Cuorips Inc.
4894・Growth Market・Pharmaceuticals
Regenerative Medicine Products Business (Cuorips Inc., single segment)
A regenerative medicine venture developing and commercializing human iPS cell-derived cardiomyocyte sheets while operating a CDMO business
| Period | Current | Previous | Change |
|---|---|---|---|
| Net sales (consolidated, full year) | ¥212 million | ¥175 million | ↑ |
| Operating loss (consolidated, full year) | -¥1,081 million | -¥590 million | ↓ |
| Ordinary loss (consolidated, full year) | -¥1,028 million | -¥642 million | ↓ |
| Net loss attributable to owners of parent (consolidated, full year) | -¥1,022 million | -¥644 million | ↓ |
| R&D expenses (total) | ¥970 million | ¥1,029 million (estimate) | ↓ |
| R&D expenses - self-funded portion (recorded as SG&A) | ¥634 million | ¥334 million (estimate) | ↑ |
| Total assets | ¥5,123 million | ¥5,741 million | ↓ |
| Equity ratio | 91.6% | 96.1% | ↓ |
| Cash and cash equivalents at fiscal year-end | ¥3,900 million | ¥4,793 million | ↓ |
| Net loss per share | -¥124.54 | -¥80.52 | ↓ |
| Cash flow from operating activities | -¥1,059 million | -¥812 million | ↓ |
Business Details
Based on joint research and development with Osaka University, the company's top priority is obtaining manufacturing and marketing approval and commercializing the human iPS cell-derived cardiomyocyte sheet "ReHeart®." In March 2026, the company obtained conditional and time-limited manufacturing and marketing approval for the indication of severe heart failure due to ischemic cardiomyopathy. In parallel, the company is developing a CDMO business utilizing its commercial cell culture processing facility "CLiC-1," and the R&D-intensive investment phase continues.
Recent Overview
Obtaining conditional approval for manufacturing and marketing of ReHeart® is the major development; the company aims for NHI price listing and sales launch around autumn 2026
In March 2026, the company obtained conditional and time-limited manufacturing and marketing approval from the Ministry of Health, Labour and Welfare for ReHeart®, indicated for severe heart failure due to ischemic cardiomyopathy (application filed in April 2025). In October 2025, the product was designated as a regenerative medicine product for rare diseases, making it eligible for insurance reimbursement premium pricing. For FY2027 (ending March 2027), the company expects NHI price listing around autumn 2026, with sales to begin in the second half of the fiscal year. Meanwhile, although net sales were ¥212 million (up 21.2% year on year), operating loss expanded to ¥1,081 million (up 83.2% year on year) due to an increase in SG&A expenses (including R&D expenses). The consolidated earnings forecast for the following fiscal year does not disclose net sales (as the NHI price has not yet been determined), and operating loss is expected to be ¥1,430 million.
Key Products
Growth Drivers
- Transition to a monetization phase following the acquisition of conditional and time-limited manufacturing and marketing approval for ReHeart® (March 2026) and expected NHI price listing and sales launch around autumn 2026
- Eligibility for insurance reimbursement price premium following designation as a regenerative medicine product for rare diseases (October 2025)
- Full-scale expansion into the US market: continued joint research with Stanford University, progress on IND application preparations following broad agreement at an FDA pre-IND meeting, and the start of preparations for consultation with European regulatory authorities
- Improved manufacturing and supply capacity following selection for the Ministry of Economy, Trade and Industry's "Regenerative Medicine CDMO Subsidy" New Technology Introduction Promotion Framework (the Nakanoshima Cross pilot plant is scheduled to begin full-scale operation in the following fiscal year)
- Potential for revenue diversification through progress in out-licensing and collaboration discussions with one overseas pharmaceutical company regarding the In Vivo Regenerative Factor Inducer (YS-1301)
- Suppression of the cash burn rate through receipt of joint R&D expense contributions from joint research and development partners (the amount received during the fiscal year under review was approximately ¥336 million, calculated by subtracting the self-funded portion of ¥634 million from total R&D expenses of ¥970 million)
Risks
- Risk of delayed NHI price listing or an unexpectedly low price setting (net sales forecast is undisclosed as of this report because the NHI price has not yet been determined)
- Risk of non-compliance with post-marketing surveillance and conditions attached to the conditional and time-limited approval
- Risk of expanding operating loss due to prolongation of the R&D-intensive investment phase (operating loss forecast for the following fiscal year is -¥1,430 million, a further expansion from the current fiscal year)
- Risk of continued decline in cash and cash equivalents (fiscal year-end balance of ¥3,900 million, down ¥893 million from the previous fiscal year-end, with operating cash flow of -¥1,059 million)
- Regulatory risk in overseas expansion (uncertainty regarding FDA IND application and approval, complexity of European regulatory response)
- Risk of customer concentration and order volume fluctuation in the CDMO business
- Risk of development delays or failures in the pipeline, including the catheter and the in vivo regenerative factor inducer
Last updated: June 24, 2026