Core Viewpoint - Scinai Immunotherapeutics Ltd. has established a U.S.-based subsidiary, Scinai Bioservices Inc., to enhance its Contract Development and Manufacturing Services (CDMO) offerings, addressing the growing demand for these services in the U.S. biotech sector [1][6]. Company Overview - Scinai Immunotherapeutics is a biopharmaceutical company focused on developing inflammation and immunology biological products and providing CDMO services through its Scinai Bioservices business unit [1][8]. - The company launched its CDMO business unit in 2024, operating from a facility in Jerusalem, Israel, which includes 1,850 square meters of clean rooms and laboratories compliant with cGMP conditions [2][8]. CDMO Business Development - The CDMO unit has executed drug development projects for nine biotech companies, covering various aspects such as process development, scale-up, and drug manufacturing for pre-clinical and clinical supplies [3][8]. - Scinai has partnered with Ayana Pharma to provide specialized liposomal encapsulated drug development services [3]. Market Demand and Trends - There is a growing demand for CDMO services for biological early-stage drugs in the U.S., driven by improved molecular biological understanding, accelerated market approvals, and an increasing number of novel drug candidates [4]. - The complexity of biologics manufacturing is leading to a heightened demand for high-quality development and manufacturing capacities that meet stringent regulatory standards [4]. Challenges in the Industry - Despite the growing demand for CDMO services, there are concerns regarding the capacity to meet this demand, particularly for early-stage projects due to complex manufacturing routes associated with biologics [5]. - The BIOSECURE Act, introduced in January 2024, may impact U.S. biopharmaceutical drugs in development by companies partnered with Chinese CDMOs, potentially affecting over 120 drugs, with many in clinical-stage development [5]. Strategic Initiatives - The new U.S. subsidiary aims to serve early-stage biotech companies by providing much-needed CDMO services, allowing these companies to utilize U.S. government grant funding without concerns related to the BIOSECURE Act [6]. - Scinai's CDMO business unit is focused on rapid growth, acquiring new clients, and enhancing brand awareness, with expectations of significant revenue increases in the coming years [7][8]. Leadership Commentary - The CEO of Scinai expressed enthusiasm about the new U.S. subsidiary, highlighting the signing of the first contract with Serpin Pharma for clinical manufacturing, which is expected to enhance the prospects of the CDMO unit [8].

Company Overview - Scinai Immunotherapeutics Ltd. is a biopharmaceutical company listed on Nasdaq (SCNI) with two main business units: one focused on the in-house development of inflammation and immunology (I&I) biological therapeutic products, and the other serving as a boutique CDMO for biological drug development and clinical trial services [4]. Key Appointments - Prof. Michael Schön has joined Scinai's Scientific Advisory Board, bringing extensive expertise in dermatology, particularly in chronic inflammatory skin diseases such as psoriasis and atopic dermatitis. His background includes over 440 scientific publications and significant experience in drug development [3]. - Dr. Jonathan Sadeh has been appointed as Chief Scientific Officer and Chief Medical Officer of Bausch Health, marking a notable change within Scinai's advisory team [3]. Innovation and Pipeline - Scinai is developing a pipeline of innovative nanosized VHH antibodies (nanoAbs) aimed at addressing diseases with significant unmet medical needs. The company emphasizes the potential of its targeted immunological therapeutic approaches in precision inflammation medicine [3][4].

JERUSALEM, Nov. 27, 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 providing CDMO services through its Scinai Bioservices business unit, announced today that Dr. Jonathan Sadeh has been appointed as a member of the Company's Scientific Advisory Board (SAB). In this capacity, Dr Sadeh will play a significant role in advancing the clinical development of ...

JERUSALEM, Nov. 22, 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 nine months ended September 30, 2024 and provided a business update.Business Update & Recent HighlightsConversion of EIB Loan into Equity bringing shareholders' equity ...

The virtual panel discussion will feature: Mr. Amir Reichman, CEO of Scinai, who will serve as moderator; Dr. Tamar Ben Yedidia, Chief Scientific Officer at Scinai; Prof. Michael Schoen, Director of Dermatology and Venerology at the University Medical Center Göttingen, Germany (UMG) and an independent medical consultant of Scinai; and Prof. Matthias Dobbelstein, Max Planck Institute Fellow and Department Head at UMG and a member of Scinai's Scientific Advisory Board. The webinar will be broadcast via Zoom. ...

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]

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 ...