JERUSALEM, May 24, 2024
/PRNewswire/ -- Scinai Immunotherapeutics Ltd. (the
"Company") (NASDAQ: SCNI), a biopharmaceutical company focused on
developing inflammation and immunology (I&I) biological
products and on providing CDMO services through its Scinai
Bioservices business unit, today announced the receipt of an
additional Nasdaq Staff determination letter regarding
noncompliance with the minimum shareholders' equity required for
continued listing and a hearing with the Nasdaq Hearings Panel (the
"Hearings Panel") to present a plan for the Company to regain
compliance (the "Plan"). Based on discussions with the European
Investment Bank (the "EIB"), one of the components of the Plan
could include conversion of a part of the Company's loan from the
EIB into equity on terms the Company considers favorable to the
Company and its shareholders.
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.
The Deficiency Notices
On May 6th, 2024, the
Company announced that on April
30th it had had received a staff determination
letter from the Listing Qualifications Department (the "Staff") of
the Nasdaq Stock Market ("Nasdaq") notifying the Company that, due
to the Company's non-compliance with the minimum $1.00 bid price requirement set forth in Nasdaq
Listing Rule 5550(a)(2), the Company's American Depositary
Shares ("ADSs") would be scheduled for delisting from Nasdaq and
would be suspended for trading unless the Company timely requests a
hearing before an independent Nasdaq Hearings Panel, which the
Company has timely requested and is scheduled for June 18th. To cure the minimum $1.00 bid price requirement deficiency, the
Company recently implemented 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, which is
equivalent to a reverse split of 1 for 10. The closing bid of
the ADS must be at least $1.00 per
share for a minimum of 10 consecutive business days for the
deficiency to be considered as cured.
On May 20, 2024, the Company
received a second staff determination letter from 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 "Stockholders Equity
Requirement"). The Company's Annual Report on Form 20-F for the
year ended December 31, 2023, filed
on May 15, 2024, reported a
stockholders' deficit of $4,569,000,
which is below the Stockholders' Equity Requirement for continued
listing on the Nasdaq Capital Market. 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.
In its May 20, 2024, notice to the
Company, Nasdaq notified the Company that the Hearing Panel
scheduled for June 18th
will consider both the Stockholders' Equity Requirement matter and
the minimum bid price matter. The Company intends to present its
views with respect to both deficiencies at the Panel Hearing,
including presenting the Plan to address the Stockholders'
Equity Requirement matter.
The letter has no immediate effect on the listing of the ADSs,
and the Company's ADSs will continue at this time to trade on the
Nasdaq Capital Market under the symbol "SCNI".
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 GMP manufacturing, and pre-clinical and
clinical trial design and execution services to early stage biotech
companies. 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
delisting of the ADSs from listing on Nasdaq, 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 maintain its listing on Nasdaq;
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.