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 regained full compliance with Nasdaq listing requirements, specifically Rule 5550(b)(1) which mandates a minimum stockholders' equity of $2.5 million. This achievement follows the company's recent Loan Restructuring Agreement with European Investment Bank, converting approximately $29 million of debt to preferred equity. The restructuring has significantly improved Scinai's balance sheet, leaving a debt balance of only €250,000 (approximately $273,000).
CEO Amir Reichman expressed that this development allows the company to focus on its R&D programs and new CDMO business unit. However, Scinai will be subject to a Mandatory Panel Monitor for one year, during which any non-compliance with the Rule could result in immediate delisting proceedings without the opportunity for a compliance plan.
Scinai Immunotherapeutics (Nasdaq: SCNI) has closed a Loan Restructuring Agreement with the European Investment Bank (EIB), converting approximately $29 million of debt into 1,000 preferred shares. This leaves a debt balance of only $273,000, maturing on December 31, 2031, with no interest accrual or prepayment option.
The restructuring boosts Scinai's stockholders' equity above $2.5 million, potentially regaining compliance with Nasdaq Listing Rule 5550(b)(1). The preferred shares are convertible into ADSs representing 19.5% of the company's fully diluted capital, with a 12-month lock-up period and a 4.99% ownership limitation. Scinai retains the option to redeem the shares at a cumulative value of $34 million.
Scinai Immunotherapeutics (Nasdaq: SCNI) has entered into a $2 million Investment Commitment Agreement with RK Stone Miami , an affiliate of its largest shareholder, Daniel Stone. The agreement allows Scinai to issue and sell ADSs to the investor until December 31, 2024, with a minimum sale amount of $200,000 and a maximum of $500,000 per transaction. The ADS price will be calculated based on the lower of two VWAP methods, subject to a 5% discount.
The agreement includes provisions to prevent the investor from exceeding 9.99% ownership of outstanding ordinary shares, with pre-funded warrants issued if necessary. Scinai will pay a commitment fee of $100,000 if an advance notice is provided, or $40,000 if no advance is made during the commitment period. The company maintains discretion over initiating sales and is not required to register the ADSs for resale.
Scinai Immunotherapeutics (Nasdaq: SCNI) published its Q2 2024 financial results and provided a business update. Key highlights include:
1. Restructuring of a €26.6 million (~$29 million) EIB loan into equity, expected to close by August 23, 2024, to regain Nasdaq compliance.
2. CDMO business unit received work orders valued at ~$600K since January 2024, maintaining 2024 revenue guidance of $1.25 million.
3. Promising results from in-vivo proof of concept study for NanoAb in psoriasis treatment.
4. Positive regulatory feedback from PEI for Phase 1/2a clinical trial of anti-IL-17A/F nanoAb in Plaque Psoriasis.
5. Q2 2024 financial results: R&D expenses decreased to $2.79 million, net loss reduced to $4.48 million, and cash position of $3.08 million as of June 30, 2024.
Scinai Immunotherapeutics (NASDAQ: SCNI) has signed a Loan Restructuring Agreement with the European Investment Bank (EIB), converting approximately $29 million of debt into 1,000 preferred shares. These shares are convertible into 19.5% of the company's fully diluted capital. The remaining loan of about $273,000 will mature on December 31, 2031, with no interest accrual.
The preferred shares are redeemable at the company's discretion for a cumulative value of $34 million. This restructuring eliminates nearly $28 million of debt, potentially establishing a more stable financial base for Scinai's plans to develop novel therapeutics for inflammation and immunology diseases.
Scinai Immunotherapeutics (NASDAQ: SCNI) has received positive regulatory feedback from the Paul Erlich Institute (PEI) for its anti-IL-17A/F nanoAb (SCN-1) drug development program in Plaque Psoriasis. Key points include:
1. Toxicology studies can be conducted in pigs instead of non-human primates.
2. Phase 1/2a clinical trial can assess both safety and efficacy, skipping healthy volunteer testing.
3. Comparison of SCN-1 to placebo on the same human subject is approved.
4. Manufacturing process and specifications are deemed acceptable.
The Phase 1/2a study, expected to include 24 patients, is planned for the second half of 2025 with results in 2026. This feedback could lead to significant time and cost savings in Scinai's drug development plans for mild to moderate plaque psoriasis treatment.
Scinai Immunotherapeutics (Nasdaq: SCNI) has announced promising results from an in-vivo preclinical study of its anti IL-17A/F VHH antibody fragment ('NanoAb') for treating mild to moderate plaque psoriasis. The study, conducted by Prof. Amos Gilhar's team at the Technion, used a human skin transplant model on mice to compare Scinai's NanoAb with approved drugs.
Key findings include:
- NanoAb's ability to neutralize both IL-17A and IL-17F isoforms was confirmed in-vivo
- The anti-inflammatory effect was similar to comparator drugs
- Results support the potential of intralesional NanoAb injection to reduce psoriatic lesion severity
Scinai plans further studies in late 2024 and aims for a first-in-human clinical trial in late 2025.
Scinai Immunotherapeutics has received an updated Letter of Intent (LoI) from the European Investment Bank (EIB) for converting a major portion of its loan into equity. The conversion involves converting $28 million of the loan into Preferred Shares, which are convertible into American Depositary Shares (ADSs), representing 19.5% of the company's fully diluted capital. The new terms eliminate variable remuneration and mandatory dividends, making the terms favorable for Scinai. The company aims to address Nasdaq's minimum shareholders' equity requirement and has presented a plan to regain compliance. The updated LoI needs approval from EIB's governing bodies and an amendment to Scinai's articles of association. The company plans to hold a shareholder meeting on August 12, 2024, to authorize these changes.
Scinai believes this conversion will significantly reduce its long-term liabilities and improve its financial standing. The conversion is expected to eliminate a shareholders' deficit of $5.1 million, creating a surplus in shareholders' equity. The company plans to file the necessary financial statements for Q2 2024 to ensure compliance with Nasdaq's requirements.
Scinai Immunotherapeutics has been granted an extension by the Nasdaq Hearings Panel to regain compliance with continued listing requirements. The company must meet certain conditions, including filing a public disclosure by August 14, 2024, to demonstrate compliance with the equity requirement of maintaining at least $2,500,000 in stockholders' equity. Previously, on May 20, 2024, Scinai had received a notification from Nasdaq about its non-compliance. During a hearing on June 18th, the company presented a plan to convert a significant portion of its loan from the European Investment Bank into equity, which led to an extension for continued listing. However, there is no assurance that Scinai will meet the imposed deadlines or conditions.
Scinai Immunotherapeutics (Nasdaq: SCNI) announced its Q1 2024 financial results, revealing key developments and financial metrics. The company raised $1.69 million via warrants issuance in January and regained compliance with Nasdaq’s $1.00 bid price requirement in June but remains non-compliant with the equity requirement.
The CDMO unit received $500K in work orders in the first half of 2024, with projected 2024 revenues of $1.25 million. Pipeline developments include promising preclinical results for NanoAb treatments for plaque psoriasis and collaborations for COVID-19 and anti-IL-17 treatments.
Financially, Scinai reported a net loss of $2.159 million, down from $3.515 million in Q1 2023. R&D expenses decreased to $1.568 million, and marketing, general, and administrative expenses fell to $484K. As of March 31, 2024, the company held $4.826 million in cash and equivalents.
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