Scinai Immunotherapeutics Ltd. Stock Price, News & Analysis

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.

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.