UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the Month of: August 2023 (Report No. 2)
Commission File Number: 001-38428
PolyPid Ltd.
(Translation of registrant’s name into
English)
18 Hasivim Street
Petach Tikva 495376, Israel
(Address of principal executive office)
Indicate by check mark whether the registrant
files or will file annual reports under cover of Form 20-F or Form 40-F:
☒ Form 20-F ☐ Form 40-F
CONTENTS
This
Report of Foreign Private Issuer on Form 6-K consists of PolyPid Ltd.’s (the “Registrant”): (i) Unaudited Interim Condensed
Consolidated Financial Statements as of June 30, 2023, which is attached hereto as Exhibit 99.1; and (ii) Management’s Discussion
and Analysis of Financial Condition and Results of Operations for the six months ended June 30, 2023, which is attached hereto as Exhibit
99.2.
The
contents of this Form 6-K are incorporated by reference into the Registrant’s registration statements on Form F-3
(File No. 333-257651) and Form S-8 (File No. 333-239517 and File No. 333-271060), filed
with the Securities and Exchange Commission, to be a part thereof from the date on which this report is submitted, to the extent not
superseded by documents or reports subsequently filed or furnished.
EXHIBIT INDEX
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
|
POLYPID LTD. |
|
|
|
Date: August 9, 2023 |
By: |
/s/ Dikla Czaczkes Akselbrad |
|
|
Name: |
Dikla Czaczkes Akselbrad |
|
|
Title: |
Chief Executive Officer |
Exhibit 99.1
POLYPID LTD.
AND ITS SUBSIDIARIES
INTERIM CONDENSED CONSOLIDATED
FINANCIAL STATEMENTS
AS OF JUNE 30, 2023
U.S. DOLLARS IN THOUSANDS
UNAUDITED
INDEX
- - - - - - - - - - - - - - - - - - - - - - -
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
per share data)
| |
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
per share data)
| |
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
per share data)
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
per share data)
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
per share data)
NOTE
1:- GENERAL
| a. | PolyPid Ltd. (the “Company”) was incorporated under
the laws of Israel and commenced operations on February 28, 2008. The Company is a Phase 3 biopharmaceutical company focused on
developing targeted, locally administered, and prolonged-release therapeutics using its proprietary PLEX (Polymer-Lipid Encapsulation
matriX) technology. The Company’s product candidates are designed to address unmet medical needs by delivering active pharmaceutical
ingredients, locally at predetermined release rates and durations over extended periods ranging from days to several months. The Company
is initially focused on the development of its lead product candidate, D-PLEX, which incorporates an antibiotic for the prevention of
surgical site infections (“SSIs”) in bone and soft tissue. Through June 30, 2023, the Company has been primarily engaged
in research and development. |
The 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 United States.
| b. | The Company’s activities since inception have consisted of performing research and development activities.
Successful completion of the Company’s development programs and, ultimately, the attainment of profitable operations is dependent
on future events, including, among other things, its ability to secure financing; obtain marketing approval from regulatory authorities;
access potential markets; build a sustainable customer base; attract, retain and motivate qualified personnel; and develop strategic alliances.
The Company’s operations are funded by its shareholders and research and development grants and the Company intends to seek further
private or public financing as well as make applications for further research and development grants for continuing its operations. Although
management believes that the Company will be able to successfully fund its operations, there can be no assurance that the Company will
be able to do so or that the Company will ever operate profitably. |
In 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 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).
The Company expects
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
per share data)
NOTE
1:- GENERAL (CONT.)
Management 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.
The 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.
There can be no
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.
NOTE
2:- SIGNIFICANT ACCOUNTING POLICIES
| a. | Basis of presentation and summary of significant accounting
policies: |
The 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, 2022, filed with the Securities and Exchange Commission on March 31, 2023.
The 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.
The 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,
2022 (the “2022 Consolidated Financial Statements”). Interim results are not necessarily indicative of the results for a full
year.
There 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, 2022.
POLYPID LTD. AND ITS SUBSIDIARY
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
U.S. dollars in thousands (except share and
per share data)
NOTE
2:- SIGNIFICANT ACCOUNTING POLICIES (CONT.)
| b. | Basic and diluted loss per share: |
The
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.
| c. | Fair value of financial instruments: |
Under
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:
|
Level 1 - |
Observable inputs that reflect quoted prices (unadjusted) in active markets for identical assets and liabilities. |
|
Level 2 - |
Include other inputs that are directly or indirectly observable in the marketplace. |
|
Level 3 - |
Unobservable inputs which are supported by little or no market activity. |
The
carrying amounts of cash and cash equivalents, restricted cash, short-term deposits, long-term deposits, other current assets, trade payables,
accrued expenses and other current and non-current liabilities approximate their fair value due to the short-term maturity of such instruments.
Fair
value estimates are made at a specific point in time, based on relevant market information and information about the financial instruments.
These estimates are subjective in nature and involve uncertainties and matters of significant judgment and, therefore, cannot be determined
with precision. Changes in assumptions could significantly affect these estimates.
| d. | Recently adopted accounting pronouncements: |
As an “Emerging
Growth Company”, the Jumpstart Our Business Startups Act (“JOBS Act”) allows the Company to delay adoption of new or
revised accounting pronouncements applicable to public companies until such pronouncements are made applicable to private companies. The
Company has elected to use this extended transition period under the JOBS Act.
The Company has
reviewed recent accounting pronouncements and concluded that they are either not applicable to its business or that no material effect
is expected on the condensed consolidated financial statements as a result of their future adoption.
POLYPID LTD. AND ITS SUBSIDIARY
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
U.S. dollars in thousands (except share and
per share data)
NOTE
3:- LEASES
The Company leases
substantially all of its office space and vehicles under operating leases. The Company’s leases have original lease periods expiring between 2023 and 2027. Some
leases include one or more options to renew. The Company does not assume renewals in its determination of the lease
term unless the renewals are deemed to be reasonably certain. Lease payments included in the measurement of the lease liability are comprised
of the following: the fixed non-cancelable lease payments, payments for optional renewal periods, where it is reasonably certain the renewal
period will be exercised, and payments for early termination options unless it is reasonably certain the lease will not be terminated
early.
The following
is a summary of weighted average remaining lease terms and discount rates for all of the Company’s operating leases as of June 30,
2023:
Weighted average remaining lease term (years) | |
| 3.26 | |
Weighted average discount rates | |
| 9.16 | % |
For the six months
ended June 30, 2023, the total operating lease cost and cash payments for operating leases were as follows:
Operating lease cost | |
$ | 582 | |
Cash payments for operating leases | |
$ | 524 | |
Minimum lease payments
over the remaining lease periods as of June 30, 2023, are as follows:
The remainder of 2023 | |
$ | 479 | |
2024 | |
| 403 | |
2025 | |
| 358 | |
2026 | |
| 349 | |
2027 | |
| 177 | |
| |
| | |
Total undiscounted lease payments | |
| 1,766 | |
Less - imputed interest | |
| (195 | ) |
| |
| | |
Present value of lease liabilities | |
$ | 1,571 | |
POLYPID
LTD. AND ITS SUBSIDIARY
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
U.S. dollars in thousands (except share and
per share data)
NOTE
4:- LINE OF CREDIT ARRANGEMENT
Further to the
discussion in Note 7 in the 2022 Consolidated Financial Statements regarding the secured line of credit agreement signed on April 5, 2022,
with Kreos Capital VI (Expert Fund) LP (“Kreos”) (the “Credit Line” or “debt”), the Company entered into
an amendment to the Credit Line on March 29, 2023 (the “Amendment”).
Pursuant to
the Amendment, 70% of the remaining principal and interest repayments will be delayed and repaid on a monthly equal basis from
August 2024 to May 2026. The amended secured credit line now bears an interest at the rate of 10%. In addition, the Company
will pay to Kreos a restructuring fee consisting of 1% on the closing date of the Amendment and an incremental 3% at the
maturity of the Amendment. In return for this additional deferral of repayment, Kreos has the right to receive a potential claw-back
payment on account of the then outstanding principal amount (the “Claw-Back”). This Claw-Back mechanism will be
triggered by additional incoming funds from future collaboration and partnership agreements or additional funding. If triggered, the
minimum Claw-Back to be paid will be $1,500, but will not exceed $3,000.
The Company evaluated the amendment
under ASC 470-50, “Debt - modification and extinguishment”, and concluded that the terms of the new debt and the original
debt are not substantially different, therefore the debt restructuring is accounted as debt modification where no gain or loss was recognized.
During the six-month period ended on
June 30, 2023, the Company recognized $813 of interest expenses related to the Credit Line, which were included as part of financial expenses
in the Company’s statements of operations.
In addition, the Company’s debt includes
Claw-Back feature that meets the definition of embedded derivative under ASC 815. Consequently, the embedded derivative was bifurcated
and accounted for separately at fair value. The fair value of the derivative amounted to $127 as of March 29, 2023, and June 30,
2023. Changes in the fair value of the derivative liabilities are determined at each period end. The liability due to the derivative was
classified under other long-term liabilities in the consolidated balance sheet as of June 30, 2023.
Further to the above, the outstanding
warrants issued to Kreos were repriced and as a result bear an exercise price of $0.42 per share. As a result of the modification, the
Company recorded an incremental value in the amount of $31, that was calculated based on the Black-Scholes option pricing model, which
increased the additional paid-in capital against an offset of the long-term debt due to the Credit Line.
The Company incurred debt restructuring
costs, which were fully paid in cash, and are presented as a direct deduction against the carrying amount of the debt and amortized to
interest expense using the effective interest method.
NOTE 5:- COMMITMENTS
AND CONTINGENT LIABILITIES
In connection with
its research and development programs, through June 30, 2023, the Company received participation payments from the Israel Innovation Authority
of the Ministry of Economy in Israel (“IIA”) in the aggregate amount of $4,888. In return for IIA’s participation, the Company
is committed to pay royalties at a rate of 3% of sales of the developed products, up to 100% of the amount of grants received plus interest
at LIBOR rate.
Through June 30,
2023, no royalties have been paid or accrued.
POLYPID LTD. AND ITS SUBSIDIARY
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
U.S. dollars in thousands (except share and
per share data)
NOTE 6:-
SHAREHOLDERS’ EQUITY
| a. | Ordinary share capital (with no par value) is composed as follows: |
| |
June 30, 2023 | | |
December 31, 2022 | |
| |
Unaudited | | |
Audited | |
| |
Authorized | | |
Issued and
outstanding | | |
Authorized | | |
Issued and
outstanding | |
| |
Number of shares | |
| |
| | | |
| | | |
| | | |
| | |
Ordinary shares | |
| 107,800,000 | | |
| 49,048,703 | | |
| 47,800,000 | | |
| 19,851,833 | |
| b. | In July 2021, the Company entered into a Controlled Equity
Offering Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. (the “Agent”), pursuant to
which the Company may offer and sell, from time to time, its Ordinary shares, no par value (the “Ordinary Shares”), through
the Agent in an At The Market offering (“ATM’”), as defined in Rule 415(a)(4) promulgated under the Securities Act
of 1933, as amended, for an aggregate offering price of up to $45,000, which was subsequently reduced to $8,707 on May 19, 2023. |
During the six-month
period ended June 30, 2023, the Company sold 1,949,029 Ordinary Shares under the ATM for a total amount of $2,212, net of issuance cost
in the amount of $68.
| c. | On March 29, 2023, the Company entered into a private placement
of unregistered pre-funded warrants to purchase up to 10,357,139 Ordinary shares (the “PFW”), at a price of $0.4199 per PFW
with certain of the Company’s existing shareholders. The PFWs have an exercise price of $0.0001 per Ordinary share. Accordingly,
the consideration for the PFWs amounted to $3,987, net of related placement fees and other offering expenses which amounted to a total
of $362. In accordance with ASC No. 480, “Distinguishing Liabilities from Equity” (“ASC 480”), and ASC
No. 815-40, “Derivatives and Hedging” (“ASC 815”), the PFWs were qualified for equity accounting. |
On March 31,
2023, the Company closed a public offering which was comprised of 16,859,000 Ordinary shares (inclusive of 2,199,000 Ordinary shares pursuant
to the full exercise of an overallotment option granted to the underwriters), at a public offering price of $0.42 per share (the “Public
Offering”). The proceeds to the Company from the Public Offering were $6,415, net of underwriting commissions and other offering
expenses which amounted to $666.
Following the
Public Offering, the Company did not have a sufficient number of authorized Ordinary shares to cover 5,013,446 PFWs, and as a result,
in accordance with ASC 815-40, these PFWs, which amounted to $2,106, were classified as a liability at fair value.
On May 5, 2023,
the shareholders of the Company approved to increase the Company’s authorized share capital by 60,000,000, from 47,800,000 to 107,800,000
Ordinary shares, and as a result, in accordance with ASC 480 and 815-40, these PFWs were classified under equity accounting at their fair
value, which amounted to $1,905. The change in the PFWs fair value was accounted for as financial expenses in the amount of $201.
On May 11, 2023,
all of the PFWs were exercised into 10,354,532 Ordinary shares on a cashless basis.
POLYPID LTD. AND ITS SUBSIDIARY
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
U.S. dollars in thousands (except share and
per share data)
NOTE 6:-
SHAREHOLDERS’ EQUITY (CONT.)
Through June 30,
2023, the Company authorized through its 2012 Share Option Plan the grant of 4,672,094 options to Ordinary shares to its officers, directors,
advisors, management and other employees. The options granted generally have a four-year or three-year vesting period and expire ten years
after the date of grant. Options granted under the Company’s option plan that are cancelled or forfeited before expiration become available
for future grant.
As of June 30, 2023,
1,206,447 of the Company’s options were available for future grants.
During the first
quarter of 2023, the Company decreased the exercise price of 2,021,599 options granted to all employees and a consultant under the 2012
Share Option Plan. As of the modification date, the options can be exercised for $0.77 (the “Repricing”). Following the Repricing
the Company accounted for an incremental value in the total amount of $562, in which $307 was recognized as of the modification date due
to vested options, and the rest of the amount will be expensed based on the vesting conditions of each grant.
On May 5, 2023,
the Company’s board of directors also approved a similar exercise price decrease of 504,169 options previously granted to the Company’s
Chief Executive Officer and board members. Therefore, the Company accounted for an incremental value in the total amount of $63, of which
$50 was recognized as of the modification date due to vested options, and the rest of the amount will be expensed based on the vesting
conditions of each grant.
A summary of
the status of options to employees under the Company’s 2012 Share Option Plan as of and for the six-month period ended June 30, 2023,
and changes during the period then ended is presented below (unaudited):
| |
Number of
options | | |
Weighted
average
exercise
price | | |
Aggregate
intrinsic
value | | |
Weighted
average remaining
contractual life (years) | |
| |
| | |
| | |
| | |
| |
Outstanding at beginning of period | |
| 3,303,346 | | |
$ | 1.92 | | |
$ | 115 | | |
| 6.14 | |
Granted | |
| 114,500 | | |
$ | 0.71 | | |
| - | | |
| | |
Exercised | |
| (34,309 | ) | |
$ | 0.23 | | |
$ | 12 | | |
| | |
Forfeited and expired | |
| (795,172 | ) | |
$ | 3.65 | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Outstanding at end of period | |
| 2,588,365 | | |
$ | 1.36 | | |
$ | - | | |
| 6.39 | |
| |
| | | |
| | | |
| | | |
| | |
Exercisable options | |
| 1,569,578 | | |
$ | 1.74 | | |
$ | - | | |
| 4.94 | |
| |
| | | |
| | | |
| | | |
| | |
Vested and expected to vest | |
| 2,588,365 | | |
$ | 1.36 | | |
$ | - | | |
| 6.39 | |
POLYPID LTD. AND ITS SUBSIDIARY
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
U.S. dollars in thousands (except share and
per share data)
NOTE 6:-
SHAREHOLDERS’ EQUITY (CONT.)
| d. | Share option plan: (Cont.) |
The Black-Scholes
option pricing model assumptions used to value the employee share options at the grant dates are presented in the following table for
the six-month period ended June 30, 2023:
Dividend yield (%) | |
| 0 | |
Expected volatility (%) | |
| 92.59-95.67 | |
Risk-free interest rate (%) | |
| 3.38-3.73 | |
Expected term (in years) | |
| 5.7-6.1 | |
The total share-based
compensation expense recognized by the Company’s departments:
| |
Six
Months Ended
June 30, | |
| |
2023 | | |
2022 | |
| |
Unaudited | |
| |
| | |
| |
Research and development | |
$ | 1,022 | | |
$ | 1,193 | |
Marketing and business development | |
| 191 | | |
| 199 | |
General and administrative | |
| 757 | | |
| 1,147 | |
| |
| | | |
| | |
| |
$ | 1,970 | | |
$ | 2,539 | |
As of June 30, 2023,
there were unrecognized compensation costs of $4,692, which are expected to be recognized over a weighted average period of approximately 2.15 years.
| e. | Options issued to non-employees (including directors and consultants): |
Outstanding options
granted to non-employees as of June 30, 2023, were as follows (unaudited):
Grant date | |
Options
outstanding as of June 30, 2023 | | |
Average Exercise price per share ($) | | |
Options exercisable as of June 30, 2023 | | |
Exercisable through |
| |
| | |
| | |
| | |
|
April 2016 | |
| 5,975 | | |
$ | 3.10 | | |
| 5,975 | | |
April 2026 |
December 2016 | |
| 7,170 | | |
$ | 3.93 | | |
| 7,170 | | |
December 2026 |
June 2017 | |
| 197,722 | | |
$ | 4.10 | | |
| 197,722 | | |
June 2027 |
November 2017 | |
| 17,925 | | |
$ | 0.77 | | |
| 17,925 | | |
November 2027 |
August 2019 | |
| 71,700 | | |
$ | 0.77 | | |
| 71,700 | | |
August 2029 |
June 2020 | |
| 64,530 | | |
$ | 2.84 | | |
| 64,530 | | |
June 2030 |
April 2021 | |
| 62,741 | | |
$ | 2.03 | | |
| 62,741 | | |
April 2031 |
August 2021 | |
| 15,000 | | |
$ | 0.77 | | |
| 8,719 | | |
August 2031 |
December 2021 | |
| 10,000 | | |
$ | 6.80 | | |
| 4,975 | | |
December 2031 |
May 2022 | |
| 65,625 | | |
$ | 1.37 | | |
| 65,625 | | |
May 2032 |
November 2022 | |
| 5,000 | | |
$ | 1.05 | | |
| 1,650 | | |
November 2032 |
February 2023 | |
| 16,000 | | |
$ | 0.81 | | |
| - | | |
February 2033 |
May 2023 | |
| 170,628 | | |
$ | 0.60 | | |
| - | | |
May 2033 |
| |
| | | |
| | | |
| | | |
|
| |
| 710,016 | | |
| | | |
| 508,732 | | |
|
POLYPID LTD. AND ITS SUBSIDIARY
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
U.S. dollars in thousands (except share and
per share data)
NOTE 6:- SHAREHOLDERS’
EQUITY (CONT.)
As
of June 30, 2023, all warrants are exercisable into Ordinary shares, in which the outstanding issued warrants as of June 30, 2023,
were as follows (unaudited):
Grant date | |
Warrants
outstanding as of June 30, 2023 | | |
Average
Exercise price per share ($) | | |
Warrants
exercisable as of June 30, 2023 | | |
Exercisable through |
| |
| | |
| | |
| | |
|
August 2019 | |
| 200,596 | | |
$ | 15.95 | | |
| 200,596 | | |
August 2023 |
September 2020 | |
| 17,925 | | |
$ | 16.00 | | |
| 17,925 | | |
September 2024 |
April 2022 | |
| 155,794 | | |
$ | *) 0.42 | | |
| 155,794 | | |
April 2029 |
July 2022 | |
| 38,948 | | |
$ | *) 0.42 | | |
| 38,948 | | |
July 2029 |
| |
| | | |
| | | |
| | | |
|
| |
| 413,263 | | |
| | | |
| 413,263 | | |
|
NOTE 7:- BASIC AND DILUTED
LOSS PER SHARE
The following table
sets forth the computation of the Company’s basic and diluted net loss per Ordinary share:
| |
Six Months Ended June 30, | | |
Three Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Unaudited | |
Numerator: | |
| | |
| | |
| | |
| |
Allocation of loss attributable to ordinary shareholders | |
| 11,905 | | |
| 23,719 | | |
| 5,837 | | |
| 11,845 | |
Denominator: | |
| | | |
| | | |
| | | |
| | |
Weighted average Ordinary shares outstanding | |
| 32,910,446 | | |
| 19,222,423 | | |
| 44,383,474 | | |
| 19,505,246 | |
| |
| | | |
| | | |
| | | |
| | |
Basic and diluted loss per share | |
$ | 0.36 | | |
$ | 1.23 | | |
$ | 0.13 | | |
$ | 0.61 | |
The potential
Ordinary shares that were excluded from the computation of diluted loss per share attributable to ordinary shareholders for the periods
presented because including them would have been anti-dilutive are as follows:
| |
Three and Six Months Ended June 30, | |
| |
2023 | | |
2022 | |
| |
Unaudited | |
| |
| | |
| |
Ordinary share options | |
| 2,078,310 | | |
| 4,146,332 | |
Warrants | |
| 413,263 | | |
| 374,315 | |
| |
| | | |
| | |
| |
| 2,491,573 | | |
| 4,520,647 | |
- 17 -
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Exhibit 99.2
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
As of June 30, 2023, and for the Six Months
then Ended
Cautionary Statement Regarding Forward-Looking
Statements
Certain information included herein may be deemed
to be “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities
laws. Forward-looking statements are often characterized by the use of forward-looking terminology such as “may,” “will,”
“expect,” “anticipate,” “estimate,” “continue,” “believe,” “should,”
“intend,” “project” or other similar words, but are not the only way these statements are identified.
These forward-looking statements may include, but
are not limited to, statements relating to our objectives, plans and strategies, statements that contain projections of results of operations
or of financial condition, expected capital needs and expenses, statements relating to the research, development, completion and use of
our products, and all statements (other than statements of historical facts) that address activities, events or developments that we intend,
expect, project, believe or anticipate will or may occur in the future.
Forward-looking statements are not guarantees of
future performance and are subject to risks and uncertainties. We have based these forward-looking statements on assumptions and assessments
made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments
and other factors they believe to be appropriate
Important factors that could cause actual results,
developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among other
things:
|
● |
our dependence on enrollment of patients in our clinical trial in order to continue development of our product candidates; |
|
|
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|
● |
the outcomes of our anticipated interim analysis in our phase 3 SHIELD II clinical trial; |
|
|
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|
● |
the outcomes of our phase 3 SHIELD II clinical trial; |
|
|
|
|
● |
our ability to raise capital through the issuance of securities; |
|
|
|
|
● |
our ability to advance the development of our product candidates, including the anticipated starting and ending dates of our anticipated clinical trials; |
|
|
|
|
● |
our assessment of the potential of our product candidates to treat certain indications; |
|
|
|
|
● |
our ability to successfully receive approvals from the U.S. Food and Drug Administration, or FDA, the European Medicines Agency or other applicable regulatory bodies, including approval to conduct clinical trials, the scope of those trials and the prospects for regulatory approval of, or other regulatory action with respect to, our product candidates, including the regulatory pathway to be designated to our product candidates; |
|
|
|
|
● |
the regulatory environment and changes in the health policies and regimes in the countries in which we operate, including the impact of any changes in regulation and legislation that could affect the pharmaceutical industry; |
|
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|
● |
our ability to commercialize our existing product candidates and future sales of our existing product candidates or any other future potential product candidates; |
|
● |
our ability to meet our expectations regarding the commercial supply of our product candidates; |
| ● | the
overall global economic environment, including the potential impact of the COVID-19 pandemic on the markets in which the Company operates; |
| ● | the
impact of competition and new technologies; |
| ● | general
market, political and economic conditions in the countries in which we operate; |
| ● | projected
capital expenditures and liquidity; |
| ● | our
ability to regain and effectively comply with the listing requirements, including the minimum bid requirement, of Nasdaq Stock Market
LLC; |
| ● | changes
in our strategy; and |
The foregoing list is intended to identify only
certain of the principal factors that could cause actual results to differ. For a more detailed description of the risks and uncertainties
affecting our company, reference is made to our Annual Report on Form 20-F for the year ended December 31, 2022, or our Annual Report,
which was filed with the Securities and Exchange Commission, or the SEC, on March 31, 2023, and the other risk factors discussed from
time to time by our company in reports filed or furnished to the SEC.
Except as otherwise required by law, we undertake
no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date
hereof or to reflect the occurrence of unanticipated events.
Unless otherwise indicated, all references to “Company,”
“we,” “our” and “PolyPid” refer to PolyPid Ltd., its wholly owned subsidiaries, PolyPid Inc., a Delaware
corporation, and PolyPid Pharma SRL, a company organized and existing under the laws of Romania. References to “U.S. dollars”
and “$” are to currency of the United States of America, and references to “shekel,” “Israeli shekel”
and “NIS” are to New Israeli Shekels. References to “Ordinary Shares” are to our Ordinary Shares, no par value.
We report our financial statements in accordance with generally accepted accounting principles in the United States.
A. Operating Results.
The following discussion and analysis of our
financial condition and results of operations should be read in conjunction with our consolidated financial statements and the related
notes included in our Annual Report, as well as our unaudited condensed consolidated financial statements and the related notes thereto
for the six months ended June 30, 2023, included elsewhere in this Report on Form 6-K. The discussion below contains forward-looking statements
that are based upon our current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially
from these expectations due to inaccurate assumptions and known or unknown risks and uncertainties.
Overview
Since our inception in 2008,
we have incurred significant operating losses. Our operating loss for the six months ended June 30, 2022 and 2023 were $23.5 million
and $11.6 million, respectively. As of June 30, 2023, we had an accumulated deficit of $226.3 million. We expect to continue to incur
significant expenses and operating losses for the foreseeable future, and our losses may fluctuate significantly from year to year. We
anticipate we will continue to incur expenses in connection with our ongoing activities, as we:
|
● |
continue clinical development of D-PLEX100, including our SHIELD II Phase 3 clinical trial for the prevention of SSIs in open abdominal surgeries; |
|
|
|
|
● |
file New Drug Applications, or NDAs, seeking regulatory approval for D-PLEX100 pursuant to the FDA’s Section 505(b)(2) regulatory pathway in the United States and the hybrid application pathway in the European Union; |
|
|
|
|
● |
continue to invest in the preclinical research and development of OncoPLEX and any other future product candidates; |
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|
● |
continue to invest in our manufacturing facility and complete commercial process validation for the facility; |
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● |
establish commercial infrastructure to support the marketing, sale and distribution of D-PLEX100 if it receives regulatory approval; |
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● |
hire field and office-based employees to prepare for and launch any approved product; |
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● |
hire additional research and development and general and administrative personnel to support our operations; |
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● |
maintain, expand and protect our intellectual property portfolio; and |
|
|
|
|
● |
incur additional costs associated with operating as a public company. |
We do not have any product
candidates approved for sale and have not generated any revenue from product sales.
During October 2022, we announced
a cost reduction plan, including a 20% reduction in headcount across all departments.
Results of Operations
Comparison
of the Six months Ended June 30, 2022 and 2023
The following table summarizes
our results of operations for the six months ended June 30, 2022 and 2023:
| |
Six months Ended June 30, | |
| |
2022 | | |
2023 | |
| |
(in thousands) | |
Research and development, net | |
$ | 17,095 | | |
$ | 7,754 | |
Marketing and business development | |
| 1,698 | | |
| 742 | |
General and administrative | |
| 4,723 | | |
| 3,112 | |
Operating loss | |
| 23,516 | | |
| 11,608 | |
Financial expense, net | |
| 203 | | |
| 262 | |
Loss before income tax | |
$ | 23,719 | | |
$ | 11,870 | |
Income tax expense | |
| - | | |
| 35 | |
Net loss | |
$ | 23,719 | | |
$ | 11,905 | |
Research and Development,
Net
Research and development,
net decreased by $9.3 million for the six months ended June 30, 2023, compared to the six months ended June 30, 2022. This decrease was
primarily related to a decrease of $7.2 million in costs related to the completion of the SHIELD I trial, a decrease of $1.0 million
in personnel costs due to the cost reduction plan we announced during October 2022, a decrease of $0.7 million in research and development
costs related to D-PLEX100 and OncoPLEX, a decrease of $0.7 million in our manufacturing facility expenses, and a decrease
of $0.2 million in non-cash share-based compensation. These decreases were offset by an increase of $0.5 million in Israel Innovation
Authority grants recognized in the six months ended June 30, 2022.
Marketing and business development
Marketing and business development
decreased by $1.0 million for the six months ended June 30, 2023, compared to the six months ended June 30, 2022. This decrease was
primarily related to a decrease of $0.7 million in pre-commercialization activities for the product candidate D-PLEX100,
and a decrease of $0.3 million in personnel costs.
General and Administrative
General and administrative
decreased by $1.6 million for the six months ended June 30, 2023, compared to the six months ended June 30, 2022. This decrease was
primarily related to a decrease of $0.9 million in directors’ and officers’ insurance premiums, a decrease of $0.3 million
in personnel costs and a decrease of $0.4 million in non-cash share-based compensation.
Financial Expense,
Net
Financial expense, net changed
by $0.1 million for the six months ended June 30, 2023, compared to the six months ended June 30, 2022.
Net loss
Net loss decreased by $11.8
million for the six months ended June 30, 2023, compared to the six months ended June 30, 2022. This decrease was primarily related to
the decrease in research and development, net of $9.3 million, a decrease in general and administrative of $1.6 million, and a decrease
in marketing and business development costs of $1.0 million offset by an increase in financial expense of $0.1 million.
Qualitative and
Quantitative Disclosures about Market Risk
Foreign Currency
Exchange Risk
We operate primarily in Israel,
and approximately 50% of our expenses are denominated in NIS. We are therefore exposed to market risk, which represents the risk of loss
that may impact our financial position due to adverse changes in financial market prices and rates. We are subject to fluctuations in
foreign currency rates in connection with these arrangements. Changes of 5% and 10% in the U.S. dollar/NIS exchange rate would have increased/decreased
operating expenses by approximately 1.2% and 2.3%, respectively, during the six months ended June 30, 2023.
We currently partially hedge
our foreign currency exchange rate risk to decrease the risk of financial exposure from fluctuations in the exchange rates of our principal
operating currencies. These measures, however, may not adequately protect us from the material adverse effects of such fluctuations.
Interest Rate
Risk
At present, our investments
consist primarily of cash and cash equivalents and short-term deposits. We may invest in investment-grade marketable securities with maturities
of up to three years, including commercial paper, money market funds, and government/non-government debt securities. The primary objective
of our investment activities is to preserve principal while maximizing the income that we receive from our investments without significantly
increasing risk and loss. Our investments may be exposed to market risk due to fluctuation in interest rates, which may affect our interest
income and the fair market value of our investments, if any.
Inflation-Related
Risks
Inflation generally affects
us by increasing our NIS-denominated expenses, including salaries and benefits, as well as facility rental costs and payment to local
suppliers. We do not believe that inflation had a material effect on our business, financial condition or results of operations during
the six months ended June 30, 2023, but we continue to monitor these closely.
JOBS Act Transition
Period
Section 107 of the Jumpstart
Our Business Startups Act provides that an “emerging growth company” can take advantage of the extended transition period
provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. Thus, an emerging growth
company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have
elected to take advantage of the extended transition period to comply with new or revised accounting standards and to adopt certain of
the reduced disclosure requirements available to emerging growth companies. As a result of the accounting standards election, we will
not be subject to the same implementation timing for new or revised accounting standards as other public companies that are not emerging
growth companies which may make comparison of our financials to those of other public companies more difficult.
B. Liquidity and Capital Resources
Sources of
Liquidity
Since our inception, we have
not generated any revenue and have incurred operating losses and negative cash flows from our operations. Prior to our initial public
offering, or IPO, we funded our operations primarily through the sale of equity securities and convertible debt.
On April 5, 2022, we entered
into a Loan Agreement, or the Loan Agreement, for up to $15 million with Kreos Capital VI (Expert
Fund) LP, or Kreos. The Loan Agreement is comprised of three tranches in the amount of $10.0 million, $2.5 million, and $2.5 million,
respectively. Drawdown of the first tranche was available upon the execution of the Loan Agreement. The second tranche of $2.5 million
was available after we met the second tranche milestone in May 2022. The third and final tranche of $2,500,000 will not be drawn since
the third tranche milestone has not been met.
The first tranche in the amount
of $10 million was drawn on April 26, 2022. The issuance costs due to the Loan Agreement amounted to $0.2 million and the second tranche
in the amount of $2.5 million was drawn on July 19, 2022.
The Loan Agreement provides
for interest-only repayments of the first tranche until December 31, 2022, followed by 36 equal monthly repayments of principal and interest.
For the second tranche, which was drawn in July 2022 we will make repayments of interest only until August 31, 2023, followed by 33 equal
monthly repayments of principal and interest. The senior secured loan initially bears interest at a rate of 9.25%. The loan is prepayable
in full, at any time at our option. The loan is secured by our owned equipment, intellectual property and all shares we hold in PolyPid
Inc. and PolyPid Pharma SRL, and we paid a customary fee to Kreos for the establishment of the loan. Additionally, PolyPid Inc. entered
into a guaranty agreement with Kreos, all as security for monies borrowed by us under the Loan Agreement. On March 29, 2023, we entered
into an amendment to the Loan Agreement. Pursuant to this amendment, 70% of the remaining principal and interest repayments will be delayed
and repaid on a monthly equal basis from August 2024 to May 2026. The amended secured loan now bears interest at a rate of 10.00%, and
we will pay a restructuring fee to Kreos consisting of 1.00% on close of the amendment and an incremental 3.00% at maturity. In return
for this additional deferral of repayment, Kreos has the right to receive a potential claw back payment on account of the then outstanding
principal amount. This claw back mechanism will be triggered by additional incoming funds from future partnership agreement or additional
financing. If triggered, the minimum claw back to be paid is $1.5 million but will not exceed $3 million. Further, the outstanding warrants
Kreos received (as described below) were repriced to have an exercise price of $0.42 per each warrant share.
As part of the line of credit,
we issued to Kreos 194,742 warrants. Such warrants are 7-year warrants to purchase our Ordinary Shares equal to 8% of the amount of each
borrowed tranche, with an exercise price of $5.14 per share. Pursuant to the March 2023 amendment, the outstanding warrants Kreos received
were repriced to have an exercise price of $0.42 per each warrant share. The Loan Agreement contains customary affirmative and restrictive
covenants and representations and warranties. The expiration date for each warrant issued will be seven years from the issuance date.
In
July 2021, we entered into a Controlled Equity Offering Sales Agreement, or the Sales Agreement, with Cantor Fitzgerald & Co., or
the Agent, pursuant to which we may offer and sell, from time to time, our Ordinary Shares, through the Agent in an at the market offering,
or the ATM, as defined in Rule 415(a)(4) under the Securities Act, for an aggregate offering price of up to $45 million. On May 19, 2023,
the aggregate offering price was reduced to $8,706,775 due to applicable
securities law restrictions resulting from a decrease in the value of the public float of our Ordinary Shares. During the six months ended
June 30, 2023, we sold 1,949,029 Ordinary Shares under the ATM for a total amount of $2.3 million, with issuance costs in the amount of
$0.1 million.
In March 2023, we completed
a public offering, pursuant to which we sold 14,660,000 Ordinary Shares at a public offering price of $0.42 per share, for total gross
proceeds of $6.2 million, or the Offering. In addition, we granted to the underwriter a 30-day option to purchase up to an additional
15% of the Ordinary Shares offered in the Offering at the public offering price, less underwriting discounts and commissions. The underwriter
exercised its option in full at the closing of the Offering. The securities were offered by us pursuant to a “shelf” registration
statement on Form F-3. Concurrently with the Offering, we entered into a private placement with some of our existing shareholders, pursuant
to which we issued pre-funded warrants, or the Pre-Funded Warrants, to acquire an aggregate of up to 10,357,139 Ordinary Shares for total
gross proceeds of $4.4 million. The exercise price per Pre-Funded Warrant is $0.0001 per Ordinary Share. On May 11, 2023, the Pre-Funded
Warrants were fully exercised on a cashless basis into 10,354,532 Ordinary Shares.
As of June 30, 2023, we had
$15.1 million in cash, cash equivalents and short-term deposits.
Cash Flows
The following table provides
information regarding our cash flows for the periods indicated:
| |
Six Months Ended June 30, | |
| |
2022 | | |
2023 | |
| |
(in thousands) | |
Net cash used in operating activities | |
$ | (20,342 | ) | |
$ | (8,281 | ) |
Net cash provided by (used in) investing activities | |
| 9,060 | | |
| (7,863 | ) |
Net cash provided by financing activities | |
| 13,255 | | |
| 10,976 | |
Net increase (decrease) in cash, cash equivalents and restricted cash | |
$ | 1,973 | | |
$ | (5,168 | ) |
Operating Activities
Net cash used in operating
activities related primarily to our net losses adjusted for non-cash charges and measurements and changes in components of working capital.
Adjustments to net loss for non-cash items mainly included depreciation, remeasurement of pre-funded warrants and share-based compensation.
Net cash used in operating
activities was $8.3 million for the six months ended June 30, 2023, as compared to $20.3 million for the six months ended June 30, 2022.
This decrease was primarily related to the completion of SHIELD I Phase 3 clinical trials in abdominal (soft tissue) surgery.
Investing Activities
Net cash provided by/used
in investing activities related primarily to the purchase and release of short-term and long-term deposits and the acquisition of laboratory
equipment, office equipment and furniture and leasehold improvements.
Net cash used in investing
activities was $7.9 million for the six months ended June 30, 2023, as compared to net cash provided by investing activities of $9.1 million
for the six months ended June 30, 2022. This change in net cash used in investing activities primarily related to the purchase of short-term
deposits in the 2023 period.
Financing Activities
Net cash provided by financing
activities was $11.0 million for the six months ended June 30, 2023, as compared to $13.3 million for the six months ended June 30, 2022.
The decrease in net cash provided by financing activities is primarily related to the net proceeds from the loan provided by Kreos and
offset by the net proceeds from the March 2023 Offering and private placement.
We have registered up to $200,000,000
of our Ordinary Shares on a Registration Statement on Form F-3 (File No. 333-257651), or the F-3. The Ordinary Shares that may be offered,
issued and sold under the Sales Agreement prospectus, as supplemented, are included in the $200,000,000 of securities that may be offered,
issued and sold by us under the F-3. Upon termination of the Sales Agreement, any portion of the amount included in the Sales Agreement
prospectus of the F-3 that is not sold pursuant to the Sales Agreement will be available for sale in other offerings pursuant to the F-3.
Current Outlook
To date, we have not generated
any revenues from the commercial sale of our product candidates, and we do not expect to generate revenue for at least the next few years.
We expect to continue to incur expenses in connection with our ongoing activities, particularly as we continue to conduct clinical trials
and seek marketing approval for our product candidates, and as we continue the research and development of our other existing and future
product candidates. In addition, if we obtain marketing approval for any product candidates, we expect to incur significant commercialization
expenses related to product sales, marketing, manufacturing and distribution to the extent that such sales, marketing, manufacturing and
distribution are not the responsibility of potential collaborators. Accordingly, we will need to obtain substantial additional funding
in connection with our continuing operations.
We
expect that our existing cash and cash equivalents and short-term deposits will enable us to fund our operating expenses and capital expenditure
requirements into late first quarter of 2024. We anticipate that we will need to raise additional capital in order to complete our clinical
and regulatory program for D-PLEX100 towards potential NDA submission, including the SHIELD II clinical trial, as well as continue
to invest in the research and development of OncoPLEX and any other future product candidates. If we are unable to raise additional capital
when desired, our business, operating results, and financial condition would be adversely affected, and there is substantial doubt about
our ability to continue as a going concern. We have a shareholders’ equity of $8.3 million as of June 30, 2023, and negative operating
cash flows in recent years. We expect to continue incurring losses and negative cash flows from operations until our products reach commercial
profitability. Our plans to reduce the going concern risk include the continued commercialization of our products, maintaining cost efficiency
and raising capital through the sale of additional equity securities, debt or capital inflows from strategic partnerships.
Our
future capital requirements will depend on many factors, including:
|
● |
the scope, progress, results and costs of our ongoing clinical trial; |
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|
● |
the costs, timing and outcome of regulatory review of D-PLEX100 and any future product candidates; |
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● |
the costs and timing of establishing and validating manufacturing processes and facilities for development and commercialization of D-PLEX100 and any future product candidates, if approved, including our manufacturing facility; |
|
● |
the number and development requirements of any future product candidates that we may pursue; |
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|
● |
the costs and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive marketing approval; |
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|
● |
the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval, which may be affected by market conditions, including obtaining coverage and adequate reimbursement of our product candidates from third-party payors, including government programs and managed care organizations, and competition; |
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● |
our ability to establish and maintain collaborations with biopharmaceutical companies on favorable terms, if at all; |
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|
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the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; and |
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the extent to which we acquire or in-license other product candidates and technologies. |
Identifying potential product
candidates and conducting clinical trials and preclinical studies is a time-consuming, expensive and uncertain process that takes many
years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales.
In addition, our product candidates, if approved, may not achieve commercial success. Our commercial revenues, if any, will be derived
from sales of product candidates that we do not expect to be commercially available for few years, if at all. Accordingly, we will need
to continue to rely on additional financing to achieve our business objectives. Adequate additional financing may not be available to
us on acceptable terms, or at all.
Until such time, if ever,
as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity offerings, including
pursuant to the ATM, debt financings, grants, collaborations, strategic alliances and licensing arrangements. If we are unable to raise
additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development
or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop
and market ourselves.
5.C Research and development, patents and licenses,
etc.
A comprehensive discussion
of our research and development, patents and licenses, etc., is included in “Item 5. Operating and Financial Review and Prospects
- Management’s Discussion and Analysis of Financial Condition and Results of Operations” section in our Annual Report.
5.D Trend Information
To date, we have not generated
any revenue from product sales and do not expect to generate any revenue from product sales for at least the next few years. From inception
through June 30, 2023, we incurred $143.2 million in research and development expenses, net to advance the development of our clinical-stage
product candidates, as well as other preclinical research and development programs. We expect to continue to incur expenses in connection
with our ongoing activities, particularly as we continue to conduct clinical trials and seek marketing approval for our product candidates,
and as we continue the research and development of our other existing and future product candidates. In addition, if we obtain marketing
approval for any product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing
and distribution to the extent that such sales, marketing, manufacturing and distribution are not the responsibility of potential collaborators.
For a description of additional factors that may affect our future performance, please see “Item 5. Operating and Financial
Review and Prospects— B. Liquidity and Capital Resources— Current Outlook.”
5.E Critical Accounting Estimates
The preparation of financial
statements requires us to make estimates and assumptions that affect the reported amounts of assets, obligations, income and expenses
during the reporting periods. In addition to our accounting estimate used in line of credit discussed below, for a comprehensive
discussion of our critical accounting estimates please see “Item 5. Operating and Financial Review and Prospects - Management’s
Discussion and Analysis of Financial Condition and Results of Operations – E. Critical Accounting Estimates” section in our
Annual Report.
8
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v3.23.2
Interim Condensed Consolidated Balance Sheets - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
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
|
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
|
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v3.23.2
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|
Jun. 30, 2023 |
Dec. 31, 2022 |
Statement of Financial Position [Abstract] |
|
|
Ordinary shares, par value (in Dollars per share) |
|
|
Ordinary shares, shares authorized |
107,800,000
|
47,800,000
|
Ordinary shares, shares issued |
49,048,703
|
19,851,833
|
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49,048,703
|
19,851,833
|
X |
- DefinitionFace amount per share of no-par value common stock.
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v3.23.2
Interim Condensed Consolidated Statements of Operations - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Operating expenses: |
|
|
|
|
Research and development, net |
$ 3,960
|
$ 8,398
|
$ 7,754
|
$ 17,095
|
Marketing and business development |
357
|
923
|
742
|
1,698
|
General and administrative |
1,503
|
2,243
|
3,112
|
4,723
|
Operating loss |
5,820
|
11,564
|
11,608
|
23,516
|
Financial expense, net |
7
|
281
|
262
|
203
|
Loss before income tax |
5,827
|
11,845
|
11,870
|
23,719
|
Income tax expenses |
10
|
|
35
|
|
Net loss |
$ 5,837
|
$ 11,845
|
$ 11,905
|
$ 23,719
|
Basic loss per ordinary share (in Dollars per share) |
$ 0.13
|
$ 0.61
|
$ 0.36
|
$ 1.23
|
Weighted average number of ordinary shares used in computing basic loss per share (in Shares) |
44,383,474
|
19,505,246
|
32,910,446
|
19,222,423
|
X |
- DefinitionThe amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.
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v3.23.2
Interim Condensed Consolidated Statements of Operations (Parentheticals) - $ / shares
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Income Statement [Abstract] |
|
|
|
|
Diluted loss per ordinary share (in Dollars per share) |
$ 0.13
|
$ 0.61
|
$ 0.36
|
$ 1.23
|
Weighted average number of ordinary shares used in computing diluted loss per share (in Shares) |
44,383,474
|
19,505,246
|
32,910,446
|
19,222,423
|
X |
- DefinitionThe amount of net income (loss) for the period available to each share of common stock or common unit outstanding during the reporting period and to each share or unit that would have been outstanding assuming the issuance of common shares or units for all dilutive potential common shares or units outstanding during the reporting period.
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v3.23.2
Interim Condensed Consolidated Statements of Shareholders’ Equity - USD ($) $ in Thousands |
Number of ordinary shares |
Additional paid-in capital |
Accumulated deficit |
Total |
Balance at Dec. 31, 2021 |
|
|
$ 210,847
|
$ (174,887)
|
$ 35,960
|
Balance (in Shares) at Dec. 31, 2021 |
|
18,756,570
|
|
|
|
Share-based compensation |
|
|
2,539
|
|
2,539
|
Issuance of shares, net |
[1] |
|
3,754
|
|
3,754
|
Issuance of shares, net (in Shares) |
[1] |
768,622
|
|
|
|
Issuance of warrants |
|
|
468
|
|
468
|
Exercise of options |
|
|
108
|
|
108
|
Exercise of options (in Shares) |
|
25,981
|
|
|
|
Net loss |
|
|
|
(23,719)
|
(23,719)
|
Balances at Jun. 30, 2022 |
|
|
217,716
|
(198,606)
|
19,110
|
Balances (in Shares) at Jun. 30, 2022 |
|
19,551,173
|
|
|
|
Balance at Dec. 31, 2021 |
|
|
210,847
|
(174,887)
|
35,960
|
Balance (in Shares) at Dec. 31, 2021 |
|
18,756,570
|
|
|
|
Share-based compensation |
|
|
4,307
|
|
4,307
|
Issuance of ordinary shares, net |
[2] |
|
4,423
|
|
4,423
|
Issuance of ordinary shares, net (in Shares) |
[2] |
1,065,057
|
|
|
|
Issuance of warrants |
|
|
588
|
|
588
|
Exercise of options |
|
|
108
|
|
108
|
Exercise of options (in Shares) |
|
30,206
|
|
|
|
Net loss |
|
|
|
(39,557)
|
(39,557)
|
Balances at Dec. 31, 2022 |
|
|
220,273
|
(214,444)
|
5,829
|
Balances (in Shares) at Dec. 31, 2022 |
|
19,851,833
|
|
|
|
Balance at Mar. 31, 2022 |
|
|
215,606
|
(186,761)
|
28,845
|
Balance (in Shares) at Mar. 31, 2022 |
|
19,470,757
|
|
|
|
Share-based compensation |
|
|
1,266
|
|
1,266
|
Issuance of ordinary shares, net |
[3] |
|
285
|
|
285
|
Issuance of ordinary shares, net (in Shares) |
[3] |
57,722
|
|
|
|
Issuance of warrants |
|
|
468
|
|
468
|
Exercise of options |
|
|
91
|
|
91
|
Exercise of options (in Shares) |
|
22,694
|
|
|
|
Net loss |
|
|
|
(11,845)
|
(11,845)
|
Balances at Jun. 30, 2022 |
|
|
217,716
|
(198,606)
|
19,110
|
Balances (in Shares) at Jun. 30, 2022 |
|
19,551,173
|
|
|
|
Balance at Dec. 31, 2022 |
|
|
220,273
|
(214,444)
|
5,829
|
Balance (in Shares) at Dec. 31, 2022 |
|
19,851,833
|
|
|
|
Share-based compensation |
|
|
1,970
|
|
1,970
|
Issuance of ordinary shares, net |
[4] |
|
8,627
|
|
8,627
|
Issuance of ordinary shares, net (in Shares) |
[4] |
18,808,029
|
|
|
|
Issuance of pre-funded warrants, net |
[5] |
|
3,987
|
|
3,987
|
Issuance of pre-funded warrants, net (in Shares) |
[5] |
|
|
|
|
Exercise of options |
|
|
9
|
|
9
|
Exercise of options (in Shares) |
|
34,309
|
|
|
|
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 |
|
|
|
|
|
Cashless exercise of pre-funded warrants (in Shares) |
|
10,354,532
|
|
|
|
Net loss |
|
|
|
(11,905)
|
(11,905)
|
Balances at Jun. 30, 2023 |
|
|
234,696
|
(226,349)
|
8,347
|
Balances (in Shares) at Jun. 30, 2023 |
|
49,048,703
|
|
|
|
Balance at Mar. 31, 2023 |
|
|
231,919
|
(220,512)
|
11,407
|
Balance (in Shares) at Mar. 31, 2023 |
|
38,694,171
|
|
|
|
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 |
|
|
|
|
|
Cashless exercise of pre-funded warrants (in Shares) |
|
10,354,532
|
|
|
|
Net loss |
|
|
|
(5,837)
|
(5,837)
|
Balances at Jun. 30, 2023 |
|
|
$ 234,696
|
$ (226,349)
|
$ 8,347
|
Balances (in Shares) at Jun. 30, 2023 |
|
49,048,703
|
|
|
|
|
|
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v3.23.2
Interim Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
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
|
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
|
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v3.23.2
General
|
6 Months Ended |
Jun. 30, 2023 |
General [Abstract] |
|
GENERAL |
NOTE
1:- GENERAL
| a. | PolyPid Ltd. (the “Company”) was incorporated under
the laws of Israel and commenced operations on February 28, 2008. The Company is a Phase 3 biopharmaceutical company focused on
developing targeted, locally administered, and prolonged-release therapeutics using its proprietary PLEX (Polymer-Lipid Encapsulation
matriX) technology. The Company’s product candidates are designed to address unmet medical needs by delivering active pharmaceutical
ingredients, locally at predetermined release rates and durations over extended periods ranging from days to several months. The Company
is initially focused on the development of its lead product candidate, D-PLEX, which incorporates an antibiotic for the prevention of
surgical site infections (“SSIs”) in bone and soft tissue. Through June 30, 2023, the Company has been primarily engaged
in research and development. |
The 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 United States.
| b. | The Company’s activities since inception have consisted of performing research and development activities.
Successful completion of the Company’s development programs and, ultimately, the attainment of profitable operations is dependent
on future events, including, among other things, its ability to secure financing; obtain marketing approval from regulatory authorities;
access potential markets; build a sustainable customer base; attract, retain and motivate qualified personnel; and develop strategic alliances.
The Company’s operations are funded by its shareholders and research and development grants and the Company intends to seek further
private or public financing as well as make applications for further research and development grants for continuing its operations. Although
management believes that the Company will be able to successfully fund its operations, there can be no assurance that the Company will
be able to do so or that the Company will ever operate profitably. |
In 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 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).
The Company expects
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. Management 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.
The 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.
There can be no
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.
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v3.23.2
Significant Accounting Policies
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
SIGNIFICANT ACCOUNTING POLICIES |
NOTE
2:- SIGNIFICANT ACCOUNTING POLICIES
| a. | Basis of presentation and summary of significant accounting
policies: |
The 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, 2022, filed with the Securities and Exchange Commission on March 31, 2023.
The 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.
The 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,
2022 (the “2022 Consolidated Financial Statements”). Interim results are not necessarily indicative of the results for a full
year.
There 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, 2022.
| b. | Basic and diluted loss per share: |
The
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.
| c. | Fair value of financial instruments: |
Under
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:
|
Level 1 - |
Observable inputs that reflect quoted prices (unadjusted) in active markets for identical assets and liabilities. |
|
Level 2 - |
Include other inputs that are directly or indirectly observable in the marketplace. |
|
Level 3 - |
Unobservable inputs which are supported by little or no market activity. |
The
carrying amounts of cash and cash equivalents, restricted cash, short-term deposits, long-term deposits, other current assets, trade payables,
accrued expenses and other current and non-current liabilities approximate their fair value due to the short-term maturity of such instruments.
Fair
value estimates are made at a specific point in time, based on relevant market information and information about the financial instruments.
These estimates are subjective in nature and involve uncertainties and matters of significant judgment and, therefore, cannot be determined
with precision. Changes in assumptions could significantly affect these estimates.
| d. | Recently adopted accounting pronouncements: |
As an “Emerging
Growth Company”, the Jumpstart Our Business Startups Act (“JOBS Act”) allows the Company to delay adoption of new or
revised accounting pronouncements applicable to public companies until such pronouncements are made applicable to private companies. The
Company has elected to use this extended transition period under the JOBS Act.
The Company has
reviewed recent accounting pronouncements and concluded that they are either not applicable to its business or that no material effect
is expected on the condensed consolidated financial statements as a result of their future adoption.
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v3.23.2
Leases
|
6 Months Ended |
Jun. 30, 2023 |
Leases [Abstract] |
|
LEASES |
NOTE
3:- LEASES
The Company leases
substantially all of its office space and vehicles under operating leases. The Company’s leases have original lease periods expiring between 2023 and 2027. Some
leases include one or more options to renew. The Company does not assume renewals in its determination of the lease
term unless the renewals are deemed to be reasonably certain. Lease payments included in the measurement of the lease liability are comprised
of the following: the fixed non-cancelable lease payments, payments for optional renewal periods, where it is reasonably certain the renewal
period will be exercised, and payments for early termination options unless it is reasonably certain the lease will not be terminated
early.
The following
is a summary of weighted average remaining lease terms and discount rates for all of the Company’s operating leases as of June 30,
2023:
Weighted average remaining lease term (years) | |
| 3.26 | |
Weighted average discount rates | |
| 9.16 | % |
For the six months
ended June 30, 2023, the total operating lease cost and cash payments for operating leases were as follows:
Operating lease cost | |
$ | 582 | |
Cash payments for operating leases | |
$ | 524 | |
Minimum lease payments
over the remaining lease periods as of June 30, 2023, are as follows:
The remainder of 2023 | |
$ | 479 | |
2024 | |
| 403 | |
2025 | |
| 358 | |
2026 | |
| 349 | |
2027 | |
| 177 | |
| |
| | |
Total undiscounted lease payments | |
| 1,766 | |
Less - imputed interest | |
| (195 | ) |
| |
| | |
Present value of lease liabilities | |
$ | 1,571 | |
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v3.23.2
Line of Credit Arrangement
|
6 Months Ended |
Jun. 30, 2023 |
Line of Credit Arrangement [Abstract] |
|
LINE OF CREDIT ARRANGEMENT |
NOTE
4:- LINE OF CREDIT ARRANGEMENT
Further to the
discussion in Note 7 in the 2022 Consolidated Financial Statements regarding the secured line of credit agreement signed on April 5, 2022,
with Kreos Capital VI (Expert Fund) LP (“Kreos”) (the “Credit Line” or “debt”), the Company entered into
an amendment to the Credit Line on March 29, 2023 (the “Amendment”).
Pursuant to
the Amendment, 70% of the remaining principal and interest repayments will be delayed and repaid on a monthly equal basis from
August 2024 to May 2026. The amended secured credit line now bears an interest at the rate of 10%. In addition, the Company
will pay to Kreos a restructuring fee consisting of 1% on the closing date of the Amendment and an incremental 3% at the
maturity of the Amendment. In return for this additional deferral of repayment, Kreos has the right to receive a potential claw-back
payment on account of the then outstanding principal amount (the “Claw-Back”). This Claw-Back mechanism will be
triggered by additional incoming funds from future collaboration and partnership agreements or additional funding. If triggered, the
minimum Claw-Back to be paid will be $1,500, but will not exceed $3,000.
The Company evaluated the amendment
under ASC 470-50, “Debt - modification and extinguishment”, and concluded that the terms of the new debt and the original
debt are not substantially different, therefore the debt restructuring is accounted as debt modification where no gain or loss was recognized.
During the six-month period ended on
June 30, 2023, the Company recognized $813 of interest expenses related to the Credit Line, which were included as part of financial expenses
in the Company’s statements of operations.
In addition, the Company’s debt includes
Claw-Back feature that meets the definition of embedded derivative under ASC 815. Consequently, the embedded derivative was bifurcated
and accounted for separately at fair value. The fair value of the derivative amounted to $127 as of March 29, 2023, and June 30,
2023. Changes in the fair value of the derivative liabilities are determined at each period end. The liability due to the derivative was
classified under other long-term liabilities in the consolidated balance sheet as of June 30, 2023.
Further to the above, the outstanding
warrants issued to Kreos were repriced and as a result bear an exercise price of $0.42 per share. As a result of the modification, the
Company recorded an incremental value in the amount of $31, that was calculated based on the Black-Scholes option pricing model, which
increased the additional paid-in capital against an offset of the long-term debt due to the Credit Line.
The Company incurred debt restructuring
costs, which were fully paid in cash, and are presented as a direct deduction against the carrying amount of the debt and amortized to
interest expense using the effective interest method.
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v3.23.2
Commitments and Contingent Liabilities
|
6 Months Ended |
Jun. 30, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
COMMITMENTS AND CONTINGENT LIABILITIES |
NOTE 5:- COMMITMENTS
AND CONTINGENT LIABILITIES
In connection with
its research and development programs, through June 30, 2023, the Company received participation payments from the Israel Innovation Authority
of the Ministry of Economy in Israel (“IIA”) in the aggregate amount of $4,888. In return for IIA’s participation, the Company
is committed to pay royalties at a rate of 3% of sales of the developed products, up to 100% of the amount of grants received plus interest
at LIBOR rate.
Through June 30,
2023, no royalties have been paid or accrued.
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v3.23.2
Shareholders’ Equity
|
6 Months Ended |
Jun. 30, 2023 |
Shareholders’ Equity [Abstract] |
|
SHAREHOLDERS’ EQUITY |
NOTE 6:-
SHAREHOLDERS’ EQUITY
| a. | Ordinary share capital (with no par value) is composed as follows: |
| |
June 30, 2023 | | |
December 31, 2022 | |
| |
Unaudited | | |
Audited | |
| |
Authorized | | |
Issued and
outstanding | | |
Authorized | | |
Issued and
outstanding | |
| |
Number of shares | |
| |
| | | |
| | | |
| | | |
| | |
Ordinary shares | |
| 107,800,000 | | |
| 49,048,703 | | |
| 47,800,000 | | |
| 19,851,833 | |
| b. | In July 2021, the Company entered into a Controlled Equity
Offering Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. (the “Agent”), pursuant to
which the Company may offer and sell, from time to time, its Ordinary shares, no par value (the “Ordinary Shares”), through
the Agent in an At The Market offering (“ATM’”), as defined in Rule 415(a)(4) promulgated under the Securities Act
of 1933, as amended, for an aggregate offering price of up to $45,000, which was subsequently reduced to $8,707 on May 19, 2023. |
During the six-month
period ended June 30, 2023, the Company sold 1,949,029 Ordinary Shares under the ATM for a total amount of $2,212, net of issuance cost
in the amount of $68.
| c. | On March 29, 2023, the Company entered into a private placement
of unregistered pre-funded warrants to purchase up to 10,357,139 Ordinary shares (the “PFW”), at a price of $0.4199 per PFW
with certain of the Company’s existing shareholders. The PFWs have an exercise price of $0.0001 per Ordinary share. Accordingly,
the consideration for the PFWs amounted to $3,987, net of related placement fees and other offering expenses which amounted to a total
of $362. In accordance with ASC No. 480, “Distinguishing Liabilities from Equity” (“ASC 480”), and ASC
No. 815-40, “Derivatives and Hedging” (“ASC 815”), the PFWs were qualified for equity accounting. |
On March 31,
2023, the Company closed a public offering which was comprised of 16,859,000 Ordinary shares (inclusive of 2,199,000 Ordinary shares pursuant
to the full exercise of an overallotment option granted to the underwriters), at a public offering price of $0.42 per share (the “Public
Offering”). The proceeds to the Company from the Public Offering were $6,415, net of underwriting commissions and other offering
expenses which amounted to $666.
Following the
Public Offering, the Company did not have a sufficient number of authorized Ordinary shares to cover 5,013,446 PFWs, and as a result,
in accordance with ASC 815-40, these PFWs, which amounted to $2,106, were classified as a liability at fair value.
On May 5, 2023,
the shareholders of the Company approved to increase the Company’s authorized share capital by 60,000,000, from 47,800,000 to 107,800,000
Ordinary shares, and as a result, in accordance with ASC 480 and 815-40, these PFWs were classified under equity accounting at their fair
value, which amounted to $1,905. The change in the PFWs fair value was accounted for as financial expenses in the amount of $201.
On May 11, 2023,
all of the PFWs were exercised into 10,354,532 Ordinary shares on a cashless basis.
Through June 30,
2023, the Company authorized through its 2012 Share Option Plan the grant of 4,672,094 options to Ordinary shares to its officers, directors,
advisors, management and other employees. The options granted generally have a four-year or three-year vesting period and expire ten years
after the date of grant. Options granted under the Company’s option plan that are cancelled or forfeited before expiration become available
for future grant.
As of June 30, 2023,
1,206,447 of the Company’s options were available for future grants.
During the first
quarter of 2023, the Company decreased the exercise price of 2,021,599 options granted to all employees and a consultant under the 2012
Share Option Plan. As of the modification date, the options can be exercised for $0.77 (the “Repricing”). Following the Repricing
the Company accounted for an incremental value in the total amount of $562, in which $307 was recognized as of the modification date due
to vested options, and the rest of the amount will be expensed based on the vesting conditions of each grant.
On May 5, 2023,
the Company’s board of directors also approved a similar exercise price decrease of 504,169 options previously granted to the Company’s
Chief Executive Officer and board members. Therefore, the Company accounted for an incremental value in the total amount of $63, of which
$50 was recognized as of the modification date due to vested options, and the rest of the amount will be expensed based on the vesting
conditions of each grant.
A summary of
the status of options to employees under the Company’s 2012 Share Option Plan as of and for the six-month period ended June 30, 2023,
and changes during the period then ended is presented below (unaudited):
| |
Number of
options | | |
Weighted
average
exercise
price | | |
Aggregate
intrinsic
value | | |
Weighted
average remaining
contractual life (years) | |
| |
| | |
| | |
| | |
| |
Outstanding at beginning of period | |
| 3,303,346 | | |
$ | 1.92 | | |
$ | 115 | | |
| 6.14 | |
Granted | |
| 114,500 | | |
$ | 0.71 | | |
| - | | |
| | |
Exercised | |
| (34,309 | ) | |
$ | 0.23 | | |
$ | 12 | | |
| | |
Forfeited and expired | |
| (795,172 | ) | |
$ | 3.65 | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Outstanding at end of period | |
| 2,588,365 | | |
$ | 1.36 | | |
$ | - | | |
| 6.39 | |
| |
| | | |
| | | |
| | | |
| | |
Exercisable options | |
| 1,569,578 | | |
$ | 1.74 | | |
$ | - | | |
| 4.94 | |
| |
| | | |
| | | |
| | | |
| | |
Vested and expected to vest | |
| 2,588,365 | | |
$ | 1.36 | | |
$ | - | | |
| 6.39 | |
The Black-Scholes
option pricing model assumptions used to value the employee share options at the grant dates are presented in the following table for
the six-month period ended June 30, 2023:
Dividend yield (%) | |
| 0 | |
Expected volatility (%) | |
| 92.59-95.67 | |
Risk-free interest rate (%) | |
| 3.38-3.73 | |
Expected term (in years) | |
| 5.7-6.1 | |
The total share-based
compensation expense recognized by the Company’s departments:
| |
Six
Months Ended
June 30, | |
| |
2023 | | |
2022 | |
| |
Unaudited | |
| |
| | |
| |
Research and development | |
$ | 1,022 | | |
$ | 1,193 | |
Marketing and business development | |
| 191 | | |
| 199 | |
General and administrative | |
| 757 | | |
| 1,147 | |
| |
| | | |
| | |
| |
$ | 1,970 | | |
$ | 2,539 | |
As of June 30, 2023,
there were unrecognized compensation costs of $4,692, which are expected to be recognized over a weighted average period of approximately 2.15 years.
| e. | Options issued to non-employees (including directors and consultants): |
Outstanding options
granted to non-employees as of June 30, 2023, were as follows (unaudited):
Grant date | |
Options
outstanding as of June 30, 2023 | | |
Average Exercise price per share ($) | | |
Options exercisable as of June 30, 2023 | | |
Exercisable through |
| |
| | |
| | |
| | |
|
April 2016 | |
| 5,975 | | |
$ | 3.10 | | |
| 5,975 | | |
April 2026 |
December 2016 | |
| 7,170 | | |
$ | 3.93 | | |
| 7,170 | | |
December 2026 |
June 2017 | |
| 197,722 | | |
$ | 4.10 | | |
| 197,722 | | |
June 2027 |
November 2017 | |
| 17,925 | | |
$ | 0.77 | | |
| 17,925 | | |
November 2027 |
August 2019 | |
| 71,700 | | |
$ | 0.77 | | |
| 71,700 | | |
August 2029 |
June 2020 | |
| 64,530 | | |
$ | 2.84 | | |
| 64,530 | | |
June 2030 |
April 2021 | |
| 62,741 | | |
$ | 2.03 | | |
| 62,741 | | |
April 2031 |
August 2021 | |
| 15,000 | | |
$ | 0.77 | | |
| 8,719 | | |
August 2031 |
December 2021 | |
| 10,000 | | |
$ | 6.80 | | |
| 4,975 | | |
December 2031 |
May 2022 | |
| 65,625 | | |
$ | 1.37 | | |
| 65,625 | | |
May 2032 |
November 2022 | |
| 5,000 | | |
$ | 1.05 | | |
| 1,650 | | |
November 2032 |
February 2023 | |
| 16,000 | | |
$ | 0.81 | | |
| - | | |
February 2033 |
May 2023 | |
| 170,628 | | |
$ | 0.60 | | |
| - | | |
May 2033 |
| |
| | | |
| | | |
| | | |
|
| |
| 710,016 | | |
| | | |
| 508,732 | | |
|
As
of June 30, 2023, all warrants are exercisable into Ordinary shares, in which the outstanding issued warrants as of June 30, 2023,
were as follows (unaudited):
Grant date | |
Warrants
outstanding as of June 30, 2023 | | |
Average
Exercise price per share ($) | | |
Warrants
exercisable as of June 30, 2023 | | |
Exercisable through |
| |
| | |
| | |
| | |
|
August 2019 | |
| 200,596 | | |
$ | 15.95 | | |
| 200,596 | | |
August 2023 |
September 2020 | |
| 17,925 | | |
$ | 16.00 | | |
| 17,925 | | |
September 2024 |
April 2022 | |
| 155,794 | | |
$ | *) 0.42 | | |
| 155,794 | | |
April 2029 |
July 2022 | |
| 38,948 | | |
$ | *) 0.42 | | |
| 38,948 | | |
July 2029 |
| |
| | | |
| | | |
| | | |
|
| |
| 413,263 | | |
| | | |
| 413,263 | | |
|
| *) | Following the modification
mentioned in Note 4. |
|
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- DefinitionThe entire disclosure for equity.
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v3.23.2
Basic and Diluted Loss Per Share
|
6 Months Ended |
Jun. 30, 2023 |
Basic and Diluted Loss Per Share [Abstract] |
|
BASIC AND DILUTED LOSS PER SHARE |
NOTE 7:- BASIC AND DILUTED
LOSS PER SHARE
The following table
sets forth the computation of the Company’s basic and diluted net loss per Ordinary share:
| |
Six Months Ended June 30, | | |
Three Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Unaudited | |
Numerator: | |
| | |
| | |
| | |
| |
Allocation of loss attributable to ordinary shareholders | |
| 11,905 | | |
| 23,719 | | |
| 5,837 | | |
| 11,845 | |
Denominator: | |
| | | |
| | | |
| | | |
| | |
Weighted average Ordinary shares outstanding | |
| 32,910,446 | | |
| 19,222,423 | | |
| 44,383,474 | | |
| 19,505,246 | |
| |
| | | |
| | | |
| | | |
| | |
Basic and diluted loss per share | |
$ | 0.36 | | |
$ | 1.23 | | |
$ | 0.13 | | |
$ | 0.61 | |
The potential
Ordinary shares that were excluded from the computation of diluted loss per share attributable to ordinary shareholders for the periods
presented because including them would have been anti-dilutive are as follows:
| |
Three and Six Months Ended June 30, | |
| |
2023 | | |
2022 | |
| |
Unaudited | |
| |
| | |
| |
Ordinary share options | |
| 2,078,310 | | |
| 4,146,332 | |
Warrants | |
| 413,263 | | |
| 374,315 | |
| |
| | | |
| | |
| |
| 2,491,573 | | |
| 4,520,647 | |
|
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v3.23.2
Accounting Policies, by Policy (Policies)
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Basis of presentation and summary of significant accounting policies |
| a. | Basis of presentation and summary of significant accounting
policies: |
The 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, 2022, filed with the Securities and Exchange Commission on March 31, 2023. The 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. The 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,
2022 (the “2022 Consolidated Financial Statements”). Interim results are not necessarily indicative of the results for a full
year. There 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, 2022.
|
Basic and diluted loss per share |
| b. | Basic and diluted loss per share: |
The
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.
|
Fair value of financial instruments |
| c. | Fair value of financial instruments: |
Under
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:
|
Level 1 - |
Observable inputs that reflect quoted prices (unadjusted) in active markets for identical assets and liabilities. |
|
Level 2 - |
Include other inputs that are directly or indirectly observable in the marketplace. |
|
Level 3 - |
Unobservable inputs which are supported by little or no market activity. |
The
carrying amounts of cash and cash equivalents, restricted cash, short-term deposits, long-term deposits, other current assets, trade payables,
accrued expenses and other current and non-current liabilities approximate their fair value due to the short-term maturity of such instruments. Fair
value estimates are made at a specific point in time, based on relevant market information and information about the financial instruments.
These estimates are subjective in nature and involve uncertainties and matters of significant judgment and, therefore, cannot be determined
with precision. Changes in assumptions could significantly affect these estimates.
|
Recently adopted accounting pronouncements |
| d. | Recently adopted accounting pronouncements: |
As an “Emerging
Growth Company”, the Jumpstart Our Business Startups Act (“JOBS Act”) allows the Company to delay adoption of new or
revised accounting pronouncements applicable to public companies until such pronouncements are made applicable to private companies. The
Company has elected to use this extended transition period under the JOBS Act. The Company has
reviewed recent accounting pronouncements and concluded that they are either not applicable to its business or that no material effect
is expected on the condensed consolidated financial statements as a result of their future adoption.
|
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v3.23.2
Leases (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Leases [Abstract] |
|
Schedule of Weighted Average Remaining Lease Terms and Discount Rates |
The following
is a summary of weighted average remaining lease terms and discount rates for all of the Company’s operating leases as of June 30,
2023:
Weighted average remaining lease term (years) | |
| 3.26 | |
Weighted average discount rates | |
| 9.16 | % |
|
Schedule of Total Operating Lease Cost |
For the six months
ended June 30, 2023, the total operating lease cost and cash payments for operating leases were as follows:
Operating lease cost | |
$ | 582 | |
Cash payments for operating leases | |
$ | 524 | |
|
Schedule of Minimum Lease Payments |
Minimum lease payments
over the remaining lease periods as of June 30, 2023, are as follows:
The remainder of 2023 | |
$ | 479 | |
2024 | |
| 403 | |
2025 | |
| 358 | |
2026 | |
| 349 | |
2027 | |
| 177 | |
| |
| | |
Total undiscounted lease payments | |
| 1,766 | |
Less - imputed interest | |
| (195 | ) |
| |
| | |
Present value of lease liabilities | |
$ | 1,571 | |
|
X |
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v3.23.2
Shareholders’ Equity (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Shareholders’ Equity [Abstract] |
|
Schedule of Ordinary Share Capital |
Ordinary share capital (with no par value) is composed as follows:
| |
June 30, 2023 | | |
December 31, 2022 | |
| |
Unaudited | | |
Audited | |
| |
Authorized | | |
Issued and
outstanding | | |
Authorized | | |
Issued and
outstanding | |
| |
Number of shares | |
| |
| | | |
| | | |
| | | |
| | |
Ordinary shares | |
| 107,800,000 | | |
| 49,048,703 | | |
| 47,800,000 | | |
| 19,851,833 | |
|
Schedule of Status of Options to Employees under the Company’s Option Plan |
A summary of
the status of options to employees under the Company’s 2012 Share Option Plan as of and for the six-month period ended June 30, 2023,
and changes during the period then ended is presented below (unaudited):
| |
Number of
options | | |
Weighted
average
exercise
price | | |
Aggregate
intrinsic
value | | |
Weighted
average remaining
contractual life (years) | |
| |
| | |
| | |
| | |
| |
Outstanding at beginning of period | |
| 3,303,346 | | |
$ | 1.92 | | |
$ | 115 | | |
| 6.14 | |
Granted | |
| 114,500 | | |
$ | 0.71 | | |
| - | | |
| | |
Exercised | |
| (34,309 | ) | |
$ | 0.23 | | |
$ | 12 | | |
| | |
Forfeited and expired | |
| (795,172 | ) | |
$ | 3.65 | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Outstanding at end of period | |
| 2,588,365 | | |
$ | 1.36 | | |
$ | - | | |
| 6.39 | |
| |
| | | |
| | | |
| | | |
| | |
Exercisable options | |
| 1,569,578 | | |
$ | 1.74 | | |
$ | - | | |
| 4.94 | |
| |
| | | |
| | | |
| | | |
| | |
Vested and expected to vest | |
| 2,588,365 | | |
$ | 1.36 | | |
$ | - | | |
| 6.39 | |
|
Schedule of Black-Scholes Option Pricing Model Assumptions Used To Value |
The Black-Scholes
option pricing model assumptions used to value the employee share options at the grant dates are presented in the following table for
the six-month period ended June 30, 2023:
Dividend yield (%) | |
| 0 | |
Expected volatility (%) | |
| 92.59-95.67 | |
Risk-free interest rate (%) | |
| 3.38-3.73 | |
Expected term (in years) | |
| 5.7-6.1 | |
|
Schedule of the Total Share-Based Compensation Expense |
The total share-based
compensation expense recognized by the Company’s departments:
| |
Six
Months Ended
June 30, | |
| |
2023 | | |
2022 | |
| |
Unaudited | |
| |
| | |
| |
Research and development | |
$ | 1,022 | | |
$ | 1,193 | |
Marketing and business development | |
| 191 | | |
| 199 | |
General and administrative | |
| 757 | | |
| 1,147 | |
| |
| | | |
| | |
| |
$ | 1,970 | | |
$ | 2,539 | |
|
Schedule of Outstanding Options Granted To Non-Employees |
Outstanding options
granted to non-employees as of June 30, 2023, were as follows (unaudited):
Grant date | |
Options
outstanding as of June 30, 2023 | | |
Average Exercise price per share ($) | | |
Options exercisable as of June 30, 2023 | | |
Exercisable through |
| |
| | |
| | |
| | |
|
April 2016 | |
| 5,975 | | |
$ | 3.10 | | |
| 5,975 | | |
April 2026 |
December 2016 | |
| 7,170 | | |
$ | 3.93 | | |
| 7,170 | | |
December 2026 |
June 2017 | |
| 197,722 | | |
$ | 4.10 | | |
| 197,722 | | |
June 2027 |
November 2017 | |
| 17,925 | | |
$ | 0.77 | | |
| 17,925 | | |
November 2027 |
August 2019 | |
| 71,700 | | |
$ | 0.77 | | |
| 71,700 | | |
August 2029 |
June 2020 | |
| 64,530 | | |
$ | 2.84 | | |
| 64,530 | | |
June 2030 |
April 2021 | |
| 62,741 | | |
$ | 2.03 | | |
| 62,741 | | |
April 2031 |
August 2021 | |
| 15,000 | | |
$ | 0.77 | | |
| 8,719 | | |
August 2031 |
December 2021 | |
| 10,000 | | |
$ | 6.80 | | |
| 4,975 | | |
December 2031 |
May 2022 | |
| 65,625 | | |
$ | 1.37 | | |
| 65,625 | | |
May 2032 |
November 2022 | |
| 5,000 | | |
$ | 1.05 | | |
| 1,650 | | |
November 2032 |
February 2023 | |
| 16,000 | | |
$ | 0.81 | | |
| - | | |
February 2033 |
May 2023 | |
| 170,628 | | |
$ | 0.60 | | |
| - | | |
May 2033 |
| |
| | | |
| | | |
| | | |
|
| |
| 710,016 | | |
| | | |
| 508,732 | | |
|
|
Schedule of Warrants Exercisable Into Ordinary Shares |
As
of June 30, 2023, all warrants are exercisable into Ordinary shares, in which the outstanding issued warrants as of June 30, 2023,
were as follows (unaudited):
Grant date | |
Warrants
outstanding as of June 30, 2023 | | |
Average
Exercise price per share ($) | | |
Warrants
exercisable as of June 30, 2023 | | |
Exercisable through |
| |
| | |
| | |
| | |
|
August 2019 | |
| 200,596 | | |
$ | 15.95 | | |
| 200,596 | | |
August 2023 |
September 2020 | |
| 17,925 | | |
$ | 16.00 | | |
| 17,925 | | |
September 2024 |
April 2022 | |
| 155,794 | | |
$ | *) 0.42 | | |
| 155,794 | | |
April 2029 |
July 2022 | |
| 38,948 | | |
$ | *) 0.42 | | |
| 38,948 | | |
July 2029 |
| |
| | | |
| | | |
| | | |
|
| |
| 413,263 | | |
| | | |
| 413,263 | | |
|
| *) | Following the modification
mentioned in Note 4. |
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v3.23.2
Basic and Diluted Loss Per Share (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Basic and Diluted Loss Per Share [Abstract] |
|
Schedule of Basic and Diluted Net Loss Per Ordinary Share |
The following table
sets forth the computation of the Company’s basic and diluted net loss per Ordinary share:
| |
Six Months Ended June 30, | | |
Three Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Unaudited | |
Numerator: | |
| | |
| | |
| | |
| |
Allocation of loss attributable to ordinary shareholders | |
| 11,905 | | |
| 23,719 | | |
| 5,837 | | |
| 11,845 | |
Denominator: | |
| | | |
| | | |
| | | |
| | |
Weighted average Ordinary shares outstanding | |
| 32,910,446 | | |
| 19,222,423 | | |
| 44,383,474 | | |
| 19,505,246 | |
| |
| | | |
| | | |
| | | |
| | |
Basic and diluted loss per share | |
$ | 0.36 | | |
$ | 1.23 | | |
$ | 0.13 | | |
$ | 0.61 | |
|
Schedule of Diluted Loss Per Share Attributable to Ordinary Shareholders |
The potential
Ordinary shares that were excluded from the computation of diluted loss per share attributable to ordinary shareholders for the periods
presented because including them would have been anti-dilutive are as follows:
| |
Three and Six Months Ended June 30, | |
| |
2023 | | |
2022 | |
| |
Unaudited | |
| |
| | |
| |
Ordinary share options | |
| 2,078,310 | | |
| 4,146,332 | |
Warrants | |
| 413,263 | | |
| 374,315 | |
| |
| | | |
| | |
| |
| 2,491,573 | | |
| 4,520,647 | |
|
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v3.23.2
General (Details) - USD ($) $ in Thousands |
1 Months Ended |
3 Months Ended |
6 Months Ended |
12 Months Ended |
Sep. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
General [Abstract] |
|
|
|
|
|
|
Description of administration |
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).
|
|
|
|
|
|
Cash equivalents and short-term deposits |
|
$ 15,106
|
|
$ 15,106
|
|
|
Income loss |
|
(5,837)
|
$ (11,845)
|
(11,905)
|
$ (23,719)
|
$ (39,557)
|
Net cash used in operating activities |
|
|
|
(8,281)
|
$ (20,342)
|
|
Accumulated deficit |
|
$ (226,349)
|
|
$ (226,349)
|
|
$ (214,444)
|
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v3.23.2
Shareholders’ Equity (Details) - USD ($) $ / shares in Units, $ in Thousands |
|
|
|
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
May 11, 2023 |
May 05, 2023 |
Mar. 31, 2023 |
May 05, 2022 |
May 19, 2023 |
Mar. 31, 2023 |
Mar. 29, 2023 |
Jul. 31, 2021 |
Mar. 31, 2023 |
Jun. 30, 2023 |
Shareholders’ Equity (Details) [Line Items] |
|
|
|
|
|
|
|
|
|
|
Aggregate offering price |
|
|
|
|
$ 8,707
|
|
|
$ 45,000
|
|
|
Total amount for ATM |
|
|
|
|
|
|
|
|
|
$ 2,212
|
Net of issuance cost |
|
|
|
|
|
|
|
|
|
$ 68
|
Purchase up to (in Shares) |
|
|
|
|
|
|
10,357,139
|
|
|
|
Price per share (in Dollars per share) |
|
|
|
|
|
|
$ 0.4199
|
|
|
|
Exercise price per share (in Dollars per share) |
|
|
|
|
|
|
$ 0.0001
|
|
|
|
Total consideration, net |
|
|
|
|
|
|
$ 3,987
|
|
|
|
Other offering expenses |
|
|
|
|
|
$ 666
|
$ 362
|
|
|
|
Ordinary shares issued (in Shares) |
10,354,532
|
|
|
|
|
16,859,000
|
|
|
|
5,013,446
|
Offering price per share (in Dollars per share) |
|
|
|
|
|
$ 0.42
|
|
|
|
|
Public offering proceeds |
|
|
|
|
|
$ 6,415
|
|
|
|
|
Fair value liability |
|
$ 1,905
|
|
|
|
|
|
|
|
$ 2,106
|
Authorized share capital (in Shares) |
|
60,000,000
|
|
|
|
|
|
|
|
|
Finance expenses |
|
$ 201
|
|
|
|
|
|
|
|
|
Stock options available for future grants (in Shares) |
|
|
|
|
|
|
|
|
|
1,206,447
|
Share options granted (in Shares) |
|
|
|
|
|
|
|
|
2,021,599
|
|
Stock option exercise price (in Shares) |
|
|
0.77
|
|
|
|
|
|
|
|
Total amount |
|
|
|
|
|
|
|
|
$ 562
|
|
Vested option amount |
|
|
|
|
|
|
|
|
$ 307
|
|
Vested option amount |
|
|
|
|
|
|
|
|
|
|
Unrecognized compensation costs |
|
|
|
|
|
|
|
|
|
$ 4,692
|
recognized over a weighted average period |
|
|
|
|
|
|
|
|
|
2 years 1 month 24 days
|
Over-Allotment Option [Member] |
|
|
|
|
|
|
|
|
|
|
Shareholders’ Equity (Details) [Line Items] |
|
|
|
|
|
|
|
|
|
|
Ordinary shares issued (in Shares) |
|
|
|
|
|
2,199,000
|
|
|
|
|
2012 Share Option Plan [Member] |
|
|
|
|
|
|
|
|
|
|
Shareholders’ Equity (Details) [Line Items] |
|
|
|
|
|
|
|
|
|
|
Grant of options shares (in Shares) |
|
|
|
|
|
|
|
|
|
4,672,094
|
Ordinary Shares [Member] |
|
|
|
|
|
|
|
|
|
|
Shareholders’ Equity (Details) [Line Items] |
|
|
|
|
|
|
|
|
|
|
Ordinary Shares, Sold (in Shares) |
|
|
|
|
|
|
|
|
|
1,949,029
|
Minimum [Member] |
|
|
|
|
|
|
|
|
|
|
Shareholders’ Equity (Details) [Line Items] |
|
|
|
|
|
|
|
|
|
|
Authorized share capital (in Shares) |
|
47,800,000
|
|
|
|
|
|
|
|
|
Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
Shareholders’ Equity (Details) [Line Items] |
|
|
|
|
|
|
|
|
|
|
Authorized share capital (in Shares) |
|
107,800,000
|
|
|
|
|
|
|
|
|
Board of Directors [Member] |
|
|
|
|
|
|
|
|
|
|
Shareholders’ Equity (Details) [Line Items] |
|
|
|
|
|
|
|
|
|
|
Total amount |
|
|
|
$ 63
|
|
|
|
|
|
|
Additional options shares (in Shares) |
|
|
|
504,169
|
|
|
|
|
|
|
Vested option amount |
|
|
|
$ 50
|
|
|
|
|
|
|
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v3.23.2
Shareholders’ Equity (Details) - Schedule of Ordinary Share Capital - shares
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Schedule of Ordinary Share Capital [Abstract] |
|
|
Ordinary shares, Authorized |
107,800,000
|
47,800,000
|
Ordinary shares, Issued and outstanding |
49,048,703
|
19,851,833
|
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v3.23.2
Shareholders’ Equity (Details) - Schedule of Status of Options to Employees under the Company’s Option Plan $ / shares in Units, $ in Thousands |
6 Months Ended |
Jun. 30, 2023
USD ($)
$ / shares
shares
|
Schedule of Status of Options to Employees Under the Company'S Option Plan [Abstract] |
|
Number of options, Outstanding beginning balance | shares |
3,303,346
|
Weighted average exercise price, Outstanding beginning balance | $ / shares |
$ 1.92
|
Aggregate intrinsic value, Outstanding beginning balance | $ |
$ 115
|
Weighted average remaining contractual life (years), Outstanding beginning balance |
6 years 1 month 20 days
|
Number of options, Granted | shares |
114,500
|
Weighted average exercise price, Granted | $ / shares |
$ 0.71
|
Aggregate intrinsic value, Granted | $ |
|
Number of options, Exercised | shares |
(34,309)
|
Weighted average exercise price, Exercised | $ / shares |
$ 0.23
|
Aggregate intrinsic value, Exercised | $ |
$ 12
|
Number of options, Forfeited and expired | shares |
(795,172)
|
Weighted average exercise price, Forfeited and expired | $ / shares |
$ 3.65
|
Number of options, Outstanding ending balance | shares |
2,588,365
|
Weighted average exercise price, Outstanding ending balance | $ / shares |
$ 1.36
|
Aggregate intrinsic value, Outstanding ending balance | $ |
|
Weighted average remaining contractual life (years), Outstanding ending balance |
6 years 4 months 20 days
|
Number of options, Exercisable options | shares |
1,569,578
|
Weighted average exercise price, Exercisable options | $ / shares |
$ 1.74
|
Aggregate intrinsic value, Exercisable options | $ |
|
Weighted average remaining contractual life (years), Exercisable options |
4 years 11 months 8 days
|
Number of options, Vested and expected to vest | shares |
2,588,365
|
Weighted average exercise price, Vested and expected to vest | $ / shares |
$ 1.36
|
Aggregate intrinsic value, Vested and expected to vest | $ |
|
Weighted average remaining contractual life (years), Vested and expected to vest |
6 years 4 months 20 days
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v3.23.2
Shareholders’ Equity (Details) - Schedule of Outstanding Options Granted To Non-Employees
|
6 Months Ended |
Jun. 30, 2023
$ / shares
shares
|
Shareholders’ Equity (Details) - Schedule of Outstanding Options Granted To Non-Employees [Line Items] |
|
Options outstanding |
710,016
|
Options exercisable |
508,732
|
April 2016 [Member] |
|
Shareholders’ Equity (Details) - Schedule of Outstanding Options Granted To Non-Employees [Line Items] |
|
Options outstanding |
5,975
|
Average Exercise price per share (in Dollars per share) | $ / shares |
$ 3.1
|
Options exercisable |
5,975
|
Exercisable |
April 2026
|
December 2016 [Member] |
|
Shareholders’ Equity (Details) - Schedule of Outstanding Options Granted To Non-Employees [Line Items] |
|
Options outstanding |
7,170
|
Average Exercise price per share (in Dollars per share) | $ / shares |
$ 3.93
|
Options exercisable |
7,170
|
Exercisable |
December 2026
|
June 2017 [Member] |
|
Shareholders’ Equity (Details) - Schedule of Outstanding Options Granted To Non-Employees [Line Items] |
|
Options outstanding |
197,722
|
Average Exercise price per share (in Dollars per share) | $ / shares |
$ 4.1
|
Options exercisable |
197,722
|
Exercisable |
June 2027
|
November 2017 [Member] |
|
Shareholders’ Equity (Details) - Schedule of Outstanding Options Granted To Non-Employees [Line Items] |
|
Options outstanding |
17,925
|
Average Exercise price per share (in Dollars per share) | $ / shares |
$ 0.77
|
Options exercisable |
17,925
|
Exercisable |
November 2027
|
August 2019 [Member] |
|
Shareholders’ Equity (Details) - Schedule of Outstanding Options Granted To Non-Employees [Line Items] |
|
Options outstanding |
71,700
|
Average Exercise price per share (in Dollars per share) | $ / shares |
$ 0.77
|
Options exercisable |
71,700
|
Exercisable |
August 2029
|
June 2020 [Member] |
|
Shareholders’ Equity (Details) - Schedule of Outstanding Options Granted To Non-Employees [Line Items] |
|
Options outstanding |
64,530
|
Average Exercise price per share (in Dollars per share) | $ / shares |
$ 2.84
|
Options exercisable |
64,530
|
Exercisable |
June 2030
|
April 2021 [Member] |
|
Shareholders’ Equity (Details) - Schedule of Outstanding Options Granted To Non-Employees [Line Items] |
|
Options outstanding |
62,741
|
Average Exercise price per share (in Dollars per share) | $ / shares |
$ 2.03
|
Options exercisable |
62,741
|
Exercisable |
April 2031
|
August 2021 [Member] |
|
Shareholders’ Equity (Details) - Schedule of Outstanding Options Granted To Non-Employees [Line Items] |
|
Options outstanding |
15,000
|
Average Exercise price per share (in Dollars per share) | $ / shares |
$ 0.77
|
Options exercisable |
8,719
|
Exercisable |
August 2031
|
December 2021 [Member] |
|
Shareholders’ Equity (Details) - Schedule of Outstanding Options Granted To Non-Employees [Line Items] |
|
Options outstanding |
10,000
|
Average Exercise price per share (in Dollars per share) | $ / shares |
$ 6.8
|
Options exercisable |
4,975
|
Exercisable |
December 2031
|
May 2022 [Member] |
|
Shareholders’ Equity (Details) - Schedule of Outstanding Options Granted To Non-Employees [Line Items] |
|
Options outstanding |
65,625
|
Average Exercise price per share (in Dollars per share) | $ / shares |
$ 1.37
|
Options exercisable |
65,625
|
Exercisable |
May 2032
|
November 2022 [Member] |
|
Shareholders’ Equity (Details) - Schedule of Outstanding Options Granted To Non-Employees [Line Items] |
|
Options outstanding |
5,000
|
Average Exercise price per share (in Dollars per share) | $ / shares |
$ 1.05
|
Options exercisable |
1,650
|
Exercisable |
November 2032
|
February 2023 [Member] |
|
Shareholders’ Equity (Details) - Schedule of Outstanding Options Granted To Non-Employees [Line Items] |
|
Options outstanding |
16,000
|
Average Exercise price per share (in Dollars per share) | $ / shares |
$ 0.81
|
Options exercisable |
|
Exercisable |
February 2033
|
May 2023 [Member] |
|
Shareholders’ Equity (Details) - Schedule of Outstanding Options Granted To Non-Employees [Line Items] |
|
Options outstanding |
170,628
|
Average Exercise price per share (in Dollars per share) | $ / shares |
$ 0.6
|
Options exercisable |
|
Exercisable |
May 2033
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v3.23.2
Shareholders’ Equity (Details) - Schedule of Warrants Exercisable Into Ordinary Shares
|
6 Months Ended |
Jun. 30, 2023
$ / shares
shares
|
Class of Warrant or Right [Line Items] |
|
|
Warrants outstanding |
413,263
|
|
Warrants exercisable |
413,263
|
|
August 2019 [Member] |
|
|
Class of Warrant or Right [Line Items] |
|
|
Warrants outstanding |
200,596
|
|
Average Exercise price per share (in Dollars per share) | $ / shares |
$ 15.95
|
|
Warrants exercisable |
200,596
|
|
Exercisable |
August 2023
|
|
September 2020 [Member] |
|
|
Class of Warrant or Right [Line Items] |
|
|
Warrants outstanding |
17,925
|
|
Average Exercise price per share (in Dollars per share) | $ / shares |
$ 16
|
|
Warrants exercisable |
17,925
|
|
Exercisable |
September 2024
|
|
April 2022 [Member] |
|
|
Class of Warrant or Right [Line Items] |
|
|
Warrants outstanding |
155,794
|
|
Average Exercise price per share (in Dollars per share) | $ / shares |
|
[1] |
Warrants exercisable |
155,794
|
|
Exercisable |
April 2029
|
|
July 2022 [Member] |
|
|
Class of Warrant or Right [Line Items] |
|
|
Warrants outstanding |
38,948
|
|
Average Exercise price per share (in Dollars per share) | $ / shares |
|
[1] |
Warrants exercisable |
38,948
|
|
Exercisable |
July 2029
|
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v3.23.2
Basic and Diluted Loss Per Share (Details) - Schedule of Basic and Diluted Net Loss Per Ordinary Share - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended |
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Schedule of basic and diluted net loss per ordinary share [Abstract] |
|
|
|
|
|
Allocation of loss attributable to ordinary shareholders |
$ 5,837
|
$ 11,845
|
$ 11,905
|
$ 23,719
|
$ 39,557
|
Weighted average Ordinary shares outstanding |
44,383,474
|
19,505,246
|
32,910,446
|
19,222,423
|
|
Basic and diluted loss per share |
$ 0.13
|
$ 0.61
|
$ 0.36
|
$ 1.23
|
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v3.23.2
Basic and Diluted Loss Per Share (Details) - Schedule of Diluted Loss Per Share Attributable to Ordinary Shareholders - shares
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Earnings Per Share, Diluted, by Common Class, Including Two Class Method [Line Items] |
|
|
|
|
Total |
2,491,573
|
4,520,647
|
2,491,573
|
4,520,647
|
Warrants [Member] |
|
|
|
|
Earnings Per Share, Diluted, by Common Class, Including Two Class Method [Line Items] |
|
|
|
|
Total |
413,263
|
374,315
|
413,263
|
374,315
|
Ordinary Share options [Member] |
|
|
|
|
Earnings Per Share, Diluted, by Common Class, Including Two Class Method [Line Items] |
|
|
|
|
Total |
2,078,310
|
4,146,332
|
2,078,310
|
4,146,332
|
X |
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