Core Insights - Scinai Immunotherapeutics Ltd. reported financial results for the first half of 2025, showing significant growth in revenues and a reduction in R&D expenses compared to the same period in 2024 [1][5]. Financial Summary - Revenues for the six months ended June 30, 2025, totaled $773 thousand, up from $284 thousand in the same period of 2024, indicating growth in the CDMO business [5]. - R&D expenses decreased to $1,237 thousand from $2,788 thousand year-over-year, primarily due to lower wage and facility allocations [5]. - Marketing, general, and administrative expenses increased to $1,256 thousand from $1,003 thousand, attributed to share-based payments and an insurance reimbursement recorded in 2024 [5]. - The net loss narrowed to $4,134 thousand from $4,481 thousand, reflecting higher revenues and lower R&D expenses [5]. - As of June 30, 2025, cash and cash equivalents were $989 thousand, with an additional $4.2 million raised in July and August 2025, enhancing the cash position [5]. Business Update - Scinai Bioservices, the CDMO unit, generated $421 thousand in revenues in the first half of 2025, with total service orders reaching $1.0 million [5]. - The company is advancing its anti-IL-17 NanoAb program, focusing on treatments for psoriasis with two product profiles in development [5]. - Scinai plans to apply for up to €15 million in grant financing under the EU STEP program to fund Phase 1/2a clinical trials, with a decision expected in Q1 2026 [5]. - In 2025, the company filed patents for four additional NanoAbs and is exercising its exclusive option to license them [5]. - The company signed an option agreement to acquire PinCell srl, with a related €12 million FENG grant application under review [5].

Core Insights - Scinai Immunotherapeutics Ltd. has published new peer-reviewed research confirming the efficacy and safety of PC111, a human anti-Fas Ligand monoclonal antibody, in treating pemphigus and other skin conditions [1][2][3] Scientific and Clinical Findings - The new study validates PC111's ability to prevent blister formation in humanized models of pemphigus by targeting soluble Fas Ligand, which is crucial for keratinocyte apoptosis [2][3] - PC111 has shown significant reduction in disease activity in a proprietary humanized FasL mouse model, confirming its non-immunosuppressive action at the keratinocyte level [3] - The research also indicates PC111's potential in treating Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), a severe dermatological condition [4] Market Opportunity - Current treatments for pemphigus and SJS/TEN involve chronic immunosuppression, which can have serious side effects; PC111 offers a differentiated, fast-acting, and safer therapeutic profile [5][6] - The combined market opportunity for pemphigus and SJS/TEN is estimated to exceed one billion dollars annually [6] Development Strategy - Scinai plans to advance PC111 through IND-enabling studies and clinical development, with orphan drug designation already granted in the EU and similar status sought in the U.S. [7] - The companies are exploring accelerated approval pathways that could facilitate market entry within three to four years [7] Program Structure and Leadership - The PC111 program is led by a team of experts including Prof. Carlo Pincelli and Dr. Antonino Amato, supported by Scinai's Scientific Advisory Board [8] - The efficacy of PC111 is backed by multiple peer-reviewed publications, enhancing its credibility [8] - Scinai may receive up to 80% cost coverage through a €15 million FENG grant to support development [8] Regulatory and Strategic Outlook - The combination of orphan designation, high unmet medical need, and a well-defined mechanism of action supports a realistic path toward Breakthrough Therapy designation and/or Accelerated Approval [9]

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].