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 In support of the Company's strategic pivot, on January 3, 2024, we raised $1.69 million in gross proceeds from the exercise of certain of our outstanding warrants and the issuance of new warrants. H.C. Wainwright & Co. acted as exclusive placement agent in connection with the offering. Nasdaq Compliance and Conversion of EIB Loan into Equity On June 7, 2024 the Company announced that on June 5, 2024, it received formal notification from the Listing Qualification Department (the "Staff") of the Nasdaq Stock Market ("Nasdaq") that the Company had regained compliance with the minimum $1.00 bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) (the "Rule"). In the notification provided by the Staff on June 5, 2024, the Staff stated that the Company remains non-compliant with the equity requirement in Listing Rule 5550(b)(1), or any of the alternative requirements under Listing Rule 5550(b), and accordingly the Company presented its plan to get back into compliance with the equity requirement with the Nasdaq Hearing Panel on June 18, 2024. The Plan presented to the panel included a debt-to-equity loan restructuring deal the Company is working on with its lender, the European Investment Bank (the "EIB"). On June 13, 2024 the Company announced that it received a letter of Intent from the EIB. This LoI outlined specific indicative terms for converting the EIB's loan into equity. The Company expects to receive a binding term sheet in July and have the financial contract with EIB fully amended by the end of August.   Based on the above plan, the Company requested from the Nasdaq Hearing Panel an extension of the deadline for regaining compliance with the equity requirement. The Company expects to receive the decision of the Hearing Panel in the coming weeks. CDMO business unit In the first six months of 2024 we received CDMO work orders valued at approximately $500K, and we are in advanced contract discussions with several other potential clients. We maintain confidence in our sales guidance for 2024 of $1.25 million in expected revenues. As our CDMO unit is new and we are in a rapid growth stage, acquiring new clients and building our reputation and brand awareness of our CDMO services,  we expect revenues from the CDMO business to increase materially in the coming years. This is also coupled with growing demand for boutique CDMO services from early-stage biotech companies looking for fast project onset at competitive pricing without compromising on meeting the most stringent scientific and quality standards. In addition, in 2024 we have been pursuing extensive targeted marketing activities, including online advertisements, direct outreach campaigns and participation in major pharmaceutical conferences, such as BIO Europe Spring in Barcelona (March 2024), and  the BioMed Israel conference  in Tel Aviv, Israel (May 2024), at which we marketed our CDMO services and met  potential partners for our R&D pipeline and potential investors.   Our CDMO unit is currently focused both on executing drug development projects for our clients and on validating our processes and facilities to be ready for cGMP inspection by the Israeli Ministry of Health. In June, we held a first of its kind, hands on aseptic processing course at our facility in Jerusalem in collaboration with key figures in the industry including Ms. Rachel Shimonovitz,  Head of GMP inspectorate of the Israeli Ministry of Health, and ADRES Int'l Biotech, a leading Israeli regulatory and quality consulting services firm. The course attracted many senior role holders from the Israeli biotech industry who came to our facility for this two-day education and training course.   Pipeline Development We are aggressively advancing the NanoAb preclinical development. At the end of April 2024, we concluded an in-vivo proof of concept animal study in collaboration with Prof. Amos Gilhar, a world-renowned dermatologist of the prestigious Technion Israel Institute of Technology. The results look promising and corroborate our aspiration for the development of a novel, local biologics therapeutic for the treatment of patients suffering from plaque psoriasis. On June 4, 2024, we met for a scientific advisory meeting with the Paul Erlich Institute (the PEI) of Germany, the scientific advice of which is considered acceptable guidance for IMPD filing with the European Medicines Agency (EMA) and is also considered the European comparable to a pre-IND meeting with the FDA in the U.S.  We expect their final minutes of the meeting in the coming couple of weeks. Upon guidance from the PEI, we expect to commence preparations for a pre-clinical toxicology study before commencing a first-in-human clinical trial of our anti-IL NanoAbs for the treatment of plaque psoriasis in 2025.    Additional NanoAbs for treatment of additional autoimmune diseases, such as asthma, atopic dermatitis and wet AMD, have been discovered and characterized at Max Planck and University Medical Center Göttingen as part of their research collaboration agreement with Scinai. Scinai holds exclusive options for exclusive licenses at pre-agreed financial terms for each of the resulting NanoAbs. We are pursuing a strategic partnership for both our COVID-19 self-administered inhaled NanoAb, which demonstrated highly promising in vivo results in animals as both a therapeutic and prophylactic treatment, and our anti-IL-17 nanoAb for the treatment of plaque psoriasis and other potential indications. Q1 2024 Financial Summary R&D expenses for the three months ended March 31, 2024, amounted to $1,568 thousands, compared to $1,995 thousands for the three months ended March 31, 2023. The decrease was primarily due to a reduction in salaries and reduced use of subcontractors. Marketing, general and administrative expenses  for the three months ended March 31, 2024, amounted to $484 thousands, compared to $1,191 thousands for the three months ended March 31, 2023. The decrease was primarily due to a reduction in each of salaries, share-based compensation and professional services. Financial income for the three months ended March 31, 2024, amounted to $231 thousands compared to $329 thousands for the three months ended March 31, 2023. Net loss for the three months ended March 31, 2024, was $2,159 thousands compared to net loss of $3,515 thousands for the three months ended March 31, 2023. As of March 31, 2024, Scinai had cash and cash equivalents and short-term deposits of $4,826 thousands compared to $4,870 thousands as of March 31, 2023.     SCINAI IMMUNOTHERAPEUTICS LTD. (Formerly known as BiondVax Pharmaceuticals Ltd.)  BALANCE SHEETS U.S. dollars in thousands (except share and per share data) March 31, December 31, 2024 2023 ASSETS  Unaudited  Audited CURRENT ASSETS: Cash and cash equivalents $ 4,826 $ 4,870 Restricted cash 140 140 Prepaid expenses and other receivables 288 437 Total current assets 5,254 5,447 NON-CURRENT ASSETS: Property, plant and equipment, net 10,671 10,825 Operating lease right-of-use assets 1,126 1,200 Total non-current assets 11,797 12,025 Total assets $ 17,051 $ 17,472 The accompanying notes are an integral part of the financial statements.      SCINAI IMMUNOTHERAPEUTICS LTD. (Formerly known as BiondVax Pharmaceuticals Ltd.)  BALANCE SHEETS U.S. dollars in thousands (except share and per share data) March 31, December 31, 2024 2023 Unaudited Audited LIABILITIES NET OF CAPITAL DEFICIENCY CURRENT LIABILITIES: Trade payables $ 928 $ 535 Operating lease liabilities 387 396 Other payables 610 849 Total current liabilities 1,925 1,780 NON-CURRENT LIABILITIES: Warrants liability - 96 Loan from others 19,510 19,368 Non-current operating lease liabilities 732 797 Total non-current liabilities 20,242 20,261 CONTINGENT LIABILITIES AND COMMITMENTS SHAREHOLDERS' DEFICIT: Ordinary shares of no par value: Authorized: 20,000,000,000 shares at March 31, 2024 and at December 31, 2023; Issued and outstanding 2,160,346,784 shares at March 31, 2024 and 1,857,169,984 shares at December 31, 2023 - - Additional paid-in capital 121,118 119,506 Accumulated deficit (124,494) (122,335) Accumulated other comprehensive loss (1,740) (1,740) Total shareholders' deficit (5,116) (4,569) Total liabilities and shareholders' deficit $ 17,051 $ 17,472 The accompanying notes are an integral part of the financial statements.      SCINAI IMMUNOTHERAPEUTICS LTD. (Formerly known as BiondVax Pharmaceuticals Ltd.)  STATEMENTS OF OPERATIONS U.S. dollars in thousands (except share and per share data) For the three months ended March 31 2024 2023 Unaudited Unaudited Research and development expenses, net $ 1,568 $ 1,995 Marketing, general, and administrative expenses 484 1,191 Other income (124) - Total operating expenses 1,928