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
PR Newswire
JERUSALEM, Nov. 22, 2024
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 Highlights
Conversion of EIB Loan into Equity bringing shareholders' equity to $10 million
On August 21, 2024, the Company announced that it had closed a Loan Restructuring Agreement, which included an amendment and restatement to the amended Finance Contract with the European Investment Bank (the "EIB"). In connection with the transaction, an amount equal to approximately EUR 26.6 million (equal to approximately $28.1 million as of November 21, 2024), including interest accrued through the closing date, owed by the Company to the EIB under the amended Finance Contract between the parties was converted into 1,000 preferred shares, no par value per share, of the Company (the "Preferred Shares") convertible into a fixed number of ADSs, calculated at the closing date to represent 19.5% of the then fully diluted outstanding capital stock of the Company (364 thousand ADSs). The Preferred Shares do not contain any anti-dilution provisions, do not accrue dividends, and are not subject to mandatory redemption, but are redeemable at the election of the Company at a cumulative redemption value of $34 million. Under the terms of the agreement, EIB may not convert its Preferred Shares into ADSs for a period of twelve (12) months from the date of issuance of the Preferred Shares. In addition, EIB may not convert its Preferred Shares into ADSs if at the time of conversion, the aggregate number of ADSs EIB will receive or would have been entitled to receive within the twelve months prior to such conversion would exceed 4.99% of the ADSs issued and outstanding at the time of such conversion.
Following the conversion, the total outstanding amount owed by the Company to the EIB was reduced to EUR 250,000 (equal to approximately $264,000 as of November 21(st) , 2024). This remaining outstanding amount has a maturity date of December 31, 2031, is not prepayable in advance, and no interest accrues or is due and payable on such amount.
On August 29, 2024, the Company announced that on August 27, 2024, it had received formal notification from the Listing Qualification Department of the Nasdaq Stock Market that the Company had regained compliance with Nasdaq Listing Rule 5550(b)(1) (the "Rule") that requires listed companies to maintain stockholders' equity of at least $2.5 million. Regaining compliance with the Rule was facilitated by the closing of the Loan Restructuring Agreement with the EIB and the concomitant conversion of the EIB loan as described above.
CDMO business unit
Since Jan 2024, the Company has received CDMO work orders valued at approximately $600K, and the Company is in advanced contract discussions with several other potential clients. The Company's sales guidance for 2024 is at $600,000 in expected revenues. The Company has also received $575,000 in grants from the Israeli Innovation Authority in support of its CDMO business unit creation. The Company applied for a grant extension that, if granted, would provide reimbursement for 66% of approved CDMO costs covering up to NIS 1.5 million (approximately $400,000 as of November 21, 2024) of costs. As the Company's CDMO unit is new, and the Company is focused on rapidly growing, acquiring new clients and building its reputation and brand awareness of its CDMO services, the Company expects 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 the Company has 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), the BioMed Israel conference in Tel Aviv, Israel (May 2024), and Bio Europe in Stockholm Sweden (November 2024) at which the Company marketed its CDMO services and met with prospective clients for its CDMO business unit, potential partners for its R&D pipeline and potential investors.
The Company's CDMO unit is currently focused both on executing drug development projects for its clients and on validating its processes and facilities as required by cGMP standards.
R&D business unit - Pipeline Development
On June 4, 2024, the Company 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. Consequently, on July 23, 2024, the Company announced the receipt of positive regulatory feedback from the PEI for its drug development program towards Phase 1/2a clinical trial of its anti-IL-17A/F nanoAb (SCN-1) in Plaque Psoriasis. The Phase 1/2a study is expected to include approximately 24 plaque psoriasis patients and is expected to commence in the second half of 2025 with readout in 2026.
On July 15, 2024, the Company announced promising results from its pre-clinical, in-vivo proof of concept study in plaque psoriasis, conducted by the team of Prof. Amos Gilhar at the internationally renowned Skin Research Laboratory at the Technion, Israel Institute of Technology, Haifa. The statistical analysis of psoriasis markers measured in the study confirmed that the effect of Scinai's nanoAb was similar to that of the two comparator drugs. This supports the hypothesis that intralesional injection of a nanoAb blocking the IL-17 cytokine can positively impact the inflammatory cytokine cascade, leading to a reduction in psoriatic lesion severity and improvement in skin integrity. By delivering a biological treatment directly into psoriatic lesions, the Company aims to improve disease management for patients suffering from mild to moderate plaque psoriasis and those with psoriatic lesions in hard-to-treat areas (such as the scalp, genitals, palms of hands, and soles of feet). This approach offers the high potency and specificity advantages of biologic drugs while providing a safer and more convenient treatment option compared to existing therapies for this patient category. On September 26, 2024, the Company filed with the Securities and Exchange Commission a Current Report on Form 6-K disclosing that it had entered into a license agreement with an unaffiliated U.S. private company ("Licensee"), pursuant to which Scinai has granted Licensee exclusive global rights to certain patents and know-how under Scinai's agreement with the Max Planck Society and the University Medical Center Göttingen for the development and commercialization of licensed products in exchange for an up-front license fee payable by the Licensee's completion of specified pre-clinical work, as well as other contingent development milestone payments across several indications and royalties on net sales of licensed products.
Additional nanoAbs for treatment of additional autoimmune diseases, such as asthma, atopic dermatitis and wet AMD, have been discovered and characterized at the Max Planck Institute in Gottingen and the University Medical Center Göttingen, both in Germany as part of their research collaboration agreement with Scinai. Scinai holds exclusive options for exclusive, world-wide licenses to develop and commercialize these nanoAbs at pre-agreed financial terms.
The Company is pursuing strategic partnerships and sublicensing options for its anti-IL-17 nanoAb for the treatment of plaque psoriasis and other potential indications and also is looking for partners to co-develop or sub license the additional nanoAbs that have been discovered and characterized. Parties interested in discussing partnering opportunities should contact the company at BD@scinai.com
Nine (9) Months of 2024 Financial Summary
-- Revenues for the nine months ended September 30, 2024, amounted to $452
thousands, compared to no revenues for the period of nine months ended
September 30, 2023.The increase is due to the CDMO starting to generate
revenues for the first time in 2024.
-- R&D expenses for the nine months ended September 30, 2024, amounted to
$4,195 thousands compared to $4,583 thousands for the nine months ended
September 30, 2023. The decrease was not material and primarily reflects
minor fluctuations in R&D activities during the period.
-- Marketing, general and administrative expenses for the nine months ended
September 30, 2024, amounted to $1,767 thousands compared to $3,300
thousands for the nine months ended September 30, 2023. The decrease was
primarily due to salaries and service providers decrease.
-- Financial income, net for the nine months ended September 30, 2024,
amounted to $13,374 thousands compared to $3,713 thousands for the nine
months ended September 30, 2023. The increase was primarily due to
$14,759 financial income from loan conversion to equity.
-- Net Gain for the nine months ended September 30, 2024, was $7,026
thousands compared to net loss of $4,170 thousands for the nine months
ended September 30, 2023. The increase was primarily due to $14,759
financial income from loan conversion.
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