Contents of this document
- Drug substance supply and technology access fee income from ClarisListed as a reason for the increase in revenue
- Contract upfront payment income from Maruishi PharmaceuticalListed as a reason for the increase in revenue
- Decline in R&D expenditure64
- Timing shift in expenses for developing a commercial formulation for vocal fold scarsListed as a reason for the decrease in expenses
- Start of an additional Phase III trial in acute spinal cord injury
- Establishment of a US subsidiary and US IND clearance
- Exclusive marketing license agreement with Maruishi Pharmaceutical for a treatment for vocal fold scars
- Advancement of preparations for a US Phase III trial in acute spinal cord injury
- Preparation for establishing a manufacturing system for recombinant human HGF drug substance using a new manufacturing process
- Funding through a private placement and stock acquisition rights
- Number of employees19 People
- Improvement of 15 or more letters in visual acuity in LSCD (at week 20, CSB-001 treatment group)41 %
- Improvement of 10 or more letters in visual acuity in LSCD (at week 20, CSB-001 treatment group)55 %
- Durability of the CSB-001 effect (eyes with an improvement of 15 or more letters)58 %
- Durability of the CSB-001 effect (eyes with an improvement of 10 or more letters)83 %
- Acute Spinal Cord InjuryApproximately ¥12.0 billionRegionJapan
- Acute Spinal Cord InjuryApproximately ¥60 billionRegionWorldwide
- Vocal Fold ScarringApproximately ¥5.0 billionRegionJapan
- Vocal Fold ScarringApproximately ¥30 billionRegionWorldwide
- ALSApproximately ¥20.0 billionRegionJapan
- ALSApproximately ¥100 billionRegionWorldwide
| Item | Details |
|---|---|
| Document type | Results presentation |
| Fiscal Period Covered | Full year ended September 2026 |
| Net Sales | ¥442 million (YoY +513.9%) |
| Operating profit | ¥-813 million (operating loss) (YoY +10.6%) |
| Ordinary income | ¥-810 million (ordinary loss) (YoY +11.4%) |
| Net income | ¥-813 million (net loss) (YoY +11.2%) |
| Selling, general and administrative expenses | ¥1,185 million |
| Full-year earnings forecast | Fiscal year ending September 2027 Net Sales ¥127 million / Cost of sales ¥0 million / Selling, General and Administrative Expenses ¥1,901 million / Research and Development Expenses ¥1,498 million / Operating loss ¥-1,773 million / Ordinary loss ¥-1,773 million / Net loss for the period ¥-1,775 million |
| Breakdown of Factors Affecting the Change | Factors Drug substance supply and technology access fee income from Claris / Amount Listed as a reason for the increase in revenue, Factors Contract upfront payment income from Maruishi Pharmaceutical / Amount Listed as a reason for the increase in revenue, Factors Decline in R&D expenditure / Amount 64, Factors Timing shift in expenses for developing a commercial formulation for vocal fold scars / Amount Listed as a reason for the decrease in expenses |
| Key KPIs | Indicator name Number of employees / Value 19 People / Year on year against the same period last year Not disclosed, Indicator name Improvement of 15 or more letters in visual acuity in LSCD (at week 20, CSB-001 treatment group) / Value 41 % / Year on year against the same period last year Not disclosed, Indicator name Improvement of 10 or more letters in visual acuity in LSCD (at week 20, CSB-001 treatment group) / Value 55 % / Year on year against the same period last year Not disclosed, Indicator name Durability of the CSB-001 effect (eyes with an improvement of 15 or more letters) / Value 58 % / Year on year against the same period last year Not disclosed, Indicator name Durability of the CSB-001 effect (eyes with an improvement of 10 or more letters) / Value 83 % / Year on year against the same period last year Not disclosed |
| Number of employees | Number of Employees 19 People / Change during the period Not disclosed / Hiring plan Not disclosed |
| Assumptions Underlying the Business Outlook | Revenue from new partnerships and other arrangements may arise, but because this is uncertain at present, it has not been included in the revenue forecast for the fiscal year ending September 2027 |
| Financial targets | Target Not disclosed / Actual results Equity ratio 57.1% |
| Market Size / Share | Subject Acute Spinal Cord Injury / Region Japan / Market Size Approximately ¥12.0 billion, Subject Acute Spinal Cord Injury / Region Worldwide / Market Size Approximately ¥60 billion, Subject Vocal Fold Scarring / Region Japan / Market Size Approximately ¥5.0 billion, Subject Vocal Fold Scarring / Region Worldwide / Market Size Approximately ¥30 billion, Subject ALS / Region Japan / Market Size Approximately ¥20.0 billion, Subject ALS / Region Worldwide / Market Size Approximately ¥100 billion |
| New initiatives | Start of an additional Phase III trial in acute spinal cord injury, Establishment of a US subsidiary and US IND clearance, Exclusive marketing license agreement with Maruishi Pharmaceutical for a treatment for vocal fold scars, Advancement of preparations for a US Phase III trial in acute spinal cord injury, Preparation for establishing a manufacturing system for recombinant human HGF drug substance using a new manufacturing process, Funding through a private placement and stock acquisition rights |
Items this document does not state (16)
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 for the fiscal year ended September 2026 was attributable to drug substance supply and technology access fee income from Claris, as well as contract upfront payment income from Maruishi Pharmaceutical. The reduction in losses was due to higher revenue, lower research and development expenses and other factors. The increase in losses forecast for the fiscal year ending September 2027 is due to higher research and development expenses for an additional domestic Phase III trial in acute spinal cord injury, preparations for a Phase III trial in the United States, and preparations for manufacturing a commercial formulation for vocal fold scars.