Full Press Release Details
ENLIVEX THERAPEUTICS LTD.
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AS OF SEPTEMBER 30, 2022 AND DECEMBER 31, 2021
AND FOR THE THREE AND NINE MONTH PERIODS ENDED
SEPTEMBER 30, 2022 AND 2021
ENLIVEX THERAPEUTICS LTD.
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AS OF SEPTEMBER 30, 2022 AND DECEMBER 31, 2021
AND FOR THE THREE AND NINE MONTH PERIODS ENDED
SEPTEMBER 30, 2022 AND 2021
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
| Page | ||
| Condensed Consolidated Balance Sheets | F-2 | |
| Condensed Consolidated Statements of Operations and Comprehensive Loss | F-3 | |
| Condensed Consolidated Statements of Changes in Shareholders' Equity | F-4 | |
| Condensed Consolidated Cash Flow Statements | F-6 | |
| Notes to the Condensed Consolidated Financial Statements | F-7 |
ENLIVEX THERAPEUTICS LTD.
CONDENSED CONSOLIDATED BALANCE
U.S. dollars in thousands (except share data)
| September 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| ASSETS | ||||||||
| Current Assets | ||||||||
| Cash and cash equivalents | $ | 57,655 | $ | 11,202 | ||||
| Short term deposits | - | 10,004 | ||||||
| Marketable securities | - | 62,924 | ||||||
| Prepaid expenses and other receivables | 1,463 | 2,199 | ||||||
| Cash held with respect to CVR Agreement | 113 | 113 | ||||||
| Total Current Assets | 59,231 | 86,442 | ||||||
| Non-Current Assets | ||||||||
| Property and equipment, net | 7,515 | 2,530 | ||||||
| Other assets | 5,668 | 6,174 | ||||||
| Total Non-Current Assets | 13,183 | 8,704 | ||||||
| TOTAL ASSETS | $ | 72,414 | $ | 95,146 | ||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| Current Liabilities | ||||||||
| Accounts payable trade | $ | 1,056 | $ | 878 | ||||
| Accrued expenses and other liabilities | 3,360 | 3,727 | ||||||
| CVR holders | 113 | 113 | ||||||
| Total Current Liabilities | 4,529 | 4,718 | ||||||
| Non-Current Liabilities | ||||||||
| Other long-term Liabilities | 4,611 | 5,389 | ||||||
| Total Non-Current Liabilities | 4,611 | 5,389 | ||||||
| Commitments and Contingent Liabilities | ||||||||
| TOTAL LIABILITIES | 9,140 | 10,107 | ||||||
| SHAREHOLDERS' EQUITY | ||||||||
| Ordinary shares of NIS 0.4 par value: Authorized: 45,000,000 shares as of September 30, 2022 and December 31, 2021; Issued and outstanding: 18,411,728 and 18,331,507 as of September 30 and December 31, 2021; | 2,116 | 2,107 | ||||||
| Additional paid in capital | 135,893 | 133,796 | ||||||
| Foreign currency translation adjustments | 1,101 | 1,101 | ||||||
| Accumulated deficit | (75,836 | ) | (51,965 | ) | ||||
| TOTAL SHAREHOLDERS' EQUITY | 63,274 | 85,039 | ||||||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 72,414 | $ | 95,146 |
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
| For the three months ended | For the nine months ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenues | $ | - | $ | - | $ | - | $ | - | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses | 4,201 | 2,679 | 12,993 | 7,715 | ||||||||||||
| General and administrative expenses | 1,476 | 1,185 | 4,959 | 3,759 | ||||||||||||
| 5,677 | 3,864 | 17,952 | 11,474 | |||||||||||||
| Operating loss | (5,677 | ) | (3,864 | ) | (17,952 | ) | (11,474 | ) | ||||||||
| Other income/(expense), net | (56 | ) | 440 | (5,919 | ) | 1,742 | ||||||||||
| Net (loss) | (5,733 | ) | (3,424 | ) | (23,871 | ) | (9,732 | ) | ||||||||
| Other comprehensive income (loss) | ||||||||||||||||
| Exchange differences arising from translating financial statements from functional to presentation currency | - | 857 | - | 124 | ||||||||||||
| Total other comprehensive income (loss) | - | 857 | - | 124 | ||||||||||||
| Total comprehensive (loss) | $ | (5,733 | ) | $ | (2,567 | ) | $ | (23,871 | ) | $ | (9,608 | ) | ||||
| Basic & diluted (loss) per share | $ | (0.31 | ) | $ | (0.19 | ) | $ | (1.30 | ) | $ | (0.54 | ) | ||||
| Weighted average number of shares outstanding | 18,391,929 | 18,312,418 | 18,379,062 | 17,705,913 |
The accompanying notes are an integral part of the condensed consolidated
financial statements.
ENLIVEX THERAPEUTICS LTD.
CONDENSED CONSOLIDATED STATEMENTS
OF CHANGES IN SHAREHOLDERS' EQUITY (UNAUDITED)
dollars in thousands (except share data)
| Additional | Currency | |||||||||||||||||||||||
| Ordinary Shares | paid in | translation | Accumulated | |||||||||||||||||||||
| Shares | Amount | capital | reserve | deficit | Total | |||||||||||||||||||
| Balance as of December 31, 2021 | 18,331,507 | $ | 2,107 | $ | 133,796 | $ | 1,101 | $ | (51,965 | ) | $ | 85,039 | ||||||||||||
| Changes during the three months period ended March 31, 2022: | ||||||||||||||||||||||||
| Restricted stock units vested | 34,295 | 4 | (4 | ) | - | - | - | |||||||||||||||||
| Exercise of options | 7,625 | 1 | 49 | - | - | 50 | ||||||||||||||||||
| Stock based compensation | - | - | 788 | - | - | 788 | ||||||||||||||||||
| Net loss | - | - | - | - | (8,225 | ) | (8,225 | ) | ||||||||||||||||
| Balance as of March 31, 2022 (unaudited) | 18,373,427 | 2,112 | 134,629 | 1,101 | (60,190 | ) | 77,652 | |||||||||||||||||
| Changes during the three months period ended June 30, 2022: | ||||||||||||||||||||||||
| Exercise of options | 7,625 | 1 | 49 | - | - | 50 | ||||||||||||||||||
| Stock based compensation | - | - | 697 | - | - | 697 | ||||||||||||||||||
| Net loss | - | - | - | - | (9,913 | ) | (9,913 | ) | ||||||||||||||||
| Balance as of June 30, 2022 (unaudited) | 18,381,052 | 2,113 | 135,375 | 1,101 | (70,103 | ) | 68,486 | |||||||||||||||||
| Changes during the three months period ended September 30, 2022: | ||||||||||||||||||||||||
| Restricted stock units vested | 23,051 | 2 | (2 | ) | - | - | - | |||||||||||||||||
| Exercise of options | 7,625 | 1 | 49 | - | - | 50 | ||||||||||||||||||
| Stock based compensation | - | - | 471 | - | - | 471 | ||||||||||||||||||
| Net loss | - | - | - | - | (5,733 | ) | (5,733 | ) | ||||||||||||||||
| Balance as of September 30, 2022 (unaudited) | 18,411,728 | $ | 2,116 | $ | 135,893 | $ | 1,101 | $ | (75,836 | ) | $ | 63,274 |
The accompanying notes are an integral
part of the condensed consolidated financial statements.
ENLIVEX THERAPEUTICS LTD.
CONDENSED CONSOLIDATED STATEMENTS
OF CHANGES IN SHAREHOLDERS' EQUITY (UNAUDITED)
U.S. dollars in thousands
| Additional | Currency | |||||||||||||||||||||||
| Ordinary Shares | paid in | translation | Accumulated | |||||||||||||||||||||
| Shares | Amount | capital | reserve | deficit | Total | |||||||||||||||||||
| Balance as of December 31, 2020 | 14,587,934 | $ | 1,646 | $ | 70,361 | $ | 977 | $ | (37,497 | ) | $ | 35,487 | ||||||||||||
| Changes during the three months period ended March 31, 2021: | ||||||||||||||||||||||||
| 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 | 13,435 | 2 | 38 | - | - | 40 | ||||||||||||||||||
| Exercise of warrants | 855,813 | 104 | 7,598 | - | - | 7,702 | ||||||||||||||||||
| Stock based compensation | - | - | 190 | - | - | 190 | ||||||||||||||||||
| Other comprehensive loss | - | - | - | (2,788 | ) | - | (2,788 | ) | ||||||||||||||||
| Net loss | - | - | - | - | (3,200 | ) | (3,200 | ) | ||||||||||||||||
| Balance as of March 31, 2021 (unaudited) | 18,305,811 | 2,104 | 131,009 | (1,811 | ) | (40,697 | ) | 90,605 | ||||||||||||||||
| Changes during the three months period ended June 30, 2021: | ||||||||||||||||||||||||
| Exercise of options | 375 | * | 2 | - | - | 2 | ||||||||||||||||||
| Stock based compensation | - | - | 652 | - | - | 652 | ||||||||||||||||||
| Other comprehensive loss | - | - | - | 2,055 | - | 2,055 | ||||||||||||||||||
| Net loss | - | - | - | - | (3,108 | ) | (3,108 | ) | ||||||||||||||||
| Balance as of June 30, 2021 (unaudited) | 18,306,186 | 2,104 | 131,663 | 244 | (43,805 | ) | 90,206 | |||||||||||||||||
| Changes during the three months period ended September 30, 2021: | ||||||||||||||||||||||||
| Exercise of options | 24,321 | 3 | 64 | 67 | ||||||||||||||||||||
| Stock based compensation | 377 | 377 | ||||||||||||||||||||||
| Other comprehensive loss | 857 | 857 | ||||||||||||||||||||||
| Net loss | - | - | - | - | (3,424 | ) | (3,424 | ) | ||||||||||||||||
| Balance as of September 30, 2021 (unaudited) | 18,330,507 | $ | 2,107 | $ | 132,104 | $ | 1,101 | $ | (47,229 | ) | $ | 88,083 |
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 nine months ended September 30, | ||||||||
| 2022 | 2021 | |||||||
| Cash flows from operating activities | ||||||||
| Net (loss) | $ | (23,871 | ) | $ | (9,732 | ) | ||
| Adjustments required to reflect net cash used in operating activities: | ||||||||
| Income and expenses not involving cash flows: | ||||||||
| Depreciation | 556 | 396 | ||||||
| Non-cash operating lease expenses | 625 | 194 | ||||||
| Share-based compensation | 1,955 | 1,219 | ||||||
| Loss (income) on marketable securities and short-term bank deposits | 1,987 | (2,212 | ) | |||||
| Changes in operating asset and liability items: | ||||||||
| Increase (decrease) in prepaid expenses and other receivables | 762 | (611 | ) | |||||
| Increase (decrease) in accounts payable trade | 179 | 596 | ||||||
| Increase in accrued expenses and other liabilities | (400 | ) | (651 | ) | ||||
| Operating lease liabilities | (928 | ) | (150 | ) | ||||
| Net cash (used in) operating activities | (19,135 | ) | (10,951 | ) | ||||
| Cash flows from investing activities | ||||||||
| Purchase of property and equipment | (5,541 | ) | (592 | ) | ||||
| Release (investment) in short-term bank deposits | 10,000 | 29,666 | ||||||
| Purchases of marketable securities | (1,608 | ) | (90,337 | ) | ||||
| Proceeds from sales of marketable securities | 62,549 | 28,201 | ||||||
| Net cash provided by (used in) investing activities | 65,400 | (33,062 | ) | |||||
| Cash flows from financing activities | ||||||||
| Proceeds from issuance of shares and warrants net of $4,455 issuance expenses | - | 53,174 | ||||||
| Proceeds from exercise of warrants | - | 7,702 | ||||||
| Proceeds from exercise of options | 150 | 109 | ||||||
| Net cash provided by financing activities | 150 | 60,985 | ||||||
| Increase in cash and cash equivalents | 46,415 | 16,972 | ||||||
| Cash and cash equivalents - beginning of period | 11,636 | 7,012 | ||||||
| Exchange rate differences on cash and cash equivalents | - | (657 | ) | |||||
| Cash and cash equivalents - end of period | $ | 58,051 | $ | 23,327 | ||||
| Non-cash transactions: | ||||||||
| Warrants issued in settlement of issuance costs to a placement agent | $ | - | $ | 2,095 | ||||
| Supplemental disclosures of cash flow information: | ||||||||
| Cash paid for taxes | $ | - | $ | - | ||||
| Cash paid (received) for interest, net | $ | (258 | ) | $ | 51 |
The accompanying notes are an integral part of the condensed consolidated
financial statements.
ENLIVEX THERAPEUTICS LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS SEPTEMBER
30, 2022 (UNAUDITED)
Enlivex Therapeutics R&D Ltd. ("Enlivex
R&D") 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, Enlivex R&D became a wholly owned subsidiary of the Company.
In January 2015, Enlivex Therapeutics
Inc. was incorporated in the State of Delaware as a wholly owned subsidiary of the Parent.
On June 21, 2021 Enlivex Therapeutics
RDO Ltd. was incorporated in Israel as a wholly owned subsidiary of the Parent.
The Company is a clinical stage macrophage
reprogramming immunotherapy company, developing AllocetraTM, a universal, off-the-shelf cell therapy designed to reprogram
macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system
rebalancing and resolution of life-threatening conditions. Non-homeostatic macrophages contribute significantly to the severity of certain
diseases, which include solid tumors, sepsis and others.
AllocetraTM is based on
the discoveries of Professor Dror Mevorach, an expert on immune activity, macrophage activation and clearance of dying (apoptotic) cells,
in his laboratory in the Hadassah University Hospital located in the State of Israel.
The Company's ordinary shares,
NIS 0.40 per share ("Ordinary Shares"), are traded under the symbol "ENLV" on both the Nasdaq Capital Market
and on the Tel Aviv Stock Exchange.
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 September
30, 2022, had an accumulated deficit of $75,836 thousand.
The Company expects to continue to
incur losses for at least the next several years, and the Company will need to raise additional debt or equity financing or enter into
partnerships to fund its development. If the Company is not able to achieve its funding requirements, it may be required to reduce discretionary
spending, may not be able to continue the development of its product candidates or may be required to delay its development programs,
which could have a material adverse effect on the Company's ability to achieve its intended business objectives. There can be no
assurances that additional financing will be secured or, if secured, will be on favorable terms. The ability of the Company to transition
to profitability in the longer term is dependent on developing products and product revenues to support its expenses.
The Company's management and
board of directors (the "Board") are of the opinion that the Company's current financial resources will be sufficient
to continue the development of the Company's product candidates for at least twelve months 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 the financing necessary for its long-term development.
The Company's ability to continue to operate in the long term is dependent upon additional financial support.
ENLIVEX THERAPEUTICS LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS SEPTEMBER
30, 2022 (UNAUDITED)
NOTE 2 - SIGNIFICANT ACCOUNTING
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