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Clinical Trials Continue Despite COVID-19 Restrictions


GlobeNewswire Inc | Aug 12, 2021 08:28AM EDT

August 12, 2021

Clinical Trials Continue Despite COVID-19 Restrictions

Fremont, CA, Aug. 12, 2021 (GLOBE NEWSWIRE) -- viaNewMediaWire --ABVC Biopharma, Inc., a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, central nervous system (CNS), and ophthalmology, today announced its unaudited financial and operating results for the three-month period ended June 30, 2021.

-- Revenues.We generated $31,441 and $226,513 in revenues for the three months ended June 30, 2021 and 2020, respectively; and incurred $646 and $4,236 in cost of sales for the three months ended June 30, 2021 and 2020, respectively. The decrease in revenues was mainly due to the impact of COVID-19 onto our CDMO business sector.

-- Operating Expenses.Our operating expenses have increased by $650,010, or 46%, to $2,066,310 for the three months ended June 30, 2021, from $1,416,290 for the three months ended June 30, 2020. Such increase in operating expenses was mainly due to the increase in selling, general and administrative expenses and research and development expenses.

Our selling, general and administrative expenses and stock-based compensation increased by $430,224, or 34%, mainly due to the increase in companys marketing and up-list related expenses.

Our research and development expenses increased by $219,796 or approximately 158% primarily because of new service agreements signed with vendors during the three months ended June 30, 2021.

-- Other Income (Expense).Our other expense was $77,005 for the three months ended June 30, 2021, as compared to $1,038,688 for the three months ended June 30, 2020. The change was principally caused by the decreasein impairment loss of $944,204 during the quarter, and increase in interest income and rental income, as well as decreasing loss on investment in equity securities, while deducted from decrease in net other income.

Interest income was $10,722 for the three months ended June 30, 2021, as compared to $9,350 for the three months ended June 30, 2020. The increase of $1,372, or approximately 15%, was primarily due to the interest income for various related-party loans.

Loss on investment in equity securities was $53,591 for the three months ended June 30, 2021, as compared to $109,656 for the three months ended June 30, 2020. The decrease of $56,065, or approximately 51%, was primarily due to the loss on investment in BioFirst.

Other income and government grant income totaled $162 for the three months ended June 30, 2021, as compared to $170,179 for the three months ended June 30, 2020. The decrease of $170,017, or approximately 100%, was primarily due to the tax refund for greenlight project recorded in the first half year of 2020.

-- Net Loss.As a result of the above factors, our net loss was $2,052,956 for the three months ended June 30, 2021, compared to $2,184,057 for the three months ended June 30, 2020, representing a decrease of $131,101, or 6%.

In spite of elevated COVID-19 restrictions, we were pleased to make significant clinical study progress during Q2 with respect to Vitargus, our medical device, and MDD for Cancer Patients, our depression medicine for cancer patients, saidDr. Howard Doong, ABVC BioPharmas chief executive officer.For example, we identified three potential trial sites and principal investigators in Australia to conduct further clinical trials of Vitargus beginning in Q4 of this year, the data of which may be included in the pivotal trial phase required by the US FDA to obtain marketing approval. And, in connection with our medicine addressing depression for cancer patients, MDD for Cancer Patients, we submitted all necessary protocol documents to Cedar-Sinai Medical Center that we believe will enable them to issue their final approval to initiate clinical trial Phase I/II for this drug before the end of 2021.

Dr. Doong continued, We also took steps during the quarter to expand our patent protection for our medicines that address MDD andAttention Deficit/Hyperactivity Disorderby applying for additional patents in both the United States and China that include the results of the Phase II human trials for these medicines.

Subsequent to the quarter, the company completed a public offering of 1,100,000 units, consisting of 1,100,000 shares of its common stock, Series A Warrants to purchase up to 1,100,000 shares of common stock at $6.30 per share and Series B Warrants to purchase up to 1,100,000 shares of common stock at $10.00 per share, resulting in net proceeds to ABVC BioPharma of$6,021,585, after deducting the underwriting commissions and offering expenses payable by us. We intend to use the net proceeds from the offering to fund clinical trials and for working capital and general business purposes. In addition, while we have not entered into any agreements, commitments or understandings relating to any significant transaction, we may use a portion of the net proceeds to pursue acquisitions, joint ventures, and other strategic transactions.

The Company's common stock began trading on The Nasdaq Capital Marketon August 3,2021,under the ticker symbol "ABVC".

About ABVC BiopharmaABVC Biopharma is a clinical-stage biopharmaceutical company focused on utilizing its licensed technology to conduct proof-of-concept trials through Phase II of the clinical development process at world-famous research institutions (such as Stanford University, University of California at San Francisco, and Cedars-Sinai Medical Center). The company has an active pipeline of six drugs and one medical device (ABV-1701/Vitargus) under development.DisclaimerClinical trials are in early stages, and there is no guarantee that any specific outcome will be achieved. Past performance is not indicative of future results. Investments may be speculative andilliquid, and there is a risk of complete loss.Forward-Looking StatementsClinical trials are in early stages, and there is no guarantee that any specific outcome will be achieved. This press release contains forward-looking statements. Such statements may be preceded by the words intends, may, will, plans, expects, anticipates, projects, predicts, estimates, aims, believes, hopes, potential, or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Companys control, and cannot be predicted or quantified, and, consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to proceed to the next level of the clinical trials or to market our product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Companys filings with the Securities and Exchange Commission (SEC), including the Companys Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors are urged to read these documents free of charge on the SECs website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.Contact:

Andy An Chief Financial Officer765-610-8826andyan@ambrivis.com

ABVC BIOPHARMA, INC. AND SUBSIDIARIESCONSOLIDATED BALANCE SHEETS

June 30, December31, 2021 2020 (Unaudited) ASSETS Current Assets Cash and cash equivalents $ 924,841 $ 4,273,208 Restricted cash and cash equivalents 732,163 728,163 Accounts receivable, net 297,024 159,712 Accounts receivable - related parties, net 145,475 143,435 Due from related parties 710,257 696,255 Inventory, net - - Prepaid expense and other current assets 817,889 172,193 Total Current Assets 3,627,649 6,172,966 Property and equipment, net 511,747 514,834 Operating lease right-of-use assets 1,636,436 1,772,747 Goodwill, net - - Long-term investments 1,095,751 1,190,727 Deferred tax assets 1,912,356 1,790,597 Prepaid expenses ? noncurrent 119,985 119,315 Security deposits 41,042 45,519 Total Assets $ 8,944,966 $ 11,606,705 LIABILITIES AND EQUITY Current Liabilities Accounts payable $ 5,047 $ 23,044 Short-term bank loans 1,634,500 1,629,000 Short-term loan 100,000 100,000 Notes payable 107,400 106,800 Accrued expenses and other current 1,865,254 2,118,854 liabilitiesAdvance from customers 10,985 12,070 Operating lease liabilities ? current 337,170 316,178 portionDue to related parties 315,676 288,445 Convertible notes payable - related - 250,000 parties, current portionTotal Current Liabilities 4,376,032 4,844,391 Paycheck Protection Program loan payable 236,498 124,400 Tenant security deposit 17,180 19,280 Operating lease liability ? noncurrent 1,299,267 1,456,567 portionConvertible notes payable ? noncurrent 2,500,000 2,500,000 portionTotal Liabilities 8,428,977 8,944,638 Equity Preferred stock, $0.001 par value,20,000,000 authorized, nil shares issued - - and outstandingCommon stock, $0.001 par value, 100,000,000authorized, 24,470,526 and 24,420,526shares issued and outstanding as of June 24,470 24,420 30, 2021 and December 31, 2020,respectivelyAdditional paid-in capital 41,001,757 40,751,807 Stock subscription receivable (2,708,880 ) (3,160,360 )Accumulated deficit (28,742,458 ) (25,642,387 )Accumulated other comprehensive income 965,581 564,860 Treasury stock (9,100,000 ) (9,100,000 )Total Stockholders? Equity 1,440,470 3,438,340 Noncontrolling interest (924,481 ) (776,273 )Total Equity 515,989 2,662,067 Total Liabilities and Equity $ 8,944,966 $ 11,606,705

ABVC BIOPHARMA, INC. AND SUBSIDIARIESCONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(UNAUDITED)

Three Months Ended Six Months Ended June30, June30, 2021 2020 2021 2020 Revenues $ 31,441 $ 226,513 $ 294,591 $ 305,299 Cost of 646 4,236 1,891 8,195 revenues Gross profit 30,795 222,277 292,700 297,104 Operating expensesSelling,general and 1,231,692 1,277,133 2,399,287 2,430,022 administrativeexpensesResearch anddevelopment 358,878 139,082 480,193 231,872 expensesStock-based 475,740 75 701,480 600 compensationTotaloperating 2,066,310 1,416,290 3,580,960 2,662,494 expenses Loss from (2,035,515 ) (1,194,013 ) (3,288,260 ) (2,365,390 )operations Other income (expense)Interest 10,722 9,350 63,251 20,070 incomeInterest (82,671 ) (140,525 ) (212,900 ) (272,042 )expenseRent income 53,331 5,249 58,198 10,480 Rent income ?related 800 1,200 2,400 2,400 partiesImpairment - (944,204 ) - (944,204 )lossInvestment - (38,937 ) - (38,937 )lossGain/Loss onforeign (5,758 ) 8,656 (4,807 ) 8,658 exchangechangesGain/Loss oninvestment in (53,591 ) (109,656 ) (101,382 ) (180,067 )equitysecuritiesOther income 162 170,179 233 176,501 Government - - 124,400 - grant incomeTotal other (77,005 ) (1,038,688 ) (70,607 ) (1,217,141 )expenses Loss beforeprovision (2,112,520 ) (2,232,701 ) (3,358,867 ) (3,582,531 )income tax Provision for (59,564 ) (48,644 ) (110,588 ) (89,212 )income tax Net loss (2,052,956 ) (2,184,057 ) (3,248,279 ) (3,493,319 ) Net lossattributableto (81,390 ) (334,760 ) (148,208 ) (396,484 )noncontrollinginterests Net lossattributed to (1,971,566 ) (1,849,297 ) (3,100,071 ) (3,096,835 )ABVC andsubsidiariesForeigncurrency 364,581 (10,568 ) 400,721 (17,019 )translationadjustmentComprehensive $ (1,606,985 ) $ (1,859,865 ) $ (2,699,350 ) $ (3,113,854 )loss Net loss per share:Basic and $ (0.08 ) $ (0.09 ) $ (0.13 ) $ (0.16 )diluted Weightedaverage numberof common sharesoutstanding:Basic and 24,421,082 19,488,168 24,420,804 19,486,355 diluted

ABVC BIOPHARMA, INC. AND SUBSIDIARIESCONSOLIDATED STATEMENTS OF CASH FLOWSFOR THE SIX MONTHS ENDED JUNE 30, 2021 AND 2020(UNAUDITED)

2021 2020 Cash flows from operating activities Net loss $ (3,248,279 ) $ (3,493,319 )Adjustments to reconcile net loss to net cash used in operating activities:Depreciation 5,869 21,599 Stock based compensation for 701,480 600 nonemployeesGain/Loss on investment in equity 101,382 180,067 securitiesGovernment grant income (124,400 ) - Other non-cash income and expenses - (5,886 )Investment loss - 983,141 Deferred tax (111,388 ) (92,062 )Changes in operating assets and liabilities:Decrease (increase) in accounts (137,312 ) (39,845 )receivableDecrease (increase) in prepaid expenses (219,020 ) 20,091 and depositsDecrease (increase) in due from related (12,346 ) (438,174 )partiesIncrease (decrease) in accounts payable (17,997 ) (16,183 )Increase (decrease) in notes payable - 51,240 Increase (decrease) in accrued expenses 201,591 736,046 and other current liabilitiesIncrease (decrease) in advance from (1,085 ) 836 othersIncrease (decrease) in due to related 4,427 44,778 partiesNet cash used in operating activities (2,857,078 ) (2,047,071 ) Cash flows from investing activities Net proceeds from sale of investment - 33,300 Prepayment for equity investment (421,974 ) - Net cash provided by (used in) (421,974 ) 33,300 investing activities Cash flows from financing activities Issuance of common stock for private - 1,697,051 placementIssuance of common stock for - 493,480 stock-based compensationProceeds from short-term loan - 100,000 Proceeds from short-term borrowing from - 31,850 third partiesProceeds from short-term borrowing from - 71,688 related partiesRepayment of convertible notes (306,836 ) - Proceeds from long-term loans 236,498 124,400 Repayment of long-term bank loans (4,396 ) (263,362 )Net cash provided by financing (74,734 ) 2,255,107 activities Effect of exchange rate changes on cashand cash equivalents and restricted 9,419 4,590 cash Net increase (decrease) in cash and (3,344,367 ) 245,926 cash equivalents and restricted cash Cash and cash equivalents and restricted cashBeginning 5,001,371 160,443 Ending $ 1,657,004 $ 406,369 Supplemental disclosure of cash flows Cash paid during the year for: Interest expense paid $ 69,623 $ 59,812 Income taxes paid $ - $ -







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