced collaboration with leading research institutions and joint research partners in Japan and overseas. Through milestone income from already out-licensed projects and upfront payments from new out-licensing deals, the company aims to achieve net sales of ¥1,100 million to ¥1,500 million and operating profit of ¥5 million to ¥50 million, turning profitable.

Last updated: July 19, 2026