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Scinai Awarded Israel Innovation Authority Grant to Expand Fill-and-Finish CDMO Capabilities
Prnewswire· 2025-10-06 11:30
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]
Scinai Immunotherapeutics .(SCNI) - 2025 Q2 - Quarterly Report
2025-09-02 20:16
Exhibit 99.2 SCINAI IMMUNOTHERAPEUTICS LTD. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS June 30, 2025 Unaudited SCINAI IMMUNOTHERAPEUTICS LTD CONSOLIDATED BALANCE SHEETS U.S. dollars in thousands | | | | December | | | --- | --- | --- | --- | --- | | | June 30, | | 31, | | | | 2025 | | 2024 | | | | Unaudited | | Audited | | | ASSETS | | | | | | CURRENT ASSETS: | | | | | | Cash and cash equivalents | $ | 989 | $ | 1,964 | | Restricted cash | | 142 | | 131 | | Prepaid expenses and other receivables | | 236 | ...
Scinai Reports Six-Month 2025 Financial Results Highlighting Continued CDMO Revenue Growth and Strengthened Balance Sheet
Prnewswire· 2025-09-02 11:30
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].
Scinai Announces New Peer-Reviewed Publication Supporting PC111 as a Disease-Modifying Therapy for Pemphigus and SJS/TEN
Prnewswire· 2025-07-29 11:15
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]
Scinai Immunotherapeutics Receives Italian Government Clearance Under Golden Power Regulation for Potential Acquisition of Pincell S.r.l.
Prnewswire· 2025-06-05 13:00
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].
Scinai Immunotherapeutics (SCNI) Earnings Call Presentation
2025-06-01 21:01
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 ...
Scinai Reports Q1 2025 Financial Results Highlighting Strong CDMO Revenue Momentum and Reduced Cash Burn
Prnewswire· 2025-05-30 11:00
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]
Scinai Immunotherapeutics (SCNI) M&A Announcement Transcript
2025-05-07 16:30
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.
Scinai Immunotherapeutics (SCNI) Update / Briefing Transcript
2025-05-07 16:30
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.
Scinai Immunotherapeutics .(SCNI) - 2024 Q4 - Annual Report
2025-05-07 11:42
Financial Performance - As of December 31, 2024, the company had cash and cash equivalents of $1.9 million, down from $4.9 million as of December 31, 2023[41]. - The company reported an operating loss of $8.6 million for the twelve months ended December 31, 2024, compared to a loss of $9.7 million for the same period in 2023[35]. - The accumulated deficit as of December 31, 2024, was $117.6 million, slightly improved from $122.5 million as of December 31, 2023[40]. - The current cash resources are insufficient to fund projected cash requirements for at least the next 12 months[41]. - The company has implemented a cost-saving plan, including layoffs and postponing capital expenditures[36]. - The company has not paid any cash dividends on the ADSs since inception and does not anticipate doing so in the foreseeable future[209]. Business Strategy and Development - The company has suspended further development of its COVID-19 NanoAb program due to decreased market interest and funding[47]. - The focus has shifted to developing NanoAbs targeting Interleukin-17 (IL-17) for conditions like plaque psoriasis and psoriatic arthritis, with a licensing agreement established in June 2023[47]. - The company is exploring an acquisition of the Italian biotech company Pincell srl, which owns a fully human monoclonal antibody[47]. - The option agreement for acquiring Pincell includes a requirement to secure $3 million by December 31, 2025, to fund the development of PC111, a monoclonal antibody[55]. - The company plans to commence a pre-clinical toxicology study for a novel VHH antibody for psoriasis in 2026[180]. - The company has established a CDMO business unit to leverage its laboratory and manufacturing capacity at its cGMP facility in Jerusalem[227]. Regulatory and Compliance Challenges - The company is focusing on the development of IL-17 NanoAb for treating psoriasis and psoriatic arthritis, facing significant regulatory challenges due to the novelty of the technology[51]. - The company may face delays in regulatory approvals due to the extensive requirements set by the FDA and other authorities, which can significantly impact commercialization timelines[59]. - Regulatory authorities may impose ongoing requirements even after approval, which could lead to loss of approvals if not complied with[62]. - The company must navigate complex regulatory environments, which may lead to increased costs and delays in product development and approval[60]. - The company is subject to extensive government regulation, which increases the cost and risk of developing and selling products[96]. - The company must comply with various federal and state healthcare laws, with non-compliance potentially resulting in significant penalties and operational restrictions[100]. Market and Competitive Landscape - The company faces competition from other products targeting the same conditions, including biosimilars, which could affect market share[64]. - The company has limited marketing capabilities and may struggle to develop its own sales force, impacting the commercialization of its product candidates[50]. - Market acceptance and sales of product candidates depend heavily on coverage and reimbursement policies from government authorities and third-party payors[89]. - In the U.S., reimbursement for pharmaceutical products varies significantly among third-party payors, impacting sales potential[90]. - The company faces significant competition from fully integrated pharmaceutical companies and smaller biotech firms, which may have greater financial resources and experience[120]. Clinical Trials and Development Risks - The company acknowledges the high rate of attrition in clinical trials, indicating that success in early trials does not guarantee later success[59]. - Participant enrollment in clinical trials is critical, and delays could significantly increase development costs and hinder timely regulatory approvals[80]. - The company may face challenges in achieving primary/secondary endpoints in clinical trials, which could necessitate additional studies and further delay commercialization[68]. - If clinical trials produce negative results, the company may be required to conduct additional trials, impacting the ability to obtain regulatory approval[77]. - The FDA may not accept data from clinical trials conducted outside the U.S., potentially leading to costly and time-consuming additional trials[74]. Operational and Financial Risks - The ability to continue operations is highly dependent on obtaining additional financing, which may not be available under favorable terms[41]. - The company faces challenges in identifying potential product candidates due to research methodology limitations[88]. - The company may struggle to find partners for the development of its COVID-19 NanoAb program, which is currently suspended due to low interest and funding[78]. - The company is exposed to potential product liability risks, which could result in substantial liabilities and affect its ability to market current and future product candidates[126]. - The company may face challenges in obtaining adequate insurance coverage, which could adversely affect its financial condition and ability to recruit qualified personnel[130]. Intellectual Property and Legal Risks - The company may face challenges in protecting its intellectual property rights, which could diminish its competitive position and future revenues[151]. - The company may need to engage in costly litigation to protect its intellectual property rights, which could divert management resources and attention[163]. - There is a risk that the company may be unable to obtain exclusive licenses for co-owned patents, potentially allowing competitors to market similar products[159]. - The company’s reliance on proprietary know-how and confidentiality agreements, but these may not provide adequate protection against unauthorized use or disclosure[161]. - The company may face significant expenses and liabilities from claims alleging violation of third-party intellectual property rights, which could harm its business[165]. External Factors and Market Conditions - The emergence of new COVID-19 variants poses ongoing risks to the company's operations and financial stability, potentially disrupting supply chains and access to capital[105]. - The ongoing conflict may disrupt the company's operations and supply chain, impacting business continuity[186]. - Moody's downgraded Israel's credit rating from A1 to A2, with a negative outlook, which may affect the company's ability to raise capital[185]. - The political and security situation in Israel may lead to delays in business agreements and affect supply chain logistics[178]. - The company is exposed to currency fluctuation risks due to operational expenses incurred in currencies other than the U.S. Dollar[198]. Nasdaq Compliance and Shareholder Issues - Failure to meet Nasdaq's continued listing requirements could result in delisting, adversely affecting market liquidity and share price[199]. - On November 1, 2023, the company received a notice of non-compliance from Nasdaq regarding the minimum bid price requirement of $1.00 per share, with a 180-day period to regain compliance[200]. - The company appealed the delisting determination and approved a reverse split of 1 for 10, increasing the number of Ordinary Shares represented by each ADS from 400 to 4,000, which allowed it to regain compliance with the Minimum Price Rule[200]. - On November 20, 2023, the company announced it had regained compliance with the Minimum Stockholders' Equity Rule after receiving formal notification from Nasdaq[201]. - A delisting from Nasdaq would likely negatively impact the price of the ADSs and impair shareholders' ability to trade their securities[205].