Reported Earnings • May 19
First quarter 2026 earnings released: NT$0.64 loss per share (vs NT$0.86 loss in 1Q 2025) First quarter 2026 results: NT$0.64 loss per share (improved from NT$0.86 loss in 1Q 2025). Net loss: NT$553.8m (loss narrowed 17% from 1Q 2025). Over the last 3 years on average, earnings per share has fallen by 40% per year whereas the company’s share price has fallen by 44% per year. Reported Earnings • Mar 14
Full year 2025 earnings released: NT$5.10 loss per share (vs NT$3.35 loss in FY 2024) Full year 2025 results: NT$5.10 loss per share (further deteriorated from NT$3.35 loss in FY 2024). Net loss: NT$3.93b (loss widened 57% from FY 2024). Over the last 3 years on average, earnings per share has fallen by 41% per year whereas the company’s share price has fallen by 36% per year. Announcement • Feb 25
Polaris Group, Annual General Meeting, May 15, 2026 Polaris Group, Annual General Meeting, May 15, 2026. Location: 1 floor no,335, jui kuang rd., neihu district, taipei city Taiwan New Risk • Feb 23
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 6.8% 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 34% per year over the past 5 years. Minor Risks Share price has been volatile over the past 3 months (6.8% average weekly change). Revenue is less than US$5m (NT$71m revenue, or US$2.2m). Announcement • Dec 27
Polaris Group announced that it expects to receive TWD 3.2 billion in funding Polaris Group announced private placement to issue not exceeding 100,000,000 common shares at a each at a price of TWD 32 per share for gross proceeds of TWD 3,200,000,000 on December 26, 2025. The issue price represents approximately 97.02% of the reference price (TWD 30.92) per share and is not lower than 80% of such reference price. The company may issue additional shares within one year from the shareholders’ resolution in future tranches, the total number of share being issued shall not exceed 150,000,000 shares. The common shares issued in this private placement shall not be transferred to any person other than those transferees specified under Article 43-8 of the Securities and Exchange Act within three years from the date of delivery. The company will issue shares in up to four tranches. The transaction is approved by board of directors and is expected to close between December 29, 2025 and December 30, 2025. Reported Earnings • Nov 13
Third quarter 2025 earnings released: NT$0.89 loss per share (vs NT$0.96 loss in 3Q 2024) Third quarter 2025 results: NT$0.89 loss per share (improved from NT$0.96 loss in 3Q 2024). Net loss: NT$686.0m (loss narrowed 4.4% from 3Q 2024). Over the last 3 years on average, earnings per share has fallen by 39% per year but the company’s share price has only fallen by 33% per year, which means it has not declined as severely as earnings. New Risk • Sep 03
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$3.3b 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 (-NT$3.3b free cash flow). Earnings have declined by 33% per year over the past 5 years. Minor Risks Share price has been volatile over the past 3 months (6.9% average weekly change). Revenue is less than US$5m (NT$64m revenue, or US$2.1m). Reported Earnings • Sep 03
Second quarter 2025 earnings released: NT$1.16 loss per share (vs NT$0.74 loss in 2Q 2024) Second quarter 2025 results: NT$1.16 loss per share (further deteriorated from NT$0.74 loss in 2Q 2024). Net loss: NT$893.7m (loss widened 62% from 2Q 2024). Over the last 3 years on average, earnings per share has fallen by 40% per year and the company’s share price has also fallen by 40% per year. New Risk • Jun 06
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of Taiwanese stocks, typically moving 10% 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 Share price has been highly volatile over the past 3 months (10% average weekly change). Earnings have declined by 30% per year over the past 5 years. Minor Risk Revenue is less than US$5m (NT$88m revenue, or US$2.9m). Reported Earnings • May 16
First quarter 2025 earnings released: NT$0.86 loss per share (vs NT$0.53 loss in 1Q 2024) First quarter 2025 results: NT$0.86 loss per share (further deteriorated from NT$0.53 loss in 1Q 2024). Net loss: NT$665.8m (loss widened 70% from 1Q 2024). Over the last 3 years on average, earnings per share has fallen by 38% per year but the company’s share price has only fallen by 25% per year, which means it has not declined as severely as earnings. New Risk • Apr 16
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 8.9% 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 27% per year over the past 5 years. Minor Risks Share price has been volatile over the past 3 months (8.9% average weekly change). Revenue is less than US$5m (NT$107m revenue, or US$3.3m). Announcement • Apr 09
Polaris Group Announces Chairman Changes Polaris Group appointed Hsu, Jaan-Pyng, CEO of Polaris Group as chairman in place of Chen, Hung-Wen, effective April 8, 2025. Reported Earnings • Mar 20
Full year 2024 earnings released: NT$3.35 loss per share (vs NT$2.12 loss in FY 2023) Full year 2024 results: NT$3.35 loss per share (further deteriorated from NT$2.12 loss in FY 2023). Net loss: NT$2.50b (loss widened 59% from FY 2023). Over the last 3 years on average, earnings per share has fallen by 37% per year but the company’s share price has only fallen by 29% per year, which means it has not declined as severely as earnings. Announcement • Mar 14
Po Group Announces Change of Representative Director Polaris Group appointed KC Tsai, Vice Chairman of Hongguan Electronics Industry Co. Ltd. as representative director in place of Wayne Lin, effective March 13, 2025. Announcement • Mar 05
Polaris Group to Report Q4, 2024 Results on Mar 14, 2025 Polaris Group announced that they will report Q4, 2024 results on Mar 14, 2025 Reported Earnings • Nov 18
Third quarter 2024 earnings released: NT$0.96 loss per share (vs NT$0.57 loss in 3Q 2023) Third quarter 2024 results: NT$0.96 loss per share (further deteriorated from NT$0.57 loss in 3Q 2023). Net loss: NT$717.6m (loss widened 69% from 3Q 2023). Over the last 3 years on average, earnings per share has fallen by 33% per year but the company’s share price has only fallen by 10% per year, which means it has not declined as severely as earnings. Announcement • Nov 05
Polaris Group to Report Q3, 2024 Results on Nov 11, 2024 Polaris Group announced that they will report Q3, 2024 results on Nov 11, 2024 Reported Earnings • Aug 29
Second quarter 2024 earnings released: NT$0.74 loss per share (vs NT$0.45 loss in 2Q 2023) Second quarter 2024 results: NT$0.74 loss per share (further deteriorated from NT$0.45 loss in 2Q 2023). Net loss: NT$550.5m (loss widened 65% from 2Q 2023). Over the last 3 years on average, earnings per share has fallen by 30% per year but the company’s share price has only fallen by 2% per year, which means it has not declined as severely as earnings. Announcement • Aug 24
IIH Strategic GP, Inc. Issues Pay Warrant to Polaris Group, It Has Now Withdrawn the Lawsuit on Its Own IIH Strategic GP Inc. issued a pay warrant to Polaris Group, it has now withdrawn the lawsuit on its own. Parties to the legal matter: Applicant (Creditor): IIH Strategic GP Inc. Respondent (Debtor): Polaris Group. Name of the court or punishing agency of the legal matter: Taiwan Taipei District Court. Reference/Case number of relevant documents of the legal matter: Case No. 792 of the year 113. Handling procedure is Lawsuit is withdrawn. There is no significant impact to company. Announcement • Aug 23
Polaris Group has filed a Follow-on Equity Offering. Polaris Group has filed a Follow-on Equity Offering.
Security Name: Common Shares
Security Type: Common Stock
Securities Offered: 24,000,000
Transaction Features: Rights Offering Announcement • Aug 15
Polaris Group to Report Q2, 2024 Results on Aug 22, 2024 Polaris Group announced that they will report Q2, 2024 results on Aug 22, 2024 Announcement • Jul 24
Polaris Group Announces the Cancellation of Position of COO of Hui-Yuan Yu Polaris Group announced the cancellation of Hui-Yuan Yu, COO. Reason for the change: In cooperation with the group's organizational adjustment and strengthening of corporate governance, the position of COO has been cancelled. Effective date: July 23, 2024. Announcement • Jun 26
Polaris Group Announces CFO Changes Polaris Group announced CFO changes. Name, title, and resume of the previous position holder: Kay Huang, CFO of the company. Name, title, and resume of the new position holder: Ray Wu, Director of Finance & Accounting Department of Genovior Biotech Corporation. Reason for the change: Kay Huang resigned due to completion of phased tasks. Effective date is June 25, 2024. The position of CFO will be temporarily taken over by Ray Wu, director of Finance & Accounting Department of Genovior Biotech. The new CFO will be announced after the appointment approved by the board of directors. New Risk • May 28
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended September 2023. 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 Earnings have declined by 5.3% per year over the past 5 years. Revenue is less than US$1m (NT$3.5m revenue, or US$109k). Minor Risk Latest financial reports are more than 6 months old (reported September 2023 fiscal period end). Announcement • May 15
Polaris Group Announces Change of the Member of Compensation Committee Polaris Group announced change of the member of Compensation Committee. Name of the previous position holder: K.C. Tsai. Resume of the previous position holder: Chairman of Champion Microelectronic Corp. Name of the new position holder: Karen Wen. Resume of the new position holder: COO/CSO of Genome Frontier Therapeutics TW Co. Ltd. Reason for the change: by-election of independent director at 2024 Annual General Meeting. Effective date of the new member: May 14, 2024. The term of the new member of Compensation Committee is same as that of the independent director, until June 11, 2026. Announcement • May 08
Polaris Group to Report Q1, 2024 Results on May 14, 2024 Polaris Group announced that they will report Q1, 2024 results on May 14, 2024 Announcement • Nov 30
Polaris Group Announces First Patient Successfully Dosed with ADI-PEG 20 in Phase II Clinical Trial for NASH at Chang Gung Memorial Hospital, Linkou, Taiwan Polaris Group announced that the first patient was dosed with ADI-PEG 20 in the Phase II a clinical trial for NASH at Chang Gung Memorial Hospital, Linkou, Taiwan. This Phase II clinical trial is a multicenter, randomized, double-blind, placebo-controlled trial that will include 60 patients from at least 5 clinical sites across Taiwan that aims to evaluate the safety, tolerability, and preliminary efficacy of the company's investigational drug ADI-PEG 20 in patients with NASH. Participants will receive ADI-PEG 20 or a placebo to assess the drug's impact on liver fat content, liver histology, and various other endpoints. The study is part of Polaris Group's broader commitment to pioneering advancements in the treatment of metabolic diseases. The company's investigational drug, ADI-PEG 20, holds promise as a potential therapy for NASH. By targeting key pathways involved in NASH pathogenesis, this innovative drug has the potential to address the root causes of the disease. Polaris Group is proud to collaborate with leading researchers, healthcare professionals, and patients on this important journey to develop a treatment for NASH. The company is dedicated to conducting rigorous research and adhering to the highest standards of safety and ethics throughout this trial. ADI-PEG 20, developed by Polaris Group, operates through a unique mechanism of action. It utilizes metabolic therapy to degrade arginine in the blood and can be combined with other cancer treatment modalities to produce synergistic effects. Board Change • Nov 29
Less than half of directors are independent No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. No highly experienced directors. 2 independent directors (4 non-independent directors). was the last director to join the board, commencing their role in . The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment. Announcement • Nov 17
Polaris Group Initiates Rolling Submission of Biologic License Application (BLA) for ADI-PEG 20 with U.S. FDA to Treat Malignant Pleural Mesothelioma Polaris Group announced that the Company has initiated the rolling submission of its Biologic License Application (BLA) for ADI-PEG 20 to the U.S. Food and Drug Administration (FDA) for the systemic treatment of patients with malignant pleural mesothelioma with non-epithelioid histology, in combination with a platinum agent and pemetrexed. This submission is based on the results of the successful phase 3 trial of ADI-PEG 20 in combination with a platinum agents and pemetrexed which met both its primary and secondary objectives for progression free survival and overall survival. The rolling submission process allows for the submission of individual modules of the BLA as they are completed, which can streamline the regulatory review process and may expedite the potential approval timeline. This initial submission to the U.S. FDA includes the nonclinical and clinical portions of the BLA for ADI-PEG20, with plans to finalize the remaining chemistry, manufacturing, and controls components in the coming months. When the final portion of the BLA is submitted, Polaris Group will actively seek priority review status for this BLA, which, if granted, could expedite the regulatory review process. Announcement • Sep 27
Polaris Group Appoints K.C. Tsai as Compensation Committee Member Polaris Group board of directors appointing K.C. Tsai as compensation committee member Resume of the new position holder: Chairman of Champion Microelectronic Corp. The term of the Compensation Committee is from September 26, 2023, until the date of the company's Annual General Meeting in 2024. Announcement • Sep 01
Polaris Group Announces Resignation of TAI, JANG-HUEI as Audit Committee and Remuneration Committee Member Polaris Group announced Resignation of TAI, JANG-HUEI as Audit Committee and Remuneration Committee Member. Resume of the previous position holder: Representative of IIH ASSETS MANAGEMENT COMPANY LIMITED. Date of occurrence of the change: August 29, 2023. Announcement • Aug 30
Polaris Group Announces of Resignation of TAI, JANG-HUEI as Independent Director Polaris Group announced of Resignation of TAI, JANG-HUEI as Independent Director. Resume of the previous position holder: IIH ASSETS MANAGEMENT COMPANY LIMITED. Announcement • Aug 05
Polaris Group Announces Dosing of First Patient in Phase 2 Trial of ADI-PEG 20 with Radiation and TMZ in Patients with GBM Polaris Group announced dosing of first patient in phase 2 trial of ADI-PEG 20 with radiation and TMZ in patients with GBM. Polaris Group announced that the first patient was dosed with ADI-PEG 20 in the Phase II clinical trial for Glioblastoma Multiforme (GBM) at Chang Gung Memorial Hospital, Linkou, Taiwan. This Phase II clinical trial is a placebo-controlled, randomized, and double-blind study, using company's novel metabolic therapy drug, ADI-PEG 20, in combination with radiation therapy and chemotherapy drug TMZ (Temozolomide). The trial is conducted in multiple countries and centers, including Taiwan and South Korea, with an anticipated enrollment of 100 patients. The primary endpoint is Overall Survival, and secondary endpoint is Progression-Free Survival (PFS). The principial Investigator for this clinical trial is Professor Wei Kuo-Chen from Chang Gung Hospital, Linkou, Taiwan. The trial is being led by Taiwanese physicians and involves international participation, which reflects recognition of Taiwan's medical capabilities and is expected to provide greater opportunities for Taiwanese hospitals in the field of new drug clinical trials. ADI-PEG 20, developed by Polaris Group, operates through a unique mechanism of action. It utilizes metabolic therapy to degrade arginine in the blood and can be combined with other cancer treatment modalities to produce synergistic effects. Announcement • Jun 28
Polaris Group Announces MFDS Approves Phase Phase 2 Clinical Protocol Treating GBM with ADI-PEG 20 Polaris Group announced the approval of phase 2 clinical protocol treating GBM with ADI-PEG 20, Phase 2 trial is a global, multi-center, randomized, double-blind, placebo controlled study to enroll 100 patients. The primary endpoint is Overall Survival and secondary endpoints are PFS, DOR and Response Rate will be examined based on investigators and assessments. Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis): approved by MFDS for clinical 2 trial. Accumulated investment expenditure incurred: No disclosure due to confidentiality. Announcement • May 31
Polaris Group Announces that TFDA Approves Phase3 Clinical Protocol Treatment HCC with ADI-PEG 20 Polaris Group announced the approval of phase 3 clinical protocol treating Hepatocellular Carcinoma (HCC) with ADI-PEG 20. This is a randomized, double-blinded, multi-center trial, and approximately 300 participants will be randomized in the study. The primary endpoint is OS with PFS as a secondary endpoint. Polaris Group will keep promote the clinical application of ADI-PEG 20. Announcement • May 06
Polaris Group Submits ADI-PEG 20 to TFDA for INR as Treatment for Hepatocellular Carcinoma Polaris Group announced the submission to TFDA of the protocol amendment submission of Initial Investigational New Drug Application (IND) for the development of ADI-PEG 20 as a treatment for Hepatocellular Carcinoma (HCC) on 04 May 2023. This is a randomized, double-blinded, multi-center trial, and approximately 300 participants will be randomized in the study. The primary endpoint is OS with PFS as a secondary endpoint. Planned development stages is Phase 3. Announcement • Feb 04
Polaris Group Receives Pre-BLA Meeting Notice from US FDA for ADI-PEG 20 Polaris Group received notice from US FDA to schedule pre-BLA meeting on March 23, 2023. ATOMIC trial is a global, multi-center, randomized, double-blind, placebo-controlled trial of ADI-PEG 20 in combination with Pemetrexed and Cisplatin in patients with unresectable Malignant Pleural Mesothelioma (MPM) with biphasic or sarcomatoid histology. The primary and secondary endpoints of the trial were both statistically significant. Polaris Group will use the FAST TRACK designation granted from the FDA to accelerate the BLA process. Current development stage: A.File application/approved/disapproved/Each of clinical trials (includeinterim analysis): BLA application B.Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significantsense, the risks and the associated measures the Company may occur: NA C. After obtaining official approval or the results (include interim analysis) of statistically significant sense, the future strategy: NA D. A ccumulated investment expenditure incurred: No disclosure due to confidentiality (5)Upcoming development plan: BLA application (6)Market: ADI-PEG 20 is a biologic being developed by Polaris Group to treat cancers. Because arginine is one of the 20 amino acids that are essential for protein synthesis and survival of cells, some cancer cells become dependent upon the external supply of arginine to survive and grow. ADI-PEG 20 is designed to deplete the external supply of arginine, which causes arginine-dependent cancer cells to die while leaving the patient's normal cells unharmed. Multiple cancers have been reported to have a high degree of arginine dependency. The difference in the primary efficacy endpoint of Overall Survival (OS) is statistically significant, and the secondary endpoint is also statistically significant for ATOMIC trial. The safety profile of ADI-PEG 20 observed in ATOMIC was similar to that of the previous clinical trial. Given these results, Polaris Group will proceed with regulatory submissions in the United States in 2023. In 2022, ADI-PEG 20 received fast track designation from the FDA. Announcement • Jan 22
Polaris Group Receives IND Approval from US FDA for the Investigational New Drug of ADI-PEG 20 to Treat Soft Tissue Sarcoma Polaris Group received approval from US clinical team of the submission of Initial Investigational New Drug Application (IND) for the development of ADI-PEG 20 as a treatment for soft tissue sarcoma. This is a randomized, double-blinded, multi-center phase 3 trial, and approximately 300 participants will be randomized in the study. The primary endpoint is PFS with OS as a secondary endpoint. Polaris Group will keep promote the clinical application of ADI-PEG20 metabolic therapy in soft tissue sarcoma. New drug name or code: ADI-PEG 20. Purpose: Treatment for soft tissue sarcoma. Announcement • Dec 28
Polaris Group Submits ADI-PEG 20 to FDA for IND as A Treatment for Soft Tissue Sarcoma Polaris Group submitted ADI-PEG 20 to FDA for IND as a treatment for soft tissue sarcoma Product: Polaris Group received notification from US clinical team of the submission of Initial Investigational New Drug Application (IND) for the development of ADI-PEG 20 as a treatment for soft tissue sarcoma. This is a randomized, double-blinded, multi-center phase 3 trial, and approximately 300 participants will be randomized in the study. The primary endpoint is PFS with OS as a secondary endpoint. Effect on company finances and business: Polaris Group will keep promote the clinical application of ADI-PEG20 metabolic therapy in soft tissue sarcoma. New drug name or code: ADI-PEG 20; Purpose: Treatment for soft tissue sarcoma; Planned development stages: Phase 3; Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis): File application IND; Upcoming development plan: Phase 3. Market: Soft tissue sarcoma is a broad term for cancers that start in soft tissues (muscle, tendons, fat, lymph and blood vessels, and nerves). These cancers can develop anywhere in the body but are found mostly in the arms, legs, chest, and abdomen. Leiomyosarcoma is one of the most popular types of soft tissue sarcoma, and it¡¦s still hard to find a balanced treatment with limited options for STS. With the positive data from previous phase 2 trial, led by Dr. Brain Van Tine at University of Washington in Saint Louis, Polaris Group will accelerate the clinical trial by moving forward with a phase 3 trial with ADI-PEG 20 combining with chemotherapy to treat STS. It takes considerable time and expenses to develop a new drug of which success can't be guaranteed. Investors shall bear such investment risk that warrants careful assessment before making investment decisions. Reported Earnings • Nov 17
Third quarter 2022 earnings released: NT$0.41 loss per share (vs NT$0.27 loss in 3Q 2021) Third quarter 2022 results: NT$0.41 loss per share (further deteriorated from NT$0.27 loss in 3Q 2021). Net loss: NT$306.2m (loss widened 59% from 3Q 2021). Over the last 3 years on average, earnings per share has increased by 28% per year but the company’s share price has increased by 108% per year, which means it is tracking significantly ahead of earnings growth. Announcement • Nov 16
TFDA Approves Polaris Group's Submitted Protocol Amendment of POLARIS2020-001 Phase2 Trial of ADI-PEG 20 Polaris Group submitted protocol amendment of POLARIS2020-001 Phase2 Trial of ADI-PEG 20 plus Radiotherapy and Temozolomide in subjects with newly diagnosed glioblastoma multiforme to TFDA has been approved. Phase 2 trial is a global, multi-center, randomized, double-blind, placebo controlled study to enroll 100 patients. The primary endpoint i Overall Survival and secondary endpoints are PFS, DOR and Response Rate will be examined based on investigators and assessments. 2. Mass production date: NA 3. Effect on company finances and business: Polaris Group will keep patient enrollment on schedule. 4. Any other matters that need to be specified: New drug name or code: ADI-PEG 20 Purpose: Treatment for cancer Planned development stages: Phase 2 Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis): approved Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks and the associated measures the Company may occur: NA. After obtaining official approval or the results (include interim analysis) of statistically significant sense, the future strategy: NA. Accumulated investment expenditure incurred: No disclosure due to confidentiality Upcoming development plan: Start Phase 3 patient enrollment Market: Glioblastoma is the most lethal form of adult diffuse gliomas, and most patients undergo surgical treatment, and followed by radiotherapy plus temozolomide. (median OS is ~12~18months). Arginine is critical to GBM physiology and signaling. Blood Brain Barrier is not an issue for ADI-PEG 20 and arginine deprivation with ADI-PEG 20 inhibits GBM cell growth in tissue culture (Syed 2013). Polaris Group will explore the possibility of systemic therapy ADI-PEG 20 in combination with the standard care of radiation therapy: Phase I trial of ADI-PEG 20 plus radiation plus temozolomide is still ongoing, amendment being submitted to TFDA for phase 2 trial. It takes considerable time and expenses to develop a new drug of which success can't be guaranteed. Investors shall bear such investment risk that warrants careful assessment before making investment decisions. Announcement • Nov 12
Polaris Group Announces CEO Changes Polaris Group announced appointment of Hung-Wen Chena as CEO in place of Shaw Chen, due After achieving successful clinical milestone with MPM, Dr. Shaw Chen's position will be adjusted to an executive advisor to instruct the clinical trials and the application of new drug for the Company. Effective November 11, 2022. Announcement • Oct 14
Polaris Group Submits Protocol Amendment of POLARIS2020-001 Phase1-2Trial of ADI-PEG 20 Plus Radiotherapy and Temozolomide in Subjects with Newly Diagnosed Glioblastoma Multiforme to FDA Polaris Group submitted protocol amendment of POLARIS2020-001 Phase1-2Trial of ADI-PEG 20 plus Radiotherapy and Temozolomide in subjects with newly diagnosed glioblastoma multiforme to FDA. Effect on company finances and business: The company will wait for the FDA's reply within 30 days, and will submit a TFDA application for phase2 trial if there is no reply after 30 days. Current development stage: A. File application/approved/disapproved/Each of clinical trials (include interim analysis): File application; B. Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks and the associated measures the Company may occur: NA; C.After obtaining official approval or the results (include interim analysis) of statistically significant sense, the future strategy: NA; D. Accumulated investment expenditure incurred: No disclosure due to confidentiality Upcoming development plan: The company will wait for FDA feedback within one month and submit protocol amendment for TFDA. Market: Glioblastoma is the most lethal form of adult diffuse gliomas, and most patients undergo surgical treatment, and followed by radiotherapy plus temozolomide. (median OS is approx. 12 to approx. 18 months). Arginine is critical to GBM physiology and signaling. Blood Brain Barrier is not an issue for ADI-PEG 20 and arginine deprivation with ADI-PEG 20 inhibits GBM cell growth in tissue culture (Syed 2013). Polaris Group will explore the possibility of systemic therapy ADI-PEG 20 in combination with the standard care of radiation therapy: Phase I trial of ADI-PEG 20 plus radiation plus temozolomide is still ongoing, amendment being submitted to FDA for phase 2 trial. Announcement • Sep 22
Polaris Group Announces Top-Line Efficacy and Safety Data from Phase 3 ATOMIC Study Polaris Group announced top-line efficacy and safety data from the Phase 3 ATOMIC Study, a global, multi-center, randomized, double-blind, placebo-controlled trial of ADI-PEG 20 in combination with Pemetrexed and Cisplatin in patients with unresectable Malignant Pleural Mesothelioma (MPM) with biphasic or sarcomatoid histology. The ATOMIC trial demonstrated that patients randomized to the combination of ADI-PEG 20 plus cisplatin and pemetrexed had a median OS of 9.3 months (95% confidence interval [CI], 7.85-11.79), versus 7.66 months (95% confidence interval [CI]:6.14-9.53) for the placebo plus cisplatin and pemetrexed control arm. (hazard ration [HR]=0.71; 95% CI, 0.55-0.93; p=0.0234). The difference in the primary efficacy endpoint of Overall Survival (OS) is statistically significant. ATOMIC also met its secondary endpoint, showing statistically significant median Progression Free Survival (PFS) of 6.11 (95% confidence interval [CI], 5.75-7.43) months for ADI-PEG 20 group and 5.59 months (95% confidence interval [CI], 4.14-5.85) for the placebo control arm. (hazard ration [HR]= 0.65; 95% CI, 0.47-0.90; p-value=0.0159.) The safety profile of ADI-PEG 20 observed in ATOMIC was similar to that of the previous clinical trial. Given these results, Polaris Group will proceed with regulatory submissions in the United States in 2023. In 2022, ADI-PEG 20 received fast track designation from the FDA. As this study evaluate a new mechanism of action to treat cancer, the endpoints reach statistical significance is a remarkable finding. The company plan to accelerate its pipeline projects and expand to other indications leveraging this unique mechanism of action to starve cancer cells by making use of combination with other chemotherapy and radiation. New drug name or code: ADI-PEG 20. Purpose: Treatment for cancer. Planned development stages: Phase 3 ATOMIC study met its primary endpoint with statistically significant improvement in Overall Survival. Data will be submitted to health authorities globally, including the U.S. Food and Drug Administration and European Medicines Agency. Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis): Complete Phase 3 cinical trials. After obtaining official approval or the results (include interim analysis) of statistically significant sense, the future strategy: Polaris Group will proceed with regulatory submissions in the US in 2023. In 2022, ADI-PEG 20 received fast track designation from the FDA. Accumulated investment expenditure incurred: No disclosure due to confidentiality. Upcoming development plan: Polaris Group will proceed with regulatory submissions in the US in 2023. In 2022, ADI-PEG 20 received fast track designation from the FDA. Announcement • Aug 17
Polaris Group Appoints Kay Huang as Corporate Governance Officer Polaris Group announced the appointment of Corporate Governance Officer. Name, title, and resume of the new position holder: Kay Huang, Chief Financial Officer of the company. Effective date is August 16, 2022. Announcement • Jun 16
Polaris Group Announces Initiation of Phase 3 Clinical Trials of Hepatocellular Carcinoma Polaris Group announces that the first patient was dosed for its phase 3 study of ADI-PEG 20 versus placebo in subjects with genotype WWOX-GG, unresectable HCC at Cheng Gung Medical Foundation-Linkou. This study is a randomized, double-blind, multi-center trial, and expected to enroll 150 patients at multiple sites in Taiwan, including Cheng Gung Medical Foundation-Linkou, Chang Gung Medical Foundation-Chia-Yi, Chang Gung Medical Foundation-Kaohsiung, Chi Mei Medical Center(YK & LY), Taipei Veterans General Hospital, Ditmanson Medical Foundation Chiayi Christian Hospital, Changhua Christian Hospital and Kaohsiung Medical University Chung-Ho Memorial Hospital. Polaris Group aims to initiate the trial in Vietnam as well. The lead investigator of this study is Dr. Chau-Ting Yeh of Linkou Cheng Gung Medical Foundation. Polaris Group expects to initiate this global multi-center trial to leverage Taiwan¡¦s good practices of clinical development to position Taiwan as a regional hub and a significant location for conducting clinical trials for promising news drugs. Is New 90 Day High Low • Feb 23
New 90-day high: NT$17.70 The company is up 2.0% from its price of NT$17.40 on 25 November 2020. The Taiwanese market is up 18% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 7.0% over the same period. Is New 90 Day High Low • Jan 27
New 90-day low: NT$15.75 The company is down 7.0% from its price of NT$17.00 on 30 October 2020. The Taiwanese market is up 21% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 2.0% over the same period. Is New 90 Day High Low • Sep 24
New 90-day low: NT$14.95 The company is down 8.0% from its price of NT$16.20 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. 