Exhibit 99.1
ENLIVEX THERAPEUTICS LTD.
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AS OF JUNE 30, 2021 AND DECEMBER 31, 2020
AND FOR THE THREE AND SIX MONTH PERIODS ENDED JUNE 30, 2021 AND 2020
ENLIVEX THERAPEUTICS LTD.
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AS OF JUNE 30, 2021 AND DECEMBER 31, 2020
AND FOR THE THREE AND SIX MONTH PERIODS ENDED JUNE 30, 2021 AND 2020
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
ENLIVEX THERAPEUTICS LTD.
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
U.S. dollars in thousands (except share data)
| | | June 30, | | | December 31, | |
| | | 2021 | | | 2020 | |
| | | | | | | |
| ASSETS | | | | | | |
| Current Assets | | | | | | |
| Cash and cash equivalents | | $ | 12,612 | | | $ | 5,673 | |
| Short term deposits | | | 10,024 | | | | 30,034 | |
| Marketable securities | | | 67,964 | | | | - | |
| Prepaid expenses and other receivables | | | 1,345 | | | | 1,164 | |
| Restricted cash | | | 90 | | | | 79 | |
| Cash held with respect to CVR Agreement | | | 793 | | | | 1,171 | |
| | | | | | | | | |
| Total Current Assets | | | 92,828 | | | | 38,121 | |
| | | | | | | | | |
| Non-Current Assets | | | | | | | | |
| Property and equipment, net | | | 1,694 | | | | 1,481 | |
| Other assets | | | 665 | | | | 756 | |
| Total Non-Current Assets | | | 2,359 | | | | 2,237 | |
| TOTAL ASSETS | | $ | 95,187 | | | $ | 40,358 | |
| | | | | | | | | |
| LIABILITIES AND SHAREHOLDERS’ EQUITY | | | | | | | | |
| Current Liabilities | | | | | | | | |
| Accounts payable trade | | $ | 558 | | | $ | 463 | |
| Accrued expenses and other liabilities | | | 3,225 | | | | 2,738 | |
| CVR holders | | | 793 | | | | 1,171 | |
| Total Current Liabilities | | | 4,576 | | | | 4,372 | |
| | | | | | | | | |
| Non-Current Liabilities | | | | | | | | |
| Other long-term Liabilities | | | 405 | | | | 499 | |
| Total Non-Current Liabilities | | | 405 | | | | 499 | |
| | | | | | | | | |
| Commitments and Contingent Liabilities | | | | | | | | |
| | | | | | | | | |
| TOTAL LIABILITIES | | | 4,981 | | | | 4,871 | |
| | | | | | | | | |
| SHAREHOLDERS’ EQUITY | | | | | | | | |
| Ordinary shares of NIS 0.40 ($0.12) par value: | | | | | | | | |
| Authorized: 45,000,000 shares as of June 30, 2021 and December 31, 2020; | | | | | | | | |
| Issued and outstanding:18,306,186 and 14,587,934 as of June 30, 2021 and December 31, 2020; | | | 2,104 | | | | 1,646 | |
| Additional paid in capital | | | 131,663 | | | | 70,361 | |
| Foreign currency translation adjustments | | | 244 | | | | 977 | |
| Accumulated deficit | | | (43,805 | ) | | | (37,497 | ) |
| TOTAL SHAREHOLDERS’ EQUITY | | | 90,206 | | | | 35,487 | |
| TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | | $ | 95,187 | | | $ | 40,358 | |
The accompanying notes are an integral part of the condensed consolidated financial statements.
ENLIVEX THERAPEUTICS LTD.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)
U.S. dollars in thousands (except share and per share data)
| | | For the three monthsended | | | For the six months ended | |
| | | June 30, | | | June 30, | |
| | | 2021 | | | 2020 | | | 2021 | | | 2020 | |
| | | | | | | | | | | | | |
| Revenues | | $ | - | | | $ | - | | | $ | - | | | $ | - | |
| | | | | | | | | | | | | | | | | |
| Operating expenses: | | | | | | | | | | | | | | | | |
| Research and development expenses | | | 2,539 | | | | 1,257 | | | | 5,036 | | | | 2,520 | |
| General and administrative expenses | | | 1,269 | | | | 976 | | | | 2,574 | | | | 1,609 | |
| | | | 3,808 | | | | 2,233 | | | | 7,610 | | | | 4,129 | |
| | | | | | | | | | | | | | | | | |
| Operating loss | | | (3,808 | ) | | | (2,233 | ) | | | (7,610 | ) | | | (4,129 | ) |
| | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | |
| Other income/(expense), net | | | 700 | | | | (808 | ) | | | 1,302 | | | | 294 | |
| | | | | | | | | | | | | | | | | |
| Net (loss) | | | (3,108 | ) | | | (3,041 | ) | | | (6,308 | ) | | | (3,835 | ) |
| | | | | | | | | | | | | | | | | |
| Other comprehensive income (loss) | | | | | | | | | | | | | | | | |
| Exchange differences arising from translating financial statements from functional to presentation currency | | | 2,055 | | | | 888 | | | | (733 | ) | | | (128 | ) |
| Total other comprehensive income (loss) | | | 2,055 | | | | 888 | | | | (733 | ) | | | (128 | ) |
| Total comprehensive (loss) | | $ | (1,053 | ) | | $ | (2,153 | ) | | $ | (7,041 | ) | | $ | (3,963 | ) |
| | | | | | | | | | | | | | | | | |
| Basic & diluted (loss) per share | | $ | (0.17 | ) | | $ | (0.23 | ) | | $ | (0.36 | ) | | $ | (0.31 | ) |
| Weighted average number of shares outstanding | | | 18,305,882 | | | | 13,441,436 | | | | 17,397,860 | | | | 12,419,643 | |
The accompanying notes are an integral part of the condensed consolidated financial statements.
ENLIVEX THERAPEUTICS LTD.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
U.S. dollars in thousands
| | | For the six months ended
June 30, | |
| | | 2021 | | | 2020 | |
| Cash flows from operating activities | | | | | | |
| Net (loss) | | $ | (6,308 | ) | | $ | (3,835 | ) |
| Adjustments required to reflect net cash used in operating activities: | | | | | | | | |
| Income and expenses not involving cash flows: | | | | | | | | |
| Depreciation | | | 239 | | | | 114 | |
| Non-cash operating lease expenses | | | 107 | | | | 66 | |
| Share-based compensation | | | 842 | | | | 320 | |
| Income on marketable securities | | | (1,583 | ) | | | - | |
| Changes in operating asset and liability items: | | | | | | | | |
| (Increase) decrease in prepaid expenses and other receivables | | | (195 | ) | | | 1,444 | |
| Increase in accounts payable trade | | | 101 | | | | 129 | |
| Increase (decrease) in accrued expenses and other liabilities | | | 153 | | | | (1,071 | ) |
| Operating lease liabilities | | | (106 | ) | | | (62 | ) |
| Net cash (used in) provided by operating activities | | | (6,750) | | | | (2,895 | ) |
| | | | | | | | | |
| Cash flows from investing activities | | | | | | | | |
| Purchase of property and equipment | | | (472) | | | | (166 | ) |
| Release (investment) in short-term bank deposits | | | 19,563 | | | | (12,000 | ) |
| Purchases of marketable securities | | | (85,695 | ) | | | - | |
| Proceeds from sales of marketable securities | | | (19,217 | | | | - | |
| Net cash (used in) investing activities | | | (47,387) | | | | (12,166 | ) |
| | | | | | | | | |
| Cash flows from financing activities | | | | | | | | |
| Proceeds from issuance of shares and warrants net of $4,455 and $2,294 issuance expenses, respectively | | | 53,174 | | | | 22,456 | |
| Proceeds from exercise of warrants | | | 7,702 | | | | - | |
| Proceeds from exercise of options | | | 42 | | | | 97 | |
| Net cash provided by financing activities | | | 60,918 | | | | 22,553 | |
| | | | | | | | | |
| Increase in cash and cash equivalents | | | 6,781 | | | | 7,492 | |
| Cash and cash equivalents - beginning of period | | | 7,012 | | | | 5,524 | |
| Exchange rate differences on cash and cash equivalents | | | (210) | | | | (124 | ) |
| Cash and cash equivalents - end of period | | $ | 13,583 | | | $ | 12,892 | |
| Non-cash transactions: | | | | | | | | |
| Warrants issued in settlement of issuance costs to a placement agent | | $ | 2,095 | | | $ | 563 | |
| Supplemental disclosures of cash flow information: | | | | | | | | |
| Cash paid for taxes | | $ | - | | | $ | - | |
| Cash received for interest, net | | $ | 62 | | | $ | 72 | |
The accompanying notes are an integral part of the condensed consolidated financial statements.
ENLIVEX THERAPEUTICS LTD.
| NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2021 (UNAUDITED) |
NOTE 1 - GENERAL
| a. | Enlivex Therapeutics Ltd. (the “Parent” and, including its consolidated subsidiaries, “we”, “us”, “our” or the “Company”) is a clinical-stage macrophage reprogramming immunotherapy company originally incorporated on January 22, 2012 under the laws of the State of Israel. |
The Company is developing AllocetraTM, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of life-threatening conditions. Non-homeostatic macrophages contribute significantly to the severity of the certain diseases, which include solid tumors, sepsis, COVID-19, and others.
The AllocetraTM concept is based on the discoveries of Professor Dror Mevorach, an expert on immune activity, macrophage activation and clearance of dying (apoptotic) cells, in his laboratory in the Hadassah University Hospital located in the State of Israel.
Enlivex Therapeutics R&D Ltd. (“Enlivex R&D”, formerly known as Enlivex Therapeutics Ltd.) was incorporated in September 2005 under the laws of the State of Israel. On March 26, 2019, upon consummation of a merger transaction between the Parent and Enlivex R&D, pursuant to which a wholly owned subsidiary of the Parent merged with and into Enlivex R&D, the Parent changed its name to Enlivex Therapeutics Ltd. Enlivex R&D is a wholly owned subsidiary of the Company.
In January 2015, Bioblast Pharma Inc. was established in the State of Delaware as a wholly owned subsidiary of the Parent. On July 1, 2020 Bioblast Pharma Inc changed its name to Enlivex Therapeutics Inc.
The Company’s ordinary shares, NIS 0.40 per share (“Ordinary Shares” or “ordinary shares”), are traded under the symbol “ENLV” on both the Nasdaq Capital Market and the Tel Aviv Stock Exchange.
The Company devotes substantially all of its efforts toward research and development activities and raising capital to support such activities. The Company’s activities are subject to significant risks and uncertainties, including failing to secure additional funding before the Company achieves sustainable revenues and profit from operations.
Research and development activities have required significant capital investment since the Company’s inception. The Company expects that its operations will require additional cash investment to pursue the Company’s research and development activities, including preclinical studies, formulation development, clinical trials and related drug manufacturing. The Company has not generated any revenues or product sales and has not achieved profitable operations or positive cash flow from operations. The Company has incurred net losses since its inception, and, as of June 30, 2021, had an accumulated deficit of $43,805.
During the first quarter of 2021 the Company raised a net aggregated amount of $53.2 million in cash from the issuance and sale of 2,848,629 of its ordinary shares and an additional $7.7 million from the exercise of 855,813 warrants and 13,435 options. However, the Company expects to continue to incur losses for at least the next several years and over that period the Company will need to raise additional debt or equity financing or enter into partnerships to fund its development. If the Company is not able to achieve its funding requirements, it may be required to reduce discretionary spending, may not be able to continue the development of its product candidates or may be required to delay its development programs, which could have a material adverse effect on the Company’s ability to achieve its intended business objectives. There can be no assurances that additional financing will be secured or, if secured, will be on favorable terms. The ability of the Company to transition to profitability in the longer term is dependent on developing products and product revenues to support its expenses.
The Company’s management and board of directors (the “Board”) are of the opinion that the Company’s current financial resources will be sufficient to continue the development of the Company’s product candidates for at least twelve months from the filing of these financial statements on Form 6-K. The Company may determine, however, to raise additional capital during such period as the Board deems prudent. The Company’s management plans to finance its operations with issuances of the Company’s equity securities and, in the longer term, revenues. There are no assurances, however, that the Company will be successful in obtaining 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.
ENLIVEX THERAPEUTICS LTD.
| NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2021 (UNAUDITED) |
Based on the Company’s current assessment, the Company does not expect any material impact on its liquidity due to the worldwide spread of the SARS-CoV-2 coronavirus. However, the timelines for the Company’s clinical development programs may be extended due to direct and indirect impacts of the COVID-19 pandemic or new variants of the virus. For example, there has been a delay in recruiting patients for the Company’s randomized, controlled Phase IIb clinical trial of AllocetraTM in patients with severe sepsis due to a lower number of pneumonic septic patients, as a result of the COVID-19 pandemic environment. As previously reported in the Company’s Annual Report on Form 20-F for the year ended December 31, 2020, the Company still expects to obtain interim results from this Phase IIb during 2021 or early 2022 followed by top-line results later in 2022. The full extent to which the COVID-19 pandemic or new variants of the virus will directly or indirectly impact the Company’s business, results of operations and financial condition will depend on future developments that are highly uncertain as of the date of issuance of these unaudited condensed consolidated financial statements. Actual results could differ materially from the Company’s estimates.
NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
These unaudited condensed consolidated financial statements include the accounts of the Company and have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information. Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been made.
These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited annual financial statements and notes thereto included in the Company’s 2020 Annual Report on Form 20-F, as filed with the SEC on April 30, 2021. The results of operations for these interim periods are not necessarily indicative of the operating results for any future period. The December 31, 2020 financial information has been derived from the Company’s audited financial statements.
Use of Estimates
The preparation of interim financial statements in conformity with U.S. GAAP requires management to make certain estimates, judgments and assumptions that affect the reported amounts in the consolidated balance sheets and statements of operations, it also requires that management exercise its judgment in applying the Company’s accounting policies. On an ongoing basis, management evaluates its estimates, including estimates related to its stock-based compensation expense and implicit interest rate on new lease liabilities. Significant estimates in these interim financial statements include estimates made for accrued research and development expenses and stock-based compensation expenses.
Functional Currency and Translation to The Reporting Currency
The functional currency of the Company is the New Israeli Shekel (“NIS”), which is the local currency where the Company 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 as of the dates of the respective equity transactions, 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.
1 U.S. $ = 3.26 NIS and 3.215 NIS as of June 30, 2021 and December 31, 2020, respectively.
The U.S. $ increased (decreased) against the NIS (2.22%), 1.4%, (2.78%) and 0.28% in the three and six months ended June 30, 2021 and 2020, respectively.
ENLIVEX THERAPEUTICS LTD.
| NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2021 (UNAUDITED) |
Reclassification of Prior Year Presentation
Certain prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications had no effect on the reported results of operations.
Recent Accounting Pronouncements
Effective January 1, 2021, the Company adopted ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes, which removes specific exceptions to the general principles in Topic 740 and simplifies the accounting for income taxes. The adoption of this standard did not have a significant impact on the Company’s consolidated financial statements.
Effective January 1, 2021, the Company adopted ASU No. 2020-10, Codification Improvements, which amends a variety of topics in the Accounting Standards Codification to improve consistency and clarify guidance. The adoption of this standard did not have a significant impact on the Company’s consolidated financial statements.
There have been no other material changes to the significant accounting policies previously disclosed in the Company’s Annual Report on Form 20-F for the year ended December 31, 2020.
Marketable Securities.
The Company has an investment policy that includes guidelines on acceptable investment securities, minimum credit quality, maturity parameters, and concentration and diversification. The Company invests its excess cash primarily in mutual funds that are classified based on the nature of their underlying securities and their availability for use in current operations. The Company’s marketable equity securities are measured at fair value with gains and losses recognized in other income/(expense), net.
Net gain recognized on equity securities for the three and six months ended June 30, 2021 was $1,195 and 1,583 thousand of which $ 950 and $1,342 thousand, respectively, were not realized.
NOTE 3 – CASH, CASH EQUIVALENTS AND RESTRICTED CASH
| | | June 30, | | | December 31, | |
| (in thousands) | | 2021 | | | 2020 | |
| | | | | | | |
| Cash held in banks | | $ | 858 | | | $ | 1,173 | |
| Bank deposits in U.S.$ (annual average interest rates 0.3% and 0.32%) | | | 11,754 | | | | 4,500 | |
| Total cash and cash equivalents | | | 12,612 | | | | 5,673 | |
| Cash held with respect to CVR Agreement | | | 793 | | | | 1,171 | |
| Short-term restricted cash | | | 90 | | | | 79 | |
| Long-term restricted cash | | | 88 | | | | 89 | |
| Total cash, cash equivalents and restricted cash shown in the statement of cash flows | | $ | 13,583 | | | $ | 7,012 | |
NOTE 4 – SHORT TERM DEPOSITS
| | | June 30, | | | December 31, | |
| (in thousands) | | 2021 | | | 2020 | |
| | | | | | | |
| Bank deposits in U.S.$ (annual average interest rates 0.61% and 0.6%) | | | 10,024 | | | | 30,034 | |
| Total short-term deposits | | $ | 10,024 | | | $ | 30,034 | |
ENLIVEX THERAPEUTICS LTD.
| NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2021 (UNAUDITED) |
NOTE 5 – PROPERTY AND EQUIPMENT
Property and equipment, net consists of the following:
| | | June 30, | | | December 31, | |
| (in thousands) | | 2021 | | | 2020 | |
| | | | | | | |
| Cost: | | | | | | |
| Laboratory equipment | | $ | 1,646 | | | $ | 1,256 | |
| Computers | | | 190 | | | | 169 | |
| Office furniture & equipment | | | 106 | | | | 102 | |
| Leasehold improvements | | | 739 | | | | 712 | |
| | | | 2,681 | | | | 2,239 | |
| Accumulated depreciation: | | | | | | | | |
| Laboratory equipment | | | 734 | | | | 588 | |
| Computers | | | 108 | | | | 87 | |
| Office furniture & equipment | | | 9 | | | | 5 | |
| Leasehold improvements | | | 136 | | | | 78 | |
| | | | 987 | | | | 758 | |
| Depreciated cost | | $ | 1,694 | | | $ | 1,481 | |
Depreciation expenses for the three and six months ended June 30, 2021 and 2020 were $122 and $239 thousand and $60 and $114 thousand, respectively.
NOTE 6 – OTHER ASSETS
| | | June 30, | | | December 31, | |
| (in thousands) | | 2021 | | | 2020 | |
| | | | | | | |
| Restricted cash | | $ | 88 | | | $ | 89 | |
| Long-term prepaid expenses | | | 6 | | | | 8 | |
| Right-of-Use assets, net | | | 571 | | | | 659 | |
| | | $ | 665 | | | $ | 756 | |
NOTE 7 – ACCRUED EXPENSES AND OTHER LIABILITIES
| | | June 30, | | | December 31, |
| (in thousands) | | 2021 | | | 2020 |
| | | | | | |
| Vacation, convalescence and bonus accruals | | $ | 411 | | | $ | 684 |
| Employees and payroll related | | | 524 | | | | 352 |
| Short term operating lease liabilities | | | 210 | | | | 203 |
| Accrued expenses and other | | | 2,080 | | | | 1,499 |
| | | $ | 3,225 | | | $ | 2,738 |
ENLIVEX THERAPEUTICS LTD.
| NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2021 (UNAUDITED) |
NOTE 8 – LEASES
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 of up to 4.25 years, some of which include options to extend the leases for up to five years.
| | | Six months ended
June 30, | |
| (in thousands) | | 2021 | | | 2020 | |
| | | | | | | |
| The components of lease expense were as follows: | | | | | | |
| Operating leases expenses | | $ | 139 | | | $ | 93 | |
| Supplemental consolidated cash flow information related to operating leases follows: | | | | | | | | |
| Cash used in operating activities | | $ | 135 | | | $ | 88 | |
| Non-cash activity: | | | | | | | | |
| Right of use assets obtained in exchange for new operating lease liabilities | | $ | 29 | | | $ | - | |
| | | June 30, | | | December 31, | |
| (in thousands) | | 2021 | | | 2020 | |
| | | | | | | |
| Supplemental information related to operating leases, including location of amounts reported in the accompanying consolidated balance sheets, follows: | | | | | | |
| Other assets - Right-of-Use assets | | $ | 952 | | | $ | 920 | |
| Accumulated amortization | | | 381 | | | | 261 | |
| Operating lease Right-of-Use assets, net | | $ | 571 | | | $ | 659 | |
| Lease liabilities – current - Accounts payable and accrued liabilities | | $ | 210 | | | $ | 203 | |
| Lease liabilities – noncurrent - Other long-term liabilities | | | 405 | | | | 499 | |
| Total operating lease liabilities | | $ | 615 | | | $ | 702 | |
| Weighted average remaining lease term in years | | | 3.14 | | | | 3.64 | |
| Weighted average annual discount rate | | | 11.9 | % | | | 11.9 | % |
| Maturities of operating lease liabilities as of June 30, 2021, were as follows: | | | |
| 2021 (after June 30) | | $ | 130 | |
| 2022 | | | 248 | |
| 2023 | | | 191 | |
| 2024 | | | 94 | |
| 2025 | | | 69 | |
| Total undiscounted lease liability | | $ | 732 | |
| Less: Imputed interest | | $ | (117 | ) |
| Present value of lease liabilities | | $ | 615 | |
NOTE 9 – COMMITMENTS AND CONTINGENT LIABILITIES
The Company is required to pay royalties to the State of Israel (represented by the Israeli Innovation Authority (the “IIA”)), computed on the basis of proceeds from the sale or license of products for which development was supported by IIA grants. These royalties are generally 3% - 5% of sales until repayment of 100% of the grants (linked to the dollar) received by the Company plus annual interest at a LIBOR-based rate.
The gross amount of grants received by the Company from the IIA, including accrued interest as of June 30, 2021, was approximately $7.6 million. As of June 30, 2021, the Company had not paid any royalties to the IIA.
In January 2021, the Company submitted a new non-dilutive grant application to the IIA for reimbursement by the IIA of certain expenses associated with its clinical development program of prevention of cytokine storms and organ dysfunction associated with sepsis for a period commencing January 1, 2021 and ending December 31, 2021 (the “2021 Sepsis Grant Application”). In May 2021 the IIA approved the 2021 Sepsis Grant Application in the total amount of NIS 3.8 million ($1.16 million).
ENLIVEX THERAPEUTICS LTD.
| NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2021 (UNAUDITED) |
NOTE 10 – EQUITY
| a. | On October 22, 2020, the Company entered into an at the market offering agreement (the “Sales Agreement”), pursuant to which the Company may, from time to time and at the Company’s option, issue and sell ordinary shares having an aggregate offering price of up to $25 million through a sales agent, subject to certain terms and conditions. All shares sold pursuant to the Sales Agreement were sold pursuant to the Company’s effective shelf registration statement on Form F-3. The Company must pay the sales agent a cash commission of 3% of the gross proceeds of the sale of any shares sold through the sales agent under the Sales Agreement. Between February 5, 2021 and February 9, 2021, the Company received gross proceeds of $6,339,095 from the sale of 284,317 ordinary shares at an average gross price per share of $22.29 under the Sales Agreement. Issuance expenses totaled $192 thousand. |
On February 9, 2021, the Company terminated the prospectus supplement related to the offer and sale of ordinary shares under the Sales Agreement, but the Sales Agreement remains in full force and effect. To that date, the Company had sold an aggregate of 476,983 ordinary shares under the Sales Agreement, having a gross aggregate offering price of $8,557,437 at a gross average price per share of $17.94. Until such time as the Company files with the SEC a new registration statement on Form F-3 and such registration statement becomes effective, the Company may not offer and sell any additional ordinary shares under the Sales Agreement.
| b. | On February 9, 2021, the Company entered into an amended and restated underwriting agreement (the “Underwriting Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”) with respect to the offer, issuance and sale (the “Offering”) of an aggregate of 2,296,107 ordinary shares, together with an option granted to Wainwright to purchase up to 344,416 additional ordinary shares. The ordinary shares were offered to the public at a price of $20 per share. |
The Offering closed on February 12, 2021, on which date the Company completed the issuance of 2,296,107 ordinary shares to Wainwright at a price, including the underwriting discount but before other associated fees, of $18.60 per ordinary share, as set forth in the Underwriting Agreement.
On February 17, 2021, Wainwright exercised in part its option to purchase additional ordinary shares and purchased 268,205 ordinary shares at a price, including the underwriting discount but before other associated fees, of $18.60 per share, as set forth in the Underwriting Agreement.
In accordance with the Underwriting Agreement, the Company paid Wainwright underwriting discounts and commissions equal to 7% of the gross proceeds received by the Company from the sale of the ordinary shares in the Offering, as well as a management fee equal to 1% of the gross proceeds received by the Company from the sale of the ordinary shares in the Offering. In addition, the Company issued to Wainwright 179,501 warrants to purchase ordinary shares of the Company (the “Underwriter Warrants”). The Underwriter Warrants are exercisable for five years from commencement of the Offering and have an exercise price of $25 per ordinary share, subject to customary adjustments as provided in the Underwriter Warrants. The Company has also paid Wainwright approximately $126,000 for various expenses.
The Underwriter Warrants were valued at $2,095 thousand using a Black-Scholes model with the following assumptions: estimated weighted average volatility 78.4%; weighted average risk-free interest rate of 0.5%; no dividend; and a weighted average contractual life of 5 years.
The net proceeds from the Offering were $47,023 thousand after deducting Wainwright’s fees and other expenses relating to the Offering.
| c. | During February 2021, 855,813 warrants were exercised for an aggregate of 855,813 ordinary shares, which provided the Company with aggregate gross proceeds of $7.7 million. |
All Company warrants are classified as a component of shareholders’ equity because such warrants are free standing financial instruments that are legally detachable, separately exercisable, do not embody an obligation for the Company to repurchase its own shares, and permit the holders to receive a fixed number of Ordinary Shares upon exercise, requires physical settlement and do not provide any guarantee of value or return.
ENLIVEX THERAPEUTICS LTD.
| NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2021 (UNAUDITED) |
| | | Number
of Warrants | | | Exercise price
per share | |
| Outstanding January 1, 2021 | | | 1,407,683 | | | | | |
| Issued to placement agent | | | 179,501 | | | $ | 25 | |
| Exercised | | | (855,813 | ) | | $ | 9 | |
| Outstanding June 30, 2021 | | | 731,371 | | | | | |
| Comprised as follows: | | Number of
Warrants | | | Exercise Price
Per Share | | | Issuance date | | Expiration date |
| | | | 27,016 | | | $ | 180 | | | March 22, 2016 | | September 22, 2021 |
| | | | 22,750 | | | $ | 10 | | | February 26, 2020 | | February 24, 2025 |
| | | | 455,937 | | | $ | 9 | | | March 5, 2020 | | March 5, 2022 |
| | | | 46,167 | | | $ | 10 | | | March 4, 2020 | | March 4, 2022 |
| | | | 160,727 | | | $ | 25 | | | February 12, 2021 | | February 9, 2026 |
| | | | 18,774 | | | $ | 25 | | | February 17, 2021 | | February 9, 2026 |
| | | | 731,371 | | | | | | | | | |
NOTE 11 – SHARE-BASED COMPENSATION
| a) | On May 28, 2021, the Board approved an increase in the number of ordinary shares authorized for issuance to employees, directors and consultants by 1,800,000. As of June 30, 2021, 4,150,704 ordinary shares were authorized for issuance to employees, directors and consultants under the 2019 Equity Incentive Plan, of which 1,610,192 shares were available for future grant. |
| b) | The following table contains information concerning options granted under the existing equity incentive plans: |
| | | Three months ended June 30, | |
| | | 2021 | | | 2020 | |
| | | Number of
options | | | Weighted
average
exercise price | | | Number of
options | | | Weighted
average
exercise price | |
| Outstanding at beginning of period | | | 1,870,485 | | | $ | 5.54 | | | | 1,694,678 | | | $ | 5.63 | |
| Granted | | | 310,500 | | | $ | 12.57 | | | | 250,000 | | | $ | 3.66 | |
| Forfeited and expired | | | (2,685 | ) | | $ | 7.38 | | | | (31,070 | ) | | $ | 6.36 | |
| Exercised | | | (375 | ) | | $ | 4.68 | | | | (35,895 | ) | | $ | 2.69 | |
| Outstanding at end of period | | | 2,177,925 | | | $ | 6.54 | | | | 1,877,713 | | | $ | 5.59 | |
| Exercisable at end of period | | | 1,404,809 | | | $ | 5.50 | | | | 1,097,953 | | | $ | 5.04 | |
| | | Three months ended June 30, | |
| | | 2021 | | | 2020 | |
| | | Number of
options | | | Weighted
average
exercise price | | | Number of
options | | | Weighted
average
exercise price | |
| Non-vested at beginning of period | | | 544,163 | | | $ | 6.04 | | | | 575,204 | | | $ | 7.05 | |
| Granted | | | 310,500 | | | $ | 12.57 | | | | 250,000 | | | $ | 3.66 | |
| Vested | | | (78,862 | ) | | $ | 13.15 | | | | (14,374 | ) | | $ | 3.63 | |
| Forfeited | | | (2,685 | ) | | $ | 7.38 | | | | (31,070 | ) | | $ | 6.38 | |
| Non-vested at the end of period | | | 773,116 | | | $ | 8.19 | | | | 779,760 | | | $ | 5.85 | |
ENLIVEX THERAPEUTICS LTD.
| NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2021 (UNAUDITED) |
| | | Six months ended June 30, | |
| | | 2021 | | | 2020 | |
| | | Number of
options | | | Weighted
average
exercise price | | | Number of options | | | Weighted
average
exercise price | |
| Outstanding at beginning of period | | | 1,884,420 | | | $ | 5.52 | | | | 1,625,042 | | | $ | 5.72 | |
| Granted | | | 310,500 | | | $ | 12.57 | | | | 320,000 | | | $ | 3.89 | |
| Forfeited and expired | | | (3,185 | ) | | $ | 6.96 | | | | (31,434 | ) | | $ | 6.39 | |
| Exercised | | | (13,810 | ) | | $ | 2.99 | | | | (35,895 | ) | | $ | 2.69 | |
| Outstanding at end of period | | | 2,177,925 | | | $ | 6.54 | | | | 1,877,713 | | | $ | 5.59 | |
| Exercisable at end of period | | | 1,404,809 | | | $ | 5.50 | | | | 1,097,953 | | | $ | 5.04 | |
| | | | | | | | | | | | | | | | | |
| Non-vested at beginning of period | | | 601,227 | | | $ | 5.93 | | | | 526,351 | | | $ | 7.03 | |
| Granted | | | 310,500 | | | $ | 12.57 | | | | 320,000 | | | $ | 3.89 | |
| Vested | | | (135,426 | ) | | $ | 8.22 | | | | (35,521 | ) | | $ | 3.73 | |
| Forfeited | | | (3,185 | ) | | $ | 6.96 | | | | (31,070 | ) | | $ | 6.37 | |
| Non-vested at the end of period | | | 773,116 | | | $ | 8.19 | | | | 779,760 | | | $ | 5.85 | |
During the three and six months ended June 30, 2021 and 2020, the Company recognized $603 thousand, $778 thousand, $188 thousand and 320 thousand, respectively, of share-based compensation expenses related to stock options. As of June 30, 2021, the total unrecognized estimated compensation cost related to outstanding non-vested stock options was $3,064 thousand which is expected to be recognized over a weighted average period of 1.7 years.
| c) | Set forth below is data regarding the range of exercise prices and remaining contractual life for all options outstanding at June 30, 2021: |
Exercise
price | | | Number of options
outstanding | | | Remaining
contractual
Life (in years) | | | Intrinsic Value of
Options
Outstanding | | | No. of options
exercisable | |
| | | | | | | | | | (in thousands) | | | | |
| $ | 2.69 | | | | 673,525 | | | | 4.01 | | | $ | 4,183 | | | | 673,525 | |
| $ | 3.66 | | | | 250,000 | | | | 8.84 | | | | 1,309 | | | | 97,223 | |
| $ | 4.68 | | | | 59,875 | | | | 8.75 | | | | 253 | | | | 15,250 | |
| $ | 6.22 | | | | 658,893 | | | | 6.55 | | | | 1,763 | | | | 498,042 | |
| $ | 8.19 | | | | 150,000 | | | | 8.38 | | | | 107 | | | | 37,500 | |
| $ | 9.02 | | | | 40,500 | | | | 9.38 | | | | - | | | | - | |
| $ | 10.12 | | | | 12,126 | | | | 7.43 | | | | - | | | | 7,274 | |
| $ | 12.21 | | | | 2,421 | | | | 7.74 | | | | - | | | | 1,211 | |
| $ | 21.4 | | | | 4,585 | | | | 8.07 | | | | - | | | | 1,256 | |
| $ | 12.22 | | | | 250,000 | | | | 9.92 | | | | | | | | 27,778 | |
| $ | 14.00 | | | | 60,500 | | | | 9.82 | | | | | | | | 30,250 | |
| $ | 90.16 | | | | 15,500 | | | | 0.15 | | | | - | | | | 15,500 | |
| | | | | | 2,177,925 | | | | | | | $ | 7,615 | | | | 1,404,809 | |
ENLIVEX THERAPEUTICS LTD.
| NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2021 (UNAUDITED) |
| d) | The following table contains information concerning restricted stock units granted under the existing equity incentive plans: |
| | | Three months ended June 30, | |
| | | 2021 | | | 2020 | |
| | | Number of shares | | | Weighted
average
grant date fair
value | | | Number of
shares | | | Weighted
average grant date fair
value | |
| Nonvested at beginning of period | | | 48,375 | | | $ | 14.67 | | | | - | | | $ | - | |
| Granted | | | 13,750 | | | $ | 10.28 | | | | - | | | $ | - | |
| Vested | | | -- | | | $ | - | | | | - | | | $ | - | |
| Forfeited | | | (2,000 | ) | | $ | 14.67 | | | | - | | | $ | - | |
| Nonvested at end of period | | | 60,125 | | | $ | 13.67 | | | | - | | | $ | - | |
| | | Six months ended June 30, | |
| | | 2021 | | | 2020 | |
| | | Number of
shares | | | Weighted
average
grant date fair
value | | | Number of shares | | | Weighted
average
grant date fair
value | |
| Nonvested at beginning of period | | | - | | | $ | - | | | | - | | | $ | - | |
| Granted | | | 62,125 | | | $ | 13.7 | | | | - | | | $ | - | |
| Vested | | | - | | | $ | - | | | | - | | | $ | - | |
| Forfeited | | | (2,000 | ) | | $ | 14.67 | | | | - | | | $ | - | |
| Nonvested at end of period | | | 60,125 | | | $ | 13.67 | | | | - | | | $ | - | |
The Company estimates the fair value of restricted stock units based on the closing sales price of the Company’s ordinary shares on the date of grant (or the closing bid price, if no sales were reported). During the three and six months ended June 30, 2021 and 2020, the Company recognized $48 thousand, $64 thousand, $0 and $0, respectively, of share-based compensation expense related to restricted stock units. Total share-based compensation expense related to restricted stock units not yet recognized as of June 30, 2021 was $765 thousand, which is expected to be recognized over a weighted average period of 3.65 years.
| e) | The following table summarizes share-based compensation expenses related to grants under the existing equity incentive plans included in the statements of operations: |
| | | Three months ended June 30, | | | Six months ended June 30, | |
| (in thousands) | | 2021 | | | 2020 | | | 2021 | | | 2020 | |
| Research & development | | $ | 358 | | | $ | 104 | | | $ | 446 | | | $ | 200 | |
| General & administrative | | | 294 | | | | 84 | | | | 396 | | | | 120 | |
| Total | | $ | 652 | | | $ | 188 | | | $ | 842 | | | $ | 320 | |
ENLIVEX THERAPEUTICS LTD.
| NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2021 (UNAUDITED) |
NOTE 12 – FAIR VALUE MEASUREMENT
The Company’s financial assets and liabilities measured at fair value on a recurring basis consisted of the following types of instruments as of June 30, 2021 and December 31, 2020:
| | | June 30, 2021 | |
| (in thousands) | | Total | | | Level 1 | | | Level 2 | | | Level 3 | |
| Cash and cash equivalents | | $ | 12,612 | | | $ | 12,612 | | | $ | - | | | $ | - | |
| Short term deposits | | | 10,024 | | | | 10,024 | | | | | | | | | |
| Marketable securities | | | 67,964 | | | | 67,964 | | | | | | | | | |
| Restricted cash | | | 178 | | | | 178 | | | | - | | | | - | |
| Cash held with respect to CVR Agreement | | | 793 | | | | 793 | | | | - | | | | - | |
| Total financial assets | | $ | 91,571 | | | $ | 91,571 | | | $ | - | | | $ | - | |
| | | | | | | | | | | | | | | | | |
| | | December 31, 2020 | |
| (in thousands) | | Total | | | Level 1 | | | Level 2 | | | Level 3 | |
| Cash and cash equivalents | | $ | 5,673 | | | $ | 5,673 | | | $ | - | | | $ | - | |
| Short term deposits | | | 30,034 | | | | 30,034 | | | | - | | | | - | |
| Cash held with respect to CVR Agreement | | | 1,171 | | | | 1,171 | | | | - | | | | - | |
| Restricted cash | | | 168 | | | | 168 | | | | - | | | | - | |
| Total financial assets | | $ | 37,046 | | | $ | 37,046 | | | $ | - | | | $ | - | |
NOTE 13 – EVENTS SUBSEQUENT TO THE BALANCE SHEET DATE
The Company evaluated all events and transactions that occurred subsequent to the balance sheet date and prior to the date on which these unaudited condensed consolidated financial statements were issued, and determined the following subsequent event necessitated disclosure:
On July 17, 2021 a single Israeli plaintiff filed a request in the Israeli court of Tel Aviv to approve his lawsuit as an Israeli class action lawsuit against the Company. The claim alleges that the Company did not make various documents filed with the Israel Securities Authority’s submission system appropriately accessible for people with disabilities, specifically that certain PDF filings were not prepared in accordance with certain provisions of the Israeli law and regulations regarding accessibility of documents to the disabled. The plaintiff filed requests for approval of similar class action lawsuits on the same day against 17 other companies whose securities are traded on the Tel-Aviv Stock Exchange. The Company believes that the plaintiff’s claims against the Company are without merit and intends to vigorously defend against them.
F-13
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