−Removed: MANAGEMENT’S DISCUSSION AND
−Removed: ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
+Added: MANAGEMENT’S DISCUSSION AND ANALYSIS
+Added: OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Caution Regarding Forward-Looking Information
2 unchanged sentences
with ABVC BioPharma, Inc.
−Removed: and its subsidiaries (“we”, “us”, “our”, or the “Company”)
−Removed: condensed unaudited financial statements and the notes thereto contained elsewhere in this report.
+Added: and its subsidiaries (“we”, “us”, “our”, or the “Company”) condensed
+Added: unaudited financial statements and the notes thereto contained elsewhere in this report.
Information in this Item 2, “Management’s
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Factors that cause
−Removed: actual results or conditions to differ from those anticipated by these and other forward-looking statements include those more fully
−Removed: described elsewhere in this report and in the “Risk Factors” section of our annual report on form 10-K.
+Added: actual results or conditions to differ from those anticipated by these and other forward-looking statements include those more fully described
+Added: elsewhere in this report and in the “Risk Factors” section of our annual report on form 10-K.
The Company disclaims any obligation to update
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BioLite Taiwan has been in the business of developing new drugs since it was incorporated.
−Removed: Yunzhiyi, a Taiwanese corporation, was incorporated
−Removed: in August 2024, with 90% owned by BioLite Taiwan and 10% owned by Shuling Jiang, the Company’s director.
−Removed: This entity is set up for
−Removed: holding land located in Puli, Tawain that AiBtl is in the process of acquiring, which land will be used for developing health related
−Removed: As of the date hereof, the transfer of the land’s title is currently under government review, pending completion of the
−Removed: title transfer registration.
−Removed: Due to Taiwan’s legal restrictions prohibiting foreign entities from directly owning farmland, the
−Removed: parties agreed to structure the arrangement through nominee holdings.
+Added: Yun Zhi Yi Co., Ltd.
+Added: (“Yun Zhi Yi”),
+Added: a Taiwanese corporation, was incorporated in August 2024, with 90% owned by BioLite Taiwan and 10% owned by Shuling Jiang (“Shuling”,
+Added: Jiang”), a director and beneficial owner of more than 10% of the ABVC’s outstanding common stock.
+Added: is set up for holding land located in Puli, Tawain that AiBtl is in the process of acquiring, which land will be used for developing health
+Added: related business.
+Added: Due to Taiwan’s legal restrictions prohibiting foreign entities from directly owning farmland, the parties agreed
+Added: to structure the arrangement through nominee holdings.
+Added: To further secure the ownership of land, the board of AiBtl authorized Ms.
+Added: in June 2025 to temporarily hold the land title until the administrative procedures are finalized.
+Added: The title was transferred to Ms.
+Added: later that month, and the Company recorded $5,421 in acquisition costs associated with the transaction.
+Added: As of the date hereof, the transfer
+Added: of the land’s title to Yun Zhi Yi is currently under government review, pending completion of the title transfer registration.
Incorporated in California on November 20, 2000,
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to identify drugs that it believes demonstrate efficacy and safety based on the Company’s internal qualifications.
−Removed: is shown to be a good candidate for further development and ultimately commercialization, BriVision licenses the drug or medical device
−Removed: from the original researchers and begins to introduce the drugs clinical plan to highly respected principal investigators in the United
−Removed: States, Australia and Taiwan.
−Removed: In almost all cases, we have found that research institutions in each of those countries are eager to work
−Removed: with the Company to move forward with Phase II clinical trials.
−Removed: Institutions that have or are now conducting
−Removed: phase II clinical trials in partnership with ABVC include:
+Added: Once a drug is
+Added: shown to be a good candidate for further development and ultimately commercialization, BriVision licenses the drug or medical device from
+Added: the original researchers and begins to introduce the drugs clinical plan to highly respected principal investigators in the United States,
+Added: Australia and Taiwan.
+Added: In almost all cases, we have found that research institutions in each of those countries are eager to work with
+Added: the Company to move forward with Phase II clinical trials.
+Added: Institutions that have or are now conducting phase
+Added: II clinical trials in partnership with ABVC include:
ABV-1504, Major Depressive Disorder (MDD), Phase II completed.
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Charles DeBattista M.D.
−Removed: Schatzberg, MD, Stanford University Medical Center, Cheng-Ta
−Removed: Li, MD, Ph.D - Taipei Veterans General Hospital
+Added: Schatzberg, MD, Stanford University Medical Center, Cheng-Ta Li, MD, Ph.D - Taipei Veterans General Hospital
ABV-1505, Adult Attention-Deficit Hyperactivity Disorder (ADHD), Phase II Part 1 completed.
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Keith McBurnett, Ph.D.
−Removed: and Linda Pfiffner, Ph.D., University of
−Removed: California San Francisco (UCSF), School of Medicine.
−Removed: Phase II, Part 2 clinical study sites
−Removed: include UCSF and 5 locations in Taiwan.
−Removed: The Principal Investigators are Keith McBurnett,
−Removed: and Linda Pfiffner, Ph.D., University of California San Francisco (UCSF), School of
+Added: and Linda Pfiffner, Ph.D., University of California San Francisco (UCSF), School of Medicine.
+Added: Phase II, Part 2 clinical study sites include UCSF and 5 locations in Taiwan.
+Added: The Principal Investigators are Keith McBurnett, Ph.D.
+Added: and Linda Pfiffner, Ph.D., University of California San Francisco (UCSF), School of Medicine;
Susan Shur-Fen Gau, M.D., National Taiwan University Hospital;
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Ton-Ping Su, M.D., Cheng Hsin General Hospital;
−Removed: Cheng-Ta Li, M.D., Taipei Veterans General
+Added: Cheng-Ta Li, M.D., Taipei Veterans General Hospital.
Phase II, Part 2 began in the 1st quarter of 2022 at the 5 Taiwan sites.
−Removed: site joined the study in the 2nd quarter of 2023.
−Removed: The subjects enrolled in the study has
−Removed: reached the number for interim analysis in December 2023, and the interim analysis of the
−Removed: study is in progress.
+Added: The UCSF site joined the study in the 2nd quarter of 2023.
+Added: The subjects enrolled in the study has reached the number for interim analysis in December 2023, and the interim analysis of the study is in progress.
ABV-1601, Major Depression in Cancer Patients, Phase I/II, NCE drug Principal Investigator:
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- Cedars Sinai Medical Center (CSMC).
−Removed: The Phase I clinical study will
−Removed: be initiated around the end of 2025.
−Removed: ABV-1701, Vitargus® in vitrectomy surgery, Phase II Study has been initiated
−Removed: in Australia and Thailand, Principal Investigator:
−Removed: Duangnate Rojanaporn, M.D., Ramathibodi
+Added: The Phase I clinical study will be initiated around the end of 2025.
+Added: Medical Device:
+Added: ABV-1701, Vitargus® in vitrectomy surgery, Phase II Study has been initiated in Australia and Thailand, Principal Investigator:
+Added: Duangnate Rojanaporn, M.D., Ramathibodi Hospital;
Thuss Sanguansak, M.D., Srinagarind Hospital of the two Thailand Sites and Professor/Dr.
Matthew Simunovic, Sydney Eye Hospital;
−Removed: Elvis Ojaimi, East Melbourne Eye Group &
−Removed: East Melbourne Retina.
−Removed: The Phase II study started in the 2nd quarter of 2023, and the company
−Removed: is working on improvements to the Vitargus Product through the new batch of investigational
+Added: Elvis Ojaimi, East Melbourne Eye Group & East Melbourne Retina.
+Added: The Phase II study started in the 2nd quarter of 2023, and the company is working on improvements to the Vitargus Product through the new batch of investigational product.
The following trials are expected to begin in
7 unchanged sentences
device upon approval by the US FDA, Taiwan TFDA and other country regulatory authorities.
−Removed: Another part of the Company’s business
−Removed: is conducted by BioKey, a wholly-owned subsidiary, that is engaged in a wide range of services, including, API characterization, pre-formulation
−Removed: studies, formulation development, analytical method development, stability studies, IND/NDA/ANDA/510K submissions, and manufacturing
−Removed: clinical trial materials (phase I through phase III) and commercial manufacturing.
+Added: Another part of the Company’s business is
+Added: conducted by BioKey, a wholly-owned subsidiary, that is engaged in a wide range of services, including, API characterization, pre-formulation
+Added: studies, formulation development, analytical method development, stability studies, IND/NDA/ANDA/510K submissions, and manufacturing clinical
+Added: trial materials (phase I through phase III) and commercial manufacturing.
The Vitargus ® Phase II study was
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By comparing the Thailand study with the First-in-Human (FIH) study completed in Australia
−Removed: in 2018, the SAEs derived from the patients in the Thailand study may be due to the modified in-situ hydrogel procedure which
−Removed: allows a longer surgical time window for the study.
−Removed: The Company is investigating the root causes of the events and is working towards
−Removed: developing a safe device in-situ procedure before reinstating the study.
+Added: in 2018, the SAEs derived from the patients in the Thailand study may be due to the modified in-situ hydrogel procedure which allows
+Added: a longer surgical time window for the study.
+Added: The Company is investigating the root causes of the events and is working towards developing
+Added: a safe device in-situ procedure before reinstating the study.
On March 5, 2025, Leeds Chow notified the Company
of his resignation as CFO.
−Removed: While the Company is looking for a full-time Chief Financial Officer to fill the vacancy created by Leeds
−Removed: Chow’s resignation, the Company’s CEO, Uttam Patil will serve as the interim Chief Financial Officer of the Company.
+Added: While the Company is looking for a full-time Chief Financial Officer to fill the vacancy created by Leeds Chow’s
+Added: resignation, the Company’s CEO, Uttam Patil will serve as the interim Chief Financial Officer of the Company.
On February 6, 2024, the Company entered into
−Removed: a definitive agreement with Shuling Jiang (“Shuling”), pursuant to which Shuling shall transfer the ownership of certain
−Removed: land she owns located at Taoyuan City, Taiwan (the “Land”) to the Company (the “Agreement”).
+Added: a definitive agreement with Shuling Jiang (“Shuling”), pursuant to which Shuling shall transfer the ownership of certain land
+Added: she owns located at Taoyuan City, Taiwan (the “Land”) to the Company (the “Agreement”).
Shuling is a director
of the Company, and owns approximately 15.4% of the Company’s issued and outstanding shares of common stock as of February 6, 2024.
−Removed: In consideration for the Land, the Company was to pay Shuling (i) 703,496 restricted shares of the Company’s common stock (the
−Removed: “Shares”) at a price of $3.50 per share and (ii) five-year warrants to purchase up to 1,000,000 shares of the Company’s
−Removed: common stock, with an exercise price of $2.00 per share.
−Removed: Under the Agreement, Shuling was to also transfer outstanding liability owed
−Removed: on the Land (approximately $500,000) to the Company.
−Removed: On May 16, 2024, the Company’s board of directors determined that it was in
−Removed: the best interest of the Company and its shareholders to terminate the Agreement and not proceed with the transfer of land ownership.
−Removed: The shares were returned and the warrants were not issued.
−Removed: On July 15, 2025, the Company entered into a
−Removed: definitive agreement with Shuling Jiang (“Shuling”), pursuant to which Shuling shall transfer the ownership of certain land
−Removed: she owns, with estimated fair value of $3,857,975, located at Taoyuan City, Taiwan (the “Land”) to the Company (the “Agreement”).
+Added: In consideration for the Land, the Company was to pay Shuling (i) 703,496 restricted shares of the Company’s common stock (the “Shares”)
+Added: at a price of $3.50 per share and (ii) five-year warrants to purchase up to 1,000,000 shares of the Company’s common stock, with
+Added: an exercise price of $2.00 per share.
+Added: Under the Agreement, Shuling was to also transfer outstanding liability owed on the Land (approximately
+Added: $500,000) to the Company.
+Added: On May 16, 2024, the Company’s board of directors determined that it was in the best interest of the Company
+Added: and its shareholders to terminate the Agreement and not proceed with the transfer of land ownership.
+Added: The shares were returned and the
+Added: warrants were not issued.
+Added: On July 15, 2025, the Company entered into a definitive
+Added: agreement with Shuling Jiang (“Shuling”), pursuant to which Shuling shall transfer the ownership of certain land she owns,
+Added: with estimated fair value of $3,857,975, located at Taoyuan City, Taiwan (the “Land”) to the Company (the “Agreement”).
Shuling is a director of the Company, and owns approximately 10.31% of the Company’s issued and outstanding shares of common stock
1 unchanged sentence
In consideration for the Land, the Company was to pay Shuling (i) 2,035,136 restricted shares of the Company’s
−Removed: common stock (the “Shares”) at a price of $1.65 per share as approved in the June 3, 2025 annual shareholder meeting and
−Removed: (ii) five-year warrants to purchase up to 1,000,000 shares of the Company’s common stock, with an exercise price of $2.50 per share.
+Added: common stock (the “Shares”) at a price of $1.65 per share as approved in the June 3, 2025 annual shareholder meeting and (ii)
+Added: five-year warrants to purchase up to 1,000,000 shares of the Company’s common stock, with an exercise price of $2.50 per share.
Under the Agreement, Shuling was to also transfer outstanding liability owed on the Land (approximately $500,000) to the Company.
−Removed: transaction is closed on the same date and restricted shares are issued on July 16, 2025.
+Added: transaction is closed on the same date and the 2,035,136 restricted shares and the 1,000,000 warrants are issued on July 16, 2025 and
+Added: July 15, 2025, respectively.
In connection with the Land transaction, on July
5 unchanged sentences
shares per year.
+Added: On July 16, 2025, the Company issued 200,000 shares of restricted stock as a prepayment for Shuling’s first year
On March 25, 2024, the Company, and one of its
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Additionally, each of the Company and BioFirst are eligible to receive royalties of 5% of net Sales.
−Removed: As of June 30,
−Removed: 2025, the Company has received 5,000,000 FEYE shares but did not recognize such licensing revenue since the fair value of
−Removed: FEYE stock is uncertain.
+Added: As of September
+Added: 30, 2025, the Company has received 5,000,000 FEYE shares but did not recognize such licensing revenue since the fair value of FEYE
+Added: stock is uncertain.
On June 18, 2024, the Company and BioFirst, each
−Removed: entered into an amendment (the “ Amendment ”) to the Licensing Agreement with FEYE, pursuant to which the Company and
−Removed: BioFirst have agreed to allow FEYE to pay the second milestone payment in the amount of $3,500,000 per Licensing Agreement, incrementally
−Removed: (such as $100,000), at any given time, rather than in one lump sum.
−Removed: As of June 30, 2025, the Company has received $296,000 as
−Removed: the partial second milestone payment and recognized as licensing revenue according to ASC 606.
−Removed: On April 16, 2024, the Company entered into a
−Removed: definitive agreement with OncoX BioPharma, Inc., a private company registered in the British Virgin Islands (“Oncox”), pursuant
−Removed: to which the Company will grant Oncox an exclusive right to develop and commercialize ABVC’s single-herb botanical drug extract
−Removed: from the dry fruit body of Maitake Mushroom (Grifola Frondosa) for treatment of Non-Small Cell Lung Cancer (the “Licensed Products”),
−Removed: within North America for 20 years (the “Oncox Agreement”).
−Removed: In consideration thereof, Oncox shall pay ABVC $6,250,000 (or
−Removed: 1,250,000 Oncox shares valued at $5 per share;
+Added: entered into an amendment (the “Amendment”) to the Licensing Agreement with FEYE, pursuant to which the Company and BioFirst
+Added: have agreed to allow FEYE to pay the second milestone payment in the amount of $3,500,000 per Licensing Agreement, incrementally (such
+Added: as $100,000), at any given time, rather than in one lump sum.
+Added: For the nine months ended September 30, 2025 and 2024, the Company received
+Added: $200,000 and $296,000, respectively, as partial milestone payments and recognized as licensing revenue according to ASC 606.
+Added: On April 16, 2024, the Company entered into a definitive agreement
+Added: with OncoX BioPharma, Inc., a private company registered in the British Virgin Islands (“Oncox”), pursuant to which the Company
+Added: will grant Oncox an exclusive right to develop and commercialize ABVC’s single-herb botanical drug extract from the dry fruit body
+Added: of Maitake Mushroom (Grifola Frondosa) for treatment of Non-Small Cell Lung Cancer (the “Licensed Products”), within North
+Added: America for 20 years (the “Oncox Agreement”).
+Added: In consideration thereof, Oncox shall pay ABVC $6,250,000 (or 1,250,000 Oncox
+Added: shares valued at $5 per share;
price was determined through private negotiations between the parties;
−Removed: no third-party
−Removed: valuation was completed.) 30 days after entering into the Oncox Agreement and $625,000 30 days following the completion of Oncox’s
−Removed: next round of fundraising, of which there is no guarantee;
−Removed: ABVC is also entitled to 5% royalties based on the Net Sales, as defined in
−Removed: the Oncox Agreement, from the first commercial sale of the Licensed Product in North America, of which there can be no guarantee.
−Removed: entered into another agreement with ABVC’s affiliate, Rgene Corporation, on the same terms.
−Removed: As of June 30, 2025, the Company has
−Removed: received $200,000 as the partial second milestone payment and recognized as licensing revenue according to ASC 606.
−Removed: On May 8, 2024, the Company entered into a definitive agreement with
−Removed: OncoX BioPharma, Inc., a private company registered in the British Virgin Islands (“Oncox”), pursuant to which the Company
−Removed: will grant Oncox an exclusive right to develop and commercialize ABVC’s BLEX 404 single-herb botanical drug extract from the dry
−Removed: fruit body of Maitake Mushroom (Grifola Frondosa) for treatment of Pancreatic Cancer (the “Licensed Products”), within a
−Removed: certain territory, specified as 50% of the Worldwide Markets for 20 years (the “May 2024 Oncox Agreement”).
+Added: no third-party valuation was completed.)
+Added: 30 days after entering into the Oncox Agreement and $625,000 30 days following the completion of Oncox’s next round of fundraising,
+Added: of which there is no guarantee;
+Added: ABVC is also entitled to 5% royalties based on the Net Sales, as defined in the Oncox Agreement, from
+Added: the first commercial sale of the Licensed Product in North America, of which there can be no guarantee.
+Added: Oncox entered into another agreement
+Added: with ABVC’s affiliate, Rgene Corporation, on the same terms.
+Added: For the nine months ended September 30, 2025 and 2024, the Company
+Added: received $595,950 and $200,000 as partial milestone payments and recognized as licensing revenue according to ASC 606.
+Added: On May 8, 2024, the Company entered into a definitive
+Added: agreement with OncoX BioPharma, Inc., a private company registered in the British Virgin Islands (“Oncox”), pursuant to which
+Added: the Company will grant Oncox an exclusive right to develop and commercialize ABVC’s BLEX 404 single-herb botanical drug extract
+Added: from the dry fruit body of Maitake Mushroom (Grifola Frondosa) for treatment of Pancreatic Cancer (the “Licensed Products”),
+Added: within a certain territory, specified as 50% of the Worldwide Markets for 20 years (the “May 2024 Oncox Agreement”).
In consideration
6 unchanged sentences
Oncox may remit cash payments of at least $100,000 towards the licensing fees and deductible from the second milestone payment;
−Removed: is also entitled to royalties of 5% of Net Sales, as defined in the May 2024 Oncox Agreement, from the first commercial sale of the Licensed
+Added: also entitled to royalties of 5% of Net Sales, as defined in the May 2024 Oncox Agreement, from the first commercial sale of the Licensed
Product in the noted territory, which remains uncertain.
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was determined through private negotiations between the parties;
−Removed: no third-party valuation was completed.) 30 days after entering the
−Removed: May 23, 2024 Oncox Agreement, with an additional milestone payment of $625,000 in cash after OncoX’s next round of fundraising,
−Removed: of which there can be no guarantee.
−Removed: Oncox may remit cash payments of at least $100,000 towards the licensing fees and deductible from
−Removed: the second milestone payment;
−Removed: each licensor is also entitled to royalties of 5% of Net Sales, from the first commercial sale of the Licensed
−Removed: Product in the noted territory, which remains uncertain.
+Added: no third-party valuation was completed.) 30 days after entering the May
+Added: 23, 2024 Oncox Agreement, with an additional milestone payment of $625,000 in cash after OncoX’s next round of fundraising, of which
+Added: there can be no guarantee.
+Added: Oncox may remit cash payments of at least $100,000 towards the licensing fees and deductible from the second
+Added: milestone payment;
+Added: each licensor is also entitled to royalties of 5% of Net Sales, from the first commercial sale of the Licensed Product
+Added: in the noted territory, which remains uncertain.
Oncox may use its revenue to fund the licensing fees.
1 unchanged sentence
On July 25, 2023, the Company filed a Certificate
−Removed: of Amendment to its Articles of Incorporation authorizing a 1-for-10 reverse stock split of the issued and outstanding shares of its
−Removed: common stock (the “2023 Split”).
+Added: of Amendment to its Articles of Incorporation authorizing a 1-for-10 reverse stock split of the issued and outstanding shares of its common
+Added: stock (the “2023 Split”).
The Company’s stockholders previously approved the Reverse Stock Split at the Company’s
9 unchanged sentences
Series A Convertible Preferred Stock
−Removed: As of June 30, 2025, no Series A Convertible
+Added: As of September 30, 2025, no Series A Convertible
Preferred Stock has been issued by the Company.
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per share and the holder received 142,857 shares of Common Stock.
−Removed: As a result of this conversion, the stockholders’ equity was
−Removed: increased by $0.5 million.
−Removed: Additionally, on August 14, 2023, the Company entered into a cooperation agreement with Zhonghui United Technology
−Removed: (Chengdu) Group Co., Ltd., pursuant to which the Company acquired a 20% ownership of certain property and a parcel of the land owned
−Removed: by Zhonghui in exchange for an aggregate of 370,000 shares of Common Stock.
+Added: As a result of this conversion, the stockholders’ equity was increased
+Added: by $0.5 million.
+Added: Additionally, on August 14, 2023, the Company entered into a cooperation agreement with Zhonghui United Technology (Chengdu)
+Added: Group Co., Ltd., pursuant to which the Company acquired a 20% ownership of certain property and a parcel of the land owned by Zhonghui
+Added: in exchange for an aggregate of 370,000 shares of Common Stock.
Accordingly, stockholders’ equity increased by $7.4M.
−Removed: On February 23, 2023, the Company entered into a securities purchase agreement with Lind, pursuant to which the Company issued Lind a
−Removed: secured, convertible note in the principal amount of $3,704,167 (the “Lind Offering”), for a purchase price of $3,175,000
−Removed: (the “Lind Note”), that is convertible into shares of Common Stock at an initial conversion price of $1.05 per share, subject
−Removed: to adjustment.
−Removed: On August 24, 2023, the Company started repaying Lind the monthly installments due under the Lind Notes;
−Removed: repaid via the issuance of 176,678 shares of Common Stock (the “Monthly Shares”) at the Redemption Share Price (as defined
−Removed: in the Lind Note) of $1.698 per share.
−Removed: Pursuant to the terms of the Lind Note, Lind increased the amount of the next monthly payment
−Removed: to one million dollars, such that as of September and together with the Monthly Shares, the Company repaid Lind a total of $1 million
−Removed: by September 2023.
−Removed: As a result, the stockholders’ equity increased by an additional $1 million.
−Removed: As a result of the four transactions
−Removed: referenced above, the Company’ estimated that its stockholders’ equity would increase by approximately $10.65 million.
−Removed: September 6, 2023, Nasdaq issued a letter that the Company is in compliance with Rule 5550(b)(1), but noted that if at the time of the
−Removed: Company’s next periodic report the Company does not evidence compliance, it may be subject to delisting.
−Removed: On July 10, 2024, we received a notification
−Removed: letter from the Nasdaq notifying the Company that the minimum bid price per share for its common shares has been below $1.00 for a period
−Removed: of 30 consecutive business days and the Company therefore no longer meets the minimum bid price requirements set forth in Nasdaq Listing
+Added: 23, 2023, the Company entered into a securities purchase agreement with Lind, pursuant to which the Company issued Lind a secured, convertible
+Added: note in the principal amount of $3,704,167 (the “Lind Offering”), for a purchase price of $3,175,000 (the “Lind Note”),
+Added: that is convertible into shares of Common Stock at an initial conversion price of $1.05 per share, subject to adjustment.
+Added: On August 24,
+Added: 2023, the Company started repaying Lind the monthly installments due under the Lind Notes;
+Added: $308,000 was repaid via the issuance of 176,678
+Added: shares of Common Stock (the “Monthly Shares”) at the Redemption Share Price (as defined in the Lind Note) of $1.698 per share.
+Added: Pursuant to the terms of the Lind Note, Lind increased the amount of the next monthly payment to one million dollars, such that as of
+Added: September and together with the Monthly Shares, the Company repaid Lind a total of $1 million by September 2023.
+Added: As a result, the stockholders’
+Added: equity increased by an additional $1 million.
+Added: As a result of the four transactions referenced above, the Company’ estimated that
+Added: its stockholders’ equity would increase by approximately $10.65 million.
+Added: On September 6, 2023, Nasdaq issued a letter that the Company
+Added: is in compliance with Rule 5550(b)(1), but noted that if at the time of the Company’s next periodic report the Company does not
+Added: evidence compliance, it may be subject to delisting.
+Added: On July 10, 2024, we received a notification letter
+Added: from the Nasdaq notifying the Company that the minimum bid price per share for its common shares has been below $1.00 for a period of
+Added: 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).
10 unchanged sentences
procedures, which the Company would have the right to appeal.
−Removed: On April 24, 2025, we received a letter from
−Removed: the listing qualifications staff (the “ Staff ”) of Nasdaq informing us that, as reported in our Annual Report on Form
−Removed: 10-K for the year ended December 31, 2024, because our stockholders’ equity was $723,959, as of April 23, 2025, we did not
−Removed: meet the alternatives of market value of listed securities or net income from continuing operations, and we no longer comply with Listing
−Removed: Rule 5550(b)(1) (the “ Rule 5550 ”).
−Removed: We have 45 calendar days to submit a plan to
−Removed: the Staff to regain compliance.
−Removed: If our plan is accepted, we may be granted an extension of up to 180 calendar days from the date of the
−Removed: letter, or until October 21, 2025, to evidence compliance.
+Added: On April 24, 2025, we received a letter from the
+Added: listing qualifications staff (the “ Staff ”) of Nasdaq informing us that, as reported in our Annual Report on Form 10-K
+Added: for the year ended December 31, 2024, because our stockholders’ equity was $723,959, as of April 23, 2025, we did not meet
+Added: the alternatives of market value of listed securities or net income from continuing operations, and we no longer comply with Listing Rule
+Added: 5550(b)(1) (the “ Rule 5550 ”).
+Added: We have 45 calendar days to submit a plan to the
+Added: Staff to regain compliance.
+Added: If our plan is accepted, we may be granted an extension of up to 180 calendar days from the date of the letter,
+Added: or until October 21, 2025, to evidence compliance.
In determining whether to accept our plan, the
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on the listing of our Common Stock on the Nasdaq Capital Market.
−Removed: We intend to actively monitor our stockholders’ equity
−Removed: and will consider options available to us to achieve compliance with Rule 5550.
−Removed: There can be no assurance that we will be able to regain
−Removed: compliance with the Listing Rule or will otherwise be in compliance with the other listing standards for the Nasdaq Capital Market.
+Added: We intend to actively monitor our stockholders’ equity and
+Added: will consider options available to us to achieve compliance with Rule 5550.
+Added: There can be no assurance that we will be able to regain compliance
+Added: 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
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equity incentives to our employees.
−Removed: On April 30, 2025, the Company reported that
−Removed: it received a letter from the listing qualifications staff (the “Staff”) of Nasdaq informing it that, as reported in its
−Removed: Annual Report on Form 10-K for the year ended December 31, 2024, because its stockholders’ equity was $723,959, as of April 23,
−Removed: 2025, the Company did not meet the alternatives of market value of listed securities or net income from continuing operations, and it
−Removed: no longer comply with Listing Rule 5550(b)(1) (the “Listing Rule”).
+Added: On April 30, 2025, the Company reported that it
+Added: received a letter from the listing qualifications staff (the “Staff”) of Nasdaq informing it that, as reported in its Annual
+Added: 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
+Added: Company did not meet the alternatives of market value of listed securities or net income from continuing operations, and it no longer
+Added: comply with Listing Rule 5550(b)(1) (the “Listing Rule”).
On May 5, 2025, the Company received a notification
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JP and its subsidiaries in Japan, or any other territory or business, as the Agreement may with mutual consent be amended from time to
−Removed: The closing of the transaction was conditioned upon the approval and receipt of all necessary government approvals, which have
−Removed: all been received.
+Added: The closing of the transaction was conditioned upon the approval and receipt of all necessary government approvals, which have all
+Added: been received.
Pursuant to the Agreement and the related share
3 unchanged sentences
there shall be 3 directors of Biolite JP, consisting of 1 director appointed by the Company and 2 appointed by Lucidiam.
−Removed: shall appoint Eugene Jiang, the Company’s current Chairman and Chief Business Officer and Lucidaim shall appoint Michihito Onishi;
−Removed: the current director of Biolite JP, Toru Seo (who is also a director of BioLite Japan’s other shareholder), is considered the second
+Added: The Company shall
+Added: appoint Eugene Jiang, the Company’s current Chairman and Chief Business Officer and Lucidaim shall appoint Michihito Onishi;
+Added: current director of Biolite JP, Toru Seo (who is also a director of BioLite Japan’s other shareholder), is considered the second
Lucidaim director.
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on the Completion Date.
−Removed: As per the Agreement, the Shareholders shall
−Removed: supervise and manage the business and operations of Biolite JP.
−Removed: The directors shall not be entitled to any renumeration for their services
−Removed: as a director and each Shareholder can remove and replace the director he/she/it appointed.
−Removed: If a Shareholder sells or disposes of all
−Removed: of its Ordinary Shares, the Shareholder-appointed director must tender his/her resignation.
−Removed: The Agreement also sets forth certain corporate
−Removed: actions that must be pre-approved by all Shareholders (the “Reserved Matters”).
−Removed: If the Shareholders are unable to make a
−Removed: decision on any Reserved Matter, then either Shareholder can submit a deadlock notice to the other shareholder, 5 days after which they
−Removed: must refer the matter to each Shareholder’s chairman and use good faith to resolve the dispute.
−Removed: If such dispute is not resolved
−Removed: within 10 days thereafter, then either Shareholder can offer to buy all of the other Shareholder’s Ordinary Shares for cash at
−Removed: a specified price;
+Added: As per the Agreement, the Shareholders shall supervise
+Added: and manage the business and operations of Biolite JP.
+Added: The directors shall not be entitled to any renumeration for their services as a
+Added: director and each Shareholder can remove and replace the director he/she/it appointed.
+Added: If a Shareholder sells or disposes of all of its
+Added: Ordinary Shares, the Shareholder-appointed director must tender his/her resignation.
+Added: The Agreement also sets forth certain corporate actions
+Added: that must be pre-approved by all Shareholders (the “Reserved Matters”).
+Added: If the Shareholders are unable to make a decision
+Added: on any Reserved Matter, then either Shareholder can submit a deadlock notice to the other shareholder, 5 days after which they must refer
+Added: the matter to each Shareholder’s chairman and use good faith to resolve the dispute.
+Added: If such dispute is not resolved within 10 days
+Added: thereafter, then either Shareholder can offer to buy all of the other Shareholder’s Ordinary Shares for cash at a specified price;
if there is not affirmative acceptance of the sale, the sale shall proceed as set forth in the sale offer.
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each Shareholder agrees to guarantee such bank facility if the bank requires a guarantee.
−Removed: Accordingly, the Company may be liable for
−Removed: the bank facility in an amount up to JPY 14,925,400 (approximately $134,000), which represents 49% of the maximum bank facility.
−Removed: Agreement further provides that Biolite JP shall issue annual dividends at the rate of at least 1.5% of Biolite JP’s profits, if
−Removed: it has sufficient cash to do so.
+Added: Accordingly, the Company may be liable for the
+Added: bank facility in an amount up to JPY 14,925,400 (approximately $134,000), which represents 49% of the maximum bank facility.
+Added: The Agreement
+Added: further provides that Biolite JP shall issue annual dividends at the rate of at least 1.5% of Biolite JP’s profits, if it has sufficient
+Added: cash to do so.
Pursuant to the Agreement, the Company and Biolite
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on behalf of Biolite JP regarding the terms of the License Agreement shall be handled by the directors appointed by Lucidaim.
−Removed: Company and such Lucidaim directors do not reach agreement on the terms, Biolite JP may at its sole discretion determine not to execute
−Removed: the License Agreement without any liability to the Company.
−Removed: The company is negotiating on the licensing terms and expects to conclude
+Added: If the Company
+Added: and such Lucidaim directors do not reach agreement on the terms, Biolite JP may at its sole discretion determine not to execute the License
+Added: Agreement without any liability to the Company.
+Added: The company is negotiating on the licensing terms and expects to conclude soon.
The Agreement contains non-solicitation and non-compete
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also allows a Shareholder to terminate the agreement upon certain defaults committed by another Shareholder, as set forth in the Agreement.
−Removed: This was a related party transaction and was
−Removed: conducted at arm’s length.
−Removed: In addition to the Company’s board of directors providing approval for the Company to enter into
−Removed: the Agreement, the Company’s audit committee approved the Company’s entry into the Agreement.
−Removed: The Board believes that this
−Removed: joint venture will enhance the Company’s ability to provide therapeutic solutions to significant unmet medical needs and to develop
−Removed: innovative botanical drugs to treat central nervous system (“CNS”) and oncology/ hematology diseases.
−Removed: The Company’s
−Removed: Board of Directors believes that the joint venture has the potential to provide the Company with access to additional early-stage product
−Removed: candidates that it would not otherwise have access to and to introduce the Company to early-stage opportunities, and therefore the Board
−Removed: believes the joint venture is in the best interest of the Company and its shareholders.
+Added: This was a related party transaction and was conducted
+Added: at arm’s length.
+Added: In addition to the Company’s board of directors providing approval for the Company to enter into the Agreement,
+Added: the Company’s audit committee approved the Company’s entry into the Agreement.
+Added: The Board believes that this joint venture
+Added: will enhance the Company’s ability to provide therapeutic solutions to significant unmet medical needs and to develop innovative
+Added: botanical drugs to treat central nervous system (“CNS”) and oncology/ hematology diseases.
+Added: The Company’s Board of Directors
+Added: believes that the joint venture has the potential to provide the Company with access to additional early-stage product candidates that
+Added: it would not otherwise have access to and to introduce the Company to early-stage opportunities, and therefore the Board believes the
+Added: joint venture is in the best interest of the Company and its shareholders.
Recent Research Results
Vitargus ® Clinical Development:
−Removed: The Phase II clinical study of Vitargus®
−Removed: commenced in the second quarter of 2023.
+Added: The Phase II clinical study of Vitargus® commenced
+Added: in the second quarter of 2023.
Study sites include Ramathibodi Hospital (Principal Investigator:
−Removed: Duangnate Rojanaporn)
−Removed: and Srinagarind Hospital (Principal Investigator:
+Added: Duangnate Rojanaporn) and Srinagarind
+Added: Hospital (Principal Investigator:
Thuss Sanguansak) in Thailand, and Sydney Eye Hospital (Principal Investigator:
Professor Dr.
−Removed: Matthew Simunovic) and East Melbourne Eye Group/East Melbourne Retina (Principal Investigator:
+Added: Simunovic) and East Melbourne Eye Group/East Melbourne Retina (Principal Investigator:
Elvis Ojaimi) in Australia.
−Removed: The Company is currently producing a new investigational batch to support product improvements.
+Added: The Company is
+Added: currently producing a new investigational batch to support product improvements.
ABV-2002 Corneal Storage Solution:
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As of the date of this report, 69 subjects have been enrolled, including 50 subjects who have completed the 56-day
−Removed: The study is a randomized, double-blind, placebo-controlled trial involving research centers in Taiwan and the University
−Removed: of California, San Francisco (UCSF).
−Removed: UCSF’s Institutional Review Board approved participation, and the site initiation visit was
−Removed: completed in March 2023.
+Added: The study is a randomized, double-blind, placebo-controlled trial involving research centers in Taiwan and the University of
+Added: California, San Francisco (UCSF).
+Added: UCSF’s Institutional Review Board approved participation, and the site initiation visit was completed
+Added: in March 2023.
On March 27, 2025, the Company has submitted the Clinical Study Report (CSR) for this study to the U.S.
−Removed: and Drug Administration (FDA).
+Added: Food and Drug Administration
The Company is currently evaluating further steps based on internal review and strategic alignment.
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Additionally, for the Senior Convertible Promissory Note issued
−Removed: in January 2024 (3 rd Lind Note), the Company has reduced the outstanding balance to $600,000, following two equity conversions
−Removed: of $200,000 each.
+Added: in January 2024 (3 rd Lind Note), the Company has repaid the entire outstanding balance by the equity conversions of $1,000,000
The remaining cash obligations for these conversions are also expected to be fulfilled in a similar warrant-based strategy,
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On March 3, 2025 and April 1, 2025, May 14, 2025,
−Removed: and June 5, 2025, Lind converted $800,000 ($200,000 in each conversion) principal balance on 3 rd Lind Note into 800,000 shares
−Removed: of the Company’s common stocks, leaving outstanding principal of $200,000 as of June 30, 2025.
+Added: June 5, 2025, and July 9, 2025, Lind converted $1,000,000 ($200,000 in each conversion) principal balance on 3 rd Lind Note
+Added: into 1,000,000 shares of the Company’s common stocks, resulting in fully settlement of the 3 rd Lind Note as of September
On July 1, 2025, Lind exercised 500,000 warrants
−Removed: and left 500,000 warrants as of the date of this report.
−Removed: On July 9, 2025, Lind converted the remaining $200,000 outstanding 3 rd
−Removed: Lind Note to the Company’s common stocks.
−Removed: During the six months ended June 30, 2025, the
−Removed: Company conducted several private offerings of its common stock to several individual investors, and issued 2,566,557 unregistered shares
−Removed: at $0.60 to $1.30 per share, raising a total of $1,868,750.
−Removed: Among these offerings, 130,771 shares are yet to be issued as of June 30,
−Removed: 2025 but issued on July 11, 2025, accounted for $170,000 fund raised.
+Added: and left 500,000 warrants, with $1.0 per share of exercise price as of the date of this report.
+Added: During the nine months ended September 30, 2025,
+Added: the Company conducted several private offerings of its common stock to several individual investors, and issued 3,083,612 unregistered
+Added: shares at $0.60 to $1.95 per share, raising a total of $2,777,120.
+Added: Among these offerings, prior unissued stocks were all issued as of
+Added: September 30, 2025.
+Added: On October 30, 2025, the Company received additional
+Added: subscriptions in the aggregate amount of $507,833 on the same terms and conditions.
+Added: Pursuant to the additional subscriptions, the Company
+Added: will issue an aggregate of 260,427 shares of the Company’s common stock by the end of 2025.
2024 Financings
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into another letter agreement (the “November Letter Agreement”), pursuant to which Lind agreed to exercise, for cash, 500,000
−Removed: of the Existing Warrants to purchase shares of Common Stock, with a current exercise price of $0.75 per share, at a reduced exercise
−Removed: price of $0.42 per share.
+Added: of the Existing Warrants to purchase shares of Common Stock, with a current exercise price of $0.75 per share, at a reduced exercise price
+Added: of $0.42 per share.
On October 18, 2024, the Company issued Lind 200,000
shares of the Company’s common stock as a repayment of $200,000 principal of 2 nd Lind Note.
−Removed: According to the
−Removed: amended agreement pursuant to Nasdaq requirements, the conversion price is subject to $1.00 floor price if the conversion price was below
−Removed: Based on the conversion price of $0.4229, the Company made an additional $147,892 cash repayment in addition to the issuance
−Removed: of 200,000 shares.
+Added: According to the amended
+Added: agreement pursuant to Nasdaq requirements, the conversion price is subject to $1.00 floor price if the conversion price was below such
+Added: Based on the conversion price of $0.4229, the Company made an additional $147,892 cash repayment in addition to the issuance of
+Added: 200,000 shares.
On September 11, 2024, the Company issued Lind
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that is convertible into shares of the Company’s common stock at a conversion price, which shall be the lesser of (i) $3.50 (the
−Removed: “Fixed Price”) and (ii) 90% of the average of the three lowest VWAPs (as defined in the 3 rd Lind Note) during
−Removed: the 20 trading days prior to conversion (“Variable Price”), subject to adjustment (the “Note Shares”).
+Added: “Fixed Price”) and (ii) 90% of the average of the three lowest VWAPs (as defined in the 3 rd Lind Note) during the
+Added: 20 trading days prior to conversion (“Variable Price”), subject to adjustment (the “Note Shares”).
Notwithstanding
−Removed: the foregoing, provided that no Event of Default (as defined in the 3 rd Lind Note) shall have occurred, conversions under
−Removed: the 3 rd Lind Note shall be at the Fixed Price for the first 180 days following the closing date.
−Removed: Lind will also receive a
−Removed: 5-year, common stock purchase warrant (the “3 rd Lind Warrant”) to purchase up to 1,000,000 shares of the Company’s
+Added: the foregoing, provided that no Event of Default (as defined in the 3 rd Lind Note) shall have occurred, conversions under the
+Added: 3 rd Lind Note shall be at the Fixed Price for the first 180 days following the closing date.
+Added: Lind will also receive a 5-year,
+Added: common stock purchase warrant (the “3 rd Lind 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, subject to adjustment (each, a “Warrant Share,” together with
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The parties later agreed to
−Removed: a floor price of $1.00 for the Variable Price and that the Company would compensate Lind in cash if the Variable Price was less than
−Removed: such floor price at the time of conversion.
+Added: a floor price of $1.00 for the Variable Price and that the Company would compensate Lind in cash if the Variable Price was less than such
+Added: floor price at the time of conversion.
Upon the occurrence of any Event of Default (as
−Removed: defined in the 3 rd Lind Note), the Company must pay Lind an amount equal to 120% of the then outstanding principal amount
−Removed: of the 3 rd Lind Note, in addition to any other remedies under the 3 rd Lind Note or the other Transaction Documents
+Added: defined in the 3 rd Lind Note), the Company must pay Lind an amount equal to 120% of the then outstanding principal amount of
+Added: the 3 rd Lind Note, in addition to any other remedies under the 3 rd Lind Note or the other Transaction Documents
(as defined below).
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new securities.
−Removed: In connection with the Offering, the Company
−Removed: and its subsidiaries:
+Added: In connection with the Offering, the Company and
+Added: its subsidiaries:
(i) Biokey, Inc., a California corporation (“BioKey”), (ii) Biolite Holding, Inc., a Nevada corporation
−Removed: (“BioLite”), (iii) Biolite BVI, Inc., a British Virgin Islands corporation (“BioLite BVI”) and (iv) American
−Removed: BriVision Corporation, a Delaware corporation (“American BriVision” and, collectively with the Company, BioKey, BioLite,
−Removed: and BioLite BVI, the “Guarantors”), jointly and severally guaranteed all of the obligations of the Company in connection
−Removed: with the offering (the “Guaranty”) with certain collateral, as set forth in the related Transaction Documents (as hereinafter
−Removed: The sale of the 3 rd Lind Note and the terms of the offering, including the Guaranty are set forth in the securities
−Removed: purchase agreement, the 3 rd Lind Note, the 3 rd Lind Warrant, the Second Amendment to Guaranty, the Second Amendment
−Removed: to Security Agreement, and the Second Amendment to Guarantor Security Agreement (collectively, the “Transaction Documents”).
+Added: (“BioLite”), (iii) Biolite BVI, Inc., a British Virgin Islands corporation (“BioLite BVI”) and (iv) American BriVision
+Added: Corporation, a Delaware corporation (“American BriVision” and, collectively with the Company, BioKey, BioLite, and BioLite
+Added: BVI, the “Guarantors”), jointly and severally guaranteed all of the obligations of the Company in connection with the offering
+Added: (the “Guaranty”) with certain collateral, as set forth in the related Transaction Documents (as hereinafter defined).
+Added: sale of the 3 rd Lind Note and the terms of the offering, including the Guaranty are set forth in the securities purchase agreement,
+Added: the 3 rd Lind Note, the 3 rd Lind Warrant, the Second Amendment to Guaranty, the Second Amendment to Security Agreement,
+Added: and the Second Amendment to Guarantor Security Agreement (collectively, the “Transaction Documents”).
Allele Capital Partners, LLC (“Allele”)
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the Company has agreed to pay certain expenses
−Removed: 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
−Removed: the same terms as set forth in the 3 rd Lind Warrant.
+Added: 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
+Added: same terms as set forth in the 3 rd Lind Warrant.
The securities purchase agreement also contains
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and other obligations and rights of the parties.
−Removed: The foregoing description of the Transaction
−Removed: Documents is qualified by reference to the full text of the forms of the Transaction Documents, which are filed as Exhibits hereto and
−Removed: incorporated herein by reference.
+Added: The foregoing description of the Transaction Documents
+Added: is qualified by reference to the full text of the forms of the Transaction Documents, which are filed as Exhibits hereto and incorporated
+Added: herein by reference.
Financing in 2023
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subject to adjustment.
−Removed: Notwithstanding the foregoing, provided that no Event of Default (as defined in the 2 nd Lind Note)
−Removed: shall have occurred, conversions under the 2 nd Lind Note shall be at the Fixed Price for the first 180 days following the
−Removed: closing date.
−Removed: Lind will also receive a 5-year, common stock purchase warrant (the “2 nd Lind Warrant”) to purchase
−Removed: up to 1,000,000 shares of the Company’s common stock at an initial exercise price of $2 per share, subject to adjustment.
+Added: Notwithstanding the foregoing, provided that no Event of Default (as defined in the 2 nd Lind Note) shall
+Added: have occurred, conversions under the 2 nd Lind Note shall be at the Fixed Price for the first 180 days following the closing
+Added: Lind will also receive a 5-year, common stock purchase warrant (the “2 nd Lind Warrant”) to purchase up to
+Added: 1,000,000 shares of the Company’s common stock at an initial exercise price of $2 per share, subject to adjustment.
later agreed to a floor price of $1.00 for the Variable Price and that the Company would compensate Lind in cash if the variable price
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Upon the occurrence of any Event of Default (as
−Removed: defined in the 2 nd Lind Note), the Company must pay Lind an amount equal to 120% of the then outstanding principal amount
−Removed: of the 2 nd Lind Note, in addition to any other remedies under the 2 nd Lind Note or the other Transaction Documents
+Added: defined in the 2 nd Lind Note), the Company must pay Lind an amount equal to 120% of the then outstanding principal amount of
+Added: the 2 nd Lind Note, in addition to any other remedies under the 2 nd Lind Note or the other Transaction Documents
(as defined below).
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corporation (“BioLite”), (iii) Biolite BVI, Inc., a British Virgin Islands corporation (“BioLite BVI”) and (iv)
−Removed: American BriVision Corporation, a Delaware corporation (“American BriVision” and, collectively with the Company, BioKey,
−Removed: BioLite, and BioLite BVI, the “Guarantors”), jointly and severally guaranteed all of the obligations of the Company in connection
−Removed: with the 2 nd Lind Offering (the “Guaranty”) with certain collateral, as set forth in the related Transaction Documents
+Added: American BriVision Corporation, a Delaware corporation (“American BriVision” and, collectively with the Company, BioKey, BioLite,
+Added: and BioLite BVI, the “Guarantors”), jointly and severally guaranteed all of the obligations of the Company in connection with
+Added: the 2 nd Lind Offering (the “Guaranty”) with certain collateral, as set forth in the related Transaction Documents
(as hereinafter defined).
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and other obligations and rights of the parties.
−Removed: The foregoing description of the Transaction
−Removed: Documents is qualified by reference to the full text of the forms of the Transaction Documents, which are filed as Exhibits hereto and
−Removed: incorporated herein by reference.
−Removed: As of June 30, 2024, this February 2023 Lind
−Removed: Note was fully repaid.
+Added: The foregoing description of the Transaction Documents
+Added: is qualified by reference to the full text of the forms of the Transaction Documents, which are filed as Exhibits hereto and incorporated
+Added: herein by reference.
+Added: As of June 30, 2024, this February 2023 Lind Note
+Added: was fully repaid.
On February 23, 2023, the Company entered into a securities purchase agreement (the “Lind Securities Purchase
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(the “Monthly Payments”).
−Removed: At the Company’s discretion, the Monthly Payments shall be made in (i) cash, (ii) shares
−Removed: of the Company’s common stock, or (iii) a combination of cash and Shares;
+Added: At the Company’s discretion, the Monthly Payments shall be made in (i) cash, (ii) shares of
+Added: the Company’s common stock, or (iii) a combination of cash and Shares;
if made in shares, the number of shares shall be determined
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In addition, if the Company is unable to increase its market capitalization and is unable
−Removed: to obtain a further waiver or amendment to the Lind Note, then the Company could experience an event of default under the Lind Note,
−Removed: which could have a material adverse effect on the Company’s liquidity, financial condition, and results of operations.
−Removed: cannot make any assurances regarding the likelihood, certainty, or exact timing of the Company’s ability to increase its market
−Removed: capitalization, as such metric is not within the immediate control of the Company and depends on a variety of factors outside the Company’s
+Added: to obtain a further waiver or amendment to the Lind Note, then the Company could experience an event of default under the Lind Note, which
+Added: could have a material adverse effect on the Company’s liquidity, financial condition, and results of operations.
+Added: The Company cannot
+Added: make any assurances regarding the likelihood, certainty, or exact timing of the Company’s ability to increase its market capitalization,
+Added: as such metric is not within the immediate control of the Company and depends on a variety of factors outside the Company’s control.
The Lind Warrant may be exercised via cashless
−Removed: Pursuant to the terms of the Lind Securities
−Removed: Purchase Agreement, if at any time prior to a date that is 18 months following the closing of the Lind Offering, the Company proposes
−Removed: to offer or sell any additional securities in a subsequent financing, the Company shall first offer Lind the opportunity to purchase
−Removed: up to 10% of such new securities.
+Added: Pursuant to the terms of the Lind Securities Purchase
+Added: Agreement, if at any time prior to a date that is 18 months following the closing of the Lind Offering, the Company proposes to offer
+Added: or sell any additional securities in a subsequent financing, the Company shall first offer Lind the opportunity to purchase up to 10%
+Added: of such new securities.
In connection with the Lind Offering, the Company
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(i) BioKey, Inc., a California corporation (“BioKey”), (ii) Biolite Holding, Inc., a Nevada corporation
−Removed: (“BioLite”), (iii) Biolite BVI, Inc., a British Virgin Islands corporation (“BioLite BVI”) and (iv) American
−Removed: BriVision Corporation, a Delaware corporation (“American BriVision” and, collectively with the Company, BioKey, BioLite,
−Removed: and BioLite BVI, the “Guarantors”), jointly and severally guaranteed all of the obligations of the Company in connection
−Removed: with the Lind Offering (the “Guaranty”) with certain collateral, as set forth in the related Transaction Documents (as hereinafter
+Added: (“BioLite”), (iii) Biolite BVI, Inc., a British Virgin Islands corporation (“BioLite BVI”) and (iv) American BriVision
+Added: Corporation, a Delaware corporation (“American BriVision” and, collectively with the Company, BioKey, BioLite, and BioLite
+Added: BVI, the “Guarantors”), jointly and severally guaranteed all of the obligations of the Company in connection with the Lind
+Added: Offering (the “Guaranty”) with certain collateral, as set forth in the related Transaction Documents (as hereinafter defined).
The sale of the Lind Note and the terms of the
Lind Offering, including the Guaranty are set forth in the Lind Securities Purchase Agreement, the Note, the Warrant, a Security Agreement,
−Removed: Guarantor Security, Guaranty, a Trademark Security Agreement with Rgene Corporation, a Trademark Security Agreement with BioFirst, a
−Removed: Patent Security Agreement, a Copyright Security Agreement and a Stock Pledge Agreement (collectively, the “Transaction Documents”).
+Added: Guarantor Security, Guaranty, a Trademark Security Agreement with Rgene Corporation, a Trademark Security Agreement with BioFirst, a Patent
+Added: Security Agreement, a Copyright Security Agreement and a Stock Pledge Agreement (collectively, the “Transaction Documents”).
Allele Capital Partners, LLC (“Allele”)
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purchase warrants to purchase 6% of the number of shares of common stock issuable under the Lind Note.
−Removed: We also agreed to pay certain
−Removed: expenses of the placement agent in connection with the Lind Offering.
+Added: We also agreed to pay certain expenses
+Added: of the placement agent in connection with the Lind Offering.
Pursuant to the Lind Securities Purchase Agreement,
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million for 10 consecutive days through February 23, 2024.
−Removed: Notwithstanding the waiver, Lind retains its right to exercise conversion
−Removed: rights under 2.2(a), 2.2(c)(2)(x) and 3.1 of the Note, which could result in a substantial amount of common stock issued at a significant
−Removed: discount to the trading price of the Company’s common stock.
+Added: Notwithstanding the waiver, Lind retains its right to exercise conversion rights
+Added: under 2.2(a), 2.2(c)(2)(x) and 3.1 of the Note, which could result in a substantial amount of common stock issued at a significant discount
+Added: to the trading price of the Company’s common stock.
In addition, if the Company is unable to increase its market capitalization
3 unchanged sentences
capitalization, as such metric is not within the immediate control of the Company and depends on a variety of factors outside the Company’s
−Removed: The foregoing description of the Transaction
−Removed: Documents is qualified by reference to the full text of the forms of the Transaction Documents, which are filed as Exhibits hereto and
−Removed: incorporated herein by reference.
+Added: The foregoing description of the Transaction Documents
+Added: is qualified by reference to the full text of the forms of the Transaction Documents, which are filed as Exhibits hereto and incorporated
+Added: herein by reference.
On August 1, 2023, Lind converted $500,000 convertible
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Key elements of our business strategy include:
−Removed: to the pivotal trial phase of ABV-1701 Vitargus ® for the treatments of Retinal
−Removed: Detachment or Vitreous Hemorrhage, which we expect to generate revenues in the future.
−Removed: on licensing ABV-1504 for the treatment of major depressive disorder, MDD, after the successful
−Removed: completion of its Phase II clinical trials.
−Removed: Phase II, Part 2 clinical trial for ABV-1505 for the treatment of attention deficit hyperactivity
−Removed: disorder, ADHD.
−Removed: licensing drug candidates and medical device candidates to major pharmaceutical companies
−Removed: for phase III and pivotal clinical trials, as applicable, and further marketing if approved
+Added: Advancing to the pivotal trial phase of ABV-1701 Vitargus ® for the treatments of Retinal Detachment or Vitreous Hemorrhage, which we expect to generate revenues in the future.
+Added: Focusing on licensing ABV-1504 for the treatment of major depressive disorder, MDD, after the successful completion of its Phase II clinical trials.
+Added: Completing Phase II, Part 2 clinical trial for ABV-1505 for the treatment of attention deficit hyperactivity disorder, ADHD.
+Added: Out licensing drug candidates and medical device candidates to major pharmaceutical companies for phase III and pivotal clinical trials, as applicable, and further marketing if approved by the FDA.
We plan to augment our core research and development
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The terms of these agreements typically include payment to the Company related to one or more of the following:
−Removed: ● nonrefundable
−Removed: upfront license fees,
−Removed: ● development
−Removed: and commercial milestones,
−Removed: or complete reimbursement of research and development costs and
−Removed: on net sales of licensed products.
+Added: nonrefundable upfront license fees,
+Added: development and commercial milestones,
+Added: partial or complete reimbursement of research and development costs and
+Added: royalties on net sales of licensed products.
Each type of payments results in revenue except
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The Company had multiple deliverables under the
−Removed: collaborative agreements, including deliverables relating to grants of technology licenses, regulatory and clinical development, and
−Removed: marketing activities.
−Removed: Estimation of the performance periods of the Company’s deliverables requires the use of management’s
−Removed: Significant factors considered in management’s evaluation of the estimated performance periods include, but are not limited
−Removed: to, the Company’s experience in conducting clinical development, regulatory and manufacturing activities.
−Removed: The Company reviews the
−Removed: estimated duration of its performance periods under its collaborative agreements on an annual basis, and makes any appropriate adjustments
−Removed: on a prospective basis.
−Removed: Future changes in estimates of the performance period under its collaborative agreements could impact the timing
−Removed: of future revenue recognition.
−Removed: Collaborative agreement with
−Removed: ForSeeCon Eye Corporation, a related party
+Added: collaborative agreements, including deliverables relating to grants of technology licenses, regulatory and clinical development, and marketing
+Added: Estimation of the performance periods of the Company’s deliverables requires the use of management’s judgment.
+Added: Significant factors considered in management’s evaluation of the estimated performance periods include, but are not limited to,
+Added: the Company’s experience in conducting clinical development, regulatory and manufacturing activities.
+Added: The Company reviews the estimated
+Added: duration of its performance periods under its collaborative agreements on an annual basis, and makes any appropriate adjustments on a
+Added: prospective basis.
+Added: Future changes in estimates of the performance period under its collaborative agreements could impact the timing of
+Added: future revenue recognition.
+Added: Collaborative agreement with ForSeeCon Eye
+Added: Corporation, a related party
On March 25, 2024, the Company and BioFirst each
2 unchanged sentences
pipeline, including Vitargus (the “Vitargus Products”).
−Removed: The license covers the Vitargus Products’ clinical trial, registration,
+Added: The license covers Vitargus Products’ clinical trial, registration,
manufacturing, supply, and distribution rights;
5 unchanged sentences
Additionally, each of the Company and BioFirst are eligible to receive royalties of 5% of net Sales.
−Removed: June 30, 2025, the Company has received 5,000,000 FEYE shares but did not recognize such licensing revenue since the fair value of FEYE
−Removed: stock is uncertain.
+Added: September 30, 2025, the Company has received 5,000,000 FEYE shares but did not recognize such licensing revenue since the fair value of
+Added: FEYE stock is uncertain.
On June 18, 2024, the Company and BioFirst, each
2 unchanged sentences
(such as $100,000), at any given time, rather than in one lump sum.
−Removed: In 2024 the Company received in cash and recognized revenue $296,000,
−Removed: pursuant to the Amendment.
−Removed: There was no transaction incurred during the period ended June 30, 2025.
+Added: For the nine months ended September 30, 2025 and 2024, the Company
+Added: received $200,000 and $296,000, respectively, as partial milestone payments and recognized as licensing revenue according to ASC 606.
Collaborative agreement with OncoX BiopPharma,
Inc., a related party
−Removed: On April 16, 2024, the Company entered into a
−Removed: definitive agreement with OncoX BioPharma, Inc., a private company registered in the British Virgin Islands (“Oncox”), pursuant
−Removed: to which the Company will grant Oncox an exclusive right to develop and commercialize ABVC’s single-herb botanical drug extract
−Removed: from the dry fruit body of Maitake Mushroom (Grifola Frondosa) for treatment of Non-Small Cell Lung Cancer (the “Lung Cancer Products”),
−Removed: within North America for 20 years (the “April 2024 Oncox Agreement”).
−Removed: In consideration thereof, Oncox shall pay ABVC $6,250,000
−Removed: (or 1,250,000 Oncox shares valued at $5 per share 1 ) 30 days after entering into the agreement and $625,000, 30 days following
−Removed: the completion of Oncox’s next round of fundraising, of which there is no guarantee;
−Removed: ABVC is also entitled to 5% royalties based
−Removed: on the Net Sales, as defined in the April 2024 Oncox Agreement, from the first commercial sale of the Lung Cancer Product in North America,
−Removed: of which there can be no guarantee.
−Removed: Oncox entered into another agreement with ABVC’s affiliate, Rgene Corporation, on the same
−Removed: terms.In 2024 the Company received in cash and recognized revenue of $200,000, pursuant to the agreement.
+Added: On April 16, 2024, the Company entered into a definitive agreement
+Added: with OncoX BioPharma, Inc., a private company registered in the British Virgin Islands (“Oncox”), pursuant to which the Company
+Added: will grant Oncox an exclusive right to develop and commercialize ABVC’s single-herb botanical drug extract from the dry fruit body
+Added: of Maitake Mushroom (Grifola Frondosa) for treatment of Non-Small Cell Lung Cancer (the “Lung Cancer Products”), within North
+Added: America for 20 years (the “April 2024 Oncox Agreement”).
+Added: In consideration thereof, Oncox shall pay ABVC $6,250,000 (or 1,250,000
+Added: Oncox shares valued at $5 per share 1 ) 30 days after entering into the agreement and $625,000, 30 days following the completion
+Added: of Oncox’s next round of fundraising, of which there is no guarantee;
+Added: ABVC is also entitled to 5% royalties based on the Net Sales,
+Added: as defined in the April 2024 Oncox Agreement, from the first commercial sale of the Lung Cancer Product in North America, of which there
+Added: can be no guarantee.
+Added: Oncox entered into another agreement with ABVC’s affiliate, Rgene Corporation, on the same terms.
+Added: months ended September 30, 2025 and 2024, the Company received $595,950 and $200,000 as partial milestone payments and recognized as licensing
+Added: revenue according to ASC 606.
On May 8, 2024, the Company entered into a definitive
19 unchanged sentences
in cash after OncoX’s next round of fundraising, of which there can be no guarantee.
−Removed: Oncox may remit cash payments of
−Removed: at least $100,000 towards the licensing fees and deductible from the second milestone payment;
−Removed: each licensor is also entitled to royalties
−Removed: of 5% of Net Sales, from the first commercial sale of the TNBC Product in the noted territory, which remains uncertain.
−Removed: The Company will
−Removed: permit Oncox to pay the license fee in installments or in a lump sum and will allow Oncox to use its revenue to fund such payments.
+Added: Oncox may remit cash payments of at least $100,000
+Added: towards the licensing fees and deductible from the second milestone payment;
+Added: each licensor is also entitled to royalties of 5% of Net
+Added: Sales, from the first commercial sale of the TNBC Product in the noted territory, which remains uncertain.
+Added: The Company will permit Oncox
+Added: to pay the license fee in installments or in a lump sum and will allow Oncox to use its revenue to fund such payments.
On May 23, 2024, the Company and its subsidiary,
11 unchanged sentences
Oncox may use its revenue to fund the licensing fees.
−Removed: Collaborative agreements with
−Removed: BHK, a related party
−Removed: (i) In February and December of
−Removed: 2015, BioLite, Inc.
−Removed: entered into a total of three joint venture agreements with BioHopeKing to jointly develop ABV-1501 for Triple Negative
−Removed: Breast Cancer (TNBC), ABV-1504 for MDD and ABV-1505 for ADHD.
−Removed: The agreements granted marketing rights to BioHopeKing for certain Asian
−Removed: countries in return for a series of milestone payments totaling $10 million in cash and equity of BioHopeKing or equity securities owned
−Removed: by BioHopeKing.
+Added: Collaborative agreements with BHK, a related
+Added: In February and December of 2015, BioLite, Inc.
+Added: entered into a total of three joint venture agreements with BioHopeKing to jointly develop ABV-1501 for Triple Negative Breast Cancer (TNBC), ABV-1504 for MDD and ABV-1505 for ADHD.
+Added: The agreements granted marketing rights to BioHopeKing for certain Asian countries in return for a series of milestone payments totaling $10 million in cash and equity of BioHopeKing or equity securities owned by BioHopeKing.
The milestone payments are determined by a schedule
5 unchanged sentences
New Drug Application (NDA) Submission
−Removed: December of 2015, BHK paid the initial cash payment of $1 million upon the execution of the
−Removed: BHK Agreement.
−Removed: The Company concluded that certain deliverables are considered separate units
−Removed: of accounting as the delivered items have value to the customer on a standalone basis and
−Removed: recognized this cash payment as collaboration revenue when all research, technical, and development
−Removed: data was delivered to BHK in 2015.
−Removed: The payment included compensation for past research efforts
−Removed: and contributions made by BioLite Taiwan before the BHK agreement was signed and does not
−Removed: relate to any future commitments made by BioLite Taiwan and BHK in the BHK Agreement.
−Removed: August 2016, the Company received the second milestone payment of $1 million, and recognized
−Removed: collaboration revenue for the year ended December 31, 2016.
−Removed: The Company completed the phase
−Removed: II clinical trial for ABV-1504 MDD on October 31, 2019, but has not yet completed the phase
−Removed: II clinical trial for ABV-1505 ADHD.
−Removed: addition to the milestone payments, BioLite Inc.
−Removed: is entitled to receive a royalty equal to
−Removed: 12% of BHK’s net sales related to ABV-1501, ABV-1504 and ABV-1505 Products.
−Removed: 30, 2025, the Company has not earned royalties under the BHK Co-Development Agreement.
−Removed: BHK Co-Development Agreement will remain in effect for fifteen years from the date of first
−Removed: commercial sale of the Product in in Asia excluding Japan.
+Added: In December of 2015, BHK paid the initial cash payment of $1 million upon the execution of the BHK Agreement.
+Added: The Company concluded that certain deliverables are considered separate units of accounting as the delivered items have value to the customer on a standalone basis and recognized this cash payment as collaboration revenue when all research, technical, and development data was delivered to BHK in 2015.
+Added: The payment included compensation for past research efforts and contributions made by BioLite Taiwan before the BHK agreement was signed and does not relate to any future commitments made by BioLite Taiwan and BHK in the BHK Agreement.
+Added: In August 2016, the Company received the second milestone payment of $1 million, and recognized collaboration revenue for the year ended December 31, 2016.
+Added: The Company completed the phase II clinical trial for ABV-1504 MDD on October 31, 2019, but has not yet completed the phase II clinical trial for ABV-1505 ADHD.
+Added: In addition to the milestone payments, BioLite Inc.
+Added: is entitled to receive a royalty equal to 12% of BHK’s net sales related to ABV-1501, ABV-1504 and ABV-1505 Products.
+Added: As of September 30, 2025, the Company has not earned royalties under the BHK Co-Development Agreement.
+Added: The BHK Co-Development Agreement will remain in effect for fifteen years from the date of first commercial sale of the Product in in Asia excluding Japan.
Co-Development agreement with BioLite Japan
9 unchanged sentences
other territory or businesses as may from time to time be agreed by an amendment to the Agreement.
−Removed: The closing of the transaction is
−Removed: conditioned upon the approval and receipt of all necessary government approvals, which have been received.
+Added: The closing of the transaction is conditioned
+Added: upon the approval and receipt of all necessary government approvals, which have been received.
Pursuant to the Agreement and the related share
3 unchanged sentences
there shall be 3 directors of BioLite JP, consisting of 1 director appointed by the Company and 2 appointed by Lucidiam.
−Removed: shall appoint Eugene Jiang, the Company’s current Chairman and Chief Business Officer and Lucidaim shall appoint Michihito Onishi;
−Removed: the current director of BioLite JP, Toru Seo (who is also a director of BioLite Japan’s other shareholder), is considered the second
+Added: The Company shall
+Added: appoint Eugene Jiang, the Company’s current Chairman and Chief Business Officer and Lucidaim shall appoint Michihito Onishi;
+Added: current director of BioLite JP, Toru Seo (who is also a director of BioLite Japan’s other shareholder), is considered the second
Lucidaim director.
3 unchanged sentences
on the Completion Date.
−Removed: As per the Agreement, the Shareholders shall
−Removed: supervise and manage the business and operations of BioLite JP.
−Removed: The directors shall not be entitled to any renumeration for their services
−Removed: as a director and each Shareholder can remove and replace the director he/she/it appointed.
−Removed: If a Shareholder sells or disposes of all
−Removed: of its Ordinary Shares, the director such Shareholder appointed must tender his/her resignation.
−Removed: The Agreement also sets forth certain
−Removed: corporate actions that must be pre-approved by all Shareholders (the “Reserved Matters”).
−Removed: If the Shareholders are unable
−Removed: to make a decision on any Reserved Matter, then either Shareholder can submit a deadlock notice to the other shareholder, 5 days after
−Removed: which they must refer the matter to each Shareholder’s chairman and use good faith to resolve the dispute.
−Removed: If such dispute is not
−Removed: resolved within 10 days thereafter, then either Shareholder can offer to buy all of the other Shareholder’s Ordinary Shares for
−Removed: cash at a specified price;
+Added: As per the Agreement, the Shareholders shall supervise
+Added: and manage the business and operations of BioLite JP.
+Added: The directors shall not be entitled to any renumeration for their services as a
+Added: director and each Shareholder can remove and replace the director he/she/it appointed.
+Added: If a Shareholder sells or disposes of all of its
+Added: Ordinary Shares, the director such Shareholder appointed must tender his/her resignation.
+Added: The Agreement also sets forth certain corporate
+Added: actions that must be pre-approved by all Shareholders (the “Reserved Matters”).
+Added: If the Shareholders are unable to make a decision
+Added: on any Reserved Matter, then either Shareholder can submit a deadlock notice to the other shareholder, 5 days after which they must refer
+Added: the matter to each Shareholder’s chairman and use good faith to resolve the dispute.
+Added: If such dispute is not resolved within 10 days
+Added: thereafter, then either Shareholder can offer to buy all of the other Shareholder’s Ordinary Shares for cash at a specified price;
if there is not affirmative acceptance of the sale, the sale shall proceed as set forth in the sale offer.
10 unchanged sentences
each Shareholder agrees to guarantee such bank facility if the bank requires a guarantee.
−Removed: Accordingly, the Company may be liable for
−Removed: the bank facility in an amount up to JPY 14,925,400 (approximately $134,000), which represents 49% of the maximum bank facility.
−Removed: Agreement further provides that BioLite JP shall issue annual dividends at the rate of at least 1.5% of Biolite’s profits, if it
−Removed: has sufficient cash to do so.
+Added: Accordingly, the Company may be liable for the
+Added: bank facility in an amount up to JPY 14,925,400 (approximately $134,000), which represents 49% of the maximum bank facility.
+Added: The Agreement
+Added: further provides that BioLite JP shall issue annual dividends at the rate of at least 1.5% of Biolite’s profits, if it has sufficient
+Added: cash to do so.
Pursuant to the agreement between the Company
35 unchanged sentences
In addition, BioKey provides a variety of regulatory
−Removed: services tailored to the needs of its customers, which include proofreading and regulatory review of submission documents related to
−Removed: formulation development, clinical trials, marketed products, generics, nutraceuticals and OTC products and training presentations.
−Removed: addition to supporting ABVC’s new drug development, BioKey submits INDs, NDAs, ANDAs, and DMFs to the FDA, on ABVC’s behalf
−Removed: in compliance with new electronic submission guidelines of the FDA.
+Added: services tailored to the needs of its customers, which include proofreading and regulatory review of submission documents related to formulation
+Added: development, clinical trials, marketed products, generics, nutraceuticals and OTC products and training presentations.
+Added: In addition to
+Added: supporting ABVC’s new drug development, BioKey submits INDs, NDAs, ANDAs, and DMFs to the FDA, on ABVC’s behalf in compliance
+Added: with new electronic submission guidelines of the FDA.
Impact of COVID-19 Outbreak
26 unchanged sentences
with policy changes planned for the summer will further increase research activity and support a return to pre-COVID-19 demand levels
−Removed: The global pandemic of COVID-19 continues to
−Removed: evolve rapidly, and we will continue to monitor the situation closely, including its potential effect on our plans and timelines.
−Removed: Additionally, it is reasonably possible that
−Removed: estimates made in the financial statements have been, or will be, materially and adversely impacted in the near term as a result of these
−Removed: conditions, including losses on inventory;
+Added: The global pandemic of COVID-19 continues to evolve
+Added: rapidly, and we will continue to monitor the situation closely, including its potential effect on our plans and timelines.
+Added: Additionally, it is reasonably possible that estimates
+Added: made in the financial statements have been, or will be, materially and adversely impacted in the near term as a result of these conditions,
+Added: including losses on inventory;
impairment losses related to goodwill and other long-lived assets and current obligations.
1 unchanged sentence
The Company restated its financial statements
−Removed: as of and for the year ended December 31, 2023 (the “2023 Restatement”), to correct misstatements in those prior periods
−Removed: related to improperly applying accounting guidance on the share-based payments, incorrectly recognizing interest expenses upon the conversion
+Added: as of and for the year ended December 31, 2023 (the “2023 Restatement”), to correct misstatements in those prior periods related
+Added: to improperly applying accounting guidance on the share-based payments, incorrectly recognizing interest expenses upon the conversion
of convertible debts, and misidentifying the existence of non-controlling interest of our subsidiary.
13 unchanged sentences
Upon further review, the Company considered ASC 718 Compensation - Stock Compensation,
−Removed: should have been the appropriate guidance to apply given the Company’s common stocks are listed in Nasdaq with more observable
−Removed: fair value (Level 1).
−Removed: Furthermore, at the time of issuance of these financial statements, no real estate title was transferred to the
−Removed: As a result, the Company adjusted the carrying value of the asset and reclassified the balance to “Prepayment for asset
−Removed: acquisition” account to reflect the value of 370,000 shares issued at $1.87, the closing price as of the contract date.
−Removed: also corrected the share price used to recognize stock compensation expense from $20 to $1.87 for the 29,600 shares of common stock issued
−Removed: on the same day to several consultants.
+Added: should have been the appropriate guidance to apply given the Company’s common stocks are listed in Nasdaq with more observable fair
+Added: value (Level 1).
+Added: Furthermore, at the time of issuance of these financial statements, no real estate title was transferred to the Company.
+Added: As a result, the Company adjusted the carrying value of the asset and reclassified the balance to “Prepayment for asset acquisition”
+Added: account to reflect the value of 370,000 shares issued at $1.87, the closing price as of the contract date.
+Added: The Company also corrected
+Added: the share price used to recognize stock compensation expense from $20 to $1.87 for the 29,600 shares of common stock issued on the same
+Added: day to several consultants.
As a result, these adjustments reduced $6,708,100 for asset recognized and $536,648 for stock-compensation
4 unchanged sentences
for the year ended December 31, 2023.
−Removed: The overstatement is offsetting against additional paid-in capital due to the convertible
−Removed: note being converted to the Company’s own common stocks instead of being repaid or disposition.
−Removed: In November 2023, the Company and one of its
−Removed: subsidiaries entered into a licensing agreement with AiBtl.
−Removed: The Company accounted for a 100% control of AiBtl as of December 31, 2023,
−Removed: but later discovered that AiBtl had outstanding founder shares that were not deposited to the stock transfer agent in the timely manner.
−Removed: Such shares reduced the Company’s controlling interest from 100% to 69.70%.
−Removed: Accordingly, the Company adjusted the relevant accounts
−Removed: in our consolidated financial statements.
+Added: The overstatement is offsetting against additional paid-in capital due to the convertible note being
+Added: converted to the Company’s own common stocks instead of being repaid or disposition.
+Added: In November 2023, the Company and one of its subsidiaries
+Added: entered into a licensing agreement with AiBtl.
+Added: The Company accounted for a 100% control of AiBtl as of December 31, 2023, but later discovered
+Added: that AiBtl had outstanding founder shares that were not deposited to the stock transfer agent in the timely manner.
+Added: Such shares reduced
+Added: the Company’s controlling interest from 100% to 69.70%.
+Added: Accordingly, the Company adjusted the relevant accounts in our consolidated
+Added: financial statements.
As discussed in Note 12 to the financial statements
5 unchanged sentences
costs of services should be recognized along with the period when services are received.
−Removed: Therefore, the Company reversed share-based
−Removed: compensation expenses of $451,480 and $902,960 for the years ended December 31, 2024 and 2023, respectively.
−Removed: The accumulated deficit
−Removed: as of December 31, 2022, was corrected with the Stock Subscription Receivables for $1,354,440 as a result of such adjustments.
−Removed: For further details about the impact of the Restatement,
−Removed: please see the Notes to the Company’s financial statements for the year ended December 31, 2024, included in its Annual Report
−Removed: on Form 10-K that was filed with the SEC on April 15, 2025.
−Removed: After discussing the issue with Simon & Edward, LLP (“S&E”),
−Removed: the Company’s management determined that the Company is not required to file an amendment to the Annual Report on Form 10-K for
−Removed: the year ended December 31, 2023.
+Added: Therefore, the Company reversed share-based compensation
+Added: expenses of $451,480 and $902,960 for the years ended December 31, 2024 and 2023, respectively.
+Added: The accumulated deficit as of December
+Added: 31, 2022, was corrected with the Stock Subscription Receivables for $1,354,440 as a result of such adjustments.
+Added: For further details about the impact of the restatement, please see
+Added: the Notes to the Company’s financial statements for the year ended December 31, 2024, included in its Annual Report on Form 10-K
+Added: that was filed with the SEC on April 15, 2025.
+Added: After discussing the issue with Simon & Edward, LLP (“S&E”), the Company’s
+Added: management determined that the Company is not required to file an amendment to the Annual Report on Form 10-K for the year ended December
Summary of Critical Accounting Policies
4 unchanged sentences
in preparing quarterly and annual financial statements.
−Removed: Certain information and footnote disclosures normally included in the annual
−Removed: consolidated financial statements prepared in accordance with accounting principles generally accepted in the United States of America
+Added: Certain information and footnote disclosures normally included in the annual consolidated
+Added: financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“U.S.
GAAP”) have been condensed or omitted.
−Removed: These unaudited consolidated financial statements should be read in conjunction
−Removed: with the Company’s audited consolidated financial statements and notes thereto included in the Company’s Annual Report on
−Removed: Form 10-K for the year ended December 31, 2024, filed with the SEC on April 15, 2025 (“2024 Form 10-K.”)
+Added: These unaudited consolidated financial statements should be read in conjunction with the
+Added: Company’s audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K
+Added: for the year ended December 31, 2024, filed with the SEC on April 15, 2025 (“2024 Form 10-K.”)
Estimates and Assumptions
6 unchanged sentences
Recent Accounting Pronouncements
−Removed: In August 2023, the FASB issued ASU 2023-05,
−Removed: Business Combinations-Joint Venture Formations (Subtopic 805-60) which requires certain joint ventures to apply a new basis of accounting
−Removed: upon formation by recognizing and initially measuring most of their assets and liabilities at fair value.
−Removed: The guidance does not apply
−Removed: to joint ventures that may be proportionately consolidated and those that are collaborative arrangements.
−Removed: ASU 2023-05 is effective for
−Removed: joint venture with a formation date on or after January 1, 2025, early adoption is permitted.
−Removed: The Company is currently evaluating the
−Removed: impact that the standard will have on its unaudited consolidated financial statements.
−Removed: Results of Operations - Three
−Removed: Months Ended June 30, 2025 Compared to Three Months Ended June 30, 2024.
+Added: In November 2024, the FASB issued ASU No.
+Added: Expense Disaggregation Disclosures (Subtopic 220-40).
+Added: The ASU requires disclosure of specified information about certain costs and expenses.
+Added: This includes purchases of inventory, employee compensation, depreciation, and intangible asset amortization.
+Added: The ASU is effective
+Added: on a prospective or retrospective basis for the annual reporting period beginning after December 15, 2026, and interim reporting period
+Added: beginning after December 15, 2027.
+Added: Early adoption is permitted.
+Added: This ASU will likely result in the required additional disclosures being
+Added: included in our consolidated financial statements once adopted.
+Added: Recent Business Developments
+Added: Land and Infrastructure Investment
+Added: During the quarter, the Company advanced its infrastructure
+Added: development strategy through the acquisition and planning of land assets in Taiwan, including the Shuling property in Taoyuan.
+Added: This investment
+Added: supports the establishment of future research, development, and manufacturing facilities intended to enhance long-term operational capabilities
+Added: and reduce reliance on third-party contractors.
+Added: Intergroup/Related Party Funding and Strategic Support
+Added: The Company provided short-term operational funding
+Added: support to BioFirst to maintain progress toward regulatory and manufacturing milestones.
+Added: These advances are intended to safeguard the
+Added: value of the Company’s existing investment and facilitate future cash inflows once BioFirst’s GMP pilot plant becomes operational
+Added: and clinical materials for Vitargus® are produced for pivotal trials.
+Added: Strengthened Capital Structure
+Added: The Company completed the full repayment of
+Added: its outstanding convertible notes (the Lind Notes) with Lind Partners, significantly reducing debt obligations and potential
+Added: dilution therefrom.
+Added: The deleveraging has strengthened the Company’s financial flexibility and improved its balance sheet position for
+Added: future partnerships and capital market activities.
+Added: Integration and Collaboration Progress within the ABVC group
+Added: ABVC continued to align its subsidiary, AiBtl
+Added: BioPharma, and equity investments, OncoX BioPharma, and ForSeeCon Eye Corporation, with the Company’s business strategies and operational
+Added: While intercompany transactions are eliminated in the consolidated financial statements, these collaborations have and will
+Added: continue to improve resource utilization, accelerate product development, and support early-stage licensing and service revenues across
+Added: Outlook and Cash Flow Planning
+Added: Management is focused on converting its strategic
+Added: investments into sustainable revenue through licensing, milestone payments, and the expansion of its CDMO service platform to CRDMO platform
+Added: as a one-shot solution for pharmaceutical solutions.
+Added: The Company anticipates that ongoing affiliate integration and project execution
+Added: will contribute positively to cash flows over the next 12 months.
+Added: Results of Operations - Three Months
+Added: Ended September 30, 2025 Compared to Three Months Ended September 30, 2024.
The following table presents, for the three months
1 unchanged sentence
Three Months Ended
+Added: 2024 (Restated)
Gross Profits
2 unchanged sentences
$ (1,168,410 )
−Removed: $ (1,434,876 )
Other Income (Expense)
−Removed: Interest (Expense), Net
+Added: Interest Income (Expense), Net
Net Income (Loss)
$ (1,287,523 )
−Removed: $ (1,047,412 )
−Removed: $ (1,285,421 )
−Removed: We generated $0 and $117,142
−Removed: in revenues for the three months ended June 30, 2025 and 2024, respectively.
−Removed: The revenue recognized in 2024 was mainly due to the milestone
−Removed: revenue recognized from licensing to ForSeeCon.
−Removed: Operating Expenses.
−Removed: Our operating
−Removed: expenses have increased by $1,317,924 or 135%, to $2,294,983 for the three months ended June 30, 2025 from $977,059 for the three months
−Removed: ended June 30, 2024.
−Removed: Such an increase in operating expenses was mainly due to the Company hired certain consultants and advisors for business
−Removed: opportunity and financial advisory services during this period.
−Removed: Other Income (Expense) .
−Removed: expense was $14,223 for the three months ended June 30, 2025, compared to other expense of $289,199 for the three months ended June 30,
−Removed: The change was principally caused by the decrease in interest expense and increase in foreign exchange income.
−Removed: Interest income (expense), net.
−Removed: was $(110,274) for the three months ended June 30, 2025, compared to ($179,938) for the three months ended June 30, 2024.
−Removed: of $69,664, or approximately 39%, was primarily due to the decrease in interest expense due to less amount of converted notes resulted
−Removed: in less amount of interest expenses.
−Removed: As a result of the
−Removed: above factors, our net loss was $2,332,833 for the three months ended June 30, 2025 compared to $1,047,412 for the three months ended
−Removed: June 30, 2024, representing an increase of $1,285,421, or 123%.
−Removed: Results of Operations - Six Months Ended June
−Removed: 30, 2025 Compared to Six Months Ended June 30, 2024.
−Removed: The following table presents, for the six months
+Added: Revenues We generated $795,950 and
+Added: $389,276 in revenues for the three months ended September 30, 2025 and 2024, respectively.
+Added: The revenue recognized in 2025 was mainly due
+Added: to the milestone revenue recognized from licensing to OncoX and ForSeeCon, while we only received milestone payments from ForSeeCon in
+Added: the same period of 2024.
+Added: Operating Expenses Our operating
+Added: expenses have increased by $1,273,064 or 184%, to $1,964,360 for the three months ended September 30, 2025 from $691,296 for the three
+Added: months ended September 30, 2024.
+Added: Such an increase in operating expenses was mainly due to the Company hiring certain consultants and advisors
+Added: for business opportunity and financial advisory services during this period.
+Added: Other Income (Expense) Our other
+Added: expense was $118,586 for the three months ended September 30, 2025, compared to other expense of $184,760 for the three months ended September
+Added: The change was principally caused by the decrease in interest expense and offset by foreign exchange loss.
+Added: Interest income (expense), net was
+Added: $16,328 for the three months ended September 30, 2025, compared to ($176,168) for the three months ended September 30, 2024.
+Added: of $192,496, or about 109%, was mainly due to lower interest expense from Lind Notes, as fewer notes were converted and thus less interest
+Added: was recognized.
+Added: Net Loss As a result of the
+Added: above factors, our net loss was $1,287,523 for the three months ended September 30, 2025 compared to $487,431 for the three months ended
+Added: September 30, 2024, representing an increase of $800,092, or 164%.
+Added: Results of Operations - Nine Months Ended September
+Added: 30, 2025 Compared to Nine Months Ended September 30, 2024.
+Added: The following table presents, for the nine months
indicated, our unaudited consolidated statements of operations information.
−Removed: Six Months Ended
+Added: Nine Months Ended
+Added: 2024 (Restated)
Gross Profits
8 unchanged sentences
$ (4,462,510 )
−Removed: We generated $0 and $118,347
−Removed: in revenues for the six months ended June 30, 2025 and 2024, respectively.
−Removed: The decrease in revenues was mainly due to no cash receipt
−Removed: from our recent licensing agreements in this period.
+Added: We generated $795,950
+Added: and $507,623 in revenues for the nine months ended September 30, 2025 and 2024, respectively.
+Added: The increase in revenues was mainly due
+Added: to the milestone revenue recognized from licensing to OncoX and ForSeeCon, while we only received milestone payments from ForSeeCon in
+Added: the same period of 2024.
Operating Expenses.
Our operating
−Removed: expenses have decreased by $828,254, or 22%, to $2,987,988 for the six months ended June 30, 2025 from $3,816,242 for the six months ended
−Removed: June 30, 2024.
−Removed: Such decrease in operating expenses was mainly attributable to the decrease in stock-based compensation expenses by $694,120
−Removed: which relates to costs in conjunction with employee compensation and non-employee share-based payments.
+Added: expenses have increased by $444,810, or 10%, to $4,952,348 for the nine months ended September 30, 2025 from $4,507,538 for the nine months
+Added: ended September 30, 2024.
+Added: Such increase in operating expenses was mainly attributable to the increase in stock-based compensation expenses
+Added: by $346,222 which relates to costs in conjunction with employee compensation and non-employee share-based payments.
Other Income (Expense) .
−Removed: expense was $265,408 for the six months ended June 30, 2025, compared to other expense of $387,611 for the six months ended June 30, 2024.
−Removed: The change was principally caused by the decrease in interest expense, while being offset by the increase in foreign exchange income for
−Removed: the six months ended June 30, 2025.
+Added: expense was $383,994 for the nine months ended September 30, 2025, compared to other expense of $572,371 for the nine months ended September
+Added: The change was principally caused by the decrease in interest expense from Lind Notes for the nine months ended September 30,
Interest income (expense), net.
−Removed: was $(314,170) for the six months ended June 30, 2025, compared to $(357,565) for the six months ended June 30, 2024.
−Removed: The decrease of
−Removed: $43,395, or approximately 12%, was primarily due to the decrease in interest expense due to recognition of interest expense for the converted
−Removed: notes for proper accounting purpose .
−Removed: As a result of the
−Removed: above factors, our net loss was $3,277,023 for the six months ended June 30, 2025 compared to $3,975,079 for the six months ended June
−Removed: 30, 2024, representing a decrease of $698,056, or 18%.
+Added: was $(297,842) for the nine months ended September 30, 2025, compared to $(533,733) for the nine months ended September 30, 2024.
+Added: decrease of $235,891, or approximately 44%, was primarily due to the decrease in interest expense due to recognition of interest expense
+Added: for the converted notes for proper accounting purpose .
+Added: Net Loss As a result of the
+Added: above factors, our net loss was $4,564,546 for the nine months ended September 30, 2025 compared to $4,462,510 for the nine months ended
+Added: September 30, 2024, representing a decrease of $102,036, or 2%.
Asset Recognition and Investment Reclassification
+Added: Acquisition of land in Puli Township, Taiwan
On March 31, 2025, the Company recorded the acquisition
6 unchanged sentences
of the investment’s expected holding period and strategic purpose, after entering into the convertible note loan in 2023.
−Removed: changes increased total assets and stockholders’ equity as of June 30, 2025.
+Added: changes increased total assets and stockholders’ equity as of September 30, 2025.
Notwithstanding these improvements in the Company’s
1 unchanged sentence
and external financing options.
+Added: To further secure the ownership of land, the
+Added: board of AiBtl authorized Ms.
+Added: Jiang in June 2025 to temporarily hold the land title until the administrative procedures are finalized.
+Added: The title was transferred to Ms.
+Added: Jiang later that month, and the Company recorded $5,421 in acquisition costs associated with the transaction.
+Added: As of the reporting date, government review of the transfer of land title to Yun Zhi Yi is pending completion.
+Added: Acquisition of land in Taoyuan City, Taiwan
+Added: On July 15, 2025, the Company entered into a definitive
+Added: agreement with Shuling Jiang (“Shuling”), pursuant to which Shuling shall transfer the ownership of certain land she owns,
+Added: with estimated fair value of $3,857,975, located at Taoyuan City, Taiwan (the “Land”) to the Company (the “Agreement”).
+Added: Shuling is a director of the Company, and owns over 10% of the Company’s issued and outstanding shares of common stock as of June
+Added: In consideration for the Land, the Company was to pay Shuling (i) 2,035,136 restricted shares of the Company’s common stock
+Added: (the “Shares”) at a price of $1.65 per share as approved in the June 3, 2025 annual shareholder meeting and (ii) five-year
+Added: warrants to purchase up to 1,000,000 shares of the Company’s common stock, with an exercise price of $2.50 per share.
+Added: Agreement, Shuling was to also transfer outstanding liability owed on the Land (approximately $500,000) to the Company.
+Added: The transaction
+Added: is closed on the same date and the warrants and restricted shares are issued on July 15, 2025 and July 16, 2025, respectively.
+Added: recognized $3,857,975 as the cost of the land and $500,000 liability on its balance sheet.
Liquidity and Capital Resources
Working Capital
+Added: September 30,
Current Assets
4 unchanged sentences
Going Concern and Liquidity Consideration
−Removed: For the six months ended June 30, 2025, the Company
−Removed: reported net loss of $3,277,023.
−Removed: As of June 30, 2025, the Company’s working capital deficit was $3,762,113.
−Removed: In addition, the
−Removed: Company had net cash outflows of $1,434,007 from operating activities for the six months ended June 30, 2025.
−Removed: These conditions give
−Removed: rise to substantial doubt as to whether the Company will be able to continue as a going concern.
+Added: For the nine months ended September 30, 2025,
+Added: the Company reported net loss of $4,564,546.
+Added: As of September 30, 2025, the Company’s working capital deficit was $2,434,951.
+Added: addition, the Company had net cash outflows of $1,567,264 from operating activities for the nine months ended September 30, 2025.
+Added: These conditions give rise to substantial doubt as to whether the Company will be able to continue as a going concern.
Management’s plan is to continue to improve
3 unchanged sentences
Notably, the Company has reduced a substantial
−Removed: amount of convertible debts during the six months ended June 30, 2025, from $0.95 million to $0.24 million.
−Removed: We also reduced our outstanding
−Removed: warrants from 2.0 million shares to 1 million shares in six months ended June 30, 2025, receiving around $411,667 in cash (further reduced
−Removed: 0.5 million shares in July 2025).
+Added: amount of convertible debts during the nine months ended September 30, 2025, from $0.95 million to $0.22 million.
+Added: We also reduced our
+Added: outstanding warrants previously issued to LIND from 2.0 million shares to 0.5 million shares in nine months ended September 30, 2025,
+Added: receiving around $991,366 in cash.
If the Company is not able to generate positive operating cash flows, and raise additional capital,
2 unchanged sentences
to generate positive cash flows to meet our operational needs.
−Removed: Six Months Ended June 30
−Removed: 2024 (Restated)
+Added: Nine Months Ended September 30
Cash Flow Used In Operating Activities
2 unchanged sentences
Cash Flow Used in Investing Activities
+Added: $ (1,939,136 )
Cash Flow Provided by Financing Activities
Cash Flow from Operating Activities
−Removed: During the six months ended June 30, 2025 and
−Removed: 2024, the net cash used in operating activities were $1,434,007 and $1,167,241, respectively.
−Removed: The increase was primarily due to the increase
−Removed: in due from related parties.
−Removed: The Company has been strictly control the operating cash outflow, such as making certain payments with shares
−Removed: in lieu of cash, extending vendors’ payment terms, and other initiatives to save the cash burn.
+Added: During the nine months ended September 30, 2025
+Added: and 2024, the net cash used in operating activities were $1,567,264 and $1,107,011, respectively.
+Added: The increase was primarily due to the
+Added: increase in due from related parties.
+Added: The Company has been strictly control the operating cash outflow, such as making certain payments
+Added: with shares in lieu of cash, extending vendors’ payment terms, and other initiatives to save the cash burn.
Cash Flow from Investing Activities
−Removed: During the six months ended June 30, 2025 and
−Removed: 2024, the main investing activity is the loan of funds to related parties for their operating needs.
+Added: During the nine months ended September 30, 2025
+Added: and 2024, the main investing activity is the loan of funds to related parties for their operating and research and development needs.
Cash Flow from Financing Activities
−Removed: During the six months ended June 30, 2025 and
−Removed: 2024, the net cash provided by financing activities were $2,356,083 and $1,726,303, respectively.
−Removed: The increase in net cash provided by
−Removed: financing activities were primarily due to the proceeds from a series of private offerings, and LIND’s exercise of warrants, offsetting
−Removed: by the repayment in short-term loans and due to related parties.
+Added: During the nine months ended September 30, 2025
+Added: and 2024, the net cash provided by financing activities were $3,488,478 and $1,644,947, respectively.
+Added: The increase in net cash provided
+Added: by financing activities were primarily due to the proceeds from a series of private offerings, and LIND’s exercise of warrants,
+Added: offsetting by the repayment in short-term loans and due to related parties.
QUANTITATIVE AND QUALITATIVE
3 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.