Core Insights - Scinai Immunotherapeutics Ltd. reported financial results for the nine months ended September 30, 2025, highlighting significant progress in both its CDMO and R&D business units [1][13]. Financial Summary - As of September 30, 2025, cash, cash equivalents, and short-term deposits totaled $3,005 thousand, an increase from $1,964 thousand as of September 30, 2024 [3]. - Revenues for the nine months ended September 30, 2025, were $1,049 thousand, compared to $452 thousand for the same period in 2024, reflecting growth in Scinai Bioservices [7]. - R&D expenses decreased to $1,799 thousand from $4,195 thousand year-over-year, primarily due to lower employee and facility cost allocations [7]. - Marketing, general, and administrative expenses increased to $1,929 thousand from $1,767 thousand, mainly due to insurance reimbursements recorded in 2024 [7]. - The net loss for the nine months ended September 30, 2025, was $6,244 thousand, compared to a net profit of $7,026 thousand for the same period in 2024, largely due to financial income from loan conversion recognized in 2024 [7]. Business Update - Scinai Bioservices is expanding its role as a boutique CDMO, serving early-stage biotech companies in Israel, the U.S., and Europe [4]. - The company received a non-dilutive grant of approximately NIS 809,000 (about $246,000) from the Israel Innovation Authority to fund part of an investment in an advanced sterile fill-and-finish system [8]. - The new system aims to enhance small-batch manufacturing capacity for early-stage biotech clients, with installation expected in Q1 2026 and commercial operations planned for Q2 2026 [8]. R&D Developments - Scinai is advancing its NanoAb pipeline focused on inflammation and immunology, with two STEP grant applications of up to €15 million each, with decisions expected in Q1 2026 [6]. - The lead program, SCN-1, is approaching Phase 1/2a for mild-moderate psoriasis, with a grant application decision expected in Q1 2026 [7]. - The company is evaluating the future of the PC111 program after its €12 million grant application was not approved, considering alternative funding routes or potential termination of the acquisition option for Pincell Srl [10][11]. Partnering Outlook - Scinai is actively seeking partnerships for co-development, licensing, or broader collaborations across all pipeline programs [12]. CEO Statement - The CEO emphasized significant progress in 2025, noting the strengthening of CDMO operations and the ongoing evaluation of strategic paths for R&D programs, particularly in light of recent grant outcomes [13].

Core Insights - Scinai Bioservices has received a non-dilutive grant of approximately NIS 809,000 (about $246,000) from the Israel Innovation Authority to fund 66% of a NIS 1.23 million ($373,000) project aimed at enhancing its fill-and-finish capabilities, addressing a significant gap for early-stage biotech companies [1][2][5] Group 1: Company Developments - The grant will enable Scinai to acquire and install an advanced fill-and-finish system for sterile manufacturing, which is crucial for local biotech firms that currently face high costs and long lead times when outsourcing overseas [1][4] - Scinai's CDMO operations, initiated in 2023, have already provided high-quality manufacturing support to various biotech companies, emphasizing close collaboration and rapid project initiation [4][6] - The planned expansion supported by the grant will enhance Scinai's ability to deliver agile, small-batch, end-to-end CDMO services compliant with EMA and FDA cGMP standards [4][5] Group 2: Industry Context - Israel's biopharma sector, comprising over 300 companies, is underserved by full-service CDMOs, a challenge that is also prevalent globally among early-stage biotech innovators [3] - Scinai aims to fill this gap by offering flexible CDMO solutions that support drug development from early clone selection through to GMP drug substance and product manufacturing [3][6] - The company focuses on providing personalized, agile, and cost-effective solutions to early-stage biotech clients in Israel, the U.S., and Europe, which is often not prioritized by larger CDMOs [6] Group 3: Future Plans - The installation and qualification of the new filling system are expected to be completed by Q1 2026, with commercial operations planned for Q2 2026 [7] - Scinai's R&D unit is also advancing novel biological drug candidates for inflammatory and immunological diseases, indicating a dual focus on both manufacturing and drug development [8][9]

Financial Performance - Total revenues for the six months ended June 30, 2025, were $773,000, a 172% increase compared to $284,000 for the same period in 2024[5] - Gross loss for the six months ended June 30, 2025, was $(1,270,000), compared to a gross loss of $(164,000) for the same period in 2024[5] - Net loss for the six months ended June 30, 2025, was $(4,134,000), compared to a net loss of $(4,481,000) for the same period in 2024, reflecting a 7.7% improvement[5] - The Company reported an operating loss of $3,763 thousand and negative cash flows from operating activities of $2,575 thousand for the six months ended June 30, 2025[18] - For the six months ended June 30, 2025, total share-based compensation was $270, a decrease of 18.9% compared to $333 for the same period in 2024[34] - The basic net loss per share for the six months ended June 30, 2025, was calculated using a weighted average number of shares of 6,364,731,650[39] Expenses - Research and development expenses for the six months ended June 30, 2025, were $1,237,000, a decrease of 56% from $2,788,000 in the same period of 2024[5] - Total operating expenses for the six months ended June 30, 2025, were $2,493,000, down 34% from $3,791,000 in the same period of 2024[5] Assets and Liabilities - Cash and cash equivalents as of June 30, 2025, were $989,000, down 50% from $1,964,000 as of December 31, 2024[2] - Total current assets decreased to $1,506,000 as of June 30, 2025, from $2,391,000 as of December 31, 2024, representing a 37% decline[2] - Total liabilities increased to $4,982,000 as of June 30, 2025, compared to $3,471,000 as of December 31, 2024, indicating a 43% rise[4] - Total shareholders' equity decreased to $7,858,000 as of June 30, 2025, from $9,977,000 as of December 31, 2024, a decline of 21%[4] Business Operations - The company is focused on R&D and CDMO business units, with ongoing collaborations with the Max Planck Society and University Medical Center Gottingen[12] - The CDMO business is in early stages, with revenues of approximately $421 thousand generated from Scinai Bioservices for the six-month period ended June 30, 2025[15] - Revenues from CDMO recognized over time amounted to $182 for the six months ended June 30, 2025, slightly up from $180 in 2024[41] Grants and Funding - The Company submitted a €12 million grant application to fund approximately 80% of the costs for the next stage of PC111 development, which has received Orphan Drug Designation from the EMA[16] - The Company has received approximately $6,160 thousand in grants from the Israeli Innovation Authority, with $1,587 thousand supporting the CDMO business[25] - The maximum royalty amounts payable by the Company as of June 30, 2025, is approximately $5,161 thousand, representing the total gross amount of grants received[26] - The Company entered into a Standby Equity Purchase Agreement with YA II PN, Ltd. to purchase up to $10 million of ADSs during a 36-month period[31] - The Company raised approximately $1,492 in gross proceeds through drawdowns under the Purchase Agreement at a volume-weighted average price of approximately $2.9 per ADS, reflecting a 3% discount to the market price at the time[32] - In July and August 2025, the Company raised $4,203 in proceeds through drawdowns under the Standby Equity Purchase Agreement, issuing 1,638,062 ADSs at a volume-weighted average price of approximately $2.57 per ADS[43] Share-Based Compensation - The Company granted 900 RSUs to employees during the six months ended June 30, 2025, with a fair value of $3, compared to 55,725 RSUs granted in the same period of 2024 with a fair value of $290[34] - As of June 30, 2025, there are $278 of total unrecognized costs related to share-based compensation expected to be recognized over a period of up to four years[35] Accounting and Compliance - The Company is currently evaluating the impact of new accounting pronouncements on its financial statements[23] - The Company has recognized issuance-related costs of approximately $100 thousand in connection with the SEPA[31] Company Structure - The Company operates as one operating segment, with the chief operating decision maker using consolidated net loss to measure segment profit or loss[42]

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 ...

Financial Performance - As of March 31, 2025, the company had cash and cash equivalents and short-term deposits of $1,018 thousand, a decrease from $1,964 thousand as of March 31, 2024 [3] - Revenues for the three months ended March 31, 2025, totaled $586 thousand, reflecting a year-over-year increase driven by a higher number of contracts executed in the CDMO business [7] - R&D expenses for the same period amounted to $1,296 thousand, down from $1,568 thousand in 2024, primarily due to lower wages and reduced direct R&D expenses [7] - Marketing, general and administrative expenses were $500 thousand, slightly up from $484 thousand in the same period last year [7] - The net loss for the three months ended March 31, 2025, was $1,557 thousand, an improvement from a net loss of $2,159 thousand for the same period in 2024 [7] Business Overview - Scinai Immunotherapeutics Ltd. is a biopharmaceutical company focused on developing innovative biological drug candidates for inflammation and immunology-related diseases [4] - The company operates two business units: one for in-house development of biological therapeutic products and another as a boutique CDMO providing various drug development services [4] - The CDMO unit began generating revenues in the second quarter of 2024, with full-year revenues for 2024 reported at $658 thousand [7]

Summary of Scinai Immunotherapeutics (SCNI) Conference Call Company and Industry Overview - **Company**: Scinai Immunotherapeutics (SCNI) - **Industry**: Biotechnology, specifically focusing on treatments for rare autoimmune diseases such as pemphigus and Stevens Johnson syndrome (SJS) Key Points and Arguments 1. **Acquisition Announcement**: Scinai has entered into a binding option agreement to acquire the Italian biotech company, Pincell, and submitted a grant application for €12 million to develop PC-one hundred eleven [1][2] 2. **Overview of Diseases**: The call discussed pemphigus, SJS, and toxic epidermal necrolysis (TEN), highlighting their symptoms, implications, and current treatment landscape [8][9] 3. **Medical Need**: There is a significant unmet medical need for effective treatments for pemphigus and SJS, with pemphigus affecting approximately 2 million people globally and SJS being a rare but severe condition [14][19] 4. **Current Treatments**: Current therapies for pemphigus include glucocorticoids and rituximab, which have severe side effects and a high relapse rate. There are no approved therapies for SJS [21][22][44] 5. **PC-one hundred eleven Mechanism**: PC-one hundred eleven is a fully human monoclonal antibody targeting soluble Fas ligand, which plays a critical role in the pathogenesis of pemphigus and SJS. It blocks keratinocyte apoptosis and acantholysis, potentially preventing blister formation [26][27][43] 6. **Efficacy Comparison**: PC-one hundred eleven is expected to have a rapid onset of action and a better safety profile compared to current treatments like rituximab, which has a medium time to remission of around six months [41][43] 7. **Development Plans**: Scinai plans to conduct parallel development for PC-one hundred eleven, focusing on chronic pemphigus and acute SJS, with an expected approval timeline of three to four years [52][53] 8. **Market Size**: The addressable patient population for pemphigus in target countries is around 164,000, with a focus on relapsing refractory patients. For SJS, the addressable population is estimated at 15,000 [56][58] 9. **Pricing and Revenue Potential**: Potential peak revenues for PC-one hundred eleven are estimated at around $500 million, with an upside of over $1 billion for both pemphigus and SJS indications [63][64] 10. **Partnership Opportunities**: There is significant interest from pharmaceutical companies in smaller indications with transformational efficacy, which could lead to partnerships for PC-one hundred eleven [66][67] Additional Important Content - **Challenges in Clinical Trials**: The company plans to address challenges in conducting clinical trials for rare diseases by collaborating with scientific societies and patient advocacy groups to identify suitable trial sites [55] - **Safety Considerations**: The non-immunosuppressive nature of PC-one hundred eleven is expected to reduce the risk of infections and complications associated with current treatments, making it a safer option for patients [70] - **Combination Therapy Potential**: PC-one hundred eleven could be used in combination with existing therapies like rituximab for pemphigus and could enhance supportive care for SJS patients [49][51] This summary encapsulates the critical insights and developments discussed during the conference call, emphasizing the potential of PC-one hundred eleven in addressing significant medical needs in the treatment of rare autoimmune diseases.

Summary of Scinai Immunotherapeutics (SCNI) Update / Briefing May 07, 2025 Company Overview - **Company**: Scinai Immunotherapeutics (SCNI) - **Focus**: Development of PC-one hundred eleven, a fully human monoclonal antibody targeting soluble Fas ligand for the treatment of pemphigus and Stevens Johnson syndrome (SJS) / toxic epidermal necrolysis (TEN) [2][3][27] Industry Context - **Diseases Discussed**: Pemphigus, Stevens Johnson syndrome, and toxic epidermal necrolysis - **Medical Need**: Significant unmet medical need for effective treatments in these rare but severe autoimmune diseases [22][25] Key Points and Arguments Disease Overview - **Pemphigus**: A rare autoimmune disease characterized by painful blisters and erosions on skin and mucous membranes, with a mortality rate of 5% to 15% if untreated [14][15] - **SJS and TEN**: Rare diseases with high mortality rates, often triggered by medications, leading to severe skin and mucous membrane reactions [20][21] Current Treatment Landscape - **Pemphigus Treatments**: Current therapies include systemic glucocorticoids and immunosuppressants like rituximab, which have significant side effects and risks [22][23] - **SJS/TEN Treatments**: No approved therapies exist; treatment is primarily supportive care and withdrawal of the triggering medication [24][25] PC-one Hundred Eleven (PC-111) - **Mechanism of Action**: Targets soluble Fas ligand, blocking keratinocyte apoptosis and preventing blister formation [27][28] - **Efficacy**: Expected to provide a rapid onset of action and better safety profile compared to current treatments [44][45] - **Development Plans**: Two parallel development plans for chronic pemphigus (subcutaneous) and acute SJS/TEN (intravenous) [53][54] Market Considerations - **Market Size**: Estimated addressable patient population for pemphigus is around 30,000 in target countries, with a potential peak revenue of approximately $500 million to over $1 billion [57][64] - **Positioning**: PC-111 is expected to be positioned as a first-line therapy for pemphigus and as a rapid intervention for SJS/TEN [62][63] Safety and Efficacy - **Non-Immunosuppressive Profile**: PC-111's unique mechanism is expected to reduce the risk of infections and complications associated with immunosuppressive therapies [71] - **Combination Therapy Potential**: Can be used in combination with existing therapies like rituximab to enhance therapeutic effects [50][51] Development Challenges - **Clinical Trials**: Identifying sites with adequate patient availability is crucial for conducting trials in rare diseases [56] Collaboration Opportunities - **Pharma Partnerships**: Increased interest from pharmaceutical companies in smaller indications with significant effect sizes, presenting opportunities for collaboration [66][68] Additional Important Insights - **Regulatory Advantages**: Smaller studies with high effect sizes may receive favorable regulatory attention, facilitating faster approvals [68][70] - **Long-term Efficacy**: Preliminary data suggests low immunogenicity for PC-111, indicating sustained efficacy without the need for increased dosages [48][49] This summary encapsulates the critical insights from the conference, highlighting the potential of PC-one hundred eleven in addressing significant medical needs in the treatment of pemphigus and SJS/TEN.