Announcement • Mar 13
Golden Biotechnology Corporation, Annual General Meeting, Jun 04, 2026 Golden Biotechnology Corporation, Annual General Meeting, Jun 04, 2026. Location: 17 floor no,27-6, sec.2 chung cheng e. rd., danshuei district, new 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 Risks Less than 1 year of cash runway based on free cash flow trend (-NT$241m free cash flow). Share price has been highly volatile over the past 3 months (16% average weekly change). Minor Risks Latest financial reports are more than 6 months old (reported June 2025 fiscal period end). Revenue is less than US$5m (NT$45m revenue, or US$1.4m). Market cap is less than US$100m (NT$2.43b market cap, or US$77.3m). New Risk • Jan 09
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: NT$3.01b (US$95.3m) This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. 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$241m free cash flow). Share price has been highly volatile over the past 3 months (15% average weekly change). Minor Risks Revenue is less than US$5m (NT$45m revenue, or US$1.4m). Market cap is less than US$100m (NT$3.01b market cap, or US$95.3m). New Risk • Nov 13
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 8.7% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-NT$241m free cash flow). Share price has been highly volatile over the past 3 months (8.7% average weekly change). Minor Risks Revenue is less than US$5m (NT$45m revenue, or US$1.4m). Market cap is less than US$100m (NT$2.51b market cap, or US$80.6m). Announcement • Mar 14
Golden Biotechnology Corporation, Annual General Meeting, Jun 11, 2025 Golden Biotechnology Corporation, Annual General Meeting, Jun 11, 2025. Location: 17 floor no,27-6, sec.2 chung cheng e. rd., danshuei district, new 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 Risks Less than 1 year of cash runway based on free cash flow trend (-NT$256m free cash flow). Earnings have declined by 0.02% per year over the past 5 years. Minor Risks Latest financial reports are more than 6 months old (reported June 2024 fiscal period end). Share price has been volatile over the past 3 months (7.3% average weekly change). Revenue is less than US$5m (NT$57m revenue, or US$1.7m). Market cap is less than US$100m (NT$2.50b market cap, or US$75.9m). New Risk • Dec 05
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 7.9% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-NT$256m free cash flow). Share price has been highly volatile over the past 3 months (7.9% average weekly change). Earnings have declined by 0.02% per year over the past 5 years. Minor Risks Shareholders have been diluted in the past year (14% increase in shares outstanding). Revenue is less than US$5m (NT$57m revenue, or US$1.8m). Market cap is less than US$100m (NT$2.67b market cap, or US$82.3m). New Risk • Sep 20
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 14% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-NT$256m free cash flow). Earnings have declined by 0.02% per year over the past 5 years. Minor Risks Share price has been volatile over the past 3 months (8.2% average weekly change). Shareholders have been diluted in the past year (14% increase in shares outstanding). Revenue is less than US$5m (NT$57m revenue, or US$1.8m). Market cap is less than US$100m (NT$3.11b market cap, or US$97.3m). New Risk • Jun 05
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: NT$3.23b (US$99.7m) This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. 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$279m free cash flow). Minor Risks Share price has been volatile over the past 3 months (6.9% average weekly change). Revenue is less than US$5m (NT$63m revenue, or US$2.0m). Market cap is less than US$100m (NT$3.23b market cap, or US$99.7m). Reported Earnings • May 04
Full year 2023 earnings released: NT$2.54 loss per share (vs NT$1.91 loss in FY 2022) Full year 2023 results: NT$2.54 loss per share (further deteriorated from NT$1.91 loss in FY 2022). Revenue: NT$63.4m (down 71% from FY 2022). Net loss: NT$361.6m (loss widened 33% from FY 2022). Over the last 3 years on average, earnings per share has increased by 22% per year but the company’s share price has fallen by 19% per year, which means it is significantly lagging earnings. Announcement • Mar 22
Golden Biotechnology Corporation, Annual General Meeting, Jun 13, 2024 Golden Biotechnology Corporation, Annual General Meeting, Jun 13, 2024. 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 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 Risk Earnings have declined by 0.2% per year over the past 5 years. Minor Risks Latest financial reports are more than 6 months old (reported June 2023 fiscal period end). Share price has been volatile over the past 3 months (6.4% average weekly change). Announcement • Jan 18
Golden Biotechnology Corp. Unveils the Findings of Its Phase II Clinical Trial Investigating Antroquinonol Golden Biotechnology Corp. had unveiled the findings of its Phase II clinical trial investigating Antroquinonol (HOCENA) in combination with the standard of care (SOC): nab-paclitaxel + gemcitabine, as first-line treatment for metastatic pancreatic cancer. The trial showed a positive median overall survival (mOS) of 14.1 months, which is a substantial increase compared to 8.5 months mOS observed in the standard of care Phase III clinical study (nab-paclitaxel + Gemcitabine). Notably, when compared to current first-line treatment options for this very difficult to treat cancer, there was a highly significant survival advantage of patients treated with oral Antroquinonol in combination with SOC. Metastatic Pancreatic Cancer remains a devastating disease with very low survival rate and significant unmet medical needs in terms of treatment options. The ASCO Gastrointestinal Cancers Symposium 2024 Committee has selected Golden Biotech's Phase 2 Study, titled "A Phase I/II study of Antroquinonol in combined with Nab-Paclitaxel and Gemcitabine for patients with metastatic pancreatic cancer," for poster presentation. For Pancreatic Cancer patients eligible for treatment with Gemcitabine or Gemcitabine/Nab-paclitaxel, the current baseline median overall survival is estimated to range from 8 to 9 months. It is considered "clinically meaningful" if the minimum improvement over current overall survival is between 3 to 4 months. Golden Biotech's Antroquinonol has gained recognition for its work in the field of cancer treatment. It has been granted Orphan Drug Designation (ODD) by the FDA for the treatment of Pancreatic Cancer, Acute Myeloid Leukemia (AML), and Hepatocellular Carcinoma (liver cancer), as well as ODD by the EMA for metastatic pancreatic Cancer. These acknowledgementgments underscore the potential of Antroquinonol In combination with the standard of care may provide patients with significantly improved median overall survival and reduced hematological side- effects. Providing new hope for patients everywhere, for this very difficult to treat Cancer. New Risk • Nov 01
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 0.2% per year over the past 5 years. Minor Risk Share price has been volatile over the past 3 months (6.8% average weekly change). Announcement • May 06
Golden Biotech Announces Positive Results with Longer Survival Compared with Standard Treatments from Interim Analysis of Phase 2 Trial for Antroquinonol as 1st Line Treatment for Stage 4 Metastatic Pancreatic Cancer Golden Biotechnology Corporation announces the release of positive interim results from its Phase II clinical trial of Antroquinonol (HOCENA®) in combination with the standard of care (SOC) nab-paclitaxel + gemcitabine for first-line treatment of metastatic pancreatic cancer. The median overall survival (mOS) was 12.6 months, which was 48% better than the 8.5 months mOS in the Phase III clinical study of the standard of care (nab-paclitaxel + gemcitabine). Compared to the current first-line treatments for this difficult to treat cancer, this study demonstrated that Antroquinonol in combination with SOC showed a significant survival advantage. The Phase II Antroquinonol clinical trial is a single-arm Phase I/II study to evaluate the safety and efficacy of Antroquinonol in combination with SOC (nab-paclitaxel + gemcitabine) as a first-line treatment for stage IV metastatic pancreatic cancer. The first stage of the study focused on treating pancreatic cancer with oral Antroquinonol at doses of 200 mg three times daily and 300 mg three times daily for a duration of 4 weeks; to determine the maximum tolerated dose regimen for Antroquinonol in combination with SOC. The expanded Phase II trial will focus on the efficacy of Antroquinonol in combination with SOC. This is a multi-national and multi-center clinical trial enrolling patients in the United States, Taiwan and South Korea. Compared to the results of the Phase III study for the SOC (nab-paclitaxel + gemcitabine combination), Antroquinonol in combination with SOC has much better median overall survival (mOS), six-month and twelve-month overall survival rates (OS rates). The overall survival rates for Antroquinonol combination therapy, standard treatment (nab-paclitaxel + gemcitabine), and gemcitabine monotherapy were 12.6, 8.5 and 6.7 months respectively; six-month overall survival rates were 86%, 67% and 55% respectively; and twelve-month overall survival rates were 60%, 35% and 22% respectively. In comparison to the FOLFIRINOX treatment for metastatic pancreatic cancer, in terms of median overall survival and six-months overall survival rates; again the Antroquinonol in combination with SOC demonstrated superiority. Data showed that the overall survival (OS) between Antroquinonol combination with SOC and FOLFIRINOX were 12.6 and 11.1 months respectively; six-month overall survival rates were 86% and 76% respectively; twelve-month overall survival rates were 60% and 48% respectively. Compared to current first-line treatments, Antroquinonol in combination with SOC has also demonstrated better survival advantage. The phase 2 study of Antroquinonol in combination with SOC demonstrates the high possibility of a new first-line agent for the treatment of Stage 4 metastatic pancreatic cancer. With its oral formulation and low side-effects, Antroquinonol can be an exciting addition to the current IV chemotherapies and immediately offer patients the possibilities of better treatment outcomes. Board Change • Nov 16
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. 7 experienced directors. No highly experienced directors. 1 independent director (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. Reported Earnings • Aug 15
First half 2022 earnings released: NT$1.46 loss per share (vs NT$1.66 loss in 1H 2021) First half 2022 results: NT$1.46 loss per share (up from NT$1.66 loss in 1H 2021). Revenue: NT$60.9m (up 68% from 1H 2021). Net loss: NT$207.8m (loss narrowed 5.4% from 1H 2021). Over the last 3 years on average, earnings per share has fallen by 10% per year but the company’s share price has increased by 33% per year, which means it is well ahead of earnings. Reported Earnings • May 04
Full year 2021 earnings released: NT$3.35 loss per share (vs NT$3.11 loss in FY 2020) Full year 2021 results: NT$3.35 loss per share (down from NT$3.11 loss in FY 2020). Net loss: NT$443.8m (loss widened 13% from FY 2020). Over the last 3 years on average, earnings per share has fallen by 7% per year but the company’s share price has increased by 52% per year, which means it is well ahead of earnings. Board Change • Apr 27
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. 7 experienced directors. No highly experienced directors. 1 independent director (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 • Jan 09
Golden Biotechnology Corporation Announces Topline Results from Unblinded COVID-19 Trial for Oral New Drug Antroquinonol in Hospitalized Mild, Moderate and Severe Patients Golden Biotechnology Corporation announced that its Phase 2 COVID-19 trial for oral new drug Antroquinonol (HOCENA®) has achieved 100% recovery results of its primary outcome measure in hospitalized mild, moderate including ICU severe patients. In line with the plan, GoldenBiotech will submit the final clinical trial analysis report and related R&D documents to the US FDA to apply for emergency use authorization (EUA) for Antroquinonol (HOCENA®). This trial is a Phase 2 randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of Antroquinonol in hospitalized patients with mild to moderate pneumonia due to COVID-19 (Coronavirus SARS-CoV-2 disease). Actually, the trial also included the ICU severe patients who need oxygen support. Following completion of all screening assessments and meeting of eligibility criteria, patients will either receive 100mg of Antroquinonol or placebo two times a day for 14 days in combination with Standard of Care (SoC) therapy per local SoC policies. The trial completed recruiting for 124 patients in the USA, Peru and Argentina where the new pandemic upheaval is rampant with highly transmitted SARS-CoV-2 variants. The clinical trial data revealed: Primary Outcome Measure: recover ratio [Time Frame: 14 days]. The proportion of patients who are alive and free of respiratory failure (e.g., no need for invasive mechanical ventilation, non-invasive ventilation, high flow oxygen, or ECMO) on Day 14. Result: In the Antroquinonol group, the recovery ratio was 97.9% at the day 14 visit. Furthermore, no death or respiratory failure was found in the Antroquinonol group at the day 28 visit with recovery ratio of 100%. Secondary Outcome Measures: (a) Duration of ICU Stay: Result: The median duration of ICU stay in Antroquinonol group was 9.5 days shorter than that in the placebo group. (b) Duration of hospitalization [Time Frame: 28 days]: time for patient discharge. Result: The median duration of hospitalization was 4 days in the Antroquinonol group. (c) Time to 2-point improvement [Time Frame: 28 days]: Clinical change score as measured by the "WHO COVID-19 Clinical Improvement Ordinal Scale". Result: The median time to score of 0 in "WHO COVID-19 Clinical Improvement Ordinal Scale" was 29 days in the antroquinonol group. (d) Time to virological clearance [ Time Frame: 28 days]: measured as study days from start of treatment to first negative SARS-CoV-2 PCR test. Result: The median time to virological clearance was 14 days in the Antroquinonol group. In safety evaluation, the data revealed that Antroquinonol showed good tolerability and safety results. Announcement • Sep 19
Golden Biotechnology Corporation Receives Antroquinonol Oral Covid-19 New Drug Trial Got Green Light from the FDA to Extend Recruiting Severe Covid-19 Patients Golden Biotechnology Corp. has made headway with COVID-19 treatment development in more broaden clinical trial patients permitted in inclusion severity as well as future marketing expansion by signing a new international MOU for cooperation and development of the new drugs in 23 European countries. On Aug. 30, 2021, pursuant to clinical trial protocol amended following the recommendation of the approved second interim Data Monitoring Committee review, GoldenBiotech was noticed by CRO that the Food and Drug Administration agreed that its ongoing phase 2 trial of Antroquinonol for treating COVID-19 patients can be extended recruiting from the mild or moderate hospitalized patients to the severe hospitalized COVID-19 patients who need non-invasive oxygen support. The total trial subjects will remain the same, 174 patients in total. The trial recruiting is expedited in full swing covering the USA, Peru and Argentina where the new upheaval pandemic is rampant with highly transmitted SARS-CoV2 variants. Currently, Golden Biotechnology Corp. is the only Taiwanese company that undergoes the formal clinical trial for COVID-19 treatment in multi-national centers and follows the FDA guidance for COVID-19 trials to set the trial as randomized, double-blinded and placebo-controlled study. Antroquinonol is a new small molecule drug with convenient oral administration design and distinguished from other emerging oral treatment drugs for COVID-19 by its multi-functional effects on anti-viral, anti-inflammation and anti-fibrosis characteristics revealed by studies. The new permitted extensive enrollment from mild, moderate to severe patients in the trial will assess the efficacy of recovery rate and prevent the milder COVID-19 patients becoming more severe conditions which will ease the heavy loading of the medical systems. Antoquinonl stands out from current many anti-viral drugs with its ingenious capability of anti-inflammation and liver protection effects which it recruits the COVID-19 confirmed patients consistent with pneumonia from their chest X-ray or computerized tomography scan. The sign of viral pneumonia indicates the inflammation and the tendency of severity which is lack of effective cure and with poor prognosis. People with liver disease are the vulnerable group to COVID-19 infection even the lower and slower antibody protection will produce after their receiving vaccination acc. to the recent studies. Reported Earnings • Apr 01
Full year 2020 earnings released: NT$3.11 loss per share (vs NT$2.48 loss in FY 2019) Full year 2020 results: Net loss: NT$391.4m (loss widened 37% from FY 2019). Over the last 3 years on average, earnings per share has increased by 6% per year whereas the company’s share price has increased by 9% per year. Announcement • Feb 05
GoldenBiotech's New Drug Antroquinonol (HOCENA) Trial Receives Positive Response from DMC Review and Licenses for 4 Countries Golden Biotechnology Corp. announced that it has made two achievements for its Covid-19 new drug candidate Antroquinonol® (HOCENA®): receiving positive response after DMC review in Phase 2 clinical trial and signed first agreement in global licensing progress. GoldenBiotech receives in Jan. the "Positive Response" from DMC, an US FDA approved independent Data Monitoring Committee for its Phase 2 Covid-19 trial in the USA. The clinical trial data of the first set of patients in the Phase 2 trial were unblinded and reviewed by the DMC on the request of FDA. The review approved by the DMC as the "positive response" to the clinical trial with no need of modification on the trial and can proceed the following recruitment of the patients for the treatment of mild to moderate hospitalized Covid-19 patients. According to the FDA's guidance, the DMC advises the sponsor regarding the continuing safety of trial subjects and those yet to be recruited to the trial, as well as the continuing validity and scientific merit of the trial. GoldenBiotech will be applying for the US Emergency Use Authorization (EUA) once the clinical trial exhibits significant clinical results which can expedite the speed of meeting of urgent market demand in the pandemic. GoldenBiotech has expanded the multi-national centers of trial to the US, Peru and Argentina to speed up the completion of the Covid-19 trial. The clinical trial will be completed the fastest in the Second Quarter of this year. This Covid-19 drug candidate has been granted ODD (Orphan drug designation) approval by the US FDA in 2015 for treating AML(Leukemia), HCC(Liver Cancer) and Pancreatic Cancer and ODD Approval by European EMA for treating Pancreatic Cancer in 2017. GoldenBiotech has started the global licensing plan of the new drug candidate Antroquinonol® (HOCENA®) for Covid-19 treatment. The first signed licensing agreement in Jan. with BNC Korea Co., Ltd, a leading South Korean company in medical device, biologicals and pharmaceuticals company is for developing and commercialization of Antroquinonol® (HOCENA®) to treat Covid-19 in four countries: S. Korea, Russia, Ukraine and Turkey. GoldenBiotech will receive totally up to USD 18 million payments including an upfront fee of USD 4 million and the stepwise development milestone payments of up to USD 14 million. GoldenBiotech will receive subsequent commercial royalty payment 25% of sales when the drug is granted of EUA (Emergency Use Authorization) by the US FDA or clears the new drug application (NDA) through the FDA and selling in the market to treat Covid-19 patients. The undergoing clinical trial of new drug Antroquinonol® is a Phase 2 clinical trial for mild to moderate COVID-19 hospitalized patients. The primary outcome measure is the proportion of patients alive and free of respiratory failure on Day 14. This is the first and only Taiwanese new drug approved by the USA, Peru and Argentina for the Covid-19 trial. Antroquinonol® has shown anti-viral, anti-inflammatory and anti-fibrotic characteristics in past animal studies, suggesting high likelihood in becoming successful treatment option for coronavirus-induced pneumonia. Other indications of clinical trials for Antroquinonol® (HOCENA®) are pancreatic cancer, NSCLC(Lung cancer), AML(Leukemia), Hyperlipidemia, Atopic dermatitis and Hepatitis B etc. Currently there is no drug in development for treating Covid-19 that can effectively improve the severe inflammatory response induced by the virus or the overall survival rate. By far there is no single drug that can simultaneously fight against the COVID-19 virus (SARS-CoV2) and the symptoms induced. Combination therapies adopted by other clinical trials may solve the shortcomings of single-drug therapies with slightly better efficacy, but the higher risk of adverse effects is inevitable. The characteristic of multiple effects makes Antroquinonol® more advantageous than other antiviral and/or anti-inflammatory drugs. GoldenBiotech is now actively promoting the Phase II study for COVID-19 in the hopes that Antroquinonol® will not only improve the symptoms of COVID-19, but also minimize the possible side effects that may be induced during the treatment process. Announcement • Jan 31
Golden Biotechnology Corporation, Annual General Meeting, Apr 28, 2021 Golden Biotechnology Corporation, Annual General Meeting, Apr 28, 2021. Is New 90 Day High Low • Jan 20
New 90-day high: NT$57.90 The company is up 26% from its price of NT$45.80 on 23 October 2020. The Taiwanese market is up 22% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 2.0% over the same period. Is New 90 Day High Low • Jan 05
New 90-day high: NT$55.40 The company is up 23% from its price of NT$44.95 on 08 October 2020. The Taiwanese market is up 17% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 3.0% over the same period. Announcement • Nov 27
Golden Biotechnology Corp. Reports New Drug Trial of Antroquinonol -Outperforms Listing Drugs in Relapsed Acute Myeloid Leukemia Golden Biotechnology Corp. announced that its new drug Antroquinonol (HOCENA®) outperforms the other listing drugs for the treatment of relapsed AML (acute myeloid leukemia) patients in its Phase 2 clinical study conducted in Russia. The outcome measures demonstrated higher remission rates (50%, CR/Cri) and survival rates guaranteeing fewer patients will require blood transfusions. This has made high safety possible during breakthroughs for AML treatment with remarkable monotherapy without combined chemotherapy. The new drug Antroquinonol has been granted orphan drug designation (ODD) by the U.S. FDA for the treatment of AML in 2015. GoldenBiotech has achieved excellent breakthrough in the unmet medical needs in AML therapy which many global pharmaceutical companies are targeting. Clinical Results Summary: Primary Outcome Measure- overall remission rate (CR/CRi): 50%. Secondary Outcome Measures: 80% of patients showed that their blasts count were less than 5%, 90% of patients did not need blood transfusion during trial period, 100% of patients were all alive during trial period (6 months) and No serious side effect. The primary efficacy indicator results exhibit that the overall remission rate (CR/CRi) of patients with relapsed acute myeloid leukemia reaches 50%. This is higher than those of other listing drugs in their Phase 2 trial ranging approximately from 21% to 33% in (CR/CRi). 80% of patients' abnormal blasts counts in bone marrow or blood were decreased to be less than 5% after treatment. For the secondary outcome measures results the overall survival rate of patients with relapsed AML reached 100% by the 6th month after treatment. This amplifies the possibility of patients receiving bone marrow transplantation. Furthermore, 90% of patients do not need to undergo blood transfusion during treatment with Antroquinonol (Hocena). Oral treatments and the decrease in blood transfusions have greatly improved the quality of life of AML patients. There is no significant side effect (SAE) that has occurred during the 6-month treatment period. The dose trial is administered orally at home by taking 200 mg twice a day. The trial of Antroquinonol (HOCENA®), Protocol No. GHAML-2-001, was an open-label, non-randomized, Phase 2a study to evaluate efficacy and safety/tolerability profiles in adult patients with relapsed acute myeloid leukemia (AML) or at initial diagnosis when no intensive treatment is possible. There is no standard treatment for relapsed/refractory adult acute myeloid leukemia (AML) patients. Based on the confidence achieved in the trial results for the treatment of second-line and recurrent AML patients, GoldenBiotech will apply the clinical trial (IND) to the U.S. FDA for the Phase 2 clinical trials as the first-line treatment of AML and continue to expand the spectrum of indications of Antroquinonol in other leukemia treatment fields including multiple myeloma (MM), chronic myelogenous leukemia (CML), and pediatric leukemia. The majority of AML patients need to undergo blood transfusions and chemotherapy to kill cancer cells due to abnormal differentiation of blood cells and proliferation of myeloblasts. Current therapies are combined with chemotherapy often causing serious side effects resulting in poor prognosis of treatment for relapsed AML patients. AML ranks the second highest incidence in all leukemia but it has the highest mortality rate and the lowest five-year survival rate (about only 25%). It is estimated that there will be about 62,000 patients with acute myeloid leukemia (AML) in 2020. According to the reports from GlobalData and other institutions, the global AML therapeutic drug market is expected to increase from USD 1.4 billion in 2019 to 5.1 billion in 2029 with a compound annual growth rate (CAGR) of 13.6%. Is New 90 Day High Low • Sep 24
New 90-day low: NT$41.20 The company is down 8.0% from its price of NT$44.75 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.