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 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 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 ☐
On June
7, 2024, Scinai Immunotherapeutics Ltd. issued a press release announcing it had regained compliance with the minimum $1.00 bid price
requirement set forth in Nasdaq Listing Rule 5550(a)(2) and that it continues to work with the European Investment Bank (the “EIB”)
to convert a significant portion of the loan owed by the Company to EIB into equity in the Company.
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the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.
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.
Date: June 13, 2024 |
Scinai Immunotherapeutics Ltd. |
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By: |
/s/ Amir Reichman |
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Amir Reichman |
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Chief Executive Officer |
2
Exhibit 99.1
Scinai Immunotherapeutics Regains Compliance
with
Nasdaq Minimum Bid Price Requirement; Continues
to Work with the
European Investment Bank to Convert Loan to Equity to Regain Compliance
with Nasdaq Minimum Shareholders’ Equity
Requirement
Jerusalem,
June 7th, 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 on June 5, 2024, it received formal notification from the Listing Qualification Department (the “Staff”)
of the Nasdaq Stock Market (“Nasdaq”) that the Company has regained compliance with the minimum $1.00 bid price requirement
set forth in Nasdaq Listing Rule 5550(a)(2) (the “Rule”).
The Company previously disclosed in a press release
dated May 6, 2024, that it received a letter from the Staff notifying the Company of its noncompliance with the Rule by failing to maintain
the required minimum bid price for the Company’s American Depositary Shares (“ADSs”). The Company also disclosed in
that press release that it had timely requested a hearing before an independent Nasdaq Hearings Panel (the “Hearings Panel”)
to present a plan to regain compliance and that its Board of Directors had already approved a ratio change of the ADSs to its non-traded
ordinary shares, increasing the number of ordinary shares represented by each ADS from 400 to 4,000, effective May 21, 2024. Following
the ratio change the closing bid price of the ADSs equaled or exceeded $1.00 per ADS for the following ten consecutive business days.
As a result, the Company regained compliance with the Rule and the Staff issued the above-mentioned notification .
On May 24, 2024, the Company announced the receipt
of a Nasdaq Staff determination letter regarding noncompliance with the minimum shareholders’ equity required for continued listing
and that as part of the hearing previously requested with the Hearings Panel it would present a plan for the Company to regain compliance
with this requirement (the “Plan”). The Company also announced that it was engaged in discussions with the European Investment
Bank (the “EIB”) regarding amending the finance contract with the EIB and the conversion of a significant portion of the loan
owed by the Company to EIB into equity in the Company on terms the Company considers favorable to the Company and its shareholders. These
discussions are advancing, and the Company believes it will be in a position to include the potential conversion as a key component of
the Plan to be presented to the Hearings Panel on June 18, 2024. Any revised terms of the finance contract with the EIB are subject to
obtaining formal approval from appropriate EIB governing bodies, negotiating and finalizing definitive agreements relating to the revised
terms, and the fulfilment of any condition precedent, all to the EIB’s satisfaction.
In the notification provided by the Staff on June
5, 2024, the Staff stated that the Company remains non-compliant with the equity requirement in Listing Rule 5550(b)(1), or any of the
alternative requirements under Listing Rule 5550(b), and accordingly the June 18, 2024, hearing will be held as scheduled.
Jerusalem BioPark, 2nd floor ●
Hadassah Ein Kerem Campus ● Jerusalem, Israel
Telephone: +972-8-9302529 ● Fax: +972-8-9302531
● www.BiondVax.com
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 to early stage biotech drug development
programs. 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, the future price of the ADSs. 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 be unable to meet the continued listing requirements
of Nasdaq, including the risk that the consummation of the conversion of the EIB loan to equity would not resolve the recent deficiency
notice from NASDAQ with respect to the Stockholders’ Equity Requirement; 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.
###
Jerusalem BioPark, 2nd floor ●
Hadassah Ein Kerem Campus ● Jerusalem, Israel
Telephone: +972-8-9302529 ● Fax: +972-8-9302531
● www.BiondVax.com
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