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

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Scinai Immunotherapeutics (SCNI) announced a five-year Master Service Agreement with Ayana Pharma for drug development and manufacturing services. The agreement is expected to generate at least $1.8 million in revenues over the next five years. Ayana's COO praised Scinai's expertise and facilities, while Scinai's COO highlighted the strategic importance of the contract in the company's growth.
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The agreement between Scinai Immunotherapeutics and Ayana Pharma represents a strategic partnership that could have a significant impact on Scinai's revenue streams and market positioning. With a minimum of $1.8 million in revenue over the next five years, this deal provides a stable financial forecast for Scinai's CDMO operations. The partnership leverages Scinai's expertise in aseptic filling and quality assurance, which are critical components in the pharmaceutical manufacturing process.

Scinai's decision to operate dual business units, focusing on both CDMO services and drug development, appears to be a strategic move to diversify revenue sources. This could potentially reduce risk and increase the resilience of the business against market fluctuations. The ability to offset fixed costs through the CDMO unit's revenue is an important financial strategy that could contribute to the company's overall growth and stability.

The collaboration underscores the importance of liposomal drug delivery systems in the biopharmaceutical industry. Liposomal technology, which enhances the delivery and efficacy of drugs, is a growing area of interest due to its potential to improve therapeutic outcomes. Ayana's selection of Scinai Bioservices as their CDMO partner is a testament to Scinai's perceived technical competence and advanced facilities.

Prof. Yechezkel Barenholz's endorsement of Scinai adds credibility and could attract further interest from other biopharma companies looking for reliable CDMO services. The alignment of Scinai's drug development expertise with Ayana's needs suggests a synergy that could lead to innovative product development, potentially impacting the biopharmaceutical sector and contributing to advancements in drug delivery technologies.

The announcement of a five-year Master Service Agreement with predictable revenue can be seen as a positive signal to investors and market analysts. It provides a clearer picture of Scinai's financial trajectory and could influence the company's stock valuation. The ability to secure long-term contracts is indicative of Scinai's competitive positioning within the CDMO market.

However, it's important to consider the scale of the contract relative to Scinai's overall financials. While $1.8 million is a substantial amount, the impact on the stock market will depend on the company's total revenue, profit margins and growth prospects. Investors should assess this deal in the context of Scinai's full financial picture and future potential to gauge the true significance of this agreement on the company's performance.

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.

Scinai Immunotherapeutics Logo

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.

FAQ

What is the ticker symbol of Scinai Immunotherapeutics ?

The ticker symbol is SCNI.

What kind of agreement was signed between Scinai and Ayana Pharma ?

Scinai signed a five-year Master Service Agreement (MSA) with Ayana Pharma

How much revenue is Scinai expected to generate from the agreement with Ayana over the next five years?

At least $1.8 million in revenues is anticipated over the next five years.

Who invented and developed Ayana's liposomal nano-pharmaceutical products?

Prof. Yechezkel (Chezi) Barenholz invented and developed Ayana's liposomal nano-pharmaceutical products.

What are the two business units that Scinai has created?

Scinai has created one business unit focused on providing CDMO services and another on drug development of biologic therapeutic products.

Which organizations have licensed the innovative pipeline of biologic therapeutic products to Scinai?

The Max Planck Society and the University Medical Center Gottingen, Germany have licensed the innovative pipeline of biologic therapeutic products to Scinai.

What was the strategic decision made by Scinai that was validated by the contract with Ayana?

The strategic decision to create two business units, one focused on providing CDMO services and the other on drug development, was validated by the contract with Ayana.

What did Ayana's COO mention as the key reasons for selecting Scinai as their CDMO?

Ayana's COO mentioned Scinai's experience in bio-pharmaceutical drug development and manufacturing for clinical trials, meeting international regulatory requirements, and personal customer responsiveness as key reasons for selecting Scinai as their CDMO.

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Biotechnology
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