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Scinai Immunotherapeutics' Strategic Reorganization

Scinai Immunotherapeutics Ltd., trading under NASDAQ: SCNI, recently made headlines by finalizing a major corporate restructuring. This transformation aims to establish a dedicated Contract Development and Manufacturing Organization (CDMO) platform while optimizing the Research and Development (R&D) structure, setting ambitious goals for 2026.

Overview of the Reorganization

In a strategic move, Scinai has completed the integration of its CDMO activities, following the notable acquisition of Recipharm Israel Ltd. earlier this year. This acquisition not only included a manufacturing site in Yavne but marked a pivotal point for Scinai in cementing its standing in the biopharmaceutical landscape. The new entity formed from these operations is now known as Scinai Biopharma Services Ltd.

This reorganization signifies a clear intention to enhance capital efficiency and sharpen operational focus by distinctly separating CDMO and R&D functions. As a result, Scinai Biopharma Services operates independently, focusing on the growing demand for biopharmaceutical manufacturing and services.

CDMO and R&D Separation

The strategic restructuring has yielded a clear delineation between Scinai Biopharma Services, dedicated to CDMO engagements, and Scinai Immunotherapeutics, which will zero in on its innovative therapeutic developments. This strategic split is designed to empower each segment of the business to better serve its stakeholders, ensuring both operational efficiency and a sharper focus on their respective goals.

The CDMO platform is established on three main pillars:
1. Biologics Development and Manufacturing: At the Jerusalem site, Scinai offers advanced capabilities for biopharmaceutical development and aseptic manufacturing.
2. Integration of Recipharm's Assets: The acquisition of the Yavne site expands Scinai's scope into small-molecule development and Active Pharmaceutical Ingredient (API) production.
3. External Partnerships: The collaboration with Recipharm facilitates expanded operational capacity, including outsourcing arrangements and a broader global reach.

Lean R&D Operations

Following the strategic shift, Scinai Immunotherapeutics has adopted a more streamlined R&D structure that prioritizes efficiency. This lean framework focuses on high-value projects, reduces overheads, and optimizes capital allocation towards programs with the greatest potential for return on investment. Non-core operational functions have been repositioned to support the revenue-generating CDMO sector, enhancing the overall business structure.

2026 Goals and Strategic Vision

Looking forward, Scinai has outlined ambitious objectives for 2026 that underscore its commitment to growth and efficiency:

• - CDMO Operations: The company aims to expand its operations across U.S. and European markets, leveraging the Recipharm partnership for early-stage development programs, with revenue targets set at approximately $5 million.
• - Research and Development: Key projects include advancing their lead therapeutic, PC111, as well as progressing the IL-17 × undisclosed second target bi-specific program, critical for validating Scinai's NanoAbs platform.

Comments from Leadership

Amir Reichman, CEO of Scinai, reflected on the reorganization's importance, stating, "This restructuring is a significant transformation for us. It positions each part of our business more effectively for stakeholders, enhancing our ability to create value and scale the CDMO division as a growth engine."

Conclusion

With this comprehensive reorganization, Scinai Immunotherapeutics and its subsidiary, Scinai Biopharma Services, are poised to elevate their operational effectiveness while pursuing innovative therapeutic solutions in the realm of inflammation and immunology. As they head into 2026, Scinai aims to distinguish itself as a leader in both biopharmaceutical development and manufacturing, ready to meet the evolving needs of the market.