UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16
Under the Securities Exchange Act of 1934
For the Month of June 2015
001-37353
(Commission File Number)
BIONDVAX PHARMACEUTICALS LTD.
(Exact name of Registrant as specified in its charter)
14 Einstein St.
Nes Ziona
Israel 74036
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover
Form 20-F or Form 40-F.
Form 20-F R Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by
Regulation S-T Rule 101(b)(1): ____
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by
Regulation S-T Rule 101(b)(7): ____
Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes ☐ No R
If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-N/A
On June 17, 2015, BiondVax Pharmaceuticals Ltd. issued a press release announcing that its Investigational New Drug Application (IND) for its Multimeric-001 vaccine (M-001) has been accepted by the US Food and Drug Administration (FDA), and the Company was notified by its regulatory advisors that the ‘study may proceed’.
In addition, below is an English translation (from Hebrew) of an immediate report by BiondVax Pharmaceuticals Ltd. relating to the subject matter of the above referenced press release, as published on the Tel-Aviv Stock Exchange Ltd. and the Israeli Securities Authority on June 17, 2015, in accordance with the Israeli Securities Regulations.
June 17, 2015
To | To | |
Israeli Securities Authority | The Tel Aviv Stock Exchange Ltd. |
Re: Immediate Report
The Company hereby announces thatits Investigational New Drug Application (IND) for its Multimeric-001 vaccine (M-001), has been accepted by the US Food and Drug Administration (FDA), and the Company was notified by its regulatory advisors that ‘study may proceed’. FDA acceptance of an IND continues BiondVax's clinical program, and will allow BiondVax to conduct an FDA approved Phase 2 clinical trial that will involve the administration of M-001, BiondVax's product candidate.
Attached to this immediate report asAppendix A is a press release for publication in the U.S. regarding the IND acceptance.
The Company's estimations regarding the development of the Company's product candidate and/or future clinical trials are forward looking statement as defined in the Israeli Securities Act, 1968-5728, regarding possible events and developments that may not materialize, in whole or in part, as a result of certain factors that are not within the company's control and/or the materialization of the risk factors included in the Annual Report, as defined below.
For more information regarding the company's product candidate and its development stages please see Section 8 to the annual report published on ISA and TASE websites on March 26, 2015, reference number 2015-01-063070 (the "Annual Report").
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Exhibit Index
Exhibit No. | Description | |
99.1 | Press Release, dated June 17, 2015 |
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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, thereunto duly authorized.
BiondVax Pharmaceuticals Ltd. | ||
Date: June 17, 2015 | By: | /s/ Ron Babecoff |
Ron Babecoff | ||
Chief Executive Officer |
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