Full Press Release Details
FINANCIAL STATEMENTS
AS OF DECEMBER 31, 2022
FINANCIAL STATEMENTS
AS OF DECEMBER 31, 2022
| Page | |
| Report of Independent Registered Public Accounting Firm | F-2 |
| Consolidated Balance Sheets | F-3 |
| Consolidated Statements of Operations and Comprehensive Loss | F-4 |
| Consolidated Statements of Changes in Shareholders' Equity | F-5 |
| Consolidated Statements of Cash Flows | F-6 |
| Notes to Consolidated Financial Statements | F-7 |
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
To the Board of Directors and Shareholders of ENLIVEX
Opinions on the Financial Statements and Internal Control
over Financial Reporting
We have audited the accompanying balance
sheets of Enlivex Therapeutics Ltd. and subsidiaries (the "Company") as of December 31, 2022 and 2021, and the related statements
of operations, comprehensive loss, shareholders' equity, and cash flows for each of the years in the three-year period ended December
31, 2022, and the related notes (collectively referred to as the financial statements).
We also have audited the Company's
internal control over financial reporting as of December 31, 2022, based on criteria established in Internal Control-Integrated
Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
In our opinion, the financial statements
referred to above present fairly, in all material respects, the financial position of the Company as of December 31, 2022 and 2021, and
the results of its operations and its cash flows for each of the years in the three-year period ended December 31, 2022, in conformity
with accounting principles generally accepted in the United States of America.
Also, in our opinion, the Company maintained, in all material
respects, effective internal control over financial reporting as of December 31, 2022, based on criteria established in Internal Control-Integrated
Framework (2013) issued by COSO.
The Company's management is responsible
for these financial statements, for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness
of internal control over financial reporting included in the accompanying Management's Annual Report on Internal Control over Financial
Reporting. Our responsibility is to express an opinion on the Company's financial statements and an opinion on the Company's
internal control over financial reporting based on our audits. We are a public accounting firm registered with the Public Company Accounting
Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal
securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance
with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether
the financial statements are free of material misstatement, whether due to error or fraud, and whether effective internal control over
financial reporting was maintained in all material respects.
Our audits of the financial statements
included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud,
and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts
and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates
made by management, as well as evaluating the overall presentation of the financial statements. Our audit of internal control over financial
reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness
exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audits also
included performing such other procedures as we considered necessary in the circumstances. We believe that our audits provide a reasonable
basis for our opinions.
Definition and Limitations of Internal Control over Financial
A company's internal control
over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company's
internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that,
in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable
assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted
accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management
and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition,
use, or disposition of the company's assets that could have a material effect on the financial statements.
Because of its inherent limitations,
internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness
to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of
compliance with the policies or procedures may deteriorate.
Critical Audit Matters
Critical audit matters are matters
arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee
and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging,
subjective, or complex judgments. We determined that there are no critical audit matters.
/s/ Yarel + Partners
Certified Public Accountants (Isr.)
We have served as the Company's auditor since
ENLIVEX THERAPEUTICS LTD.
CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands (except share data)
| December 31, | ||||||||
| 2022 | 2021 | |||||||
| ASSETS | ||||||||
| Current Assets | ||||||||
| Cash and cash equivalents (note 3) | $ | 49,945 | $ | 11,202 | ||||
| Short term deposits (note 4) | 299 | 10,004 | ||||||
| Marketable securities | - | 62,924 | ||||||
| Prepaid expenses and other receivables (note 5) | 2,086 | 2,312 | ||||||
| Total Current Assets | 52,330 | 86,442 | ||||||
| Non-Current Assets | ||||||||
| Property and equipment, net (note 6) | 9,875 | 2,530 | ||||||
| Other assets (notes 7 & 9) | 5,437 | 6,174 | ||||||
| Total Non-Current Assets | 15,312 | 8,704 | ||||||
| TOTAL ASSETS | $ | 67,642 | $ | 95,146 | ||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| Current Liabilities | ||||||||
| Accounts payable trade (note 14) | $ | 1,948 | $ | 878 | ||||
| Accrued expenses and other liabilities (note 8) | 4,659 | 3,840 | ||||||
| Total Current Liabilities | 6,607 | 4,718 | ||||||
| Non-Current Liabilities | ||||||||
| Other long-term Liabilities (note 9) | 4,194 | 5,389 | ||||||
| Total Non-Current Liabilities | 4,194 | 5,389 | ||||||
| Commitments and Contingent Liabilities (note 10) | ||||||||
| TOTAL LIABILITIES | 10,801 | 10,107 | ||||||
| SHAREHOLDERS' EQUITY | ||||||||
| Ordinary shares of NIS 0.40 par value: (note 11) Authorized: 45,000,000 shares as of December 31, 2022 and 2021; Issued and outstanding: 18,421,852 and 18,331,507 as of December 31, 2022 and 2021, respectively; | 2,117 | 2,107 | ||||||
| Additional paid in capital | 136,648 | 133,796 | ||||||
| Foreign currency translation reserve | 1,101 | 1,101 | ||||||
| Accumulated deficit | (83,025 | ) | (51,965 | ) | ||||
| TOTAL SHAREHOLDERS' EQUITY | 56,841 | 85,039 | ||||||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 67,642 | $ | 95,146 |
The accompanying notes are an integral part of these consolidated
financial statements.
ENLIVEX THERAPEUTICS LTD.
CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
U.S. dollars in thousands (except share and per share
| Year ended December 31, | ||||||||||||
| 2022 | 2021 | 2020 | ||||||||||
| Revenues | $ | - | $ | - | $ | - | ||||||
| Operating expenses: | ||||||||||||
| Research and development expenses, net (note 16a) | 18,693 | 12,881 | 6,086 | |||||||||
| General and administrative expenses (note 16b) | 7,104 | 6,407 | 3,699 | |||||||||
| 25,797 | 19,288 | 9,785 | ||||||||||
| Operating (loss) | (25,797 | ) | (19,288 | ) | (9,785 | ) | ||||||
| Other income (expenses), net (note 16c) | (5,263 | ) | 4,820 | (2,039 | ) | |||||||
| Net (loss) | $ | (31,060 | ) | $ | (14,468 | ) | $ | (11,824 | ) | |||
| Other comprehensive gain | ||||||||||||
| Exchange differences arising from translating financial statements from functional to presentation currency | - | 124 | 2,277 | |||||||||
| Total other comprehensive gain | - | 124 | 2,277 | |||||||||
| Total comprehensive (loss) | $ | (31,060 | ) | $ | (14,344 | ) | $ | (9,547 | ) | |||
| Basic & diluted (loss) per share | $ | (1.69 | ) | $ | (0.81 | ) | $ | (0.90 | ) | |||
| Weighted average number of shares outstanding | 18,394,886 | 17,859,713 | 13,169,208 |
The accompanying notes are an integral part of these
consolidated financial statements.
ENLIVEX THERAPEUTICS LTD.
CONSOLIDATED STATEMENTS OF CHANGES
IN SHAREHOLDERS' EQUITY
U.S. dollars in thousands (except share data)
| Ordinary Shares | ||||||||||||||||||||||||
| Number of shares | Share capital | Additional paid in capital | Currency translation reserve | Accumulated deficit | Total | |||||||||||||||||||
| JANUARY 1, 2020 | 10,334,126 | 1,151 | 37,104 | (1,300 | ) | (25,673 | ) | 11,282 | ||||||||||||||||
| Issuance of shares and warrants for cash consideration of $26,968 net of $2,501 issuance costs | 3,286,416 | 382 | 24,085 | 24,467 | ||||||||||||||||||||
| Exercise of options | 37,746 | 4 | 97 | 101 | ||||||||||||||||||||
| Exercise of warrants | 929,646 | 109 | 8,405 | 8,514 | ||||||||||||||||||||
| Stock based compensation | - | 670 | 670 | |||||||||||||||||||||
| Other comprehensive loss | - | 2,277 | 2,277 | |||||||||||||||||||||
| Net loss | - | - | (11,824 | ) | (11,824 | ) | ||||||||||||||||||
| DECEMBER 31, 2020 | 14,587,934 | 1,646 | 70,361 | 977 | (37,497 | ) | 35,487 | |||||||||||||||||
| Issuance of shares and warrants for cash consideration of $57,629 net of $4,455 issuance costs | 2,848,629 | 352 | 52,822 | 53,174 | ||||||||||||||||||||
| Exercise of options | 39,131 | 5 | 101 | 106 | ||||||||||||||||||||
| Exercise of warrants | 855,813 | 104 | 7,598 | 7,702 | ||||||||||||||||||||
| Stock based compensation | 2,914 | 2,914 | ||||||||||||||||||||||
| Other comprehensive loss | 124 | 124 | ||||||||||||||||||||||
| Net loss | - | (14,468 | ) | (14,468 | ) | |||||||||||||||||||
| DECEMBER 31, 2021 | 18,331,507 | 2,107 | 133,796 | 1,101 | (51,965 | ) | 85,039 | |||||||||||||||||
| Exercise of options | 22,875 | 3 | 147 | 150 | ||||||||||||||||||||
| Exercise of warrants | - | |||||||||||||||||||||||
| Restricted stock units vested | 67,470 | 7 | (7 | ) | - | |||||||||||||||||||
| Stock based compensation | - | 2,712 | 2,712 | |||||||||||||||||||||
| Net loss | - | (31,060 | ) | (31,060 | ) | |||||||||||||||||||
| DECEMBER 31, 2022 | 18,421,852 | $ | 2,117 | $ | 136,648 | $ | 1,101 | $ | (83,025 | ) | $ | 56,841 |
The accompanying notes are an
integral part of these consolidated financial statements.
ENLIVEX THERAPEUTICS LTD.
CONSOLIDATED STATEMENTS OF CASH
U.S. dollars in thousands
| Year ended December 31, | ||||||||||||
| 2022 | 2021 | 2020 | ||||||||||
| Cash flows from operating activities | ||||||||||||
| Net loss | $ | (31,060 | ) | $ | (14,468 | ) | $ | (11,824 | ) | |||
| Adjustments required to reflect net cash used in operating activities: | ||||||||||||
| Income and expenses not involving cash flows: | ||||||||||||
| Depreciation | 777 | 546 | 286 | |||||||||
| Loss (income) on marketable securities and short-term bank deposits | 1,983 | (5,590 | ) | - | ||||||||
| Non-cash operating lease expenses | 831 | 413 | 167 | |||||||||
| Share-based compensation | 2,712 | 2,914 | 670 | |||||||||
| Changes in operating asset and liability items: | ||||||||||||
| (Increase) decrease in prepaid expenses and other receivables | 278 | (1,249 | ) | 1,823 | ||||||||
| Increase in accounts payable trade | 1,168 | 442 | 36 | |||||||||
| (Decrease) increase in accrued expenses and other liabilities | 684 | (466 | ) | (2,022 | ) | |||||||
| Operating lease liabilities | (1,326 | ) | (84 | ) | (143 | ) | ||||||
| Net cash used in operating activities | (23,953 | ) | (17,542 | ) | (11,007 | ) | ||||||
| Cash flows from investing activities | ||||||||||||
| Purchase of property and equipment | (8,122 | ) | (1,625 | ) | (1,019 | ) | ||||||
| (Release) investment in short-term bank deposits, net | 9,705 | 20,030 | (19,958 | ) | ||||||||
| Purchases of marketable securities | (1,608 | ) | (104,417 | ) | - | |||||||
| Proceeds from sale of marketable securities | 62,549 | 47,604 | - | |||||||||
| Net cash provided by (used in) investing activities | 62,524 | (38,408 | ) | (20,977 | ) | |||||||
| Cash flows from financing activities | ||||||||||||
| Proceeds from issuance of shares and warrants, net | - | 53,174 | 24,467 | |||||||||
| Proceeds from exercise of warrants | - | 7,702 | 8,514 | |||||||||
| Proceeds from exercise of options | 150 | 106 | 101 | |||||||||
| Net cash provided by financing activities | 150 | 60,982 | 33,082 | |||||||||
| Increase (decrease) in cash, cash equivalents and restricted cash | 38,721 | 5,032 | 1,098 | |||||||||
| Cash, cash equivalents and restricted cash - beginning of year | 11,636 | 7,012 | 5,524 | |||||||||
| Exchange rate differences on cash, cash equivalents and restricted cash | - | (408 | ) | 390 | ||||||||
| Cash, cash equivalents and restricted cash - end of year | $ | 50,357 | $ | 11,636 | $ | 7,012 | ||||||
| Supplemental disclosures of cash flow information: | ||||||||||||
| Cash paid for taxes | $ | - | $ | - | $ | - | ||||||
| Cash received for interest, net | $ | 666 | $ | 39 | $ | 160 |
The accompanying notes are an integral part of these consolidated
financial statements.
ENLIVEX THERAPEUTICS LTD.
NOTES TO CONSOLIDATED FINANCIAL
NOTE 1 - GENERAL INFORMATION
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
The Company is a clinical stage macrophage
reprogramming immunotherapy company, developing AllocetraTM, a universal, off-the-shelf cell therapy designed to reprogram
macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system