Full Press Release Details
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
| Page | |
| Condensed Consolidated Balance Sheets | F-1 |
| Condensed Consolidated Statements of Operations and Comprehensive Loss | F-2 |
| Condensed Consolidated Cash Flow Statements | F-3 |
| Notes to the Condensed Consolidated Financial Statements | F-4 |
ENLIVEX THERAPEUTICS LTD.
CONDENSED CONSOLIDATED BALANCE
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
| 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.
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
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
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