View ValuationDelta-Fly Pharma 将来の成長Future 基準チェック /06現在、 Delta-Fly Pharmaの成長と収益を予測するのに十分なアナリストの調査がありません。主要情報n/a収益成長率n/aEPS成長率Biotechs 収益成長39.0%収益成長率n/a将来の株主資本利益率n/aアナリストカバレッジNone最終更新日n/a今後の成長に関する最新情報更新なしすべての更新を表示Recent updatesお知らせ • Jun 28Delta-Fly Pharma, Inc. to Report Q1, 2027 Results on Aug 07, 2026Delta-Fly Pharma, Inc. announced that they will report Q1, 2027 results on Aug 07, 2026New Risk • Jun 05New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 44% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-JP¥1.6b free cash flow). Earnings have declined by 15% per year over the past 5 years. Shareholders have been substantially diluted in the past year (44% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (7.2% average weekly change). Market cap is less than US$100m (JP¥2.02b market cap, or US$12.6m).New Risk • May 20New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -JP¥1.6b This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-JP¥1.6b free cash flow). Earnings have declined by 15% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (7.8% average weekly change). Shareholders have been diluted in the past year (25% increase in shares outstanding). Market cap is less than US$100m (JP¥2.12b market cap, or US$13.3m).お知らせ • May 15Delta-Fly Pharma, Inc., Annual General Meeting, Jun 26, 2026Delta-Fly Pharma, Inc., Annual General Meeting, Jun 26, 2026.お知らせ • Feb 03Delta-Fly Pharma, Inc. announced that it has received ¥1.68 million in funding from Macquarie Bank LimitedOn February 2, 2026, Delta-Fly Pharma, Inc. closed the transaction. The company announced that it has disclosed the returning investor Macquarie Bank LimitedNew Risk • Jan 03New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 32% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-JP¥1.6b free cash flow). Share price has been highly volatile over the past 3 months (12% average weekly change). Earnings have declined by 13% per year over the past 5 years. Shareholders have been substantially diluted in the past year (32% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (JP¥6.20b market cap, or US$39.5m).お知らせ • Dec 27Delta-Fly Pharma, Inc. to Report Q3, 2026 Results on Feb 13, 2026Delta-Fly Pharma, Inc. announced that they will report Q3, 2026 results on Feb 13, 2026お知らせ • Sep 27Delta-Fly Pharma, Inc. to Report Q2, 2026 Results on Nov 14, 2025Delta-Fly Pharma, Inc. announced that they will report Q2, 2026 results on Nov 14, 2025New Risk • Aug 11New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -JP¥1.8b This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-JP¥1.8b free cash flow). Share price has been highly volatile over the past 3 months (8.4% average weekly change). Earnings have declined by 10% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (18% increase in shares outstanding). Market cap is less than US$100m (JP¥6.58b market cap, or US$44.5m).お知らせ • Jun 27Delta-Fly Pharma, Inc. to Report Q1, 2026 Results on Aug 08, 2025Delta-Fly Pharma, Inc. announced that they will report Q1, 2026 results on Aug 08, 2025お知らせ • May 15Delta-Fly Pharma, Inc., Annual General Meeting, Jun 26, 2025Delta-Fly Pharma, Inc., Annual General Meeting, Jun 26, 2025.お知らせ • Apr 30Delta-Fly Pharma, Inc. announced that it has received ¥252.5515 million in funding from Macquarie Bank LimitedOn April 30, 2025, Delta-Fly Pharma, Inc closed the transaction. The company issued 24,300 units of stock acquisition rights at ¥105 per unit for aggregate gross proceeds of ¥2,551,500 and Zero coupon 2nd Series, non convertible, unsecured bonds at a price of ¥100 per bond for aggregate gross proceeds of ¥250,000,000. The bonds have a conversion price of ¥100 and a maturity date of April 30, 2027.お知らせ • Mar 07Delta-Fly Pharma, Inc. to Report Fiscal Year 2025 Results on May 15, 2025Delta-Fly Pharma, Inc. announced that they will report fiscal year 2025 results on May 15, 2025お知らせ • Feb 28Delta-Fly Pharma, Inc. Announces Progress of Development Status of the Combination Study of Dfp-10917 with VenetoclaxDelta-Fly Pharma, Inc. announced that regarding the Phase I/II clinical trial of DFP-10917 in combination with Venetoclax (VEN) in patients with acute myeloid leukemia (AML) in second-line therapy (NCT06382168), the Data Management Committee (DMC) has approved the tolerability of all six patients in the Phase I (dose finding) portion of the Phase I/II study, and are moving to the Phase II portion of the trial for efficacy testing as of February 28, 2025.New Risk • Feb 16New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -JP¥1.7b This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-JP¥1.7b free cash flow). Share price has been highly volatile over the past 3 months (11% average weekly change). Earnings have declined by 5.4% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (18% increase in shares outstanding). Market cap is less than US$100m (JP¥5.70b market cap, or US$37.4m).New Risk • Jan 22New minor risk - Shareholder dilutionThe company's shareholders have been diluted in the past year. Increase in shares outstanding: 18% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (13% average weekly change). Earnings have declined by 3.8% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (18% increase in shares outstanding). Market cap is less than US$100m (JP¥5.13b market cap, or US$33.0m).お知らせ • Dec 10Delta-Fly Pharma Inc. Provides Update for Development Status of the Combination Study of DFP-10917 with VenetoclaxDelta-Fly Pharma, Inc. announced that the data review committee has approved the tolerability of the first three patients enrolled in the Phase I/II clinical trial of DFP-10917 in combination with Venetoclax (NCT06382168) conducted at five US clinical sites for patients with acute myeloid leukemia (who have failed/relapsed after standard VEN therapy (first-line therapy). Additionally, the bone marrow cell count in peripheral blood in all three cases was 0 (zero) within 4 weeks of starting treatment, and complete remission (CR or CRi) was confirmed by subsequent bone marrow biopsy. Three more patients will be added at the current dosage regimen, and after confirmation of the tolerability, the study will move to Phase II. Complete remission has been observed in patients who have failed/relapsed after existing VEN combination therapy (first-line therapy), so this is expected to be a new, highly effective second-line therapy for patients with AML. As previously reported, the data cleaning processes for interim analysis are currently underway for Phase III comparative clinical trial (150 cases) of DFP-10917 monotherapy targeting patients with AML receiving third-line or later therapy. Once this is completed, the results will be submitted to the Independent Data Safety Monitoring Committee (DSMB) along with electrocardiogram and pharmacokinetic study results for their advice.お知らせ • Dec 05Delta-Fly Pharma, Inc. to Report Q3, 2025 Results on Feb 14, 2025Delta-Fly Pharma, Inc. announced that they will report Q3, 2025 results on Feb 14, 2025お知らせ • Dec 04Delta-Fly Pharma Inc. Provides Update for Development Status of DFP-17729Delta-Fly Pharma, Inc. announce that as a result of consultation with the PMDA on December 3rd, 2024, the Phase II/III clinical trial of DFP-17729 in combination with TS-1 versus TS-1 alone in patients with pancreatic cancer after third-line treatment was approved. In a Phase I/II study of DFP-17729 in combination with TS-1 in patients with end-stage pancreatic cancer, no significant difference was observed against the control treatment (TS-1 or gemcitabine), but stratified analysis showed that when patients in the third-line or later treatment were treated for more than 6 weeks, DFP-17729 in combination with TS-1 showed a predominant median overall survival (mOS) prolongation (9.0 months vs. 6.1 months) and a significant correlation was also observed between urinary alkalinization and mOS in pancreatic cancer patients treated with DFP-17729, as key proof of concept. Had presented these results at the ESMO Gastrointestinal Cancers Congress 2024 and the 55 Annual Meeting of the Japan Pancreas Society, where much attention was paid to the presentation. DFP-17729 is a novel approach to neutralize the acidic cancer microenvironment, and several patents on related inventions have been granted in major countries around the world, and its potential of efficacy has been published in peer-reviewed journals. first identify DFP-17729 as a treatment for refractory pancreatic cancer, for which effective treatment is not yet available, and then seek to expand the indication to other types of cancer through partnership with major global pharmaceutical companies.お知らせ • Nov 26Delta-Fly Pharma, Inc. Announces Progress Update of the Phase III Clinical Trial of DFP-14323Delta-Fly Pharma, Inc. announced that Afatinib, which is being treated with DFP-14323 in ongoing Phase III clinical trial, has been approved by the Japanese Lung Cancer Society in its “Lung Cancer Treatment Guidelines 2024” (issued on October 20, 2024) as a first-line treatment for EGFR mutation-positive (uncommon mutation) non-small cell lung cancer (NSCLC), with a stronger recommendation than Osimertinib. The development of DFP-14323 is being conducted in patients (stage III/IV) with epidermal growth factor receptor (EGFR) mutation-positive uncommon mutation NSCLC in a Phase III clinical trial (superiority study) comparing DFP-14323 in combination with Afatinib (20 mg/day) and Afatinib (40 mg/day) alone. The strongly recommended treatment with afatinib as first-line therapy must accelerate the enrollment of NSCLC patients through this trial. The study is being conducted at 30 core hospitals throughout Japan involved in the treatment of NSCLC, and clinical efficacy will be finally determined by progression-free survival (PFS). DFP-14323 is a small molecule substance (oral absorption rate of approximately 100%) that inhibits the CD13/APN receptor, which is frequently found on cells in NSCLC including cancer stem cells.お知らせ • Nov 05Delta-Fly Pharma Inc Provides Update for Expanded Phase I Study of DFP-14927As informed dated October 28, an interim analysis for the Phase III study ofDFP-10917 in R/R AML patients is ongoing. The Phase I/II combination study of DFP-10917 with Venetoclax in AML patients is well ongoing. Today, Delta-Fly Pharma, Inc. to talk about an update for development of the drug delivery of DFP-10917 selective to solid tumor, which is namely, DFP-14927 showed nice safety and efficacy in the Phase I study in solid tumor patients. Accordingly, company have moved forward into an expanded Phase I study of DFP-14927 at 3200 mg/m weekly dosing in R/R colorectal cancer patients at MD Anderson Cancer Center and UCLA. Efficacy in expanded Phase I study is evaluated by Disease Control Ratio (DCR) and it shall be evaluated by OS in the next registration study for NDA approval.お知らせ • Oct 28Delta-Fly Pharma Inc. announces Phase I/II Study of Dfp-10917 and Venetoclax in Aml Patients Begins with Promising Initial DataDelta-Fly Pharma, Inc. announced that following to the previous information on September 10th. 2024, the company share latest development status. Enrollment of patients is progressing smoothly into the Phase I portion of the Phase I/II study of DFP-10917 combined with Venetoclax in AML patients previously treated with Venetoclax, one regimen. The first three patients are showing encouraging safety and efficacy results suggested further promising development. The existing standard combination chemotherapy for AML patients is Azacitidine and Venetoclax, but it is not comfortable for AML patients. We’re trying to do a combination of DFP-10917 with Venetoclax, as an alternative safer AML therapy, objective NDA approval from the FDA in the US under possible collaboration with a global mega-pharma. The Phase III study of DFP-10917 in relapsed/refractory AML patients is planned data cut-off as decreasing in the number of long-term survivors since then.分析記事 • Sep 06We're A Little Worried About Delta-Fly Pharma's (TSE:4598) Cash Burn RateWe can readily understand why investors are attracted to unprofitable companies. For example, although...お知らせ • Aug 28Delta-Fly Pharma, Inc. to Report Q2, 2025 Results on Nov 14, 2024Delta-Fly Pharma, Inc. announced that they will report Q2, 2025 results on Nov 14, 2024New Risk • Aug 18New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -JP¥1.3b This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-JP¥1.3b free cash flow). Share price has been highly volatile over the past 3 months (11% average weekly change). Earnings have declined by 3.4% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (26% increase in shares outstanding). Market cap is less than US$100m (JP¥4.71b market cap, or US$31.9m).お知らせ • Jul 03Delta-Fly Pharma, Inc. Announces Enrollment of Patients in the Phase III Clinical Trial of DFP-14323Delta-Fly Pharma, Inc. announced that the enrollment of patients in the Phase III clinical trial of DFP-14323 in combination with Afatinib (20 mg/day) versus Afatinib (40 mg/day) alone in stage III/IV non-small cell lung cancer patients with uncommon EGFR mutation positive that was approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Feb. 2024, has started as of July 3, 2024 in Japan. This Phase III clinical trial will be conducted at 30 sites with NSCLC experts in Japan and the superiority of the add-on effect of DFP-14323 on progression-free survival (PFS) as primary endpoint will be confirmed. As DFP-14323 selectively binds to the aminopeptidase N, which is widely expressed on various cells, as lung cancer and inflammatory cells, it is expected to be effective in the treatment of patients with refractory cancer and when the superiority of the add-on effect can be confirmed in this study, it is expected to provide a novel cancer immunotherapy that is independent of EGFR mutation types, uncommon or common mutation. The company will accelerate the progress of the trial by expanding this Phase III clinical trial outside of Japan to Asian countries with large numbers of EGFR mutation-positive non-small cell lung cancer patients, and at the same time, the company will promote out-licensing activities to Asian pharmaceutical companies.Board Change • Jul 01Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. 3 highly experienced directors. Independent Outside Director Akifumi Taniguchi was the last director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment.お知らせ • Jun 02Delta-Fly Pharma, Inc. to Report Q1, 2025 Results on Aug 09, 2024Delta-Fly Pharma, Inc. announced that they will report Q1, 2025 results on Aug 09, 2024分析記事 • May 22Is Delta-Fly Pharma (TSE:4598) In A Good Position To Deliver On Growth Plans?We can readily understand why investors are attracted to unprofitable companies. For example, although...お知らせ • May 17Delta-Fly Pharma, Inc., Annual General Meeting, Jun 27, 2024Delta-Fly Pharma, Inc., Annual General Meeting, Jun 27, 2024.お知らせ • Apr 09Delta-Fly Pharma Inc. Receives Notice of Authorization to Conduct the Phase I/II Study of DFP-10917 Combined with VenetoclaxDelta-Fly Pharma, Inc. shared latest development status. The company announced the protocol for the Phase I/II clinical trial of DFP-10917 combined with Venetoclax (VTX) in patients with acute myeloid leukemia (AML) with prior VTX involved one regimen, which was submitted to the FDA in US on March 8 has been approved by the FDA in US dated April 8, 2024. Accordingly, the company can start the Phase I/II combo-study very soon. The aim for conducting this study is to judge if DFP-10917 combined with VTX is to show superiority to the standard chemotherapy (azacitidine combined with VTX) for AML. This combo-study shall be done by major clinical sites in US like Wake Forest University, expertise with clinical study of novel chemotherapy for AML. The interim analysis of the Phase III trial of DFP-10917 monotherapy in patients with recurrent or refractory AML is under follow-up for a number of long-term survivors that have a significant impact on the overall survival (OS) analysis.お知らせ • Mar 11Delta-Fly Pharma Inc. Announces FDA Submission of the Protocol of the Phase I/II Study of DFP-10917 Combined with Venetoclax (VTX) in the AML Patients Treated by VTX in the AMLDelta-Fly Pharma Inc. announced that FDA submission of the protocol of the Phase I/II study of DFP-10917 combined with Venetoclax (VTX) in the AML patients pretreated by VTX involved one regimen have been done on March 8th, 2024. The Phase I/II study ofDFP-10917 with VTX in the above AML patients shall be started at Wake Forest and the other hospitals soon after FDA approval. The interim analysis of the Phase III study of DFP-109 17 in patients with recurrent or refractory acute myeloid leukemia (R/R AML) at multicenter in the US is undergoing for the reason there are patients with a long-term survival may effect on OS analysis. The invention with the combination of DFP-14927 with VTX in AML was granted in Japan, US, and Taiwan.お知らせ • Mar 02Delta-Fly Pharma, Inc. to Report Fiscal Year 2024 Results on May 15, 2024Delta-Fly Pharma, Inc. announced that they will report fiscal year 2024 results on May 15, 2024お知らせ • Feb 04Delta-Fly Pharma Inc Announces Initiation of Phase III Pivotal Comparative Clinical Trial of DFP-14323Delta-Fly Pharma, Inc. announced that as presented at 2022 ASCO Annual Meeting on June 6, 2022, DFP-14323 in combination with afatinib (20 mg/day) in stage III/IV non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) mutation positive in a Phase II clinical trial, has demonstrated fascinating longer median progression-free survival (mPFS; 23.1 months). Subsequently, based on these results, they have been in negotiation with the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan with the aim of submitting a conditional approval application, resulting in decision to conduct a Phase III clinical trial (superiority study) of DFP-14323 in combination with afatinib (20 mg/day) versus afatinib (40 mg/day) alone in stage III/IV non-small cell lung cancer patients with uncommon EGFR mutation positive based on the PMDA's recommendation. And finally, the company announced that the submission of the protocol for the Phase III study to the PMDA has been approved and are ready to initiate the study. This Phase III clinical trial will be conducted at 30 sites in Japan and if the superiority of the add-on effect of DFP-14323 on progression-free survival (PFS) as primary endpoint, is confirmed in this trial, they believe that DFP-14323 will be a novel cancer immunotherapy drug with highly beneficial for patients and their families, as it is orally available, safe, and economical. Furthermore, if non-inferiority to osimertinib (80 mg/day) can be confirmed in a comparative study, a huger market can be expected.お知らせ • Jan 30Delta-Fly Pharma, Inc. Provides Update on Interim Analysis Status of Phase III Study of DFP-10917 in Patients with R/R AMLDelta-Fly Pharma, Inc. announced that the following is the current status of the interim analysis of a Phase III study of DFP-10917 monotherapy in patients with recurrent or refractory acute myeloid leukemia (R/R AML) at multicenter in the US. As there are a long-term surviving patients in the 150 patients enrolled in this study, the company intend to continue to follow up these patients without any data cut-off for the time being to determine the final overall survival (OS) results of the study. The company ask for understanding that under a randomized and controlled study, the company is unable to identify at this stage whether these surviving patients are in the DFP-10917 group or the control group (NCT03926624). The company look forward to showing the results when the data is ready to disclose.お知らせ • Dec 28Delta-Fly Pharma, Inc. to Report Q3, 2024 Results on Feb 13, 2024Delta-Fly Pharma, Inc. announced that they will report Q3, 2024 results on Feb 13, 2024New Risk • Dec 22New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 52% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Earnings have declined by 2.2% per year over the past 5 years. Shareholders have been substantially diluted in the past year (52% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (JP¥7.31b market cap, or US$51.4m).New Risk • Oct 23New major risk - Share price stabilityThe company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of Japanese stocks, typically moving 8.1% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-JP¥1.3b free cash flow). Share price has been highly volatile over the past 3 months (8.1% average weekly change). Earnings have declined by 1.3% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (21% increase in shares outstanding). Market cap is less than US$100m (JP¥6.22b market cap, or US$41.5m).お知らせ • Sep 28Delta-Fly Pharma, Inc. to Report Q2, 2024 Results on Nov 13, 2023Delta-Fly Pharma, Inc. announced that they will report Q2, 2024 results on Nov 13, 2023お知らせ • Jun 28Delta-Fly Pharma, Inc. to Report Q1, 2024 Results on Aug 14, 2023Delta-Fly Pharma, Inc. announced that they will report Q1, 2024 results on Aug 14, 2023Reported Earnings • Feb 17Third quarter 2023 earnings released: JP¥75.09 loss per share (vs JP¥51.67 loss in 3Q 2022)Third quarter 2023 results: JP¥75.09 loss per share (further deteriorated from JP¥51.67 loss in 3Q 2022). Net loss: JP¥416.0m (loss widened 49% from 3Q 2022). Over the last 3 years on average, earnings per share has increased by 24% per year but the company’s share price has fallen by 2% per year, which means it is significantly lagging earnings.お知らせ • Dec 06Delta-Fly Pharma, Inc. announced that it has received ¥1.300842 billion in funding from Macquarie Group LimitedOn December 5, 2022, Delta-Fly Pharma, Inc. closed the transaction.お知らせ • Nov 18Delta-Fly Pharma, Inc. announced that it expects to receive ¥1.300842 billion in funding from Macquarie Group LimitedDelta-Fly Pharma, Inc. announced a private placement of unsecured bonds for an aggregate gross proceeds of ¥1,300,842,000 on November 17, 2022. The transaction included participation from Macquarie Group Limited. The transaction has been approved by the board of directors of the company.Reported Earnings • Nov 16First half 2023 earnings released: JP¥115 loss per share (vs JP¥103 loss in 1H 2022)First half 2023 results: JP¥115 loss per share (further deteriorated from JP¥103 loss in 1H 2022). Net loss: JP¥622.0m (loss widened 12% from 1H 2022). Over the last 3 years on average, earnings per share has increased by 24% per year but the company’s share price has fallen by 17% per year, which means it is significantly lagging earnings.Board Change • Nov 16Less than half of directors are independentNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 11 experienced directors. 1 highly experienced director. 3 independent directors (4 non-independent directors). Senior MD, Head of Research & Development and Director Kenzo Iizuka was the last director to join the board, commencing their role in 2013. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment.Reported Earnings • Aug 16First quarter 2023 earnings released: JP¥56.83 loss per share (vs JP¥56.58 loss in 1Q 2022)First quarter 2023 results: JP¥56.83 loss per share (down from JP¥56.58 loss in 1Q 2022). Net loss: JP¥308.0m (flat on 1Q 2022). Over the last 3 years on average, earnings per share has increased by 18% per year but the company’s share price has fallen by 18% per year, which means it is significantly lagging earnings.お知らせ • May 29+ 2 more updatesDelta-Fly Pharma, Inc. to Report Q3, 2023 Results on Feb 14, 2023Delta-Fly Pharma, Inc. announced that they will report Q3, 2023 results on Feb 14, 2023お知らせ • May 18Delta-Fly Pharma, Inc., Annual General Meeting, Jun 29, 2022Delta-Fly Pharma, Inc., Annual General Meeting, Jun 29, 2022.Board Change • Apr 27Less than half of directors are independentNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 11 experienced directors. 1 highly experienced director. 3 independent directors (4 non-independent directors). Senior MD, Head of Research & Development and Director Kenzo Iizuka was the last director to join the board, commencing their role in 2013. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment.お知らせ • Apr 08Delta-Fly Pharma, Inc. to Report Fiscal Year 2022 Results on May 13, 2022Delta-Fly Pharma, Inc. announced that they will report fiscal year 2022 results on May 13, 2022Is New 90 Day High Low • Mar 05New 90-day low: JP¥1,067The company is down 35% from its price of JP¥1,653 on 04 December 2020. The Japanese market is up 6.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 11% over the same period.Is New 90 Day High Low • Jan 29New 90-day low: JP¥1,119The company is down 50% from its price of JP¥2,233 on 30 October 2020. The Japanese market is up 16% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 12% over the same period.Is New 90 Day High Low • Dec 08New 90-day low: JP¥1,521The company is down 35% from its price of JP¥2,330 on 09 September 2020. The Japanese market is up 8.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 5.0% over the same period. このセクションでは通常、投資家が会社の利益創出能力を理解する一助となるよう、プロのアナリストのコンセンサス予想に基づく収益と利益の成長予測を提示する。しかし、Delta-Fly Pharma は十分な過去のデータを提供しておらず、アナリストの予測もないため、過去のデータを外挿したり、アナリストの予測を使用しても、その将来の収益を確実に算出することはできません。 シンプリー・ウォール・ストリートがカバーする企業の97%は過去の財務データを持っているため、これはかなり稀な状況です。 業績と収益の成長予測TSE:4598 - アナリストの将来予測と過去の財務データ ( )JPY Millions日付収益収益フリー・キャッシュフロー営業活動によるキャッシュ平均アナリスト数3/31/2026N/A-1,625-1,557-1,557N/A12/31/2025N/A-1,662N/AN/AN/A9/30/2025N/A-1,645-1,579-1,579N/A6/30/2025N/A-1,588N/AN/AN/A3/31/2025N/A-1,721-1,834-1,834N/A12/31/2024N/A-1,764N/AN/AN/A9/30/2024N/A-1,746-1,727-1,726N/A6/30/2024N/A-1,649N/AN/AN/A3/31/2024N/A-1,429-1,280-1,279N/A12/31/2023N/A-1,262N/AN/AN/A9/30/2023N/A-1,306-1,322-1,322N/A6/30/2023N/A-1,300N/AN/AN/A3/31/2023N/A-1,328-1,303-1,303N/A12/31/2022200-1,168N/AN/AN/A9/30/2022200-1,032-1,009-1,009N/A6/30/2022200-969N/AN/AN/A3/31/2022300-967-940-940N/A12/31/2021300-926N/AN/AN/A9/30/2021300-955-901-901N/A6/30/2021400-915N/AN/AN/A3/31/2021300-862-726-726N/A12/31/2020200-1,096N/AN/AN/A9/30/2020200-1,288-1,270-1,270N/A6/30/2020100-1,589N/AN/AN/A3/31/2020100-1,555-1,662-1,649N/A12/31/2019N/A-1,402N/AN/AN/A9/30/2019N/A-1,126N/A-1,073N/A6/30/2019N/A-787N/AN/AN/A3/31/2019N/A-673N/A-585N/A3/31/2018150-246N/AN/AN/A3/31/2017902305N/AN/AN/Aもっと見るアナリストによる今後の成長予測収入対貯蓄率: 4598の予測収益成長が 貯蓄率 ( 0.8% ) を上回っているかどうかを判断するにはデータが不十分です。収益対市場: 4598の収益がJP市場よりも速く成長すると予測されるかどうかを判断するにはデータが不十分です高成長収益: 4598の収益が今後 3 年間で 大幅に 増加すると予想されるかどうかを判断するにはデータが不十分です。収益対市場: 4598の収益がJP市場よりも速く成長すると予測されるかどうかを判断するにはデータが不十分です。高い収益成長: 4598の収益が年間20%よりも速く成長すると予測されるかどうかを判断するにはデータが不十分です。一株当たり利益成長率予想将来の株主資本利益率将来のROE: 4598の 自己資本利益率 が 3 年後に高くなると予測されるかどうかを判断するにはデータが不十分です成長企業の発掘7D1Y7D1Y7D1YPharmaceuticals-biotech 業界の高成長企業。View Past Performance企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/07/17 23:54終値2026/07/17 00:00収益2026/03/31年間収益2026/03/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレークこのレポートを生成するために使用した分析モデルの詳細は、当社のGitHubページでご覧いただけます。また、レポートの活用方法に関するガイドやYouTubeのチュートリアルも用意しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Delta-Fly Pharma, Inc. 0 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。1 アナリスト機関Kiyokazu YamazakiIchiyoshi Research Institute Inc.
お知らせ • Jun 28Delta-Fly Pharma, Inc. to Report Q1, 2027 Results on Aug 07, 2026Delta-Fly Pharma, Inc. announced that they will report Q1, 2027 results on Aug 07, 2026
New Risk • Jun 05New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 44% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-JP¥1.6b free cash flow). Earnings have declined by 15% per year over the past 5 years. Shareholders have been substantially diluted in the past year (44% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (7.2% average weekly change). Market cap is less than US$100m (JP¥2.02b market cap, or US$12.6m).
New Risk • May 20New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -JP¥1.6b This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-JP¥1.6b free cash flow). Earnings have declined by 15% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (7.8% average weekly change). Shareholders have been diluted in the past year (25% increase in shares outstanding). Market cap is less than US$100m (JP¥2.12b market cap, or US$13.3m).
お知らせ • May 15Delta-Fly Pharma, Inc., Annual General Meeting, Jun 26, 2026Delta-Fly Pharma, Inc., Annual General Meeting, Jun 26, 2026.
お知らせ • Feb 03Delta-Fly Pharma, Inc. announced that it has received ¥1.68 million in funding from Macquarie Bank LimitedOn February 2, 2026, Delta-Fly Pharma, Inc. closed the transaction. The company announced that it has disclosed the returning investor Macquarie Bank Limited
New Risk • Jan 03New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 32% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-JP¥1.6b free cash flow). Share price has been highly volatile over the past 3 months (12% average weekly change). Earnings have declined by 13% per year over the past 5 years. Shareholders have been substantially diluted in the past year (32% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (JP¥6.20b market cap, or US$39.5m).
お知らせ • Dec 27Delta-Fly Pharma, Inc. to Report Q3, 2026 Results on Feb 13, 2026Delta-Fly Pharma, Inc. announced that they will report Q3, 2026 results on Feb 13, 2026
お知らせ • Sep 27Delta-Fly Pharma, Inc. to Report Q2, 2026 Results on Nov 14, 2025Delta-Fly Pharma, Inc. announced that they will report Q2, 2026 results on Nov 14, 2025
New Risk • Aug 11New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -JP¥1.8b This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-JP¥1.8b free cash flow). Share price has been highly volatile over the past 3 months (8.4% average weekly change). Earnings have declined by 10% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (18% increase in shares outstanding). Market cap is less than US$100m (JP¥6.58b market cap, or US$44.5m).
お知らせ • Jun 27Delta-Fly Pharma, Inc. to Report Q1, 2026 Results on Aug 08, 2025Delta-Fly Pharma, Inc. announced that they will report Q1, 2026 results on Aug 08, 2025
お知らせ • May 15Delta-Fly Pharma, Inc., Annual General Meeting, Jun 26, 2025Delta-Fly Pharma, Inc., Annual General Meeting, Jun 26, 2025.
お知らせ • Apr 30Delta-Fly Pharma, Inc. announced that it has received ¥252.5515 million in funding from Macquarie Bank LimitedOn April 30, 2025, Delta-Fly Pharma, Inc closed the transaction. The company issued 24,300 units of stock acquisition rights at ¥105 per unit for aggregate gross proceeds of ¥2,551,500 and Zero coupon 2nd Series, non convertible, unsecured bonds at a price of ¥100 per bond for aggregate gross proceeds of ¥250,000,000. The bonds have a conversion price of ¥100 and a maturity date of April 30, 2027.
お知らせ • Mar 07Delta-Fly Pharma, Inc. to Report Fiscal Year 2025 Results on May 15, 2025Delta-Fly Pharma, Inc. announced that they will report fiscal year 2025 results on May 15, 2025
お知らせ • Feb 28Delta-Fly Pharma, Inc. Announces Progress of Development Status of the Combination Study of Dfp-10917 with VenetoclaxDelta-Fly Pharma, Inc. announced that regarding the Phase I/II clinical trial of DFP-10917 in combination with Venetoclax (VEN) in patients with acute myeloid leukemia (AML) in second-line therapy (NCT06382168), the Data Management Committee (DMC) has approved the tolerability of all six patients in the Phase I (dose finding) portion of the Phase I/II study, and are moving to the Phase II portion of the trial for efficacy testing as of February 28, 2025.
New Risk • Feb 16New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -JP¥1.7b This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-JP¥1.7b free cash flow). Share price has been highly volatile over the past 3 months (11% average weekly change). Earnings have declined by 5.4% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (18% increase in shares outstanding). Market cap is less than US$100m (JP¥5.70b market cap, or US$37.4m).
New Risk • Jan 22New minor risk - Shareholder dilutionThe company's shareholders have been diluted in the past year. Increase in shares outstanding: 18% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (13% average weekly change). Earnings have declined by 3.8% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (18% increase in shares outstanding). Market cap is less than US$100m (JP¥5.13b market cap, or US$33.0m).
お知らせ • Dec 10Delta-Fly Pharma Inc. Provides Update for Development Status of the Combination Study of DFP-10917 with VenetoclaxDelta-Fly Pharma, Inc. announced that the data review committee has approved the tolerability of the first three patients enrolled in the Phase I/II clinical trial of DFP-10917 in combination with Venetoclax (NCT06382168) conducted at five US clinical sites for patients with acute myeloid leukemia (who have failed/relapsed after standard VEN therapy (first-line therapy). Additionally, the bone marrow cell count in peripheral blood in all three cases was 0 (zero) within 4 weeks of starting treatment, and complete remission (CR or CRi) was confirmed by subsequent bone marrow biopsy. Three more patients will be added at the current dosage regimen, and after confirmation of the tolerability, the study will move to Phase II. Complete remission has been observed in patients who have failed/relapsed after existing VEN combination therapy (first-line therapy), so this is expected to be a new, highly effective second-line therapy for patients with AML. As previously reported, the data cleaning processes for interim analysis are currently underway for Phase III comparative clinical trial (150 cases) of DFP-10917 monotherapy targeting patients with AML receiving third-line or later therapy. Once this is completed, the results will be submitted to the Independent Data Safety Monitoring Committee (DSMB) along with electrocardiogram and pharmacokinetic study results for their advice.
お知らせ • Dec 05Delta-Fly Pharma, Inc. to Report Q3, 2025 Results on Feb 14, 2025Delta-Fly Pharma, Inc. announced that they will report Q3, 2025 results on Feb 14, 2025
お知らせ • Dec 04Delta-Fly Pharma Inc. Provides Update for Development Status of DFP-17729Delta-Fly Pharma, Inc. announce that as a result of consultation with the PMDA on December 3rd, 2024, the Phase II/III clinical trial of DFP-17729 in combination with TS-1 versus TS-1 alone in patients with pancreatic cancer after third-line treatment was approved. In a Phase I/II study of DFP-17729 in combination with TS-1 in patients with end-stage pancreatic cancer, no significant difference was observed against the control treatment (TS-1 or gemcitabine), but stratified analysis showed that when patients in the third-line or later treatment were treated for more than 6 weeks, DFP-17729 in combination with TS-1 showed a predominant median overall survival (mOS) prolongation (9.0 months vs. 6.1 months) and a significant correlation was also observed between urinary alkalinization and mOS in pancreatic cancer patients treated with DFP-17729, as key proof of concept. Had presented these results at the ESMO Gastrointestinal Cancers Congress 2024 and the 55 Annual Meeting of the Japan Pancreas Society, where much attention was paid to the presentation. DFP-17729 is a novel approach to neutralize the acidic cancer microenvironment, and several patents on related inventions have been granted in major countries around the world, and its potential of efficacy has been published in peer-reviewed journals. first identify DFP-17729 as a treatment for refractory pancreatic cancer, for which effective treatment is not yet available, and then seek to expand the indication to other types of cancer through partnership with major global pharmaceutical companies.
お知らせ • Nov 26Delta-Fly Pharma, Inc. Announces Progress Update of the Phase III Clinical Trial of DFP-14323Delta-Fly Pharma, Inc. announced that Afatinib, which is being treated with DFP-14323 in ongoing Phase III clinical trial, has been approved by the Japanese Lung Cancer Society in its “Lung Cancer Treatment Guidelines 2024” (issued on October 20, 2024) as a first-line treatment for EGFR mutation-positive (uncommon mutation) non-small cell lung cancer (NSCLC), with a stronger recommendation than Osimertinib. The development of DFP-14323 is being conducted in patients (stage III/IV) with epidermal growth factor receptor (EGFR) mutation-positive uncommon mutation NSCLC in a Phase III clinical trial (superiority study) comparing DFP-14323 in combination with Afatinib (20 mg/day) and Afatinib (40 mg/day) alone. The strongly recommended treatment with afatinib as first-line therapy must accelerate the enrollment of NSCLC patients through this trial. The study is being conducted at 30 core hospitals throughout Japan involved in the treatment of NSCLC, and clinical efficacy will be finally determined by progression-free survival (PFS). DFP-14323 is a small molecule substance (oral absorption rate of approximately 100%) that inhibits the CD13/APN receptor, which is frequently found on cells in NSCLC including cancer stem cells.
お知らせ • Nov 05Delta-Fly Pharma Inc Provides Update for Expanded Phase I Study of DFP-14927As informed dated October 28, an interim analysis for the Phase III study ofDFP-10917 in R/R AML patients is ongoing. The Phase I/II combination study of DFP-10917 with Venetoclax in AML patients is well ongoing. Today, Delta-Fly Pharma, Inc. to talk about an update for development of the drug delivery of DFP-10917 selective to solid tumor, which is namely, DFP-14927 showed nice safety and efficacy in the Phase I study in solid tumor patients. Accordingly, company have moved forward into an expanded Phase I study of DFP-14927 at 3200 mg/m weekly dosing in R/R colorectal cancer patients at MD Anderson Cancer Center and UCLA. Efficacy in expanded Phase I study is evaluated by Disease Control Ratio (DCR) and it shall be evaluated by OS in the next registration study for NDA approval.
お知らせ • Oct 28Delta-Fly Pharma Inc. announces Phase I/II Study of Dfp-10917 and Venetoclax in Aml Patients Begins with Promising Initial DataDelta-Fly Pharma, Inc. announced that following to the previous information on September 10th. 2024, the company share latest development status. Enrollment of patients is progressing smoothly into the Phase I portion of the Phase I/II study of DFP-10917 combined with Venetoclax in AML patients previously treated with Venetoclax, one regimen. The first three patients are showing encouraging safety and efficacy results suggested further promising development. The existing standard combination chemotherapy for AML patients is Azacitidine and Venetoclax, but it is not comfortable for AML patients. We’re trying to do a combination of DFP-10917 with Venetoclax, as an alternative safer AML therapy, objective NDA approval from the FDA in the US under possible collaboration with a global mega-pharma. The Phase III study of DFP-10917 in relapsed/refractory AML patients is planned data cut-off as decreasing in the number of long-term survivors since then.
分析記事 • Sep 06We're A Little Worried About Delta-Fly Pharma's (TSE:4598) Cash Burn RateWe can readily understand why investors are attracted to unprofitable companies. For example, although...
お知らせ • Aug 28Delta-Fly Pharma, Inc. to Report Q2, 2025 Results on Nov 14, 2024Delta-Fly Pharma, Inc. announced that they will report Q2, 2025 results on Nov 14, 2024
New Risk • Aug 18New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -JP¥1.3b This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-JP¥1.3b free cash flow). Share price has been highly volatile over the past 3 months (11% average weekly change). Earnings have declined by 3.4% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (26% increase in shares outstanding). Market cap is less than US$100m (JP¥4.71b market cap, or US$31.9m).
お知らせ • Jul 03Delta-Fly Pharma, Inc. Announces Enrollment of Patients in the Phase III Clinical Trial of DFP-14323Delta-Fly Pharma, Inc. announced that the enrollment of patients in the Phase III clinical trial of DFP-14323 in combination with Afatinib (20 mg/day) versus Afatinib (40 mg/day) alone in stage III/IV non-small cell lung cancer patients with uncommon EGFR mutation positive that was approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Feb. 2024, has started as of July 3, 2024 in Japan. This Phase III clinical trial will be conducted at 30 sites with NSCLC experts in Japan and the superiority of the add-on effect of DFP-14323 on progression-free survival (PFS) as primary endpoint will be confirmed. As DFP-14323 selectively binds to the aminopeptidase N, which is widely expressed on various cells, as lung cancer and inflammatory cells, it is expected to be effective in the treatment of patients with refractory cancer and when the superiority of the add-on effect can be confirmed in this study, it is expected to provide a novel cancer immunotherapy that is independent of EGFR mutation types, uncommon or common mutation. The company will accelerate the progress of the trial by expanding this Phase III clinical trial outside of Japan to Asian countries with large numbers of EGFR mutation-positive non-small cell lung cancer patients, and at the same time, the company will promote out-licensing activities to Asian pharmaceutical companies.
Board Change • Jul 01Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. 3 highly experienced directors. Independent Outside Director Akifumi Taniguchi was the last director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment.
お知らせ • Jun 02Delta-Fly Pharma, Inc. to Report Q1, 2025 Results on Aug 09, 2024Delta-Fly Pharma, Inc. announced that they will report Q1, 2025 results on Aug 09, 2024
分析記事 • May 22Is Delta-Fly Pharma (TSE:4598) In A Good Position To Deliver On Growth Plans?We can readily understand why investors are attracted to unprofitable companies. For example, although...
お知らせ • May 17Delta-Fly Pharma, Inc., Annual General Meeting, Jun 27, 2024Delta-Fly Pharma, Inc., Annual General Meeting, Jun 27, 2024.
お知らせ • Apr 09Delta-Fly Pharma Inc. Receives Notice of Authorization to Conduct the Phase I/II Study of DFP-10917 Combined with VenetoclaxDelta-Fly Pharma, Inc. shared latest development status. The company announced the protocol for the Phase I/II clinical trial of DFP-10917 combined with Venetoclax (VTX) in patients with acute myeloid leukemia (AML) with prior VTX involved one regimen, which was submitted to the FDA in US on March 8 has been approved by the FDA in US dated April 8, 2024. Accordingly, the company can start the Phase I/II combo-study very soon. The aim for conducting this study is to judge if DFP-10917 combined with VTX is to show superiority to the standard chemotherapy (azacitidine combined with VTX) for AML. This combo-study shall be done by major clinical sites in US like Wake Forest University, expertise with clinical study of novel chemotherapy for AML. The interim analysis of the Phase III trial of DFP-10917 monotherapy in patients with recurrent or refractory AML is under follow-up for a number of long-term survivors that have a significant impact on the overall survival (OS) analysis.
お知らせ • Mar 11Delta-Fly Pharma Inc. Announces FDA Submission of the Protocol of the Phase I/II Study of DFP-10917 Combined with Venetoclax (VTX) in the AML Patients Treated by VTX in the AMLDelta-Fly Pharma Inc. announced that FDA submission of the protocol of the Phase I/II study of DFP-10917 combined with Venetoclax (VTX) in the AML patients pretreated by VTX involved one regimen have been done on March 8th, 2024. The Phase I/II study ofDFP-10917 with VTX in the above AML patients shall be started at Wake Forest and the other hospitals soon after FDA approval. The interim analysis of the Phase III study of DFP-109 17 in patients with recurrent or refractory acute myeloid leukemia (R/R AML) at multicenter in the US is undergoing for the reason there are patients with a long-term survival may effect on OS analysis. The invention with the combination of DFP-14927 with VTX in AML was granted in Japan, US, and Taiwan.
お知らせ • Mar 02Delta-Fly Pharma, Inc. to Report Fiscal Year 2024 Results on May 15, 2024Delta-Fly Pharma, Inc. announced that they will report fiscal year 2024 results on May 15, 2024
お知らせ • Feb 04Delta-Fly Pharma Inc Announces Initiation of Phase III Pivotal Comparative Clinical Trial of DFP-14323Delta-Fly Pharma, Inc. announced that as presented at 2022 ASCO Annual Meeting on June 6, 2022, DFP-14323 in combination with afatinib (20 mg/day) in stage III/IV non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) mutation positive in a Phase II clinical trial, has demonstrated fascinating longer median progression-free survival (mPFS; 23.1 months). Subsequently, based on these results, they have been in negotiation with the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan with the aim of submitting a conditional approval application, resulting in decision to conduct a Phase III clinical trial (superiority study) of DFP-14323 in combination with afatinib (20 mg/day) versus afatinib (40 mg/day) alone in stage III/IV non-small cell lung cancer patients with uncommon EGFR mutation positive based on the PMDA's recommendation. And finally, the company announced that the submission of the protocol for the Phase III study to the PMDA has been approved and are ready to initiate the study. This Phase III clinical trial will be conducted at 30 sites in Japan and if the superiority of the add-on effect of DFP-14323 on progression-free survival (PFS) as primary endpoint, is confirmed in this trial, they believe that DFP-14323 will be a novel cancer immunotherapy drug with highly beneficial for patients and their families, as it is orally available, safe, and economical. Furthermore, if non-inferiority to osimertinib (80 mg/day) can be confirmed in a comparative study, a huger market can be expected.
お知らせ • Jan 30Delta-Fly Pharma, Inc. Provides Update on Interim Analysis Status of Phase III Study of DFP-10917 in Patients with R/R AMLDelta-Fly Pharma, Inc. announced that the following is the current status of the interim analysis of a Phase III study of DFP-10917 monotherapy in patients with recurrent or refractory acute myeloid leukemia (R/R AML) at multicenter in the US. As there are a long-term surviving patients in the 150 patients enrolled in this study, the company intend to continue to follow up these patients without any data cut-off for the time being to determine the final overall survival (OS) results of the study. The company ask for understanding that under a randomized and controlled study, the company is unable to identify at this stage whether these surviving patients are in the DFP-10917 group or the control group (NCT03926624). The company look forward to showing the results when the data is ready to disclose.
お知らせ • Dec 28Delta-Fly Pharma, Inc. to Report Q3, 2024 Results on Feb 13, 2024Delta-Fly Pharma, Inc. announced that they will report Q3, 2024 results on Feb 13, 2024
New Risk • Dec 22New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 52% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Earnings have declined by 2.2% per year over the past 5 years. Shareholders have been substantially diluted in the past year (52% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (JP¥7.31b market cap, or US$51.4m).
New Risk • Oct 23New major risk - Share price stabilityThe company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of Japanese stocks, typically moving 8.1% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-JP¥1.3b free cash flow). Share price has been highly volatile over the past 3 months (8.1% average weekly change). Earnings have declined by 1.3% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (21% increase in shares outstanding). Market cap is less than US$100m (JP¥6.22b market cap, or US$41.5m).
お知らせ • Sep 28Delta-Fly Pharma, Inc. to Report Q2, 2024 Results on Nov 13, 2023Delta-Fly Pharma, Inc. announced that they will report Q2, 2024 results on Nov 13, 2023
お知らせ • Jun 28Delta-Fly Pharma, Inc. to Report Q1, 2024 Results on Aug 14, 2023Delta-Fly Pharma, Inc. announced that they will report Q1, 2024 results on Aug 14, 2023
Reported Earnings • Feb 17Third quarter 2023 earnings released: JP¥75.09 loss per share (vs JP¥51.67 loss in 3Q 2022)Third quarter 2023 results: JP¥75.09 loss per share (further deteriorated from JP¥51.67 loss in 3Q 2022). Net loss: JP¥416.0m (loss widened 49% from 3Q 2022). Over the last 3 years on average, earnings per share has increased by 24% per year but the company’s share price has fallen by 2% per year, which means it is significantly lagging earnings.
お知らせ • Dec 06Delta-Fly Pharma, Inc. announced that it has received ¥1.300842 billion in funding from Macquarie Group LimitedOn December 5, 2022, Delta-Fly Pharma, Inc. closed the transaction.
お知らせ • Nov 18Delta-Fly Pharma, Inc. announced that it expects to receive ¥1.300842 billion in funding from Macquarie Group LimitedDelta-Fly Pharma, Inc. announced a private placement of unsecured bonds for an aggregate gross proceeds of ¥1,300,842,000 on November 17, 2022. The transaction included participation from Macquarie Group Limited. The transaction has been approved by the board of directors of the company.
Reported Earnings • Nov 16First half 2023 earnings released: JP¥115 loss per share (vs JP¥103 loss in 1H 2022)First half 2023 results: JP¥115 loss per share (further deteriorated from JP¥103 loss in 1H 2022). Net loss: JP¥622.0m (loss widened 12% from 1H 2022). Over the last 3 years on average, earnings per share has increased by 24% per year but the company’s share price has fallen by 17% per year, which means it is significantly lagging earnings.
Board Change • Nov 16Less than half of directors are independentNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 11 experienced directors. 1 highly experienced director. 3 independent directors (4 non-independent directors). Senior MD, Head of Research & Development and Director Kenzo Iizuka was the last director to join the board, commencing their role in 2013. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment.
Reported Earnings • Aug 16First quarter 2023 earnings released: JP¥56.83 loss per share (vs JP¥56.58 loss in 1Q 2022)First quarter 2023 results: JP¥56.83 loss per share (down from JP¥56.58 loss in 1Q 2022). Net loss: JP¥308.0m (flat on 1Q 2022). Over the last 3 years on average, earnings per share has increased by 18% per year but the company’s share price has fallen by 18% per year, which means it is significantly lagging earnings.
お知らせ • May 29+ 2 more updatesDelta-Fly Pharma, Inc. to Report Q3, 2023 Results on Feb 14, 2023Delta-Fly Pharma, Inc. announced that they will report Q3, 2023 results on Feb 14, 2023
お知らせ • May 18Delta-Fly Pharma, Inc., Annual General Meeting, Jun 29, 2022Delta-Fly Pharma, Inc., Annual General Meeting, Jun 29, 2022.
Board Change • Apr 27Less than half of directors are independentNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 11 experienced directors. 1 highly experienced director. 3 independent directors (4 non-independent directors). Senior MD, Head of Research & Development and Director Kenzo Iizuka was the last director to join the board, commencing their role in 2013. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment.
お知らせ • Apr 08Delta-Fly Pharma, Inc. to Report Fiscal Year 2022 Results on May 13, 2022Delta-Fly Pharma, Inc. announced that they will report fiscal year 2022 results on May 13, 2022
Is New 90 Day High Low • Mar 05New 90-day low: JP¥1,067The company is down 35% from its price of JP¥1,653 on 04 December 2020. The Japanese market is up 6.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 11% over the same period.
Is New 90 Day High Low • Jan 29New 90-day low: JP¥1,119The company is down 50% from its price of JP¥2,233 on 30 October 2020. The Japanese market is up 16% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 12% over the same period.
Is New 90 Day High Low • Dec 08New 90-day low: JP¥1,521The company is down 35% from its price of JP¥2,330 on 09 September 2020. The Japanese market is up 8.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 5.0% over the same period.