Core Insights - Scinai Immunotherapeutics Ltd. has appointed Dr. Jonathan Sadeh to its Scientific Advisory Board, aiming to enhance the clinical development of its IL-17 program and VHH antibody pipeline [1][5] Company Overview - Scinai Immunotherapeutics is a biopharmaceutical company focused on developing inflammation and immunology biological products and providing CDMO services through its Scinai Bioservices unit [5] - The company has a pipeline of nanosized VHH antibodies targeting diseases with significant unmet medical needs [5] Dr. Jonathan Sadeh's Background - Dr. Sadeh has over 20 years of experience in drug development and clinical research, previously holding senior positions at Bristol-Myers Squibb, Sanofi, AstraZeneca, and Schering-Plough [2][3] - He was responsible for multiple drug approvals, including the first-in-class TYK2 inhibitor Sotyktu for psoriasis [2] Strategic Importance - Dr. Sadeh's expertise is expected to be invaluable for advancing Scinai's innovative I&I biological products [5] - His commitment to developing therapies for unmet medical needs aligns with Scinai's mission to establish itself as a leader in scientifically driven drug development [4][5]

Core Insights - Scinai Immunotherapeutics Ltd. reported financial results for the nine months ended September 30, 2024, highlighting significant developments in its business operations and financial position [1] Business Update & Recent Highlights - The conversion of a European Investment Bank (EIB) loan into equity increased shareholders' equity to $10 million, with approximately $28.1 million converted into 1,000 preferred shares representing 19.5% of the company's fully diluted outstanding capital stock [2][3] - Following the conversion, the outstanding amount owed to the EIB was reduced to EUR 250,000 (approximately $264,000), with a maturity date of December 31, 2031 [3] - The company regained compliance with Nasdaq Listing Rule 5550(b)(1), which requires a minimum stockholders' equity of $2.5 million, facilitated by the loan restructuring agreement with the EIB [4] CDMO Business Unit - Since January 2024, Scinai has received CDMO work orders valued at approximately $600,000 and is in advanced discussions with potential clients, expecting revenues from this unit to increase significantly in the coming years [5][6] - The company has received $575,000 in grants from the Israeli Innovation Authority to support its CDMO business unit and is pursuing a grant extension for reimbursement of 66% of approved CDMO costs [5] - Scinai is actively marketing its CDMO services through various channels, including participation in major pharmaceutical conferences [6] R&D Business Unit - Pipeline Development - Scinai received positive regulatory feedback from the Paul Erlich Institute for its drug development program targeting Phase 1/2a clinical trials of its anti-IL-17A/F nanoAb (SCN-1) in plaque psoriasis, expected to commence in the second half of 2025 [8][9] - Promising results from pre-clinical studies in plaque psoriasis were reported, indicating that Scinai's nanoAb could effectively reduce psoriatic lesion severity [10] - The company has entered into a license agreement granting exclusive global rights to certain patents and know-how for the development and commercialization of licensed products [10][11] Financial Summary - Revenues for the nine months ended September 30, 2024, amounted to $452,000, a significant increase from no revenues in the same period of 2023, attributed to the CDMO unit generating revenues for the first time [12] - R&D expenses decreased to $4,195,000 from $4,583,000 year-over-year, reflecting minor fluctuations in activities [13] - Marketing, general, and administrative expenses decreased to $1,767,000 from $3,300,000, primarily due to reduced salaries and service provider costs [14] - Financial income increased to $13,374,000, primarily due to $14,759,000 from the loan conversion to equity [14] - The net gain for the nine months ended September 30, 2024, was $7,026,000, compared to a net loss of $4,170,000 in the same period of 2023 [15]

Core Insights - The virtual panel discussion will focus on the plaque psoriasis landscape, treatment options, unmet needs, and the potential of Scinai's anti-IL-17A/F VHH antibodies [2][3] - Scinai Immunotherapeutics is a biopharmaceutical company with a focus on developing innovative nanosized VHH antibodies for inflammation and immunology [4] Group 1: Panel Discussion Details - The panel will include key figures such as Mr. Amir Reichman (CEO of Scinai), Dr. Tamar Ben Yedidia (Chief Scientific Officer), and professors from UMG and Max Planck Institute [1] - The discussion will cover the current treatment landscape for plaque psoriasis, the science behind single domain VHH antibodies, and Scinai's drug development process [2] Group 2: Scinai's Business Model - Scinai operates two business units: one for in-house development of biological therapeutic products and another as a boutique CDMO for early-stage biotech projects [4] - The company is developing a novel anti-IL-17 VHH antibody for psoriasis treatment, with plans for clinical trials and a target product profile for intralesional application [2][4] Group 3: Engagement Opportunities - Participants in the webinar will have the chance to submit questions and engage in a Q&A session at the end of the discussion [3]

Financial Performance - Revenues for the six months ended June 30, 2024, were $284,000, compared to $0 in the same period of 2023, indicating a significant increase in revenue generation [6]. - Net loss for the six months ended June 30, 2024, was $4,481,000, down from $7,277,000 in the same period of 2023, reflecting a 38% improvement [6]. - The company reported a gross loss of $164,000 for the six months ended June 30, 2024, with a cost of revenues of $448,000 [6]. - For the six months ended June 30, 2024, the company reported an operating loss of $3,955,000 and negative cash flows from operating activities of $3,221,000 [18]. - The total share-based compensation expense for the six months ended June 30, 2024, was $333,000, down from $452,000 in the same period of 2023 [34]. Assets and Liabilities - Total assets decreased from $17,472,000 in December 2023 to $14,851,000 in June 2024, a decline of approximately 15% [2]. - Cash and cash equivalents decreased from $4,870,000 to $3,076,000, representing a reduction of about 37% [2]. - Total liabilities increased slightly from $20,261,000 in December 2023 to $20,463,000 in June 2024, an increase of about 1% [4]. - As of June 30, 2024, the company's cash and cash equivalents totaled $3,076,000, a decrease from $7,506,000 at the end of the previous year [18]. - As of June 30, 2024, the outstanding principal amount related to the EIB loan is $25,668,000, with finance expenses recorded at $594,000 for the six months ended June 30, 2024 [29]. Shareholder Information - The number of ordinary shares outstanding increased from 1,857,169,984 as of December 31, 2023, to 3,349,431,584 as of June 30, 2024, indicating a significant increase in share issuance [5]. - The weighted average number of shares used in computing net loss per share increased from 1,322,019,241 in 2023 to 2,288,278,248 in 2024, reflecting a dilution effect due to increased share issuance [6]. - The Company announced a reverse split of its ADSs from 400 ordinary shares per ADS to 4,000 ordinary shares per ADS to regain compliance with Nasdaq listing requirements [32]. - The Company regained compliance with Nasdaq's Minimum Shareholders' Equity Rule, maintaining stockholders' equity of at least $2.5 million [41]. Research and Development - Research and development expenses decreased from $3,449,000 in 2023 to $2,788,000 in 2024, a reduction of approximately 19% [6]. - The company has received approximately $6,431,000 in grants from the Israeli Innovation Authority, with $5,979,000 allocated for R&D of M-001 and $589,000 for the new CDMO business [26]. - The Company received a non-dilutive grant covering 66% of the costs of a $975,000 project to support its new CDMO business, which is not subject to repayment or royalty payments [28]. Business Operations - The company launched a new business named Scinai Bioservices to provide CDMO services and signed its first contract in October 2023 [15]. - The company is in advanced contract discussions with additional potential clients for its CDMO services [15]. - The Company recognized revenues from CDMO services, which include manufacturing, quality assurance, and method development [39]. Financial Commitments and Concerns - The company has substantial doubt about its ability to continue as a going concern due to insufficient cash to fund operations for at least a year [18]. - The maximum royalty amounts payable by the company as of June 30, 2024, is approximately $6,431,000, which includes accrued interest on grants received [27]. - The company has not paid any royalties to the Israeli Innovation Authority as of June 30, 2024 [27]. - The Company issued new warrants to purchase up to 5,213,104 ADSs at a reduced exercise price of $0.65 per ADS, generating gross proceeds of approximately $1,696,000 [30]. - The Company entered into a $2 million Investment Commitment Agreement with RK Stone Miami LLC, allowing for the issuance of ADSs through December 31, 2024 [48]. - The Company will pay a commitment fee of $100,000 if an advance notice is provided during the Commitment Period, payable at the closing of the first advance [49]. - If no advance notice is given during the Commitment Period, the commitment fee will be $40,000, payable promptly after the Commitment Period ends [49]. - The number of ADSs for the commitment fee will be based on the market price determined for the advance or as of December 31, 2024, depending on the payment method chosen by the Company [49]. Currency and Financial Adjustments - The company changed its functional currency to the U.S. dollar effective July 1, 2023, to align with its operational environment [16]. - On August 21, 2024, the Company amended its financing contract with the EIB, reducing the outstanding principal and accrued interest to approximately €250,000, with no interest accruing [41].

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]

Core Viewpoint - Scinai Immunotherapeutics Ltd. has successfully restructured its loan agreement with the European Investment Bank, converting approximately EUR 26.6 million (around $29 million) of debt into equity, which is expected to strengthen the company's financial position and support its development of new therapeutics in inflammation and immunology [1][2][4]. Financial Restructuring - The loan restructuring agreement includes the conversion of approximately EUR 26.6 million into 1,000 preferred shares, reducing the outstanding loan amount to EUR 250,000 (approximately $273,000) with a maturity date of December 31, 2031 [2]. - The new loan amount will not accrue interest and is not prepayable [2]. - The preferred shares can be converted into a fixed number of American Depositary Shares (ADSs) representing 19.5% of the fully diluted capital of the company [3]. Preferred Shares Details - The preferred shares do not have anti-dilution provisions, do not accrue dividends, and are redeemable at the company's discretion at a cumulative redemption value of $34 million [3][4]. - Holders of preferred shares are entitled to redemption payments and distributions in the event of liquidation before ordinary shareholders [4]. - There are restrictions on the conversion of preferred shares to ADSs to prevent any holder from owning more than 4.99% of the company's outstanding ADSs [5]. Company Operations - Scinai Immunotherapeutics focuses on developing biological products for inflammation and immunology, alongside providing CDMO services for early-stage biotech projects [8].

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].

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]