Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) has entered into a binding option agreement to acquire Italian biotech company Pincell srl, gaining access to a promising antibody therapy for severe and rare skin disorders. The acquisition would strengthen Scinai's inflammation and immunology (I&I) portfolio with Pincell's lead candidate PC111, which targets devastating conditions with significant mortality rates and limited treatment options.
PC111 is a fully human monoclonal antibody designed to treat Pemphigus, Stevens-Johnson Syndrome (SJS), and Toxic Epidermal Necrolysis (TEN) through a novel mechanism of action. The antibody binds to human soluble Fas ligand, blocking the activation of apoptosis in skin cells (keratinocytes) without suppressing the immune system—a significant advantage over current immunosuppressive treatments.
Target Conditions and Unmet Medical Needs
Pemphigus, SJS, and TEN represent severe dermatological conditions with substantial mortality rates and limited effective treatment options.
Pemphigus is an autoimmune disorder characterized by painful blisters and sores on the skin and mucous membranes. Current management typically involves long-term immunosuppressive medications, yet still carries a 5-10% mortality rate.
Stevens-Johnson Syndrome, a rare but serious reaction typically triggered by medications or infections, has a mortality rate of 5-10%. Its more severe form, Toxic Epidermal Necrolysis, involves extensive skin peeling and blistering affecting more than 30% of the body surface, with mortality rates reaching 30-40%.
"We are truly excited to have the opportunity to acquire Pincell and develop, in collaboration with the Pincell team, PC111 to treat these devastating skin disorders," said Amir Reichman, CEO of Scinai. "Prof. Carlo Pincelli, founder and chief medical officer of Pincell, is considered a global leader in the dermatology field and in research relating to Pemphigus, and SJS/TEN."
Regulatory Status and Development Strategy
PC111 has already received Orphan Drug Designation for Pemphigus from the European Medicines Agency. The companies plan to file applications with the FDA for both Orphan Drug and Breakthrough Therapy Designations for Pemphigus as well as SJS/TEN.
In anticipation of the acquisition, the companies have jointly prepared a grant application seeking €12 million in non-dilutive funding through the European Funds for a Modern Economy (FENG) program in Poland. To facilitate this application, Pincell has exclusively licensed PC111 to Scinai's wholly owned Polish subsidiary.
"The grant we have applied for is under an EU program well suited to our development plans," Reichman explained. "While the application only covers the next stage of development, under current regulations we will have the opportunity to apply for successive grants in similar amounts if we achieve the target development milestones outlined in the initial application."
This funding strategy could provide the majority of capital needed for development through non-dilutive grants, limiting Scinai's direct investment to approximately €3 million. A decision on the grant application is expected by mid-July or early August 2025.
Scientific Foundation and Preclinical Evidence
Pincell has developed a proprietary FasL humanized mouse model to study the involvement of the Fas/FasL pathway in these diseases. Through extensive in-vitro, ex-vivo, and in-vivo experiments, the company has demonstrated that PC111 can block blister formation without steroids in validated models of pemphigus.
Importantly, the data suggest that PC111 may be effective in a humanized setting, positioning it as a potential novel targeted therapy for these conditions. The research also indicates that PC111 could inhibit disease progression in SJS/TEN by ameliorating ocular conjunctivitis and edema, key early features of the disease.
Dr. Antonino Amato, Chairman and CEO of Pincell, commented: "We are very pleased to join forces with Scinai, a company with great expertise in R&D of inflammatory skin diseases, as well as in the development and manufacturing of biologics. Their scientific knowledge, international reach and access to capital represent the ideal match to our development plans and needs."
Terms of the Acquisition
The option agreement allows Scinai to exercise a full sale and transfer of Pincell's shares by the end of 2025, subject to meeting closing requirements and obtaining regulatory clearance from the Italian government. If exercised, Pincell's current shareholders will be eligible for development milestone payments and royalties on future net sales of PC111 in the low single digits.
Additionally, Pincell's management team will join Scinai's newly created subsidiary in Poland, and Prof. Carlo Pincelli will join Scinai's Scientific Advisory Board.
Market Potential and Strategic Fit
The acquisition aligns with Scinai's focus on inflammation and immunology biologics targeting diseases with significant unmet medical needs. The company sees potential for accelerated regulatory approval given the severity of these diseases, PC111's innovative mode of action, and the lack of effective alternative treatments.
"Combined with the potential for accelerated approval given the severity and lack of effective alternative treatments, we find the opportunity particularly appealing and a very good fit with our own I&I focus," said Reichman.
Scinai Immunotherapeutics operates two complementary business units: one focused on in-house development of biological therapeutic products for inflammation and immunology conditions, and the other providing contract development and manufacturing services to early-stage biotech companies.
