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Presentation materials for financial results4884Kringle Pharma,Inc.Pharmaceuticals

Materials for the Second-Quarter Financial Results Briefing for the Fiscal Year Ending September 2026

In the first half, revenue increased slightly year on year, while the operating loss and net loss widened. In development, the Company agreed with PMDA on the outline of an additional clinical trial for acute spinal cord injury and completed patient enrollment in the Phase III trial for vocal fold scarring.

Worth reading
42Recurring
0–100. This measures how worthwhile something is to read, not how good or bad the company is.
Direction
Mixed performance
Direction inferred from the company’s description.
Scale
4
Year-on-year deterioration in operating loss (¥ million)
Wording
Avoiding a definitive answer
How definitive the wording is.

Contents of this document

Presentation materials for financial resultsSecond quarter of the fiscal year ending September 20266 items taken from the company’s own explanation
Financial Results Figures (The key points of this material are explained below)
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
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
What the company explained in this material
Breakdown of Factors Affecting the ChangeReasons cited by the Company for the change in the figures.
  • 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
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
Key KPIsA metric the company considers important as a management benchmark.
  • 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 %
Financial targets
Equity ratio
Actual results45.9 %
Comparison61.5% at the end of the fiscal year ended September 2025
Market Size / Share
  • 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 scarring
    DetailsThe 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
Number of employees
Number of Employees19 People
Reference dateEnd of March 2026
Contents of this document
ItemDetails
Document typePresentation materials for financial results
Fiscal Period CoveredSecond 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 forecastNet 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 ChangeFactors 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 KPIsIndicator 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 employeesNumber of Employees 19 People / Reference date End of March 2026 / Changes during the period and hiring plan Not disclosed
Financial targetsEquity ratio Actual results 45.9 % / Comparison 61.5% at the end of the fiscal year ended September 2025
Market Size / ShareSubject 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 initiativesAgreement 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)
Gross Profit MarginOperating profit marginResults for the three months of the current quarterProgress against full-year forecastSelf-assessment against the planSegment resultsUnit price and quantity metricsNumber of stores and locationsAssumptions Underlying the Business OutlookRisk amount incorporated into the outlookMedium-term management plan targetsAnnual DividendPayout ratioAcquisition of treasury sharesCapital expendituresOrders received and order backlogKey points of the Q&A

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.

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Materials for the Second-Quarter Financial Results Briefing for the Fiscal Year Ending September 2026 | Kringle Pharma,Inc. (4884) timely disclosure | Komori