Exhibit 99.1 

ENLIVEX THERAPEUTICS LTD.

CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

AS OF JUNE 30, 2019 AND DECEMBER 31, 2018

AND FOR THE THREE AND SIX MONTH PERIODS ENDED JUNE 30, 2019 AND 2018

ENLIVEX THERAPEUTICS LTD.

CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

AS OF JUNE 30, 2019 AND DECEMBER 31, 2018

AND FOR THE THREE AND SIX MONTH PERIODS ENDED JUNE 30, 2019 AND 2018

INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

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

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

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

ENLIVEX THERAPEUTICS LTD.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2019 (UNAUDITED)

U.S. dollars in thousands

NOTE 1 - GENERAL

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

On March 26, 2019, upon consummation of a merger transaction between the Parent and Enlivex Therapeutics R&D 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 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 the 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”.

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 $20,415 as of June 30, 2019. There is no assurance that profitable operations will ever be achieved, or, if ever achieved, could be sustained on a continuing basis.

ENLIVEX THERAPEUTICS LTD.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2019 (UNAUDITED)

U.S. dollars in thousands

NOTE 1 - GENERAL (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 these financial 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

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.

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

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

As of June 30, 2019, 1 U.S.$ = 3.566 NIS

As of December 31, 2018, 1 U.S.$ = 3.748 NIS

Increase (decrease) of the U.S. $ against the NIS during the period:

ENLIVEX THERAPEUTICS LTD.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2019 (UNAUDITED)

U.S. dollars in thousands

NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (cont.)

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 condensed 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.

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

Effective January 1, 2019, the Company adopted changes issued by the FASB related to Stock Compensation. In June 2018, the FASB issued ASU No. 2018-07, Compensation - Stock Compensation (Topic 718), Improvements to Nonemployee Share-Based Payment Accounting. This ASU simplifies aspects of share-based compensation issued to non-employees by making the guidance consistent with the accounting for employee share-based compensation.

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.

ENLIVEX THERAPEUTICS LTD.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2019 (UNAUDITED)

U.S. dollars in thousands

For the three and six months ended June 30, 2019 and 2018, depreciation expenses were $92 and $22, and $95 and $55, respectively.

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 only as of and for the six-month period ended June 30, 2019.

The Company is a party to operating leases for its corporate offices, laboratory space and vehicles. The Company's operating leases have remaining lease terms up to 4.2 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 $480 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.

ENLIVEX THERAPEUTICS LTD.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2019 (UNAUDITED)

U.S. dollars in thousands

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 Company’s aggregate contingent obligation to pay as of June 30, 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.

In January 2019, the Company submitted a new grant application to 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 ($2,150) 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.

As of June 30, 2019, the Company had not paid any royalties to the Israel Innovation Authority.

NOTE 8 – EQUITY

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

ENLIVEX THERAPEUTICS LTD.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2019 (UNAUDITED)

U.S. dollars in thousands

NOTE 9 – SHARE-BASED COMPENSATION

In March 2019, the Company approved an increase in the number of shares authorized under the 2014 Equity Incentive Plan by 500,000 Ordinary Shares to a total of 2,350,704.

In June 2019, the Company adopted its Global Share Incentive Plan (2019) (the “2019 Equity Incentive Plan”) under which, all shares remaining available for future grant under the 2014 Equity Incentive Plan, shall be deemed reserved for issuance with respect to awards that will be granted under the 2019 Equity Incentive Plan.

Options granted under the Equity Incentive Plans and agreements vest over a period of four years and expire ten years following the date of grant. Upon termination of the optionee’s employment or other relationship with the Company, options cease vesting and options are forfeited. Ordinary Shares underlying options that are canceled or not exercised within the option term become available for future grant under the 2019 Equity Incentive Plan.

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

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

As of June 30, 2019, the total unrecognized estimated compensation cost related to outstanding non-vested employees' stock options was $1,085, which is expected to be recognized over a weighted average period of 2.25 years.

ENLIVEX THERAPEUTICS LTD.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2019 (UNAUDITED)

U.S. dollars in thousands

NOTE 9 – SHARE-BASED COMPENSATION (cont.)

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

Following is a summary of changes in non-vested shares granted to consultants:

As of June 30, 2019, the unrecognized estimated compensation cost related to outstanding non-vested consultants' stock options was $501 which is expected to be recognized over a weighted average period of 1.75 years.

ENLIVEX THERAPEUTICS LTD.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2019 (UNAUDITED)

U.S. dollars in thousands

NOTE 9 – SHARE-BASED COMPENSATION (cont.)

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:

On July 22, 2019, the Company’s Ordinary Shares commenced trading on the Tel Aviv Stock Exchange in addition to the Ordinary Shares’ existing trading on the Nasdaq Capital Market.

F-11

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 June 30, 2019, we had $14.5 million in cash and cash equivalents and short-term bank deposits. As of June 30, 2019, we had an accumulated deficit of approximately $20.4 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 and 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.

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 legal and regulatory requirements 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).

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:

There was no active external or internal market for our pre-Merger 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 our 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.

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 permit net settlement. The warrants are valued at each financial reporting period using option pricing models that 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.

The table below provides our results of operations for the three months ended June 30, 2019 and June 30, 2018:

Research and Development Expenses

For the six and three months ended June 30, 2019 and 2018, we incurred research and development expenses in the aggregate of $ 2 , 2 74,000 $ 1,586 ,000, $696,000 and $668,000, respectively. The increase in research and development expenses for the six months ended June 30, 2019 of $688,000, or 43%, as compared to the six-months ended June 30, 2018 was primarily due to a $ 403 ,000 increase in salaries, $ 428 ,000 increase in stock-based compensation to employees and consultants, $341,000 increase in clinical expenses and $601,000 decrease in Israel Innovation Authority grants relating to 50% participation in an approved clinical development program of the Company for the prevention of cytokine storm and organ dysfunction associated with sepsis. The increase of $ 28 ,000, or 4 %, in research and development expenses for the three months ended June 30, 2019, as compared to the three months ended June 30, 2018, was primarily due to a $259,000 increase in salaries, $260,000 increase in clinical expenses, $ 92 ,000 increase in depreciation expenses and stock-based compensation to employees and consultants and $601,000 decrease in Israel Innovation Authority grants relating to a 50% participation of an approved clinical development program of the Company for the prevention of cytokine storm and organ dysfunction associated with sepsis.

General and Administrative Expenses

For the six and three months ended June 31, 2019 and 2018, we incurred general and administrative expenses in the aggregate of $1,385,000, $404,000, $601,000 and $180,000, respectively. The increase in general and administrative expenses of $981,000, or 242%, for the six months ended June 30, 2019 as compared to the six months ended June 30, 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), $162,000 increase in salaries, $172,000 increase in stock-based compensation to employees and directors, $119,000 increase in professional services fees and $91,000 increase in insurance expenses. The increase in general and administrative expenses of $421,000, or 233%, for the three months ended June 30, 2019 as compared to the three months ended June 30, 2018 was primarily due to an $87,000 increase in salaries, $85,000 increase in stock-based compensation to employees and directors, $114,000 increase in professional services fees and $86,000 increase in insurance expenses.

Operating Loss

As a result of the foregoing research and development and general and administrative expenses for the six and three months ended June 30, 2019, our operating loss was $3,659,000 and $1,297,000, respectively, representing an increase of $1,669,000 and $449,000, or 84% and 53%, respectively, as compared to our operating loss for the six and three months ended June 30, 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:

For the six and three months ended June 30, 2019 and 2018, we recorded net financial (expenses) income of $(467,000), $435,000, $(164,000) and $317,000, respectively. The increase in financial expense for the six and three months ended June 30, 2019 as compared to the six and three months ended June 30, 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 six and three months ended June 30, 2019, our net loss was $4,126,000 and $1,461,000, respectively, representing an increase of $2,571,000 and $930,000, respectively, as compared to our net loss of $1,555,000 and $531,000, respectively, for the comparable prior year period. This increase in net loss 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 4.86% and 1.82% in the U.S. dollar against the NIS for the six and three months ended June 30, 2019, respectively, as compared to an increase of 5.28% and 3.87% for the comparable prior year periods, we recorded income of $534,000 and $234,000 from exchange rate differences arising from translating our unaudited consolidated financial statements from functional to presentation currency for the six and three months ended June 30, 2019, respectively, as compared to losses of $373,000 and $272,000, respectively, for the comparable prior year period.

Cash Flows

Six Months Ended June 30, 2019 Compared to Six Months Ended June 30, 2018

For the six months ended June 30, 2019 and 2018, net cash used in operations was $3,261,000 and $1,397,000, 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, and consultants’ fees, as well as preparation for the expected commencement of clinical trials in 2019.

For the six months ended June 30, 2019 and 2018, net cash (used in) investing activities was $(88,000) and $(181,000), 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 as well as a decrease in purchases of property and equipment

For the six months ended June 30, 2019 and 2018, net cash provided by financing activities was $7,710,000 and $0 respectively. This increase in cash provided by financing activities for 2019 as compared to 2018 resulted primarily from net proceeds of $7,706 from the 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 June 30, 2019, we had an accumulated deficit of approximately $20.4 million and working capital (current assets minus current liabilities) of approximately $14 million. 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:

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.

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