Komori
Management planning4598Delta-Fly Pharma,Inc.Pharmaceuticals

Disclosure of Matters Concerning Business Plans and Growth Potential

Updated the previous disclosure to present results for the fiscal year ended March 2026 and the business plan for the fiscal year ending March 2027. No milestone revenue is included in the plan, and R&D expenses and losses are expected to decrease from the previous fiscal year's results while investment in the key development pipelines continues.

Worth reading
48Recurring
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
275
Millions of yen (improvement in operating loss)
Wording
Avoiding a definitive answer
How definitive the wording is.

Items stated in the management plan

Annual update
Business Plan (Forecast for the Fiscal Year Ending March 2027)Plan period Fiscal year ending March 2027
Publication date 22 June 2026
Operating profit-17.1%
基準 1,605Target1,330million
Net income for the current fiscal year-16.9%
基準 1,625Target1,350million

Each line is the climb from the baseline the document states to the target it sets. The slope is scaled against the largest climb in this document. The increase shown by the dotted line is calculated from the two reported figures because the company did not provide the amount of growth.

What happened to the previous planForecast for the fiscal year ended March 2026: business expenses 1,500, operating profit △1,500, net income △1,512 → Actual results for the fiscal year ended March 2026: business expenses 1,605, operating profit △1,605, net income △1,625(Business expenses 107%, operating profit 107%, net income 107% (progress against forecast))0.0%Calculated from the two disclosed figures
Investment amount by sectorField Clinical Development / Amount Not disclosed, Field Strengthening the Development Structure / Amount Not disclosed
Key initiatives
01Advance clinical trials
02Conduct additional analyses and maximize value
03Regulatory approval, commercialization and partnering
04Continue discussions with the FDA
05Conduct additional and subgroup analyses
06Advance development of venetoclax combination therapy
07Advance strategic partnering
08DFP-10917 plus venetoclax combination therapy
09DFP-14323
10DFP-14927
11DFP-17729
Plan assumptionsAlthough milestone revenue may be secured, no revenue is included at this time due to uncertainty regarding the timing of negotiations and development progress.
Non-financial targetsIndicator Overall response rate (ORR) for DFP-10917 plus venetoclax combination therapy / Target value 50% in the Phase 1 part and 53% in the Phase 2 part (achieving the target ORR) / Timing As of May 2026
Size of the Target MarketSubject Acute myeloid leukemia (AML) / Scale Approximately 100,000 worldwide and approximately 8,800 in Japan (estimated annual number of patients) / Source Prepared by the Company based on Cancer Statistics 2026 (Japan Foundation for the Promotion of Cancer Research), Cancer Statistics, 2026 (United States), and other sources, Subject Relapsed/refractory AML (United States) / Scale Approximately 11,500 patients eligible for treatment; an estimated 50% of patients with the disease are relapsed/refractory / Source Not disclosed, Subject Lung cancer / Scale Approximately 1.8 million worldwide and approximately 75,700 in Japan (estimated annual number of patients) / Source Prepared by the Company based on Cancer Statistics 2026 (Japan Foundation for the Promotion of Cancer Research) and other sources, Subject Pancreatic cancer / Scale Approximately 505,000 worldwide and approximately 41,500 in Japan (estimated annual number of patients) / Source Prepared by the Company based on Cancer Statistics 2026 (Japan Foundation for the Promotion of Cancer Research) and other sources, Subject Biliary tract cancer / Scale Approximately 200,000 worldwide and approximately 17,200 in Japan (estimated annual number of patients) / Source Prepared by the Company based on Cancer Statistics 2026 (Japan Foundation for the Promotion of Cancer Research) and other sources, Subject Stomach cancer / Scale Approximately 1 million worldwide and approximately 104,000 in Japan (estimated annual number of patients) / Source Prepared by the Company based on Cancer Statistics 2026 (Japan Foundation for the Promotion of Cancer Research) and other sources
Risks identified by the company
Management of R&D risks
Ensuring business continuity
Uncertainty regarding development progress
Uncertainty regarding the timing of negotiations
Reason for revision or withdrawal

Although milestone revenue may be secured, the plan does not include revenue at this time due to uncertainty regarding the timing of negotiations and development progress. Business expenses are expected to decline as R&D expenses decrease through efficiency gains following the completion of certain clinical trials, although investment in key pipelines will continue.

Items stated in the management plan
ItemDetails
Plan nameBusiness Plan (Forecast for the Fiscal Year Ending March 2027)
Plan periodFiscal year ending March 2027
Progress against the planAnnual update
Operating profit target△1,605 → △1,330(83%)
Net income target△1,625 → △1,350(83%)
Investment amount by sectorField Clinical Development / Amount Not disclosed, Field Strengthening the Development Structure / Amount Not disclosed
Non-financial targetsIndicator Overall response rate (ORR) for DFP-10917 plus venetoclax combination therapy / Target value 50% in the Phase 1 part and 53% in the Phase 2 part (achieving the target ORR) / Timing As of May 2026
Plan assumptionsAlthough milestone revenue may be secured, no revenue is included at this time due to uncertainty regarding the timing of negotiations and development progress.
Key initiativesAdvance clinical trials, Conduct additional analyses and maximize value, Regulatory approval, commercialization and partnering, Continue discussions with the FDA, Conduct additional and subgroup analyses, Advance development of venetoclax combination therapy, Advance strategic partnering, DFP-10917 plus venetoclax combination therapy, DFP-14323, DFP-14927, DFP-17729
Results under the previous planForecast for the fiscal year ended March 2026: business expenses 1,500, operating profit △1,500, net income △1,512 → Actual results for the fiscal year ended March 2026: business expenses 1,605, operating profit △1,605, net income △1,625(Business expenses 107%, operating profit 107%, net income 107% (progress against forecast))
Reason for revision or withdrawalAlthough milestone revenue may be secured, the plan does not include revenue at this time due to uncertainty regarding the timing of negotiations and development progress. Business expenses are expected to decline as R&D expenses decrease through efficiency gains following the completion of certain clinical trials, although investment in key pipelines will continue.
Size of the Target MarketSubject Acute myeloid leukemia (AML) / Scale Approximately 100,000 worldwide and approximately 8,800 in Japan (estimated annual number of patients) / Source Prepared by the Company based on Cancer Statistics 2026 (Japan Foundation for the Promotion of Cancer Research), Cancer Statistics, 2026 (United States), and other sources, Subject Relapsed/refractory AML (United States) / Scale Approximately 11,500 patients eligible for treatment; an estimated 50% of patients with the disease are relapsed/refractory / Source Not disclosed, Subject Lung cancer / Scale Approximately 1.8 million worldwide and approximately 75,700 in Japan (estimated annual number of patients) / Source Prepared by the Company based on Cancer Statistics 2026 (Japan Foundation for the Promotion of Cancer Research) and other sources, Subject Pancreatic cancer / Scale Approximately 505,000 worldwide and approximately 41,500 in Japan (estimated annual number of patients) / Source Prepared by the Company based on Cancer Statistics 2026 (Japan Foundation for the Promotion of Cancer Research) and other sources, Subject Biliary tract cancer / Scale Approximately 200,000 worldwide and approximately 17,200 in Japan (estimated annual number of patients) / Source Prepared by the Company based on Cancer Statistics 2026 (Japan Foundation for the Promotion of Cancer Research) and other sources, Subject Stomach cancer / Scale Approximately 1 million worldwide and approximately 104,000 in Japan (estimated annual number of patients) / Source Prepared by the Company based on Cancer Statistics 2026 (Japan Foundation for the Promotion of Cancer Research) and other sources
Risks identifiedManagement of R&D risks, Ensuring business continuity, Uncertainty regarding development progress, Uncertainty regarding the timing of negotiations
Publication date22 June 2026
Items this document does not state (11)
Sales TargetOperating profit margin targetROE targetROIC targetPayout ratio / DOE policyTreasury share acquisition policyCost of capitalSelf-assessment of PBR and share priceTotal investment planSegment targetDate of board resolution

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.

Although milestone revenue may be secured, it is not included at this time due to uncertainty regarding the timing of negotiations and development progress. For business expenses, the Company expects R&D expenses to decrease through efficiency gains following the completion of certain clinical trials, while continuing to invest in key pipelines.

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Disclosure of Matters Concerning Business Plans and Growth Potential | Delta-Fly Pharma,Inc. (4598) timely disclosure | Komori