Renascience Inc.
4889・Growth Market・Pharmaceuticals
Business
Renascience Inc. is a university-originated drug discovery venture founded in 2000, listed on the Growth Market of the Tokyo Stock Exchange. Targeting age-related diseases such as cancer, anti-aging/longevity, and respiratory diseases, the company develops diverse modalities including pharmaceuticals (PAI-1 inhibitors RS5614 and RS5441), medical devices (disposable ultra-thin endoscope), and AI program medical devices (support for maintenance hemodialysis, respiratory function testing and diagnosis, etc.). It has established Open Innovation Labs at Tohoku University and Hiroshima University, promoting efficient development through the use of physician-led clinical trials. The core of its business is creating medical innovation through licensing out to domestic and overseas pharmaceutical and medical device companies.
Business Model
The company nurtures seeds through joint research with domestic and overseas universities and research institutions, obtains PoC (proof of concept) through investigator-initiated clinical trials, and then licenses out to pharmaceutical companies and others. Revenue takes four forms: upfront lump-sum payments, development milestones, sales milestones, and royalties. By actively utilizing public research grants (such as AMED), the company reduces self-funded R&D expenses, enabling a structure that advances multiple pipelines in parallel with a small workforce and limited capital.
Company Strengths
As of the end of May 2026, the company has a track record of 31 physician-led clinical trials, etc. (24 completed, 5 ongoing, 2 planned), with 7 pipeline candidates in clinical trials during FY2027 (ending March 2027) (3 Phase III, 3 Phase II, 1 clinical research). All target new indications for unapproved drugs (first-in-human), and the trials are designed to enable regulatory approval while strictly complying with GLP, GMP, and GCP.
Substance patents for RS5614 (PAI-1 inhibitor) have been registered in Japan, the United States, Europe, Canada, Australia, China, South Korea, and India. Additional use patents (for CML, immune checkpoints, the fibrinolytic system, efferocytosis, and anti-aging) have been filed, extending the patent term to 2041. For malignant melanoma, the drug has received designation as an "orphan drug" by the Minister of Health, Labour and Welfare, securing exclusivity through market size premiums in drug pricing calculations and extended re-examination periods.
Against total R&D expenses of ¥201,663 thousand in FY2026 (ending March 2026), the company secured ¥36.29 million in public funding such as from AMED, reducing self-funded expenses to ¥165,360 thousand. Public funding has been secured for CML Phase III, malignant melanoma Phase III, late-stage Phase II for non-small cell lung cancer, the maintenance hemodialysis AI, and the diabetes AI. Through a third-party allotment of new shares (to CVI Investments), the company secured cash and deposits of ¥3,402 million, building a financial foundation capable of sustaining multiple Phase III trials.
ENVALITH's Perspective
Performance Trend
Business revenue over the past five fiscal years has shown unstable trends: ¥139 million → ¥101 million → ¥194 million → ¥133 million → ¥69 million, and in FY2026 (ending March 2026), it declined 48.3% year-on-year to ¥68 million. The revenue breakdown consists of milestone/upfront income of ¥60 million (from Toray Medical and Nipro) and contracted research income of ¥9 million. Operating loss roughly doubled to ¥357 million (versus ¥179 million in the prior period), mainly due to an increase in business expenses to ¥421 million (versus ¥308 million in the prior period). The prior period's net income of ¥113 million was attributable to extraordinary income such as a ¥304 million gain on debt forgiveness, whereas in the current period there was no extraordinary income, resulting in a net loss of ¥301 million. The forecast for FY2027 (ending March 2027) anticipates business revenue of ¥43 million and an operating loss of ¥585 million, indicating a further expansion of losses. On the financial side, the company secured cash of ¥3,403 million and an equity ratio of 94.5% through a third-party allotment capital increase, maintaining sound financial health.
Growth Strategy
Establishing a dual-layer revenue structure through completion of Phase III trials and regulatory approval of the PAI-1 inhibitor, together with commercialization of SaMD
A randomized, placebo-controlled, double-blind Phase III trial targeting 124 patients across 18 domestic sites is underway. As of April 2026, 89 patients have been enrolled, indicating steady progress. The orphan drug designation confers benefits including priority review, marketability premium, and extended exclusivity period. Regulatory approval in Taiwan is also being pursued in parallel through a bridging trial agreement with Taipei Medical University.
Preliminary results from the Phase II trial showed PFS of 4.0 months and OS of 20.8 months, surpassing existing treatment (pazopanib: 2.8 months and 12.1 months). The clinical study report is scheduled for around June 2026, and the Phase III trial will be initiated promptly once the results are finalized. As this is an extremely rare cancer affecting approximately 300 people domestically, there is potential for early approval.
The clinical performance trial achieved an accuracy rate of 92.2% (exceeding the 80% target by 10 percentage points), demonstrating non-inferiority to specialist physicians. A memorandum amending the joint development agreement with Nipro was concluded to accelerate the regulatory approval application and commercialization. A joint development agreement has also been concluded with Toray Medical. Practical application is being accelerated with an additional allocation of ¥143,000 thousand in adjustment funding from AMED.
Selected as an XPRIZE Healthspan semifinalist (TOP40) and received a prize of USD 250,000. The semifinal clinical trial (20 patients, 16 weeks of administration) is being conducted at Tohoku University, with preliminary results expected around mid-May 2026. Memoranda of understanding have been concluded with Northwestern University, KAIMRC, and Taipei Medical University to establish a joint implementation framework for the final trial (following selection to the TOP10). Selection to the TOP10 in August 2026 is the next key milestone.
A late-phase II trial evaluating the addition of RS5614 to chemoradiotherapy plus durvalumab for locally advanced non-small cell lung cancer was initiated in April 2026 across 12 medical institutions, including Hiroshima University Hospital. As the trial was adopted under AMED's FY2026 (Reiwa 8) Clinical Research and Trial Promotion Project, expenditures are expected to be lower than initially anticipated, leading to improved profitability from FY2027 (ending March 2027) through FY2029 (ending March 2029).
Last updated: July 19, 2026