What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-11-14 compared with 2024-08-14 · 384 added, 332 removed, 1048 unchanged (41% of the section changed)

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II clinical trials in partnership with ABVC include:

ABV-1504, Major Depressive

Disorder (MDD), Phase II completed.

ABV-1504, Major Depressive Disorder (MDD), Phase II completed.

NCE drug Principal Investigators:

Charles DeBattista M.D.

Schatzberg, MD, Stanford University

Medical Center, Cheng-Ta Li, MD, Ph.D - Taipei Veterans General Hospital

ABV-1505, Adult Attention-Deficit

Hyperactivity Disorder (ADHD), Phase II Part 1 completed.

Schatzberg, MD, Stanford University Medical Center, Cheng-Ta Li, MD, Ph.D - Taipei Veterans General Hospital

ABV-1505, Adult Attention-Deficit Hyperactivity Disorder (ADHD), Phase II Part 1 completed.

Principal Investigators:

Keith McBurnett, Ph.D.

and Linda Pfiffner, Ph.D.,

University of California San Francisco (UCSF), School of Medicine.

Phase II, Part 2 clinical study sites include UCSF and 5 locations

and Linda Pfiffner, Ph.D., University of California San Francisco (UCSF), School of Medicine.

Phase II, Part 2 clinical study sites include UCSF and 5 locations in Taiwan.

The Principal Investigators are Keith McBurnett, Ph.D.

and Linda Pfiffner, Ph.D., University of California San Francisco (UCSF),

School of Medicine;

and Linda Pfiffner, Ph.D., University of California San Francisco (UCSF), School of Medicine;

Susan Shur-Fen Gau, M.D., National Taiwan University Hospital;

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Ton-Ping Su, M.D., Cheng Hsin General Hospital;

Cheng-Ta Li, M.D., Taipei

Veterans General Hospital.

Cheng-Ta Li, M.D., Taipei Veterans General Hospital.

Phase II, Part 2 began in the 1st quarter of 2022 at the 5 Taiwan sites.

The UCSF site joined the study in

the 2nd quarter of 2023.

The subjects enrolled in the study has reached the number for interim analysis in 2023 December, and the interim

analysis of the study is in progress.

ABV-1601, Major Depression

in Cancer Patients, Phase I/II, NCE drug Principal Investigator:

The UCSF site joined the study in the 2nd quarter of 2023.

The subjects enrolled in the study has reached the number for interim analysis in December 2023, and the interim analysis of the study is in progress.

ABV-1601, Major

Depression in Cancer Patients, Phase I/II, NCE drug Principal Investigator:

Scott Irwin, MD, Ph.D.

- Cedars Sinai Medical Center (CSMC).

I clinical study will be initiated in the 2nd quarter of 2024.

- Cedars Sinai Medical Center

The Phase I clinical study will be initiated in the fourth quarter of 2024.

Medical Device:

ABV-1701, Vitargus®

in vitrectomy surgery, Phase II Study has been initiated in Australia and Thailand, Principal Investigator:

Duangnate Rojanaporn, M.D.,

Ramathibodi Hospital;

ABV-1701, Vitargus® in vitrectomy surgery, Phase II Study has been initiated in Australia and Thailand, Principal Investigator:

Duangnate Rojanaporn, M.D., Ramathibodi Hospital;

Thuss Sanguansak, M.D., Srinagarind Hospital of the two Thailand Sites and Professor/Dr.

Matthew Simunovic, Sydney

Eye Hospital;

Matthew Simunovic, Sydney Eye Hospital;

Elvis Ojaimi, East Melbourne Eye Group & East Melbourne Retina.

The Phase II study started in the 2nd quarter of

2023, and the company is working on improvements to the Vitargus Product through the new batch of investigational product.

The Phase II study started in the 2nd quarter of 2023, and the company is working on improvements to the Vitargus Product through the new batch of investigational product.

The following trials are expected to begin in

the third quarter of 2024:

ABV-1519, Non-Small Cell

Lung Cancer treatment, Phase I/II Study in Taiwan, Principal Investigator:

Yung-Hung Luo, M.D., Taipei Veterans General Hospital

ABV-1703, Advanced Inoperable

or Metastatic Pancreatic Cancer, Phase II, Principal Investigator:

the fourth quarter of 2024:

ABV-1519, Non-Small Cell Lung Cancer treatment, Phase I/II Study in Taiwan, Principal Investigator:

Yung-Hung Luo, M.D., Taipei Veterans General Hospital (TVGH)

ABV-1703, Advanced Inoperable or Metastatic Pancreatic Cancer, Phase II, Principal Investigator:

Hendifar, MD - Cedars Sinai Medical Center (CSMC)

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processes with other biotechnology, pharmaceutical, and nutraceutical companies.

1 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.

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.

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.

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.

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.

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.

As of June 21, 2023, Dr.

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as the Company’s CEO and was replaced by Dr.

The Company and its CFO, Leeds Chow have been negotiating the terms of

his employment agreement since the end of July 2024;

due to disagreements regarding salaries due and payable, Mr.

Chow informed the Company

that he is suspending his work as CFO.

The disagreement relates solely to salary owed and payable to Mr.

Chow and is not the result of

any disagreements with the Company on any matter related to the Company’s disclosures in its public filings.

The Company’s

CEO, Uttam Patil, will assume the duties of interim Chief Financial Officer until the parties settle the disagreement and Leeds resumes

his position as CFO.

On August 14, 2023, the Company entered into a

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The valuation of the Property as of April 18, 2023, which was assessed by an independent

third party, is estimated to be approximately CNY 264,299,400 or approximately US$37,000,000.

In exchange, the Company agreed to issue

to Zhonghui, an aggregate of 370,000 shares of the Company’s common stock, at a per share price of $20 (the “ Zhonghui Shares ”).

third party, is estimated to be approximately RMB 264,299,400 or approximately $37,000,000.

In exchange, the Company agreed to issue to

Zhonghui, an aggregate of 370,000 shares of the Company’s common stock, at a per share price of $20 (the “ Zhonghui Shares ”).

On September 4, 2023, the Company and Zhonghui entered into an amendment to the Agreement to clarify that, in no event will the Company

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the shares, AIBL became a subsidiary of ABVC.

On June 23, 2024, the Company and BioLite, each entered

into an amendment (the “ Amendment ”) to the Licensing Agreement with AIBL,

pursuant to which the Company and BioLite have agreed to allow AIBL to pay the second milestone 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 sum.

On February 6, 2024,

the Company entered into a definitive agreement with Shuling Jiang (“Shuling”), pursuant to which Shuling shall transfer the

ownership of certain land she owns located at Taoyuan City, Taiwan (the “Land”) to the Company (the “Agreement”).

Shuling is a director of the Company, is married to TS Jiang, the Company’s Chief Strategic Officer and owns approximately 15.4%

of the Company’s issued and outstanding shares of common stock.

In consideration for the Land, the Company was to pay Shuling (i)

703,495 restricted shares of the Company’s common stock (the “Shares”) at a price of $3.50 per share and (ii) five-year

warrants to purchase up to 1,000,000 shares of the Company’s common stock, with an exercise price of $2.00 per share.

Agreement, Shuling was to also transfer outstanding liability owed on the Land (approximately $500,000) to the Company.

On May 16, 2024,

the Company’s board of directors determined that it was in the best interest of the Company and its shareholders to terminate the

Agreement and not proceed with the transfer of land ownership;

the Company may reconsider the transaction at a later date.

were returned and the warrants were not issued.

On March 25, 2024, the Company, and one of its co-development partners,

BioFirst Corporation, a company registered in Taiwan (“BioFirst”), each entered into a twenty-year, global definitive licensing

agreement (the “Licensing Agreement”) with ForSeeCon Eye Corporation, a company registered in the British Virgin Islands (“FEYE”)

for the products in the Company and BioFirst’s Ophthalmology pipeline, including Vitargus (the “Licensed Products”).

The license covers the Licensed Products’ clinical trial, registration, manufacturing, supply, and distribution rights;

has the rights to sublicense or partner with a third party to develop the Licensed Products.

As per each of the respective FEYE Licensing

Agreements, each of the Company and BioFirst shall receive a total licensing fee 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 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 of next round fundraising.

Additionally, each of the Company

and BioFirst are eligible to receive royalties of 5% of net Sales.

As of June 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 uncertain.

June 18, 2024, the Company and BioFirst, each entered into an amendment (the “ Amendment ”)

to the Licensing Agreement with FEYE, pursuant to which the Company and BioFirst have agreed to allow FEYE to pay the second milestone

On June 23, 2024, the Company and BioLite, each entered into an amendment (the “ Amendment ”)

to the Licensing Agreement with AIBL, pursuant to which the Company and BioLite have agreed to allow AIBL to pay the second milestone

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

For the period ended June 30, 2024, the Company has received $116,000 as the partial second milestone payment and recognized as licensing

revenue according to ASC 606.

On February 6, 2024, the Company entered into

a definitive agreement with Shuling Jiang (“Shuling”), pursuant to which Shuling shall transfer the ownership of certain land

she owns located at Taoyuan City, Taiwan (the “Land”) to the Company (the “Agreement”).

Shuling is a director

of the Company, is married to TS Jiang, the Company’s Chief Strategic Officer and owns approximately 15.4% of the Company’s

issued and outstanding shares of common stock.

In consideration for the Land, the Company was to pay Shuling (i) 703,496 restricted shares

of the Company’s common stock (the “Shares”) at a price of $3.50 per share and (ii) five-year warrants to purchase up

to 1,000,000 shares of the Company’s common stock, with an exercise price of $2.00 per share.

Under the Agreement, Shuling was to

also transfer outstanding liability owed on the Land (approximately $500,000) to the Company.

On May 16, 2024, the Company’s board

of directors determined that it was in the best interest of the Company and its shareholders to terminate the Agreement and not proceed

with the transfer of land ownership;

the Company may reconsider the transaction at a later date.

The shares were returned and the warrants

were not issued.

On March 25, 2024, the Company, and one of its

co-development partners, BioFirst Corporation, a company registered in Taiwan (“BioFirst”), each entered into a twenty-year,

global definitive licensing agreement (the “Licensing Agreement”) with ForSeeCon Eye Corporation, a company registered in

the British Virgin Islands (“FEYE”) for the products in the Company and BioFirst’s Ophthalmology pipeline, including

Vitargus (the “Licensed Products”).

The license covers the Licensed Products’ clinical trial, registration, manufacturing,

supply, and distribution rights;

FEYE also has the rights to sublicense or partner with a third party to develop the Licensed Products.

As per each of the respective FEYE Licensing Agreements, each of the Company and BioFirst shall receive a total licensing fee 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 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 of next

round fundraising.

Additionally, each of the Company and BioFirst are eligible to receive royalties of 5% of net Sales.

As of September

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

On June 18, 2024, the Company and BioFirst, each

entered into an amendment (the “ Amendment ”) to the Licensing Agreement with FEYE, pursuant to which the Company and

BioFirst have agreed to allow FEYE to pay the second milestone payment in the amount of $3,500,000 per Licensing Agreement, incrementally

(such as $100,000), at any given time, rather than in one lump sum.

For the period ended September 30, 2024, the Company has received

$296,000 as the partial second milestone payment and recognized as licensing revenue according to ASC 606.

On April 16, 2024, the Company entered into a

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In consideration thereof, Oncox shall pay ABVC $6,250,000 (or 1,250,000

Oncox shares valued at $5 per share 1 ) 30 days after entering into the Oncox Agreement and $625,000 30 days following the completion

of Oncox’s next round of fundraising, of which there is no guarantee;

ABVC is also entitled to 5% royalties based on the Net Sales,

as defined in the Oncox Agreement, from the first commercial sale of the Licensed Product in North America, of which there can be no guarantee.

Oncox entered into the same agreement with ABVC’s affiliate, Rgene Corporation.

Oncox shares valued at $5 per share 5 ) 30 days after entering into the Oncox Agreement and $625,000 30 days following the

completion of Oncox’s next round of fundraising, of which there is no guarantee;

ABVC is also entitled to 5% royalties based on

the Net Sales, as defined in the Oncox Agreement, from the first commercial sale of the Licensed Product in North America, of which there

can be no guarantee.

Oncox entered into another agreement with ABVC’s affiliate, Rgene Corporation, on the same terms.

For the period

ended September 30, 2024, the Company has received $200,000 as the partial second milestone payment and recognized as licensing revenue

according to ASC 606.

On May 8, 2024, the Company entered into a definitive

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from the dry fruit body of Maitake Mushroom (Grifola Frondosa) for treatment of Pancreatic Cancer (the “Licensed Products”),

within a certain territory, specified as 50% of the Worldwide Marketsfor 20 years (the “May 2024 Oncox Agreement”).

within a certain territory, specified as 50% of the Worldwide Markets for 20 years (the “May 2024 Oncox Agreement”).

In consideration

thereof, Oncox shall pay ABVC a total of $6,250,000 (or 1,250,000 Oncox shares valued at $5 per share 1 ) within 30 days of entering

into the May 2024 Oncox Agreement, with an additional milestone payment of $625,000 in cash after OncoX’s next round of fundraising,

of which there can be no guarantee.

Oncox may remit cash payments of at least $100,000 towards the licensing fees and deductible from

the second milestone payment;

ABVC is also entitled to royalties of 5% of Net Sales, as defined in the May 2024 Oncox Agreement, from

the first commercial sale of the Licensed Product in the noted territory, which remains uncertain.

The Company 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.

Oncox entered into the

same agreement with ABVC’s affiliate, Rgene Corporation.

On May 23, 2024, the Company entered into a definitive agreement with

OncoX BioPharma, Inc., a private company registered in the British Virgin Islands (“Oncox”), pursuant to which the Company

will grant Oncox an exclusive right to develop and commercialize ABVC’s BLEX 404 single-herb botanical drug extract from the dry

fruit body of Maitake Mushroom (Grifola Frondosa) for treatment of Myelodysplastic Syndrome (the “Licensed Products”), within

a certain territory, specified as 50% of the Worldwide Markets for 20 years (the “Oncox Agreement”).

In consideration thereof,

Oncox shall pay ABVC a total of $6,250,000 (or 1,250,000 Oncox shares valued at $5 per share 1 ) 30 days after entering the Oncox

Agreement, with an additional milestone payment of $625,000 in cash after OncoX’s next round of fundraising, of which there can

be no guarantee.

Oncox may remit cash payments of at least $100,000 towards the licensing fees and deductible from the second milestone

ABVC is also entitled to royalties of 5% of Net Sales, as defined in the Oncox Agreement, from the first commercial sale of the

Licensed Product in the noted territory, which remains uncertain.

Oncox may use its revenue to fund the licensing fees.

Oncox entered

into the same agreement with ABVC’s affiliate, Biolite, Inc.

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

entering into the May 2024 Oncox Agreement, with an additional milestone payment of $625,000 in cash after OncoX’s next round of

fundraising, of which there can be no guarantee.

Oncox may remit cash payments of at least $100,000 towards the licensing fees and deductible

from the second milestone payment;

ABVC is also entitled to royalties of 5% of Net Sales, as defined in the May 2024 Oncox Agreement,

from the first commercial sale of the Licensed Product in the noted territory, which remains uncertain.

The Company 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.

Oncox entered into

another agreement with ABVC’s affiliate, Rgene Corporation, on the same terms.

On May 14, 2024, the Company and its subsidiary,

BioLite Inc (collectively, the “licensor”), each entered into a licensing agreement with OncoX, on the same terms, pursuant

to which the licensors will grant Oncox an exclusive right to develop and commercialize ABVC’s BLEX 404 single-herb botanical drug

extract from the dry fruit body of Maitake Mushroom (Grifola Frondosa) for treatment of Tripple Negative Breast Cancer (the TNBC Product),

within a certain territory, specified as 50% of the Worldwide Markets for 20 years (the “May 14, 2024 Oncox Agreements”).

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

$5 per share 7 ) within 30 days of entering into the May 14, 2024 Oncox Agreements, with an additional milestone payment of

$625,000 in cash after OncoX’s next round of fundraising, of which there can be no guarantee.

Oncox may remit cash payments of at

least $100,000 towards the licensing fees and deductible from the second milestone payment;

each licensor is also entitled to royalties

of 5% of Net Sales, from the first commercial sale of the TNBC Product in the noted territory, which remains uncertain.

The Company 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.

On May 23, 2024, the Company and its subsidiary,

BioLite Inc (collectively, the “licensor”), each entered into a licensing agreement with OncoX, on the same terms, pursuant

to which the licensors will grant Oncox an exclusive right to develop and commercialize ABVC’s BLEX 404 single-herb botanical drug

extract from the dry fruit body of Maitake Mushroom (Grifola Frondosa) for treatment of Myelodysplastic Syndrome (the “Licensed

Products”), within a certain territory, specified as 50% of the Worldwide Markets for 20 years (the “Oncox Agreements”).

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 )

30 days after entering the May 23, 2024 Oncox Agreement, with an additional milestone payment of $625,000 in cash after OncoX’s

next round of fundraising, of which there can be no guarantee.

Oncox may remit cash payments of at least $100,000 towards the licensing

fees and deductible from the second milestone payment;

each licensor is also entitled to royalties of 5% of Net Sales, from the first

commercial sale of the Licensed Product in the noted territory, which remains uncertain.

Oncox may use its revenue to fund the licensing

5 P rice was determined through

private negotiations between the parties;

no third-party valuation was completed.

Common Stock Reverse Split

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Series A Convertible Preferred Stock

As of June 30, 2024, no Series A Convertible Preferred

Stock has been issued by the Company.

As of September 30, 2024, no Series A Convertible

Preferred Stock has been issued by the Company.

NASDAQ Listing

On May 24, 2023, we received a deficiency letter from the Nasdaq Listing

Qualifications Department (the “Staff”) of the Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that it

is not currently in compliance with the minimum stockholders’ equity requirement, or the alternatives of market value of listed

securities or net income from continuing operations, for continued listing on the Nasdaq Capital Market.

Nasdaq Listing Rule 5550(b)(1)

requires listed companies to maintain stockholders’ equity of at least $2,500,000, and the Company’s stockholders’ equity

was $1,734,507 as of March 31, 2023.

In accordance with Nasdaq rules, the Company had 45 calendar days, or until July 10, 2023, to submit

a plan to regain compliance.

After submitting a plan to regain compliance, on July 10, 2023, Nasdaq granted the Company an extension until

August 30, 20203, to comply with Listing Rule 5550(b)(1).

On May 24, 2023, we received a deficiency letter

from the Nasdaq Listing Qualifications Department (the “Staff”) of the Nasdaq Stock Market LLC (“Nasdaq”) notifying

the Company that it is not currently in compliance with the minimum stockholders’ equity requirement, or the alternatives of market

value of listed securities or net income from continuing operations, for continued listing on the Nasdaq Capital Market.

Nasdaq Listing

Rule 5550(b)(1) requires listed companies to maintain stockholders’ equity of at least $2,500,000, and the Company’s stockholders’

equity was $1,734,507 as of March 31, 2023.

In accordance with Nasdaq rules, the Company had 45 calendar days, or until July 10, 2023,

to submit a plan to regain compliance.

After submitting a plan to regain compliance, on July 10, 2023, Nasdaq granted the Company an extension

until August 30, 20203, to comply with Listing Rule 5550(b)(1).

On July 31, 2023, the Company issued 300,000 shares of Common Stock and

200,000 pre-funded warrants, at an exercise price of $0.01 per share, in a registered direct offering.

Pursuant to this transaction, the stockholders’

equity was increased by $1.75M.

On August 1, 2023, $500,000 of Notes were converted at $3.50 per share and the holder received 142,857

shares of Common Stock.

Pursuant to this transaction, the

stockholders’ equity was increased by $1.75M.

On August 1, 2023, $500,000 of Notes were converted at $3.50 per share and the holder

received 142,857 shares of Common Stock.

As a result of this conversion, the stockholders’ equity was increased by $0.5 million.

Additionally, on

August 14, 2023, the Company entered into a cooperation agreement with Zhonghui United Technology (Chengdu) Group Co., Ltd., pursuant

to which the Company acquired a 20% ownership of certain property and a parcel of the land owned by Zhonghui in exchange for an aggregate

of 370,000 shares of Common Stock.

Additionally, on August 14, 2023, the Company entered into a cooperation agreement with Zhonghui United Technology (Chengdu) Group Co.,

Ltd., pursuant to which the Company acquired a 20% ownership of certain property and a parcel of the land owned by Zhonghui in exchange

for an aggregate of 370,000 shares of Common Stock.

Accordingly, stockholders’ equity increased by $7.4M.

On February 23, 2023, the Company entered

into a securities purchase agreement with Lind, pursuant to which the Company issued Lind a secured, convertible note in the principal

amount of $3,704,167 (the “Lind Offering”), for a purchase price of $3,175,000 (the “Lind Note”), that is convertible

into shares of Common Stock at an initial conversion price of $1.05 per share, subject to adjustment.

On August 24, 2023, the Company

started repaying Lind the monthly installments due under the Lind Notes;

$308,000 was repaid via the issuance of 176,678 shares of Common

Stock (the “Monthly Shares”) at the Redemption Share Price (as defined in the Lind Note) of $1.698 per share.

the terms of the Lind Note, Lind increased the amount of the next monthly payment to one million dollars, such that as of September and

together with the Monthly Shares, the Company repaid Lind a total of $1 million by September 2023.

On February 23, 2023,

the Company entered into a securities purchase agreement with Lind, pursuant to which the Company issued Lind a secured, convertible note

in the principal amount of $3,704,167 (the “Lind Offering”), for a purchase price of $3,175,000 (the “Lind Note”),

that is convertible into shares of Common Stock at an initial conversion price of $1.05 per share, subject to adjustment.

On August 24,

2023, the Company started repaying Lind the monthly installments due under the Lind Notes;

$308,000 was repaid via the issuance of 176,678

shares of Common Stock (the “Monthly Shares”) at the Redemption Share Price (as defined in the Lind Note) of $1.698 per share.

Pursuant to the terms of the Lind Note, Lind increased the amount of the next monthly payment to one million dollars, such that as of

September and together with the Monthly Shares, the Company repaid Lind a total of $1 million by September 2023.

As a result, the stockholders’

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Ordinary Shares.

The Agreement also requires Biolite JP to obtain

a bank facility in the amount of JPY 30,460,000 (approximately USD272,000), for its initial working capital purposes.

Pursuant to the

Agreement, each Shareholder agrees to guarantee such bank facility if the bank requires a guarantee.

Accordingly, the Company may be liable

for the bank facility in an amount up to JPY 14,925,400 (approximately USD134,000), which represents 49% of the maximum bank facility.

The Agreement 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 cash to do so.

The Agreement also requires Biolite JP to obtain a bank facility in

the amount of JPY 30,460,000 (approximately $272,000), for its initial working capital purposes.

Pursuant to the Agreement, each Shareholder

agrees to guarantee such bank facility if the bank requires a guarantee.

Accordingly, the Company may be liable for the bank facility

in an amount up to JPY 14,925,400 (approximately $134,000), which represents 49% of the maximum bank facility.

The Agreement 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 cash to

Pursuant to the Agreement, the Company and Biolite

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terms, except that no indemnifying party shall have any liability for an individual liability unless it exceeds JPY 500,000 (approximately

USD4,500) and until the aggregate amount of all liabilities exceeds JPY 2,000,000 (approximately USD18,000) and then only to the extent

such liability exceed such limit.

$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

liability exceed such limit.

The Company paid $150,000 towards the setup of

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The Phase II study has started in the 2 nd quarter of 2023.

is working on improvements to the Vitargus product through the new batch of investigational product.

The company is

working on improvements to the Vitargus product through the new batch of investigational product.

Initially the Company will focus on ABV-2002,

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2024 Financings

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.

the amended agreement pursuant to Nasdaq requirements, the conversion price is subject to $1.00 floor price if the conversion price

was below such floor.

Based on the conversion price of $0.4229, the Company made an additional $147,892 cash repayment in addition

to the issuance of 200,000 shares.

On September 11, 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.

to the amended agreement pursuant to Nasdaq requirements, the conversion price is subject to $1.00 floor price if the conversion

price was below such floor.

Based on the conversion price of $0.6575, the Company made an additional $90,722 cash repayment in

addition to the issuance 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.

the amended agreement pursuant to Nasdaq requirements, the conversion price is subject to $1.00 floor price if the conversion price

was below such floor.

Based on the conversion price of $0.7907, the Company made an additional $88,403 cash repayment in addition to

the issuance of 200,000 shares.

On May 22, 2024, the Company and Lind entered

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herein by reference.

On February 23, 2023, the Company entered into a securities purchase

agreement (the “Lind Securities Purchase Agreement”) with Lind Global Fund II, LP (“Lind”), pursuant to which

the Company issued Lind a secured, convertible note in the principal amount of $3,704,167 (the “Lind Offering”), for a purchase

price of $3,175,000 (the “Lind Note”), that is convertible into shares of the Company’s common stock at an initial conversion

price of $10.5 per share, subject to adjustment (the “Note Shares”).

The Company also issued Lind a common stock purchase

warrant (the “Lind Warrant”) to purchase up to 529,1,67 shares (post-split) of the Company’s common stock at an initial

exercise price of $10.5 per share, subject to adjustment (each, a “Warrant Share,” together with the Note, Note Shares and

Warrants, the “Lind Securities”).

As of June 30, 2024, this February 2023 Lind Note

was fully repaid.

On February 23, 2023, the Company entered into a securities purchase agreement (the “Lind Securities Purchase

Agreement”) with Lind Global Fund II, LP (“Lind”), pursuant to which the Company issued Lind a secured, convertible

note in the principal amount of $3,704,167 (the “Lind Offering”), for a purchase price of $3,175,000 (the “Lind Note”),

that is convertible into shares of the Company’s common stock at an initial conversion price of $10.5 per share, subject to adjustment

(the “Note Shares”).

The Company also issued Lind a common stock purchase warrant (the “Lind Warrant”) to purchase

up to 529,1,67 shares (post-split) of the Company’s common stock at an initial exercise price of $10.5 per share, subject to adjustment

(each, a “Warrant Share,” together with the Note, Note Shares and Warrants, the “Lind Securities”).

The Lind Note does not carry any interest.

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herein by reference.

On August 1, 2023, Lind converted $500,000 convertible notes into 142,857

shares of Common Stock, at a conversion price of $3.50 per share, as an installment repayment to the Lind Note.

On August 1, 2023, Lind converted $500,000 convertible

notes into 142,857 shares of Common Stock, at a conversion price of $3.50 per share, as an installment repayment to the Lind Note.

On July 27, 2023, the Company entered into that

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Key elements of our business strategy include:

● Advancing to the pivotal trial

phase of ABV-1701 Vitargus ® for the treatments of Retinal Detachment or Vitreous Hemorrhage, which we expect to generate

revenues in the future.

● Focusing on licensing ABV-1504

for the treatment of major depressive disorder, MDD, after the successful completion of its Phase II clinical trials.

● Completing Phase II, Part 2

clinical trial for ABV-1505 for the treatment of attention deficit hyperactivity disorder, ADHD.

● Out licensing drug candidates

and medical device candidates to major pharmaceutical companies for phase III and pivotal clinical trials, as applicable, and further

marketing if approved by the FDA.

Advancing to the pivotal trial phase of ABV-1701 Vitargus ® for the treatments of Retinal Detachment or Vitreous Hemorrhage, which we expect to generate revenues in the future.

Focusing on licensing ABV-1504 for the treatment of major depressive disorder, MDD, after the successful completion of its Phase II clinical trials.

Completing Phase II, Part 2 clinical trial for ABV-1505 for the treatment of attention deficit hyperactivity disorder, ADHD.

Out licensing drug candidates and medical device candidates to major pharmaceutical companies for phase III and pivotal clinical trials, as applicable, and further marketing if approved by the FDA.

We plan to augment our core research and development

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The terms of these agreements typically include payment to the Company related to one or more of the following:

● nonrefundable upfront license

● development and commercial

● partial or complete reimbursement

of research and development costs and

● royalties on net sales of licensed

nonrefundable upfront license fees,

development and commercial milestones,

partial or complete reimbursement of research and development costs and

royalties on net sales of licensed products.

Each type of payments results in revenue except

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should include additional payments in the transaction price.

The Company receives payments from its customers

based on billing schedules established in each contract.

Upfront payments and fees may be recorded as contract liabilities upon receipt

or when due, and may require deferral of revenue recognition to a future period until the Company performs its obligations under these

arrangements.

Amounts are recorded as accounts receivable when the right of the Company to consideration is unconditional.

does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period

between payment by the customers and the transfer of the promised goods or services to the customers will be one year or less.

The Company receives payments from its

customers based on billing schedules established in each contract.

Upfront payments and fees may be recorded as contract liabilities

upon receipt or when due, and may require deferral of revenue recognition to a future period until the Company fulfills its

obligations under these arrangements.

Amounts are recorded as accounts receivable when the right of the Company to consideration is

unconditional.

The Company does not assess whether a contract has a significant financing component if the expectation at contract

inception is such that the period between payment by the customers and the transfer of the promised goods or services to the

customers will be one year or less.

Examples of collaborative agreements the Company

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Collaborative agreements with BHK, a related

(i) In February and December of 2015,

BioLite, Inc.

entered into a total of three joint venture agreements with BioHopeKing to jointly develop ABV-1501 for Triple Negative

Breast Cancer (TNBC), ABV-1504 for MDD and ABV-1505 for ADHD.

The agreements granted marketing rights to BioHopeKing for certain Asian

countries in return for a series of milestone payments totaling $10 million in cash and equity of BioHopeKing or equity securities owned

by BioHopeKing.

In February and December of 2015, BioLite, Inc.

entered into a total of three joint venture agreements with BioHopeKing to jointly develop ABV-1501 for Triple Negative Breast Cancer (TNBC), ABV-1504 for MDD and ABV-1505 for ADHD.

The agreements granted marketing rights to BioHopeKing for certain Asian countries in return for a series of milestone payments totaling $10 million in cash and equity of BioHopeKing or equity securities owned by BioHopeKing.

The milestone payments are determined by a schedule

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New Drug Application (NDA) Submission

(ii) In December of 2015, BHK paid

the initial cash payment of $1 million upon the execution of the BHK Agreement.

The Company concluded that certain deliverables are considered

separate units of accounting as the delivered items have value to the customer on a standalone basis and recognized this cash payment

as collaboration revenue when all research, technical, and development data was delivered to BHK in 2015.

The payment included compensation

for past research efforts and contributions made by BioLite Taiwan before the BHK agreement was signed and does not relate to any future

commitments made by BioLite Taiwan and BHK in the BHK Agreement.

(iii) In August 2016, the Company received

the second milestone payment of $1 million, and recognized collaboration revenue for the year ended December 31, 2016.

The Company completed

the phase II clinical trial for ABV-1504 MDD on October 31, 2019, but has not yet completed the phase II clinical trial for ABV-1505

(iv) In addition to the milestone payments,

In December of 2015, BHK paid the initial cash payment of $1 million upon the execution of the BHK Agreement.

The Company concluded that certain deliverables are considered separate units of accounting as the delivered items have value to the customer on a standalone basis and recognized this cash payment as collaboration revenue when all research, technical, and development data was delivered to BHK in 2015.

The payment included compensation for past research efforts and contributions made by BioLite Taiwan before the BHK agreement was signed and does not relate to any future commitments made by BioLite Taiwan and BHK in the BHK Agreement.

In August 2016, the Company received the second milestone payment of $1 million, and recognized collaboration revenue for the year ended December 31, 2016.

The Company completed the phase II clinical trial for ABV-1504 MDD on October 31, 2019, but has not yet completed the phase II clinical trial for ABV-1505 ADHD.

In addition to the milestone payments, BioLite Inc.

is entitled to receive a royalty equal to 12% of BHK’s net sales related to ABV-1501, ABV-1504 and ABV-1505 Products.

As of June 30, 2024, the Company has not earned royalties under the BHK Co-Development Agreement.

(v) 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.

As of September 30, 2024, 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.

Collaborative agreement with BioLite, Inc.,

a related party

our subsidiary

The Company entered into a collaborative agreement

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During the year ended December

31, 2017, the Company has received $450,000 in cash.

31, 2017, the Company received $450,000 in cash.

On December 24, 2018, the Company received the remaining balance of $2,550,000 in

the form of newly issued shares of Rgene’s Common Stock, at the price of NT$50 (approximately equivalent to $1.64 per share), for

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

an aggregate number of 1,530,000 shares, which accounted for equity method long-term investment as of December 31, 2018.

During the year

ended December 31, 2018, the Company has recognized investment loss of $549.

On December 31, 2018, the Company determined to fully write

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a related party

On July 24, 2017, BriVision entered into a collaborative

agreement (the “BioFirst Collaborative Agreement”) with BioFirst Corporation (“BioFirst”), pursuant to which BioFirst

granted the Company the global licensing right for medical use of the product (the “Product”):

BFC-1401 Vitreous Substitute

for Vitrectomy.

BioFirst is a related party to the Company because a controlling beneficiary shareholder of YuanGene Corporation and the

Company is one of the directors and Common Stock shareholders of BioFirst (See Note 8).

On July 24, 2017, BriVision entered into a collaborative agreement

(the “BioFirst Collaborative Agreement”) with BioFirst Corporation (“BioFirst”), pursuant to which BioFirst granted

the Company the global licensing right for medical use of the product (the “Product”):

BFC-1401 Vitreous Substitute for Vitrectomy.

BioFirst is a related party to the Company because a controlling beneficiary shareholder of YuanGene Corporation and the Company is one

of the directors and Common Stock shareholders of BioFirst (See Note 10).

Pursuant to the BioFirst Collaborative Agreement,

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right to co-develop BFC-1401 or ABV-1701 Vitreous Substitute for Vitrectomy for medical purposes in consideration for the Total Payment.

On August 5, 2019, BriVision entered into a second Stock Purchase Agreement

(“Purchase Agreement 2”) with BioFirst Corporation.

Pursuant to Purchase Agreement 2, the Company issued 41,470 shares (post-split)

of the Company’s common stock to BioFirst in consideration for $2,902,911 owed by the Company to BioFirst in connection with a loan

provided to BriVision from BioFirst.

On August 5, 2019, BriVision entered into a second

Stock Purchase Agreement (“Purchase Agreement 2”) with BioFirst Corporation.

Pursuant to Purchase Agreement 2, the Company

issued 41,470 shares (post-split) of the Company’s common stock to BioFirst in consideration for $2,902,911 owed by the Company

to BioFirst in connection with a loan provided to BriVision from BioFirst.

On November 4, 2020, the Company executed an amendment

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osmolarity to maintain a range of 330 to 390 mOsM, thereby permitting hydration within the corneal stroma during the storage period.

hydration typically results in (a) maintaining acceptable corneal transparency and (b) prevents donor cornea swelling.

ABV-2002 also contains

an abundant phenolic phytochemical found in plant cell walls that provides antioxidant antibacterial properties and neuroprotection.

Stromal hydration typically results in (a) maintaining acceptable corneal transparency and (b) prevents donor cornea swelling.

also contains an abundant phenolic phytochemical found in plant cell walls that provides antioxidant antibacterial properties and neuroprotection.

Early testing by BioFirst indicates that ABV-2002

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occurred on the Completion Date.

As per the Agreement, the Shareholders shall supervise

and manage the business and operations of BioLite JP.

The directors shall not be entitled to any renumeration for their services as a

director and each Shareholder can remove and replace the director he/she/it appointed.

If a Shareholder sells or disposes of all of its

Ordinary Shares, the director such Shareholder appointed must tender his/her resignation.

The Agreement also sets forth certain corporate

actions that must be pre-approved by all Shareholders (the “ Reserved Matters ”).

If the Shareholders are unable to make

a decision on any Reserved Matter, then either Shareholder can submit a deadlock notice to the other shareholder, 5 days after which they

must refer the matter to each Shareholder’s chairman and use good faith to resolve the dispute.

If such dispute is not resolved

within 10 days thereafter, then either Shareholder can offer to buy all of the other Shareholder’s Ordinary Shares for cash at a

specified price;

As per the Agreement, the Shareholders shall

supervise and manage the business and operations of BioLite JP.

The directors shall not be entitled to any renumeration for their services

as a director and each Shareholder can remove and replace the director he/she/it appointed.

If a Shareholder sells or disposes of all

of its Ordinary Shares, the director such Shareholder appointed must tender his/her resignation.

The Agreement also sets forth certain

corporate actions that must be pre-approved by all Shareholders (the “ Reserved Matters ”).

If the Shareholders are

unable to make a decision on any Reserved Matter, then either Shareholder can submit a deadlock notice to the other shareholder, 5 days

after which they must refer the matter to each Shareholder’s chairman and use good faith to resolve the dispute.

If such dispute

is not resolved within 10 days thereafter, then either Shareholder can offer to buy all of the other Shareholder’s Ordinary Shares

for cash at a specified price;

if there is not affirmative acceptance of the sale, the sale shall proceed as set forth in the sale offer.

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Ordinary Shares.

The Agreement also requires BioLite JP to obtain

a bank facility in the amount of JPY 30,460,000 (approximately USD272,000), for its initial working capital purposes.

Pursuant to the

Agreement, each Shareholder agrees to guarantee such bank facility if the bank requires a guarantee.

Accordingly, the Company may be liable

for the bank facility in an amount up to JPY 14,925,400 (approximately USD134,000), which represents 49% of the maximum bank facility.

The Agreement 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 cash to do so.

The Agreement also requires BioLite JP to obtain a bank facility in

the amount of JPY 30,460,000 (approximately $272,000), for its initial working capital purposes.

Pursuant to the Agreement, each Shareholder

agrees to guarantee such bank facility if the bank requires a guarantee.

Accordingly, the Company may be liable for the bank facility

in an amount up to JPY 14,925,400 (approximately $134,000), which represents 49% of the maximum bank facility.

The Agreement 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 cash to do

Pursuant to the Agreement, the Company and BioLite

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activities, shall belong to BioLite JP.

The Agreement contains standard indemnification

terms, except that no indemnifying party shall have any liability for an individual liability unless it exceeds JPY 500,000 (approximately

USD4,500) and until the aggregate amount of all liabilities exceeds JPY 2,000,000 (approximately USD18,000) and then only to the extent

such liability exceed such limit.

The Agreement contains standard indemnification terms, except that

no indemnifying party shall have any liability for an individual liability unless it exceeds JPY 500,000 (approximately $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 liability exceed

The Company paid $150,000 towards the setup of

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In addition, BioKey provides a variety of regulatory

services tailored to the needs of its customers, which include proofreading and regulatory review of submission documents related to formulation

development, clinical trials, marketed products, generics, nutraceuticals and OTC products and training presentations.

In addition to

supporting ABVC’s new drug development, BioKey submits INDs, NDAs, ANDAs, and DMFs to the FDA, on ABVC’s behalf in compliance

with new electronic submission guidelines of the FDA.

services tailored to the needs of its customers, which include proofreading and regulatory review of submission documents related to

formulation development, clinical trials, marketed products, generics, nutraceuticals and OTC products and training presentations.

addition to supporting ABVC’s new drug development, BioKey submits INDs, NDAs, ANDAs, and DMFs to the FDA, on ABVC’s behalf

in compliance with new electronic submission guidelines of the FDA.

Impact of COVID-19 Outbreak

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in preparing quarterly and annual financial statements.

Certain information and footnote disclosures normally included in the annual

consolidated financial statements prepared in accordance with accounting principles generally accepted in the United States of America

Certain information and footnote disclosures normally included in the annual consolidated

financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“U.S.

GAAP”) have been condensed or omitted.

These unaudited consolidated financial statements should be read in conjunction

with the Company’s audited consolidated financial statements and notes thereto included in the Company’s Annual Report on

Form 10-K for the year ended December 31, 2023, filed with the SEC on March 13, 2024 (“2023 Form 10-K.”)

These unaudited consolidated financial statements should be read in conjunction with the

Company’s audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K

for the year ended December 31, 2023, filed with the SEC on March 13, 2024 (“2023 Form 10-K.”)

Estimates and Assumptions

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impact that the standard will have on its unaudited consolidated financial statements.

of Operations - Three Months Ended June 30, 2024 Compared to Three Months Ended June 30, 2023.

Results of Operations - Three Months Ended

September 30, 2024 Compared to Three Months Ended September 30, 2023.

The following table presents, for the three months

indicated, our unaudited consolidated statements of operations information.

Three Months Ended June 30,

Gross Profits

Three Months Ended

September 30,

Gross Profits (Loss)

Operating Expenses

Loss from Operations

Other Income (Expense)

$ (1,802,110 )

Income (Loss) from Operations

$ (2,154,873 )

Interest (Expense), Net

We generated $117,142 and $6,109 in revenues for the three months ended

June 30, 2024 and 2023, respectively.

The increase in revenues was mainly due to the milestone revenue recognized from licensing to ForSeeCon.

$ (1,178,378 )

Other Expense

$ (3,369,080 )

We generated $389,276

and $15,884 in revenues for the three months ended September 30, 2024 and 2023, respectively.

The increase in revenues was mainly due

to the revenue recognized from licensing to ForSeeCon and OncoX.

In addition to FDA application service revenue generated in both periods, the licensing revenues contributed the main growth in the revenue.

Please refer to the above collaborative agreements for details.

Operating Expenses.

Our operating expenses have decreased by $1,033,377 or 49%, to $1,093,593

for the three months ended June 30, 2024 from $2,126,970 for the three months ended June 30, 2023.

Such decrease in operating expenses

was mainly attributable to the decrease in selling, general and administrative expenses and research and development expenses.

Other Income (Expense) .

Our other expense was $406,942 for the three months ended June 30, 2024,

compared to other expense of $39,688 for the three months ended June 30, 2023.

The change was principally caused by the increase in interest

expense and the loss on equity investment, while being offset by the increase in interest income for the three months ended June 30, 2024.

operating expenses have decreased by $1,802,110 or 84%, to $339,033 for the three months ended September 30, 2024 from $,2141,143

for the three months ended September 30, 2023.

Such a decrease in operating expenses was mainly attributable to the decrease in

selling, general and administrative expenses and research and development expenses.

Interest income (expense), net.

was $(232,891) for the three months ended June 30, 2024, compared to ($59,711) for the three months ended June 30, 2023.

of $173,180, or approximately 290%, was primarily due to the increase in interest expense due to recognition of interest expense for

the converted notes for proper accounting purpose .

As a result of the above factors, our net loss was $1,272,689 for the

three months ended June 30, 2024 compared to $2,315,225 for the three months ended June 30, 2023, representing a decrease of $1,042,536,

Results of Operations - Six Months Ended June

30, 2024 Compared to Six Months Ended June 30, 2023.

The following table presents, for the six months

was $(175,272) for the three months ended September 30, 2024, compared to ($1,178,378) for the three months ended September 30, 2023.

The decrease in net interest expense of $1,003,106, or approximately 85%, was primarily due to the decrease in interest expense due to

recognition of interest expense for the converted notes for proper accounting purposes .

Other Expense .

Our other expense

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,

The change was principally caused by the increase in loss on equity investment and offsetting by increase in gain on foreign exchanges

in the three months ended September 30, 2024.

As a result of the

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

September 30, 2023, representing a decrease of $3,234,808, or 96%.

Results of Operations - Nine months Ended September

30, 2024 Compared to Nine months Ended September 30, 2023.

The following table presents, for the nine months

indicated, our unaudited consolidated statements of operations information.

Six Months Ended June 30,

Gross Profits

Nine Months Ended

September 30,

Gross Profits (Loss)

Operating Expenses

$ (1,364,389 )

Loss from Operations

Other Income (Expense)

$ (4,371,084 )

$ (6,254,899 )

Interest (Expense), Net

We generated $118,347 and $134,381 in revenues for the six months ended

June 30, 2024 and 2023, respectively.

The decrease in revenues was mainly due to the decrease in revenue from Contract Development and

Manufacturing Organization (“CDMO”) services.

$ (1,088,797 )

$ (1,242,041 )

Other Expense

Net Income Loss

$ (5,387,980 )

$ (7,580,535 )

We generated $507,623 and

$150,265 in revenues for the nine months ended September 30, 2024 and 2023, respectively.

The increase in revenues was mainly due to

the revenue recognized from licensing to ForSeeCon and OncoX.

In addition to FDA application service revenue generated in both periods, the licensing revenues contributed the main growth in the revenue.

Please refer to the above collaborative agreements for details.

Operating Expenses.

Our operating expenses have increased by $437,721, or 11%, to $4,538,911

for the six months ended June 30, 2024 from $4,101,190 for the six months ended June 30, 2023.

Such increase in operating expenses was

mainly attributable to the increase in stock-based compensation expenses by $2,365,507 which relates to costs in conjunction with employee

compensation and non-employee share-based payments.

Other Income (Expense) .

Our other expense was $943,571 for the six months ended June 30, 2024,

compared to other expense of $30,734 for the six months ended June 30, 2023.

The change was principally caused by the increase in interest

expense and loss on equity method investment, while being offset by the increase in foreign exchange income for the six months ended June

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

for the nine months ended September 30, 2023.

Such a decrease in operating expenses was mainly attributable to the decrease in

stock-based compensation expenses by $2,957,736 which relates to costs in conjunction with employee compensation and non-employee

share-based payments.

Interest income (expense), net.

was $(913,525) for the six months ended June 30, 2024, compared to $(63,663) for the six months ended June 30, 2023.

The increase of

$849,862, or approximately 1335%, was primarily due to the increase in interest expense due to recognition of interest expense for the

converted notes for proper accounting purpose .

As a result of the above factors, our net loss was $5,253,708 for the

six months ended June 30, 2024 compared to $4,212,455 for the six months ended June 30, 2023, representing an increase of $1,041,253,

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.

decrease of $153,244, or approximately 12%, was primarily due to the decrease in interest expense due to recognition of interest expense

for the converted notes for proper accounting purpose .

Other Expense .

Our other expense

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,

The change was principally caused by the increase in loss on equity method investment, while being offset by the increase in foreign

exchange income for the nine months ended September 30, 2024.

As a result of the

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

September 30, 2023, representing an decrease of $2,192,555, or 29%.

Liquidity and Capital Resources

Working Capital

September 30,

Current Assets

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$ (4,275,781 )

Going Concern and

Liquidity Consideration

For the nine months ended September 30, 2024, the Company reported net loss of $5,387,980.

of September 30, 2024, the Company’s working capital deficit was $4,167,315.

In addition, the Company had net cash outflows of $1,315,534

from operating activities for the nine months ended September 30, 2024.

These conditions give rise to substantial doubt as to whether

the Company will be able to continue as a going concern.

Management’s plan is to continue to improve operations to generate positive

cash flows by 1) ensuring our cash consideration from our licensing agreements be fully collected soon, 2) raising additional capital

through private or public offerings, 3) strictly controlling cash operating expenses, and 4) reducing debts and interest expense.

the Company has generated cash inflow and reduced a substantial amount of debts during the first nine months ended September 30, 2024,

from $2.2 million to $1.6 million.

We also reduced our outstanding warrants from 2.5 million shares to 2 million shares in October, receiving

around $210,000 in cash.

If the Company is not able to generate positive operating cash flows, and raise additional capital, there is

the risk that the Company may not be able to meet its short-term obligations.

Management is committed to enhancing operations to generate

positive cash flows to meet our operation needs.

Cash Flow from Operating Activities

During the six months ended June 30, 2024 and 2023, the net cash used

in operating activities were $1,487,251 and $2,397,460, respectively.

The decrease was primarily due to the increase in licensing cash

payment from ForSeeCon, and the decrease in operating expenses.

Company has been strictly control the operating cash outflow, such as

making certain payments with shares in lieu of cash, extending vendors’ payment terms, and other initiatives to save the cash burn.

During the nine months ended September 30, 2024 and 2023, the net cash

used in operating activities were $1,315,534 and $3,756,385, respectively.

The decrease was primarily due to the increase in licensing

cash payment from ForSeeCon and OncoX, and the decrease in operating expenses.

Company has been strictly controlling the operating cash outflow,

such as making certain payments with shares in lieu of cash, extending vendors’ payment terms, and other initiatives to save the

Cash Flow from Investing Activities

During the six months ended June 30, 2024 and

2023, the net cash used in investing activities were $0 and $440,575 respectively.

The increases were mainly due to the increase in prepayment

for long-term investments during six months ended June 30, 2024.

During the nine months ended September 30, 2024

and 2023, the net cash used in investing activities were $0 and $514,359 respectively.

The increases were mainly due to the increase in

prepayment for long-term investments during the nine months ended September 30, 2024.

Cash Flow from Financing Activities

During the six months ended June 30, 2024 and 2023, the net cash provided

by financing activities were $1,544,706 and $2,175,000, respectively.

The decrease in net cash provided by financing activities were primarily

due to the proceeds from issuance of convertible notes, Lind’s exercise of warrants, and common stock subscription in advance.

During the nine months ended September 30, 2024

and 2023, the net cash provided by financing activities were $1,399,313 and $3,831,540, respectively.

The decrease in net cash provided

by financing activities were primarily due to the proceeds from issuance of convertible notes, Lind’s exercise of warrants, and

common stock subscription in advance.

QUANTITATIVE AND QUALITATIVE

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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.

What changed 10-Q

Item 2. Management’s Discussion and Analysis