UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 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): December 5, 2019
AMERICAN BRIVISION (HOLDING) CORPORATION
(Exact name of registrant as specified in its charter)
| Nevada | 333-91436 | 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
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 (see General Instruction A.2. below):
| ☐ | 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) |
Indicate by check mark whether the registrant is an emerging growth company 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. ☐
Securities registered pursuant to Section 12(b) of the Act: None
Item 7.01 Regulation FD Disclosure
On December 5, 2019, American BriVision (Holding) Corporation (the “Company”) issued a press release (the “Press Release”) announcing that it initiated the Phase II Part I clinical trial for ABV-1505 for adult attention-deficit hyperactivity disorder at the University of California, San Francisco Medical Center.
A copy of the Press Release is being furnished as Exhibit 99.1 to this current report on Form 8-K. The information contained in this Current Report on Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”) or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing. The furnishing of the information in this Current Report on Form 8-K is not intended to, and does not, constitute a representation that such furnishing is required by Regulation FD or that the information contained in this Current Report on Form 8-K constitutes material investor information that is not otherwise publicly available.
This Current Report on Form 8-K and exhibits may contain these types of statements, which are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, and which involve risks, uncertainties and reflect the Registrant’s judgment as of the date of this Current Report on Form 8-K. Forward-looking statements may relate to, among other things, operating results and are indicated by words or phrases such as “expects,” “should,” “will,” and similar words or phrases. These statements are subject to inherent uncertainties and risks that could cause actual results to differ materially from those anticipated at the date of this Current Report on Form 8-K. The Company disclaims any obligation to, and will not, update any forward-looking statements to reflect events or circumstances after the date hereof. Investors are cautioned not to rely unduly on forward-looking statements when evaluating the information presented within.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
The following exhibit is furnished herewith:
| Exhibit Number |
Description | |
| 99.1 | Press Release dated December 5, 2019 |
1
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| AMERICAN BRIVISION (HOLDING) CORPORATION | ||
| Date: December 6, 2019 | By: | /s/ Howard Doong |
| Name: | Howard Doong | |
| Title: | Chief Executive Officer | |
2
Exhibit 99.1
American BriVision Initiates Phase II Part I Clinical Trial for ABV-1505 in Adult Attention-Deficit Hyperactivity Disorder (ADHD)
GlobeNewswire December 5, 2019
| ● | PDC-1421, the active ingredient of ABV-1505, is being expanded into adult ADHD trials following encouraging Phase II trial results in major depressive disorder (MDD) |
| ● | Phase II Part I trial of ABV-1505 to be conducted at the University of California, San Francisco (UCSF) Medical Center |
| ● | Phase II Part II trial of ABV-1505 is expected to follow Part I and be conducted at UCSF and major medical centers in Taiwan |
FREMONT, CA, Dec. 05, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- American BriVision (Holding) Corporation (ABVC) (the “Company”), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced the initiation of a new ABV-1505 Phase II Part I clinical trial, under the U.S. Food and Drug Administration (FDA) clinical protocol code BLI-1008-001, for adult attention-deficit hyperactivity disorder (ADHD). The new study will be conducted at the University of California San Francisco (UCSF) Medical Center.
This trial is an open label, single-center, dose escalation study to be conducted in six adult ADHD patients. Each patient will receive a low-dose treatment (380 mg) of ABV-1505 thrice daily for 28 days followed by a high-dose treatment (760 mg) thrice daily for another 28 days. PDC-1421, the active pharmaceutical ingredient of ABV-1505 and ABV-1504, has been successfully evaluated in a recently completed Phase II study for major depressive disorder (MDD) conducted at Stanford University and five major medical centers in Taiwan.
The primary objective of this study is to determine the effective doses and treatment period of PDC-1421 in adult patients with ADHD. The secondary objective is to evaluate the safety of PDC-1421 in patents receiving the drug at various dose levels. A Phase II Part II study is expected to follow at the UCSF Medical Center, along with major medical centers in Taiwan, after and assuming successful completion of this Phase II Part I study.
“Following the Phase II clinical study of ABV-1504 for the treatment of MDD patients taken from trials completed at Stanford University and five major medical centers in Taiwan, we are initiating this new clinical study with ABV-1505 for the treatment of adult ADHD patients at UCSF Medical Center in order to expand PDC-1421’s therapeutic indication,” said Dr. Howard Doong, Chief Executive Officer of the Company. “We are excited to see if the same mechanism of action that has benefited MDD patients in our trials thus far has therapeutic benefits in adult ADHD patients as well.”
According to Grand View Research, the global ADHD market size was valued at $16.4 billion in 2018 and is estimated to exhibit a CAGR of 6.4% through 2025, driven by worldwide drug product approvals and launches and increased research and development activities.
About American BriVision
American BriVision 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). The company has an active pipeline of six drugs and one medical device (ABV-1701/Vitargus®) under development.
Disclaimer
Clinical trials are in early stages and there is no guarantee that any specific outcome will be achieved. Past performance is not indicative of future results. Investments may be speculative and illiquid, and there is a risk of loss.
CAUTIONARY STATEMENT CONCERNING FORWARD LOOKING STATEMENTS
This document contains forward-looking statements. In addition, from time to time, we or our representatives may make forward-looking statements orally or in writing. We base these forward-looking statements on our expectations and projections about future events, which we derive from the information currently available to us. Such forward-looking statements relate to future events or our future performance, including: our financial performance and projections; our growth in revenue and earnings; and our business prospects and opportunities. You can identify forward-looking statements by those that are not historical in nature, particularly those that use terminology such as “may,” “should,” “expects,” “anticipates,” “contemplates,” “estimates,” “believes,” “plans,” “projected,” “predicts,” “potential,” or “hopes” or the negative of these or similar terms. In evaluating these forward-looking statements, you should consider various factors, including: our ability to change the direction of the Company; our ability to keep pace with new technology and changing market needs; our having adequate funding to conduct our clinical trials; and the competitive environment of our business. These and other factors may cause our actual results to differ materially from any forward-looking statement. Forward-looking statements are only predictions. The forward-looking events discussed in this document and other statements made from time to time by us or our representatives, may not occur, and actual events and results may differ materially and are subject to risks, uncertainties and assumptions about us. We are not obligated to publicly update or revise any forward-looking statement, whether as a result of uncertainties and assumptions, the forward-looking events discussed in this document, and other statements made from time to time by us or our representatives that might occur.
Contact:
Andy An – Chief Financial Officer
765-610-8826
andyan@ambrivis.com