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ABVC Biopharma Reports First Quarter 2022 Financial and Operational Results

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FREMONT, CA, May 16, 2022 (GLOBE NEWSWIRE) -- 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 first quarter of 2022.

First Quarter 2022 Financial Results

All comparisons are made on a year-over-year basis.

  • Revenues. The Company generated $25,660 and $263,150 in revenues for the three months ended March 31, 2022 and 2021, respectively. The decrease in revenues was mainly due to the impact of COVID-19 on the Contract Development & Manufacturing Organization (“CDMO”) business sector. 
  • Operating Expenses increased by $4,727,835 to $6,242,485 for the three months ended March 31, 2022 from $1,514,650 for the three months ended March 31, 2021. The increase in operating expenses was mainly attributable to the increase in stock-based compensation and selling, general and administrative expenses by $4,489,746, which relates to costs in conjunction with the recent stock issuance, as well as the increase in research and development expenses of $238,089 to continue developing the Company’s pipeline.
  • Other Income (Expense) was $44,239 and $6,398 for the three months ended March 31, 2022 and 2021, respectively. The change was principally caused by the increase in rental income and decrease in interest expense, as well as the loss on investment in equity securities and government grant income, which occurred in the three months ended March 31, 2021.Net interest income (expense) was $21,962 for the three months ended March 31, 2022, compared to $(77,700) for the three months ended March 31, 2021. The increase of $99,662, or approximately 128%, was primarily due to the repayment of convertible notes payable during the year ended 2021. Government grant income totaled $0 for the three months ended March 31, 2022, compared to $124,400 for the three months ended March 31, 2021, which was recorded as receipt of the first round of PPP loan forgiveness.
  • Net Loss was $6,087,615 for the three months ended March 31, 2022 compared to $1,195,323 for the three months ended March 31, 2021.

Recent 2022 Highlights

  • Engaged the FreeMind Group to help explore and identify funding opportunities from non-dilutive sources, such as the NIH, DOD, NSF, FDA and BARDA, as well as private foundations.
  • All five clinical study sites in Taiwan participating in the Phase II part 2 clinical study of the company’s ADHD medicine completed site initiation visits (SIV).  
  • The Company entered into a $3.0 million clinical services contract with NeuCen BioMed Co. Ltd. to guide two NeuCen drug products, CEN501 and NEU001, through completion of Phase II clinical studies under U.S. FDA IND regulatory requirements.
  • The first subject treatment in the Phase II part 2 clinical study of the Company’s ADHD medicine (ABV-1505) began at the Cheng Hsin General Hospital.  The study is a randomized, double-blind, placebo-controlled study, involving a total of approximately 100 patients in the United States and Taiwan. This is a continuation of the Phase II part 1 study of ABV-1505, which was completed successfully at the University of California, San Francisco, and accepted by the U.S. FDA in October 2020.

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; 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.

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

ICR, LLC
Lucy Peng
Phone: +1 646-677-1872
Email: Lucy.Peng@icrinc.com

ABVC BIOPHARMA, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

   March 31, December 31,
   2022 2021
ASSETS       
Current Assets     
 Cash and cash equivalents$        2,717,936   $         5,828,548 
 Restricted cash and cash equivalents            714,652              736,667 
 Accounts receivable, net            281,197              280,692 
 Accounts receivable - related parties, net            145,399              145,399 
 Due from related parties         2,715,375           1,286,618 
 Inventory, net              22,700                25,975 
 Short-term investments              95,553              108,147 
 Prepayment for long-term investments            663,798              684,720 
 Prepaid expense and other current assets            631,321              528,354 
  Total Current Assets               7,987,931           9,625,120 
        
Property and equipment, net            598,648              525,881 
Operating lease right-of-use assets         1,382,695           1,471,899 
Goodwill, net                     -                         -   
Long-term investments            904,254              932,755 
Deferred tax assets         1,036,830              981,912 
Prepaid expenses - noncurrent            115,664              119,309 
Security deposits              40,733                41,157 
  Total Assets $       12,066,755   $       13,698,033 
        
LIABILITIES AND EQUITY       
Current Liabilities     
 Short-term bank loans$        1,609,750  $        1,640,000 
 Accrued expenses and other current liabilities         1,247,558           1,300,803 
 Advance from customers              10,985                10,985 
 Operating lease liability – current portion            349,008              347,100 
 Due to related parties            446,397              393,424 
  Total Current Liabilities         3,663,698           3,692,312 
       
 Tenant security deposit                7,980                10,580 
 Operating lease liability – noncurrent portion         1,033,686           1,124,799 
  Total Liabilities         4,705,364           4,827,691 
        
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, 30,307,329 and 28,926,322 shares issued and outstanding              30,307                28,926 
 Additional paid-in capital       62,578,549         58,113,667 
 Stock subscription receivable        (2,031,660)   (2,257,400)
 Accumulated deficit      (44,476,640)   (38,481,200)
 Accumulated other comprehensive income            426,321              539,660 
 Treasury stock        (9,100,000)   (9,100,000)
  Total Stockholders’ equity         7,426,877           8,843,653 
Noncontrolling Interest            (65,486)               26,689 
  Total Equity         7,361,391           8,870,342 
        
Total Liabilities and Equity $       12,066,755   $       13,698,033 

ABVC BioPharma Inc

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About ABVC

american brivision (holding) corporation, a clinical stage biopharmaceutical company, develops drugs and medical devices to fulfill unmet medical needs in the united states. the company is developing abv-1501, a combination therapy for triple negative breast cancer; abv-1504 for major depressive disorders; abv-1505 for attention deficit hyperactivity disorder; abv-1703 for the treatment of pancreatic cancer; abv-1702 to treat myelodysplastic syndromes; and abv-1601 for treating depression in cancer patients. it has a co-development agreement with rgene corporation; collaboration agreement with biohopeking corporation to develop abv-1501; and collaborative agreement with biofirst corporation to co-develop bfc-1401 vitreous substitute for vitrectom; and license with biofirst corporation to research and develop a medical device, abv-1701 vitargus for the treatment of retinal detachment or vitreous hemorrhage. the company was founded in 2015 and is based in fremont, california. american br