"Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI), a biopharmaceutical company specializing in inflammation and immunology (I&I) biological products and providing CDMO services through its Scinai Bioservices unit, today announced that the Italian government has granted clearance under the Golden Power regulation (Law Decree No. 21/2012) for Scinai's option to acquire 100% of the share capital and voting rights of Pincell S.r.l., an Italian biotechnology company.
This approval was issued following a review by the Coordination Group for the exercise of special powers, based on the outcome of the assessment conducted by the Ministry of Health, the competent authority. The clearance pertains to the transaction as presented in the notification submitted on April 5, 2025, which includes the granting of a license by Pincell and Scinai's Polish subsidiary, Scinai Immunotherapeutics Sp. Z.O.O, for the use of Pincell's intellectual property rights.
""We are pleased to have received this regulatory clearance, which represents a significant step forward in our planned acquisition of Pincell,"" said Amir Reichman, CEO of Scinai Immunotherapeutics. ""While this approval addresses a key regulatory requirement, it does not signify the completion of the transaction. We continue to work diligently to satisfy all remaining conditions necessary to exercise our option and finalize the acquisition.""
Scinai entered into a binding option agreement to acquire Pincell in March 2025. Pincell's lead candidate, PC111, is a fully human monoclonal antibody targeting the Fas/FasL pathway, currently in development for treating severe dermatological conditions such as Pemphigus, Stevens-Johnson Syndrome (SJS), and Toxic Epidermal Necrolysis (TEN). PC111 has already received Orphan Drug Designation in Pemphigus by the European Medicines Agency.
In anticipation of the acquisition, Scinai's wholly owned Polish subsidiary submitted a €12 million grant application under the European Funds for a Modern Economy (FENG) program to fund the next stage of PC111's development. An award decision is expected by mid-July to early August 2025.
Completion of the acquisition remains subject to the fulfillment of additional closing conditions, including the successful outcome of the grant application and other customary requirements.
About Scinai Immunotherapeutics
Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) is a biopharmaceutical company with two complementary business units, one focused on in-house development of inflammation and immunology (I&I) biological therapeutic products beginning with an innovative, de-risked pipeline of nanosized VHH antibodies (nanoAbs) targeting diseases with large unmet medical needs, and the other a boutique CDMO providing biological drug development, analytical methods development, clinical cGMP manufacturing, and pre-clinical and clinical trial design and execution services for early stage biotech drug development projects.
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