Full Press Release Details
ENLIVEX THERAPEUTICS LTD.
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AS OF JUNE 30, 2020 AND DECEMBER 31,
AND FOR THE THREE AND SIX MONTH PERIODS
ENDED JUNE 30, 2020 AND 2019
ENLIVEX THERAPEUTICS LTD.
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AS OF JUNE 30, 2020 AND DECEMBER 31,
AND FOR THE THREE AND SIX MONTH PERIODS
ENDED JUNE 30, 2020 AND 2019
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 SHEETS (UNAUDITED)
U.S. dollars in thousands (except share data)
| June 30, | December 31, | |||||||
| 2020 | 2019 | |||||||
| ASSETS | ||||||||
| Current Assets | ||||||||
| Cash and cash equivalents | $ | 10,163 | $ | 3,948 | ||||
| Short term deposits | 20,043 | 8,060 | ||||||
| Prepaid expenses | 708 | 510 | ||||||
| Other receivables | 751 | 403 | ||||||
| Restricted cash | 145 | 100 | ||||||
| Cash held with respect to CVR Agreement | 2,524 | 1,400 | ||||||
| Receivables for the sale of Trehalose | - | 2,000 | ||||||
| Total Current Assets | 34,334 | 16,421 | ||||||
| Non-Current Assets | ||||||||
| Restricted cash | 60 | 76 | ||||||
| Long-term prepaid expenses | 5 | 5 | ||||||
| Property and equipment, net | 696 | 648 | ||||||
| Other assets | 342 | 410 | ||||||
| Total Non-Current Assets | 1,103 | 1,139 | ||||||
| TOTAL ASSETS | $ | 35,437 | $ | 17,560 | ||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| Current Liabilities | ||||||||
| Accounts payable trade | $ | 524 | $ | 395 | ||||
| Accrued expenses and other liabilities | 1,961 | 2,185 | ||||||
| CVR holders | 2,524 | 3,400 | ||||||
| Total Current Liabilities | 5,009 | 5,980 | ||||||
| Non-Current Liabilities | ||||||||
| Lease liabilities | 236 | 298 | ||||||
| Total Non-Current Liabilities | 236 | 298 | ||||||
| TOTAL LIABILITIES | 5,245 | 6,278 | ||||||
| Commitments and Contingencies | ||||||||
| SHAREHOLDERS' EQUITY | ||||||||
| Common stock of NIS 0.40 ($0.11) par value: | ||||||||
| Authorized: 45,000,000 shares as of June 30, 2020 and December 31, 2019; Issued and outstanding: 13,463,771 and 10,334,126 as of June 30, 2020 and December 31, 2019; | 1,513 | 1,151 | ||||||
| Additional paid in capital | 59,615 | 37,104 | ||||||
| Foreign currency translation adjustments | (1,428 | ) | (1,300 | ) | ||||
| Accumulated deficit | (29,508 | ) | (25,673 | ) | ||||
| TOTAL SHAREHOLDERS' EQUITY | 30,192 | 11,282 | ||||||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 35,437 | $ | 17,560 |
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 shares and per share data)
| For the three months ended | For the six months ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Revenues | $ | - | $ | - | $ | - | $ | - | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses | 1,360 | 696 | 2,732 | 2,274 | ||||||||||||
| General and administrative expenses | 873 | 601 | 1,397 | 1,385 | ||||||||||||
| 2,233 | 1,297 | 4,129 | 3,659 | |||||||||||||
| Operating loss | (2,233 | ) | (1,297 | ) | (4,129 | ) | (3,659 | ) | ||||||||
| Financial income | 89 | 38 | 298 | 93 | ||||||||||||
| Financial expenses | (897 | ) | (202 | ) | (4 | ) | (560 | ) | ||||||||
| Net (loss) | (3,041 | ) | (1,461 | ) | (3,835 | ) | (4,126 | ) | ||||||||
| Other comprehensive income (loss) | ||||||||||||||||
| Exchange differences arising from translating financial statements from functional to presentation currency | 888 | 234 | (128 | ) | 534 | |||||||||||
| Total other comprehensive income (loss) | 888 | 234 | (128 | ) | 534 | |||||||||||
| Total comprehensive (loss) | $ | (2,153 | ) | $ | (1,227 | ) | $ | (3,963 | ) | $ | (3,592 | ) | ||||
| Basic & diluted (loss) per share | $ | (0.23 | ) | $ | (0.14 | ) | $ | (0.31 | ) | $ | (0.62 | ) | ||||
| Weighted average number of shares outstanding | 13,441,436 | 10,108,265 | 12,419,643 | 7,021,027 |
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, | ||||||||
| 2020 | 2019 | |||||||
| Cash flows from operating activities | ||||||||
| Net (loss) | $ | (3,835 | ) | $ | (4,126 | ) | ||
| Adjustments required to reflect net cash used in operating activities: | ||||||||
| Income and expenses not involving cash flows: | ||||||||
| Depreciation | 114 | 95 | ||||||
| Non-cash operating lease expenses | 66 | 67 | ||||||
| Share-based compensation | 320 | 643 | ||||||
| Changes in values of warrants exercisable into shares liability | 50 | |||||||
| Changes in operating asset and liability items: | ||||||||
| Decrease (increase) in prepaid expenses | (196 | ) | 41 | |||||
| Decrease (increase) in other receivables | 1,640 | (359 | ) | |||||
| (Decrease) increase in accounts payable trade | 129 | 127 | ||||||
| (Decrease) increase in accrued expenses and other liabilities | (1,071 | ) | 199 | |||||
| Operating lease liabilities | (62 | ) | (81 | ) | ||||
| Net cash provided by (used in) operating activities | (2,895 | ) | (3,344 | ) | ||||
| Cash flows from investing activities | ||||||||
| Purchase of property and equipment | (166 | ) | (132 | ) | ||||
| Investment in short-term bank deposits | (12,000 | ) | - | |||||
| Net cash received in the issuance of shares for the net assets of Bioblast Pharma Ltd. | - | 1,544 | ||||||
| Net cash (used in) provided by investing activities | (12,166 | ) | 1,412 | |||||
| Cash flows from financing activities | ||||||||
| Proceeds from issuance of shares and warrants net of $2,294 and $655 issuance expenses, respectively | 22,456 | 7,706 | ||||||
| Proceeds from exercise of options | 97 | 4 | ||||||
| Net cash (used in) provided by financing activities | 22,553 | 7,710 | ||||||
| Increase (decrease) in cash and cash equivalents | 7,492 | 5,778 | ||||||
| Cash and cash equivalents - beginning of year | 5,524 | 9,792 | ||||||
| Exchange rate differences on cash and cash equivalents | (124 | ) | 535 | |||||
| Cash and cash equivalents - end of period | $ | 12,892 | $ | 16,105 | ||||
| Non-cash transactions: | ||||||||
| Warrants issued in settlement of issuance costs to a placement agent | $ | 563 | $ | - | ||||
| Conversion of preferred stock to ordinary shares | $ | - | $ | 525 | ||||
| Conversion of 6% preference on preferred stock to ordinary shares | $ | - | $ | 2,071 | ||||
| Issuance of ordinary shares upon exercise of warrants | $ | - | $ | 249 | ||||
| Issuance of shares in connection with merger | $ | - | $ | 47 | ||||
| Assets acquired excluding cash and cash equivalents | $ | - | $ | (2,632 | ) | |||
| Less - liabilities assumed | - | 3,532 | ||||||
| Net assets acquired excluding cash and cash equivalents | $ | - | $ | 900 | ||||
| Supplemental disclosures of cash flow information: | ||||||||
| Cash paid for taxes | $ | - | $ | - | ||||
| Cash received for interest, net | $ | 72 | $ | 93 |
The accompanying notes are an integral part of the condensed
consolidated financial statements.
ENLIVEX THERAPEUTICS LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE
30, 2020 (UNAUDITED)
U.S. dollars in thousands (except shares and per share data)
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 and/or hematopoietic stem cell transplants,
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 and therapies targeting T-Cell Receptor Therapy. 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 located in the State of Israel.
In January 2015, Bioblast Pharma
Inc. was established in the State of Delaware as a wholly owned subsidiary of the Parent (the "Subsidiary"). 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 on the on the Tel Aviv Stock Exchange.
The Company devotes substantially
all of its efforts toward research and development activities and raising capital. 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 its operations to continue
to require 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's has experienced losses since its
inception, and, as of June 30, 2020, had an accumulated deficit of $29,508.
In the first quarter of 2020,
the Company raised $24,750 in cash (before deducting placement agent fees and offering expenses) in conjunction with registered
securities offerings of an aggregate of 3,093,750 Ordinary Shares and 2,093,750 warrants. However, the Company expects to continue
to incur additional 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 part of 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 are of the opinion that its 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 with no additional
need to raise capital. The Company may determine, however, to raise additional capital during such period as its Board of Directors
deems prudent The Company's management plans to finance the Company's operations with issuances of its 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. .
addition to the foregoing, based on the Company's current assessment, the Company does not expect any material impact on
its development timeline or its liquidity due to currently ongoing COVID-19 pandemic. The full extent to which the COVID-19 pandemic
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 from the Company's estimates.
ENLIVEX THERAPEUTICS LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE
30, 2020 (UNAUDITED)
U.S. dollars in thousands (except shares and per share data)
These unaudited 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 for annual periods 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
These unaudited condensed consolidated
financial statements should be read in conjunction with the Company's audited annual financial statements and notes thereto