Renascience Inc.

Business Details

Centered on the PAI-1 inhibitor RS5614, the company advances drug development in oncology, respiratory disease, and anti-aging fields in parallel with development of AI-utilizing program medical devices (SaMD). It employs an open-innovation development model leveraging physician-initiated clinical trials, deploying numerous pipelines with limited in-house resources through collaboration with universities and medical institutions. Business revenue is mainly derived from milestone income, upfront contract payments, and contracted research income. Operated as a single segment.

Recent Overview

Financial base significantly strengthened through third-party allotment capital increases; clinical trials progressed across multiple pipelines

In FY2026 (ending March 2026), the company recorded ¥1,881 million in stock issuance proceeds through four rounds of third-party allotment capital increases based on an equity program agreement with U.S. institutional investor CVI Investments, increasing cash balance to ¥3,402 million. Business revenue was ¥68 million (down 48.3% year-on-year), and operating loss was ¥356 million (widened year-on-year). The Phase II angiosarcoma trial was completed, achieving results of PFS 4.0 months and OS 20.8 months, surpassing existing treatments. The Phase III malignant melanoma trial progressed well, with 89 patients enrolled as of April 21, 2026. The early-stage Phase II non-small cell lung cancer trial was completed, confirming a response rate of 8.3% (18.2% for third-line monotherapy), and a late-stage Phase II trial began in April 2026. The Phase II systemic sclerosis-associated ILD trial was completed, but no statistically significant difference was found in the primary endpoint. The XPRIZE Healthspan semifinal clinical trial (20 subjects) was conducted, with preliminary results expected in mid-May 2026. The maintenance hemodialysis SaMD achieved a 92.2% accuracy rate, and a memorandum amending the joint development agreement with Nipro was concluded.

Key Products

Growth Drivers

• Steady progress in the Phase III malignant melanoma trial for the PAI-1 inhibitor RS5614 (target of 124 patients across 18 domestic sites, with 89 enrolled as of April 2026) is expected to expand opportunities for regulatory approval and licensing-out
• Results from the Phase II angiosarcoma trial showing PFS of 4.0 months and OS of 20.8 months, surpassing existing treatment (pazopanib: 2.8 months and 12.1 months), with a swift transition to Phase III planned
• The late-stage Phase II non-small cell lung cancer trial (started April 2026) was selected for AMED's FY2026 Clinical Research and Trial Promotion Project, with profitability improvement expected from FY2027 (ending March 2027) through FY2029 (ending March 2029)
• International expansion in the anti-aging and longevity field following selection as an XPRIZE Healthspan semifinalist (receiving a $250,000 prize), including basic agreements concluded with Northwestern University, KAIMRC, and Taipei Medical University
• The maintenance hemodialysis support SaMD (RSAI02) achieved a 92.2% accuracy rate, demonstrating non-inferiority to specialist physicians, and a memorandum amending the joint development agreement with Nipro is accelerating regulatory approval application and commercialization
• Cash and deposits increased to ¥3,402 million through third-party allotment capital increases (CVI Investments), securing a financial base to continue multiple Phase III and Phase II trials
• Conclusion of a bridging trial agreement for malignant melanoma with Taipei Medical University, and acceleration of international regulatory approval and business development through collaboration with KAIMRC and Northwestern University

Risks

• Most business revenue depends on milestone payments, upfront contract fees, and contracted research income, making revenue recognition timing irregular and difficult to predict (forecast business revenue for FY2027, ending March 2027, is ¥43 million, a further decrease year-on-year)
• The operating loss forecast for the next fiscal year (FY2027, ending March 2027) is expected to expand significantly to ¥585 million from ¥356 million in FY2026 (ending March 2026), as R&D expenses continue to rise due to simultaneous execution of multiple Phase III and Phase II trials
• The substance patent for the PAI-1 inhibitor RS5614 is set to expire at the end of March 2030 (Japan, etc.) and August 2030 (U.S.), making extension of protection through use patents important for maintaining business value
• Risk of share dilution from third-party allotment capital increases (equity program agreement) (1,065,200 shares issued in FY2026, ending March 2026, with 3,499 outstanding stock acquisition rights representing 692,300 potential shares)
• In the Phase II systemic sclerosis-associated ILD trial, no statistically significant difference was found in the primary endpoint (%FVC change), manifesting a risk of development discontinuation or strategic changes for some pipelines
• If clinical trial results fail to meet efficacy and safety standards, there is a risk of losing licensing-out opportunities and incurring additional development costs
• While no note regarding going concern assumptions is deemed applicable, operating cash outflow has been expanding to ¥291 million, posing a business continuity risk should fundraising be delayed