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 manufacturing services.

• Focuses on developing nanosized VHH antibodies targeting diseases with unmet needs, leveraging exclusive licenses from Max Planck Society and University Medical Center Göttingen.

• CDMO unit offers process development and GMP manufacturing for clinical supplies, utilizing a modular facility in Jerusalem.

• Recent strategic shift to prioritize anti-IL-17 NanoAb for psoriasis and psoriatic arthritis, with COVID-19 program development suspended pending partnership.

• Signed a license agreement granting exclusive global rights to a U.S. company for certain patents, with milestone and royalty payments.

Financial performance and metrics

• As of June 30, 2024, cash and cash equivalents were $3.1 million; operating loss for H1 2024 was $4.5 million.

• Accumulated deficit reached $126.8 million as of June 30, 2024.

• Revenues for H1 2024 were $0.3 million, primarily from initial CDMO contracts.

• Net loss for 2023 was $6.5 million, with negative cash flows from operations of $9.4 million.

• Financial statements include a going concern warning; current resources are insufficient to fund operations for 12 months without additional financing.

Use of proceeds and capital allocation

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

• Proceeds will be used for continued NanoAbs development, CDMO business support, and general corporate purposes.

• Management has broad discretion over use of proceeds, which may include working capital, R&D, regulatory, and capital investments.