Full Press Release Details
AND ITS SUBSIDIARIES
INTERIM CONDENSED CONSOLIDATED
FINANCIAL STATEMENTS
U.S. DOLLARS IN THOUSANDS
| Page | |
| Interim Condensed Consolidated Balance Sheets | 2 - 3 |
| Interim Condensed Consolidated Statements of Operations | 4 |
| Interim Condensed Consolidated Statements of Shareholders' Equity | 5 - 6 |
| Interim Condensed Consolidated Statements of Cash Flows | 7 - 8 |
| Notes to Interim Condensed Consolidated Financial Statements | 9 - 17 |
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POLYPID LTD. AND ITS SUBSIDIARY
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
| June 30, | December 31, | |||||||
| 2023 | 2022 | |||||||
| Unaudited | Audited | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 3,396 | $ | 8,552 | ||||
| Short-term deposits | 11,710 | 4,042 | ||||||
| Restricted deposits | 503 | 511 | ||||||
| Prepaid expenses and other current assets | 144 | 1,089 | ||||||
| Total current assets | 15,753 | 14,194 | ||||||
| LONG-TERM ASSETS: | ||||||||
| Property and equipment, net | 8,529 | 9,247 | ||||||
| Operating lease right-of-use assets | 1,892 | 2,431 | ||||||
| Other long-term assets | 89 | 99 | ||||||
| Total long-term assets | 10,510 | 11,777 | ||||||
| Total assets | $ | 26,263 | $ | 25,971 |
The accompanying notes are an integral part of
the interim condensed consolidated financial statements.
POLYPID LTD. AND ITS SUBSIDIARY
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands (except share and
| June 30, | December 31, | |||||||
| 2023 | 2022 | |||||||
| Unaudited | Audited | |||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Current maturities of long-term debt | $ | 2,068 | $ | 4,024 | ||||
| Accrued expenses and other current liabilities | 1,842 | 2,429 | ||||||
| Trade payables | 903 | 1,141 | ||||||
| Current maturities of operating lease liabilities | 638 | 959 | ||||||
| Total current liabilities | 5,451 | 8,553 | ||||||
| LONG-TERM LIABILITIES: | ||||||||
| Long-term debt | 8,538 | 7,574 | ||||||
| Deferred revenues | 2,548 | 2,548 | ||||||
| Long-term operating lease liabilities | 933 | 1,173 | ||||||
| Other liabilities | 446 | 294 | ||||||
| Total long-term liabilities | 12,465 | 11,589 | ||||||
| COMMITMENTS AND CONTINGENT LIABILITIES | ||||||||
| SHAREHOLDERS' EQUITY: | ||||||||
| Ordinary shares with no par value - Authorized: 107,800,000 and 47,800,000 shares at June 30, 2023 (unaudited) and December 31, 2022, respectively; Issued and outstanding: 49,048,703 and 19,851,833 shares at June 30, 2023 (unaudited) and December 31, 2022, respectively | - | - | ||||||
| Additional paid-in capital | 234,696 | 220,273 | ||||||
| Accumulated deficit | ( 226,349 | ) | ( 214,444 | ) | ||||
| Total shareholders' equity | 8,347 | 5,829 | ||||||
| Total liabilities and shareholders' equity | $ | 26,263 | $ | 25,971 |
The accompanying notes are an integral part of
the interim condensed consolidated financial statements.
POLYPID LTD. AND ITS SUBSIDIARY
INTERIM CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share and
| Six Months Ended | Three Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development, net | $ | 7,754 | $ | 17,095 | $ | 3,960 | $ | 8,398 | ||||||||
| Marketing and business development | 742 | 1,698 | 357 | 923 | ||||||||||||
| General and administrative | 3,112 | 4,723 | 1,503 | 2,243 | ||||||||||||
| Operating loss | 11,608 | 23,516 | 5,820 | 11,564 | ||||||||||||
| Financial expense, net | 262 | 203 | 7 | 281 | ||||||||||||
| Loss before income tax | 11,870 | 23,719 | 5,827 | 11,845 | ||||||||||||
| Income tax expenses | 35 | - | 10 | - | ||||||||||||
| Net loss | $ | 11,905 | $ | 23,719 | $ | 5,837 | $ | 11,845 | ||||||||
| Basic and diluted loss per ordinary share | $ | 0.36 | $ | 1.23 | $ | 0.13 | $ | 0.61 | ||||||||
| Weighted average number of ordinary shares used in computing basic and diluted loss per share | 32,910,446 | 19,222,423 | 44,383,474 | 19,505,246 |
The accompanying notes are an integral part of
the interim condensed consolidated financial statements.
POLYPID LTD. AND ITS SUBSIDIARY
INTERIM CONDENSED CONSOLIDATED
STATEMENTS OF SHAREHOLDERS' EQUITY
U.S. dollars in thousands (except share and
| 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 | 38,694,171 | $ | 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 | 10,354,532 | - | - | - | ||||||||||||
| Net loss | - | - | ( 5,837 | ) | ( 5,837 | ) | ||||||||||
| Balances as of June 30, 2023 (unaudited) | 49,048,703 | $ | 234,696 | $ | ( 226,349 | ) | $ | 8,347 |
| Three Months Ended June 30, 2022 | Number of ordinary shares | Additional paid-in capital | Accumulated deficit | Total shareholders' equity | ||||||||||||
| Balances as of March 31, 2022 | 19,470,757 | $ | 215,606 | $ | ( 186,761 | ) | $ | 28,845 | ||||||||
| Share-based compensation | - | 1,266 | - | 1,266 | ||||||||||||
| Issuance of ordinary shares, net (1) | 57,722 | 285 | - | 285 | ||||||||||||
| Issuance of warrants | - | 468 | - | 468 | ||||||||||||
| Exercise of options | 22,694 | 91 | - | 91 | ||||||||||||
| Loss | - | - | ( 11,845 | ) | ( 11,845 | ) | ||||||||||
| Balances as of June 30, 2022 (unaudited) | 19,551,173 | $ | 217,716 | $ | ( 198,606 | ) | $ | 19,110 |
The accompanying notes are an integral part of
the interim condensed consolidated financial statements.
POLYPID LTD. AND ITS SUBSIDIARY
INTERIM CONDENSED CONSOLIDATED
STATEMENTS OF SHAREHOLDERS' EQUITY
U.S. dollars in thousands (except share and
| 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 | 19,851,833 | $ | 220,273 | $ | ( 214,444 | ) | $ | 5,829 | ||||||||
| Share-based compensation | - | 1,970 | - | 1,970 | ||||||||||||
| Issuance of Ordinary shares, net (1) | 18,808,029 | 8,627 | - | 8,627 | ||||||||||||
| Issuance of pre-funded warrants, net (2) | - | 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 | 10,354,532 | - | - | - | ||||||||||||
| Exercise of options | 34,309 | 9 | - | 9 | ||||||||||||
| Net loss | - | - | ( 11,905 | ) | ( 11,905 | ) | ||||||||||
| Balances as of June 30, 2023 (unaudited) | 49,048,703 | $ | 234,696 | $ | ( 226,349 | ) | $ | 8,347 |
| Six Months Ended June 30, 2022 | Number of Ordinary shares | Additional paid-in capital | Accumulated deficit | Total shareholders' equity | ||||||||||||
| Balances as of January 1, 2022 | 18,756,570 | $ | 210,847 | $ | ( 174,887 | ) | $ | 35,960 | ||||||||
| Share-based compensation | - | 2,539 | - | 2,539 | ||||||||||||
| Issuance of shares, net (1) | 768,622 | 3,754 | - | 3,754 | ||||||||||||
| Issuance of warrants | - | 468 | - | 468 | ||||||||||||
| Exercise of options | 25,981 | 108 | - | 108 | ||||||||||||
| Loss | - | - | ( 23,719 | ) | ( 23,719 | ) | ||||||||||
| Balances as of June 30, 2022 (unaudited) | 19,551,173 | $ | 217,716 | $ | ( 198,606 | ) | $ | 19,110 |
| Year Ended December 31, 2022 | Number of ordinary shares | Additional paid-in capital | Accumulated deficit | Total shareholders' equity | ||||||||||||
| Balances as of January 1, 2022 | 18,756,570 | $ | 210,847 | $ | ( 174,887 | ) | $ | 35,960 | ||||||||
| Share-based compensation | - | 4,307 | - | 4,307 | ||||||||||||
| Issuance of ordinary shares, net (1) | 1,065,057 | 4,423 | - | 4,423 | ||||||||||||
| Issuance of warrants | - | 588 | - | 588 | ||||||||||||
| Exercise of options | 30,206 | 108 | - | 108 | ||||||||||||
| Net loss | - | - | ( 39,557 | ) | ( 39,557 | ) | ||||||||||
| Balances as of December 31, 2022 (audited) | 19,851,833 | $ | 220,273 | $ | ( 214,444 | ) | $ | 5,829 |
The accompanying notes are an integral part of
the interim condensed consolidated financial statements.
POLYPID LTD. AND ITS SUBSIDIARY
INTERIM CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOWS
U.S. dollars in thousands
| Six Months Ended June 30, | ||||||||
| 2023 | 2022 | |||||||
| Unaudited | ||||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | ( 11,905 | ) | $ | ( 23,719 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation of property and equipment | 913 | 805 | ||||||
| Non-cash financial expenses, net | 813 | 146 | ||||||
| Remeasurement of warrants classified as a liability | ( 201 | ) | - | |||||
| Share-based compensation expenses | 1,970 | 2,539 | ||||||
| Changes in assets and liabilities: | ||||||||
| Prepaid expenses and other assets | 950 | 1,584 | ||||||
| Operating lease liabilities and right-of-use-assets, net | ( 22 | ) | - | |||||
| Trade payables | ( 238 | ) | ( 1,748 | ) | ||||
| Accrued expenses and other liabilities | ( 561 | ) | 51 | |||||
| Net cash used in operating activities | ( 8,281 | ) | ( 20,342 | ) | ||||
| Cash flows from investing activities: | ||||||||
| Short-term and long-term deposits, net | ( 7,668 | ) | 10,245 | |||||
| Purchase of property and equipment | ( 195 | ) | ( 1,185 | ) | ||||
| Net cash provided (used) by investing activities | ( 7,863 | ) | 9,060 | |||||
| Cash flows from financing activities: | ||||||||
| Proceeds from issuance of ordinary shares, net | 8,627 | 3,754 | ||||||
| Proceeds from long-term debt, net | - | 9,331 | ||||||
| Payments due to long-term debt | ( 1,522 | ) | ( 406 | ) | ||||
| Payment of fees due to modification of debt | ( 125 | ) | - | |||||
| Proceeds from issuance of pre-funded warrants | 3,987 | 468 | ||||||
| Proceeds from exercise of options | 9 | 108 | ||||||
| Net cash provided by financing activities | 10,976 | 13,255 | ||||||
| Increase (decrease) in cash, cash equivalents and restricted cash | ( 5,168 | ) | 1,973 | |||||
| Cash, cash equivalents and restricted cash at the beginning of the period | 9,142 | 10,456 | ||||||
| Cash, cash equivalents and restricted cash at the end of the period | $ | 3,974 | $ | 12,429 |
The accompanying notes are an integral part of
the interim condensed consolidated financial statements.
POLYPID LTD. AND ITS SUBSIDIARY
INTERIM CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOWS
U.S. dollars in thousands
| Six Months Ended June 30, | ||||||||
| 2023 | 2022 | |||||||
| Unaudited | ||||||||
| Non-cash activities: | ||||||||
| Modification of warrants | $ | 31 | $ | - | ||||
| Credit line derivative | $ | 127 | $ | - | ||||
| Property and equipment acquired by credit | $ | - | $ | 42 | ||||
| Supplemental disclosures of cash flows: | ||||||||
| Interest paid | $ | 492 | $ | 77 | ||||
| Supplemental disclosures of cash flow information: | ||||||||
| Cash and cash equivalents | $ | 3,396 | $ | 11,640 | ||||
| Restricted cash | 503 | 576 | ||||||
| Restricted cash included in other long-term assets | 75 | 213 | ||||||
| Cash, cash equivalents and restricted cash at the end of the period | $ | 3,974 | $ | 12,429 |
The accompanying notes are an integral part of
the interim condensed consolidated financial statements.
POLYPID LTD. AND ITS SUBSIDIARY
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
U.S. dollars in thousands (except share and
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 United States.
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 of reduction in SSIs, re-interventions due to SSIs and mortality:
in the Intent to Treat population, the local administration of D-PLEX100 and standard of care ("SoC"), (n=485)
resulted in a decrease in the primary endpoint of 23 percent compared to SoC alone (n=489) (p=0.1520).
to continue to incur substantial losses over the next several years during its clinical development phase. To fully execute its business
plan, the Company will need to complete Phase 3 clinical studies and certain development activities as well as manufacture the required
clinical and commercial production batches in the pilot manufacturing plant. Further, the Company's product candidates will require
regulatory approval prior to commercialization, and the Company will need to establish sales, marketing and logistic infrastructures.
These activities may span many years and require substantial expenditures to complete and may ultimately be unsuccessful. Any delays in
completing these activities could adversely impact the Company.
As of June 30, 2023,
the Company's cash, cash equivalents and short-term deposits amounted to a total of $15,106. During the six-month period ended June 30,
2023, the Company incurred a loss of $11,905 and had negative cash flows from operating activities of $8,281. In addition, the Company
had an accumulated deficit of $226,349 as of June 30, 2023.
POLYPID LTD. AND ITS SUBSIDIARY
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
U.S. dollars in thousands (except share and
to seek additional equity financing through private and public offerings or strategic partnerships and, in the longer term, by generating
revenues from product sales.
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.
assurance that the Company will succeed in achieving the clinical, scientific and commercial milestones as detailed above.
Based 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 as a going concern.
2:- SIGNIFICANT ACCOUNTING POLICIES
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, 2022, filed with the Securities and Exchange Commission on March 31, 2023.
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.
The interim financial