JERUSALEM, Dec. 16,
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 providing CDMO services through its Scinai
Bioservices business unit, announced today the establishment of a
U.S.-based subsidiary for its Contract Development and
Manufacturing Services. The new subsidiary, incorporated in
Delaware, will operate under the
name Scinai Bioservices Inc.
In 2024, Scinai launched its CDMO business unit, branded as
Scinai Bioservices, operating from the Company's site in
Jerusalem, Israel. This facility
includes 1,850 square meters (approximately 20,000 square feet) of
clean rooms and laboratories, all operating under cGMP conditions
in compliance with European Medicines Agency (EMA) and FDA
requirements.
Since its inception, the CDMO unit has executed drug development
projects for nine different biotech companies. These activities
have included upstream and downstream process development,
scale-up, analytical methods development and drug manufacturing for
pre-clinical and clinical supplies. Additionally, the Company has
partnered with Ayana Pharma to provide liposomal encapsulated drug
development services.
According to GlobalData, the demand for Contract Development and
Manufacturing Services (CDMO) for biological early-stage drugs is
growing in the U.S. This trend is driven by several factors,
including improved molecular biological understanding, accelerated
market approvals, and the increasing number of novel drug
candidates. As the complexity of biologics increases, so does the
demand for high-quality development and manufacturing capacities
that meet stringent regulatory standards.
However, while there is a growing demand for CDMO services, the
capacity to meet this demand is currently a concern. The specific
capacity to handle early-stage projects, an area where Scinai
BioServices operates, may be strained due to the complex
manufacturing routes associated with biologics. Additionally,
the BIOSECURE Act, introduced in January
2024, aims to prevent "foreign adversary biotech companies"
from receiving U.S. federal funding. According to GlobalData's
Pharma Intelligence Center Deal Database, this legislation could
impact over 120 U.S. biopharmaceutical drugs in development by
companies partnered with Chinese CDMOs and biotechnology companies.
Of these, approximately half are in clinical-stage development
(Phases I to III) and a third are in early-stage preclinical trials
and discovery.
Scinai's new U.S. subsidiary, Scinai Bioservices Inc., aims to
serve U.S.-based early-stage biotech companies by providing the
required CDMO services that are currently in short supply. This is
coupled with growing demand for boutique CDMO services from
early-stage biotech companies seeking fast project onset at
competitive pricing without compromising on scientific and quality
standards. Moreover, Scinai Bioservices Inc. allows early
stage biotech startups, supported by U.S. government grant funding,
to use their grant money by contracting with us, avoiding any
concerns related to the BIOSECURE Act.
Scinai's CDMO business unit is focused on rapid growth,
acquiring new clients, and building its reputation and brand
awareness. The Company expects revenues from the CDMO business to
increase materially in the coming years.
Amir Reichman, CEO of Scinai,
commented: "We are thrilled and energized by the opening of our new
subsidiary in the U.S. Last week, we signed our first contract with
U.S. customer, Serpin Pharma, to support their clinical
manufacturing. I believe that our expanded presence in the U.S.
will significantly enhance the prospects of our CDMO unit."
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 expected revenues and prospects of Scinai's 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; lower than
anticipated revenues of Scinai's CDMO business; the risk that
Scinai's expanded presence in the U.S. will not significantly
enhance the prospects of its CDMO unit; the risk that the Company
will otherwise be unable to remain compliant with the
continued listing requirements of Nasdaq; 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, including the Phase 1/2a study for psoriasis, 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; 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.
