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

 

Commission file number: 001-36578

 

ENLIVEX THERAPEUTICS LTD.

(Translation of registrant’s name into English)

 

14 Einstein Street, Nes Ziona, Israel 7403618

(Address of principal executive offices)

 

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 ☐

 

 

 

 

 

 

Financial Statements

 

The unaudited condensed consolidated financial statements for Enlivex Therapeutics Ltd., a company organized under the laws of the State of Israel (“Enlivex”), as of and for the three and six month periods ended June 30, 2024 and 2023, and the Operating and Financial Review and Prospects of Enlivex for the corresponding periods are furnished as Exhibits 99.1 and Exhibit 99.2, respectively, to this Report on Form 6-K and incorporated by reference into Enlivex’s registration statements on Forms S-8, F-3 and F-3MEF (File No. 333-256799, File No. 333-232413, File No. 333-232009, File No. 333-252926 and File No. 333-264561), filed with the Securities and Exchange Commission.

 

Exhibit No.  
99.1 Unaudited condensed consolidated financial statements for Enlivex as of June 30, 2024 and December 31, 2023 and for the three and six month periods ended June 30, 2024 and 2023.
99.2 Operating and Financial Review and Prospects as of and for the three and six month periods ended June 30, 2024 and 2023.
101.INS Inline XBRL Instance Document
101.SCH Inline Taxonomy Extension Schema Document
101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF Inline XBRL Taxonomy Defeinition Linkbase Document
101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

1

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  Enlivex Therapeutics Ltd.
  (Registrant)
   
  By: /s/ Oren Hershkovitz
  Name:  Oren Hershkovitz
  Title: Chief Executive Officer

 

Date: August 30, 2024

 

 

2

 

 

Exhibit 99.1

 

ENLIVEX THERAPEUTICS LTD.

  

CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

AS OF JUNE 30, 2024 AND DECEMBER 31, 2023

AND FOR THE THREE AND SIX MONTH PERIODS ENDED JUNE 30, 2024 AND 2023

 

 

 

 

 

 

 

 

ENLIVEX THERAPEUTICS LTD.

 

CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

AS OF JUNE 30, 2024 AND DECEMBER 31, 2023

AND FOR THE THREE AND SIX MONTH PERIODS ENDED JUNE 30, 2024 AND 2023

 

INDEX TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

  Page
Condensed Consolidated Balance Sheets F-2
Condensed Consolidated Statements of Operations and Comprehensive Loss F-3
Condensed Consolidated Statements of Changes in Shareholders’ Equity F-4
Condensed Consolidated Cash Flow Statements F-5
Notes to the Condensed Consolidated Financial Statements F-6

 

F-1

 

 

ENLIVEX THERAPEUTICS LTD.

 

CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)

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

 

   June 30,   December 31, 
   2024   2023 
         
ASSETS        
Current Assets        
Cash and cash equivalents  $3,747   $813 
Short-term interest-bearing deposits   22,195    26,507 
Prepaid expenses and other receivables   2,400    1,336 
Assets classified as held for sale   228    5,108 
Total Current Assets   28,570    33,764 
           
Non-Current Assets          
Other receivables   898    
-
 
Property and equipment, net   1,158    1,539 
Other assets   1,276    1,528 
Total Non-Current Assets   3,332    3,067 
TOTAL ASSETS  $31,902   $36,831 
           
LIABILITIES AND SHAREHOLDERS’ EQUITY          
Current Liabilities          
Accounts payable  $303   $827 
Accrued expenses and other liabilities   2,538    4,001 
Liability classified as held for sale   
-
    1,233 
Total Current Liabilities   2,841    6,061 
           
Non-Current Liabilities          
Other long-term liabilities   499    686 
Total Non-Current Liabilities   499    686 
           
Commitments and Contingent Liabilities   
 
    
 
 
           
TOTAL LIABILITIES   3,340    6,747 
           
SHAREHOLDERS’ EQUITY          
Ordinary shares of NIS 0.40 par value per share:           
Authorized: 45,000,000 shares as of June 30, 2024 and December 31, 2023; Issued and outstanding: 20,883,312 and 18,598,555 as of June 30, 2024 and December 31, 2023, respectively;
   2,385    2,137 
Additional paid in capital   144,405    138,939 
Foreign currency translation adjustments   1,101    1,101 
Accumulated deficit   (119,329)   (112,093)
TOTAL SHAREHOLDERS’ EQUITY   28,562    30,084 
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY  $31,902   $36,831 

 

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

 

F-2

 

 

ENLIVEX THERAPEUTICS LTD.

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)

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

 

   For the three months ended   For the six months ended 
   June 30,   June 30, 
   2024   2023   2024   2023 
                 
Revenues  $
-
   $
-
   $
-
   $
-
 
                     
Operating expenses:                    
Research and development expenses   1,999    5,035    4,856    10,211 
General and administrative expenses   987    1,614    2,080    3,221 
Loss on disposal group of assets held for sale   
-
    
-
    201    
-
 
    2,986    6,649    7,137    13,432 
                     
Operating loss   (2,986)   (6,649)   (7,137)   (13,432)
                     
Finance income (expense)   (110)   (143)   (99)   (578)
                     
Net loss   (3,096)   (6,792)   (7,236)   (14,010)
                     
Basic & diluted loss per share
  $(0.16)  $(0.37)  $(0.38)  $(0.76)
Weighted average number of shares outstanding   19,545,056    18,584,801    19,138,066    18,550,702 

  

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

 

F-3

 

 

ENLIVEX THERAPEUTICS LTD.

 

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY (UNAUDITED)

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

 

   Ordinary Shares   Additional
paid in
   Currency
translation
   Accumulated     
   Shares   Amount   capital   reserve   deficit   Total 
                         
Balance as of December 31, 2023   18,598,555    2,137    138,939   $1,101    (112,093)   30,084 
Changes during the three months period ended March 31, 2024:                              
Restricted stock units vested   34,295    3    (3)   
 -
    
-
    
-
 
Issuance of shares for cash consideration of 540 net of $16 of issuance costs   178,931    20    504    
-
    
-
    524 
Stock based compensation   -    
-
    383    
-
    
-
    383 
Net loss   -    
-
    
-
    
-
    (4,140)   (4,140)
Balance as of March 31, 2024 (unaudited)   18,811,781    2,160    139,823    1,101    (116,233)   26,851 
                               
Changes during the three months period ended June 30, 2024:                              
Issuance of shares for cash consideration of $5,001 net of $582 of issuance costs   2,061,776    224    4,195    
-
    
-
    4,419 
Restricted stock units vested   9,755    1    (1)   
-
    
-
    
-
 
Exercise of options   -    
-
    
-
    
-
    
-
    
-
 
Stock based compensation   -    
-
    388    
-
    
-
    388 
Net loss   -    
-
    
-
    
-
    (3,096)   (3,096)
Balance as of June 30, 2024 (unaudited)   20,883,312   $2,385   $144,405   $1,101   $(119,329)  $28,562 
                               
Balance as of December 31, 2022   18,421,852   $2,117   $136,648   $1,101   $(83,025)  $56,841 
Changes during the three months period ended March 31, 2022:                              
Restricted stock units vested   34,295    3    (3)   
-
    
-
    
-
 
Issuance of shares for cash consideration of $470 net of $152 of issuance costs   110,115    13    305    
-
    
-
    318 
Stock based compensation   -    
-
    633    
-
    
-
    633 
Net loss   -    
-
    
-
    
-
    (7,218)   (7,218)
Balance as of March 31, 2023 (unaudited)   18,566,262    2,133    137,583    1,101    (90,243)   50,574 
                               
Changes during the three months period ended June 30, 2023:                              
Issuance of shares for cash consideration of $43 net of $1 of issuance costs   14,056    2    40    
-
    
-
    42 
Restricted stock units vested   8,821    1    (1)   
-
    
-
    
-
 
Exercise of options   
-
    
-
    
-
    
-
    
-
    
-
 
Stock based compensation   -    
-
    511    
-
    
-
    511 
Net loss   -    
-
    
-
    
-
    (6,792)   (6,792)
Balance as of June 30, 2023 (unaudited)   18,589,139   $2,136   $138,133   $1,101   $(97,035)  $44,335 

 

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

F-4

 

 

ENLIVEX THERAPEUTICS LTD.

 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)

U.S. dollars in thousands

 

   For the six months ended
June 30,
 
   2024   2023 
Cash flows from operating activities        
Net loss  $(7,236)  $(14,010)
Adjustments required to reflect net cash used in operating activities:          
Income and expenses not involving cash flows:          
Depreciation   348    421 
Capital gain on sale of property and equipment   (79)   
-
 
Loss on short-term bank deposits   166    1,626 
Gain on assets and liabilities classified as held for sale   (66)   
-
 
Non-cash operating lease expenses   181    434 
Share-based compensation   771    1,144 
Changes in operating asset and liability items:          
Decrease in prepaid expenses and other receivables   1,792    (169)
Decrease in accounts payable   (524)   (240)
Decrease in accrued expenses and other liabilities   (1,453)   (1,389)
Operating lease liabilities   (207)   (624)
Net cash used in operating activities   (6,307)   (12,807)
           
Cash flows from investing activities          
Purchase of property and equipment   (59)   (200)
Proceeds from sale of property and equipment   171    82 
Proceeds from sale of assets held for sale   54    
-
 
Investment in short-term interest-bearing bank deposits   (18,774)   (34,218)
Release of short-term interest-bearing bank deposits   22,912    288 
Net cash provided by (used in) investing activities   4,304    (34,048)
           
Cash flows from financing activities          
Proceeds from issuance of shares and warrants, net   4,943    360 
Proceeds from exercise of options   
-
    
-
 
Net cash provided by financing activities   4,943    360 
           
Increase (decrease) in cash and cash equivalents   2,940    (46,495)
Cash and cash equivalents - beginning of period   1,226    50,357 
           
Cash and cash equivalents - end of period  $4,166   $3,862 
Supplemental disclosures of cash flow information:          
Cash paid for taxes  $
-
   $
-
 
Cash received for interest, net  $906   $233 

  

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

 

F-5

 

 

ENLIVEX THERAPEUTICS LTD.

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2024 (UNAUDITED)

 

 

NOTE 1 - GENERAL INFORMATION

 

a.General

 

Enlivex Therapeutics Ltd. (the “Parent” and, including its consolidated subsidiaries, “we”, “us”, “our” or the “Company”) was originally incorporated on January 22, 2012 under the laws of the State of Israel.

 

The Company is a clinical stage macrophage reprogramming immunotherapy company, developing AllocetraTM, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of debilitating and life-threatening conditions. Non-homeostatic macrophages contribute significantly to the severity of certain diseases, which include, sepsis, osteoarthritis and others.

 

AllocetraTM is based on the discoveries of Professor Dror Mevorach, an expert on immune activity, macrophage activation and clearance of dying (apoptotic) cells, in his laboratory in the Hadassah University Hospital located in the State of Israel. 

 

The Company’s ordinary shares, par value of NIS 0.40 per share (“Ordinary Shares”), are traded under the symbol “ENLV” on both the Nasdaq Capital Market and on the Tel Aviv Stock Exchange.

 

b.Financial Resources

 

The Company devotes substantially all of its efforts toward research and development activities and raising capital to support such activities. The Company’s activities are subject to significant risks and uncertainties, including failing to secure additional funding before the Company achieves sustainable revenues and profit from operations.

 

Research and development activities have required significant capital investment since the Company’s inception. The Company expects that its operations will require additional cash investment to pursue the Company’s research and development activities, including preclinical studies, formulation development, clinical trials and related drug manufacturing. The Company has not generated any revenues or product sales and has not achieved profitable operations or positive cash flow from operations. The Company has incurred net losses since its inception, and, as of June 30, 2024, had an accumulated deficit of $119,329 thousand.

 

The Company expects to continue to incur losses for the foreseeable future, and the Company will need to raise additional debt or equity financing or enter into partnerships to fund its development. If the Company is not able to achieve its funding requirements, it may be required to reduce discretionary spending, may not be able to continue the development of its product candidates or may be required to delay its development programs, which could have a material adverse effect on the Company’s ability to achieve its intended business objectives. There can be no assurances that additional financing will be secured or, if secured, will be on favorable terms. The ability of the Company to transition to profitability in the longer term is dependent on developing products and product revenues to support its expenses.

 

The Company’s management and board of directors (the “Board”) are of the opinion that the Company’s current financial resources will be sufficient to continue the development of the Company’s product candidates for at least twelve months following the filing of these financial statements on Form 6-K. The Company may determine, however, to raise additional capital during such period as the Board deems prudent. The Company’s management plans to finance its operations with issuances of the Company’s equity securities and, in the longer term, revenues. There are no assurances, however, that the Company will be successful in obtaining the financing necessary for its long-term development. The Company’s ability to continue to operate in the long term is dependent upon additional financial support.

 

NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES

 

Basis of Presentation

 

These unaudited condensed consolidated financial statements include the accounts of the Company and have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information. Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been made.

 

F-6

 

 

ENLIVEX THERAPEUTICS LTD.

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2024 (UNAUDITED)

 

 

These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited annual financial statements and notes thereto included in the Company’s 2023 Annual Report on Form 20-F, as filed with the U.S. Securities and Exchange Commission on April 30, 2024. The results of operations for these interim periods are not necessarily indicative of the operating results for any future period. The December 31, 2023 financial information has been derived from the Company’s audited financial statements.

 

Use of Estimates

 

The preparation of interim financial statements in conformity with U.S. GAAP requires management to make certain estimates, judgments and assumptions that affect the reported amounts in the consolidated balance sheets and statements of operations, it also requires that management exercise its judgment in applying the Company’s accounting policies. On an ongoing basis, management evaluates its estimates, including estimates related to its stock-based compensation expense and implicit interest rate on new lease liabilities. Significant estimates in these interim financial statements include estimates made for accrued research and development expenses and stock-based compensation expenses.

 

Functional Currency and Translation to The Reporting Currency

 

The functional currency of the Company is the U.S. dollar because the U.S. dollar is the currency of the primary economic environment in which the Company operates and expects to continue to operate in the foreseeable future.

 

Balances related to non-monetary assets and liabilities are based on translated amounts as of the date of the change, and non-monetary assets acquired and liabilities were translated at the approximate exchange rate prevailing at the date of the transaction. Transactions included in the statement of income were translated at the approximate exchange rate in effect at the time of the transaction.

 

1 U.S. dollar = 3.759 NIS and 3.627 NIS as of June 30, 2024 and December 31, 2023, respectively.

 

The U.S. dollar increased against the NIS 2.12%, 3.64%, 2.35% and 5.14% in the three and six month periods ended June 30, 2024 and 2023, respectively.

 

Recently Adopted Accounting Standards

 

During the three months ended June 30, 2024, the Company was not required to adopt any recently issued accounting standards.

 

Recently Issued Accounting Pronouncements Not Yet Adopted

 

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which is intended to provide enhanced segment disclosures. The standard will require disclosures about significant segment expenses and other segment items and identifying the Chief Operating Decision Maker and how they use the reported segment profitability measures to assess segment performance and allocate resources. These enhanced disclosures are required for all entities on an interim and annual basis, even if they have only a single reportable segment. The standard is effective for years beginning after December 15, 2023 and interim periods within annual periods beginning after December 15, 2024, and early adoption is permitted. The Company does not believe that adoption of this ASU will have a material impact on the Company’s consolidated financial statements.

 

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which is intended to provide enhancements to annual income tax disclosures. The standard will require more detailed information in the rate reconciliation table and for income taxes paid, among other enhancements. The standard is effective for years beginning after December 15, 2024, early adoption is permitted. The Company does not believe that adoption of this ASU will have a material impact on the Company’s consolidated financial statements.

 

Significant Accounting Policies

 

There have been no material changes to the significant accounting policies previously disclosed in the Company’s Annual Report on Form 20-F for the year ended December 31, 2023.

 

F-7

 

 

ENLIVEX THERAPEUTICS LTD.

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2024 (UNAUDITED)

 

 

NOTE 3 – CASH, CASH EQUIVALENTS AND RESTRICTED CASH

 

   June 30,   December 31, 
(in thousands)  2024   2023 
         
Cash held in banks  $3,747   $813 
Total cash and cash equivalents   3,747    813 
Restricted cash – current – Prepaid expenses and other receivables   113    113 
Restricted cash – noncurrent – Other assets   306    300 
Total cash, cash equivalents and restricted cash shown in the statement of cash flows  $4,166   $1,226 

 

NOTE 4 – SHORT TERM DEPOSITS

 

   June 30,   December 31, 
(in thousands)  2024   2023 
         
Bank deposits in U.S.$ (annual average interest rates 5.86% and 6.195%)  $9,652   $6,240 
Bank deposits in NIS (annual average interest rates 4.317% and 4.568%)   12,543    20,267 
Total short-term deposits  $22,195   $26,507 

 

NOTE 5 – PREPAID EXPENSES AND OTHER RECEIVABLES

 

   June 30,   December 31, 
(in thousands)  2024   2023 
         
Prepaid expenses  $1,141   $1,107 
Tax authorities   47    116 
Others   1,212    113 
   $2,400   $1,336 

 

NOTE 6 – PROPERTY AND EQUIPMENT

 

Property and equipment, net consists of the following:

 

  June 30,   December 31, 
(in thousands)  2024   2023 
         
Cost:          
Laboratory equipment  $2,130   $2,412 
Computers   431    380 
Office furniture & equipment   184    186 
Leasehold improvements   1,431    1,431 
Total cost   4,176    4,409 
Accumulated depreciation:          
Laboratory equipment   1,876    1,891 
Computers   296    263 
Office furniture & equipment   47    40 
Leasehold improvements   799    676 
Total accumulated depreciation   3,018    2,870 
Depreciated cost  $1,158   $1,539 

 

Depreciation expenses for the three and six month periods ended June 30, 2024 and 2023 were $160, $348, $212 and $421 thousand, respectively.

 

F-8

 

 

ENLIVEX THERAPEUTICS LTD.

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2024 (UNAUDITED)

 

 

NOTE 7 – OTHER ASSETS

 

   June 30,   December 31, 
(in thousands)  2024   2023 
         
Restricted cash  $306   $300 
Long Term Deposit   8    8 
Long-term prepaid expenses   92    179 
Right-of-Use assets, net   870    1,041 
   $1,276   $1,528 

 

NOTE 8 – ACCRUED EXPENSES AND OTHER LIABILITIES

 

   June 30,   December 31, 
(in thousands)  2024   2023 
         
Vacation, convalescence and bonus accruals  $291   $341 
Employees and payroll related   314    422 
Short term operating lease liabilities   336    346 
Accrued expenses and other   1,597    2,892 
   $2,538   $4,001 

 

NOTE 9 – LEASES

 

The Company is a party to operating leases for its corporate offices, laboratory space, plant space and vehicles.

 

   Six months ended
June 30,
 
(in thousands)  2024   2023 
         
The components of lease expense were as follows:          
Operating leases expenses  $207   $522 
Supplemental consolidated cash flow information related to operating leases follows:          
Cash used in operating activities  $212   $520 
Non-cash activity:          
Right of use assets obtained in exchange for new operating lease liabilities  $25   $145 

 

   June 30,   December 31, 
(in thousands)  2024   2023 
Supplemental information related to operating leases, including location of amounts reported in the accompanying consolidated balance sheets, follows:          
Other assets - Right-of-Use assets  $1,722   $2,161 
Accumulated amortization   852    1,120 
Operating lease Right-of-Use assets, net  $870   $1,041 
Lease liabilities – current - Accounts payable and accrued liabilities  $336   $346 
Lease liabilities – noncurrent   499    686 
Total operating lease liabilities  $835   $1,032 
Weighted average remaining lease term in years   2.89    3.3 
Weighted average annual discount rate   6.8%   6.7%

 

F-9

 

 

ENLIVEX THERAPEUTICS LTD.

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2024 (UNAUDITED)

 

 

Maturities of operating lease liabilities as of June 30, 2024, were as follows:    
2024 (after June 30)  $191 
2025   355 
2026   193 
2027   117 
2028 and onwards   89 
Total undiscounted lease liability   945 
Less: Imputed interest   (110)
Present value of lease liabilities  $835 

 

NOTE 10 – COMMITMENTS AND CONTINGENT LIABILITIES

 

The Company is required to pay royalties to the State of Israel (represented by the Israeli Innovation Authority (the “IIA”)), computed on the basis of proceeds from the sale or license of products for which development was supported by IIA grants. These royalties are generally 3% - 5% of sales until repayment of 100% of the grants (linked to the dollar) received by the Company plus annual interest at a SOFR-based rate.

 

The gross amount of grants received by the Company from the IIA, including accrued interest as of June 30, 2024, was approximately 9.9 million. As of June 30, 2024, the Company had not paid any royalties to the IIA.

 

NOTE 11 – EQUITY

 

a)On May 27, 2024, the Company entered into a securities purchase agreement with a single institutional investor in connection with the issuance and sale by the Company in a registered direct offering (the “Offering”) of (i) 2,060,000 Ordinary Shares, (ii) pre-funded warrants to purchase up to 1,511,429 Ordinary Shares (the “Pre-Funded Warrants”), (iii) Series A warrants to purchase up to 3,571,429 Ordinary Shares (the “Series A Warrants”) and (iv) Series B warrants to purchase up to 3,571,429 Ordinary Shares (the “Series B Warrants” and, together with the Series A Warrants, the “Investor Warrants”), at a combined purchase price of (a) $1.40 per Ordinary Share and the associated Investor Warrants, each to purchase one Ordinary Share, and (b) $1.399 per Pre-Funded Warrant and the associated Investor Warrants, each to purchase one Ordinary Share, pursuant to the Company’s effective shelf registration statement on Form F-3 (File No. 333-364561) and related base prospectus and prospectus supplement.

 

Each Investor Warrant has an exercise price of $1.40 per Ordinary Share and is immediately exercisable. The Series A Warrants expire upon the earlier of 18 months following the issuance date and 60 days following the Company’s public announcement of positive topline trail results of AllocetraTM for the treatment of moderate-to-severe knee osteoarthritis (the “Series A Milestone Event”). The Series B warrants expire upon the earlier of five and one-half years following the issuance date and 60 days following the Company’s public announcement of its filing with the U.S. Food and Drug Administration (the “FDA”) for approval for AllocetraTM’s osteoarthritis related indication (the “Series B Milestone Event”). Each Pre-Funded Warrant has an exercise price of $0.001 per Ordinary Share, is immediately exercisable, may be exercised at any time and has no expiration date.

 

H.C. Wainwright & Co. (“Wainwright”) acted as placement agent in connection with the Offering, and in consideration therefor the Company agreed to register and issue to Wainwright warrants (the “Placement Agent Warrants”, and together with the Investor Warrants and the Pre-Funded Warrants, the “Warrants”) to purchase up to 250,000 Ordinary Shares. The Placement Agent Warrants comprise Series A Warrants to purchase 125,000 Ordinary Shares and Series B Warrants to purchase 125,000 Ordinary Shares, containing the same terms as the Investor Warrants, except that they are exercisable at a price of $1.75 per Ordinary Share, and the Series B Warrants will expire upon the earlier of five years following the commencement of the sale of the securities offered in the Offering and 60 days following the Company’s public announcement of its filing with the FDA for approval for AllocetraTM’s osteoarthritis related indication.

 

In addition, the Company agreed to pay Wainwright an aggregate cash fee equal to 7% of the gross proceeds raised in the Offering, a management fee equal to 1% of the gross proceeds raised in the Offering and $90,950 for various fees and expenses.

 

F-10

 

 

ENLIVEX THERAPEUTICS LTD.

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2024 (UNAUDITED)

 

 

The closing of the Offering occurred on May 29, 2024. The net proceeds from the Offering were approximately $4.5 million after deducting Wainwright’s fees and other expenses relating to the Offering. The Company intends to use the net proceeds from the Offering for working capital and other general corporate purposes.

 

b)All Company warrants are classified as components of shareholders’ equity because such warrants are free standing financial instruments that are legally detachable, separately exercisable, do not embody an obligation for the Company to repurchase its own shares and permit the holders to receive a fixed number of Ordinary Shares upon exercise, require physical settlement and do not provide any guarantee of value or return (unless, in accordance with ASC 815-40-55-3, there is a fundamental transaction, as defined in the warrant agreements, which allows the holders of the warrants to receive the same form of consideration payable to the holders of Ordinary Shares, in which case equity treatment is not precluded).

 

  

Number

of Warrants

  

Weighted

average

exercise price

 
Outstanding January 1, 2024   202,251   $23.31 
Issued   8,904,287   $1.17 
Outstanding and exercisable June 30, 2024   9,106,538   $1.66 

 

Composed of:

 

Number of
Warrants
   Exercise
Price
Per
Share
   Issuance
date
  Expiration
date
 22,750   $10.00   February 26, 2020  February 24, 2025
 160,727   $25.00   February 12, 2021  February 9, 2026
 18,774   $25.00   February 17, 2021  February 9, 2026
 1,511,429   $0.001   May 29, 2024  No expiration date
 3,571,429   $1.40   May 29, 2024  December 1, 2025(i)
 3,571,429   $1.40   May 29, 2024  November 29, 2029 (ii)
 125,000   $1.75   May 29, 2024  December 1, 2025(i)
 125,000   $1.75   May 29, 2024  May 27, 2029 (iii)
 9,106,538            

 

(i)The earlier of (a) December 1, 2025 and (b) the 60th day following the occurrence of the Series A Milestone Event.
(ii)The earlier of (a) November 29, 2029 and (b) the 60th day following the occurrence of the Series B Milestone Event.
(iii)The earlier of (a) May 27, 2029 and (b) 60 days following the Company’s public announcement of its filing with the FDA for approval for AllocetraTM’s osteoarthritis related indication.

 

c)During the six months ended June 30, 2024 the Company issued 180,707 Ordinary Shares under our ATM agreement with Cantor Fitzgerald & Co. and JMP Securities LLC for a gross consideration of $543 thousand net of $16 thousand of issuance expenses.

 

NOTE 12 – SHARE-BASED COMPENSATION

 

a)As of June 30, 2024, 5,028,704 Ordinary Shares were authorized for issuance to employees, directors and consultants under the 2019 Equity Incentive Plan (the “2019 Plan”), of which 966,057 shares remained available for future grant.

 

F-11

 

 

ENLIVEX THERAPEUTICS LTD.

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2024 (UNAUDITED)

 

 

b)The following table contains information concerning options granted under the 2019 Plan:

 

   Three months ended
June 30,
 
   2024   2023 
   Number of options   Weighted average exercise price  

Number

of options

   Weighted
average
exercise price
 
Outstanding at beginning of period   3,007,624   $5.41    2,929,868   $5.84 
Forfeited and expired   (21,921)  $5.06    (14,375)  $6.82 
Outstanding at end of period   2,985,703   $5.41    2,915,493   $5.84 
Exercisable at end of period   2,228,902   $5.67    2,090,378   $5.59 
                     
Non-vested at beginning of period   772,301   $4.67    876,851   $6.48 
Vested   -   $-    (37,861)  $11.13 
Forfeited   (13,750)  $3.79    (13,875)  $5.90 
Non-vested at the end of period   758,551   $4.6 8    825,115   $6.27 

 

  

Six months ended
June 30,

 
   2024   2023 
   Number of
options
   Weighted
average
exercise price
   Number of options   Weighted
average
exercise price
 
 Outstanding at beginning of period   2,842,496   $5.63    2,939,434   $5.85 
 Granted   250,000   $3.21    
-
   $
-
 
 Forfeited and expired   (106,793)  $6.00    (23,941)  $6.71 
 Outstanding at end of period   2,985,703   $5.41    2,915,493   $5.84 
 Exercisable at end of period   2,228,902   $5.67    2,090,378   $5.59 
                     
 Non vested at beginning of period   596,503   $5.53    986,005   $6.46 
 Granted   250,000   $3.21    
-
   $
-
 
 Forfeited and expired   (24,313)  $5.04    (15,375)  $6.73 
 vested   (63,639)  $6.75    (145,515)  $7.44 
 Outstanding at end of period   758,551   $4.68    825,115   $6.27 

 

During the three and six month periods ended June 30, 2024 and 2023, the Company recognized $237, $460, $427 and $957 thousand, respectively, of share-based compensation expenses related to stock options. As of June 30, 2024, the total unrecognized estimated compensation cost related to outstanding non-vested stock options was $1,061 thousand, which is expected to be recognized over a weighted average period of 1.36 years.

  

F-12

 

 

ENLIVEX THERAPEUTICS LTD.

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2024 (UNAUDITED)

 

 

c)Set forth below is data regarding the range of exercise prices and remaining contractual life for all options outstanding at June 30, 2024:

 

Exercise price   Number of options
outstanding
   Remaining
contractual
Life (in years)
   Intrinsic Value
of Options  
Outstanding
(in thousands)
   No. of options
exercisable
 
$2.69    649,591    0.92   $
     -
    649,591 
$3.21    240,000    9.63    
-
    
-
 
$3.53    53,192    9.35    
-
    
-
 
$3.66    250,000    5.84    
-
    250,000 
$4.68    34,500    5.75    
-
    34,500 
$5.34    160,750    7.75    
-
    84,000 
$5.34    442,410    8.39    
-
    178,176 
$5.96    150,000    8.39    
-
    37,500 
$6.22    552,883    2.67    
-
    552,883 
$8.19    150,000    5.39    
-
    150,000 
$9.02    40,500    6.38    
-
    30,375 
$10.12    10,407    4.43    
-
    10,407 
$12.23    250,000    6.91    
-
    250,000 
$21.40    970    5.07    
-
    970 
$90.16    500    0.42    
-
    500 
      2,985,703        $
-
    2,228,902 

 

d)The following table contains information concerning restricted stock units granted under the 2019 Plan:

 

   Three months ended
June 30,
 
   2024    2023 
   Number
of shares
 
   Weighted
average
grant date fair
value
   Number
of shares
   Weighted
average
grant date fair
value
 
Nonvested at beginning of period   571,460   $2.65    114,329   $9.97 
Granted       $     
-
   $
-
 
Vested   (3,444)  $10.28    (3,438)  $10.28 
Forfeited   (5,757)  $3.87    (313)  $14.67 
Nonvested at end of period   562,259   $2.59    110,578   $9.95 

 

   Six months ended
June 30,
 
   2024    2023 
   Number
of shares
 
   Weighted
average
grant date fair
value
   Number
of shares
   Weighted
average
grant date fair
value
 
Nonvested at beginning of period   621,135   $3.14    157,560   $10.02 
Granted   
-
   $
-
    
-
   $
-
 
Vested   (44,050)  $9.9    (46,544)  $10.15 
Forfeited   (14,826)  $3.64    (438)  $14.67 
Nonvested at end of period   562,259   $2.59    110,578   $9.95 

 

The Company estimates the fair value of restricted stock units based on the closing sales price of the Ordinary Shares on the date of grant (or the closing bid price, if no sales were reported).

 

F-13

 

 

ENLIVEX THERAPEUTICS LTD.

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2024 (UNAUDITED)

 

 

For the three and six month periods ended June 30, 2024 and 2023, the Company recognized $151, $311, $84 and $187 thousand, respectively, of share-based compensation expense related to restricted stock units.

 

Total share-based compensation expense related to restricted stock units not yet recognized as of June 30, 2024 was $653 thousand, which is expected to be recognized over a weighted average period of 1.27 years.

 

e)The following table summarizes share-based compensation expenses included in the statements of operations related to grants under the 2019 Plan:

 

   Three months ended
June 30,
   Six months ended
June 30,
 
(in thousands)  2024   2023   2024   2023 
Research & development  $145   $122   $269   $318 
General & administrative   243    389    502    826 
Total  $388   $511   $771   $1,144 

 

NOTE 13 – FAIR VALUE MEASUREMENT

 

The Company’s financial assets and liabilities measured at fair value on a recurring basis consisted of the following types of instruments as of June 30, 2024 and December 31, 2023:

 

 

(in thousands)  June 30, 2024 
   Total   Level 1   Level 2   Level 3 
Cash and cash equivalents  $3,747  
$
          $
      -
   $
     -
 
Short term deposits   22,195  
 
     
-
    
-
 
Restricted cash   306  
 
     
-
    
-
 
Total financial assets  $26,248  
$
    $
-
   $
-
 

 

(in thousands)  December 31, 2023 
   Total   Level 1   Level 2   Level 3 
Cash and cash equivalents  $813   $813   $
     -
   $
      -
 
Short term deposits   26,507    26,507    
-
    
-
 
Restricted cash   413    413    
-
    
-
 
Total financial assets  $27,733   $27,733   $
-
   $
-
 

 

NOTE 14 – EVENTS SUBSEQUENT TO THE BALANCE SHEET DATE

 

The Company evaluated all events and transactions that occurred subsequent to the balance sheet date and prior to the date on which these unaudited condensed consolidated financial statements were issued and determined that the following subsequent event necessitated disclosure:

 

1.In July 2024, 518,429 Pre-Funded Warrants were exercised for 518,429 Ordinary Shares.

 

 

F-14

 

 

 

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Exhibit 99.2

 

OPERATING AND FINANCIAL REVIEW AND PROSPECTS

 

This Operating and Financial Review and Prospects contains forward-looking statements, which may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “would”, “could”, “intends,” “estimates,” “suggests,” “has the potential to” and other words and phrases of similar meaning, including, without limitation, statements regarding expected cash balances, market opportunities for the results of current clinical studies and preclinical experiments, and the effectiveness of, and market opportunities for, ALLOCETRATM programs, all of which statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivex’s business and prospects, including the risks that Enlivex may not succeed in generating any revenues or developing any commercial products; that the products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the ALLOCETRATM product line could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Enlivex’s filings with the Securities and Exchange Commission, including in its Annual Report on Form 20-F for the year ended December 31, 2023.  The forward-looking statements contained in this Operating and Financial Review and Prospects speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law.

 

Overview

 

Enlivex Therapeutics, Ltd., a company organized under the laws of the State of Israel (including its consolidated subsidiaries, “we”, “us”, “our” or the “Company”), is a clinical-stage macrophage reprogramming immunotherapy company, developing AllocetraTM, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of life-threatening conditions. Non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra™ has the potential to provide a novel immunotherapeutic mechanism of action for debilitating and life-threatening clinical indications that are defined as “unmet medical needs,” as a stand-alone therapy or in combination with leading therapeutic agents.

 

We believe the Company’s primary innovative immunotherapy, AllocetraTM, represents a paradigm shift in macrophage reprogramming, moving from targeting a specific subset of macrophages or a specific pathway affecting macrophages activity, to a fundamental view of macrophage homeostasis. Restoring macrophage homeostasis may induce the immune system to rebalance itself to normal levels of operation, thereby promoting disease resolution.

 

The Company is focused on two clinical program verticals as its main inflammatory and autoimmune indications: sepsis and osteoarthritis. Additionally, the Company is seeking external collaborations or out-licensing opportunities for the development of Allocetra™ as a next-generation solid cancer immunotherapy. The Company believes that negatively-reprogrammed macrophages may be key contributors to disease severity across the Indications (the “Indications”), and thus effective reprogramming of these previously negative-reprogrammed macrophages into their respective homeostatic states may provide diseases resolution for these Indications, some of which are considered “unmet medical needs”.

 

 

 

Financial and Operational Overview

 

Since inception, we have incurred significant losses in connection with our research and development and have not generated any revenue. We have funded our operations primarily through grants from the Israeli Innovation Authority (“IIA”) and the sale of equity and equity linked securities in public and private offerings. As of June 30, 2024, we had approximately $26 million in cash and cash equivalents and short-term bank deposits and had an accumulated deficit of approximately $119 million, see “—Liquidity and Capital Resources” below.

 

In September 2023, we announced a strategic reprioritization plan, pursuant to which we determined to increase our existing focus on inflammatory and autoimmune indications. As part of the strategic reprioritization plan, in addition to the ongoing Phase II trial of AllocetraTM in patients with sepsis, the Company initiated a clinical program in osteoarthritis, which is a degenerative disease with low grade inflammation and an indication with a substantial unmet medical need that potentially represents a multibillion dollar commercial market. Within the osteoarthritis program, the Company announced the dosing of the first patient in a Phase I/II investigator-initiated clinical trial enrolling patients with severe knee osteoarthritis who had been indicated for knee replacement surgeries and are offered to inject AllocetraTM locally into the diseased knee as a potential alternative for pain resolution and knee functionality in lieu of replacement surgery. In addition to this Phase I/II trial, following receipt of the approval of the Israeli Ministry of Health (the “IMOH”) in January 2024, the Company initiated a multi-country randomized, controlled Phase I/II clinical trial evaluating AllocetraTM in patients with moderate knee osteoarthritis in early 2024. In April 2024, we announced that the Danish Medicines Agency authorized the expansion of this trial into Denmark, as well as the dosing of the first two patients in the trial. This Phase I/II clinical trial is expected to enroll up to 160 patients and is designed to be a multi-center, multi-country, double-blinded, placebo-controlled and statistically-powered study to evaluate efficacy as well as safety of AllocetraTM, and potentially allow the Company to design and initiate a clinical registrational trial upon its completion.

 

The Company’s revised strategy is targeted at obtaining a topline data readout from the randomized, controlled Phase I/II trial in up to 160 patients with moderate knee osteoarthritis by the third quarter of 2025 and from the Phase I/II investigator-initiated clinical trial in 12 patients with severe knee osteoarthritis who had been indicated for knee replacement surgeries by the end of the third quarter of 2024.

 

Pursuant to the strategic reprioritization plan, and in light of the new guidelines and regulatory initiatives set by the FDA for drug development in oncology, which may result in longer clinical development cycles as foundations for regulatory approvals, the Company ceased the internal clinical development of its various oncology indications and plans to seek external collaborations or out-licensing opportunities for the development of Allocetra™ as a next-generation solid cancer immunotherapy.

 

As a result of the Company’s reprioritization of its clinical indications and focus on the inflammatory and auto-immune verticals, the Company reduced its workforce by approximately 50%. The workforce reductions and the savings associated with the reclassification of the oncology indications as candidates for external collaborations or out-licensing opportunities in lieu of internal development has resulted in a substantial extension of the Company’s cash runway. Given the implementation of our reprioritization plan, the sale of our manufacturing facility in Yavne, Israel in April 2024 and the receipt of approximately $4,416 thousand of net proceeds from the May 2024 Offering (as defined below), management currently believes that our existing cash resources will be sufficient to fund our projected cash requirements through the end of 2026. Management currently expects that the Company’s existing cash and cash equivalents support the timeline for the topline data readouts from the end-stage knee osteoarthritis Phase I/II trial, the randomized, controlled Phase I/II clinical trial in knee osteoarthritis, and the randomized, controlled Phase II clinical trial in basal thumb osteoarthritis, as well as the one-year follow up for each of the foregoing trials. Additionally, management expects that our current cash and cash equivalents will continue to support additional research and development activities related to our Allocetra™ platform.

 

We expect that we will continue to incur operating losses, which may be substantial over the next several years, and we may need to obtain additional funds to further develop our research and development programs

 

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Recent Developments

 

IMOH Approval of Investigator-Initiated Phase I/II Trial

 

In June 2024, the IMOH authorized the initiation of an investigator-initiated, randomized, placebo-controlled Phase I/II trial to evaluate the efficacy, safety and tolerability of Allocetra™ following injection into patients with basal thumb joint (first carpometacarpal (CMC) joint) osteoarthritis. The investigator-initiated Phase I/II trial plans to recruit up to 46 patients and is composed of two stages. The first stage is a safety run-in, open-label dose escalation phase to characterize the safety and tolerability of Allocetra™ injection to patients with osteoarthritis of the first basal thumb joint (first CMC joint) of the target thumb who have failed conventional therapies, to identify the dose for the randomized stage. The second stage is a double-blind, randomized, placebo-controlled stage, which is expected to be initiated following the completion of the safety run-in stage and selection of the safe and tolerable dose. Up to 40 patients will be randomized in a 1:1 ratio for treatment with Allocetra™ at the selected dose or placebo. The primary safety endpoint will measure the frequency and severity of adverse events and serious adverse events and the efficacy endpoints will include assessments of change from baseline in pain and function for up to 12 months.

 

Topline Interim Data Readout

 

In June 2024, the Company released a positive interim data readout from a Phase I/II investigator-initiated clinical trial of Allocetra™ in patients with end-stage knee osteoarthritis who had been indicated for knee replacement surgery. In this study, patients with end-stage knee osteoarthritis are offered a single Allocetra™ injection to the knee as a potential “last resort” alternative for pain resolution and knee functionality in lieu of knee-replacement surgery. A total of nine patients have been enrolled and treated with a single Allocetra™ injection to the knee and evaluated for at least three months following treatment. Patients reported pain using a scale of zero (0, representing no pain) to ten (10, representing maximum pain).

 

At the three-month follow up, a substantial reduction (51%) in average reported pain was observed compared to baseline, with 89% (8/9) of treated patients reporting an improvement in their knee pain compared to their baseline pain prior to treatment, and 22% (2/9) of the patients reporting complete pain relief from an average pain level of 9 to a pain level of 0.

 

During the three-month period post injection of Allocetra™, only a single patient (1/9, 11%) decided to move forward with knee-replacement surgery, while 89% (8/9) of the patients decided not to proceed with such surgery. In all cases, dosing was successfully completed, and no severe related adverse events were reported following treatment.

 

Recruitment to the study and long-term follow up are ongoing. The study aims to enroll a total of 18 patients to be treated with a single injection of Allocetra™ to the afflicted knee. Patients are assessed for safety following dosing, and pain and function responses to treatment up to 12 months following injection.

 

IMOH Approval of Phase I Clinical Trial

 

In July 2024, the Company announced that the IMOH has authorized the initiation of a Phase I clinical trial to evaluate the safety and tolerability of Allocetra™ following injection into an affected joint in patients with psoriatic arthritis.

 

The trial currently plans to recruit six patients who have insufficiently responded to conventional therapies for psoriatic arthritis. The primary safety endpoint will measure the frequency and severity of adverse events and serious adverse events, and secondary endpoints will include assessments of change from baseline in pain and other parameters of disease activity for up to 12 months following administration of Allocetra™.

 

Recent Developments In Israel

 

In October 2023, Hamas terrorists infiltrated Israel’s southern border from the Gaza Strip and conducted a series of attacks on civilian and military targets. Hamas also launched extensive rocket attacks on the Israeli population and industrial centers located along Israel’s border with the Gaza Strip and in other areas within the State of Israel. These attacks resulted in thousands of deaths and injuries, and Hamas additionally kidnapped many Israeli civilians and soldiers. Following the attack, Israel’s security cabinet declared war against Hamas and commenced a military campaign against Hamas.

 

3

 

 

In April 2024, Israel experienced a direct attack from Iran, involving hundreds of drones and missiles launched towards various parts of the country, mostly targeting military bases. The Israeli defense systems, aided by international allies, successfully intercepted the majority of these attacks, minimizing physical damage and casualties. Additionally, Since October 2023, the Houthis, a military organization based in Yemen, have launched a series of attacks on global shipping routes in the Red Sea, as well as direct attacks on various parts of Israel. Such incidents contribute to regional instability and could potentially escalate into broader conflicts with Iran and its proxies in the Middle East, affecting Israel’s political and trade relations, especially with neighboring countries and global allies. The situation remains fluid, and the potential for further escalation exists.

 

The ongoing war with Hamas, and the conflict with Iran and its proxies have not, to date, materially impacted our business or operations. Furthermore, we do not expect any delays to any of our clinical trials or programs as a result of such conflicts. However, we cannot currently predict the intensity or duration of Israel’s war against Hamas or the conflict with Iran and its proxies, nor can we predict how such conflicts will ultimately affect our business and operations or Israel’s economy in general.

 

Costs and Operating Expenses

 

Our current costs and operating expenses consist of two components: (i) research and development expenses; and (ii) general and administrative expenses.

 

Research and Development Expenses

 

Our research and development expenses consist primarily of research and development activities at our laboratory in Israel, including drug and laboratory supplies and costs for facilities and equipment, outsourced development expenses, including the costs of regulatory consultants and certain other service providers, salaries and related personnel expenses (including share based compensation) and fees paid to external service providers and the costs of preclinical studies and clinical trials. We charge all research and development expenses to operations as they are incurred. We expect our research and development expenses to remain our primary expenses for the foreseeable future as we continue to develop our product candidates. Increases or decreases in research and development expenditures are primarily attributable to the number and duration of our preclinical and clinical studies.

 

We expect that a large percentage of our research and development expenses in the future will be incurred in support of our current and future preclinical and clinical development projects. Due to the inherently unpredictable nature of preclinical and clinical development processes, we are unable to estimate with any certainty the costs we will incur in the continued development of our product candidates in our pipeline for potential commercialization. Furthermore, although we expect to apply for additional grants from the IIA, we cannot be certain that we will obtain such grants. Clinical development timelines, the probability of success and development costs can differ materially from expectations. We expect to continue to test our product candidates in preclinical and clinical studies for, among other things, toxicology, safety and efficacy.

 

While we are currently focused on advancing our product development, our future research and development expenses will depend on the clinical success of our product candidates, as well as ongoing assessments of each candidate’s commercial potential. As we obtain results from clinical trials, we may elect to discontinue or delay clinical trials for our product candidates in certain of the Indications in order to focus our resources on more promising indications for any such product candidate. Completion of clinical trials may take several years or more, but the length of time generally varies according to the type, complexity, novelty and intended use of a product candidate.

 

We expect our research and development expenses to increase in the future as we continue the development of our product candidates for the Indications and as we potentially pursue additional indications. The lengthy process of completing clinical trials and seeking regulatory approval for our product candidates requires the expenditure of substantial resources. Any failure or delay in completing clinical trials, or in obtaining regulatory approvals, could cause a delay in generating product revenue and cause our research and development expenses to increase and, in turn, have a material adverse effect on our financial position and operations.

 

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General and Administrative Expenses

 

General and administrative expenses consist primarily of compensation (including share-based compensation) for employees in executive and operational roles, including accounting, finance, investor relations, information technology and human resources. Our other significant general and administrative expenses include facilities costs, professional fees for outside accounting and legal services, including legal work in connection with patent applications, travel costs and insurance premiums. We expect that our general and administrative expenses will increase over time, as we currently expect increases in the number of our executive, accounting and administrative personnel due to our anticipated growth.

 

Other expenses, net

 

Other expenses, net consists of bank fees, exchange rate differences and gains and losses resulting from our investments in bank deposits and marketable securities.

 

Critical Accounting Policies and Estimates

 

The preparation of financial statements in accordance with U.S. generally accepted accounting principles (“GAAP”) requires management to make estimates and assumptions that affect the amounts reported in our financial statements and accompanying notes. Management bases its estimates on historical experience, market and other conditions, and various other assumptions it believes to be reasonable. Although these estimates are based on management’s best knowledge of current events and actions that may impact us in the future, the estimation process is, by its nature, uncertain given that estimates depend on events over which we may not have control. If market and other conditions change from those that we anticipate, our financial statements may be materially affected. In addition, if our assumptions change, we may need to revise our estimates, or take other corrective actions, either of which may also have a material effect in our financial statements. We review our estimates, judgments, and assumptions used in our accounting practices periodically and reflect the effects of revisions in the period in which they are deemed to be necessary. We believe that these estimates are reasonable; however, our actual results may differ from these estimates.

 

We believe the following accounting policies to be the most critical to the judgments and estimates used in the preparation of our financial statements. For additional detail regarding our significant accounting policies, please see the notes to our audited consolidated financial statements contained in our Annual Report on Form 20-F for the year ended December 31, 2023 as filed with the U.S. Securities and Exchange Commission (the “SEC”) on April 30, 2024.

 

Share-Based Compensation

 

We have issued restricted stock units and options to purchase our ordinary shares. Share-based compensation cost is measured at the grant date based on the fair value of the award and is recognized as an expense over the requisite service/vesting period. Determining the appropriate fair value model and calculating the fair value of share-based payment awards require the use of highly subjective assumptions, including the expected life of the share-based payment awards and share price volatility.

 

We estimate the grant date fair value of share options and the related compensation expense, using the Black-Scholes option valuation model. This option valuation model requires the input of subjective assumptions including: (1) expected life (estimated period of time outstanding) of the options granted, (2) volatility, (3) risk-free rate and (4) dividends. In general, the assumptions used in calculating the fair value of share-based payment awards represent management’s best estimates, but the estimates involve inherent uncertainties and the application of management judgment.

 

Preclinical and clinical trial accruals

 

The Company makes estimates of its accrued expenses as of each balance sheet date in the financial statements based on the facts and circumstances known at that time. Accrued expenses for preclinical studies and clinical trials are based on estimates of costs incurred and fees that may be associated with services provided by contract research organizations, clinical trial sites and other clinical trial-related activities. Payments under certain contracts with such parties depend on factors such as successful enrollment of patients, site initiation and the completion of clinical trial milestones. If possible, the Company obtains information regarding unbilled services directly from these service providers. However, the Company may be required to estimate these services based on other available information. If the Company underestimates or overestimates the activities or fees associated with a study or service at a given point in time, adjustments to research and development expenses may be necessary in future periods. Historically, estimated accrued liabilities have approximated actual expense incurred.

 

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Results of Operations

 

Six-Months Ended June 30, 2024 Compared to Six-Months Ended June 30, 2023 

 

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

  

   Six Months Ended
June 30
 
   2024   2023 
   (In thousands, except per share data)
(unaudited)
 
Research and development expenses  $4,856   $10,211 
General and administrative expenses   2,080    3,221 
Loss on disposal group of assets held for sale   201      
Operating loss   (7,137)   (13,432)
Finance expenses, net   (99)   (578)
Operating loss post other expenses, net   (7,236)   (14,010)
Taxes on income   -    - 
Net loss   (7,236)   (14,010)
           
Basic loss per share  $(0.38)  $(0.76)
Diluted loss per share  $(0.38)  $(0.76)

  

Three-Months Ended June 30, 2024 Compared to Three-Months Ended June 30, 2023

 

The table below provides our results of operations for the three months ended June 30, 2024 and June 30, 2023:

 

   Three  Months Ended
June 30
 
   2024   2023 
   (In thousands, except per share data)
(unaudited)
 
Research and development expenses  $1,999   $5,035 
General and administrative expenses   987    1,614 
Loss on disposal group of assets held for sale   -    - 
Operating loss   (2,986)   (6,649)
Finance expenses, net   (110)   (143)
Operating loss post other expenses, net        (6,792)
Taxes on income   -    - 
Net loss   (3,096)   (6,792)
           
Basic loss per share  $(0.16)  $(0.37)
Diluted loss per share  $(0.16)  $(0.37)

 

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Research and Development Expenses

 

For the six months ended June 30, 2024 and 2023, we incurred research and development expenses in the aggregate of $4,856,000 and $10,211,000, respectively. The decrease of $5,355,000, or 52%, in research and development expenses for the six months ended June 30, 2024 as compared to the comparable six month period in 2023 was primarily due to a $1,472,000 decrease in salaries as a result of the reduction in workforce as part of the strategic reprioritization plan, a $3,702,000 decrease in expenses for clinical studies and pre-clinical studies and purchase of materials due to a decrease in the number of AllocetraTM doses that were manufactured, and a $227,000 decrease in lease and overhead expenses.

 

For the three months ended June 30, 2024 and 2023, we incurred research and development expenses in the aggregate of $1,999,000 and $5,035,000, respectively. The decrease of $3,036,000, or 60%, in research and development expenses for the three months ended June 30, 2024 as compared to the second quarter of 2023 was primarily due to a $731,000 decrease in salaries as a result of the reduction in workforce as part of the strategic reprioritization plan, and a $2,414,000 decrease in expenses for clinical studies and pre-clinical studies and purchase of materials due to a decrease in the number of AllocetraTM doses that were manufactured.

 

General and Administrative Expenses

 

For the six months ended June 30, 2024 and 2023, we incurred general and administrative expenses in the aggregate of $2,080,000 and $3,221,000, respectively. The decrease of $1,141,000 or 35%, in general and administrative expenses for the six months ended June 30, 2024 as compared to the comparable six month period in 2023 was primarily due to a $324,000 decrease in expense with respect to equity awards granted to directors, officers and employees, a $136,000 decrease in insurance expenses (due to a decrease in our directors’ and officer’s liability insurance premium), a $292,000 decrease in lease and overhead expense, a $116,000 decrease in professional fees related to intellectual property regulatory expenses, and a $125,000 decrease in salaries.

 

For the three months ended June 30, 2024 and 2023, we incurred general and administrative expenses in the aggregate of $987,000 and $1,614,000, respectively. The decrease of $627,000, or 39%, in general and administrative expenses for the three months ended June 30, 2024 as compared to the second quarter of 2023 was primarily due to a $146,000 decrease in expense with respect to equity awards granted to directors, officers and employees, a $202,000 decrease in lease and overhead expense, a $80,000 decrease in professional fees related to intellectual property regulatory expenses, a $49,000 decrease in professional fees, and a $78,000 decrease in salaries.

  

Loss on Disposal Group of Assets Held for Sale

 

During 2023, the Company adopted its strategic reprioritization plan, as described above, as part of which the Company determined to sell its manufacturing plant facility in Yavne, Israel. Therefore, the right of use of the manufacturing plant, the lease liability relating to the manufacturing plant and the leasehold improvements installed in the leased plant were classified as assets held for sale and liability held for sale (as applicable). As a result, for the year ended December 31, 2023, we recognized a loss of $4,244,000 on the group of assets held for sale. For the first half of 2024, we recorded an additional $201,000 loss on the group of assets held for sale.

 

In September 2021, we entered into a lease agreement for a 2,500 square meter property in Yavne, Israel to construct a new 1,600 square meter facility for the manufacture of Allocetra™, which was completed in the fourth quarter of 2022. As part of our strategic reprioritization plan, we determined to sell such leased manufacturing facility, together with related equipment, and assign the lease agreement. On March 31, 2024, we entered into a sale agreement with a purchaser, pursuant to which the purchaser agreed to acquire such equipment and assume all of our obligations under the lease agreement, effective as of April 1, 2024. The 13.0 million NIS (approximately $3.5 million) aggregate purchase price payable to the Company, which is payable in installments, consists of an initial payment of NIS 4.0 million (approximately $1.08 million), which was paid on April 2, 2024, and 24 equal monthly installment payments of NIS 375,000 (approximately $102,000), commencing on April 1, 2024. Under the sale agreement, title to the equipment will transfer to the purchaser only upon full payment of the total purchase price, but risk of loss to the equipment passed to the purchaser on April 1, 2024. Subject to certain conditions, the purchaser may, in its sole discretion, prior to October 1, 2025, prepay (i) all of the remaining outstanding purchase price at a 4% discount, or (ii) a portion of the remaining outstanding purchase price, in an amount of not less than NIS 4.0 million (approximately $1.08 million), at a 2% discount, in which case, the purchase price remaining outstanding thereafter shall continue to be paid in monthly instalments of NIS 375,000 each (approximately $102,000).

 

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Operating Loss

 

Due to a decrease in research and development expenses and a decrease in general and administrative expenses for the six and three months ended June 30, 2024, our operating loss was $7,137,000 and $2,986,000, respectively, representing a decrease of $6,295,000 and $3,663,000, or 47%% and 55%, respectively, as compared to our operating loss of $13,432,000 and $6,649,000 for the six and three months ended June 30, 2023, respectively. This decrease resulted primarily from a decrease in research and development expenses, including expenses relating to conducting studies and trials, and a decrease in salaries as a result of the reduction in workforce as part of the strategic reprioritization plan, in each case as described above.

 

Finance expenses, net

 

Finance expenses, net consists of the following:

  

  Interest earned on our cash and cash equivalents and bank deposits; and

 

  Expenses or income resulting from fluctuations of the NIS and Euro, in which a portion of our assets and liabilities are denominated, against the U.S. dollar.

 

For the six and three months ended June 30, 2024 and 2023, we recorded finance expenses, net of $99,000, $110,000, $578,000 and $143,000 respectively. The decrease of $479,000, or 83%, in finance expenses, net for the six months ended June 30, 2024 as compared to the six months ended June 30, 2023 was primarily due to $540,000 of interest income earned on cash equivalents and bank deposits in 2024, as compared to $884,000 in 2023, offset by a loss of $639,000 resulting from foreign exchange currency fluctuations on cash and cash equivalents in 2024 as compared to a loss of $1,458,000 in 2023.

 

The decrease of $33,000, or 23%, in finance expenses, net for the three months ended June 30, 2024 as compared to the three months ended June 30, 2023 was primarily due to $265,000 interest income on bank deposits in 2024 as compared to $422,000 in 2023, offset by a loss of $375,000 resulting from foreign exchange currency fluctuations on cash and cash equivalents in 2024 as compared to $558,000 in 2023.

 

Net Loss

 

For the six and three months ended June 30, 2024 and 2023, our net loss was $7,236,000, $3,096,000, $14,010,000 and $6,792,000, respectively, representing a decrease of $6,774,000 and $3,696,000, or 48% and 54%, respectively, as compared to our net loss for the comparable prior year periods.

 

This decrease resulted primarily from a decrease in clinical and pre-clinical studies, material consumption and salaries, and from an increase in finance income, net.

 

Cash Flows

 

Six Months Ended June 30, 2024 Compared to Six Months Ended June 30, 2023

 

For the six months ended June 30, 2024 and 2023, net cash used in operations was $6,307,000 and $12,807,000, respectively. The decrease in net cash used in operations for 2024 was primarily due to a decrease in payments to suppliers, service providers and employees as result of a decrease in payroll and insurance expenses, as well as a decrease in research and development expenses, mainly from decreased clinical and pre-clinical study expenses.

 

For the six months ended June 30, 2024 and 2023, net cash provided by (used in) investing activities was $4,304,000 and $(34,048,000) respectively. The increase in net cash provided by investing activities for 2024 as compared to 2023 resulted primarily from a net release of investments in bank deposits of $4,138,000 in 2024 as compared to a net investment in bank deposits of $33,930,000 in the comparable prior year period.

 

8

 

 

For the six months ended June 30, 2024 and 2023, net cash provided by financing activities was $4,943,000 and $360,000, respectively. This increase in cash provided by financing activities for 2024 as compared to 2023 resulted primarily from net proceeds of $4,416,000 from issuance of ordinary shares and warrants in the May 2024 Offering (as defined below) and from net proceeds of $527,000 from our issuance of ordinary shares under the ATM Agreement (as defined below), as compared to net proceeds of $360,000 from our issuance of ordinary shares under the ATM Agreement in the comparable prior year period.

 

Liquidity and Capital Resources

 

We have incurred substantial losses since our inception. As of June 30, 2024, we had an accumulated deficit of approximately $119.3 million and working capital (current assets less current liabilities) of approximately $25.7 million. We expect to incur losses from operations for the foreseeable future.

 

Developing product candidates, conducting clinical trials and commercializing products are expensive, and we will need to raise substantial additional funds to achieve our strategic objectives. We believe that our existing cash resources will be sufficient to fund our projected cash requirements approximately through the end of 2026. Nevertheless, we will require significant additional financing in the future to fund our operations, including if and when we progress into additional clinical trials, obtain regulatory approval for any of our product candidates and commercialize the same. We believe that we will need to raise significant additional funds before we have any cash flow from operations, if at all. Our future capital requirements will depend on many factors, including:

 

the progress and costs of our preclinical studies, clinical trials and other research and development activities;

 

  the scope, prioritization and number of our clinical trials and other research and development programs;

 

  the amount of revenues and contributions we receive under future licensing, development and commercialization arrangements with respect to our product candidates;

 

  the costs of the development and expansion of our operational infrastructure;

 

  the costs and timing of obtaining regulatory approval for our product candidates;

 

  the costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights;

 

  the costs and timing of securing manufacturing arrangements for clinical or commercial production;

 

  the costs of contracting with third parties to provide sales and marketing capabilities for us;

 

  the costs of acquiring or undertaking development and commercialization efforts for any future products, product candidates or platforms;

 

  the receipt of additional government grants;

 

  the magnitude of our general and administrative expenses; and

 

  any cost that we may incur under future in- and out-licensing arrangements relating to our product candidates.

 

Other than under our ATM Agreement, we currently do not have any agreements for future external funding. In the future, we will need to raise additional funds, and we may decide to raise additional funds even before we need such funds if the conditions for raising capital are favorable. Until we can generate significant recurring revenues, we expect to satisfy our future cash needs through debt or equity financings, credit facilities or by out-licensing applications of our product candidates. The sale of equity, including under our ATM Agreement, or convertible debt securities may result in dilution to our existing shareholders. The incurrence of indebtedness would result in increased fixed obligations and could also subject us to covenants that restrict our operations. We cannot be certain that additional funding, whether through grants from the IIA, financings, credit facilities or out-licensing arrangements, will be available to us on acceptable terms, if at all. If sufficient funds are not available, we may be required to delay, reduce the scope of or eliminate research or development plans for, or commercialization efforts with respect to, one or more applications of our product candidates, or obtain funds through arrangements with collaborators or others that may require us to relinquish rights to certain potential products that we might otherwise seek to develop or commercialize independently.

  

9

 

 

ATM Agreement

 

On December 30, 2022, we entered into an agreement (the “ATM Agreement”) with Cantor Fitzgerald & Co. and JMP Securities LLC (each referred to as an “Agent”, and together, the “Agents”), as sales agents, pursuant to which we may elect to sell, but are not obligated to sell, ordinary shares having an aggregate offering price of up to $100,000,000 from time to time through the Agents. Our offer and sale of ordinary shares under the ATM Agreement may be made in transactions deemed to be “at-the-market” offerings as defined in Rule 415 under the Securities Act, including sales made directly on or through the Nasdaq Capital Market, or any other existing trading market in the United States for the ordinary shares, sales made to or through a market maker other than on an exchange or otherwise, directly to an Agent as principal, in negotiated transactions, or in any other method permitted by law, which may include block trades. We have agreed to pay the Agents an aggregate commission of 3.0% of the gross sales price from each sale of ordinary shares under the ATM Agreement. Any sale of ordinary shares under the ATM Agreement will be made pursuant to our effective shelf registration statement on Form F-3, including the prospectus contained therein (File No. 333-264561). During the six months ended June 30 2024, we received aggregate net proceeds of approximately $527,000 from the sale of 180,707 ordinary shares under the ATM Agreement.

 

May 2024 Financing

 

On May 27, 2024, we entered into a securities purchase agreement with a single institutional investor in connection with the issuance and sale by the Company in a registered direct offering (the “May 2024 Offering”) of (i) 2,060,000 of our ordinary shares, (ii) pre-funded warrants to purchase up to 1,511,429 ordinary shares (the “Pre-Funded Warrants”), (iii) Series A warrants to purchase up to 3,571,429 ordinary shares (the “Series A Warrants”) and (iv) Series B warrants to purchase up to 3,571,429 ordinary shares (the “Series B Warrants” and, together with the Series A Warrants, the “Investor Warrants”), at a combined purchase price of (a) $1.40 per ordinary share and the associated Investor Warrants, each to purchase one ordinary share, and (b) $1.399 per Pre-Funded Warrant and the associated Investor Warrants, each to purchase one ordinary share, pursuant to the Company’s effective shelf registration statement on Form F-3 (File No. 333-264561) and a related base prospectus, together with the related prospectus supplement, dated as of May 27, 2024, filed with the SEC.

 

Each Investor Warrant has an exercise price of $1.40 per ordinary share and is immediately exercisable. The Series A Warrants expire upon the earlier of 18 months following the issuance date and 60 days following our public announcement of positive topline results from the ENX-CL-05-001 trial of AllocetraTM for the treatment of moderate-to-severe knee osteoarthritis. The Series B warrants expire upon the earlier of five and one-half years following the issuance date and 60 days following our public announcement of our filing with the U.S. Food and Drug Administration (the “FDA”) for approval for AllocetraTM’s osteoarthritis related indication. Each Pre-Funded Warrant has an exercise price of $0.001 per ordinary share, is immediately exercisable and may be exercised at any time and has no expiration date. The Investor Warrants and the Pre-Funded Warrants are subject to customary adjustments; however, no such warrants contain any “ratchet” or other financial antidilution provisions. None of the Investor Warrants may be exercised if the aggregate number of ordinary shares beneficially owned by the holder thereof would exceed 4.99% immediately after exercise thereof, subject to increase to 9.99% at the option of the holder. None of the Pre-Funded Warrants may be exercised if the aggregate number of ordinary shares beneficially owned by the holder thereof would exceed 9.99% immediately after exercise thereof.

 

H.C. Wainwright & Co. (“Wainwright”) acted as placement agent in connection with the May 2024 Offering, and in consideration therefor we agreed to register and issue to Wainwright warrants (the “Placement Agent Warrants”) to purchase up to 250,000 of our ordinary shares pursuant to the above noted registration statement. The Placement Agent Warrants comprise Series A Warrants to purchase 125,000 of our ordinary shares and Series B Warrants to purchase 125,000 of our ordinary shares, containing the same terms as the Investor Warrants, except that they are exercisable at a price of $1.75 per ordinary share, and the Series B Warrants will expire upon the earlier of five years following the commencement of the sale of the securities offered in the May 2024 Offering and 60 days following the public announcement of our filing with the FDA for approval for AllocetraTM’s osteoarthritis related indication. The net proceeds from the May 2024 Offering were approximately $4,416 thousand after deducting Wainwright’s fees and other offering expenses. We intend to use the net proceeds from the May 2024 Offering for working capital and other general corporate purposes.

 

Foreign Currency Exchange Risk

 

Our foreign currency exposures give rise to market risk associated with exchange rate movements of the NIS mainly against the U.S. dollar, and vice versa, because a considerable portion of our expenses are denominated in the NIS. Our NIS expenses consist principally of payments made to employees, sub-contractors and consultants for preclinical studies, clinical trials and other research and development activities. We anticipate that a sizable portion of our expenses will continue to be denominated in the NIS. Our financial position, results of operations and cash flow are subject to fluctuations due to changes in foreign currency exchange rates. Our results of operations and cash flow are, therefore, subject to fluctuations due to changes in foreign currency exchange rates and may be adversely affected in the future due to changes in foreign exchange rates.

 

 

10

 

 

v3.24.2.u1
Document And Entity Information
6 Months Ended
Jun. 30, 2024
Document Information Line Items  
Entity Registrant Name ENLIVEX THERAPEUTICS LTD.
Document Type 6-K
Current Fiscal Year End Date --12-31
Amendment Flag false
Entity Central Index Key 0001596812
Document Period End Date Jun. 30, 2024
Document Fiscal Year Focus 2024
Document Fiscal Period Focus Q2
Entity File Number 001-36578
v3.24.2.u1
Condensed Consolidated Balance Sheets (Unaudited) - USD ($)
$ in Thousands
Jun. 30, 2024
Dec. 31, 2023
Current Assets    
Cash and cash equivalents $ 3,747 $ 813
Short-term interest-bearing deposits 22,195 26,507
Prepaid expenses and other receivables 2,400 1,336
Assets classified as held for sale 228 5,108
Total Current Assets 28,570 33,764
Non-Current Assets    
Other receivables 898
Property and equipment, net 1,158 1,539
Other assets 1,276 1,528
Total Non-Current Assets 3,332 3,067
TOTAL ASSETS 31,902 36,831
Current Liabilities    
Accounts payable 303 827
Accrued expenses and other liabilities 2,538 4,001
Liability classified as held for sale 1,233
Total Current Liabilities 2,841 6,061
Non-Current Liabilities    
Other long-term liabilities 499 686
Total Non-Current Liabilities 499 686
Commitments and Contingent Liabilities
TOTAL LIABILITIES 3,340 6,747
SHAREHOLDERS’ EQUITY    
Ordinary shares of NIS 0.40 par value per share Authorized: 45,000,000 shares as of June 30, 2024 and December 31, 2023; Issued and outstanding: 20,883,312 and 18,598,555 as of June 30, 2024 and December 31, 2023, respectively; 2,385 2,137
Additional paid in capital 144,405 138,939
Foreign currency translation adjustments 1,101 1,101
Accumulated deficit (119,329) (112,093)
TOTAL SHAREHOLDERS’ EQUITY 28,562 30,084
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY $ 31,902 $ 36,831
v3.24.2.u1
Condensed Consolidated Balance Sheets (Unaudited) (Parentheticals) - $ / shares
Jun. 30, 2024
Dec. 31, 2023
Statement of Financial Position [Abstract]    
Ordinary shares, par value (in Dollars per share) $ 0.4 $ 0.4
Ordinary shares, authorized 45,000,000 45,000,000
Ordinary shares, Issued 20,883,312 18,598,555
Ordinary shares, outstanding 20,883,312 18,598,555
v3.24.2.u1
Condensed Consolidated Statements Of Operations And Comprehensive Loss (Unaudited) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Income Statement [Abstract]        
Revenues
Operating expenses:        
Research and development expenses 1,999 5,035 4,856 10,211
General and administrative expenses 987 1,614 2,080 3,221
Loss on disposal group of assets held for sale 201
Total 2,986 6,649 7,137 13,432
Operating loss (2,986) (6,649) (7,137) (13,432)
Finance income (expense) (110) (143) (99) (578)
Net loss $ (3,096) $ (6,792) $ (7,236) $ (14,010)
Basic loss per share (in Dollars per share) $ (0.16) $ (0.37) $ (0.38) $ (0.76)
Weighted average number of shares outstanding (in Shares) 19,545,056 18,584,801 19,138,066 18,550,702
v3.24.2.u1
Condensed Consolidated Statements Of Operations And Comprehensive Loss (Unaudited) (Parentheticals) - $ / shares
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Income Statement [Abstract]        
Basic & diluted loss per share $ (0.16) $ (0.37) $ (0.38) $ (0.76)
v3.24.2.u1
Condensed Consolidated Statements of Changes in Shareholders' Equity (Unaudited) - USD ($)
$ in Thousands
Ordinary Shares
Additional paid in capital
Currency translation reserve
Accumulated deficit
Total
Balance at Dec. 31, 2022 $ 2,117 $ 136,648 $ 1,101 $ (83,025) $ 56,841
Balance (in Shares) at Dec. 31, 2022 18,421,852        
Restricted stock units vested $ 3 (3)
Restricted stock units vested (in Shares) 34,295        
Issuance of shares for cash consideration $ 13 305 318
Issuance of shares for cash consideration (in Shares) 110,115        
Stock based compensation 633 633
Net loss (7,218) (7,218)
Balance at Mar. 31, 2023 $ 2,133 137,583 1,101 (90,243) 50,574
Balance (in Shares) at Mar. 31, 2023 18,566,262        
Balance at Dec. 31, 2022 $ 2,117 136,648 1,101 (83,025) 56,841
Balance (in Shares) at Dec. 31, 2022 18,421,852        
Net loss         (14,010)
Balance at Jun. 30, 2023 $ 2,136 138,133 1,101 (97,035) 44,335
Balance (in Shares) at Jun. 30, 2023 18,589,139        
Balance at Mar. 31, 2023 $ 2,133 137,583 1,101 (90,243) 50,574
Balance (in Shares) at Mar. 31, 2023 18,566,262        
Restricted stock units vested $ 1 (1)
Restricted stock units vested (in Shares) 8,821        
Exercise of options
Exercise of options (in Shares)        
Issuance of shares for cash consideration $ 2 40 42
Issuance of shares for cash consideration (in Shares) 14,056        
Stock based compensation 511 511
Net loss (6,792) (6,792)
Balance at Jun. 30, 2023 $ 2,136 138,133 1,101 (97,035) 44,335
Balance (in Shares) at Jun. 30, 2023 18,589,139        
Balance at Dec. 31, 2023 $ 2,137 138,939 1,101 (112,093) $ 30,084
Balance (in Shares) at Dec. 31, 2023 18,598,555       18,598,555
Restricted stock units vested $ 3 (3)
Restricted stock units vested (in Shares) 34,295        
Issuance of shares for cash consideration $ 20 504 524
Issuance of shares for cash consideration (in Shares) 178,931        
Stock based compensation 383 383
Net loss (4,140) (4,140)
Balance at Mar. 31, 2024 $ 2,160 139,823 1,101 (116,233) 26,851
Balance (in Shares) at Mar. 31, 2024 18,811,781        
Balance at Dec. 31, 2023 $ 2,137 138,939 1,101 (112,093) $ 30,084
Balance (in Shares) at Dec. 31, 2023 18,598,555       18,598,555
Net loss         $ (7,236)
Balance at Jun. 30, 2024 $ 2,385 144,405 1,101 (119,329) $ 28,562
Balance (in Shares) at Jun. 30, 2024 20,883,312       20,883,312
Balance at Mar. 31, 2024 $ 2,160 139,823 1,101 (116,233) $ 26,851
Balance (in Shares) at Mar. 31, 2024 18,811,781        
Restricted stock units vested $ 1 (1)
Restricted stock units vested (in Shares) 9,755        
Exercise of options
Issuance of shares for cash consideration $ 224 4,195 4,419
Issuance of shares for cash consideration (in Shares) 2,061,776        
Stock based compensation 388 388
Net loss (3,096) (3,096)
Balance at Jun. 30, 2024 $ 2,385 $ 144,405 $ 1,101 $ (119,329) $ 28,562
Balance (in Shares) at Jun. 30, 2024 20,883,312       20,883,312
v3.24.2.u1
Condensed Consolidated Statements of Changes in Shareholders' Equity (Unaudited) (Parentheticals) - USD ($)
$ in Thousands
3 Months Ended
Jun. 30, 2024
Mar. 31, 2024
Jun. 30, 2023
Mar. 31, 2023
Statement of Stockholders' Equity [Abstract]        
Cash consideration $ 5,001 $ 540 $ 43 $ 470
Net of issuance costs $ 582 $ 16 $ 1 $ 152
v3.24.2.u1
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 $ (7,236) $ (14,010)
Income and expenses not involving cash flows:    
Depreciation 348 421
Capital gain on sale of property and equipment (79)
Loss on short-term bank deposits 166 1,626
Gain on assets and liabilities classified as held for sale (66)
Non-cash operating lease expenses 181 434
Share-based compensation 771 1,144
Changes in operating asset and liability items:    
Decrease in prepaid expenses and other receivables 1,792 (169)
Decrease in accounts payable (524) (240)
Decrease in accrued expenses and other liabilities (1,453) (1,389)
Operating lease liabilities (207) (624)
Net cash used in operating activities (6,307) (12,807)
Cash flows from investing activities    
Purchase of property and equipment (59) (200)
Proceeds from sale of property and equipment 171 82
Proceeds from sale of assets held for sale 54
Investment in short-term interest-bearing bank deposits (18,774) (34,218)
Release of short-term interest-bearing bank deposits 22,912 288
Net cash provided by (used in) investing activities 4,304 (34,048)
Cash flows from financing activities    
Proceeds from issuance of shares and warrants, net 4,943 360
Proceeds from exercise of options
Net cash provided by financing activities 4,943 360
Increase (decrease) in cash and cash equivalents 2,940 (46,495)
Cash and cash equivalents - beginning of period 1,226 50,357
Cash and cash equivalents - end of period 4,166 3,862
Supplemental disclosures of cash flow information:    
Cash paid for taxes
Cash received for interest, net $ 906 $ 233
v3.24.2.u1
General Information
6 Months Ended
Jun. 30, 2024
General Information [Abstract]  
GENERAL INFORMATION

NOTE 1 - GENERAL INFORMATION

 

a.General

 

Enlivex Therapeutics Ltd. (the “Parent” and, including its consolidated subsidiaries, “we”, “us”, “our” or the “Company”) was originally incorporated on January 22, 2012 under the laws of the State of Israel.

 

The Company is a clinical stage macrophage reprogramming immunotherapy company, developing AllocetraTM, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of debilitating and life-threatening conditions. Non-homeostatic macrophages contribute significantly to the severity of certain diseases, which include, sepsis, osteoarthritis and others.

 

AllocetraTM is based on the discoveries of Professor Dror Mevorach, an expert on immune activity, macrophage activation and clearance of dying (apoptotic) cells, in his laboratory in the Hadassah University Hospital located in the State of Israel. 

 

The Company’s ordinary shares, par value of NIS 0.40 per share (“Ordinary Shares”), are traded under the symbol “ENLV” on both the Nasdaq Capital Market and on the Tel Aviv Stock Exchange.

 

b.Financial Resources

 

The Company devotes substantially all of its efforts toward research and development activities and raising capital to support such activities. The Company’s activities are subject to significant risks and uncertainties, including failing to secure additional funding before the Company achieves sustainable revenues and profit from operations.

 

Research and development activities have required significant capital investment since the Company’s inception. The Company expects that its operations will require additional cash investment to pursue the Company’s research and development activities, including preclinical studies, formulation development, clinical trials and related drug manufacturing. The Company has not generated any revenues or product sales and has not achieved profitable operations or positive cash flow from operations. The Company has incurred net losses since its inception, and, as of June 30, 2024, had an accumulated deficit of $119,329 thousand.

 

The Company expects to continue to incur losses for the foreseeable future, and the Company will need to raise additional debt or equity financing or enter into partnerships to fund its development. If the Company is not able to achieve its funding requirements, it may be required to reduce discretionary spending, may not be able to continue the development of its product candidates or may be required to delay its development programs, which could have a material adverse effect on the Company’s ability to achieve its intended business objectives. There can be no assurances that additional financing will be secured or, if secured, will be on favorable terms. The ability of the Company to transition to profitability in the longer term is dependent on developing products and product revenues to support its expenses.

 

The Company’s management and board of directors (the “Board”) are of the opinion that the Company’s current financial resources will be sufficient to continue the development of the Company’s product candidates for at least twelve months following the filing of these financial statements on Form 6-K. The Company may determine, however, to raise additional capital during such period as the Board deems prudent. The Company’s management plans to finance its operations with issuances of the Company’s equity securities and, in the longer term, revenues. There are no assurances, however, that the Company will be successful in obtaining the financing necessary for its long-term development. The Company’s ability to continue to operate in the long term is dependent upon additional financial support.

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

 

Basis of Presentation

 

These unaudited condensed consolidated financial statements include the accounts of the Company and have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information. Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been made.

 

These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited annual financial statements and notes thereto included in the Company’s 2023 Annual Report on Form 20-F, as filed with the U.S. Securities and Exchange Commission on April 30, 2024. The results of operations for these interim periods are not necessarily indicative of the operating results for any future period. The December 31, 2023 financial information has been derived from the Company’s audited financial statements.

 

Use of Estimates

 

The preparation of interim financial statements in conformity with U.S. GAAP requires management to make certain estimates, judgments and assumptions that affect the reported amounts in the consolidated balance sheets and statements of operations, it also requires that management exercise its judgment in applying the Company’s accounting policies. On an ongoing basis, management evaluates its estimates, including estimates related to its stock-based compensation expense and implicit interest rate on new lease liabilities. Significant estimates in these interim financial statements include estimates made for accrued research and development expenses and stock-based compensation expenses.

 

Functional Currency and Translation to The Reporting Currency

 

The functional currency of the Company is the U.S. dollar because the U.S. dollar is the currency of the primary economic environment in which the Company operates and expects to continue to operate in the foreseeable future.

 

Balances related to non-monetary assets and liabilities are based on translated amounts as of the date of the change, and non-monetary assets acquired and liabilities were translated at the approximate exchange rate prevailing at the date of the transaction. Transactions included in the statement of income were translated at the approximate exchange rate in effect at the time of the transaction.

 

1 U.S. dollar = 3.759 NIS and 3.627 NIS as of June 30, 2024 and December 31, 2023, respectively.

 

The U.S. dollar increased against the NIS 2.12%, 3.64%, 2.35% and 5.14% in the three and six month periods ended June 30, 2024 and 2023, respectively.

 

Recently Adopted Accounting Standards

 

During the three months ended June 30, 2024, the Company was not required to adopt any recently issued accounting standards.

 

Recently Issued Accounting Pronouncements Not Yet Adopted

 

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which is intended to provide enhanced segment disclosures. The standard will require disclosures about significant segment expenses and other segment items and identifying the Chief Operating Decision Maker and how they use the reported segment profitability measures to assess segment performance and allocate resources. These enhanced disclosures are required for all entities on an interim and annual basis, even if they have only a single reportable segment. The standard is effective for years beginning after December 15, 2023 and interim periods within annual periods beginning after December 15, 2024, and early adoption is permitted. The Company does not believe that adoption of this ASU will have a material impact on the Company’s consolidated financial statements.

 

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which is intended to provide enhancements to annual income tax disclosures. The standard will require more detailed information in the rate reconciliation table and for income taxes paid, among other enhancements. The standard is effective for years beginning after December 15, 2024, early adoption is permitted. The Company does not believe that adoption of this ASU will have a material impact on the Company’s consolidated financial statements.

 

Significant Accounting Policies

 

There have been no material changes to the significant accounting policies previously disclosed in the Company’s Annual Report on Form 20-F for the year ended December 31, 2023.

v3.24.2.u1
Cash, Cash Equivalents and Restricted Cash
6 Months Ended
Jun. 30, 2024
Cash, Cash Equivalents and Restricted Cash [Abstract]  
CASH, CASH EQUIVALENTS AND RESTRICTED CASH

NOTE 3 – CASH, CASH EQUIVALENTS AND RESTRICTED CASH

 

   June 30,   December 31, 
(in thousands)  2024   2023 
         
Cash held in banks  $3,747   $813 
Total cash and cash equivalents   3,747    813 
Restricted cash – current – Prepaid expenses and other receivables   113    113 
Restricted cash – noncurrent – Other assets   306    300 
Total cash, cash equivalents and restricted cash shown in the statement of cash flows  $4,166   $1,226 
v3.24.2.u1
Short Term Deposits
6 Months Ended
Jun. 30, 2024
Short Term Deposits [Abstract]  
SHORT TERM DEPOSITS

NOTE 4 – SHORT TERM DEPOSITS

 

   June 30,   December 31, 
(in thousands)  2024   2023 
         
Bank deposits in U.S.$ (annual average interest rates 5.86% and 6.195%)  $9,652   $6,240 
Bank deposits in NIS (annual average interest rates 4.317% and 4.568%)   12,543    20,267 
Total short-term deposits  $22,195   $26,507 
v3.24.2.u1
Prepaid Expenses and Other Receivables
6 Months Ended
Jun. 30, 2024
Prepaid Expenses and Other Receivables [Abstract]  
PREPAID EXPENSES AND OTHER RECEIVABLES

NOTE 5 – PREPAID EXPENSES AND OTHER RECEIVABLES

 

   June 30,   December 31, 
(in thousands)  2024   2023 
         
Prepaid expenses  $1,141   $1,107 
Tax authorities   47    116 
Others   1,212    113 
   $2,400   $1,336 
v3.24.2.u1
Property and Equipment
6 Months Ended
Jun. 30, 2024
Property and Equipment [Abstract]  
PROPERTY AND EQUIPMENT

NOTE 6 – PROPERTY AND EQUIPMENT

 

Property and equipment, net consists of the following:

 

  June 30,   December 31, 
(in thousands)  2024   2023 
         
Cost:          
Laboratory equipment  $2,130   $2,412 
Computers   431    380 
Office furniture & equipment   184    186 
Leasehold improvements   1,431    1,431 
Total cost   4,176    4,409 
Accumulated depreciation:          
Laboratory equipment   1,876    1,891 
Computers   296    263 
Office furniture & equipment   47    40 
Leasehold improvements   799    676 
Total accumulated depreciation   3,018    2,870 
Depreciated cost  $1,158   $1,539 

 

Depreciation expenses for the three and six month periods ended June 30, 2024 and 2023 were $160, $348, $212 and $421 thousand, respectively.

v3.24.2.u1
Other Assets
6 Months Ended
Jun. 30, 2024
Other Assets [Abstract]  
OTHER ASSETS

NOTE 7 – OTHER ASSETS

 

   June 30,   December 31, 
(in thousands)  2024   2023 
         
Restricted cash  $306   $300 
Long Term Deposit   8    8 
Long-term prepaid expenses   92    179 
Right-of-Use assets, net   870    1,041 
   $1,276   $1,528 
v3.24.2.u1
Accrued Expenses and Other Liabilities
6 Months Ended
Jun. 30, 2024
Accrued Expenses and Other Liabilities [Abstract]  
ACCRUED EXPENSES AND OTHER LIABILITIES

NOTE 8 – ACCRUED EXPENSES AND OTHER LIABILITIES

 

   June 30,   December 31, 
(in thousands)  2024   2023 
         
Vacation, convalescence and bonus accruals  $291   $341 
Employees and payroll related   314    422 
Short term operating lease liabilities   336    346 
Accrued expenses and other   1,597    2,892 
   $2,538   $4,001 
v3.24.2.u1
Leases
6 Months Ended
Jun. 30, 2024
Leases [Abstract]  
LEASES

NOTE 9 – LEASES

 

The Company is a party to operating leases for its corporate offices, laboratory space, plant space and vehicles.

 

   Six months ended
June 30,
 
(in thousands)  2024   2023 
         
The components of lease expense were as follows:          
Operating leases expenses  $207   $522 
Supplemental consolidated cash flow information related to operating leases follows:          
Cash used in operating activities  $212   $520 
Non-cash activity:          
Right of use assets obtained in exchange for new operating lease liabilities  $25   $145 

 

   June 30,   December 31, 
(in thousands)  2024   2023 
Supplemental information related to operating leases, including location of amounts reported in the accompanying consolidated balance sheets, follows:          
Other assets - Right-of-Use assets  $1,722   $2,161 
Accumulated amortization   852    1,120 
Operating lease Right-of-Use assets, net  $870   $1,041 
Lease liabilities – current - Accounts payable and accrued liabilities  $336   $346 
Lease liabilities – noncurrent   499    686 
Total operating lease liabilities  $835   $1,032 
Weighted average remaining lease term in years   2.89    3.3 
Weighted average annual discount rate   6.8%   6.7%

 

Maturities of operating lease liabilities as of June 30, 2024, were as follows:    
2024 (after June 30)  $191 
2025   355 
2026   193 
2027   117 
2028 and onwards   89 
Total undiscounted lease liability   945 
Less: Imputed interest   (110)
Present value of lease liabilities  $835 
v3.24.2.u1
Commitments and Contingent Liabilities
6 Months Ended
Jun. 30, 2024
Commitments and Contingent Liabilities [Abstract]  
COMMITMENTS AND CONTINGENT LIABILITIES

NOTE 10 – COMMITMENTS AND CONTINGENT LIABILITIES

 

The Company is required to pay royalties to the State of Israel (represented by the Israeli Innovation Authority (the “IIA”)), computed on the basis of proceeds from the sale or license of products for which development was supported by IIA grants. These royalties are generally 3% - 5% of sales until repayment of 100% of the grants (linked to the dollar) received by the Company plus annual interest at a SOFR-based rate.

 

The gross amount of grants received by the Company from the IIA, including accrued interest as of June 30, 2024, was approximately 9.9 million. As of June 30, 2024, the Company had not paid any royalties to the IIA.

v3.24.2.u1
Equity
6 Months Ended
Jun. 30, 2024
Equity [Abstract]  
EQUITY

NOTE 11 – EQUITY

 

a)On May 27, 2024, the Company entered into a securities purchase agreement with a single institutional investor in connection with the issuance and sale by the Company in a registered direct offering (the “Offering”) of (i) 2,060,000 Ordinary Shares, (ii) pre-funded warrants to purchase up to 1,511,429 Ordinary Shares (the “Pre-Funded Warrants”), (iii) Series A warrants to purchase up to 3,571,429 Ordinary Shares (the “Series A Warrants”) and (iv) Series B warrants to purchase up to 3,571,429 Ordinary Shares (the “Series B Warrants” and, together with the Series A Warrants, the “Investor Warrants”), at a combined purchase price of (a) $1.40 per Ordinary Share and the associated Investor Warrants, each to purchase one Ordinary Share, and (b) $1.399 per Pre-Funded Warrant and the associated Investor Warrants, each to purchase one Ordinary Share, pursuant to the Company’s effective shelf registration statement on Form F-3 (File No. 333-364561) and related base prospectus and prospectus supplement.

 

Each Investor Warrant has an exercise price of $1.40 per Ordinary Share and is immediately exercisable. The Series A Warrants expire upon the earlier of 18 months following the issuance date and 60 days following the Company’s public announcement of positive topline trail results of AllocetraTM for the treatment of moderate-to-severe knee osteoarthritis (the “Series A Milestone Event”). The Series B warrants expire upon the earlier of five and one-half years following the issuance date and 60 days following the Company’s public announcement of its filing with the U.S. Food and Drug Administration (the “FDA”) for approval for AllocetraTM’s osteoarthritis related indication (the “Series B Milestone Event”). Each Pre-Funded Warrant has an exercise price of $0.001 per Ordinary Share, is immediately exercisable, may be exercised at any time and has no expiration date.

 

H.C. Wainwright & Co. (“Wainwright”) acted as placement agent in connection with the Offering, and in consideration therefor the Company agreed to register and issue to Wainwright warrants (the “Placement Agent Warrants”, and together with the Investor Warrants and the Pre-Funded Warrants, the “Warrants”) to purchase up to 250,000 Ordinary Shares. The Placement Agent Warrants comprise Series A Warrants to purchase 125,000 Ordinary Shares and Series B Warrants to purchase 125,000 Ordinary Shares, containing the same terms as the Investor Warrants, except that they are exercisable at a price of $1.75 per Ordinary Share, and the Series B Warrants will expire upon the earlier of five years following the commencement of the sale of the securities offered in the Offering and 60 days following the Company’s public announcement of its filing with the FDA for approval for AllocetraTM’s osteoarthritis related indication.

 

In addition, the Company agreed to pay Wainwright an aggregate cash fee equal to 7% of the gross proceeds raised in the Offering, a management fee equal to 1% of the gross proceeds raised in the Offering and $90,950 for various fees and expenses.

 

The closing of the Offering occurred on May 29, 2024. The net proceeds from the Offering were approximately $4.5 million after deducting Wainwright’s fees and other expenses relating to the Offering. The Company intends to use the net proceeds from the Offering for working capital and other general corporate purposes.

 

b)All Company warrants are classified as components of shareholders’ equity because such warrants are free standing financial instruments that are legally detachable, separately exercisable, do not embody an obligation for the Company to repurchase its own shares and permit the holders to receive a fixed number of Ordinary Shares upon exercise, require physical settlement and do not provide any guarantee of value or return (unless, in accordance with ASC 815-40-55-3, there is a fundamental transaction, as defined in the warrant agreements, which allows the holders of the warrants to receive the same form of consideration payable to the holders of Ordinary Shares, in which case equity treatment is not precluded).

 

  

Number

of Warrants

  

Weighted

average

exercise price

 
Outstanding January 1, 2024   202,251   $23.31 
Issued   8,904,287   $1.17 
Outstanding and exercisable June 30, 2024   9,106,538   $1.66 

 

Composed of:

 

Number of
Warrants
   Exercise
Price
Per
Share
   Issuance
date
  Expiration
date
 22,750   $10.00   February 26, 2020  February 24, 2025
 160,727   $25.00   February 12, 2021  February 9, 2026
 18,774   $25.00   February 17, 2021  February 9, 2026
 1,511,429   $0.001   May 29, 2024  No expiration date
 3,571,429   $1.40   May 29, 2024  December 1, 2025(i)
 3,571,429   $1.40   May 29, 2024  November 29, 2029 (ii)
 125,000   $1.75   May 29, 2024  December 1, 2025(i)
 125,000   $1.75   May 29, 2024  May 27, 2029 (iii)
 9,106,538            

 

(i)The earlier of (a) December 1, 2025 and (b) the 60th day following the occurrence of the Series A Milestone Event.
(ii)The earlier of (a) November 29, 2029 and (b) the 60th day following the occurrence of the Series B Milestone Event.
(iii)The earlier of (a) May 27, 2029 and (b) 60 days following the Company’s public announcement of its filing with the FDA for approval for AllocetraTM’s osteoarthritis related indication.

 

c)During the six months ended June 30, 2024 the Company issued 180,707 Ordinary Shares under our ATM agreement with Cantor Fitzgerald & Co. and JMP Securities LLC for a gross consideration of $543 thousand net of $16 thousand of issuance expenses.
v3.24.2.u1
Share-Based Compensation
6 Months Ended
Jun. 30, 2024
Share-Based Compensation [Abstract]  
SHARE-BASED COMPENSATION

NOTE 12 – SHARE-BASED COMPENSATION

 

a)As of June 30, 2024, 5,028,704 Ordinary Shares were authorized for issuance to employees, directors and consultants under the 2019 Equity Incentive Plan (the “2019 Plan”), of which 966,057 shares remained available for future grant.

 

b)The following table contains information concerning options granted under the 2019 Plan:

 

   Three months ended
June 30,
 
   2024   2023 
   Number of options   Weighted average exercise price  

Number

of options

   Weighted
average
exercise price
 
Outstanding at beginning of period   3,007,624   $5.41    2,929,868   $5.84 
Forfeited and expired   (21,921)  $5.06    (14,375)  $6.82 
Outstanding at end of period   2,985,703   $5.41    2,915,493   $5.84 
Exercisable at end of period   2,228,902   $5.67    2,090,378   $5.59 
                     
Non-vested at beginning of period   772,301   $4.67    876,851   $6.48 
Vested   -   $-    (37,861)  $11.13 
Forfeited   (13,750)  $3.79    (13,875)  $5.90 
Non-vested at the end of period   758,551   $4.6 8    825,115   $6.27 

 

  

Six months ended
June 30,

 
   2024   2023 
   Number of
options
   Weighted
average
exercise price
   Number of options   Weighted
average
exercise price
 
 Outstanding at beginning of period   2,842,496   $5.63    2,939,434   $5.85 
 Granted   250,000   $3.21    
-
   $
-
 
 Forfeited and expired   (106,793)  $6.00    (23,941)  $6.71 
 Outstanding at end of period   2,985,703   $5.41    2,915,493   $5.84 
 Exercisable at end of period   2,228,902   $5.67    2,090,378   $5.59 
                     
 Non vested at beginning of period   596,503   $5.53    986,005   $6.46 
 Granted   250,000   $3.21    
-
   $
-
 
 Forfeited and expired   (24,313)  $5.04    (15,375)  $6.73 
 vested   (63,639)  $6.75    (145,515)  $7.44 
 Outstanding at end of period   758,551   $4.68    825,115   $6.27 

 

During the three and six month periods ended June 30, 2024 and 2023, the Company recognized $237, $460, $427 and $957 thousand, respectively, of share-based compensation expenses related to stock options. As of June 30, 2024, the total unrecognized estimated compensation cost related to outstanding non-vested stock options was $1,061 thousand, which is expected to be recognized over a weighted average period of 1.36 years.

  

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2024 (UNAUDITED)

c)Set forth below is data regarding the range of exercise prices and remaining contractual life for all options outstanding at June 30, 2024:

 

Exercise price   Number of options
outstanding
   Remaining
contractual
Life (in years)
   Intrinsic Value
of Options  
Outstanding
(in thousands)
   No. of options
exercisable
 
$2.69    649,591    0.92   $
     -
    649,591 
$3.21    240,000    9.63    
-
    
-
 
$3.53    53,192    9.35    
-
    
-
 
$3.66    250,000    5.84    
-
    250,000 
$4.68    34,500    5.75    
-
    34,500 
$5.34    160,750    7.75    
-
    84,000 
$5.34    442,410    8.39    
-
    178,176 
$5.96    150,000    8.39    
-
    37,500 
$6.22    552,883    2.67    
-
    552,883 
$8.19    150,000    5.39    
-
    150,000 
$9.02    40,500    6.38    
-
    30,375 
$10.12    10,407    4.43    
-
    10,407 
$12.23    250,000    6.91    
-
    250,000 
$21.40    970    5.07    
-
    970 
$90.16    500    0.42    
-
    500 
      2,985,703        $
-
    2,228,902 

 

d)The following table contains information concerning restricted stock units granted under the 2019 Plan:

 

   Three months ended
June 30,
 
   2024    2023 
   Number
of shares
 
   Weighted
average
grant date fair
value
   Number
of shares
   Weighted
average
grant date fair
value
 
Nonvested at beginning of period   571,460   $2.65    114,329   $9.97 
Granted       $     
-
   $
-
 
Vested   (3,444)  $10.28    (3,438)  $10.28 
Forfeited   (5,757)  $3.87    (313)  $14.67 
Nonvested at end of period   562,259   $2.59    110,578   $9.95 

 

   Six months ended
June 30,
 
   2024    2023 
   Number
of shares
 
   Weighted
average
grant date fair
value
   Number
of shares
   Weighted
average
grant date fair
value
 
Nonvested at beginning of period   621,135   $3.14    157,560   $10.02 
Granted   
-
   $
-
    
-
   $
-
 
Vested   (44,050)  $9.9    (46,544)  $10.15 
Forfeited   (14,826)  $3.64    (438)  $14.67 
Nonvested at end of period   562,259   $2.59    110,578   $9.95 

 

The Company estimates the fair value of restricted stock units based on the closing sales price of the Ordinary Shares on the date of grant (or the closing bid price, if no sales were reported).

 

For the three and six month periods ended June 30, 2024 and 2023, the Company recognized $151, $311, $84 and $187 thousand, respectively, of share-based compensation expense related to restricted stock units.

 

Total share-based compensation expense related to restricted stock units not yet recognized as of June 30, 2024 was $653 thousand, which is expected to be recognized over a weighted average period of 1.27 years.

 

e)The following table summarizes share-based compensation expenses included in the statements of operations related to grants under the 2019 Plan:

 

   Three months ended
June 30,
   Six months ended
June 30,
 
(in thousands)  2024   2023   2024   2023 
Research & development  $145   $122   $269   $318 
General & administrative   243    389    502    826 
Total  $388   $511   $771   $1,144 
v3.24.2.u1
Fair Value Measurement
6 Months Ended
Jun. 30, 2024
Fair Value Measurement [Abstract]  
FAIR VALUE MEASUREMENT

NOTE 13 – FAIR VALUE MEASUREMENT

 

The Company’s financial assets and liabilities measured at fair value on a recurring basis consisted of the following types of instruments as of June 30, 2024 and December 31, 2023:

 

 

(in thousands)  June 30, 2024 
   Total   Level 1   Level 2   Level 3 
Cash and cash equivalents  $3,747  
$
          $
      -
   $
     -
 
Short term deposits   22,195  
 
     
-
    
-
 
Restricted cash   306  
 
     
-
    
-
 
Total financial assets  $26,248  
$
    $
-
   $
-
 

 

(in thousands)  December 31, 2023 
   Total   Level 1   Level 2   Level 3 
Cash and cash equivalents  $813   $813   $
     -
   $
      -
 
Short term deposits   26,507    26,507    
-
    
-
 
Restricted cash   413    413    
-
    
-
 
Total financial assets  $27,733   $27,733   $
-
   $
-
 
v3.24.2.u1
Events Subsequent to the Balance Sheet Date
6 Months Ended
Jun. 30, 2024
Events Subsequent to the Balance Sheet Date [Abstract]  
EVENTS SUBSEQUENT TO THE BALANCE SHEET DATE

NOTE 14 – EVENTS SUBSEQUENT TO THE BALANCE SHEET DATE

 

The Company evaluated all events and transactions that occurred subsequent to the balance sheet date and prior to the date on which these unaudited condensed consolidated financial statements were issued and determined that the following subsequent event necessitated disclosure:

 

1.In July 2024, 518,429 Pre-Funded Warrants were exercised for 518,429 Ordinary Shares.
v3.24.2.u1
Accounting Policies, by Policy (Policies)
6 Months Ended
Jun. 30, 2024
Significant Accounting Policies [Abstract]  
Basis of Presentation

Basis of Presentation

These unaudited condensed consolidated financial statements include the accounts of the Company and have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information. Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been made.

 

These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited annual financial statements and notes thereto included in the Company’s 2023 Annual Report on Form 20-F, as filed with the U.S. Securities and Exchange Commission on April 30, 2024. The results of operations for these interim periods are not necessarily indicative of the operating results for any future period. The December 31, 2023 financial information has been derived from the Company’s audited financial statements.

Use of Estimates

Use of Estimates

The preparation of interim financial statements in conformity with U.S. GAAP requires management to make certain estimates, judgments and assumptions that affect the reported amounts in the consolidated balance sheets and statements of operations, it also requires that management exercise its judgment in applying the Company’s accounting policies. On an ongoing basis, management evaluates its estimates, including estimates related to its stock-based compensation expense and implicit interest rate on new lease liabilities. Significant estimates in these interim financial statements include estimates made for accrued research and development expenses and stock-based compensation expenses.

Functional Currency and Translation to The Reporting Currency

Functional Currency and Translation to The Reporting Currency

The functional currency of the Company is the U.S. dollar because the U.S. dollar is the currency of the primary economic environment in which the Company operates and expects to continue to operate in the foreseeable future.

Balances related to non-monetary assets and liabilities are based on translated amounts as of the date of the change, and non-monetary assets acquired and liabilities were translated at the approximate exchange rate prevailing at the date of the transaction. Transactions included in the statement of income were translated at the approximate exchange rate in effect at the time of the transaction.

1 U.S. dollar = 3.759 NIS and 3.627 NIS as of June 30, 2024 and December 31, 2023, respectively.

The U.S. dollar increased against the NIS 2.12%, 3.64%, 2.35% and 5.14% in the three and six month periods ended June 30, 2024 and 2023, respectively.

Recently Adopted Accounting Standards

Recently Adopted Accounting Standards

During the three months ended June 30, 2024, the Company was not required to adopt any recently issued accounting standards.

Recently Issued Accounting Pronouncements Not Yet Adopted

Recently Issued Accounting Pronouncements Not Yet Adopted

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which is intended to provide enhanced segment disclosures. The standard will require disclosures about significant segment expenses and other segment items and identifying the Chief Operating Decision Maker and how they use the reported segment profitability measures to assess segment performance and allocate resources. These enhanced disclosures are required for all entities on an interim and annual basis, even if they have only a single reportable segment. The standard is effective for years beginning after December 15, 2023 and interim periods within annual periods beginning after December 15, 2024, and early adoption is permitted. The Company does not believe that adoption of this ASU will have a material impact on the Company’s consolidated financial statements.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which is intended to provide enhancements to annual income tax disclosures. The standard will require more detailed information in the rate reconciliation table and for income taxes paid, among other enhancements. The standard is effective for years beginning after December 15, 2024, early adoption is permitted. The Company does not believe that adoption of this ASU will have a material impact on the Company’s consolidated financial statements.

Significant Accounting Policies

Significant Accounting Policies

There have been no material changes to the significant accounting policies previously disclosed in the Company’s Annual Report on Form 20-F for the year ended December 31, 2023.

v3.24.2.u1
Cash, Cash Equivalents and Restricted Cash (Tables)
6 Months Ended
Jun. 30, 2024
Cash, Cash Equivalents and Restricted Cash [Abstract]  
Schedule of Cash and Cash Equivalents and Restricted Cash
   June 30,   December 31, 
(in thousands)  2024   2023 
         
Cash held in banks  $3,747   $813 
Total cash and cash equivalents   3,747    813 
Restricted cash – current – Prepaid expenses and other receivables   113    113 
Restricted cash – noncurrent – Other assets   306    300 
Total cash, cash equivalents and restricted cash shown in the statement of cash flows  $4,166   $1,226 
v3.24.2.u1
Short Term Deposits (Tables)
6 Months Ended
Jun. 30, 2024
Short Term Deposits [Abstract]  
Schedule of Short Term Deposits
   June 30,   December 31, 
(in thousands)  2024   2023 
         
Bank deposits in U.S.$ (annual average interest rates 5.86% and 6.195%)  $9,652   $6,240 
Bank deposits in NIS (annual average interest rates 4.317% and 4.568%)   12,543    20,267 
Total short-term deposits  $22,195   $26,507 
v3.24.2.u1
Prepaid Expenses and Other Receivables (Tables)
6 Months Ended
Jun. 30, 2024
Prepaid Expenses and Other Receivables [Abstract]  
Schedule of Prepaid Expenses and Other Receivables
   June 30,   December 31, 
(in thousands)  2024   2023 
         
Prepaid expenses  $1,141   $1,107 
Tax authorities   47    116 
Others   1,212    113 
   $2,400   $1,336 
v3.24.2.u1
Property and Equipment (Tables)
6 Months Ended
Jun. 30, 2024
Property and Equipment [Abstract]  
Schedule of Property and Equipment Property and equipment, net consists of the following:
  June 30,   December 31, 
(in thousands)  2024   2023 
         
Cost:          
Laboratory equipment  $2,130   $2,412 
Computers   431    380 
Office furniture & equipment   184    186 
Leasehold improvements   1,431    1,431 
Total cost   4,176    4,409 
Accumulated depreciation:          
Laboratory equipment   1,876    1,891 
Computers   296    263 
Office furniture & equipment   47    40 
Leasehold improvements   799    676 
Total accumulated depreciation   3,018    2,870 
Depreciated cost  $1,158   $1,539 
v3.24.2.u1
Other Assets (Tables)
6 Months Ended
Jun. 30, 2024
Other Assets [Abstract]  
Schedule of Other Assets
   June 30,   December 31, 
(in thousands)  2024   2023 
         
Restricted cash  $306   $300 
Long Term Deposit   8    8 
Long-term prepaid expenses   92    179 
Right-of-Use assets, net   870    1,041 
   $1,276   $1,528 
v3.24.2.u1
Accrued Expenses and Other Liabilities (Tables)
6 Months Ended
Jun. 30, 2024
Accrued Expenses and Other Liabilities [Abstract]  
Schedule of Accrued Expenses and Other Liabilities ACCRUED EXPENSES AND OTHER LIABILITIES
   June 30,   December 31, 
(in thousands)  2024   2023 
         
Vacation, convalescence and bonus accruals  $291   $341 
Employees and payroll related   314    422 
Short term operating lease liabilities   336    346 
Accrued expenses and other   1,597    2,892 
   $2,538   $4,001 
v3.24.2.u1
Leases (Tables)
6 Months Ended
Jun. 30, 2024
Leases [Abstract]  
Schedule of Operating Lease The Company is a party to operating leases for its corporate offices, laboratory space, plant space and vehicles.
   Six months ended
June 30,
 
(in thousands)  2024   2023 
         
The components of lease expense were as follows:          
Operating leases expenses  $207   $522 
Supplemental consolidated cash flow information related to operating leases follows:          
Cash used in operating activities  $212   $520 
Non-cash activity:          
Right of use assets obtained in exchange for new operating lease liabilities  $25   $145 
Schedule of Supplemental Information Related to Operating Leases
   June 30,   December 31, 
(in thousands)  2024   2023 
Supplemental information related to operating leases, including location of amounts reported in the accompanying consolidated balance sheets, follows:          
Other assets - Right-of-Use assets  $1,722   $2,161 
Accumulated amortization   852    1,120 
Operating lease Right-of-Use assets, net  $870   $1,041 
Lease liabilities – current - Accounts payable and accrued liabilities  $336   $346 
Lease liabilities – noncurrent   499    686 
Total operating lease liabilities  $835   $1,032 
Weighted average remaining lease term in years   2.89    3.3 
Weighted average annual discount rate   6.8%   6.7%

 

Schedule of Maturities of Operating Lease Liabilities
Maturities of operating lease liabilities as of June 30, 2024, were as follows:    
2024 (after June 30)  $191 
2025   355 
2026   193 
2027   117 
2028 and onwards   89 
Total undiscounted lease liability   945 
Less: Imputed interest   (110)
Present value of lease liabilities  $835 
v3.24.2.u1
Equity (Tables)
6 Months Ended
Jun. 30, 2024
Equity [Abstract]  
Schedule of Number of Ordinary Shares Upon Exercise
  

Number

of Warrants

  

Weighted

average

exercise price

 
Outstanding January 1, 2024   202,251   $23.31 
Issued   8,904,287   $1.17 
Outstanding and exercisable June 30, 2024   9,106,538   $1.66 
Schedule of Changes in Exercisable Ordinary Shares Warrants Composed of:
Number of
Warrants
   Exercise
Price
Per
Share
   Issuance
date
  Expiration
date
 22,750   $10.00   February 26, 2020  February 24, 2025
 160,727   $25.00   February 12, 2021  February 9, 2026
 18,774   $25.00   February 17, 2021  February 9, 2026
 1,511,429   $0.001   May 29, 2024  No expiration date
 3,571,429   $1.40   May 29, 2024  December 1, 2025(i)
 3,571,429   $1.40   May 29, 2024  November 29, 2029 (ii)
 125,000   $1.75   May 29, 2024  December 1, 2025(i)
 125,000   $1.75   May 29, 2024  May 27, 2029 (iii)
 9,106,538            
(i)The earlier of (a) December 1, 2025 and (b) the 60th day following the occurrence of the Series A Milestone Event.
(ii)The earlier of (a) November 29, 2029 and (b) the 60th day following the occurrence of the Series B Milestone Event.
(iii)The earlier of (a) May 27, 2029 and (b) 60 days following the Company’s public announcement of its filing with the FDA for approval for AllocetraTM’s osteoarthritis related indication.
v3.24.2.u1
Share-Based Compensation (Tables)
6 Months Ended
Jun. 30, 2024
Share-Based Compensation [Abstract]  
Schedule of Employees and Directors Stock Options Granted Under the 2019 Plan The following table contains information concerning options granted under the 2019 Plan:
   Three months ended
June 30,
 
   2024   2023 
   Number of options   Weighted average exercise price  

Number

of options

   Weighted
average
exercise price
 
Outstanding at beginning of period   3,007,624   $5.41    2,929,868   $5.84 
Forfeited and expired   (21,921)  $5.06    (14,375)  $6.82 
Outstanding at end of period   2,985,703   $5.41    2,915,493   $5.84 
Exercisable at end of period   2,228,902   $5.67    2,090,378   $5.59 
                     
Non-vested at beginning of period   772,301   $4.67    876,851   $6.48 
Vested   -   $-    (37,861)  $11.13 
Forfeited   (13,750)  $3.79    (13,875)  $5.90 
Non-vested at the end of period   758,551   $4.6 8    825,115   $6.27 
  

Six months ended
June 30,

 
   2024   2023 
   Number of
options
   Weighted
average
exercise price
   Number of options   Weighted
average
exercise price
 
 Outstanding at beginning of period   2,842,496   $5.63    2,939,434   $5.85 
 Granted   250,000   $3.21    
-
   $
-
 
 Forfeited and expired   (106,793)  $6.00    (23,941)  $6.71 
 Outstanding at end of period   2,985,703   $5.41    2,915,493   $5.84 
 Exercisable at end of period   2,228,902   $5.67    2,090,378   $5.59 
                     
 Non vested at beginning of period   596,503   $5.53    986,005   $6.46 
 Granted   250,000   $3.21    
-
   $
-
 
 Forfeited and expired   (24,313)  $5.04    (15,375)  $6.73 
 vested   (63,639)  $6.75    (145,515)  $7.44 
 Outstanding at end of period   758,551   $4.68    825,115   $6.27 
Schedule of Exercise Prices and Remaining Contractual Life Set forth below is data regarding the range of exercise prices and remaining contractual life for all options outstanding at June 30, 2024:
Exercise price   Number of options
outstanding
   Remaining
contractual
Life (in years)
   Intrinsic Value
of Options  
Outstanding
(in thousands)
   No. of options
exercisable
 
$2.69    649,591    0.92   $
     -
    649,591 
$3.21    240,000    9.63    
-
    
-
 
$3.53    53,192    9.35    
-
    
-
 
$3.66    250,000    5.84    
-
    250,000 
$4.68    34,500    5.75    
-
    34,500 
$5.34    160,750    7.75    
-
    84,000 
$5.34    442,410    8.39    
-
    178,176 
$5.96    150,000    8.39    
-
    37,500 
$6.22    552,883    2.67    
-
    552,883 
$8.19    150,000    5.39    
-
    150,000 
$9.02    40,500    6.38    
-
    30,375 
$10.12    10,407    4.43    
-
    10,407 
$12.23    250,000    6.91    
-
    250,000 
$21.40    970    5.07    
-
    970 
$90.16    500    0.42    
-
    500 
      2,985,703        $
-
    2,228,902 
Schedule of Restricted Stock Units Granted Under the 2019 Plan The following table contains information concerning restricted stock units granted under the 2019 Plan:
   Three months ended
June 30,
 
   2024    2023 
   Number
of shares
 
   Weighted
average
grant date fair
value
   Number
of shares
   Weighted
average
grant date fair
value
 
Nonvested at beginning of period   571,460   $2.65    114,329   $9.97 
Granted       $     
-
   $
-
 
Vested   (3,444)  $10.28    (3,438)  $10.28 
Forfeited   (5,757)  $3.87    (313)  $14.67 
Nonvested at end of period   562,259   $2.59    110,578   $9.95 
   Six months ended
June 30,
 
   2024    2023 
   Number
of shares
 
   Weighted
average
grant date fair
value
   Number
of shares
   Weighted
average
grant date fair
value
 
Nonvested at beginning of period   621,135   $3.14    157,560   $10.02 
Granted   
-
   $
-
    
-
   $
-
 
Vested   (44,050)  $9.9    (46,544)  $10.15 
Forfeited   (14,826)  $3.64    (438)  $14.67 
Nonvested at end of period   562,259   $2.59    110,578   $9.95 
Schedule of Share-Based Compensation Expenses Related to Grants Under the 2019 Plan The following table summarizes share-based compensation expenses included in the statements of operations related to grants under the 2019 Plan:
   Three months ended
June 30,
   Six months ended
June 30,
 
(in thousands)  2024   2023   2024   2023 
Research & development  $145   $122   $269   $318 
General & administrative   243    389    502    826 
Total  $388   $511   $771   $1,144 
v3.24.2.u1
Fair Value Measurement (Tables)
6 Months Ended
Jun. 30, 2024
Fair Value Measurement [Abstract]  
Schedule of Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis The Company’s financial assets and liabilities measured at fair value on a recurring basis consisted of the following types of instruments as of June 30, 2024 and December 31, 2023:
(in thousands)  June 30, 2024 
   Total   Level 1   Level 2   Level 3 
Cash and cash equivalents  $3,747  
$
          $
      -
   $
     -
 
Short term deposits   22,195  
 
     
-
    
-
 
Restricted cash   306  
 
     
-
    
-
 
Total financial assets  $26,248  
$
    $
-
   $
-
 
(in thousands)  December 31, 2023 
   Total   Level 1   Level 2   Level 3 
Cash and cash equivalents  $813   $813   $
     -
   $
      -
 
Short term deposits   26,507    26,507    
-
    
-
 
Restricted cash   413    413    
-
    
-
 
Total financial assets  $27,733   $27,733   $
-
   $
-
 
v3.24.2.u1
General Information (Details)
$ / shares in Units, $ in Thousands
Jun. 30, 2024
USD ($)
$ / shares
Jun. 30, 2024
₪ / shares
Dec. 31, 2023
USD ($)
$ / shares
General Information [Line Items]      
Par value | $ / shares $ 0.4   $ 0.4
Accumulated deficit | $ $ (119,329)   $ (112,093)
Common Stock [Member]      
General Information [Line Items]      
Par value | ₪ / shares   ₪ 0.4  
v3.24.2.u1
Significant Accounting Policies (Details)
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Dec. 31, 2023
Significant Accounting Policies [Line Items]          
Functional currency increased percentage 2.12% 2.35% 3.64% 5.14%  
NIS [Member]          
Significant Accounting Policies [Line Items]          
Exchange rate 3.759   3.759   3.627
v3.24.2.u1
Cash, Cash Equivalents and Restricted Cash (Details) - Schedule of Cash and Cash Equivalents and Restricted Cash - USD ($)
$ in Thousands
Jun. 30, 2024
Dec. 31, 2023
Jun. 30, 2023
Dec. 31, 2022
Schedule of Cash and Cash Equivalents and Restricted Cash [Abstract]        
Cash held in banks $ 3,747 $ 813    
Total cash and cash equivalents 3,747 813    
Restricted cash – current – Prepaid expenses and other receivables 113 113    
Restricted cash – noncurrent – Other assets 306 300    
Total cash, cash equivalents and restricted cash shown in the statement of cash flows $ 4,166 $ 1,226 $ 3,862 $ 50,357
v3.24.2.u1
Short Term Deposits (Details) - Schedule of Short Term Deposits - USD ($)
$ in Thousands
Jun. 30, 2024
Dec. 31, 2023
Schedule of Short Term Deposits [Line Items]    
Total short-term deposits $ 22,195 $ 26,507
U.S [Member]    
Schedule of Short Term Deposits [Line Items]    
Bank deposits 9,652 6,240
NIS [Member]    
Schedule of Short Term Deposits [Line Items]    
Bank deposits $ 12,543 $ 20,267
v3.24.2.u1
Short Term Deposits (Details) - Schedule of Short Term Deposits (Parentheticals)
Jun. 30, 2024
Dec. 31, 2023
U.S [Member]    
Schedule of Short Term Deposits [Line Items]    
Average annual interest rates 5.86% 6.195%
NIS [Member]    
Schedule of Short Term Deposits [Line Items]    
Average annual interest rates 4.317% 4.568%
v3.24.2.u1
Prepaid Expenses and Other Receivables (Details) - Schedule of Prepaid Expenses and Other Receivables - USD ($)
$ in Thousands
Jun. 30, 2024
Dec. 31, 2023
Schedule of Prepaid Expenses and Other Receivables [Abstract]    
Prepaid expenses $ 1,141 $ 1,107
Tax authorities 47 116
Others 1,212 113
Total $ 2,400 $ 1,336
v3.24.2.u1
Property and Equipment (Details) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Property and Equipment [Abstract]        
Depreciation expenses $ 160 $ 348 $ 212 $ 421
v3.24.2.u1
Property and Equipment (Details) - Schedule of Property and Equipment - USD ($)
$ in Thousands
Jun. 30, 2024
Dec. 31, 2023
Property, Plant and Equipment [Line Items]    
Total cost $ 4,176 $ 4,409
Total accumulated depreciation 3,018 2,870
Depreciated cost 1,158 1,539
Laboratory equipment [Member]    
Property, Plant and Equipment [Line Items]    
Total cost 2,130 2,412
Total accumulated depreciation 1,876 1,891
Computers [Member]    
Property, Plant and Equipment [Line Items]    
Total cost 431 380
Total accumulated depreciation 296 263
Office furniture & equipment [Member]    
Property, Plant and Equipment [Line Items]    
Total cost 184 186
Total accumulated depreciation 47 40
Leasehold improvements [Member]    
Property, Plant and Equipment [Line Items]    
Total cost 1,431 1,431
Total accumulated depreciation $ 799 $ 676
v3.24.2.u1
Other Assets (Details) - Schedule of Other Assets - USD ($)
$ in Thousands
Jun. 30, 2024
Dec. 31, 2023
Schedule of Other Assets [Abstract]    
Restricted cash $ 306 $ 300
Long Term Deposit 8 8
Long-term prepaid expenses 92 179
Right-of-Use assets, net 870 1,041
Total $ 1,276 $ 1,528
v3.24.2.u1
Accrued Expenses and Other Liabilities (Details) - Schedule of Accrued Expenses and Other Liabilities - USD ($)
$ in Thousands
Jun. 30, 2024
Dec. 31, 2023
Schedule of Accrued Expenses and Other Liabilities [Abstract]    
Vacation, convalescence and bonus accruals $ 291 $ 341
Employees and payroll related 314 422
Short term operating lease liabilities 336 346
Accrued expenses and other 1,597 2,892
Accrued expenses and other liabilities, total $ 2,538 $ 4,001
v3.24.2.u1
Leases (Details) - Schedule of Operating Lease - USD ($)
$ in Thousands
6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
The components of lease expense were as follows:    
Operating leases expenses $ 207 $ 522
Supplemental consolidated cash flow information related to operating leases follows:    
Cash used in operating activities 212 520
Non-cash activity:    
Right of use assets obtained in exchange for new operating lease liabilities $ 25 $ 145
v3.24.2.u1
Leases (Details) - Schedule of Supplemental Information Related to Operating Leases - USD ($)
$ in Thousands
Jun. 30, 2024
Dec. 31, 2023
Schedule of Supplemental Information Related to Operating Leases [Abstract]    
Other assets - Right-of-Use assets $ 1,722 $ 2,161
Accumulated amortization 852 1,120
Operating lease Right-of-Use assets, net 870 1,041
Lease liabilities – current - Accounts payable and accrued liabilities 336 346
Lease liabilities – noncurrent 499 686
Total operating lease liabilities $ 835 $ 1,032
Weighted average remaining lease term in years 2 years 10 months 20 days 3 years 3 months 18 days
Weighted average annual discount rate 6.80% 6.70%
v3.24.2.u1
Leases (Details) - Schedule of Maturities of Operating Lease Liabilities - USD ($)
$ in Thousands
Jun. 30, 2024
Dec. 31, 2023
Schedule of Maturities of Operating Lease Liabilities [Abstract]    
2024 (after June 30) $ 191  
2025 355  
2026 193  
2027 117  
2028 and onwards 89  
Total undiscounted lease liability 945  
Less: Imputed interest (110)  
Present value of lease liabilities $ 835 $ 1,032
v3.24.2.u1
Commitments and Contingent Liabilities (Details)
$ in Millions
6 Months Ended
Jun. 30, 2024
USD ($)
Commitments and Contingent Liabilities [Line Items]  
Repayment of grants percentage 100.00%
Grants received including accrued interest (in Dollars) $ 9.9
Minimum [Member]  
Commitments and Contingent Liabilities [Line Items]  
Percentage of royalties in sales 3.00%
Maximum [Member]  
Commitments and Contingent Liabilities [Line Items]  
Percentage of royalties in sales 5.00%
v3.24.2.u1
Equity (Details) - USD ($)
$ / shares in Units, $ in Thousands
6 Months Ended
May 29, 2024
May 27, 2024
Jun. 30, 2024
Equity [Line Items]      
Issuance of shares     180,707
Cash fee percentage     7.00%
Management fee percentage     1.00%
Various fees and expenses related to offering (in Dollars)     $ 90,950
Net proceeds from the offering on may 2024 (in Dollars) $ 4,500    
Gross consideration from ATM (in Dollars)     543
Issuance expenses from ATM (in Dollars)     $ 16
Warrant [Member]      
Equity [Line Items]      
Pre- funded warrants   1,511,429  
Exercise price pre-funded warrants (in Dollars per share)     $ 0.001
Series A Warrant [Member]      
Equity [Line Items]      
Series A warrants   3,571,429  
Exercise price of warrant (in Dollars per share)   $ 1.4  
Warrants expire term     18 months
Placement agent warrants     125,000
Exercise price placement agent warrants (in Dollars per share)     $ 1.75
Series B Warrants [Member]      
Equity [Line Items]      
Series B warrants   3,571,429  
Exercise price of warrant (in Dollars per share)   $ 1.4  
Warrants expire term     5 years
Warrants expire upon earlier     five and one-half years
Placement agent warrants     125,000
Exercise price placement agent warrants (in Dollars per share)     $ 1.75
Ordinary Shares [Member]      
Equity [Line Items]      
Issuance of shares   2,060,000  
v3.24.2.u1
Equity (Details) - Schedule of Number of Ordinary Shares Upon Exercise - Warrants [Member]
6 Months Ended
Jun. 30, 2024
$ / shares
shares
Schedule of Number of Ordinary Shares Upon Exercise [Line Items]  
Number of Warrants Outstanding | shares 202,251
Weighted average exercise price Outstanding | $ / shares $ 23.31
Number of Warrants Issued | shares 8,904,287
Weighted average exercise price Issued | $ / shares $ 1.17
Number of Warrants Outstanding | shares 9,106,538
Weighted average exercise price Outstanding | $ / shares $ 1.66
v3.24.2.u1
Equity (Details) - Schedule of Changes in Exercisable Ordinary Shares Warrants - Warrant [Member]
6 Months Ended
Jun. 30, 2024
$ / shares
shares
Schedule of Changes in Exercisable Ordinary Shares Warrants [Line Items]  
Number of Warrants 9,106,538
10.00 [Member]  
Schedule of Changes in Exercisable Ordinary Shares Warrants [Line Items]  
Number of Warrants 22,750
Exercise price per share | $ / shares $ 10
Issuance date Feb. 26, 2020
Expiration date Feb. 24, 2025
25.00 [Member]  
Schedule of Changes in Exercisable Ordinary Shares Warrants [Line Items]  
Number of Warrants 160,727
Exercise price per share | $ / shares $ 25
Issuance date Feb. 12, 2021
Expiration date Feb. 09, 2026
25.00 [Member]  
Schedule of Changes in Exercisable Ordinary Shares Warrants [Line Items]  
Number of Warrants 18,774
Exercise price per share | $ / shares $ 25
Issuance date Feb. 17, 2021
Expiration date Feb. 09, 2026
0.001 [Member]  
Schedule of Changes in Exercisable Ordinary Shares Warrants [Line Items]  
Number of Warrants 1,511,429
Exercise price per share | $ / shares $ 0.001
Issuance date May 29, 2024
1.40 [Member]  
Schedule of Changes in Exercisable Ordinary Shares Warrants [Line Items]  
Number of Warrants 3,571,429
Exercise price per share | $ / shares $ 1.4
Issuance date May 29, 2024
Expiration date Dec. 01, 2025 [1]
1.40 [Member]  
Schedule of Changes in Exercisable Ordinary Shares Warrants [Line Items]  
Number of Warrants 3,571,429
Exercise price per share | $ / shares $ 1.4
Issuance date May 29, 2024
Expiration date Nov. 29, 2029 [2]
1.75 [Member]  
Schedule of Changes in Exercisable Ordinary Shares Warrants [Line Items]  
Number of Warrants 125,000
Exercise price per share | $ / shares $ 1.75
Issuance date May 29, 2024
Expiration date Dec. 01, 2025 [1]
1.75 [Member]  
Schedule of Changes in Exercisable Ordinary Shares Warrants [Line Items]  
Number of Warrants 125,000
Exercise price per share | $ / shares $ 1.75
Issuance date May 29, 2024
Expiration date May 27, 2029 [3]
[1] The earlier of (a) December 1, 2025 and (b) the 60th day following the occurrence of the Series A Milestone Event.
[2] The earlier of (a) November 29, 2029 and (b) the 60th day following the occurrence of the Series B Milestone Event.
[3] The earlier of (a) May 27, 2029 and (b) 60 days following the Company’s public announcement of its filing with the FDA for approval for AllocetraTM’s osteoarthritis related indication.
v3.24.2.u1
Share-Based Compensation (Details) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Share-Based Compensation [Line Items]        
Share-based compensation expense $ 388 $ 511 $ 771 $ 1,144
Share-Based Payment Arrangement, Option [Member]        
Share-Based Compensation [Line Items]        
Share-based compensation expense 237 460 427 957
Unrecognized estimated compensation cost 1,061   $ 1,061  
Weighted average period     1 year 4 months 9 days  
Restricted Stock Units [Member]        
Share-Based Compensation [Line Items]        
Share-based compensation expense 151 $ 311 $ 84 $ 187
Weighted average period     1 year 3 months 7 days  
Share-based compensation expense not yet recognized $ 653   $ 653  
Common Stock [Member]        
Share-Based Compensation [Line Items]        
Ordinary shares were authorized for issuance to employe, directors and consultants (in Shares) 5,028,704   5,028,704  
Shares available for future grant (in Shares) 966,057   966,057  
v3.24.2.u1
Share-Based Compensation (Details) - Schedule of Employees and Directors Stock Options Granted Under the 2019 Plan - Stock Option Plan [Member] - $ / shares
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Schedule of Employees and Directors Stock Options [Line Items]        
Number of options, Outstanding at beginning of period 3,007,624 2,929,868 2,842,496 2,939,434
Weighted average exercise price, Outstanding at beginning of period $ 5.41 $ 5.84 $ 5.63 $ 5.85
Number of options, Granted     250,000
Weighted average exercise price, Granted     $ 3.21
Number of options, Forfeited and expired (21,921) (14,375) (106,793) (23,941)
Weighted average exercise price, Forfeited and expired $ 5.06 $ 6.82 $ 6 $ 6.71
Number of options, Outstanding at end of period 2,985,703 2,915,493 2,985,703 2,915,493
Weighted average exercise price, Outstanding at end of period $ 5.41 $ 5.84 $ 5.41 $ 5.84
Number of options, Exercisable at end of period 2,228,902 2,090,378 2,228,902 2,090,378
Weighted average exercise price, Exercisable at end of period $ 5.67 $ 5.59 $ 5.67 $ 5.59
Number of options, Non-vested at beginning of period 772,301 876,851 596,503 986,005
Weighted average exercise price, Non-vested at beginning of period $ 4.67 $ 6.48 $ 5.53 $ 6.46
Number of options, Vested (37,861) (63,639) (145,515)
Weighted average exercise price, Vested $ 11.13 $ 6.75 $ 7.44
Number of options, Forfeited (13,750) (13,875) (24,313) (15,375)
Weighted average exercise price, Forfeited $ 3.79 $ 5.9 $ 5.04 $ 6.73
Number of options, Non-vested at the end of period 758,551 825,115 758,551 825,115
Weighted average exercise price, Non-vested at the end of period $ 4.68 $ 6.27 $ 4.68 $ 6.27
v3.24.2.u1
Share-Based Compensation (Details) - Schedule of Exercise Prices and Remaining Contractual Life - Stock Options [Member]
6 Months Ended
Jun. 30, 2024
USD ($)
$ / shares
shares
Schedule of Exercise Prices and Remaining Contractual Life [Line Items]  
Number of options outstanding 2,985,703
Intrinsic Value of Options Outstanding (in Dollars) | $
No. of options exercisable 2,228,902
Exercise Price One [Member]  
Schedule of Exercise Prices and Remaining Contractual Life [Line Items]  
Exercise price (in Dollars per share) | $ / shares $ 2.69
Number of options outstanding 649,591
Remaining contractual Life (in years) 11 months 1 day
Intrinsic Value of Options Outstanding (in Dollars) | $
No. of options exercisable 649,591
Exercise Price Two [Member]  
Schedule of Exercise Prices and Remaining Contractual Life [Line Items]  
Exercise price (in Dollars per share) | $ / shares $ 3.21
Number of options outstanding 240,000
Remaining contractual Life (in years) 9 years 7 months 17 days
Intrinsic Value of Options Outstanding (in Dollars) | $
No. of options exercisable
Exercise Price Three [Member]  
Schedule of Exercise Prices and Remaining Contractual Life [Line Items]  
Exercise price (in Dollars per share) | $ / shares $ 3.53
Number of options outstanding 53,192
Remaining contractual Life (in years) 9 years 4 months 6 days
Intrinsic Value of Options Outstanding (in Dollars) | $
No. of options exercisable
Exercise Price Four [Member]  
Schedule of Exercise Prices and Remaining Contractual Life [Line Items]  
Exercise price (in Dollars per share) | $ / shares $ 3.66
Number of options outstanding 250,000
Remaining contractual Life (in years) 5 years 10 months 2 days
Intrinsic Value of Options Outstanding (in Dollars) | $
No. of options exercisable 250,000
Exercise Price Five [Member]  
Schedule of Exercise Prices and Remaining Contractual Life [Line Items]  
Exercise price (in Dollars per share) | $ / shares $ 4.68
Number of options outstanding 34,500
Remaining contractual Life (in years) 5 years 9 months
Intrinsic Value of Options Outstanding (in Dollars) | $
No. of options exercisable 34,500
Exercise Price Six [Member]  
Schedule of Exercise Prices and Remaining Contractual Life [Line Items]  
Exercise price (in Dollars per share) | $ / shares $ 5.34
Number of options outstanding 160,750
Remaining contractual Life (in years) 7 years 9 months
Intrinsic Value of Options Outstanding (in Dollars) | $
No. of options exercisable 84,000
Exercise Price Seven [Member]  
Schedule of Exercise Prices and Remaining Contractual Life [Line Items]  
Exercise price (in Dollars per share) | $ / shares $ 5.34
Number of options outstanding 442,410
Remaining contractual Life (in years) 8 years 4 months 20 days
Intrinsic Value of Options Outstanding (in Dollars) | $
No. of options exercisable 178,176
Exercise Price Eight [Member]  
Schedule of Exercise Prices and Remaining Contractual Life [Line Items]  
Exercise price (in Dollars per share) | $ / shares $ 5.96
Number of options outstanding 150,000
Remaining contractual Life (in years) 8 years 4 months 20 days
Intrinsic Value of Options Outstanding (in Dollars) | $
No. of options exercisable 37,500
Exercise Price Nine [Member]  
Schedule of Exercise Prices and Remaining Contractual Life [Line Items]  
Exercise price (in Dollars per share) | $ / shares $ 6.22
Number of options outstanding 552,883
Remaining contractual Life (in years) 2 years 8 months 1 day
Intrinsic Value of Options Outstanding (in Dollars) | $
No. of options exercisable 552,883
Exercise Price Ten [Member]  
Schedule of Exercise Prices and Remaining Contractual Life [Line Items]  
Exercise price (in Dollars per share) | $ / shares $ 8.19
Number of options outstanding 150,000
Remaining contractual Life (in years) 5 years 4 months 20 days
Intrinsic Value of Options Outstanding (in Dollars) | $
No. of options exercisable 150,000
Exercise Price Eleven [Member]  
Schedule of Exercise Prices and Remaining Contractual Life [Line Items]  
Exercise price (in Dollars per share) | $ / shares $ 9.02
Number of options outstanding 40,500
Remaining contractual Life (in years) 6 years 4 months 17 days
Intrinsic Value of Options Outstanding (in Dollars) | $
No. of options exercisable 30,375
Exercise Price Twelve [Member]  
Schedule of Exercise Prices and Remaining Contractual Life [Line Items]  
Exercise price (in Dollars per share) | $ / shares $ 10.12
Number of options outstanding 10,407
Remaining contractual Life (in years) 4 years 5 months 4 days
Intrinsic Value of Options Outstanding (in Dollars) | $
No. of options exercisable 10,407
Exercise Price Thirteen [Member]  
Schedule of Exercise Prices and Remaining Contractual Life [Line Items]  
Exercise price (in Dollars per share) | $ / shares $ 12.23
Number of options outstanding 250,000
Remaining contractual Life (in years) 6 years 10 months 28 days
Intrinsic Value of Options Outstanding (in Dollars) | $
No. of options exercisable 250,000
Exercise Price Fourteen [Member]  
Schedule of Exercise Prices and Remaining Contractual Life [Line Items]  
Exercise price (in Dollars per share) | $ / shares $ 21.4
Number of options outstanding 970
Remaining contractual Life (in years) 5 years 25 days
Intrinsic Value of Options Outstanding (in Dollars) | $
No. of options exercisable 970
Exercise Price Fifteen [Member]  
Schedule of Exercise Prices and Remaining Contractual Life [Line Items]  
Exercise price (in Dollars per share) | $ / shares $ 90.16
Number of options outstanding 500
Remaining contractual Life (in years) 5 months 1 day
Intrinsic Value of Options Outstanding (in Dollars) | $
No. of options exercisable 500
v3.24.2.u1
Share-Based Compensation (Details) - Schedule of Restricted Stock Units Granted Under the 2019 Plan - $ / shares
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Schedule of Restricted Stock Units Granted Under the 2019 Plan [Line Items]        
Number of shares, Nonvested at beginning of period 571,460 114,329 621,135 157,560
Weighted average grant date fair value, Nonvested at beginning of period $ 2.65 $ 9.97 $ 3.14 $ 10.02
Number of shares, Granted  
Weighted average grant date fair value, Granted  
Number of shares, Vested (3,444) (3,438) (44,050) (46,544)
Weighted average grant date fair value, Vested $ 10.28 $ 10.28 $ 9.9 $ 10.15
Number of shares, Forfeited (5,757) (313) (14,826) (438)
Weighted average grant date fair value, Forfeited $ 3.87 $ 14.67 $ 3.64 $ 14.67
Number of shares, Nonvested at end of period 562,259 110,578 562,259 110,578
Weighted average grant date fair value, Nonvested at end of period $ 2.59 $ 9.95 $ 2.59 $ 9.95
v3.24.2.u1
Share-Based Compensation (Details) - Schedule of Share-Based Compensation Expenses Related to Grants Under the 2019 Plan - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Schedule of Share-Based Compensation Expenses Related to Grants Under the 2019 Plan [Line Items]        
Share-based compensation $ 388 $ 511 $ 771 $ 1,144
Research & development [Member]        
Schedule of Share-Based Compensation Expenses Related to Grants Under the 2019 Plan [Line Items]        
Share-based compensation 145 122 269 318
General & administrative [Member]        
Schedule of Share-Based Compensation Expenses Related to Grants Under the 2019 Plan [Line Items]        
Share-based compensation $ 243 $ 389 $ 502 $ 826
v3.24.2.u1
Fair Value Measurement (Details) - Schedule of Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis - USD ($)
$ in Thousands
Jun. 30, 2024
Dec. 31, 2023
Schedule of Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis [Line Items]    
Cash and cash equivalents $ 3,747 $ 813
Short term deposits 22,195 26,507
Restricted cash 306 413
Total financial assets 26,248 27,733
Level 1 [Member]    
Schedule of Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis [Line Items]    
Cash and cash equivalents 813
Short term deposits 26,507
Restricted cash 413
Total financial assets 27,733
Level 2 [Member]    
Schedule of Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis [Line Items]    
Cash and cash equivalents
Short term deposits
Restricted cash
Total financial assets
Level 3 [Member]    
Schedule of Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis [Line Items]    
Cash and cash equivalents
Short term deposits
Restricted cash
Total financial assets
v3.24.2.u1
Events Subsequent to the Balance Sheet Date (Details) - Subsequent Event [Member]
Jul. 31, 2024
shares
Pre-Funded Warrants [Member]  
Events Subsequent to the Balance Sheet Date [Line Items]  
Pre-funded warrants exercised 518,429
Common Stock [Member]  
Events Subsequent to the Balance Sheet Date [Line Items]  
Exercised ordinary shares 518,429

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