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 May 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 May 6, 2024, Scinai Immunotherapeutics
Ltd. issued a press release announcing the publishing of FY 2023 financial statements and filing of Annual Report on Form 20-F and providing
a business update.
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this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.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: May 15, 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 Publishes FY 2023 Financial Statements,
Files Annual Report on
Form 20-F and Provides Business Update
JERUSALEM, ISRAEL – May 15, 2024 - Scinai Immunotherapeutics
Ltd. (Nasdaq: SCNI; “Scinai”, or the “Company”), 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 published
its full-year financial results for the year ended December 31, 2023, and provided a business update.
Business Update & Recent Highlights
Financing
In support of the Company’s strategic pivot, on January 3, 2024,
we raised $1.69 million in gross proceeds from the exercise of certain of our outstanding warrants and the issuance of new warrants. H.C.
Wainwright & Co. acted as exclusive placement agent in connection with the offering.
On November 6, 2023, we announced that the Israel Innovation Authority
had approved a non-dilutive grant reimbursing us for 66% of the costs of a project valued at NIS 3.5 million supporting the establishment
of a CDMO service business unit out of our cGMP biologics site.
CDMO business unit
As reported in our financial statements for the year ended December
31, 2023, and our Annual Report on Form 20F for the year ended December 31, 2023, filed with the SEC today, in the first four months of
2024 we received CDMO work orders valued at approximately $500K. Our current guidance for 2024 is approximately $1.25 million in expected
revenues, and we are in advanced contract discussions with several other potential clients. We expect revenues from the CDMO business
to increase materially in the coming years due to growing demand for boutique CDMO services from early-stage biotech companies. In addition,
we have been pursuing extensive targeted marketing activities, including participating in major pharmaceutical conferences, such as CPHI
in Barcelona (October 2023), BIO-Europe in Munich (November 2023), and BIO Europe Spring in Barcelona (March 2024). Next week, at the
BioMed Israel conference to be held in Tel Aviv, Israel, we will be marketing our CDMO services, meeting potential partners for our R&D
pipeline and meeting with potential investors.
Pipeline Development
We are aggressively advancing the NanoAb preclinical development. On
December 12, 2023 we announced promising results in a psoriatic human skin model, Ex-Vivo. The statistically significant results demonstrated
the potential for Scinai’s anti-IL-17 NanoAbs to noticeably improve psoriatic skin lesions as indicated by skin viability and structural
integrity. This finding was corroborated by cytokine release analysis, which showed significantly reduced IL-17 release (p<0.001) in
the human skin in response to treatment with our anti-IL-17 nanoAb intradermally, as compared to the untreated control, similar to the
effects of Betamethasone and Cosentyx.
At the end of April 2024, we concluded an in-vivo proof of concept
animal study in collaboration with Prof. Amos Gilhar, a world-renowned dermatologist of the prestigious Technion Israel Institute of Technology.
Data is currently being reviewed, and we expect to announce the full results of the study by June 2024.
On June 4, 2024, we are scheduled to meet for a scientific advisory
meeting with the Paul Erlich Institute (the PEI) of Germany, the scientific advice of which is considered acceptable guidance for IMPD
filing with the European Medicines Agency (EMA) and is also considered the European comparable to a pre-IND meeting with the FDA in the
U.S. Next, and upon guidance from the PEI, we expect to commence preparations for a pre-clinical toxicology study before commencing a
first-in-human clinical trial in mid-2025.
Additional NanoAbs for treatment of additional autoimmune diseases,
such as asthma, atopic dermatitis and wet AMD, have been discovered and characterized at Max Planck and University Medical Center Göttingen
as part of their research collaboration agreement with Scinai. Scinai holds exclusive options for exclusive licenses at pre-agreed financial
terms for each of the resulting NanoAbs.
We are pursuing a strategic partnership for both our COVID-19 self-administered
inhaled NanoAb, which demonstrated highly promising in vivo results in animals as both a therapeutic and prophylactic treatment, and for
our anti-IL-17 nanoAb for the treatment of plaque psoriasis and other potential indications.
Full-Year 2023 Financial Summary
| ● | R&D expenses for 2023 amounted to $5.2 million, compared to $5.7 million for 2022. The decrease of $0.5 million was primarily
due to a decrease in salaries and share-based payments of $0.26 million, Max Plank-related expenses of $0.15 million and expenses related
to regulation of $0.3 million. |
| ● | Marketing, general and administrative expenses for 2023 amounted to $4.5 million, compared to $5.3 million for 2022. The decrease
of $0.8 million was primarily due to a decrease in salaries and share-based payments of $ 0.58 million and legal and professional services
of $0.33 million. |
| ● | Financial income for 2023 amounted to $3.2 million compared to $5.2 million for 2022. The financial income was primarily from
remeasurement of warrants liabilities of $4.0 million and finance income in respect of loans from others of $0.05 million, offset by exchange
rate differences of $0.85 million. |
Net loss for 2023 was $6.5 million compared to net
loss of $5.8 million for 2022. The increase in net loss was primarily due to a decrease in financial income.
As of December 31, 2023, Scinai had cash and cash equivalents and short-term
deposits of $4.9 million as compared to $14.1 million as of December 31, 2022.
The complete audited financial results are available in our Annual
Report on Form 20-F for the year ended December 31, 2023, filed with the Securities and Exchange Commission on May 15, 2024.
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, the potential of Scinai’s NanoAb program, expected revenues of Scinai’s CDMO business and timing of
pre-clinical and clinical studies and of 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, 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 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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