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Presentation materials for financial results4598Delta-Fly Pharma,Inc.Pharmaceuticals

Financial Results Briefing Materials for the Fiscal Year Ending March 2026

The fiscal year ending March 2026 generated no business revenue, while expenses, mainly research and development expenses, exceeded the plan, resulting in an operating loss and net loss. However, the loss narrowed from the previous fiscal year, and research and development expenses are expected to decline in the fiscal year ending March 2027 following the completion of some clinical trials.

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
1605
¥ million (business expenses for the fiscal year ending March 2026)
Wording
Avoiding a definitive answer
How definitive the wording is.

Contents of this document

Presentation materials for financial resultsFiscal year ending March 2026, full year5 items taken from the company’s own explanation
Financial Results Figures (The key points of this material are explained below)
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
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 通期の予想に対して、いまどこまで進んだかの割合です。
Operating Costs107%
Research and development costs110%
General and administrative expenses95%
Operating profit107%
Ordinary income107%
Net income for the current fiscal year107%
What the company explained in this material
Self-assessment against the planThe company's self-assessment against its own plan.
Overall, results were broadly in line with the full-year forecast
Breakdown of Factors Affecting the ChangeReasons cited by the Company for the change in the figures.
Additional costs associated with the progress of the DFP-10917 trialAmount not disclosed
Clinical development costs for the DFP-10917 plus VEN combination therapyAmount not disclosed
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
Key KPIsA metric the company considers important as a management benchmark.
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 worldwideApproximately 100,000 people
Annual leukemia deaths in JapanApproximately 8,800 people
Potential AML treatment patients in the United StatesApproximately 23,000 people
AML patients eligible for treatment in the United StatesApproximately 11,500 people
Annual lung cancer deaths worldwideApproximately 1,800,000 people
Annual lung cancer deaths in JapanApproximately 75,700 people
Annual pancreatic cancer deaths worldwideApproximately 505,000 people
Annual pancreatic cancer deaths in JapanApproximately 41,500 people
Annual biliary tract cancer deaths worldwideApproximately 200,000 people
Annual biliary tract cancer deaths in JapanApproximately 17,200 people
Contents of this document
ItemDetails
Document typePresentation materials for financial results
Fiscal Period CoveredFiscal 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 forecastBusiness 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 forecastOperating 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 planOverall, results were broadly in line with the full-year forecast
Breakdown of Factors Affecting the ChangeAdditional 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 KPIsNumber 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 / ShareAnnual 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 initiativesLaunch 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)
Net SalesGross Profit MarginOperating profit marginResults for the three months of the current quarterSegment resultsUnit 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 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.

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.

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Financial Results Briefing Materials for the Fiscal Year Ending March 2026 | Delta-Fly Pharma,Inc. (4598) timely disclosure | Komori