Full Press Release Details
As the ABVC team works
diligently to have our shares uplisted and trading on a senior exchange as soon as possible,
we would like to take this opportunity to review our progress to date:
Recently there were two news releases about ABVC. The first one,
released on April 13, 2020, announced execution of agreements for two financing transactions. Completion of these financings would
strengthen our balance sheet, improve working capital and reduce company debt (see Appendix 1). The second one, released on May
21, 2020, announced the increased size of our private placement from the initial $1,000,000 USD to $2,000,000 USD. This was done
in response to greater demand; and, as a result, the company will now raise a total of approximately $2,000,000 (see Appendix 2).
2020 5 21 1,000,000 2,000,000
Currently, we have six new drugs and one medical device in the product
pipeline. In this update, we will focus on the latest developments for three of them:
A First-in-Human clinical study of Vitargus (ABV-1701) was successfully
completed with positive results in July 2018 at Sydney (Australia) Retina Clinic and Day Surgery. The feasibility study results
were reported by Dr. Andrew Chang, the Principal Investigator, at the Retina Subspecialty Day program of the American Academy of
Ophthalmology (AAO) 2019 Annual Meeting.
ABV-1701 2018 7 Andrew
We are now planning for the pivotal study and the steps necessary
to obtain premarket approval for this device. The pivotal study for ABV-1701 is designed to be a multi-nation and multi-site clinical
trial involving several countries, including Australia, USA, Japan, Thailand, Taiwan, and People's Republic of China. Business
negotiations for establishing global and regional licensing partners are in progress.
A Phase II clinical study for the treatment of major depressive
disorder (MDD) was successfully completed in Q2 2019. The study was conducted by Stanford University and five major medical centers
in Taiwan with a total enrollment of 72 patients. A full clinical study report (CSR) was submitted to the US FDA on December 5,
2019 and Taiwan TFDA on April 22, 2020 after revision approval.
MDD II 2019 72 CSR 2019 12 5 FDA 2020 4 22 TFDA
We are now planning for an End-of-Phase II Type C meeting with the
US FDA to review further clinical development requirements. Negotiations for establishing global and regional licensing partners
A Phase II Part I clinical study for the treatment of Adult Attention
Deficit Hyperactivity Disorder ("ADHD") was initiated at University of California at San Francisco on September 20,
2019. Currently, 66% of planned subject enrollment has been achieved. The estimated timeline for completing the in-live study is
by the end of Q3 2020. Upon completion of the Phase II Part I study, we will initiate a multi-nation, multi-center clinical study
2019 9 20 "ADHD" II I 66 2020 II I II II
We deeply appreciate your
continued trust and support as we continue to focus on commercializing Vitargus and these promising drugs and getting ABVC shares
uplisted to a senior exchange, (e.g., NASDAQ or NYSE) as soon as possible. Going forward,
we will continue to update you on the company's developments as they occur. Also, the updates will be bilingual in both
English and Traditional Chinese to let all ABVC investors understand the content more easily.
ABVC Management. Team