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Neutral
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Displayed only when the document provides numerical figures.Wording
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How definitive the wording is.Contents of this document
Summary of Q&ASecond quarter of the fiscal year ending September 20262 items taken from the company’s own explanation
What the company explained in this material
Key points of the Q&AKey questions raised by investors at the briefing and the company's answers
- Issues Additional domestic clinical trial in acute spinal cord injury / Summary of response The company aims to submit the clinical trial notification within several months and will disclose details after it is accepted. The trial is expected to begin by the end of the current fiscal year. It is planned as a single-arm, open-label study comparing results with real-world data and enrolling patients classified as AIS Grade A.
- Issues Development strategy in the United States / Summary of response The company is preparing an IND application for acute spinal cord injury and is working to raise awareness among KOLs and patients, collect evidence, secure public grants, and establish business development and partnering capabilities.
- Issues Partnering discussions / Summary of response The company cannot disclose the parties involved or specific progress because of confidentiality obligations, but discussions with multiple companies are deepening. It aims to report results in vocal cord scarring by the end of the year.
- Issues Response to conference presentations / Summary of response The company received strong interest from specialists and researchers, and discussions covered results suggesting functional improvement in severe cervical spinal cord injury as well as the difficulty of development.
- Issues クラリス社's activities / Summary of response クラリス社 is advancing clinical development in multiple ophthalmic fields in the United States, and placed an order for HGF active pharmaceutical ingredient in March. The company expects further orders in the future.
- Issues Chronic spinal cord injury / Summary of response For the time being, the company will prioritize development of HGF protein as a monotherapy for acute spinal cord injury. For chronic spinal cord injury, it will advance basic and preclinical research and consider future options, including partnering.
- Issues Fundraising Through Stock Acquisition Rights / Summary of response At the current share price, reaching the initially planned financing amount will be difficult, but the company expects to secure nearly all of the additional clinical development costs and commercial formulation development costs. It aims to obtain working capital through sales of active pharmaceutical ingredient and business development activities.
- Issues Pipeline review / Summary of response The company is not considering any specific development discontinuations. It explained that it is in a position to decide when to incur expenses and whether to stop or resume development spending depending on its funding situation.
- Issues European Expansion / Summary of response The company has obtained orphan designations in Japan, the United States and Europe, but will prioritize clinical development in Japan and the United States for the time being. In Europe, it will progressively develop its strategy on the assumption that it will work with external partners.
- Issues New Pipeline / Summary of response The company is conducting research activities with more than 10 universities and research institutions, and joint research on conditions including osteonecrosis of the femoral head and idiopathic pulmonary fibrosis is progressing.
New initiatives
- Preparation for an additional domestic clinical trial in acute spinal cord injury
- Preparation for an IND application for acute spinal cord injury in the United States
- Securing grants from the U.S. government and public institutions and establishing business development and partnering capabilities
- Partnering discussions with multiple pharmaceutical companies aimed at regulatory approval and commercialization of a treatment for vocal cord scarring
- Research into, and consideration of future partnering for, an approach combining HGF protein and cell therapy for chronic spinal cord injury
- Research into new pipeline candidates with universities and research institutions
| Item | Details |
|---|---|
| Document type | Summary of Q&A |
| Fiscal Period Covered | Second quarter of the fiscal year ending September 2026 |
| Key points of the Q&A | Issues Additional domestic clinical trial in acute spinal cord injury / Summary of response The company aims to submit the clinical trial notification within several months and will disclose details after it is accepted. The trial is expected to begin by the end of the current fiscal year. It is planned as a single-arm, open-label study comparing results with real-world data and enrolling patients classified as AIS Grade A., Issues Development strategy in the United States / Summary of response The company is preparing an IND application for acute spinal cord injury and is working to raise awareness among KOLs and patients, collect evidence, secure public grants, and establish business development and partnering capabilities., Issues Partnering discussions / Summary of response The company cannot disclose the parties involved or specific progress because of confidentiality obligations, but discussions with multiple companies are deepening. It aims to report results in vocal cord scarring by the end of the year., Issues Response to conference presentations / Summary of response The company received strong interest from specialists and researchers, and discussions covered results suggesting functional improvement in severe cervical spinal cord injury as well as the difficulty of development., Issues クラリス社's activities / Summary of response クラリス社 is advancing clinical development in multiple ophthalmic fields in the United States, and placed an order for HGF active pharmaceutical ingredient in March. The company expects further orders in the future., Issues Chronic spinal cord injury / Summary of response For the time being, the company will prioritize development of HGF protein as a monotherapy for acute spinal cord injury. For chronic spinal cord injury, it will advance basic and preclinical research and consider future options, including partnering., Issues Fundraising Through Stock Acquisition Rights / Summary of response At the current share price, reaching the initially planned financing amount will be difficult, but the company expects to secure nearly all of the additional clinical development costs and commercial formulation development costs. It aims to obtain working capital through sales of active pharmaceutical ingredient and business development activities., Issues Pipeline review / Summary of response The company is not considering any specific development discontinuations. It explained that it is in a position to decide when to incur expenses and whether to stop or resume development spending depending on its funding situation., Issues European Expansion / Summary of response The company has obtained orphan designations in Japan, the United States and Europe, but will prioritize clinical development in Japan and the United States for the time being. In Europe, it will progressively develop its strategy on the assumption that it will work with external partners., Issues New Pipeline / Summary of response The company is conducting research activities with more than 10 universities and research institutions, and joint research on conditions including osteonecrosis of the femoral head and idiopathic pulmonary fibrosis is progressing. |
| New initiatives | Preparation for an additional domestic clinical trial in acute spinal cord injury, Preparation for an IND application for acute spinal cord injury in the United States, Securing grants from the U.S. government and public institutions and establishing business development and partnering capabilities, Partnering discussions with multiple pharmaceutical companies aimed at regulatory approval and commercialization of a treatment for vocal cord scarring, Research into, and consideration of future partnering for, an approach combining HGF protein and cell therapy for chronic spinal cord injury, Research into new pipeline candidates with universities and research institutions |
Items this document does not state (27)
Net SalesOperating profitOrdinary incomeNet incomeGross Profit MarginOperating profit marginSelling, general and administrative expensesResults for the three months of the current quarterFull-year earnings forecastProgress against full-year forecastSelf-assessment against the planSegment resultsBreakdown of Factors Affecting the ChangeKey KPIsUnit price and quantity metricsNumber of stores and locationsNumber of employeesAssumptions Underlying the Business OutlookRisk amount incorporated into the outlookMedium-term management plan targetsFinancial targetsAnnual DividendPayout ratioAcquisition of treasury sharesCapital expendituresOrders received and order backlogMarket Size / Share
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 company explained its future development and partnering strategies and the timing of disclosures, citing discussions with the PMDA, preparations for submitting clinical trial notifications, preparations for an IND application in the United States, securing development funding and confidentiality obligations with potential partners.
How to read this page
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