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 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].