Contents of this document
- Launch a physician-initiated clinical trial for DFP-11207 jointly with the Japan Hepato-Biliary-Pancreatic Oncology Network
- Prepare for discussions with the US FDA toward a conditional NDA for DFP-10917 monotherapy
- Pursue out-licensing negotiations with overseas pharmaceutical companies, mainly concerning DFP-10917
- Explore overseas partnerships and co-development opportunities for other pipeline candidates
| Item | Details |
|---|---|
| Document type | Presentation materials for financial results |
| Fiscal Period Covered | Fiscal year ending March 2026, full year |
| Operating profit | ¥-1,605 million |
| Ordinary income | ¥-1,623 million |
| Net income | ¥-1,625 million |
| Selling, general and administrative expenses | ¥275 million |
| Full-year earnings forecast | Business profitability Not disclosed / Operating Costs ¥1,330 million / Research and development costs ¥1,070 million / General and administrative expenses ¥260 million / Operating profit ¥-1,330 million / Ordinary income ¥-1,340 million / Net income for the current fiscal year ¥-1,350 million |
| Progress against full-year forecast | Operating Costs 107% / Research and development costs 110% / General and administrative expenses 95% / Operating profit 107% / Ordinary income 107% / Net income for the current fiscal year 107% |
| Self-assessment against the plan | Overall, results were broadly in line with the full-year forecast |
| Breakdown of Factors Affecting the Change | Additional costs associated with the progress of the DFP-10917 trial Amount not disclosed / Clinical development costs for the DFP-10917 plus VEN combination therapy Amount not disclosed |
| Key KPIs | Number of development pipeline candidates 6 bottles / Number of pipeline candidates in clinical development 5 bottles / Response rate in the Phase 1 part of DFP-10917 plus VEN 50 % / Response rate in the Phase 2 part of DFP-10917 plus VEN 53 % / Number of DFP-10917 plus VEN patients proceeding to hematopoietic stem cell transplantation 4 Example / Number of sites enrolling patients for DFP-17729 16 Facility / Number of sites enrolling patients for DFP-14323 30 Sites (approximately 30 sites in Japan) |
| Market Size / Share | Annual leukemia deaths worldwide Approximately 100,000 people / Annual leukemia deaths in Japan Approximately 8,800 people / Potential AML treatment patients in the United States Approximately 23,000 people / AML patients eligible for treatment in the United States Approximately 11,500 people / Annual lung cancer deaths worldwide Approximately 1,800,000 people / Annual lung cancer deaths in Japan Approximately 75,700 people / Annual pancreatic cancer deaths worldwide Approximately 505,000 people / Annual pancreatic cancer deaths in Japan Approximately 41,500 people / Annual biliary tract cancer deaths worldwide Approximately 200,000 people / Annual biliary tract cancer deaths in Japan Approximately 17,200 people |
| New initiatives | Launch a physician-initiated clinical trial for DFP-11207 jointly with the Japan Hepato-Biliary-Pancreatic Oncology Network, Prepare for discussions with the US FDA toward a conditional NDA for DFP-10917 monotherapy, Pursue out-licensing negotiations with overseas pharmaceutical companies, mainly concerning DFP-10917, Explore overseas partnerships and co-development opportunities for other pipeline candidates |
Items this document does not state (18)
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.There was no business revenue. Business expenses increased mainly because of higher research and development expenses, including additional costs associated with the progress of the DFP-10917 trial, such as subgroup analyses and trial organization, as well as clinical development costs for the DFP-10917 plus VEN combination therapy. Research and development expenses are expected to decline in the fiscal year ending March 2027 as some clinical trials are completed and operations become more efficient, although investment in key pipelines will continue.