JERUSALEM, April 8,
2024 /PRNewswire/ -- Scinai Immunotherapeutics
Ltd. (Nasdaq: SCNI) today announced that Ayana Pharma Ltd.
signed a five-year Master Service Agreement (MSA) with the
Company's CDMO business unit, Scinai Bioservices.
Under the MSA, Scinai will provide drug development and cGMP
manufacturing services, including aseptic filling and quality
assurance, to Ayana, including encapsulating drug substances of
various partners of Ayana into Ayana's proprietary liposomal drug
delivery system.
Ayana COO Yanir Aldouby,
commented, "After an extensive search, we are pleased to have
selected Scinai Bioservices as our CDMO for our future projects. We
were particularly attracted to the team's experience in
bio-pharmaceutical drug development and manufacturing for clinical
trials while meeting stringent international regulatory
requirements. We also appreciated Scinai's personal customer
responsiveness. These initial stages lay the groundwork for a
collaborative and productive relationship going forward. As Scinai
is also in the business of biological drug development, we believe
they understand our needs as a small biopharma company. The
pristine condition of Scinai's modern and highly equipped
laboratories and clean rooms demonstrate the competence and
attention to details that are imperative for a CDMO to successfully
serve our future needs. We're confident that we're in good hands
with Scinai."
Elad Mark, Scinai's COO,
noted, "We are pleased to welcome Ayana as a client. Their
innovative liposomal nano-pharmaceutical products were invented and
developed by Prof. Yechezkel (Chezi)
Barenholz, a renowned expert in the area of liposomal drug
delivery systems. As a biologics CDMO with end-to-end capabilities,
we provide personal and professional services to our clients. We
are proud that Prof. Barenholz and Ayana recognized the
capabilities of Scinai Bioservices as the best fit to support their
liposomal product portfolio drug development needs."
The agreement is anticipated to provide Scinai with at least
$1.8 million in revenues over the
next five years.
Amir Reichman, Scinai's
CEO, added "This five-year contract validates our strategic
decision to create two business units, one focused on providing
CDMO services and the other on drug development of an innovative
pipeline of biologic therapeutic products under license from the
Max Planck Society and the University Medical Center Gottingen,
Germany. This important CDMO
contract with Ayana joins additional contracts already signed with
other clients by our CDMO unit, all of which are generating
revenues, offsetting fixed costs and allowing for rapid growth of
our business".
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.
About Scinai Bioservices
The CDMO business unit of Scinai Immunotherapeutic Ltd, Scinai
Bioservices, serves pharmaceutical and biotech companies with drug
development and manufacturing services for clinical supplies.
Leveraging Scinai's state-of-the-art GMP facility in Jerusalem, Israel, the CDMO offers
manufacturing process development, analytical method development,
manufacturing for pre-clinical and clinical studies under cGMP
conditions, and quality control under GLP conditions coupled with
robust Quality Assurance. CDMO website: www.scinai.com/cdmo.
About Ayana Pharma Ltd.
Ayana Pharma Ltd is a pharmaceutical company focused on the
development and manufacturing of liposomal therapeutics for the
treatment of cancer and other diseases. Its flagship product,
Doxorubicin HCl Liposome Injection, is FDA-approved for treatment
of ovarian cancer, multiple myeloma and AIDS-related Kaposi's
sarcoma, and is marketed in the USA. Ayana develops additional liposomal
pharmaceutical products and has vast experience in development and
manufacturing of complex liposomal therapeutics. Ayana Pharma
website: www.ayanapharma.com.
Contact Details
Scinai: Business Development bd@scinai.com |
Investor Relations ir@scinai.com | +972 8 930 2529
Ayana: Yanir
Aldouby, COO | +972 2 572 2041 | Yanir@ayanapharma.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, included in this press release
regarding strategy, future operations, future financial position,
future revenue, projected expenses, prospects, plans and objectives
of management are forward-looking statements. Examples of such
statements include, but are not limited to, statements regarding
the anticipated revenues from the agreement with Ayana
Pharmaceuticals and the potential of the Company's business,
including its CDMO business. 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 some or all of the expected benefits of the agreement
with Ayana Pharmaceuticals will not be achieved; the risk that the
Company's business, including CDMO business, will not grow; the
risk that the Company will not maintain its listing on Nasdaq; 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; 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 loans under its
finance contract with Scinai; risks relating to the SARS-CoV-2
(COVID-19) virus; 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 10-K filed with the Securities and
Exchange Commission on April 17,
2023. Scinai undertakes no obligation to revise or update
any forward-looking statement for any reason.
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SOURCE Scinai Immunotherapeutics Ltd.