Scinai Immunotherapeutics' CDMO Unit Selected by Ayana Pharma to Provide Drug Development and cGMP Manufacturing Services

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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