JERUSALEM, July 3, 2024
/PRNewswire/ -- 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.
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SOURCE Scinai Immunotherapeutics Ltd.