Full Press Release Details
Now that 2020 has ended, we believe it will be informative to
you, our shareholders, to hear about our goals for 2021. But first, we note that 2020 was an exceptional year for the company,
particularly with respect to our medical device, Vitargus , and our medicine ABV-1505, which is designed to alleviate attention-deficit
hyperactivity disorder (ADHD).
2020 2020 Vitargus ADHD ABV-1505
2020 - A Year of Accomplishment
Vitargus is the world's first bio-degradable
vitreous substitute utilized during vitrectomy surgery. Vitargus offers important advantages over current vitreous substitutes
by minimizing medical complications and reducing the need for additional surgeries. In October of 2020, we sent a full clinical
study report (CSR) of Vitargus First-in-Human Phase I Clinical Trial to the United States Food and Drug Administration. The
participants in the study showed significant improvement in visual acuity immediately following retina re-attachment surgery. Additionally,
since Vitargus is a stable semisolid gel adhering to the retina during surgery, patients do not need to remain face-down after
surgery, which provides a significant improvement to patients' post-surgical comfort. Vitargus addresses a large and
growing market according to Grand View Research, with worldwide vitrectomy cases expected to increase from 1.26 million in 2012
to 4 million by 2030 (6.8% CAGR), reaching a $2 billion market value.
2020 10 (FDA) Vitargus CSR Vitargus Grand
View Research Vitargus 2012 126 2030 400 6.8 20
Equally as exciting, a successful Phase II, Part 1 Clinical
Trial of ABV 1505 was completed at the University of California, San Francisco (UCSF) Medical Center and a clinical study report
(CSR) was issued this past November. ABV-1505 targets adult attention deficit disorder and has the same active pharmaceutical ingredient,
PDC-1421, used in ABV-1504, one of our drugs that successfully completed a Phase II clinical study conducted at Stanford University
to treat major depression disorder (MDD) in 2019.
In July of 2020, we filed for a patent for certain aspects
of ABV-1504 in the United States under the Patent Cooperation Treaty (PCT); this treaty
has legal effect in other countries. We believe that the patent, when granted, will greatly enhance our existing portfolio
of PDC-1421 related patents and strengthen our global IP position. PDC-1421, the active ingredient in ABV-1504 and ABV-1505, is
an extract of Polygala tenuifolia, a plant grown primarily in China.
ABV-1505 ABV-1504 PDC-1421 ABV-1504 2019 MDD II
PDC-1421 PDC-1421 ABV-1504
ABV-2002 - Corneal Storage Solution
On November 4, 2020, we executed an amendment to our development
collaboration agreement with BioFirst, an affiliate, to add a Corneal Storage Solution and an Intraocular Irrigation Solution to
the agreement. The Corneal Storage Solution is utilized during a corneal transplant procedure to replace a damaged or diseased
cornea. The Intraocular Irrigation Solution has broader utilization and is used during a variety of ocular procedures.
Initially, ABVC will focus on the Corneal Storage Solution,
designated ABV-2002 under ABVC's product identification system. A donor cornea is stored in the ABV-2002 solution prior to
penetrating keratoplasty (full thickness cornea transplant) or endothelial keratoplasty (back layer cornea transplant). Early testing
indicates that ABV-2002 may be more effective at protecting the cornea during long-term storage than other storage media currently
available and can be manufactured at lower cost.
ABVC ABV-2002 ABV-2002
Finally, 2020 was a year that set the stage for a potential
listing on NASDAQ, an elusive goal we have been pursuing for over a year. To reach this goal and fund our clinical trials, we improved
our balance sheet during the year by raising more than $8.0 million of fresh equity and converting more than $4.0 million of debt
to equity. We are pleased that both new and previous investors stepped up to assure that we have the resources to continue the
execution of our business plan.
In addition, on December 28, 2020
an S-1 registration statement to register more than 4 million shares already owned by our shareholders was declared effective by
the US Securities & Exchange Commission. This will increase the number of shares in our outstanding share float which we believe
will result in an increase in the liquidity of our stock trading.
2021 - The Year Ahead
During the first quarter of 2021, we anticipate receiving
approval from the Australia Therapeutic Goods Administration (TGA) to proceed with the pivotal clinical trial for Vitargus .
Since one or more of the potential pharmaceutical partners for the distribution of this medical device will be funding the pivotal
trial, receipt of this approval will be a key milestone leading to a distribution and manufacturing agreement. Any such agreement
will bring the first significant revenue generated from our pipeline of drugs and medical devices.
Also, during the first half of 2021, we hope to execute
a licensing agreement with a Chinese pharmaceutical company for China distribution of our Corneal Storage Solution, ABV-2002. This
agreement, if finalized, will require the Chinese partner to (a) obtain China FDA approval for marketing in China, at their expense
and (b) pay milestone payments to ABVC beginning in the first or second quarter of 2021. Further, we intend to submit a Premarket
Notification 510(K) submission to the United States and Taiwan FDAs before the end of 2021 to demonstrate that ABV-2002 is at least
as safe and effective as current products on the market.
2021 TGA Vitargus Vitargus
ABV-2002 a FDA b 2021 ABVC 2021 FDA 510 K - ABV-2002
ABV-1504, 1505 and 1601
In the first quarter of 2021, we
will initiate an ABV-1601 Phase II Part 1 clinical trial for the treatment of major depression disorder in cancer patients at Cedars-Sinai
Medical Center in Los Angeles, California. The clinical study report (CSR) should be finalized at the year end. In the second quarter
of 2021, we plan to initiate a Phase II, Part 2 clinical trial of ABV-1505 for ADHD. The CSRs of ABV-1504 Phase II for MDD, ABV-1601
Phase II for MDD for cancer patients and ABV-1505 Phase II for ADHD will enable us to have further discussions with major pharmaceutical
companies about funding Phase III clinical trials and distribution. We believe that ABV-1504, ABV-1505 and ABV-1601 have the potential
to be significant new entries in the market to alleviate depression and attention deficit hyperactivity disorders since they both
offer alternative treatments with more promising outcomes and fewer serious adverse side effects than the current standard of care.
Traditional antidepressants, such as SSRI's, MAO inhibitors and TCA's have been used in the treatment of depression over the last
few decades, although none are ubiquitous in efficacy, and each have their own share of adverse side effects. SSRI's for example
can result in anxiety, sleep disruption and weight gain alongside gastrointestinal events. Our active ingredient PDC-1421, in comparison,
has less adverse side effects.
2021 Cedars-Sinai ABV-1601
ADHD II 2 ABV-1504 ( )
ABV-1505 ( ) ABV-1601( ) II III ABV-1504
ABV-1505 ABV-1601 SSRI's MAO TCA's SSRI PDC-1421
Based upon our discussions with potential partners for the
manufacture and distribution of ABV-1504, ABV-1505 and ABV-1601, we believe it is important to demonstrate a secure and consistent
source of the plant material, Polygala tenuifolia, from which the active ingredient for these medicines is derived. As a
result, much of our focus in 2021 will be directed toward establishing a supply chain for this plant material (and other medicinal
plants) from both China and a western country, such as Canada.
ABV-1504 ABV-1505 ABV-1601
In the second half of 2021, we will start an ABV-1703 Phase
II Part 1clinical trial of Maitake BLEX404 oral liquid drug for the treatment of metastatic pancreatic cancer and biliary tract
cancer at Cedars-Sinai Medical Center in Los Angeles, California. If Part 1 is successful, the second part of Phase II will be
conducted as a multi-nation, multi-site study including at least one major medical center in Taiwan.
2021 Cedars-Sinai ABV-1703 II 1
In 2019, we completed our acquisition of BioKey, Inc., located
in Fremont, California. BioKey is a valuable addition to ABVC that provides Contract Development & Manufacturing Organization services
to discovery biotechnology companies engaged in clinical trials of various drugs. Its GMP manufacturing facility can produce short
runs of capsules, tablets or solutions needed for clinical trials. In 2020, BioKey suffered revenue losses of approximately $500,000,
so our main goal for 2021 is to bring the business to profitability. To reach that goal, we appointed Dr. Richard King as BioKey's
CEO to lead the turnaround of this subsidiary; he will continue to engage in his role as the Chief Science Officer of ABVC.
- BioKey Fremont ABVC BioKey
2020 BioKey 500,000 2021
Richard King BioKey BioKey ABVC