#Scinai Immunotherapeutics #Israel #Jerusalem #IIA #Recipharm

Scinai's Ambitious Move Towards Next-Gen Manufacturing

Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) recently revealed a significant advancement in its operations with the announcement of expanded support from the Israel Innovation Authority (IIA) for its robotic aseptic fill and finish platform. This approval follows a meticulous review process by the IIA, showcasing Scinai's commitment to modernizing its manufacturing capabilities.

The financial backing from the IIA amounts to an impressive NIS 5 million over the course of two years, with around 66% classified as non-dilutive funding. Scinai plans to leverage these funds to facilitate the acquisition and validation of an advanced robotic interventional system designed specifically for aseptic fill and finish processes, adhering to the stringent EU GMP Annex 1 standards. This cutting-edge technology aims to minimize human intervention in sterile manufacturing, significantly enhancing both reproducibility and contamination control.

Looking ahead, validation of this sophisticated robotic platform is scheduled for completion by the third quarter of 2026. This development aligns seamlessly with Scinai's broader strategic vision to enhance its Contract Development and Manufacturing Organization (CDMO) capabilities, a move prompted by its recent acquisition of Recipharm Israel Ltd. and the establishment of a strategic commercial partnership with Recipharm.

The collaboration between the two entities signifies the creation of an integrated two-site platform for both development and manufacturing, combining the resources of Scinai's biologics facility in Jerusalem and the newly acquired small-molecule site in Yavne. This partnership is particularly advantageous for clients transitioning from early clinical development to late-stage and commercial manufacturing, as it opens up opportunities within Recipharm's expansive global network.

The robotic aseptic processing will allow Scinai to upgrade its clinical manufacturing abilities significantly at its Jerusalem site. CEO Amir Reichman noted that the expanded support from the IIA not only enhances their investment capacity for next-gen sterile manufacturing but also emphasizes Scinai's disciplined approach to capital allocation.

Reichman stated, "With the acquisition of Recipharm Israel and our commercial collaboration framework now active, we're poised to scale our two-site CDMO model and deepen our technological offerings in the biologics sector. Ensuring maximum utilization of non-dilutive funding will be essential in driving our strategy forward."

Adding to this, Scinai's Chief Operating Officer, Elad Mark, expressed his enthusiasm regarding the robotic aseptic fill and finish platform. Mark described it as a critical advancement that will bolster their sterile manufacturing operations. The automated system promises to reduce operator input, improve batch consistency, and strengthen contamination management, all in compliance with EU GMP guidelines. Elad emphasized that this initiative enhances the company's ability to cater to complex biologics programs while expanding their footprint in development and manufacturing.

Scinai is also keeping an eye on a potential new IIA program slated to support industrial capital expenditures, contingent on the approval of Israel's state budget for 2026 and further announcements by the IIA. With the prospect of additional non-dilutive support, Scinai aims to explore further enhancements at its Yavne site—central to its CDMO expansion strategy.

About Scinai Immunotherapeutics

Scinai Immunotherapeutics is a biopharmaceutical company, primarily operating a CDMO alongside an innovative immunology research and development pipeline. The company provides specialized development and manufacturing services for biotech and pharmaceutical industries. With two operational sites in Israel—a biologics facility in Jerusalem and a small-molecule API site in Yavne—Scinai supports clients from preclinical development to commercial manufacturing. Their strategic partnership with Recipharm provides clients with a seamless transition pathway for development programs, thereby minimizing risks associated with scaling production. Scinai is dedicated to advancing its immunology pipeline, striving for strategic partnerships and licensing opportunities to promote clinical validation of its therapeutic programs.

For more information, you can visit Scinai's official website at www.scinai.com.