Full Press Release Details
ABVC BioPharma Reports Third Quarter 2023 Financial
and Operational Results
FREMONT, CA, November 15, 2023 -- ABVC BioPharma, Inc. (Nasdaq: ABVC),
a biotechnology company specializing in botanically based solutions that seeks to deliver high efficacy and low toxicity to improve health
outcomes, today announced its financial and operating results for the third quarter of 2023. 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
Quarter 2023 Financial Results
All comparisons are made on a year-over-year basis.
Shareholders' Equity
On February 23, 2023, the Company entered into a securities purchase agreement with Lind Global Fund II, LP ("Lind"), pursuant
to which the Company issued Lind a secured, convertible note in the principal amount of $3,704,167, for a purchase price of $3,175,000,
that is convertible into shares of the Company's common stock at an initial conversion price of $1.05 per share, subject to adjustment.
The Company also issued Lind a common stock purchase warrant to purchase up to 5,291,667 shares of the Company's common stock at
an initial exercise price of $1.05 per share, subject to adjustment. During the period ended September 30, 2023, the Company has been
repaying Lind with securities for 614,912 shares, totaling $1,814,800. During July 2023, the warrant exercise price was reset to $3.5
in accordance to the issuance of common stock in relation to securities purchase agreement on July 2023. As of September 30, 2023, the
warrant has not yet been exercised.
On July 27, 2023, the Company entered into that certain securities purchase agreement. relating to
the offer and sale of 300,000 shares of common stock, par value $0.001 per share and 200,000 pre-funded warrants, at an exercise price
of $0.001 per share, in a registered direct offering. Pursuant to the Purchase Agreement, the Company agreed to sell the Shares and/or
Pre-funded Warrants at a per share purchase price of $3.50, for gross proceeds of $1,750,000, before deducting any estimated offering
expenses. On August 1, 2023, the pre-funded warrants were exercised.
On August 14, 2023, the Company entered into a cooperation agreement
with Zhonghui. Pursuant thereto, the Company acquired 20% of the ownership of a property and the parcel of the land owned by Zhonghui
in Leshan, Sichuan, China. During the third quarter of 2023, the Company issued to Zhonghui, an aggregate of 370,000 shares of the Company's
common stock, at a per share price of $20.
The above-mentioned equity is before the reverse stock split in 2023.
As of September 30, 2023, the Company achieved
a total shareholders' equity of $9.10M and therefore believes it has regained the compliance with NASDAQ's shareholders'
II trials for ABV-1504 were completed successfully with good tolerance to the drug, and no serious adverse effects were reported. The
product is ready for an End-of-Phase 2 meeting with the FDA to finalize the protocol for Phase III trials. At the same time, we commenced
the ADHD Phase IIb trials at the University of California, San Francisco (UCSF) and another five sites in Taiwan. The trials are heading
for the interim report, which we expect to complete by the end of 2023. ABV-1601 for MDD in cancer patients has completed Phase I study
preparation, including the Site Initiation Visit (SIV).
2023, ABVC signed a legally binding term sheet with a Chinese pharmaceutical company, Xinnovation Therapeutics Co., Ltd, for the exclusive
licensing of ABV-1504 for Major Depressive Disorder (MDD) and ABV-1505 for Attention-Deficit/Hyperactivity Disorder in mainland China.
Under this agreement, Xinnovation will hold exclusive rights to develop, manufacture, market, and distribute our innovative drugs for
MDD and ADHD in the Chinese market and shall bear the costs for clinical trials and product registration in China. We are negotiating
definitive agreements with Xinnovation and are excited that the licensing deal carries a possible aggregate income of $20 million for
ABVC if all expected sales are made.
In November 2023, each of ABVC and one of its subsidiaries, BioLite,
Inc. ("BioLite") entered into a multi-year, global licensing agreement with AIBL for the Company and BioLites's CNS
drugs with the indications of MDD (Major Depressive Disorder) and ADHD (Attention Deficit Hyperactivity Disorder) (the "Licensed
Products"). The potential license will cover the Licensed Products' clinical trial, registration, manufacturing, supply, and
distribution rights. The Licensed Products for MDD and ADHD, owned by ABVC and BioLite, were valued at $667M by a third-party evaluation.
The parties are determined to collaborate on the global development of the Licensed Products. The parties are also working to strengthen
new drug development and business collaboration, including technology, interoperability, and standards development. As per each of the
respective agreements, each of ABVC and BioLite shall receive 23 million shares of AIBL stock at $10 per share, and if certain milestones
are met, $3,500,000 and royalties equaling 5% of net sales, up to $100 million.
a vitreous substitute, is a groundbreaking, advanced-staged R&D product that we believe will be the first biodegradable hydrogel
used in retinal detachment surgery. Vitargus has completed the feasibility study in Australia and was approved by the
Australian Therapeutic Goods Administration (TGA) to initiate the next trial phase in two participating sites. This is vital to obtaining
final regulatory approval for Vitargus in Australia.
Park Administration in Taiwan approved ABVC's plan to set up a pilot Good Manufacturing Practice (GMP) facility to produce Vitargus
and to pursue the process development work for manufacturing optimization. We are undertaking this project, proposed by ABVC's Taiwan
affiliate and co-development partner, BioFirst Corporation, to upgrade the Vitargus manufacturing processes so it can
ultimately handle the global market supply. ABVC and BioFirst Corporation expect to complete the facility's construction in Hsinchu Biomedical
Science Park, Taiwan, in 2024.
Food & Drug Administration (US FDA) approved the Investigational New Drug (IND) application for the proposed clinical investigation
of BLEX 404, the primary active ingredient in ABV-1519, for advanced inoperable or metastatic EGFR-mutated non-small cell lung cancer.
This treatment is being co-developed by BioKey, Inc. ("BioKey") and by the Rgene Corporation, Taiwan. The study is under review
at the Taiwan FDA for approval. This is the fourth IND approved by the US FDA for BLEX 404. The previous three INDs are for the combination
therapies of triple-negative breast cancer, myelodysplastic syndromes (MDS), and pancreatic cancer.
BioKey, a wholly-owned subsidiary of the Company
based in Fremont, California, produces dietary supplements derived from the maitake mushroom in tablet and liquid forms. BioKey has entered
the second year of the distribution agreement with Define Biotech Co. Ltd. BioKey is currently set to produce an additional $1 million
worth of products for the global market. We continue to work on distribution for the US and Canadian markets with Shogun Maitake.
On the regulatory services front for our clients,
we received two ANDA approvals from the US FDA. We have a three-year contract, worth up to $3 million,
for clinical development services between BioKey and Rgene Corporation. With this base, we are actively developing BioKey as a contract
research, development, and manufacturing organization (CRDMO) to become a one-stop solution for pharmaceutical services. We also established
BioKey (Cayman), Inc. to attract strategic investors to aid BioKey in getting listed on the Taiwan Stock Exchange.
Strategic Investments
ABVC entered a cooperation agreement with Zhonghui
United Technology (Zhonghui) Group Co., Ltd. and its affiliated enterprises that contemplates a joint development of a large-scale
health and wellness base in Chengdu, China. The anticipated partnership aims to establish an integrated platform to facilitate collaborations
between researchers and industry leaders. ABVC issued 370,000 shares of common stock to Zhonghui at $20 per share in consideration for
a 20% ownership of certain property owned by Zhonghui, estimated at $37 million by a third-party valuation company, and another piece
of land Zhonghui currently owns in that same area. The parties are waiting for final asset ownership certification over these properties
from the Chinese government, but based on the cooperation agreement, Zhongui does maintain the right to replace these properties with
suitable replacements, acceptable to ABVC.
2023, we entered a definitive securities purchase agreement with a single institutional investor to purchase $1.75 million worth of our
common stock and pre-funded warrants in a registered direct offering. Under the terms of the securities purchase agreement, the Company
sold 300,000 shares of common stock and 200,000 pre-funded warrants. The purchase price per share of common stock is $3.50, and the purchase
price for the pre-funded warrants is identical to the purchase price for a share of common stock, less the exercise price of $0.01 per
The Company has regained compliance with Nasdaq
Marketplace Rules relating to maintaining a minimum $1.00 bid price and believes it regained compliance with the $2.5 million minimum
shareholders equity requirements, as explained above.
As per Nasdaq Marketplace Rules, the Company had
to present evidence on closing bid price of at least $1.00 per share for ten consecutive trading days, which it completed on August 08,
"We are delighted with our remarkable accomplishments
and meaningful progress in 2023, and look forward to upcoming reports to end 2023 on a positive note," said Uttam Patil, Ph.D., Chief
Executive Officer of ABVC BioPharma. "I am pleased with ABV-1505 (ADHD) Phase II, part II study making substantial progress at five
Taiwan study sites and UCSF and expecting to be completed in 2023, Phase I studies of ABV-1601 for treating depression in cancer patients
being initiated at CSMC in the US, and 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 a Phase I clinical study completed in Australia in 2018, indicating a promising outcome from the Phase
II trials. We remain excited about our ongoing research initiatives and look forward to expanding our product pipeline."
About ABVC BioPharma