Aankondiging • May 16
ABVC BioPharma, Inc. announced delayed 10-Q filing On 05/15/2026, ABVC BioPharma, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. New Risk • Mar 03
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 American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$2.3m free cash flow). Shareholders have been substantially diluted in the past year (102% increase in shares outstanding). Revenue is less than US$1m (US$798k revenue). Minor Risks Share price has been volatile over the past 3 months (11% average weekly change). Market cap is less than US$100m (US$36.5m market cap). Aankondiging • Feb 07
ABVC BioPharma, Inc., Annual General Meeting, Mar 09, 2026 ABVC BioPharma, Inc., Annual General Meeting, Mar 09, 2026. Location: meeting id: 271 131 5701, United States Reported Earnings • Nov 04
Third quarter 2025 earnings released: US$0.054 loss per share (vs US$0.015 loss in 3Q 2024) Third quarter 2025 results: US$0.054 loss per share (further deteriorated from US$0.015 loss in 3Q 2024). Net loss: US$1.25m (loss widened US$1.06m from 3Q 2024). Over the last 3 years on average, earnings per share has increased by 93% per year but the company’s share price has fallen by 28% per year, which means it is significantly lagging earnings. New Risk • Aug 15
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$2.1m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$2.1m free cash flow). Share price has been highly volatile over the past 3 months (24% average weekly change). Shareholders have been substantially diluted in the past year (90% increase in shares outstanding). Revenue is less than US$1m (US$391k revenue). Minor Risk Market cap is less than US$100m (US$67.7m market cap). Reported Earnings • Aug 15
First half 2025 earnings released: US$0.19 loss per share (vs US$0.36 loss in 1H 2024) First half 2025 results: US$0.19 loss per share (improved from US$0.36 loss in 1H 2024). Net loss: US$3.10m (loss narrowed 18% from 1H 2024). Over the last 3 years on average, earnings per share has increased by 86% per year but the company’s share price has fallen by 30% per year, which means it is significantly lagging earnings. Board Change • Jul 25
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 11 experienced directors. 1 highly experienced director. Independent Director Francis Chung was the last director to join the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Aankondiging • May 16
ABVC Biopharma Regains Nasdaq Minimum Bid Price Compliance ABVC BioPharma, Inc. announced that it has received official notice from the Nasdaq Listing Qualifications Department confirming that the Company has regained compliance with Nasdaq Listing Rule 5550(a)(2), which requires a minimum bid price of $1.00 per share. According to Nasdaq’s notification dated May 13, 2025, ABVC’s common stock successfully maintained a closing bid price at or above $1.00 for 10 consecutive trading days from April 29, 2025 to May 12, 2025, satisfying the exchange’s compliance standard for the referenced rule. This development formally closes this deficiency matter. “This is more than a compliance milestone — it is a clear validation of our turnaround strategy and unwavering commitment to shareholder value,” said Dr. Uttam Patil, ABVC Chief Executive Officer. Comparing fiscal year 2024 to 2023, ABVC has made significant strides: Revenue increased by 234% year-over-year, driven by strategic out-licensing of its proprietary drug candidates. Operating expenses were reduced by 21%, demonstrating disciplined execution and operational efficiency. EPS improved by 77%, reflecting the positive impact of stock-based compensation and streamlined R&D spending. The Company secured three major licensing partnerships across the U.S. and Asia, unlocking the potential for over 7 million in upfront payments and up to 660 million in milestone and royalty payments. In fiscal year 2025, we have received close to 0.5 million of upfront payments. The reinstatement of Nasdaq compliance follows a period of focused restructuring, paving the way for future success. ABVC is currently in preliminary discussions with leading pharmaceutical and AI companies to co-develop its Phase III-ready candidates for Major Depressive Disorder (MDD) and ADHD, both multibillion-dollar global markets. “We see this as a critical inflection point,” said Dr. Patil. “ABVC is no longer just a clinical-stage biotech — we are building a platform for global commercialization, powered by science, supported by strategy, and our continued Nasdaq listing demonstrates our ability to meet high listing standards”. Aankondiging • May 07
ABVC BioPharma, Inc. Resolves Nasdaq Compliance Issue Regarding Stockholder Equity On April 30, 2025, ABVC BioPharma, Inc. reported that it received a letter from the listing qualifications staff (the Staff") of Nasdaq informing it that, as reported in its Annual Report on Form 10-K for the year ended December 31, 2024, because its stockholders' equity was $723,959, as of April 23, 2025, the Company did not meet the alternatives of market value of listed securities or net income from continuing operations, and it no longer comply with Listing Rule 5550(b)(1) (the Listing Rule"). On May 5, 2025, the Company received a notification letter (the Notification Letter") from Nasdaq notifying the Company that the Staff has determined that based on the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, which evidenced stockholders' equity of $7,956,295, the Company complies with the Listing Rule and the matter is closed. Aankondiging • May 01
ABVC Biopharma Receives a Letter from the Listing Qualifications Staff of Nasdaq As a company listed on the Nasdaq Capital Market, ABVC BioPharma, Inc. required to maintain a minimum of $2,500,000 in stockholders’ equity for continued listing per Listing Rule 5550(b)(1) (the “Listing Rule”). On April 24, 2025, we received a letter from the listing qualifications staff (the “Staff”) of Nasdaq informing that, as reported in Annual Report on Form 10-K for the year ended December 31, 2024, because our stockholders’ equity was $723,959, as of April 23, 2025, we did not meet the alternatives of market value of listed securities or net income from continuing operations, and we no longer comply with the Listing Rule. We have 45 calendar days to submit a plan to the Staff to regain compliance. If our plan is accepted, we may be granted an extension of up to 180 calendar days from the date of the letter, or until October 21, 2025, to evidence compliance. In determining whether to accept our plan, the Staff will consider such things as the likelihood that the plan will result in compliance with Nasdaq’s continued listing criteria, our past compliance history, the reasons for our current non-compliance, other corporate events that may occur within our review period, our overall financial condition, and our public disclosures. If the Staff does not accept our plan, we will have the opportunity to appeal that decision to a Hearings Panel. The Nasdaq notification has no immediate effect on the listing of our Common Stock on the Nasdaq Capital Market. We intend to actively monitor our stockholders’ equity and will consider options available to us to achieve compliance with the Listing Rule. There can be no assurance that we will be able to regain compliance with the Listing Rule or will otherwise be in compliance with the other listing standards for the Nasdaq Capital Market. If our Common Stock ultimately were to be delisted for any reason, it could negatively impact us by (i) reducing the liquidity and market price of our Common Stock; (ii) reducing the number of investors willing to hold or acquire our Common Stock; (ii) limiting our ability to use a registration statement to offer and sell freely tradable securities, thereby preventing us from accessing the public capital markets; and (iv) impairing our ability to provide equity incentives to our employees. Aankondiging • Apr 28
ABVC BioPharma, Inc., Annual General Meeting, Jun 03, 2025 ABVC BioPharma, Inc., Annual General Meeting, Jun 03, 2025. Aankondiging • Apr 01
ABVC BioPharma, Inc. announced delayed annual 10-K filing On 03/31/2025, ABVC BioPharma, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC. Aankondiging • Mar 08
ABVC BioPharma, Inc. Announces Executive Changes On March 5, 2025, Mr. Leeds Chow, the Chief Financial Officer of ABVC BioPharma, Inc. notified the Company of his resignation as CFO. While the Company is looking for a full-time Chief Financial Officer to fill the vacancy created by Leeds Chow’s resignation, the Company’s CEO, Uttam Patil will serve as the interim Chief Financial Officer of the Company. Aankondiging • Jan 14
Nasdaq Grants 180-Day Grace Period to ABVC Biopharma to Regain Compliance with Bid Price Requirement On January 9, 2025, ABVC BioPharma, Inc. (the "Company") received a notification from Nasdaq granting the Company an additional 180 days, until July 7, 2025, to meet the minimum bid price requirement of $1.00 per share, as outlined in Nasdaq Listing Rule 5550(a)(2) (the Rule"). On July 12, 2024, the Company disclosed that Nasdaq had informed it that its stock had failed to maintain the minimum bid price over the preceding 30 business days. At that time, the Company was given until January 6, 2025, to regain compliance. The current extension was granted based on the Company's adherence to other listing requirements and assurance that it would take necessary steps to meet the compliance. To satisfy the Rule, the Company's common stock must achieve a closing bid price of at least $1.00 for a minimum of ten consecutive trading days within this extension period; if successful, Nasdaq will confirm compliance with the Rule and close this matter. If compliance is not achieved by the new deadline, Nasdaq may initiate delisting procedures, which the Company would have the right to appeal. This extension has no immediate impact on the Company's listing, and its stock will continue to trade on the Nasdaq Capital Market under the ticker symbol "ABVC." The Company is actively monitoring its stock price and evaluating potential measures to ensure compliance within the given timeframe, including executing a reverse stock split. Aankondiging • Dec 20
ABVC BioPharma Seeks to Revolutionize Mental Health Treatment With a Safe Prozac Alternative, Boasting a MADRS Score Reduction of -13.21 ABVC BioPharma, Inc. announced in response to the discontinuation of Prozac due to increasing concerns around side effects, ABVC believes its ABV-1504, which has the API, “Radix Polygala”, known as Polygala tenuifolia Willd or PDC-1421, can fill this void in the mental health market. With a robust formulation designed to reduce adverse effects, PDC-1421 promises to offer a safer and more effective solution for patients dealing with MDD and ADHD. ABVC’s ABV-1504 has completed Phase II clinical trials and is heading towards Phase III trials worldwide. ABVC holds patents for MDD and ADHD that have been approved in the USA and other countries and are valid until 2041. The suspension of Prozac production highlights a rising demand for safer, all-natural alternatives to advanced mental health treatments, marking a pivotal moment for the pharmaceutical and mental health awareness industry. ABVC's ABV-1504 and 1505 have undergone rigorous clinical testing to ensure safety and efficacy, positioning them as real potential options for patients needing reliable, low-risk treatments. Aankondiging • Jul 13
ABVC BioPharma Receives Notification Letter from Nasdaq Regarding Non-Compliance with the Minimum Bid Price Requirements Set Forth in Nasdaq Listing Rule 5550(a)(2) On July 10, 2024, ABVC BioPharma, Inc. received a notification letter from the Nasdaq Listing Qualifications Staff of The NASDAQ Stock Market LLC (‘Nasdaq’) notifying the Company that the minimum bid price per share for its common shares has been below $1.00 for a period of 30 consecutive business days and the Company therefore no longer meets the minimum bid price requirements set forth in Nasdaq Listing Rule 5550(a)(2). The notification received has no immediate effect on the listing of the Company’s common stock on Nasdaq. Under the Nasdaq Listing Rules, the Company has until January 6, 2025, to regain compliance. If at any time during such 180-day period the closing bid price of the Company’s common shares is at least $1 for a minimum of 10 consecutive business days, Nasdaq will provide the Company written confirmation of compliance. If the Company does not regain compliance during such 180-day period, the Company may be eligible for an additional 180 calendar days, provided that the Company meets the continued listing requirement for market value of publicly held shares and all other initial listing standards for Nasdaq except for Nasdaq Listing Rule 5550(a)(2), and provide a written notice of its intention to cure this deficiency during the second compliance period, by effecting a reverse stock split, if necessary. Aankondiging • May 17
ABVC BioPharma, Inc. announced delayed 10-Q filing On 05/15/2024, ABVC BioPharma, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Aankondiging • Mar 15
ABVC BioPharma, Inc., Annual General Meeting, Apr 16, 2024 ABVC BioPharma, Inc., Annual General Meeting, Apr 16, 2024, at 09:00 US Eastern Standard Time. Agenda: To re-elect the nominees listed in the Proxy Statement to the Company’s Board of Directors; to ratify the selection of WWC P.C. CPA as the Company’s independent registered public accounting firm for year ending December 31, 2024; to approve an increase in the number of shares authorized for issuance under the Company’s stock option plan; and to approve the issuance of shares of common stock underlying convertible notes and warrants in an amount equal to or in excess of 20% of common stock outstanding immediately prior to the issuance of such convertible note and warrants. Aankondiging • Mar 01
ABVC BioPharma, Inc., Annual General Meeting, Apr 17, 2024 ABVC BioPharma, Inc., Annual General Meeting, Apr 17, 2024. Aankondiging • Jan 18
ABVC BioPharma, Inc. announced that it has received $0.833333 million in funding from The Lind Partners, LLC ABVC BioPharma, Inc announced that it has entered into a securities purchase agreement with Lind Global Fund II to issue a secured, convertible note in the principal amount of $1,000,000, for the purchase price of $833,333 on January 17, 2024. The Warrant may be exercised via cashless exercise in the event a registration statement covering the Warrant Shares is not available for the resale of such Warrant Shares or upon exercise of the Warrant in connection with a Fundamental Transaction. Allele Capital Partners, LLC together with its executing broker dealer, Wilmington Capital Securities, LLC , served as the exclusive placement agent of the Offering. We have agreed to pay certain expenses of the placement agent in connection with the Offering and issued them a warrant to purchase up to 25,000 shares of common stock, on the same terms as set forth in the Warrant. The securities mentioned herein have not been registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements under the Securities Act and applicable state securities laws. Based in part upon the representations of Lind in the Securities Purchase Agreement, the offering and sale of the Securities was made in reliance on the exemption afforded by Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D under the Securities Act and corresponding provisions of state securities or “blue sky” laws. The note is convertible into shares of the Company’s common stock at a conversion price, which shall be the lesser of $3.50 and 90% of the average of the three lowest VWAPs during the 20 trading days prior to conversion. The investor will also receive a 5-year, common stock purchase warrant to purchase up to 1,000,000 shares of the Company’s common stock at an initial exercise price of $2.00 per share. Aankondiging • Dec 30
ABVC BioPharma, Inc., Annual General Meeting, Jan 16, 2024 ABVC BioPharma, Inc., Annual General Meeting, Jan 16, 2024, at 09:00 US Eastern Standard Time. Agenda: To consider and re-elect the nominees listed in the Proxy Statement to the Company’s Board of Directors; to consider and ratify the selection of WWC P.C. CPA as the Company’s independent registered public accounting firm for year ending December 31, 2024; to consider and approve of the issuance of shares of common stock underlying convertible notes and warrants in an amount equal to or in excess of 20% of common stock outstanding immediately prior to the issuance of such convertible note and warrants; to consider and approve of an increase in the number of shares authorized for issuance under the Company’s stock option plan; and to consider other business issues. Aankondiging • Dec 07
ABVC BioPharma, Inc. Announces Completion of Subject Treatment for Interim Analysis on ADHD Phase IIb Clinical Study ABVC BioPharma, Inc. announced an update on the Company's eight-week long ADHD Phase II part II clinical study taking place at the University of California San Francisco (UCSF) Medical Center and five Taiwan medical centers. A total of 94 subjects were screened, out of which 69 enrolled in the study; 60 subjects completed the eight-week study. The study entitled "A Phase II Tolerability and Efficacy Study of PDC-1421 Treatment in Adult Patients With attention-Deficit Hyperactivity Disorder (ADHD), Part II" is a randomized, double-blind, placebo-controlled study involving a total of approximately 100 patients in the United States and Taiwan. The Phase II part II clinical study continues the Phase II part I clinical study of ABV-1505. Phase II part I of the study successfully achieved the specified primary endpoints at UCSF and was accepted by the U.S. Food & Drug Administration in October 2020. Aankondiging • Nov 15
ABVC BioPharma, Inc. announced delayed 10-Q filing On 11/14/2023, ABVC BioPharma, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Aankondiging • Oct 18
Abvc Biopharma, Inc. Announces Completion of Subject Recruitment for Interim Analysis on Adhd Phase Iib Clinical Study ABVC BioPharma, Inc. announced an update on the Company's eight-week long ADHD Phase IIb clinical study taking place at the University of California San Francisco (UCSF) Medical Center and five Taiwanese medical centers. Sixty-nine subjects enrolled in the study, 50 completed the study, and 11 are currently undergoing treatment. The study entitled "A Phase IIb Study of PDC-1421 Capsule to Evaluate the Safety and Efficacy in Patients with Adult attention-Deficit/Hyperactivity Disorder" is a randomized, double-blind, placebo-controlled study involving a total of approximately 100 patients in the United States and Taiwan. The Phase IIb clinical study continues the Phase IIa clinical study of ABV-1505. Phase IIa successfully achieved the specified primary endpoints at UCSF and was accepted by the U.S. Food & Drug Administration in October 2020. Aankondiging • Aug 10
ABVC BioPharma Regains Compliance with Nasdaq's Minimum Bid Price Requirement On August 10, 2023, ABVC BioPharma, Inc. that on August 08, 2023, it received a letter from the Nasdaq Listing Qualifications Department notifying the Company that it had regained compliance with the minimum bid price requirement. On August 19, 2022, the Company received a notification that its common stock failed to maintain a minimum bid price of $1.00 over the previous 30 consecutive business days, as required by Nasdaq Listing Rules of The Nasdaq Stock Market. The closing bid price of the Company's common stock was at $1.00 per share or greater from July 25 to August 7, 2023. Accordingly, the Company has regained compliance with Nasdaq Capital Market Minimum Bid Price Requirement per Listing Rule 5550(a)(2) and this matter is now closed. Aankondiging • Aug 01
ABVC BioPharma, Inc. has completed a Follow-on Equity Offering in the amount of $1.75 million. ABVC BioPharma, Inc. has completed a Follow-on Equity Offering in the amount of $1.75 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 300,000
Price\Range: $3.5
Discount Per Security: $0.21
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 200,000
Price\Range: $3.5
Discount Per Security: $0.21
Transaction Features: Registered Direct Offering Aankondiging • Jul 28
ABVC BioPharma, Inc. announced that it expects to receive $1.75 million in funding ABVC BioPharma, Inc. announced that it has entered into a securities purchase agreement with certain investors to issue 300,000 shares of common stock at par vale of $0.01 per share and 200,000 pre-funded warrants at a price of $3.5 per share for the gross proceeds of $1,750,000. The exercise price of the warrants is $0.01 per share. The transaction is expected to close on or about July 31, 2023. The securities issued have not been registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements under the Securities Act and applicable state securities laws. Aankondiging • Jul 16
Nasdaq Grants ABVC Biopharma an Extension to Comply with Listing Rule 5550(b)(1) On May 26, 2023, ABVC BIOPHARMA, INC. filed the original 8-K to report that it received a deficiency letter from the Nasdaq Listing Qualifications Department of the Nasdaq Stock Market LLC notifying the Company that it is not currently in compliance with the minimum stockholders' equity requirement, or the alternatives of market value of listed securities or net income from continuing operations, for continued listing on the Nasdaq Capital Market. After submitting a plan to regain compliance, on July 10, 2023, Nasdaq granted the Company an extension to comply with Listing Rule 5550(b)(1). The Company must now achieve compliance with this rule on or before August 31, 2023. If the Company fails to evidence compliance upon filing its periodic report for the quarter ending September 30, 2023, the Company may be subject to delisting. If Nasdaq determines to delist the Company’s securities, the Company will have an opportunity to appeal Nasdaq’s decision. Aankondiging • Jun 27
ABVC Biopharma, Inc. Appoints Dr. Uttam Yashwant Patil as Chief Executive Officer ABVC BioPharma, Inc. announced the appointment of Dr. Uttam Yashwant Patil (Dr. Uttam) as the new Chief Executive Officer (CEO). Dr. Uttam is very familiar with ABVC and their subsidiaries, because of his role as Chief Operating Officer & Chief Scientific Officer of BioKey, Inc., a GMP-certified facility owned by ABVC that provides its clients with integrated pharmaceutical services, including early-phase product development, formulation development, analytical development & drug product manufacturing. He is also the R&D Manager for an ABVC collaborative program, committed to developing new plant-based drugs and combination cancer therapies to provide better medical assistance for improving the patient's quality of life. This background and experience give ABVC solid leadership in plant-based therapeutics. Dr. Uttam's employment with ABVC began on June 23, 2023. Aankondiging • May 29
ABVC BioPharma Receives Deficiency Letter from Nasdaq Due to Non-Compliance with the Minimum Stockholders' Equity Requirement On May 24, 2023, ABVC BioPharma, Inc. received a deficiency letter from the Nasdaq Listing Qualifications Department (the ‘Staff’) of the Nasdaq Stock Market LLC (‘Nasdaq’) notifying the Company that it is not currently in compliance with the minimum stockholders' equity requirement, or the alternatives of market value of listed securities or net income from continuing operations, for continued listing on the Nasdaq Capital Market. Nasdaq Listing Rule 5550(b)(1) requires listed companies to maintain stockholders’ equity of at least $2,500,000, and the Company’s stockholders’ equity was $1,734,507 as of March 31, 2023. In accordance with Nasdaq rules, the Company has 45 calendar days, or until July 10, 2023, to submit a plan to regain compliance. If the plan is accepted, Nasdaq can grant an extension of up to 180 calendar days from the date of the letter, or until December 11, 2023, to evidence compliance. If Nasdaq does not accept the Company’s compliance plan, the Company may appeal the decision to a Hearing’s Panel. The Nasdaq deficiency letter has no immediate effect on the listing of the Company’s Common Stock, and its Common Stock will continue to trade on The Nasdaq Capital Market under the symbol ‘ABVC’ at this time. Aankondiging • May 24
ABVC BioPharma, Inc. Announces Vitargus®? Phase II Study Receives Ethical Approval At Sydney Eye Hospital in Australia ABVC BioPharma, Inc. announced that the Vitrargus(R) Phase II study at the Sydney Eye Hospital in New South Wales, Australia received ethical approval from the St. Vincent's Hospital Melbourne Human Research Ethics Committee (HREC) on May 15, 2023. Early clinical studies indicate that Vitargus(R) has unique properties that could eliminate the need for patients to remain face-down after retinal detachment and vitreous hemorrhage surgery, as well as significantly improve patient comfort and visual acuity during the surgical recovery period compared to currently available products. The objective of the Phase II study entitled "A Perspective Multi-Site Open-Label Randomized Controlled Clinical Investigation of the Safety and Effectiveness of ABV-1701 Ocular Endotamponade (OE)" is to demonstrate the safety and efficacy of Vitargus(R) for the treatment of uncomplicated retinal detachment when compared to the commonly used SF6 Gas OE. The Phase II study will enroll at least forty patients and will be conducted in both Australia and Thailand. Reported Earnings • May 18
First quarter 2023 earnings released: US$0.055 loss per share (vs US$0.20 loss in 1Q 2022) First quarter 2023 results: US$0.055 loss per share (improved from US$0.20 loss in 1Q 2022). Revenue: US$128.3k (up 400% from 1Q 2022). Net loss: US$1.82m (loss narrowed 70% from 1Q 2022). Revenue is forecast to grow 75% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has fallen by 21% per year but the company’s share price has fallen by 36% per year, which means it is performing significantly worse than earnings. Aankondiging • Feb 18
ABVC BioPharma Receives an Additional 180 Days, Until August 14, 2023, to Comply with Rule 5550(a)(2) On August 19, 2022, ABVC BioPharma, Inc. (the Company") filed a Current Report on Form 8-K to report that it received a deficiency letter from the Nasdaq Listing Qualifications Department (the Staff") of the Nasdaq StockMarket LLC (Nasdaq") notifying the Company that, for the last 30 consecutive business days, the closing bid price for the Company's common stock was below the minimum $1.00 per share required for continued listing on TheNasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (Rule 5550(a)(2)"). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company was initially given until February 14, 2023 to regain compliance withRule 5550(a)(2). Since the Company did not regain compliance by such date, it requested and received an additional 180 days, until August 14, 2023, to comply with Rule 5550(a)(2). The deficiency has no immediate effect on the listing of the Company's common stock, and its common stock continues to trade on The Nasdaq Capital Market under the symbol ABVC" at this time. If at any time before August 14, 2023, the bid price of the Company's common stock closes at $1.00 per share or more for a minimum of 10 consecutive business days, the Staff will provide written confirmation that the Company has achieved compliance and the matter will be closed. If the Company does not regain compliance with Rule 5550(a)(2) by August 14, 2023, the Staff will provide written notification that the Company's securities will be delisted, although the Company maintains the right to appeal such determination. The Company intends to actively monitor the closing bid price for its common stock and will consider available options to resolve the deficiency and regain compliance with Rule 5550(a)(2). Aankondiging • Jan 20
Abvc Biopharma Abv-1505 Adhd Phase Iia Results Presented At 2023 Apsard Conference ABVC BioPharma, Inc. announced that Dr. Keith McBurnett, Professor of Psychiatry at the University of California San Francisco, presented the results of the Phase IIa study of its medical treatment, ABV-1505 ADHD, on January 14, 2023 at the 2023 Conference of The American Professional Society of ADHD and Related Disorders (APSARD) Poster Session. APSARD is a world-renowned organization consisting of a broad spectrum of allied mental health experts working to improve the quality of care for patients with ADHD through the advancement and dissemination of research, and evidence-based practices. The active pharmaceutical ingredient of ABV-1505, PDC-1421, was used in the Phase IIa study which involved six adult subjects with confirmed ADHD. Each patient was administered two doses of PDC-1421 (low, 380mg; and high, 760mg) three times a day for four weeks and a one-week post-treatment follow-up. Aankondiging • Jan 06
FDA Approves IND Submission Allowing ABVC BioPharma to Proceed With Clinical Study of ABV-1519 for Treatment of Non-Small Cell Lung Cancer ABVC BioPharma, Inc. announced that the US Food & Drug Administration notified the company that the IND application for the proposed clinical investigation of BLEX 404, the primary active ingredient in ABV-1519, for advanced inoperable or metastatic EGFR-mutated non-small cell lung cancer has been approved and the study can proceed. The treatment, which is being co-developed by BioKey, Inc., a wholly owned subsidiary of ABVC based in Fremont, California and by the Rgene Corporation was submitted to the FDA by Rgene on November 30, 2022. The application, designated IND 161602, was approved on December 30, 2022. It contained the clinical protocol for ABV-1519 and was entitled A Phase I/II, Open Label Study to Evaluate the Safety and Efficacy of BLEX 404 Oral Liquid Combined with Pemetrexed + Carboplatin Therapy in Patients with Advanced Inoperable or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer Patients. BLEX 404, the primary active ingredient, is extracted from the Maitake mushroom (Grifola frondosa), an edible mushroom, whose immunological effects and safety have been demonstrated in two Phase I/II clinical studies performed at Memorial Sloan Kettering Cancer Center (MSKCC) with breast cancer and myelodysplastic syndromes (MDS) patients. Aankondiging • Nov 18
ABVC BioPharma, Inc. Receives Thai FDA Approval for Phase II Vitargus Study Protocol ABVC BioPharma, Inc. announced that the Vitargus® Phase II Clinical Study Protocol has been approved by the Thailand Food and Drug Administration (FDA). Import licenses for the Vitargus medical device and SF6-Gas used as a comparator in the clinical study were issued to both TH001 and TH002 study sites in Thailand on November 2, 2022. Vitargus medical devices and SF6-Gas comparators will be shipped to Ramathibodi Hospital, Mahidol University located in Bangkok (TH001) and Srinagarind Hospital, Khon Kaen University located in Khon Kaen Province (TH002) in preparation for the Site Initiation Visit (SIV) of the study planned to begin before the end of 2022. It is expected that a total of 20 or more patients undergoing vitreo-retinal surgery will be included in the study at the two selected sites. Reported Earnings • Nov 16
Third quarter 2022 earnings: EPS and revenues exceed analyst expectations Third quarter 2022 results: US$0.11 loss per share (further deteriorated from US$0.067 loss in 3Q 2021). Net loss: US$3.70m (loss widened 105% from 3Q 2021). Revenue exceeded analyst estimates by 61%. Earnings per share (EPS) also surpassed analyst estimates by 45%. Revenue is forecast to grow 93% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has fallen by 32% per year but the company’s share price has fallen by 51% per year, which means it is performing significantly worse than earnings. 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. 12 experienced directors. No highly experienced directors. 5 independent directors (6 non-independent directors). Member of Scientific Advisory Board & Independent Director Yoshinobu Odaira was the last independent director to join the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment. Aankondiging • Nov 08
ABVC BioPharma Receives Notice of Allowance from US Patent and Trademark Office for ABV-1504 Used to Treat Major Depressive Disorder ABVC Biopharma, Inc. announced that on October 20, 2022, it received a Notice of Allowance for ABV-1504 from the US Patent and Trademark Office. The patent, entitled “Polygala Extract for the Treatment of Major Depressive Disorder,” outlines a method for treating major depressive disorder by oral administration of a composition, ABV-1504, containing Radix Polygalae (Polygala tenuifolia Willd). The polygala extract, designated PDC-1421, is the key active ingredient in ABV-1504 which was orally administered to healthy volunteers and proved to be safe and well-tolerated for a daily dose from 380 mg to 3800 mg. The study indicated that the drug can be administered chronically over at least 25 days with the daily dose administered once per day, twice per day, or three times per day, wherein each dose contains from 380 mg to 760 mg of the botanical extraction. In addition to the United States, the patent was also filed in China, Taiwan and under the Patent Cooperation Treaty (PCT). The PCT patent application was published on January 27, 2022, and subsequently was filed in Japan, Australia and with the European Patent Office (EPO). Aankondiging • Nov 03
ABVC BioPharma, Inc. Announces That Cedars-Sinai Medical Center Institutional Review Board (IRB) Approves Institution Joining the Phase I Study of ABV-1601 ABVC Biopharma, Inc. announced that the Cedars-Sinai Medical Center (CSMC, West Hollywood CA) Institutional Review Board (IRB) has approved their institution joining the Phase I study of ABV-1601 for treating depression in cancer patients. The Principal Investigator of the CSMC study will be Dr. Scott A. Irwin, MD, PhD., an eminent Professor of Psychiatry & Behavioral Neurosciences. The Phase I study is open label and will be conducted with 12 cancer patients with moderate to severe depressive symptoms. The main objective of the study is to evaluate the safety of PDC-1421, the primary active ingredient in ABV-1601. The second objective is to determine the most effective dosages for a randomized, double-blind, non-inferiority Phase II trial of PDC-1421 that ABVC expects to initiate in 2023. The Company then intends to compare results of the Phase II study of ABV-1601 to Wellbutrin XL, a commonly used medicine to treat cancer patients suffering with depression. Aankondiging • Oct 06
ABVC BioPharma, Inc. Announces Vitargus(R) Phase II Study Plan Approved by Hrec in Australia ABVC Biopharma, Inc. announced that its Vitrargus Phase II study plan was approved by the Australian Bellberry Human Research Ethics Committee (HREC) on September 29, 2022. Subsequently, a Clinical Trial Notification (CTN) was submitted to the Australian Therapeutic Goods Administration (TGA) for the initiation of the study in Australia. Early clinical studies indicate that Vitargus has unique properties that eliminate the need for positioning patients face-down post-surgery and result in significantly greater patient comfort and visual acuity during surgical recovery than currently available products. The objective of the Phase II study entitled "A Perspective Multi-Site Open Label Randomized Controlled Clinical Investigation of the Safety and Effectiveness of ABV-1701 Ocular Endotamponade (OE)" is to demonstrate the safety and effectiveness of Vitargus for the treatment of uncomplicated retinal detachment when compared to the commonly used SF6 Gas OE. The Phase II study will be conducted in Thailand as well as Australia and will include a total of at least 40 subjects. Aankondiging • Sep 24
Abvc Biopharma, Inc. Provides Adhd Phase Ii Part 2 Clinical Study Update and Announces Ucsf Institutional Review Board Approval ABVC BioPharma, Inc. announced enrollment progress in the Phase II Part 2 clinical study of the Company's ADHD medicine, ABV-1505, currently being conducted at five prestigious medical centers in Taiwan. The Part 2 study is a randomized, double-blind, placebo-controlled study, titled "A Phase II Tolerability and Efficacy Study of PDC-1421 Treatment in Adult Patients with Attention-Deficit Hyperactivity Disorder (ADHD), Part 2" and is expected to eventually enroll approximately 100 patients in Taiwan and the United States. Since results of the first subject treated in Taiwan were reported on May 10, 2022, 30 subjects have now been enrolled in the study from a total of 43 subjects screened. Eighteen of the enrolled participants have already completed the 8-week treatment in accordance with the study design. In addition, the company has been notified that the University of California, San Francisco (UCSF) Medical Center Institutional Review Board has approved participation in the Part 2 study, set to begin in the fourth quarter of this year. Part 1 of the Phase II study of ABV-1505 was conducted at UCSF from January 2020 through July 2020 and was accepted by the US Food & Drug Administration in October of 2020. The Part 1 study found that the active ingredient of ABV-1505, PDC-1421, was safe, well-tolerated and efficacious during the treatment and follow-up period with six adult patients. For the primary endpoints, the percentages of improvement in Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated-IV (ADHD-RS-IV) score frombaseline through eight weeks of treatment were 83.3% (N=5) in the Intention-To-Treat (ITT) population and 80.0% (N=4) in the Per-Protocol (PP) population. Both low and high doses of PDC-1421 met the primary end points by passing the required 40% population in ADHD-RS-IV test scores. Overall, the results from the Part 1 study demonstrated the therapeutic value of PDC-1421 and support further clinical development of ABV-1505 for the treatment of ADHD. Aankondiging • Aug 19
ABVC BioPharma, Inc. Provides Vitargus Update ABVC BioPharma, Inc. announced that, on August 2, 2022, approval was received from the Ethics Committee (EC) of the Ramathibodi Hospital, Mahidol University to conduct the Vitargus Phase II Study Protocol (ABV-1701-02). This follows a similar approval received on July 18, 2022, by Srinagarind Hospital, Khon Kaen University of Thailand. Both hospitals now expect to receive a Thai FDA investigational product (IP) import license within the next 30 days, which will allow them to initiate the clinical study in Thailand entitled “A Prospective Multi-Site Randomized Controlled Clinical Investigation of the Safety and Effectiveness of the ABV1701 Ocular Endotamponade (OE).” In parallel, Vitargus Phase II Study protocol documents have been submitted to the Australian Bellberry Human Research Ethics Committee (HREC). Upon approval by the HREC, ABVC will submit an application to the Australian Therapeutic Goods Administration (TGA) for a Clinical Trial Notification (CTN) of the study, which is the final step before the three selected study sites in Australia can begin the trial. Reported Earnings • Aug 17
Second quarter 2022 earnings: EPS and revenues exceed analyst expectations Second quarter 2022 results: US$0.059 loss per share (up from US$0.081 loss in 2Q 2021). Net loss: US$1.86m (loss narrowed 5.7% from 2Q 2021). Revenue exceeded analyst estimates by 1,107%. Earnings per share (EPS) also surpassed analyst estimates by 52%. Over the next year, revenue is expected to shrink by 92% compared to a 40% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has fallen by 26% per year but the company’s share price has fallen by 53% per year, which means it is performing significantly worse than earnings. Aankondiging • Aug 03
ABVC BioPharma, Inc. Provides Vitargus Update ABVC BioPharma, Inc. announced that the Ethics Committee (EC) of Srinagarind Hospital, Khon Kaen University of Thailand approved the Vitargus Phase II Clinical Study Protocol (ABV-1701-02). Srinagarind is one of two sites in Thailand that have agreed to participate in the study. The other site, Ramathibodi Hospital, Mahidol University, expects to receive EC approval in the near future. It is anticipated that a total of 20 or more patients undergoing vitreo-retinal surgery will be included in the studies at the selected sites. The final step prior to initiating the two studies is the issuance of an EC investigational product (IP) import license by the Food and Drug Administration of Thailand. In addition, Vitargus Phase II Clinical Study protocol documents are now under review by the Australian Bellberry Human Research Ethics Committee (HREC). Upon approval, a Clinical Trial Notification (CTN) of the study will be issued leading to a final review by the Australian Therapeutic Goods Administration (TGA). Upon TGA approval, the clinical trial will begin in Australia at the previously selected sites. Aankondiging • Jul 15
ABVC BioPharma, Inc. Announces Board Changes On July 10, 2022, Mr. Kuang-Tseng Chen, a director ABVC BioPharma, Inc. notified the Company of his resignation from the board of directors for personal reasons, effective immediately. His resignation was not a result of any disagreements with the Company or any of its subsidiaries and affiliates on any matter related to the operations, policies, or practices of the Company or any of its subsidiaries and affiliates. On July 10, 2022, the board of directors (“Board”) of the Company appointed Mr. Yu-Min (Francis) Chung as a director to fill the vacancy resulting from Mr. Chen’s resignation. Mr. Chung was a Partner at Maxpro Ventures, an investment firm in Taiwan focused on breakthrough biomedical technology companies, from July 2018 to May 2022. Prior to that, he served as Vice President at TaiAn Technology, which is a biotechnology service company and a management company for biotechnology venture capital funds in Taiwan, from June 2016 to June 2018. Mr. Chung received his Bachelor’s Degree of Science in Chemistry from National Taiwan University in 1987, Master’s Degree in Business Administration from National Taiwan University in 2006, and Ph.D in Pharmacy from University of Iowa in 1995. Aankondiging • Jul 01
ABVC BioPharma, Inc. Announces the Vitargus® Phase II Clinical Study Protocol Approval by the Central Research Ethics Committee (CREC) of the National Research Council of Thailand ABVC BioPharma, Inc. announced that the Vitargus® Phase II Clinical Study Protocol has been approved by the Central Research Ethics Committee (CREC) of The National Research Council of Thailand. The approval encompasses the study protocol as well as the Master Informed Consent Form (Master ICF), Case Report Form (CRF) and the Investigator’s Brochure (IB), along with other relevant documents. ABVC has selected the Thailand, Ramathibodi Hospital, Mahidol University located in Bangkok and Srinagarind Hospital, Khon Kaen University located in Khon Kaen Province to initiate the study subject to local Ethics Committee (EC) approval and receipt of a Thai FDA study product import license. It is expected that a total of 20 or more patients undergoing vitreo-retinal surgery will be included in the study at the selected sites. Aankondiging • Jun 17
ABVC BioPharma, Inc. Submitts Vitargus(R) Phase II Study Plan to Australia HREC ABVC Biopharma, Inc. announced the submission of its Vitrargus Phase II study to the Australian Bellberry Human Research Ethics Committee. If received, HREC approval will lead to a Clinical Trial Notification submission to the Australian Therapeutic Goods Administration for review, which is the final regulatory step before study initiation. Early clinical studies indicate that Vitargus has unique properties that result in eliminating the need for post-surgery patient face-down positioning, as well as significantly greater patient comfort and visual acuity during the surgical recovery period than currently available products. The objective of the Phase II study, titled "A Perspective Multi-Site Open Label Randomized Controlled Clinical Investigation of the Safety and Effectiveness of ABV-1701 Ocular Endotamponade," is to demonstrate the safety and effectiveness of Vitargus when compared to the commonly used SF6 Gas OE. Aankondiging • Jun 10
Abvc Biopharma, Inc. Appoints Ms. Hsin-Hui Miao to its Board ABVC BioPharma, Inc. announced that at the board meeting held on June 4, 2022, the board appointed Ms. Hsin-Hui Miao to fill the vacancy created by Dr. Miao's passing. Ms. Miao is Dr. Miao's sister. Ms. Miao shall serve until the next shareholders' meeting at which directors are elected. Ms. Miao shall serve on the following committees: Audit committee, Corporate Governance and Nomination committee, and Compensation committee. Aankondiging • May 28
ABVC BioPharma, Inc. Announces Board Elections ABVC BioPharma, Inc. announced that at its annual meeting of shareholders held on May 20, 2022, elected Che Wei Hsu, Shuling Jiang and Kuang-Tseng Chen as directors to the Company’s Board, with such directors to serve until the 2023 annual meeting of shareholders. Reported Earnings • May 18
First quarter 2022 earnings: EPS and revenues miss analyst expectations First quarter 2022 results: US$0.20 loss per share (down from US$0.046 loss in 1Q 2021). Net loss: US$6.00m (loss widened 431% from 1Q 2021). Revenue missed analyst estimates by 40%. Earnings per share (EPS) also missed analyst estimates by 122%. Over the last 3 years on average, earnings per share has fallen by 18% per year but the company’s share price has fallen by 51% per year, which means it is performing significantly worse than earnings. Aankondiging • May 13
ABVC BioPharma, Inc. has completed a Follow-on Equity Offering in the amount of $4.22 million. ABVC BioPharma, Inc. has completed a Follow-on Equity Offering in the amount of $4.22 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 2,000,000
Price\Range: $2.11
Transaction Features: Registered Direct Offering Aankondiging • May 12
ABVC BioPharma, Inc. Announces ADHD Phase II Part 2 Clinical Study First Subject ABVC Biopharma, Inc. announced that the first subject began treatment at the Cheng Hsin General Hospital in the Phase II part 2 clinical study of the Company’s ADHD medicine (ABV-1505). The study, entitled “A Phase II Tolerability and Efficacy Study of PDC-1421 Treatment in Adult Patients with Attention-Deficit Hyperactivity Disorder, Part II,” is a randomized, double-blind, placebo-controlled study involving a total of approximately 100 patients in the United States and Taiwan. This is a continuation of the Phase II part 1 study of ABV-1505, which was completed successfully at the University of California, San Francisco and accepted by the U.S. Food & Drug Administration in October 2020. Cheng Hsin General Hospital is one of five sites in Taiwan that will participate in part 2 of the clinical trial, along with the UC, San Francisco site in the United States. At Cheng Hsin, five subjects were enrolled and randomized into the study from a total of twelve subjects screened from the participating sites, as prescribed by the study protocol inclusion and exclusion criteria. Aankondiging • May 06
ABVC Biopharma Announces Streamlined Vitargus® Manufacturing Process ABVC BioPharma, Inc. announced that Vitargus®, its gel-like substance that helps the eye maintain a round shape and keeps the retina in place during and after retinal re-attachment surgery, will be manufactured through a new aseptic process that enhances the stability, consistency and efficacy of the final product, while significantly reducing manufacturing time. This new manufacturing process eliminates the labor-intensive and time-consuming gamma ray sterilization of the Vitargus components by using a sterile fill-lyophilization-finish. Early clinical studies indicate that Vitargus has unique properties that eliminate the need for post-surgery patient face-down positioning, while significantly improving patient comfort and visual acuity during the surgical recovery period, as compared to current products available on the market. It is the first biodegradable vitreous substitute to eliminate the need for a second post-op surgery to remove surgical fluids. The upcoming Phase II study to be initiated in Australia and Thailand is expected to demonstrate the safety and effectiveness of Vitargus®, compared to the commonly used SF6 Gas OE. The new streamlined manufacturing process has been successfully scaled up under cGMP conditions to ensure enough Vitargus can be economically produced for both Phase II, as well as subsequent Phase III clinical studies involving more than 175 patients. Board Change • Apr 27
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 12 experienced directors. No highly experienced directors. Chief Strategy Officer, Member of Scientific Advisory Board & Director T.S. Jiang was the last director to join the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Aankondiging • Apr 27
ABVC BioPharma, Inc. Announces Vitargus Phase II Clinical Study Investigator Meeting ABVC BioPharma, Inc. announced that the principal investigators of the Phase II clinical study of Vitargus® will hold a virtual meeting on April 27, 2022. The meeting will be attended by all principal investigators currently selected from the Australian and Thailand sites to help coordinate the study, entitled “A Prospective Multi-Site Open Label Randomized Controlled Clinical Investigation of the Safety and Effectiveness of ABV-1701 Ocular Endotamponade (OE).” Early clinical studies indicate that Vitargus® has unique properties that eliminate the need for post-surgery patient face-down positioning, while significantly improving patient comfort and visual acuity during the surgical recovery period, as compared to current products available on the market. It is the first biodegradable vitreous substitute to eliminate the need for a second post-op surgery to remove surgical fluids. The objective of the Phase II study is to demonstrate the safety and effectiveness of Vitargus®, compared to the commonly used SF6 Gas OE. Reported Earnings • Apr 02
Full year 2021 earnings: EPS exceeds analyst expectations while revenues lag behind Full year 2021 results: US$0.51 loss per share (down from US$0.50 loss in FY 2020). Net loss: US$12.8m (loss widened 31% from FY 2020). Revenue missed analyst estimates by 40%. Earnings per share (EPS) exceeded analyst estimates by 122%. Over the last 3 years on average, earnings per share has fallen by 6% per year but the company’s share price has fallen by 54% per year, which means it is performing significantly worse than earnings. Aankondiging • Feb 03
ABVC BioPharma Announces Principal Investigator Meeting for Phase II Part 2 ADHD Clinical Study ABVC Biopharma, Inc. announced that the Principal Investigator Meeting for the ABV-1505 Phase II Part 2 ADHD clinical study will be held on February 14, 2022. Principal investigators from the University of California San Francisco (“UCSF”) Medical Center and five prestigious Taiwan medical centers, including National Taiwan University Hospital, Taipei Veterans General Hospital, Linkou Chang Gung Memorial Hospital, Kaohsiung Chang Gung Memorial Hospital and Cheng Hsin General Hospital, will virtually participate in the meeting to discuss potential further improvement to the study protocol prior to initiation. This randomized, double-blind, placebo-controlled Part 2 study involves a total of approximately 100 patients from the United States and Taiwan. Part 1 of the Phase II study on ABV-1505 was conducted at UCSF from January to July of 2020 and received by the U.S. Food & Drug Administration in October of 2020, without comment. The Part 2 study is targeted to begin in the first quarter of 2022 and expected to be completed at the end of 2022. The Part 1 study with six adult patients found that the active ingredient of ABV-1505, PDC-1421, was safe, well-tolerated and effective during the treatment and follow-up period. For the primary endpoints, the percentage of improvement in Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated-IV (ADHD-RS-IV) score from baseline through eight weeks of treatment was 83.3% (N=5) in the Intention-To-Treat (ITT) population and 80.0% (N=4) in the Per-Protocol (PP) population. Both low and high doses of PDC-1421 met the primary endpoints, passing the required 40% population in ADHD-RS-IV test scores. The results from the Part 1 study demonstrated the therapeutic value of PDC-1421 and support further clinical development of ABV-1505 for the treatment of ADHD. Aankondiging • Jan 06
ABVC BioPharma, Inc. Selects Additional Vitargus Phase II Study Sites ABVC BioPharma, Inc. announced two clinical sites in Thailand have been selected to participate in the Phase II clinical study of Vitargus, the first bio-degradable vitreous substitute intended to facilitate retina re-attachment surgery. The new sites, located at the Ramathibodi Hospital at Mahidol University and the Srinagarind Hospital at Khon Kaen University, will join two planned Australian sites already selected to participate in the study. The Company expects the Thailand Food and Drug Administration (“FDA”) and the Australian Therapeutic Goods Administration to approve the study sites and principal investigators in First Quarter of 2022 with first patient enrollments beginning during Second Quarter of 2022. Early clinical studies indicate that Vitargus® has unique properties that eliminate the need for post-surgery patient face-down positioning and significantly improves recovery period patient comfort and visual acuity compared to existing products. The objective of the Phase II study, “A Prospective Multi-Site Randomized Controlled Clinical Investigation of the Safety and Effectiveness of the ABV-1701 Ocular Endotamponade (OE),” is to demonstrate the safety and efficacy of Vitargus as compared to SF6 Gas OE, now commonly used for retina re-attachment. The incident of retinal detachment in Thailand is about 3% by the age of 85, compared to the incident of retinal detachment in Australia, which affects about 1% of the population. Board Change • Dec 05
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Chief Strategy Officer, Member of Scientific Advisory Board & Director T.S. Jiang was the last director to join the board, commencing their role in 2019. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Reported Earnings • Nov 18
Third quarter 2021 earnings released: US$0.067 loss per share (vs US$0.095 loss in 3Q 2020) Third quarter 2021 results: Net loss: US$1.81m (loss narrowed 2.1% from 3Q 2020). Over the last 3 years on average, earnings per share has fallen by 9% per year but the company’s share price has fallen by 51% per year, which means it is performing significantly worse than earnings. Board Change • Sep 19
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Chief Strategy Officer, Member of Scientific Advisory Board & Director T.S. Jiang was the last director to join the board, commencing their role in 2019. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Board Change • Sep 18
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Chief Strategy Officer, Member of Scientific Advisory Board & Director T.S. Jiang was the last director to join the board, commencing their role in 2019. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Board Change • Sep 16
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Chief Strategy Officer, Member of Scientific Advisory Board & Director T.S. Jiang was the last director to join the board, commencing their role in 2019. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Aankondiging • Sep 14
ABVC BioPharma Completes Site Selection for ABV-1505 ADHD Phase II Part 2 Clinical Study ABVC Biopharma, Inc. announced it has completed clinical site selection for its ABV-1505 Attention-Deficit Hyperactivity Disorder (ADHD) Phase II Part 2 study. The Phase II, Part 1 study, completed at the University of California, San Francisco, was accepted by the US Food & Drug Administration in October 2020. The Part 2 study of ABV-1505 (ADHD) is a multi-nation multi-site randomized, double-blind, placebo-controlled study involving approximately 100 patients. The study sites selected are the University of California, San Francisco (UCSF) in the USA and five prestigious medical centers in Taiwan, including the National Taiwan University (NTU) Hospital, Cheng Hsin General Hospital, Linkou Chang Gung Memorial Hospital, Kaohsiung Chang Gung Memorial Hospital, and Taipei Veterans General Hospital. In parallel with the Institutional Review Board (IRB) submission at UCSF, a central IRB (cIRB) submission of the protocol and study-related dossiers will be issued by ABVC in Q4, 2021 for all five Taiwan sites. The study is targeted to begin in the first quarter of 2022. Board Change • Sep 12
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Chief Strategy Officer, Member of Scientific Advisory Board & Director T.S. Jiang was the last director to join the board, commencing their role in 2019. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Board Change • Aug 31
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Chief Strategy Officer, Member of Scientific Advisory Board & Director T.S. Jiang was the last director to join the board, commencing their role in 2019. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Board Change • Aug 22
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Chief Strategy Officer, Member of Scientific Advisory Board & Director T.S. Jiang was the last director to join the board, commencing their role in 2019. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Board Change • Aug 19
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Chief Strategy Officer, Member of Scientific Advisory Board & Director T.S. Jiang was the last director to join the board, commencing their role in 2019. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Board Change • Aug 15
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Chief Strategy Officer, Member of Scientific Advisory Board & Director T.S. Jiang was the last director to join the board, commencing their role in 2019. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Reported Earnings • Aug 13
Second quarter 2021 earnings released: US$0.081 loss per share (vs US$0.095 loss in 2Q 2020) Second quarter 2021 results: Net loss: US$1.97m (loss widened 6.6% from 2Q 2020). Over the last 3 years on average, earnings per share has fallen by 4% per year but the company’s share price has fallen by 60% per year, which means it is performing significantly worse than earnings. Board Change • Aug 13
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Chief Strategy Officer, Member of Scientific Advisory Board & Director T.S. Jiang was the last director to join the board, commencing their role in 2019. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Aankondiging • Aug 06
ABVC BioPharma, Inc. has completed a Composite Units Offering in the amount of $6.875 million. ABVC BioPharma, Inc. has completed a Composite Units Offering in the amount of $6.875 million.
Security Name: Units
Security Type: Equity/Derivative Unit
Securities Offered: 1,100,000
Price\Range: $6.25
Discount Per Security: $0.5 Board Change • Aug 05
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Chief Strategy Officer, Member of Scientific Advisory Board & Director T.S. Jiang was the last director to join the board, commencing their role in 2019. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Aankondiging • Jan 09
American BriVision (Holding) Corporation, Annual General Meeting, Feb 08, 2021 American BriVision (Holding) Corporation, Annual General Meeting, Feb 08, 2021, at 08:30 Eastern Standard Time. Agenda: To re-elect all 11 directors (the “Director Nominees”) to serve on the Company’s Board of Directors (the “Board”) until the next annual meeting of shareholders or until removed; to ratify the appointment KCCW Accountancy Corp. (“KCCW”) as the Company’s independent registered public accounting firm for fiscal year ending December 31, 2020 and for the period ended March 31, 2021; to approve an amendment to the Company’s Articles of Incorporation to change the Company’s corporate name to “ABVC BioPharma, Inc.” and approve and adopt the Certificate of Amendment to affect same (the “Name Change Proposal”); and to transact such other business as may properly come before the Meeting or any adjournment or postponement thereof. Aankondiging • Nov 18
American BriVision (Holding) Corporation announced delayed 10-Q filing On 11/16/2020, American BriVision (Holding) Corporation announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Aankondiging • Nov 10
American BriVision (Holding) Corporation Issues Clinical Study Report for Phase II Part I Clinical Trial for ABV-1505 in Adult Attention-Deficit Hyperactivity Disorder (ADHD) American BriVision (Holding) Corporation issued a full clinical study report (CSR) of its ABV-1505 Phase II Part I clinical trial conducted at the University of California, San Francisco (UCSF) for the treatment of adult Attention-Deficit Hyperactivity Disorder (ADHD). Additionally, PDC-1421, the active pharmaceutical ingredient of ABV-1505, had been used recently in a Phase II clinical study conducted at Stanford University to successfully treat Major Depression Disorder (MDD). The Phase II Part I clinical study for treating ADHD found that the PDC-1421 Capsule was safe, well-tolerated and efficacious during its treatment and follow-up period with six adult patients. For the primary endpoints, the percentages of improvement in Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated-IV (ADHD-RS-IV) score from baseline through eight weeks of treatment were 83.3% (N=5) in the Intention-To-Treat (ITT) population and 80.0% (N=4) in the Per-Protocol (PP) population. Both low and high doses of PDC-1421 Capsule met the primary end points by passing the required 40% population in ADHD-RS-IV test scores. Overall, the results from this study, which demonstrate the therapeutic value of PDC-1421, support further clinical development of ABV-1505 for the treatment of adult ADHD.