Delta-Fly Pharma,Inc.
4598・Growth Market・Pharmaceuticals
Business
Delta-Fly Pharma, Inc. is a drug discovery venture established in December 2010, dedicated exclusively to anticancer drug development. Through its proprietary "module-based drug discovery" method, the company combines existing anticancer active substances as building blocks (modules) to create novel anticancer drugs with an improved balance of efficacy and safety. Its target diseases are focused on refractory cancers such as acute myeloid leukemia (AML), lung cancer, pancreatic cancer, and biliary tract cancer. The company owns no research laboratories or manufacturing facilities, instead adopting a lightweight R&D management structure that utilizes external contract organizations. It listed on the Tokyo Stock Exchange (now the Growth Market) in October 2018.
Business Model
The Company does not manufacture or sell products itself but adopts a business model of earning revenue by licensing out its development pipeline to pharmaceutical companies. Revenue takes four forms: an "upfront payment" upon contract execution, "milestone payments" tied to development progress, "development cost contributions" whereby the partner bears development expenses, and "royalties" following market launch. The Company has already concluded exclusive domestic licensing agreements with Nippon Shinyaku Co., Ltd. (DFP-10917) and Nippon Chemiphar Co., Ltd. (DFP-14323, DFP-17729), and continues to pursue the development of global partners in the US, Europe, and Asia.
Company Strengths
Module-based drug discovery, which combines active substances from existing approved anticancer drugs, largely eliminates the need for basic exploratory research and has a track record of enabling clinical trials to begin within 1 to 2 years of initiation. High predictive accuracy for clinical efficacy and safety, together with reduced development risk compared with typical anticancer drug development, constitute the Company's unique competitive advantage.
Six products are at the clinical stage, including DFP-10917 (AML; US Phase 3 completed, Phase 1/2 ongoing), DFP-14323 (lung cancer; domestic Phase 3 ongoing), and DFP-17729 (pancreatic cancer; domestic Phase 2/3 ongoing). Exclusive licensing agreements have been concluded with Nippon Shinyaku Co., Ltd. and Japan Chemical Research Co., Ltd., and the diversity of the pipeline together with the Company's existing track record of partnerships constitute its unique strengths.
The Company owns no research facilities or manufacturing facilities of its own, and instead outsources operations to external contract research organizations and contract manufacturing organizations. A small team of specialists with extensive experience in anticancer drug development focuses exclusively on management, achieving an organizational structure that can advance multiple pipelines in parallel while keeping fixed costs low.
ENVALITH's Perspective
Performance Trend
Operating loss for FY2026 (ending March 2026) narrowed 6.0% to ¥1,605 million (prior period: ¥1,708 million), turning from an expanding-loss trend to improvement. R&D expenses decreased to ¥1,330 million (prior period: ¥1,438 million), while other SG&A expenses were roughly flat at ¥275 million (prior period: ¥270 million). Business revenue remained at zero for the fifth consecutive fiscal year. On the financial front, total assets fell sharply to ¥246 million (prior period: ¥434 million) and net assets fell sharply to ¥33 million (prior period: ¥277 million). Capital reinforcement through the exercise of stock acquisition rights (¥1,381 million) partially offset the loss, but the accumulated deficit in retained earnings expanded to ¥11,557 million. Regarding the external environment, uncertainties such as US tariff policy and the situation in the Middle East may affect the costs of conducting clinical trials and foreign exchange rates.
Growth Strategy
Advancing clinical progress across multiple pipelines and monetization through global license agreement conclusion
The Phase 1/2 trial in the United States achieved the target overall response rate, and the DMC recommended proceeding to the next-phase trial. Follow-up will continue and preparations for the Phase 3 clinical trial will proceed in the next fiscal period. This program is positioned as the flagship development program following the discontinuation of the monotherapy Phase 3 trial.
Patient enrollment for the Phase 3 clinical trial is continuing at approximately 30 major core hospitals in Japan. Based on the license agreement with Japan Chemical Research Co., Ltd. (Nippon Chemiphar), the company aims to obtain milestone revenue in line with trial progress. This is expected to continue into the next fiscal period.
Patient enrollment for the Phase 2 portion of the domestic Phase 2/3 clinical trial is continuing. This development is based on the license agreement with Japan Chemical Research Co., Ltd. (Nippon Chemiphar). It is expected to continue into the next fiscal period, with transition to Phase 3 following completion of Phase 2 as the next milestone.
Manufacturing of the investigational drug was completed, and a new Phase 1/2 clinical trial was launched as an investigator-initiated trial targeting biliary tract cancer, in collaboration with the Japan Hepato-Biliary-Pancreatic Oncology Network. The aim is to enhance corporate value through pipeline expansion.
Preclinical trials have been completed, and the company is at the stage of examination and preparation for initiating the Phase 1 clinical trial. Progress in the development stage is expected to serve as material for new licensing negotiations.
With an effective date of August 3, 2026, the company plans to implement a no-cost capital reduction reducing capital stock by ¥5,772,971 thousand and capital reserve by ¥5,784,268 thousand, transferring these amounts to other capital surplus, in order to cover an accumulated deficit of ¥11,557,239 thousand in retained earnings. There will be no change to net assets or the number of shares issued.
Last updated: July 19, 2026