6-K

Scinai Immunotherapeutics Ltd. (SCNI)

6-K 2023-08-01 For: 2023-08-01
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Added on April 09, 2026

UNITED STATES

SECURITIES AND EXCHANGECOMMISSION

Washington D.C. 20549

Form 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE13A-16 OR 15D-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of August 2023

Commission File Number: 001-37353

BIONDVAX PHARMACEUTICALS LTD.

(Translation of registrant’s name into English)

Jerusalem BioPark, 2nd Floor

Hadassah Ein Kerem Campus

Jerusalem, Israel

(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 ☒ Form 40-F ☐

Item 7.01 Regulation FD Disclosure.

On August 1, 2023, BiondVax Pharmaceuticals Ltd. (the “Company”) issued a press release announcing that Nasdaq reviewed the Company’s plan to regain compliance with Nasdaq’s Listing Rule 5550(b) and has granted the Company an extension until October 31, 2023, to demonstrate that the Company has regained compliance. A copy of the press release is attached hereto as Exhibit 99.1.

Item 9.01. FinancialStatements and Exhibits.

(d) Exhibits.


Exhibit No. Description
99.1 Press Release, dated August 1, 2023.

SIGNATURE

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.
By: /s/ Amir Reichman
Amir Reichman<br>Chief Executive Officer

August 1, 2023

Exhibit 99.1

Nasdaq GrantsBiondVax Extension to Regain Compliance with Listing Rules

Jerusalem, Israel – Aug. 1, 2023 -- via IBN --BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biotechnology company focused on developing, manufacturing, and commercializing innovative immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases, today announced that Nasdaq reviewed BiondVax’s multi-faceted plan to regain compliance with Nasdaq’s Listing Rule 5550(b) and provided it an extension until October 30, 2023, to demonstrate compliance.

As previously disclosed, BiondVax received a deficiency letter dated May 1, 2023, from Nasdaq notifying the Company that it is not in compliance with the minimum stockholders’ equity requirement for continued listing on the Nasdaq Capital Market.

“We are very pleased that NASDAQ has reviewed our plan and provided us the time to proceed with various initiatives already underway that alone or together will allow us to regain compliance with the shareholders’ equity listing requirement,” said Mr. Amir Reichman, BiondVax’s CEO. “Among other things we are pursuing a strategic partnership for our COVID-19 self-administered inhaled therapeutic/prophylactic product and advancing ahead of schedule our IL-17 NanoAb inhibitor for the treatment of autoimmune diseases such as psoriasis. This is expected to enter the clinic in 2024.”

“In addition, we decided to leverage our state-of-the-art biologics pilot manufacturing plant by commencing a new contract manufacturing and development services business unit (CDMO),” Reichman continued. “The need for CDMO services by small biotech companies is high and growing and the current offerings by large, multi-national CDMO companies are expensive and with limited available capacity. Our site is a perfect match for a small biotech in that it is well equipped, staffed with highly trained personnel, and its business and quality processes are in place. We see quite a lot of demand for our services and are aggressively pursuing clients. If successful, this business unit could generate meaningful income in the relatively short term.”

BiondVax has provided Nasdaq with its business plan, which includes the pursuit of several non-dilutive grants, potential capital-raising transactions, and development of the company’s new CDMO business. Based on BiondVax’s plans, Nasdaq has provided an extension of time until October 30, 2023, for the company to demonstrate it has regained compliance. In the event the Company fails to show compliance upon filing its annual report on Form 20-F for the year ended December 31, 2023, it may receive notification from Nasdaq that its securities will be delisted; should this occur, the Company may appeal Nasdaq’s determination to a Hearings Panel.

About BiondVax


BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biotechnology company focused on developing, manufacturing, and commercializing innovative immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases. Since its inception, the company has executed eight clinical trials including a seven-country, 12,400-participant Phase 3 trial of its vaccine candidate and has built a state-of-the-art manufacturing facility for biopharmaceutical products. With highly experienced pharmaceutical industry leadership, BiondVax is aiming to develop a pipeline of diversified and commercially viable products and platforms beginning with an innovative nanosized antibody (NanoAb) pipeline. www.biondvax.com.

Company Contact Details


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



Forward Looking Statements


This press release contains forward-looking statementswithin 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 intendedto identify forward-looking statements. All statements, other than statements of historical facts, included in this press release regardingstrategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives of managementare forward-looking statements. These forward-looking statements reflect management's current views with respect to certain current andfuture events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from thoseexpected by the management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include, but are not limited to, the risk that BiondVaxmay not be able to secure additional capital on attractive terms, if at all; the risk that the therapeutic and commercial potential ofNanoAbs will not be met; the risk of a delay in the preclinical and clinical trials data for NanoAbs, if any; the risk that our businessstrategy may not be successful; the risk that the European Investment Bank (EIB) may accelerate the loans under its finance contract withBiondVax; risks relating to the SARS-CoV-2 (COVID-19) virus; BiondVax's ability to acquire rights to additional product opportunities;BiondVax's ability to enter into collaborations on terms acceptable to BiondVax or at all; timing of receipt of regulatory approval ofBiondVax's manufacturing facility in Jerusalem, if at all or when required; the risk that the manufacturing facility will not be ableto be used for a wide variety of applications and other vaccine and treatment technologies; and the risk that drug development involvesa lengthy and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Companyis contained under the heading "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and ExchangeCommission on April 17, 2023. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.

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