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): October 11, 2019 (October 10, 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: (845) 291-1291
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 October 10, 2019, American BriVision (Holding) Corporation (the “Company”) issued a press release announcing that the feasibility study results of Vitargus®, the Company’s investigational medical device, will be presented at the Retina Subspecialty Day program of the American Academy of Ophthalmology (the “AAO”) 2019 Annual Meeting on October 11, 2019.
A copy of the Press Release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K. Exhibits 99.1 shall not be deemed “filed” for purposed of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities under that Section and shall not be deemed to be incorporated into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act.
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 October 10, 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: October 11, 2019 | By: | /s/ Howard Doong |
| Name: | Howard Doong | |
| Title: | Chief Executive Officer | |
2
Exhibit 99.1
American BriVision Announces Vitargus® Presentation at Upcoming AAO 2019 Annual Meeting
GlobeNewswire• October 10, 2019
| ● | Dr. Andrew Chang, principal investigator, will present encouraging results on Vitargus® from recently completed feasibility study |
| ● | Company to initiate multi-national, multi-site pivotal study for Vitargus® in 2020, assuming sufficient funding |
FREMONT, CA, Oct. 10, 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 that feasibility study results regarding Vitargus®, its investigational medical device, will be reported during a presentation at the Retina Subspecialty Day program of the American Academy of Ophthalmology (AAO) 2019 Annual Meeting.
Dr. Andrew Chang, the principal investigator of the feasibility study, will present the results at 5:12pm PST on Friday, October 11, at the Moscone Center in San Francisco. Dr. Chang will discuss the lack of toxicity and any treatment-related serious adverse events (SAEs) in the study as well as data that demonstrate the efficacy of Vitargus® as a viable potential alternative for vitreous substitution in the surgical treatment of retinal detachment and vitreous hemorrhage. Given the encouraging study results, the Company plans to initiate a multi-national, multi-site pivotal study for Vitargus® in 2020, assuming sufficient funding.
Details of the presentation are as follows:
Title: Vitreous Substitutes Following
Vitrectomy Surgery
Presenter: Dr. Andrew Chang, MBSS, PhD – Principal Investigator
Session date/time: Friday, October 11, 2019, 5:12 p.m. PST
Session title: First-Time Results of Clinical Trials
Room: Moscone Center – WEST 3002 Room
Grand View Research estimates the global retinal surgery devices market size to be $1.56 billion in 2016, growing at a 7.8% CAGR through 2025, and driven by the growing prevalence of diabetic retinopathy, a major complication arising from diabetes. Vitargus® is an injectable hydrogel that transforms into a gel matrix in the eye after injection and upon exposure to physiological temperatures.
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.
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 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.