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 2024 (Report No. 3)

 

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 “Company”): (i) Unaudited Interim Condensed Consolidated Financial Statements as of June 30, 2024, 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, 2024, which is attached hereto as Exhibit 99.2.

 

The contents of this Form 6-K are incorporated by reference into the Company’s registration statements on Form F-3 (File No. 333-276826 and File No. 333-280658) and Form S-8 (File No. 333-239517, File No. 333-271060, File No. 333-277703 and File No. 333-280662) 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and Exchange Commission to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.

 

1

 

 

EXHIBIT INDEX

 

Exhibit No.    
     
99.1   PolyPid Ltd.’s Unaudited Interim Condensed Financial Statements as of June 30, 2024.
99.2   PolyPid Ltd.’s Management’s Discussion and Analysis of Financial Condition and Results of Operation for the Six Months Ended June 30, 2024.
101   The following financial information from the Registrant’s Unaudited Interim Condensed Financial Statements as of June 30, 2024, formatted in XBRL (eXtensible Business Reporting Language): (i) Interim Condensed Consolidated Balance Sheets, (ii) Interim Condensed Consolidated Statements of Operations, (iii) Interim Condensed Consolidated Statements of Shareholders’ Equity (Deficit); (iv) Interim Condensed Consolidated Statements of Cash Flows, and (v) Notes to Interim Condensed Consolidated Financial Statements.
104   Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

2

 

 

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 14, 2024 By: /s/ Dikla Czaczkes Akselbrad
    Name: Dikla Czaczkes Akselbrad
    Title: Chief Executive Officer

 

 

3

 

Exhibit 99.1

 

POLYPID LTD.

AND ITS SUBSIDIARIES

 

INTERIM CONDENSED CONSOLIDATED

FINANCIAL STATEMENTS

 

AS OF JUNE 30, 2024

 

U.S. DOLLARS IN THOUSANDS

 

UNAUDITED

 

INDEX

 

  Page
   
Interim Condensed Consolidated Balance Sheets 1 - 2
   
Interim Condensed Consolidated Statements of Operations 3
   
Interim Condensed Consolidated Statements of Shareholders’ Equity (Deficit) 4 - 6
   
Interim Condensed Consolidated Statements of Cash Flows 7 - 8
   
Notes to Interim Condensed Consolidated Financial Statements 9 - 17

 

- - - - - - - - - - - - - - - - - - - - - - -

 

- i -

 

 

POLYPID LTD. AND ITS SUBSIDIARY

 

INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

 

   June 30,   December 31, 
   2024   2023 
   Unaudited   Audited 
         
ASSETS        
         
CURRENT ASSETS:        
Cash and cash equivalents  $3,076   $5,309 
Restricted deposits   163    300 
Short-term deposits   6,271    - 
Prepaid expenses and other current assets   268    458 
           
Total current assets   9,778    6,067 
           
LONG-TERM ASSETS:          
Property and equipment, net   6,813    7,621 
Operating lease right-of-use assets   2,679    1,597 
Other long-term assets   257    87 
           
Total long-term assets   9,749    9,305 
           
Total assets  $19,527   $15,372 

 

The accompanying notes are an integral part of the interim condensed consolidated financial statements.

 

- 1 -

 

 

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, 
   2024   2023 
   Unaudited   Audited 
         
LIABILITIES AND SHAREHOLDERS’ EQUITY (DEFICIT)        
         
CURRENT LIABILITIES:        
Current maturities of long-term debt  $5,437   $4,003 
Accrued expenses and other current liabilities   2,984    1,971 
Trade payables   992    772 
Current maturities of operating lease liabilities   873    540 
           
Total current liabilities   10,286    7,286 
           
LONG-TERM LIABILITIES:          
Long-term debt   3,127    6,379 
Deferred revenues   2,548    2,548 
Long-term operating lease liabilities   1,594    857 
Other liabilities   371    398 
           
Total long-term liabilities   7,640    10,182 
           
COMMITMENTS AND CONTINGENT LIABILITIES   
 
    
 
 
           
SHAREHOLDERS’ EQUITY (DEFICIT):          
Ordinary shares with no par value - Authorized: 107,800,000 shares at June 30, 2024 (unaudited) and December 31, 2023; Issued and outstanding: 4,797,252 and 1,653,559 shares at June 30, 2024 (unaudited) and December 31, 2023, respectively   -    - 
Additional paid-in capital   252,652    236,213 
Accumulated deficit   (251,051)   (238,309)
           
Total shareholders’ equity (deficit)   1,601    (2,096)
           
Total liabilities and shareholders’ equity   19,527    15,372 

 

The accompanying notes are an integral part of the interim condensed consolidated financial statements.

  

- 2 -

 

 

POLYPID LTD. AND ITS SUBSIDIARY

 

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)

U.S. dollars in thousands (except share and per share data)

 

   Six Months Ended   Three Months Ended 
   June 30,   June 30, 
   2024   2023   2024   2023 
                 
Operating expenses:                  
Research and development, net    $9,810   $7,754   $4,760   $3,960 
Marketing and business development      501    742    265    357 
General and administrative      2,111    3,112    1,096    1,503 
                     
Operating loss     12,422    11,608    6,121    5,820 
Financial expense, net     311    262    171    7 
                     
Loss before income tax     12,733    11,870    6,292    5,827 
Income tax expenses     9    35    2    10 
                     
Net loss    $12,742   $11,905   $6,294   $5,837 
                     
Basic and diluted loss per ordinary share *)  $2.62   $10.85   $1.25   $3.95 
                     
Weighted average number of ordinary shares used in computing basic and diluted loss per share *)     4,858,158    1,097,015    5,024,871    1,479,449 

 

*)Prior period results have been retroactively adjusted to reflect the 1-for-30 reverse share split effected on September 18, 2023 (see Note 1b).

 

The accompanying notes are an integral part of the interim condensed consolidated financial statements.

 

- 3 -

 

 

POLYPID LTD. AND ITS SUBSIDIARY

 

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY (DEFICIT)

U.S. dollars in thousands (except share and per share data)

 

Three Months Ended June 30, 2024  Number of
ordinary shares		   Additional
paid-in capital		   Accumulated
deficit		   Total
shareholders’
equity		 
                 
Balances as of March 31, 2024   4,797,252   $251,902   $(244,757)  $7,145 
                     
Share-based compensation   -    750    -    750 
Net loss   -    -    (6,294)   (6,294)
                     
Balances as of June 30, 2024 (unaudited)   4,797,252   $252,652   $(251,051)  $1,601 

 

Three Months Ended June 30, 2023  Number of
ordinary shares *)		   Additional
paid-in capital		   Accumulated
deficit		   Total
shareholders’
equity		 
                 
Balances as of March 31, 2023   1,297,682   $231,919   $(220,512)  $11,407 
                     
Share-based compensation   -    841    -    841 
Modification of warrants   -    31    -    31 
Reclassification of pre-funded warrants to Equity   -    1,905    -    1,905 
Cashless exercise of pre-funded warrants   345,151    -    -    - 
Net loss   -    -    (5,837)   (5,837)
                     
Balances as of June 30, 2023 (unaudited)   1,642,833   $234,696   $(226,349)  $8,347 

 

*)Prior period results have been retroactively adjusted to reflect the 1-for-30 reverse share split effected on September 18, 2023 (see Note 1b).

 

The accompanying notes are an integral part of the interim condensed consolidated financial statements.

 

- 4 -

 

 

POLYPID LTD. AND ITS SUBSIDIARY

 

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY (DEFICIT)

U.S. dollars in thousands (except share and per share data)

 

Six Months Ended June 30, 2024  Number of
ordinary shares		   Additional
paid-in capital		   Accumulated
deficit		   Total
shareholders’
equity		 
                 
Balances as of January 1, 2024   1,653,559   $236,213   $(238,309)  $(2,096)
                     
Share-based compensation   -    1,440    -    1,440 
Issuance of Ordinary shares, warrants and pre-funded warrants, net (1)   3,143,693    14,999    -    14,999 
Net loss   -    -    (12,742)   (12,742)
                     
Balances as of June 30, 2024 (unaudited)   4,797,252   $252,652   $(251,051)  $1,601 

 

(1)Net of issuance cost of $1,217.

 

Six Months Ended June 30, 2023  Number of
ordinary shares *)		   Additional
paid-in capital		   Accumulated
deficit		   Total
shareholders’
equity		 
                 
Balances as of January 1, 2023   669,605   $220,273   $(214,444)  $5,829 
                     
Share-based compensation   -    1,970    -    1,970 
Issuance of Ordinary shares, net (2)   626,934    8,627    -    8,627 
Issuance of pre-funded warrants, net (3)   -    3,987    -    3,987 
Modification of warrants   -    31    -    31 
Reclassification of pre-funded warrants to Liabilities   -    (2,106)   -    (2,106)
Reclassification of pre-funded warrants to Equity   -    1,905    -    1,905 
Cashless exercise of pre-funded warrants   345,151    -    -    - 
Exercise of options   1,143    9    -    9 
Net loss   -    -    (11,905)   (11,905)
                     
Balances as of June 30, 2023 (unaudited)   1,642,833   $234,696   $(226,349)  $8,347 

 

(2)Net of issuance cost of $734.

(3)Net of issuance cost of $362.

 

*)Prior period results have been retroactively adjusted to reflect the 1-for-30 reverse share split effected on September 18, 2023 (see Note 1b).

 

The accompanying notes are an integral part of the interim condensed consolidated financial statements.

 

- 5 -

 

 

POLYPID LTD. AND ITS SUBSIDIARY

 

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY (DEFICIT)

U.S. dollars in thousands (except share and per share data)

 

Year Ended December 31, 2023   Number of
ordinary shares		     Additional
paid-in capital		     Accumulated
deficit		     Total
shareholders’
equity
(deficit)		  
                         
Balances as of January 1, 2023     669,605     $ 220,273     $ (214,444 )   $ 5,829  
                                 
Share-based compensation     -       3,391       -       3,391  
Issuance of Ordinary shares, net (1)     637,660       8,723       -       8,723  
Issuance of pre-funded warrants, net (2)     -       3,987       -       3,987  
Modification of warrants     -       31       -       31  
Reclassification of pre-funded warrants into liabilities     -       (2,106 )     -       (2,106 )
Reclassification of pre-funded warrants into equity     -       1,905       -       1,905  
Cashless exercise of pre-funded warrants     345,151       -       -       -  
Exercise of options     1,143       9       -       9  
Net loss     -       -       (23,865 )     (23,865 )
                                 
Balances as of December 31, 2023     1,653,559     $ 236,213     $ (238,309 )   $ (2,096 )

 

(1)Net of issuance costs of $757.
(2)Net of issuance costs of $362.

 

The accompanying notes are an integral part of the interim condensed consolidated financial statements.

 

- 6 -

 

 

POLYPID LTD. AND ITS SUBSIDIARY

 

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

U.S. dollars in thousands

 

   Six Months Ended
June 30,		 
   2024   2023 
   Unaudited 
Cash flows from operating activities:        
Net loss  $(12,742)  $(11,905)
Adjustments to reconcile net loss to net cash used in operating activities:          
Depreciation of property and equipment   827    913 
Non-cash financial expenses, net   676    813 
Remeasurement of warrants classified as a liability   -    (201)
Share-based compensation expenses   1,440    1,970 
Changes in assets and liabilities:          
Prepaid expenses and other assets   188    950 
Operating lease right-of-use-assets   400    539 
Operating lease liabilities   (412)   (561)
Trade payables   220    (238)
Accrued expenses and other liabilities   909    (561)
           
Net cash used in operating activities   (8,494)   (8,281)
           
Cash flows from investing activities:          
Investment in bank deposits   (14,691)   (17,600)
Proceeds from bank deposits   8,500    9,932 
Purchase of property and equipment   (19)   (195)
           
Net cash used in investing activities   (6,210)   (7,863)
           
Cash flows from financing activities:          
Proceeds from issuance of Ordinary shares, warrants and pre-funded warrants, net   15,076    12,614 
Payments due to long-term debt   (2,574)   (1,522)
Payment of fees due to modification of debt   -    (125)
Proceeds from exercise of options   -    9 
           
Net cash provided by financing activities   12,502    10,976 
           
Decrease in cash, cash equivalents and restricted deposits   (2,202)   (5,168)
Cash, cash equivalents and restricted deposits at the beginning of the period   5,686    9,142 
           
Cash, cash equivalents and restricted deposits at the end of the period  $3,484   $3,974 

 

The accompanying notes are an integral part of the interim condensed consolidated financial statements.

 

- 7 -

 

 

POLYPID LTD. AND ITS SUBSIDIARY

 

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

U.S. dollars in thousands

 

   Six Months Ended
June 30,		 
   2024   2023 
   Unaudited 
Non-cash activities:        
Modification of warrants  $-   $31 
Credit line derivative  $-   $127 
Issuance costs  $77   $- 
Right-of-use asset recognized with corresponding lease liability  $1,482   $- 
           
Supplemental disclosures of cash flows:          
Interest paid  $471   $492 
           
Supplemental disclosures of cash flow information:          
Cash and cash equivalents  $3,076   $3,396 
Restricted deposits   163    503 
Restricted deposits included in other long-term assets   245    75 
           
Cash, cash equivalents and restricted deposits at the end of the period  $3,484   $3,974 

 

The accompanying notes are an integral part of the interim condensed consolidated financial statements.

 

- 8 -

 

 

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-PLEX100, which incorporates an antibiotic for the prevention of surgical site infections (“SSIs”) in bone and soft tissue. Through June 30, 2024, 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.On September 18, 2023, the Company’s board of directors approved 1-for-30 reverse share split. No fractional shares were issued, and no cash or other consideration was paid as a result of the reverse share split. Instead, the Company issued one additional whole share of the post-reverse share split Ordinary share to any shareholder who otherwise would have received a fractional share as a result of the reverse share split. The amount of authorized Ordinary shares was not affected. All issued and outstanding share and per share amounts included in the accompanying consolidated financial statements have been adjusted to reflect this reverse share split for all periods presented.

 

c.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. That said, in a pre-specified subgroup analysis requested by the United States Food and Drug Administration (“FDA”) of a total of 423 subjects with large incisions (>20 centimeters), the local administration of D-PLEX100 resulted in a significant reduction of 54 percent in the primary endpoint, compared to SoC alone (p=0.0032). The FDA acknowledged that the SHIELD I results may provide supportive evidence on this population and recommended that the Company conduct an additional study to support a potential NDA submission. The FDA stated that the ongoing SHIELD II study could potentially serve as such a study. The Company resumed recruitment into the SHIELD II trial in June 2023.

 

- 9 -

 

 

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.)

 

d.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, 2024, the Company’s cash, cash equivalents and short-term deposits amounted to a total of $9,347. During the six-month period ended June 30, 2024, the Company incurred a loss of $12,742 and had negative cash flows from operating activities of $8,494. In addition, the Company had an accumulated deficit of $251,051 as of June 30, 2024.

 

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, 2023, filed with the Securities and Exchange Commission on March 6, 2024. 

 

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.

 

- 10 -

 

 

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.)

 

a.Basis of presentation and summary of significant accounting policies: (Cont.)

 

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, 2023 (the “2023 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, 2023.

 

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 deposits, short-term deposits, long-term debt, 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.

 

- 11 -

 

 

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.)

 

e.Recently issued accounting pronouncements, not yet adopted:

 

In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, “Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures”, which requires public entities to disclose information about their reportable segments’ significant expenses and other segment items on an interim and annual basis. Public entities with a single reportable segment are required to apply the disclosure requirements in ASU 2023-07, as well as all existing segment disclosures and reconciliation requirements in Accounting Standards Codification (“ASC”) 280 on an interim and annual basis. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2023-07.

 

In December 2023, the FASB issued ASU 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures”, which requires public entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for fiscal years beginning after December 15, 2025, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2023-09.

 

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 2024 and 2027.

 

On January 14, 2024, the Company entered into a new lease agreement for one of its premises, with the lease term extending through July 2027. 

 

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 comprise 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, 2024:

 

Weighted average remaining lease term (years)   2.97 
Weighted average discount rates   10.40%

 

For the six months ended June 30, 2024, the total operating lease cost and cash payments for operating leases were as follows:

 

Operating lease cost  $526 
Cash payments for operating leases  $419 

 

Minimum lease payments over the remaining lease periods as of June 30, 2024, are as follows:

 

The remainder of 2024   $481 
2025   958 
2026   919 
2027   455 
      
Total undiscounted lease payments   2,813 
Less - imputed interest   (346)
      
Present value of lease liabilities  $2,467 

 

- 12 -

 

 

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 2023 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”).

 

On January 9, 2024, the Company repaid $1,494 due to the included claw back mechanism in the Credit Line.

 

During the six-month periods ended on June 30, 2024 and 2023, the Company recognized $756 and $813 of interest expenses related to the Credit Line, respectively, which were included as part of financial expenses in the Company’s statements of operations.

 

NOTE 5:-COMMITMENTS AND CONTINGENT LIABILITIES

 

In connection with its research and development programs, through June 30, 2024, 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 Secured Overnight Financing Rate.

 

For the six-month period ended June 30, 2024, no new participation payments were received.

 

Through June 30, 2024, no royalties have been paid or accrued.

 

NOTE 6:-SHAREHOLDERS’ EQUITY (DEFICIT)

 

a.Ordinary share capital (with no par value) is composed as follows:

 

   June 30, 2024   December 31, 2023 
   Unaudited   Audited 
   Authorized   Issued and
outstanding		   Authorized   Issued and
outstanding		 
   Number of shares 
                     
Ordinary shares   107,800,000    4,797,252    107,800,000    1,653,559 

 

b.Financing rounds:

 

On March 29, 2023, the Company entered into a private placement of unregistered pre-funded warrants to purchase up to 345,238 Ordinary shares (the “PFW”), at a price of $12.60 per PFW with certain of the Company’s existing shareholders. The PFWs have an exercise price of $0.003 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 561,967 Ordinary shares (inclusive of 73,300 Ordinary shares pursuant to the full exercise of an overallotment option granted to the underwriters), at a public offering price of $12.60 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 $665.

 

Following the Public Offering, the Company did not have a sufficient number of authorized Ordinary shares to cover 167,115 PFWs, and as a result, in accordance with ASC 815, these PFWs, which amounted to $2,106, were classified as a liability at fair value.

 

- 13 -

 

 

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 (DEFICIT) (CONT.)

 

b.Financing rounds: (Cont.)

 

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 345,151 Ordinary shares on a cashless basis.

 

On January 4, 2024, the Company entered into a definitive securities purchase agreement for a private placement financing, led by leading U.S. life sciences-focused investors and certain existing investors. Under the securities purchase agreement, the investors purchased 3,143,693 of the Company’s Ordinary shares at a purchase price of $4.81 per share, pre-funded warrants to purchase up to 227,619 Ordinary shares at an exercise price of $0.0001 per share and warrants to purchase up to 3,371,312 Ordinary shares at an exercise price of $5.50 per share. The warrants expire upon the earlier of two years from the date of issuance and 10 trading days following the Company’s announcement of the positive recommendation by Data Safety Monitoring Board regarding the Company’s unblinded interim analysis in its SHIELD II Phase 3 trial of D-PLEX100 resulting in the stopping of the trial due to positive efficacy. The proceeds to the Company amounted to $14,999, net of issuance cost. Exercise of the warrants in full would result in an additional $18,542 in proceeds to the Company. The closing of the offering occurred on January 9, 2024.

 

In accordance with ASC 480 and ASC 815, the pre-funded warrants and the warrants were qualified for equity accounting. The fair value for warrant to purchase an ordinary share is $4.52.

 

The Black-Scholes option pricing model assumptions used to value the warrants at the grant date are presented in the following table:

 

Dividend yield (%)   0 
Expected volatility (%)   117.40-134.00 
Risk-free interest rate (%)   4.36-5.08 
Expected term (in years)   0.68-2.00 

 

c.Share option plan:

 

The Company’s board of directors authorizes option grants through its 2012 Share Option Plan to officers, directors, advisors, management and other key employees. The options granted generally have a four-year vesting period and expire ten years after the date of grant. Options granted under the Company’s option plan that are canceled or forfeited before expiration become available for future grant.

 

On May 6, 2024, the Company’s board of directors approved to increase the Company’s options pool by an additional 2,000,000 options from 312,403 to 2,312,403.

 

As of June 30, 2024, 867,124 of the Company’s options were available for future grants.

 

During the first quarter of 2023, the Company decreased the exercise price of 67,385 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 $23.07 (the “Repricing”). Following the Repricing, the Company accounted for an incremental value in the total amount of $562, of 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.

 

- 14 -

 

 

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 (DEFICIT) (CONT.)

 

c.Share option plan: (Cont.)

 

On May 5, 2023, the Company’s board of directors also approved a similar exercise price decrease of 17,417 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 and non-employees, including Directors, under the Company’s 2012 Share Option Plan as of and for the six-month period ended June 30, 2024, 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   254,436   $22.41   $                 -    8.24 
Granted   1,199,975   $4.64    
 
      
Forfeited and expired   (14,706)  $51.53           
                     
Outstanding at end of period   1,439,705   $7.30   $-    9.52 
                     
Exercisable options   73,501   $38.73   $-    5.30 
                     
Vested and expected to vest   1,439,705   $7.30   $-    9.44 

 

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, 2024:

 

Dividend yield (%)   0 
Expected volatility (%)   97.10-98.39 
Risk-free interest rate (%)   4.43-5.06 
Expected term (in years)   0.5-6.1 

 

The total share-based compensation expense recognized by the Company’s departments:

 

  

Six Months Ended

June 30,

 
   2024   2023 
   Unaudited 
         
Research and development  $849   $1,022 
Marketing and business development   144    191 
General and administrative   447    757 
           
   $1,440   $1,970 

 

As of June 30, 2024, there were unrecognized compensation costs of $6,305, which are expected to be recognized over a weighted average period of approximately 3.07 years.

 

- 15 -

 

 

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 (DEFICIT) (CONT.)

 

c.Share option plan: (Cont.)

 

On May 6, 2024, the Board of directors granted a total of 280,000 milestone-based options to the Company’s officers (collectively, the “Milestone-Based Options”). The milestone condition was set as either the interim analysis outcome of early stopping of the Company’s SHIELD II Phase 3 trial of D-PLEX100 for efficacy or top-line results (primary endpoint) with overall alpha level of up to (and including) 5%.

 

The average exercise price for Milestone-Based Options is $4.64.

 

As of June 30, 2024, the milestone condition is not probable of being achieved; therefore, no compensation costs were recognized.

 

d.Warrants and pre-funded warrants:

 

As of June 30, 2024, all warrants are exercisable into Ordinary shares, in which the outstanding issued warrants as of June 30, 2024, were as follows (unaudited):

 

Grant date   Warrants
outstanding
as of
June 30, 2024		     Average
Exercise
price
per share ($)		     Warrants
exercisable
as of
June 30, 2024		     Exercisable
through
                       
September 2020     597     $ 480.00       597     September 2024
April 2022     5,193     $ 12.60       5,193     April 2029
July 2022     1,298     $ 12.60       1,298     April 2029
January 2024     3,371,312     $ 5.50       3,371,312     January 2026 *)
January 2024     227,619     $ 0.0001       227,619     No maturity date *)
                             
      3,606,019               3,606,019      

 

No Warrants were exercised during the six-month period ended June 30, 2024.

 

*) See note 6b.

 

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,

 
   2024   2023   2024   2023 
   Unaudited 
Numerator:                
Allocation of loss attributable to ordinary shareholders  $12,742   $11,905   $6,294   $5,837 
Denominator:                    
Weighted average Ordinary shares outstanding   4,858,158    1,097,015    5,024,871    1,479,449 
                     
Basic and diluted loss per share  $2.62   $10.85   $1.25   $3.95 

 

- 16 -

 

 

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 7:-BASIC AND DILUTED LOSS PER SHARE (CONT.)

 

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,		 
   2024   2023 
   Unaudited 
         
Ordinary share options   73,501    69,277 
Warrants   3,606,019    13,775 
           
    3,679,520    83,052 

 

NOTE 8:-SUBSEQUENT EVENTS

 

1.On July 2, 2024, the shareholders meeting approved a grant of 198,000 options to the Company’s Chief Executive Officer and 132,600 milestone-based options. The exercise price for both grants was set at $4.64.

 

2.On August 1, 2024, the Company entered into a definitive securities purchase agreement for a private placement financing. Under the securities purchase agreement, the investors have agreed to purchase 2,235,457 of the Company’s Ordinary shares, or pre-funded warrants in lieu thereof, at a purchase price of $3.61 per share and warrants to purchase up to 1,676,588 Ordinary shares at an exercise price of $3.61 per share. The warrants expire upon the earlier of two years from the date of issuance and 10 trading days following the Company’s announcement of the recommendation by Data Safety Monitoring Board regarding the Company’s unblinded interim analysis in its SHIELD II Phase 3 trial of D-PLEX100 resulting in either the stopping of the trial due to positive efficacy, or continuation to planned patient recruitment (up to 630 subjects). The closing of the offering occurred on August 6, 2024. The net proceeds to the Company amounted to approximately $7,500. Exercise of the warrants in full would result in an additional $6,052 in proceeds to the Company.

  

3.Further to the discussed in Note 4, on August 1, 2024, the Company entered into a second amendment (the “Second Amendment”) to the Credit Line. Pursuant to the Second Amendment, 60% of the remaining principal and interest repayments under the Credit Line will be delayed and repaid on a monthly equal basis from April 1, 2025. The amended secured loan now bears interest at a rate of 12.00%, and the Company will pay a restructuring fee to Kreos of $125. 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 agreements or additional financing. The claw back to be paid will not exceed $4,500, out of which $1,500 was already paid.

 

As part of the Second Amendment, the Company issued to Kreos a warrant to purchase 40,000 Ordinary shares of the Company at an exercise price of $3.61 per share. The expiration date of the warrant issued is seven years from the issuance date.

 

-----------------------------

 

 

- 17 -

 

 

10.85 1.25 2.62 3.95 1097015 1479449 4858158 5024871 10.85 1.25 2.62 3.95 false --12-31 Q2 2024-06-30 0001611842 0001611842 2024-01-01 2024-06-30 0001611842 2024-06-30 0001611842 2023-12-31 0001611842 2023-01-01 2023-06-30 0001611842 2024-04-01 2024-06-30 0001611842 2023-04-01 2023-06-30 0001611842 us-gaap:CommonStockMember 2024-03-31 0001611842 us-gaap:AdditionalPaidInCapitalMember 2024-03-31 0001611842 us-gaap:RetainedEarningsMember 2024-03-31 0001611842 2024-03-31 0001611842 us-gaap:AdditionalPaidInCapitalMember 2024-04-01 2024-06-30 0001611842 us-gaap:RetainedEarningsMember 2024-04-01 2024-06-30 0001611842 us-gaap:CommonStockMember 2024-06-30 0001611842 us-gaap:AdditionalPaidInCapitalMember 2024-06-30 0001611842 us-gaap:RetainedEarningsMember 2024-06-30 0001611842 us-gaap:CommonStockMember 2023-03-31 0001611842 us-gaap:AdditionalPaidInCapitalMember 2023-03-31 0001611842 us-gaap:RetainedEarningsMember 2023-03-31 0001611842 2023-03-31 0001611842 us-gaap:AdditionalPaidInCapitalMember 2023-04-01 2023-06-30 0001611842 us-gaap:RetainedEarningsMember 2023-04-01 2023-06-30 0001611842 us-gaap:CommonStockMember 2023-04-01 2023-06-30 0001611842 us-gaap:CommonStockMember 2023-06-30 0001611842 us-gaap:AdditionalPaidInCapitalMember 2023-06-30 0001611842 us-gaap:RetainedEarningsMember 2023-06-30 0001611842 2023-06-30 0001611842 us-gaap:CommonStockMember 2023-12-31 0001611842 us-gaap:AdditionalPaidInCapitalMember 2023-12-31 0001611842 us-gaap:RetainedEarningsMember 2023-12-31 0001611842 us-gaap:AdditionalPaidInCapitalMember 2024-01-01 2024-06-30 0001611842 us-gaap:CommonStockMember 2024-01-01 2024-06-30 0001611842 us-gaap:RetainedEarningsMember 2024-01-01 2024-06-30 0001611842 us-gaap:CommonStockMember 2022-12-31 0001611842 us-gaap:AdditionalPaidInCapitalMember 2022-12-31 0001611842 us-gaap:RetainedEarningsMember 2022-12-31 0001611842 2022-12-31 0001611842 us-gaap:AdditionalPaidInCapitalMember 2023-01-01 2023-06-30 0001611842 us-gaap:CommonStockMember 2023-01-01 2023-06-30 0001611842 us-gaap:RetainedEarningsMember 2023-01-01 2023-06-30 0001611842 us-gaap:AdditionalPaidInCapitalMember 2023-01-01 2023-12-31 0001611842 2023-01-01 2023-12-31 0001611842 us-gaap:CommonStockMember 2023-01-01 2023-12-31 0001611842 us-gaap:RetainedEarningsMember 2023-01-01 2023-12-31 0001611842 us-gaap:LineOfCreditMember 2024-01-09 2024-01-09 0001611842 srt:MaximumMember pypd:PreFundedWarrantsMember 2023-03-29 2023-03-29 0001611842 pypd:PreFundedWarrantsMember 2023-03-29 0001611842 us-gaap:PrivatePlacementMember 2023-03-29 0001611842 pypd:PreFundedWarrantsMember 2023-03-29 2023-03-29 0001611842 2023-03-29 2023-03-29 0001611842 us-gaap:IPOMember 2023-03-31 2023-03-31 0001611842 us-gaap:OverAllotmentOptionMember 2023-03-31 2023-03-31 0001611842 us-gaap:IPOMember 2023-03-31 0001611842 2023-05-05 0001611842 srt:MinimumMember 2023-05-05 0001611842 srt:MaximumMember 2023-05-05 0001611842 2023-05-05 2023-05-05 0001611842 us-gaap:CommonStockMember 2023-05-11 2023-05-11 0001611842 pypd:DefinitiveSecuritiesPurchaseAgreementMember 2024-01-04 2024-01-04 0001611842 pypd:DefinitiveSecuritiesPurchaseAgreementMember 2024-01-04 0001611842 pypd:PreFundedWarrantsMember pypd:DefinitiveSecuritiesPurchaseAgreementMember 2024-01-04 0001611842 pypd:DefinitiveSecuritiesPurchaseAgreementMember 2024-01-04 0001611842 us-gaap:PrivatePlacementMember 2024-01-04 0001611842 2024-01-04 2024-01-04 0001611842 2024-05-06 0001611842 srt:MinimumMember 2024-05-06 0001611842 srt:MaximumMember 2024-05-06 0001611842 us-gaap:StockOptionMember 2024-01-01 2024-06-30 0001611842 pypd:TwoThousandAndTwelveShareOptionPlanMember 2023-01-01 2023-03-31 0001611842 2023-01-01 2023-03-31 0001611842 2024-01-01 2024-03-31 0001611842 srt:BoardOfDirectorsChairmanMember 2022-05-05 2022-05-05 0001611842 srt:BoardOfDirectorsChairmanMember 2024-05-06 2024-05-06 0001611842 2024-05-06 2024-05-06 0001611842 pypd:MilestoneBasedOptionsMember 2024-05-06 2024-05-06 0001611842 us-gaap:WarrantMember 2024-01-01 2024-06-30 0001611842 srt:MinimumMember us-gaap:WarrantMember 2024-01-01 2024-06-30 0001611842 srt:MaximumMember us-gaap:WarrantMember 2024-01-01 2024-06-30 0001611842 us-gaap:EmployeeStockOptionMember 2024-01-01 2024-06-30 0001611842 srt:MinimumMember us-gaap:EmployeeStockOptionMember 2024-01-01 2024-06-30 0001611842 srt:MaximumMember us-gaap:EmployeeStockOptionMember 2024-01-01 2024-06-30 0001611842 2023-12-31 2023-12-31 0001611842 us-gaap:ResearchAndDevelopmentExpenseMember 2024-01-01 2024-06-30 0001611842 us-gaap:ResearchAndDevelopmentExpenseMember 2023-01-01 2023-06-30 0001611842 pypd:MarketingAndBusinessDevelopmentMember 2024-01-01 2024-06-30 0001611842 pypd:MarketingAndBusinessDevelopmentMember 2023-01-01 2023-06-30 0001611842 us-gaap:GeneralAndAdministrativeExpenseMember 2024-01-01 2024-06-30 0001611842 us-gaap:GeneralAndAdministrativeExpenseMember 2023-01-01 2023-06-30 0001611842 pypd:September2020Member 2024-06-30 0001611842 pypd:September2020Member 2024-01-01 2024-06-30 0001611842 pypd:April2022Member 2024-06-30 0001611842 pypd:April2022Member 2024-01-01 2024-06-30 0001611842 pypd:July2022Member 2024-06-30 0001611842 pypd:July2022Member 2024-01-01 2024-06-30 0001611842 pypd:January2024Member 2024-06-30 0001611842 pypd:January2024Member 2024-01-01 2024-06-30 0001611842 pypd:January2024OneMember 2024-06-30 0001611842 pypd:January2024OneMember 2024-01-01 2024-06-30 0001611842 us-gaap:StockOptionMember 2024-01-01 2024-06-30 0001611842 us-gaap:StockOptionMember 2024-04-01 2024-06-30 0001611842 us-gaap:StockOptionMember 2023-01-01 2023-06-30 0001611842 us-gaap:StockOptionMember 2023-04-01 2023-06-30 0001611842 us-gaap:WarrantMember 2024-01-01 2024-06-30 0001611842 us-gaap:WarrantMember 2024-04-01 2024-06-30 0001611842 us-gaap:WarrantMember 2023-01-01 2023-06-30 0001611842 us-gaap:WarrantMember 2023-04-01 2023-06-30 0001611842 srt:ChiefExecutiveOfficerMember us-gaap:SubsequentEventMember 2024-07-02 0001611842 us-gaap:SubsequentEventMember 2024-07-02 0001611842 us-gaap:SubsequentEventMember 2024-07-02 2024-07-02 0001611842 us-gaap:SubsequentEventMember pypd:DefinitiveSecuritiesPurchaseAgreementMember 2024-08-01 2024-08-01 0001611842 pypd:PreFundedWarrantsMember us-gaap:SubsequentEventMember 2024-08-01 0001611842 us-gaap:SubsequentEventMember 2024-08-01 0001611842 us-gaap:SubsequentEventMember 2024-08-01 2024-08-01 0001611842 pypd:KreosCapitalVIMember us-gaap:SubsequentEventMember 2024-08-01 2024-08-01 0001611842 pypd:KreosCapitalVIMember us-gaap:SubsequentEventMember 2024-08-01 0001611842 pypd:KreosCapitalVIMember 2024-08-01 iso4217:USD iso4217:USD xbrli:shares xbrli:shares xbrli:pure

Exhibit 99.2

 

MANAGEMENT’S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

As of June 30, 2024, 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 trials in order to continue development of our product candidates;

 

●the outcomes of our anticipated interim analysis in our 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;

 

●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;

 

●the potential impact of the COVID-19 pandemic on the territories 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;

 

●changes in our strategy; and

 

●litigation.

 

 

 

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, 2023, or our Annual Report, which was filed with the Securities and Exchange Commission, or the SEC, on March 6, 2024, 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.

 

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, 2024, 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 losses for the six months ended June 30, 2023 and 2024 were $11.6 million and $12.4 million, respectively. As of June 30, 2024, we had an accumulated deficit of $251.1 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 patients undergoing abdominal colorectal surgery with large incisions;
     
  ● 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;
     
  ● continue to invest in our manufacturing facility and complete commercial process validation for the facility;
     
  ● establish commercial infrastructure to support the marketing, sale and distribution of D-PLEX100 if it receives regulatory approval;
     
  ● hire field and office-based employees to prepare for and launch any approved product;

 

2

 

  ● hire additional research and development and general and administrative personnel to support our operations;
     
  ● 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.

 

Results of Operations

 

Comparison of the Six months Ended June 30, 2023 and 2024

 

The following table summarizes our results of operations for the six months ended June 30, 2023 and 2024:

 

   Six months Ended
June 30,		 
   2023   2024 
   (in thousands) 
Research and development, net  $7,754   $9,810 
Marketing and business development   742    501 
General and administrative   3,112    2,111 
Operating loss   11,608    12,422 
Financial expense, net   262    311 
Loss before income tax  $11,870   $12,733 
Income tax expense   35    9 
Net loss  $11,905   $12,742 

 

Research and Development, Net

 

Research and development, net increased by $2.1 million for the six months ended June 30, 2024, compared to the six months ended June 30, 2023. This increase was primarily related to an increase of $2.7 million in costs related to the ongoing SHIELD II trial and an increase of $0.1 million in our manufacturing facility expenses. These increases were offset by a decrease of $0.4 million in research and development costs related to D-PLEX100 and OncoPLEX, a decrease of $0.1 million in personnel costs and a decrease of $0.2 million in non-cash share-based compensation.

 

Marketing and business development

 

Marketing and business development decreased by $0.2 million for the six months ended June 30, 2024, compared to the six months ended June 30, 2023. This decrease was primarily related to a decrease of $0.1 million in pre-commercialization activities for the product candidate D-PLEX100, and a decrease of $0.1 million in personnel costs and non-cash share-based compensation.

 

General and Administrative

 

General and administrative decreased by $1.0 million for the six months ended June 30, 2024, compared to the six months ended June 30, 2023. This decrease was primarily related to a decrease of $0.2 million in directors’ and officers’ insurance premiums, a decrease of $0.3 million in personnel costs and a decrease of $0.3 million in non-cash share-based compensation and a decrease of $0.2 million in professional services costs.

 

3

 

Financial Expense, Net

 

Financial expense, net generally remained unchanged for the six months ended June 30, 2024, compared to the six months ended June 30, 2023.

  

Net loss

 

Net loss increased by $0.8 million for the six months ended June 30, 2024, compared to the six months ended June 30, 2023. This increase was primarily related to the increase in research and development, net of $2.1 million, offset by a decrease in general and administrative of $1.0 million and a decrease in marketing and business development costs of $0.2 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 2.4%, respectively, during the six months ended June 30, 2024.

 

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, 2024, 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.

 

4

 

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.

 

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 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 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 third and final tranche of $2.5 million will not be drawn since the third tranche milestone has not been met. 

 

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, 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. 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 and August 1, 2024, we entered into amendments to the Loan Agreement. Pursuant to the most recent amendment, 60% of the remaining principal and interest repayments will be delayed and repaid on a monthly equal basis from April 2025. The amended secured loan now bears interest at a rate of 12.00%, and we will pay a restructuring fee to Kreos of $125,000. 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. The claw back will not exceed $4.5 million. As of June 30, 2024, the Company has paid $1.5 million of the claw back.

 

As part of the recent amendment, we issued to Kreos a warrant to purchase 40,000 ordinary shares of the Company at an exercise price of $3.61 per share. Following the execution of the recent amendment, Kreos holds warrants to purchase a total of 46,491 ordinary shares of the Company, as follows: (i) 6,491 shares at an exercise price of $12.60 per share; and (ii) 40,000 shares at an exercise price of $3.61 per share. The expiration date for each warrant issued is seven years from the respective issuance date.  

 

In March 2023, we completed an offering, or the March 2023 Offering, pursuant to which we sold 488,667 Ordinary Shares at a public offering price of $12.60 per share, for total gross proceeds of $6.2 million. 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” under the F-3. Concurrently with the March 2023 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 345,238 Ordinary Shares for total gross proceeds of $4.4 million. The exercise price per Pre-Funded Warrant is $0.003 per Ordinary Share. Exercise of the Pre-Funded Warrants was subject to an increase in our authorized share capital. We held an annual and extraordinary general meeting of shareholders on May 5, 2023 under which we obtained shareholders’ approval to increase the number of our authorized share capital. On May 11, 2023, all of the Pre-Funded Warrants were exercised into 345,151 Ordinary shares on a cashless basis.

 

On January 4, 2024, we entered into a definitive securities purchase agreement, or the January Securities Purchase Agreement, for a private placement financing. Pursuant to the January Securities Purchase Agreement, on January 9, 2024, certain investors purchased 3,143,693 of our Ordinary Shares at a purchase price of $4.81 per share, pre-funded warrants to purchase up to 227,619 Ordinary Shares at an exercise price of $0.0001 and warrants to purchase up to 3,371,312 Ordinary Shares at an exercise price of $5.50 per share. The pre-funded warrants do not expire and the warrants expire upon the earlier of two years from the date of issuance and 10 trading days following the Company’s announcement of the positive recommendation by Data Safety Monitoring Board regarding the Company’s unblinded interim analysis in the SHIELD II Phase 3 trial of D-PLEX100 resulting in the stopping of the trial due to positive efficacy. The offering resulted in net proceeds of approximately $15.0 million. Exercise of the warrants in full would result in an additional $18.5 million in gross proceeds. We intend to use the net proceeds from the sale of the securities for our ongoing SHIELD II phase 3 clinical trial for the prevention of SSIs in patients undergoing abdominal colorectal surgery with large incisions, working capital and general corporate purposes.

 

5

 

On August 1, 2024, we entered into a definitive securities purchase agreement, or the August Securities Purchase Agreement, for a private placement financing, or the August 2024 Private Placement. Pursuant to the August Securities Purchase Agreement, on August 6, 2024, certain investors purchased 2,006,226 of our Ordinary Shares at a purchase price of $3.61 per share, pre-funded warrants to purchase up to 229,231 Ordinary Shares at an exercise price of $0.0001 and warrants to purchase up to 1,676,588 Ordinary Shares at an exercise price of $3.61 per share. The pre-funded warrants do not expire and the warrants expire upon the earlier of two years from the date of issuance and 10 trading days following our announcement of the recommendation by Data Safety Monitoring Board regarding our unblinded interim analysis in its SHIELD II Phase 3 trial of D-PLEX100 resulting in either the stopping of the trial due to positive efficacy, or continuation to planned patient recruitment (up to 630 subjects). The offering resulted in net proceeds of approximately $7.5 million. Exercise of the warrants in full would result in an additional $6.1 million in gross proceeds. We intend to use the net proceeds from the sale of the securities for our ongoing SHIELD II phase 3 clinical trial for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery, working capital and general corporate purposes.

 

As of June 30, 2024, we had $9.3 million in cash and 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,		 
   2023   2024 
   (in thousands) 
Net cash used in operating activities  $(8,281)  $(8,494)
Net cash provided by (used in) investing activities   (7,863)   (6,210)
Net cash provided by financing activities   10,976    12,502 
Net increase (decrease) in cash, cash equivalents and restricted cash  $(5,168)  $(2,202)

 

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 $8.5 million for the six months ended June 30, 2024, as compared to $8.3 million for the six months ended June 30, 2023. This increase was primarily related to the ongoing SHIELD II Phase 3 clinical trials in abdominal colorectal surgery with large incisions.

 

Investing Activities

 

Net cash used in investing activities related primarily to the purchase and release of short-term deposits and the acquisition of laboratory equipment, office equipment and furniture and leasehold improvements.

 

Net cash used in investing activities was $6.2 million for the six months ended June 30, 2024, as compared to net cash used in investing activities of $7.9 million for the six months ended June 30, 2023. This change in net cash used in investing activities primarily related to change in short-term deposits, net. 

 

6

 

Financing Activities

 

Net cash provided by financing activities was $12.5 million for the six months ended June 30, 2024, as compared to $11.0 million for the six months ended June 30, 2023. The increase in net cash provided by financing activities is primarily related to the net proceeds from the January 2024 Private Placement offset by the repayments of the loan provided by Kreos.

  

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 first quarter of 2025. 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 had a shareholders’ equity of $1.6 million as of June 30, 2024, and negative operating cash flows in recent years. As of August 11, 2024, however, our shareholders’ equity is approximately $7 million following the completion of the August 2024 Private Placement. 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;
     
  ● the costs, timing and outcome of regulatory review of D-PLEX100 and any future product candidates;
     
  ● 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;

 

7

 

  ● the number and development requirements of any future product candidates that we may pursue;
     
  ● 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;
     
  ● 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;
     
  ● our ability to establish and maintain collaborations with biopharmaceutical companies on favorable terms, if at all;
     
  ● the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; and
     
  ● 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, 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.

 

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.

 

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, 2024, we incurred $161.4 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.”

 

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

 

 

v3.24.2.u1
Document And Entity Information
 6 Months Ended
Jun. 30, 2024
Document Information Line Items  
Entity Registrant Name PolyPid Ltd.
Document Type 6-K
Current Fiscal Year End Date --12-31
Amendment Flag false
Entity Central Index Key 0001611842
Document Period End Date Jun. 30, 2024
Document Fiscal Year Focus 2024
Document Fiscal Period Focus Q2
Entity File Number 001-38428
v3.24.2.u1
Interim Condensed Consolidated Balance Sheets - USD ($)
$ in Thousands
Jun. 30, 2024
Dec. 31, 2023
CURRENT ASSETS:    
Cash and cash equivalents $ 3,076 $ 5,309
Restricted deposits 163 300
Short-term deposits 6,271
Prepaid expenses and other current assets 268 458
Total current assets 9,778 6,067
LONG-TERM ASSETS:    
Property and equipment, net 6,813 7,621
Operating lease right-of-use assets 2,679 1,597
Other long-term assets 257 87
Total long-term assets 9,749 9,305
Total assets 19,527 15,372
CURRENT LIABILITIES:    
Current maturities of long-term debt 5,437 4,003
Accrued expenses and other current liabilities 2,984 1,971
Trade payables 992 772
Current maturities of operating lease liabilities 873 540
Total current liabilities 10,286 7,286
LONG-TERM LIABILITIES:    
Long-term debt 3,127 6,379
Deferred revenues 2,548 2,548
Long-term operating lease liabilities 1,594 857
Other liabilities 371 398
Total long-term liabilities 7,640 10,182
COMMITMENTS AND CONTINGENT LIABILITIES
SHAREHOLDERS’ EQUITY (DEFICIT):    
Ordinary shares with no par value - Authorized: 107,800,000 shares at June 30, 2024 (unaudited) and December 31, 2023; Issued and outstanding: 4,797,252 and 1,653,559 shares at June 30, 2024 (unaudited) and December 31, 2023, respectively
Additional paid-in capital 252,652 236,213
Accumulated deficit (251,051) (238,309)
Total shareholders’ equity (deficit) 1,601 (2,096)
Total liabilities and shareholders’ equity $ 19,527 $ 15,372
v3.24.2.u1
Interim Condensed Consolidated Balance Sheets (Parentheticals) - $ / shares
Jun. 30, 2024
Dec. 31, 2023
Statement of Financial Position [Abstract]    
Ordinary shares, par value (in Dollars per share)
Ordinary shares, shares authorized 107,800,000 107,800,000
Ordinary shares, shares issued 4,797,252 1,653,559
Ordinary shares, shares outstanding 4,797,252 1,653,559
v3.24.2.u1
Interim Condensed Consolidated Statements of Operations (Unaudited) - USD ($)
$ in Thousands
 3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Operating expenses:        
Research and development, net $ 4,760 $ 3,960 $ 9,810 $ 7,754
Marketing and business development 265 357 501 742
General and administrative 1,096 1,503 2,111 3,112
Operating loss 6,121 5,820 12,422 11,608
Financial expense, net 171 7 311 262
Loss before income tax 6,292 5,827 12,733 11,870
Income tax expenses 2 10 9 35
Net loss $ 6,294 $ 5,837 $ 12,742 $ 11,905
Basic loss per ordinary share (in Dollars per share) $ 1.25 $ 3.95 $ 2.62 $ 10.85
Weighted average number of ordinary shares used in computing basic loss per share (in Shares) 5,024,871 1,479,449 4,858,158 1,097,015
v3.24.2.u1
Interim Condensed Consolidated Statements of Operations (Unaudited) (Parentheticals) - $ / shares
 3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Income Statement [Abstract]        
Diluted loss per ordinary share $ 1.25 $ 3.95 $ 2.62 $ 10.85
Weighted average number of ordinary shares used in computing diluted loss per share (in Shares) 5,024,871 1,479,449 4,858,158 1,097,015
v3.24.2.u1
Interim Condensed Consolidated Statements of Shareholders’ Equity (Deficit) - USD ($)
$ in Thousands
Number of ordinary shares
Additional paid-in capital
Accumulated deficit
Total
Balance at Dec. 31, 2022   $ 220,273 $ (214,444) $ 5,829
Balance (in Shares) at Dec. 31, 2022 [1] 669,605      
Balance at Mar. 31, 2023   231,919 (220,512) 11,407
Balance (in Shares) at Mar. 31, 2023 [1] 1,297,682      
Balance at Dec. 31, 2022   220,273 (214,444) 5,829
Balance (in Shares) at Dec. 31, 2022 [1] 669,605      
Share-based compensation   1,970   1,970
Issuance of Ordinary shares, net [2]   8,627 8,627
Issuance of Ordinary shares, net (in Shares) [1],[2] 626,934      
Issuance of pre-funded warrants, net [3]   3,987 3,987
Issuance of pre-funded warrants, net (in Shares)      
Modification of warrants   31   31
Reclassification of pre-funded warrants to Liabilities   (2,106) (2,106)
Reclassification of pre-funded warrants into equity   1,905 1,905
Cashless exercise of pre-funded warrants (in Shares) [1] 345,151      
Exercise of options   9 9
Exercise of options (in Shares) [1] 1,143      
Net loss   (11,905) (11,905)
Balance at Jun. 30, 2023   234,696 (226,349) 8,347
Balance (in Shares) at Jun. 30, 2023 [1] 1,642,833      
Balance at Dec. 31, 2022   220,273 (214,444) 5,829
Balance (in Shares) at Dec. 31, 2022 [1] 669,605      
Share-based compensation   3,391   3,391
Issuance of Ordinary shares, net [4]   8,723 8,723
Issuance of Ordinary shares, net (in Shares) [4] 637,660      
Issuance of pre-funded warrants, net [5]   3,987 3,987
Issuance of pre-funded warrants, net (in Shares)      
Modification of warrants   31   31
Reclassification of pre-funded warrants to Liabilities   (2,106) (2,106)
Reclassification of pre-funded warrants into equity   1,905 1,905
Cashless exercise of pre-funded warrants (in Shares) 345,151      
Exercise of options   9 9
Exercise of options (in Shares) 1,143      
Net loss   (23,865) (23,865)
Balance at Dec. 31, 2023   236,213 (238,309) $ (2,096)
Balance (in Shares) at Dec. 31, 2023 1,653,559     1,653,559
Balance at Mar. 31, 2023   231,919 (220,512) $ 11,407
Balance (in Shares) at Mar. 31, 2023 [1] 1,297,682      
Share-based compensation   841   841
Modification of warrants   31   31
Reclassification of pre-funded warrants into equity   1,905 1,905
Cashless exercise of pre-funded warrants (in Shares) [1] 345,151      
Net loss   (5,837) (5,837)
Balance at Jun. 30, 2023   234,696 (226,349) 8,347
Balance (in Shares) at Jun. 30, 2023 [1] 1,642,833      
Balance at Dec. 31, 2023   236,213 (238,309) $ (2,096)
Balance (in Shares) at Dec. 31, 2023 1,653,559     1,653,559
Share-based compensation   1,440   $ 1,440
Issuance of Ordinary shares, warrants and pre-funded warrants, net [6]   14,999 14,999
Issuance of Ordinary shares, warrants and pre-funded warrants, net (in Shares) [6] 3,143,693      
Net loss   (12,742) (12,742)
Balance at Jun. 30, 2024   252,652 (251,051) $ 1,601
Balance (in Shares) at Jun. 30, 2024 4,797,252     4,797,252
Balance at Mar. 31, 2024   251,902 (244,757) $ 7,145
Balance (in Shares) at Mar. 31, 2024 4,797,252      
Share-based compensation   750   750
Net loss   (6,294) (6,294)
Balance at Jun. 30, 2024   $ 252,652 $ (251,051) $ 1,601
Balance (in Shares) at Jun. 30, 2024 4,797,252     4,797,252
[1] Prior period results have been retroactively adjusted to reflect the 1-for-30 reverse share split effected on September 18, 2023 (see Note 1b).
[2] Net of issuance cost of $734.
[3] Net of issuance cost of $362.
[4] Net of issuance costs of $757.
[5] Net of issuance costs of $362.
[6] Net of issuance cost of $1,217.
v3.24.2.u1
Interim Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
$ in Thousands
 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Cash flows from operating activities:    
Net loss $ (12,742) $ (11,905)
Adjustments to reconcile net loss to net cash used in operating activities:    
Depreciation of property and equipment 827 913
Non-cash financial expenses, net 676 813
Remeasurement of warrants classified as a liability (201)
Share-based compensation expenses 1,440 1,970
Changes in assets and liabilities:    
Prepaid expenses and other assets 188 950
Operating lease right-of-use-assets 400 539
Operating lease liabilities (412) (561)
Trade payables 220 (238)
Accrued expenses and other liabilities 909 (561)
Net cash used in operating activities (8,494) (8,281)
Cash flows from investing activities:    
Investment in bank deposits (14,691) (17,600)
Proceeds from bank deposits 8,500 9,932
Purchase of property and equipment (19) (195)
Net cash used in investing activities (6,210) (7,863)
Cash flows from financing activities:    
Proceeds from issuance of Ordinary shares, warrants and pre-funded warrants, net 15,076 12,614
Payments due to long-term debt (2,574) (1,522)
Payment of fees due to modification of debt (125)
Proceeds from exercise of options 9
Net cash provided by financing activities 12,502 10,976
Decrease in cash, cash equivalents and restricted deposits (2,202) (5,168)
Cash, cash equivalents and restricted deposits at the beginning of the period 5,686 9,142
Cash, cash equivalents and restricted deposits at the end of the period 3,484 3,974
Non-cash activities:    
Modification of warrants 31
Credit line derivative 127
Issuance costs 77
Right-of-use asset recognized with corresponding lease liability 1,482
Supplemental disclosures of cash flows:    
Interest paid 471 492
Supplemental disclosures of cash flow information:    
Cash and cash equivalents 3,076 3,396
Restricted deposits 163 503
Restricted deposits included in other long-term assets 245 75
Cash, cash equivalents and restricted deposits at the end of the period $ 3,484 $ 3,974
v3.24.2.u1
General
 6 Months Ended
Jun. 30, 2024
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-PLEX100, which incorporates an antibiotic for the prevention of surgical site infections (“SSIs”) in bone and soft tissue. Through June 30, 2024, 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.On September 18, 2023, the Company’s board of directors approved 1-for-30 reverse share split. No fractional shares were issued, and no cash or other consideration was paid as a result of the reverse share split. Instead, the Company issued one additional whole share of the post-reverse share split Ordinary share to any shareholder who otherwise would have received a fractional share as a result of the reverse share split. The amount of authorized Ordinary shares was not affected. All issued and outstanding share and per share amounts included in the accompanying consolidated financial statements have been adjusted to reflect this reverse share split for all periods presented.

 

c.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. That said, in a pre-specified subgroup analysis requested by the United States Food and Drug Administration (“FDA”) of a total of 423 subjects with large incisions (>20 centimeters), the local administration of D-PLEX100 resulted in a significant reduction of 54 percent in the primary endpoint, compared to SoC alone (p=0.0032). The FDA acknowledged that the SHIELD I results may provide supportive evidence on this population and recommended that the Company conduct an additional study to support a potential NDA submission. The FDA stated that the ongoing SHIELD II study could potentially serve as such a study. The Company resumed recruitment into the SHIELD II trial in June 2023.

 

d.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, 2024, the Company’s cash, cash equivalents and short-term deposits amounted to a total of $9,347. During the six-month period ended June 30, 2024, the Company incurred a loss of $12,742 and had negative cash flows from operating activities of $8,494. In addition, the Company had an accumulated deficit of $251,051 as of June 30, 2024.

 

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.
v3.24.2.u1
Significant Accounting Policies
 6 Months Ended
Jun. 30, 2024
Significant 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, 2023, filed with the Securities and Exchange Commission on March 6, 2024. 

 

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, 2023 (the “2023 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, 2023.

 

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 deposits, short-term deposits, long-term debt, 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.

 

e.Recently issued accounting pronouncements, not yet adopted:

 

In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, “Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures”, which requires public entities to disclose information about their reportable segments’ significant expenses and other segment items on an interim and annual basis. Public entities with a single reportable segment are required to apply the disclosure requirements in ASU 2023-07, as well as all existing segment disclosures and reconciliation requirements in Accounting Standards Codification (“ASC”) 280 on an interim and annual basis. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2023-07.

 

In December 2023, the FASB issued ASU 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures”, which requires public entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for fiscal years beginning after December 15, 2025, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2023-09.
v3.24.2.u1
Leases
 6 Months Ended
Jun. 30, 2024
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 2024 and 2027.

 

On January 14, 2024, the Company entered into a new lease agreement for one of its premises, with the lease term extending through July 2027. 

 

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 comprise 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, 2024:

 

Weighted average remaining lease term (years)   2.97 
Weighted average discount rates   10.40%

 

For the six months ended June 30, 2024, the total operating lease cost and cash payments for operating leases were as follows:

 

Operating lease cost  $526 
Cash payments for operating leases  $419 

 

Minimum lease payments over the remaining lease periods as of June 30, 2024, are as follows:

 

The remainder of 2024   $481 
2025   958 
2026   919 
2027   455 
      
Total undiscounted lease payments   2,813 
Less - imputed interest   (346)
      
Present value of lease liabilities  $2,467 
v3.24.2.u1
Line of Credit Arrangement
 6 Months Ended
Jun. 30, 2024
Line of Credit Arrangement [Abstract]  
LINE OF CREDIT ARRANGEMENT
NOTE 4:-LINE OF CREDIT ARRANGEMENT

 

Further to the discussion in Note 7 in the 2023 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”).

 

On January 9, 2024, the Company repaid $1,494 due to the included claw back mechanism in the Credit Line.

 

During the six-month periods ended on June 30, 2024 and 2023, the Company recognized $756 and $813 of interest expenses related to the Credit Line, respectively, which were included as part of financial expenses in the Company’s statements of operations.
v3.24.2.u1
Commitments and Contingent Liabilities
 6 Months Ended
Jun. 30, 2024
Commitments and Contingent Liabilities [Abstract]  
COMMITMENTS AND CONTINGENT LIABILITIES
NOTE 5:-COMMITMENTS AND CONTINGENT LIABILITIES

 

In connection with its research and development programs, through June 30, 2024, 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 Secured Overnight Financing Rate.

 

For the six-month period ended June 30, 2024, no new participation payments were received.

 

Through June 30, 2024, no royalties have been paid or accrued.
v3.24.2.u1
Shareholders’ Equity (Deficit)
 6 Months Ended
Jun. 30, 2024
Shareholders’ Equity (Deficit) [Abstract]  
SHAREHOLDERS’ EQUITY (DEFICIT)
NOTE 6:-SHAREHOLDERS’ EQUITY (DEFICIT)

 

a.Ordinary share capital (with no par value) is composed as follows:

 

   June 30, 2024   December 31, 2023 
   Unaudited   Audited 
   Authorized   Issued and
outstanding		   Authorized   Issued and
outstanding		 
   Number of shares 
                     
Ordinary shares   107,800,000    4,797,252    107,800,000    1,653,559 

 

b.Financing rounds:

 

On March 29, 2023, the Company entered into a private placement of unregistered pre-funded warrants to purchase up to 345,238 Ordinary shares (the “PFW”), at a price of $12.60 per PFW with certain of the Company’s existing shareholders. The PFWs have an exercise price of $0.003 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 561,967 Ordinary shares (inclusive of 73,300 Ordinary shares pursuant to the full exercise of an overallotment option granted to the underwriters), at a public offering price of $12.60 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 $665.

 

Following the Public Offering, the Company did not have a sufficient number of authorized Ordinary shares to cover 167,115 PFWs, and as a result, in accordance with ASC 815, 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 345,151 Ordinary shares on a cashless basis.

 

On January 4, 2024, the Company entered into a definitive securities purchase agreement for a private placement financing, led by leading U.S. life sciences-focused investors and certain existing investors. Under the securities purchase agreement, the investors purchased 3,143,693 of the Company’s Ordinary shares at a purchase price of $4.81 per share, pre-funded warrants to purchase up to 227,619 Ordinary shares at an exercise price of $0.0001 per share and warrants to purchase up to 3,371,312 Ordinary shares at an exercise price of $5.50 per share. The warrants expire upon the earlier of two years from the date of issuance and 10 trading days following the Company’s announcement of the positive recommendation by Data Safety Monitoring Board regarding the Company’s unblinded interim analysis in its SHIELD II Phase 3 trial of D-PLEX100 resulting in the stopping of the trial due to positive efficacy. The proceeds to the Company amounted to $14,999, net of issuance cost. Exercise of the warrants in full would result in an additional $18,542 in proceeds to the Company. The closing of the offering occurred on January 9, 2024.

 

In accordance with ASC 480 and ASC 815, the pre-funded warrants and the warrants were qualified for equity accounting. The fair value for warrant to purchase an ordinary share is $4.52.

 

The Black-Scholes option pricing model assumptions used to value the warrants at the grant date are presented in the following table:

 

Dividend yield (%)   0 
Expected volatility (%)   117.40-134.00 
Risk-free interest rate (%)   4.36-5.08 
Expected term (in years)   0.68-2.00 

 

c.Share option plan:

 

The Company’s board of directors authorizes option grants through its 2012 Share Option Plan to officers, directors, advisors, management and other key employees. The options granted generally have a four-year vesting period and expire ten years after the date of grant. Options granted under the Company’s option plan that are canceled or forfeited before expiration become available for future grant.

 

On May 6, 2024, the Company’s board of directors approved to increase the Company’s options pool by an additional 2,000,000 options from 312,403 to 2,312,403.

 

As of June 30, 2024, 867,124 of the Company’s options were available for future grants.

 

During the first quarter of 2023, the Company decreased the exercise price of 67,385 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 $23.07 (the “Repricing”). Following the Repricing, the Company accounted for an incremental value in the total amount of $562, of 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 17,417 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 and non-employees, including Directors, under the Company’s 2012 Share Option Plan as of and for the six-month period ended June 30, 2024, 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   254,436   $22.41   $                 -    8.24 
Granted   1,199,975   $4.64    
 
      
Forfeited and expired   (14,706)  $51.53           
                     
Outstanding at end of period   1,439,705   $7.30   $-    9.52 
                     
Exercisable options   73,501   $38.73   $-    5.30 
                     
Vested and expected to vest   1,439,705   $7.30   $-    9.44 

 

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, 2024:

 

Dividend yield (%)   0 
Expected volatility (%)   97.10-98.39 
Risk-free interest rate (%)   4.43-5.06 
Expected term (in years)   0.5-6.1 

 

The total share-based compensation expense recognized by the Company’s departments:

 

  

Six Months Ended

June 30,

 
   2024   2023 
   Unaudited 
         
Research and development  $849   $1,022 
Marketing and business development   144    191 
General and administrative   447    757 
           
   $1,440   $1,970 

 

As of June 30, 2024, there were unrecognized compensation costs of $6,305, which are expected to be recognized over a weighted average period of approximately 3.07 years.

 

On May 6, 2024, the Board of directors granted a total of 280,000 milestone-based options to the Company’s officers (collectively, the “Milestone-Based Options”). The milestone condition was set as either the interim analysis outcome of early stopping of the Company’s SHIELD II Phase 3 trial of D-PLEX100 for efficacy or top-line results (primary endpoint) with overall alpha level of up to (and including) 5%.

 

The average exercise price for Milestone-Based Options is $4.64.

 

As of June 30, 2024, the milestone condition is not probable of being achieved; therefore, no compensation costs were recognized.

 

d.Warrants and pre-funded warrants:

 

As of June 30, 2024, all warrants are exercisable into Ordinary shares, in which the outstanding issued warrants as of June 30, 2024, were as follows (unaudited):

 

Grant date   Warrants
outstanding
as of
June 30, 2024		     Average
Exercise
price
per share ($)		     Warrants
exercisable
as of
June 30, 2024		     Exercisable
through
                       
September 2020     597     $ 480.00       597     September 2024
April 2022     5,193     $ 12.60       5,193     April 2029
July 2022     1,298     $ 12.60       1,298     April 2029
January 2024     3,371,312     $ 5.50       3,371,312     January 2026 *)
January 2024     227,619     $ 0.0001       227,619     No maturity date *)
                             
      3,606,019               3,606,019      

 

No Warrants were exercised during the six-month period ended June 30, 2024.

 

*) See note 6b.
v3.24.2.u1
Basic and Diluted Loss Per Share
 6 Months Ended
Jun. 30, 2024
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,

 
   2024   2023   2024   2023 
   Unaudited 
Numerator:                
Allocation of loss attributable to ordinary shareholders  $12,742   $11,905   $6,294   $5,837 
Denominator:                    
Weighted average Ordinary shares outstanding   4,858,158    1,097,015    5,024,871    1,479,449 
                     
Basic and diluted loss per share  $2.62   $10.85   $1.25   $3.95 

 

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,		 
   2024   2023 
   Unaudited 
         
Ordinary share options   73,501    69,277 
Warrants   3,606,019    13,775 
           
    3,679,520    83,052 
v3.24.2.u1
Subsequent Events
 6 Months Ended
Jun. 30, 2024
Subsequent Events [Abstract]  
SUBSEQUENT EVENTS
NOTE 8:-SUBSEQUENT EVENTS

 

1.On July 2, 2024, the shareholders meeting approved a grant of 198,000 options to the Company’s Chief Executive Officer and 132,600 milestone-based options. The exercise price for both grants was set at $4.64.

 

2.On August 1, 2024, the Company entered into a definitive securities purchase agreement for a private placement financing. Under the securities purchase agreement, the investors have agreed to purchase 2,235,457 of the Company’s Ordinary shares, or pre-funded warrants in lieu thereof, at a purchase price of $3.61 per share and warrants to purchase up to 1,676,588 Ordinary shares at an exercise price of $3.61 per share. The warrants expire upon the earlier of two years from the date of issuance and 10 trading days following the Company’s announcement of the recommendation by Data Safety Monitoring Board regarding the Company’s unblinded interim analysis in its SHIELD II Phase 3 trial of D-PLEX100 resulting in either the stopping of the trial due to positive efficacy, or continuation to planned patient recruitment (up to 630 subjects). The closing of the offering occurred on August 6, 2024. The net proceeds to the Company amounted to approximately $7,500. Exercise of the warrants in full would result in an additional $6,052 in proceeds to the Company.

  

3.Further to the discussed in Note 4, on August 1, 2024, the Company entered into a second amendment (the “Second Amendment”) to the Credit Line. Pursuant to the Second Amendment, 60% of the remaining principal and interest repayments under the Credit Line will be delayed and repaid on a monthly equal basis from April 1, 2025. The amended secured loan now bears interest at a rate of 12.00%, and the Company will pay a restructuring fee to Kreos of $125. 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 agreements or additional financing. The claw back to be paid will not exceed $4,500, out of which $1,500 was already paid.

 

As part of the Second Amendment, the Company issued to Kreos a warrant to purchase 40,000 Ordinary shares of the Company at an exercise price of $3.61 per share. The expiration date of the warrant issued is seven years from the issuance date.
v3.24.2.u1
Accounting Policies, by Policy (Policies)
 6 Months Ended
Jun. 30, 2024
Significant 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, 2023, filed with the Securities and Exchange Commission on March 6, 2024. 

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, 2023 (the “2023 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, 2023.
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 deposits, short-term deposits, long-term debt, 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.

 
Recently issued accounting pronouncements, not yet adopted
e.Recently issued accounting pronouncements, not yet adopted:

In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, “Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures”, which requires public entities to disclose information about their reportable segments’ significant expenses and other segment items on an interim and annual basis. Public entities with a single reportable segment are required to apply the disclosure requirements in ASU 2023-07, as well as all existing segment disclosures and reconciliation requirements in Accounting Standards Codification (“ASC”) 280 on an interim and annual basis. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2023-07.

In December 2023, the FASB issued ASU 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures”, which requires public entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for fiscal years beginning after December 15, 2025, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2023-09.
v3.24.2.u1
Leases (Tables)
 6 Months Ended
Jun. 30, 2024
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, 2024:
Weighted average remaining lease term (years)   2.97 
Weighted average discount rates   10.40%
Schedule of Total Operating Lease Cost For the six months ended June 30, 2024, the total operating lease cost and cash payments for operating leases were as follows:
Operating lease cost  $526 
Cash payments for operating leases  $419 
Schedule of Minimum Lease Payments Minimum lease payments over the remaining lease periods as of June 30, 2024, are as follows:
The remainder of 2024   $481 
2025   958 
2026   919 
2027   455 
      
Total undiscounted lease payments   2,813 
Less - imputed interest   (346)
      
Present value of lease liabilities  $2,467 
v3.24.2.u1
Shareholders’ Equity (Deficit) (Tables)
 6 Months Ended
Jun. 30, 2024
Shareholders’ Equity (Deficit) [Abstract]  
Schedule of Ordinary Share Capital Ordinary share capital (with no par value) is composed as follows:
   June 30, 2024   December 31, 2023 
   Unaudited   Audited 
   Authorized   Issued and
outstanding		   Authorized   Issued and
outstanding		 
   Number of shares 
                     
Ordinary shares   107,800,000    4,797,252    107,800,000    1,653,559 
Schedule of Black-Scholes Option Pricing Model Assumptions Used to Value The Black-Scholes option pricing model assumptions used to value the warrants at the grant date are presented in the following table:
Dividend yield (%)   0 
Expected volatility (%)   117.40-134.00 
Risk-free interest rate (%)   4.36-5.08 
Expected term (in years)   0.68-2.00 
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, 2024:
Dividend yield (%)   0 
Expected volatility (%)   97.10-98.39 
Risk-free interest rate (%)   4.43-5.06 
Expected term (in years)   0.5-6.1 
Schedule of Options to Employees Under the Company’s Option Plan A summary of the status of options to employees and non-employees, including Directors, under the Company’s 2012 Share Option Plan as of and for the six-month period ended June 30, 2024, 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   254,436   $22.41   $                 -    8.24 
Granted   1,199,975   $4.64    
 
      
Forfeited and expired   (14,706)  $51.53           
                     
Outstanding at end of period   1,439,705   $7.30   $-    9.52 
                     
Exercisable options   73,501   $38.73   $-    5.30 
                     
Vested and expected to vest   1,439,705   $7.30   $-    9.44 
Schedule of Share-Based Compensation Expense The total share-based compensation expense recognized by the Company’s departments:
  

Six Months Ended

June 30,

 
   2024   2023 
   Unaudited 
         
Research and development  $849   $1,022 
Marketing and business development   144    191 
General and administrative   447    757 
           
   $1,440   $1,970 
Schedule of Warrants Exercisable Into Ordinary Shares As of June 30, 2024, all warrants are exercisable into Ordinary shares, in which the outstanding issued warrants as of June 30, 2024, were as follows (unaudited):
Grant date   Warrants
outstanding
as of
June 30, 2024		     Average
Exercise
price
per share ($)		     Warrants
exercisable
as of
June 30, 2024		     Exercisable
through
                       
September 2020     597     $ 480.00       597     September 2024
April 2022     5,193     $ 12.60       5,193     April 2029
July 2022     1,298     $ 12.60       1,298     April 2029
January 2024     3,371,312     $ 5.50       3,371,312     January 2026 *)
January 2024     227,619     $ 0.0001       227,619     No maturity date *)
                             
      3,606,019               3,606,019      

*) See note 6b.
v3.24.2.u1
Basic and Diluted Loss Per Share (Tables)
 6 Months Ended
Jun. 30, 2024
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,

 
   2024   2023   2024   2023 
   Unaudited 
Numerator:                
Allocation of loss attributable to ordinary shareholders  $12,742   $11,905   $6,294   $5,837 
Denominator:                    
Weighted average Ordinary shares outstanding   4,858,158    1,097,015    5,024,871    1,479,449 
                     
Basic and diluted loss per share  $2.62   $10.85   $1.25   $3.95 

 
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,		 
   2024   2023 
   Unaudited 
         
Ordinary share options   73,501    69,277 
Warrants   3,606,019    13,775 
           
    3,679,520    83,052 
v3.24.2.u1
General (Details) - USD ($)
$ in Thousands
 3 Months Ended 6 Months Ended 12 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Dec. 31, 2023
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. That said, in a pre-specified subgroup analysis requested by the United States Food and Drug Administration (“FDA”) of a total of 423 subjects with large incisions (>20 centimeters), the local administration of D-PLEX100 resulted in a significant reduction of 54 percent in the primary endpoint, compared to SoC alone (p=0.0032).    
Cash equivalents and short-term deposits $ 9,347   $ 9,347    
Income loss (6,294) $ (5,837) (12,742) $ (11,905) $ (23,865)
Net cash used in operating activities     (8,494) $ (8,281)  
Accumulated deficit $ (251,051)   $ (251,051)   $ (238,309)
v3.24.2.u1
Leases (Details) - Schedule of Weighted Average Remaining Lease Terms and Discount Rates
Jun. 30, 2024
Leases [Abstract]  
Weighted average remaining lease term (years) 2 years 11 months 19 days
Weighted average discount rates 10.40%
v3.24.2.u1
Leases (Details) - Schedule of Total Operating Lease Cost
$ in Thousands
 6 Months Ended
Jun. 30, 2024
USD ($)
Schedule of Operating Lease Cost [Abstract]  
Operating lease cost $ 526
Cash payments for operating leases $ 419
v3.24.2.u1
Leases (Details) - Schedule of Minimum Lease Payments
$ in Thousands
Jun. 30, 2024
USD ($)
Schedule of Minimum Lease Payments [Abstract]  
The remainder of 2024 $ 481
2025 958
2026 919
2027 455
Total undiscounted lease payments 2,813
Less - imputed interest (346)
Present value of lease liabilities $ 2,467
v3.24.2.u1
Line of Credit Arrangement (Details) - USD ($)
$ in Thousands
 6 Months Ended
Jan. 09, 2024
Jun. 30, 2024
Jun. 30, 2023
Line of Credit Arrangement [Line Items]      
Interest expenses   $ 756 $ 813
Line of Credit [Member]      
Line of Credit Arrangement [Line Items]      
Repaid amount $ 1,494    
v3.24.2.u1
Commitments and Contingent Liabilities (Details)
$ in Thousands
 6 Months Ended
Jun. 30, 2024
USD ($)
Commitments and Contingent Liabilities [Abstract]  
Participation payments (in Dollars) $ 4,888
Percentage of royalties rate of sales 3.00%
Percentage of grant received 100.00%
v3.24.2.u1
Shareholders’ Equity (Deficit) (Details) - USD ($)
$ / shares in Units, $ in Thousands
 3 Months Ended 6 Months Ended 12 Months Ended
May 06, 2024
Jan. 04, 2024
Dec. 31, 2023
May 11, 2023
May 05, 2023
Mar. 31, 2023
Mar. 29, 2023
May 05, 2022
Mar. 31, 2024
Jun. 30, 2023
Mar. 31, 2023
Jun. 30, 2024
Jun. 30, 2023
Dec. 31, 2023
Shareholders’ Equity [Line Items]                            
Exercise price per share (in Dollars per share)                       $ 6,052    
Placement fees and other offering expenses (in Dollars)             $ 362              
Underwriting commissions and other offering expenses (in Dollars)           $ 665         $ 665      
Number of Authorized Shares to Cover Pre Funded Warrants                       167,115    
Fair value liability (in Dollars)                       $ 2,106    
Authorized share capital         60,000,000                  
Classification of pre-funded warrants to Equity (in Dollars)         $ 1,905         $ 1,905     $ 1,905 $ 1,905
Financial expenses (in Dollars)         $ 201             $ 201  
Net of issuance cost (in Dollars)   $ 14,999                        
Gross proceeds (in Dollars)   $ 18,542                        
Fair value warrant price per share (in Dollars per share)                       $ 4.52    
Number of option 2,000,000   254,436                 1,439,705   254,436
Available for future grants                       1,199,975    
Stock option exercise price                     23.07      
Total amount (in Dollars)                 $ 562          
Vested option amount (in Dollars)                 $ 307          
Vested option amount (in Dollars)                          
Unrecognized compensation costs (in Dollars)                       $ 6,305    
Weighted average remaining contractual term     8 years 2 months 26 days                 9 years 6 months 7 days    
Overall alpha level up percentage 5.00%                          
Pre Funded Warrants [Member]                            
Shareholders’ Equity [Line Items]                            
Price per Share (in Dollars per share)             $ 12.6              
Consideration received (in Dollars)             $ 3,987              
Definitive Securities Purchase Agreement [Member]                            
Shareholders’ Equity [Line Items]                            
Number of share issued   3,143,693                        
Warrants to purchase   3,371,312                        
Warrants expire   2 years                        
Definitive Securities Purchase Agreement [Member] | Pre Funded Warrants [Member]                            
Shareholders’ Equity [Line Items]                            
Exercise price per share (in Dollars per share)   $ 0.0001                        
Warrants to purchase   227,619                        
Maximum [Member]                            
Shareholders’ Equity [Line Items]                            
Authorized share capital         107,800,000                  
Number of option 2,312,403                          
Maximum [Member] | Pre Funded Warrants [Member]                            
Shareholders’ Equity [Line Items]                            
Number of shares issued             345,238              
Minimum [Member]                            
Shareholders’ Equity [Line Items]                            
Authorized share capital         47,800,000                  
Number of option 312,403                          
2012 Share Option Plan [Member]                            
Shareholders’ Equity [Line Items]                            
Number of options                     67,385      
Option [Member]                            
Shareholders’ Equity [Line Items]                            
Available for future grants                       867,124    
Weighted average remaining contractual term                       3 years 25 days    
Milestone-Based Options [Member]                            
Shareholders’ Equity [Line Items]                            
Average exercise price (in Dollars per share) $ 4.64                          
Definitive Securities Purchase Agreement [Member]                            
Shareholders’ Equity [Line Items]                            
Price per Share (in Dollars per share)   $ 4.81                        
Board of Directors [Member]                            
Shareholders’ Equity [Line Items]                            
Number of options               17,417            
Total amount (in Dollars)               $ 63            
Vested option amount (in Dollars)               $ 50            
Share options granted 280,000                          
Common Stock [Member]                            
Shareholders’ Equity [Line Items]                            
Cashless exercise of pre-funded warrants       345,151                    
Private Placement [Member]                            
Shareholders’ Equity [Line Items]                            
Exercise price per share (in Dollars per share)   $ 5.5         $ 0.003              
IPO [Member]                            
Shareholders’ Equity [Line Items]                            
Price per Share (in Dollars per share)           $ 12.6         $ 12.6      
Number of share issued           561,967                
Additional gross proceeds (in Dollars)           $ 6,415                
Over-Allotment Option [Member]                            
Shareholders’ Equity [Line Items]                            
Number of share issued           73,300                
v3.24.2.u1
Shareholders’ Equity (Deficit) (Details) - Schedule of Ordinary Share Capital - shares
Jun. 30, 2024
Dec. 31, 2023
Schedule of Ordinary Share Capital [Abstract]    
Ordinary shares, Authorized 107,800,000 107,800,000
Ordinary shares, Issued 4,797,252 1,653,559
Ordinary shares, Outstanding 4,797,252 1,653,559
v3.24.2.u1
Shareholders’ Equity (Deficit) (Details) - Schedule of Black-Scholes Option Pricing Model Assumptions Used to Value
 6 Months Ended
Jun. 30, 2024
Share-Based Payment Arrangement, Option [Member]  
Share Based Payment Award [Line Items]  
Dividend yield (%) 0.00%
Warrant [Member]  
Share Based Payment Award [Line Items]  
Dividend yield (%) 0.00%
Minimum [Member] | Share-Based Payment Arrangement, Option [Member]  
Share Based Payment Award [Line Items]  
Expected volatility (%) 97.10%
Risk-free interest rate (%) 4.43%
Expected term (in years) 6 months
Minimum [Member] | Warrant [Member]  
Share Based Payment Award [Line Items]  
Expected volatility (%) 117.40%
Risk-free interest rate (%) 4.36%
Expected term (in years) 8 months 4 days
Maximum [Member] | Share-Based Payment Arrangement, Option [Member]  
Share Based Payment Award [Line Items]  
Expected volatility (%) 98.39%
Risk-free interest rate (%) 5.06%
Expected term (in years) 6 years 1 month 6 days
Maximum [Member] | Warrant [Member]  
Share Based Payment Award [Line Items]  
Expected volatility (%) 134.00%
Risk-free interest rate (%) 5.08%
Expected term (in years) 2 years
v3.24.2.u1
Shareholders’ Equity (Deficit) (Details) - Schedule of Options to Employees Under the Company’s Option Plan - USD ($)
 6 Months Ended
Dec. 31, 2023
Jun. 30, 2024
Schedule of Options to Employees Under the Company’s Option Plan [Abstract]    
Number of options, ending balance 254,436 1,439,705
Weighted average exercise price, ending balance $ 22.41 $ 7.3
Aggregate intrinsic value, ending balance
Weighted average remaining contractual life (years), ending balance 8 years 2 months 26 days 9 years 6 months 7 days
Number of options, Exercisable options   73,501
Weighted average exercise price, Exercisable options   $ 38.73
Aggregate intrinsic value, Exercisable options  
Weighted average remaining contractual life (years), Exercisable options   5 years 3 months 18 days
Number of options, Vested and expected to vest   1,439,705
Weighted average exercise price, Vested and expected to vest   $ 7.3
Aggregate intrinsic value, Vested and expected to vest  
Weighted average remaining contractual life (years), Vested and expected to vest   9 years 5 months 8 days
Number of options, Granted   1,199,975
Weighted average exercise price, Granted   $ 4.64
Aggregate intrinsic value, Granted  
Number of options, Forfeited and expired   (14,706)
Weighted average exercise price, Forfeited and expired   $ 51.53
v3.24.2.u1
Shareholders’ Equity (Deficit) (Details) - Schedule of Share-Based Compensation Expense - USD ($)
$ in Thousands
 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Schedule of Share-Based Compensation Expense [Line Items]    
Total share-based compensation expense $ 1,440 $ 1,970
Research and development [Member]    
Schedule of Share-Based Compensation Expense [Line Items]    
Total share-based compensation expense 849 1,022
Marketing and business development [Member]    
Schedule of Share-Based Compensation Expense [Line Items]    
Total share-based compensation expense 144 191
General and administrative [Member]    
Schedule of Share-Based Compensation Expense [Line Items]    
Total share-based compensation expense $ 447 $ 757
v3.24.2.u1
Shareholders’ Equity (Deficit) (Details) - Schedule of Warrants Exercisable Into Ordinary Shares
 6 Months Ended
Jun. 30, 2024
$ / shares
shares
Share Based Payment Award [Line Items]  
Warrants outstanding as of June 30, 2024 (in Shares) | shares 3,606,019
Average Exercise price per share $ 6,052
Warrants exercisable as of June 30, 2024 $ 3,606,019
September 2020 [Member]  
Share Based Payment Award [Line Items]  
Warrants outstanding as of June 30, 2024 (in Shares) | shares 597
Average Exercise price per share $ 480
Warrants exercisable as of June 30, 2024 $ 597
Exercisable through September 2024
April 2022 [Member]  
Share Based Payment Award [Line Items]  
Warrants outstanding as of June 30, 2024 (in Shares) | shares 5,193
Average Exercise price per share $ 12.6
Warrants exercisable as of June 30, 2024 $ 5,193
Exercisable through April 2029
July 2022 [Member]  
Share Based Payment Award [Line Items]  
Warrants outstanding as of June 30, 2024 (in Shares) | shares 1,298
Average Exercise price per share $ 12.6
Warrants exercisable as of June 30, 2024 $ 1,298
Exercisable through April 2029
January 2024 [Member]  
Share Based Payment Award [Line Items]  
Warrants outstanding as of June 30, 2024 (in Shares) | shares 3,371,312
Average Exercise price per share $ 5.5
Warrants exercisable as of June 30, 2024 $ 3,371,312
Exercisable through January 2026 *) [1]
January 2024 [Member]  
Share Based Payment Award [Line Items]  
Warrants outstanding as of June 30, 2024 (in Shares) | shares 227,619
Average Exercise price per share $ 0.0001
Warrants exercisable as of June 30, 2024 $ 227,619
Exercisable through No maturity date *) [1]
[1] See note 6b.
v3.24.2.u1
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
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Numerator:        
Allocation of loss attributable to ordinary shareholders $ 6,294 $ 5,837 $ 12,742 $ 11,905
Denominator:        
Weighted average Ordinary shares outstanding 5,024,871 1,479,449 4,858,158 1,097,015
Basic loss per share $ 1.25 $ 3.95 $ 2.62 $ 10.85
v3.24.2.u1
Basic and Diluted Loss Per Share (Details) - Schedule of Basic and Diluted Net Loss Per Ordinary Share (Parentheticals) - $ / shares
 3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Basic and Diluted Loss Per Share [Abstract]        
Diluted loss per share $ 1.25 $ 3.95 $ 2.62 $ 10.85
v3.24.2.u1
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, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]        
Antidilutive shares 3,679,520 83,052 3,679,520 83,052
Ordinary Share options [Member]        
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]        
Antidilutive shares 73,501 69,277 73,501 69,277
Warrants [Member]        
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]        
Antidilutive shares 3,606,019 13,775 3,606,019 13,775
v3.24.2.u1
Subsequent Events (Details) - USD ($)
 6 Months Ended
Aug. 01, 2024
Jul. 02, 2024
Jun. 30, 2024
Subsequent Event [Line Items]      
Warrant purchase price     $ 6,052
Net proceeds     $ 7,500
Kreos Capital VI [Member]      
Subsequent Event [Line Items]      
Warrants expire 7 years    
Subsequent Event [Member]      
Subsequent Event [Line Items]      
Grant of options   132,600  
Exercise price   $ 4.64  
Warrants to purchase 1,676,588    
Exercise price $ 3.61    
Warrants expire 2 years    
Percentage of credit line 60.00%    
Percentage of bears interest 12.00%    
Claw back amount $ 4,500    
Claw back amount paid $ 1,500    
Subsequent Event [Member] | Pre Funded Warrants [Member]      
Subsequent Event [Line Items]      
Warrant purchase price $ 3.61    
Subsequent Event [Member] | Kreos Capital VI [Member]      
Subsequent Event [Line Items]      
Restructuring fee $ 125    
Subsequent Event [Member] | Kreos Capital VI [Member]      
Subsequent Event [Line Items]      
Warrant purchase price $ 3.61    
Warrants to purchase 40,000    
Subsequent Event [Member] | Definitive Securities Purchase Agreement [Member]      
Subsequent Event [Line Items]      
Number of shares or pre-funded warrants issued 2,235,457    
Chief Executive Officer [Member] | Subsequent Event [Member]      
Subsequent Event [Line Items]      
Grant of options   198,000  
Grafico Azioni PolyPid (NASDAQ:PYPD)
Storico
Da Ott 2024 a Nov 2024 Clicca qui per i Grafici di PolyPid
Grafico Azioni PolyPid (NASDAQ:PYPD)
Storico
Da Nov 2023 a Nov 2024 Clicca qui per i Grafici di PolyPid