Core Insights - ABVC BioPharma, Inc. has received an additional $50,000 in licensing fees from AiBtl BioPharma, bringing the total to $346,000, which supports the confidence in ABVC's mission [1][2] - The payment is linked to ABVC's psychiatric disorder pipeline, which includes treatments for Major Depressive Disorder (MDD) and Attention Deficit Hyperactivity Disorder (ADHD), valued at $667 million [2] - ABVC is strategically positioned in growing markets, with the global MDD market projected to grow from $11.51 billion in 2022 to $14.96 billion by 2032, and the ADHD treatment market expected to increase from $15.23 billion in 2022 at a CAGR of 7.3% [3] Company Overview - ABVC BioPharma is a clinical-stage biopharmaceutical company with an active pipeline of six drugs and one medical device (ABV-1701/Vitargus®) under development [3] - The company utilizes in-licensed technology from renowned research institutions, including Stanford University and Cedars-Sinai Medical Center, to conduct proof-of-concept trials through Phase II of clinical development [3]

Core Insights - ABVC BioPharma, Inc. has executed significant global licensing agreements that could yield up to $292 million in income, enhancing its financial position and operational capabilities [1][2][3] Group 1: Licensing Agreements - The company secured a licensing agreement for Vitargus® with ForSeeCon Eye Corporation, potentially generating up to $187 million, including $60 million in upfront payments and $120 million in royalties post-launch [1] - ABVC entered into eight licensing agreements with OncoX BioPharma, Inc. for oncology products, which could provide up to $105 million, including $55 million in upfront payments and $50 million in royalties [2] Group 2: Financial Performance - Earnings Per Share (EPS) improved by approximately 86.8%, reaching -$0.09 in Q2 2024 from -$0.68 in Q2 2023, reflecting effective management of operational expenses [3] - Revenue surged to $117,142 in Q2 2024, a significant increase from $6,109 in Q2 2023, driven by the successful execution of licensing agreements [3] - Shareholders' equity as of June 30, 2024, was reported at $7.8 million, indicating a solid financial foundation [3] Group 3: Strategic Partnerships and Market Positioning - ABVC has formed strategic partnerships that are expected to enhance the value of its equity holdings and drive shareholder value [3] - The company is positioned for significant market capitalization growth by leveraging its pipeline accomplishments and international partnerships [4] Group 4: Operational and Regulatory Milestones - ABVC received multiple patents and FDA approvals for treatments targeting major depressive disorder, ADHD, and ophthalmology, expanding its intellectual property portfolio [4][9] - The company completed Phase II trials for major depressive disorder and initiated Phase IIb trials for ADHD, with FDA approvals for multiple IND applications [5][10] Group 5: Future Outlook - ABVC BioPharma is on a promising trajectory focused on sustainable growth, innovation, and value creation through strategic partnerships, preparing for future success [8]

Financial Performance - The company reported a significant year-over-year improvement in earnings per share (EPS), rising approximately 86.8% to -$0.09 in Q2 2024 from -$0.68 in Q2 2023[3]. - Revenue increased to $117,142 in Q2 2024, a substantial rise from $6,109 in Q2 2023, driven by strategic licensing agreements[3]. - Shareholders' equity as of June 30, 2024, stood at $7.8 million, indicating a solid financial foundation[3]. Licensing Agreements - ABVC BioPharma executed global licensing agreements that could provide up to $292 million in income, including $187 million from Vitargus® and $105 million from oncology products[1][2]. - A legally binding term sheet was signed with Xinnovation Therapeutics for exclusive licensing of ABV-1504 and ABV-1505 in mainland China, with a potential aggregate income of $20 million[10]. Intellectual Property and Regulatory Approvals - ABVC received multiple patents and FDA approvals for treatments targeting major depressive disorder, ADHD, and ophthalmology, enhancing its intellectual property portfolio[4]. - ABVC is advancing the development of Vitargus, a biodegradable hydrogel for retinal detachment surgery, with regulatory approval to initiate the next trial phase in Australia[12][13]. Clinical Development - The company completed Phase II trials for major depressive disorder (MDD) and initiated Phase IIb trials for ADHD, positioning itself for continued growth[4][9]. Strategic Focus - The company is focused on expanding its partnerships and driving sustainable growth through strategic licensing agreements and innovative therapies[6][5]. - ABVC's operational achievements and strategic partnerships are expected to enhance shareholder value and market positioning[4][6].

Financial Performance - Revenues for the three months ended June 30, 2024, were $117,142, a significant increase from $6,109 for the same period in 2023[14]. - The net loss for the six months ended June 30, 2024, was $5,253,708, compared to a net loss of $4,212,455 for the same period in 2023, indicating a decline in performance[14]. - The company reported a gross profit of $116,952 for the three months ended June 30, 2024, compared to a gross loss of $66,872 for the same period in 2023[14]. - The net loss for the six months ended June 30, 2024, was $5,253,708, compared to a net loss of $4,212,455 for the same period in 2023, representing an increase of approximately 24.7%[17]. - For the six months ended June 30, 2024, the Company reported a net loss of $5,253,708 and a working capital deficit of $4,359,360[25]. - Net loss attributable to common stockholders for the three months ended June 30, 2024, was $1,012,645, compared to a net loss of $2,263,511 for the same period in 2023, representing a 55.3% improvement[197]. - For the six months ended June 30, 2024, net loss attributable to common stockholders was $4,945,621, compared to $4,087,206 for the same period in 2023, indicating a 21% increase in losses[199]. Assets and Liabilities - Total current assets increased to $2,189,567 as of June 30, 2024, compared to $1,656,709 as of December 31, 2023, representing a growth of approximately 32%[11]. - Cash and cash equivalents increased to $124,296 as of June 30, 2024, from $60,155 as of December 31, 2023, showing a growth of about 106%[11]. - Total liabilities rose to $6,805,409 as of June 30, 2024, compared to $6,361,627 as of December 31, 2023, marking an increase of approximately 7%[11]. - The accumulated deficit increased to $(70,365,716) as of June 30, 2024, from $(65,420,095) as of December 31, 2023, indicating a worsening financial position[11]. - As of June 30, 2024, the Company's cash and cash equivalents amounted to $124,296, an increase from $60,155 as of December 31, 2023[37]. - The Company's restricted cash as of June 30, 2024, was $618,473, down from $656,625 as of December 31, 2023[38]. Operating Expenses - Operating expenses for the three months ended June 30, 2024, totaled $1,093,593, down from $2,126,970 in the same period of 2023, reflecting a reduction of approximately 48%[14]. - Cash used in operating activities decreased to $1,487,258 for the six months ended June 30, 2024, from $2,397,460 in the prior year, indicating an improvement of about 37.9%[17]. - The total employee benefits expense for the three months ended June 30, 2024, was $3,759,000, compared to $2,455,000 for the same period in 2023, representing a 53.1% increase[81]. - Total employee stock-based compensation expenses for the six months ended June 30, 2024, were $2,122,756, compared to $0 for the same period in 2023[82]. - Total non-employee stock-based compensation expenses for the six months ended June 30, 2024, were $834,980, up from $592,229 in 2023, reflecting a 41.0% increase[83]. Financing Activities - The company raised $1,544,706 from financing activities during the six months ended June 30, 2024, compared to $2,175,000 in the same period of 2023[17]. - The Company executed a 1-for-10 reverse stock split to reduce the number of outstanding shares and increase the per-share trading value[31]. - The Company plans to raise additional capital through private or public offerings to improve operations and generate positive cash flows[26]. - The company entered into a secured, convertible note agreement with Lind Global Fund II, LP, for a principal amount of $3,704,167, convertible at an initial price of $10.5 per share[144]. - The company issued a secured, convertible note (the "2 Lind Note") with a principal amount of $1,200,000 for a purchase price of $1,000,000, convertible at a price of the lesser of $3.50 or 90% of the average of the three lowest VWAPs during the prior 20 trading days[149]. Revenue Recognition - The Company recognizes revenue based on the control of promised goods or services, following the ASC 606 guidelines[45]. - The Company recognizes revenue from arrangement consideration allocated to each unit of accounting when all revenue recognition criteria in ASC 606 are satisfied[55]. - Revenue from combined units of accounting is recognized over the contractual or estimated performance period, typically the term of the Company's research and development obligations[55]. - The Company evaluates whether each milestone payment is substantive and at risk, considering factors such as performance and payment terms[56]. - Royalties on product sales are recognized as contingent revenues based on the resolution of applicable contingencies[57]. Investments and Collaborations - The company has entered into a multi-year global licensing agreement with AIBL for CNS drugs targeting Major Depressive Disorder and ADHD, which includes potential milestone payments of $3,500,000 and royalties of 5% on net sales, up to $100 million[24]. - The Company has a controlling interest in AIBL following the licensing agreement, receiving 23 million shares of AIBL stock as part of the deal[24]. - The Company has a collaborative agreement with BHK to develop BLI-1401-2 for Triple Negative Breast Cancer, with development costs shared 50/50[95]. - The Company entered into a licensing agreement with ForSeeCon Eye Corporation, with a total licensing fee of $33,500,000, including an upfront payment of $30,000,000[118]. - The Company is currently evaluating the impact of ASU 2023-05 on its unaudited consolidated financial statements, which pertains to joint venture formations[94]. Shareholder and Related Party Transactions - The outstanding loan balance to Rgene was $500,000 as of June 30, 2024, with accrued interest of $51,319[169]. - The Company expects to receive repayment from BioFirst within the next 12 months, with an outstanding loan balance of $687,714 as of June 30, 2024[171]. - As of June 30, 2024, the total amount due to related parties was $326,298, an increase from $173,132 as of December 31, 2023, reflecting a significant rise in outstanding balances[179]. - The outstanding balance due to the Jiangs increased from $19,789 to $178,533, indicating a substantial reliance on their funding for working capital[179]. Impairments and Valuation - Goodwill impairment testing was completed as of June 30, 2024, indicating impairment due to the Company's current financial condition and uncertainty in generating future operating income[74]. - Deferred tax assets as of June 30, 2024, totaled $6,242,485, with a valuation allowance of the same amount, indicating no net deferred tax assets recognized[182]. Property and Equipment - As of June 30, 2024, total property and equipment, net, amounted to $7,929,121, a decrease from $7,969,278 as of December 31, 2023, representing a decline of approximately 0.5%[124]. - The company acquired a 20% ownership in a property valued at $37,000,000, resulting in an investment of $7,400,000, issued as 370,000 shares at $20.0 per share[125]. - Depreciation expenses for the three months ended June 30, 2024, were $13,305, compared to $6,997 for the same period in 2023, indicating a significant increase of approximately 90.5%[126]. Market Conditions - The risk-free interest rate was reported at 2.79% for the year ended December 31, 2023[195]. - Expected volatility was noted at 83.86%, indicating a high level of uncertainty in the market[195].

Financial Performance - The company reported revenues of $1,205 for the three months ended March 31, 2024, a significant decrease from $128,272 for the same period in 2023, indicating a decline of approximately 99.1%[13] - Operating expenses for the three months ended March 31, 2024, totaled $3,445,318, compared to $1,974,220 for the same period in 2023, reflecting an increase of approximately 74.4%[13] - The net loss for the three months ended March 31, 2024, was $3,981,019, compared to a net loss of $1,897,230 for the same period in 2023, representing an increase in loss of approximately 109.5%[13] - The company reported a gross loss of $928 for the three months ended March 31, 2024, compared to a gross profit of $68,036 for the same period in 2023, indicating a significant decline in profitability[13] - For the three months ended March 31, 2024, the company reported a net loss of $3,981,019, compared to a net loss of $1,897,230 for the same period in 2023, representing an increase in loss of approximately 109%[23] - The company experienced net cash outflows of $473,161 from operating activities for the three months ended March 31, 2024[23] - The company reported a net loss attributable to common stockholders of $3,932,976 for the three months ended March 31, 2024, compared to a net loss of $1,823,695 for the same period in 2023[189] Assets and Liabilities - Total current assets as of March 31, 2024, increased to $1,794,450 from $1,656,709 as of December 31, 2023, representing an increase of approximately 8.3%[11] - Cash and cash equivalents decreased to $30,489 as of March 31, 2024, from $60,155 as of December 31, 2023, a decline of approximately 49.3%[11] - Total liabilities increased to $6,973,447 as of March 31, 2024, from $6,361,627 as of December 31, 2023, an increase of approximately 9.6%[11] - The total stockholders' equity decreased to $7,486,955 as of March 31, 2024, from $8,130,972 as of December 31, 2023, a decrease of approximately 7.9%[11] - The company's working capital deficit as of March 31, 2024, was $4,839,164, indicating significant financial strain[23] - The company’s accumulated deficit increased to $69,353,071 as of March 31, 2024, from $65,420,095 as of December 31, 2023, indicating a rise of approximately 4.5%[11] Shareholder Information - The weighted average shares used in computing net loss per share increased to 9,736,150 for the three months ended March 31, 2024, compared to 3,307,577 for the same period in 2023, an increase of approximately 194.5%[13] - The company issued 751,795 common shares upon the exercise of convertible notes, raising approximately $681,000[19] - The company believes the reverse stock split will help restore compliance with NASDAQ Capital Market listing standards[29] Cash Flow and Financing - The company has substantial doubt regarding its ability to continue as a going concern due to ongoing losses and working capital deficits[23] - The company issued a secured, convertible note to Lind Global Fund II, LP, in the principal amount of $3,704,167, convertible at an initial price of $1.05 per share[140] - The company entered into a new securities purchase agreement with Lind on November 17, 2023, issuing a convertible note of $1,200,000 for a purchase price of $1,000,000[144] - The outstanding loan balance with Rgene was $500,000 as of March 31, 2024, with accrued interest of $38,819[166] Research and Development - The company is focused on the development of new drugs and medical devices derived from plants, with clinical trials being conducted at prestigious institutions[22] - The Company accounts for research and development expenses as incurred, including personnel-related costs and clinical trial costs, with no alternative future use[77] - The Company recognizes revenues from research and development activities when related services are performed, typically having one performance obligation at contract inception[55] Agreements and Collaborations - The Company has a co-development agreement with BHK for the development of BLI-1401-2, with development costs shared 50/50, and the agreement lasts for fifteen years from the first commercial sale in Asia excluding Japan[93] - The total milestone payments under the BHK Co-Development Agreement amount to $10 million, with specific payments tied to clinical trial phases and regulatory submissions[94] - The Company has a co-development agreement with Rgene Corporation, requiring Rgene to pay $3 million for past research efforts, with future net licensing income shared 50/50[99] Employee Compensation - The Company recognized total employee stock-based compensation expenses of $1,935,755 for the three months ended March 31, 2024, compared to $0 for the same period in 2023[79] - The company issued 1,241,615 restricted shares to employees and directors under the 2016 Equity Incentive Plan, with a three-year restriction period[181] Tax and Deferred Assets - The company has a net deferred tax asset of approximately $6,252,782 as of March 31, 2024, primarily due to net operating loss carryforwards[173] - The Company assesses the need for a valuation allowance on deferred tax assets based on projections of future taxable income and tax planning strategies[86] Property and Equipment - The Company has a total of $11,271,552 in property and equipment as of March 31, 2024, with a net value of $7,949,150 after depreciation[117] - The Company acquired 20% ownership of a property valued at $37 million in Chengdu, China, for $7.4 million, aimed at developing a healthcare center[120]

Core Insights - ABVC BioPharma, Inc. announced the acquisition of TT Life Company by its subsidiary AiBtl BioPharma Inc. for approximately $8.33 million, involving a share swap of 1.66 million shares at $5 per share [1][2] - The acquisition aims to enhance AiBtl's capabilities in precision medicine, combining its global development expertise with TT Life's design and manufacturing strengths [2][3] - TT Life Company is projected to achieve targeted sales of $10 million in 2024, with a net profit margin of 11% [5] Company Overview - ABVC BioPharma is a clinical-stage biopharmaceutical company with a pipeline of six drugs and one medical device under development, utilizing in-licensed medicine from renowned research institutions [6] - AiBtl BioPharma focuses on integrating health and resort industries, aiming to deliver AI-powered products and services [4] - TT Life Company specializes in precision medicine, known for its innovative cell-related products and strong marketing presence in Asia, particularly Malaysia [5]

Core Insights - ABVC BioPharma, Inc. has entered a licensing agreement with OncoX to advance treatments for Non-Small Cell Lung Cancer (NSCLC) through the development of a botanical drug extract from Maitake Mushroom [1][2][3] Company Overview - ABVC BioPharma is a clinical-stage biopharmaceutical company focused on developing therapeutic solutions in ophthalmology, CNS, and Oncology/Hematology [1][6] - The company has an active pipeline of six drugs and one medical device, utilizing in-licensed technology from renowned research institutions [6] Licensing Agreement Details - The agreement grants OncoX exclusive rights to develop, manufacture, and commercialize BLEX 404, a combination therapy drug for NSCLC [2][4] - ABVC and its affiliate will receive an aggregate license fee of $12.5 million, with an additional milestone payment of $1.25 million after OncoX's next fundraising round [1][4] - Royalties of 5% on net sales of BLEX 404, capped at $12.5 million, will also be provided after the product launch [1][4] Market Potential - The global cancer therapeutics market is projected to grow from $164 billion in 2022 to approximately $393.61 billion by 2032, at a CAGR of 9.20% [5] - The lung cancer market was valued at $29.5 billion in 2022 and is expected to grow at an 11% CAGR through 2032 [5] Clinical Development - The FDA has approved four INDs for ABVC's products, including ABV-1519 for NSCLC, which is proposed as a combination therapy with chemotherapy [2][4] - BLEX 404, containing β-glucan from Maitake mushrooms, has shown promising results in clinical studies and is expected to improve treatment outcomes for NSCLC patients [2][4][3]

FREMONT, CA, April 10, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire -- ABVC BioPharma, Inc. (NASDAQ:ABVC) ("Company"), a clinical-stage biopharmaceutical company developing therapeutic solutions in ophthalmology, CNS (central nervous systems), and Oncology/Hematology, announced today that the Company together with its affiliates BioLite, Inc., and Rgene Corporation entered into a term sheet with OncoX BioPharma, Inc. (OncoX) for the Company's Oncology/Hematology pipeline(the "Licensed Products"). Subject to ne ...

Core Insights - ABVC BioPharma, Inc. announced that its subsidiary AiBtl BioPharma Inc. has entered into an agreement to exchange a 100% ownership stake in certain real estate for 1,533,333 shares of AIBL stock at $5 per share, with the property valued at approximately $7.6 million [1][2] Group 1: Company Developments - The agreement is expected to add several hundred million dollars in value to ABVC's assets, which currently have a market cap of $12 million, indicating that the company is significantly undervalued [2] - The real estate will be utilized to establish controlled-condition farms for growing botanicals, which will help reduce manufacturing costs for ABVC's drug products and facilitate clinical studies at a lower expense [2][3] - A portion of the real estate will also be developed into a senior citizen rehabilitation center, contributing to cost savings and revenue generation for AIBL's major shareholder, ABVC [2] Group 2: Company Overview - ABVC BioPharma is a clinical-stage biopharmaceutical company with an active pipeline of six drugs and one medical device (ABV-1701/Vitargus®) under development [3] - The company collaborates with renowned research institutions, including Stanford University and Cedars-Sinai Medical Center, to conduct proof-of-concept trials through Phase II of clinical development [3] - For its medical device, Vitargus®, ABVC intends to conduct global clinical trials through Phase III [3]

Core Insights - ABVC BioPharma, Inc. reported its 2023 annual financial and operating results, highlighting a significant decrease in revenue and a reduction in net loss compared to the previous year [1][13][14]. Financial Performance - Revenues for 2023 were $152,430, down approximately 84% from $969,783 in 2022, primarily due to the completion of ongoing projects and awaiting new approvals [13]. - Operating expenses decreased to $8,066,902 in 2023 from $15,797,780 in 2022, mainly due to reduced stock-based compensation and lower selling, general, and administrative expenses [13]. - The net loss for 2023 was $10,910,288, a reduction of approximately 31% from the net loss of $16,312,374 in 2022, attributed to more effective funding usage and discontinuation of certain consulting services [14]. Licensing and Strategic Agreements - The company entered a multi-year global licensing agreement with AiBtl BioPharma Inc. for CNS drugs targeting Major Depressive Disorder (MDD) and Attention Deficit Hyperactivity Disorder (ADHD), receiving 23 million shares of AIBL stock valued at $10 per share [3][21]. - ABVC also signed a cooperation agreement with Zhong Hui Lian He Ji Tuan, Ltd., acquiring 20% ownership of a property in Leshan, Sichuan, China, valued at $37 million, to develop a healthcare center [5][10]. Compliance and Equity - The company regained compliance with Nasdaq Marketplace Rules regarding minimum bid price and stockholders' equity requirements [4]. - As of December 31, 2023, total stockholders' equity was reported at $8,388,050, an increase from $3,098,585 in 2022 [13][31]. Research and Development Highlights - ABVC received multiple patents for Polygala extract for treating MDD and ADHD, with patents valid until 2040 and 2041 [16]. - The company successfully completed Phase II trials for MDD and commenced Phase IIb trials for ADHD, with further studies planned for 2024 [18]. Cash Flow and Investments - Cash and cash equivalents as of December 31, 2023, were $60,155, down from $85,265 in 2022 [15]. - The company reported net cash used in operating activities of $4,235,845 for 2023, an improvement from $7,398,391 in 2022 [36].