UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
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
Commission File Number:
(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
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
EXPLANATORY NOTE
On August 11, 2021, PolyPid Ltd. (the “Company”) furnished a Form 6-K including unaudited interim condensed consolidated financial statements as of June 30, 2021 (the “Original Form 6-K”). This Amendment on Form 6-K/A to the Original Form 6-K (this “Amendment”) is furnished to include as exhibits the unaudited interim condensed consolidated financial statements and the XBRL Data Files for such unaudited interim condensed consolidated financial statements. The XBRL Data Files should be read in conjunction with the unaudited consolidated interim financial statements included in the Original Form 6-K furnished on August 11, 2021 and included again in this Amendment as Exhibit 99.1
Other than as expressly set forth above, this Amendment does not, and does not purport to, amend, update or restate the information in any other item of the Original Form 6-K, or reflect any events that have occurred after the time of the Original Form 6-K.
This Amendment is incorporated by reference into the Company’s registration statements on Form F-3 (File No. 333-257651) and Form S-8 (File No. 333-239517), filed with the SEC, to be a part thereof from the date on which this Form 6-K is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.
Exhibit No. | Document Description | |
99.1 | PolyPid Ltd.’s Unaudited Interim Condensed Consolidated Financial Statements as of June 30, 2021. | |
EX-101.INS | Inline XBRL Taxonomy Instance Document | |
EX-101.SCH | Inline XBRL Taxonomy Extension Schema Document | |
EX-101.CAL | Inline XBRL Taxonomy Calculation Linkbase Document | |
EX-101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document | |
EX-101.LAB | Inline XBRL Taxonomy Label Linkbase Document | |
EX-101.PRE | Inline XBRL Taxonomy Presentation Linkbase Document |
1
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 30, 2021 | By: | /s/ Dikla Czaczkes Akselbrad | |
Name | Dikla Czaczkes Akselbrad | ||
Title: | Executive Vice President and Chief Financial Officer |
2
Exhibit 99.1
POLYPID LTD. AND ITS SUBSIDIARY
INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AS OF JUNE 30, 2021
U.S. DOLLARS IN THOUSANDS
UNAUDITED
INDEX
- - - - - - - - - - -
-1-
POLYPID LTD. AND ITS SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
June 30, | December 31, | |||||||
2021 | 2020 | |||||||
Unaudited | ||||||||
ASSETS | ||||||||
CURRENT ASSETS: | ||||||||
Cash and cash equivalents | $ | $ | ||||||
Restricted cash | ||||||||
Short-term deposits | ||||||||
Prepaid expenses and other current assets | ||||||||
Total current assets | ||||||||
LONG-TERM ASSETS: | ||||||||
Property and equipment, net | ||||||||
Long-term deposits | ||||||||
Other long-term assets | ||||||||
Total long-term assets | ||||||||
Total assets | $ | $ |
The accompanying notes are an integral part of the interim condensed consolidated financial statements.
-2-
POLYPID LTD. AND ITS SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands (except share and per share data)
June 30, | December 31, | |||||||
2021 | 2020 | |||||||
Unaudited | ||||||||
LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||
CURRENT LIABILITIES: | ||||||||
Trade payables | $ | $ | ||||||
Other payables and accrued expenses | ||||||||
Total current liabilities | ||||||||
LONG-TERM LIABILITIES: | ||||||||
Other long-term liabilities | ||||||||
Total long-term liabilities | ||||||||
COMMITMENTS AND CONTINGENCIES | ||||||||
SHAREHOLDERS’ EQUITY: | ||||||||
Share capital - | ||||||||
Ordinary Shares with no par value | Authorized: ||||||||
Additional paid-in capital | ||||||||
Accumulated deficit | ( | ) | ( | ) | ||||
Total shareholders’ equity | ||||||||
Total liabilities and shareholders’ equity | $ |
The accompanying notes are an integral part of the interim condensed consolidated financial statements.
-3-
POLYPID LTD. AND ITS SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share and per share data)
Six months ended June 30, | Three months ended June 30, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Unaudited | ||||||||||||||||
Operating expenses: | ||||||||||||||||
Research and development, net | $ | $ | $ | $ | ||||||||||||
Marketing and business development expenses | ||||||||||||||||
General and administrative | ||||||||||||||||
Operating loss | ||||||||||||||||
Financial (income) expense, net | ( | ) | ( | ) | ||||||||||||
Net loss | ||||||||||||||||
Deemed dividend | ||||||||||||||||
Net loss attributable to Ordinary Shares | $ | $ | $ | $ | ||||||||||||
Basic and diluted net loss per Ordinary Share | $ | $ | $ | $ | ||||||||||||
Weighted average number of Ordinary Shares used in computing basic and diluted net loss per share |
The accompanying notes are an integral part of the interim condensed consolidated financial statements.
-4-
POLYPID LTD. AND ITS SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN CONVERTIBLE PREFERRED SHARES AND SHAREHOLDERS’ EQUITY
U.S. dollars in thousands (except share data)
Convertible Preferred shares | Shareholders’ equity | |||||||||||||||||||||||||||
Number of Preferred shares | Amount | Total | Number of Ordinary Shares | Additional paid-in capital | Accumulated deficit | Total shareholders’ equity | ||||||||||||||||||||||
Balances as of January 1, 2021 | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||||||
Share-based compensation | - | - | ||||||||||||||||||||||||||
Exercise of Warrants | - | |||||||||||||||||||||||||||
Exercise of options | ||||||||||||||||||||||||||||
Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||
Balances as of June 30, 2021 (unaudited) | $ | $ | $ | $ | ( | ) | $ |
Convertible Preferred shares | Shareholders’ equity | |||||||||||||||||||||||||||
Number of Preferred shares | Amount | Total | Number of Ordinary Shares | Additional paid-in capital | Accumulated deficit | Total shareholders’ equity | ||||||||||||||||||||||
Balances as of January 1, 2020 (audited) | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||
Share-based compensation | - | - | ||||||||||||||||||||||||||
Deemed dividend related to Series E-1 Preferred shares | - | ( | ) | |||||||||||||||||||||||||
Issuance of Ordinary Shares in connection with IPO, net of issuance costs of $ | - | |||||||||||||||||||||||||||
Conversion of Convertible Preferred shares to Ordinary Shares | ( | ) | ( | ) | ( | ) | - | |||||||||||||||||||||
Exercise of Warrants | - | |||||||||||||||||||||||||||
Reclassification of Warrants into equity | - | - | ||||||||||||||||||||||||||
Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||
Balances as of June 30, 2020 (unaudited) | $ | $ | $ | $ | ( | ) | $ |
The accompanying notes are an integral part of the interim condensed consolidated financial statements.
-5-
POLYPID LTD. AND ITS SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN CONVERTIBLE PREFERRED SHARES AND SHAREHOLDERS’ EQUITY
U.S. dollars in thousands (except share data)
Convertible Preferred shares | Shareholders’ equity | |||||||||||||||||||||||||||
Number of Preferred shares | Amount | Total | Number of Ordinary Shares | Additional paid-in capital | Accumulated deficit | Total shareholders’ equity | ||||||||||||||||||||||
Balances as of January 1, 2020 (audited) | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||
Share-based compensation | - | - | - | |||||||||||||||||||||||||
Issuance of Ordinary Shares in connection with IPO, net of issuance costs of $ | - | - | ||||||||||||||||||||||||||
Conversion of Convertible Preferred shares to Ordinary Shares | ( | ) | ( | ) | ( | ) | - | |||||||||||||||||||||
Deemed dividend related to Series E-1 Preferred shares | - | - | ( | ) | ||||||||||||||||||||||||
Reclassification of Warrants into equity | - | - | ||||||||||||||||||||||||||
Exercise of Warrants | - | - | - | - | ||||||||||||||||||||||||
Issuance of Warrants | - | - | ||||||||||||||||||||||||||
Exercise of options | - | |||||||||||||||||||||||||||
Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||
Balances as of December 31, 2020 (audited) | - | $ | $ | $ | $ | ( | ) | $ |
The accompanying notes are an integral part of the interim condensed consolidated financial statements.
-6-
POLYPID LTD. AND ITS SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands
Six months ended June 30, | ||||||||
2021 | 2020 | |||||||
Unaudited | ||||||||
Cash flows from operating activities: | ||||||||
Net loss | $ | ( | ) | $ | ( | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation | ||||||||
Remeasurement of warrants | - | |||||||
Share-based compensation | ||||||||
Changes in assets and liabilities: | ||||||||
Decrease (increase) in receivables and prepaid expenses | ( | ) | ||||||
Decrease (increase) in other long-term assets | ( | ) | ||||||
Increase (decrease) in trade payables | ( | ) | ||||||
Increase in other payables and accrued expenses and other liabilities | ||||||||
Net cash used in operating activities | ( | ) | ( | ) | ||||
Cash flows from investing activities: | ||||||||
Purchase of property and equipment | ( | ) | ( | ) | ||||
Short-term deposits, net | ( | ) | ||||||
Long-term deposits, net | - | |||||||
Pre-payment for equipment | ( | ) | - | |||||
Net cash provided by investing activities | ||||||||
Cash flows from financing activities: | ||||||||
Proceeds from exercise of Warrants | ||||||||
Proceeds from exercise of options | - | |||||||
Proceeds from issuance of Ordinary Shares in connection with IPO, net | - | |||||||
Net cash provided by financing activities | ||||||||
Increase in cash, cash equivalents and restricted cash | ||||||||
Cash, cash equivalents and restricted cash at the beginning of the period | ||||||||
Cash, cash equivalents and restricted cash at the end of the period | $ | $ | ||||||
Reconciliation of cash, cash equivalents and restricted cash as shown in the condensed consolidated statements of cash flow: | ||||||||
Cash and cash equivalents | ||||||||
Restricted cash and restricted cash included in long-term assets | ||||||||
Total cash, cash equivalents and restricted cash | $ | $ |
The accompanying notes are an integral part of the interim consolidated financial statements.
-7-
POLYPID LTD. AND ITS SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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 its operations on February 28, 2008. The Company is a late-stage biopharma company focused on developing and commercializing novel, locally administered therapies using its PLEX (Polymer-Lipid Encapsulation matriX) technology. The Company’s product candidates are designed to address unmet medical needs by delivering active pharmaceutical ingredients (“APIs”) 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-PLEX100, which incorporates an antibiotic, for the prevention of surgical site infection in bone and soft tissue. |
The Company wholly-owns subsidiaries in the Unites States of America and Romania.
Through June 30, 2021, the Company has been primarily engaged in research and development.
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 are dependent on future events, including, among other things, its ability to obtain marketing approval from regulatory authorities and access potential markets; secure financing, develop a 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 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. |
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 III 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 over 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, 2021, the Company’s
had cash, cash equivalents, short-term deposits and long-term deposits of $
-8-
POLYPID LTD. AND ITS SUBSIDIARY |
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS |
U.S. dollars in thousands (except share and per share data) |
NOTE 1:- GENERAL (Cont.)
The Company’s future operations are highly dependent on a combination of factors, including (i) the timely and successful completion of additional financing discussed above; (ii) completion of all required clinical studies; (iii) the success of its research and development; activities; (iv) the manufacture of all required clinical and commercial production batches; (v) marketing approval by the relevant regulatory authorities; and (vi) market acceptance of the Company’s product candidates.
There can be no assurance that the Company will be successful in obtaining additional financing on favorable terms, or at all or will succeed in achieving the clinical, scientific and commercial milestones as detailed above.
c. | On March 11, 2020, the World Health Organization declared the outbreak of a respiratory disease caused by a new coronavirus as a “pandemic,” which is now known as COVID-19. The outbreak has impacted millions of individuals worldwide. In response, many countries have implemented measures to combat the outbreak which have impacted global business operations. Our business was affected by the effects of the recent and evolving COVID-19 pandemic, which has resulted in travel and other restrictions in order to reduce the spread of the disease, including in Israel, the United States and the European Union, where the Company is conducting its clinical trials. No impairments were recorded as of the balance sheet date as no triggering events or changes in circumstances had occurred; however, due to significant uncertainty surrounding the situation, management’s judgment regarding this could change in the future. |
d. | On June 21, 2020, |
e. | On June 30, 2020, the Company closed its initial public offering (“IPO”), whereby |
-9-
POLYPID LTD. AND ITS SUBSIDIARY |
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS |
U.S. dollars in thousands (except share and per share data) |
NOTE 2:- SIGNIFICANT ACCOUNTING POLICIES
a. | Basis of presentation: |
The unaudited interim consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes for the year ended December 31, 2020.
These unaudited interim consolidated financial statements of the Company as of June 30, 2021 and for the six months then ended, have been prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”).
The unaudited interim consolidated financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information. Accordingly, they do not include all the information and footnotes required by generally
accepted accounting principles for annual consolidated financial statements. In the opinion of our management, all material adjustments considered necessary for a fair presentation of the financial information as of and for the periods presented have been included.
b. | Accounting policies: |
The significant accounting policies followed in the preparation of these unaudited interim consolidated financial statements are consistent to those applied in the preparation of the latest annual consolidated financial statements.
c. | Use of estimates: |
The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates.
d. | Recently issued 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 adoption dates discussed below reflect this election.
In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-02, “Leases,” which would require lessees to recognize assets and liabilities on the balance sheet for most leases, whether operating or financing, while continuing to recognize the expenses on their income statements in a manner similar to current practice. Under the guidance, the Company would also be required to provide enhanced disclosures. The guidance states that a lessee would recognize a lease liability for the obligation to make lease payments and a right-to-use asset for the right to use the underlying asset for the lease term.
-10-
POLYPID LTD. AND ITS SUBSIDIARY |
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS |
U.S. dollars in thousands (except share and per share data) |
NOTE 2:- SIGNIFICANT ACCOUNTING POLICIES (Cont.)
The guidance will be effective for the Company beginning January 1, 2022, and interim periods in fiscal years beginning January 1, 2023. The Company is in the initial stage of its assessment of the new standard and is currently evaluating the quantitative impact of adoption, and the related disclosure requirements. The Company anticipates the adoption of this standard will result in an increase in its noncurrent assets, and current and noncurrent liabilities recorded on the consolidated balance sheets. The Company is currently evaluating the effect that ASU 2016-02 will have on its consolidated financial statements.
In December 2019, the FASB issued ASU No. 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes,” which simplifies the accounting for income taxes by removing a variety of exceptions within the framework of Accounting Standards Codification (“ASC”) Topic 740. These exceptions include the exception to the incremental approach for intra period tax allocation in the event of a loss from continuing operations and income or a gain from other items (such as other comprehensive income), and the exception to using general methodology for the interim period tax accounting for year-to-date losses that exceed anticipated losses. The guidance will be effective for the Company beginning January 1, 2022, and interim periods in fiscal years beginning January 1, 2023. Early adoption is permitted. The Company is currently evaluating the effect that ASU 2019-12 will have on its consolidated financial statements and related disclosures.
-11-
POLYPID LTD. AND ITS SUBSIDIARY |
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS |
U.S. dollars in thousands (except share and per share data) |
NOTE 3:- COMMITMENTS AND CONTINGENT LIABILITIES
a. | The facilities of the Company are leased under various operating lease agreements for periods ending no later than 2027. The Company also leases motor vehicles under various operating leases, which expire on various dates, the latest of which is in 2024. |
Future minimum lease payments under non-cancelable operating leases as of June 30, 2021 (unaudited) are as follows:
June 30, 2021 | ||||
Unaudited | ||||
2021 | $ | |||
2022 | ||||
2023 | ||||
2024 | ||||
Thereafter | ||||
Total | $ |
As of June 30, 2021 (unaudited),
the Company made advance payments on account of installments on car leases in the amount of $
Lease and rental expenses for the six
months ended June 30, 2021 (unaudited) and June 30, 2020 were $
b. | In connection with its research and development programs, the Company received participation payments from the Israel Innovation Authority of the Ministry of Economy in Israel (“IIA”) of $ |
c. | On January 9, 2020, the Company entered into an agreement for an automatic filling machine for the Company’s manufacturing plant in a total amount of EUR |
-12-
POLYPID LTD. AND ITS SUBSIDIARY |
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS |
U.S. dollars in thousands (except share and per share data) |
NOTE 4:- FAIR VALUE MEASUREMENTS
Financial instruments measured at fair value on a recurring basis include warrants to purchase Convertible Preferred shares (see Note 5). The warrants are classified as a liability in accordance with ASC 480-10-25. These warrants were classified as level 3 in the fair value hierarchy since some of the inputs used in the valuation (the “Share Price”) were determined based on management’s assumptions up until the IPO date.
To calculate the fair value of the warrants, we first calculated the underlying preferred share value by using the income approach and the market approach. Then the equity value was allocated by using the hybrid model method utilizing two scenarios of OPM and IPO. Once the preferred shares value was derived from the two scenarios, the Black-Scholes model was utilized to calculate the warrants value in each one of the scenarios, by using probability for each one of the scenarios to derive the weighted average fair value of the warrants.
As of June 30, 2020:
According to the IPO scenario, the
underlying share price was $
According to the IPO scenario, the
underlying share price was $
According to the IPO scenario, the
underlying Share Price was $
On June 30, 2020, as a result of the IPO, the warrant liability to Convertible Preferred shares has been classified to warrants to Ordinary Shares in equity.
The change in the fair value of the preferred share warrant liability is summarized below:
June 30, | December 31, | |||||||
2021 | 2020 | |||||||
Unaudited | ||||||||
Beginning of year | $ | $ | ||||||
Change in fair value | ||||||||
Reclassification of Warrants into equity | ( | ) | ||||||
End of period | $ | $ |
-13-
POLYPID LTD. AND ITS SUBSIDIARY |
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS |
U.S. dollars in thousands (except share and per share data) |
NOTE 5:- WARRANTS
In March 2008,
In connection with the first financing
round that occurred in 2016, the Company granted to the investors warrants to purchase up to
The survival of Series D-2 Warrants shall be limited to a period ending upon the earlier of: (i) the lapse of 5 years from closing; or (ii) deemed liquidation event.
The Series D-2 Warrants will be exercised automatically if they are still outstanding on the final day of the warrant period as defined in the warrants grant letter, and if the fair market value of a warrant share is more than the exercise price for such share.
All outstanding Series A and D-2 warrants are classified as a long-term liability and are re-measured at each reporting date, as the underlying shares may be redeemed upon an event which is not solely in the control of the Company. Following the warrants conversions during 2020 and 2021, no Series A or Series D-2 Warrants were outstanding as of June 30, 2021.
As of June 30, 2021,
-14-
POLYPID LTD. AND ITS SUBSIDIARY |
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS |
U.S. dollars in thousands (except share and per share data) |
NOTE 6:- SHAREHOLDERS’ DEFICIENCY
a. | General: |
On June 21, 2020, the Company’s Board of Directors resolved to consolidate the Company’s share capital by applying an additional reverse share split and cancelling the shares’ par value (see Note 1d).
Following the Split and the cancellation of the par value, all Ordinary Shares, Convertible Preferred shares, options, convertible loans, warrants, exercise prices and per share data have been adjusted retroactively for all periods presented in these consolidated financial statements.
b. | Ordinary share capital is composed as follows: |
June 30, 2021 | December 31, 2020 | |||||||||||||||
Authorized | Issued and outstanding | Authorized | Issued and outstanding | |||||||||||||
Unaudited | ||||||||||||||||
Number of shares | ||||||||||||||||
Ordinary Shares with no par value |
c. | Share option plans: |
The Company authorized through its 2012
Share Option Plan, the grant of options to officers, directors, advisors, management and other key employees of up to
A summary of the status of the Company’s option plan as of June 30, 2021 (unaudited), and changes during the period then ended is presented below:
Number of options | Weighted average exercise price | Aggregate intrinsic value | ||||||||||
Unaudited | ||||||||||||
Outstanding at beginning of period | $ | |||||||||||
Granted | ||||||||||||
Exercised | ( | ) | ||||||||||
Forfeited and cancelled | ( | ) | ||||||||||
Outstanding at end of period | ||||||||||||
Exercisable options | ||||||||||||
Vested and expected to vest |
-15-
POLYPID LTD. AND ITS SUBSIDIARY |
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS |
U.S. dollars in thousands (except share and per share data) |
NOTE 6:- SHAREHOLDERS’ DEFICIENCY (Cont.)
As of June 30, 2021 (unaudited),
there were unrecognized compensation costs of $
The total equity-based compensation expense related to all of the Company’s equity-based awards recognized for the six months ended June 30, 2021 and for the six months ended June 30, 2020 (unaudited), was comprised as follows:
Six months ended June 30, | ||||||||
2021 | 2020 | |||||||
Unaudited | ||||||||
Research and development | $ | $ | ||||||
Market and business development | ||||||||
General and administrative | ||||||||
Total share-based compensation expense | $ | $ |
The options outstanding as of June 30, 2021 (unaudited) have been separated into ranges of exercise prices, as follows:
Exercise price | Options outstanding as of June 30, 2021 | Weighted average exercise price | Weighted average remaining contractual term | Options exercisable as of June 30, 2021 | Weighted average exercise price | Weighted average remaining contractual term | ||||||||||||||||||
(years) | (years) | |||||||||||||||||||||||
*)0.22 | *)0.22 | *)0.22 | ||||||||||||||||||||||
1.75 | ||||||||||||||||||||||||
3.59 | ||||||||||||||||||||||||
5.07 | ||||||||||||||||||||||||
9.23 | ||||||||||||||||||||||||
3.10 | ||||||||||||||||||||||||
3.93 | ||||||||||||||||||||||||
4.10 | ||||||||||||||||||||||||
4.18 | ||||||||||||||||||||||||
7.70 | ||||||||||||||||||||||||
8.42 | ||||||||||||||||||||||||
8.65 | ||||||||||||||||||||||||
8.02 | ||||||||||||||||||||||||
6.80 | ||||||||||||||||||||||||
6.62 | ||||||||||||||||||||||||
11.04 | ||||||||||||||||||||||||
10.07 | ||||||||||||||||||||||||
*) |
-16-
POLYPID LTD. AND ITS SUBSIDIARY |
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS |
U.S. dollars in thousands (except share and per share data) |
NOTE 6:- SHAREHOLDERS’ DEFICIENCY (Cont.)
d. | Options issued to non-employees: |
The outstanding options granted to consultants as of June 30, 2021 (unaudited) were as follows:
Grant date | Options outstanding as of June 30, 2021 | Exercise price per share | Options exercisable as of June 30, 2021 | Exercisable through | ||||||||||
October 2013 | $ | |||||||||||||
September 2014 | $ | |||||||||||||
April 2016 | $ | |||||||||||||
December 2016 | $ | |||||||||||||
June 2017 | $ | |||||||||||||
November 2017 | $ | |||||||||||||
August 2019 | $ | |||||||||||||
June 2020 | $ | |||||||||||||
April 2021 | $ | |||||||||||||
-17-
POLYPID LTD. AND ITS SUBSIDIARY |
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS |
U.S. dollars in thousands (except share and per share data) |
NOTE 7:- BASIC AND DILUTED NET 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, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Unaudited | ||||||||||||||||
Numerator: | ||||||||||||||||
Net loss attributable to Ordinary Shares as reported | $ | $ | $ | $ | ||||||||||||
Deemed dividend | - | |||||||||||||||
Net loss applicable to Ordinary shareholders | ||||||||||||||||
Denominator: | ||||||||||||||||
Weighted average shares used in computing net loss per Ordinary share, basic and diluted: | ||||||||||||||||
Ordinary share – basic and dilutive | ||||||||||||||||
Net loss per Ordinary share, basic and diluted | $ | $ | $ | $ |
- 18 -
Document And Entity Information |
6 Months Ended |
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Jun. 30, 2021 | |
Document Information Line Items | |
Entity Registrant Name | PolyPid Ltd. |
Document Type | 6-K/A |
Current Fiscal Year End Date | --12-31 |
Amendment Flag | true |
Amendment Description | On August 11, 2021, PolyPid Ltd. (the “Company”) furnished a Form 6-K including unaudited interim condensed consolidated financial statements as of June 30, 2021 (the “Original Form 6-K”). This Amendment on Form 6-K/A to the Original Form 6-K (this “Amendment”) is furnished to include as exhibits the unaudited interim condensed consolidated financial statements and the XBRL Data Files for such unaudited interim condensed consolidated financial statements. The XBRL Data Files should be read in conjunction with the unaudited consolidated interim financial statements included in the Original Form 6-K furnished on August 11, 2021 and included again in this Amendment as Exhibit 99.1 |
Entity Central Index Key | 0001611842 |
Document Period End Date | Jun. 30, 2021 |
Document Fiscal Year Focus | 2021 |
Document Fiscal Period Focus | Q2 |
Entity File Number | 001-38428 |
Condensed Consolidated Balance Sheets (Parentheticals) - $ / shares |
Jun. 30, 2021 |
Dec. 31, 2020 |
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Statement of Financial Position [Abstract] | ||
Ordinary shares par value (in Dollars per share) | ||
Ordinary shares, shares authorized | 47,800,000 | 47,800,000 |
Ordinary shares, shares issued | 18,756,570 | 18,494,739 |
Ordinary shares, shares outstanding | 18,756,570 | 18,494,739 |
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2021 |
Jun. 30, 2020 |
Jun. 30, 2021 |
Jun. 30, 2020 |
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Operating expenses: | ||||
Research and development, net | $ 7,442 | $ 4,339 | $ 13,460 | $ 7,772 |
Marketing and business development expenses | 739 | 305 | 1,391 | 581 |
General and administrative | 2,449 | 2,628 | 4,576 | 3,355 |
Operating loss | 10,630 | 7,272 | 19,427 | 11,708 |
Financial (income) expense, net | (153) | 9,721 | (263) | 11,154 |
Net loss | 10,477 | 16,993 | 19,164 | 22,862 |
Deemed dividend | 2,114 | 2,114 | ||
Net loss attributable to Ordinary Shares | $ 10,477 | $ 19,107 | $ 19,164 | $ 24,976 |
Basic and diluted net loss per Ordinary Share (in Dollars per share) | $ 0.56 | $ 25.30 | $ 1.03 | $ 37.87 |
Weighted average number of Ordinary Shares used in computing basic and diluted net loss per share (in Shares) | 18,747,967 | 755,289 | 18,685,906 | 659,551 |
Condensed Consolidated Statements of Changes In Convertible Preferred Shares and Shareholders’ Equity (Parentheticals) - USD ($) $ in Thousands |
6 Months Ended | 12 Months Ended |
---|---|---|
Jun. 30, 2020 |
Dec. 31, 2020 |
|
Statement of Stockholders' Equity [Abstract] | ||
Net of issuance costs | $ 6,224 | $ 6,243 |
General |
6 Months Ended | |||||||||||||||
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Jun. 30, 2021 | ||||||||||||||||
General [Abstract] | ||||||||||||||||
GENERAL | NOTE 1:- GENERAL
The Company wholly-owns subsidiaries in the Unites States of America and Romania.
Through June 30, 2021, the Company has been primarily engaged in research and development.
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 III 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 over 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, 2021, the Company’s had cash, cash equivalents, short-term deposits and long-term deposits of $52,906. During the six months ended June 30, 2021, the Company incurred a net loss of $19,164 and had negative cash flows from operating activities of $13,551. In addition, the Company had an accumulated deficit of $151,450 as of June 30, 2021. 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) the timely and successful completion of additional financing discussed above; (ii) completion of all required clinical studies; (iii) the success of its research and development; activities; (iv) the manufacture of all required clinical and commercial production batches; (v) marketing approval by the relevant regulatory authorities; and (vi) market acceptance of the Company’s product candidates.
There can be no assurance that the Company will be successful in obtaining additional financing on favorable terms, or at all or will succeed in achieving the clinical, scientific and commercial milestones as detailed above.
|
Significant Accounting Policies |
6 Months Ended | ||||||||||||
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Jun. 30, 2021 | |||||||||||||
Accounting Policies [Abstract] | |||||||||||||
SIGNIFICANT ACCOUNTING POLICIES | NOTE 2:- SIGNIFICANT ACCOUNTING POLICIES
The unaudited interim consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes for the year ended December 31, 2020.
These unaudited interim consolidated financial statements of the Company as of June 30, 2021 and for the six months then ended, have been prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”).
The unaudited interim consolidated financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information. Accordingly, they do not include all the information and footnotes required by generally accepted accounting principles for annual consolidated financial statements. In the opinion of our management, all material adjustments considered necessary for a fair presentation of the financial information as of and for the periods presented have been included.
The significant accounting policies followed in the preparation of these unaudited interim consolidated financial statements are consistent to those applied in the preparation of the latest annual consolidated financial statements.
The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates.
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 adoption dates discussed below reflect this election.
In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-02, “Leases,” which would require lessees to recognize assets and liabilities on the balance sheet for most leases, whether operating or financing, while continuing to recognize the expenses on their income statements in a manner similar to current practice. Under the guidance, the Company would also be required to provide enhanced disclosures. The guidance states that a lessee would recognize a lease liability for the obligation to make lease payments and a right-to-use asset for the right to use the underlying asset for the lease term.
The guidance will be effective for the Company beginning January 1, 2022, and interim periods in fiscal years beginning January 1, 2023. The Company is in the initial stage of its assessment of the new standard and is currently evaluating the quantitative impact of adoption, and the related disclosure requirements. The Company anticipates the adoption of this standard will result in an increase in its noncurrent assets, and current and noncurrent liabilities recorded on the consolidated balance sheets. The Company is currently evaluating the effect that ASU 2016-02 will have on its consolidated financial statements.
In December 2019, the FASB issued ASU No. 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes,” which simplifies the accounting for income taxes by removing a variety of exceptions within the framework of Accounting Standards Codification (“ASC”) Topic 740. These exceptions include the exception to the incremental approach for intra period tax allocation in the event of a loss from continuing operations and income or a gain from other items (such as other comprehensive income), and the exception to using general methodology for the interim period tax accounting for year-to-date losses that exceed anticipated losses. The guidance will be effective for the Company beginning January 1, 2022, and interim periods in fiscal years beginning January 1, 2023. Early adoption is permitted. The Company is currently evaluating the effect that ASU 2019-12 will have on its consolidated financial statements and related disclosures. |
Commitments and Contingent Liabilities |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2021 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Commitments and Contingencies Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
COMMITMENTS AND CONTINGENT LIABILITIES | NOTE 3:- COMMITMENTS AND CONTINGENT LIABILITIES
Future minimum lease payments under non-cancelable operating leases as of June 30, 2021 (unaudited) are as follows:
As of June 30, 2021 (unaudited), the Company made advance payments on account of installments on car leases in the amount of $74.
Lease and rental expenses for the six months ended June 30, 2021 (unaudited) and June 30, 2020 were $566 and $500, respectively.
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Fair Value Measurements |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2021 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Disclosures [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
FAIR VALUE MEASUREMENTS | NOTE 4:- FAIR VALUE MEASUREMENTS
Financial instruments measured at fair value on a recurring basis include warrants to purchase Convertible Preferred shares (see Note 5). The warrants are classified as a liability in accordance with ASC 480-10-25. These warrants were classified as level 3 in the fair value hierarchy since some of the inputs used in the valuation (the “Share Price”) were determined based on management’s assumptions up until the IPO date.
To calculate the fair value of the warrants, we first calculated the underlying preferred share value by using the income approach and the market approach. Then the equity value was allocated by using the hybrid model method utilizing two scenarios of OPM and IPO. Once the preferred shares value was derived from the two scenarios, the Black-Scholes model was utilized to calculate the warrants value in each one of the scenarios, by using probability for each one of the scenarios to derive the weighted average fair value of the warrants.
As of June 30, 2020:
According to the IPO scenario, the underlying share price was $16 for the series E-1 Preferred shares. The following assumptions were used to estimate the value of the series E-1 Preferred share warrants as of June 30, 2020: exercise price of $15.95, expected volatility of 78.07%, risk free interest rates of 0.76%, dividend yield of 0%, and expected term of 4.17 years. Accordingly, the fair value of the series E-1 Preferred share warrants as of June 30, 2020 was $1,868. As of June 30, 2021, 200,596 warrants were outstanding.
According to the IPO scenario, the underlying share price was $16 for the series D-2 Preferred shares. The following assumptions were used to estimate the value of the series D-2 Preferred share warrants as of June 30, 2020: exercise price of $9.24, expected volatility of 82.48%, risk free interest rates of 0.46%, dividend yield of 0%, and expected term of 0.6 years. Accordingly, the fair value of the series D-2 Preferred share warrants as of June 30, 2020 was $20,930. As of June 30, 2021, all warrants had been exercised into 1,069,850 Ordinary Shares.
According to the IPO scenario, the underlying Share Price was $16.00 for the series A Preferred shares. The following assumptions were used to estimate the value of the series A Preferred share warrants as of June 30, 2020: exercise price of 0.84 NIS ($0.23) and dividend yield of 0%. Accordingly, the fair value of the series A Preferred share warrants as of June 30, 2020 was $816. As of June 30, 2020, as part of the IPO, 53,775 warrants had been exercised into 53,775 Ordinary Shares.
On June 30, 2020, as a result of the IPO, the warrant liability to Convertible Preferred shares has been classified to warrants to Ordinary Shares in equity.
The change in the fair value of the preferred share warrant liability is summarized below:
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Warrants |
6 Months Ended |
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Jun. 30, 2021 | |
Warrants [Abstract] | |
WARRANTS | NOTE 5:- WARRANTS
In March 2008, in connection with the March 2008 Founders and Share Purchase Agreement, the Company granted to the investor warrants to purchase Convertible Preferred A shares (“Series A Warrants”), with an exercise price of NIS 0.84 ($0.23). The Series A Warrants may be converted at any time until the earlier of: (1) consummation of an initial public offering on certain stock exchanges as set forth in the warrant terms, with net proceeds to the Company of at least $15,000 (and pre-money valuation of at least $75,000), (2) merger or consolidation of the Company with another company, and (3) the sale of substantially all of the Company’s assets or substantially all of the shares to another party.
In connection with the first financing round that occurred in 2016, the Company granted to the investors warrants to purchase up to 2,775,398 Convertible D-2 Preferred shares (“Series D-2 Warrants”) at a price per share of $9.23.
The survival of Series D-2 Warrants shall be limited to a period ending upon the earlier of: (i) the lapse of 5 years from closing; or (ii) deemed liquidation event.
The Series D-2 Warrants will be exercised automatically if they are still outstanding on the final day of the warrant period as defined in the warrants grant letter, and if the fair market value of a warrant share is more than the exercise price for such share.
All outstanding Series A and D-2 warrants are classified as a long-term liability and are re-measured at each reporting date, as the underlying shares may be redeemed upon an event which is not solely in the control of the Company. Following the warrants conversions during 2020 and 2021, no Series A or Series D-2 Warrants were outstanding as of June 30, 2021.
On June 28, 2019, in connection with a Private Placement Memorandum (the “2019 PPM”), the Company included the following as part of its issuance costs: (i) warrants to purchase up to 200,596 series E-1 Preferred shares (“Series E-1 warrants”) at a price per share of $15.95 against payment of a total exercise amount of up to $3,200 and (ii) a cash fee of 10% of any new investment that were introduced by National Securities. The survival of the Series E-1 warrants shall be limited to a period ending upon 4 years from closing.
As of June 30, 2021, 200,596 Series E-1 warrants were outstanding and as a result of the IPO, the warrant liability to Convertible Preferred shares has been classified to warrants to Ordinary Shares in equity. |
Shareholders’ Deficiency |
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Stockholders' Equity Note [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
SHAREHOLDERS’ DEFICIENCY | NOTE 6:- SHAREHOLDERS’ DEFICIENCY
On June 21, 2020, the Company’s Board of Directors resolved to consolidate the Company’s share capital by applying an additional reverse share split and cancelling the shares’ par value (see Note 1d).
Following the Split and the cancellation of the par value, all Ordinary Shares, Convertible Preferred shares, options, convertible loans, warrants, exercise prices and per share data have been adjusted retroactively for all periods presented in these consolidated financial statements.
The Company authorized through its 2012 Share Option Plan, the grant of options to officers, directors, advisors, management and other key employees of up to 3,672,094 Ordinary Shares. 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, 2021 (unaudited), 932,189 of the Company’s options were available for future grants.
A summary of the status of the Company’s option plan as of June 30, 2021 (unaudited), and changes during the period then ended is presented below:
As of June 30, 2021 (unaudited), there were unrecognized compensation costs of $8,286, which are expected to be recognized over a weighted average period of approximately 2.3 years.
The total equity-based compensation expense related to all of the Company’s equity-based awards recognized for the six months ended June 30, 2021 and for the six months ended June 30, 2020 (unaudited), was comprised as follows:
43,866 options were exercised by employees during the six months ended June 30, 2021 (unaudited).
The options outstanding as of June 30, 2021 (unaudited) have been separated into ranges of exercise prices, as follows:
The outstanding options granted to consultants as of June 30, 2021 (unaudited) were as follows:
33,492 options were exercised by non- employees during the six months ended June 30, 2021 (unaudited). |
Basic and Diluted Net Loss Per Share |
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Earnings Per Share [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
BASIC AND DILUTED NET LOSS PER SHARE | NOTE 7:- BASIC AND DILUTED NET LOSS PER SHARE
The following table sets forth the computation of the Company’s basic and diluted net loss per Ordinary Share:
|
Accounting Policies, by Policy (Policies) |
6 Months Ended | |||
---|---|---|---|---|
Jun. 30, 2021 | ||||
Accounting Policies [Abstract] | ||||
Basis of presentation |
The unaudited interim consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes for the year ended December 31, 2020.
These unaudited interim consolidated financial statements of the Company as of June 30, 2021 and for the six months then ended, have been prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”).
The unaudited interim consolidated financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information. Accordingly, they do not include all the information and footnotes required by generally accepted accounting principles for annual consolidated financial statements. In the opinion of our management, all material adjustments considered necessary for a fair presentation of the financial information as of and for the periods presented have been included.
|
|||
Accounting policies |
The significant accounting policies followed in the preparation of these unaudited interim consolidated financial statements are consistent to those applied in the preparation of the latest annual consolidated financial statements.
|
|||
Use of estimates |
The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates.
|
|||
Recently Issued 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 adoption dates discussed below reflect this election.
In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-02, “Leases,” which would require lessees to recognize assets and liabilities on the balance sheet for most leases, whether operating or financing, while continuing to recognize the expenses on their income statements in a manner similar to current practice. Under the guidance, the Company would also be required to provide enhanced disclosures. The guidance states that a lessee would recognize a lease liability for the obligation to make lease payments and a right-to-use asset for the right to use the underlying asset for the lease term.
The guidance will be effective for the Company beginning January 1, 2022, and interim periods in fiscal years beginning January 1, 2023. The Company is in the initial stage of its assessment of the new standard and is currently evaluating the quantitative impact of adoption, and the related disclosure requirements. The Company anticipates the adoption of this standard will result in an increase in its noncurrent assets, and current and noncurrent liabilities recorded on the consolidated balance sheets. The Company is currently evaluating the effect that ASU 2016-02 will have on its consolidated financial statements.
In December 2019, the FASB issued ASU No. 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes,” which simplifies the accounting for income taxes by removing a variety of exceptions within the framework of Accounting Standards Codification (“ASC”) Topic 740. These exceptions include the exception to the incremental approach for intra period tax allocation in the event of a loss from continuing operations and income or a gain from other items (such as other comprehensive income), and the exception to using general methodology for the interim period tax accounting for year-to-date losses that exceed anticipated losses. The guidance will be effective for the Company beginning January 1, 2022, and interim periods in fiscal years beginning January 1, 2023. Early adoption is permitted. The Company is currently evaluating the effect that ASU 2019-12 will have on its consolidated financial statements and related disclosures. |
Commitments and Contingent Liabilities (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||
Commitments and Contingencies Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of future minimum lease payments under operating leases |
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Fair Value Measurements (Tables) |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2021 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Disclosures [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of change in the fair value of the preferred share warrants liability |
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Shareholders’ Deficiency (Tables) |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2021 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stockholders' Equity Note [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of ordinary share capital |
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Schedule of status of the company’s option plan |
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Schedule of the total equity-based compensation expense related to all of the company’s equity-based awards recognized |
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Schedule of options outstanding |
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Schedule of outstanding options granted to consultants |
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Basic and Diluted Net Loss Per Share (Tables) |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2021 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Earnings Per Share [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of basic and diluted net loss per ordinary share |
|
General (Details) - USD ($) $ in Thousands |
1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
---|---|---|---|---|---|---|
Jun. 21, 2020 |
Jun. 30, 2021 |
Jun. 30, 2020 |
Jun. 30, 2021 |
Jun. 30, 2020 |
Dec. 31, 2020 |
|
General (Details) [Line Items] | ||||||
Cash equivalents, short-term deposits and long-term deposits | $ 52,906 | $ 52,906 | ||||
Net Income (Loss) Attributable to Parent | (10,477) | $ (16,993) | (19,164) | $ (22,862) | $ (36,869) | |
Cash flows from operating activities | 13,551 | |||||
Accumulated deficit | $ (151,450) | $ (151,450) | $ (132,286) | |||
Description of reverse share split | the Company’s Board of Directors resolved to consolidate the Company’s share capital by applying a reverse share split at a ratio of 1.046:1 and to cancel the Company’s ordinary shares (the “Ordinary Shares”) par value, such that every 1.046 Ordinary Shares of NIS 0.8 par value, were substituted by 1 Ordinary Share with no par value (“the Split”). The Split was applied in the same proportion and manner to all of the Company’s authorized, issued and outstanding securities, including preferred shares, options and warrants. | |||||
Initial Public Offering [Member] | ||||||
General (Details) [Line Items] | ||||||
Sale of ordinary shares (in Shares) | 4,312,500 | |||||
Aggregate net proceeds | $ 62,757 | |||||
Over-Allotment Option [Member] | ||||||
General (Details) [Line Items] | ||||||
Sale of ordinary shares (in Shares) | 562,500 |
Commitments and Contingent Liabilities (Details) € in Thousands, $ in Thousands |
6 Months Ended | |||
---|---|---|---|---|
Jan. 09, 2020
EUR (€)
|
Jun. 30, 2021
USD ($)
|
Jun. 30, 2021
EUR (€)
|
Jun. 30, 2020
USD ($)
|
|
Commitments and Contingent Liabilities (Details) [Line Items] | ||||
Advance payments | $ 74 | |||
Rental and lease expenses | 566 | $ 500 | ||
Participation payments | $ 5,139 | |||
Automatic filing machine (in Euro) | € | € 1,377 | |||
Pre-payment for automatic filing machine (in Euro) | € | € 505 | |||
Business Acquisition [Member] | ||||
Commitments and Contingent Liabilities (Details) [Line Items] | ||||
Commitments and Contingent liabilities, description | 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. During the six months ended June 30, 2021 (unaudited) and the year ended December 31, 2020, no royalties have been paid or accrued. | 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. During the six months ended June 30, 2021 (unaudited) and the year ended December 31, 2020, no royalties have been paid or accrued. |
Commitments and Contingent Liabilities (Details) - Schedule of future minimum lease payments under operating leases $ in Thousands |
Jun. 30, 2021
USD ($)
|
---|---|
Schedule of future minimum lease payments under operating leases [Abstract] | |
2021 | $ 635 |
2022 | 1,232 |
2023 | 1,052 |
2024 | 294 |
Thereafter | 705 |
Total | $ 3,918 |
Fair Value Measurements (Details) - Schedule of change in the fair value of the preferred share warrants liability - USD ($) $ in Thousands |
6 Months Ended | |
---|---|---|
Jun. 30, 2021 |
Dec. 31, 2020 |
|
Schedule of change in the fair value of the preferred share warrants liability [Abstract] | ||
Beginning of year | $ 12,241 | |
Change in fair value | 11,373 | |
Reclassification of Warrants into equity | (23,614) | |
End of period |
Warrants (Details) - $ / shares |
1 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 28, 2019 |
Mar. 31, 2008 |
Jun. 30, 2021 |
Dec. 31, 2016 |
|
Warrant [Member] | ||||
Warrants (Details) [Line Items] | ||||
Warrants to purchase, description | in connection with the March 2008 Founders and Share Purchase Agreement, the Company granted to the investor warrants to purchase Convertible Preferred A shares (“Series A Warrants”), with an exercise price of NIS 0.84 ($0.23). The Series A Warrants may be converted at any time until the earlier of: (1) consummation of an initial public offering on certain stock exchanges as set forth in the warrant terms, with net proceeds to the Company of at least $15,000 (and pre-money valuation of at least $75,000), (2) merger or consolidation of the Company with another company, and (3) the sale of substantially all of the Company’s assets or substantially all of the shares to another party. | |||
Series D-2 Convertible Preferred Shares [Member] | Warrant [Member] | ||||
Warrants (Details) [Line Items] | ||||
Shares issued | 2,775,398 | |||
Share price | $ 9.23 | |||
Series E-1 Convertible Preferred Shares [Member] | ||||
Warrants (Details) [Line Items] | ||||
Warrants to purchase, description | As of June 30, 2021, 200,596 Series E-1 warrants were outstanding and as a result of the IPO, the warrant liability to Convertible Preferred shares has been classified to warrants to Ordinary Shares in equity. | |||
Series E-1 Convertible Preferred Shares [Member] | Warrant [Member] | ||||
Warrants (Details) [Line Items] | ||||
Warrants to purchase, description | On June 28, 2019, in connection with a Private Placement Memorandum (the “2019 PPM”), the Company included the following as part of its issuance costs: (i) warrants to purchase up to 200,596 series E-1 Preferred shares (“Series E-1 warrants”) at a price per share of $15.95 against payment of a total exercise amount of up to $3,200 and (ii) a cash fee of 10% of any new investment that were introduced by National Securities. | |||
Preferred shares | 200,596 |
Shareholders’ Deficiency (Details) $ in Thousands |
6 Months Ended |
---|---|
Jun. 30, 2021
USD ($)
shares
| |
Shareholders’ Deficiency (Details) [Line Items] | |
Stock options available for future grants | 932,189 |
Unrecognized compensation costs (in Dollars) | $ | $ 8,286 |
Recognized over weighted average period | 2 years 3 months 18 days |
Options were exercised | 43,866 |
Officers [Member] | 2012 Share Option Plan [Member] | |
Shareholders’ Deficiency (Details) [Line Items] | |
Total options unallocated, granted and exercised to shares | 3,672,094 |
Non-Employees [Member] | |
Shareholders’ Deficiency (Details) [Line Items] | |
Options were exercised | 33,492 |
Shareholders’ Deficiency (Details) - Schedule of ordinary share capital - shares |
Jun. 30, 2021 |
Dec. 31, 2020 |
---|---|---|
Number of shares | ||
Ordinary shares Authorized | 47,800,000 | 47,800,000 |
Ordinary shares Issued | 18,756,570 | 18,494,739 |
Ordinary shares outstanding | 18,756,570 | 18,494,739 |
Shareholders’ Deficiency (Details) - Schedule of outstanding options granted to consultants |
6 Months Ended |
---|---|
Jun. 30, 2021
$ / shares
shares
| |
Shareholders’ Deficiency (Details) - Schedule of outstanding options granted to consultants [Line Items] | |
Options outstanding | 439,201 |
Options exercisable | 287,981 |
October 2013 [Member] | |
Shareholders’ Deficiency (Details) - Schedule of outstanding options granted to consultants [Line Items] | |
Options outstanding | 5,719 |
Exercise price per share (in Dollars per share) | $ / shares | $ 5.07 |
Options exercisable | 5,719 |
Exercisable | October 2023 |
September 2014 [Member] | |
Shareholders’ Deficiency (Details) - Schedule of outstanding options granted to consultants [Line Items] | |
Options outstanding | 5,719 |
Exercise price per share (in Dollars per share) | $ / shares | $ 5.07 |
Options exercisable | 5,719 |
Exercisable | September 2024 |
April 2016 [Member] | |
Shareholders’ Deficiency (Details) - Schedule of outstanding options granted to consultants [Line Items] | |
Options outstanding | 5,975 |
Exercise price per share (in Dollars per share) | $ / shares | $ 3.10 |
Options exercisable | 5,975 |
Exercisable | April 2026 |
December 2016 [Member] | |
Shareholders’ Deficiency (Details) - Schedule of outstanding options granted to consultants [Line Items] | |
Options outstanding | 7,170 |
Exercise price per share (in Dollars per share) | $ / shares | $ 3.93 |
Options exercisable | 7,170 |
Exercisable | December 2026 |
June 2017 [Member] | |
Shareholders’ Deficiency (Details) - Schedule of outstanding options granted to consultants [Line Items] | |
Options outstanding | 197,722 |
Exercise price per share (in Dollars per share) | $ / shares | $ 4.10 |
Options exercisable | 156,970 |
Exercisable | June 2027 |
November 2017 [Member] | |
Shareholders’ Deficiency (Details) - Schedule of outstanding options granted to consultants [Line Items] | |
Options outstanding | 17,925 |
Exercise price per share (in Dollars per share) | $ / shares | $ 7.70 |
Options exercisable | 17,925 |
Exercisable | November 2027 |
August 2019 [Member] | |
Shareholders’ Deficiency (Details) - Schedule of outstanding options granted to consultants [Line Items] | |
Options outstanding | 71,700 |
Exercise price per share (in Dollars per share) | $ / shares | $ 8.18 |
Options exercisable | 67,197 |
Exercisable | August 2029 |
June 2020 [Member] | |
Shareholders’ Deficiency (Details) - Schedule of outstanding options granted to consultants [Line Items] | |
Options outstanding | 64,530 |
Exercise price per share (in Dollars per share) | $ / shares | |
Options exercisable | 21,306 |
Exercisable | June 2030 |
April 2021 [Member] | |
Shareholders’ Deficiency (Details) - Schedule of outstanding options granted to consultants [Line Items] | |
Options outstanding | 62,741 |
Exercise price per share (in Dollars per share) | $ / shares | $ 9.57 |
Options exercisable | |
Exercisable | April 2031 |
Minimum [Member] | June 2020 [Member] | |
Shareholders’ Deficiency (Details) - Schedule of outstanding options granted to consultants [Line Items] | |
Exercise price per share (in Dollars per share) | $ / shares | $ 6.62 |
Maximum [Member] | June 2020 [Member] | |
Shareholders’ Deficiency (Details) - Schedule of outstanding options granted to consultants [Line Items] | |
Exercise price per share (in Dollars per share) | $ / shares | $ 6.80 |
Basic and Diluted Net 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 | ||
---|---|---|---|---|
Jun. 30, 2021 |
Jun. 30, 2020 |
Jun. 30, 2021 |
Jun. 30, 2020 |
|
Numerator: | ||||
Net loss attributable to Ordinary Shares as reported | $ 10,477 | $ 16,993 | $ 19,164 | $ 22,862 |
Deemed dividend | 2,114 | 2,114 | ||
Net loss applicable to Ordinary shareholders | $ 10,477 | $ 19,107 | $ 19,164 | $ 24,976 |
Denominator: | ||||
Weighted average shares used in computing net loss per Ordinary share, basic and diluted: (in Shares) | 18,747,967 | 755,289 | 18,685,906 | 659,551 |
Ordinary share – basic and dilutive (in Dollars per share) | $ 18,747,967 | $ 755,289 | $ 18,685,906 | $ 659,551 |
Net loss per Ordinary share, basic and diluted (in Dollars per share) | $ 0.56 | $ 25.30 | $ 1.03 | $ 37.87 |
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