THIRD QUARTER 2023 FINANCIAL SUMMARY
- R&D expenses for the three months ended
Sept. 30, 2023 amounted to$1.13 million compared to$1.19 million for the three months endedSept. 30, 2022 . - Marketing, general and administrative expenses for the three months ended
Sept. 30, 2023 amounted to$0.97 million compared to$0.96 million for the three months endedSept. 30, 2022 . - Total operating expenses for the three months ended
Sept. 30, 2023 amounted to$2.1 million compared to$2.1 million for the three months endedSept. 30, 2022 . - Financial income for the three months ended
Sept. 30, 2023 amounted to$5.2 million compared to$6.9 million income for the three months endedSept. 30, 2022 . - Net Income (loss) for the three months ended
Sept. 30, 2023 amounted to$3.1 million income compared to$4.7 million loss for the three months endedSept. 30, 2022 .
As of
In the nine months ended
A summary of unaudited financial results is included in the tables below.
BUSINESS UPDATE
Strategic pivot
- In support of the Company’s strategic pivot, in
Sept. 2023 , we raised$1.33 million in gross proceeds ($1.08 million in net proceeds) via a registered direct offering withH.C. Wainwright & Co. acting as placement agent. - In order to extend our cash runway and address the Nasdaq minimum shareholders’ equity compliance issue, our primary creditor, the
European Investment Bank (EIB), is currently considering favorably adjusting the terms of the EIB’s financial facility contract with the Company, in particular by extending the facility’s maturity. There is no guarantee that the EIB will approve the adjustment of the terms of the EIB’s financial facility with the Company. In addition, we are implementing a cost saving plan as mentioned in our Q2’23 financial results press release. - As part of the strategic pivot, in
September 2023 the company rebranded as Scinai Immunotherapeutics.
New CDMO Business Unit’s first client
- In
October 2023 , the Company closed its first contract to provide CDMO services. We are in advanced contract discussions with several other potential clients. In addition, we are pursuing extensive targeted marketing activities, including participation at major pharmaceutical conferences such as CPHI inBarcelona (October 2023 ) and BIO-Europe inMunich (November 2023).
- We are aggressively advancing the NanoAb preclinical development. Meaningful ex vivo results for our IL-17 NanoAb tested in human psoriatic skin specimens are anticipated in Q4 ’23, and we continue to expect to enter clinical testing of the NanoAb as a biobetter psoriasis treatment in 2024.
- NanoAbs for treatment of additional autoimmune diseases, such as asthma 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 our COVID-19 self-administered inhaled NanoAb which demonstrated highly promising in vivo results in animals as both a therapeutic and prophylactic treatment.
About
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Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements regarding the Company’s cash runway, adjustments to the terms of the EIB’s loan to the Company and compliance with the Nasdaq Listing Rules. These forward-looking statements reflect management's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of
CONDENSED BALANCE SHEETS (Unaudited) | |||||
2023 | 2022 | ||||
Unaudited | Audited | ||||
ASSETS | |||||
CURRENT ASSETS: | |||||
Cash and cash equivalents | 6,362 | 14,075 | |||
Restricted cash | 122 | 140 | |||
Prepaid expenses and other receivables | 228 | 155 | |||
Total current assets | 6,712 | 14,370 | |||
NON-CURRENT ASSETS: | |||||
Property, plant and equipment, net | 10,660 | 11,245 | |||
Operating lease right-of-use assets | 1,210 | 1,452 | |||
Total non-current assets | 11,870 | 12,697 | |||
Total assets | 18,582 | 27,067 | |||
LIABILITIES AND SHAREHOLDERS’ EQUITY | |||||
CURRENT LIABILITIES: | |||||
Trade payables | 546 | 716 | |||
Operating lease liabilities | 382 | 382 | |||
Other payables | 610 | 1,240 | |||
Total current liabilities | 1,538 | 2,338 | |||
NON-CURRENT LIABILITIES: | |||||
Warrants liability | 311 | 5,329 | |||
Loan from others | 18,602 | 20,082 | |||
Non-current operating lease liabilities | 823 | 1,078 | |||
Total non-current liabilities | 19,736 | 26,489 | |||
CONTINGENT LIABILITIES AND COMMITMENTS | |||||
SHAREHOLDERS’ EQUITY (DEFICIT): | |||||
Ordinary shares of no par value: Authorized: 20,000,000,000 shares at | - | - | |||
Additional paid-in capital | 119,053 | 116,082 | |||
Accumulated deficit | (120005 | ) | (115835 | ) | |
Accumulated other comprehensive loss | (1740 | ) | (2007 | ) | |
Total shareholders’ deficit | (2692 | ) | (1760 | ) | |
Total liabilities and shareholders’ deficit | 18,582 | 27,067 | |||
CONDENSED STATEMENTS OF OPERATIONS (Unaudited) | ||||||||||||||
Three months ended | Nine months ended | |||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||
Unaudited | ||||||||||||||
Research and development expenses, net | 1,134 | 1,194 | 4,583 | 4,331 | ||||||||||
Marketing, general and administrative | 968 | 967 | 3,300 | 3,708 | ||||||||||
Total operating loss | 2,102 | 2,161 | 7,883 | 8,039 | ||||||||||
Financial loss (income), net | (5,209 | ) | (6,939 | ) | (3,713 | ) | (7,359 | ) | ||||||
Net loss (income) | (3,107 | ) | (4,778 | ) | 4,170 | 680 | ||||||||
basic ordinary shareholders, | (0.002 | ) | (0.01 | ) | 0.002 | 0.001 | ||||||||
diluted ordinary shareholders | (0.002 | ) | (0.01 | ) | 0.002 | 0.001 | ||||||||
Weighted average number of shares used for computing basic net loss per share | 1,876,885,253 | 781,436,944 | 1,682,990,012 | 746,294,693 | ||||||||||
CONDENSEDSTATEMENTS OF COMPREHENSIVE LOSS (Unaudited) | ||||||||||||
Three months ended | Nine months ended | |||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||
Unaudited | ||||||||||||
Net loss (income) | (3,107 | ) | $ | (4,778 | ) | 4,170 | 680 | |||||
Other comprehensive (income) loss: | ||||||||||||
Foreign currency translation adjustments | - | 413 | 267) | ( | 460 | |||||||
Total comprehensive loss | (3,107 | ) | (4,365( | 3,903 | 1,140 | |||||||
CONDENSED STATEMENTS CHANGES IN SHAREHOLDERS’ EQUITY (Unaudited) | |||||||||||||||
Three months ended | |||||||||||||||
Ordinary shares | Additional paid-in | Accumulated | Accumulated | Total shareholders’ | |||||||||||
Number | Amount | capital | comprehensive loss | deficit | equity | ||||||||||
Balance as of | 1,453,970,784 | - | 117,740 | (1,740 | ) | (123,112 | ) | (7,112 | ) | ||||||
Exercise of warrants | 120,000,000 | - | - | - | - | - | |||||||||
Vested RSU's | 6,800,000 | - | - | - | - | - | |||||||||
Issuance of shares and warrants, net | 160,000,000 | 1,086 | 1,086 | ||||||||||||
Share-based compensation | - | - | 227 | - | - | 227 | |||||||||
Other comprehensive income | - | - | - | - | - | - | |||||||||
- | - | - | - | 3,107 | 3,107 | ||||||||||
Balance as of | 1,740,770,784 | - | 119,053 | (1,740 | ) | (120,005 | ) | (2,692 | ) | ||||||
Nine months endedSeptember30, 2023 | |||||||||||||||
Ordinary shares | Additional paid-in | Accumulated | Accumulated | Total shareholders’ | |||||||||||
Number | Amount | capital | comprehensive loss | deficit | equity | ||||||||||
Balance as of | 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 | 1,740,770,784 | - | 119,053 | (1,740 | ) | (120,005 | ) | (2,692 | ) | ||||||
Three months ended | |||||||||||||||
Ordinary shares | Additional paid-in | Accumulated | Accumulated | Total shareholders’ | |||||||||||
Number | Amount | capital | comprehensive loss | deficit | equity | ||||||||||
Balance as of | 747,153,064 | - | (2,102 | ) | (115,497 | ) | (3,264 | ) | |||||||
Share-based compensation | - | 341 | - | - | 341 | ||||||||||
Other comprehensive loss | - | - | - | (413 | ) | - | (413 | ) | |||||||
Net loss | - | - | - | - | 4,778 | 4,778 | |||||||||
Balance as of | 747,153,064 | - | 114,676 | (2,515 | ) | (110,719 | ) | 1,442 | |||||||
Nine months ended | |||||||||||||||
Ordinary shares | Additional paid-in | Accumulated | Accumulated | Total shareholders’ | |||||||||||
Number | Amount | capital | comprehensive loss | deficit | equity | ||||||||||
Balance as of | 739,048,544 | - | 113,076 | )2,055 | ) | (110,039 | ) | 982 | |||||||
Issuance of shares, net of issuance costs of | 6,000,000 | - | 216 | - | - | 216 | |||||||||
Vested RSU's | 2,104,520 | - | - | - | - | - | |||||||||
Expiration of employees options | - | 180 | - | - | 180 | ||||||||||
Share-based compensation | - | 1,204 | - | - | 1,204 | ||||||||||
Other comprehensive loss | - | - | - | (460 | ) | - | (460 | ) | |||||||
Net loss | - | - | - | - | (680 | ) | (680 | ) | |||||||
Balance as of | 747,153,064 | - | 114,676 | (2,515 | ) | (110,719 | ) | 1,442 |
Starting
CONDENSED STATEMENTS OF CASH FLOWS (Unaudited) | |||||
Nine months ended | |||||
2023 | 2022 | ||||
Unaudited | Unaudited | ||||
Cash flows from operating activities: | |||||
Net loss | (4,170 | ) | (680 | ) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||
Depreciation of property, plant and equipment | 430 | 378 | |||
Expense of in-process research and development | - | 179 | |||
Financial expenses related to loan from others | (369 | ) | (6,948 | ) | |
Share-based compensation | 686 | 1,204 | |||
Decrease in other receivables | (82 | ) | 96 | ||
Warrants revaluation | (3,924 | ) | - | ||
Changes in operating lease right-of-use assets | (14 | ) | (10 | ) | |
Increase in trade payables | (135 | ) | (580 | ) | |
Changes in operating lease liabilities | - | 10 | |||
(Decrease) increase in other payables | (579 | ) | (321 | ) | |
Net cash used in operating activities | (8,157 | ) | (6,672 | ) | |
Cash flows from investing activities: | |||||
Purchase of property, plant and equipment | (403 | ) | (566 | ) | |
Net cash used in investing activities | (403 | ) | (566 | ) | |
CONDENSED STATEMENTS OF CASH FLOWS (Unaudited) | |||||
Nine months ended | |||||
2023 | 2022 | ||||
Unaudited | Unaudited | ||||
Cash flows from financing activities: | |||||
Issuance of shares and warrants | 1,086 | - | |||
Net cash provided by financing activities | 1,086 | - | |||
Effect of exchange rate changes on cash, cash equivalents and restricted cash | (258 | ) | (1,826 | ) | |
Decrease in cash, cash equivalents and restricted cash | (7,732 | ) | (9,064 | ) | |
Cash, cash equivalents and restricted cash at the beginning of the period | 14,215 | 17,518 | |||
Cash, cash equivalents and restricted cash at the end of the period | 6,484 | 8,447 | |||
Supplementary disclosure of cash flows activities: | |||||
(1) Cash paid during the year for: | |||||
Interest | 725 | - | |||
(2) Non-cash transactions: | |||||
Issuance of warrants | 1,345 | - | |||
Exercise of warrants liability to equity | 801 | - | |||
Reconciliation of cash, cash equivalents and restricted cash: | |||||
Cash and cash equivalents | 6,362 | 8,310 | |||
Restricted cash | 122 | 137 | |||
Cash, cash equivalents and restricted cash | 6,484 | 8,447 | |||
Notes in the Company’s audited financial reports are an integral part of the financial statements and are filed with the
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