via NewMediaWire - ABVC BioPharma, Inc. (NASDAQ: ABVC)
("Company"), a clinical-stage biopharmaceutical company developing
therapeutic solutions in ophthalmology, neurology, and
oncology/hematology, today published a Corporate Update and
Letter to Shareholders from recently appointed Chief Executive
Officer, Dr. Uttam Patil.
Dear Fellow Shareholders,
As we move into the second half of 2023, I am delighted to speak
about ABVC's recent developments and plans. Over the past few
months, ABVC has undergone a significant transformation. Moving
beyond our recently announced leadership changes, I would like to
take this opportunity to update you on the status of this
transformation, with a focus on the progress of our diverse
pipeline in clinical trials.
We have completed controlled-release tablet formulation
development for PDC-1421, the primary active ingredient in our
neurological programs. Our studies show that the controlled-release
formulation enables the active ingredient to be absorbed slower
over time compared to conventional tablet formulations, thereby
reducing the dosage frequency from TID to BID and increasing the
bioavailability. We are also excited about our major depressive
disorder (MDD) and adult attention-deficit/hyperactivity disorder
(ADHD) trials, which, if successful, will take us closer to Phase
III trials for those products and drive our multi-product biopharma
company forward.
Ophthalmology
Vitargus®, a vitreous substitute, is a groundbreaking,
advanced-staged R&D product that we believe will be the first
biodegradable hydrogel product 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 phase of the trial 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.
According to iHealthcare Analyst, Inc., the global market for
retinal surgery devices is expected to reach $4.3 billion by 2029,
at a CAGR of 7.7%, driven, in part, by the rising geriatric
population worldwide[1].
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 II 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). 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.
As per the Future Market Insights report, the MDD market was
valued at $11.51 billion in 2022 and is expected to reach $14.96
billion by 2032 with a CAGR of 2.8% over the forecast period[2].
According to the Polaris market research report, the global ADHD
treatment market was valued at $16.13 billion in 2022 and is
expected to reach $32.14 billion by 2030 with a CAGR of 7.1% over
the forecast period[3].
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-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.
Straits Research reports that the global botanical drug market
size was valued at $163 million in 2021 and is expected to be
valued at $3.2 billion. The market is expected to grow at a CAGR of
39% during the forecast period (2022–2030)[4].
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. We also established BioKey (Cayman),
Inc. to attract strategic investors to aid BioKey in getting listed
on the Taiwan Stock Exchange.
According to a report by Vantage Market Research, the global
Dietary Supplements Market was valued at $152.3 billion in 2022 and
is projected to reach $269.5 billion by 2030, with a compound
annual growth rate (CAGR) of 8.5% over the forecast period[5]. The
global pharmaceutical CDMO market size was valued at $94.17 billion
in 2022 and will expand to reach $172.0 billion by 2032 with a CAGR
of 6.2% from 2023 to 2032[6].
Strategic Investments
ABVC contemplates a planned acquisition of real estate assets
via an equity transfer, estimated at $7.4 million, all to advance
the development of a large-scale health and wellness base in
Chengdu, China, through a proposed partnership with Zhonghui United
Technology (Zhonghui) Group Co., Ltd. and its affiliated
enterprises. The anticipated partnership aims to establish an
integrated platform to facilitate collaborations between
researchers and industry leaders. ABVC intends to transfer common
shares to Zhonghui at $20 per share in consideration for a 20%
ownership of Zhonghui's property, estimated at $37 million by a
third-party valuation company, and another piece of land Zhonghui
currently owns in that same area.
On July 27, 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 share.
Our Team, Our Strength
At ABVC, we firmly believe that our success has been on the
shoulders of our employees. Recently, a new young team has stepped
into the veterans' shoes. The new team brings with them expertise
from major international financial firms, making them an invaluable
addition to our management team.
Advancement
So far, our portfolio of diverse product pipelines and resilient
business models have laid a strong foundation for us to enter a new
chapter of growth. Thanks to our team's constant dedication and
unwavering commitment, we are working hard to enter new markets,
grow our revenue streams, and deliver long-term value for our
shareholders. I am proud to provide this summary of our
accomplishments to date, and I am confident we will have more
exciting news to share at the end of 2023.
Sincerely,
Uttam Patil, Ph.D.
Chief Executive Officer, ABVC BioPharma
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
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 any of the Company's securities,
nor shall such securities be offered or sold in the United States
absent registration or an applicable exemption from registration,
nor shall there be any offer, solicitation or sale of any of the
Company's 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 such state or
jurisdiction.
Contact:
Tom Masterson
Email: tmasterson@allelecomms.com
[1] https://www.ihealthcareanalyst.com/technological-advancement-ophthalmic-surgery-retinal-surgery-devices-market/
[2] https://www.futuremarketinsights.com/reports/major-depressive-disorder-treatment-market#:~:text=The%20major%20depressive%20disorder%20(MDD,US%24%2011.51%20billion%20in%202022
[3] https://www.prnewswire.com/news-releases/global-attention-deficit-hyperactivity-disorder-adhd-market-size-projected-to-reach-usd-32-14-billion-by-2032--with-cagr-of-7-1-study-by-polaris-market-research-301729196.html#:~:text=According%20to%20the%20research%20report,Deficit%20Hyperactivity%20Disorder%20(ADHD)%3F
[4] https://straitsresearch.com/report/botanical-drugs-market
[5]https://www.vantagemarketresearch.com/industry-report/dietary-supplements-market-2031
[6] https://www.globenewswire.com/en/news-release/2023/06/07/2683991/0/en/Pharmaceutical-CDMO-Market-Size-Will-Expand-to-USD-172-02-BN-by-2032.html
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