Scinai Immunotherapeutics .(SCNI)

Search documents
Dr. Jonathan Sadeh, Former Senior Vice President of Immunology R&D at Bristol-Myers Squibb, Joins Scinai Immunotherapeutics' Scientific Advisory Board
Prnewswire· 2024-11-27 13:00
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 ...
Scinai Publishes Financial Results and Provides Business Update; Shareholders' Equity up from negative $7.3 million as of June 30, 2024, to positive $10 million
Prnewswire· 2024-11-22 12:15
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 ...
Scinai to Host Online Expert Panel on Plaque Psoriasis Treatment and Intralesional Injections of anti-IL-17A/F VHH Antibodies
Prnewswire· 2024-09-16 11:00
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. ...
Scinai Immunotherapeutics .(SCNI) - 2024 Q2 - Quarterly Report
2024-09-09 11:23
Exhibit 99.2 SCINAI IMMUNOTHERAPEUTICS LTD. (Formerly known as BiondVax Pharmaceuticals Ltd.) CONDENSED FINANCIAL STATEMENTS June 30, 2024 Unaudited SCINAI IMMUNOTHERAPEUTICS LTD. (Formerly known as BiondVax Pharmaceuticals Ltd.) – (Unaudited) BALANCE SHEETS U.S. dollars in thousands June 30, December 31, 2024 2023 ASSETS The accompanying notes are an integral part of the financial statements. | --- | --- | --- | --- | --- | --- | |------------------------------------------------|-------|-------|--------|-- ...
Scinai Announces Closing of Loan Restructuring Agreement with European Investment Bank Converting Approximately $29 million of Debt to Preferred Equity and Leaving Debt Balance of $273,000
Prnewswire· 2024-08-21 12:45
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 ...
Scinai Immunotherapeutics .(SCNI) - 2024 Q2 - Earnings Call Transcript
2024-08-20 18:28
Scinai Immunotherapeutics Ltd. (NASDAQ:SCNI) Q2 2024 Results Conference Call August 20, 2024 11:00 AM ET Company Participants Liat Halpert - Head of Business Development Amir Reichman - CEO Liat Halpert Good morning, everyone. And welcome to Scinai Immunotherapeutics Investor Webinar. My name is Liat Halpert, and I'm Head of Business Development at Scinai. Thank you for joining us. Today, Mr. Amir Reichman, Scinai's CEO, will present our Q2 financial results and provide a business update of our activities i ...
Scinai Announces Entering into $2 Million Private Equity Commitment Agreement with its largest Existing Shareholder
Prnewswire· 2024-08-20 13:30
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]
Scinai Announces Signing of Loan Restructuring Agreement with European Investment Bank; Converting Approximately $29 million of Debt to Preferred Equity Convertible into 19.5% Common Equity
Prnewswire· 2024-08-13 11:00
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 ...
Scinai Immunotherapeutics Announces Positive Regulatory Feedback from the PEI on the path for Phase 1/2a in Plaque Psoriasis with its anti-IL-17 nanoAb
Prnewswire· 2024-07-23 11:00
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].
Why Is Scinai Immunotherapeutics (SCNI) Stock Up 56% Today?
Investor Place· 2024-07-15 16:04
Core Insights - Scinai Immunotherapeutics (NASDAQ:SCNI) stock surged by 55.8% following the announcement of positive results from an early-stage study of its anti IL-17A/F VHH antibody fragment NanoAb, aimed at treating mild to moderate plaque psoriasis [2][4]. Company Developments - The company revealed successful results from an in-vivo preclinical study where NanoAb was tested on mice with human skin grafts infected with psoriasis, indicating its potential as a local treatment for the disease [4]. - Chief Science Officer Dr. Tamar Ben-Yedidia highlighted the significance of these results, stating they represent a major advancement in developing a treatment for patients with mild to moderate plaque psoriasis [5]. Market Activity - The trading volume of SCNI shares saw a substantial increase, with over 26 million shares traded, compared to the daily average of approximately 570,000 shares [6].