Reported Earnings • May 12
First quarter 2026 earnings released: NT$0.31 loss per share (vs NT$0.34 loss in 1Q 2025) First quarter 2026 results: NT$0.31 loss per share (improved from NT$0.34 loss in 1Q 2025). Net loss: NT$150.6m (loss narrowed 7.2% from 1Q 2025). Over the last 3 years on average, earnings per share has fallen by 12% per year but the company’s share price has fallen by 35% per year, which means it is performing significantly worse than earnings. Reported Earnings • Mar 27
Full year 2025 earnings released: NT$2.18 loss per share (vs NT$2.44 loss in FY 2024) Full year 2025 results: NT$2.18 loss per share (improved from NT$2.44 loss in FY 2024). Net loss: NT$1.04b (loss narrowed 10% from FY 2024). Over the last 3 years on average, earnings per share has fallen by 33% per year whereas the company’s share price has fallen by 38% per year. Announcement • Mar 23
Oneness Biotech Co., Ltd.(TPEX:4743) dropped from FTSE All-World Index (USD) Oneness Biotech Co., Ltd.(TPEX:4743) dropped from FTSE All-World Index (USD) Announcement • Jan 14
Oneness Biotech Co., Ltd., Annual General Meeting, May 20, 2026 Oneness Biotech Co., Ltd., Annual General Meeting, May 20, 2026. Location: 8 floor no,11, chung shan s. rd., jhongjheng district, taipei city Taiwan Announcement • Jan 06
Oneness Biotech Co., Ltd. Receives Medical Device Marketing Authorization Approval for All Indications in Wounds by EDA Egypt Oneness Biotech Co., Ltd. has received notification from the agent that the Bonvadis topical cream received medical device marketing authorization approval for all indications in wounds under EDA imported registration license number R275954Irg25V1 and with permission to be marketed in the Egypt. 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 approvals or the results (include interim analysis) of statistically significant sense, the future strategy: To plan for marketing and distribution. Accumulated investment expenditure incurred: No disclosure in consideration of future marketing strategies. Oneness shall pay the licensor sales royalties at a certain percentage according to the licensing contract once the product is commercialized. With a population of approximately 108 million and a diabetic population of approximately 11 million, Egypt's wound care market has great potential. Oneness implements a dual regulatory strategy, marketing the wound care product as both a drug and a medical device so that it may receive approval for commercialization in major countries and regions by 2025/2026. Oneness continues to progress the market access and collaboration in the major target markets according to the plan. Bonvadis obtained commercial approval for the indication of acute wounds in September 2024. For extending the indications of Bonvadis, the clearance of Bonvadis is for all indications of wounds, including acute wounds, chronic wounds, and scars. Indications for acute wounds include minor lacerations, abrasions, cuts, and burns; indications for chronic wounds include partial and full thickness wounds, 1st and 2nd degree burns, pressure ulcers, diabetic foot ulcers, venous ulcers, and post-surgical wounds; other indications are to remain the moisture in wounds and reduce scar formation. Announcement • Dec 20
Oneness Biotech Co., Ltd. Receives Medical Device Import License for All Indications in Wound Dressing for India Oneness BiotECH Co., Ltd. announced that the Bonvadis topical cream received medical device import license for all indications in wounds under import license no. IMP/MD/2025/000739 and with permission to be marketed in India. 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 approvals or the results (include interim analysis) of statistically significant sense, the future strategy: To plan for marketing and distribution. Accumulated investment expenditure incurred: No disclosure in consideration of future marketing strategies. Upcoming development plan: Scheduled completion date:NA. Estimated responsibilities: Oneness shall pay the licensor a certain percentage of sales royalties according to the licensing contract once the product is commercialized. The clearance on Bonvadis is for all indications of wounds including acute wounds, chronic wounds, and scars. Indications for acute wounds include minor lacerations, abrasions, cuts, and burns; indications for acute wounds include partial and full thickness wounds, first and second degree burns, pressure ulcers, diabetic foot ulcers, venous ulcers, and post-surgical wounds; other indications are to remain the moisture in wounds and reduce scar formation. According to Guidelines by Taipei Exchange on the Material Information Announced by Listed and OTC Companies, new drug development companies shall make public announcement when filing application for a clinical trial to domestic or overseas regulatory authorities with respect to its receiving approval or approval, obtaining the statistical date of endpoints in each clinical trial (including interim analysis), and/or receiving approval or approval on drug license application. New Risk • Dec 09
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 Risk Earnings have declined by 38% 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$117m revenue, or US$3.8m). Reported Earnings • Nov 11
Third quarter 2025 earnings released: NT$0.01 loss per share (vs NT$1.06 loss in 3Q 2024) Third quarter 2025 results: NT$0.01 loss per share (improved from NT$1.06 loss in 3Q 2024). Net loss: NT$3.32m (loss narrowed 99% from 3Q 2024). Over the last 3 years on average, earnings per share has fallen by 59% per year but the company’s share price has only fallen by 34% per year, which means it has not declined as severely as earnings. Reported Earnings • Sep 10
Second quarter 2025 earnings released: NT$1.76 loss per share (vs NT$0.36 loss in 2Q 2024) Second quarter 2025 results: NT$1.76 loss per share (further deteriorated from NT$0.36 loss in 2Q 2024). Net loss: NT$844.2m (loss widened 387% from 2Q 2024). Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 42 percentage points per year, which is a significant difference in performance. Reported Earnings • Aug 09
Second quarter 2025 earnings released: NT$1.76 loss per share (vs NT$0.36 loss in 2Q 2024) Second quarter 2025 results: NT$1.76 loss per share (further deteriorated from NT$0.36 loss in 2Q 2024). Net loss: NT$844.2m (loss widened 387% from 2Q 2024). Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 51 percentage points per year, which is a significant difference in performance. New Risk • Aug 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 7.6% 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 (7.6% average weekly change). Earnings have declined by 34% per year over the past 5 years. Minor Risk Revenue is less than US$5m (NT$117m revenue, or US$3.9m). Board Change • Jun 02
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 4 experienced directors. 2 highly experienced directors. Director Tu-Mu Kuo was the last director to join the board, commencing their role in 2024. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Announcement • May 18
Oneness Biotech Co., Ltd. and Microbio (Shanghai) Co., Ltd. Selects Sns812 for Oral Presentation At the 2025 American Thoracic Society International Conference The broad-spectrum antiviral siRNA drug SNS812, co-developed by Oneness Biotech and Microbio (Shanghai), has been selected for oral presentation at the prestigious 2025 American Thoracic Society (ATS) International Conference. The presentation will deliver the latest clinical data to leading global experts in the fields of respiratory and infectious diseases. SNS812 is the world's first fully modified siRNA drug, clinically validated and administered via aerosol inhalation, demonstrating potent and broad-spectrum inhibitory activity against the SARS-CoV-2 virus. Results from a Phase II clinical trial show that SNS812 significantly reduces viral load, accelerates the resolution of key symptoms such as shortness of breath, and effectively shortens the recovery time of smell and taste loss. These results indicate a strong potential for preventing severe disease progression and offering neuroprotective effects. Furthermore, SNS812 has shown excellent safety and tolerability, with no serious adverse events reported, making it a promising candidate as an inhalable broad-spectrum COVID-19 therapy. The presentation will be delivered in a Mini Symposium, the highest-tier session format at the ATS conference. This premier session is reserved for studies demonstrating exceptional scientific originality, clinical significance, and contributions to global health, and inclusion requires rigorous scientific review. The selection of SNS812 affirms the international recognition of Oneness Biotech and Microssio (Shanghai) for their technological platform in nucleic acid drug development and their innovative capabilities in precision antiviral therapy. Oneness Biotech and MicroBio (Shanghai) continue to advance the global clinical development and licensing collaborations for SNS812, accelerating its path to commercialization, and expanding siRNA applications across major infectious diseases and global public health challenges-- bringing transformative solutions to human health. Reported Earnings • May 14
First quarter 2025 earnings released: NT$0.34 loss per share (vs NT$0.19 loss in 1Q 2024) First quarter 2025 results: NT$0.34 loss per share (further deteriorated from NT$0.19 loss in 1Q 2024). Net loss: NT$162.3m (loss widened 75% from 1Q 2024). Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 48 percentage points per year, which is a significant difference in performance. Announcement • May 03
Oneness Biotech Co., Ltd. to Report Q1, 2025 Results on May 12, 2025 Oneness Biotech Co., Ltd. announced that they will report Q1, 2025 results on May 12, 2025 Price Target Changed • Apr 25
Price target increased by 31% to NT$308 Up from NT$234, the current price target is provided by 1 analyst. New target price is 402% above last closing price of NT$61.30. Stock is down 58% over the past year. The company is forecast to post a net loss per share of NT$1.26 next year compared to a net loss per share of NT$2.44 last year. Announcement • Apr 24
Oneness Biotech Co., Ltd. Announces EDA Accepts Medical Device Registration Application of Bonvadis for All Indications in Wounds in Egypt Oneness Biotech Co., Ltd. announced that the medical device registration application of Bonvadis for all indications in wounds has been accepted by Egypt EDA. Date of occurrence of the event: April 23, 2025. For extending the indications of Bonvadis, the application of Bonvadis is for all indications of wounds including acute wounds, chronic wounds, and scars. Indications for acute wounds include minor lacerations, abrasions, cuts, and burns; indications for chronic wounds include partial and full thickness wounds, first and second degree burns, pressure ulcers, diabetic foot ulcers, venous ulcers, and post-surgical wounds; other indications are to remain the moisture in wounds and reduce scar formation. Announcement • Apr 17
Oneness Biotech Co., Ltd. Announces the Medical Device Registration Application of Bonvadis for All Indications of Wound Dressing Oneness BiOTECH Co., Ltd. announced that the medical device registration application of Bonvadis for all indications of wounds has been accepted by TGA in Australia. 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 approvals or the results (include interim analysis) of statistically significant sense, the future strategy: N. Accumulated investment expenditure incurred: No disclosure in consideration of future marketing strategies. Upcoming development plan: Scheduled completion date: The review timeline will be determined based on the regulatory authority's review process. Estimated responsibilities:Oneness shall pay the licensor a certain percentage of sales royalties according to the licensing contract once the product is marketed. New Risk • Mar 31
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 6.0% 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 Risk Earnings have declined by 31% per year over the past 5 years. Minor Risks Currently unprofitable and not forecast to become profitable next year (NT$697m net loss next year). Share price has been volatile over the past 3 months (6.0% average weekly change). Revenue is less than US$5m (NT$118m revenue, or US$3.5m). Announcement • Mar 19
Oneness Biotech Co., Ltd. Announces Medical Device Registration Application of Bonvadis for All Indications in Wounds Has Been Accepted by UAE MOHAP Date of occurrence of the event: March 18, 2025 . New drug name or code: Bonvadis. Indication: Wound Dressing. Planned development stages: NA5. Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis): Oneness has received notification by the agent that the medical device registration application of Bonvadis for all indications has been accepted by MOHAP in UAE. 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 approvals or the results (include interim analysis) of statistically significant sense, the future strategy: NA. Accumulated investment expenditure incurred: No disclosure in consideration of future marketing strategies. Upcoming development plan. Scheduled completion date: The review timeline will be determined based on the regulatory authority's review process. Estimated responsibilities: Oneness shall pay the licensor a certain percentage of sales royalties according to the licensing contract once the product is marketed. Market situation: The advanced wound care market in the Middle East is showing stable growth, primarily driven by the increasing number of chronic wound cases, particularly DFU. Data indicates that the advanced wound caremarket in the Middle East is expected to reach USD 4.8 billion by 2028, with a compound annual growth rate (CAGR) of 5.8%. The rising prevalence of diabetes remains a key factor driving market growth,leading to an increased demand for innovative wound care solutions. Any other matters that need to be specified: Oneness implements a dual regulatory strategy, marketing the wound care product as both a drug and a medical device so that it may receive approval for commercialization in major countries and regions by 2025. Oneness continues to progress the market access and collaboration in the major target markets according to the plan. The application on Bonvadis by the MOHAP in UAE is for all indications of wounds including acute wounds, chronic wounds, and scars. Indications for acute wounds include minor lacerations, abrasions, cuts, and burns; indications for chronic wounds include partial and full thickness wounds, first and second degree burns, pressure ulcers, diabetic foot ulcers, venous ulcers, and post-surgical wounds; other indications are to remain the moisture in wounds and reduce scar formation. According to Guidelines by Taipei Exchange on the Material Information Announced by Listed and OTC Companies, new drug development companies shall make public announcement when filing application for a clinical trial to domestic or overseas regulatory authorities with respect to its receiving approval or disapproval, obtaining the statistical date of endpoints in each clinical trial (including interim analysis), and/or receiving approval or disapproval on drug license application. 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. Reported Earnings • Mar 04
Full year 2024 earnings released: NT$2.44 loss per share (vs NT$2.77 loss in FY 2023) Full year 2024 results: NT$2.44 loss per share (improved from NT$2.77 loss in FY 2023). Net loss: NT$1.17b (loss narrowed 11% from FY 2023). Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 45 percentage points per year, which is a significant difference in performance. Announcement • Mar 03
Oneness Biotech Co., Ltd., Annual General Meeting, May 22, 2025 Oneness Biotech Co., Ltd., Annual General Meeting, May 22, 2025. Location: 8 floor no,11, chung shan s. rd., jhongjheng district, taipei city Taiwan Announcement • Feb 20
Oneness Biotech Co., Ltd. to Report Fiscal Year 2024 Results on Feb 27, 2025 Oneness Biotech Co., Ltd. announced that they will report fiscal year 2024 results on Feb 27, 2025 New Risk • Jan 30
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 6.1% 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: Minor Risks Currently unprofitable and not forecast to become profitable next year (NT$702m net loss next year). Share price has been volatile over the past 3 months (6.1% average weekly change). Revenue is less than US$5m (NT$112m revenue, or US$3.4m). Announcement • Jan 10
Oneness Biotech Co., Ltd. Receives GMP Compliance Assessment of Foreign Pharmaceutical Manufacturers Reviewed by the Drug Administration of Vietnam Oneness Biotech Co., Ltd. announced that company has been notified by the local agent that Oneness Nanchou manufacturing site has passed the GMP compliance assessment of foreign pharmaceutical manufacturers reviewed by the Drug Administration of Vietnam (DAV). New Risk • Dec 16
New major risk - Financial data availability The company has not reported any financial data. This is considered a major risk. With no or incomplete audited reported financial data, it is virtually impossible to assess the company's investment potential. This is currently the only risk that has been identified for the company. New Risk • Nov 26
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 101% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Shareholders have been substantially diluted in the past year (101% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable next year (NT$702m net loss next year). Revenue is less than US$5m (NT$112m revenue, or US$3.5m). Reported Earnings • Nov 13
Third quarter 2024 earnings: Revenues exceed analysts expectations while EPS lags behind Third quarter 2024 results: NT$1.06 loss per share (further deteriorated from NT$0.48 loss in 3Q 2023). Net loss: NT$506.4m (loss widened 123% from 3Q 2023). Revenue exceeded analyst estimates by 2.8%. Earnings per share (EPS) missed analyst estimates by 179%. Revenue is forecast to grow 98% p.a. on average during the next 2 years, compared to a 60% growth forecast for the Pharmaceuticals industry in Taiwan. Over the last 3 years on average, earnings per share has fallen by 50% per year but the company’s share price has only fallen by 20% per year, which means it has not declined as severely as earnings. Price Target Changed • Sep 26
Price target decreased by 19% to NT$234 Down from NT$291, the current price target is an average from 2 analysts. New target price is 67% above last closing price of NT$141. Stock is down 15% over the past year. The company is forecast to post a net loss per share of NT$1.48 next year compared to a net loss per share of NT$2.77 last year. Reported Earnings • Aug 14
Second quarter 2024 earnings: EPS and revenues miss analyst expectations Second quarter 2024 results: NT$0.36 loss per share (improved from NT$0.71 loss in 2Q 2023). Net loss: NT$173.3m (loss narrowed 48% from 2Q 2023). Revenue missed analyst estimates by 67%. Earnings per share (EPS) also missed analyst estimates by 5.0%. Over the last 3 years on average, earnings per share has fallen by 32% per year but the company’s share price has only fallen by 4% per year, which means it has not declined as severely as earnings. Announcement • Aug 04
Oneness Biotech Co., Ltd. to Report Q2, 2024 Results on Aug 12, 2024 Oneness Biotech Co., Ltd. announced that they will report Q2, 2024 results on Aug 12, 2024 New Risk • Jul 09
New major risk - Revenue and earnings growth Earnings have declined by 22% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risk Earnings have declined by 22% per year over the past 5 years. Minor Risks Shareholders have been diluted in the past year (2.2% increase in shares outstanding). Revenue is less than US$5m (NT$90m revenue, or US$2.8m). Reported Earnings • May 19
First quarter 2024 earnings: EPS and revenues exceed analyst expectations First quarter 2024 results: NT$0.20 loss per share (improved from NT$0.59 loss in 1Q 2023). Net loss: NT$92.6m (loss narrowed 65% from 1Q 2023). Revenue exceeded analyst estimates by 3.2%. Earnings per share (EPS) also surpassed analyst estimates by 38%. Revenue is forecast to grow 41% p.a. on average during the next 2 years, compared to a 36% growth forecast for the Pharmaceuticals industry in Taiwan. Over the last 3 years on average, earnings per share has fallen by 35% per year but the company’s share price has only fallen by 4% per year, which means it has not declined as severely as earnings. Announcement • May 18
Oneness Biotech Co., Ltd. Agrees to Withdraw the 510(K) for Bonvadis Chronic Wound and Resubmit After the Supplementing Animal Study Data Oneness Biotech Co., Ltd. announced that Bonvadis has obtained 510(K) Acute wound medical device approval and is currently applying for 510(k) Chronic wound medical device. Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis): Bonvadis has obtained 510(K) Acute wound medical device approval and is currently applying for 510(k) Chronic wound medical device. Upcoming development plan: Scheduled completion date: In accordance with U.S FDA suggestion, company will submit the 510(k) chronic wound medical device after supplementing the required animal study data. The company submitted technical documents in April 2024 in accordance with the U.S. FDA's review requirements in November 2023. The U.S. FDA temporarily notified the company to hold a conference call last night and requested additional animal study data. The company responded to the FDA's suggestion and will withdraw the application. After completing the animal study and obtaining the data this year, the company will resubmit the 510(k) chronic wound medical device application. The regulatory authority will conduct the final review. Bonvadis is one of the wound medical devices developed by company. It has obtained 510(k) approval for acute wound indications. After supplementing animal study data as required by the U.S FDA, the chronic wound application will be submitted in second half of 2024 and commercialization arrangements will be made simultaneously. Application will not affect the company's business. According to Guidelines by Taipei Exchange on the Material Information Announced by Listed and OTC Companies, new drug development companies shall make public announcement when filing application for clinical trials to domestic or overseas regulatory authorities, receiving approval or disapproval, obtaining the statistical date of endpoints in each clinical trial (including interim analysis), or receiving approval or disapproval on drug license application. 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. Announcement • May 10
US FDA Agrees Oneness Biotech Co., Ltd.'s S.C. Injection Formulation of FB825 to Proceed with Phase 2 Clinical Trial to Treat Moderate-To-Severe Atopic Dermatitis Oneness Biotech Co., Ltd. announced that S.C. injection formulation of FB825 has been agreed by US FDA to proceed with Phase 2 clinical trial to treat moderate-to-severe atopic dermatitis. Indication: Treatment for moderate-to-severe atopic dermatitis, allergic asthma and other IgE-mediated allergic diseases. Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis): Subcutaneous injection formulation of FB825, anti-CemX antibody, has been agreed by US FDA to proceed with Phase 2 clinical trial. Accumulated investment expenditure incurred: No disclosure of investment expenditure at the moment in consideration of future marketing strategies and to protect the interests of the company and investors. Market situation: Atopic dermatitis is a chronic and heterogeneous skin condition characterized by intense itching and eczematous lesions. It is the most common inflammatory skin disease in developed countries. According to the Global Report on Atopic Dermatitis 2022 by the International Eczema Council, up to 20% of children and 10% of adults in developed nations suffer from this condition. The market for atopic dermatitis is gradually gaining attention, becoming one of the target indications for pharmaceutical companies. According to a report from Mordor Intelligence, the atopic dermatitis treatment market is estimated to be $10.06 billion in 2024, with a projected compound annual growth rate (CAGR) of 7.18%, reaching $14.23 billion by 2029. On April 22, 2024, subcutaneous injection formulation of FB825 to treat moderate-to-severe atopic dermatitis was greenlighted by TFDA to proceed with a phase II clinical trial. The trial is jointly conducted with international partner and will be concurrently implemented in multiple medical centers in the United States and Taiwan. According to Guidelines by Taipei Exchange on the Material Information Announced by Listed and OTC Companies, new drug development companies shall make public announcement when filing application for clinical trials to domestic or overseas regulatory authorities, receiving approval or disapproval, obtaining the statistical date of endpoints in each clinical trial (including interim analysis), or receiving approval or disapproval on drug license application. New Risk • Mar 15
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 2.2% 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: Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (NT$890m net loss in 2 years). Shareholders have been diluted in the past year (2.2% increase in shares outstanding). Revenue is less than US$5m (NT$87m revenue, or US$2.7m). Reported Earnings • Mar 12
Full year 2023 earnings: EPS and revenues miss analyst expectations Full year 2023 results: NT$2.91 loss per share (down from NT$0.81 profit in FY 2022). Net loss: NT$1.31b (down 465% from profit in FY 2022). Revenue missed analyst estimates by 70%. Earnings per share (EPS) also missed analyst estimates by 38%. Revenue is forecast to grow 47% p.a. on average during the next 2 years, compared to a 38% growth forecast for the Pharmaceuticals industry in Taiwan. Over the last 3 years on average, earnings per share has fallen by 27% per year but the company’s share price has only fallen by 9% per year, which means it has not declined as severely as earnings. New Risk • Mar 12
New major risk - Revenue and earnings growth Earnings have declined by 6.8% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risk Earnings have declined by 6.8% per year over the past 5 years. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (NT$890m net loss in 2 years). Revenue is less than US$5m (NT$76m revenue, or US$2.4m). Announcement • Mar 01
Oneness Biotech Co., Ltd. has filed a Follow-on Equity Offering. Oneness Biotech Co., Ltd. has filed a Follow-on Equity Offering.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 22,755,261 Announcement • Jan 31
Oneness Biotech Co., Ltd. Announces Submission of A Phase II Clinical Trial Protocol Forsubcutaneous Injection Formulation of FB825 in Patientswith Moderate-To-Severe Atopic Dermatitis Oneness Biotech Co., Ltd. announced the Submission of a phase II clinical trial protocol forsubcutaneous injection formulation of FB825 in patientswith moderate-to-severe atopic dermatitis. Current development stage: FB825 has successfully developed a subcutaneous injection formulation and completed the enrollment of a bridging trial involving both intravenous and subcutaneous formulations among healthy subjects in the United States. Initial findings have affirmed the safety of the subcutaneous injection formulation. A phase 2 clinical trial application for the subcutaneous injection formulation of FB825 in patients with moderate-to-severe atopic dermatitis has been submitted via IND to the US FDA. The primary objectives of this study are to investigate the efficacy, safety, and pharmacokinetics associated with FB825's subcutaneous injection formulation in moderate-to-severe atopic dermatitis patients. Announcement • Jan 21
Oneness Biotech Co., Ltd. Obtains Import License in Thailand from Thai Food and Drug Administration Oneness Biotech Co., Ltd. announced that the Bonvadis, the wound care topical cream has been approved for import of medical device by Thai Food and Drug Administration (Thai FDA) in Thailand with registration number 67-2-2-2-0000197 and permission for market distribution in Thailand. After obtaining official approval or the results the future strategy is to proceed planning for marketing and distribution. Upcoming development plan: Extensions of indications will be applied. A. Scheduled completion date: The review timeline is subject to the review process regulated by competent authorities in each country. B. Estimate responsibilities: Oneness shall pay the licensor sales royalties according to the licensing contract once the product is put onto the market. Oneness implements dual strategies of both medicinal products and medical devices for development and marketing of wound care products. Each type of product will comply with corresponding regulatory requirements to get earlier access to the markets. New drug Fespixon Cream has been approved with medicine licenses for Taiwan, Singapore, Malaysia, and China markets, as well as under the process of pre-market reviews or preparation of submissions for other countries. Bonvadis as a medical device has been approved with medical device licenses for wound management in the US, India, New Zealand, South Africa and Thailand as well as for scar management in European Union. Price Target Changed • Dec 08
Price target decreased by 14% to NT$262 Down from NT$306, the current price target is an average from 2 analysts. New target price is 35% above last closing price of NT$194. Stock is down 15% over the past year. The company is forecast to post a net loss per share of NT$2.12 compared to earnings per share of NT$0.82 last year. Major Estimate Revision • Nov 15
Consensus revenue estimates increase by 158% The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast increased from NT$95.0m to NT$245.5m. EPS estimate unchanged from -NT$2.12 at last update. Pharmaceuticals industry in Taiwan expected to see average net income growth of 19% next year. Consensus price target of NT$306 unchanged from last update. Share price fell 5.5% to NT$214 over the past week. Announcement • Nov 10
Oneness Biotech Co., Ltd. Announces Approval of FESPIXON Oneness Biotech Co., Ltd. announced that it has been approved as Class 1.1 natural new drug by National Medical Products Administration (NMPA) in China. Product: FESPIXON, a new drug for the treatment of diabetic foot ulcers, has a generic name approved in China as Xianglei Tangzu Gao. Effect on company finances and business: New drug name or code: FESPIXON (research code: ON101). Purpose: Treatment of diabetic foot ulcers. Planned development stages: The second phase 3 clinical trial (ON101CLCT04) in the US, and other exploratory studies for new indications. Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis): The new drug application (NDA) of FESPIXON, the new drug in treatment of diabetic foot ulcers. The approved generic name is Xianglei Tangzu Go, and the approval number is ZC20230001. Once disapproved by competent authority or each of clinical trials (include interim analyses) results less than statistically significant sense, the risks and the associated measures the Company may occur: After obtaining official approval or the results (include interim analysis) of statistically significant sense, the future strategy: Microbio (Shanghai) Co. Ltd. will be responsible for the marketing and sales of FESPIXON. Accumulated investment expenditure incurred: No disclosure of the investment expenditure at the moment in consideration of the future marketing strategies. Upcoming development plan: Scheduled completion date: The second phase 3 trial in the US is scheduled to complete in 3-4 years after initiation accroding to the current plan. Estimate responsibilities: After product commercialization, the company shall pay the licensor a certain percentage of royalties according to the agreement during the validity of licensed patents. New Risk • Oct 28
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 5.6% 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: Minor Risks Currently unprofitable and not forecast to become profitable next year (NT$590m net loss next year). Share price has been volatile over the past 3 months (5.6% average weekly change). Shareholders have been diluted in the past year (2.6% increase in shares outstanding). Revenue is less than US$5m (NT$71m revenue, or US$2.2m). New Risk • Sep 10
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 2.6% 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: Minor Risks Currently unprofitable and not forecast to become profitable next year (NT$584m net loss next year). Shareholders have been diluted in the past year (2.6% increase in shares outstanding). Revenue is less than US$5m (NT$71m revenue, or US$2.2m). Announcement • Sep 01
Oneness Biotech Co., Ltd. Submits 510(k) Application to the U.S. FDA to Expand the Intended Patient Population and Add Multiple Chronic Wound Indications for Bonvadis Oneness Biotech Co., Ltd. has submitted a 510(k) application to the U.S. FDA to expand the intended patient population and add multiple chronic wound indications for Bonvadis. Scheduled completion date: The review timeline is subject to the review process regulated by competent authorities in each country. Estimate responsibilities: Oneness shall pay the licensor sales royalties according to the licensing contract once the product is put onto the market. Oneness implements dual strategies of both medicine products and medical devices for development and marketing of wound care products. Each type of product will comply with corresponding regulatory requirements to get quick access of the markets. New drug Fespixon Cream has been approved with medicine licenses for Taiwan and Singapore markets, as well as under the process of pre-market reviews or preparation of submissions for other countries. Bonvadis as a medical device for wound management has been granted with market approvals for the US, India, and New Zealand, and for scar management in European Union. This 510(k) application to the U.S. FDA to expand the intended patient population and add multiple indications, will be followed by the submission of market access applications in countries where the company plan to market the medical device. According to Guidelines by Taipei Exchange on the Material Information Announced by Listed and OTC Companies, new drug development companies shall make public announcement when filing application for clinical trials to domestic or overseas regulatory authorities, receiving approval or disapproval, obtaining the statistical date of endpoints in each clinical trial (including interim analysis), or receiving approval or disapproval on drug license application. 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. New Risk • Aug 13
New minor risk - Revenue size The company makes less than US$5m in revenue. Total revenue: NT$71m (US$2.2m) This is considered a minor risk. Companies with a small amount of revenue 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: Minor Risks Currently unprofitable and not forecast to become profitable next year (NT$584m net loss next year). Revenue is less than US$5m (NT$71m revenue, or US$2.2m). Reported Earnings • Aug 12
Second quarter 2023 earnings: EPS misses analyst expectations Second quarter 2023 results: NT$0.74 loss per share (down from NT$0.77 profit in 2Q 2022). Net loss: NT$335.2m (down 199% from profit in 2Q 2022). Revenue was in line with analyst estimates. Earnings per share (EPS) missed analyst estimates by 8.8%. Revenue is forecast to grow 185% p.a. on average during the next 2 years, compared to a 23% growth forecast for the Pharmaceuticals industry in Taiwan. Over the last 3 years on average, earnings per share has increased by 6% per year but the company’s share price has fallen by 9% per year, which means it is significantly lagging earnings. New Risk • Aug 06
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next year. Trailing 12-month net loss: NT$293m Forecast net loss in 1 year: NT$852m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. This is currently the only risk that has been identified for the company. Price Target Changed • Aug 05
Price target decreased by 10% to NT$274 Down from NT$306, the current price target is provided by 1 analyst. New target price is 43% above last closing price of NT$192. Stock is up 24% over the past year. The company is forecast to post a net loss per share of NT$2.91 compared to earnings per share of NT$0.82 last year. Announcement • Aug 05
Oneness Biotech Co., Ltd. Announces Submission of Registration Application for Bonvadis, the Wound Care Topical Cream to the Drug Regulatory Authority of Pakistan (DRAP) Oneness Biotech Co., Ltd. Announces submission of registration application for Bonvadis, the wound care topical cream to the Drug Regulatory Authority of Pakistan (DRAP). New drug name or code: Bonvadis. Purpose: Wound Dressing. Planned development stages-GNA. Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis): Regulatory Agent in Pakistan has notified Oneness that Bonvadis topical cream for wound care has submitted a registration application to the Drug Regulatory Authority of Pakistan (DRAP). Oneness implements dual strategies of both medicine products and medical devices for development and marketing of company's wound care products. Each type of product will comply with corresponding regulatory requirements to get quick access of the markets. New drug Fespixon Cream has been approved with medicine licenses for Taiwan, Singapore, Malaysia markets, as well as under the process of pre-market reviews or preparation of submissions for other countries. Bonvadis as a medical device for wound management has been granted with market approvals for the US, India, and New Zealand, and for scar management in European Union. The subsequent market access plan with medical device submissions in other countries are ongoing. Announcement • Aug 03
US FDA agrees to proceed with Phase 2 clinical trial for SNS812, a broad-spectrum siRNA for COVID-19 infection, co-developed by Oneness & Microbio (Shanghai) US FDA agreed to proceed with Phase 2 clinical trial for SNS812, a broad-spectrum siRNA for COVID-19 infection, co-developed by Oneness & Microbio (Shanghai). Planned development stages:Phase II clinical trial/Phase III clinical trial/NDA. Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis):SNS812, a broad-spectrum siRNA for treatment of SARS- COV-2 infection, has been agreed by the US FDA to proceed with the phase 2 clinical trial. 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: Not applicable. C. After obtaining official approval or the results (include interim analysis) of statistically significant sense, the future strategy: Not applicable Upcoming development plan: phase II /III clinical trial. A. Scheduled completion date: The actual timeline will depend on the progress of the trial and the review of the regulatory agency. B. Estimate responsibilities: SNS812, a broad-spectrum antiviral siRNA for COVID-19, is developed jointly by Oneness Biotech Co., Ltd. and Microbio (Shanghai) Co., Ltd. Announcement • Jul 15
Oneness Biotech Co., Ltd. Receives Approval from Malaysia NPRA for FESPIXON, the New Drug in Treatment of Diabetic Footulcers Oneness Biotech Co., Ltd. announced FESPIXON, a new drug for the treatment of diabetic foot ulcers. Planned development stages: The second phase 3 clinical trial (ON101CLCT04) in the US, and other exploratory studies for new indications. Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis):Oneness has been informed by the local agent that the DFU new drug, FESPIXON, has been approved by Malaysia National Pharmaceutical Regulatory Agency (NPRA). 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: Marketing and sales of FESPIXON in both Singapore and Malaysia will be jointly planned. D. Accumulated investment expenditure incurred:No disclosure of the investment expenditure at the moment in consideration of the future marketing strategies. (5) Upcoming development plan: A. Scheduled completion date: The second phase 3 trial in the US is scheduled to complete in 3-4 years after initiation. B. Estimate responsibilities: After product commercialization, the company shall pay the licensor a certain percentage of royalties according to the agreement during the validity of licensed patents. Market: The prevalence of diabetes mellitus (DM) in Malaysia is the highest among the ASEAN countries. According to the systematic review published on Int. J. Environ. Res. Public Health, 2020, the annual medical costs on DM is USD 600 million per year and one of the most costly complications is amputation which brings a huge medical burden. FESPIXON has been the first Natural Product with Therapeutic Claim applied with and approved by Malaysia NPRA after the guideline of Natural Products with Therapeutic Claim was published by Malaysia NPRA in 2020. With novel mechanism and significant clinical efficacy, FESPIXON is the only new drug approved by NPRA in the classification to treat diabetic foot ulcer. Currently, FESPIXON has been approved in Taiwan, Singapore and Malaysia. The health authorities in China, the Philippines, Vietnam and Indonesia are reviewing the NDA application of FESPIXON. According to Guidelines by Taipei Exchange on the Material Information Announced by Listed and OTC Companies, new drug development companies shall make public announcement when filing application for clinical trials to domestic or overseas regulatory authorities, receiving approval or disapproval, obtaining the statistical date of endpoints in each clinical trial (including interim analysis), or receiving approval or disapproval on drug license application. 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. Upcoming Dividend • Jun 09
Upcoming dividend of NT$0.098 per share Eligible shareholders must have bought the stock before 16 June 2023. Payment date: 21 July 2023. The company last paid an ordinary dividend in August 2012. The average dividend yield among industry peers is 1.6%. Announcement • May 31
Oneness Biotech Co., Ltd. Announces Cash Dividend, Payable on July 21, 2023 Oneness Biotech Co., Ltd. announced a cash dividend of TWD 39,177,285, with a distribution of TWD 0.09839518 per share. The ex-rights (Ex-dividend) date is on June 16, 2023. The record date is on June 24, 2023. The payment date of cash dividend distribution is on July 21, 2023. Reported Earnings • Mar 10
Full year 2022 earnings: EPS exceeds analyst expectations Full year 2022 results: EPS: NT$0.93 (up from NT$1.06 loss in FY 2021). Revenue: NT$1.07b (up NT$999.8m from FY 2021). Net income: NT$360.0m (up NT$763.3m from FY 2021). Profit margin: 34% (up from net loss in FY 2021). The move to profitability was driven by higher revenue. Revenue was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates by 98%. Revenue is forecast to grow 86% p.a. on average during the next 2 years, compared to a 47% growth forecast for the Pharmaceuticals industry in Taiwan. Over the last 3 years on average, earnings per share has increased by 61% per year but the company’s share price has increased by 115% per year, which means it is tracking significantly ahead of earnings growth. Reported Earnings • Dec 02
Third quarter 2022 earnings released Third quarter 2022 results: Revenue: NT$13.9m (down 42% from 3Q 2021). Net income: NT$275.6m (up NT$451.5m from 3Q 2021). Over the last 3 years on average, earnings per share has increased by 23% per year but the company’s share price has increased by 115% per year, which means it is tracking significantly ahead of earnings growth. Reported Earnings • Nov 12
Third quarter 2022 earnings released: EPS: NT$0.71 (vs NT$0.46 loss in 3Q 2021) Third quarter 2022 results: EPS: NT$0.71 (up from NT$0.46 loss in 3Q 2021). Revenue: NT$13.9m (down 42% from 3Q 2021). Net income: NT$275.6m (up NT$451.5m from 3Q 2021). Over the last 3 years on average, earnings per share has increased by 53% 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 • Sep 24
Microbio (Shanghai) and Oneness Co-Develop Broad-Spectrum siRNA (SNS812) to Treat SARS-CoV-2 Infection, Greenlighted by FDA to Proceed with A Phase I Study Microbio (Shanghai) and Oneness co-developed broad-spectrum siRNA (SNS812) to treat SARS-CoV-2 infection, was greenlighted by FDA to proceed with a phase I study. New drug name or code: SNS812; Purpose: Treatment for COVID-19 infection; Information Website: has not submitted; Planned development stages:Phase I, Phase II, Phase III, NDA; Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis):SNS812, a broad-spectrum siRNA for treatment of SARS-COV-2 infection has been greenlighted by the US FDA to proceed with the phase I study. 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: Not applicable. After obtaining official approval or the results (include interim analysis) of statistically significant sense, the future strategy: Not applicable. Accumulated investment expenditure incurred: Considering the future marketing strategy and to protect the rights and interests of the company and investors, it will not be disclosed publicly. Upcoming development plan: Phase I, Phase II, Phase III; Scheduled completion date: The actual time schedule will depend on the progress of the trial and the review of the regulatory agency. Estimate responsibilities: SNS812 is a broad-spectrum siRNA for treatment of SARS-CoV-2 infection that co-developed by Microbio (Shanghai) and Oneness Biotech Co., Ltd. Market: Based on the data published on September 22, 2022, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has infected more than 613 million people worldwide and caused more than 6 million deaths. With the occurrence of vaccine breakthrough and repeated COVID-19 infections caused by new variants, it is anticipated that the future new variants will lead to periodic global epidemics. The coexistence of the SARS-CoV-2 and human beings seems inevitable and the broad-spectrum therapeutics to treat SARS-CoV-2 will be able to address the large medical needs. Any other matters that need to be specified: SNS812 is a broad-spectrum siRNA therapeutic to treat SARS-CoV-2 variants covering 99.8% of current SARS-CoV-2 variants and shown a picomolar inhibition of dominant ones, including Alpha, Delta, Gamma, Epsilon and Omicron. Moreover, the K18-hACE2-transgenic mice studies demonstrated that SNS812 could completely inhibit the replication of infectious virions in lungs by prophylactic treatment and decrease 96.2% of virions by post-treatment. It is also noted that virus-associated extensive pulmonary alveolar damage, vascular thrombi, and immune cell infiltrations have been significantly reduced by SNS812 treatment. The COVID-19 pandemic has continued to evolve. In addition to verifying SNS812 in treatment and prevention of SARS-CoV-2 infection, SNS812 is positioned as a treatment solution to the periodic outbreak of life-threatening COVID-19. According to the Guidelines by Taipei Exchange on the Material Information Announced by Listed and OTC Companies, new drug development companies shall make public announcement when filing application for clinical trials to domestic or overseas regulatory authorities, receiving approval or disapproval, obtaining the statistical date of endpoints in each clinical trial (including interim analysis), or receiving approval or disapproval on drug license application. 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 • Aug 24
Oneness Biotech Co., Ltd. Submits an IND to US FDA for A Phase Iclinical Trial on the Broad-Spectrum Anti-SARS-CoV-2siRNA (SNS812) Co-Developed with Microbio (Shanghai) Oneness Biotech Co., Ltd. Submitted an IND to US FDA for A Phase I clinical Trial on the Broad-Spectrum Anti-SARS-CoV-2siRNA (SNS812) Co-Developed with Microbio (Shanghai). Product: SNS812, a broad-spectrum siRNA against SARS-COV-2 virus. Effect on company finances and business: New drug name or code: SNS812; Purpose: Treatment for COVID-19 infection; Planned development stages: Phase I, Phase II, Phase III, NDA. Current development stage: A. File application/approved/disapproved/Each of clinical trials (include interim analysis):Submit an IND application to the US FDA for Phase I clinical trial. 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: Not applicable; C. After obtaining official approval or the results (include interim analysis) of statistically significant sense, the future strategy: Not applicable; D. Accumulated investment expenditure incurred: Considering the future marketing strategy and to protect the rights and interests of the company and investors, it will not be disclosed publicly. Upcoming development plan: Phase I, Phase II, Phase III A. Scheduled completion date: The actual schedule will depend on the progress of the US FDA review; B. Estimate responsibilities: SNS812 is a broad-spectrum siRNA new drug co-developed by Oneness Biotech Co., Ltd. and Microbio (Shanghai) Co., Ltd. Reported Earnings • Aug 15
Second quarter 2022 earnings released: EPS: NT$0.87 (vs NT$1.24 loss in 2Q 2021) Second quarter 2022 results: EPS: NT$0.87 (up from NT$1.24 loss in 2Q 2021). Revenue: NT$1.02b (up NT$1.00b from 2Q 2021). Net income: NT$338.5m (up NT$811.2m from 2Q 2021). Profit margin: 33% (up from net loss in 2Q 2021). Over the last 3 years on average, earnings per share has increased by 24% per year but the company’s share price has increased by 77% per year, which means it is tracking significantly ahead of earnings growth. Announcement • May 26
Oneness Biotech Co., Ltd. Announces the By-Election of Lin, Yi-Fu as Director Oneness Biotech Co., Ltd. announced the by-election of Lin, Yi-Fu as director of the board. Effective date of the new appointment is May 24, 2022. Reported Earnings • May 15
First quarter 2022 earnings released: EPS: NT$1.01 (vs NT$0.31 in 1Q 2021) First quarter 2022 results: EPS: NT$1.01 (up from NT$0.31 in 1Q 2021). Net income: NT$388.5m (up 232% from 1Q 2021). Over the last 3 years on average, earnings per share has fallen by 6% per year but the company’s share price has increased by 90% per year, which means it is well ahead of earnings. Announcement • Apr 19
Oneness Biotech Co., Ltd. Announces Food and Drug Administration Philippines Accepts NDA Application of Diabetic Foot Ulcer New Drug, Fespixon Oneness Biotech Co., Ltd. announced that The Food and Drug Administration–Philippines (PFDA) has accepted the NDA application of the diabetic foot ulcer new drug, Fespixon. Current development stage: file application/approved/disapproved/Each of clinical trials (include interim analysis): Oneness has been notified by the consultant company that the Philippines FDA has accepted the NDA application of FESPIXON, the diabetic foot ulcer new drug. 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 of the investment expenditure at the moment in consideration of the future marketing strategies to protect the company and investors interests. Upcoming development plan: Scheduled completion date: The second phase 3 trial in the US is scheduled to complete in 2 to 3 years after initiation. Estimate responsibilities: NA. Reported Earnings • Mar 19
Full year 2021 earnings: Revenues and EPS in line with analyst expectations Full year 2021 results: NT$1.06 loss per share (down from NT$0.68 loss in FY 2020). Net loss: NT$403.3m (loss widened 67% from FY 2020). Revenue was in line with analyst estimates. Over the last 3 years on average, earnings per share has fallen by 11% per year but the company’s share price has increased by 97% per year, which means it is well ahead of earnings. Announcement • Mar 06
Oneness Biotech Co., Ltd. Announces The Malaysia National Pharmaceutical Regulatory Agency Accepts NDA Application of the Diabetic Foot Ulcer New Drug, Fespixon Oneness Biotech Co., Ltd. has been notified by the Singaporean consultant company that the National Pharmaceutical Regulatory Agency of Malaysia has accepted the NDA application of FESPIXON, the diabetic foot ulcer new drug. The second phase 3 trial in the US is scheduled to complete in 2 to 3 years after initiation. FESPIXON has been accepted for NDA review by NPRA and will fulfill the local unmet medical need once it is approved in Malaysia in the future. The announcement is with regards to the acceptance by NPRA in Malaysia on NDA application of FESPIXON, the diabetic foot ulcer new drug. The application will be under regulatory and scientific review and shall not be regarded as an approval. Announcement • Feb 27
Oneness Biotech Co., Ltd., Annual General Meeting, May 24, 2022 Oneness Biotech Co., Ltd., Annual General Meeting, May 24, 2022. Location: Building A. 2F., No. 19-10, Sanchong Rd., Nangang Dist The conference room located on Building A. 2F. in Nankang Software Park 1 Taipei City Taiwan Agenda: To consider the Business Report of 2021; to consider the Audit Committee's Review Report of 2021; to consider the 2021 implementation report for the sound business plan; to consider the amendments to the Company's Corporate Governance Best Practice Principles; to consider the directors' remuneration of 2021; to consider the 2021 Business Report and Financial Statements; to consider the 2021 deficit compensation proposal; to consider the proposal for amendments to the Company's Articles of Association; to consider the proposal for amendments to the Company's Regulations Governing the Acquisition and Disposal of Assets; and to consider the proposal for amendments to the Company's Rules of Procedure for Shareholders Meetings. Announcement • Feb 22
Oneness Biotech Co., Ltd. Announces the Data of Sns812 Were Published by EMBO Molecular Medicine Oneness Biotech Co., Ltd. announced data of SNS812, an anti-Pan-COVID19 siRNA, co-developed by Oneness & MBS and supervised by NTU professors, were published by EMBO Mol. Medicine. Cause of occurrence: SNS812 is a siRNA new drug targeting a highly conserved region of SARS-CoV-2. Unlike traditional antiviral agents, such as nucleoside analog (eg. molnupiravir) or proteinase inhibitor (eg. paxlovid) which inhibits the virus by interrupting replication or interfering protein maturation, SNS812 directly and specifically cleaves and destroys the viral RNA by a special mechanism called RNA interference. The analysis indicates that SNS812 is capable to cover 99.8% of SARS-CoV-2 variants and has the high coverage rate among all currently available medicines. SNS812 can inhibit original(A.3),Alpha, Beta, Gamma, Epsilon and Delta strains with pM range of IC50 in vitro,and effectively prevent or treat SARS-CoV-2 infection in hACE2 transgenic mice.Furthermore, SNS812 is highly specific to the virus, which represents non-immunogenicity and safety in animal toxicity studies and thus potentially reduce treatment risk and side effects compared with other small-molecule drugs. The research article has been accepted by EMBO Molecular Medicine and published on 2022/02/21. Announcement • Dec 13
Oneness Biotech Co., Ltd. Announces the Partial Efficacy Data for the Phase 2a Study of FB825 in the Treatment of Atopic Dermatitis in the U.S Oneness Biotech Co., Ltd. announced the partial efficacy data for the Phase 2a study of FB825 in the treatment of atopic dermatitis in the U.S. have been analyzed New drug name or code: FB825 anti-CemX humanized monoclonal antibody Purpose: Treatment of moderate-to-severe atopic dermatitis, allergic asthma, and other IgE related diseases. Planned development stages: Phase II, Phase III, NDA. Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis): The contracted CRO has proceeded according to the statistical analysis plan (SAP) with the efficacy analysis on EASI for the Phase 2a study of FB825 in the treatment of atopic dermatitis in the U.S. The efficacy exploration analysis will be provided to the licensed partner to proceed with data interpretation and evaluation. This study has enrolled 99 subjects with moderate-to-severe atopic dermatitis. The patients were dosed with FB825 every 4 weeks, in total of 4 doses for the 16-week treatment period. This Phase 2a study is ongoing and all the efficacy endpoints, biochemical parameters, biopsies, pharmacokinetic and safety data are anticipated to be unblinded and analyzed upon completion with database lock in the 1st half of 2022. The final data and results will be announced upon the completion of all analyses.The analysis will not be disclosed according to the license agreement (c)LEO Pharma has acquired the worldwide exclusive license to develop and commercialize FB825. 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:No disclosure of the investment expenditure at the moment in consideration of the future marketing strategies to protect the company and investors interests.Any other matters that need to be specified: 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 07
Third quarter 2021 earnings released: NT$0.46 loss per share (vs NT$0.064 profit in 3Q 2020) Third quarter 2021 results: Net loss: NT$175.8m (down NT$198.5m from profit in 3Q 2020). 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 106% per year, which means it is well ahead of earnings. Executive Departure • Aug 24
Independent Director Kun-Ta Li has left the company On the 18th of August, Kun-Ta Li's tenure as Independent Director ended after 11.3 years in the role. We don't have any record of a personal shareholding under Kun-Ta's name. Kun-Ta is the only executive to leave the company over the last 12 months. Reported Earnings • Aug 09
Second quarter 2021 earnings released: NT$1.24 loss per share (vs NT$1.40 profit in 2Q 2020) Second quarter 2021 results: Net loss: NT$472.7m (down 196% from profit in 2Q 2020). Over the last 3 years on average, earnings per share has increased by 12% per year but the company’s share price has increased by 97% per year, which means it is tracking significantly ahead of earnings growth. Announcement • Jun 04
Oneness Biotech Co., Ltd. Announces Phase 3 International MRCT Study Results of the Diabetic Foot Ulcer New Drug Oneness Biotech Co., Ltd. announced the Phase 3 international MRCT results of Fespixon,new drug for diabetic foot ulcers, have been accepted for an oral presentation at the 57th European Association for the Study of Diabetes (EASD) Annual Meeting on 30 September 2021. The annual meeting of this year will be held virtually due to the global pandemic of COVID-19. (2)The European Association for the Study of Diabetes (EASD) has been established since 1965. The EASD Annual Meeting has been one of the largest and most reputable scientific congress on diabetes in Europe. The congress covers diabetes-related researches and focuses in the important progress of fundamental science, prevention, diagnosis and treatments in diabetes. Over 15,000 scientists or healthcare professionals from more than 130 countries participated in the congress each year. Reported Earnings • May 23
First quarter 2021 earnings released: EPS NT$0.31 (vs NT$0.54 loss in 1Q 2020) First quarter 2021 results: Net income: NT$117.2m (up NT$306.4m from 1Q 2020). Over the last 3 years on average, earnings per share has increased by 40% per year but the company’s share price has increased by 77% per year, which means it is tracking significantly ahead of earnings growth. Reported Earnings • May 07
First quarter 2021 earnings released: EPS NT$0.31 (vs NT$0.54 loss in 1Q 2020) First quarter 2021 results: Net income: NT$117.2m (up NT$306.4m from 1Q 2020). Over the last 3 years on average, earnings per share has increased by 40% per year but the company’s share price has increased by 81% per year, which means it is tracking significantly ahead of earnings growth. Announcement • Mar 14
Oneness Notified That FB704A Is Safe to Proceed with the Phase 2 Clinical Trial in Severe Asthma Under US FDA IND Oneness Biotech Co., Ltd. announced that it has been notified that FB704A, a fully-human anti-IL6 antibody new drug, is safe to proceed with the phase 2 clinical trial in severe asthma under US FDA IND. Reported Earnings • Feb 27
Full year 2020 earnings released: NT$0.68 loss per share (vs NT$1.28 loss in FY 2019) Full year 2020 results: Net loss: NT$241.9m (loss narrowed 25% from FY 2019). Over the last 3 years on average, earnings per share has increased by 22% per year but the company’s share price has increased by 125% per year, which means it is tracking significantly ahead of earnings growth. Announcement • Feb 26
Oneness Biotech Co., Ltd. Receives the Letter from MOHW Informing that ON101 for DFUs has Obtained the New Drug Approval Andits Drug Certificate Will Be Notified for Receipt Oneness Biotech Co., Ltd. announced The second phase 3 clinical trial (ON101CLCT04)in the US, and other exploratory studies for new indications. Current development stage: A.File application/approved/disapproved/Each of clinical trials (include interim analysis): New drug approval is obtained from The Ministry of Health and Welfare Food and Drug Administration (TFDA) and its official drug certificate will be notified for receipt. 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: Product launch for commercialization is proceeding including drug listing plan in hospitals, sales training and strategic collaboration with medical associations and societies. D.Accumulated investment expenditure incurred:No disclosure of the investment expenditure at the moment in consideration of the future marketing strategies to protect the company and investors interests. (5)Upcoming development plan: A.Scheduled completion date:2-3 years after initiation of the second phase 3 trial in the US. B.Estimate responsibilities:After product commercialization, the company shall pay the licenser a certain percentage of royalties according to the agreement. (6)Market:According to the statistics of the International Diabetes Federation, the total number of diabetic patients worldwide was 425 million and will reach 629 million in 2045. Among those patients, 19–34% will encounter a foot ulcer during their lifetime. Some of the patients would end up with amputation and the 5-year survival of the amputees is about 60%, which indicates DFU is a serious complication causing death and disability in diabetes patients. According to the 2018 Diabetes Clinical Care Guidelines, there are about 22,000 diabetic foot patients being hospitalized in Taiwan per year, of which about 6,700 proceeded to amputation. Further, based on a retrospective analysis of an international journal, Diabetes Care in May 2020 (Diabetes Care. 2020;43 (8):1732-1740), the average annual treatment cost for a DFU in Taiwan is NT$140,000, and the average annual cost of an amputation is about NT$390,000. It shows that the medical burden caused by DFU is tremendous that not only affects patients and their families, but also imposes a heavy burden on the government and society. Announcement • Feb 25
Oneness Biotech Co., Ltd., Annual General Meeting, May 21, 2021 Oneness Biotech Co., Ltd., Annual General Meeting, May 21, 2021. Location: 10F., No.236, Sec. 4, Xinyi Rd., Da'an Dist. Taipei Taiwan Agenda: To consider 2020 business report and financial statements; to consider 3rd election of directors and supervisors; to consider Lift non-competition restrictions on 3rd directors of the board. Announcement • Feb 16
Oneness Submits an IND to US FDA on Phase II Clinical Trial on Severe Asthma of FB704A Oneness Biotech Co., Ltd. announced the phase I study of FB704A has been completed in US and demonstrated pharmacokinetic parameters, safety profiles and pharmacological activity. An IND application for the phase II study in severe asthma has been submitted to explore the potential indication in order to increase the drug value of FB704A. File phase II investigational new drug (IND) application for severe asthma to the US FDA. The Company filed a phase 2 clinical trial application for FB704A in treatment of neutrophilic asthma to TFDA. It is evaluated that FB704A (anti-IL6 mAb) may improve symptoms of neutrophilic and mixed granulocytic severe asthma by inhibition of classic and trans-signaling pathways of IL-6.Among the patients with these two subtypes of severe asthma, it is likely that FB704A may reduce Th1, Th2 and Th17 inflammation as well as airway hyper-responsiveness. Announcement • Feb 10
Oneness Will Not Proceed with the ON101 Phase3 Clinical Trial (ON101CLCT04) Application with BfArM of Germany Based on Strategic Consideration Oneness Biotech Co., Ltd. has been notified by the contract research organization (CRO) that BfArM has declined the clinical trial application for ON101CLCT04 due to insufficient non-clinical documents and allowed a rebuttal to be submitted within 1 month. The Company will not proceed with rebuttal for the clinical trial application with BfArM. 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: The European authorities may review data generated by the clinical trials conducted in the US for future regulatory submission. The Company will initiate a second phase 3 clinical trial in the US in 1H of this year, so for strategic consideration, it will not affect the Company's planning for deciding not to perform the clinical trial in Europe. The company Aims to complete in 2 to 3 years after initiation. Is New 90 Day High Low • Jan 30
New 90-day low: NT$185 The company is down 37% from its price of NT$293 on 30 October 2020. The Taiwanese market is up 22% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is down 16% over the same period. Is New 90 Day High Low • Jan 11
New 90-day low: NT$213 The company is down 38% from its price of NT$346 on 14 October 2020. The Taiwanese market is up 19% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is down 15% over the same period. Announcement • Jan 09
TFDA Notifies Oneness of Submitting Supplementary information for Rebuttal of FB704A Phase II Clinical trial Application for Severe Neutrophilic Asthma Oneness Biotech Co., Ltd. announced that TFDA notified Oneness of submitting supplementary information for a rebuttal of FB704A Phase II clinical trial application for severe neutrophilic asthma. Taiwan Food and Drug Administration (TFDA) requires Oneness to submit a rebuttal within four months with requested information or submit a new application. This is the first anti-IL-6 new drug clinical trial application for severe neutrophilic asthma in the world. Oneness has completed FB704A functional mechanism experiments and safety evaluation. Based on therapeutic mechanism and risk consideration of the subjects, TFDA requires Oneness to submit a rebuttal with required information within four months or submit a new application. Oneness will submit a rebuttal in accordance with TFDA's requirements and also apply for a face-to-face consultation meeting next week. According to Article 2 under Guidelines by Taipei Exchange on the Material Information Announced by Listed and OTC Companies, new drug development companies shall make public announcement when filing application for clinical trials to domestic or overseas regulatory authorities, receiving approval or disapproval, obtaining the statistical date of endpoints in each clinical trial (including interim analysis), or receiving approval or disapproval on drug license application. 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. Is New 90 Day High Low • Dec 04
New 90-day low: NT$260 The company is down 13% from its price of NT$300 on 04 September 2020. The Taiwanese market is up 10.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is down 7.0% over the same period. Reported Earnings • Nov 15
Third quarter 2020 earnings released: EPS NT$0.06 Third quarter 2020 results: Net income: NT$22.7m (up NT$78.2m from 3Q 2019). Over the last 3 years on average, earnings per share has increased by 18% per year but the company’s share price has increased by 131% per year, which means it is tracking significantly ahead of earnings growth. Is New 90 Day High Low • Nov 12
New 90-day low: NT$265 The company is down 4.0% from its price of NT$275 on 14 August 2020. The Taiwanese market is up 4.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is down 3.0% over the same period. 
