Full Press Release Details
Publishes Financial Results and Provides Business Update; Shareholders' Equity up from negative $7.3 million as of June 30, 2024,
to positive $10 million
JERUSALEM, November 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.
Update & Recent Highlights
of EIB Loan into Equity bringing shareholders' equity to $10 million
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.
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 21st, 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.
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.
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
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
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.
business unit - Pipeline Development
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.
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 G ttingen
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.
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 G ttingen, 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.
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
(9) Months of 2024 Financial Summary
of September 30, 2024, Scinai had cash and cash equivalents and short-term deposits of $1,169 thousands compared to $5,010 thousands
as of September 30, 2023.
IMMUNOTHERAPEUTICS LTD.
known as BiondVax Pharmaceuticals Ltd.)
FINANCIAL STATEMENTS
IMMUNOTHERAPEUTICS LTD. (Formerly known as BiondVax Pharmaceuticals Ltd.) - (Unaudited)
dollars in thousands
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 1,032 | $ | 4,870 | ||||
| Restricted cash | 137 | 140 | ||||||
| Trade receivables | 120 | - | ||||||
| Prepaid expenses and other receivables | 328 | 437 | ||||||
| Total current assets | 1,617 | 5,447 | ||||||
| NON-CURRENT ASSETS: | ||||||||
| Property, plant and equipment, net | 9,686 | 10,825 | ||||||
| Operating lease right-of-use assets | 958 | 1,200 | ||||||
| Total non-current assets | 10,644 | 12,025 | ||||||
| Total assets | $ | 12,261 | $ | 17,472 |
accompanying notes are an integral part of the financial statements.
IMMUNOTHERAPEUTICS LTD. (Formerly known as BiondVax Pharmaceuticals Ltd.) - (Unaudited)
dollars in thousands (except share data)
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| LIABILITIES NET OF CAPITAL DEFICIENCY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Trade payables | $ | 430 | $ | 535 | ||||
| Operating lease liabilities | 364 | 396 | ||||||
| Other payables | 598 | 849 | ||||||
| Total current liabilities | 1,392 | 1,780 | ||||||
| NON-CURRENT LIABILITIES: | ||||||||
| Warrants liability | 3 | 96 | ||||||
| Loan from others | 280 | 19,368 | ||||||
| Non-current operating lease liabilities | 583 | 797 | ||||||
| Total non-current liabilities | 866 | 20,261 | ||||||
| SHAREHOLDERS' DEFICIT: | ||||||||
| Ordinary shares of no-par value: Authorized: 20,000,000,000 shares at September 30, 2024 and at December 31, 2023; Issued and outstanding 3,411,983,584 shares at September 30, 2024 and 1,857,169,984 shares at December 31, 2023 | - | - | ||||||
| Preferred shares, no par value; Authorized: 1,000 shares at September 30, 2024 and 0 shares at December 31, 2023; Issued and outstanding: 1,000 shares at September 30, 2024 and 0 shares at December 31, 2023 | 5,627 | - | ||||||
| Additional paid-in capital | 121,425 | 119,506 | ||||||
| Accumulated deficit | (115,309 | ) | (122,335 | ) | ||||
| Accumulated other comprehensive loss | (1,740 | ) | (1,740 | ) | ||||
| Total shareholders' equity (deficit) | 10,003 | (4,569 | ) | |||||
| Total liabilities and shareholders' equity (deficit) | $ | 12,261 | $ | 17,472 |
accompanying notes are an integral part of the financial statements.
IMMUNOTHERAPEUTICS LTD. (Formerly known as BiondVax Pharmaceuticals Ltd.) - (Unaudited)
dollars in thousands (except share data)
| For the Three months ended September 30, | For the Nine months ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Unaudited | ||||||||||||||||
| Revenues | $ | 168 | - | $ | 452 | - | ||||||||||
| Cost of revenues | (417 | ) | - | (865 | ) | - | ||||||||||
| Gross loss | (249 | ) | - | (413 | ) | |||||||||||
| Research and development expenses, net | $ | (1,407 | ) | $ | (1,134 | ) | $ | (4,195 | ) | $ | (4,583 | ) | ||||
| Marketing, general and administrative | (764 | ) | (968 | ) | (1,767 | ) | (3,300 | ) | ||||||||
| Total operating expenses | (2,171 | ) | (2,102 | ) | (5,962 | ) | (7,883 | ) | ||||||||
| Total operating loss | (2,420 | ) | (2,102 | ) | (6,375 | ) | (7,883 | ) | ||||||||
| Financial income from loan conversion | 14,759 | - | 14,759 | - | ||||||||||||
| Other Financial income, (expenses) net | (1,884 | ) | (5,209 | ) | (1,385 | ) | 3,713 | |||||||||
| Financial income )loss(, net | 12,875 | (5,209 | ) | 13,374 | 3,713 | |||||||||||
| Net gain (loss) | $ | 10,455 | $ | (3,107 | ) | $ | 7,026 | $ | (4,170 | ) | ||||||
| Net gain (loss) per share attributable to basic ordinary shareholders, | 0.0021 | (0.002 | ) | 0.0026 | (0.002 | ) | ||||||||||
| Weighted average number of shares used for computing basic net loss per share | 3,374,265,323 | 1,876,885,253 | 2,652,916,244 | 1,682,990,012 |
accompanying notes are an integral part of the financial statements.
IMMUNOTHERAPEUTICS LTD. (Formerly known as BiondVax Pharmaceuticals Ltd.) - (Unaudited)
OF COMPREHENSIVE LOSS
dollars in thousands
| For the Three months ended September 30, | For the Nine months ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Net gain (loss) | $ | 10,455 | $ | (3,107 | ) | $ | 7,026 | $ | (4,170 | ) | ||||||
| Other comprehensive income: | - | - | - | - | ||||||||||||
| Foreign currency translation adjustments | - | - | - | 267 | ||||||||||||
| Total comprehensive gain (loss) | $ | 10,455 | $ | (3,107 | ) | $ | 7,026 | $ | (3,903 | ) |
accompanying notes are an integral part of the financial statements.
IMMUNOTHERAPEUTICS LTD. (Formerly known as BiondVax Pharmaceuticals Ltd.) - (Unaudited)
OF CHANGES IN SHAREHOLDERS' EQUITY
dollars in thousands (except share data)
| Ordinary shares | Preferred shares | Additional paid-in | Accumulated comprehensive | Accumulated | Total shareholders' | |||||||||||||||||||||||||||
| Number | Amount | Number | Amount | capital | loss | deficit | equity | |||||||||||||||||||||||||
| Balance as of January 1, 2024 | 1,857,169,984 | $ | - | - | $ | - | $ | 119,506 | $ | (1, 740 | ) | $ | (122,335 | ) | $ | (4,569 | ) | |||||||||||||||
| Issuance and exercise of warrants, net of issuance costs of $275 | 1,553,792,800 | - | 1,441 | - | - | 1,441 | ||||||||||||||||||||||||||
| Loan conversion into preferred shares | - | - | 1,000 | 5,627 | - | - | - | 5,627 | ||||||||||||||||||||||||
| Vested RSU's | 1,020,800 | - | - | - | - | - | ||||||||||||||||||||||||||
| Share-based compensation | - | - | 478 | - | - | 478 | ||||||||||||||||||||||||||
| Net gain | - | - | - | - | 7,026 | 7,026 | ||||||||||||||||||||||||||
| Balance as of September 30, 2024 | 3,411,983,584 | - | 1,000 | $ | 5,627 | $ | 121,425 | $ | (1, 740 | ) | $ | (115,309 | ) | $ | 10,003 |
| Nine months ended September 30, 2023 | ||||||||||||||||||||||||
| Ordinary shares | Additional paid-in | Accumulated comprehensive | Accumulated | Total shareholders' | ||||||||||||||||||||
| Number | Amount | capital | loss | deficit | equity | |||||||||||||||||||
| Balance as of January 1, 2023 | 989,290,784 | $ | - | $ | 116,082 | $ | (2,007 | ) | $ | (115,835 | ) | $ | (1,760 | ) | ||||||||||
| Exercise of warrants | 584,015,200 | - | 801 | - | - | 801 | ||||||||||||||||||
| Vested RSU's | 7,464,800 | - | - | - | - | - | ||||||||||||||||||
| Issuance of shares and warrants, net | 160,000,000 | 1,484 | 1,484 | |||||||||||||||||||||
| Share-based compensation | - | - | 686 | - | - | 686 | ||||||||||||||||||
| Other comprehensive income | - | - | - | 267 | - | 267 | ||||||||||||||||||
| Net loss | - | - | - | - | (4,170 | ) | (4,170 | ) | ||||||||||||||||
| Balance as of September 30, 2023 | 1,740,770,784 | $ | - | $ | 119,053 | $ | (1,740 | ) | $ | (120,005 | ) | $ | (2,692 | ) |
accompanying notes are an integral part of the financial statements.
IMMUNOTHERAPEUTICS LTD. (Formerly known as BiondVax Pharmaceuticals Ltd.) - (Unaudited)
dollars in thousands