ABVC

The Company may not be able to reach such transition point or make such a transition, which would have affected our business, financial condition, results of operations and prospects.
To date, the Company’s operations have been funded partially from the proceeds from financing or loans from its shareholders.
Any delay in obtaining, or inability to obtain, regulatory approvals of any of our drug candidates will prevent us from sublicensing such product.
If the side effects associated with our current or future products are not identified prior to their marketing and sales, we may be required to withdraw such products from the market, perform lengthy additional clinical trials or change the labeling of our products, any of which could adversely impact our growth.
We currently have insurance policies to cover liabilities under the clinic trials but do not maintain general liability insurance; and even if we have general liability insurance in the future, this insurance may not fully cover potential liabilities that we may incur.
Pursuant to the Yukiguni License Agreement, if BioLite fails to meet the milestone sales requirement or submits certain applications to the appropriate health authorities on a schedule prescribed therein, Yukiguni shall have the right to terminate the Yukiguni License Agreement.
BioLite Taiwan and BioLite have submitted the IND for PDC-1421 and subsequently conducted Phase II clinical trials of two drug candidates developed from PDC-1421 according to the schedule listed in the license agreement between BioLite Taiwan and MPITDC.
Proceedings to enforce the Company’s and its licensors’ patent rights in foreign jurisdictions could result in substantial costs and divert its efforts and attention from other aspects of the business.
Sales to customers outside the United States accounted for 100% and 100% for the years ended December 31, 2025 and 2024, respectively.
A small number of licensees account for a substantial portion of the revenue we generate and the loss of one or more of these key licensees would negatively impact our revenue and cash flow.
From its inception, we have not generated substantial revenue from our medical device and new drug development.
For the year ended December 31, 2025, we did not receive any payment from the collection of outstanding balances from outlicensing our intellectual property in the prior years, and in turn no revenue was recognized.
We do not have long-term license arrangements with any of our licensees and they can cancel their agreements at any time.
A reduction in or termination of these license agreements from these licensees would negatively impact our revenue and cash flow.
Much of the scrutiny, criticism and negative publicity has centered on financial and accounting irregularities, lack of effective internal control over financial accounting, inadequate corporate governance and ineffective implementation thereof and, in many cases, allegations of fraud.
If the Company becomes the subject of any unfavorable allegations, whether such allegations are proven to be true or untrue, the Company will have to expend significant resources to investigate such allegations and defend the Company.
As of December 31, 2025, our working capital is in deficit of $3.6 million, consisting of outstanding current liabilities were approximately $6.2 million, which consisted primarily of short-term bank loans, short-term convertible note payables, and accrued expenses.
Our management has identified a material weakness in our internal control over financial reporting related to not having sufficient and skilled accounting personnel with appropriate level of technical accounting knowledge and experience in the application of accounting principles generally accepted in the United States commensurate with the Company’s financial reporting requirements and has concluded that, due to such material weakness, our disclosure controls and procedures were not effective as of December 31, 2025.
Insiders might have substantial influence over us, which could delay or prevent a change in our corporate control even if our other shareholders wanted it to occur.
Our executive officers, directors, and principal shareholders own, in the aggregate, approximately 19% of our outstanding Common Stock.
As a result of their stockholdings, these shareholders may have significant influence over matters requiring shareholder approval, including the election of directors and approval of significant corporate transactions.
This concentration of ownership could delay or prevent an outside party from acquiring or merging with us even if our other shareholders wanted it to occur.
On May 22, 2025, we filed a registration statement on Form S-3, which has not been declared effective as of the date of this report.
On July 10, 2024, the Company received a notification letter from the listing qualifications staff (the “Staff”) of 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 “Rule”).
Under the Nasdaq Listing Rules, the Company had until January 6, 2025, to regain compliance.
On January 9, 2025, 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 the Rule.
On May 13, 2025, the Company received a notification letter from Nasdaq notifying the Company that the Staff has determined that the Company has met the Bid Requirement and therefore the matter is closed.
Accordingly, no reverse stock split is necessary at this time.
On April 24, 2025, the Company received a letter from the Staff informing the Company 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, it did not meet the alternatives of market value of listed securities or net income from continuing operations, and it no longer complied with Listing Rule 5550(b)(1) (“Rule 5550”).
The Company had 45 calendar days to submit a plan to the Staff to regain compliance.
If the plan wass accepted, the Company was eligible to receive an extension of up to 180 calendar days from the date of the letter, or until October 21, 2025, to evidence compliance.
On April 30, 2025, the Company reported that it received a letter from the Staff 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 complied with Listing Rule 5550.
On May 5, 2025, the Company received a 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 Listing Rule 5550 and the matter is closed.

Gone since FY2024

The Company may not be able to reach such transition point or make such a transition, which would have affect our business, financial condition, results of operations and prospects.
To date, the Company’s operations have been funded partially from the proceeds from financings or loans from its shareholders.
Any delay in obtaining, or inability to obtain, regulatory approvals of any of our drug candidate will prevent us from sublicensing such product.
If the side effects associated with our current or future products are not identified prior to their marketing and sale, we may be required to withdraw such products from the market, perform lengthy additional clinical trials or change the labeling of our products, any of which could adversely impact our growth.
We currently have insurance policies to cover liabilities under the clinic trials but do not maintain general liability insurance; and even if we have a general liability insurance in the future, this insurance may not fully cover potential liabilities that we may incur.
Pursuant to the Yukiguni License Agreement, if BioLite fails to meet the milestone sales requirement or submit certain applications to the appropriate health authorities on a schedule prescribed therein, Yukiguni shall have the right to terminate the Yukiguni License Agreement.
BioLite Taiwan and BioLite have submitted the IND for PDC-1421 and subsequently conducted Phase II clinical trials of two drug candidiates developed from PDC-1421 according to the schedule listed in the license agreement between BioLite Taiwan and MPITDC.
Proceedings to enforce the Company’s and its licensors’ patent rights in foreign jurisdictions could result in substantial costs and divert its efforts and attention from other aspects of the businesses.
Sales to customers outside the United States accounted for 100% and 93% for the years ended December 31, 2024 and 2023, respectively.
Much of the scrutiny, criticism and negative publicity has centered on financial and accounting irregularities, lack of effective internal control over financial accountings, inadequate corporate governance and ineffective implementation thereof and, in many cases, allegations of fraud.
If the Company becomes a subject of any unfavorable allegations, whether such allegations are proven to be true or untrue, the Company will have to expend significant resources to investigate such allegations and defend the Company.
As of December 31, 2024, our working capital is in deficit of $4.4 million, consisting of outstanding current liabilities were approximately $6.6 million, which consisted primarily of short-term bank loans and accrued expenses.
Our management has identified a material weakness in our internal control over financial reporting related to not having sufficient and skilled accounting personnel with appropriate level of technical accounting knowledge and experience in the application of accounting principles generally accepted in the United States commensurate with the Company’s financial reporting requirements and has concluded that, due to such material weakness, our disclosure controls and procedures were not effective as of December 31, 2024.
Insiders have substantial control over us, and they could delay or prevent a change in our corporate control even if our other shareholders wanted it to occur.
Our executive officers, directors, and principal shareholders own, in the aggregate, approximately 61.4% of our outstanding Common Stock.
As a result of their stockholdings, these shareholders are able to assert substantial control over matters requiring shareholder approval, including the election of directors and approval of significant corporate transactions.
This could delay or prevent an outside party from acquiring or merging with us even if our other shareholders wanted it to occur.
On October 29, 2021, we filed a registration statement on Form S-3, as amended on November 16, 2021, which was declared effective on November 29, 2021.
On May 11, 2022, we agreed to issue 2,000,000 shares of Common Stock, par value $0.001 per share, at a price of $2.11 per share and 5-year warrants to purchase up to 2,000,000 shares of Common Stock, exercisable at a price of $2.45 per share pursuant to certain securities purchase agreement dated May 11, 2022, which was effected as a takedown off the Company’s shelf registration statement on Form S-3, as amended.
We also issued the co-placement agents warrants to purchase up to 160,000 shares of Common Stock, on the same terms as the investors warrants in connection with the transaction.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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