Scinai Immunotherapeutics Ltd 6-K, filed Aug 17, 2020

UNITEDSTATES

SECURITIESAND EXCHANGE COMMISSION

Washington,D.C. 20549

FORM6-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 August 2020

Commission File Number: 001-37353

BIONDVAXPHARMACEUTICALS LTD.

(Translation of registrant’s name into English)

JerusalemBioPark, 2nd Floor

HadassahEin Kerem Campus

Jeusalem,Israel

(Address of principal executive office)

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 ☒     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): ____

On August 13, 2020, BiondVax Pharmaceuticals Ltd. issued a press release announcing a Notice of Annual General Meeting of Shareholders and providing a clinical trial update.

Exhibit Index

This Report on Form 6-K is hereby incorporated by reference into the Company’s Registration Statement on Form F-3 (Registration No. 333-240189) and its Registration Statement on Form S-8 (Registration No. 333-239344).

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, thereunto duly authorized.

2

Exhibit 99.1

BiondVax Announces Notice of Annual GeneralMeeting of Shareholders and Provides a Clinical Trial Update

Jerusalem, Israel – August 13, 2020 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), developer of the Phase 3 clinical trial M-001 universal influenza vaccine candidate, today announced that the Annual General Meeting of Shareholders of the Company will be held on September 2, 2020 in Tel Aviv, Israel. Details, including a link to the Proxy Statement and voting card, are available on the SEC website at https://www.sec.gov/Archives/edgar/data/1611747/000121390020020357/ea125062-6k_biondvaxpharma.htm. Shareholders are invited to contact their broker for voting procedures. Note that votes must be received prior to the deadline noted on the proxy.

Clinical trial update: BiondVax currently anticipates announcing results from the pivotal Phase 3 clinical trial in late September to the end of October this year based on the schedule of current operational activities. However, there are no assurances that this timetable will be met in the event that we encounter any delays.

About BiondVax

BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect. In a total of seven completed Phase 1/2 and Phase 2 clinical trials enrolling 818 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3 clinical trial aims to assess safety and effectiveness of M-001 in reducing flu illness and severity. For more information, please visit www.biondvax.com.

Contact Details

Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com

Forward Looking Statements

Thispress release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as“expect,” “believe,” “intend,” “plan,” “continue,” “may,”“will,” “anticipate,” and similar expressions are intended to identify forward-looking statements. Theseforward-looking statements reflect the management’s current views with respect to certain current and future events and aresubject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected bythe management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include, but are not limited to, risks relating to theCOVID-19 (coronavirus) pandemic, including a risk of delay in the availability of the top line results from our pivotal clinicalefficacy Phase 3 trial for M-001, the prosecution, timing and results of the ongoing Phase 2 and Phase 3 trials and any subsequenttrials; timing of receipt of regulatory approval of our manufacturing facility in Jerusalem; ability to demonstrate the efficacyand safety of the vaccine; the timing of clinical trials and marketing approvals; the risk that drug development involves a lengthyand expensive process with uncertain outcome; the ability of the Company to maintain, preserve and defend its intellectual propertyand patents granted; whether our vaccine candidate will successfully advance through the clinical trial process on a timely basis,or at all, and receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; the adequacyof available cash resources and the ability to raise additional capital when needed. More detailed information about the risksand uncertainties affecting the Company is contained under the heading “Risk Factors” in our Annual Report on Form20-F for the year ended December 31, 2019 filed with the U.S. Securities and Exchange Commission, or SEC, which is available onthe SEC’s website, www.sec.gov. We undertake no obligation to revise or update any forward-looking statement for any reason.