Core Insights - Scinai Immunotherapeutics Ltd. has announced successful preclinical study results for its anti IL-17A/F VHH antibody fragment ('NanoAb'), which is designed as a local treatment for mild to moderate plaque psoriasis, addressing a significant unmet medical need in this patient population [1][13][20] Market Need - Approximately 13 million patients are diagnosed with plaque psoriasis in major markets, with 50% suffering from mild disease and 28% from moderate psoriasis [2] - Current treatments for mild to moderate plaque psoriasis are primarily corticosteroids and phototherapy, which have limitations such as frequent use, local adverse effects, and low patient adherence [2][10] - The existing therapies for moderate to severe psoriasis are biologics and JAK inhibitors, which are expensive and carry long-term health risks [2] Study Overview - The study included Scinai's anti-IL-17 NanoAbs, two comparator drugs (Betamethasone and Secukinumab), and a negative control [4] - The anti-inflammatory effects were evaluated by measuring cytokine levels and conducting histopathological analysis [4][11] - Results indicated that the intralesional injection of the NanoAb could reduce psoriatic lesion severity and improve skin integrity [5][18] Product Development - Scinai's product candidate aims to provide a local, intradermal treatment that minimizes side effects associated with systemic biologics and corticosteroids [10] - The treatment is designed to be administered using a short, painless needle, allowing for low-frequency applications [10] - The company plans to conduct further studies to fine-tune dosing and drug half-life, with a follow-up in-vivo animal study scheduled for late 2024 [20]

Core Viewpoint - Scinai Immunotherapeutics Ltd. has received an updated non-binding Letter of Intent from the European Investment Bank to convert a significant portion of its loan into equity, which is expected to improve its financial standing and compliance with Nasdaq listing requirements [1][2][6]. Financial Restructuring - The updated Letter of Intent outlines the conversion of approximately $28 million of the loan into preferred shares, representing 19.5% of the fully diluted capital of the Company at closing [1][6]. - The outstanding principal amount owed to the EIB will be reduced to approximately $270,000, with a maturity date of December 31, 2031 [4][9]. - The Company plans to file financial statements for Q2 2024, which will include the implications of the LOI [2]. Preferred Shares Details - The preferred shares will not have anti-dilution rights and will be convertible into a fixed number of American Depositary Shares [1][9]. - Holders of the preferred shares will have veto rights over certain corporate actions, including incurring additional debt and entering mergers and acquisitions [9]. - The current variable remuneration rights, including a 10% payment on equity raises and a 3% royalty on revenues exceeding EUR 5 million, will be canceled [9]. Compliance and Future Plans - The Company aims to regain compliance with Nasdaq's minimum shareholders' equity requirement through this restructuring [2][6]. - A white paper analyzing the accounting impact of the loan-to-equity conversion is under review, which is expected to eliminate the shareholders' deficit of $5.1 million [6]. - The Company will seek shareholder approval for the creation of the preferred shares at a meeting scheduled for August 12, 2024 [9].

Core Viewpoint - Scinai Immunotherapeutics Ltd. has reported its financial results for Q1 2024, highlighting a significant reduction in net loss and ongoing efforts to regain compliance with Nasdaq listing requirements while advancing its CDMO services and R&D pipeline [1][9]. Business Update & Recent Highlights - The company regained compliance with Nasdaq's minimum bid price requirement of $1.00 but remains non-compliant with the equity requirement, presenting a plan to the Nasdaq Hearing Panel for compliance [2][4]. - Scinai received a letter of intent from the European Investment Bank (EIB) regarding the conversion of its loan into equity, with expectations for a binding term sheet in July 2024 [3]. - The company is actively marketing its CDMO services through various channels, including participation in major pharmaceutical conferences [5][39]. - A hands-on aseptic processing course was conducted in collaboration with industry experts, attracting senior figures from the Israeli biotech sector [7]. - A scientific advisory meeting with the Paul Erlich Institute (PEI) is expected to guide the company in preparing for a pre-clinical toxicology study for its anti-IL NanoAbs targeting plaque psoriasis [8]. Financial Summary - For the three months ended March 31, 2024, research and development expenses were $1,568 thousand, down from $1,995 thousand in the same period of 2023, primarily due to reduced salaries and subcontractor use [40]. - Marketing, general, and administrative expenses decreased to $484 thousand from $1,191 thousand year-over-year, attributed to lower salaries and professional services [40]. - The net loss for Q1 2024 was $2,159 thousand, a reduction from $3,515 thousand in Q1 2023, indicating improved financial performance [40][41]. - Cash and cash equivalents at the end of Q1 2024 were $4,826 thousand, slightly down from $4,870 thousand a year earlier [20].

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 ...

Core Viewpoint - Scinai Immunotherapeutics Ltd. is facing compliance issues with Nasdaq regarding minimum shareholders' equity and bid price requirements, prompting the company to present a plan to regain compliance at an upcoming hearing [1][4][5]. Group 1: Compliance Issues - The company received a determination letter from Nasdaq indicating non-compliance with the minimum shareholders' equity requirement of $2,500,000, reporting a deficit of $4,569,000 as of December 31, 2023 [4][5]. - The company also faces a deficiency regarding the minimum bid price requirement of $1.00 per share, having implemented a reverse split of its American Depositary Shares (ADSs) to address this issue [3][5]. - A hearing with the Nasdaq Hearings Panel is scheduled for June 18, 2024, to discuss both compliance matters [5][6]. Group 2: Proposed Plan - The company is considering converting part of its loan from the European Investment Bank (EIB) into equity as part of its plan to regain compliance [1][2]. - Any revised terms of the finance contract with the EIB will require formal approval and negotiation of definitive agreements [2]. Group 3: Company Overview - Scinai Immunotherapeutics Ltd. focuses on developing inflammation and immunology biological products and offers CDMO services through its Scinai Bioservices unit [1][7]. - The company is working on a pipeline of nanosized VHH antibodies (NanoAbs) targeting diseases with significant unmet medical needs [7].

Financial Position - As of December 31, 2023, the company's cash and cash equivalents totaled $4.9 million, with an operating loss of $9.7 million for the twelve months ended December 31, 2023[46]. - The company reported negative cash flows from operating activities of $9.3 million, raising substantial doubt about its ability to continue as a going concern[46]. - The current cash position is insufficient to fund planned operations for at least one year beyond the filing date of the financial statements[46]. - The company had $4.9 million in cash and cash equivalents and short-term deposits, with working capital of $3.6 million, which is insufficient to fund projected cash requirements for at least the next 12 months[52]. - As of December 31, 2023, the company had an accumulated deficit of $122.5 million and expects to incur substantial losses for the foreseeable future[51]. Business Strategy and Operations - The company is implementing a cost-saving plan that includes reducing headcount costs and postponing/canceling non-essential capital expenditures[48]. - The company has suspended further development of its COVID-19 NanoAbs program due to changing market conditions and is seeking a partner for future development[34]. - The company is focusing on developing VHH antibodies (NanoAbs) targeting Interleukin-17 (IL-17) for conditions like psoriasis and psoriatic arthritis, having suspended further development of its COVID-19 NanoAb due to decreased market conditions[63]. - The company has licensed anti-COVID-19 NanoAbs and anti-IL-17 NanoAbs, with the latter targeting conditions like psoriasis[34]. - The company is reliant on entering agreements with partners for the development and commercialization of its product candidates[44]. Regulatory and Compliance Risks - The company faces significant challenges in developing and commercializing its product candidates due to regulatory uncertainties and market acceptance issues[66]. - Regulatory approval for current and future product candidates is expensive and time-consuming, with a high rate of attrition in clinical trials[71]. - The FDA or comparable authorities can delay or deny approval for various reasons, which could severely undermine the company's business[72]. - Ongoing regulatory requirements must be met even after obtaining approval, and failure to comply could result in loss of approvals and reduced revenues[74]. - The company must submit an Investigational New Drug application to the FDA before commencing clinical trials, which adds to the regulatory burden[83]. Competition and Market Challenges - The company faces significant competition in the biopharmaceutical sector, particularly in the development of NanoAbs[44]. - The company may face competition from biosimilar products sooner than anticipated, impacting the commercial prospects of its biological products[76]. - Intense competition from larger pharmaceutical companies could reduce the company's commercial opportunities and profitability[135]. - The company faces significant competition from well-established CDMO providers and small biotech firms, which may hinder its planned CDMO business[123]. Financial and Capital Requirements - The company may require additional financing to achieve its goals, and failure to obtain necessary capital could delay or terminate product development efforts[52]. - The company’s ability to execute its business plan is dependent on raising capital through various means, including private or public financings[53]. - The company’s future capital requirements are uncertain and may not be available on favorable terms, impacting its ability to acquire new product candidates and conduct necessary research[55]. - Recent financial market disruptions could affect the company's ability to raise capital on acceptable terms[146]. Intellectual Property Risks - The company faces risks related to the adequacy of its patent protection, which may not sufficiently shield against competitors with similar products and technologies[169]. - There is uncertainty regarding the issuance of patents from pending applications, and existing patents may be challenged or invalidated, impacting the company's competitive position[170]. - The company may incur significant costs and resource diversion due to litigation related to intellectual property rights, which could adversely affect its financial condition[180]. - The company may need to obtain licenses for third-party intellectual property, which could involve significant fees and may not be available on favorable terms[173]. Operational Risks - The company relies on third parties for clinical trials and manufacturing, which increases the risk of delays and impacts on product development[160]. - A disruption to the GMP biologics manufacturing facility in Jerusalem could impede the advancement of NanoAbs programs and CDMO services[164]. - The company may not obtain necessary materials for future clinical trials, which could delay regulatory approvals[167]. - The company has exclusive licenses for its NanoAbs program, and disputes with licensors could adversely affect operations[157]. Geopolitical and Environmental Risks - The company is subject to geopolitical risks that could adversely affect its operations and financial conditions[190]. - The ongoing conflict has led to Moody's downgrading Israel's credit rating from A1 to A2, which could impact the company's ability to raise capital on reasonable terms[200]. - Since October 7, 2023, the IDF has called up more than 350,000 reserve forces, which may affect the company's operations due to potential labor shortages[197]. Nasdaq Compliance and Corporate Governance - The company received a notice of non-compliance from Nasdaq on November 1, 2023, regarding the minimum bid price requirement of $1.00 per share, with a 180-day period to regain compliance[214]. - As of December 31, 2023, the company's shareholders' equity was less than the required minimum of $2,500,000 for continued listing on Nasdaq, posing a risk of delisting[215]. - The company has appealed the delisting determination and requested a hearing, which has temporarily stayed any suspension of trading[214]. - The company follows home country corporate governance practices, which may provide less protection to investors compared to U.S. domestic issuers[221].

As filed with the Securities and Exchange Commission on December 22, 2023. Registration No. 333-275217 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Scinai Immunotherapeutics Ltd. (Exact Name of Registrant as Specified in Its Charter) Not Applicable (Translation of Registrant's name into English) State of Israel 2836 Not Applicable (State or Other Jurisdiction of Incorporation or Organization) (Prim ...

As filed with the Securities and Exchange Commission on October 30, 2023. Registration No. 333-_________ UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 (Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant's Principal Executive Offices) Puglisi & Associates 850 Library Avenue, Suite 204 Newark, Delaware +1 (302) 738-6680 Scinai Immunotherapeutics Ltd. (Exact Name of Registrant as Specif ...

Clinical Trials and Product Development - BiondVax Pharmaceuticals has executed eight clinical trials, including a phase 3 trial with 12,400 participants for its previous lead drug candidate, M-001[68] - The company has developed a pipeline of diversified products based on its innovative nanosized antibody (NanoAb) platform, which is expected to provide competitive advantages in treatment efficacy and delivery methods[71] - BiondVax signed a definitive exclusive License Agreement with the Max Planck Society and University Medical Center Göttingen for the development of NanoAbs for COVID-19, which includes upfront payments and royalties based on sales[69] - The company anticipates that its NanoAbs can be developed and brought to clinical trials at a lower cost and faster timeline compared to traditional monoclonal antibodies[73] - BiondVax's NanoAbs demonstrate binding affinity and neutralization at doses 100 to 1000 times lower than other antibodies, potentially leading to faster medical efficacy[72] - The company aims to leverage its unique NanoAb attributes to address large and underserved medical needs in various therapeutic areas, including psoriasis and asthma[71] Manufacturing and Financial Support - BiondVax's GMP biologics manufacturing facility in Jerusalem is capable of producing clinical-grade NanoAbs, allowing for direct control over production and reduced reliance on third-party manufacturers[76] - The company has borrowed €24 million under a finance contract with the European Investment Bank to support the development of its previous drug candidate and manufacturing facility[77] - The company has received $5.8 million in IIA grants and €24 million ($25.6 million) in EIB loans since its inception[87] Financial Performance and Projections - For the three months ended March 31, 2023, the net loss was $3.5 million, compared to a net loss of $2.47 million for the same period in 2022, reflecting an increase in operating expenses[89] - Research and development expenses for the three months ended March 31, 2023, amounted to $2 million, up from $1.2 million in the same period in 2022, primarily due to the launch of NanoAb development[80] - As of March 31, 2023, the company had cash and cash equivalents of $10.9 million, a decrease from $15.5 million as of March 31, 2022[90] - The company raised gross proceeds of approximately $8 million from a public follow-on offering completed in December 2022[84] - The company expects to incur additional losses due to ongoing research and development activities and may need to secure additional funding to support these initiatives[79] - General and administrative expenses for the three months ended March 31, 2023, were $1.2 million, down from $1.4 million in the same period in 2022[88] - The company has an accumulated deficit of $119.3 million as of March 31, 2023[93] - The company plans to continue funding operations through public and private equity offerings, grants, and loans, but there is no assurance that additional funding will be available on acceptable terms[86] - The company anticipates that a significant portion of future research and development expenses will be directed towards clinical development projects, which are inherently unpredictable[81] Strategic Partnerships and Leadership - The company is actively engaged in identifying and evaluating partnership opportunities within the pharmaceutical industry to enhance its market presence[73] - BiondVax's leadership team has extensive experience in the biotech and pharmaceutical sectors, which is expected to drive the company's strategic initiatives[76]

Financial Performance - For the year ended December 31, 2022, the net loss was $5.8 million, a decrease from the net loss of $8.2 million for the year ended December 31, 2021, reflecting improved financial performance [313]. - The accumulated deficit amounted to $115.8 million as of December 31, 2022, indicating ongoing financial challenges [318]. - The company expects to continue incurring operating losses and may need to raise additional funds to support its research and development activities [303]. Research and Development - Research and development expenses increased to $5.7 million for the year ended December 31, 2022, compared to $3.2 million for the year ended December 31, 2021, primarily due to increased salaries and expenses related to the COVID-19 NanoAb project [304]. - The company signed a five-year Research Collaboration Agreement with MPG and UMG for the discovery and development of NanoAbs for various diseases, which are expected to address large and growing markets [300]. - The company anticipates that a significant portion of future research and development expenses will be related to its clinical development projects, which are inherently unpredictable [305]. Cash and Funding - As of December 31, 2022, the company had cash and cash equivalents of $14 million, down from $17.3 million as of December 31, 2021 [314]. - The company raised gross proceeds of approximately $8 million from a public follow-on offering completed in December 2022 [308]. - The Company closed an underwritten offering selling 1,600,000 units, receiving a net sum of $7.3 million after issuance expenses [321]. - Each unit was sold at a combined purchase price of $5.00, with pre-funded units priced at $4.999 [321]. - The company has received $5.8 million in IIA grants and €24 million ($25.6 million) in EIB loans since its inception, which have supported its operations [311]. Clinical Trials - The company has executed eight clinical trials, including a phase 3 trial with 12,400 participants for its previous lead drug candidate, M-001, which is no longer under development [297]. Asset Valuation - No impairment indicators for long-lived assets were identified during the years ended December 31, 2022 and 2021 [324]. - The fair value of financial instruments is measured based on a three-tiered hierarchy prioritizing inputs used in valuation methodologies [325]. - The Company is not required to provide market risk disclosures as it qualifies as a smaller reporting company [326].