Scinai Immunotherapeutics (SCNI) Status Update summary

Strategic partnership and acquisition

• A binding option agreement was signed to acquire PinCell, an Italian biotech company, to advance the development of PC111, a fully human monoclonal antibody targeting soluble Fas ligand for rare dermatological diseases.

• A joint grant application was submitted to the Polish government for €12 million in non-dilutive funding to support the next stage of PC111 development.

Disease overview and unmet needs

• Pemphigus and SJS/TEN are rare, severe autoimmune and hypersensitivity skin diseases with high morbidity and mortality, affecting over 2 million people globally.

• Current treatments rely on immunosuppressants like steroids and rituximab, which have significant side effects and limited long-term efficacy.

• There is a substantial unmet medical need for safer, more effective therapies for these conditions.

PC111 mechanism and preclinical evidence

• PC111 specifically targets and neutralizes soluble Fas ligand, a key driver of keratinocyte apoptosis and blister formation in both pemphigus and SJS/TEN.

• Preclinical models show PC111 blocks blister formation and cell death in both mouse and humanized models, with efficacy exceeding 90%.

• The antibody is non-immunosuppressive, has low immunogenicity, and is suitable for both subcutaneous and intravenous administration.