Reported Earnings • Mar 27
Full year 2025 earnings released: NT$1.30 loss per share (vs NT$0.87 loss in FY 2024) Full year 2025 results: NT$1.30 loss per share (further deteriorated from NT$0.87 loss in FY 2024). Net loss: NT$754.4m (loss widened 52% from FY 2024). Announcement • Mar 05
Acepodia, Inc., Annual General Meeting, May 22, 2026 Acepodia, Inc., Annual General Meeting, May 22, 2026, at 09:00 Taipei Standard Time. Location: 1 floor no,508, sec.7 chung hsiao e. rd., nangang district, taipei city Taiwan New Risk • Mar 01
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 2025. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m (NT$301k revenue, or US$9.6k). Minor Risk Latest financial reports are more than 6 months old (reported June 2025 fiscal period end). New Risk • Apr 07
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Taiwanese stocks, typically moving 7.5% a week. This is considered a minor risk. Share price volatility indicates 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. It also 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. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m (NT$427k revenue, or US$13k). Minor Risk Share price has been volatile over the past 3 months (7.5% average weekly change). Announcement • Mar 20
Acepodia, Inc., Annual General Meeting, Jun 27, 2025 Acepodia, Inc., Annual General Meeting, Jun 27, 2025. Location: 1 floor no,508, sec.7 chung hsiao e. rd., nangang district, taipei city Taiwan New Risk • Feb 28
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 2024. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m (NT$17m revenue, or US$514k). Minor Risk Latest financial reports are more than 6 months old (reported June 2024 fiscal period end). Announcement • Feb 18
AcePodia Biotech, Inc. Announces Clearance of the IND by the Taiwan Food and Drug Administration for Investigational Product ACE2016 AcePodia Biotech, Inc. announced that on February 17th, 2025, it received notification from the Taiwan Food and Drug Administration (TFDA) approving the Phase I clinical trial for investigational product ACE2016. Trial Plan Name: A Phase 1 Multicenter Study Evaluating the Safety and Efficacy of ACE2016, an Allogeneic Anti-EGFR Conjugated Gamma Delta T cell (gdT) Therapy in Adult Subjects with Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR). Clinical Trial Population and Locations: Approximately 30 subjects are expected to be enrolled in the study, in the US and Taiwan. Primary Objectives of the Trial: The study aims to evaluate the safety and tolerability of ACE2016. Classification of Trial Stages: Phase I, First in Human (FIH) Clinical Study Trial Number: ACE2016-001. R&D New Drug Name or Code: ACE2016. Indication: A phase 1 study evaluating the safety, efficacy, and pharmacodynamics of ACE2016 in adult subjects with locally advanced or metastatic solid tumors expressing Epidermal Growth Factor Re receptor (EGFR). Planned development stages: Phase 1 V 3 clinical studies, New Drug Application (NDA) submission Current development stage: Submission/Approval/Non-Approval/Results of Each Phase of Human Clinical Trials (In Including Interim Analysis)/Occurrence of Other Significant Events Affecting New Drug Development: Re received an approval letter from the TFDA to initiate a Phase 1 study. For those not approved by the competent authority for the intended purpose, or when the results of each phase of human clinical trials (including interim analysis) are not statistically significant or other significant events affecting new drug development occur, the future operational direction: Not applicable. Announcement • Nov 14
Acepodia Biotech, Inc. Announces Clearance of the Investigational New Drug Application by the U.S. Food and Drug Administration for Investigational Product ACE1831 Acepodia Biotech, Inc. announced clearance of the Investigational New Drug application (IND) by the U.S. Food and Drug Administration (FDA) for investigational product ACE1831, on November 13, 2024. Trial Plan Name: Phase Ib/IIa Prospective, Open Label, Multicenter, Single Arm Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects with Immunoglobulin G4-Related Disease. Clinical Trial Population and Locations: Approximately 30 subjects are expected to be enrolled in the study, in the US. Primary Objectives of the Trial: To assess the safety and tolerability of ACE1831 in subjects with IgG4-related disease (IgG4-RD). Primary Objectives of the trial: to assess the safety and tolerability the safety and tolerability of ACE1831 in subjects with Ig G4-related disease (I gG4-RD). Trial Code: ACE1831-201; R&D New Drug Name or Code: ACE1831; Indication: A phase Ib/IIa study evaluating the safety, tolerability, and efficacy of ACE1831 in subjects with IgG4-related disease (IgG4-RD). Planned development stages: Phase 1 V 3 clinical studies, New Drug Application (NDA) submission: Current development stage: Submission/Approval/Non-Approval/Results of Each Phase of Human Clinical Trials (Including Interim Analysis)/Occurrence of Other Significant Events Affecting New Drug Development: Received a Study May Proceed notification from the FDA to initiate a Phase Ib/IIa study. Cumulative R&D expenses incurred: Not disclosed at the moment due to concerns about future international collaboration negotiation information or product marketing strategy to protect investor interests; Upcoming development plan: Expected Completion Time: Enrollment milestones are estimated to be completed at the end of 2027. The actual timeline will be continuously adjusted based on study progress. Market situation: Immunoglobulin G4-related disease (IgG4-RD) is a chronic systemic fibroinflammatory disorder that can affect nearly any organ. IgG4-RD is a rare disease. On 01 January 2019, the point prevalence of IgG4-RD was 5.3 per 100,000 individuals. Existing treatments for IgG4-RD include glucocorticoids (GC), immunosuppressive agents, and B cell depleting agents (eg, rituximab). Although GC has been shown to be effective in inducing remission, high flare rates up to 50% of the patients have been associated with GC tapering or discontinuation. Given the lack of approved efficacious therapy aimed at long-term remission, there is an obvious unmet need for advancements in the management of this condition. ACE1831 is an off-the-shelf £^£_2 T cell therapy candidate developed from Acepodia proprietary ACC platform. ACE1831 targets CD20-expressing B cells via anti-CD20 antibody conjugated £^£_2 T cells. Leveraging the advantages of the ACC technology and Acepodia proprietary £^£_2 T cell platform, ACE1831 has already shown cytotoxicity against B cells in preclinical studies. Medicinal drug product clinical research and development necessitates a considerable duration, and involves a significant financial investment without any guarantee of success. These factors may expose investors to risk, and investors are advised to exercise careful judgment before investing. Announcement • Jun 19
Acepodia, Inc. Announces Change of Chief Technology Officer, Effective June 21, 2024 Acepodia, Inc. announced the change in the Company's Chief Technology Officer. Name, title, and resume of the previous position holder: Harry Lam, Chief Technical Officer, Acepodia, Inc. Name, title, and resume of the new position holder: WANG YAJUN, the Chief Quality Officer, will temporarily take over the duties of the Chief Technology Officer. Reason for the change: Due to the completion of a phase-specific mission, he will step down from his position as Chief Technology Officer and transition to a consultant role within the company. He will continue to guide and support the development of cell-based new drug processes and manufacturing. Effective date is June 21, 2024. The appointment of a new Chief Technology Officer will be announced after approval by the Board of Directors. Announcement • May 09
Acepodia Announces Preliminary Clinical Data From Phase 1 Clinical Trial of ACE1831, First-Ever Anti-CD20 Antibody Conjugated Allogenic Gamma Delta T Cell Therapy for Non-Hodgkins Lymphoma Acepodia announced preliminary data from its Phase 1 dose escalation clinical trial of ACE1831, an anti-CD20 antibody conjugated allogeneic gamma delta T cell therapy being evaluated in patients with non-Hodgkin's lymphoma (NHL). Key Results From Preliminary Clinical Data One out of five patients demonstrated complete response (CR) and three out of five patients experienced disease stabilization (SD) with single dose of ACE1831 at the lowest dose level. Among those patients, one CR and two SD patients were previously treated with CD19 CAR-T. Durability of clinical response was observed for three months after a single dose of ACE1831. The lowest dose of ACE1831 was well tolerated with no ACE1831-related serious adverse events or dose limiting toxicities. Dose escalation is ongoing. ACE1831 is Acepodia's first cell therapy to enter clinical development from its proprietary ACC platform, which uses biorthogonal chemistry to conjugate gamma delta 2 (?d2) T cells with antibodies targeting CD20. The platform, based on the pioneering work of 2022 Nobel Prize laureate Dr. Carolyn Bertozzi that applied click chemistry to living systems, creates an off-the-shelf, non genetically engineered version of CAR-T cell therapy that is more easily scaled and avoids cytokine release storms, neurotoxity and other side effects associated with CAR-T cell therapies. The preliminary data demonstrates that ACE1831 activates both an innate and adaptive immune response by direct killing of tumor cells, tumor opsonization, and recruitment of T cells through cytokine secretion, and may therefore generate a more comprehensive immune response than standard CAR-T cell therapies. The first-in-human, phase 1 trial is an open-label, dose escalation study that aims to evaluate the safety and tolerability, pharmacokinetics, and efficacy of ACE1831 in patients with relapsed/refractory non-Hodgkin's lymphoma. The multi-center trial is expected to enroll up to 42 patients in the United States and Taiwan. Announcement • Mar 23
Acepodia, Inc., Annual General Meeting, Jun 13, 2024 Acepodia, Inc., Annual General Meeting, Jun 13, 2024. New Risk • Feb 25
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended December 2022. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Negative equity (-NT$3.0b). Revenue is less than US$1m. Minor Risk Latest financial reports are more than 6 months old (reported December 2022 fiscal period end). Announcement • Feb 03
Acepodia Biotech, Inc. Announces Clearance of Investigational New Drug Application by U.S. Food and Drug Administration for Investigational Product ACE2016 Acepodia Biotech, Inc. announced clearance of the Investigational New Drug application (IND) by the U.S. Food and Drug Administration (FDA) for investigational product ACE2016,on February 2,2024,Taiwan time. Having received a Study May Proceed notification from the FDA, Acepodia expects to initiate a Phase 1 study in the coming months and to treat the first patient in the second half of 2024. Introduction to Clinical Trial Design: Trial Plan Name: A Phase 1 Multicenter Study Evaluating the Safety and Efficacy of ACE2016,an Allogeneic Anti-EGFR Conjugated Gamma Delta T cell (gdT) Therapy in Adult Subjects with Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR) Clinical Trial Population and Locations: Approximately 30 subjects are expected to be enrolled in the study, in the US. Primary Objectives of the Trial: The study aims to evaluate the safety and tolerability of ACE2016. Classification of Trial Stages: Phase I, First in Human (FIH) Clinical Study. Trial Code: ACE2016-001 R&D New Drug Name or Code: ACE2016 Indication: A phase 1 study evaluating the safety, efficacy, and pharmacodynamics of ACE2016 in adult subjects with locally advanced or metastatic solid tumors expressing Epidermal Growth Factor Receptor (EGFR). Planned development stages: Phase 1 – 3 clinical studies, New Drug Application (NDA) submission Current development stage: Submission/Approval/Non-Approval/Results of Each Phase of Human Clinical Trials (Including Interim Analysis)/Occurrence of Other Significant Events Affecting New Drug Development: Received a Study May Proceed notification from the FDA to initiate a Phase 1 study. For those not approved by the competent authority for the intended purpose,or when the results of each phase of human clinical trials (including interim analysis) are not statistically significant or other significant events affecting new drug development occur, the risks the company faces and corresponding measures: Not applicable. For those already approved by the competent authority for the intended purpose,or when the results of each phase of human clinical trials (including interim analysis) are statistically significant or other significant events affecting new drug development occur, the future operational direction: Not applicable. Cumulative R&D expenses incurred: Not disclosed at the moment due to concerns about future international collaboration negotiation information or product marketing strategy to protect investor interests Upcoming development plan: Expected Completion Time: Enrollment milestones are estimated to be completed at the end of 2026. The actual timeline will be continuously adjusted based on study progress. Expected Obligations: Not applicable. Announcement • Sep 19
Acepodia Appoints Nobel Laureate Carolyn Bertozzi as Chief Scientific Advisor Acepodia announced that Nobel Laureate Carolyn Bertozzi, Ph.D., was recently appointed Chief Scientific Advisor. Dr. Bertozzi's work applying click chemistry to living cells is the basis of Acepodia's ACC platform, and her expertise will support the development and innovation of the company's differentiated therapeutic approach. Dr. Bertozzi was awarded the 2022 Nobel Prize in Chemistry for discovering a novel form of click chemistry, known as bioorthogonal chemistry. The revolutionary approach utilizes, bioorthogonal reactions that transpire inside living organism, seamlessly integrating with cellular functions without disrupting the normal functions of a cell. She advanced these reactions that are now used to explore cells, track biological processes and improve disease targeting in cancer more efficiently, moving click chemistry into living organisms. Dr. Bertozzi is the Anne T. and Robert M. Bass Professor of Chemistry at Stanford University and an investigator at the Howard Hughes Medical Institute. She is a member of the National Academy of Sciences, National Academy of Medicine and National Academy of Inventors and has been a significant leader in advancing novel approaches to treating a variety of diseases, including cancer. As Chief Scientific Advisor, Dr. Bertozzi will lead Acepodia's Scientific Advisory Board in guiding the company's scientific progress and offering insights based on their relevant experience. The esteemed list of members includes experts in immunology and pioneers of innovative strategies to design new therapies. Board Change • Aug 09
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 3 non-independent directors. Advisor Richard Lopez was the last director to join the board, commencing their role in 2022. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. 