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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934
Date of Report (Date of earliest event reported):
August 15, 2024
ABVC BIOPHARMA, INC.
(Exact name of registrant as specified in its charter)
Nevada |
|
001-40700 |
|
26-0014658 |
(State or other jurisdiction
of incorporation) |
|
(Commission File Number) |
|
(IRS Employer
Identification No.) |
44370 Old Warm Springs Blvd.
Fremont, CA |
|
94538 |
(Address of principal executive offices) |
|
(Zip Code) |
Registrant’s telephone number including area
code: (510) 668-0881
(Former name or former address, if changed since
last report)
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class |
|
Trading Symbol |
|
Name of each exchange on which registered |
Common Stock, par value $0.001 per share |
|
ABVC |
|
The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant
is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule
12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial
Condition.
On August 15, 2024, ABVC BioPharma, Inc. (the
“Company”) issued a press release announcing its financial results for the second quarter ended June 30, 2024, which
were disclosed in the Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission on August 14, 2024. A copy
of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information reported under this Item 2.02
of Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed to be “filed” for the purposes of Section
18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of
such section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended,
or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Neither this Current Report on Form 8-K, nor any
exhibit attached hereto, is an offer to sell or the solicitation of an offer to buy the Securities described herein. Such disclosure does
not constitute an offer to sell, or the solicitation of an offer to buy nor shall there be any sales of the Company’s securities
in any state in which such an offer, solicitation or sale would be unlawful. The securities mentioned herein have not been registered
under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or
an applicable exemption from the registration requirements under the Securities Act and applicable state securities laws.
Item 9.01 Exhibits
(d) Exhibits
Exhibit No. |
|
Description |
99.1 |
|
Press Release |
104 |
|
Cover Page Interactive Data File, formatted in Inline XBRL |
SIGNATURE
Pursuant to the requirements
of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
|
ABVC BioPharma, Inc. |
|
|
|
August 15, 2024 |
By: |
/s/ Uttam Patil |
|
|
Uttam Patil |
|
|
Chief Executive Officer |
Exhibit 99.1
ABVC BioPharma Inc. Reports Strong Q2 2024 Financial
Results
and Strategic Achievements
| ● | Executed Global Licensing Agreements that could provide up
to $292 million in income |
| ● | Received Cash Milestone Incomes of $116,000 |
| ● | Achieved Significant Improvements in Earnings |
| ● | Obtained Multiple Patents and FDA Approvals |
Fremont, CA (August 15, 2024) – ABVC BioPharma,
Inc. (NASDAQ: ABVC), a clinical-stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology,
is pleased to announce its financial results and key operational highlights for the second quarter ended June 30, 2024.
Key Financial and Operational Highlights:
1. Significant Global Licensing Agreements:
Vitargus® Licensing: Along with our subsidiary,
BioFirst Corporation, we secured licensing agreements with ForSeeCon Eye Corporation that have the potential to provide up to a total
of $187 million in income. The agreements include total upfront payments of $60 million that can be paid in cash or shares of ForSeeCon
stock, milestone cash payments of $7.0 million and potential royalties up to $120 million after the product launches, of which there can
be no guarantee; initial $116,000 milestone payment received in June 2024. This agreement underscores our commitment to advancing innovative
therapies and enhancing shareholder value.
- Oncology Products Licensing: Along with our
subsidiary and affiliate, BioLite, Inc. and Rgene Corporation, we entered into a total of 8 licensing agreements with OncoX BioPharma,
Inc., that have the potential to provide up to an aggregate of $105 million in income. The agreements include total upfront payments of
$55,000,000 that can be paid in cash or shares of OncoX stock and royalties up to a total of $50 million after the product launches, of
which there can be no guarantee. These potential payments and relationships will further solidify our financial foundation and strategic
partnerships.
2. Financial Performance:
- Earnings Per Share (EPS): Demonstrated a remarkable
year-over-year improvement of approximately 86.8%, with EPS improving to -$0.09 in Q2 2024 from -$0.68 in the same period last year. This
significant progress reflects our successful efforts in managing operational expenses and capitalizing on milestone payment revenue from
licensing agreements.
- Revenue Growth: Revenue increased to $117,142
in Q2 2024, a substantial rise from $6,109 in Q2 2023. This growth directly results from our strategic execution of licensing agreements,
which have begun generating meaningful cash inflows.
- Shareholders' Equity: As of June 30, 2024, shareholders'
equity stood at $7.8 million, maintaining a solid financial foundation despite challenging macroeconomic conditions.
3. Strategic Partnerships and Market Positioning:
- ABVC has strategically aligned itself with promising
partners that we believe will ultimately enhance the value of ABVC's equity holdings. These partnerships are pivotal in driving shareholder
value as we believe they will help market valuations grow.
- We believe the Company is poised for significant
market capitalization growth, leveraging its pipeline accomplishments and international partnerships to bring breakthrough therapies to
market.
4. Operational and Regulatory Milestones:
- Patent and FDA Approvals: Received multiple
patents and regulatory approvals across the US, Taiwan, and Australia for treatments targeting major depressive disorder, ADHD, and ophthalmology.
These achievements highlight our continued progress in expanding our intellectual property portfolio and advancing clinical trials.
- Neurology and Oncology Advancements: Completed
Phase II trials for MDD, initiated Phase IIb trials for ADHD, and received FDA approval for multiple IND applications, positioning us
for continued growth and innovation in these critical therapeutic areas.
Management Commentary:
Dr. Uttam Patil, ABVC Chief Executive Officer,
commented, "We are thrilled with the substantial progress we have made in Q2 2024. Our financial performance and strategic licensing
agreements have enhanced our cash reserves and strengthened our position in the biopharmaceutical industry. We remain focused on advancing
our pipeline, expanding our partnerships, and driving sustainable growth for the benefit of our shareholders."
Board of Directors Statement:
"We sincerely thank our shareholders for
their continued support and confidence in ABVC. Our focus remains on advancing our licensing agreements and maximizing the value they
bring. The execution of these agreements provides us with a solid foundation for future growth and stability. We are excited about these
partnerships' prospects and are committed to driving our strategic goals forward."
Outlook:
We believe ABVC BioPharma is on a promising trajectory,
focusing on sustainable growth, innovation, and value creation through strategic partnerships. Our improving financial strength and unwavering
commitment to advancing healthcare solutions prepare us for future success. We sincerely thank our shareholders, partners, and dedicated
team for their continued support and look forward to a prosperous future.
Recent Operational Highlights
Patents and FDA Approvals
The Company received a US patent (US 16/936,032),
valid until September 04, 2040, a Taiwanese (TW I821593) Patent, valid until July 22, 2040, and an Australian (AU2021314052B2) Patent,
valid until April 09, 2041, for Polygala extract for the treatment of major depressive disorder. The Company received a US (US17/120,965),
valid until December 20, 2040, and Taiwanese (TW 110106546), valid until February 24, 2041, Patent for Polygala Extract for treating Attention
Deficit Hyperactive Disorder. A Taiwanese Patent (TW I792427) for Storage Media for the Preservation of Corneal Tissue was obtained on
February 11, 2023, and is valid till July 19, 2041. As we work towards expanding our patent map into global coverage, we eagerly await
the results of patent applications in the European Union, China, Japan, and others.
On December 30, 2022, the Company received US
FDA approval for the IND ABV-1519 to proceed with the Combination therapy for treating Advanced Inoperable or Metastatic EGFR Wild-type
Non-Small Cell Lung Cancer was approved and the study can proceed. The IND was then submitted to the Taiwan FDA, and the approval was
received on January 04, 2024. The United States Food & Drug Administration (US FDA) has approved four INDs, ABV-1501 for Triple Negative
Breast Cancer (TNBC), ABV-1519 for Non-Small Cell Lung Cancer (NSCLC), ABV-1702 for Myelodysplastic Syndrome (MDS), and ABV-1703 for Pancreatic
Cancer Therapy.
Neurology
The MDD Phase 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 five other sites in Taiwan. The trials are heading for the interim report, which we expect to
complete by the end of Q3 2024. ABV-1601 for MDD in cancer patients has completed Phase I study preparation, including the Site Initiation
Visit (SIV). The study is set to initiate by the end of 2024.
On July 31, 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, of
which there can be no guarantee. This transaction remains subject to the negotiation of definitive documents and therefore there is no
guarantee that this transaction will occur.
In November 2023, each of ABVC and one of its
subsidiaries, BioLite, Inc. ("BioLite"), entered a multi-year, global licensing agreement with AIBL for the Company and BioLite'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 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 that the parties value at $10 per share (not independently validated)
and if certain milestones are met, $3,500,000 and royalties equaling 5% of net sales, up to $100 million, which is not guaranteed.
Ophthalmology
Vitargus®, 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.
The Science 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.
Oncology/Hematology
The United States 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 wild-type non-small cell lung cancer. This treatment is being co-developed
by BioKey, Inc. ("BioKey") and by the Rgene Corporation, Taiwan. The study received approval from the Taiwan FDA. 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.
CDMO
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.
About ABVC BioPharma, Inc.
ABVC BioPharma, Inc. 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) and then out-licensing the products to international pharmaceutical companies for pivotal Phase III studies and, eventually, generating
global sales. The Company has an active pipeline of six drugs and one medical device (ABV-1701/Vitargus®) under development.
Forward-looking Statements
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 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:
Uttam Patil
Email: uttam@ambrivis.com
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