Clinical Trials Continue Despite COVID-19 Restrictions
Fremont, CA, Aug. 12, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- 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 company’s 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 decrease in 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,” said Dr. Howard Doong, ABVC BioPharma’s 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 Market on August 3, 2021,under the ticker symbol "ABVC".
About ABVC Biopharma
ABVC 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.
Disclaimer
Clinical 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 and illiquid, and there is a risk of complete loss.
Forward-Looking Statements
Clinical 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 Company’s 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 Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s 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 SEC’s 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 Officer
765-610-8826
andyan@ambrivis.com
ABVC BIOPHARMA, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
| | June 30, 2021 | December 31, 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 liabilities | 1,865,254 | 2,118,854 | ||||||
| Advance from customers | 10,985 | 12,070 | ||||||
| Operating lease liabilities – current portion | 337,170 | 316,178 | ||||||
| Due to related parties | 315,676 | 288,445 | ||||||
| Convertible notes payable - related parties, current portion | - | 250,000 | ||||||
| Total 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 portion | 1,299,267 | 1,456,567 | ||||||
| Convertible notes payable – noncurrent portion | 2,500,000 | 2,500,000 | ||||||
| Total Liabilities | 8,428,977 | 8,944,638 | ||||||
| Equity | ||||||||
| Preferred stock, $0.001 par value, 20,000,000 authorized, nil shares issued and outstanding | - | - | ||||||
| Common stock, $0.001 par value, 100,000,000 authorized, 24,470,526 and 24,420,526 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively | 24,470 | 24,420 | ||||||
| Additional 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 SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenues | $ | 31,441 | $ | 226,513 | $ | 294,591 | $ | 305,299 | ||||||||
| Cost of revenues | 646 | 4,236 | 1,891 | 8,195 | ||||||||||||
| Gross profit | 30,795 | 222,277 | 292,700 | 297,104 | ||||||||||||
| Operating expenses | ||||||||||||||||
| Selling, general and administrative expenses | 1,231,692 | 1,277,133 | 2,399,287 | 2,430,022 | ||||||||||||
| Research and development expenses | 358,878 | 139,082 | 480,193 | 231,872 | ||||||||||||
| Stock-based compensation | 475,740 | 75 | 701,480 | 600 | ||||||||||||
| Total operating expenses | 2,066,310 | 1,416,290 | 3,580,960 | 2,662,494 | ||||||||||||
| Loss from operations | (2,035,515 | ) | (1,194,013 | ) | (3,288,260 | ) | (2,365,390 | ) | ||||||||
| Other income (expense) | ||||||||||||||||
| Interest income | 10,722 | 9,350 | 63,251 | 20,070 | ||||||||||||
| Interest expense | (82,671 | ) | (140,525 | ) | (212,900 | ) | (272,042 | ) | ||||||||
| Rent income | 53,331 | 5,249 | 58,198 | 10,480 | ||||||||||||
| Rent income – related parties | 800 | 1,200 | 2,400 | 2,400 | ||||||||||||
| Impairment loss | - | (944,204 | ) | - | (944,204 | ) | ||||||||||
| Investment loss | - | (38,937 | ) | - | (38,937 | ) | ||||||||||
| Gain/Loss on foreign exchange changes | (5,758 | ) | 8,656 | (4,807 | ) | 8,658 | ||||||||||
| Gain/Loss on investment in equity securities | (53,591 | ) | (109,656 | ) | (101,382 | ) | (180,067 | ) | ||||||||
| Other income | 162 | 170,179 | 233 | 176,501 | ||||||||||||
| Government grant income | - | - | 124,400 | - | ||||||||||||
| Total other expenses | (77,005 | ) | (1,038,688 | ) | (70,607 | ) | (1,217,141 | ) | ||||||||
| Loss before provision income tax | (2,112,520 | ) | (2,232,701 | ) | (3,358,867 | ) | (3,582,531 | ) | ||||||||
| Provision for income tax | (59,564 | ) | (48,644 | ) | (110,588 | ) | (89,212 | ) | ||||||||
| Net loss | (2,052,956 | ) | (2,184,057 | ) | (3,248,279 | ) | (3,493,319 | ) | ||||||||
| Net loss attributable to noncontrolling interests | (81,390 | ) | (334,760 | ) | (148,208 | ) | (396,484 | ) | ||||||||
| Net loss attributed to ABVC and subsidiaries | (1,971,566 | ) | (1,849,297 | ) | (3,100,071 | ) | (3,096,835 | ) | ||||||||
| Foreign currency translation adjustment | 364,581 | (10,568 | ) | 400,721 | (17,019 | ) | ||||||||||
| Comprehensive loss | $ | (1,606,985 | ) | $ | (1,859,865 | ) | $ | (2,699,350 | ) | $ | (3,113,854 | ) | ||||
| Net loss per share: | ||||||||||||||||
| Basic and diluted | $ | (0.08 | ) | $ | (0.09 | ) | $ | (0.13 | ) | $ | (0.16 | ) | ||||
| Weighted average number of common shares outstanding: | ||||||||||||||||
| Basic and diluted | 24,421,082 | 19,488,168 | 24,420,804 | 19,486,355 | ||||||||||||
ABVC BIOPHARMA, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR 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 nonemployees | 701,480 | 600 | ||||||
| Gain/Loss on investment in equity securities | 101,382 | 180,067 | ||||||
| Government 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 receivable | (137,312 | ) | (39,845 | ) | ||||
| Decrease (increase) in prepaid expenses and deposits | (219,020 | ) | 20,091 | |||||
| Decrease (increase) in due from related parties | (12,346 | ) | (438,174 | ) | ||||
| Increase (decrease) in accounts payable | (17,997 | ) | (16,183 | ) | ||||
| Increase (decrease) in notes payable | - | 51,240 | ||||||
| Increase (decrease) in accrued expenses and other current liabilities | 201,591 | 736,046 | ||||||
| Increase (decrease) in advance from others | (1,085 | ) | 836 | |||||
| Increase (decrease) in due to related parties | 4,427 | 44,778 | ||||||
| Net 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) investing activities | (421,974 | ) | 33,300 | |||||
| Cash flows from financing activities | ||||||||
| Issuance of common stock for private placement | - | 1,697,051 | ||||||
| Issuance of common stock for stock-based compensation | - | 493,480 | ||||||
| Proceeds from short-term loan | - | 100,000 | ||||||
| Proceeds from short-term borrowing from third parties | - | 31,850 | ||||||
| Proceeds from short-term borrowing from related parties | - | 71,688 | ||||||
| Repayment 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 activities | (74,734 | ) | 2,255,107 | |||||
| Effect of exchange rate changes on cash and cash equivalents and restricted cash | 9,419 | 4,590 | ||||||
| Net increase (decrease) in cash and cash equivalents and restricted cash | (3,344,367 | ) | 245,926 | |||||
| Cash and cash equivalents and restricted cash | ||||||||
| Beginning | 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 | $ | - | $ | - | ||||
