Scinai Immunotherapeutics Establishes U.S. Subsidiary for CDMO Services

• Scinai Immunotherapeutics has launched a U.S.-based subsidiary, Scinai Bioservices Inc., to provide contract development and manufacturing services to early-stage biotech companies.

• The subsidiary addresses growing demand for boutique CDMO services in the U.S., particularly as regulatory policies like the BIOSECURE Act shift the landscape for biotech partnerships.

Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) has announced the establishment of a U.S.-based subsidiary, Scinai Bioservices Inc., incorporated in Delaware. The new unit will focus on providing contract development and manufacturing (CDMO) services to early-stage biotech companies, addressing a critical gap in the U.S. market.

Scinai’s CDMO division, launched in 2024 under the Scinai Bioservices brand, already operates a 1,850-square-metre facility in Jerusalem, Israel. The site adheres to EMA and FDA regulatory standards and has completed drug development projects for nine biotech companies. Services include upstream and downstream process development, scale-up, analytical methods development, and manufacturing for pre-clinical and clinical supplies.

The company’s expansion comes amid increasing U.S. demand for CDMO services for biologics, driven by improved molecular understanding and accelerated drug approvals. Additionally, legislative changes like the BIOSECURE Act restrict U.S. federal funding for projects involving certain foreign biotech firms, further increasing demand for domestic and allied CDMO capacity.

CEO Amir Reichman 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.”

By establishing a U.S. subsidiary, Scinai Bioservices Inc. aims to provide fast, high-quality project onset and compliance with U.S. government funding requirements, catering to a growing number of early-stage biotech startups. The company anticipates a substantial increase in revenues from its CDMO services in the coming years.