52 unchanged sentences
and medical devices, all of which are derived from plants.
+Added: The Company has four wholly-owned subsidiaries, BriVision, BioLite Holding
+Added: (“BioLite Holding”), BioKey Inc.
+Added: (“BioKey”), BioKey (Cayman), Inc (“BioKey Cayman”), and a majority-owned
+Added: subsidiary, AiBtl BioPharma Inc.
+Added: BioLite Holding was incorporated in the State
+Added: of Nevada with wholly owned subsidiary BioLite BVI, Inc.
+Added: (“BioLite BVI”) that was incorporated in the British Virgin Islands.
+Added: BioLite BVI holds 73% ownership of BioLite Inc.
+Added: (“BioLite Taiwan”), a Taiwanese corporation that was founded in February 2006.
+Added: BioLite Taiwan has been in the business of developing new drugs since it was incorporated.
+Added: Yunzhiyi, a Taiwanese corporation, was incorporated
+Added: in August 2024, with 90% owned by BioLite Taiwan and 10% owned by Shuling Jiang, the Company’s director.
+Added: This entity is set up for
+Added: holding land located in Puli, Tawain that AiBtl is in the process of acquiring, which land will be used for developing health related
+Added: As of the date hereof, the transfer of the land’s title is currently under government review, pending completion of the
+Added: title transfer registration.
+Added: Due to Taiwan’s legal restrictions prohibiting foreign entities from directly owning farmland, the
+Added: parties agreed to structure the arrangement through nominee holdings.
+Added: Incorporated in California on November 20, 2000,
+Added: BioKey has chosen to initially focus on developing generic drugs to ride the opportunity of the booming industry.
+Added: BioKey Cayman was incorporated in Cayman Islands
+Added: in July 2023, which is 100% owned by ABVC.
+Added: This subsidiary has no activities since inception.
Medicines derived from plants have a long history
42 unchanged sentences
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.
−Removed: ABV-1601, Major
−Removed: Depression in Cancer Patients, Phase I/II, NCE drug Principal Investigator:
+Added: ABV-1601, Major Depression in Cancer Patients, Phase I/II, NCE drug Principal Investigator:
Scott Irwin, MD, Ph.D.
−Removed: - Cedars Sinai Medical Center
−Removed: The Phase I clinical study will be initiated in the fourth quarter of 2024.
+Added: - Cedars Sinai Medical Center (CSMC).
+Added: The Phase I clinical study will be initiated around the end of 2025.
Medical Device:
18 unchanged sentences
trial materials (phase I through phase III) and commercial manufacturing.
−Removed: On February 8, 2019, the Company, BioLite Holding,
−Removed: (“BioLite”), BioKey, Inc.
−Removed: (“BioKey”), BioLite Acquisition Corp., a direct wholly-owned subsidiary of the
−Removed: Company (“Merger Sub 1”), and BioKey Acquisition Corp., a direct wholly-owned subsidiary of the Company (“Merger Sub
−Removed: 2”) (collectively referred to as the “Parties”) completed the business combination pursuant to that certain Agreement
−Removed: and Plan of Merger (the “Merger Agreement”), dated January 31, 2018, pursuant to which the Company acquired BioLite and BioKey
−Removed: via issuing shares of the Company’s Common Stock to the shareholders of BioLite and BioKey.
−Removed: As a result, BioLite and BioKey became
−Removed: two wholly-owned subsidiaries of the Company on February 8, 2019.
−Removed: The Company issued an aggregate of 104,558,777 shares of Common Stock
−Removed: (prior to the reverse stock split in 2019 and 2023) to the shareholders of both BioLite and BioKey under a registration statement on Form
−Removed: S-4 (file number 333-226285), which became effective by operation of law on or about February 5, 2019.
−Removed: 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 common
−Removed: stock (the “2023 Split”).
−Removed: The Company’s stockholders previously approved the Reverse Stock Split at the Company’s
−Removed: Special Shareholder Meeting held on July 7, 2023.
−Removed: The Reverse Stock Split was effected to reduce the number of issued and outstanding
−Removed: shares and to increase the per share trading value of the Company’s common stock, although that outcome is not guaranteed.
−Removed: the Company believes that the Reverse Stock Split will enable the Company to restore compliance with certain continued listing standards
−Removed: of NASDAQ Capital Market.
−Removed: BioLite was incorporated under the laws of the
−Removed: State of Nevada on July 27, 2016, with 500,000,000 shares authorized, par value $0.0001.
−Removed: BioLite’s key subsidiaries include BioLite
−Removed: (“BioLite BVI”), which was incorporated in the British Virgin Islands on September 13, 2016 and BioLite, Inc.
−Removed: Taiwan”), a Taiwanese corporation that was founded in February 2006.
−Removed: BioLite Taiwan has been in the business of developing new drugs
−Removed: for over ten years.
−Removed: BioLite and BioLite BVI are holding companies
−Removed: and have not carried out substantive business operations of their own.
−Removed: In January 2017, BioLite, BioLite BVI, BioLite
−Removed: Taiwan, and certain shareholders of BioLite Taiwan entered into a share purchase / exchange agreement (the “BioLite Share Purchase
−Removed: / Exchange Agreement”).
−Removed: Pursuant to the BioLite Share Purchase / Exchange Agreement, the shareholder participants to the BioLite
−Removed: Share Purchase / Exchange Agreement sold their equity in BioLite Taiwan and used the proceeds from such sales to purchase shares of Common
−Removed: Stock of BioLite at the same price per share, resulting in share ownership in BioLite Common Stock equal to the number of shares they
−Removed: had held in BioLite Taiwan Common Stock.
−Removed: Upon closing of the Share Purchase/ Exchange Agreement in August 2017, BioLite owned, via BioLite
−Removed: BVI, approximately 73% of BioLite Taiwan.
−Removed: The other shareholders who did not enter this Share Purchase/ Exchange Agreement retained their
−Removed: equity ownership in BioLite Taiwan.
−Removed: BioKey was incorporated on August 9, 2000 in the
−Removed: State of California.
−Removed: It is engaged primarily in research and development, manufacturing, and distribution of generic drugs and nutraceuticals
−Removed: with strategic partners.
−Removed: BioKey provides a wide range of services, including, API characterization, pre-formulation studies, formulation
−Removed: development, analytical method development, stability studies, IND/NDA/ANDA/510K submissions, and manufacturing clinical trial materials
−Removed: (phase 1 through phase 3) and commercial manufacturing.
−Removed: It also licenses out its technologies and initiates joint research and development
−Removed: processes with other biotechnology, pharmaceutical, and nutraceutical companies.
−Removed: The Vitargus ® Phase II study was put on hold due to Serious Adverse Events (SAEs) observed in patients with retinal detachment treated with either Vitargus or SF6 comparator after vitrectomy surgeries at the Thailand sites.
−Removed: By comparing the Thailand study with the First-in-Human (FIH) study completed in Australia in 2018, the SAEs derived from the patients in the Thailand study may be due to the modified in-situ hydrogel procedure which allows a longer surgical time window for the study.
−Removed: The Company is investigating the root causes of the events and is working towards developing a safe device in-situ procedure before reinstating the study.
−Removed: As of June 21, 2023, Dr.
−Removed: Howard Doong resigned
−Removed: as the Company’s CEO and was replaced by Dr.
−Removed: The Company and its CFO, Leeds Chow have been negotiating the terms of
−Removed: his employment agreement since the end of July 2024;
−Removed: due to disagreements regarding salaries due and payable, Mr.
−Removed: Chow informed the Company
−Removed: that he is suspending his work as CFO.
−Removed: The disagreement relates solely to salary owed and payable to Mr.
−Removed: Chow and is not the result of
−Removed: any disagreements with the Company on any matter related to the Company’s disclosures in its public filings.
−Removed: The Company’s
−Removed: CEO, Uttam Patil, will assume the duties of interim Chief Financial Officer until the parties settle the disagreement and Leeds resumes
−Removed: his position as CFO.
−Removed: On August 14, 2023, the Company entered into a
−Removed: cooperation agreement (the “ Agreement ”, the transaction contemplated therein the “ Transaction ”)
−Removed: with Zhonghui United Technology (Chengdu) Group Co., Ltd., a Company established under the Law of People’s Republic of China (“ Zhonghui ”).
−Removed: Pursuant thereto, the Company acquired 20% of the ownership of a property and the parcel of the land (the “ Property ”)
−Removed: owned by Zhonghui in Leshan, Sichuan, China.
−Removed: The valuation of the Property as of April 18, 2023, which was assessed by an independent
−Removed: third party, is estimated to be approximately RMB 264,299,400 or approximately $37,000,000.
−Removed: In exchange, the Company agreed to issue to
−Removed: Zhonghui, an aggregate of 370,000 shares of the Company’s common stock, at a per share price of $20 (the “ Zhonghui Shares ”).
−Removed: On September 4, 2023, the Company and Zhonghui entered into an amendment to the Agreement to clarify that, in no event will the Company
−Removed: issue to Zhonghui shares of common stock, in connection with the Transaction, in an amount exceeding 19.99% of the issued and outstanding
−Removed: shares as of the date of the Agreement.
−Removed: The Company and Zhonghui plan to jointly develop
−Removed: the Property into a healthcare center for senior living, long-term care, and medical care in the areas of ABVCs’ special interests,
−Removed: such as Ophthalmology, Oncology, and Central Nervous Systems.
−Removed: The plan is to establish a base for the China market and global development
−Removed: of these interests.
−Removed: The asset ownership certification is in the application process and pending approval from the Chinese government.
−Removed: During the third quarter of 2023, the Company
−Removed: issued the Zhonghui Shares.
−Removed: The Zhonghui Shares are subject to a lock-up period of one year following the closing date of this Transaction.
−Removed: In addition, the parties agreed that, after one year following the closing of the Transaction, the market value of the shares issued or
−Removed: the value of the Property increase or decrease, the parties will negotiate in good faith to make reasonable adjustment.
−Removed: On July 31, 2023, the Company entered into a binding
−Removed: term sheet with Xinnovation Therapeutics Co., Ltd., a Company incorporated under the Law of People’s Republic of China.
−Removed: sheet contemplates that, pursuant to definitive agreements, Xinnovation will be granted an exclusive license to develop, manufacture,
−Removed: market, and distribute ABV-1504 for Major Depressive Disorder (MDD) and ABV-1505 for Attention-Deficit/Hyperactivity Disorder, in the
−Removed: Chinese market and shall bear the costs for clinical trials and product registration in China and the Company would receive an initial
−Removed: license fee and royalty payments ranging from 5% to 12% based on the projected annual net sales of the licensed drugs by Xinnovation in
−Removed: This transaction remains subject to the negotiation of definitive documents and therefore there is no guarantee that this transaction
−Removed: In November 2023, the Company and one of its subsidiaries,
−Removed: BioLite, Inc.
−Removed: (“BioLite”) each entered into a multi-year, global licensing agreement with AIBL for the Company and BioLite’s
−Removed: CNS drugs with the indications of MDD (Major Depressive Disorder) and ADHD (Attention Deficit Hyperactivity Disorder) (the “Licensed
−Removed: The potential license will cover the Licensed Products’ clinical trial, registration, manufacturing, supply, and
−Removed: distribution rights.
−Removed: The Licensed Products for MDD and ADHD, owned by ABVC and BioLite, were valued at $667M by a third-party evaluation.
−Removed: The parties are determined to collaborate on the global development of the Licensed Products.
−Removed: The parties are also working to strengthen
−Removed: new drug development and business collaboration, including technology, interoperability, and standards development.
−Removed: As per each of the
−Removed: respective agreements, each of ABVC and BioLite received 23 million shares of AIBL stock at $10 per share, and if certain milestones are
−Removed: met, shall receive $3,500,000 and royalties equaling 5% of net sales, up to $100 million, which is not guaranteed.
−Removed: Upon the issuance of
−Removed: the shares, AIBL became a subsidiary of ABVC.
−Removed: On June 23, 2024, the Company and BioLite, each entered into an amendment (the “ Amendment ”)
−Removed: to the Licensing Agreement with AIBL, pursuant to which the Company and BioLite have agreed to allow AIBL to pay the second milestone
−Removed: payment in the amount of $3,500,000 per Licensing Agreement, incrementally (such as $50,000), at any given time, rather than in one lump
+Added: \The Vitargus ® Phase II study was
+Added: put on hold due to Serious Adverse Events (SAEs) observed in patients with retinal detachment treated with either Vitargus or SF6 comparator
+Added: after vitrectomy surgeries at the Thailand sites.
+Added: By comparing the Thailand study with the First-in-Human (FIH) study completed in Australia
+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.
+Added: On March 5, 2025, Leeds Chow notified the Company
+Added: of his resignation as CFO.
+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
28 unchanged sentences
Additionally, each of the Company and BioFirst are eligible to receive royalties of 5% of net Sales.
−Removed: As of September
−Removed: 30, 2024, the Company received 5,000,000 FEYE shares but did not recognize such licensing revenue since the fair value of FEYE stock is
+Added: As of March 31,
+Added: 2025, the Company has received 5,000,000 FEYE shares but did not recognize such licensing revenue since the fair value of FEYE stock is
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: For the period ended September 30, 2024, the Company has received
−Removed: $296,000 as 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”),
+Added: As of March 31, 2025, the Company has received $296,000 as the partial
+Added: second milestone payment and recognized as licensing revenue according to ASC 606.
+Added: On April 16, 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 single-herb botanical drug extract from the
+Added: dry fruit body of Maitake Mushroom (Grifola Frondosa) for treatment of Non-Small Cell Lung Cancer (the “Licensed Products”),
within North America for 20 years (the “Oncox Agreement”).
In consideration thereof, Oncox shall pay ABVC $6,250,000 (or 1,250,000
−Removed: Oncox shares valued at $5 per share 5 ) 30 days after entering into the Oncox Agreement and $625,000 30 days following the
−Removed: completion of Oncox’s next round of fundraising, of which there is no guarantee;
−Removed: ABVC is also entitled to 5% royalties based on
−Removed: the Net Sales, as defined in the Oncox Agreement, from the first commercial sale of the Licensed Product in North America, of which there
−Removed: can be no guarantee.
+Added: Oncox shares valued at $5 per share;
+Added: p rice was determined through private negotiations between the
+Added: no third-party valuation was completed.
+Added: ) 30 days after entering into the Oncox Agreement and $625,000 30 days following
+Added: the completion of Oncox’s next round of fundraising, of which there is no guarantee;
+Added: ABVC is also entitled to 5% royalties based
+Added: on the Net Sales, as defined in the Oncox Agreement, from the first commercial sale of the Licensed Product in North America, of which
+Added: there can be no guarantee.
Oncox entered into another agreement with ABVC’s affiliate, Rgene Corporation, on the same terms.
−Removed: For the period
−Removed: ended September 30, 2024, the Company has received $200,000 as the partial second milestone payment and recognized as licensing revenue
−Removed: according to ASC 606.
−Removed: On May 8, 2024, the Company entered into a definitive
−Removed: agreement with OncoX BioPharma, Inc., a private company registered in the British Virgin Islands (“Oncox”), pursuant to which
−Removed: the Company will grant Oncox an exclusive right to develop and commercialize ABVC’s BLEX 404 single-herb botanical drug extract
−Removed: from the dry fruit body of Maitake Mushroom (Grifola Frondosa) for treatment of Pancreatic Cancer (the “Licensed Products”),
−Removed: within a certain territory, specified as 50% of the Worldwide Markets for 20 years (the “May 2024 Oncox Agreement”).
−Removed: In consideration
−Removed: thereof, Oncox shall pay ABVC a total of $6,250,000 (or 1,250,000 Oncox shares valued at $5 per share 6 ) within 30 days of
−Removed: entering into the May 2024 Oncox Agreement, with an additional milestone payment of $625,000 in cash after OncoX’s next round of
−Removed: fundraising, of which there can be no guarantee.
−Removed: Oncox may remit cash payments of at least $100,000 towards the licensing fees and deductible
−Removed: from the second milestone payment;
−Removed: ABVC is also entitled to royalties of 5% of Net Sales, as defined in the May 2024 Oncox Agreement,
−Removed: from the first commercial sale of the Licensed Product in the noted territory, which remains uncertain.
−Removed: The Company will permit Oncox
−Removed: to pay the license fee in installments or in a lump sum and will allow Oncox to use its revenue to fund such payments.
−Removed: Oncox entered into
−Removed: another agreement with ABVC’s affiliate, Rgene Corporation, on the same terms.
−Removed: On May 14, 2024, the Company and its subsidiary,
−Removed: BioLite Inc (collectively, the “licensor”), each entered into a licensing agreement with OncoX, on the same terms, pursuant
−Removed: to which the licensors will grant Oncox an exclusive right to develop and commercialize ABVC’s BLEX 404 single-herb botanical drug
−Removed: extract from the dry fruit body of Maitake Mushroom (Grifola Frondosa) for treatment of Tripple Negative Breast Cancer (the TNBC Product),
−Removed: within a certain territory, specified as 50% of the Worldwide Markets for 20 years (the “May 14, 2024 Oncox Agreements”).
−Removed: In each agreement for consideration thereof, Oncox shall pay each licensor a total of $6,250,000 (or 1,250,000 Oncox shares valued at
−Removed: $5 per share 7 ) within 30 days of entering into the May 14, 2024 Oncox Agreements, with an additional milestone payment of
−Removed: $625,000 in cash after OncoX’s next round of fundraising, of which there can be no guarantee.
−Removed: Oncox may remit cash payments of at
−Removed: 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.
−Removed: On May 23, 2024, the Company and its subsidiary,
−Removed: BioLite Inc (collectively, the “licensor”), each entered into a licensing agreement with OncoX, on the same terms, pursuant
−Removed: to which the licensors will grant Oncox an exclusive right to develop and commercialize ABVC’s BLEX 404 single-herb botanical drug
−Removed: extract from the dry fruit body of Maitake Mushroom (Grifola Frondosa) for treatment of Myelodysplastic Syndrome (the “Licensed
−Removed: Products”), within a certain territory, specified as 50% of the Worldwide Markets for 20 years (the “Oncox Agreements”).
−Removed: In consideration thereof, Oncox shall pay each licensor a total of $6,250,000 (or 1,250,000 Oncox shares valued at $5 per share 8 )
−Removed: 30 days after entering the May 23, 2024 Oncox Agreement, with an additional milestone payment of $625,000 in cash after OncoX’s
−Removed: next round of fundraising, of which there can be no guarantee.
−Removed: Oncox may remit cash payments of at least $100,000 towards the licensing
−Removed: fees and deductible from the second milestone payment;
−Removed: each licensor is also entitled to royalties of 5% of Net Sales, from the first
−Removed: commercial sale of the Licensed Product in the noted territory, which remains uncertain.
−Removed: Oncox may use its revenue to fund the licensing
−Removed: 5 P rice was determined through
−Removed: private negotiations between the parties;
+Added: of March 31, 2025, the Company has received $200,000 as the partial second milestone payment and recognized as licensing revenue according
+Added: On May 8, 2024, the Company entered into a definitive agreement with OncoX
+Added: BioPharma, Inc., a private company registered in the British Virgin Islands (“Oncox”), pursuant to which the Company will
+Added: grant Oncox an exclusive right to develop and commercialize ABVC’s BLEX 404 single-herb botanical drug extract from the dry fruit
+Added: body of Maitake Mushroom (Grifola Frondosa) for treatment of Pancreatic Cancer (the “Licensed Products”), within a certain
+Added: territory, specified as 50% of the Worldwide Markets for 20 years (the “May 2024 Oncox Agreement”).
+Added: In consideration thereof,
+Added: Oncox shall pay ABVC a total of $6,250,000 (or 1,250,000 Oncox shares valued at $5 per share;
+Added: was determined through private negotiations between the parties;
no third-party valuation was completed.
+Added: ) within 30 days of entering
+Added: into the May 2024 Oncox Agreement, with an additional milestone payment of $625,000 in cash after OncoX’s next round of fundraising,
+Added: of which there can be no guarantee.
+Added: Oncox may remit cash payments of at least $100,000 towards the licensing fees and deductible from
+Added: the second milestone payment;
+Added: ABVC is also entitled to royalties of 5% of Net Sales, as defined in the May 2024 Oncox Agreement, from
+Added: the first commercial sale of the Licensed Product in the noted territory, which remains uncertain.
+Added: The Company will permit Oncox to pay
+Added: the license fee in installments or in a lump sum and will allow Oncox to use its revenue to fund such payments.
+Added: Oncox entered into another
+Added: agreement with ABVC’s affiliate, Rgene Corporation, on the same terms.
+Added: On May 14, 2024, the Company and its subsidiary, BioLite Inc (collectively,
+Added: the “licensor”), each entered into a licensing agreement with OncoX, on the same terms, pursuant to which the licensors will
+Added: grant Oncox an exclusive right to develop and commercialize ABVC’s BLEX 404 single-herb botanical drug extract from the dry fruit
+Added: body of Maitake Mushroom (Grifola Frondosa) for treatment of Tripple Negative Breast Cancer (the TNBC Product), within a certain territory,
+Added: specified as 50% of the Worldwide Markets for 20 years (the “May 14, 2024 Oncox Agreements”).
+Added: In each agreement for consideration
+Added: thereof, Oncox shall pay each licensor a total of $6,250,000 (or 1,250,000 Oncox shares valued at $5 per share;
+Added: was determined through private negotiations between the parties;
+Added: no third-party valuation was completed.
+Added: ) within 30 days of entering
+Added: into the May 14, 2024 Oncox Agreements, with an additional milestone payment of $625,000 in cash after OncoX’s next round of fundraising,
+Added: of which there can be no guarantee.
+Added: Oncox may remit cash payments of at least $100,000 towards the licensing fees and deductible from
+Added: the second milestone payment;
+Added: each licensor is also entitled to royalties of 5% of Net Sales, from the first commercial sale of the TNBC
+Added: Product in the noted territory, which remains uncertain.
+Added: The Company will permit Oncox to pay the license fee in installments or in a
+Added: lump sum and will allow Oncox to use its revenue to fund such payments.
+Added: On May 23, 2024, the Company and its subsidiary, BioLite Inc (collectively,
+Added: the “licensor”), each entered into a licensing agreement with OncoX, on the same terms, pursuant to which the licensors will
+Added: grant Oncox an exclusive right to develop and commercialize ABVC’s BLEX 404 single-herb botanical drug extract from the dry fruit
+Added: body of Maitake Mushroom (Grifola Frondosa) for treatment of Myelodysplastic Syndrome (the “Licensed Products”), within a
+Added: certain territory, specified as 50% of the Worldwide Markets for 20 years (the “Oncox Agreements”).
+Added: In consideration thereof,
+Added: Oncox shall pay each licensor a total of $6,250,000 (or 1,250,000 Oncox shares valued at $5 per share;
+Added: was determined through private negotiations between the parties;
+Added: no third-party valuation was completed.
+Added: ) 30 days after entering
+Added: the May 23, 2024 Oncox Agreement, with an additional milestone payment of $625,000 in cash after OncoX’s next round of fundraising,
+Added: of which there can be no guarantee.
+Added: Oncox may remit cash payments of at least $100,000 towards the licensing fees and deductible from
+Added: the second milestone payment;
+Added: each licensor is also entitled to royalties of 5% of Net Sales, from the first commercial sale of the Licensed
+Added: Product in the noted territory, which remains uncertain.
+Added: Oncox may use its revenue to fund the licensing fees.
Common Stock Reverse Split
13 unchanged sentences
Series A Convertible Preferred Stock
−Removed: As of September 30, 2024, no Series A Convertible
+Added: As of March 31, 2025, no Series A Convertible
Preferred Stock has been issued by the Company.
45 unchanged sentences
the Nasdaq Listing Rules, the Company has until January 6, 2025, to regain compliance.
−Removed: If at any time during such 180-day period the closing
−Removed: bid price of the Company’s common shares is at least $1 for a minimum of 10 consecutive business days, Nasdaq will provide the Company
−Removed: written confirmation of compliance.
−Removed: If the Company does not regain compliance during such 180-day period, the Company may be eligible
−Removed: for an additional 180 calendar days, provided that the Company meets the continued listing requirement for market value of publicly held
−Removed: shares and all other initial listing standards for Nasdaq except for Nasdaq Listing Rule 5550(a)(2), and provide a written notice of its
−Removed: intention to cure this deficiency during the second compliance period, by effecting a reverse stock split, if necessary.
+Added: On January 9, 2025, the Company received a notification
+Added: from Nasdaq granting the Company an additional 180 days, until July 7, 2025, to meet the minimum bid price requirement of $1.00 per share,
+Added: as outlined in Nasdaq Listing Rule 5550(a)(2) (the “Rule”).
+Added: To satisfy the Rule, the Company’s common stock must achieve
+Added: a closing bid price of at least $1.00 for a minimum of ten consecutive trading days within this extension period;
+Added: if successful, Nasdaq
+Added: will confirm compliance with the Rule and close this matter.
+Added: If compliance is not achieved by the new deadline, Nasdaq may initiate delisting
+Added: procedures, which the Company would have the right to appeal.
+Added: April 24, 2025, we received a letter from the listing qualifications staff (the “ Staff ”) of Nasdaq informing us that,
+Added: as reported in our Annual Report on Form 10-K for the year ended December 31, 2024, because our stockholders’ equity was
+Added: $723,959, as of April 23, 2025, we did not meet the alternatives of market value of listed securities or net income from continuing operations,
+Added: and we no longer comply with Listing Rule 5550(b)(1) (the “ Rule 5550 ”).
+Added: have 45 calendar days to submit a plan to the Staff to regain compliance.
+Added: If our plan is accepted, we may be granted an extension of up
+Added: to 180 calendar days from the date of the letter, or until October 21, 2025, to evidence compliance.
+Added: determining whether to accept our plan, the Staff will consider such things as the likelihood that the plan will result in compliance
+Added: with Nasdaq’s continued listing criteria, our past compliance history, the reasons for our current non-compliance, other corporate
+Added: events that may occur within our review period, our overall financial condition, and our public disclosures.
+Added: If the Staff does not accept
+Added: our plan, we will have the opportunity to appeal that decision to a Hearings Panel.
+Added: The Nasdaq notification has
+Added: no immediate effect on the listing of our Common Stock on the Nasdaq Capital Market.
+Added: We intend to actively monitor our stockholders’
+Added: equity and will consider options available to us to achieve compliance with Rule 5550.
+Added: There can be no assurance that we will
+Added: be able to regain compliance with the Listing Rule or will otherwise be in compliance with the other listing standards for the Nasdaq
+Added: Capital Market.
+Added: If our Common Stock ultimately
+Added: were to be delisted for any reason, it could negatively impact us by (i) reducing the liquidity and market price of our Common Stock;
+Added: (ii) reducing the number of investors willing to hold or acquire our Common Stock;
+Added: (ii) limiting our ability to use a registration statement
+Added: to offer and sell freely tradable securities, thereby preventing us from accessing the public capital markets;
+Added: and (iv) impairing our
+Added: ability to provide equity incentives to our employees.
Joint Venture Agreement
1 unchanged sentence
ABVC BioPharma, Inc.
−Removed: (the “ Company ”), Lucidaim Co., Ltd., a Japanese corporation (“ Lucidaim ,” together
−Removed: with the Company, the “ Shareholders ”), and BioLite Japan K.K., a Japanese corporation (“ Biolite JP” )
−Removed: entered into a Joint Venture Agreement (the “ Agreement ”).
−Removed: Biolite JP is a private limited company (a Japanese Kabushiki
−Removed: Kaisha ) incorporated on December 18, 2018 and at the date of the Agreement had 10,000 ordinary shares authorized, with 3,049 ordinary
−Removed: shares issued and outstanding (the “ Ordinary Shares ”).
−Removed: Immediately prior to the execution of the Agreement, Lucidaim
−Removed: owned 1,501 ordinary shares and the Company owned 1,548 ordinary shares.
−Removed: The Shareholders entered into the joint venture to formally reduce
−Removed: to writing their intention to invest in and operate Biolite JP as a joint venture.
−Removed: The business of the joint venture shall be the research
−Removed: and development of drugs, medical device and digital media, investment, fund raising and consulting, distribution and marketing of supplements
−Removed: carried by Biolite JP and its subsidiaries in Japan, or any other territory or business, as the Agreement may with mutual consent be amended
−Removed: from time to time.
−Removed: The closing of the transaction was conditioned upon the approval and receipt of all necessary government approvals,
−Removed: which have all been received.
+Added: (the “Company”), Lucidaim Co., Ltd., a Japanese corporation (“Lucidaim,” together with the
+Added: Company, the “Shareholders”), and BioLite Japan K.K., a Japanese corporation (“Biolite JP”) entered into a Joint
+Added: Venture Agreement (the “Agreement”).
+Added: Biolite JP is a private limited company (a Japanese Kabushiki Kaisha ) incorporated
+Added: on December 18, 2018 and at the date of the Agreement had 10,000 ordinary shares authorized, with 3,049 ordinary shares issued and outstanding
+Added: (the “Ordinary Shares”).
+Added: Immediately prior to the execution of the Agreement, Lucidaim owned 1,501 ordinary shares and the
+Added: Company owned 1,548 ordinary shares.
+Added: The Shareholders entered into the joint venture to formally reduce to writing their intention to
+Added: invest in and operate Biolite JP as a joint venture.
+Added: The business of the joint venture shall be the research and development of drugs,
+Added: medical device and digital media, investment, fund raising and consulting, distribution and marketing of supplements carried by Biolite
+Added: JP and its subsidiaries in Japan, or any other territory or business, as the Agreement may with mutual consent be amended from time to
+Added: The closing of the transaction was conditioned upon the approval and receipt of all necessary government approvals, which have
+Added: all 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: The Company shall
−Removed: appoint Eugene Jiang, the Company’s current Chairman and Chief Business Officer and Lucidaim shall appoint Michihito Onishi;
−Removed: current director of Biolite JP, Toru Seo (who is also a director of BioLite Japan’s other shareholder), is considered the second
+Added: shall appoint Eugene Jiang, the Company’s current Chairman and Chief Business Officer and Lucidaim shall appoint Michihito Onishi;
+Added: the current director of Biolite JP, Toru Seo (who is also a director of BioLite Japan’s other shareholder), is considered the second
Lucidaim director.
1 unchanged sentence
agreement between them to Biolite JP or prepare the same (the “License Agreement”).
−Removed: The aforementioned transactions
−Removed: occurred on the Completion Date.
−Removed: As per the Agreement, the Shareholders shall supervise
−Removed: and manage the business and operations of Biolite JP.
−Removed: The directors shall not be entitled to any renumeration for their services as a
−Removed: director and each Shareholder can remove and replace the director he/she/it appointed.
−Removed: If a Shareholder sells or disposes of all of its
−Removed: Ordinary Shares, the Shareholder-appointed director must tender his/her resignation.
−Removed: The Agreement also sets forth certain corporate actions
−Removed: that must be pre-approved by all Shareholders (the “ Reserved Matters ”).
−Removed: If the Shareholders are unable to make a decision
−Removed: on any Reserved Matter, then either Shareholder can submit a deadlock notice to the other shareholder, 5 days after which they must refer
−Removed: the matter to each Shareholder’s chairman and use good faith to resolve the dispute.
−Removed: If such dispute is not resolved within 10 days
−Removed: thereafter, then either Shareholder can offer to buy all of the other Shareholder’s Ordinary Shares for cash at a specified price;
+Added: The aforementioned transactions occurred
+Added: on the Completion Date.
+Added: As per the Agreement, the Shareholders shall
+Added: supervise and manage the business and operations of Biolite JP.
+Added: The directors shall not be entitled to any renumeration for their services
+Added: as a director and each Shareholder can remove and replace the director he/she/it appointed.
+Added: If a Shareholder sells or disposes of all
+Added: of its Ordinary Shares, the Shareholder-appointed director 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
+Added: decision on any Reserved Matter, then either Shareholder can submit a deadlock notice to the other shareholder, 5 days after which they
+Added: must refer the matter to each Shareholder’s chairman and use good faith to resolve the dispute.
+Added: If such dispute is not resolved
+Added: within 10 days thereafter, then either Shareholder can offer to buy all of the other Shareholder’s Ordinary Shares for cash at
+Added: a specified price;
if there is not affirmative acceptance of the sale, the sale shall proceed as set forth in the sale offer.
6 unchanged sentences
Ordinary Shares.
−Removed: The Agreement also requires Biolite JP to obtain a bank facility in
−Removed: the amount of JPY 30,460,000 (approximately $272,000), for its initial working capital purposes.
−Removed: Pursuant to the Agreement, each Shareholder
−Removed: agrees to guarantee such bank facility if the bank requires a guarantee.
−Removed: Accordingly, the Company may be liable for the bank facility
−Removed: in an amount up to JPY 14,925,400 (approximately $134,000), which represents 49% of the maximum bank facility.
−Removed: The Agreement further provides
−Removed: that Biolite JP shall issue annual dividends at the rate of at least 1.5% of Biolite JP’s profits, if it has sufficient cash to
−Removed: Pursuant to the Agreement, the Company and Biolite
−Removed: JP agree to use their best efforts to execute the License Agreement by the end of December 2021.
−Removed: The Company agreed that any negotiation
−Removed: on behalf of Biolite JP regarding the terms of the License Agreement shall be handled by the directors appointed by Lucidaim.
−Removed: If the Company
−Removed: and such Lucidaim directors do not reach agreement on the terms, Biolite JP may at its sole discretion determine not to execute the License
−Removed: Agreement without any liability to the Company.
+Added: The Agreement also requires Biolite JP to obtain
+Added: a bank facility in the amount of JPY 30,460,000 (approximately $272,000), for its initial working capital purposes.
+Added: Pursuant to the Agreement,
+Added: each Shareholder agrees to guarantee such bank facility if the bank requires a guarantee.
+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.
+Added: Pursuant to the Agreement, the Company and Biolite JP agree to use their
+Added: best efforts to execute the License Agreement by the end of December 2021.
+Added: The Company agreed that any negotiation on behalf of Biolite
+Added: JP regarding the terms of the License Agreement shall be handled by the directors appointed by Lucidaim.
+Added: If the Company and such Lucidaim
+Added: directors do not reach agreement on the terms, Biolite JP may at its sole discretion determine not to execute the License Agreement without
+Added: 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
16 unchanged sentences
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
−Removed: was conducted at arm’s length.
−Removed: In addition to the Company’s board of directors providing approval for the Company to enter
−Removed: into the Agreement, the Company’s audit committee approved the Company’s entry into the Agreement.
−Removed: The Board believes that
−Removed: this joint venture will enhance the Company’s ability to provide therapeutic solutions to significant unmet medical needs and to
−Removed: develop 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
−Removed: Vitargus® Phase II Study has been initiated
−Removed: in Australia and Thailand, Principal Investigator:
−Removed: Duangnate Rojanaporn, M.D., Ramathibodi Hospital;
−Removed: Thuss Sanguansak, M.D., Srinagarind
−Removed: Hospital of the two Thailand sites and Professor/Dr.
−Removed: Matthew Simunovic, Sydney Eye Hospital;
−Removed: Elvis Ojaimi, East Melbourne Eye Group&
−Removed: East Melbourne Retina of the two Australian sites.
−Removed: The Phase II study has started in the 2 nd quarter of 2023.
+Added: Vitargus® Clinical Development:
+Added: The Phase II clinical study of Vitargus® commenced
+Added: in the second quarter of 2023.
+Added: Study sites include Ramathibodi Hospital (Principal Investigator:
+Added: Duangnate Rojanaporn) and Srinagarind
+Added: Hospital (Principal Investigator:
+Added: Thuss Sanguansak) in Thailand, and Sydney Eye Hospital (Principal Investigator:
+Added: Professor Dr.
+Added: Simunovic) and East Melbourne Eye Group/East Melbourne Retina (Principal Investigator:
+Added: Elvis Ojaimi) in Australia.
The Company is
−Removed: working on improvements to the Vitargus product through the new batch of investigational product.
−Removed: Initially the Company will focus on ABV-2002,
−Removed: a solution utilized to store a donor cornea prior to either penetrating keratoplasty (full thickness cornea transplant) or endothelial
−Removed: keratoplasty (back layer cornea transplant).
−Removed: Designated ABV-2002 under the Company’s product identification system, the solution
−Removed: is comprised of a specific poly amino acid that protects ocular tissue from damage caused by external osmolarity exposure during pre-surgery
−Removed: The specific polymer in ABV-2002 can adjust osmolarity to maintain a range of 330 to 390 mOsM thereby permitting hydration within
−Removed: the corneal stroma during the storage period.
−Removed: Stromal hydration results in (a) maintaining acceptable corneal transparency and (b) prevents
−Removed: donor cornea swelling.
−Removed: ABV-2002 also contains an abundant phenolic phytochemical found in plant cell walls that provides antioxidant antibacterial
−Removed: properties and neuroprotection.
−Removed: Early testing by BioFirst indicates that ABV-2002
−Removed: may be more effective for protecting the cornea and retina during long-term storage than other storage media available today and can be
−Removed: manufactured at lower cost.
−Removed: Further clinical development task was put on hold due to the lack of funding.
−Removed: In addition, BioFirst was incorporated on November
−Removed: 7, 2006, focusing on the R&D, manufacturing, and sales of innovative patented pharmaceutical products.
−Removed: The technology of BioFirst
−Removed: comes from the global exclusive licensing agreements BioFirst maintains with domestic R & D institutions.
−Removed: Currently, BioFirst’s
−Removed: main research and development product is the vitreous substitute (Vitargus®), licensed by the National Health Research Institutes.
−Removed: Vitargus is the world’s first bio-degradable vitreous substitute and offers a number of advantages over current vitreous substitutes
−Removed: by minimizing medical complications and reducing the need for additional surgeries.
−Removed: Vitargus has started the construction of a GMP
−Removed: factory in Hsinchu Biomedical Science Park, Taiwan, with the aim at building a production base to supply the global market, and promote
−Removed: the construction of bio-degradable vitreous substitute manufacturing centers in Taiwan.
−Removed: Completion of this factory would allow ABVC to
−Removed: manufacture Vitargus with world-class technology in a GMP certified pharmaceutical factory.
−Removed: BioFirst is targeting to complete the construction
−Removed: On July 12, 2022, the Company announced the enrollment
−Removed: progress in the Phase II Part II clinical study of the company’s ADHD medicine (ABV-1505).
−Removed: Since the first-treated subject reported
−Removed: on May 10, 2022, a total of sixty-nine (69) subjects have been enrolled in the study, including 50 who have completed the 56-day treatment.
−Removed: The study, a randomized, double-blind, placebo-controlled study entitled “A Phase II Tolerability and Efficacy Study of PDC-1421
−Removed: Treatment in Adult Patients with Attention-Deficit Hyperactivity Disorder (ADHD), Part II, is expected to eventually involve approximately
−Removed: 100 patients.
−Removed: Five prestigious research hospitals in Taiwan and the research hospital at the University of California, San Francisco (UCSF)
−Removed: are participating in the study which is a continuation of the Phase II part 1 study of ABV-1505 completed successfully at UCSF and accepted
−Removed: Food & Drug Administration in October of 2020.
−Removed: The UCSF Medical Center Institutional Review Board has approved participation
−Removed: in the Part II study, and the site initiation visit was conducted in March 2023.
+Added: currently producing a new investigational batch to support product improvements.
+Added: ABV-2002 Corneal Storage Solution:
+Added: The Company is developing ABV-2002, a corneal
+Added: storage solution intended for use prior to penetrating keratoplasty or endothelial keratoplasty.
+Added: ABV-2002 is formulated with a poly amino
+Added: acid polymer that adjusts osmolarity to maintain hydration and prevent corneal swelling.
+Added: It also contains a phenolic phytochemical providing
+Added: antioxidant and antibacterial properties.
+Added: Preliminary internal testing by BioFirst indicated potential advantages over existing storage
+Added: Further clinical development has been temporarily suspended due to funding constraints.
+Added: BioFirst Corporation Operations:
+Added: BioFirst Corporation, incorporated in 2006, focuses
+Added: on research, development, manufacturing, and commercialization of patented pharmaceutical products, primarily through global exclusive
+Added: licensing agreements with domestic R&D institutions.
+Added: BioFirst’s principal product under development is Vitargus®, licensed
+Added: from the National Health Research Institutes.
+Added: BioFirst is currently constructing a GMP-compliant manufacturing facility in Hsinchu Biomedical
+Added: Science Park, Taiwan, with targeted completion in 2025.
+Added: This facility is intended to support global supply of Vitargus®.
+Added: ABV-1505 ADHD Clinical Study:
+Added: On July 12, 2022, the Company announced enrollment
+Added: progress in the Phase II Part II clinical study of ABV-1505, a treatment candidate for adult Attention-Deficit Hyperactivity Disorder
+Added: As of the date of this report, 69 subjects have been enrolled, including 50 subjects who have completed the 56-day treatment.
+Added: The study is a randomized, double-blind, placebo-controlled trial involving research centers in Taiwan and the University of California,
+Added: San Francisco (UCSF).
+Added: UCSF’s Institutional Review Board approved participation, and the site initiation visit was completed in March
Public Offering & Financings
2025 Financings
+Added: During the first quarter of 2025, the Company
+Added: continued to strategically manage its outstanding convertible debt obligations with Lind Global Fund II, LP.
+Added: In connection with the Senior
+Added: Convertible Promissory Note issued in November 2023 (2 nd Lind Note), the Company has successfully completed all conversions
+Added: through equity issuances, thereby extinguishing the remaining principal balance.
+Added: As of the date of this filing, only the corresponding
+Added: cash components for four prior conversions remain to be settled, which the Company intends to address through the exercise of outstanding
+Added: warrants-demonstrating a proactive and non-dilutive repayment approach.
+Added: Additionally, for the Senior Convertible Promissory Note issued
+Added: in January 2024 (3 rd Lind Note), the Company has reduced the outstanding balance to $600,000, following two equity conversions
+Added: of $200,000 each.
+Added: The remaining cash obligations for these conversions are also expected to be fulfilled in a similar warrant-based strategy,
+Added: although no definitive agreement has been entered as of the date hereof and there is no guarantee that a definitive agreement will be
+Added: These steps reflect the Company’s commitment to meeting its obligations while preserving long-term shareholder value and
+Added: capitalizing on structured equity mechanisms to support operational continuity and financial health.
+Added: On January 5, 2025, the Company and Lind entered
+Added: into a third letter agreement (the “December Letter Agreement”), pursuant to which Lind agreed to exercise for cash, 1,029,167
+Added: of the Existing Warrants (the number of warrants so exercised is herein referred to as the “Outstanding Exercised Warrants”)
+Added: to purchase shares of Common Stock, with a current exercise price of $0.75 per share, at a reduced exercise price of $0.40 per share.
+Added: Other than the Outstanding Exercised Warrants, the exercise price of the remaining warrants held by Lind remained unchanged.
+Added: to the December Letter Agreement, the Company also agreed not to sell or issue any additional shares of common stock for a period of 15
+Added: days following the closing, with some noted exceptions.
+Added: 2024 Financings
+Added: On November 4, 2024, the Company and Lind entered
+Added: into another letter agreement (the “November Letter Agreement”), pursuant to which Lind agreed to exercise, for cash, 500,000
+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: the amended agreement pursuant to Nasdaq requirements, the conversion price is subject to $1.00 floor price if the conversion price
−Removed: was below such floor.
−Removed: Based on the conversion price of $0.4229, the Company made an additional $147,892 cash repayment in addition
−Removed: to the issuance of 200,000 shares.
−Removed: On September 11, 2024, the Company issued
−Removed: Lind 200,000 shares of the Company’s common stock as a repayment of $200,000 principal of 2 nd Lind Note.
−Removed: to the amended agreement pursuant to Nasdaq requirements, the conversion price is subject to $1.00 floor price if the conversion
−Removed: price was below such floor.
−Removed: Based on the conversion price of $0.6575, the Company made an additional $90,722 cash repayment in
−Removed: addition to the issuance 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.
+Added: On September 11, 2024, the Company issued Lind
+Added: 200,000 shares of the Company’s common stock as a repayment of $200,000 principal of 2 nd Lind Note.
+Added: According to the
+Added: amended agreement pursuant to Nasdaq requirements, the conversion price is subject to $1.00 floor price if the conversion price was below
+Added: Based on the conversion price of $0.6575, the Company made an additional $90,722 cash repayment in addition to the issuance
+Added: of 200,000 shares.
On July 12, 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: the amended agreement pursuant to Nasdaq requirements, the conversion price is subject to $1.00 floor price if the conversion price
−Removed: was below such floor.
−Removed: Based on the conversion price of $0.7907, the Company made an additional $88,403 cash repayment in addition to
−Removed: the issuance 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 $0.7907, the Company made an additional $88,403 cash repayment in addition to the issuance of
+Added: 200,000 shares.
On May 22, 2024, the Company and Lind entered
250 unchanged sentences
future revenue recognition.
−Removed: (i) Nonrefundable upfront payments
−Removed: If a license to the Company’s intellectual
−Removed: property is determined to be distinct from the other performance obligations identified in an arrangement, the Company recognizes revenue
−Removed: from the related nonrefundable upfront payments based on the relative standalone selling price prescribed to the license compared to the
−Removed: total selling price of the arrangement.
−Removed: The revenue is recognized when the license is transferred to the collaboration partners and the
−Removed: collaboration partners are able to use and benefit from the license.
−Removed: To date, the receipt of nonrefundable upfront fees was solely for
−Removed: the compensation of past research efforts and contributions made by the Company before the collaborative agreements were entered into
−Removed: and does not relate to any future obligations and commitments made between the Company and the collaboration partners in the collaborative
−Removed: (ii) Milestone payments
−Removed: The Company is eligible to receive milestone payments
−Removed: under the collaborative agreement with collaboration partners based on achievement of specified development, regulatory and commercial
−Removed: Management evaluated the nature of the events triggering these contingent payments, and concluded that these events fall into
−Removed: two categories:
−Removed: (a) events which involve the performance of the Company’s obligations under the collaborative agreement with collaboration
−Removed: partners, and (b) events which do not involve the performance of the Company’s obligations under the collaborative agreement with
−Removed: collaboration partners.
−Removed: The former category of milestone payments consists
−Removed: of those triggered by development and regulatory activities in the territories specified in the collaborative agreements.
−Removed: Management concluded
−Removed: that each of these payments constitute substantive milestone payments.
−Removed: This conclusion was based primarily on the facts that (i) each
−Removed: triggering event represents a specific outcome that can be achieved only through successful performance by the Company of one or more
−Removed: of its deliverables, (ii) achievement of each triggering event was subject to inherent risk and uncertainty and would result in additional
−Removed: payments becoming due to the Company, (iii) each of the milestone payments is nonrefundable, (iv) substantial effort is required to complete
−Removed: each milestone, (v) the amount of each milestone payment is reasonable in relation to the value created in achieving the milestone, (vi)
−Removed: a substantial amount of time is expected to pass between the upfront payment and the potential milestone payments, and (vii) the milestone
−Removed: payments relate solely to past performance.
−Removed: Based on the foregoing, the Company recognizes any revenue from these milestone payments in
−Removed: the period in which the underlying triggering event occurs.
−Removed: (iii) Multiple Element Arrangements
−Removed: The Company evaluates multiple element arrangements
−Removed: to determine (1) the deliverables included in the arrangement and (2) whether the individual deliverables represent separate units of
−Removed: accounting or whether they must be accounted for as a combined unit of accounting.
−Removed: This evaluation involves subjective determinations
−Removed: and requires management to make judgments about the individual deliverables and whether such deliverables are separate from other aspects
−Removed: of the contractual relationship.
−Removed: Deliverables are considered separate units of accounting provided that:
−Removed: (i) the delivered item(s) has
−Removed: value to the customer on a standalone basis and (ii) if the arrangement includes a general right of return relative to the delivered item(s),
−Removed: delivery or performance of the undelivered item(s) is considered probable and substantially within its control.
−Removed: In assessing whether an
−Removed: item under a collaboration has standalone value, the Company considers factors such as the research, manufacturing, and commercialization
−Removed: capabilities of the collaboration partner and the availability of the associated expertise in the general marketplace.
−Removed: The Company also
−Removed: considers whether its collaboration partners can use the other deliverable(s) for their intended purpose without the receipt of the remaining
−Removed: element(s), whether the value of the deliverable is dependent on the undelivered item(s), and whether there are other vendors that can
−Removed: provide the undelivered element(s).
−Removed: The Company recognizes arrangement consideration
−Removed: allocated to each unit of accounting when all of the revenue recognition criteria in ASC 606 are satisfied for that particular unit of
−Removed: In the event that a deliverable does not represent a separate unit of accounting, the Company recognizes revenue from the
−Removed: combined unit of accounting over the Company’s contractual or estimated performance period for the undelivered elements, which is
−Removed: typically the term of the Company’s research and development obligations.
−Removed: If there is no discernible pattern of performance or objectively
−Removed: measurable performance measures do not exist, then the Company recognizes revenue under the arrangement on a straight-line basis over
−Removed: the period the Company is expected to complete its performance obligations.
−Removed: Conversely, if the pattern of performance in which the service
−Removed: is provided to the customer can be determined and objectively measurable performance measures exist, then the Company recognizes revenue
−Removed: under the arrangement using the proportional performance method.
−Removed: Revenue recognized is limited to the lesser of the cumulative amount
−Removed: of payments received or the cumulative amount of revenue earned, as determined using the straight-line method or proportional performance
−Removed: method, as applicable, as of the period ending date.
−Removed: At the inception of an arrangement that includes
−Removed: milestone payments, the Company evaluates whether each milestone is substantive and at risk to both parties on the basis of the contingent
−Removed: nature of the milestone.
−Removed: This evaluation includes an assessment of whether:
−Removed: (1) the consideration is commensurate with either the Company’s
−Removed: performance to achieve the milestone or the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting
−Removed: from its performance to achieve the milestone, (2) the consideration relates solely to past performance and (3) the consideration is reasonable
−Removed: relative to all of the deliverables and payment terms within the arrangement.
−Removed: The Company evaluates factors such as the scientific, clinical,
−Removed: regulatory, commercial, and other risks that must be overcome to achieve the particular milestone and the level of effort and investment
−Removed: required to achieve the particular milestone in making this assessment.
−Removed: There is considerable judgment involved in determining whether
−Removed: a milestone satisfies all of the criteria required to conclude that a milestone is substantive.
−Removed: Milestones that are not considered substantive
−Removed: are recognized as earned if there are no remaining performance obligations or over the remaining period of performance, assuming all other
−Removed: revenue recognition criteria are met.
−Removed: (iv) Royalties and Profit-Sharing Payments
−Removed: Under the collaborative agreement with the collaboration
−Removed: partners, the Company is entitled to receive royalties on sales of products, which is at certain percentage of the net sales.
−Removed: recognizes revenue from these events based on the revenue recognition criteria set forth in ASC 606.
−Removed: Based on those criteria, the Company
−Removed: considers these payments to be contingent revenues, and recognizes them as revenue in the period in which the applicable contingency is
−Removed: Revenues Derived from Research and Development
−Removed: Activities Services - Revenues related to research and development and regulatory activities are recognized when the related services
−Removed: or activities are performed, in accordance with the contract terms.
−Removed: The Company typically has only one performance obligation at the inception
−Removed: of a contract, which is to perform research and development services.
−Removed: The Company may also provide its customers with an option to request
−Removed: that the Company provides additional goods or services in the future, such as active pharmaceutical ingredient, API, or IND/NDA/ANDA/510K
−Removed: The Company evaluates whether these options are material rights at the inception of the contract.
−Removed: If the Company determines
−Removed: an option is a material right, the Company will consider the option a separate performance obligation.
−Removed: If the Company is entitled to reimbursement from
−Removed: its customers for specified research and development expenses, the Company accounts for the related services that it provides as separate
−Removed: performance obligations if it determines that these services represent a material right.
−Removed: The Company also determines whether the reimbursement
−Removed: of research and development expenses should be accounted for as revenues or an offset to research and development expenses in accordance
−Removed: with provisions of gross or net revenue presentation.
−Removed: The Company recognizes the corresponding revenues or records the corresponding offset
−Removed: to research and development expenses as it satisfies the related performance obligations.
−Removed: The Company then determines the transaction price
−Removed: by reviewing the amount of consideration the Company is eligible to earn under the contracts, including any variable consideration.
−Removed: the outstanding contracts, consideration typically includes fixed consideration and variable consideration in the form of potential milestone
−Removed: At the start of an agreement, the Company’s transaction price usually consists of the payments made to or by the Company
−Removed: based on the number of full-time equivalent researchers assigned to the project and the related research and development expenses incurred.
−Removed: The Company does not typically include any payments that the Company may receive in the future in its initial transaction price because
−Removed: the payments are not probable.
−Removed: The Company would reassess the total transaction price at each reporting period to determine if the Company
−Removed: should include additional payments in the transaction price.
−Removed: The Company receives payments from its
−Removed: customers based on billing schedules established in each contract.
−Removed: Upfront payments and fees may be recorded as contract liabilities
−Removed: upon receipt or when due, and may require deferral of revenue recognition to a future period until the Company fulfills its
−Removed: obligations under these arrangements.
−Removed: Amounts are recorded as accounts receivable when the right of the Company to consideration is
−Removed: unconditional.
−Removed: The Company does not assess whether a contract has a significant financing component if the expectation at contract
−Removed: inception is such that the period between payment by the customers and the transfer of the promised goods or services to the
−Removed: customers will be one year or less.
−Removed: Examples of collaborative agreements the Company
−Removed: has entered into are as follows:
+Added: Collaborative agreement with ForSeeCon Eye
+Added: Corporation, a related party
+Added: On March 25, 2024, the Company and BioFirst each
+Added: entered into a twenty-year, global definitive licensing agreement (the “FEYE Licensing Agreement”) with ForSeeCon Eye Corporation,
+Added: a company registered in the British Virgin Islands (“FEYE”) for the products in the Company and BioFirst’s Ophthalmology
+Added: pipeline, including Vitargus (the “Vitargus Products”).
+Added: The license covers the Vitargus Products’ clinical trial, registration,
+Added: manufacturing, supply, and distribution rights;
+Added: FEYE also has the rights to sublicense or partner with a third party to develop the Licensed
+Added: As per each of the respective FEYE Licensing Agreements, each of the Company and BioFirst shall receive a total licensing fee
+Added: of $33,500,000, composed of an upfront payment of $30,000,000, which can instead be paid with 5 million shares of FEYE stock at $6 per
+Added: share within 30 days after the execution of the FEYE Licensing Agreement, and a $3,500,000 cash milestone payment, due 30 days upon completion
+Added: of next round fundraising.
+Added: Additionally, each of the Company and BioFirst are eligible to receive royalties of 5% of net Sales.
+Added: March 31, 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.
+Added: On June 18, 2024, the Company and BioFirst, each
+Added: entered into an amendment (the “ Amendment ”) to the Licensing Agreement with FEYE, pursuant to which the Company and
+Added: BioFirst have agreed to allow FEYE to pay the second milestone payment in the amount of $3,500,000 per Licensing Agreement, incrementally
+Added: (such as $100,000), at any given time, rather than in one lump sum.
+Added: In 2024 the Company received in cash and recognized revenue $296,000,
+Added: pursuant to the Amendment.
+Added: There was no transaction incurred during the period ended March 31, 2025.
+Added: Collaborative agreement with OncoX BiopPharma,
+Added: Inc., a related party
+Added: On April 16, 2024, the Company entered into a
+Added: definitive agreement with OncoX BioPharma, Inc., a private company registered in the British Virgin Islands (“Oncox”), pursuant
+Added: to which the Company will grant Oncox an exclusive right to develop and commercialize ABVC’s single-herb botanical drug extract
+Added: from the dry fruit body of Maitake Mushroom (Grifola Frondosa) for treatment of Non-Small Cell Lung Cancer (the “Lung Cancer Products”),
+Added: within North America for 20 years (the “April 2024 Oncox Agreement”).
+Added: In consideration thereof, Oncox shall pay ABVC $6,250,000
+Added: (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
+Added: the completion of Oncox’s next round of fundraising, of which there is no guarantee;
+Added: ABVC is also entitled to 5% royalties based
+Added: 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,
+Added: of which there can be no guarantee.
+Added: Oncox entered into another agreement with ABVC’s affiliate, Rgene Corporation, on the same terms.In
+Added: 2024 the Company received in cash and recognized revenue of $200,000, pursuant to the agreement.
+Added: On May 8, 2024, the Company entered into a definitive
+Added: agreement with OncoX, pursuant to which the Company will grant Oncox an exclusive right to develop and commercialize ABVC’s BLEX
+Added: 404 single-herb botanical drug extract from the dry fruit body of Maitake Mushroom (Grifola Frondosa) for treatment of Pancreatic (the
+Added: Pancreatic Product), within a certain territory, specified as 50% of the Worldwide Markets for 20 years (the “May 8, 2024 Oncox
+Added: In consideration thereof, Oncox shall pay ABVC a total of $6,250,000 (or 1,250,000 Oncox shares valued at $5 per share 2 )
+Added: within 30 days of entering into the May 8, 2024 Oncox Agreement, with an additional milestone payment of $625,000 in cash after OncoX’s
+Added: next round of fundraising, of which there can be no guarantee.
+Added: Oncox may remit cash payments of at least $100,000 towards the licensing
+Added: fees and deductible from the second milestone payment;
+Added: ABVC is also entitled to royalties of 5% of Net Sales, as defined in the May 8,
+Added: 2024 Oncox Agreement, from the first commercial sale of the Pancreatic Product in the noted territory, which remains uncertain.
+Added: will 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 entered into another agreement with ABVC’s affiliate, Rgene Corporation, on the same terms.
+Added: On May 14, 2024, the Company and its subsidiary,
+Added: BioLite Inc (collectively, the “licensor”), each entered into a licensing agreement with OncoX, on the same terms, pursuant
+Added: to which the licensors will grant Oncox an exclusive right to develop and commercialize ABVC’s BLEX 404 single-herb botanical drug
+Added: extract from the dry fruit body of Maitake Mushroom (Grifola Frondosa) for treatment of Tripple Negative Breast Cancer (the TNBC Product),
+Added: within a certain territory, specified as 50% of the Worldwide Markets for 20 years (the “May 14, 2024 Oncox Agreements”).
+Added: In each agreement for consideration thereof, Oncox shall pay each licensor a total of $6,250,000 (or 1,250,000 Oncox shares valued at
+Added: $5 per share 3 ) within 30 days of entering into the May 14, 2024 Oncox Agreements, with an additional milestone payment of $625,000
+Added: in cash after OncoX’s next round of fundraising, of which there can be no guarantee.
+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.
+Added: On May 23, 2024, the Company and its subsidiary,
+Added: BioLite Inc (collectively, the “licensor”), each entered into a licensing agreement with OncoX, on the same terms, pursuant
+Added: to which the licensors will grant Oncox an exclusive right to develop and commercialize ABVC’s BLEX 404 single-herb botanical drug
+Added: extract from the dry fruit body of Maitake Mushroom (Grifola Frondosa) for treatment of Myelodysplastic Syndrome (the “MS Products”),
+Added: within a certain territory, specified as 50% of the Worldwide Markets for 20 years (the “May 23, 2024 Oncox Agreements”).
+Added: In consideration thereof, Oncox shall pay each licensor a total of $6,250,000 (or 1,250,000 Oncox shares valued at $5 per share 4 )
+Added: 30 days after entering the May 23, 2024 Oncox Agreements, with an additional milestone payment of $625,000 in cash after OncoX’s
+Added: next round of fundraising, of which there can be no guarantee.
+Added: Oncox may remit cash payments of at least $100,000 towards the licensing
+Added: fees and deductible from the second milestone payment;
+Added: each licensor is also entitled to royalties of 5% of Net Sales, from the first
+Added: commercial sale of the MS Product in the noted territory, which remains uncertain.
+Added: Oncox may use its revenue to fund the licensing fees.
Collaborative agreements with BHK, a related
16 unchanged sentences
is entitled to receive a royalty equal to 12% of BHK’s net sales related to ABV-1501, ABV-1504 and ABV-1505 Products.
−Removed: As of September 30, 2024, the Company has not earned royalties under the BHK Co-Development Agreement.
+Added: As of March 31, 2025, the Company has not earned royalties under the BHK Co-Development Agreement.
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.
−Removed: Collaborative agreement with BioLite, Inc.,
−Removed: our subsidiary
−Removed: The Company entered into a collaborative agreement
−Removed: with BioLite, Inc.
−Removed: on December 29, 2015, and then entered into two addendums to such agreement, as amended and revised, (the “BioLite
−Removed: The majority shareholder of BioLite is one of the Company’s subsidiaries, Mr.
−Removed: Jiang, the Company’s Chairman
−Removed: is a director of BioLite and Dr.
−Removed: Jiang, the Company’s Chief Strategy Officer and a director, is the Chairman of BioLite.
−Removed: Pursuant to the BioLite Agreement, the Company
−Removed: acquired the sole licensing rights to develop and commercialize for therapeutic purposes six compounds from BioLite.
−Removed: In accordance with
−Removed: the terms of the Agreement, the Company shall pay BioLite (i) milestone payments of up to $100 million in cash and equity of the Company
−Removed: or equity securities owned by it at various stages on a schedule dictated by BioLite’s achievements of certain milestones, as set
−Removed: forth in the Agreement (the “Milestone Payments”) and (ii) a royalty payment equal to 5% of net sales of the drug products
−Removed: when ABV-1501 is approved for sale in the licensed territories.
−Removed: If BioLite fails to reach any of the milestones in a timely manner, it
−Removed: may not receive the rest of the payments from the Company.
−Removed: According to the BioLite Agreement, after Phase
−Removed: II clinical trials are completed, 15% of the Milestone Payment becomes due and shall be paid in two stages:
−Removed: (i) 5% no later than December
−Removed: 31, 2021 (the “December 2021 Payment”) and (ii) 10% no later than December 31, 2022.
−Removed: On February 12, 2022, the Company’s Board
−Removed: of Directors determined that the December 2021 Payment, which is equal to $5,000,000, shall be paid via the cancellation of certain outstanding
−Removed: debt, in the amount of $5,000,000, that BioLite owes the Company as of December 31, 2021.
−Removed: On February 22, 2022, the parties entered into
−Removed: an amendment to the BioLite Agreement allowing the Company to make all payments due under the Agreement via the forgiveness of debt, in
−Removed: equal value, owed by BioLite to the Company.
−Removed: On September 13, 2023, the BioLite received a
−Removed: new patent granted notice (application no.
−Removed: 109130285) for PDC-1421 from the Intellectual Property Office of Taiwan.
−Removed: This was a related party transaction.
−Removed: Co-Development agreement with Rgene Corporation,
−Removed: a related party
−Removed: On May 26, 2017, BriVision entered into a co-development
−Removed: agreement (the “Co-Dev Agreement”) with Rgene Corporation (the “Rgene”), a related party under common control
−Removed: by controlling beneficiary shareholder of YuanGene Corporation and the Company (See Note 4).
−Removed: Pursuant to Co-Dev Agreement, BriVision and
−Removed: Rgene agreed to co-develop and commercialize ABV-1507 HER2/neu Positive Breast Cancer Combination Therapy, ABV-1511 Pancreatic Cancer
−Removed: Combination Therapy and ABV-1527 Ovary Cancer Combination Therapy.
−Removed: Under the terms of the Co-Dev Agreement, Rgene is required to pay the
−Removed: Company $3,000,000 in cash or stock of Rgene with equivalent value by August 15, 2017.
−Removed: The payment is for the compensation of BriVision’s
−Removed: past research efforts and contributions made by BriVision before the Co-Dev Agreement was signed and it does not relate to any future
−Removed: commitments made by BriVision and Rgene in this Co-Dev Agreement.
−Removed: In addition to $3,000,000, the Company is entitled to receive 50% of
−Removed: the future net licensing income or net sales profit earned by Rgene, if any, and any development costs shall be equally shared by both
−Removed: BriVision and Rgene.
−Removed: On June 1, 2017, the Company has delivered all
−Removed: research, technical, data and development data to Rgene.
−Removed: Since both Rgene and the Company are related parties and under common control
−Removed: by a controlling beneficiary shareholder of YuanGene Corporation and the Company, the Company has recorded the full amount of $3,000,000
−Removed: in connection with the Co-Dev Agreement as additional paid-in capital during the year ended December 31, 2017.
−Removed: During the year ended December
−Removed: 31, 2017, the Company received $450,000 in cash.
−Removed: On December 24, 2018, the Company received the remaining balance of $2,550,000 in
−Removed: the form of newly issued shares of Rgene’s Common Stock, at the price of NTD$50 (approximately equivalent to $1.64 per share), for
−Removed: an aggregate number of 1,530,000 shares, which accounted for equity method long-term investment as of December 31, 2018.
−Removed: On December 31, 2018, the Company determined to fully write
−Removed: off this investment based on the Company’s assessment of the severity and duration of the impairment, and qualitative and quantitative
−Removed: analysis of the operating performance of the investee, adverse changes in market conditions and the regulatory or economic environment,
−Removed: changes in operating structure of Rgene, additional funding requirements, and Rgene’s ability to remain in business.
−Removed: that have been initiated will be managed and supported by the Company and Rgene.
−Removed: The Company and Rgene signed an amendment to the
−Removed: Rgene Agreement on November 10, 2020, pursuant to which both parties agreed to delete AB-1507 HER2/neu Positive Breast Cancer Combination
−Removed: Therapy and AB-1527 Ovary Cancer Combination Therapy and add ABV-1519 EGFR Positive Non-Small Cell Lung Cancer Combination Therapy and
−Removed: ABV-1526 Large Intestine / Colon / Rectal Cancer Combination Therapy to the products to be co-developed and commercialized.
−Removed: Other provisions
−Removed: of the Rgene Agreement remain in full force and effect.
−Removed: Clinical Development Service Agreement with
−Removed: Rgene Corporation, a related party
−Removed: On June 10, 2022, the Company expanded its co-development
−Removed: partnership with Rgene.
−Removed: The Company’s subsidiary, BioKey, entered into a Clinical Development Service Agreement with Rgene (“Service
−Removed: Agreement”) to guide certain Rgene drug products, RGC-1501 for the treatment of Non-Small Cell Lung Cancer (NSCLC), RGC-1502 for
−Removed: the treatment of pancreatic cancer and RGC 1503 for the treatment of colorectal cancer patients, through completion of Phase II clinical
−Removed: studies under U.S.
−Removed: FDA IND regulatory requirements (the “Rgene Studies”).
−Removed: Under the terms of the Service Agreement, BioKey
−Removed: is eligible to receive payments totaling up to $3.0 million over a 3-year period with each payment amount to be determined by certain
−Removed: regulatory milestones obtained during the agreement period.
−Removed: The Service Agreement shall remain in effect until the expiration date of
−Removed: the last patent and automatically renew for 5 more years unless terminated earlier by either party with six months written notice.
−Removed: party may terminate the Service Agreement for cause by providing 30 days written notice.
−Removed: Through a series of transactions over the past
−Removed: 5 years, the Company and Rgene have co-developed the three drug products covered by the Service Agreement, which has resulted in the Company
−Removed: owning 31.62% of Rgene.
−Removed: As part of the Rgene Studies, the Company agreed
−Removed: to loan $1.0 million to Rgene, for which Rgene has provided the Company with a 5% working capital convertible loan (the “Note”).
−Removed: If the Note is fully converted, the Company will own an additional 6.4% of Rgene.
−Removed: The Company is expected to receive the outstanding loan
−Removed: from the related party by the 2023 Q4, either by cash or conversion of shares of Rgene.
−Removed: The Company may convert the Note at any time into
−Removed: shares of Rgene’s common stock at either (i) a fixed conversion price equal to $1.00 per share or (ii) 20% discount of the stock
−Removed: price of the then most recent offering, whichever is lower;
−Removed: the conversion price is subject to adjustment as set forth in the Note.
−Removed: Note includes standard events of default, as well as a cross default provision pursuant to which a breach of the Service Agreement will
−Removed: trigger an event of default under the Note if not cured after 5 business days of written notice regarding the breach is provided.
−Removed: an event of default, the outstanding principal and any accrued and unpaid interest shall be immediately due and payable.
−Removed: The Service Agreement shall remain in effect until
−Removed: the expiration date of the last patent and automatically renew for 5 more years unless terminated earlier by either party with six months
−Removed: written notice.
−Removed: Either party may terminate the Service Agreement for cause by providing 30 days written notice.
−Removed: Rgene has further agreed, effective July 1, 2022,
−Removed: to provide the Company with a seat on Rgene’s Board of Directors until the loan is repaid in full.
−Removed: The Company has nominated Dr.
−Removed: Jiang, its Chief Strategy Officer and Director to occupy that seat;
−Removed: Jiang is also one of the Company’s largest shareholders,
−Removed: owning 12.8% of the Company.
−Removed: The Rgene Studies is a related party transaction.
−Removed: Collaborative agreement with BioFirst Corporation,
−Removed: a related party
−Removed: On July 24, 2017, BriVision entered into a collaborative agreement
−Removed: (the “BioFirst Collaborative Agreement”) with BioFirst Corporation (“BioFirst”), pursuant to which BioFirst granted
−Removed: the Company the global licensing right for medical use of the product (the “Product”):
−Removed: BFC-1401 Vitreous Substitute for Vitrectomy.
−Removed: BioFirst is a related party to the Company because a controlling beneficiary shareholder of YuanGene Corporation and the Company is one
−Removed: of the directors and Common Stock shareholders of BioFirst (See Note 10).
−Removed: Pursuant to the BioFirst Collaborative Agreement,
−Removed: the Company will co-develop and commercialize the Product with BioFirst and pay BioFirst in a total amount of $3,000,000 in cash or stock
−Removed: of the Company before September 30, 2018.
−Removed: The amount of $3,000,000 is in connection with the compensation for BioFirst’s past research
−Removed: efforts and contributions made by BioFirst before the BioFirst Collaborative Agreement was signed and it does not relate to any future
−Removed: commitments made by BioFirst and BriVision in this BioFirst Collaborative Agreement.
−Removed: In addition, the Company is entitled to receive 50%
−Removed: of the future net licensing income or net sales profit, if any, and any development cost shall be equally shared by both BriVision and
−Removed: On September 25, 2017, BioFirst has delivered
−Removed: all research, technical, data and development data to BriVision.
−Removed: The Company determined to fully expense the entire amount of $3,000,000
−Removed: since currently the related licensing rights do not have alternative future uses.
−Removed: According to ASC 730-10-25-1, absent alternative future
−Removed: uses the acquisition of product rights to be used in research and development activities must be charged to research and development expenses
−Removed: Hence, the entire amount of $3,000,000 is fully expensed as research and development expense during the year ended December
−Removed: On June 30, 2019, BriVision entered into a Stock
−Removed: Purchase Agreement (the “Purchase Agreement”) with BioFirst Corporation.
−Removed: Pursuant to the Purchase Agreement, the Company issued
−Removed: 42,857 shares (post-split) of the Company’s common stock to BioFirst in consideration for $3,000,000 owed by the Company to BioFirst
−Removed: (the “Total Payment”) in connection with a certain collaborative agreement between the Company and BioFirst dated July 24,
−Removed: 2017 (the “Collaborative Agreement”).
−Removed: Pursuant to the Collaborative Agreement, BioFirst granted the Company the global licensing
−Removed: right to co-develop BFC-1401 or ABV-1701 Vitreous Substitute for Vitrectomy for medical purposes in consideration for the Total Payment.
−Removed: On August 5, 2019, BriVision entered into a second
−Removed: Stock Purchase Agreement (“Purchase Agreement 2”) with BioFirst Corporation.
−Removed: Pursuant to Purchase Agreement 2, the Company
−Removed: issued 41,470 shares (post-split) of the Company’s common stock to BioFirst in consideration for $2,902,911 owed by the Company
−Removed: to BioFirst in connection with a loan provided to BriVision from BioFirst.
−Removed: On November 4, 2020, the Company executed an amendment
−Removed: to the BioFirst Agreement with BioFirst, to add ABV-2001 Intraocular Irrigation Solution and ABV-2002 Corneal Storage Solution to the
−Removed: ABV-2002 is utilized during a corneal transplant procedure to replace a damaged or diseased cornea, while ABV-2001 has broader
−Removed: utilization during a variety of ocular procedures.
−Removed: Initially, the Company will focus on ABV-2002,
−Removed: a solution utilized to store a donor cornea prior to either penetrating keratoplasty (full thickness cornea transplant) or endothelial
−Removed: keratoplasty (back layer cornea transplant).
−Removed: ABV-2002 is a solution comprised of a specific poly amino acid that is intended to protect
−Removed: ocular tissue from damage caused by external osmolarity exposure during pre-surgery storage.
−Removed: The specific polymer in ABV-2002 can adjust
−Removed: osmolarity to maintain a range of 330 to 390 mOsM, thereby permitting hydration within the corneal stroma during the storage period.
−Removed: Stromal hydration typically results in (a) maintaining acceptable corneal transparency and (b) prevents donor cornea swelling.
−Removed: also contains an abundant phenolic phytochemical found in plant cell walls that provides antioxidant antibacterial properties and neuroprotection.
−Removed: Early testing by BioFirst indicates that ABV-2002
−Removed: may be more effective for protecting the cornea and retina during long-term storage than other storage media available today and can be
−Removed: manufactured at lower cost.
−Removed: Further clinical development was put on hold due to the lack of funding.
−Removed: In addition, BioFirst was incorporated on November
−Removed: 7, 2006, focusing on the R&D, manufacturing, and sales of innovative patented pharmaceutical products.
−Removed: The technology of BioFirst
−Removed: comes from the global exclusive licensing agreements BioFirst maintains with domestic R & D institutions.
−Removed: Currently, BioFirst’s
−Removed: main research and development product is the vitreous substitute (Vitargus ® ), licensed by the National Health Research
−Removed: Vitargus is the world’s first bio-degradable vitreous substitute and offers a number of advantages over current vitreous
−Removed: substitutes by minimizing medical complications and reducing the need for additional surgeries.
−Removed: Vitargus has started the construction of a GMP
−Removed: factory in Hsinchu Biomedical Science Park, Taiwan, with the aim at building a production base to supply the global market, and promote
−Removed: the construction of bio-degradable vitreous substitute manufacturing centers in Taiwan.
−Removed: Completion of this factory would allow ABVC to
−Removed: manufacture Vitargus with world-class technology in a GMP certified pharmaceutical factory.
−Removed: BioFirst is targeting to complete the construction
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 conditioned
−Removed: upon the approval and receipt of all necessary government approvals, which have been received.
+Added: The closing of the transaction is
+Added: conditioned 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: The Company shall
−Removed: appoint Eugene Jiang, the Company’s current Chairman and Chief Business Officer and Lucidaim shall appoint Michihito Onishi;
−Removed: current director of BioLite JP, Toru Seo (who is also a director of BioLite Japan’s other shareholder), is considered the second
+Added: shall appoint Eugene Jiang, the Company’s current Chairman and Chief Business Officer and Lucidaim shall appoint Michihito Onishi;
+Added: the current director of BioLite JP, Toru Seo (who is also a director of BioLite Japan’s other shareholder), is considered the second
Lucidaim director.
1 unchanged sentence
agreement between them to BioLite JP or prepare the same (the “License Agreement”).
−Removed: The aforementioned transactions
−Removed: occurred on the Completion Date.
+Added: The aforementioned transactions occurred
+Added: on the Completion Date.
As per the Agreement, the Shareholders shall
6 unchanged sentences
corporate actions that must be pre-approved by all Shareholders (the “Reserved Matters”).
−Removed: If the Shareholders are
−Removed: unable to make a decision on any Reserved Matter, then either Shareholder can submit a deadlock notice to the other shareholder, 5 days
−Removed: after which they must refer the matter to each Shareholder’s chairman and use good faith to resolve the dispute.
−Removed: If such dispute
−Removed: is not resolved within 10 days thereafter, then either Shareholder can offer to buy all of the other Shareholder’s Ordinary Shares
−Removed: for cash at a specified price;
+Added: If the Shareholders are unable
+Added: to make a decision on any Reserved Matter, then either Shareholder can submit a deadlock notice to the other shareholder, 5 days after
+Added: which they must refer the matter to each Shareholder’s chairman and use good faith to resolve the dispute.
+Added: If such dispute is not
+Added: resolved within 10 days thereafter, then either Shareholder can offer to buy all of the other Shareholder’s Ordinary Shares for
+Added: 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.
6 unchanged sentences
Ordinary Shares.
−Removed: The Agreement also requires BioLite JP to obtain a bank facility in
−Removed: the amount of JPY 30,460,000 (approximately $272,000), for its initial working capital purposes.
−Removed: Pursuant to the Agreement, each Shareholder
−Removed: agrees to guarantee such bank facility if the bank requires a guarantee.
−Removed: Accordingly, the Company may be liable for the bank facility
−Removed: in an amount up to JPY 14,925,400 (approximately $134,000), which represents 49% of the maximum bank facility.
−Removed: The Agreement further provides
−Removed: that BioLite JP shall issue annual dividends at the rate of at least 1.5% of Biolite’s profits, if it has sufficient cash to do
−Removed: Pursuant to the Agreement, the Company and BioLite
−Removed: JP agree to use their best efforts to execute the License Agreement by the end of December 2021.
−Removed: The Company agreed that any negotiation
−Removed: on behalf of BioLite JP regarding the terms of the License Agreement shall be handled by the directors appointed by Lucidaim.
−Removed: If the Company
−Removed: and such Lucidaim directors do not reach agreement on the terms, Biolite may at its sole discretion determine not to execute the License
−Removed: Agreement without any liability to the Company.
+Added: The Agreement also requires BioLite JP to obtain
+Added: a bank facility in the amount of JPY 30,460,000 (approximately $272,000), for its initial working capital purposes.
+Added: Pursuant to the Agreement,
+Added: each Shareholder agrees to guarantee such bank facility if the bank requires a guarantee.
+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.
+Added: Pursuant to the agreement between the Company and BioLite JP, both
+Added: parties agreed to use their best efforts to execute a License Agreement by the end of December 2021.
+Added: Under the terms of the agreement,
+Added: negotiations on behalf of BioLite JP are conducted by directors appointed by Lucidaim.
+Added: If the Company and such directors do not reach
+Added: agreement on the terms, BioLite JP may, at its sole discretion, elect not to execute the License Agreement without any liability to the
+Added: The company is negotiating on the licensing terms and expects to conclude soon.
The Agreement contains non-solicitation and non-compete
3 unchanged sentences
activities, shall belong to BioLite JP.
−Removed: The Agreement contains standard indemnification terms, except that
−Removed: no indemnifying party shall have any liability for an individual liability unless it exceeds JPY 500,000 (approximately $4,500) and until
−Removed: the aggregate amount of all liabilities exceeds JPY 2,000,000 (approximately $18,000) and then only to the extent such liability exceed
+Added: The Agreement contains standard indemnification
+Added: terms, except that no indemnifying party shall have any liability for an individual liability unless it exceeds JPY 500,000 (approximately
+Added: $4,500) and until the aggregate amount of all liabilities exceeds JPY 2,000,000 (approximately $18,000) and then only to the extent such
+Added: liability exceed such limit.
The Company paid $150,000 towards the setup of
6 unchanged sentences
This was a related party transaction.
+Added: the Company recognized fully $150,000 loss in equity method investment based on continuing operating losses of BioLite JP.
+Added: In April 2024, the Japan Patent Office
+Added: granted a new patent protection for the Company’s Major Depressive Disorder (MDD) candidate, ABV-1504.
+Added: The patent is valid through
+Added: 2040 and will help BioLite Japan market and commercialize the product.
BioKey Revenues
43 unchanged sentences
impairment losses related to goodwill and other long-lived assets and current obligations.
+Added: Restatement of Consolidated Financial Statements
+Added: The Company restated its financial statements as of and for the year
+Added: ended December 31, 2023 (the “2023 Restatement”), to correct misstatements in those prior periods related to improperly applying
+Added: accounting guidance on the share-based payments, incorrectly recognizing interest expenses upon the conversion of convertible debts, and
+Added: misidentifying the existence of non-controlling interest of our subsidiary.
+Added: The Company entered into a cooperation agreement
+Added: on August 14, 2023, with Zhong Hui Lian He Ji Tuan, Ltd.
+Added: (the “Zhonghui”) to acquire 20% of the ownership of certain property
+Added: and a parcel of the land.
+Added: According to the agreement, the Company issued 370,000 shares of its common stock as the consideration, and
+Added: used $20 dollar per share to recognize the right as construction in progress on the balance sheet.
+Added: At the time of preparing its financial statements
+Added: for fiscal 2024, the Company reviewed the entire transaction, its relevant agreements and documentation, as well as the applicable accounting
+Added: The Company applied FASB Accounting Standard Codification (“ASC”) 845 Nonmonetary Transactions to determine the
+Added: fair value of the asset acquired would be more evident than the fair value of the consideration in exchange, the Company’s restricted
+Added: common stocks.
+Added: The real estates acquired comes with a third-party valuation of $7,400,000 per the Company’s stake, which the value
+Added: of the acquired assets is guaranteed by Zhonghui.
+Added: Upon further review, the Company considered ASC 718 Compensation - Stock Compensation,
+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.
+Added: As a result, these adjustments reduced $6,708,100 for asset recognized and $536,648 for stock-compensation
+Added: expense incurred in 2023.
+Added: In February 2023, the Company issued a convertible
+Added: note to LIND Global Fund II, LP.
+Added: Due to misapplication of ASC 470-20 instead of ASC 815-40, the Company overstated interest expenses $1,179,667
+Added: for the year ended December 31, 2023.
+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.
+Added: As discussed in Note 12 to the financial statements
+Added: for the year ended December 31, 2024, in July 2019 the Company issued 644,972 shares (post-split) of the Company’s common stock
+Added: to four consultants for their services.
+Added: Such stock-based expenses were amortized over 5 years starting from the issuance date.
+Added: Company’s further review, the services, along with the agreements, were completed by December 31, 2022.
+Added: Pursuant to ASC 718, the
+Added: costs of services should be recognized along with the period when services are received.
+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,
+Added: please see the Notes to the Company’s financial statements for the year ended December 31, 2024, included in its Annual Report on
+Added: Form 10-K that was filed with the SEC on April 15, 2025.
Summary of Critical Accounting Policies
9 unchanged sentences
Company’s audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K
−Removed: for the year ended December 31, 2023, filed with the SEC on March 13, 2024 (“2023 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
7 unchanged sentences
In August 2023, the FASB issued ASU 2023-05, Business
−Removed: 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.
+Added: Combinations-Joint Venture Formations (Subtopic 805-60) which requires certain joint ventures to apply a new basis of accounting upon
+Added: formation by recognizing and initially measuring most of their assets and liabilities at fair value.
+Added: The guidance does not apply to joint
+Added: ventures that may be proportionately consolidated and those that are collaborative arrangements.
+Added: ASU 2023-05 is effective for joint venture
+Added: with a formation date on or after January 1, 2025, early adoption is permitted.
+Added: The Company is currently evaluating the impact that the
+Added: standard will have on its unaudited consolidated financial statements.
Results of Operations - Three Months Ended
−Removed: September 30, 2024 Compared to Three Months Ended September 30, 2023.
+Added: March 31, 2025 Compared to Three Months Ended March 31, 2024 (Restated).
The following table presents, for the three months
indicated, our unaudited consolidated statements of operations information.
−Removed: Three Months Ended
−Removed: September 30,
−Removed: Gross Profits (Loss)
−Removed: Operating Expenses
−Removed: $ (1,802,110 )
−Removed: Income (Loss) from Operations
−Removed: $ (2,154,873 )
−Removed: Interest (Expense), Net
−Removed: $ (1,178,378 )
−Removed: Other Expense
−Removed: $ (3,369,080 )
−Removed: We generated $389,276
−Removed: and $15,884 in revenues for the three months ended September 30, 2024 and 2023, respectively.
−Removed: The increase in revenues was mainly due
−Removed: to the revenue recognized from licensing to ForSeeCon and OncoX.
−Removed: In addition to FDA application service revenue generated in both periods, the licensing revenues contributed the main growth in the revenue.
−Removed: Please refer to the above collaborative agreements for details.
−Removed: Operating Expenses.
−Removed: operating expenses have decreased by $1,802,110 or 84%, to $339,033 for the three months ended September 30, 2024 from $,2141,143
−Removed: for the three months ended September 30, 2023.
−Removed: Such a decrease in operating expenses was mainly attributable to the decrease in
−Removed: selling, general and administrative expenses and research and development expenses.
−Removed: Interest income (expense), net.
−Removed: was $(175,272) for the three months ended September 30, 2024, compared to ($1,178,378) for the three months ended September 30, 2023.
−Removed: The decrease in net interest expense of $1,003,106, or approximately 85%, was primarily due to the decrease in interest expense due to
−Removed: recognition of interest expense for the converted notes for proper accounting purposes .
−Removed: Other Expense .
−Removed: Our other expense
−Removed: was $8,592 for the three months ended September 30, 2024, compared to other expense of $35,828 for the three months ended September 30,
−Removed: The change was principally caused by the increase in loss on equity investment and offsetting by increase in gain on foreign exchanges
−Removed: in the three months ended September 30, 2024.
−Removed: As a result of the
−Removed: above factors, our net loss was $134,272 for the three months ended September 30, 2024 compared to $3,369,080 for the three months ended
−Removed: September 30, 2023, representing a decrease of $3,234,808, or 96%.
−Removed: Results of Operations - Nine months Ended September
−Removed: 30, 2024 Compared to Nine months Ended September 30, 2023.
−Removed: The following table presents, for the nine months
−Removed: indicated, our unaudited consolidated statements of operations information.
−Removed: Nine Months Ended
−Removed: September 30,
−Removed: Gross Profits (Loss)
+Added: Gross Profits
Operating Expenses
2 unchanged sentences
$ (2,838,255 )
−Removed: $ (6,254,899 )
+Added: Other Income (Expense)
Interest (Expense), Net
−Removed: $ (1,088,797 )
−Removed: $ (1,242,041 )
−Removed: Other Expense
Net Income (Loss)
$ (2,927,667 )
−Removed: $ (7,580,535 )
We generated $0 and $1,205
−Removed: $150,265 in revenues for the nine months ended September 30, 2024 and 2023, respectively.
−Removed: The increase in revenues was mainly due to
−Removed: the revenue recognized from licensing to ForSeeCon and OncoX.
−Removed: In addition to FDA application service revenue generated in both periods, the licensing revenues contributed the main growth in the revenue.
−Removed: Please refer to the above collaborative agreements for details.
+Added: in revenues for the three months ended March 31, 2025 and 2024, respectively.
+Added: Besides assisting our licensees seeking for potential business
+Added: opportunities and investors, the Company also is exploring other revenue streams, including the FDA application services which generated
+Added: limited revenue in the three months ended March 31, 2024.
+Added: For out-licensing agreements, please refer to the above collaborative agreements
Operating Expenses.
−Removed: operating expenses have decreased by $1,364,389, or 22%, to $4,877,944 for the nine months ended September 30, 2024 from $6,242,333
−Removed: for the nine months ended September 30, 2023.
−Removed: Such a decrease in operating expenses was mainly attributable to the decrease in
−Removed: stock-based compensation expenses by $2,957,736 which relates to costs in conjunction with employee compensation and non-employee
−Removed: share-based payments.
+Added: Our operating expenses
+Added: have decreased by $2,146,178 or 76%, to $693,005 for the three months ended March 31, 2025 from $2,839,183 for the three months ended
+Added: March 31, 2024.
+Added: Such a decrease in operating expenses was mainly attributable to the decrease in selling, general and administrative expenses
+Added: and research and development expenses.
Interest income (expense), net.
−Removed: was $(1,088,797) for the nine months ended September 30, 2024, compared to $(1,242,041) for the nine months ended September 30, 2023.
−Removed: decrease of $153,244, or approximately 12%, was primarily due to the decrease in interest expense due to recognition of interest expense
−Removed: for the converted notes for proper accounting purpose .
+Added: Our net interest expense was $(203,896) for the three months ended March 31, 2025, compared to ($177,627) for the three months ended
+Added: March 31, 2024.
+Added: The increase in net interest expense of $26,269, or approximately 15%, was primarily due to the increase in
+Added: recognition of interest expense for the converted notes for proper accounting purposes .
Other Expense .
−Removed: Our other expense
−Removed: was $38,638 for the nine months ended September 30, 2024, compared to other expense of $2,899 for the nine months ended September 30,
−Removed: The change was principally caused by the increase in loss on equity method investment, while being offset by the increase in foreign
−Removed: exchange income for the nine months ended September 30, 2024.
−Removed: As a result of the
−Removed: above factors, our net loss was $5,387,980 for the nine months ended September 30, 2024 compared to $7,580,535 for the nine months ended
−Removed: September 30, 2023, representing an decrease of $2,192,555, or 29%.
+Added: Our other expense was
+Added: $251,185 for the three months ended March 31, 2025, compared to other expense of $89,412 for the three months ended March 31, 2024.
+Added: change was principally caused by the increase in loss on equity investment, interest expense, and offsetting by decrease in gain on foreign
+Added: exchanges in the three months ended March 31, 2025.
+Added: As a result of the above
+Added: factors, our net loss was $944,190 for the three months ended March 31, 2025 compared to $2,927,667 for the three months ended March 31,
+Added: 2024, representing a decrease of $1,983,477, or 68%.
+Added: Asset Recognition and Investment Reclassification
+Added: During the three months ended March 31, 2025, the Company recognized certain
+Added: updates to its financial position.
+Added: The Company recorded the acquisition of land located in Puli, Taiwan, with a carrying value of approximately
+Added: $7.67 million, based on control obtained over the asset during the period.
+Added: The Company intends to utilize the land for future development
+Added: of its health-related business operations.
+Added: In addition, amounts previously classified as "Due from Related Parties" were reclassified
+Added: to "Long-Term Investments" to reflect the nature of the Company’s ongoing investment in Rgene Corporation.
+Added: The reclassification
+Added: was based on management’s ongoing evaluation of the investment’s expected holding period and strategic purpose, after entering
+Added: into the convertible note loan in 2023.
+Added: These changes increased total assets and stockholders’ equity as of March 31, 2025.
+Added: Notwithstanding
+Added: these improvements in the Company’s asset base, management continues to evaluate liquidity risks and is seeking to address working
+Added: capital needs through operational activities and external financing options.
Liquidity and Capital Resources
Working Capital
−Removed: September 30,
Current Assets
2 unchanged sentences
$ (5,261,178 )
−Removed: Going Concern and
−Removed: Liquidity Consideration
−Removed: For the nine months ended September 30, 2024, the Company reported net loss of $5,387,980.
−Removed: of September 30, 2024, the Company’s working capital deficit was $4,167,315.
−Removed: In addition, the Company had net cash outflows of $1,315,534
−Removed: from operating activities for the nine months ended September 30, 2024.
−Removed: These conditions give rise to substantial doubt as to whether
−Removed: the Company will be able to continue as a going concern.
−Removed: Management’s plan is to continue to improve operations to generate positive
−Removed: cash flows by 1) ensuring our cash consideration from our licensing agreements be fully collected soon, 2) raising additional capital
−Removed: through private or public offerings, 3) strictly controlling cash operating expenses, and 4) reducing debts and interest expense.
−Removed: the Company has generated cash inflow and reduced a substantial amount of debts during the first nine months ended September 30, 2024,
−Removed: from $2.2 million to $1.6 million.
−Removed: We also reduced our outstanding warrants from 2.5 million shares to 2 million shares in October, receiving
−Removed: around $210,000 in cash.
−Removed: If the Company is not able to generate positive operating cash flows, and raise additional capital, there is
−Removed: the risk that the Company may not be able to meet its short-term obligations.
−Removed: Management is committed to enhancing operations to generate
−Removed: positive cash flows to meet our operation needs.
+Added: $ (4,677,646 )
+Added: Going Concern and Liquidity Consideration
+Added: For the three months ended March 31, 2025, the Company reported net loss
+Added: As of March 31, 2025, the Company’s working capital deficit was $5,261,178.
+Added: In addition, the Company had net cash outflows
+Added: of $539,833 from operating activities for the three months ended March 31, 2025.
+Added: These conditions give rise to substantial doubt as to
+Added: whether the Company will be able to continue as a going concern.
+Added: Management’s plan is to continue to improve
+Added: operations to generate positive cash flows by 1) ensuring our cash consideration from our licensing agreements be fully collected soon,
+Added: 2) raising additional capital through private or public offerings, 3) strictly controlling cash operating expenses, and 4) reducing debts
+Added: and interest expense.
+Added: Notably, the Company has generated cash inflow and
+Added: reduced a substantial amount of convertible debts during the first three months ended March 31, 2025, from $0.95 million to $0.84 million.
+Added: We also reduced our outstanding warrants from 2.0 million shares to 1 million shares in three months ended March 31, 2025, receiving around
+Added: $411,667 in cash.
+Added: If the Company is not able to generate positive operating cash flows, and raise additional capital, there is the risk
+Added: that the Company may not be able to meet its short-term obligations.
+Added: Management is committed to enhancing operations to generate positive
+Added: cash flows to meet our operation needs.
+Added: Three Months Ended March 31
+Added: 2024 (Restated)
+Added: Cash Flow Used In Operating Activities
+Added: Cash Flow Used in Investing Activities
+Added: Cash Flow Provided by Financing Activities
Cash Flow from Operating Activities
−Removed: During the nine months ended September 30, 2024 and 2023, the net cash
−Removed: used in operating activities were $1,315,534 and $3,756,385, respectively.
−Removed: The decrease was primarily due to the increase in licensing
−Removed: cash payment from ForSeeCon and OncoX, and the decrease in operating expenses.
−Removed: Company has been strictly controlling the operating cash outflow,
−Removed: such as making certain payments with shares in lieu of cash, extending vendors’ payment terms, and other initiatives to save the
+Added: During the three months ended March 31, 2025 and 2024,
+Added: the net cash used in operating activities were $539,833 and $955,816, respectively.
+Added: The decrease was primarily due to the decrease in
+Added: operating expenses.
+Added: Company has been strictly controlling the operating cash outflow, such as making certain payments with shares in lieu
+Added: of cash, extending vendors’ payment terms, and other initiatives to save the cash burn.
Cash Flow from Investing Activities
−Removed: During the nine months ended September 30, 2024
−Removed: and 2023, the net cash used in investing activities were $0 and $514,359 respectively.
−Removed: The increases were mainly due to the increase in
−Removed: prepayment for long-term investments during the nine months ended September 30, 2024.
+Added: During the three months ended March 31, 2025 and 2024,
+Added: the net cash used in investing activities were $0 and $0 respectively.
+Added: The Company does not plan to make further cash investment with
+Added: cash in the near future.
Cash Flow from Financing Activities
−Removed: During the nine months ended September 30, 2024
−Removed: and 2023, the net cash provided by financing activities were $1,399,313 and $3,831,540, respectively.
−Removed: The decrease in net cash provided
−Removed: by financing activities were primarily due to the proceeds from issuance of convertible notes, Lind’s exercise of warrants, and
−Removed: common stock subscription in advance.
+Added: During the three months ended March 31, 2025 and 2024, the net cash provided
+Added: by financing activities were $428,756 and $924,147, respectively.
+Added: The decrease in net cash provided by financing activities were primarily
+Added: due to the proceeds from issuance of convertible notes, Lind’s exercise of warrants, and less short-term funding from our related
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.