Full Press Release Details
CONDENSED CONSOLIDATED
| Page | |
| Interim Condensed Consolidated Balance Sheets | 1 - 2 |
| Interim Condensed Consolidated Statements of Operations | 3 |
| Interim Condensed Consolidated Statements of Shareholders' Equity (Deficit) | 4 - 6 |
| Interim Condensed Consolidated Statements of Cash Flows | 7 - 8 |
| Notes to Interim Condensed Consolidated Financial Statements | 9 - 17 |
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LTD. AND ITS SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
| June 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Unaudited | Audited | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 3,076 | $ | 5,309 | ||||
| Restricted deposits | 163 | 300 | ||||||
| Short-term deposits | 6,271 | - | ||||||
| Prepaid expenses and other current assets | 268 | 458 | ||||||
| Total current assets | 9,778 | 6,067 | ||||||
| LONG-TERM ASSETS: | ||||||||
| Property and equipment, net | 6,813 | 7,621 | ||||||
| Operating lease right-of-use assets | 2,679 | 1,597 | ||||||
| Other long-term assets | 257 | 87 | ||||||
| Total long-term assets | 9,749 | 9,305 | ||||||
| Total assets | $ | 19,527 | $ | 15,372 |
accompanying notes are an integral part of the interim condensed consolidated financial statements.
LTD. AND ITS SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
dollars in thousands (except share and per share data)
| June 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Unaudited | Audited | |||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT) | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Current maturities of long-term debt | $ | 5,437 | $ | 4,003 | ||||
| Accrued expenses and other current liabilities | 2,984 | 1,971 | ||||||
| Trade payables | 992 | 772 | ||||||
| Current maturities of operating lease liabilities | 873 | 540 | ||||||
| Total current liabilities | 10,286 | 7,286 | ||||||
| LONG-TERM LIABILITIES: | ||||||||
| Long-term debt | 3,127 | 6,379 | ||||||
| Deferred revenues | 2,548 | 2,548 | ||||||
| Long-term operating lease liabilities | 1,594 | 857 | ||||||
| Other liabilities | 371 | 398 | ||||||
| Total long-term liabilities | 7,640 | 10,182 | ||||||
| COMMITMENTS AND CONTINGENT LIABILITIES | ||||||||
| SHAREHOLDERS' EQUITY (DEFICIT): | ||||||||
| Ordinary shares with no par value - Authorized: 107,800,000 shares at June 30, 2024 (unaudited) and December 31, 2023; Issued and outstanding: 4,797,252 and 1,653,559 shares at June 30, 2024 (unaudited) and December 31, 2023, respectively | - | - | ||||||
| Additional paid-in capital | 252,652 | 236,213 | ||||||
| Accumulated deficit | ( 251,051 | ) | ( 238,309 | ) | ||||
| Total shareholders' equity (deficit) | 1,601 | ( 2,096 | ) | |||||
| Total liabilities and shareholders' equity | 19,527 | 15,372 |
accompanying notes are an integral part of the interim condensed consolidated financial statements.
LTD. AND ITS SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
dollars in thousands (except share and per share data)
| Six Months Ended | Three Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development, net | $ | 9,810 | $ | 7,754 | $ | 4,760 | $ | 3,960 | ||||||||
| Marketing and business development | 501 | 742 | 265 | 357 | ||||||||||||
| General and administrative | 2,111 | 3,112 | 1,096 | 1,503 | ||||||||||||
| Operating loss | 12,422 | 11,608 | 6,121 | 5,820 | ||||||||||||
| Financial expense, net | 311 | 262 | 171 | 7 | ||||||||||||
| Loss before income tax | 12,733 | 11,870 | 6,292 | 5,827 | ||||||||||||
| Income tax expenses | 9 | 35 | 2 | 10 | ||||||||||||
| Net loss | $ | 12,742 | $ | 11,905 | $ | 6,294 | $ | 5,837 | ||||||||
| Basic and diluted loss per ordinary share *) | $ | 2.62 | $ | 10.85 | $ | 1.25 | $ | 3.95 | ||||||||
| Weighted average number of ordinary shares used in computing basic and diluted loss per share *) | 4,858,158 | 1,097,015 | 5,024,871 | 1,479,449 |
accompanying notes are an integral part of the interim condensed consolidated financial statements.
LTD. AND ITS SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY (DEFICIT)
dollars in thousands (except share and per share data)
| Three Months Ended June 30, 2024 | Number of ordinary shares | Additional paid-in capital | Accumulated deficit | Total shareholders' equity | ||||||||||||
| Balances as of March 31, 2024 | 4,797,252 | $ | 251,902 | $ | ( 244,757 | ) | $ | 7,145 | ||||||||
| Share-based compensation | - | 750 | - | 750 | ||||||||||||
| Net loss | - | - | ( 6,294 | ) | ( 6,294 | ) | ||||||||||
| Balances as of June 30, 2024 (unaudited) | 4,797,252 | $ | 252,652 | $ | ( 251,051 | ) | $ | 1,601 |
| Three Months Ended June 30, 2023 | Number of ordinary shares *) | Additional paid-in capital | Accumulated deficit | Total shareholders' equity | ||||||||||||
| Balances as of March 31, 2023 | 1,297,682 | $ | 231,919 | $ | ( 220,512 | ) | $ | 11,407 | ||||||||
| Share-based compensation | - | 841 | - | 841 | ||||||||||||
| Modification of warrants | - | 31 | - | 31 | ||||||||||||
| Reclassification of pre-funded warrants to Equity | - | 1,905 | - | 1,905 | ||||||||||||
| Cashless exercise of pre-funded warrants | 345,151 | - | - | - | ||||||||||||
| Net loss | - | - | ( 5,837 | ) | ( 5,837 | ) | ||||||||||
| Balances as of June 30, 2023 (unaudited) | 1,642,833 | $ | 234,696 | $ | ( 226,349 | ) | $ | 8,347 |
accompanying notes are an integral part of the interim condensed consolidated financial statements.
LTD. AND ITS SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY (DEFICIT)
dollars in thousands (except share and per share data)
| Six Months Ended June 30, 2024 | Number of ordinary shares | Additional paid-in capital | Accumulated deficit | Total shareholders' equity | ||||||||||||
| Balances as of January 1, 2024 | 1,653,559 | $ | 236,213 | $ | ( 238,309 | ) | $ | ( 2,096 | ) | |||||||
| Share-based compensation | - | 1,440 | - | 1,440 | ||||||||||||
| Issuance of Ordinary shares, warrants and pre-funded warrants, net (1) | 3,143,693 | 14,999 | - | 14,999 | ||||||||||||
| Net loss | - | - | ( 12,742 | ) | ( 12,742 | ) | ||||||||||
| Balances as of June 30, 2024 (unaudited) | 4,797,252 | $ | 252,652 | $ | ( 251,051 | ) | $ | 1,601 |
| Six Months Ended June 30, 2023 | Number of ordinary shares *) | Additional paid-in capital | Accumulated deficit | Total shareholders' equity | ||||||||||||
| Balances as of January 1, 2023 | 669,605 | $ | 220,273 | $ | ( 214,444 | ) | $ | 5,829 | ||||||||
| Share-based compensation | - | 1,970 | - | 1,970 | ||||||||||||
| Issuance of Ordinary shares, net (2) | 626,934 | 8,627 | - | 8,627 | ||||||||||||
| Issuance of pre-funded warrants, net (3) | - | 3,987 | - | 3,987 | ||||||||||||
| Modification of warrants | - | 31 | - | 31 | ||||||||||||
| Reclassification of pre-funded warrants to Liabilities | - | ( 2,106 | ) | - | ( 2,106 | ) | ||||||||||
| Reclassification of pre-funded warrants to Equity | - | 1,905 | - | 1,905 | ||||||||||||
| Cashless exercise of pre-funded warrants | 345,151 | - | - | - | ||||||||||||
| Exercise of options | 1,143 | 9 | - | 9 | ||||||||||||
| Net loss | - | - | ( 11,905 | ) | ( 11,905 | ) | ||||||||||
| Balances as of June 30, 2023 (unaudited) | 1,642,833 | $ | 234,696 | $ | ( 226,349 | ) | $ | 8,347 |
accompanying notes are an integral part of the interim condensed consolidated financial statements.
LTD. AND ITS SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY (DEFICIT)
dollars in thousands (except share and per share data)
| Year Ended December 31, 2023 | Number of ordinary shares | Additional paid-in capital | Accumulated deficit | Total shareholders' equity (deficit) | ||||||||||||
| Balances as of January 1, 2023 | 669,605 | $ | 220,273 | $ | ( 214,444 | ) | $ | 5,829 | ||||||||
| Share-based compensation | - | 3,391 | - | 3,391 | ||||||||||||
| Issuance of Ordinary shares, net (1) | 637,660 | 8,723 | - | 8,723 | ||||||||||||
| Issuance of pre-funded warrants, net (2) | - | 3,987 | - | 3,987 | ||||||||||||
| Modification of warrants | - | 31 | - | 31 | ||||||||||||
| Reclassification of pre-funded warrants into liabilities | - | ( 2,106 | ) | - | ( 2,106 | ) | ||||||||||
| Reclassification of pre-funded warrants into equity | - | 1,905 | - | 1,905 | ||||||||||||
| Cashless exercise of pre-funded warrants | 345,151 | - | - | - | ||||||||||||
| Exercise of options | 1,143 | 9 | - | 9 | ||||||||||||
| Net loss | - | - | ( 23,865 | ) | ( 23,865 | ) | ||||||||||
| Balances as of December 31, 2023 | 1,653,559 | $ | 236,213 | $ | ( 238,309 | ) | $ | ( 2,096 | ) |
accompanying notes are an integral part of the interim condensed consolidated financial statements.
LTD. AND ITS SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
dollars in thousands
| Six Months Ended June 30, | ||||||||
| 2024 | 2023 | |||||||
| Unaudited | ||||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | ( 12,742 | ) | $ | ( 11,905 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation of property and equipment | 827 | 913 | ||||||
| Non-cash financial expenses, net | 676 | 813 | ||||||
| Remeasurement of warrants classified as a liability | - | ( 201 | ) | |||||
| Share-based compensation expenses | 1,440 | 1,970 | ||||||
| Changes in assets and liabilities: | ||||||||
| Prepaid expenses and other assets | 188 | 950 | ||||||
| Operating lease right-of-use-assets | 400 | 539 | ||||||
| Operating lease liabilities | ( 412 | ) | ( 561 | ) | ||||
| Trade payables | 220 | ( 238 | ) | |||||
| Accrued expenses and other liabilities | 909 | ( 561 | ) | |||||
| Net cash used in operating activities | ( 8,494 | ) | ( 8,281 | ) | ||||
| Cash flows from investing activities: | ||||||||
| Investment in bank deposits | ( 14,691 | ) | ( 17,600 | ) | ||||
| Proceeds from bank deposits | 8,500 | 9,932 | ||||||
| Purchase of property and equipment | ( 19 | ) | ( 195 | ) | ||||
| Net cash used in investing activities | ( 6,210 | ) | ( 7,863 | ) | ||||
| Cash flows from financing activities: | ||||||||
| Proceeds from issuance of Ordinary shares, warrants and pre-funded warrants, net | 15,076 | 12,614 | ||||||
| Payments due to long-term debt | ( 2,574 | ) | ( 1,522 | ) | ||||
| Payment of fees due to modification of debt | - | ( 125 | ) | |||||
| Proceeds from exercise of options | - | 9 | ||||||
| Net cash provided by financing activities | 12,502 | 10,976 | ||||||
| Decrease in cash, cash equivalents and restricted deposits | ( 2,202 | ) | ( 5,168 | ) | ||||
| Cash, cash equivalents and restricted deposits at the beginning of the period | 5,686 | 9,142 | ||||||
| Cash, cash equivalents and restricted deposits at the end of the period | $ | 3,484 | $ | 3,974 |
accompanying notes are an integral part of the interim condensed consolidated financial statements.
LTD. AND ITS SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
dollars in thousands
| Six Months Ended June 30, | ||||||||
| 2024 | 2023 | |||||||
| Unaudited | ||||||||
| Non-cash activities: | ||||||||
| Modification of warrants | $ | - | $ | 31 | ||||
| Credit line derivative | $ | - | $ | 127 | ||||
| Issuance costs | $ | 77 | $ | - | ||||
| Right-of-use asset recognized with corresponding lease liability | $ | 1,482 | $ | - | ||||
| Supplemental disclosures of cash flows: | ||||||||
| Interest paid | $ | 471 | $ | 492 | ||||
| Supplemental disclosures of cash flow information: | ||||||||
| Cash and cash equivalents | $ | 3,076 | $ | 3,396 | ||||
| Restricted deposits | 163 | 503 | ||||||
| Restricted deposits included in other long-term assets | 245 | 75 | ||||||
| Cash, cash equivalents and restricted deposits at the end of the period | $ | 3,484 | $ | 3,974 |
accompanying notes are an integral part of the interim condensed consolidated financial statements.
LTD. AND ITS SUBSIDIARY
TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
dollars in thousands (except share and per share data)
Company's wholly owned subsidiaries include a subsidiary in the United States (the "US Subsidiary") and a subsidiary
in Romania. The US Subsidiary's operation focuses on marketing and business development of the Company's operation in the
September 2022, the Company announced top-line results from the Surgical site Hospital acquired Infection prEvention with Local D-PLEX100
("SHIELD") I Phase 3 trial. SHIELD I did not achieve its primary endpoint. That said, in a pre-specified subgroup analysis
requested by the United States Food and Drug Administration ("FDA") of a total of 423 subjects with large incisions (>20
centimeters), the local administration of D-PLEX100 resulted in a significant reduction of 54 percent in the primary endpoint,
compared to SoC alone (p=0.0032). The FDA acknowledged that the SHIELD I results may provide supportive evidence on this population and
recommended that the Company conduct an additional study to support a potential NDA submission. The FDA stated that the ongoing SHIELD
II study could potentially serve as such a study. The Company resumed recruitment into the SHIELD II trial in June 2023.
LTD. AND ITS SUBSIDIARY
TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
dollars in thousands (except share and per share data)
of June 30, 2024, the Company's cash, cash equivalents and short-term deposits amounted to a total of $9,347. During the six-month
period ended June 30, 2024, the Company incurred a loss of $12,742 and had negative cash flows from operating activities of $8,494. In
addition, the Company had an accumulated deficit of $251,051 as of June 30, 2024.
plans to seek additional equity financing through private and public offerings or strategic partnerships and, in the longer term, by
generating revenues from product sales.
Company's future operations are highly dependent on a combination of factors, including (i) completion of all required clinical
studies; (ii) the success of its research and development activities; (iii) manufacture of all required clinical and commercial production
batches; (iv) marketing approval by the relevant regulatory authorities; and (v) market acceptance of the Company's product candidates.
can be no assurance that the Company will succeed in achieving the clinical, scientific and commercial milestones as detailed above.
on the abovementioned, as of the approval date of these interim consolidated financial statements, the Company has not raised the necessary
funding in order to continue its activity for a period of at least one year. Therefore, these factors raise a substantial doubt about
the Company's ability to continue as a going concern. The interim condensed consolidated financial statements do not include any
adjustments to the carrying amounts and classifications of assets and liabilities that might result should the Company be unable to continue
accompanying interim condensed consolidated financial statements of the Company have been prepared in conformity with accounting principles
generally accepted in the United States and are consistent in all material respects with those applied in the Company's Annual
Report on Form 20-F for the year ended December 31, 2023, filed with the Securities and Exchange Commission on March 6, 2024.
preparation of interim condensed consolidated financial statements in conformity with U.S. generally accepted accounting principles ("U.S.
GAAP") requires management to make estimates and judgments that affect the amounts reported in the interim condensed consolidated
financial statements and accompanying notes. Significant items subject to such estimates and assumptions, but are not limited to, the
fair value of financial assets and liabilities, the useful lives of property and equipment and the determination of the fair value of
the Company's share-based compensation. The Company bases these estimates on historical and anticipated results, trends and various
other assumptions that it believes are reasonable under the circumstances, including assumptions as to future events. Actual results
could differ from those estimates.
LTD. AND ITS SUBSIDIARY
TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
dollars in thousands (except share and per share data)
interim financial information is unaudited, but reflects all normal recurring adjustments that are, in the opinion of management, necessary
to fairly present the information set forth herein. The interim condensed consolidated financial statements should be read in conjunction
with the audited consolidated financial statements and related notes included in the Company's Annual Report on Form 20-F for the
year ended December 31, 2023 (the "2023 Consolidated Financial Statements"). Interim results are not necessarily indicative
of the results for a full year.
have been no material changes in the Company's significant accounting policies as compared to the significant accounting policies
described in the Company's Annual Report on Form 20-F for the year ended December 31, 2023.
Company's basic loss per share is calculated by dividing the loss attributable to ordinary shareholders by the weighted-average
number of shares of ordinary shares outstanding for the period, without consideration of potentially dilutive securities. The diluted
loss per share is calculated by giving effect to all potentially dilutive securities outstanding for the period using the treasury share
method or the if-converted method based on the nature of such securities. Diluted loss per share is the same as basic loss per share
in periods when the effects of potentially dilutive shares of ordinary shares are anti-dilutive.
U.S. GAAP, fair value is defined as the amount that would be received for selling an asset or paid to transfer a liability in an
orderly transaction between market participants and requires that assets and liabilities carried at fair value are classified and disclosed
in the following three categories: