Scinai Immunotherapeutics Ltd 6-K, filed Jul 1, 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 July 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 July 1, 2020, BiondVax Pharmaceuticals Ltd. issued a press release announcing that the last of 12,400 participants completes final visit in BiondVax’s M-001 universal flu vaccine pivotal Phase 3 clinical trial.

Exhibit Index

This Report on Form 6-K is hereby incorporated by reference into the Company’s 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

Last of 12,400 Participants CompletesFinal Visit in BiondVax’s M-001 Universal Flu Vaccine Pivotal Phase 3 Clinical Trial

Jerusalem, Israel – July 1, 2020 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) today announced that all participants in the placebo-controlled, blinded, pivotal, clinical efficacy, Phase 3 trial of BiondVax’s M-001 universal influenza vaccine candidate have now completed their site visits. In total, over 12,400 volunteers aged 50+ (with half aged 65+) were enrolled in the trial over the past two flu seasons in 83 sites across seven European countries. The purpose of the study is to assess M-001’s ability as a standalone non-adjuvanted vaccine to provide clinical protection from circulating influenza strains as measured by reduction of influenza illness rate (as a primary endpoint) and severity (as a secondary endpoint), as well as to assess M-001’s safety.

Seasonal influenza annually infects approximately 10-20% of the world’s population^1^ resulting in up to about five million cases of severe illness and 650,000 deaths.^2^ In addition, pandemic influenza, such as the H1N1 Swine Flu pandemic of 2009, is a constant global threat. However, current influenza vaccines, which target frequently mutating parts of the flu virus and therefore must be updated annually in the hope they will match the next flu season’s circulating strains, achieve on average only about 40% vaccine effectiveness in the general population^3^ and as low as 12% in older adults.^4^

BiondVax’s M-001 is a single recombinant protein of highly conserved influenza epitopes. Consequently:

Dr.Tamar Ben-Yedida, BiondVax’s Chief Scientist, commented, “We are pleased that despite the ongoing COVID-19 pandemic,and the challenge of conducting the trial across 83 sites and seven countries, thanks to all the people involved – includingthe CRO, investigators, and thousands of participants – we have maintained the planned timelines of our pivotal Phase 3 trial.In light of the ongoing COVID-19 pandemic, the need for improved influenza vaccines has arguably never been clearer. To betterprotect lives and economies, influenza vaccines must be more effective in reducing illness rates and severity. Needless to say,we are eagerly anticipating results of our trial by the end of this year.”

Participants in the trial’s second cohort were enrolled prior to the 2019/20 flu season and monitored for influenza-like illness (ILI) symptoms throughout the flu season. Swabs samples were collected from those participants with ILI, and influenza confirmation is currently being conducted by a qualified laboratory. Analysis will continue in the coming months, and results are expected by the end of 2020.

As part of this Phase 3 study, cell-mediated immunogenicity markers of M-001 will be evaluated in a subset of participants. The recently completed clinical study report (CSR) of a U.S. National Institute of Allergy and Infectious Diseases (NIAID) supported Phase 2 clinical trial of M-001 concluded that, “M-001 induced significant polyfunctional T cell responses.”

In addition to the ongoing pivotal, clinical efficacy, Phase 3 trial, equipment installation and manufacturing process scale-up in BiondVax’s pilot facility in Jerusalem are in progress. The facility has planned annual capacity of up to between 10 and 20 million doses in bulk.

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.