JERUSALEM, Aug. 21, 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 announced that it has closed the previously announced Loan Restructuring Agreement (the "Restructuring Agreement") with its lender, the European Investment Bank (the "EIB"). The Restructuring Agreement also in ...

Financial Data and Key Metrics Changes - R&D expenses for the first six months of 2024 were approximately $2.79 million, down from $3.45 million in the same period of 2023, primarily due to reduced salaries and subcontractor usage [6] - Marketing and G&A expenses decreased to $1 million from $2.3 million year-over-year, attributed to lower salaries, share-based compensation, and professional services [6] - Financial expenses also decreased from $1.5 million in the first half of 2023 to $0.53 million in 2024, mainly due to prior year adjustments related to warrants and loan revaluation [6] - The net loss for the first six months of 2024 was $4.48 million, compared to $7.28 million in the same period of 2023, reflecting reduced operating expenses across all business units [6] - Cash available as of June 30, 2024, was $3.21 million, down from $7.63 million a year earlier [7] - Shareholder equity at the end of Q2 2024 was negative $7.28 million, but a debt-to-equity deal expected to close soon should increase it by approximately $19 million, potentially resulting in positive equity [7][8] Business Line Data and Key Metrics Changes - The company reported its first CDMO revenues in Q2 2024 and received a grant from the Israel Innovation Authority to support CDMO ramp-up, contributing to reduced cash burn [7] - The CDMO business unit aims for sales of $1.25 million in 2024, with a current pipeline of work orders valued at $600,000 from five clients [21] Market Data and Key Metrics Changes - The company is actively pursuing marketing activities, including participation in major pharmaceutical conferences to enhance brand awareness and attract potential partners [21] - The CDMO unit is positioned to meet the growing demand for boutique services from early-stage biotech companies, which is expected to increase revenues materially in the coming years [21] Company Strategy and Development Direction - The strategic guidelines for 2024 include fast-tracking IL-17 development, ramping up the CDMO business unit, and careful spending to sustain cash flow [5] - The company aims to partner with other pharmaceutical companies to hedge R&D risks and ensure sufficient capital for ongoing projects [5] - The focus is on developing a pipeline of nanoAb-based drugs targeting diseases with unmet needs, leveraging collaborations with prestigious institutions like the Max Planck Society [22] Management's Comments on Operating Environment and Future Outlook - Management believes Scinai is undervalued and highlights the potential for growth following the resolution of significant liabilities on the balance sheet [23] - The company is optimistic about its regulatory strategy and the potential for its lead antibody candidate, with plans to commence human trials in 2025 [25][28] - The long-term vision includes engaging with larger pharmaceutical companies for partnerships and sublicensing to ensure reliable commercial launches [29] Other Important Information - The company has received positive regulatory feedback from the Paul Erlich Institute regarding its drug development program, which is expected to lead to a Phase 1/2a clinical trial in the second half of 2025 [11][12] - The EIB debt-to-equity restructuring is anticipated to close soon, which will significantly improve the company's financial position [9][27] Q&A Session Summary Question: What do you see as the long-term future and share price of Scinai? - Management believes Scinai is undervalued and invites comparisons with similar companies at a preclinical stage, emphasizing the depth of its product pipeline and the unique position of its CDMO business [23] Question: Can you elaborate on the clinical and commercial potential and timeline of your lead antibody candidate? - The company plans to conduct further animal studies to optimize dosing schedules before initiating human trials, with the goal of starting Phase 1/2a trials in the second half of 2025 [25] Question: What are some key regulatory considerations and strategies Scinai is employing? - The company is working with experienced regulatory advisors to develop a robust data package for regulatory agencies, aiming for a more efficient path to market [28] Question: What is your long-term vision for Scinai? - The strategy involves leveraging patented technology through partnerships with larger pharma companies while maintaining a focus on R&D and the CDMO business unit to generate cash flow and reduce risks [29]

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 ...