4598.T

• Financial Position and Capital Raising

  • Exercise of the 10th new share purchase warrants issued in April was fully completed between October 1 and November 7, after prior exercises through September increased cash and cash equivalents, net assets, and current assets.
  • 500,000 shares of the 9th fixed-type new share purchase warrants remain outstanding, with the exercise price adjusted from 850 yen to 812 yen in April.
  • All remaining funds from the 5th and 6th new share purchase warrants, allocated to DFP-14323 Phase 3 trial R&D, were fully utilized by the end of the second quarter. Minor remaining funds for DFP-17729 and DFP-11207 from the 7th tranche are being sequentially allocated to DFP-17729's upcoming Phase 2/3 trial. The 8th tranche, allocated to DFP-10917 monotherapy and combination trials, has a relatively high utilization rate, and the 10th tranche is primarily allocated to DFP-10917 and DFP-14323 at present.

• Pipeline Development Status

  • DFP-10917 (for refractory/relapsed acute myeloid leukemia): Phase 3 monotherapy trial is progressing as scheduled in the US. Trial data is currently being entered by statistical analysts, and will be submitted to the DSMB for review once data entry and interim analysis are complete, to determine whether to file for FDA approval. The Phase 1/2 combination trial with VEN is on schedule, with Phase 2 patient enrollment expected to complete soon, followed by a short follow-up period for efficacy assessment, then DMC review and consultation with the FDA on whether to advance to Phase 3. In Japan, license partner Nippon Shinyaku is conducting Phase 1 trial in Japanese patients as scheduled.
  • DFP-14323 (oral therapy for end-stage lung cancer): Phase 3 trial is progressing as planned, with patient enrollment ongoing at 30 major domestic cancer centers.
  • DFP-17729 (oral therapy for end-stage pancreatic cancer): First patient has been enrolled for the planned Phase 2/3 trial, with enrollment ongoing at 15 sites.
  • DFP-11207 (oral therapy for post-surgical recurrence prevention for pancreatic/gastric cancer): Preparations for Phase 2 trial are progressing as scheduled.
  • DFP-14927 (DDS variant of DFP-10917, once-weekly dosing): Phase 2 trial is ongoing at two US cancer centers. No tumor shrinkage effects were observed in the completed colorectal cancer expansion trial, and preclinical work confirmed that DFP-10917 release rate from DFP-14927 is the key efficacy driver. The colorectal cancer trial is paused, and the expansion trial will continue with pancreatic cancer patients instead.
  • DFP-10825: Preparations for Phase 1 trial (to be conducted in the US or Japan) are ongoing.

• Management maintained the full-year 2026 March Fiscal Year guidance announced in May, with no changes. The full-year plan forecasts total business expenses of 1.5 billion yen, including just over 1.2 billion yen in R&D expenses and just under 0.3 billion yen in general and administrative expenses, with a projected net loss of 1.512 billion yen. Current budget execution is slightly above the planned rate.
  • Management will make timely disclosures and consider budget revisions if any revenue-generating events occur in the future.
  • Management expects next fiscal year (2027 March Fiscal Year) R&D expenses to be lower than the current fiscal year, though a final detailed budget will be prepared by March next year. R&D cost changes will depend on trial results: if the DFP-10917 + VEN combination trial confirms efficacy and advances to Phase 3, costs will increase in the second half of next fiscal year; DFP-14323, DFP-17729, and DFP-14927 are expected to have similar R&D costs to the current fiscal year; cost growth for DFP-11207 and DFP-10825 is dependent on finding licensing or co-development partners.

Delta-Fly Pharma reported 0 business revenue for the 2026 March Fiscal Year Second Quarter. Total business expenses were 831 million yen (0.831 billion yen), of which research and development expenses accounted for approximately 700 million yen (0.7 billion yen, 84.2% of total expenses), and general and administrative expenses were 133 million yen (0.133 billion yen, 16.0% of total expenses). Operating loss, ordinary loss, and net loss all fell between 830 million yen (0.83 billion yen) and 840 million yen (0.84 billion yen). Total assets ended the quarter at just over 500 million yen (0.5 billion yen).

• All R&D progress and cost projections are contingent on positive clinical trial results; negative efficacy or safety outcomes could alter trial timelines, increase costs, or lead to trial termination.
  • The company is still in the clinical development stage with no revenue, and R&D progress is dependent on continued successful capital raising to fund trials.
  • DFP-14927 failed to show efficacy in colorectal cancer, and its future efficacy in pancreatic cancer is unproven, carrying clinical development risk.

Q: When can DFP-10917 US Phase 3 data be submitted to the DSMB, and will submission happen this year or this fiscal half? / A: Management states the process does not take an extended period of time, but cannot give an exact timing, and the team is actively working to complete preparations for submission.\n\nQ: Will the DFP-10917 + VEN combination trial finish this fiscal year, and when will a decision on advancing to Phase 3 be made? / A: Patient enrollment for the Phase 2 portion is expected to complete soon, but a period of follow-up is needed to assess clinical benefit for enrolled patients. This follow-up will likely take around one quarter, and a decision on advancing to Phase 3 is expected to come in the 2027 March fiscal year.\n\nQ: After the negative colorectal cancer results, will DFP-14927 complete the current colorectal cancer expansion phase before starting pancreatic cancer trials? / A: DFP-14927 is already in an expansion trial, and its safety has already been confirmed in Phase 1. The company will amend the trial protocol to shift the expansion trial enrollment from colorectal cancer to pancreatic cancer directly, rather than completing the current colorectal cancer cohort first.\n\nQ: Will next fiscal year's R&D expenses increase or decrease compared to this year, given potential changes in trial activity? / A: If DFP-10917's Phase 3 monotherapy concludes, that cost burden will be eliminated. If the combination trial advances to Phase 3, new costs will arise in the second half of next fiscal year, dependent on trial results. DFP-14323, DFP-17729, and DFP-14927 will have similar costs to this year; slower-moving pipelines will only incur costs if partners are found. Overall, management expects next fiscal year R&D expenses to be lower than this year, with a final budget due by March next year.