Core Viewpoint - The Italian government's regulatory approval is a significant milestone for Scinai Immunotherapeutics Ltd. in its planned acquisition of Pincell S.r.l., allowing the company to move forward with the transaction, subject to customary remaining conditions [1][2][4]. Group 1: Regulatory Approval and Acquisition Details - The Italian government granted clearance under the Golden Power regulation for Scinai's option to acquire 100% of Pincell's share capital and voting rights [2][3]. - The approval followed an assessment by the Ministry of Health and pertains to the transaction as notified on April 5, 2025, which includes licensing agreements for Pincell's intellectual property rights [3][4]. - Scinai's CEO expressed satisfaction with the regulatory clearance, emphasizing that while it is a key requirement, it does not complete the transaction, and the company is working to meet all remaining conditions [4]. Group 2: Product Development and Funding - Pincell's lead candidate, PC111, is a fully human monoclonal antibody targeting the Fas/FasL pathway, currently in development for severe dermatological conditions, including Pemphigus, Stevens-Johnson Syndrome, and Toxic Epidermal Necrolysis [4]. - PC111 has received Orphan Drug Designation in Pemphigus from the European Medicines Agency [4]. - In anticipation of the acquisition, Scinai's Polish subsidiary submitted a €12 million grant application under the European Funds for a Modern Economy program to support the next stage of PC111's development, with a decision expected by mid-July to early August 2025 [5]. Group 3: Company Overview - Scinai Immunotherapeutics Ltd. specializes in inflammation and immunology biological products and provides CDMO services through its Scinai Bioservices unit [2][6]. - The company has a dual focus: developing biological therapeutic products and offering drug development services for early-stage biotech projects [6].