Scinai Immunotherapeutics Ltd. Stock Price, News & Analysis

Scinai Immunotherapeutics (NASDAQ: SCNI) reported its H1 2025 financial results, showcasing growth in its CDMO business. Revenues reached $773,000, up from $284,000 in H1 2024, while net loss decreased to $4.13 million from $4.48 million.

The company strengthened its balance sheet through a $4.2 million raise via its Standby Equity Purchase Agreement. CDMO operations generated $1.0 million in total orders for 2025, with $850,000 already invoiced. R&D initiatives include advancing anti-IL-17 NanoAb programs, pursuing EU grant funding, and exploring an acquisition opportunity with PinCell srl.

Scinai Immunotherapeutics (NASDAQ:SCNI) announced a new peer-reviewed publication validating PC111, their first-in-class human anti-Fas Ligand monoclonal antibody, as a potential disease-modifying therapy for pemphigus and SJS/TEN. The research, published in the Journal of Dermatological Treatment, demonstrates PC111's ability to prevent blister formation across multiple study models.

The study confirms PC111's unique non-immunosuppressive mechanism, acting locally at the keratinocyte level. The treatment represents a market opportunity exceeding $1 billion annually. Scinai and Pincell plan to advance PC111 through IND-enabling studies, with potential market entry in 3-4 years. The program may receive up to 80% cost coverage through a €15 million FENG grant, pending Q3 2025 decision.

Scinai Immunotherapeutics (NASDAQ:SCNI) announces that Dr. Roberta Lotti from Pincell Srl has received the prestigious "Oscar of Italian Dermatology" for her groundbreaking research on PC111, a first-in-class anti-Fas Ligand monoclonal antibody. The award recognizes Dr. Lotti's paper demonstrating PC111's efficacy in treating pemphigus through a novel, non-immunosuppressive approach.

PC111, which Scinai has rights to through a strategic option agreement to acquire Pincell srl, targets soluble Fas Ligand (sFasL) in Pemphigus Vulgaris (PV) and Stevens-Johnson/Toxic Epidermal Necrolysis (SJS/TEN). The research confirms that PC111 blocks blister formation by inhibiting keratinocyte apoptosis, representing a potential paradigm shift from current immunosuppressive treatments.

Scinai Immunotherapeutics (NASDAQ: SCNI) announced CEO Amir Reichman's participation in BIO International Convention 2025, highlighting recent company developments. The company secured $1.38M through a SEPA with Yorkville Advisors at $3.03 per ADS. Scinai's CDMO business shows strong growth, with Q1 2025 revenues nearly matching full-year 2024, leading to 2025 revenue guidance of $2M. The company expects CDMO unit breakeven by end-2026, with potential annual revenue of $12M under a single production shift. A cost-reduction program is expected to reduce annual employment expenses by $815,000. The company aims to advance its nanobody pipeline while expanding CDMO operations, with CEO Reichman scheduled to meet potential partners and investors at the upcoming convention.

Scinai Immunotherapeutics (NASDAQ: SCNI) has received Italian government clearance under the Golden Power regulation for its potential acquisition of Pincell S.r.l., an Italian biotech company. The approval, granted after review by the Coordination Group and Ministry of Health, removes a major regulatory hurdle for the acquisition planned since March 2025. Pincell's key asset is PC111, a human monoclonal antibody targeting Fas/FasL pathway for severe dermatological conditions, which has received EMA Orphan Drug Designation for Pemphigus. Scinai's Polish subsidiary has applied for a €12 million FENG grant to fund PC111's development, with a decision expected by August 2025. The acquisition's completion remains contingent on successful grant approval and other customary conditions.

Scinai Immunotherapeutics (NASDAQ: SCNI) reported Q1 2025 financial results, showing significant progress in its CDMO business unit. Revenues reached $586 thousand, demonstrating strong growth compared to 2024 when CDMO operations began. R&D expenses decreased to $1,296 thousand from $1,568 thousand year-over-year, while marketing and administrative expenses slightly increased to $500 thousand. The company's net loss improved to $1,557 thousand from $2,159 thousand in Q1 2024, primarily due to lower R&D expenses, reduced financial expenses, and revenue recognition. Cash position stood at $1,018 thousand as of March 31, 2025, down from $1,964 thousand year-over-year.

Scinai Immunotherapeutics (NASDAQ: SCNI) reported its 2024 annual financial results, marking significant changes in its financial position. The company generated its first-ever revenue of $658,000 through its CDMO business unit. R&D expenses slightly increased to $5.6 million from $5.2 million in 2023. Marketing and administrative expenses decreased to $2.6 million from $4.5 million. Notably, the company achieved a net gain of $4.8 million in 2024, compared to a $6.5 million loss in 2023, primarily due to $14.8 million in financial income from loan conversion to equity. However, cash position decreased to $1.9 million as of December 31, 2024, down from $4.9 million in 2023.

Scinai Immunotherapeutics (NASDAQ: SCNI) announced a webinar scheduled for May 7th, 2025, at 11:30 AM EST to discuss PC111, a novel monoclonal antibody targeting soluble Fas ligand (sFasL) for treating Pemphigus Vulgaris and Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN). The webinar follows Scinai's March 27th binding option agreement to acquire Italian biotech Pincell srl.

The company's Polish subsidiary has submitted a €12 million grant application under the European Funds for Modern Economy program, with a decision expected in Q3 2025. The webinar will feature key executives and medical experts who will discuss the diseases, current treatments, and PC111's development plan.

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