Contents of this document
- Increase in revenue (supply of HGF active pharmaceutical ingredients to クラリス社)¥260 million
- Increase in SG&A expenses¥107 million
- Increase in R&D expenses¥74 million
- Agreement with PMDA on the outline of an additional clinical trial for acute spinal cord injury
- Establishment of a U.S. subsidiary to advance development in the United States and Europe, fundraising, and clinical development
- Registration of a Japanese patent for a therapeutic agent for chronic spinal cord injury
- Joint research with Kyoto University on a sustained-release wound treatment
- Preparation for the U.S. IND filing for acute spinal cord injury
- Development of a commercial formulation for vocal fold scarring
- Number of employees19 People
- Number of patients in the Phase III trial for acute spinal cord injury25 cases
- Number of enrolled patients in the Phase III trial for vocal fold scarring65 cases
- Number of sites conducting the Phase III trial for vocal fold scarring8 Facility
- Exercise rate of stock acquisition rights69.7 %
- Acute spinal cord injuryJapan: approximately ¥12 billion; worldwide: approximately ¥60 billion
- Vocal fold scarringJapan: approximately ¥5 billion; worldwide: approximately ¥30 billion
- ALSJapan: approximately ¥20 billion; worldwide: approximately ¥100 billion
- Competitive comparison for vocal fold scarringDetailsThe Company is the only company with a product in Phase III, the only company conducting a company-sponsored clinical trial, and the only company using a non-cell-therapy modality
| Item | Details |
|---|---|
| Document type | Presentation materials for financial results |
| Fiscal Period Covered | Second quarter of the fiscal year ending September 2026 |
| Net Sales | ¥36 million |
| Operating profit | ¥-515 million |
| Ordinary income | ¥-513 million |
| Net income | ¥-516 million |
| Selling, general and administrative expenses | ¥552 million |
| Full-year earnings forecast | Net 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 / Net loss for the period ¥-1,020 million |
| Breakdown of Factors Affecting the Change | Factors Increase in revenue (supply of HGF active pharmaceutical ingredients to クラリス社) / Amount ¥260 million, Factors Increase in SG&A expenses / Amount ¥107 million, Factors Increase in R&D expenses / Amount ¥74 million |
| Key KPIs | Indicator name Number of employees / Value 19 People / Year on year against the same period last year Not disclosed, Indicator name Number of patients in the Phase III trial for acute spinal cord injury / Value 25 cases / Year on year against the same period last year Not disclosed, Indicator name Number of enrolled patients in the Phase III trial for vocal fold scarring / Value 65 cases / Year on year against the same period last year Not disclosed, Indicator name Number of sites conducting the Phase III trial for vocal fold scarring / Value 8 Facility / Year on year against the same period last year Not disclosed, Indicator name Exercise rate of stock acquisition rights / Value 69.7 % / Year on year against the same period last year Not disclosed |
| Number of employees | Number of Employees 19 People / Reference date End of March 2026 / Changes during the period and hiring plan Not disclosed |
| Financial targets | Equity ratio Actual results 45.9 % / Comparison 61.5% at the end of the fiscal year ended September 2025 |
| Market Size / Share | Subject Acute spinal cord injury / Market Size Japan: approximately ¥12 billion; worldwide: approximately ¥60 billion, Subject Vocal fold scarring / Market Size Japan: approximately ¥5 billion; worldwide: approximately ¥30 billion, Subject ALS / Market Size Japan: approximately ¥20 billion; worldwide: approximately ¥100 billion, Subject Competitive comparison for vocal fold scarring / Details The Company is the only company with a product in Phase III, the only company conducting a company-sponsored clinical trial, and the only company using a non-cell-therapy modality |
| New initiatives | Agreement with PMDA on the outline of an additional clinical trial for acute spinal cord injury, Establishment of a U.S. subsidiary to advance development in the United States and Europe, fundraising, and clinical development, Registration of a Japanese patent for a therapeutic agent for chronic spinal cord injury, Joint research with Kyoto University on a sustained-release wound treatment, Preparation for the U.S. IND filing for acute spinal cord injury, 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.Revenue was generated from a technology access fee from クラリス社. Research and development expenses were allocated to preparations for filing for approval for the spinal cord injury treatment, preparations for development in the United States, and the clinical trial for vocal fold scarring. The revision to the full-year forecast reflects an increase in revenue from supplying HGF active pharmaceutical ingredients to クラリス社 and higher research and development expenses for preparations for the U.S. IND filing for spinal cord injury and the development of new pipelines, among other items.