Investment Commitment Agreement - Scinai Immunotherapeutics has entered into a $2 million Investment Commitment Agreement with RK Stone Miami LLC, an affiliate of its largest shareholder, Daniel Stone [1] - The agreement allows the company to issue and sell American Depositary Shares (ADSs) to the investor, with a total purchase price of up to $2 million, through December 31, 2024 [2] - Each sale of ADSs can be initiated by the company, with a minimum amount of $200,000 and a maximum of $500,000 per notice, and a monthly cap of $500,000 [2] - The price of ADSs will be based on the lower of the 10-day or 3-day volume-weighted average price (VWAP), subject to a 5% discount [2] - If the investor's ownership exceeds 9.99% of ordinary shares after issuing ADSs, the number of ADSs will be reduced, and pre-funded warrants will be issued for the reduced amount [3] Commitment Fee - The company will pay a commitment fee of $100,000 if it provides an advance notice during the commitment period, payable in cash or ADSs at the company's discretion [4] - If no advance notice is provided, the commitment fee will be $40,000, payable promptly after the commitment period ends, also in cash or ADSs [4] Company Overview - Scinai Immunotherapeutics is a biopharmaceutical company with two business units: one focused on developing inflammation and immunology (I&I) biological products, and the other providing CDMO services through its Scinai Bioservices unit [6] - The company's I&I pipeline includes innovative nanosized VHH antibodies (NanoAbs) targeting diseases with significant unmet medical needs [6] - The CDMO unit offers services such as biological drug development, analytical methods development, clinical cGMP manufacturing, and pre-clinical and clinical trial design and execution [6]

JERUSALEM, Aug. 13, 2024 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) (the "Company"), a biopharmaceutical company focused on developing inflammation and immunology (I&I) biological products and on providing CDMO services through its Scinai Bioservices business unit, today announced that it has signed a definitive Loan Restructuring Agreement (the "Restructuring Agreement") with its lender, the European Investment Bank (the "EIB"). The Restructuring Agreement also included an amendment and ...

Core Viewpoint - Scinai Immunotherapeutics received positive regulatory feedback from the Paul Erlich Institute (PEI) regarding its anti-IL-17A/F nanoAb (SCN-1) drug development program for treating mild to moderate plaque psoriasis, which is expected to lead to significant time and cost savings in the clinical trial process [10][11][21]. Drug Development Program - The company plans to initiate a preclinical toxicology study in preparation for a first-in-human clinical trial of SCN-1, anticipated to start in late 2025 [3][14]. - The PEI accepted the company's proposal to conduct toxicology studies in pigs instead of Non-Human Primates, which will save time and costs [19]. Clinical Trial Design - The Phase 1/2a clinical trial will evaluate both safety and efficacy, comparing SCN-1 to a placebo in patients with mild to moderate plaque psoriasis, skipping the need for testing in healthy volunteers [12][17]. - The trial is expected to include approximately 24 patients and commence in the second half of 2025, with results anticipated in 2026 [17][19]. Market Need and Product Advantages - There are about 13 million patients diagnosed with plaque psoriasis in major markets, with 50% suffering from mild disease and 28% from moderate disease [13]. - Current treatments for mild to moderate plaque psoriasis, such as corticosteroids and phototherapy, require frequent applications and have low patient adherence due to local side effects [13]. - Scinai's nanoAb is designed for localized, intradermal delivery, offering a less demanding treatment regimen with reduced risks of local and systemic side effects compared to existing therapies [4][11]. Regulatory Feedback - The PEI's guidance is considered acceptable for the Investigational Medicinal Product Dossier (IMPD) filing with the European Medicines Agency (EMA), akin to a pre-IND meeting with the FDA [10]. - The PEI acknowledged the well-developed manufacturing process and acceptable specifications presented by the company [19].

JERUSALEM, July 15, 2024 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) (the "Company"), a biotechnology company focused on developing inflammation and immunology (I&I) biological products and on providing CDMO services through its Scinai Bioservices business unit, today announced successful in-vivo preclinical study results of its innovative anti IL-17A/F VHH antibody fragment ('NanoAb') as a local, first of its kind, intralesional biological treatment for the large and underserved populatio ...

JERUSALEM, July 8, 2024 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) (the "Company"), a biotechnology company focused on developing inflammation and immunology (I&I) biological products and on providing CDMO services through its Scinai Bioservices business unit, today announced that it has received an updated non-binding Letter of Intent ("LoI") from the European Investment Bank (the "EIB"). This updated LoI outlines specific indicative terms for converting the majority of the EIB's loan in ...

JERUSALEM, July 2, 2024 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) ("Scinai", or the "Company"), a biopharmaceutical company focused on developing inflammation and immunology (I&I) biological products and on providing CDMO services through its Scinai Bioservices business unit, today published its financial results for the quarter ended March 31, 2024, and provided a business update. Business Update & Recent Highlights Financing Nasdaq Compliance and Conversion of EIB Loan into Equity On J ...

As previously announced, the Company has received a Nasdaq Staff determination letter regarding noncompliance with the minimum shareholders' equity required for continued listing (under Listing Rule 5550(b)(1) or the "Rule") and that as part of the hearing previously requested with the Nasdaq Hearings Panel (the 'Hearings Panel") it would present its plan to regain and remain compliant with the Rule (the "Plan") The Company believes that the substantial reduction in long-term liabilities should not only ena ...

The Deficiency Notices On May 6th, 2024, the Company announced that on April 30th it had had received a staff determination letter from the Listing Qualifications Department (the "Staff") of the Nasdaq Stock Market ("Nasdaq") notifying the Company that, due to the Company's non-compliance with the minimum $1.00 bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2), the Company's American Depositary Shares ("ADSs") would be scheduled for delisting from Nasdaq and would be suspended for trading un ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of event requiring this shell company report: For the transition period from ____________ to ____________ Commission file No. 001-373 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission File Number: 001-37353 BIONDVAX PHARMACEUTICALS LTD. (Exact name of registrant as specified in its charter) | Israel | Not Applic ...