Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) announced that its project to advance a robotic aseptic fill & finish platform has been approved for expanded support by the Israel Innovation Authority. The approval allows the company to utilize the full approved grant budget of NIS 5 million over two years, with approximately 66% of the funding being non-dilutive. This financial support is significant as it enables Scinai to maintain disciplined capital allocation while advancing critical manufacturing capabilities.
The program specifically supports the acquisition and validation of a fully automated robotic-arm aseptic fill & finish system that aligns with EU GMP Annex 1 standards. Validation of this system is targeted for completion by the third quarter of 2026. This timeline provides a clear roadmap for the implementation of advanced manufacturing technology that meets stringent European regulatory requirements.
This investment supports Scinai's broader contract development and manufacturing organization expansion strategy, which has been strengthened by its acquisition of Recipharm Israel Ltd. and commercial collaboration with Recipharm. The collaboration, detailed in the company's strategic commercial agreement available at https://ibn.fm/SxadB, offers clients a defined pathway from early clinical development to late-stage and commercial manufacturing within Recipharm's global network. This structure enables continuity of development, streamlined tech transfer, and reduced scale-up risk as programs advance.
The expanded grant funding enhances Scinai's integrated two-site manufacturing platform in Israel, which includes a biologics development and clinical manufacturing facility in Jerusalem and a small-molecule API development and GMP manufacturing site in Yavne. The CDMO unit provides fee-for-service development and manufacturing solutions to biotech and pharmaceutical companies, supporting external clients from preclinical development through Phase I/II clinical supply. Services include biologics process development, analytical method development, sterile fill and finish, clinical cGMP manufacturing, and small-molecule API process development and optimization.
For the biotechnology industry, this development represents an important advancement in manufacturing infrastructure that could potentially reduce contamination risks and improve efficiency in sterile biologics production. The robotic aseptic fill & finish platform addresses a critical need in biopharmaceutical manufacturing where maintaining sterility during the final stages of drug production is paramount. By implementing automated systems that meet EU GMP Annex 1 standards, Scinai positions itself to serve clients with higher quality manufacturing capabilities while potentially reducing human error in aseptic processes.
The non-dilutive nature of the majority of the funding is particularly noteworthy for investors and the company's financial health, as it allows Scinai to advance its capabilities without significantly diluting shareholder value. This approach demonstrates strategic financial management while pursuing growth opportunities in the competitive CDMO market. The company's parallel focus on advancing its immunology pipeline, including PC111, a first-in-class anti-FasL monoclonal antibody targeting orphan dermatologic indications, and next-generation NanoAb-based programs in inflammation, creates a diversified business model that combines service revenue with potential therapeutic development.
The implications of this announcement extend beyond Scinai's immediate operations to the broader biopharmaceutical ecosystem. As more companies outsource early development programs to specialized CDMOs, the availability of advanced, automated manufacturing capabilities becomes increasingly important for accelerating drug development timelines and ensuring product quality. Scinai's enhanced capabilities through this grant-supported project may attract additional biotech and pharmaceutical clients seeking sophisticated manufacturing solutions for complex biologics.
