Scinai Immunotherapeutics (SCNI) Registration Filing summary

Company overview and business model

• Operates two business units: R&D for inflammation and immunology biologics (NanoAbs) and a boutique CDMO for biotech clients.

• R&D focuses on VHH antibodies (NanoAbs) for diseases with unmet needs, leveraging exclusive licenses from Max Planck Society and UMG.

• CDMO unit offers process development and GMP manufacturing services, utilizing a modern, flexible facility in Jerusalem.

• Recent strategic shift after prior lead candidate failed Phase 3; now focused on anti-IL-17 NanoAbs for psoriasis and related indications.

• CDMO business launched in 2023, with initial contracts signed and a U.S. subsidiary established in late 2024.

Financial performance and metrics

• As of June 30, 2024: $3.1M in cash and cash equivalents; operating loss of $4.0M for six months; accumulated deficit of $126.8M.

• Revenues for six months ended June 30, 2024: $0.3M, all from CDMO services; R&D expenses $2.8M; net loss $4.5M.

• 2023 net loss: $6.5M; 2022 net loss: $5.8M; negative cash flows from operations in both years.

• Going concern risk disclosed; current cash not sufficient for 12 months of operations without additional financing.

• EIB loan restructured in August 2024, converting €26.6M debt to preferred shares, reducing outstanding debt to €250,000.

Use of proceeds and capital allocation

• May receive up to $10M in gross proceeds from sales of ADSs to YA under a Standby Equity Purchase Agreement over 36 months.

• Proceeds intended for continued NanoAbs development, CDMO business support, and general corporate purposes.

• Management has broad discretion over use of proceeds; actual allocation may vary based on business needs.