Full Press Release Details
CONSOLIDATED FINANCIAL STATEMENTS
OF SEPTEMBER 30, 2020 AND DECEMBER 31, 2019
FOR THE THREE AND NINE MONTH PERIODS ENDED SEPTEMBER 30, 2020 AND 2019
CONSOLIDATED FINANCIAL STATEMENTS
OF SEPTEMBER 30, 2020 AND DECEMBER 31, 2019
FOR THE THREE AND NINE MONTH PERIODS ENDED SEPTEMBER 30, 2020 AND 2019
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 |
CONSOLIDATED BALANCE SHEETS (UNAUDITED)
dollars in thousands (except share data)
| September 30, | December 31, | |||||||
| 2020 | 2019 | |||||||
| ASSETS | ||||||||
| Current Assets | ||||||||
| Cash and cash equivalents | $ | 4,148 | $ | 3,948 | ||||
| Short term deposits | 24,028 | 8,060 | ||||||
| Prepaid expenses | 569 | 510 | ||||||
| Other receivables | 717 | 403 | ||||||
| Restricted cash | 145 | 100 | ||||||
| Cash held with respect to CVR Agreement | 1,999 | 1,400 | ||||||
| Receivables for the sale of Trehalose | - | 2,000 | ||||||
| Total Current Assets | 31,606 | 16,421 | ||||||
| Non-Current Assets | ||||||||
| Restricted cash | 105 | 76 | ||||||
| Long-term prepaid expenses | 5 | 5 | ||||||
| Property and equipment, net | 1,010 | 648 | ||||||
| Other assets | 646 | 410 | ||||||
| Total Non-Current Assets | 1,766 | 1,139 | ||||||
| TOTAL ASSETS | $ | 33,372 | $ | 17,560 | ||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| Current Liabilities | ||||||||
| Accounts payable trade | $ | 334 | $ | 395 | ||||
| Accrued expenses and other liabilities | 2,041 | 2,185 | ||||||
| CVR holders | 1,999 | 3,400 | ||||||
| Total Current Liabilities | 4,374 | 5,980 | ||||||
| Non-Current Liabilities | ||||||||
| Lease liabilities | 499 | 298 | ||||||
| Total Non-Current Liabilities | 499 | 298 | ||||||
| TOTAL LIABILITIES | 4,873 | 6,278 | ||||||
| Commitments and Contingencies | ||||||||
| SHAREHOLDERS' EQUITY | ||||||||
| Common stock of NIS 0.40 ($0.12) par value: | ||||||||
| Authorized: 45,000,000 shares as of September 30, 2020 and December 31, 2019; Issued and outstanding: 13,463,771 and 10,334,126 as of September 30, 2020 and December 31, 2019; | 1,513 | 1,151 | ||||||
| Additional paid in capital | 59,820 | 37,104 | ||||||
| Foreign currency translation adjustments | (1,201 | ) | (1,300 | ) | ||||
| Accumulated deficit | (31,633 | ) | (25,673 | ) | ||||
| TOTAL SHAREHOLDERS' EQUITY | 28,499 | 11,282 | ||||||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 33,372 | $ | 17,560 |
accompanying notes are an integral part of the condensed consolidated financial statements.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)
dollars in thousands (except shares and per share data)
| For the three months ended | For the nine months ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Revenues | $ | - | $ | - | $ | - | $ | - | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses | 1,202 | 1,576 | 3,934 | 3,850 | ||||||||||||
| General and administrative expenses | 757 | 545 | 2,154 | 1,930 | ||||||||||||
| 1,959 | 2,121 | 6,088 | 5,780 | |||||||||||||
| Operating loss | (1,959 | ) | (2,121 | ) | (6,088 | ) | (5,780 | ) | ||||||||
| Financial income | 57 | 72 | 211 | 165 | ||||||||||||
| Financial expenses | (223 | ) | (342 | ) | (83 | ) | (902 | ) | ||||||||
| Net (loss) | (2,125 | ) | (2,391 | ) | (5,960 | ) | (6,517 | ) | ||||||||
| Other comprehensive income (loss) | ||||||||||||||||
| Exchange differences arising from translating financial statements from functional to presentation currency | 227 | 350 | 99 | 884 | ||||||||||||
| Total other comprehensive income (loss) | 227 | 350 | 99 | 884 | ||||||||||||
| Total comprehensive (loss) | $ | (1,898 | ) | $ | (2,041 | ) | $ | (5,861 | ) | $ | (5,633 | ) | ||||
| Basic & diluted (loss) per share | $ | (0.16 | ) | $ | (0.23 | ) | $ | (0.47 | ) | $ | (0.83 | ) | ||||
| Weighted average number of shares outstanding | 13,463,771 | 10,206,837 | 12,770,226 | 8,098,581 |
accompanying notes are an integral part of the condensed consolidated financial statements.
CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
dollars in thousands
| For the nine months ended September 30, | ||||||||
| 2020 | 2019 | |||||||
| Cash flows from operating activities | ||||||||
| Net (loss) | $ | (5,960 | ) | $ | (6,517 | ) | ||
| Adjustments required to reflect net cash used in operating activities: | ||||||||
| Income and expenses not involving cash flows: | ||||||||
| Depreciation | 186 | 144 | ||||||
| Non-cash operating lease expenses | 117 | 126 | ||||||
| Share-based compensation | 525 | 512 | ||||||
| Loss on sale of property and equipment | - | 75 | ||||||
| Changes in values of warrants exercisable into shares liability | - | 50 | ||||||
| Changes in operating asset and liability items: | ||||||||
| Decrease (increase) in prepaid expenses | (41 | ) | 126 | |||||
| Decrease (increase) in other receivables | 1,689 | (63 | ) | |||||
| (Decrease) increase in accounts payable trade | (62 | ) | (58 | ) | ||||
| (Decrease) increase in accrued expenses and other liabilities | (1,609 | ) | 341 | |||||
| Operating lease liabilities | (93 | ) | (125 | ) | ||||
| Net cash provided by (used in) operating activities | (5,248 | ) | (5,389 | ) | ||||
| Cash flows from investing activities | ||||||||
| Purchase of property and equipment | (538 | ) | (159 | ) | ||||
| Investment in short-term bank deposits | (16,000 | ) | (7,960 | ) | ||||
| 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 | (16,538 | ) | (6,575 | ) | ||||
| Cash flows from financing activities | ||||||||
| Proceeds from issuance of shares and warrants net of $2,294 and $655 issuance expenses, respectively | 22,456 | 7,707 | ||||||
| Proceeds from exercise of options | 97 | 599 | ||||||
| Net cash (used in) provided by financing activities | 22,553 | 8,306 | ||||||
| Increase (decrease) in cash and cash equivalents | 767 | (3,658 | ) | |||||
| Cash and cash equivalents - beginning of year | 5,524 | 9,792 | ||||||
| Exchange rate differences on cash and cash equivalents | 106 | 875 | ||||||
| Cash and cash equivalents - end of period | $ | 6,397 | $ | 7,009 | ||||
| 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 | $ | 204 | $ | 93 |
accompanying notes are an integral part of the condensed consolidated financial statements.
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS SEPTEMBER 30, 2020 (UNAUDITED)
dollars in thousands (except shares and per share data)
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.
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.
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.
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.
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 September 30, 2020, had an accumulated deficit of $31,633.
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.
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.
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS SEPTEMBER 30, 2020 (UNAUDITED)
dollars in thousands (except shares and per share data)
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.
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 have been made.
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 2019 Annual Report on Form 20-F, as filed with the SEC on April 30,
2020. The results of operations for these interim periods are not necessarily indicative of the operating results for any future
period. The December 31, 2019 financial information has been derived from the Company's audited financial statements.
functional currency of the Company is the New Israeli Shekel ("NIS"), which is the local currency in which it 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 of the date of the equity transaction, and income and expense items were translated at average
exchange rates during the period .
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)".
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.
U.S. $ = NIS 3.441 and NIS 3.456 as of September 30, 2020 and December 31, 2019, respectively.
U.S. $ decreased against the NIS (0.72%) and (2.36%) in the three months ended September 30, 2020 and 2019, respectively, and
(0.43%) and (7.10%) in the nine months ended September 30, 2020 and 2019, respectively.
prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications had no effect
on the reported results of operations.
August 2018, the Financial Accounting Standards Board ("FASB") issued ASU 2018-13, "Fair Value Measurement (Topic
820), - Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement," which makes a number
of changes meant to add, modify or remove certain disclosure requirements associated with the movement amongst or hierarchy associated
with Level 1, Level 2 and Level 3 fair value measurements. This guidance is effective for fiscal years, and interim periods within
those fiscal years, beginning after December 15, 2019. The Company adopted this ASU on January 1, 2020. The adoption of this ASU