PART I - FINANCIAL INFORMATION [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited consolidated financial statements for American BriVision (Holding) Corporation as of September 30, 2020, and for the three and nine-month periods then ended, accompanied by detailed notes [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) The Consolidated Balance Sheet as of September 30, 2020, shows a decrease in total assets to $6.53 million from $6.93 million at year-end 2019, with total liabilities increasing to $7.72 million from $7.05 million, leading to a significant increase in total equity deficit from $(0.12) million to $(1.19) million Consolidated Balance Sheet Summary (in USD) | Metric | September 30, 2020 (Unaudited) | December 31, 2019 | | :--- | :--- | :--- | | **Total Current Assets** | $1,177,789 | $878,238 | | **Total Assets** | $6,529,385 | $6,927,811 | | **Total Current Liabilities** | $6,045,547 | $6,814,193 | | **Total Liabilities** | $7,721,225 | $7,052,628 | | **Total Equity (Deficit)** | $(1,191,840) | $(124,817) | [Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the nine months ended September 30, 2020, revenues decreased to $420,852 from $601,757 in the prior year period, and the net loss attributable to the company widened significantly to $4.94 million from $2.56 million, resulting in a net loss per share of $(0.25) compared to $(0.15) in 2019 Statement of Operations Summary (in USD) | Metric | Nine Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2019 | | :--- | :--- | :--- | | **Revenues** | $420,852 | $601,757 | | **Gross Profit** | $404,038 | $584,109 | | **Loss from Operations** | $(3,655,157) | $(2,334,995) | | **Net Loss** | $(5,624,450) | $(2,817,454) | | **Net Loss Attributed to ABVC** | $(4,942,881) | $(2,564,105) | | **Net Loss Per Share (Basic & Diluted)** | $(0.25) | $(0.15) | [Consolidated Statements of Cash Flows](index=7&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2020, net cash used in operating activities was $2.38 million, net cash used in investing activities was $0.33 million, and net cash provided by financing activities was $2.70 million, primarily from common stock issuance, resulting in a net decrease in cash and cash equivalents of $8,590 Cash Flow Summary (in USD) | Metric | Nine Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2019 | | :--- | :--- | :--- | | **Net cash used in operating activities** | $(2,375,873) | $(1,638,709) | | **Net cash used in investing activities** | $(332,539) | $(35,079) | | **Net cash provided by financing activities** | $2,698,793 | $2,483,244 | | **Net increase (decrease) in cash** | $(8,590) | $809,019 | [Notes to Unaudited Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Consolidated%20Financial%20Statements) These notes provide detailed information on the company's business, significant accounting policies, and key corporate events impacting its financial position - The company is a clinical-stage biopharmaceutical firm focused on developing new drugs and medical devices derived from plants, licensing promising candidates from research institutions for further clinical trials[20](index=20&type=chunk) - On February 8, 2019, the company completed a business combination with BioLite Holding, Inc. and BioKey, Inc., making them wholly-owned subsidiaries[28](index=28&type=chunk)[29](index=29&type=chunk) - A 1-for-18 reverse stock split was effected on May 8, 2019, with all share and per-share data in the report reflecting this split[42](index=42&type=chunk) - In November 2020, the company raised **$5 million** through the sale of common stock and warrants to two non-U.S. investors, and also received **$2.5 million** from issuing a convertible promissory note[242](index=242&type=chunk)[244](index=244&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=50&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's business overview, strategic objectives, financial performance, and liquidity, highlighting the impact of COVID-19 and increased operating expenses [Business Overview and Strategy](index=50&type=section&id=Business%20Overview%20and%20Strategy) The company is a clinical-stage biopharmaceutical firm focused on developing plant-derived drugs and medical devices through a licensing and out-partnering strategy, with a focus on advancing its clinical pipeline - The company's business model is to license new drugs and medical devices from research institutions, conduct Phase II clinical trials, and then out-license to larger pharmaceutical companies for Phase III and commercialization[258](index=258&type=chunk)[259](index=259&type=chunk) - Key strategic elements include advancing Vitargus® to pivotal trials, licensing out ABV-1504 for major depressive disorder, and completing Phase II trials for ABV-1505 for ADHD[296](index=296&type=chunk) - Recent clinical study reports were issued for Vitargus® (Phase I), ABV-1505 for ADHD (Phase II Part I), and ABV-1504 for MDD (Phase II), with all showing positive results supporting further development[285](index=285&type=chunk)[288](index=288&type=chunk)[290](index=290&type=chunk) [Results of Operations](index=70&type=section&id=Results%20of%20Operations) For the nine months ended September 30, 2020, revenues fell 30% to $420,852 due to COVID-19's impact on the CDMO business, operating expenses rose 39% to $4.06 million, and other expenses surged to $2.1 million, primarily due to impairment and investment losses, consequently nearly doubling the net loss to $5.62 million Three-Month Performance Comparison (in USD) | Metric | Q3 2020 | Q3 2019 | Change (%) | | :--- | :--- | :--- | :--- | | **Revenues** | $115,553 | $197,733 | -41.5% | | **Operating Expenses** | $1,396,700 | $1,310,558 | +6.6% | | **Net Loss** | $(2,131,131) | $(1,329,685) | +60.3% | Nine-Month Performance Comparison (in USD) | Metric | Nine Months 2020 | Nine Months 2019 | Change (%) | | :--- | :--- | :--- | :--- | | **Revenues** | $420,852 | $601,757 | -30.1% | | **Operating Expenses** | $4,059,195 | $2,919,104 | +39.0% | | **Net Loss** | $(5,624,450) | $(2,817,454) | +99.6% | - The decrease in revenue for both the three and nine-month periods was mainly attributed to the impact of COVID-19 on the company's CDMO business, as clients postponed projects[388](index=388&type=chunk)[396](index=396&type=chunk) - The significant increase in net loss was driven by higher SG&A expenses related to marketing and up-listing, a **$952,711** impairment loss, and a **$1,067,298** loss on investment in equity securities for the nine-month period[398](index=398&type=chunk)[399](index=399&type=chunk)[400](index=400&type=chunk)[402](index=402&type=chunk) [Liquidity and Capital Resources](index=74&type=section&id=Liquidity%20and%20Capital%20Resources) As of September 30, 2020, the company had a working capital deficit of $4.87 million, an improvement from a deficit of $5.94 million at the end of 2019, with net cash used in operations at $2.38 million and $2.70 million generated from financing activities Working Capital (in USD) | Metric | September 30, 2020 | December 31, 2019 | | :--- | :--- | :--- | | **Current Assets** | $1,177,789 | $878,238 | | **Current Liabilities** | $6,045,547 | $6,814,193 | | **Working Capital (Deficit)** | $(4,867,758) | $(5,935,955) | - Net cash used in operating activities increased to **$2.38 million** for the nine months ended Sep 30, 2020, from **$1.64 million** in the prior-year period, mainly due to a higher net loss[405](index=405&type=chunk) - Net cash from financing activities was **$2.70 million** for the first nine months of 2020, an increase from **$2.48 million** in 2019, driven by successful fundraising through private placements[407](index=407&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=76&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is a smaller reporting company and is therefore not required to provide the information for this item - As a smaller reporting company, the registrant is not required to provide quantitative and qualitative disclosures about market risk[410](index=410&type=chunk) [Item 4. Controls and Procedures](index=76&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were not effective as of September 30, 2020, and plans to remediate material weaknesses through additional staff training and expanded use of external consultants - Management concluded that the company's disclosure controls and procedures were not effective as of September 30, 2020[412](index=412&type=chunk) - Planned remediation measures include continued training for financial staff on U.S. GAAP and expanding the involvement of qualified external consultants to review the financial reporting process[415](index=415&type=chunk) PART II - OTHER INFORMATION [Item 1. Legal Proceedings](index=77&type=section&id=Item%201.%20Legal%20Proceedings) The company reported no legal proceedings during the period - There were no legal proceedings to report[416](index=416&type=chunk) [Item 1A. Risk Factors](index=77&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's annual report on Form 10-K filed on May 15, 2020, and the Form 10-Q filed on August 14, 2020 - No material changes to risk factors were reported since the last Form 10-K and Form 10-Q filings[417](index=417&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=77&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company issued common stock and warrants in unregistered sales to settle convertible notes and compensate consultants, relying on Regulation D or S exemptions - On September 30, 2020, the company issued **795,735** shares of common stock and warrants to six noteholders to settle outstanding convertible debt[419](index=419&type=chunk)[420](index=420&type=chunk) - The company issued **60,000** shares and **60,000** warrants to ViewTrade Securities, Inc. as compensation for capital markets advisory services[426](index=426&type=chunk) - An additional **420,000** shares were issued to three other consulting firms for investor relations and business development services[428](index=428&type=chunk) [Item 3. Defaults Upon Senior Securities](index=77&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - There were no defaults upon senior securities[429](index=429&type=chunk)[430](index=430&type=chunk) [Item 5. Other Information](index=78&type=section&id=Item%205.%20Other%20Information) The company reported no other information for this item - No other information was disclosed[430](index=430&type=chunk) [Item 6. Exhibits](index=79&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the quarterly report, including certifications pursuant to the Sarbanes-Oxley Act (Sections 302 and 906) and XBRL data files - Exhibits filed include CEO and CFO certifications under Sarbanes-Oxley Sections 302 and 906, as well as XBRL instance and taxonomy documents[431](index=431&type=chunk)

26-0014658 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ Commission file number 333-91436 American BriVision (Holding) Corporation. (Exact name of Registrant as specified in its charter) Nev ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2020 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ Commission file number 333-91436 American BriVision (Holding) Corporation. (Exact name of Registrant as specified in its charter) State or juri ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT UNDER SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended: December 31, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 333-91436 AMERICAN BRIVISION (HOLDING) CORPORATION (Exact name of Company in its charter) Nevada 26-0014658 (State or other jurisdiction of incorporatio ...

Financial Performance - Total revenues for the three months ended September 30, 2019, were $197,733, compared to $601,757 for the nine months ended September 30, 2019[9]. - Gross profit for the three months ended September 30, 2019, was $194,936, while total operating expenses were $1,310,558, resulting in a loss from operations of $(1,115,622)[9]. - The company reported a net loss of $(1,329,685) for the three months ended September 30, 2019, compared to a net loss of $(687,300) for the same period in 2018[9]. - For the nine months ended September 30, 2019, the net loss was $2,817,454, compared to a net loss of $2,136,962 for the same period in 2018, representing an increase of approximately 31.8%[11]. - The company reported a comprehensive loss of $(1,275,920) for the three months ended September 30, 2019, compared to $(582,849) for the same period in 2018[9]. - The net loss for the nine months ended September 30, 2019, was $2,817,454, an increase from a net loss of $2,136,962 for the same period in 2018[94]. - Basic loss per share for the nine months ended September 30, 2019, was $(0.16), compared to $(0.18) for the same period in 2018[203]. Assets and Liabilities - Total current assets increased to $1,707,567 as of September 30, 2019, from $566,476 as of December 31, 2018[8]. - Total liabilities decreased to $6,674,702 as of September 30, 2019, from $11,280,510 as of December 31, 2018[8]. - The company had total assets of $7,404,893 as of September 30, 2019, compared to $5,940,124 as of December 31, 2018[9]. - The total accumulated deficit as of September 30, 2018, was $(8,438,433), which increased to $(12,209,446) by December 31, 2018[12]. - The Company reported an accumulated deficit of $14,773,552 as of September 30, 2019, compared to $12,209,446 as of December 31, 2018[94]. - The Company had a working capital deficiency of $4,170,357 as of September 30, 2019, improved from $10,421,310 at December 31, 2018[94]. Cash Flow and Financing Activities - Net cash used in operating activities for the nine months ended September 30, 2019, was $1,638,709, an increase from $1,168,300 in the prior year, indicating a rise of about 39.9%[11]. - The company reported a net cash provided by financing activities of $2,483,244 for the nine months ended September 30, 2019, compared to $667,114 in the same period of 2018, reflecting a significant increase of approximately 272.5%[11]. - The ending cash, cash equivalents, and restricted cash equivalents as of September 30, 2019, totaled $1,051,800, up from $216,659 at the end of September 30, 2018[11]. - Cash and cash equivalents increased significantly to $1,035,678 as of September 30, 2019, compared to $226,688 as of December 31, 2018[8]. - The company issued common stock for acquisition amounting to $531,147 during the reporting period[11]. Research and Development - Research and development expenses for the three months ended September 30, 2019, were $269,239, up from $54,514 in the same period of 2018[9]. - The company has a business model focused on developing new drugs and innovative medical devices, integrating research from world-renowned institutions[19]. - The Company has entered into a co-development agreement with BioHopeKing Corporation to develop BLI-1401-2 for Triple Negative Breast Cancer, sharing development costs 50/50[98]. Stock and Equity - The weighted average number of common shares outstanding for the three months ended September 30, 2019, was 19,020,824, compared to 11,884,804 for the same period in 2018[9]. - The total number of common shares outstanding as of September 30, 2019, was 19,477,504, reflecting an increase from 11,884,804 shares as of September 30, 2018, due to stock issuances[13]. - The Company converted a total of $4,872,340 of debt into common stock at a conversion price of $7.00 per share, resulting in the issuance of 696,051 shares[200]. Debt and Interest Expenses - The total short-term bank loans amounted to $1,885,500 as of September 30, 2019, up from $899,250 in 2018, indicating a growth of 109%[138]. - Total interest expenses related to convertible notes payable for the three months ended September 30, 2019, were $18,755, compared to $3,567 for the same period in 2018, representing a significant increase of 426%[137]. - Interest expenses for the short-term bank loans were $1,351 for the three months ended September 30, 2019, slightly down from $1,402 in 2018[141]. - The Company received a loan of $500,000 from Cathay Bank with a revolving line of credit of $1,000,000, maturing on January 1, 2020[144]. - The Company entered into a new unsecured loan agreement for NT$3,000,000 (approximately $96,600) at a fixed interest rate of 12% per annum for working capital purposes[152]. Accounting and Revenue Recognition - The Company adopted ASC 606 for revenue recognition starting January 1, 2018, with no significant change in revenue reported during the periods presented[44]. - Revenue is recognized when customers obtain control of goods or services, reflecting the expected consideration[45]. - Merchandise sales revenue is recognized upon delivery to customers, recorded at the net sales price after accounting for discounts and returns[46]. - Collaborative revenues include nonrefundable upfront license fees, development milestones, and reimbursements for R&D costs, with no royalty revenues received to date[51]. - The Company assesses long-lived assets for impairment annually, adjusting carrying values based on future discounted cash flows if necessary[69]. Impairment and Goodwill - The Company anticipates future cash flows indicate that the recoverability of goodwill is not reasonably assured[75]. - The Company evaluates goodwill for impairment annually, with the last evaluation indicating impairment due to the current financial condition and uncertainty in generating future operating income[75].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2019 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ Commission file number 333-91436 American BriVision (Holding) Corporation. (Exact name of Registrant as specified in its charter) Nevada 26-0014 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2019 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ Commission file number 333-91436 American BriVision (Holding) Corporation. (Exact name of Registrant as specified in its charter) Nevada State ...

Part I [Business Overview](index=4&type=section&id=Item%201.%20Business) American BriVision is a clinical-stage biopharmaceutical company developing drugs and a medical device, primarily through out-licensing - The company is a clinical-stage biopharmaceutical firm with a pipeline of **six new drugs** and **one medical device**, all licensed from related parties, focusing on cancer and central nervous system (CNS) indications[7](index=7&type=chunk)[8](index=8&type=chunk) - The business model involves conducting clinical trials for **Proof of Concept (POC)** and then out-licensing results to larger pharmaceutical companies for further development and commercialization[8](index=8&type=chunk) - On **February 8, 2019**, the company completed a merger with BioLite Holding, Inc. and BioKey, Inc., making them wholly-owned subsidiaries[10](index=10&type=chunk) Key Development Pipeline | Product Candidate | Indication | Development Stage/Status | | :--- | :--- | :--- | | ABV-1501 | Triple Negative Breast Cancer | Phase II IND approved by U.S. FDA in March 2016 | | ABV-1504 | Major Depressive Disorder (MDD) | Phase I completed. Phase II Part I completed; Part II in-live study completed, awaiting data analysis | | ABV-1505 | Attention Deficit Hyperactivity Disorder (ADHD) | Phase II IND approved by U.S. FDA in January 2016. Part I trial planned for Q2 2019 | | ABV-1702 | Myelodysplastic Syndromes (MDS) | Phase II IND approved by U.S. FDA in July 2016. Planned to commence in Q4 2019 | | ABV-1703 | Pancreatic Cancer | Phase II trial approved by FDA in August 2017. Planned to initiate in Q4 2019 | | ABV-1601 | Depression in Cancer Patients | Phase II clinical protocol approved by FDA in December 2018 | | ABV-1701 (Vitargus) | Retinal Detachment / Vitreous Hemorrhage | Phase I clinical trial completed in Australia with positive results in July 2018. Pivotal study is being planned | - The company provides **Contract Development and Manufacturing Organization (CDMO) services**, including formulation development, analytical services, and GMP manufacturing for clinical trial materials[35](index=35&type=chunk)[36](index=36&type=chunk) [Risk Factors](index=18&type=section&id=Item%201A.%20Risk%20Factors) Risk factors disclosure is not applicable for a smaller reporting company - Risk factors disclosure is not applicable for a smaller reporting company[65](index=65&type=chunk) [Properties](index=18&type=section&id=Item%202.%20Properties) The company and its subsidiaries lease office, laboratory, and manufacturing facilities in Fremont, CA and Hsinchu, Taiwan Key Leased Properties and Rental Expenses (FY 2018) | Subsidiary | Location | Property Type | 2018 Rental Expense | | :--- | :--- | :--- | :--- | | ABVC | Fremont, CA | Office | $800/month (sublease from BioKey) | | BioLite | Hsinchu, Taiwan | Dormitory | ~$20,497 | | BioLite | Hsinchu, Taiwan | Laboratories | ~$9,000/month | | BioKey | Fremont, CA | Office, Labs, Mfg. | $275,638 | [Legal Proceedings](index=18&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any material legal or administrative proceedings - As of the report date, the company is not involved in any material legal proceedings[68](index=68&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=19&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock is quoted on the OTCQB under "ABVC", with 262 shareholders, and no dividends are anticipated - The company's common stock is quoted on the OTCQB under the symbol **"ABVC"**[69](index=69&type=chunk) Common Stock Price Range (High/Low Bid) | Quarter Ended | 2018 High Bid | 2018 Low Bid | 2017 High Bid | 2017 Low Bid | | :--- | :--- | :--- | :--- | :--- | | March 31 | $2.00 | $1.50 | $2.00 | $2.00 | | June 30 | $2.00 | $1.65 | $2.00 | $2.00 | | Sept 30 | $2.00 | $1.89 | $2.00 | $2.00 | | Dec 31 | $2.00 | $2.00 | $2.00 | $2.00 | - As of **April 8, 2019**, there were approximately **262 shareholders** of record[70](index=70&type=chunk) - No dividends have ever been paid, and none are anticipated in the foreseeable future[71](index=71&type=chunk) - From **January 1, 2018**, the company issued convertible notes totaling **$800,000** to three non-U.S. investors for general working capital[73](index=73&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%207.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) The company reported a $4.1 million net loss in 2018 with no revenue, a $5.5 million working capital deficit, and a going concern opinion Consolidated Statement of Operations Summary (Years Ended Dec 31) | Metric | 2018 | 2017 | Change (%) | | :--- | :--- | :--- | :--- | | Revenues | $0 | $0 | N/A | | Research & Development Expenses | $669,668 | $3,171,665 | (78.9%) | | Total Operating Expenses | $1,393,616 | $4,138,750 | (66.3%) | | Loss on Investment in Equity Securities | ($2,549,451) | $0 | N/A | | Net Loss | ($4,101,303) | ($4,242,860) | (3.3%) | - The decrease in operating expenses was primarily due to a reduction in research and development costs, which were at a more normalized rate in 2018 after establishing key collaborative agreements in the prior year[149](index=149&type=chunk) Working Capital Summary (As of Dec 31) | Metric | 2018 | 2017 | | :--- | :--- | :--- | | Current Assets | $96,273 | $2,643,332 | | Current Liabilities | $5,568,224 | $4,400,247 | | Working Capital (Deficit) | ($5,471,951) | ($1,756,915) | Cash Flow Summary (Years Ended Dec 31) | Metric | 2018 | 2017 | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | ($630,195) | ($1,485,313) | | Net Cash Provided by Financing Activities | $593,000 | $1,560,000 | - The company has incurred significant losses since inception, resulting in an accumulated deficit of **$19.9 million** as of December 31, 2018, raising substantial doubt about its ability to continue as a going concern[159](index=159&type=chunk) [Controls and Procedures](index=32&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure and internal controls were ineffective due to monitoring and segregation of duties issues - Management concluded that disclosure controls and procedures were not effective as of the end of the reporting period[349](index=349&type=chunk) - Internal controls over financial reporting were deemed not effective due to a lack of monitoring and segregation of duties, stemming from a small financial staff of only one person[350](index=350&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=33&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) This section lists the company's directors and executive officers, including Chairman Eugene Jiang and CEO Dr. Howard Doong Key Executive Officers and Directors | Name | Position | | :--- | :--- | | Eugene Jiang | Chairman of the Board and Interim CFO | | Dr. Howard Doong | Chief Executive Officer (CEO) | | Dr. Tsung-Shann (T.S.) Jiang | Chief Strategy Officer and Director | | Dr. Chi-Hsin (Richard) King | Chief Scientific Officer (CSO) | [Executive Compensation](index=35&type=section&id=Item%2011.%20Executive%20Compensation) Executive compensation for 2018 is detailed, with CEO Dr. Howard Doong receiving $100,000 and Chairman Eugene Jiang receiving $60,000 Summary Compensation Table (2018) | Name and Principal Position | Year | Salary ($) | Total ($) | | :--- | :--- | :--- | :--- | | Howard Doong (CEO) | 2018 | 100,000 | 100,000 | | Chun Mu Hung (former CFO) | 2018 | 14,434 | 14,434 | | Eugene Jiang (Chairman & interim CFO) | 2018 | 60,000 | 60,000 | - The company adopted an Equity Incentive Plan in 2016, but no new securities were issued under the plan during fiscal year 2018[375](index=375&type=chunk)[376](index=376&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=38&type=section&id=Item%2012.%20SECURITY%20OWENERSHIP%20OF%20CERTAIN%20BENEFICIAL%20OWNERS%20AND%20MANAGEMENT%20AND%20RELATED%20STOCKHOLDER%20MATTERS) As of April 8, 2019, Dr. Tsung-Shann Jiang is the principal beneficial owner, holding approximately **57.0%** of the company's outstanding shares Beneficial Ownership of Common Stock (as of April 8, 2019) | Name of Beneficial Owner | Amount of Beneficial Ownership | Percent of Class | | :--- | :--- | :--- | | Dr. Tsung-Shann Jiang | 121,891,654 | 57.0% | | All officers and directors as a group (12 persons) | 123,280,745 | 57.63% | - Dr. Tsung-Shann Jiang holds his shares primarily through YuanGene Corporation, as well as LionArts Promotion Inc., Rgene Corporation, and BioLite, Inc[393](index=393&type=chunk) [Certain Relationships and Related Transactions, Director Independence](index=40&type=section&id=Item%2013.%20CERTAIN%20RELATIONSHIPS%20AND%20RELATED%20TRANSACTIONS%2C%20DIRECTOR%20INDEPENDENCE) The company has extensive related-party transactions, including collaboration agreements and significant loans for working capital - The company has a collaboration agreement with BioLite Inc., a related party, for five drug products, with total potential payments of **$100 million** based on milestones, of which **$10 million** has been paid in cash and stock[395](index=395&type=chunk)[396](index=396&type=chunk) - A collaboration agreement with BioFirst Corporation, another related party, requires the company to pay **$3 million** for a global license to co-develop a vitreous substitute medical device, which remains unpaid as of the report date[401](index=401&type=chunk)[402](index=402&type=chunk) - The company has received multiple loans and advances from related parties for working capital, including from BioLite, BioFirst, AsianGene, and YuanGene Corporation[400](index=400&type=chunk)[403](index=403&type=chunk)[409](index=409&type=chunk) - In 2018, the company issued convertible promissory notes to related parties: **$250,000** to Keypoint Technology Ltd. and **$250,000** to director Yoshinobu Odaira, both bearing **8% interest**[410](index=410&type=chunk)[411](index=411&type=chunk) [Principal Accountant Fees and Services](index=41&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) This section details the fees paid to the company's principal accountant for 2018 and 2017, with all fees for audit services Accountant Fees | Fee Category | 2018 | 2017 | | :--- | :--- | :--- | | Audit Fees | $27,400 | $36,930 | | Audit Related Fees | $0 | $0 | | Tax Fees | $0 | $0 | | All Other Fees | $0 | $0 | | **Total Fees** | **$27,400** | **$36,930** | Financial Statements and Supplementary Data [Report of Independent Registered Public Accounting Firm](index=33&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) The auditor issued a fair opinion on financial statements but highlighted a **going concern** uncertainty due to recurring losses and working capital deficit - The auditor's report highlights a **"going concern" uncertainty** due to the company's history of losses, working capital deficit, and need for additional capital[168](index=168&type=chunk) [Consolidated Financial Statements](index=34&type=section&id=Consolidated%20Financial%20Statements) The consolidated financial statements show no revenue, significant operating losses, a growing accumulated deficit, and reliance on financing Consolidated Balance Sheet Highlights (As of Dec 31) | Metric | 2018 | 2017 | | :--- | :--- | :--- | | Total Assets | $96,273 | $2,643,332 | | Total Liabilities | $5,845,691 | $4,400,247 | | Total Stockholders' Deficit | ($5,749,418) | ($1,756,915) | | Accumulated Deficit | ($19,877,901) | ($15,776,598) | Consolidated Statement of Operations Highlights (Years Ended Dec 31) | Metric | 2018 | 2017 | | :--- | :--- | :--- | | Revenues | $0 | $0 | | Loss from Operations | ($1,393,616) | ($4,138,750) | | Net Loss | ($4,101,303) | ($4,242,860) | | Net Loss Per Share (Basic & Diluted) | ($0.02) | ($0.02) | Consolidated Statement of Cash Flows Highlights (Years Ended Dec 31) | Metric | 2018 | 2017 | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | ($630,195) | ($1,485,313) | | Net Cash Provided by Financing Activities | $593,000 | $1,560,000 | | Net (Decrease) Increase in Cash | ($37,195) | $74,687 | [Notes to Consolidated Financial Statements](index=38&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes detail accounting policies, financial position, and significant related-party transactions, including a **going concern** issue and reliance on related-party financing - Note 3 (Going Concern): The company has an accumulated deficit of **$19,877,901** as of Dec 31, 2018, and its ability to continue as a going concern depends on obtaining additional financing and achieving profitable operations[240](index=240&type=chunk) - Note 4 (Collaborative Agreements): The company has significant financial commitments under its collaboration agreement with BioLite, with total potential payments of **$100 million** contingent on development milestones, and a **$3 million** commitment to BioFirst[243](index=243&type=chunk)[257](index=257&type=chunk) - Note 5 (Long-Term Investment): The company received **1,530,000 shares** of Rgene Corporation common stock valued at **$2.55 million** in December 2018, but fully wrote off this investment in the same period due to impairment[254](index=254&type=chunk)[259](index=259&type=chunk) - Note 8 (Related Parties Transactions): The company is heavily reliant on related parties for financing, with amounts due totaling **$4.46 million** as of Dec 31, 2018, primarily to BioFirst Corporation (**$4.15 million**)[274](index=274&type=chunk) - Note 14 (Subsequent Events): In **January 2019**, the company secured a **$1 million** revolving line of credit from Cathay Bank, guaranteed by key individuals from its merger partners, BioLite and BioKey[345](index=345&type=chunk)[346](index=346&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=38&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists all financial statements and exhibits filed with the report, including key agreements and officer certifications - This section provides an index of all financial statements and exhibits filed with the Form 10-K[416](index=416&type=chunk)[417](index=417&type=chunk)