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 July 2024
Commission File Number: 001-37353
SCINAI IMMUNOTHERAPEUTICS LTD.
(Translation of registrant’s name into English)
Jerusalem BioPark, 2nd Floor
Hadassah Ein Kerem Campus
Jerusalem, 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 ☐
On July 3, 2024, Scinai Immunotherapeutics
Ltd. issued a press release announcing the extension granted by the Nasdaq Hearing Panel to the registrant to regain compliance with the
continued listing requirements.
A copy of the press release is
furnished herewith as Exhibit 99.1.
This
Report on Form 6-K is hereby incorporated by reference into the registrant’s Registration Statements on Form S-8 (File No.
333-271293 and File No.
333-239344) and Form F-3 (File No. 333-274078 and File No. 333-276767), to be a part thereof from the date on which this report
is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.
Exhibit Index
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.
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Scinai Immunotherapeutics Ltd. |
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Date: July 8, 2024 |
By: |
/s/ Amir Reichman |
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Amir Reichman |
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Chief Executive Officer |
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Exhibit 99.1
Scinai Immunotherapeutics Granted Extension
by Nasdaq Hearing Panel to Regain Compliance with Continued Listing Requirements
JERUSALEM, July
3, 2024 – Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) (the “Company”), a biotechnology company focused
on developing inflammation and immunology (I&I) biological products and on providing CDMO services through its Scinai Bioservices
business unit, today announced that it has received notice from the Nasdaq Hearings Panel (the “Hearings Panel”) of The Nasdaq
Stock Market LLC (“Nasdaq”) that the Hearings Panel has determined to grant the Company’s request to continue its listing
on The Nasdaq Stock Market, subject to the Company meeting certain conditions, including filing on or before August 14, 2024, a public
disclosure demonstrating compliance with the Equity Requirement (defined below).
As previously disclosed, on May 20, 2024, the
Company received a staff determination letter from the Listing Qualifications Department (the “Staff”) of Nasdaq notifying
the Company that it is not in compliance with the minimum stockholders’ equity requirement for continued listing on the Nasdaq Capital
Market. Nasdaq Listing Rule 5550(b)(1) requires companies listed on the Nasdaq Capital Market to maintain stockholders’ equity of
at least $2,500,000 (the “Equity Requirement”). The letter from the Staff noted that the Company does not currently meet the
alternative quantitative standards for continued listing on the Nasdaq Capital Market of either market value of listed securities or net
income from continuing operations. The Company also announced that it had scheduled a hearing for June 18th before an independent
Nasdaq Hearings Panel
At the June 18th hearing the Company
presented its views with respect to the stockholders’ equity deficiency, including presenting a plan to address the Equity Requirement
matter by converting a significant portion of the loan owed by the Company the European Investment Bank (the “EIB”) into equity.
The notice received by the Company from the Staff stated that based on the plan presented the Staff determined to grant the extension
for continued listing through August 14th to provide the Company with the opportunity to regain compliance.
Notwithstanding the foregoing, there can be no
assurance that the Company will be able to meet the deadlines or conditions imposed by the Hearings Panel or regain compliance with all
applicable requirements for continued listing.
About Scinai Immunotherapeutics
Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI)
is a biopharmaceutical company with two complementary business units, one focused on in-house development of inflammation and immunology
(I&I) biological therapeutic products beginning with an innovative, de-risked pipeline of nanosized VHH antibodies (NanoAbs) targeting
diseases with large unmet medical needs, and the other a boutique CDMO providing biological drug development, analytical methods development,
clinical cGMP manufacturing, and pre-clinical and clinical trial design and execution services for early stage biotech drug development
projects.
Company website: www.scinai.com.
Company Contacts
Investor Relations | +972 8 930 2529 | ir@scinai.com
Business Development | +972 8 930 2529 | bd@scinai.com
Forward-Looking Statements
This press 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. All statements, other than statements of historical facts, are forward-looking statements. Examples
of such statements include, but are not limited to, execution of a binding term sheet providing for revised terms of the Finance Contract
with EIB, the accounting impact of execution of such revised terms and the ability of the Company to regain and remain compliant with
the continued listing standards of Nasdaq, the potential of Scinai’s NanoAb program, expected revenues of Scinai’s CDMO business
and timing of pre-clinical and clinical studies of the Company’s anti-IL NanoAbs for the treatment of plaque psoriasis and their
results. These forward-looking statements reflect management’s current views with respect to certain current and future events and are
subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management
of Scinai Immunotherapeutics Ltd. Risks and uncertainties include, but are not limited to, the risk that the Company will not execute
a binding term sheet with the EIB providing for revised terms of the Finance Contract with EIB and the risk that execution of such binding
term sheet will not resolve the deficiency notice of Nasdaq with respect to the Company’s shareholders’ equity; the risk that
the Company will otherwise be unable to regain compliance and remain compliant with the continued listing requirements of Nasdaq; lower
than anticipated revenues of Scinai’s CDMO business in 2024 and thereafter, failure to sign agreements with other potential clients
of the CDMO business; a delay in the commencement and results of pre-clinical and clinical studies, the risk of delay in, Scinai’s
inability to conduct, or the unsuccessful results of, its research and development activities, including the contemplated in-vivo studies
and a clinical trial; the risk that Scinai will not be successful in expanding its CDMO business or in-license other NanoAbs; the risk
that Scinai may not be able to secure additional capital on attractive terms, if at all; the risk that the therapeutic and commercial
potential of NanoAbs will not be met or that Scinai will not be successful in bringing the NanoAbs towards commercialization; the risk
of a delay in the preclinical and clinical trials data for NanoAbs, if any; the risk that our business strategy may not be successful;
the risk that the European Investment Bank (EIB) may accelerate the financial facility under its finance contract with Scinai; Scinai’s
ability to acquire rights to additional product opportunities; Scinai’s ability to enter into collaborations on terms acceptable to Scinai
or at all; timing of receipt of regulatory approval of Scinai’s manufacturing facility in Jerusalem, if at all or when required;
the risk that the manufacturing facility will not be able to be used for a wide variety of applications and other vaccine and treatment
technologies; and the risk that drug development involves a lengthy and expensive process with uncertain outcomes. More detailed information
about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Company’s Annual
Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on May 15, 2024, and the Company’s subsequent
filings with the SEC. Scinai undertakes no obligation to revise or update any forward-looking statement for any reason.
Scinai Immunotherapeutics (NASDAQ:SCNI)
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