Scinai Immunotherapeutics Ltd. SEC Filings

Scinai Immunotherapeutics Ltd. disclosed that investor Daniel E. Stone and RK Stone Miami, LLC together beneficially own 584,534 American Depositary Shares (ADSs), representing 16.61% of the ADS class. Each ADS represents 4,000 ordinary shares. Stone individually reports 346,667 ADSs with sole voting and dispositive power, while RK Stone Miami, LLC reports 237,867 ADSs with sole voting and dispositive power.

The filing explains that RK Stone Miami, LLC holds ADSs and pre-funded warrants that cannot be exercised if this would raise its beneficial ownership, together with affiliates and certain other persons, above 9.99% of the issuer’s ordinary shares. The reporting persons certify the securities are not held for the purpose of changing or influencing control of the company.

Scinai Immunotherapeutics Ltd. completed the acquisition of 100% of the shares of Recipharm Israel Ltd., which operates a cGMP active pharmaceutical ingredient manufacturing site in Yavne, Israel, and entered into a long-term strategic commercial collaboration with Recipharm.

The deal adds a second Israeli facility to Scinai’s CDMO platform, broadening its services from early chemistry development and small-scale API manufacturing through to late-stage clinical and commercial supply via Recipharm’s global network. The collaboration is structured around planned Master Quality and Tech Transfer Framework Agreements to support seamless client transitions as programs advance.

Scinai Immunotherapeutics Ltd. scheduled its Annual General Meeting of Shareholders for December 22, 2025 at 11:00 a.m. Israel time at Goldfarb Gross Seligman & Co., One Azrieli Center, Round Tower, Tel Aviv.

The company furnished a Notice and Proxy Statement as Exhibit 99.1 and a Proxy Card as Exhibit 99.2. This report is incorporated by reference into the company’s Registration Statements on Forms S-8 (File Nos. 333-271293, 333-239344) and F-3 (File Nos. 333-274078, 333-276767).

Scinai Immunotherapeutics reported governance and audit changes linked to cost-cutting. Prof. Avner Rotman and Dr. Morris Laster tendered resignations as directors, effective December 31, 2025, at the request of the Chairman and after consultation with major shareholders.

The Audit Committee recommended appointing Ziv Haft as independent registered public accounting firm for the fiscal year ending December 31, 2025 and until the next annual meeting, subject to shareholder approval. PwC’s engagement will conclude at the upcoming meeting. The company noted no disagreements and no reportable events with PwC for 2023 and 2024.

Scinai Immunotherapeutics Ltd. filed a Form S-8 to register an additional 4,000,000,000 ordinary shares, no par value, deposited as American Depositary Shares represented by ADRs, for issuance under the Company’s 2018 Israeli Share Option Plan.

This filing adds capacity for equity compensation grants under the plan. The document incorporates by reference the Company’s future Exchange Act reports and includes standard undertakings, exhibit references, and Israeli law indemnification provisions for directors and officers.

Scinai Immunotherapeutics Ltd. filed a Form 6-K describing a new grant award from the Israel Innovation Authority. The grant is intended to support expansion of the company’s fill-and-finish capabilities as a contract development and manufacturing organization (CDMO), which are services used by biopharma companies to prepare and package biological products.

The company reports that it issued a press release about this grant on October 6, 2025, which is attached as an exhibit to the filing. Scinai also states that this Form 6-K, with limited exceptions, is incorporated by reference into its existing registration statements on Form S-8 and Form F-3, meaning the disclosed information becomes part of those previously filed securities registration documents.

Scinai Immunotherapeutics Ltd. (SCNI) Schedule 13G/A reports that Daniel E. Stone and RK Stone Miami, LLC disclosed beneficial ownership in the issuer's American Depositary Shares, each representing 4,000 ordinary shares. Daniel E. Stone reports 346,667 ADSs (9.9%) and RK Stone Miami, LLC reports 282,467 ADSs (8.1%). The filing notes RK holds a mix of directly held ADSs and ADSs issuable upon exercise of pre-funded warrants and that exercise is limited to avoid beneficial ownership above 9.99%. The filers certify the holdings were not acquired to influence control.

Scinai Immunotherapeutics Ltd. reports that a Euro 12 million non-dilutive grant application to fund further development of PC111, a monoclonal antibody licensed from Italian biotech Pincell srl, was not selected for funding by Poland’s National Center for Research and Development under the FENG program. PC111 is being developed for pemphigus vulgaris, Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis.

The notification is an interim decision, and Scinai plans to appeal within the allowed 14-day period. The appeal is expected to be reviewed within about one month after submission, with a final determination anticipated before the end of 2025. The company believes aspects of the project were misconstrued or misanalyzed and will focus its appeal on those points, while cautioning there is no assurance the grant will ultimately be awarded.

Scinai Immunotherapeutics Ltd. entered a new Standby Equity Purchase Agreement with YA II PN, Ltd. (Yorkville), giving Scinai the right, but not the obligation, to sell up to $15.0 million of its American Depositary Shares over 36 months. The ADSs, each representing 4,000 ordinary shares, will be priced at 97% of the lowest of three daily VWAPs during the three trading days starting on the date Scinai delivers an Advance Notice, and Scinai may set a minimum price per ADS in each Advance. Yorkville’s beneficial ownership is capped at 9.99% of the company’s voting power or ordinary shares. Scinai will pay a $108,000 commitment fee, half via issuance of 35,461 ADSs and half in cash, and the prior March 3, 2025 standby equity agreement with Yorkville will terminate once the new related registration statement is declared effective.