JERUSALEM, Sept. 2, 2025 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) ("Scinai", or the "Company"), a biopharmaceutical company focused on developing novel and innovative biological drug candidates for the treatment of inflammation and immunology (I&I) related diseases and on providing CDMO services through its Scinai Bioservices business unit, today announced its financial results for the six months ended June 30, 2025.Six-Month 2025 Financial Summary  Revenues for the six months ended Jun ...

New data builds on award-winning research and confirms efficacy and safety of PC111 across in-vitro, ex-vivo, and in-vivo humanized models JERUSALEM, July 29, 2025 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI), a biopharmaceutical company developing inflammation and immunology (I&I) biological products and providing boutique CDMO services, announced the publication of a new peer-reviewed article in the Journal of Dermatological Treatment validating the disease-modifying potential of PC111, a ...

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].

SCIENTIFIC WEBINAR 2025 PC111 - A New Drug Candidate for Rare Skin Diseases: Pemphigus and SJS/TEN Pincell Acquisition Option 1 Agenda Ø Overview of Pemphigus and SJS/TEN Symptoms, implications and patho-mechanisms Ø Overview of Current Treatment Landscape Ø PC111 Deep Dive: -- Mechanism of Action -- Achievements to Date -- Comparison to Current SOC -- Safety Profile -- Combination with Existing Therapies (Risks/Benefits) -- Development Plan -- Challenges in Conducting Rare Disease Clinical Trials Ø Commerc ...

Core Viewpoint - Scinai Immunotherapeutics Ltd. has filed for a Euro 12 million grant to support the development of its monoclonal antibody PC111, which targets severe dermatological conditions, and has entered into an option agreement to acquire the Italian biotech company Pincell srl [1][2][7]. Company Overview - Scinai Immunotherapeutics Ltd. specializes in inflammation and immunology biological products and offers CDMO services through its Scinai Bioservices unit [1][10]. - Pincell srl focuses on developing first-in-class anti-inflammatory therapies for rare and severe skin diseases, founded by experts in dermatology [11]. Product Development - PC111 is a fully human monoclonal antibody that blocks the activation of apoptosis in skin cells, addressing significant unmet medical needs in skin blistering disorders [3][5]. - The antibody has shown potential in preclinical studies to block blister formation in pemphigus without the use of steroids, indicating its promise as a targeted therapy [5][7]. Grant Application - The grant application submitted by Scinai's Polish subsidiary is part of the European Funds for a Modern Economy (FENG) program, with a decision expected by mid-July to early August [2]. - The funding will primarily be non-dilutive, requiring only Euro 3 million from Scinai's capital, which is one-fifth of the total budget [8]. Market Need - Pemphigus, Stevens-Johnson Syndrome (SJS), and Toxic Epidermal Necrolysis (TEN) are severe conditions with high mortality rates (5-10% for pemphigus and SJS, 30-40% for TEN), highlighting the urgent need for effective treatments [6][7]. Strategic Partnership - The acquisition of Pincell is expected to enhance Scinai's capabilities in developing PC111, leveraging Pincell's expertise in dermatology and research [8][9]. - The management team from Pincell will integrate into Scinai's operations, further strengthening the collaboration [9].