Contents of this document
- Submission of the clinical trial notification and start of an additional Phase 3 trial for acute spinal cord injury
- Basic agreement with 丸石製薬 on exclusive domestic sales of a treatment for vocal fold scarring
- Start of joint research on protein biomarkers with Keio University
- Participation in the international SCI PFDD consortium
- Preparation for U.S. development, including an IND filing
- Development of a commercial formulation for vocal fold scarring
- Improvement rate from AIS A to AIS C or above in the Phase 3 trial for acute spinal cord injury12 %
- Improvement rate from AIS A to AIS B or above in the Phase 3 trial for acute spinal cord injury56 %
- Percentage of patients with reduced MRI abnormal areas in the Phase 3 HGF treatment group52 %
- Number of enrolled cases in the Phase 3 trial for vocal fold scarring65 cases
- Warrant exercise rate87.6 %
- Acute spinal cord injury, Japan¥120 100 million
- Acute spinal cord injury, worldwide¥600 100 million
- Vocal fold scarring, Japan¥50 100 million
- Vocal fold scarring, worldwide¥300 100 million
- ALS, Japan¥200 100 million
- ALS, worldwide¥1,000 100 million
| Item | Details |
|---|---|
| Document type | Financial results presentation |
| Fiscal Period Covered | Q3 FY2026 |
| Net Sales | ¥323 million |
| Operating profit | ¥-633 million |
| Ordinary income | ¥-628 million |
| Net income | ¥-631 million |
| Selling, general and administrative expenses | ¥887 million |
| Full-year earnings forecast | Sales ¥332 million / Cost of sales Not disclosed / Selling, General and Administrative Expenses ¥1,351 million / Research and development costs ¥973 million / Operating loss ¥-1,018 million / Ordinary loss ¥-1,018 million / Extraordinary Gains and Losses Not disclosed / Income Taxes ¥1 million / Quarterly net loss ¥-1,020 million |
| Breakdown of Factors Affecting the Change | Revenue: supply of active pharmaceutical ingredients to クラリス and technology access fees. Research and development expenses: preparation costs for an additional spinal cord injury trial, preparation costs for U.S. development, including an IND filing, and clinical trial costs for vocal fold scarring. |
| Key KPIs | Indicator name Improvement rate from AIS A to AIS C or above in the Phase 3 trial for acute spinal cord injury / Value 12 % / Year on year against the same period last year Not disclosed, Indicator name Improvement rate from AIS A to AIS B or above in the Phase 3 trial for acute spinal cord injury / Value 56 % / Year on year against the same period last year Not disclosed, Indicator name Percentage of patients with reduced MRI abnormal areas in the Phase 3 HGF treatment group / Value 52 % / Year on year against the same period last year Not disclosed, Indicator name Number of enrolled cases in the Phase 3 trial for vocal fold scarring / Value 65 cases / Year on year against the same period last year Not disclosed, Indicator name Warrant exercise rate / Value 87.6 % / Year on year against the same period last year Not disclosed |
| Number of employees | Number of Employees 19 people / Reference date End of June 2026 |
| Financial targets | Equity ratio Actual value 60.9 % |
| Market Size / Share | Subject Acute spinal cord injury, Japan / Market Size ¥120 100 million, Subject Acute spinal cord injury, worldwide / Market Size ¥600 100 million, Subject Vocal fold scarring, Japan / Market Size ¥50 100 million, Subject Vocal fold scarring, worldwide / Market Size ¥300 100 million, Subject ALS, Japan / Market Size ¥200 100 million, Subject ALS, worldwide / Market Size ¥1,000 100 million |
| New initiatives | Submission of the clinical trial notification and start of an additional Phase 3 trial for acute spinal cord injury, Basic agreement with 丸石製薬 on exclusive domestic sales of a treatment for vocal fold scarring, Start of joint research on protein biomarkers with Keio University, Participation in the international SCI PFDD consortium, Preparation for U.S. development, including an IND filing, Development of a commercial formulation for vocal fold scarring |
Items this document does not state (17)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.The increase in revenue was attributable to the supply of active pharmaceutical ingredients to クラリス and technology access fees. The increase in research and development expenses was attributable to preparation costs for an additional spinal cord injury trial, preparation costs for U.S. development, including an IND filing, and clinical trial costs for vocal fold scarring.