Full Year 2022 Financial Results

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

• Revenues. We generated $969,783 and $355,797 in revenues for the years ended December 31, 2022 and 2021, respectively. The increase of $613,986, or approximately 173%, was primarily caused by the increase in contract services with Rgene.
• Operating Expenses. Our operating expenses were $15,797,780 in the year ended December 31, 2022, as compared to $12,056,679 in the year ended December 31, 2021. Such increase in operating expenses was mainly attributable to the increase in stock-based compensation and selling, general and administrative expenses by $2,051,449 which relates to costs in conjunction with our public offering and our recent stock issuances, as well as increasing research and development expenses of $1,689,652 to continue to develop our pipeline.
• Other Income (expense). The other expense was $400,184 in the year ended December 31, 2022 as compared to other income of $495,141 in the year ended December 31, 2021. The change was principally caused by the increase in interest expense, while being offset by the increase in interest income for the year ended December 31, 2022, and loss on investment in equity securities and decrease in government grant income for the year ended December 31, 2022.
• Net Loss. The net loss was $16,312,374 for the year ended December 31, 2022 compared to $12,035,851 for the year ended December 31, 2021. The Company’s net loss increased by $4,276,523 or approximately 36% during the year ended December 31, 2021 from 2021.
• Working (Deficit) Capital. Working deficit as of December 31, 2022 was $2,832,282, compared to working capital of $3,691,470 as of December 31, 2021, primarily as a result of a decrease in net cash from financing activities. The net cash provided by financing activities decreased by $5,981,625, due to the increase in proceeds from short-term loans, partially offset by the decrease in issuance of common stock through up-list, as well as decrease in payment of offering costs, repayment of convertible notes and notes payable, and proceeds from long-term loans during the year ended December 31, 2021.
• Cash and Cash Equivalents. The Company considers highly liquid investments with maturities of three months or less, when purchased, to be cash equivalents. As of December 31, 2022 and 2021, the Company’s cash and cash equivalents amounted $85,265and $5,828,548, respectively.

Fourth Quarter 2022 Highlights

ABV-1701 Vitargus®:

Vitargus is intended to be the first biodegradable vitreous substitute to facilitate retina reattachment surgery. The company expects to complete Phase II trials of Vitargus in Thailand, Australia and Taiwan by the end of 2023, the successful completion of which is expected to lead to distribution agreements in Asia soon thereafter.   ABVC expects the study to further demonstrate that Vitargus has properties that eliminate the need for post-surgery patient face-down positioning and can provide greater patient comfort and visual acuity during the surgical recovery period.

ABV-1505 ADHD:

The company’s ADHD medicine, ABV-1505, is currently in Phase II, part 2, clinical trials at five prestigious medical centers in Taiwan. A Phase II, part 2 study will begin at the University of California, San Francisco (UCSF) Medical Center in the next few months. This study is expected to eventually enroll approximately 100 patients in Taiwan and the United States.

Following the May 2022 reports of the first subject treated in Taiwan, 42 subjects have been enrolled in the study from a total of 64 subjects screened. 36 of the enrolled participants have already completed the 8-week treatment in accordance with the study design.

ABV-1601 Cancer Patient Depression:

A Phase I study of ABV-1601 for treating depression in cancer patients is expected to begin in the first quarter of 2023 at the Cedars-Sinai Medical Center (CSMC, West Hollywood CA). 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 in cancer patients. The Phase II study is to determine the most effective dosages using a randomized, double-blind, non-inferiority protocol of PDC-1421 vs Wellbutrin XL. ABVC expects to initiate the Phase II study in the fourth quarter of 2023 and then compare the results to Wellbutrin XL, a commonly used medicine to treat cancer patients suffering with depression.

ABV-1504 Major Depressive Disorder:

ABVC’s MDD medicine, ABV-1504, has successfully completed Phase II at the Stanford University Medical Center and five major medical centers in Taiwan. Later this year, with the help of Dr. Maurizio Fava and Dr. Thomas Laughren, the company expects to conclude discussions with the US FDA on acceptable protocols for Phase III trials for MDD, allowing ABVC to seek potential distribution partners active in manufacturing and distributing Central Nervous System (CNS) medicines.

“We are delighted with our remarkable accomplishments and meaningful progress in 2022,” said Dr. Howard Doong, M.D., Ph.D., Chief Executive Officer of ABVC BioPharma. “I am pleased that ABV-1504 ADHD Phase II, part II study is making substantial progress at five Taiwan study sites and UCSF and expecting to be completed in 2023, that Phase I studies of ABV-1601 for treating depression in cancer patients is being initiated at CSMC in US, and with the progress of End-of-Phase II meeting preparation for ABV-1504 (MDD) with Dr. Maurizio Fava and Dr. Thomas Laughren of Clinical Trials Network and Institute, (CTNI). In addition, ABV-1701 Vitargus, a hydrogel we developed to make retina reattachment surgery more comfortable and successful for patients, has shown advantages over existing devices available to surgeons in Phase I clinical study completed in Australia in 2018, prompting us to start a Phase II trial in Australia and Thailand in 2022. The study has received the approvals from both Australian TGA and Thai FDA with patient enrollment planned in early Q2 of 2023. We remain excited about our ongoing research initiatives and look forward to expanding our product pipeline in the future.”

About ABVC BioPharma

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, the company utilizes in-licensed technology from its network of world-renowned research institutions to conduct proof-of-concept trials through Phase II of clinical development. The company’s network of research institutions includes Stanford University, University of California at San Francisco, and Cedars-Sinai Medical Center. For Vitargus®, the company intends to conduct global clinical trials through Phase III. 

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. None of the outcomes expressed herein are guaranteed. 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.

ABVC BIOPHARMA, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS

ABVC BIOPHARMA, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

ABVC BIOPHARMA, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE YEAR ENDED DECEMBER 31, 2022 AND 2021