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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of event requiring this shell company report: For the transition period from ____________ to ____________ Commission file No. 001-373 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission File Number: 001-37353 BIONDVAX PHARMACEUTICALS LTD. (Exact name of registrant as specified in its charter) | Israel | Not Applic ...

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].

BiondVax Pharmaceuticals Ltd. (BVXV) Q4 2021 Earnings Conference Call April 4, 2022 10:00 AM ET Company Participants Kenny Green - Edison Group, IR Josh Phillipson - Director of Business Development and Investor Relations Amir Reichman - Chief Executive Officer Matthias Dobbelstein - Professor at University Medical Center, Gottingen Kenny Green Hi everyone. Good day. I would like to welcome all of you to BiondVax's Webinar. My name is Kenny Green from Edison Group and I'm part of the IR team at BiondVax. I ...