ABVC BioPharma Reports Third Quarter 2022 Financial and Operational Results
15 November 2022 - 10:20AM
via NewMediaWire – ABVC BioPharma, Inc. (Nasdaq: ABVC), a clinical
stage biopharmaceutical company developing therapeutic solutions in
oncology/hematology, CNS, and ophthalmology, today announced its
financial and operating results for the third quarter of
2022. These results, including the financial statements
included herein, can be found in the Company’s Quarterly Report on
Form 10-Q that was filed earlier today with the Securities and
Exchange Commission.
Third Quarter 2022 Financial Results
All comparisons are made on a year-over-year basis.
- Revenues. The Company
generated $42,269 and $98,999 in revenues for the three months
ended September 30, 2022 and 2021, respectively. The decrease in
revenues was mainly due to the completion of certain contract
services during Q3 2021.
- Operating Expenses
increased by $1,678,209, or 81%, to $3,747,369 for the three months
ended September 30, 2022 from $2,069,160 for the three months ended
September 30, 2021. Such increase in operating expenses was mainly
attributable to the increase in selling, general and administrative
expenses by $1,636,150 which relates to costs in conjunction with
our recent stock issuance and increase in research and development
expenses of $42,059 to continue developing our pipeline.
- Other Income (Expense) Our
other (expense) income was $(56,461) for the three months ended
September 30, 2022, compared to $8,643 for the three months ended
September 30, 2021. The change was principally caused by the
increase in interest expense, while being offset by the increase in
interest income for the three months ended September 30, 2022, and
loss on investment in equity securities and government grant income
for the three months ended September 30, 2021.
- Net Interest income
(Expense) was $(78,372) for the three months ended September
30, 2022, compared to $(29,344) for the three months ended
September 30, 2021. The increase of $49,028, or approximately 167%,
was primarily due to the increase in interest expense due to
recognition of interest expense for the converted notes for proper
accounting purposes.
- Net Loss. As a result of
the above factors, our net loss was $3,776,524 for the three months
ended September 30, 2022 compared to $1,886,244 for the three
months ended September 30, 2021, representing a decrease of
$1,890,280, or 100%.
Recent Operational Highlights
Vitargus® Phase II Study
- Australia: Vitargus® Phase II
Clinical Study protocol documents were accepted by the Australian
Bellberry Human Research Ethics Committee (“HREC”) and a Clinical
Trial Notification (“CTN”) was submitted to the Australian
Therapeutic Goods Administration (TGA) to initiate the study in
Australia.
- Thailand: On August 2, 2022, the
Ethics Committee (EC) of the Ramathibodi Hospital, Mahidol
University provided approval allowing the hospital to conduct the
Vitargus Phase II Study. This follows a similar approval received
on July 18, 2022, by Srinagarind Hospital, Khon Kaen University of
Thailand. On November 2, 2022, both hospitals received Thai FDA
investigational product (IP) import licenses allowing them to
initiate the clinical study in Thailand.
ADHD Phase II Part 2 Clinical Update
- Taiwan: The Phase II Part 2
clinical study of the Company’s ADHD medicine, ABV-1505 has been
initiated at five prestigious medical centers in Taiwan. The Part 2
study is a randomized, double-blind, placebo-controlled study,
titled “A Phase II Tolerability and Efficacy Study of PDC-1421
Treatment in Adult Patients with Attention-Deficit Hyperactivity
Disorder (ADHD), Part 2”. Thirty-five subjects have already been
enrolled including 20 subjects who have completed the 56-day
treatment. It is expected that eventually approximately 100
patients in Taiwan and the United States will participate in the
study.
- United States: The University of
California, San Francisco (UCSF) Medical Center Institutional
Review Board has approved participation in the Part 2 study, set to
begin in the first quarter of 2023. Part 1 of the Phase II study of
ABV-1505 was conducted at UCSF from January 2020 through July 2020
and was accepted by the US Food & Drug Administration in
October of 2020.
Other Developments
- On October 20, 2022, ABVC
received a Notice of Allowance for ABV-1504 from the US Patent and
Trademark Office that substantially extends the existing patent
life of ABV-1504 to the year 2041. The patent, entitled
“Polygala Extract for the Treatment of Major Depressive Disorder,”
outlines a method for treating major depressive disorder by oral
administration of a composition, ABV-1504, containing Radix
Polygalae (Polygala tenuifolia Willd). The polygala extract,
designated PDC-1421, is the key active ingredient in ABV-1504 which
was orally administered to healthy volunteers and proved to be safe
and well-tolerated for a daily dose from 380 mg to 3800 mg. The
completed Phase II clinical study indicated that the drug can be
administered chronically over at least 42 days with the daily dose
administered three times per day, wherein each dose contains from
380 mg to 760 mg of the botanical extraction.
- The Cedars-Sinai Medical Center
(CSMC, West Hollywood CA) Institutional Review Board (IRB) has
approved their institution joining the Phase I study of ABV-1601
for treating depression in cancer patients. The Principal
Investigator of the CSMC study will be Dr. Scott A. Irwin, MD,
PhD., an eminent Professor of Psychiatry & Behavioral
Neurosciences. The Phase I study is open label and will be
conducted with 12 cancer patients with moderate to severe
depressive symptoms. The main objective of the study is to evaluate
the safety of PDC-1421, the primary active ingredient in ABV-1601.
The second objective is to determine the most effective dosages for
a randomized, double-blind, non-inferiority Phase II trial of
PDC-1421 that ABVC expects to initiate in 2023. The Company then
intends to compare results of the Phase II study of ABV-1601 to
Wellbutrin XL, a commonly used medicine to treat cancer patients
suffering with depression.
About ABVC BioPharma, Inc.
ABVC BioPharma is a clinical-stage biopharmaceutical company
with an active pipeline of six drugs and one medical device
(ABV-1701/Vitargus®) under development. For its drug products, it
is 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). For Vitargus®, the company intends to
conduct the clinical trials through Phase III at various locations
throughout the globe.
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; (v) difficulties in securing regulatory approval
to proceed to the next level of the clinical trials or to market
our product candidates; and (vi) impact of COVID-19 pandemic on our
business, results of operations, financial condition and cash
flows. 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.
This press release does not constitute an offer to sell or the
solicitation of an offer to buy these securities, nor shall there
be any sale of these securities in any state or jurisdiction in
which such offer, solicitation or sale would be unlawful prior to
registration or qualification under the securities laws of that
state or jurisdiction.
Contact:Leeds ChowCFOEmail: leedschow@ambrivis.com
ABVC
BIOPHARMA, INC. AND SUBSIDIARIES |
CONSOLIDATED
BALANCE SHEETS |
|
|
|
|
|
|
|
|
|
|
|
September
30, |
|
December
31, |
|
|
|
2022 |
|
|
2021 |
|
|
|
|
|
(Unaudited) |
|
|
|
ASSETS |
|
|
|
|
|
Current Assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
1,323,543 |
|
|
$ |
5,828,548 |
|
Restricted cash and cash equivalents |
|
646,604 |
|
|
|
736,667 |
|
Accounts receivable, net |
|
47,680 |
|
|
|
280,692 |
|
Accounts receivable - related parties, net |
|
- |
|
|
|
145,399 |
|
Due from related party - Current |
|
500,000 |
|
|
|
- |
|
Inventory, net |
|
20,489 |
|
|
|
25,975 |
|
Short-term Investment |
|
77,583 |
|
|
|
108,147 |
|
Prepaid expense and other current assets |
|
287,181 |
|
|
|
528,354 |
|
Total Current Assets |
|
2,903,080 |
|
|
|
7,653,782 |
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
566,751 |
|
|
|
525,881 |
|
Operating lease right-of-use assets |
|
1,243,930 |
|
|
|
1,471,899 |
|
Goodwill, net |
|
- |
|
|
|
- |
|
Long-term investments |
|
816,160 |
|
|
|
932,755 |
|
Deferred tax assets |
|
1,013,159 |
|
|
|
981,912 |
|
Prepaid expenses - noncurrent |
|
103,218 |
|
|
|
119,309 |
|
Security deposits |
|
57,656 |
|
|
|
41,157 |
|
Prepayment for long-term investments |
|
2,586,358 |
|
|
|
1,153,155 |
|
Due from related parties - noncurrent |
|
1,190,255 |
|
|
|
818,183 |
|
Total Assets |
$ |
10,480,567 |
|
|
$ |
13,698,033 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND EQUITY |
|
|
|
|
|
Current Liabilities |
|
|
|
|
|
Short-term bank loans |
$ |
1,866,250 |
|
|
$ |
1,640,000 |
|
Accrued expenses and other current liabilities |
|
1,201,497 |
|
|
|
1,300,803 |
|
Advance from customers |
|
10,985 |
|
|
|
10,985 |
|
Operating lease liability – current portion |
|
363,752 |
|
|
|
347,100 |
|
Due to related parties |
|
451,826 |
|
|
|
393,424 |
|
Total Current Liabilities |
|
3,894,310 |
|
|
|
3,692,312 |
|
|
|
|
|
|
|
|
|
Tenant security deposit |
|
12,880 |
|
|
|
10,580 |
|
Operating lease liability – noncurrent portion |
|
880,178 |
|
|
|
1,124,799 |
|
Total Liabilities |
|
4,787,368 |
|
|
|
4,827,691 |
|
|
|
|
|
|
|
|
|
COMMITMENTS AND CONTINGENCIES |
|
|
|
|
|
|
|
|
|
|
|
|
|
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, 32,632,329
and 28,926,322 shares issued and outstanding as of September 30,
2022 and December 31, 2021, respectively |
|
32,632 |
|
|
|
28,926 |
|
Additional paid-in capital |
|
66,493,649 |
|
|
|
58,113,667 |
|
Stock subscription receivable |
|
(1,580,180 |
) |
|
|
(2,257,400 |
) |
Accumulated deficit |
|
(50,040,501 |
) |
|
|
(38,481,200 |
) |
Accumulated other comprehensive income |
|
113,081 |
|
|
|
539,660 |
|
Treasury stock |
|
(9,100,000 |
) |
|
|
(9,100,000 |
) |
Total Stockholders’ equity |
|
5,918,681 |
|
|
|
8,843,653 |
|
Noncontrolling Interest |
|
(225,482 |
) |
|
|
26,689 |
|
Total Equity |
|
5,693,199 |
|
|
|
8,870,342 |
|
|
|
|
|
|
|
|
|
Total Liabilities and Equity |
$ |
10,480,567 |
|
|
$ |
13,698,033 |
|
|
|
|
|
|
|
|
|
ABVC
BIOPHARMA, INC. AND SUBSIDIARIES |
CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS |
(UNAUDITED) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Revenue |
$ |
42,269 |
|
|
$ |
98,999 |
|
|
$ |
380,789 |
|
|
$ |
393,590 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue |
|
10,741 |
|
|
|
393 |
|
|
|
21,004 |
|
|
|
2,284 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
31,528 |
|
|
|
98,606 |
|
|
|
359,785 |
|
|
|
391,306 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative expenses |
|
3,216,146 |
|
|
|
1,579,996 |
|
|
|
6,000,055 |
|
|
|
3,979,283 |
|
Research and development expenses |
|
305,483 |
|
|
|
263,424 |
|
|
|
1,197,669 |
|
|
|
743,617 |
|
Stock based compensation |
|
225,740 |
|
|
|
225,740 |
|
|
|
5,143,483 |
|
|
|
927,220 |
|
Total operating expenses |
|
3,747,369 |
|
|
|
2,069,160 |
|
|
|
12,341,207 |
|
|
|
5,650,120 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(3,715,841 |
) |
|
|
(1,970,554 |
) |
|
|
(11,981,422 |
) |
|
|
(5,258,814 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
48,165 |
|
|
|
9,333 |
|
|
|
127,354 |
|
|
|
72,584 |
|
Interest expense |
|
(126,537 |
) |
|
|
(38,677 |
) |
|
|
(159,507 |
) |
|
|
(251,577 |
) |
Operating sublease income |
|
21,597 |
|
|
|
2,624 |
|
|
|
78,523 |
|
|
|
60,822 |
|
Operating sublease income - related parties |
|
- |
|
|
|
1,200 |
|
|
|
- |
|
|
|
3,600 |
|
Gain/Loss on foreign exchange changes |
|
(177 |
) |
|
|
(5,999 |
) |
|
|
17,865 |
|
|
|
(10,806 |
) |
Gain/Loss on investment in equity securities |
|
- |
|
|
|
(91,765 |
) |
|
|
- |
|
|
|
(193,147 |
) |
Other (expense) income |
|
491 |
|
|
|
(404 |
) |
|
|
(59,381 |
) |
|
|
(171 |
) |
Government grant income |
|
- |
|
|
|
132,331 |
|
|
|
- |
|
|
|
256,731 |
|
Total other income (expense) |
|
(56,461 |
) |
|
|
8,643 |
|
|
|
4,854 |
|
|
|
(61,964 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before provision for income tax |
|
(3,772,302 |
) |
|
|
(1,961,911 |
) |
|
|
(11,976,568 |
) |
|
|
(5,320,778 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for income tax |
|
4,222 |
|
|
|
(75,667 |
) |
|
|
(165,096 |
) |
|
|
(186,255 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
(3,776,524 |
) |
|
|
(1,886,244 |
) |
|
|
(11,811,472 |
) |
|
|
(5,134,523 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to noncontrolling interests |
|
(71,660 |
) |
|
|
(79,756 |
) |
|
|
(252,171 |
) |
|
|
(227,964 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributed to ABVC and subsidiaries |
|
(3,704,864 |
) |
|
|
(1,806,488 |
) |
|
|
(11,559,301 |
) |
|
|
(4,906,559 |
) |
Foreign currency translation adjustment |
|
(190,019 |
) |
|
|
16,138 |
|
|
|
(426,579 |
) |
|
|
416,859 |
|
Comprehensive loss |
$ |
(3,894,883 |
) |
|
$ |
(1,790,351 |
) |
|
$ |
(11,985,880 |
) |
|
$ |
(4,489,700 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share: |
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
$ |
(0.11 |
) |
|
$ |
(0.07 |
) |
|
$ |
(0.37 |
) |
|
$ |
(0.20 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding: |
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
32,574,551 |
|
|
|
26,882,181 |
|
|
|
31,193,397 |
|
|
|
25,053,522 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ABVC
BIOPHARMA, INC. AND SUBSIDIARIES |
CONSOLIDATED
STATEMENTS OF CASH FLOWS |
(UNAUDITED) |
|
|
|
|
|
Nine Months Ended September 30, |
|
|
|
|
|
|
|
|
|
|
2022 |
|
|
2021 |
|
Cash flows from operating activities |
|
|
|
|
|
Net loss |
|
$ |
(11,811,472 |
) |
|
$ |
(5,134,523 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
Depreciation |
|
17,364 |
|
|
|
8,725 |
|
Stock based compensation for non employees |
|
5,143,483 |
|
|
|
927,220 |
|
Gain/Loss on investment in equity securities |
|
- |
|
|
|
193,147 |
|
Government grant income |
|
- |
|
|
|
(256,731 |
) |
Provision for doubtful accounts |
|
521,955 |
|
|
|
- |
|
Other non-cash income and expenses |
|
30,564 |
|
|
|
- |
|
Deferred tax |
|
(31,247 |
) |
|
|
(187,055 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
Decrease (increase) in accounts receivable |
|
(31,909 |
) |
|
|
(171,655 |
) |
Decrease (increase) in prepaid expenses and deposits |
|
243,065 |
|
|
|
(647,219 |
) |
Decrease (increase) in due from related parties |
|
(983,707 |
) |
|
|
422,651 |
|
Decrease (increase) in inventory |
|
5,486 |
|
|
|
(59,673 |
) |
Increase (decrease) in accounts payable |
|
- |
|
|
|
(6,547 |
) |
Increase (decrease) in accrued expenses and other current
liabilities |
(99,306 |
) |
|
|
(338,928 |
) |
Increase (decrease) in advanced from others |
|
- |
|
|
|
(1,085 |
) |
Increase (decrease) in due to related parties |
|
58,402 |
|
|
|
178,570 |
|
Net cash used in operating activities |
|
(6,937,322 |
) |
|
|
(5,073,103 |
) |
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities |
|
|
|
|
|
Purchase of equipment |
|
(119,603 |
) |
|
|
- |
|
Purchase of investment |
|
- |
|
|
|
(110,700 |
) |
Purchase of property, plant and equipment |
|
- |
|
|
|
(18,503 |
) |
Prepayment for equity investment |
|
(1,518,793 |
) |
|
|
(1,104,609 |
) |
Net cash used in investing activities |
|
(1,638,396 |
) |
|
|
(1,233,812 |
) |
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities |
|
|
|
|
|
Issuance of common stock |
|
3,917,425 |
|
|
|
6,875,000 |
|
Payment for offering costs |
|
- |
|
|
|
(850,429 |
) |
Proceeds from short-term loan |
|
350,000 |
|
|
|
- |
|
Repayment of convertible notes |
|
- |
|
|
|
(306,836 |
) |
Repayment of short-term loan |
|
- |
|
|
|
(100,000 |
) |
Repayment of notes payable |
|
- |
|
|
|
(107,100 |
) |
Proceeds from long-term loan |
|
- |
|
|
|
236,498 |
|
Repayment of long-term bank loans |
|
- |
|
|
|
(4,396 |
) |
Net cash provided by (used in) financing
activities |
|
4,267,425 |
|
|
|
5,742,737 |
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash and cash
equivalents and restricted cash |
|
(286,775 |
) |
|
|
11,579 |
|
|
|
|
|
|
|
|
|
|
|
Net decrease in cash and cash equivalents and restricted
cash |
|
(4,595,068 |
) |
|
|
(552,599 |
) |
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents and restricted cash |
|
|
|
|
|
Beginning |
|
|
6,565,215 |
|
|
|
5,001,371 |
|
Ending |
|
|
$ |
1,970,147 |
|
|
$ |
4,448,772 |
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flows |
|
|
|
|
|
Cash paid during the year for: |
|
|
|
|
|
Interest expense paid |
$ |
161,741 |
|
|
$ |
327,642 |
|
Income taxes paid |
$ |
1,600 |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
|
ABVC BioPharma (NASDAQ:ABVC)
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From Mar 2024 to Apr 2024
ABVC BioPharma (NASDAQ:ABVC)
Historical Stock Chart
From Apr 2023 to Apr 2024