Reported Earnings • May 14
First quarter 2026 earnings released: NT$3.00 loss per share (vs NT$3.89 loss in 1Q 2025) First quarter 2026 results: NT$3.00 loss per share (improved from NT$3.89 loss in 1Q 2025). Net loss: NT$440.5m (loss narrowed 14% from 1Q 2025). Over the last 3 years on average, earnings per share has fallen by 19% per year but the company’s share price has fallen by 42% per year, which means it is performing significantly worse than earnings. Reported Earnings • Mar 14
Full year 2025 earnings released: NT$15.61 loss per share (vs NT$19.78 loss in FY 2024) Full year 2025 results: NT$15.61 loss per share (improved from NT$19.78 loss in FY 2024). Net loss: NT$2.05b (loss narrowed 11% from FY 2024). Over the last 3 years on average, earnings per share has fallen by 19% per year but the company’s share price has fallen by 37% per year, which means it is performing significantly worse than earnings. Aankondiging • Mar 10
OBI Pharma, Inc., Annual General Meeting, Jun 26, 2026 OBI Pharma, Inc., Annual General Meeting, Jun 26, 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 • Nov 18
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 7.0% 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 Risks Less than 1 year of cash runway based on free cash flow trend (-NT$2.0b free cash flow). Earnings have declined by 11% per year over the past 5 years. Minor Risks Share price has been volatile over the past 3 months (7.0% average weekly change). Revenue is less than US$5m (NT$49m revenue, or US$1.6m). Reported Earnings • Nov 12
Third quarter 2025 earnings released: NT$1.78 loss per share (vs NT$2.27 loss in 3Q 2024) Third quarter 2025 results: NT$1.78 loss per share (improved from NT$2.27 loss in 3Q 2024). Net loss: NT$468.3m (loss narrowed 9.8% from 3Q 2024). Over the last 3 years on average, earnings per share has fallen by 18% per year but the company’s share price has fallen by 31% per year, which means it is performing significantly worse than earnings. Aankondiging • Sep 03
OBI Pharma Announces Phase 1/2 Study Initiation for OBI-902, a TROP2 Targeted Antibody-Drug Conjugate Therapy in Advanced Solid Tumors OBI Pharma announced the initiation of a Phase 1/2 clinical trial of OBI-902, an antibody-drug conjugate (ADC) targeting TROP2 (Trophoblast cell-surface antigen 2), an antigen overexpressed in multiple tumor types. OBI-902 is the first OBI- developed ADC that uses proprietary GlycOBI® ADC enabling technology. OBI plans to enroll patients with advanced solid tumors with the objective of verifying the safety, pharmacokinetics, and preliminary efficacy profile of OBI-902 in these patient populations. Postolia M.Tsimberidou, MD, PhD, of MD Anderson Cancer Center in Houston, TX. USA is the lead investigator for the study. OBI- 902 is a novel TROP2 ADC utilizing OBI's proprietary GlycOBI®® ADC enabling technology. At the 2025 American Association for Cancer Research (AACR) meeting, OBI presented data demonstrating enhanced linker-payload stability, favorable pharmacokinetics with superior and durable antitumor activities of OBI-902 In-vitro and animal studies compared to other TROP2 ADCs. About OBI-902: OBI-902 is a TROP2-targeted antibody-drug conjugate ("ADC") that carries a potent topoisomerase I inhibitor load to kill tumor cells and with a drug-antibody ratio (DAR) of 4. TROP2 is highly expressed in a variety of solid tumors such as breast, biliary, ovarian, gastric, and many other cancer types, rendering it an ideal target for cancer therapy. OBI-902 are a novel site-specific glycan-conjugated ADC using OBI's proprietary Glyc OBI® platform, which provides improved stability and enhanced hydrophilicity. OBI-902 demonstrated remarkable antitumor efficacy, improved pharmacokinetic characteristics, and a favorable safety profile in various animal models. The IND of OBI-902 was cleared by the U.S. FDA on April 30, 2025. OBI has licensed the TROP2 targeting antibody from Biosion, Inc. since December 2021, holding exclusive rights worldwide except in China. OBI holds worldwide commercial rights to OBI-902, with the exception of the rights pertaining to the antibody in China. OBI has not granted Biosion with any right to any OBI ADC, including the OBI-902 product. OBI-902, a novel TROP2 targeted antibody-drug conjugate via GlycOBI® platform, has favorable pharmacokinetics and sustained antitumor activities in challenging solid tumors. AACR Annual Meeting 2025 Abstracts online. Harnessing the GlycOBI® enabling technologies: next-generation site-specific glycan ADCs with versatile DAR to enhance therapeutic index. New Risk • Sep 02
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 6.4% 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 Risks Less than 1 year of cash runway based on free cash flow trend (-NT$2.0b free cash flow). Earnings have declined by 9.4% per year over the past 5 years. Minor Risks Share price has been volatile over the past 3 months (6.4% average weekly change). Revenue is less than US$5m (NT$62m revenue, or US$2.0m). Reported Earnings • Aug 15
Second quarter 2025 earnings released: NT$2.48 loss per share (vs NT$2.36 loss in 2Q 2024) Second quarter 2025 results: NT$2.48 loss per share (further deteriorated from NT$2.36 loss in 2Q 2024). Net loss: NT$653.5m (loss widened 21% from 2Q 2024). Over the last 3 years on average, earnings per share has fallen by 15% per year but the company’s share price has fallen by 27% per year, which means it is performing significantly worse than earnings. New Risk • Jul 22
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 6.3% 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 Earnings have declined by 7.0% per year over the past 5 years. Minor Risks Share price has been volatile over the past 3 months (6.3% average weekly change). Revenue is less than US$5m (NT$68m revenue, or US$2.3m). Board Change • Jul 02
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 3 non-independent directors. Independent Director Ming-Chin Chen was the last independent director to join the board, commencing their role in 2022. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Reported Earnings • May 14
First quarter 2025 earnings released: NT$1.95 loss per share (vs NT$2.28 loss in 1Q 2024) First quarter 2025 results: NT$1.95 loss per share (improved from NT$2.28 loss in 1Q 2024). Net loss: NT$511.5m (loss narrowed 2.1% from 1Q 2024). Over the last 3 years on average, earnings per share has fallen by 10% per year but the company’s share price has fallen by 30% per year, which means it is performing significantly worse than earnings. Aankondiging • May 13
OBI Pharma, Inc. announced a financing transaction OBI Pharma, Inc announced a private placement to issue 75 million shares on May 12, 2025. The transaction has been approved by shareholders and restricted to a hold period of 3 years. Aankondiging • Apr 24
OBI Decides to Terminate OBI-822 Phase 3 Studybased on DSMB's Recommendation and to Redirect Resources Towards ADCs Development On April 23, 2025, OBI decided to terminate OBI-822 Phase 3 studybased on DSMB's recommendation and to redirect resources towards ADCs development. New drug name or code: The active cancer immunotherapy Adagloxad Simolenin (OBI-822)/OBI-8213.Indication: Adagloxad Simolenin (OBI-822) is a therapeutic cancer vaccine classified as an active cancer immunotherapy. Globo H-KLH conjugate triggers an immune response against solid tumors when injected into humans. OBI-821 is an adjuvant that is administered with OBI-822 to strengthen the immune response. The anticipated indication for the drug, if approved, will be in patients with early stage, high risk, Globo H-Positive Triple Negative Breast Cancer. Planned development stages: Phase III clinical trial, and BLA Current development stage:(1)Application submission/approval/disapproval/each of clinical trials (include interim analysis):2nd interim analysis of Adagloxad Simolenin (OBI-822)/OBI-821 in TNBC Phase III clinical trial A. Clinical Study Design: a. Protocol Title: The GLORIA Study: A Phase III, Randomized, Open-Label Study of the Anti-Globo H Vaccine Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Early Stage, High Risk, Globo H-Positive Triple Negative Breast Cancer b. Study Purpose: To assess the efficacy and safety of Adagloxad Simolenin (OBI-822)/OBI-821 c. Phase of Clinical Study: Phase III clinical trial d. Investigational product: The active cancer immunotherapy Adagloxad Simolenin (OBI-822)/OBI-821 e. Indication: Early stage, high risk, Globo H-Positive Triple Negative Breast Cancer f. Endpoints: Primary endpoints: To determine the effect of Adagloxad Simolenin (OBI-822)/OBI-821 treatment on improving invasive disease free survival (IDFS) in the study population. Secondary endpoints: To determine the impact of Adagloxad Simolenin (OBI-822)/OBI-821 treatment in the study population, on: -Overall survival Quality of Life Breast cancer-free interval-Distant disease-free survival Safety and tolerability Number of subjects enrolled: 668 (target) Primary and secondary endpoints and the statistical results: a. The company’s Phase III clinical trial targeting patients with early stage, high risk, Globo H-Positive Triple Negative Breast Cancer is still in progress. The DSMB (Data and Safety Monitoring Board) recommendation is announced after their review of the second interim analysis data. The DSMB will not reveal data to OBI until the clinical trial completion. OBI remains blinded and will only announce DSMB’s recommendation. conducted at 60% of information fraction (estimated to be when 113 of the total 187 primary endpoint events occurred) to assess futility. Based on the outcome of this second interim futility analysis, the Data and Safety Monitoring Board recommended termination of the trial. After a thorough evaluation, the company has decided to follow the DSMB's recommendation and to terminate Adagloxad Simolenin (OBI-822) /OBI-821 Phase III clinical trial. The resources saved will be redirected towards the development of next-generation antibody-drug conjugates. The Company will continue to provide medical care to the enrolled patients in accordance with the clinical study protocol and will manage the unused investigational products in compliance with related regulations and the Good Clinical Practice. The results of a single clinical trial (including the p value or whether there are statistical significance in primary, secondary endpoints) shall not be sufficient to reflect the success or failure of the new drug in the future development. Investors should be careful in judgement and investment. If not approved by competent authority, or should the interim analysis or the clinical trial not reach statistical significance, the risks and the associated measures the Company may occur: Please refer to the 5.(1).B.b. for clarification. (3)After obtaining official approval or the results of interim analysis or the clinical trial reaching statistical significance, the future strategy will be: Not applicable. (4)Accumulated investment expenditure incurred: For negotiation on potential licensing deals in the future, and for the best interest of shareholders, this information is kept confidential temporarily. Aankondiging • Apr 23
OBI Pharma, Inc. Announces Nonclinical Data for OBI-992 and OBI-902 Antibody-Drug Conjugates, GlycOBI and ThiOBI ADC Enabling Technologies, the OBI-3424 Prodrug, and Globo H (GH) Science at the AACR 2025 Annual Meeting OBI Pharma, Inc. announced nonclinical data for OBI-902, a potential best-in-class anti-TROP2 ADC developed using the next generation proprietary GlycOBI technologies. OBI-992, a cysteine-based TROP2 targeting ADC, demonstrated a differentiated resistance profile compared to benchmark ADCs. Additionally, characterization and non-clinical in vivo data will be presented for the glycan-specific GlycOBI and ThiOBI proprietary ADC platforms, highlighting enhanced antitumor activity and stability in animal model studies. ThiOBI is a new next-generation platform and adds to OBI's armamentarium of ADC enabling technologies. Additionally, the non-clinical and antitumor activity of OBI-3424, a novel AKR1C3 targeted prodrug, will be presented. Furthermore, the potential correlation between GH expression and poor prognosis in cholangiocarcinoma (CCA), along with GH's role in modulating immune responses in CCA patients will be discussed. These data will be presented at the American Association of Cancer Research (AACR) Annual Meeting from April 25 to 30, 2025 in Chicago, Illinois (USA). Aankondiging • Apr 02
Obi Pharma, Inc. Submits the IND Application of A Phase I/II Human Clinical Trial for OBI-902 Trop2 ADC to the US FDA OBI Pharma, Inc. announced that it has submitted the IND application of a Phase I/II human clinical trial for OBI-902 TROP2 ADC to the US FDA. OBI-902 is the first antibody-drug conjugate (ADC) developed using OBI's proprietary GlycOBI ADC enabling technologies and targets TROP2. The asset has consistently shown superior antitumor activities across multiple tumor types in various animal models. GlycOBI is a glycan-based site-specific conjugation technology, powered by a patented dual function enzyme, EndoSymeOBI, to precisely control the drug-to-antibody ratio (DAR) to generate homogeneous ADCs. OBI's proprietary HYPrOBI linker technology allows for the masking of the hydrophobic payload to enhance the solubility and stability of ADCs in circulation. Separately, this linker technology enables efficient payload release after ADC entry into target cancer cells, with the potential to improve the therapeutic index. Further, the GlycOBIADC enabling technologies have been validated in GMP production. OBI-902 will be studied in a Phase 1 /2 study evaluating the safety, pharmacokinetics, and therapeutic activity in patients with advanced solid tumors. Reported Earnings • Mar 30
Full year 2024 earnings released: NT$9.89 loss per share (vs NT$4.57 loss in FY 2023) Full year 2024 results: NT$9.89 loss per share (further deteriorated from NT$4.57 loss in FY 2023). Net loss: NT$2.31b (loss widened 121% from FY 2023). Over the last 3 years on average, earnings per share has remained flat but the company’s share price has fallen by 19% per year, which means it is significantly lagging earnings. Aankondiging • Mar 12
OBI Pharma, Inc., Annual General Meeting, Jun 27, 2025 OBI Pharma, Inc., Annual General Meeting, Jun 27, 2025, at 10:00 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 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 Earnings have declined by 0.3% per year over the past 5 years. Minor Risks Latest financial reports are more than 6 months old (reported June 2024 fiscal period end). Revenue is less than US$5m (NT$58m revenue, or US$1.8m). Reported Earnings • Nov 19
Third quarter 2024 earnings released: NT$2.27 loss per share (vs NT$2.48 loss in 3Q 2023) Third quarter 2024 results: NT$2.27 loss per share (improved from NT$2.48 loss in 3Q 2023). Net loss: NT$519.3m (loss narrowed 8.5% from 3Q 2023). Over the last 3 years on average, earnings per share has increased by 2% per year but the company’s share price has fallen by 15% per year, which means it is significantly lagging earnings. Aankondiging • Oct 25
OBI Pharma, Inc. to Report Q3, 2024 Results on Nov 04, 2024 OBI Pharma, Inc. announced that they will report Q3, 2024 results on Nov 04, 2024 Reported Earnings • Aug 17
Second quarter 2024 earnings released: NT$2.36 loss per share (vs NT$1.79 profit in 2Q 2023) Second quarter 2024 results: NT$2.36 loss per share (down from NT$1.79 profit in 2Q 2023). Net loss: NT$540.7m (down 232% from profit in 2Q 2023). Over the last 3 years on average, earnings per share has increased by 7% per year but the company’s share price has fallen by 6% per year, which means it is significantly lagging earnings. Aankondiging • Jul 24
OBI Pharma, Inc. to Report Q2, 2024 Results on Aug 02, 2024 OBI Pharma, Inc. announced that they will report Q2, 2024 results on Aug 02, 2024 Aankondiging • May 31
OBI Pharma, Inc. Files the Application of Phase I/II human clinical trial for OBI-992 TROP2 ADC to TFDA OBI Pharma, Inc. has filed the application of a Phase I/II human clinical trial for OBI-992 TROP2 ADC to TFDA. Indication: OBI-992 is an antibody drug conjugate (ADC) for cancer treatment that is based on TROP2 to target cancer cells. ADC releases a small molecule payload through the specificity of the antibody and directly deploys cytotoxic molecule at the targeted cancer cells. The Trop2 antibody that is linked with a payload, binds to the targets on tumor cells followed by entering into cells via internalization. The small molecule payload will then be released through enzymatic cleavage to achieve the goal of killing tumor. Planned development stages: Phase I, II, III clinical trial, and Biologics License Application (BLA). Current development stage: (1)Application submission/approval/disapproval/each of clinical trials (include interim analysis): OBI has filed the application of Phase I/II human clinical trial for OBI-992 TROP2 ADC to TFDA; (2) Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks & the associated measures the Company may occur: Not applicable; (3) After obtaining official approval or the results of statistically significant sense, the future strategy: Not applicable; (4) Accumulated investment expenditure incurred: For negotiation on potential licensing deals in the future, and for the best interest of shareholders, this information is kept confidential. Upcoming development plan: Phase I/II clinical trial V Phase I Dose Escalation;(1) Estimated date of completion: second quarter 2025; 2) Estimated responsibilities: The company is responsible for clinical trial related expenses, including development and regulatory milestones to be paid to Biosion, Inc. under the terms of the license agreement. New Risk • May 19
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -NT$1.9b 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 Risk Less than 1 year of cash runway based on free cash flow trend (-NT$1.9b free cash flow). Minor Risk Revenue is less than US$5m (NT$49m revenue, or US$1.5m). Aankondiging • Apr 28
OBI Pharma, Inc. to Report Q1, 2024 Results on May 10, 2024 OBI Pharma, Inc. announced that they will report Q1, 2024 results at 9:00 AM, Taipei Standard Time on May 10, 2024 Reported Earnings • Mar 29
Full year 2023 earnings released: NT$4.57 loss per share (vs NT$7.27 loss in FY 2022) Full year 2023 results: NT$4.57 loss per share (improved from NT$7.27 loss in FY 2022). Net loss: NT$1.05b (loss narrowed 35% from FY 2022). Over the last 3 years on average, earnings per share has increased by 12% per year but the company’s share price has fallen by 25% per year, which means it is significantly lagging earnings. Aankondiging • Feb 01
OBI Pharma, Inc. Announces Adagloxad Simolenin (OBI-822) Receives Positive 1st Interim Analysis Recommendation, Recommending the Continues of the Phase III TNBC Trial OBI Pharma, Inc. announced Adagloxad Simolenin (OBI-822)/OBI-821, receives a positive first interim analysis recommendation, suggestingthe continuation of the Phase III TNBC trial. Indication:Adagloxad Simolenin (OBI-822) is a therapeutic cancer vaccine classified as an active cancer immunotherapy. Globo H-KLH conjugate triggers immune response against hard-to-treat cancers once injected into the human system. OBI-821 is an adjuvant that is mixed with OBI-822 to strengthen the immune response. Current development stage: Application submission/approval/disapproval/each of clinical trials (include interim analysis):1st interim analysis of Adagloxad Simolenin (OBI-822)/OBI-821 TNBC (triple-negative breast cancer) Phase III clinical trial. A. Clinical Study Design: a. Protocol Title: The GLORIA Study: A Phase III, Randomized, Open-Label Study of the Anti-Globo H Vaccine Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Early Stage, High Risk, Globo H-Positive Triple Negative Breast Cancer; b. Study Purpose: To assess the efficacy and safety of Adagloxad Simolenin (OBI-822)/OBI-821; c. Phase of Clinical Study: Phase III clinical trial; d. Investigational product: The active cancer immunotherapy Adagloxad Simolenin (OBI-822)/OBI-821; e. Indication: Early stage, high risk, Globo H-Positive Triple Negative Breast Cancer; f. Endpoints: Primary endpoints: To determine the effect of Adagloxad Simolenin (OBI-822)/OBI-821 treatment on improving invasive disease free survival (IDFS) in the study population. Secondary endpoints: To determine the impact of Adagloxad Simolenin (OBI-822)/OBI-821 treatment in the study population, on: -Overall survival (OS); -Quality of Life (QoL); -Breast cancer-free interval (BCFI); -Distant disease-free survival (DDFS); -To determine safety and tolerability of Adagloxad Simolenin (OBI-822)/OBI-821 in the study population; g. Number of subjects enrolled: 668 (target). Primary and secondary endpoints and the statistical results: a. The company’s Phase III clinical trial targeting patients with early stage, high risk, Globo H-Positive Triple Negative Breast Cancer is still in progress. This time, DSMB (Data and Safety Monitoring Board) recommendation is announced after their review of the first interim analysis data. The DSMB will not reveal data to OBI until the clinical trial completion. OBI remains blinded and will only announce DSMB’s recommendation. b. Based on the GLORIA study protocol, the first interim analysis is conducted at 40% of information fraction (estimated to be when 75 of the total 187 primary endpoint events occurred) to assess futility. The DSMB reviewed the interim analysis data, evaluated the patient’s risk-benefit, and provided a positive recommendation. After their recommendation, the company will continue the clinical trial according to the proposed timeline. C. The results of a single clinical trial (including the p value or whether there are statistical significance in primary, secondary endpoints) shall not be sufficient to reflect the success or failure of the new drug in the future development. The investors shall be careful in judgement and investment. Upcoming development plan: Adagloxad Simolenin (OBI-822)/OBI-821 TNBC phase III clinical trial (1)Estimated date of completion: The clinical trial enrollment is expected to be completed by the end of 2025, but the progress will be adjusted based on the actual recruitment. This is a Phase III clinical trial targeting patients with early stage, high risk, Globo H-Positive Triple; Negative Breast Cancer. The primary efficacy endpoints is invasive disease free survival (IDFS), defined as the time from the date of randomization to the date of first invasive disease recurrence (local, regional, or distant), the date of second primary invasive cancer (breast or not), or death from any cause, whichever occurs first. Assuming a treatment effect with a hazard ration (HR) of 0.66 in the final analysis, a total of 187 primary endpoint events will be required to detect a treatment difference with 80% power, based on a two-sided log-rank test with an overall type I error rate of 5%. Once it reaches the 187 primary events, it will trigger the condition to unblind the study. An interim analysis will be conducted at 40% and 60 % of information fraction (estimated to be when approximately 75 and 113 primary endpoint events occur) to assess futility. The company will remain blinded to study results until the final analysis. Interim analyses will be conducted by the contract research organization (CRO) assigned to the study, with the DSMB providing recommendations on the conclusion of the futility assessments. Aankondiging • Dec 21
OBI Pharma, Inc. Announces Resignation of Yun Yen as Chairperson and Director, Effective December 29, 2023 OBI Pharma, Inc. announced the The Company received the resignation letter of Dr. Yun Yen on December 20, 2023, to resign his position as Chairperson and director of the Company. The effective date is set on December 29, 2023. Aankondiging • Dec 02
Obi Pharma, Inc. Files the Application of Phase I/II Human Clinical Trial for OBI-992 TROP2 ADC to US FDA OBI Pharma, Inc. has filed the application of Phase I/II human clinical trial for OBI-992 TROP2 ADC to US FDA. Indication: OBI-992 is an Antibody Drug Conjugate (ADC) for cancer treatment that is based on TROP2 to target cancer cells. ADC releases a small molecule payload through the specificity of the antibody and directly deploys cytotoxic molecule at the targeted cancer cells. Antibody that is linked with a payload binds to the targets on tumor cells followed by entering into cells via internalization. The small molecule payload will then be released through enzymatic cleavage to achieve the goal of killing tumor. Planned development stages: Phase I, II, III clinical trial, and Biologics License Application (BLA). Current development stage: Application submission/approval/disapproval/each of clinical trials (include interim analysis): OBI has filed the application of Phase I/II human clinical trial for OBI-992 TROP2 ADC to US FDA. Accumulated investment expenditure incurred: For negotiation on potential licensing deals in the future, and for the best interest of shareholders, this information is kept confidential temporarily. Upcoming development plan: Phase I clinical trial. Estimated date of completion: 2024. Aankondiging • Nov 08
OBI Pharma, Inc. Announces CFO Changes OBI Pharma, Inc. announced the change of financial officer. Name, title, and resume of the previous position holder: Frank Chen /CFO /Board member and CFO, OBI Pharma Inc. Name, title, and resume of the new position holder: Colin Kao /Director /Finance director, OBI Pharma Inc. Reason for the change: Position adjustment. Effective date: November 6, 2023. The Board of Directors resolved to appoint Colin Kao as financial officer. Frank Chen will no longer serve as CFO. Aankondiging • Nov 07
OBI Pharma, Inc. Announces Internal Audit Officer Changes OBI Pharma, Inc. announced the change of internal audit officer. Name, title, and resume of the previous position holder: Neo Chien/Director /Internal audit director, OBI Pharma Inc. Name, title, and resume of the new position holder: Hanna Hsu/Supervisor /Internal audit supervisor, OBI Pharma Inc. Reason for the change: Position adjustment. Effective date: November 6, 2023. Board Change • Aug 11
Less than half of directors are independent Following the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Director Ming-Chin Chen was the last independent director to join the board, commencing their role in 2022. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Reported Earnings • Aug 08
Second quarter 2023 earnings released: EPS: NT$1.79 (vs NT$1.50 loss in 2Q 2022) Second quarter 2023 results: EPS: NT$1.79 (up from NT$1.50 loss in 2Q 2022). Net income: NT$409.0m (up NT$752.1m from 2Q 2022). Over the last 3 years on average, earnings per share has increased by 4% per year but the company’s share price has fallen by 9% per year, which means it is significantly lagging earnings. Aankondiging • Jun 29
OBI Pharma, Inc. Announces Appointment of Yun Yen as the Chairman OBI Pharma, Inc. announced appointment of Yun Yen, Representative of institutional director, Sheng Cheng Investment Co. Ltd., as the Chairman with effect from June 27, 2023. Aankondiging • Jun 28
OBI Pharma, Inc. Announces Appointment of Yun Yen as Natural-Person Director OBI Pharma, Inc. announced appointment of Yun Yen as Natural-person director with effect from June 27, 2023. Resume of the new position holder: Yun Yen/Chairman of the Board, OBI Pharma Inc. Aankondiging • Jun 03
OBI Pharma, Inc. Announces COVID-19 Vaccine, BCVax, Has Been Granted by TFDA to Proceed to Phase I Clinical Trial OBI Pharma, Inc. announced that it has been granted by TFDA to proceed to Phase I clinical trial. COVID-19 vaccine, BCVax, is composed of the Delta spike protein with nanoparticle saponins as adjuvant that can induce high-titer antibodies and has neutralization activities on various SARS-CoV-2 variants. As a conventional vaccine, BCVax has the advantages of stability, production Maturity, and low requirements for ultracold storage. It is easy-to-store and convenient-to-deliver, which enables the vaccine to spread over the world. Planned development stages: Phase I, II, III clinical trial, and Biologics License Application (BLA). Current development stage: Application submission/approval/disapproval/each of clinical trials (include interim analysis): The COVID-19 vaccine,BCVax, has been granted by TFDA To proceed to Phase I clinical trial; Once disapproved by competent authority or each of clinical trials (include interim analyses) results less than statistically significant sense, the risks & the associated measures the Company may occur: Not applicable; After obtaining official approval or the results of statistically significant sense, the future strategy: The Company plans to proceed to phase I human clinical trial, while flexibly adjusting the R&D strategy of the product based on the progress of pandemic at the same time; Accumulated investment expenditure incurred: For negotiation on potential licensing deals in the future, and for the best interest of shareholders, this information is kept confidential temporarily. Upcoming development plan: Phase I human clinical trial; Estimated date of completion: 2024; Estimated responsibilities: None. Market situation: According to WHO's Global Vaccine Market Report 2022, the global COVID-19 vaccine market was valued at USD 99 billion in 2021. As BCVax is still in the phase of clinical trial, the Company will flexibly adjust the R&D strategy of The product based on the progress of p pandemic. Aankondiging • Jun 02
OBI Pharma Appoints Heidi Wang as Chief Executive Officer OBI Pharma, Inc. have appointed Heidi Wang, Ph.D. as Chief Executive Officer, a position previously held by Chairman and CEO, Yun Yen, MD. Dr. Wang brings a wealth of global executive management, scientific knowledge, development, and regulatory experience during her ~30 years tenure at Bristol Myers Squibb company (BMS)™.Prior to joining OBI Pharma, she was Vice President, Head of Global Regulatory Sciences Oncology. Additionally, she has held executive and senior management roles of increasing responsibilities as Interim Head of R&D and Regulatory in China, US and International Regulatory Strategy, Global Product Labeling, Medical Communications, and Research Discovery. Dr. Wang has received the following degrees: Ph.D. and M.S. degrees at the University of Notre Dame (South Bend, IN) and B.S. degree at Fu-Jen University (Taipei, Taiwan). She also received postdoctoral training in cancer biology at The Cold Spring Harbor Laboratory (Cold Spring Harbor, NY). She has won numerous awards and authored numerous scientific publications during her career. Reported Earnings • Mar 17
Full year 2022 earnings released: NT$7.27 loss per share (vs NT$7.69 loss in FY 2021) Full year 2022 results: NT$7.27 loss per share. Net loss: NT$1.61b (loss widened 5.4% from FY 2021). Aankondiging • Feb 03
Obi Pharma, Inc. Files Application for Phase II Human Clinical Trial of First-In-Class Novel Prodrug, Obi-3424, to TFDA OBI Pharma, Inc. filed application for Phase II human clinical trialof first-in-class novel prodrug, OBI-3424, to TFDA. New drug name or code: first-in-class novel prodrug, OBI-3424. OBI-3424 is converted into a potently cytotoxic DNA alkylating agent specifically by the AKR1C3 enzyme, which is expressed by a variety of tumors leading to selective killing of those cells. Potential study subjects will have their tumor cells tested by IHC to assess expression of AKR1C3 to decide whether they can be enrolled into this Phase II clinical trial. Planned development stages: Phase I, II, III clinical trial, and NDA. Current development stage: Application submission/approval/disapproval/each of clinical trials (include interim analysis): OBI submitted this application to TFDA in support of this OBI-3424 Phase II human clinical trial. Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks & the associated measures the Company may occur: Not applicable After obtaining official approval or the results of statistically significant sense, the future strategy: Not applicable Accumulated investment expenditure incurred: To negotiate future licensing deals, and in the best interest of shareholders, this information is kept temporarily confidential. Upcoming development plan: Phase II human clinical trial: Estimated date of completion: Subject recruitment will be completed for the phase II trial in 2024. Market situation: According to a public research report from IQVIA, the global oncology drug market size was valued at USD 185 billion in 2021, with a 10.7% compound annual growth rate (CAGR). OBI-3424 is intended to target unmet medical needs when a meaningful clinical benefit to patients has been identified. Therefore, selection of future OBI-3424 studies will be based on data from this study and determined as part of an overall development strategy. New drug development requires long process, vast investments and with no guarantee in success which may pose investment risks. The investors are advised to exercise caution and conduct thorough evaluation. Aankondiging • Dec 30
OBI Pharma, Inc. Announces Demise of Chairman of the Board, Michael Chang OBI Pharma, Inc. announced the demise of Chairman of the Board, Michael Chang. Board Change • Nov 16
Less than half of directors are independent Following the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Director Ming-Chin Chen was the last independent director to join the board, commencing their role in 2022. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Reported Earnings • Aug 15
Second quarter 2022 earnings released: NT$1.50 loss per share (vs NT$2.09 loss in 2Q 2021) Second quarter 2022 results: NT$1.50 loss per share (up from NT$2.09 loss in 2Q 2021). Net loss: NT$343.1m (loss narrowed 18% from 2Q 2021). Over the last 3 years on average, earnings per share has increased by 1% per year but the company’s share price has fallen by 17% per year, which means it is significantly lagging earnings. Aankondiging • Aug 09
OBI Pharma, Inc. announced that it expects to receive TWD 800 million in funding OBI Pharma, Inc. announced a private placement of 16,000,000 common shares of par value TWD 10 per share, at issue price of TWD 50 per share for gross proceeds of TWD 800,000,000 on August 8, 2022. The new shares will issue to existing shareholders for 14,400,000 shares and employees for 1,600,000 shares of the company. The transaction has been approved by the board of directors of the company. Aankondiging • Jul 06
Obi Pharma Announces Discontinuation of the Phase 1/2 Study of Iis Antibody- OBI 888 OBI Pharma announced discontinuation of the Phase 1/2 Study for OBI 888, a Globo H antibody, upon completion of enrollment in the investigative sites. Reported Earnings • May 16
First quarter 2022 earnings released: NT$1.52 loss per share (vs NT$1.16 loss in 1Q 2021) First quarter 2022 results: NT$1.52 loss per share (down from NT$1.16 loss in 1Q 2021). Net loss: NT$305.6m (loss widened 32% from 1Q 2021). Over the last 3 years on average, earnings per share has remained flat but the company’s share price has fallen by 7% per year, which means it is significantly lagging earnings. Board Change • Apr 27
Less than half of directors are independent There is 1 new director who has joined the board in the last 3 years. The new board member was an independent director. The company's board is composed of: 1 new director. 5 experienced directors. 1 highly experienced director. 3 independent directors (4 non-independent directors). Independent Director Howard S. Lee was the last independent 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: Minority of independent directors. Insufficient board refreshment. Aankondiging • Apr 08
OBI Pharma, Inc. Announces That AEMPS of Spain Revokes Previous Approval for the Active Cancer Immunotherapy, OBI-822, to Proceed to Phase III Clinical Trial OBI Pharma, Inc. announced that AEMPS of Spain revokes previous approval for the Active Cancer Immunotherapy, OBI-822, to proceed to Phase III Clinical Trial. The Company was informed by The Spanish Agency of Medicines and Medical Devices (hereinafter referred to as “ AEMPS”) on 2022/1/25 of the approval for the Active Cancer Immunotherapy, OBI-822, to proceed to Phase III Clinical Trial. The Company announced the material information on the same date in accordance with the rules related. However, at the beginning of February, 2022, AEMPS informed the Company that due to procedural errors, the review of Phase III Clinical Trial was not completed and supplementary information was needed. Despite that the Company responded immediately to the inquiry, AEMPS informed the Company on 2022/4/6 that previous approval for OBI-822 to proceed to Phase III Clinical Trial had been revoked. According to the letter missive, AEMPS revokes the approval of Phase III Clinical Trial as the information integrity of Keyhole Limpet Hemocyanin (KLH) and Chemistry, Manufacturing and Controls (CMC), is considered not satisfactory. OBI-822 with its Phase I Clinical Trial finished was transferred from MSKCC and completed its Phase II Clinical Trial by the Company itself. The results of hundreds of patients revealed that OBI-822 had no safety or tolerability concerns. Health authorities in 13 countries, including the United States, Australia, Taiwan, and China, have granted OBI-822 to proceed to Phase III Clinical Trial. The Company will continue to conduct Phase III Clinical Trial while the trial was granted by several countries in South Africa and South America recently to increase the enrollment. It is estimated that the withdrawal of AEMPS’s previous approval will not cause material impact to the progress of OBI-822 Phase III Clinical Trial. Reported Earnings • Mar 28
Full year 2021 earnings released: NT$7.69 loss per share (vs NT$7.34 loss in FY 2020) Full year 2021 results: NT$7.69 loss per share (down from NT$7.34 loss in FY 2020). Net loss: NT$1.72b (loss widened 18% from FY 2020). Over the last 3 years on average, earnings per share has remained flat but the company’s share price has fallen by 13% per year, which means it is significantly lagging earnings. Aankondiging • Feb 24
OBI Pharma, Inc. Announces TFDA Grants Approval for Active Cancer Immunotherapy OBI-833 to Proceed to Phase II Clinical Trial OBI Pharma, Inc. announced that TFDA has granted the approval for the active cancer immunotherapy OBI-833 to proceed to a Phase II clinical trial. After obtaining official approval or the results of statistically significant sense, the future strategy: Phase II clinical trial in progress. Accumulated investment expenditure incurred: As the information is involved in future negotiation of licensing deals, to avoid influence on licensing deals and for best interest of shareholders, it will be kept confidential temporary. Upcoming development plan: Phase II human clinical trial. Estimated date of completion: Expected to evaluate primary endpoint in 2024, actual schedule will be adjusted according to the patient enrollment and completion of therapy timeline. Aankondiging • Jan 25
OBI Pharma, Inc. Announces Phase 2 Studies Patient Enrollment for Obi-999 and Obi-3424 OBI Pharma, a Taiwan biopharma company announced that the first patients have been enrolled in both of the Phase 2 studies of OBI-999, an antibody drug conjugate (ADC) cancer therapy targeting Globo H, and OBI-3424, a prodrug targeting the enzyme aldo-keto reductase 1C3 (AKR1C3). The Phase 2 cohort expansion part of the OBI-999-001 (ClinicalTrials.gov Identifier: NCT04084366) entitled "A Phase 1/2, Open-Label, Dose-Escalation and Cohort-Expansion Study Evaluating the Safety, Pharmacokinetics, and Therapeutic Activity of OBI-999 in Patients with Advanced Solid Tumors" has now begun enrollment. The Phase 2 part of the study will enroll Globo H expressing patients with pancreatic, colorectal and other high Globo H expression solid tumors in more than ten medical centers in the United States and Taiwan. The Phase 2 cohort expansion part of the OBI-3424-001 (ClinicalTrials.gov Identifier: NCT03592264) entitled "A Phase 1/2 Study of OBI-3424 in Subjects with Advanced Solid Tumors" has also begun enrollment. This study will enroll AKR1C3 expressing patients with pancreatic and other high AKR1C3 expressing solid tumors in select oncology medical centers in the United States. OBI anticipates completing the enrollment of both Phase 2 studies in the second half of 2023. OBI-999 is a novel first-in-class Antibody Drug Conjugate (ADC) with a proprietary linker technology that provides a consistent Drug-to-Antibody ratio (DAR) for cancer treatment that is based on Globo H, an antigen expressed in up to 15 epithelial cancers. OBI-999 uses a Globo H antibody to target cancer cells of high Globo H expression. By releasing a small molecule chemotherapeutic drug through the specificity of the antibody, it directly deploys cytotoxic therapy at the targeted cancer cells. In pre-clinical xenograft animal models in multiple tumor types (gastric, pancreatic, lung and breast), OBI-999 has demonstrated profound tumor shrinkage at various doses. In human Phase 1 study, OBI-999 was well-tolerated, and achieved a favorable safety margin which warrants further clinical development. OBI-999 is currently in a Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04084366) in medical centers in the US and Taiwan. OBI Pharma owns global rights to OBI-999. OBI-3424 is a first-in-class novel small-molecule prodrug that selectively targets cancers overexpressing the enzyme aldo-keto reductase 1C3 (AKR1C3), and selectively releases a potent DNA alkylating agent in the presence of the AKR1C3 enzyme. This selective mode of activation distinguishes OBI-3424 from traditional alkylating agents, such as cyclophosphamide and ifosfamide, which are non-selective. AKR1C3 overexpression has been documented in a number of treatment-resistant and difficult-to-treat cancers including hepatocellular carcinomas (HCC), castrate-resistant prostate cancer (CRPC), and T-cell acute lymphoblastic leukemia (T-ALL). AKR1C3 is highly expressed in up to 15 solid and liquid tumors. Furthermore, individualized patient selection by staining for AKR1C3 overexpression by immunohistochemistry can be performed based on tumor biopsies or circulating tumor cells to identify patients with other tumor types most likely to respond to treatment with OBI-3424, and thus offering the possibility for a streamlined clinical development strategy. OBI-3424 is currently in a Phase 2 trial (ClinicalTrials.gov Identifier: NCT03592264) in medical centers in the US. OBI owns global rights to OBI-3424 except the Asia Pacific region. Aankondiging • Dec 19
Directorate General of Drug Supplies and Drugs of Peru Grants OBI Pharma, Inc.'s OBI-822 (Adagloxad Simolenin) to Proceed to Phase III Clinical Trial OBI Pharma, Inc. announced that active cancer immunotherapy OBI-822 (Adagloxad Simolenin) has been granted by Directorate General Of Drug Supplies And Drugs (DIGEMID) of Peru to proceed to Phase III clinical trial and New Drug Application (NDA). OBI-822 is a therapeutic cancer vaccine classified as active cancer immunotherapy. Globo H-KLH conjugate triggers immune response against hard-to-treat cancers once injected into the human system. The Phase III human clinical trial in progress. Expected to perform interim analysis in 2023, actual schedule will be adjusted according to the patient enrollment and completion of therapy timeline. The future development will be determined after comprehensive consideration of product development strategy. Aankondiging • Dec 16
OBI Files the Application for Phase II clinical Trial for Obi-833, an Active Cancer immunotherapy, to TFDA OBI has filed the application for a Phase II clinical trial for OBI-833, an active cancer immunotherapy, to TFDA New drug name or code: Active cancer immunotherapy, OBI-833. Indication: OBI-833 is a therapeutic cancer vaccine against Globo H, which is classified as an active cancer immunotherapy. Once injected into the human body, the Globo H-CRM197 conjugate can elicit anti-Globo H antibodies to treat cancers. Potential subjects will be tested by IHC to assess the expression of Globo H in the tumor to decide whether they can be enrolled into this Phase II clinical trial. Planned development stages: Phase I, II, III clinical trial, and New Drug Application (NDA) Current development stage: (1)Application submission/approval/disapproval/each of clinical trials (include interim analysis): Filed application (2)Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significantsense, the risks & the associated measures the Company may occur: Not applicable (3)After obtaining official approval or the results of statistically significant sense, the future strategy: Not applicable (4)Accumulated investment expenditure incurred: As the information is involved in future negotiation of licensing deals, to avoid influence on licensing deals and for best interest of shareholders, it will be kept confidential temporary. Upcoming development plan: Phase II human clinical trial (1)Estimated date of completion: expected to evaluate primary endpoint in 2024, actual schedule will be adjusted according to the patientenrollment and completion of therapy timeline. Reported Earnings • Nov 15
Third quarter 2021 earnings released: NT$1.64 loss per share (vs NT$2.02 loss in 3Q 2020) Third quarter 2021 results: Net loss: NT$324.9m (loss narrowed 15% from 3Q 2020). Over the last 3 years on average, earnings per share has fallen by 1% per year whereas the company’s share price has fallen by 3% per year. Reported Earnings • Aug 12
Second quarter 2021 earnings released: NT$2.09 loss per share (vs NT$1.67 loss in 2Q 2020) Second quarter 2021 results: Net loss: NT$415.8m (loss widened 32% from 2Q 2020). Over the last 3 years on average, earnings per share has fallen by 4% per year but the company’s share price has fallen by 10% per year, which means it is performing significantly worse than earnings. Reported Earnings • May 13
First quarter 2021 earnings released: NT$1.16 loss per share (vs NT$1.67 loss in 1Q 2020) First quarter 2021 results: Net loss: NT$231.3m (loss narrowed 26% from 1Q 2020). Over the last 3 years on average, earnings per share has fallen by 4% per year whereas the company’s share price has fallen by 9% per year. Aankondiging • Apr 27
OBI Pharma, Inc. Announces First Patient Enrolled on SWOG Cancer Research Network's OBI-3424 Phase 1/2 Study Targeting AKR1C3 in T-ALL and T-LBL OBI Pharma, Inc. announced that the U.S.-based SWOG Cancer Research Network has started patient enrollment for a Phase I/II study of OBI-3424, a first-in-class (small-molecule prodrug) DNA alkylating agent that targets cancers expressing the aldo-keto reductase 1C3 (AKR1C3) enzyme. The study, S1905 (ClinicalTrials.gov Identifier: NCT04315324), is titled "A Phase 1/2 Study of AKR1C3-Activated Prodrug OBI-3424 in Patients with Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL)/T-Cell Lymphoblastic Lymphoma (T-LBL)." SWOG is a member of the National Cancer Institute's (NCI) National Clinical Trials Network (NCTN). In the NCTN, cancer trials are designed by some of the nation's leading cancer experts, funded by tax dollars, and powered by patient volunteers. OBI-3424 is a first-in-class novel small-molecule prodrug that selectively targets cancers overexpressing the enzyme aldo-keto reductase 1C3 (AKR1C3), and selectively releases a potent DNA alkylating agent in the presence of the AKR1C3 enzyme. This selective mode of activation distinguishes OBI-3424 from traditional alkylating agents, such as cyclophosphamide and ifosfamide, which are non-selective. AKR1C3 overexpression has been documented in a number of treatment-resistant and difficult-to-treat cancers including hepatocellular carcinomas (HCC), castrate-resistant prostate cancer (CRPC), and T-cell acute lymphoblastic leukemia (T-ALL). AKR1C3 is highly expressed in up to 15 solid and liquid tumors. Reported Earnings • Mar 30
Full year 2020 earnings released: NT$7.34 loss per share (vs NT$7.76 loss in FY 2019) Full year 2020 results: Net loss: NT$1.49b (loss widened 5.9% from FY 2019). Over the last 3 years on average, earnings per share has fallen by 3% per year whereas the company’s share price has fallen by 5% per year. Aankondiging • Mar 17
OBI Pharma, Inc., Annual General Meeting, Jun 21, 2021 OBI Pharma, Inc., Annual General Meeting, Jun 21, 2021. Is New 90 Day High Low • Mar 03
New 90-day high: NT$153 The company is up 32% from its price of NT$116 on 03 December 2020. The Taiwanese market is up 13% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 8.0% over the same period. Is New 90 Day High Low • Dec 14
New 90-day high: NT$124 The company is up 7.0% from its price of NT$116 on 16 September 2020. The Taiwanese market is up 11% over the last 90 days, indicating the company underperformed over that time. However, it outperformed the Biotechs industry, which is down 5.0% over the same period. Aankondiging • Nov 20
OBI Pharma, Inc. Announces Presentation of Data from the OBI-833 Phase 1 Clinical Study at European Society of Clinical Oncology Asia 2020 Virtual Scientific Program OBI Pharma, Inc. announced that data from the OBI-833 Phase 1 clinical study targeting the Globo H antigen in lung cancer will be presented at the European Society of Clinical Oncology Asia (ESMO Asia) 2020 Virtual Scientific Program from November 20-22, 2020. These results will be presented by the lead investigators of OBI Pharma's novel anti-Globo H therapeutic cancer vaccine, OBI-833. Reported Earnings • Nov 10
Third quarter 2020 earnings released: NT$2.02 loss per share Third quarter 2020 results: Net loss: NT$380.5m (loss widened 19% from 3Q 2019). Over the last 3 years on average, earnings per share has fallen by 3% per year but the company’s share price has fallen by 12% per year, which means it is performing significantly worse than earnings. Is New 90 Day High Low • Sep 24
New 90-day low: NT$108 The company is down 7.0% from its price of NT$116 on 24 June 2020. The Taiwanese market is up 7.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is flat over the same period. 