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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