JERUSALEM, May 15, 2024
/PRNewswire/ -- 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.
Logo -
https://mma.prnewswire.com/media/2310190/Scinai_Immunotherapeutics_Logo.jpg
View original
content:https://www.prnewswire.com/news-releases/scinai-publishes-fy-2023-financial-statements-files-annual-report-on-form-20-f-and-provides-business-update-302146622.html
SOURCE Scinai Immunotherapeutics Ltd.