Core Insights - Scinai Immunotherapeutics Ltd. reported financial results for the nine months ended September 30, 2025, highlighting significant progress in both its CDMO and R&D business units [1][13]. Financial Summary - As of September 30, 2025, cash, cash equivalents, and short-term deposits totaled $3,005 thousand, an increase from $1,964 thousand as of September 30, 2024 [3]. - Revenues for the nine months ended September 30, 2025, were $1,049 thousand, compared to $452 thousand for the same period in 2024, reflecting growth in Scinai Bioservices [7]. - R&D expenses decreased to $1,799 thousand from $4,195 thousand year-over-year, primarily due to lower employee and facility cost allocations [7]. - Marketing, general, and administrative expenses increased to $1,929 thousand from $1,767 thousand, mainly due to insurance reimbursements recorded in 2024 [7]. - The net loss for the nine months ended September 30, 2025, was $6,244 thousand, compared to a net profit of $7,026 thousand for the same period in 2024, largely due to financial income from loan conversion recognized in 2024 [7]. Business Update - Scinai Bioservices is expanding its role as a boutique CDMO, serving early-stage biotech companies in Israel, the U.S., and Europe [4]. - The company received a non-dilutive grant of approximately NIS 809,000 (about $246,000) from the Israel Innovation Authority to fund part of an investment in an advanced sterile fill-and-finish system [8]. - The new system aims to enhance small-batch manufacturing capacity for early-stage biotech clients, with installation expected in Q1 2026 and commercial operations planned for Q2 2026 [8]. R&D Developments - Scinai is advancing its NanoAb pipeline focused on inflammation and immunology, with two STEP grant applications of up to €15 million each, with decisions expected in Q1 2026 [6]. - The lead program, SCN-1, is approaching Phase 1/2a for mild-moderate psoriasis, with a grant application decision expected in Q1 2026 [7]. - The company is evaluating the future of the PC111 program after its €12 million grant application was not approved, considering alternative funding routes or potential termination of the acquisition option for Pincell Srl [10][11]. Partnering Outlook - Scinai is actively seeking partnerships for co-development, licensing, or broader collaborations across all pipeline programs [12]. CEO Statement - The CEO emphasized significant progress in 2025, noting the strengthening of CDMO operations and the ongoing evaluation of strategic paths for R&D programs, particularly in light of recent grant outcomes [13].

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]

FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Scinai Immunotherapeutics Ltd. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Israel 2836 Not Applicable As filed with the United States Securities and Exchange Commission on September 22, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (I.R.S. Employer Identificatio ...

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].

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]

Core Viewpoint - Scinai Immunotherapeutics Ltd. has filed for a Euro 12 million grant to support the development of its monoclonal antibody PC111, which targets severe dermatological conditions, and has entered into an option agreement to acquire the Italian biotech company Pincell srl [1][2][7]. Company Overview - Scinai Immunotherapeutics Ltd. specializes in inflammation and immunology biological products and offers CDMO services through its Scinai Bioservices unit [1][10]. - Pincell srl focuses on developing first-in-class anti-inflammatory therapies for rare and severe skin diseases, founded by experts in dermatology [11]. Product Development - PC111 is a fully human monoclonal antibody that blocks the activation of apoptosis in skin cells, addressing significant unmet medical needs in skin blistering disorders [3][5]. - The antibody has shown potential in preclinical studies to block blister formation in pemphigus without the use of steroids, indicating its promise as a targeted therapy [5][7]. Grant Application - The grant application submitted by Scinai's Polish subsidiary is part of the European Funds for a Modern Economy (FENG) program, with a decision expected by mid-July to early August [2]. - The funding will primarily be non-dilutive, requiring only Euro 3 million from Scinai's capital, which is one-fifth of the total budget [8]. Market Need - Pemphigus, Stevens-Johnson Syndrome (SJS), and Toxic Epidermal Necrolysis (TEN) are severe conditions with high mortality rates (5-10% for pemphigus and SJS, 30-40% for TEN), highlighting the urgent need for effective treatments [6][7]. Strategic Partnership - The acquisition of Pincell is expected to enhance Scinai's capabilities in developing PC111, leveraging Pincell's expertise in dermatology and research [8][9]. - The management team from Pincell will integrate into Scinai's operations, further strengthening the collaboration [9].

Core Insights - Scinai Bioservices, a CDMO unit launched by Scinai in 2024, operates from a facility in Jerusalem, Israel, featuring 1,850 square meters of clean rooms and laboratories compliant with cGMP standards [2][3] - The CDMO unit has engaged in drug development projects for various biotech companies, including upstream and downstream process development, scale-up, and drug manufacturing for clinical trials [3] - Scinai's U.S. subsidiary, Scinai Bioservices Inc., aims to support early-stage biotech companies in the U.S. by providing essential CDMO services that are currently in short supply [4] Company Overview - Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) operates two business units: one focused on developing biological therapeutic products for inflammation and immunology, and the other providing CDMO services to early-stage biotech companies [5] - The company is actively seeking partnerships with potential pharma partners in the fields of inflammation and immunology, as well as institutional and private investors interested in its value proposition [7]

Core Viewpoint - Scinai Immunotherapeutics Ltd. has entered into a Standby Equity Purchase Agreement (SEPA) with Yorkville Advisors, allowing the company to sell up to $10 million of its American Depository Shares (ADSs) over a three-year period to support its R&D and CDMO business expansion [1][2][5]. Group 1: SEPA Details - The SEPA allows Scinai to sell ADSs at a 3% discount to the lowest daily volume-weighted average price over three consecutive trading days following an advance notice [3]. - Scinai retains full control over the timing and amount of sales under the SEPA, with no obligation to utilize the full $10 million [4]. - The agreement includes a beneficial ownership cap of 9.99% of Scinai's share capital at any one time, along with other restrictions [2]. Group 2: Use of Proceeds - Proceeds from the potential offering of ADSs under the SEPA will be used to further develop NanoAbs programs, support the CDMO business, and for general corporate purposes including working capital and regulatory matters [5]. Group 3: Company Overview - Scinai Immunotherapeutics is focused on developing inflammation and immunology biological products and offers CDMO services through its Scinai Bioservices unit [1][7]. - The company has a pipeline of nanosized VHH antibodies (NanoAbs) targeting diseases with significant unmet medical needs [7].