Welcome to our dedicated page for Scinai Immunotherapeutics Ltd. news (Ticker: SCNI), a resource for investors and traders seeking the latest updates and insights on Scinai Immunotherapeutics Ltd. stock.
Overview
Scinai Immunotherapeutics Ltd. (SCNI) is a biopharmaceutical company with a dual-focus business model that integrates in-house research and development of novel inflammation and immunology therapeutic products with a robust Contract Development and Manufacturing Organization (CDMO) service. Leveraging state-of-the-art technology and a deep understanding of biologic therapeutics, Scinai specializes in the development of nanosized VHH antibodies (NanoAbs) designed to address diseases with significant unmet medical needs. The company operates in an environment driven by cutting-edge scientific research, clinical expertise, and stringent manufacturing standards.
Innovative Therapeutic Platform
At the core of Scinai’s operations is a diversified therapeutic pipeline anchored in the development of NanoAbs. These nanoscale antibody fragments are engineered to offer targeted modulation of the immune response, particularly within the realms of inflammation and immunology. By focusing on localized biological treatments, the company aims to enhance the specificity and potency of biologic drugs while mitigating risks associated with conventional therapies. The scientific approach exemplifies the company’s commitment to technological innovation and demonstrates a clear expertise in antibody engineering and molecular biology.
Clinical and Regulatory Experience
Scinai has built a solid reputation in the biopharmaceutical sector through its execution of multiple clinical trials across various international markets. With extensive clinical research experience, the company has tested its therapeutic candidates in diverse populations, ensuring that its products are both effective and safe. The company’s operations are supported by a state-of-the-art, GMP-compliant biologics manufacturing facility, which adheres to the highest regulatory standards and quality control measures. Such regulatory compliance underscores Scinai’s commitment to transparency, reliability, and the highest standards of industry practice.
CDMO Services
Complementing its in-house product development, Scinai also operates a boutique CDMO business unit. This division offers a full range of services including biological drug development, clinical cGMP manufacturing, analytical methods development, and the design and execution of both pre-clinical and clinical trials. The CDMO model is strategically positioned to serve early stage biotech companies looking for efficient project onboarding and high-quality manufacturing services. This integrated approach not only supports the company’s own R&D initiatives but also enhances its reputation as a trusted partner in the biopharmaceutical industry.
Operational Excellence and Industry Expertise
Scinai’s operational prowess is rooted in its cutting-edge manufacturing capabilities and multidisciplinary scientific teams. The company’s internal focus on developing and optimizing its NanoAb platform reflects a commitment to addressing specific therapeutic needs within the fields of inflammation and immunology. By pursuing a strategy that combines innovation with proven development processes, Scinai ensures that its product candidates are developed in compliance with rigorous quality standards. Detailed process control, robust analytical methods, and adherence to strict cGMP requirements contribute to establishing Scinai as a technically proficient and reliable organization in the evolving biopharmaceutical landscape.
Significance in the Competitive Landscape
Within a competitive field characterized by rapid scientific advancement and high regulatory expectations, Scinai Immunotherapeutics Ltd. distinguishes itself through its dual focus on novel therapeutic product development and CDMO service provision. The company’s ability to successfully bridge advanced R&D with high-quality manufacturing services places it in a unique strategic position. Its use of cutting-edge nanosized antibodies and commitment to delivering localized, potent treatment modalities ensure that it remains a credible and authoritative entity within the industry. Whether by executing complex clinical trials or delivering precise contract manufacturing solutions, Scinai continuously reinforces its expertise, authoritativeness, and overall trustworthiness to both industry peers and investors.
Key Highlights
- Diversified Pipeline: Focus on developing nanosized antibody therapeutics for inflammation and immunological disorders.
- Robust Clinical Expertise: Extensive experience executing clinical trials across multiple international markets.
- CDMO Services: Comprehensive biologics development, manufacturing, and analytical services tailored for early stage biotechs.
- Quality Manufacturing: Fully GMP-compliant facilities ensuring the highest standards of product quality and regulatory compliance.
- Scientific Innovation: Advanced technology platforms including precision antibody engineering and localized biologic treatments.
This comprehensive integration of research, development, and manufacturing expertise positions Scinai Immunotherapeutics Ltd. as a trusted and innovative player in the biopharmaceutical sector. The company’s focus on addressing significant medical needs through advanced NanoAb technology, coupled with its commitment to operational excellence in CDMO services, reinforces its standing as an authority in both therapeutic development and high-quality biologics manufacturing.
Scinai Immunotherapeutics (Nasdaq: SCNI) has entered a binding option agreement to acquire Italian biotech company Pincell srl. The acquisition centers around PC111, a monoclonal antibody in development for treating severe dermatological conditions including Pemphigus, Steven Johnson's Syndrome (SJS), and Toxic Epidermal Necrolysis (TEN).
Key developments include:
- PC111 has received Orphan Drug Designation in Pemphigus from the European Medicines Agency
- Plans to file for FDA Orphan Drug and Breakthrough Designation for both Pemphigus and SJS/TEN
- Scinai's Polish subsidiary has submitted a €12 million grant application under the European Funds for Modern Economy program
- Grant decision expected by mid-July/beginning of August 2025
Scinai Immunotherapeutics (NASDAQ: SCNI) has announced its participation in the BIO-Europe Spring 2025 conference in Milan, Italy, from March 17-19. The company's leadership team, including CEO Amir Reichman, CTO Dr. Dalit Weinstein-Fischer, and Business Development Director Solomon Gahtan, will engage with various stakeholders.
The company will focus on three main objectives: showcasing their inflammation and immunology (I&I) product pipeline to potential pharma partners interested in co-development or licensing of NanoAbs, presenting their end-to-end biologics CDMO services, and meeting with institutional and private investors. Interested parties can schedule meetings through the conference partnering platform or by emailing bd@scinai.com. Scinai will maintain presence at exhibitor booth #22 throughout the conference.
Scinai Immunotherapeutics (Nasdaq: SCNI) has secured a $10 million Standby Equity Purchase Agreement (SEPA) with Yorkville Advisors Global's fund YA II PN, The three-year agreement allows Scinai to sell American Depository Shares (ADSs) at its discretion, with each ADS representing 4,000 ordinary shares.
The purchase price will be set at a 3% discount to the lowest daily volume-weighted average price over three consecutive trading days. Key features include:
- No obligation to utilize the facility
- 9.99% beneficial ownership cap
- No minimum commitments or penalties
- No restrictions on other capital-raising activities
The company plans to use potential proceeds for developing NanoAbs programs, supporting its CDMO business, and general corporate purposes including R&D, regulatory matters, and capital investments.
Scinai Immunotherapeutics (Nasdaq: SCNI), a biopharmaceutical company focused on inflammation and immunology products and CDMO services, has announced its leadership's participation in three major US healthcare conferences in January 2025. CEO Amir Reichman and Board Chairman Mark Germain will attend the IATI Mini Mixiii Conference in Miami (Jan 9), the JP Morgan HealthCare Conference in San Francisco (Jan 13-15), and the SIC Biotech Symposium in San Francisco (Jan 14).
During these events, they will meet with institutional and private investors, potential pharma partners interested in their NanoAbs technology, and prospective CDMO services clients. Interested parties can schedule meetings through the conference platforms or by contacting ir@scinai.com. The company has also released a video showcasing their 2024 achievements.
Scinai Immunotherapeutics (Nasdaq: SCNI) has established a U.S. subsidiary, Scinai Bioservices Inc., for its Contract Development and Manufacturing Services (CDMO) business unit. The company's Jerusalem facility includes 20,000 square feet of clean rooms and laboratories operating under cGMP conditions, compliant with EMA and FDA requirements.
Since launching in 2024, the CDMO unit has executed drug development projects for nine biotech companies, including process development, scale-up, and drug manufacturing services. The U.S. expansion aims to capitalize on growing demand for biological early-stage drug development services, particularly amid capacity constraints and the BIOSECURE Act's restrictions on foreign biotech companies. The company has already secured its first U.S. customer, Serpin Pharma, for clinical manufacturing support.
Scinai Immunotherapeutics (Nasdaq: SCNI) has appointed Prof. Michael Schön to its Scientific Advisory Board. Prof. Schön is currently the Director of Dermatology, Venereology, and Allergology at the University Medical Center Göttingen and serves as Vice Dean and Deputy Director for Research and Teaching. He brings extensive expertise in dermatology and immunology, with over 440 scientific publications and significant experience in treating inflammatory skin diseases.
Prof. Schön expressed enthusiasm about contributing to Scinai's innovative pipeline, particularly in addressing unmet medical needs in chronic inflammatory skin diseases. The company's CEO, Amir Reichman, highlighted Prof. Schön's expertise in psoriasis and atopic dermatitis as valuable assets for advancing Scinai's inflammation and immunology biological products pipeline.
Scinai Immunotherapeutics (Nasdaq: SCNI) has appointed Dr. Jonathan Sadeh to its Scientific Advisory Board. Dr. Sadeh, former Senior Vice President of Immunology R&D at Bristol-Myers Squibb, brings over 20 years of experience in drug development and clinical research. He will focus on advancing Scinai's lead IL-17 program and VHH antibody pipeline. At BMS, he led multiple drug approvals, including Sotyktu for psoriasis. Dr. Sadeh previously held senior positions at Sanofi, AstraZeneca, and Schering-Plough, and earned his MD from Mount Sinai School of Medicine and M.Sc. from Harvard Medical School.
Scinai Immunotherapeutics (NASDAQ: SCNI) reported financial results for the nine months ended September 30, 2024. The company's shareholders' equity improved to positive $10 million from negative $7.3 million, primarily due to the conversion of a EUR 26.6 million EIB loan into preferred shares. Revenue reached $452,000, compared to no revenues in the same period of 2023. The company reported a net gain of $7,026,000 versus a net loss of $4,170,000 in the previous year. Cash position decreased to $1,169,000 from $5,010,000. The CDMO business unit received work orders valued at approximately $600,000 and expects material revenue growth in coming years.
Scinai Immunotherapeutics (Nasdaq: SCNI) announced its participation in the BIO-Europe 2024 conference in Stockholm, Sweden, from November 4-6. The company's leadership team will showcase their cGMP biologics CDMO services and innovative I&I pipeline. CEO Amir Reichman and CTO Dr. Dalit Weinstein-Fischer will hold meetings with potential CDMO clients, pharma partners interested in NanoAbs and dermatology programs (including their psoriasis treatment), and investors. The company will be exhibiting at booth #150.
Scinai Immunotherapeutics (Nasdaq: SCNI) is hosting a scientific webinar on September 18, 2024, at 11 AM EDT / 18:00 Israel time. The event will focus on treating mild to moderate plaque psoriasis using intralesional injections of Scinai's novel anti-IL-17A/F VHH antibody. The panel will feature experts including Scinai's CEO and CSO, along with professors from the University Medical Center Göttingen.
The webinar will cover:
- Current plaque psoriasis treatment landscape and unmet needs
- Introduction to single domain VHH antibodies
- Scinai's pipeline and biological drug development process
- Advantages of VHH antibodies over conventional monoclonal antibodies
- Scinai's pre-clinical results and plans for clinical trials
Participants can register for the Zoom webinar and will have the opportunity to ask questions during a Q&A session.
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