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: May 2019

 

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 ☐

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulations S-T Rule 101(b)(1): ☐

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulations S-T Rule 101(b)(7): ☐

 

 

 

 

 

 

Financial Statements

 

The unaudited consolidated financial statements for Enlivex Therapeutics Ltd. (“Enlivex”), a company organized under the laws of the State of Israel, as of and for the three months ended March 31, 2019 and 2018, and the Operating and Financial Review and Prospects of Enlivex for the corresponding periods are furnished as Exhibit 99.1 and Exhibit 99.2, respectively, to this Report on Form 6-K and incorporated by reference herein.

 

Exhibit No.

 

99.1   Unaudited historical financial information for Enlivex as of March 31, 2019 and December 31, 2018 and for the three months ended September 30, 2018 and September 30, 2017
99.2   Operating and Financial Review and Prospects as of March 31, 2019 and December 31, 2018 and for the three months ended September 30, 2018 and September 30, 2017

 

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.

 

Date: May 20, 2019 Enlivex Therapeutics Ltd.
  (Registrant)
   
  By: /s/ Shai Novik
 

Name:

Title:

Shai Novik
Executive Chairman

 

 

2

 

Exhibit 99.1

 

 

 

 

 

 

 

 

 

 

 

 

ENLIVEX THERAPEUTICS LTD.

 

CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

AS OF MARCH 31, 2019 AND DECEMBER 31, 2018

AND FOR THE THREE-MONTH PERIODS ENDED MARCH 31, 2019 AND 2018

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ENLIVEX THERAPEUTICS LTD.

 

CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

AS OF MARCH 31, 2019 AND DECEMBER 31, 2018

AND FOR THE THREE-MONTH PERIODS ENDED MARCH 31, 2019 AND 2018

 

INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

 

  Page
Condensed Consolidated Balance Sheets F-2
Condensed Consolidated Statements of Operations and Comprehensive Loss F-3
Condensed Consolidated Cash Flow Statements F-4
Notes to the Condensed Consolidated Financial Statements F-5

 

F- 1

 

 

ENLIVEX THERAPEUTICS LTD.

 

CONDENSED CONSOLIDATED BALANCE SHEETS

 

U.S. dollars in thousands

 

   

March 31,

2019

    December 31, 2018  
    (Unaudited)        
ASSETS            
Current Assets:            
Cash and cash equivalents (note 3)   $ 13,642     $ 9,736  
Short term deposits     40       40  
Prepaid expenses     504       288  
Cash held for CVR holders (note 1a)     1,500       -  
Other receivables     92       213  
Receivables for the sale of Trehalose (note 1a)     2,000       -  
Total Current Assets     17,778       10,277  
Non-Current Assets                
Restricted cash     58       56  
Long-term prepaid expenses     5       16  
Property and equipment, net (note 4)     742       685  
Other assets     463       -  
Total Non-Current Assets     1,268       757  
Total Assets   $ 19,046     $ 11,034  
                 
LIABILITIES AND STOCKHOLDERS’ EQUITY                
Current Liabilities                
Accounts payable trade   $ 279   $ 173
Accrued expenses and other liabilities (notes 5, 6)     899       722  
CVR holders (note 1a.)     3,500       -  
Related parties     14       13  
Total Current Liabilities     4,692       908  
Non-Current Liabilities                
Retirement benefit obligations     7       6  
Other long-term Liabilities (note 6)     891       222  
Warrants (note 8)     -       192  
Total Non-Current Liabilities     898       420  
Commitments and Contingent Liabilities                
TOTAL LIABILITIES     5,590       1,328  
SHAREHOLDERS’ EQUITY (note 8)                
Ordinary shares of NIS 0.4 ($0.11) par value as of March 31, 2019 and December 31, 2018: Authorized: 45,000,000 and 11,861,073 shares; Issued and outstanding: 9,868,809 and 3,509,405 shares     1,099       396  
Series A Preferred Stock, NIS 0.4 ($0.11) par value as of March 31, 2019 and December 31, 2018: Authorized: none and 3,146,815 shares; issued and outstanding: none and 3,059,730 shares     -       309  
Series B Preferred Stock, NIS 0.4 ($0.11) par value as of March 31, 2019 and December 31, 2018: Authorized: none and 3,485,703 shares; Issued and outstanding: none and 1,373,804 shares     -       156  
Series C Preferred Stock, NIS 0.4 ($0.11) par value as of March 31, 2019 and December 31, 2018: Authorized: none and 3,146,815 shares; Issued and outstanding: none and 525,171 shares     -       59  
               
Additional paid in capital     33,262       27,326  
Foreign currency translation adjustments     (1,951 )     (2,251 )
Accumulated deficit     (18,954 )     (16,289 )
TOTAL SHAREHOLDERS’ EQUITY     13,456       9,706  
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY   $ 19,046     $ 11,034  

 

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 (UNADITED)

 

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

 

    For the three months ended  
    March 31,  
    2019     2018  
             
Revenues   $ -     $ -  
Operating expenses:                
Research and development expenses     1,578       918  
General and administrative expenses     784       224  
      2,362       1,142  
                 
Operating loss     (2,362 )     (1,142 )
                 
Financial income     55       132  
Financial expenses     (358 )     15 ))
                 
Net (loss)     (2,665 )     (1,025 )
                 
Other comprehensive (loss)                
Exchange differences arising from translating financial statements from functional to presentation currency     300       (99 )
Total other comprehensive (loss)     300       (99 )
Total comprehensive (loss)   $ (2,365 )   $ (1,124 )
                 
Basic & diluted (loss) per share   $ (0.74 )   $ (0.41 )
Weighted average number of shares outstanding     3,867,101       3,509,344  

 

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

 

F- 3

 

 

ENLIVEX THERAPEUTICS LTD.

 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNADITED)

 

U.S. dollars in thousands

 

   

For the three months ended

March 31,

 
    2019     2018  
Cash flows from operating activities            
Net (loss)   $ (2,665 )   $ (1,025 )
Adjustments required to reflect net cash used in operating activities:                
Income and expenses not involving cash flows:                
Depreciation     44       33  
Share-based compensation     512       18  
Changes in values of warrants exercisable into shares liability     50       14  
Changes in operating asset and liability items:                
Decrease (increase) in prepaid expenses     255       (3 )
Decrease (increase) in other receivables     294       53  
(Decrease) increase in accounts payable trade     90       4  
(Decrease) increase in accrued expenses and other liabilities     347       41  
(Decrease) increase in related parties     1       (1 )
Net cash (used in) operating activities     (1,072 )     (866 )
                 
Cash flows from investing activities                
Purchase of property and equipment     (78 )     (139 )
Net cash received in the issuance of shares for the net assets of Bioblast Pharma Ltd.     44          
Net cash (used in) investing activities     (34 )     (139 )
                 
Cash flows from financing activities                
Proceeds from issuance of shares net of $655 issuance expenses     4,707       -  
Proceeds from exercise of options     4       -  
Net cash (used in) provided by financing activities     4,711       -  
                 
Increase (decrease) in cash and cash equivalents     3,605       (1,005 )
Cash and cash equivalents - beginning of year     9,736       9,005  
Exchange rate differences on cash and cash equivalents     301       105 ))
Cash and cash equivalents - end of period   $ 13,642     $ 7,895  
                 
Non-cash transactions:                
            $ -  
Conversion of preferred stock to ordinary shares     525       -  
Conversion of 6% preference on preferred stock to ordinary shares   $ 2,071          
Issuance of ordinary shares upon exercise of warrants   $ 249     $ -  
Issuance of subscription ordinary shares   $ 5,362          
Issuance of shares in connection with merger   $ 47     $ -  
Assets acquired excluding cash and cash equivalents     4,132       -  
Less - liabilities assumed     (3,532 )     -  
Net assets acquired excluding cash and cash equivalents   $ 600     $ -  
                 
Supplemental disclosures of cash flow information:                
Cash paid for taxes   $ -     $ -  
Cash received for interest   $ 55     $ 29  

 

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

 

F- 4

 

 

ENLIVEX THERAPEUTICS LTD.

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS MARCH 31, 2019 (UNAUDITED)

U.S. dollars in thousands

 

NOTE 1 – GENERAL

 

a. 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 as Bioblast Pharma Ltd.

 

In January 2015, Bioblast Pharma Inc. was established in the state of Delaware as a wholly owned subsidiary of Parent (the “Subsidiary”).

 

On March 26, 2019, upon consummation of a merger transaction between the Parent and Enlivex R&D Therapeutics Ltd., (“Enlivex R&D”, formerly known as “Enlivex Therapeutics Ltd.”), whereby Enlivex R&D merged with Treblast Ltd. (a subsidiary of the Parent) with Enlivex R&D remaining as the surviving entity in the merger (the “ Merger ”), the Parent changed its name to Enlivex Therapeutics Ltd.

 

The Company is a clinical-stage biotechnology company. Enlivex R&D was incorporated in September 2005 under the laws of the State of Israel and has been engaged since inception in the development of an allogeneic drug pipeline for immune system rebalancing. Immune system rebalancing is critical for the treatment of life-threatening immune and inflammatory conditions, which involve the hyper-expression of cytokines (Cytokine Release Syndrome) and for which there are no U.S. Food and Drug Administration (“ FDA ”) approved treatments, as well as treating solid tumors via modulating immune-checkpoint rebalancing. The Company’s innovative immunotherapy candidate, Allocetra™, is a novel immunotherapy candidate based on a unique mechanism of action that targets clinical indications that are defined as “unmet medical needs” such as preventing or treating complications associated with bone marrow transplants (“ BMT ”) and/or hematopoietic stem cell transplants (“ HSCT ”), sepsis and acute multiple organ failure. The Company also intends to develop its cell-based therapy to be combined with currently effective treatments of solid tumors via immune checkpoint rebalancing to increase the efficacy of various anti-cancer therapies, including Chimeric Antigen Receptor T-Cell Therapy (“ CAR-T ”) and therapies targeting T-Cell Receptor Therapy (“ TCR ”). The Company’s development is based on the discoveries of Professor Dror Mevorach, an expert on clearance of dying (apoptotic) cells, in his laboratory in the Hadassah University Hospital (“Hadassah”). located in the State of Israel.

 

At the closing of the Merger, the Parent, Enlivex R&D, the Parent’s pre-Merger CEO - as representative of the pre-Merger Parent’s stockholders, and a rights agent entered into a Contingent Value Rights Agreement (the “CVR Agreement”). Pursuant to the CVR Agreement, the Parent’s stockholders immediately prior to the Merger received one CVR for each share of the Parent’s’ ordinary shares held of record immediately prior to the closing of the Merger. Each CVR represents the right to receive payments based on the Parent’s pre-Merger clinical development programs. CVR holders are entitled to receive 100% of any payments up to $20,000 received and 50% of any subsequent consideration in excess of such amount, in each case, net of all related transaction expenses.

 

On February 19, 2019 the Parent sold its pre-Merger clinical development programs for “Trehalose” to Seelos Therapeutics, Inc. (“Seelos”), a clinical-stage biopharmaceutical company. Under the terms of the agreement between Parent and Seelos, Seelos paid $1,500 upon closing and will pay additional $2,000 upon the first anniversary of the closing. Seelos has agreed to pay additional milestone payments of up to $17,000 upon completion of the related clinical study and approval of a New Drug Application by the FDA, as well as royalties.

 

The Merger has been treated as a reverse recapitalization of the Parent for financial accounting and reporting purposes. As such, Enlivex R&D is treated as the acquirer and the Parent is treated as the acquired entity for accounting and financial reporting purposes.

 

The Company’s ordinary shares (“Ordinary shares”) are traded on the Nasdaq Capital Market under the symbol “ENLV”.

 

b. Financial resources

 

The Company devotes substantially all of its efforts toward research and development activities. In the course of such activities, the Company has sustained operating losses and expects such losses to continue for the foreseeable future. The Company has not generated any revenues or product sales and has not achieved profitable operations or positive cash flow from operations. The Company’s accumulated deficit aggregated $18,954 as of March 31, 2019. There is no assurance that profitable operations, will ever be achieved, or if ever achieved, could be sustained on a continuing basis.

 

F- 5

 

 

ENLIVEX THERAPEUTICS LTD.

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS MARCH 31, 2019 (UNAUDITED)

U.S. dollars in thousands

 

NOTE 1 – GENERAL (cont.)

 

b. Financial resources (cont.)

 

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 an adequate level of financing needed for its long-term development.

 

The Company’s ability to continue to operate in the long term is dependent upon additional financial support.

 

The Company’s management and board of directors believes that its current cash sources will enable the continuance of the Company’s activities for at least the twelve month period following the date on which thesefinancial statements are issued with no need for additional fundraising. The Company may determine, however, to raise additional capital during such period as its Board of Directors deems prudent.

   

NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES

 

a. Basis of presentation: These unaudited 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 accordance with applicable accounting and SEC reporting rules and regulations.

 

In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been made.

 

These unaudited consolidated financial statements should be read in conjunction with the Company’s audited annual financial statements and notes thereto included in the Company’s 2018 Annual Report on Form 20-F, as filed with the SEC on April 30, 2019.

 

The results of operations for these interim periods are not necessarily indicative of the operating results for any future period. The December 31, 2018 financial information has been derived from the Company’s audited financial statements.

 

b. Functional currency and translation to the reporting currency

 

The functional currency of the Company is the New Israeli Shekel (“NIS”), which is the local currency in which it operates.   

 

The financial statements of the Company were translated into U.S. dollars in accordance with ASC 830, “Foreign Currency Matters”.  Accordingly, assets and liabilities were translated from NIS to U.S. dollars using period -end exchange rates, equity items were translated at the exchange rates of the date of the equity transaction, and income and expense items were translated at average exchange rates during the period.

 

Gains or losses resulting from translation adjustments (which result from translating an entity’s financial statements into U.S. dollars if its functional currency is other than the U.S. dollar) are reported in other comprehensive income (loss) and are reflected in equity, under “accumulated other comprehensive income (loss)”.

 

Balances denominated in, or linked to foreign currencies are stated on the basis of the exchange rates prevailing at the balance sheet date.  For foreign currency transactions included in the statement of income, the exchange rates applicable on the relevant transaction dates are used.  Transaction gains or losses arising from changes in the exchange rates used in the translation of such balances are carried to financing income or expenses as applicable.

 

Exchange rate 1 U.S.$ =
As of March 31, 2019, 3.632 NIS
As of December 31, 2018, 3.748 NIS
 
Increase (decrease) of the U.S. $ against the NIS during the period:
Three months ended March 31, 2019 (3.09)%  
Three months ended March 31, 2018 1.36%  

 

F- 6

 

     

ENLIVEX THERAPEUTICS LTD.

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS MARCH 31, 2019 (UNAUDITED)

U.S. dollars in thousands

 

NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES (cont.)

 

c. Leases

 

In accordance with ASU No. 2016-02, Leases (Topic 842), right-of-use (“ROU”) assets represent our right to use the underlying leased assets over the lease term, and lease liabilities represent our obligation to make lease payments arising from the related leases. ROU assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. Lease terms may include options to extend or terminate the lease when we believe it is reasonably certain that we will exercise such options. Operating lease ROU assets are reported in other assets, and operating lease liabilities are reported in accounts payable and accrued liabilities (current), and other long-term liabilities (non-current) in our consolidated balance sheets.

 

Because most of the Company’s leases do not provide an implicit interest rate, the Company generally uses its incremental borrowing rate to determine the present value of lease payments. Lease expenses for operating lease payments are recognized on a straight-line basis over the lease term, and the related ROU assets and liabilities are reduced to the present value of the remaining lease payments at the end of each period. Short-term leases (with a term of 12 months or less) are not recorded as ROU assets or liabilities in the consolidated balance sheets. The Company’s lease agreements include rental payments that adjust periodically for inflation and do not contain any material residual value guarantees or material restrictive covenants.

 

d. New Accounting Pronouncements Adopted

 

Effective January 1, 2019, the Company adopted changes issued by the Financial Accounting Standards Board (FASB) related to leases. See Note 6 for further explanation related to this adoption, including all newly expanded disclosure requirements.

 

Pending Accounting Pronouncements

 

In August 2018, the FASB issued new disclosure guidance on fair value measurement. This new guidance modifies the disclosure requirements on fair value measurements, including removal and modifications of various current disclosures as well as some additional disclosure requirements for Level 3 fair value measurements. Some of these disclosure changes must be applied prospectively while others retrospectively depending on requirement. This guidance is required to be adopted by the Company beginning in fiscal year 2020 with early adoption permitted. The Company does not plan to early adopt this guidance. The adoption of these changes is not expected to have an impact on the Company’s consolidated financial statements.

  

NOTE 3 – CASH AND CASH EQUIVALENTS

 

    March 31,     December 31,  
    2019     2018  
    unaudited        
             
Cash held in banks   $ 6,640     $ 1,029  
Bank deposits in U.S.$ (annual average interest rates 1.49% and 1.81%)     7,002       8,707  
    $ 13,642     $ 9,736  

 

NOTE 4 – PROPERTY AND EQUIPMENT

 

    March 31,     December 31,  
Property and equipment, net consists of the following:   2019     2018  
    unaudited        
             
Cost:            
Laboratory equipment   $ 867     $ 797  
Computers     111       86  
Office furniture & equipment     63       58  
Leasehold improvements     243       228  
      1,284       1,169  

 

F- 7

 

   

ENLIVEX THERAPEUTICS LTD.

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS MARCH 31, 2019 (UNAUDITED)

U.S. dollars in thousands

 

NOTE 4 – PROPERTY AND EQUIPMENT (cont.)

 

    March 31,     December 31,  
    2019     2018  
    unaudited        
Accumulated depreciation:            
Laboratory equipment     376       331  
Computers     68       62  
Office furniture & equipment     14       13  
Leasehold improvements     84       78  
      542       484  
Depreciated cost   $ 742     $ 685  

 

For the three months ended March 31, 2019 and 2018, depreciation expenses were $44 and $33, respectively.

 

NOTE 5 – ACCRUED EXPENSES AND OTHER LIABILITIES

 

    March 31,     December 31,  
    2019     2018  
    unaudited        
             
Employees and payroll related   $ 354     $ 369  
Accrued expenses and other     545       353  
                 
    $ 899     $ 722  

 

NOTE 6 – LEASES

 

The Company elected the transition provision provided by ASU no. 2018-11, Leases (Topic 842) that allows entities to continue to apply the legacy guidance in Topic 840, Leases, including its disclosure requirements, in the comparative periods presented in the year of adoption. Accordingly, the Topic 842 disclosures below are presented as of and for the three-month period ended March 31, 2019, only.

 

The Company is a party to operating leases for its corporate offices, laboratory space and vehicle leases. The Company’s operating leases have remaining lease terms up to four years, some of which include options to extend the leases for up to 5 years.

 

On January 1, 2019, the Company recognized $494 of ROU assets and $494 of lease liabilities ($110 short-term and $370 long-term) on the consolidated balance sheet for operating leases, with the difference due to prepaid deposit balances as of December 31, 2018 that reduced the lease liability balance on January 1, 2019.

 

    March 31,  
    unaudited  
       
The components of lease expense were as follows:      
Operating leases cost for the three months ended March 31, 2019   $ 45  
         
Supplemental consolidated cash flow information related to operating leases follows:        
Cash used in operating activities   $ 45  
Right of use assets obtained in exchange for new operating lease liabilities   $ 480  
Supplemental information related to operating leases, including location of amounts reported in the accompanying consolidated balance sheets, follows:        
Other assets - Right-of-use asset   $ 463  
Accounts payable and accrued liabilities   $ 159  
Other long-term liabilities     287  
Total operating lease liabilities   $ 446  
Weighted average remaining lease term in years     4  
Weighted average annual discount rate     5 %

 

F- 8

 

 

ENLIVEX THERAPEUTICS LTD.

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS MARCH 31, 2019 (UNAUDITED)

U.S. dollars in thousands

 

NOTE 6 – LEASES (cont.)

 

    March 31,  
    2019  
    unaudited  
       
Maturities of operating lease liabilities as of March 31, 2019, were as follows:      
2019   $ 159  
2020     112  
2021     86  
2022     68  
2023     21  
Thereafter     -  
Total lease payments   $ 446  

  

NOTE 7 – COMMITMENTS AND CONTINGENT LIABILITIES

 

Obligation to pay royalties to the State of Israel

 

The Company is required to pay royalties to the State of Israel (represented by the Israel Innovation Authority), computed on the basis of proceeds from the sale or license of products the development of which was supported by State grants.

 

These royalties are generally 3% - 5% of sales until repayment of 100% of the grants (linked to the U.S dollar) received by the Company plus annual interest at the LIBOR rate.

 

The aggregate contingent obligation payable by the Company as of March 31, 2019 was approximately $4,864 which represented the gross amount of grants actually received by the Company from the Israel Innovation Authority, to such date including accrued interest.

 

As of March 31, 2019, the Company had not paid any royalties to the Israel Innovation Authority.

   

NOTE 8 – EQUITY

 

The Company was a party to the agreement in respect of the Merger consummated on March 26, 2019 as described in footnote 1 to these unaudited consolidated financial statements. Upon consummation of the Merger:

 

a. All outstanding preferred stock with all accrued and unpaid dividends thereon of approximately $2,070 and all outstanding warrants of the Company were converted into 5,499,896 ordinary shares.

 

b. 437,733 ordinary shares were issued for an aggregate purchase price of $5,362 in a private offering (and an additional 244,898 ordinary shares were issued on April 3, 2019 see Note 11).

 

c. The Company incurred direct merger-related costs totaling $652 which were recorded as a reduction to additional paid in capital in the Company’s consolidated balance sheet.

 

F- 9

 

 

ENLIVEX THERAPEUTICS LTD.

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS MARCH 31, 2019 (UNAUDITED)

U.S. dollars in thousands

 

NOTE 9 – SHARE-BASED COMPENSATION

 

a) Employees’ and directors stock options

 

The following table contains additional information concerning options granted to employees and directors under the existing stock-option plans:

 

    Three months ended March 31,  
    2019  
   

Number

of options

   

Weighted

average

exercise price

 
Outstanding at beginning of  period     1,083,023     $ 4.75  
Granted     2,421     $ 12.21  
Forfeited and expired     (1,779 )   $ 4.12  
Exercised     (1,222 )   $ 3.39  
Outstanding at end of  period     1,082,443     $ 4.81  
Exercisable at end of  period     537,831     $ 3.61  

 

Following is a summary of changes in non-vested shares granted to employees and directors:

 

    Three months ended March 31,  
    2019  
   

Number

of options

   

Weighted

average

exercise price

 
Balance at beginning of the period     625,302     $ 5.58  
Granted     2,421       12.21  
Vested during the year     (81,332 )     3.22  
Forfeited during the year     (1,779 )     4.12  
Balance at the end of the period     544,612       6.02  

 

As of March 31, 2019, the total unrecognized estimated compensation cost related to outstanding non-vested employees’ stock options was $1,505 which is expected to be recognized over a weighted average period of 2.5 years.

 

b) Consultants’ stock options

 

The following table contains additional information concerning options granted to consultants under the existing stock-option plans:

 

    Three months ended March 31,  
    2019  
   

Number

of options

   

Weighted

average

exercise price

 
Outstanding at beginning of period     718,395     $ 3.72  
Pre-merger Bioblast options     15,500     $ 90.16  
Outstanding at end of  period     733,895     $ 5.55  
Exercisable at end of  period     591,683     $ 5.26  

 

F- 10

 

  

ENLIVEX THERAPEUTICS LTD.

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS MARCH 31, 2019 (UNAUDITED)

U.S. dollars in thousands

 

NOTE 9 – SHARE-BASED COMPENSATION (cont.)

 

Following is a summary of changes in nonvested shares granted to consultants:

 

    Three months ended March 31,  
    2019  
   

Number

of options

   

Weighted

average

exercise price

 
Balance at beginning of the period     149,474     $ 6.20  
Vested during the year     (7,262 )   $ 6.22  
Balance at the end of the period     142,212     $ 6.29  

 

As of March 31, 2019, the unrecognized estimated compensation cost related to outstanding non-vested consultants’ stock options was $735, which is expected to be recognized over a weighted average period of two years.

 

c) Set forth below is data regarding the range of exercise prices and remaining contractual life for all options outstanding at March 31, 2019:

 

exercise price    

Number of options

outstanding

   

Remaining contractual

Life (in years)

    Intrinsic Value of Options Outstanding     No. of options exercisable  
$ 1.86       533       0.8     $ 6       533  
$ 2.69       735,452       6.0       7,034       735,452  
$ 2.69       35,895       1.5       343       35,895  
$ 2.69       6,584       7.2       63       4,454  
$ 2.69       137,087       8.2       1,311       133,868  
$ 2.69       16,622       9.0       159       16,622  
$ 6.22       561,000       9.0       3,381       168,814  
$ 6.22       73,504       9.1       443       18,376  
$ 6.22       53,192       9.6       321       -  
$ 6.22       3,147       9.7       19       -  
$ 6.22       108,928       9.8       657       -  
$ 2.69       49,867       9.8       477       -  
$ 6.22       16,606       9.9       100       -  
$ 10.12       2,421       9.9       5       -  
$ 90.16       15,500       2.4       -       15,500  
          1,816,338             $ 14,319       1,129,514  

 

d) The following table summarizes share-based compensation expenses related to grants under the Equity Incentive Plans included in the statements of operations:

 

    Three months ended
March 31,
 
    2019     2018  
Research & development   $ 413     $ 6  
General & administrative     99       12  
Total   $ 512     $ 18  

 

F- 11

 

     

ENLIVEX THERAPEUTICS LTD.

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS MARCH 31, 2019 (UNAUDITED)

U.S. dollars in thousands

 

NOTE 10 – 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 March 31, 2019 and December 31, 2018:

 

    March 31, 2019  
    Total     Level 1     Level 2     Level 3  
Cash and cash equivalents   $ 13,642     $ 13,642     $ -     $ -  
Short term deposits     40       40                  
Restricted cash     58       58       -       -  
Cash held for CVR holders     1,500       1,500       -       -  
Total financial assets   $ 15,240     $ 15,240     $ -     $ -  

 

    December 31, 2018  
    Total     Level 1     Level 2     Level 3  
Cash and cash equivalents   $ 9,736     $ 9,736     $ -     $ -  
Short term deposits     40       40       -       -  
Restricted cash     56       56       -       -  
Total financial assets   $ 9,832     $ 9,832     $ -     $ -  
                                 
Warrants   $ 192     $ -     $ -     $ 192  
Total financial liabilities   $ 192     $ -     $ -     $ 192  

    

NOTE 11 – 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 financial statements were issued, and determined that the following events necessitated disclosure:

 

In January 2019, the Company submitted a new grant application to the State of Israel (the Israel Innovation Authority) for funding of its clinical development program of prevention of cytokine storm and organ dysfunction associated with Sepsis. On April 16, 2019, the Company’s application for grants at 50% participation of a NIS 7,668 ($2,111) plan to be executed in Israel was approved by the Israel Innovation Authority. The plan was approved for a period commencing January 1, 2019 and ending December 31, 2019.

 

On April 3, 2019, the Company entered into a securities purchase agreement with a private investor, pursuant to which, such investor acquired, in a private transaction, an aggregate of 244,898 of the Company’s ordinary shares at a purchase price of $12.25 per share, providing gross proceeds to the Company of approximately $3,000.

 

F-12

 

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”, “intends,” “estimates,” “suggests,” “has the potential to” and other words and phrases of similar meaning, including statements regarding expected cash balances, market opportunities for the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, ALLOCETRA TM  programs, and potential future payments to holders of CVRs, 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; that the Trehalose program may not generate any revenues for the Company or for holders of the CVRs, 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 ALLOCETRA TM  product line or the Trehalose program 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, 2018.  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 are a clinical stage immunotherapy company, developing an allogeneic drug pipeline for immune system rebalancing. Immune system rebalancing is critical for the treatment of life-threatening immune and inflammatory conditions, which involve the hyper-expression of cytokines (Cytokine Release Syndrome) and for which there are no FDA-approved treatments, as well as treating solid tumors via modulating immune-checkpoint rebalancing. Our innovative immunotherapy candidate, Allocetra™, is a novel immunotherapy candidate based on a unique mechanism of action that targets clinical indications that are defined as “unmet medical needs” such as preventing or treating complications associated with BMT and/or HSCT, sepsis and acute multiple organ failure. We also intend to develop our cell-based therapy to be combined with effective treatments of solid tumors via immune checkpoint rebalancing to increase the efficacy of various anti-cancer therapies, including CAR-T and TCR.

 

The Merger

 

On March 26, 2019, we consummated a merger transaction, pursuant to which our wholly owned subsidiary, Treblast Ltd., merged with and into Enlivex Therapeutics R&D Ltd., (“Enlivex R&D”, formerly known as “Enlivex Therapeutics Ltd.”), with Enlivex R&D remaining as the surviving entity in the merger (the “Merger”). Upon consummation of the Merger, we changed our name from Bioblast Pharma Inc. to Enlivex Therapeutics Ltd.

  

 

 

 

At the closing of the Merger, we, Enlivex R&D, a representative of the Company’s pre-Merger stockholders, and a rights agent, entered into a Contingent Value Rights Agreement (the “CVR Agreement”). Pursuant to the CVR Agreement, the Company’s stockholders immediately prior to the Merger received one contingent value right (each, a “CVR”) for each share of the Company’s ordinary shares held of record immediately prior to the closing of the Merger. Each CVR represents the right to receive payments based on the Company’s pre-Merger clinical development programs. CVR holders are entitled to receive 100% of any payments up to $20.0 million received by the Company and 50% of any subsequent consideration received by the Company in excess of such amount, in each case with respect to such pre-Merger clinical development programs and net of all related transaction expenses.

 

On February 19, 2019 the Company sold its pre-Merger clinical development programs to Seelos Therapeutics, Inc.(“Seelos”), a clinical-stage biopharmaceutical company. Under the terms of the agreement between the Company and Seelos, Seelos paid $1.5 million upon closing and has agreed to pay an additional $2.0 million upon the first anniversary of the closing. Seelos has agreed to pay additional milestone payments of up to $17.0 million upon completion of the related clinical study and approval of a New Drug Application by the FDA, as well as royalties.

 

The Merger has been treated as a reverse recapitalization of the pre-Merger Company for financial accounting and reporting purposes. As such, Enlivex R&D is treated as the acquirer, and the pre-Merger Company is treated as the acquired entity for accounting and financial reporting purposes.

 

The Company’s ordinary shares are traded on the Nasdaq Capital Market under the symbol “ENLV”.

  

Financial 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 Israel Innovation Authority, the sale of equity and equity-linked securities in private equity offerings to our affiliates, shareholders and third-party investors. As of March 31, 2019, we had $13.6 million in cash and cash equivalents and short-term bank deposits. In April 2019, we completed an additional private placement of our ordinary shares which generated an additional of $3 million proceeds. As of March 31, 2019, we had an accumulated deficit of approximately $18.9 million. Although we provide no assurance, we believe that our existing funds and the proceeds of the private placements will be sufficient to continue our business and operations as currently conducted through the second quarter of 2020. We expect that we will continue to incur operating losses, which may be substantial over the next several years, and we will likely need to obtain additional funds to further develop our research and development programs.

  

Revenue

 

We have not generated any revenue since our inception. To date, we have funded our operations primarily through grants from the Israel Innovation Authority, the sale of equity and equity-linked securities in private equity offerings to our affiliates, shareholders and third-party investors. Our ability to generate revenue and become profitable depends upon the clinical success of our product candidates, regulatory approvals and our ability to successfully commercialize products.

 

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.

   

2

 

 

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 stock-based compensation) and fees paid to external service providers, patent-related legal fees 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 in the near future as we continue to develop our product candidates. Increases or decreases in research and development expenditures are 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 obtain additional grants from the Israel Innovation Authority, we cannot be certain that we will do so. 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 studies for toxicology, safety and efficacy and to conduct additional clinical trials for our product candidates.

 

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 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 advancement of our clinical product development for our current 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 liquidity, financial position and results of operation.

   

General and Administrative Expenses

 

General and administrative expenses consist primarily of compensation (including stock-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, travel costs and insurance premiums.

 

Having completed the Merger, we expect our general and administrative expenses, such as accounting and legal fees, to increase given the requirements of applicable to a foreign private issuer in the United States, and we additionally expect increases in the number of our executive, accounting and administrative personnel due to our anticipated growth.

 

Financial Income and Expenses

 

Our financial income and expenses consist of bank fees, exchange rate differences and expenses associated with financial derivative liabilities, such as warrants.

  

Other Comprehensive income (Loss)

 

Our functional currency is the New Israeli Shekel (“NIS”), while our presentation currency is the U.S. dollar. Gains or losses resulting from the translation from our functional currency to our presentation currency are recognized in other comprehensive income (loss).

   

3

 

 

Critical Accounting Policies and Estimate

 

The preparation of financial statements in accordance with United States 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, among other things, 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 materially from these estimates.

   

Our significant accounting policies are described in detail in the notes to our audited consolidated financial statements appearing in our Annual Report on Form 20-F for the year ended December 31, 2018, as filed with the SEC on April 30, 2019; however, we believe that the following accounting policies are most critical to the judgments and estimates used in the preparation of our unaudited consolidated financial statements.

 

Jumpstart Our Business Startups Act of 2012

 

We are an “emerging growth company,” as defined in Section 2(a) of the Securities Act of 1933, as amended. As such, we are eligible to, and intend to, take advantage of certain exemptions from various reporting requirements otherwise applicable to public companies that are not “emerging growth companies”, such as the exemption from compliance with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002. We will continue to be an “emerging growth company” until December 31, 2019.

 

The JOBS Act also permits us, as an emerging growth company, to take advantage of an extended transition period to comply with certain new or revised accounting standards until such standards become applicable to private companies. However, we have irrevocably chosen to “opt out” of this provision and, as a result, we will comply with new or revised accounting standards when they are required to be adopted by public issuers.

 

Share-Based Compensation and Fair Value of Ordinary Shares

 

ASC 718 - “Compensation-stock Compensation”- (“ASC 718”) requires companies to estimate the fair value of equity-based payment awards on the date of grant using an Option Pricing Model. The value of the portion of the award that is ultimately expected to vest is recognized as an expense over the requisite service periods.

 

We estimate the fair value of our share-based awards to employees and non-employees using Black-Scholes, which requires the input of assumptions, some of which are highly subjective, including:

  

  expected volatility of our ordinary shares;

 

  expected term of the award;

 

  risk-free interest rate;

 

  expected dividends; and

 

  estimated fair value of our ordinary shares on the measurement date.

  

There was no active external or internal market for our ordinary shares for substantially all of the 2019 period (and all of the comparable 2018 period) presented in our unaudited consolidated financial statements to which the discussion and analysis contained herein relate. Such financial statements are furnished as an exhibit to our Report on Form 6-K to which this discussion and analysis is similarly furnished as an exhibit. Thus, it was not possible to estimate the expected volatility of our share price in estimating fair value of options granted. Accordingly, as a substitute for such volatility, we used the historical volatility of comparable companies in the industry. The expected term of options granted represents the period of time that options granted are expected to be outstanding, we use management’s estimates for the expected term of options due to insufficient readily available historical exercise data.

   

4

 

 

Compensation expense for options granted to non-employees is determined based on the fair value of the consideration received or the fair value of the equity instruments issued, whichever is more reliably measured. Compensation expense for awards granted to non-employees is re-measured in each quarterly period. Determining the appropriate fair value of the stock-based compensation requires the input of subjective assumptions, including the expected life of the stock-based payment, stock price volatility and value of our ordinary shares upon measurement date.

  

Valuation of Warrant Liability

 

Our outstanding warrants issued in September and October 2017 are classified as derivative liabilities, as such warrants permits net settlement. The warrants are valued at each financial reporting period using option pricing models which incorporate the Company’s stock price, volatility, U.S. risk-free rate, dividend rate, and estimated life, with changes in fair value being recognized as profit of loss.

  

Results of Operations

 

Three-Months Ended March 31, 2019 Compared to Three-Months Ended March 31, 2018

 

The table below provides our results of operations for the three Months ended March 31, 2019 and March 31, 2018:

  

    Three Months Ended
March 31
 
    2019     2018  
   

(In thousands, except

per share data)
(unaudited)

 
Research and development expenses   $ 1,578     $ 918  
General and administrative expenses     784       224  
Operating loss     (2,362 )     (1,142 )
Financial income (expenses), net     (303 )     (117 )
Operating income (loss) post-finance expense & other income, net     (2,665 )     (1,025 )
Taxes on income     -       -  
Net income (loss)     (2,665 )     (1,025 )
Other comprehensive income (loss)     300 )     (99  
Total comprehensive income (loss)   $ (2,365 )   $ (1,124 )
Basic income (loss) per share   $ (0.74 )   $ (0.41 )
Diluted income (loss) per share   $ (0.74 )   $ (0.41 )

   

5

 

 

Research and Development Expenses

 

For the three months ended March 31, 2019 and 2018, we incurred research and development expenses in the aggregate of $1,578,000 and $918,000, respectively. The increase of $660,000, or 72%, in research and development expenses for 2019 as compared to 2018 was primarily due to a $150,000 increase in salaries and a $412,000 increase in stock-based compensation to employees and consultants.

 

General and Administrative Expenses

 

For the three months ended March 31, 2019 and 2018, we incurred general and administrative expenses in the aggregate of $784,000 and $224,000, respectively. The increase of $560,000, or 250%, in general and administrative expenses for 2019 as compared to 2018 was primarily due to a $374,000 increase in withholding tax provision on preferred shares dividends (all such preferred shares have been converted to ordinary shares), an $82,000 increase in salaries and an $87,000 increase in stock-based compensation to employees and directors.

 

Operating Loss

 

As a result of the foregoing research and development and general and administrative expenses for three months ended March 31, 2019, our operating loss was $2,362,000, representing an increase of $1,220,000, or 107%, as compared to our operating loss of $1,142,000 for the three months ended March 31, 2018. This increase primarily resulted from an increase in research and development salaries and stock-based compensation, the costs of preclinical studies and material consumption and an increase in accounting and legal expenses.

 

Financial Income (Expenses), Net

 

Financial expenses, net and income, net consist of the following:

 

  interest earned on our cash and cash equivalents; 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 three months ended March 31, 2019 and 2018, we recorded net financial (expenses) income of $(303,000) and $(117,000), respectively. The increase in financial expense for the three months ended March 31, 2019 as compared to the three months ended March 31, 2018 was primarily due to currency fluctuations on cash and cash equivalents and deposits denominated in currencies other than the NIS, changes in the fair value of our warrants and from interest earned on our cash and cash equivalents.

 

Net Loss

 

As a result of the foregoing research and development and general and administrative expenses, for the three months ended March 31, 2019, our net loss was $2,665,000, representing an increase of $1,640,000 as compared to our net loss of 1,025,000 for the comparable prior year period. This increase primarily resulted from an increase in research and development expenses, including salaries and stock-based compensation, the costs of preclinical studies and material consumption and an increase in accounting and legal expenses.

  

Other Comprehensive Income (Loss)

 

As a result of a decrease of 3% in the U.S. dollar against the NIS in three months ended March 31, 2019, as compared to an increase of 1.3% in the comparable prior year period, we recorded income of $300,000 from exchange rate differences arising from translating our unaudited consolidated financial statements from functional to presentation currency, as compared to losses of $99,000 for the comparable prior year period.

  

6

 

 

Cash Flows

 

Three Months Ended March 31, 2019 Compared to Three Months Ended March 31, 2018

 

For the three months ended March 31, 2019 and 2018. net cash used in operations was $1,072,000 and $866,000, respectively. The increase in net cash used in operations for 2019 as compared to the comparable prior year period was primarily due to an increase in research and development expenses, as a result of increases in salaries, preclinical study expenses, consultants’ fees, as well as preparation for the expected commencement of clinical trials in 2019.

 

For the three months ended March 31, 2019 and 2018, net cash provided by (used in) investing activities was $(34,000) and $(139,000), respectively. The decrease in net cash used in investing activities for 2019 as compared to 2018 resulted primarily from net cash received in the Merger.

 

For the three months ended March 31, 2019 and 2018, net cash provided by financing activities was $4,711,000 and $0 respectively. This increase in cash provided by financing activities for 2019 as compared to 2018 resulted primarily from net proceeds of $4,707 from issuance of shares in the private placement that took place concurrently with the closing of the Merger.

  

Liquidity and Capital Resources

 

We have incurred substantial losses since our inception. As of March 31, 2019, we had an accumulated deficit of approximately $18.9 million and working capital (current assets minus current liabilities) of approximately $13 million ($16 million as of April 3, 2019, see Note 11 to the unaudited consolidated financial statements). We expect to incur losses from operations for the foreseeable future, and we expect to incur increasing research and development expenses, including expenses related to the hiring of personnel, conducting preclinical studies and clinical trials and outsourcing of certain development activities. We expect that general and administrative expenses will also increase as we expand our finance and administrative staff and add infrastructure.

 

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 second quarter of 2020. 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. We currently anticipate that we will utilize approximately $3.1 million for clinical trial activities over the course of the next 12 months. 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;

  

7

 

 

  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 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.

 

We currently do not have any commitments 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 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 Israel Innovation Authority, 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.

  

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 most of our expenses are denominated in NIS and the U.S. dollar. Our NIS and U.S. dollar 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 and U.S. dollar. 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.

  

To date, we have not engaged in hedging our foreign currency exchange risk. In the future, we may enter into formal currency hedging transactions to decrease the risk of financial exposure from fluctuations in the exchange rates of our principal operating currencies. These measures, however, may not adequately protect us from the material adverse effects of such fluctuations.

 

 

8