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

 

 

 

0.4 0.4 0.16 0.37 0.38 0.76 4.68 false --12-31 Q2 2024-06-30 0001596812 0001596812 2024-01-01 2024-06-30 0001596812 2024-06-30 0001596812 2023-12-31 0001596812 2024-04-01 2024-06-30 0001596812 2023-04-01 2023-06-30 0001596812 2023-01-01 2023-06-30 0001596812 us-gaap:CommonStockMember 2023-12-31 0001596812 us-gaap:AdditionalPaidInCapitalMember 2023-12-31 0001596812 enth:CurrencyTranslationReserveMember 2023-12-31 0001596812 us-gaap:RetainedEarningsMember 2023-12-31 0001596812 us-gaap:CommonStockMember 2024-01-01 2024-03-31 0001596812 us-gaap:AdditionalPaidInCapitalMember 2024-01-01 2024-03-31 0001596812 enth:CurrencyTranslationReserveMember 2024-01-01 2024-03-31 0001596812 us-gaap:RetainedEarningsMember 2024-01-01 2024-03-31 0001596812 2024-01-01 2024-03-31 0001596812 us-gaap:CommonStockMember 2024-03-31 0001596812 us-gaap:AdditionalPaidInCapitalMember 2024-03-31 0001596812 enth:CurrencyTranslationReserveMember 2024-03-31 0001596812 us-gaap:RetainedEarningsMember 2024-03-31 0001596812 2024-03-31 0001596812 us-gaap:CommonStockMember 2024-04-01 2024-06-30 0001596812 us-gaap:AdditionalPaidInCapitalMember 2024-04-01 2024-06-30 0001596812 enth:CurrencyTranslationReserveMember 2024-04-01 2024-06-30 0001596812 us-gaap:RetainedEarningsMember 2024-04-01 2024-06-30 0001596812 us-gaap:CommonStockMember 2024-06-30 0001596812 us-gaap:AdditionalPaidInCapitalMember 2024-06-30 0001596812 enth:CurrencyTranslationReserveMember 2024-06-30 0001596812 us-gaap:RetainedEarningsMember 2024-06-30 0001596812 us-gaap:CommonStockMember 2022-12-31 0001596812 us-gaap:AdditionalPaidInCapitalMember 2022-12-31 0001596812 enth:CurrencyTranslationReserveMember 2022-12-31 0001596812 us-gaap:RetainedEarningsMember 2022-12-31 0001596812 2022-12-31 0001596812 us-gaap:CommonStockMember 2023-01-01 2023-03-31 0001596812 us-gaap:AdditionalPaidInCapitalMember 2023-01-01 2023-03-31 0001596812 enth:CurrencyTranslationReserveMember 2023-01-01 2023-03-31 0001596812 us-gaap:RetainedEarningsMember 2023-01-01 2023-03-31 0001596812 2023-01-01 2023-03-31 0001596812 us-gaap:CommonStockMember 2023-03-31 0001596812 us-gaap:AdditionalPaidInCapitalMember 2023-03-31 0001596812 enth:CurrencyTranslationReserveMember 2023-03-31 0001596812 us-gaap:RetainedEarningsMember 2023-03-31 0001596812 2023-03-31 0001596812 us-gaap:CommonStockMember 2023-04-01 2023-06-30 0001596812 us-gaap:AdditionalPaidInCapitalMember 2023-04-01 2023-06-30 0001596812 enth:CurrencyTranslationReserveMember 2023-04-01 2023-06-30 0001596812 us-gaap:RetainedEarningsMember 2023-04-01 2023-06-30 0001596812 us-gaap:CommonStockMember 2023-06-30 0001596812 us-gaap:AdditionalPaidInCapitalMember 2023-06-30 0001596812 enth:CurrencyTranslationReserveMember 2023-06-30 0001596812 us-gaap:RetainedEarningsMember 2023-06-30 0001596812 2023-06-30 0001596812 enth:NISMember 2024-06-30 0001596812 enth:NISMember 2023-12-31 0001596812 currency:USD 2024-06-30 0001596812 currency:USD 2023-12-31 0001596812 currency:ILS 2024-06-30 0001596812 currency:ILS 2023-12-31 0001596812 enth:LaboratoryEquipmentMember 2024-06-30 0001596812 enth:LaboratoryEquipmentMember 2023-12-31 0001596812 us-gaap:ComputerEquipmentMember 2024-06-30 0001596812 us-gaap:ComputerEquipmentMember 2023-12-31 0001596812 us-gaap:OfficeEquipmentMember 2024-06-30 0001596812 us-gaap:OfficeEquipmentMember 2023-12-31 0001596812 us-gaap:LeaseholdImprovementsMember 2024-06-30 0001596812 us-gaap:LeaseholdImprovementsMember 2023-12-31 0001596812 srt:MinimumMember 2024-01-01 2024-06-30 0001596812 srt:MaximumMember 2024-01-01 2024-06-30 0001596812 us-gaap:CommonStockMember 2024-05-27 2024-05-27 0001596812 us-gaap:WarrantMember 2024-05-27 0001596812 enth:SeriesAWarrantMember 2024-05-27 0001596812 enth:SeriesBWarrantsMember 2024-05-27 0001596812 enth:SeriesAWarrantMember 2024-06-30 0001596812 enth:SeriesBWarrantsMember 2024-06-30 0001596812 us-gaap:WarrantMember 2024-06-30 0001596812 enth:SeriesBWarrantsMember 2024-01-01 2024-06-30 0001596812 enth:SeriesAWarrantMember 2024-01-01 2024-06-30 0001596812 2024-05-29 2024-05-29 0001596812 us-gaap:WarrantMember 2023-12-31 0001596812 us-gaap:WarrantMember 2024-01-01 2024-06-30 0001596812 us-gaap:WarrantMember enth:ExercisePriceOneZeroZeroPointZeroZeroMember 2024-06-30 0001596812 us-gaap:WarrantMember enth:ExercisePriceOneZeroZeroPointZeroZeroMember 2024-01-01 2024-06-30 0001596812 us-gaap:WarrantMember enth:ExercisePriceTwoFivePointZeroZeroMember 2024-06-30 0001596812 us-gaap:WarrantMember enth:ExercisePriceTwoFivePointZeroZeroMember 2024-01-01 2024-06-30 0001596812 us-gaap:WarrantMember enth:ExercisePriceOneTwoFivePointZeroZeroMember 2024-06-30 0001596812 us-gaap:WarrantMember enth:ExercisePriceOneTwoFivePointZeroZeroMember 2024-01-01 2024-06-30 0001596812 us-gaap:WarrantMember enth:ExercisePriceZeroPointZeroZeroOneMember 2024-06-30 0001596812 us-gaap:WarrantMember enth:ExercisePriceZeroPointZeroZeroOneMember 2024-01-01 2024-06-30 0001596812 us-gaap:WarrantMember enth:ExercisePriceOnePointFourZeroMember 2024-06-30 0001596812 us-gaap:WarrantMember enth:ExercisePriceOnePointFourZeroMember 2024-01-01 2024-06-30 0001596812 us-gaap:WarrantMember enth:ExercisePriceOneOnePointFourZeroMember 2024-06-30 0001596812 us-gaap:WarrantMember enth:ExercisePriceOneOnePointFourZeroMember 2024-01-01 2024-06-30 0001596812 us-gaap:WarrantMember enth:ExercisePriceOnePointSevenFiveMember 2024-06-30 0001596812 us-gaap:WarrantMember enth:ExercisePriceOnePointSevenFiveMember 2024-01-01 2024-06-30 0001596812 us-gaap:WarrantMember enth:ExercisePriceOneOnePointSevenFiveMember 2024-06-30 0001596812 us-gaap:WarrantMember enth:ExercisePriceOneOnePointSevenFiveMember 2024-01-01 2024-06-30 0001596812 us-gaap:CommonStockMember 2024-06-30 0001596812 us-gaap:EmployeeStockOptionMember 2024-04-01 2024-06-30 0001596812 us-gaap:EmployeeStockOptionMember 2023-04-01 2023-06-30 0001596812 us-gaap:EmployeeStockOptionMember 2024-01-01 2024-06-30 0001596812 us-gaap:EmployeeStockOptionMember 2023-01-01 2023-06-30 0001596812 us-gaap:EmployeeStockOptionMember 2024-06-30 0001596812 us-gaap:RestrictedStockUnitsRSUMember 2024-04-01 2024-06-30 0001596812 us-gaap:RestrictedStockUnitsRSUMember 2023-04-01 2023-06-30 0001596812 us-gaap:RestrictedStockUnitsRSUMember 2024-01-01 2024-06-30 0001596812 us-gaap:RestrictedStockUnitsRSUMember 2023-01-01 2023-06-30 0001596812 us-gaap:RestrictedStockUnitsRSUMember 2024-06-30 0001596812 us-gaap:EmployeeStockOptionMember 2024-03-31 0001596812 us-gaap:EmployeeStockOptionMember 2023-03-31 0001596812 us-gaap:EmployeeStockOptionMember 2023-06-30 0001596812 us-gaap:EmployeeStockOptionMember 2023-12-31 0001596812 us-gaap:EmployeeStockOptionMember 2022-12-31 0001596812 us-gaap:StockOptionMember enth:ExercisePriceOneMember 2024-01-01 2024-06-30 0001596812 us-gaap:StockOptionMember enth:ExercisePriceOneMember 2024-06-30 0001596812 us-gaap:StockOptionMember enth:ExercisePriceTwoMember 2024-01-01 2024-06-30 0001596812 us-gaap:StockOptionMember enth:ExercisePriceTwoMember 2024-06-30 0001596812 us-gaap:StockOptionMember enth:ExercisePriceThreeMember 2024-01-01 2024-06-30 0001596812 us-gaap:StockOptionMember enth:ExercisePriceThreeMember 2024-06-30 0001596812 us-gaap:StockOptionMember enth:ExercisePriceFourMember 2024-01-01 2024-06-30 0001596812 us-gaap:StockOptionMember enth:ExercisePriceFourMember 2024-06-30 0001596812 us-gaap:StockOptionMember enth:ExercisePriceFiveMember 2024-01-01 2024-06-30 0001596812 us-gaap:StockOptionMember enth:ExercisePriceFiveMember 2024-06-30 0001596812 us-gaap:StockOptionMember enth:ExercisePriceSixMember 2024-01-01 2024-06-30 0001596812 us-gaap:StockOptionMember enth:ExercisePriceSixMember 2024-06-30 0001596812 us-gaap:StockOptionMember enth:ExercisePriceSevenMember 2024-01-01 2024-06-30 0001596812 us-gaap:StockOptionMember enth:ExercisePriceSevenMember 2024-06-30 0001596812 us-gaap:StockOptionMember enth:ExercisePriceEightMember 2024-01-01 2024-06-30 0001596812 us-gaap:StockOptionMember enth:ExercisePriceEightMember 2024-06-30 0001596812 us-gaap:StockOptionMember enth:ExercisePriceNineMember 2024-01-01 2024-06-30 0001596812 us-gaap:StockOptionMember enth:ExercisePriceNineMember 2024-06-30 0001596812 us-gaap:StockOptionMember enth:ExercisePriceTenMember 2024-01-01 2024-06-30 0001596812 us-gaap:StockOptionMember enth:ExercisePriceTenMember 2024-06-30 0001596812 us-gaap:StockOptionMember enth:ExercisePriceElevenMember 2024-01-01 2024-06-30 0001596812 us-gaap:StockOptionMember enth:ExercisePriceElevenMember 2024-06-30 0001596812 us-gaap:StockOptionMember enth:ExercisePriceTwelveMember 2024-01-01 2024-06-30 0001596812 us-gaap:StockOptionMember enth:ExercisePriceTwelveMember 2024-06-30 0001596812 us-gaap:StockOptionMember enth:ExercisePriceThirteenMember 2024-01-01 2024-06-30 0001596812 us-gaap:StockOptionMember enth:ExercisePriceThirteenMember 2024-06-30 0001596812 us-gaap:StockOptionMember enth:ExercisePriceFourteenMember 2024-01-01 2024-06-30 0001596812 us-gaap:StockOptionMember enth:ExercisePriceFourteenMember 2024-06-30 0001596812 us-gaap:StockOptionMember enth:ExercisePriceFifteenMember 2024-01-01 2024-06-30 0001596812 us-gaap:StockOptionMember enth:ExercisePriceFifteenMember 2024-06-30 0001596812 us-gaap:StockOptionMember 2024-06-30 0001596812 us-gaap:StockOptionMember 2024-01-01 2024-06-30 0001596812 us-gaap:ResearchAndDevelopmentExpenseMember 2024-04-01 2024-06-30 0001596812 us-gaap:ResearchAndDevelopmentExpenseMember 2023-04-01 2023-06-30 0001596812 us-gaap:ResearchAndDevelopmentExpenseMember 2024-01-01 2024-06-30 0001596812 us-gaap:ResearchAndDevelopmentExpenseMember 2023-01-01 2023-06-30 0001596812 us-gaap:GeneralAndAdministrativeExpenseMember 2024-04-01 2024-06-30 0001596812 us-gaap:GeneralAndAdministrativeExpenseMember 2023-04-01 2023-06-30 0001596812 us-gaap:GeneralAndAdministrativeExpenseMember 2024-01-01 2024-06-30 0001596812 us-gaap:GeneralAndAdministrativeExpenseMember 2023-01-01 2023-06-30 0001596812 us-gaap:FairValueInputsLevel1Member 2024-06-30 0001596812 us-gaap:FairValueInputsLevel2Member 2024-06-30 0001596812 us-gaap:FairValueInputsLevel3Member 2024-06-30 0001596812 us-gaap:FairValueInputsLevel1Member 2023-12-31 0001596812 us-gaap:FairValueInputsLevel2Member 2023-12-31 0001596812 us-gaap:FairValueInputsLevel3Member 2023-12-31 0001596812 enth:PreFundedWarrantsMember us-gaap:SubsequentEventMember 2024-07-31 0001596812 us-gaap:CommonStockMember us-gaap:SubsequentEventMember 2024-07-31 iso4217:USD iso4217:USD xbrli:shares xbrli:shares iso4217:ILS xbrli:shares xbrli:pure