Scinai Immunotherapeutics Secures Expanded IIA Grant for Robotic Aseptic Manufacturing Platform

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, allowing the company to utilize the full approved grant budget of NIS 5 million over two years. Approximately 66% of this funding is non-dilutive, representing significant financial support that minimizes shareholder dilution while advancing critical manufacturing infrastructure. This expanded grant follows additional review by the IIA and reflects confidence in the technical and commercial viability of Scinai's automated manufacturing initiative.

The program specifically supports acquisition and validation of a fully automated robotic-arm aseptic fill & finish system aligned with EU GMP Annex 1 standards, with validation targeted for completion by the third quarter of 2026. This timeline establishes a clear development pathway for implementing advanced sterile manufacturing capabilities that meet rigorous European regulatory requirements. The investment supports Scinai's broader contract development and manufacturing organization expansion strategy, which has been strengthened through its acquisition of Recipharm Israel Ltd. and subsequent commercial collaboration with Recipharm. This integrated approach creates a two-site manufacturing platform that enhances sterile biologics capabilities while maintaining disciplined capital allocation through maximized non-dilutive funding.

The robotic aseptic fill & finish platform represents a significant technological advancement in biologics manufacturing, addressing critical needs in sterile production while potentially reducing contamination risks and improving production efficiency. By aligning with EU GMP Annex 1 standards, Scinai positions itself to serve both European and global markets requiring the highest quality manufacturing standards for biological products. The company's CDMO unit provides fee-for-service development and manufacturing solutions to biotech and pharmaceutical companies, operating two sites in Israel: a biologics development and clinical manufacturing facility in Jerusalem and a small-molecule API development and GMP manufacturing site in Yavne.

Through its strategic commercial collaboration agreement with Recipharm, Scinai 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 CDMO unit engages with early-stage and emerging biotech companies and mid-size pharmaceutical companies outsourcing early development programs, providing services from preclinical development through Phase I/II clinical supply. These services include biologics process development, analytical method development, sterile fill and finish, clinical cGMP manufacturing, and small-molecule API process development and optimization.

The expanded IIA grant support comes at a strategic time for Scinai as it continues to develop its immunology pipeline alongside its CDMO operations. The company is advancing PC111, a first-in-class anti-FasL monoclonal antibody targeting orphan dermatologic indications, and next-generation NanoAb-based programs in inflammation. While pursuing strategic partnerships, co-development agreements, and regional licensing opportunities to advance selected programs toward clinical validation, the company maintains its focus on building manufacturing capabilities that can support both internal pipeline development and external client needs. The robotic aseptic platform represents a critical component of this dual strategy, potentially enhancing both service offerings and internal development capabilities.