Scinai Immunotherapeutics Ltd.

Overview

Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) operates two complementary business units: Scinai Biopharma Services (CDMO) and Scinai R&D (internal pipeline focused on inflammation and immunology therapeutics).

CDMO Services (Scinai Biopharma Services)

Scinai's boutique biologics CDMO is designed to support biotech innovators through every stage of drug development—from early research to Phase 3 manufacturing. The platform delivers flexible, agile, and cost-effective solutions combining scientific innovation with process excellence.

Core Capabilities

• Analytical Methods Development: Comprehensive analytical method development for in-process control, release testing, and detailed analysis of recombinant proteins using advanced analytical technologies.
• Process Development & Scale-Up: Extensive expertise in recombinant protein development with cost-effective, flexible, and scalable solutions guiding clients through each stage of R&D.
• cGMP Manufacturing: High-end manufacturing suites designed to meet FDA and EMA cGMP standards. Facilities have successfully passed European QP (EMA) and Israeli Ministry of Health audits for Phase 3 clinical trial production.
• Aseptic Processing: Included in service portfolio.
• CMC Support: Regulatory and CMC activities across the development continuum.

Development Stages Supported

Molecule & clone selection → Lab scale → CMC → Pre-clinical → Preparation for clinical trial → Regulatory → Tech transfer → Clinical trials (Phase 3).

Facilities

• Yavne CDMO Facility (Israel): Acquired from Recipharm; integrated into Scinai Biopharma Services platform with ongoing operational expansion.
• Additional manufacturing infrastructure in Israel supporting clinical and commercial operations.

Regulatory & Quality

• cGMP-compliant manufacturing suites meeting FDA and EMA standards.
• Passed European QP (EMA) audits and Israeli Ministry of Health audits for Phase 3 clinical supply.
• Over 20 years of operational experience in biologics development and manufacturing.

R&D Pipeline (Internal)

Scinai R&D focuses on developing innovative inflammation and immunology (I&I) therapeutics based on NanoAbs (VHH antibody fragments derived from alpaca-derived nanosized antibodies). Current pipeline includes:

• Targeted Intradermal IL-17: For mild to moderate plaque psoriasis (preclinical stage with positive human skin model results).
• Systemic Bi-Specific IL-17: For systemic autoimmune and infectious disease indications.
• PC111 (via Pincell acquisition option): Fully human monoclonal antibody targeting soluble Fas ligand for severe dermatological conditions (Pemphigus, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis); Orphan Drug Designation in Pemphigus (EMA); seeking FDA Orphan Drug and Breakthrough Designations.

Scientific Partnerships

NanoAbs developed in collaboration with Max Planck Institute for Multidisciplinary Sciences and University Medical Center Göttingen, Germany—world leaders in NanoAb design and optimization.