UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
under the Securities Exchange Act of 1934
For the month of: September 2023
Commission file number: 001-36578
ENLIVEX THERAPEUTICS LTD.
(Translation of registrant’s name into English)
14 Einstein Street, Nes Ziona, Israel 7403618
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form
40-F ☐
Financial Statements
The
unaudited condensed consolidated financial statements for Enlivex Therapeutics Ltd., a company organized under the laws of the State
of Israel (“Enlivex”), as of and for the three and six month periods ended June
30, 2023 and 2022, and the Operating and Financial Review and Prospects of Enlivex for the corresponding periods are furnished
as Exhibits 99.1 and Exhibit 99.2, respectively, to this Report on Form 6-K and incorporated by reference into Enlivex’s registration
statements on Forms S-8, F-3 and F-3MEF (File No. 333-256799,
File No. 333-232413,
File No. 333-232009, File No. 333-252926 and
File No. 333-264561), filed with the Securities and Exchange Commission.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|
Enlivex Therapeutics Ltd. |
|
(Registrant) |
|
|
|
By: |
/s/ Oren Hershkovitz |
|
Name: |
Oren Hershkovitz |
|
Title: |
Chief Executive Officer |
Date: September 1, 2023
2
2023-06-30
Exhibit 99.1
ENLIVEX THERAPEUTICS LTD.
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AS OF JUNE 30, 2023 AND DECEMBER 31, 2022
AND FOR THE THREE AND SIX MONTH PERIODS ENDED
JUNE 30, 2023 AND 2022
ENLIVEX THERAPEUTICS LTD.
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AS OF JUNE 30, 2023 AND DECEMBER 31, 2022
AND FOR THE THREE AND SIX MONTH PERIODS ENDED
JUNE 30, 2023 AND 2022
INDEX TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
ENLIVEX THERAPEUTICS LTD.
CONDENSED CONSOLIDATED BALANCE
SHEETS (UNAUDITED)
U.S. dollars in thousands (except share data)
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
ASSETS | |
| | |
| |
Current Assets | |
| | |
| |
Cash and cash equivalents | |
$ | 3,458 | | |
$ | 49,945 | |
Short term interest-bearing bank deposits | |
| 25,443 | | |
| 299 | |
Prepaid expenses and other receivables | |
| 1,884 | | |
| 2,086 | |
Total Current Assets | |
| 30,785 | | |
| 52,330 | |
| |
| | | |
| | |
Non-Current Assets | |
| | | |
| | |
Long term interest-bearing bank deposits | |
| 7,159 | | |
| - | |
Property and equipment, net | |
| 9,574 | | |
| 9,875 | |
Other assets | |
| 5,510 | | |
| 5,437 | |
Total Non-Current Assets | |
| 22,243 | | |
| 15,312 | |
TOTAL ASSETS | |
$ | 53,028 | | |
$ | 67,642 | |
| |
| | | |
| | |
LIABILITIES AND SHAREHOLDERS’ EQUITY | |
| | | |
| | |
Current Liabilities | |
| | | |
| | |
Accounts payable | |
$ | 1,554 | | |
$ | 1,948 | |
Accrued expenses and other liabilities | |
| 3,437 | | |
| 4,659 | |
Total Current Liabilities | |
| 4,991 | | |
| 6,607 | |
| |
| | | |
| | |
Non-Current Liabilities | |
| | | |
| | |
Other long-term liabilities | |
| 3,702 | | |
| 4,194 | |
Total Non-Current Liabilities | |
| 3,702 | | |
| 4,194 | |
| |
| | | |
| | |
Commitments and Contingent Liabilities | |
| | | |
| | |
| |
| | | |
| | |
TOTAL LIABILITIES | |
| 8,693 | | |
| 10,801 | |
| |
| | | |
| | |
SHAREHOLDERS’ EQUITY | |
| | | |
| | |
Ordinary shares of NIS 0.4 par value: Authorized: 45,000,000 shares as of June 30, 2023 and December 31, 2022; Issued and outstanding: 18,589,139 and 18,421,852 as of June 30, 2023 and December 31, 2022; | |
| 2,136 | | |
| 2,117 | |
Additional paid in capital | |
| 138,133 | | |
| 136,648 | |
Foreign currency translation adjustments | |
| 1,101 | | |
| 1,101 | |
Accumulated deficit | |
| (97,035 | ) | |
| (83,025 | ) |
TOTAL SHAREHOLDERS’ EQUITY | |
| 44,335 | | |
| 56,841 | |
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | |
$ | 53,028 | | |
$ | 67,642 | |
The accompanying notes are an integral part of the condensed consolidated
financial statements.
ENLIVEX THERAPEUTICS LTD.
CONDENSED CONSOLIDATED STATEMENTS
OF OPERATIONS AND LOSS (UNAUDITED)
U.S. dollars in thousands (except share and
per share data)
| |
For the three months ended | | |
For the six months ended | |
| |
June 30, | | |
June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Revenues | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development expenses | |
| 5,035 | | |
| 4,110 | | |
| 10,211 | | |
| 8,792 | |
General and administrative expenses | |
| 1,614 | | |
| 1,761 | | |
| 3,221 | | |
| 3,483 | |
| |
| 6,649 | | |
| 5,871 | | |
| 13,432 | | |
| 12,275 | |
| |
| | | |
| | | |
| | | |
| | |
Operating loss | |
| (6,649 | ) | |
| (5,871 | ) | |
| (13,432 | ) | |
| (12,275 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other expenses, net | |
| (143 | ) | |
| (4,042 | ) | |
| (578 | ) | |
| (5,863 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss | |
| (6,792 | ) | |
| (9,913 | ) | |
| (14,010 | ) | |
| (18,138 | ) |
| |
| | | |
| | | |
| | | |
| | |
Basic & diluted loss per share | |
$ | (0.37 | ) | |
$ | (0.54 | ) | |
$ | (0.76 | ) | |
$ | (0.99 | ) |
Weighted average number of shares outstanding | |
| 18,584,801 | | |
| 18,375,206 | | |
| 18,550,702 | | |
| 18,372,521 | |
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 (except share data)
| |
Ordinary Shares | | |
Additional
paid in | | |
Currency
translation | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
capital | | |
reserve | | |
deficit | | |
Total | |
| |
| | |
| | |
| | |
| | |
| | |
| |
Balance as of December 31, 2022 | |
| 18,421,852 | | |
$ | 2,117 | | |
$ | 136,648 | | |
$ | 1,101 | | |
$ | (83,025 | ) | |
$ | 56,841 | |
Changes during the three months period ended March 31, 2022: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Restricted stock units vested | |
| 34,295 | | |
| 3 | | |
| (3 | ) | |
| - | | |
| - | | |
| - | |
Issuance of shares for cash consideration of $470 net of $152 issuance costs | |
| 110,115 | | |
| 13 | | |
| 305 | | |
| - | | |
| - | | |
| 318 | |
Stock based compensation | |
| - | | |
| - | | |
| 633 | | |
| - | | |
| - | | |
| 633 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| (7,218 | ) | |
| (7,218 | ) |
Balance as of March 31, 2023 (unaudited) | |
| 18,566,262 | | |
| 2,133 | | |
| 137,583 | | |
| 1,101 | | |
| (90,243 | ) | |
| 50,574 | |
Changes during the three months period ended June 30, 2023: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Issuance of shares for cash consideration of $43 net of $1 issuance costs | |
| 14,056 | | |
| 2 | | |
| 40 | | |
| - | | |
| - | | |
| 42 | |
Restricted stock units vested | |
| 8,821 | | |
| 1 | | |
| (1 | ) | |
| - | | |
| - | | |
| - | |
Exercise of options | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
Stock based compensation | |
| - | | |
| - | | |
| 511 | | |
| - | | |
| - | | |
| 511 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| (6,792 | ) | |
| (6,792 | ) |
Balance as of June 30, 2023 (unaudited) | |
| 18,589,139 | | |
$ | 2,136 | | |
$ | 138,133 | | |
$ | 1,101 | | |
$ | (97,035 | ) | |
$ | 44,335 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
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 | |
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, | |
| |
2023 | | |
2022 | |
Cash flows from operating activities | |
| | | |
| | |
Net (loss) | |
$ | (14,010 | ) | |
$ | (18,138 | ) |
Adjustments required to reflect net cash used in operating activities: | |
| | | |
| | |
Income and expenses not involving cash flows: | |
| | | |
| | |
Depreciation | |
| 421 | | |
| 364 | |
Non-cash operating lease expenses | |
| 434 | | |
| 411 | |
Share-based compensation | |
| 1,144 | | |
| 1,485 | |
Loss on marketable securities and short-term bank deposits | |
| 1,626 | | |
| 4,886 | |
Changes in operating asset and liability items: | |
| | | |
| | |
Increase in prepaid expenses and other receivables | |
| (169 | ) | |
| (205 | ) |
Decrease in accounts payable trade | |
| (240 | ) | |
| (211 | ) |
Decrease in accrued expenses and other liabilities | |
| (1,389 | ) | |
| (307 | ) |
Operating lease liabilities | |
| (624 | ) | |
| (827 | ) |
Net cash used in operating activities | |
| (12,807 | ) | |
| (12,542 | ) |
| |
| | | |
| | |
Cash flows from investing activities | |
| | | |
| | |
Purchase of property and equipment | |
| (200 | ) | |
| (4,351 | ) |
Proceeds from sale of property and equipment | |
| 82 | | |
| - | |
Investment in short-term interest bearing bank deposits | |
| (34,218 | ) | |
| (35,234 | ) |
Release of short-term interest bearing bank deposits | |
| 288 | | |
| | |
Purchases of marketable securities | |
| - | | |
| (1,608 | ) |
Proceeds from sales of marketable securities | |
| - | | |
| 62,549 | |
Net cash (used in) provided by investing activities | |
| (34,048 | ) | |
| 21,356 | |
| |
| | | |
| | |
Cash flows from financing activities | |
| | | |
| | |
Proceeds from issuance of shares, net | |
| 360 | | |
| - | |
Proceeds from exercise of options | |
| - | | |
| 100 | |
Net cash provided by financing activities | |
| 360 | | |
| 100 | |
| |
| | | |
| | |
Increase (decrease) in cash and cash equivalents | |
| (46,495 | ) | |
| 8,914 | |
Cash and cash equivalents - beginning of period | |
| 50,357 | | |
| 11,636 | |
Cash and cash equivalents - end of period | |
$ | 3,862 | | |
$ | 20,550 | |
| |
| | | |
| | |
Supplemental disclosures of cash flow information: | |
| | | |
| | |
Cash paid for taxes | |
$ | - | | |
$ | - | |
Cash paid (received) for interest, net | |
$ | 233 | | |
$ | 45 | |
The accompanying notes are an integral part of the condensed consolidated
financial statements.
ENLIVEX THERAPEUTICS LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2023
(UNAUDITED)
NOTE 1 – GENERAL
| a. | 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 of Israel. |
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 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, par
value of 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 June
30, 2023, had an accumulated deficit of $97,035 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 date of 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.
NOTE 2 – SIGNIFICANT ACCOUNTING
POLICIES
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.
ENLIVEX THERAPEUTICS LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2023
(UNAUDITED)
NOTE 2 – SIGNIFICANT ACCOUNTING
POLICIES (Cont.)
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 2022 Annual Report on Form 20-F, as filed with the SEC on April 10, 2023. The results of operations for the interim
periods presented herein are not necessarily indicative of the operating results for any future period. The December 31, 2022 financial
information has been derived from the Company’s audited financial statements.
Use of Estimates
The preparation of interim financial
statements in conformity with U.S. GAAP requires management to make certain estimates, judgments and assumptions that affect the reported
amounts in the consolidated balance sheets and statements of operations, it also requires that management exercise its judgment in applying
the Company’s accounting policies. On an ongoing basis, management evaluates its estimates, including estimates related to its stock-based
compensation expense and implicit interest rate on new lease liabilities. Significant estimates in these interim financial statements
include estimates made for accrued research and development expenses and stock-based compensation expenses.
Functional Currency and Translation
to The Reporting Currency
The functional currency of the Company
is the U.S. dollar because the U.S. dollar is the currency of the primary economic environment in which the Company operates and expects
to continue to operate in the foreseeable future.
Balances related to non-monetary assets
and liabilities are based on translated amounts as of the date of the change, and non-monetary assets acquired and liabilities were translated
at the approximate exchange rate prevailing at the date of the transaction. Transactions included in the statement of income were translated
at the approximate exchange rate in effect at the time of the applicable transaction.
1 U.S. dollar = 3.7 NIS and 3.519 NIS
as of June 30, 2023 and December 31, 2022, respectively.
The U.S. dollar increased against the
NIS: 2.35%, 5.14%, 10.2% and 12.54% in the three and six month periods ended June 30, 2023 and 2022, respectively.
Recently Adopted Accounting Standards
During the six months ended June 30,
2023, the Company was not required to adopt any recently issued accounting standards.
Recently Issued Accounting Pronouncements
Not Yet Adopted
The Company has evaluated other recently
issued accounting pronouncements and does not currently believe that any of these pronouncements will have a material impact on its condensed
consolidated financial statements and related disclosures.
Significant Accounting Policies
There have been no material changes
to the significant accounting policies previously disclosed in the Company’s Annual Report on Form 20-F for the year ended December
31, 2022.
Marketable Securities.
The Company has an investment policy
that includes guidelines on acceptable investment securities, minimum credit quality, maturity parameters, and concentration and diversification.
The Company from time-to-time invests a portion of its excess cash in mutual funds that are classified based on the nature of their underlying
securities and their availability for use in current operations. The Company’s marketable equity securities are measured at fair
value with gains and losses recognized in other expense, net.
Net (loss) realized on equity securities
for the three and six month periods ended June 30, 2023 and 2022 was $0, $0, $0 and $(1,982) thousand, respectively.
ENLIVEX THERAPEUTICS LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2023
(UNAUDITED)
NOTE 3 – CASH, CASH EQUIVALENTS
AND RESTRICTED CASH
| |
June 30, | | |
December 31, | |
(in thousands) | |
2023 | | |
2022 | |
Cash held in banks | |
$ | 1,024 | | |
$ | 2,123 | |
Bank deposits in U.S.$ (annual average interest rates 4.29%% and 0.1%) | |
| 2,434 | | |
| 47,822 | |
Total cash and cash equivalents | |
| 3,458 | | |
| 49,945 | |
Restricted cash – current – Prepaid expenses and other receivables | |
| 113 | | |
| 113 | |
Restricted cash – noncurrent – Other assets | |
| 291 | | |
| 299 | |
Total cash, cash equivalents and restricted cash shown in the statement of cash flows | |
$ | 3,862 | | |
$ | 50,357 | |
NOTE 4 – SHORT TERM INTEREST-BEARING BANK DEPOSITS
| |
June 30, | | |
December 31, | |
(in thousands) | |
2023 | | |
2022 | |
Bank deposits in U.S.$ (annual average interest rates 5.94% and 0.3%) | |
$ | 6,165 | | |
$ | 299 | |
Bank deposits in NIS (annual average interest rates 4.31%) | |
| 19,278 | | |
| - | |
Total short-term deposits | |
$ | 25,443 | | |
$ | 299 | |
NOTE 5 – LONG
TERM INTEREST-BEARING BANK DEPOSITS
| |
June 30, | | |
December 31, | |
(in thousands) | |
2023 | | |
2022 | |
Bank deposits in U.S.$ (annual average interest rates 4.22%) | |
$ | 7,159 | | |
$ | - | |
Total long-term interest-bearing bank deposits | |
$ | 7,159 | | |
$ | - | |
ENLIVEX THERAPEUTICS LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2023
(UNAUDITED)
NOTE 6 – PROPERTY AND EQUIPMENT
Property and equipment, net consisted of the following:
| |
June 30, | | |
December 31, | |
(in thousands) | |
2023 | | |
2022 | |
| |
| | |
| |
Cost: | |
| | |
| |
Laboratory equipment | |
$ | 2,837 | | |
$ | 2,851 | |
Computers | |
| 276 | | |
| 276 | |
Office furniture & equipment | |
| 317 | | |
| 249 | |
Leasehold improvements | |
| 8,672 | | |
| 8,606 | |
| |
| 12,102 | | |
| 11,982 | |
Accumulated depreciation: | |
| | | |
| | |
Laboratory equipment | |
| 1,690 | | |
| 1,432 | |
Computers | |
| 242 | | |
| 203 | |
Office furniture & equipment | |
| 34 | | |
| 28 | |
Leasehold improvements | |
| 562 | | |
| 444 | |
| |
| 2,528 | | |
| 2,107 | |
Depreciated cost | |
$ | 9,574 | | |
$ | 9,875 | |
Depreciation expenses for the three and six month periods
ended June 30, 2023 and 2022 were $212, $421, $176 and $364 thousand, respectively.
NOTE 7 – OTHER ASSETS
| |
June 30, | | |
December 31, | |
(in thousands) | |
2023 | | |
2022 | |
| |
| | |
| |
Restricted cash | |
$ | 291 | | |
$ | 299 | |
Long-term prepaid expenses | |
| 485 | | |
| 113 | |
Right-of-Use assets, net | |
| 4,734 | | |
| 5,025 | |
| |
$ | 5,510 | | |
$ | 5,437 | |
NOTE 8 – ACCRUED EXPENSES AND OTHER LIABILITIES
| |
June 30, | | |
December 31, | |
(in thousands) | |
2023 | | |
2022 | |
| |
| | |
| |
Vacation, convalescence and bonus accruals | |
$ | 461 | | |
$ | 759 | |
Employees and payroll related | |
| 612 | | |
| 539 | |
Short term operating lease liabilities | |
| 667 | | |
| 653 | |
Accrued expenses and other | |
| 1,697 | | |
| 2,708 | |
| |
$ | 3,437 | | |
$ | 4,659 | |
ENLIVEX THERAPEUTICS LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2023
(UNAUDITED)
NOTE 9 – LEASES
The Company is a party to operating
leases for its corporate offices, laboratory space and vehicles. The Company’s real property operating leases have remaining lease
terms of up to 3.25 years, some of which include options to extend the leases for up to five years.
| |
Six months ended June 30, | |
(in thousands) | |
2023 | | |
2022 | |
| |
| | |
| |
The components of lease expense were as follows: | |
| | |
| |
Operating leases expenses | |
$ | 522 | | |
$ | 517 | |
Supplemental consolidated cash flow information related to operating leases follows: | |
| | | |
| | |
Cash used in operating activities | |
$ | 520 | | |
$ | 478 | |
Non-cash activity: | |
| | | |
| | |
Right of use assets obtained in exchange for new operating lease liabilities | |
$ | 145 | | |
$ | 91 | |
| |
June 30, | | |
December 31, | |
(in thousands) | |
2023 | | |
2022 | |
Supplemental information related to operating leases, including location of amounts reported in the accompanying consolidated balance sheets, follows: | |
| | |
| |
Other assets - Right-of-Use assets | |
$ | 6,590 | | |
$ | 6,445 | |
Accumulated amortization | |
| 1,856 | | |
| 1,420 | |
Operating lease Right-of-Use assets, net | |
$ | 4,734 | | |
$ | 5,025 | |
Lease liabilities – current - Accounts payable and accrued liabilities | |
$ | 667 | | |
$ | 653 | |
Lease liabilities – noncurrent | |
| 3,702 | | |
| 4,194 | |
Total operating lease liabilities | |
$ | 4,369 | | |
$ | 4,847 | |
Weighted average remaining lease term in years | |
| 7.1 | | |
| 7.6 | |
Weighted average annual discount rate | |
| 3.4 | % | |
| 3.4 | % |
Maturities
of operating lease liabilities as of June 30, 2022, were as follows:
2023(after June 30) | |
$ | 344 | |
2024 | |
| 696 | |
2025 | |
| 717 | |
2026 | |
| 581 | |
2027 | |
| 551 | |
2028 and onwards | |
| 2,069 | |
Total undiscounted lease liability | |
$ | 4,958 | |
Less: Imputed interest | |
$ | (589 | ) |
Present value of lease liabilities | |
$ | 4,369 | |
NOTE 10 – COMMITMENTS AND CONTINGENT LIABILITIES
The Company is required to pay royalties
to the State of Israel (represented by the Israeli Innovation Authority (the “IIA”)), computed on the basis of proceeds
from the sale or license of products for which development was supported by IIA grants. These royalties are generally 3% - 5% of sales
until repayment of 100% of the grants (linked to the dollar) received by the Company plus accrued interest
The gross amount of grants received
by the Company from the IIA, including accrued interest as of June 30, 2023, was approximately $9.6 million. As of June 30, 2023, the
Company had not paid any royalties to the IIA.
ENLIVEX THERAPEUTICS LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2023
(UNAUDITED)
NOTE 11 – EQUITY
All
Company warrants are classified as a component of shareholders’ equity because such warrants are free standing financial instruments
that are legally detachable, separately exercisable, do not embody an obligation for the Company to repurchase its own shares, and permit
the holders to receive a fixed number of Ordinary Shares upon exercise, requires physical settlement and do not provide any guarantee
of value or return.
|
|
Number of
Warrants |
|
|
Weighted
average
exercise
price |
|
Outstanding January 1, 2023 |
|
|
202,251 |
|
|
$ |
23.31 |
|
Outstanding and exercisable June 30, 2023 |
|
|
202,251 |
|
|
$ |
23.31 |
|
Composed of the following:
Number of
Warrants |
|
|
Exercise Price
Per Share |
|
|
Issuance date |
|
Expiration date |
|
22,750 |
|
|
$ |
10 |
|
|
February 26, 2020 |
|
February 24, 2025 |
|
160,727 |
|
|
$ |
25 |
|
|
February 12, 2021 |
|
February 9, 2026 |
|
18,774 |
|
|
$ |
25 |
|
|
February 17, 2021 |
|
February 9, 2026 |
|
202,251 |
|
|
|
|
|
|
|
|
|
NOTE 12 – SHARE-BASED COMPENSATION
| a) | As of June 30, 2023, 5,028,704 Ordinary Shares were authorized
for issuance to employees, directors and consultants under the 2019 Equity Incentive Plan, of which 1,537,973 shares were available for
future grant. |
| b) | The following table contains information concerning options
granted under the existing equity incentive plan: |
| |
Three months ended June 30, | |
| |
2023 | | |
2022 | |
| |
Number of
options | | |
Weighted
average
exercise
price | | |
Number of
options | | |
Weighted
average
exercise
price | |
Outstanding at beginning of period | |
| 2,929,868 | | |
$ | 5.84 | | |
| 2,399,622 | | |
$ | 5.95 | |
Forfeited and expired | |
| (14,375 | ) | |
$ | 6.82 | | |
| (3,000 | ) | |
$ | 5.34 | |
Exercised | |
| - | | |
$ | - | | |
| (7,625 | ) | |
$ | 6.49 | |
Outstanding at end of period | |
| 2,915,493 | | |
$ | 5.84 | | |
| 2,388,997 | | |
$ | 5.95 | |
Exercisable at end of period | |
| 2,090,378 | | |
$ | 5.59 | | |
| 1,728,623 | | |
$ | 5.10 | |
| |
| | | |
| | | |
| | | |
| | |
Non-vested at beginning of period | |
| 876,851 | | |
$ | 6.48 | | |
| 722,749 | | |
$ | 7.67 | |
Vested | |
| (37,861 | ) | |
$ | 11.13 | | |
| (59,375 | ) | |
$ | (8.78 | ) |
Forfeited | |
| (13,875 | ) | |
$ | 5.90 | | |
| (3,000 | ) | |
$ | (5.34 | ) |
Non-vested at the end of period | |
| 825,115 | | |
$ | 6.27 | | |
| 660,374 | | |
$ | 7.59 | |
ENLIVEX THERAPEUTICS LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2023
(UNAUDITED)
NOTE 12 – SHARE-BASED COMPENSATION (Cont.)
| |
Six months ended June 30, | |
| |
2023 | | |
2022 | |
| |
Number of
options | | |
Weighted
average
exercise
price | | |
Number of
options | | |
Weighted
average
exercise
price | |
Outstanding at beginning of period | |
| 2,939,434 | | |
$ | 5.85 | | |
| 2,142,547 | | |
$ | 6.02 | |
Granted | |
| - | | |
| | | |
$ | 264,700 | | |
$ | 5.48 | |
Forfeited and expired | |
| (23,941 | ) | |
$ | 6.71 | | |
| (3,000 | ) | |
$ | 5.34 | |
Exercised | |
| - | | |
| | | |
$ | (15,250 | ) | |
$ | 6.49 | |
Outstanding at end of period | |
| 2,915,493 | | |
$ | 5.84 | | |
| 2,388,997 | | |
$ | 5.95 | |
Exercisable at end of period | |
| 2,090,378 | | |
$ | 5.59 | | |
| 1,728,623 | | |
$ | 5.10 | |
| |
| | | |
| | | |
| | | |
| | |
Non vested at beginning of period | |
| 986,005 | | |
$ | 6.46 | | |
| 529,082 | | |
$ | 8.69 | |
Granted | |
| - | | |
$ | - | | |
| 264,700 | | |
$ | 5.48 | |
Forfeited and expired | |
| (15,375 | ) | |
$ | 6.73 | | |
| (3,000 | ) | |
$ | 5.34 | |
vested | |
| (145,515 | ) | |
$ | 7.44 | | |
| (130,408 | ) | |
$ | 7.82 | |
Outstanding at end of period | |
| 825,115 | | |
$ | 6.27 | | |
| 660,374 | | |
$ | 7.59 | |
During the three and six month periods ended June 30, 2023
and 2022, the Company recognized $427, $957, $509 and $1,074 thousand, respectively, of share-based compensation expenses related to stock
options.
As of June 30, 2023, the total
unrecognized estimated compensation cost related to outstanding non-vested stock options was $1,766 thousand, which is expected to be
recognized over a weighted average period of 1.32 years.
| c) | Set forth below is data regarding the range of exercise prices
and remaining contractual life for all options outstanding on June 30, 2023: |
Exercise
price | | |
Number of
options outstanding | | |
Remaining
contractual
Life (in years) | | |
Intrinsic
Value of
Options
Outstanding
(in thousands) | | |
No. of options
exercisable | |
$ | 2.69 | | |
| 649,883 | | |
| 1.92 | | |
| - | | |
| 649,883 | |
$ | 3.66 | | |
| 250,000 | | |
| 6.84 | | |
| - | | |
| 250,000 | |
$ | 4.68 | | |
| 48,750 | | |
| 6.75 | | |
| - | | |
| 36,563 | |
$ | 5.34 | | |
| 208,825 | | |
| 8.75 | | |
| - | | |
| 53,800 | |
$ | 5.34 | | |
| 445,792 | | |
| 9.38 | | |
| - | | |
| 69,263 | |
$ | 5.96 | | |
| 150,000 | | |
| 9.38 | | |
| - | | |
| - | |
$ | 6.22 | | |
| 634,177 | | |
| 4.00 | | |
| - | | |
| 634,177 | |
$ | 8.19 | | |
| 150,000 | | |
| 6.38 | | |
| - | | |
| 112,500 | |
$ | 8.23 | | |
| 12,500 | | |
| 8.38 | | |
| - | | |
| 5,000 | |
$ | 9.02 | | |
| 40,500 | | |
| 7.38 | | |
| - | | |
| 20,250 | |
$ | 10.12 | | |
| 12,126 | | |
| 5.43 | | |
| - | | |
| 12,126 | |
$ | 12.23 | | |
| 250,000 | | |
| 7.91 | | |
| - | | |
| 194,444 | |
$ | 14.00 | | |
| 60,500 | | |
| 7.82 | | |
| - | | |
| 50,417 | |
$ | 21.40 | | |
| 1,940 | | |
| 6.07 | | |
| - | | |
| 1,455 | |
$ | 90.16 | | |
| 500 | | |
| 1.42 | | |
| - | | |
| 500 | |
| | | |
| 2,915,493 | | |
| | | |
| - | | |
| 2,090,378 | |
ENLIVEX THERAPEUTICS LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2023
(UNAUDITED)
NOTE 12 – SHARE-BASED COMPENSATION (Cont.)
| d) | The following table contains information concerning restricted
stock units granted under the existing equity incentive plan: |
| |
Three months ended June 30, | |
| |
2023 | | |
2022 | |
| |
Number of
shares | | |
Weighted
average
grant date
fair value | | |
Number of
shares | | |
Weighted
average
grant date
fair value | |
Nonvested at beginning of period | |
| 114,329 | | |
$ | 9.97 | | |
| 184,787 | | |
$ | 10.02 | |
Vested | |
| (3,438 | ) | |
$ | 10.28 | | |
| (3,437 | ) | |
$ | 10.28 | |
Forfeited | |
| (313 | ) | |
$ | 14.67 | | |
| - | | |
$ | - | |
Nonvested at end of period | |
| 110,578 | | |
$ | 9.95 | | |
| 181,350 | | |
$ | 10.02 | |
| |
Six months ended June 30, | |
| |
2023 | | |
2022 | |
| |
Number of
shares | | |
Weighted average grant date
fair value | | |
Number of
shares | | |
Weighted average grant date
fair value | |
Nonvested at beginning of period | |
| 157,560 | | |
$ | 10.02 | | |
| 229,331 | | |
$ | 10.08 | |
Vested | |
| (46,544 | ) | |
$ | 10.15 | | |
| (47,981 | ) | |
$ | 10.29 | |
Forfeited | |
| (438 | ) | |
$ | 14.67 | | |
| - | | |
$ | - | |
Nonvested at end of period | |
| 110,578 | | |
$ | 9.95 | | |
| 181,350 | | |
$ | 10.02 | |
The Company estimates the fair value
of restricted stock units based on the closing sales price of the Ordinary Shares on the date of grant (or the closing bid price, if no
sales were reported). For the three and six month periods ended June 30, 2023 and 2022, the Company recognized $84, $187, $188 and $411
thousand, respectively, of share-based compensation expense related to restricted stock units. Total share-based compensation expense
related to restricted stock units not yet recognized as of June 30, 2023 was $331 thousand, which is expected to be recognized over a
weighted average period of 0.66 years.
| e) | The
following table summarizes share-based compensation expenses related to grants under the existing equity incentive plan included in the
statements of operations: |
| |
Three months ended
June 30, | | |
Six months ended
June 30, | |
(in thousands) | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Research & development | |
$ | 122 | | |
$ | 119 | | |
$ | 318 | | |
$ | 509 | |
General & administrative | |
| 389 | | |
| 578 | | |
| 826 | | |
| 976 | |
Total | |
$ | 511 | | |
$ | 697 | | |
$ | 1,144 | | |
$ | 1,485 | |
ENLIVEX THERAPEUTICS LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2023
(UNAUDITED)
NOTE 13 – FAIR VALUE MEASUREMENT
The Company’s financial assets and liabilities measured
at fair value on a recurring basis consisted of the following types of instruments as of June 30, 2023 and December 31, 2022:
(in thousands) | |
June 30, 2023 | |
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Cash and cash equivalents | |
$ | 3,862 | | |
$ | 3,862 | | |
$ | - | | |
$ | - | |
Short term deposits | |
| 25,443 | | |
| 25,443 | | |
| - | | |
| - | |
Long term deposits | |
| 7,159 | | |
| 7,159 | | |
| - | | |
| - | |
Restricted cash current | |
| 113 | | |
| 113 | | |
| - | | |
| - | |
Restricted cash non-current | |
| 291 | | |
| 291 | | |
| - | | |
| - | |
Total financial assets | |
$ | 38,868 | | |
$ | 38,868 | | |
$ | - | | |
$ | - | |
(in thousands) | |
December 31, 2022 | |
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Cash and cash equivalents | |
$ | 49,945 | | |
$ | 49,945 | | |
$ | - | | |
$ | - | |
Short term deposits | |
| 299 | | |
| 299 | | |
| - | | |
| - | |
Restricted cash current | |
| 113 | | |
| 113 | | |
| - | | |
| - | |
Restricted cash non-current | |
| 299 | | |
| 299 | | |
| - | | |
| - | |
Total financial assets | |
$ | 50,656 | | |
$ | 50,656 | | |
$ | - | | |
$ | - | |
NOTE 14 – EVENTS SUBSEQUENT TO THE BALANCE
SHEET DATE
The Company evaluated all events and
transactions that occurred subsequent to the balance sheet date and prior to the date on which these unaudited condensed consolidated
financial statements were issued and determined that no subsequent event necessitated disclosure.
F-14
0.37
0.54
0.76
0.99
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Exhibit 99.2
OPERATING AND FINANCIAL REVIEW AND PROSPECTS
This Operating and Financial Review and Prospects
contains forward-looking statements, which may be identified by words such as “expects,” “plans,” “projects,”
“will,” “may,” “anticipates,” “believes,” “should,” “would”, “could”,
“intends,” “estimates,” “suggests,” “has the potential to” and other words and phrases
of similar meaning, including, without limitation, statements regarding expected cash balances, market opportunities for the results of
current clinical studies and preclinical experiments, and the effectiveness of, and market opportunities for, ALLOCETRATM programs,
all of which statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivex’s business and prospects,
including the risks that Enlivex may not succeed in generating any revenues or developing any commercial products; that the products in
development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval
or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show
substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the
forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of
clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage
trials. The development of any products using the ALLOCETRATM product line could also be affected by a number of other
factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making,
the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary
rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider the economic,
competitive, governmental, technological and other factors discussed in Enlivex’s filings with the Securities and Exchange Commission,
including in its Annual Report on Form 20-F for the year ended December 31, 2022. The forward-looking statements contained in this
Operating and Financial Review and Prospects speak only as of the date the statements were made, and we do not undertake any obligation
to update forward-looking statements, except as required under applicable law.
Overview
Enlivex Therapeutics, Ltd.,
a company organized under the laws of the State of Israel (including its consolidated subsidiaries, “we”, “us”,
“our” or 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 the respective diseases, which include solid tumors, sepsis and others.
We
believe the Company’s primary innovative immunotherapy, AllocetraTM, represents a paradigm
shift in macrophage reprogramming, moving from targeting a specific subset of macrophages or a specific pathway effecting macrophages
activity, to a fundamental view of macrophage homeostasis. Restoring macrophage homeostasis may induce the immune system to rebalance
itself to normal levels of operation, thereby promoting disease resolution.
The
Company is focused on two main clinical verticals: sepsis and solid tumors (the “Indications”). The Company believes that
negatively-reprogrammed macrophages may be key contributors to disease severity across the Indications, and thus effective reprogramming
of these previously negative-reprogrammed macrophages into their respective homeostatic states may provide diseases resolution for these
Indications, some of which are considered “unmet medical needs”.
Financial Overview
Since inception, we have incurred
significant losses in connection with our research and development and have not generated any revenue. We have funded our operations primarily
through grants from the Israel Innovation Authority (the “IIA”) and the sale of equity and equity linked securities in public
and private offerings. As of June 30, 2023, we had approximately $36 million in cash and cash equivalents and bank deposits and had an
accumulated deficit of approximately $97 million, see “—Liquidity and Capital Resources” below.
Although we provide no assurance,
we believe that our existing funds will be sufficient to continue our business and operations as currently conducted through the fourth
quarter of 2024. During 2022, we introduced a Company-wide cost cutting program designed to extend
our cash runway potentially into 2025. We expect that we will continue to incur operating losses, which may be substantial over
the next several years, and we will require additional funds to further develop our research and development programs.
Costs and Operating Expenses
Our current costs and operating
expenses consist of two components: (i) research and development expenses; and (ii) general and administrative expenses.
Research and Development
Expenses
Our research and development
expenses consist primarily of research and development activities at our laboratory in Israel, including drug and laboratory supplies
and costs for facilities and equipment, outsourced development expenses, including the costs of regulatory consultants and certain other
service providers, salaries and related personnel expenses (including share based compensation) and fees paid to external service providers
and the costs of preclinical studies and clinical trials. We charge all research and development expenses to operations as they are incurred.
We expect our research and development expenses to remain our primary expenses in the near future as we continue to develop our product
candidates. Increases or decreases in research and development expenditures are attributable to the number and duration of our preclinical
and clinical studies.
We expect that a large percentage
of our research and development expenses in the future will be incurred in support of our current and future preclinical and clinical
development projects. Due to the inherently unpredictable nature of preclinical and clinical development processes, we are unable to estimate
with any certainty the costs we will incur in the continued development of our product candidates in our pipeline for potential commercialization.
Furthermore, although we expect to apply for additional grants from the IIA, we cannot be certain that we will obtain such grants. Clinical
development timelines, the probability of success and development costs can differ materially from expectations. We expect to continue
to test our product candidates in preclinical studies for toxicology, safety and efficacy and to conduct additional clinical trials for
our product candidates.
While we are currently focused
on advancing our product development, our future research and development expenses will depend on the clinical success of our product
candidates, as well as ongoing assessments of each candidate’s commercial potential. As we obtain results from clinical trials,
we may elect to discontinue or delay clinical trials for our product candidates in certain of the Indications in order to focus our resources
on more promising indications for any such product candidate. Completion of clinical trials may take several years or more, but the length
of time generally varies according to the type, complexity, novelty and intended use of a product candidate.
We expect our research and
development expenses to increase in the future as we continue the advancement of our clinical product development for the Indications
and as we potentially pursue additional indications. The lengthy process of completing clinical trials and seeking regulatory approval
for our product candidates requires the expenditure of substantial resources. Any failure or delay in completing clinical trials, or in
obtaining regulatory approvals, could cause a delay in generating product revenue and cause our research and development expenses to increase
and, in turn, have a material adverse effect on our operations.
General and Administrative
Expenses
General and administrative
expenses consist primarily of compensation (including share-based compensation) for employees in executive and operational roles, including
accounting, finance, investor relations, information technology and human resources. Our other significant general and administrative
expenses include facilities costs, professional fees for outside accounting and legal services, including legal work in connection with
patent applications, travel costs and insurance premiums. We expect that our general and administrative expenses will increase over time,
as we currently expect increases in the number of our executive, accounting and administrative personnel due to our anticipated growth.
Other expenses, net
Other expenses, net consists
of bank fees, exchange rate differences and gains and losses resulting from our investments in bank deposits and marketable securities.
Critical Accounting Policies and Estimates
The preparation of financial
statements in accordance with U.S. generally accepted accounting principles (“GAAP”) requires management to make estimates
and assumptions that affect the amounts reported in our financial statements and accompanying notes. Management bases its estimates on
historical experience, market and other conditions, and various other assumptions it believes to be reasonable. Although these estimates
are based on management’s best knowledge of current events and actions that may impact us in the future, the estimation process
is, by its nature, uncertain given that estimates depend on events over which we may not have control. If market and other conditions
change from those that we anticipate, our financial statements may be materially affected. In addition, if our assumptions change, we
may need to revise our estimates, or take other corrective actions, either of which may also have a material effect in our financial statements.
We review our estimates, judgments, and assumptions used in our accounting practices periodically and reflect the effects of revisions
in the period in which they are deemed to be necessary. We believe that these estimates are reasonable; however, our actual results may
differ from these estimates.
We believe the following accounting
policies to be the most critical to the judgments and estimates used in the preparation of our financial statements. For additional detail
regarding our significant accounting policies, please see the notes to our audited consolidated financial statements contained in our
Annual Report on Form 20-F for the year ended December 31, 2022 as filed with the SEC on April 10, 2023.
Share-Based Compensation
We have issued restricted
stock units and options to purchase our ordinary shares. Share-based compensation cost is measured at the grant date based on the fair
value of the award and is recognized as an expense over the requisite service/vesting period. Determining the appropriate fair value model
and calculating the fair value of share-based payment awards require the use of highly subjective assumptions, including the expected
life of the share-based payment awards and share price volatility.
We estimate the grant date
fair value of share options and the related compensation expense, using the Black-Scholes option valuation model. This option valuation
model requires the input of subjective assumptions including: (1) expected life (estimated period of time outstanding) of the options
granted, (2) volatility, (3) risk-free rate and (4) dividends. In general, the assumptions used in calculating the fair value of share-based
payment awards represent management’s best estimates, but the estimates involve inherent uncertainties and the application of management
judgment.
Leases:
We determine if an arrangement
includes a lease at inception. Right-of-use assets represent our right to use an underlying asset for the lease term; and lease liabilities
represent our obligation to make lease payments arising from the lease. Right-of-use assets and lease liabilities are recognized at the
commencement date of the lease, renewal date of the lease or significant remodeling of the lease space based on the present value of the
remaining future minimum lease payments. Leases with a term greater than one year are recognized on the balance sheet as right-of-use
assets and short-term and long-term lease liabilities, as applicable.
Operating lease liabilities
and their corresponding right-of-use assets are initially recorded based on the present value of lease payments over the expected remaining
lease term. The interest rate implicit in lease contracts is typically not readily determinable. As a result, we utilize our incremental
borrowing rate to discount lease payments, which reflects the fixed rate at which we could borrow on a collateralized basis the amount
of the lease payments in the same currency, for a similar term, in a similar economic environment.
Our leases include options
to extend or terminate the lease. In determining the lease term, management uses its judgement to determine whether or not an option would
be reasonably certain to be exercised. Management considers all facts and circumstances, including their past practice and any cost that
will be incurred to change the asset if an option to extend is not taken, to help determine the lease term. Extension options are only
included in the lease term if the lease is reasonably certain to be extended.
Results of Operations
Six-Months
Ended June 30, 2023 Compared to Six-Months Ended June 30, 2022
The
table below provides our results of operations for the six months ended June 30, 2023 and June 30, 2022
| |
Six
Months Ended June 30 | |
| |
2023 | | |
2022 | |
| |
(In thousands, except per share data) (unaudited) | |
Research and development expenses | |
$ | 10,211 | | |
$ | 8,792 | |
General and administrative expenses | |
| 3,221 | | |
| 3,483 | |
Operating loss | |
| (13,432 | ) | |
| (12,275 | ) |
Other expense, net | |
| (578 | ) | |
| (5,863 | ) |
Operating loss post other expenses, net | |
| (14,010 | ) | |
| (18,138 | ) |
Taxes on income | |
| | | |
| - | |
Net loss | |
| (14,010 | ) | |
| (18,138 | ) |
Basic loss per share | |
$ | (0.76 | ) | |
$ | (0.99 | ) |
Diluted loss per share | |
$ | (0.76 | ) | |
$ | (0.99 | ) |
Three-Months
Ended June 30, 2023 Compared to Three-Months Ended June 30, 2022
The
table below provides our results of operations for the three months ended June 30, 2023 and June 30, 2022:
| |
Three Months Ended June 30 | |
| |
2023 | | |
2022 | |
| |
(In thousands, except per share data) (unaudited) | |
Research and development expenses | |
$ | 5,035 | | |
$ | 4,110 | |
General and administrative expenses | |
| 1,614 | | |
| 1,761 | |
Operating loss | |
| (6,649 | ) | |
| (5,871 | ) |
Other income(expenses), net | |
| (143 | ) | |
| (4,042 | ) |
Operating loss post other expenses, net | |
| (6,792 | ) | |
| (9,913 | ) |
Taxes on income | |
| | | |
| | |
Net income (loss) | |
| (6,792 | ) | |
| (9,913 | ) |
Basic loss per share | |
$ | (0.37 | ) | |
$ | (0.54 | ) |
Diluted loss per share | |
$ | (0.37 | ) | |
$ | (0.54 | ) |
Research and Development
Expenses
For the six and three months
ended June 30, 2023 and 2022, we incurred research and development expenses in the aggregate of $10,211,000, $5,035,000, $8,792,000 and
$4,110,000, respectively. The increase of $1,419,000, or 16%, in research and development expenses for the six months ended June 30, 2023
as compared to the comparable six month period in 2022 was primarily due to a $2,054,000 increase in expenses for clinical studies and
pre-clinical studies, partially offset by a $189,000 decrease in share based compensation expense and a $379,000 decrease in lease payments
and overhead expenses related to our manufacturing plant space in Yavne Israel, which is intended to be used for the manufacture of AllocetraTM.
Due to our management’s decision in September 2022 to delay the use of this manufacturing plant space and to lease such space to
potential clients for a period of approximately three years, all plant related expenses were classified as of that date to general and
administrative expenses.
The
increase of $925,000, or 22%, in research and development expenses for the three months ended June 30, 2023, as compared to the second
quarter of 2022 was primarily due to a $1,137,000 increase in pre-clinical studies, clinical studies and consumption of materials, offset
by a $219,000 decrease in lease payments and overhead expenses related to our manufacturing plant space.
General and Administrative
Expenses
For the six and three months
ended June 30, 2023 and 2022, we incurred general and administrative expenses in the aggregate of $3,221,000, $1,614,000, $3,483,000,
and $1,761,000, respectively. The decrease of $262,000, or 8%, in general and administrative expenses for the six months ended June 30,
2023 as compared to the 2022 period was primarily due to a $150,000 decrease in stock-based compensation expense with respect to equity
granted to employees and directors, a $119,000 decrease in insurance expenses, a $112,000 decrease in professional fees related to intellectual
property regulatory expenses and a $165,000 decrease in payroll expenses, offset by a $345,000 increase in rent and maintenance expenses.
The decrease of $147,000,
or 8%, in general and administrative expenses for the three months ended June 30, 2023 as compared to the 2022 period was primarily due
to a $153,000 decrease in payroll expenses and a $125,000 decrease in professional fees related to intellectual property regulatory expenses,
offset by a $159,000 increase in rent and maintenance expenses.
Operating Loss
Due
to an increase in research and development expenses for the six and three month periods ended June 30, 2023, our operating loss was $13,432,000
and $6,649,000, respectively, representing an increase of $1,157,000 and $778,000, or 9% and 13%, respectively, as compared to our operating
loss for the six and three month periods ended June 30, 2022. This increase resulted primarily from increased research and development
expenses, including expenses relating to conducting clinical studies and trials.
Other Expenses, Net
Other expenses, net consists
of the following:
| ● | Interest
earned on our cash and cash equivalents; |
|
● |
Expenses or income resulting from fluctuations of the NIS and Euro, in which a portion of our assets and liabilities are denominated, against the U.S. dollar; and |
|
|
|
|
● |
Realized and unrealized gains and losses from marketable equity securities. |
For the six and three
months ended June 30, 2023 and 2022, we recorded other expenses, net of $578,000, $143,000, $5,863,000 and $4,042,000 respectively.
The decrease of $5,285,000, or 90%, in other expenses, net for the six months ended June 30, 2023 as compared to the six months ended
June 30, 2022 was primarily due to $884,000 of interest income from bank deposits in 2023, as compared to $145,000 in 2022, a loss of
$1,983,000 from marketable securities in 2022 that was not repeated in 2023, as well as by a loss of $1,458,000 resulting from foreign
exchange currency fluctuations on cash and cash equivalents in 2023 as compared to a loss of $4,025,000 in 2022.
The decrease of $3,899,000,
or 96%, in other expenses, net for the three months ended June 30, 2023 as compared to the three months ended June 30, 2022 was primarily
due to $422,000 of income from interest on bank deposits in 2023 as compared to $100,000 in 2022, as well as by a loss of $558,000 resulting
from foreign exchange currency fluctuations on cash and cash equivalents in 2023 as compared to $4,142,000 in 2022.
Net Loss
For
the six and three months ended June 30, 2023, our net loss was $14,010,000, $6,792,000, $18,138,000 and $9,913,000 respectively, representing
a decrease of $4,128,000 and $3,121,000, or 22% and 32%, respectively, as compared to our net loss for the comparable prior year periods
This decrease resulted primarily from a decrease in other expenses, net, which was partially offset by an increase in the costs of clinical
and pre-clinical studies.
Cash Flows
Six
Months Ended June 30, 2023 Compared to Six Months Ended June 20, 2022
For the six months ended June
30, 2023 and 2022, net cash used in operations was $12,807,000 and 12,542,000, respectively. The increase in net cash used in operations
for 2023 was primarily due to an increase in research and development expenses as a result of increases in the costs of clinical and pre-clinical
studies.
For the six months ended June
30, 2023 and 2022, net cash (used in) provided by investing activities was $(34,048,000) and $21,356,000 respectively. The decrease in
net cash provided by investing activities for 2023 as compared to 2022 resulted primarily from net investment in bank deposits of $33,930,000
as compared to net proceeds from sales of marketable securities of $60,941,000 in the comparable prior year period.
For the six months ended June
30, 2023 and 2022, net cash provided by financing activities was $360,000 and $100,000, respectively. This increase in cash provided by
financing activities for 2023 as compared to 2022 resulted primarily from net proceeds of $360,000 from our issuance of ordinary shares
under the ATM Agreement (as defined below) as compared to proceeds of $100,000 from the exercise of options in the comparable prior year
period.
Liquidity and Capital Resources
We have incurred substantial
losses since our inception. As of June 30, 2023, we had an accumulated deficit of approximately $97 million and working capital (current
assets less current liabilities) of approximately $25.8 million. An additional $7.1 of our cash was classified as a long-term interest-bearing
bank deposit, resulting in total working capital and deposits which mature within the next 18 months of $32.9 million as of June 30, 2023.
We expect to incur losses from operations for the foreseeable future, and we expect to incur increasing research and development expenses,
including expenses related to the hiring of personnel, conducting preclinical studies and clinical trials and outsourcing of certain development
activities. We expect that general and administrative expenses will also increase as we expand our finance and administrative staff and
add infrastructure.
Developing product candidates,
conducting clinical trials and commercializing products are expensive, and we will need to raise substantial additional funds to achieve
our strategic objectives. We believe that our existing cash resources will be sufficient to fund our projected cash requirements approximately
through the fourth quarter of 2024. During 2022, we introduced a Company-wide cost cutting program designed to extend our cash runway
potentially into 2025. Nevertheless, we will require significant additional financing in the future to fund our operations, including
if and when we progress into additional clinical trials, obtain regulatory approval for any of our product candidates and commercialize
the same. We believe that we will need to raise significant additional funds before we have any cash flow from operations, if at all.
Our future capital requirements will depend on many factors, including:
| ● | the
progress and costs of our preclinical studies, clinical trials and other research and development activities; |
|
● |
the scope, prioritization and number of our clinical trials and other research and development programs; |
|
● |
the amount of revenues and contributions we receive under future licensing, development and commercialization arrangements with respect to our product candidates; |
|
● |
the costs of the development and expansion of our operational infrastructure; |
|
● |
the costs and timing of obtaining regulatory approval for our product candidates; |
|
● |
the costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights; |
|
● |
the costs and timing of securing manufacturing arrangements for clinical or commercial production; |
|
● |
the costs of contracting with third parties to provide sales and marketing capabilities for us; |
|
● |
the costs of acquiring or undertaking development and commercialization efforts for any future products, product candidates or platforms; |
|
|
|
|
● |
the receipt of additional government grants; |
|
|
|
|
● |
the magnitude of our general and administrative expenses; and |
|
● |
any cost that we may incur under future in- and out-licensing arrangements relating to our product candidates. |
Other than under our ATM Agreement,
we currently do not have any commitments for future external funding. In the future, we will need to raise additional funds, and we may
decide to raise additional funds even before we need such funds if the conditions for raising capital are favorable. Until we can generate
significant recurring revenues, we expect to satisfy our future cash needs through debt or equity financings, credit facilities or by
out-licensing applications of our product candidates. The sale of equity, including under out ATM Agreement, or convertible debt securities
may result in dilution to our existing shareholders. The incurrence of indebtedness would result in increased fixed obligations and could
also subject us to covenants that restrict our operations. We cannot be certain that additional funding, whether through grants from the
IIA, financings, credit facilities or out-licensing arrangements, will be available to us on acceptable terms, if at all. If sufficient
funds are not available, we may be required to delay, reduce the scope of or eliminate research or development plans for, or commercialization
efforts with respect to, one or more applications of our product candidates, or obtain funds through arrangements with collaborators or
others that may require us to relinquish rights to certain potential products that we might otherwise seek to develop or commercialize
independently.
ATM Agreement
On December 30, 2022 we entered
into an agreement (the “ATM Agreement”) with Cantor Fitzgerald & Co. and JMP Securities LLC (each referred to as an “Agent”,
and together, the “Agents”), as sales agents, pursuant to which we may elect to sell, but are not obligated to sell, ordinary
shares having an aggregate offering price of up to $100,000,000 from time to time through the Agents. Our offer and sale of ordinary shares
under the ATM Agreement may be made in transactions deemed to be “at-the-market” offerings as defined in Rule 415 under the
Securities Act, including sales made directly on or through the Nasdaq Capital Market, or any other existing trading market in the
United States for the ordinary shares, sales made to or through a market maker other than on an exchange or otherwise, directly to an
Agent as principal, in negotiated transactions, or in any other method permitted by law, which may include block trades. We have agreed
to pay the Agents an aggregate commission of 3.0% of the gross sales price from each sale of ordinary shares under the ATM Agreement.
Any sale of ordinary shares under the ATM Agreement will be made pursuant to our effective shelf registration statement on Form F-3, including
the prospectus contained therein (File No. 333-264561). During the six months ended June 30, 2023, we received net proceeds of $360,000
from our issuance of ordinary shares under the ATM Agreement.
Foreign Currency Exchange Risk
Our foreign currency exposures
give rise to market risk associated with exchange rate movements of the U.S. dollar, mainly against the NIS, and vice versa, because a
considerable portion of our expenses are denominated in the NIS. Our NIS expenses consist principally of payments made to employees, sub-contractors
and consultants for preclinical studies, clinical trials, rent and other research and development activities. We anticipate that a sizable
portion of our expenses will continue to be denominated in the NIS. Our financial position, results of operations and cash flow are subject
to fluctuations due to changes in foreign currency exchange rates. Our results of operations and cash flow are, therefore, subject to
fluctuations due to changes in foreign currency exchange rates and may be adversely affected in the future due to changes in foreign exchange
rates.
7
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v3.23.2
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
Current Assets |
|
|
Cash and cash equivalents |
$ 3,458
|
$ 49,945
|
Short term interest-bearing bank deposits |
25,443
|
299
|
Prepaid expenses and other receivables |
1,884
|
2,086
|
Total Current Assets |
30,785
|
52,330
|
Non-Current Assets |
|
|
Long term interest-bearing bank deposits |
7,159
|
|
Property and equipment, net |
9,574
|
9,875
|
Other assets |
5,510
|
5,437
|
Total Non-Current Assets |
22,243
|
15,312
|
TOTAL ASSETS |
53,028
|
67,642
|
Current Liabilities |
|
|
Accounts payable |
1,554
|
1,948
|
Accrued expenses and other liabilities |
3,437
|
4,659
|
Total Current Liabilities |
4,991
|
6,607
|
Non-Current Liabilities |
|
|
Other long-term liabilities |
3,702
|
4,194
|
Total Non-Current Liabilities |
3,702
|
4,194
|
Commitments and Contingent Liabilities |
|
|
TOTAL LIABILITIES |
8,693
|
10,801
|
SHAREHOLDERS’ EQUITY |
|
|
Ordinary shares of NIS 0.4 par value: Authorized: 45,000,000 shares as of June 30, 2023 and December 31, 2022; Issued and outstanding: 18,589,139 and 18,421,852 as of June 30, 2023 and December 31, 2022; |
2,136
|
2,117
|
Additional paid in capital |
138,133
|
136,648
|
Foreign currency translation adjustments |
1,101
|
1,101
|
Accumulated deficit |
(97,035)
|
(83,025)
|
TOTAL SHAREHOLDERS’ EQUITY |
44,335
|
56,841
|
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY |
$ 53,028
|
$ 67,642
|
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v3.23.2
Condensed Consolidated Balance Sheets (Unaudited) (Parentheticals) - ₪ / shares
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Statement of Financial Position [Abstract] |
|
|
Ordinary shares, par value (in New Shekels per share) |
₪ 0.4
|
₪ 0.4
|
Ordinary shares, authorized |
45,000,000
|
45,000,000
|
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18,589,139
|
18,421,852
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18,589,139
|
18,421,852
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v3.23.2
Condensed Consolidated Statements of Operations and Loss (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Income Statement [Abstract] |
|
|
|
|
Revenues |
|
|
|
|
Operating expenses: |
|
|
|
|
Research and development expenses |
5,035
|
4,110
|
10,211
|
8,792
|
General and administrative expenses |
1,614
|
1,761
|
3,221
|
3,483
|
Total operating expenses |
6,649
|
5,871
|
13,432
|
12,275
|
Operating loss |
(6,649)
|
(5,871)
|
(13,432)
|
(12,275)
|
Other expenses, net |
(143)
|
(4,042)
|
(578)
|
(5,863)
|
Net loss |
$ (6,792)
|
$ (9,913)
|
$ (14,010)
|
$ (18,138)
|
Basic loss per share (in Dollars per share) |
$ (0.37)
|
$ (0.54)
|
$ (0.76)
|
$ (0.99)
|
Weighted average number of shares outstanding (in Shares) |
18,584,801
|
18,375,206
|
18,550,702
|
18,372,521
|
X |
- DefinitionThe amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.
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v3.23.2
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|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Income Statement [Abstract] |
|
|
|
|
Diiluted loss per share |
$ (0.37)
|
$ (0.54)
|
$ (0.76)
|
$ (0.99)
|
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- DefinitionThe amount of net income (loss) for the period available to each share of common stock or common unit outstanding during the reporting period and to each share or unit that would have been outstanding assuming the issuance of common shares or units for all dilutive potential common shares or units outstanding during the reporting period.
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v3.23.2
Condensed Consolidated Statements of Changes in Shareholders' Equity (Unaudited) - USD ($) $ in Thousands |
Ordinary Shares |
Additional paid in capital |
Currency translation reserve |
Accumulated deficit |
Total |
Balance at Dec. 31, 2021 |
$ 2,107
|
$ 133,796
|
$ 1,101
|
$ (51,965)
|
$ 85,039
|
Balance (in Shares) at Dec. 31, 2021 |
18,331,507
|
|
|
|
|
Restricted stock units vested |
$ 4
|
(4)
|
|
|
|
Restricted stock units vested (in Shares) |
34,295
|
|
|
|
|
Exercise of options |
$ 1
|
49
|
|
|
50
|
Exercise of options (in Shares) |
7,625
|
|
|
|
|
Stock based compensation |
|
788
|
|
|
788
|
Net loss |
|
|
|
(8,225)
|
(8,225)
|
Balance at Mar. 31, 2022 |
$ 2,112
|
134,629
|
1,101
|
(60,190)
|
77,652
|
Balance (in Shares) at Mar. 31, 2022 |
18,373,427
|
|
|
|
|
Balance at Dec. 31, 2021 |
$ 2,107
|
133,796
|
1,101
|
(51,965)
|
85,039
|
Balance (in Shares) at Dec. 31, 2021 |
18,331,507
|
|
|
|
|
Net loss |
|
|
|
|
(18,138)
|
Balance at Jun. 30, 2022 |
$ 2,113
|
135,375
|
1,101
|
(70,103)
|
68,486
|
Balance (in Shares) at Jun. 30, 2022 |
18,381,052
|
|
|
|
|
Balance at Mar. 31, 2022 |
$ 2,112
|
134,629
|
1,101
|
(60,190)
|
77,652
|
Balance (in Shares) at Mar. 31, 2022 |
18,373,427
|
|
|
|
|
Exercise of options |
$ 1
|
49
|
|
|
50
|
Exercise of options (in Shares) |
7,625
|
|
|
|
|
Stock based compensation |
|
697
|
|
|
697
|
Net loss |
|
|
|
(9,913)
|
(9,913)
|
Balance at Jun. 30, 2022 |
$ 2,113
|
135,375
|
1,101
|
(70,103)
|
68,486
|
Balance (in Shares) at Jun. 30, 2022 |
18,381,052
|
|
|
|
|
Balance at Dec. 31, 2022 |
$ 2,117
|
136,648
|
1,101
|
(83,025)
|
56,841
|
Balance (in Shares) at Dec. 31, 2022 |
18,421,852
|
|
|
|
|
Restricted stock units vested |
$ 3
|
(3)
|
|
|
|
Restricted stock units vested (in Shares) |
34,295
|
|
|
|
|
Issuance of shares for cash consideration |
$ 13
|
305
|
|
|
318
|
Issuance of shares for cash consideration (in Shares) |
110,115
|
|
|
|
|
Stock based compensation |
|
633
|
|
|
633
|
Net loss |
|
|
|
(7,218)
|
(7,218)
|
Balance at Mar. 31, 2023 |
$ 2,133
|
137,583
|
1,101
|
(90,243)
|
50,574
|
Balance (in Shares) at Mar. 31, 2023 |
18,566,262
|
|
|
|
|
Balance at Dec. 31, 2022 |
$ 2,117
|
136,648
|
1,101
|
(83,025)
|
56,841
|
Balance (in Shares) at Dec. 31, 2022 |
18,421,852
|
|
|
|
|
Net loss |
|
|
|
|
(14,010)
|
Balance at Jun. 30, 2023 |
$ 2,136
|
138,133
|
1,101
|
(97,035)
|
44,335
|
Balance (in Shares) at Jun. 30, 2023 |
18,589,139
|
|
|
|
|
Balance at Mar. 31, 2023 |
$ 2,133
|
137,583
|
1,101
|
(90,243)
|
50,574
|
Balance (in Shares) at Mar. 31, 2023 |
18,566,262
|
|
|
|
|
Restricted stock units vested |
$ 1
|
(1)
|
|
|
|
Restricted stock units vested (in Shares) |
8,821
|
|
|
|
|
Exercise of options |
|
|
|
|
|
Exercise of options (in Shares) |
|
|
|
|
|
Issuance of shares for cash consideration |
$ 2
|
40
|
|
|
42
|
Issuance of shares for cash consideration (in Shares) |
14,056
|
|
|
|
|
Stock based compensation |
|
511
|
|
|
511
|
Net loss |
|
|
|
(6,792)
|
(6,792)
|
Balance at Jun. 30, 2023 |
$ 2,136
|
$ 138,133
|
$ 1,101
|
$ (97,035)
|
$ 44,335
|
Balance (in Shares) at Jun. 30, 2023 |
18,589,139
|
|
|
|
|
X |
- DefinitionThe portion of profit or loss for the period, net of income taxes, which is attributable to the parent.
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v3.23.2
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Cash flows from operating activities |
|
|
Net (loss) |
$ (14,010)
|
$ (18,138)
|
Adjustments required to reflect net cash used in operating activities: |
|
|
Depreciation |
421
|
364
|
Non-cash operating lease expenses |
434
|
411
|
Share-based compensation |
1,144
|
1,485
|
Loss on marketable securities and short-term bank deposits |
1,626
|
4,886
|
Changes in operating asset and liability items: |
|
|
Increase in prepaid expenses and other receivables |
(169)
|
(205)
|
Decrease in accounts payable trade |
(240)
|
(211)
|
Decrease in accrued expenses and other liabilities |
(1,389)
|
(307)
|
Operating lease liabilities |
(624)
|
(827)
|
Net cash used in operating activities |
(12,807)
|
(12,542)
|
Cash flows from investing activities |
|
|
Purchase of property and equipment |
(200)
|
(4,351)
|
Proceeds from sale of property and equipment |
82
|
|
Investment in short-term interest bearing bank deposits |
(34,218)
|
(35,234)
|
Release of short-term interest bearing bank deposits |
288
|
|
Purchases of marketable securities |
|
(1,608)
|
Proceeds from sales of marketable securities |
|
62,549
|
Net cash (used in) provided by investing activities |
(34,048)
|
21,356
|
Cash flows from financing activities |
|
|
Proceeds from issuance of shares, net |
360
|
|
Proceeds from exercise of options |
|
100
|
Net cash provided by financing activities |
360
|
100
|
Increase (decrease) in cash and cash equivalents |
(46,495)
|
8,914
|
Cash and cash equivalents - beginning of period |
50,357
|
11,636
|
Cash and cash equivalents - end of period |
3,862
|
20,550
|
Supplemental disclosures of cash flow information: |
|
|
Cash paid for taxes |
|
|
Cash paid (received) for interest, net |
$ 233
|
$ 45
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v3.23.2
General
|
6 Months Ended |
Jun. 30, 2023 |
General [Abstract] |
|
GENERAL |
NOTE 1 – GENERAL
| a. | 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 of Israel. |
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 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, par
value of 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 June
30, 2023, had an accumulated deficit of $97,035 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 date of 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.
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v3.23.2
Significant Accounting Policies
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
SIGNIFICANT ACCOUNTING POLICIES |
NOTE 2 – SIGNIFICANT ACCOUNTING
POLICIES
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 2022 Annual Report on Form 20-F, as filed with the SEC on April 10, 2023. The results of operations for the interim
periods presented herein are not necessarily indicative of the operating results for any future period. The December 31, 2022 financial
information has been derived from the Company’s audited financial statements.
Use of Estimates
The preparation of interim financial
statements in conformity with U.S. GAAP requires management to make certain estimates, judgments and assumptions that affect the reported
amounts in the consolidated balance sheets and statements of operations, it also requires that management exercise its judgment in applying
the Company’s accounting policies. On an ongoing basis, management evaluates its estimates, including estimates related to its stock-based
compensation expense and implicit interest rate on new lease liabilities. Significant estimates in these interim financial statements
include estimates made for accrued research and development expenses and stock-based compensation expenses.
Functional Currency and Translation
to The Reporting Currency
The functional currency of the Company
is the U.S. dollar because the U.S. dollar is the currency of the primary economic environment in which the Company operates and expects
to continue to operate in the foreseeable future.
Balances related to non-monetary assets
and liabilities are based on translated amounts as of the date of the change, and non-monetary assets acquired and liabilities were translated
at the approximate exchange rate prevailing at the date of the transaction. Transactions included in the statement of income were translated
at the approximate exchange rate in effect at the time of the applicable transaction.
1 U.S. dollar = 3.7 NIS and 3.519 NIS
as of June 30, 2023 and December 31, 2022, respectively.
The U.S. dollar increased against the
NIS: 2.35%, 5.14%, 10.2% and 12.54% in the three and six month periods ended June 30, 2023 and 2022, respectively.
Recently Adopted Accounting Standards
During the six months ended June 30,
2023, the Company was not required to adopt any recently issued accounting standards.
Recently Issued Accounting Pronouncements
Not Yet Adopted
The Company has evaluated other recently
issued accounting pronouncements and does not currently believe that any of these pronouncements will have a material impact on its condensed
consolidated financial statements and related disclosures.
Significant Accounting Policies
There have been no material changes
to the significant accounting policies previously disclosed in the Company’s Annual Report on Form 20-F for the year ended December
31, 2022.
Marketable Securities.
The Company has an investment policy
that includes guidelines on acceptable investment securities, minimum credit quality, maturity parameters, and concentration and diversification.
The Company from time-to-time invests a portion of its excess cash in mutual funds that are classified based on the nature of their underlying
securities and their availability for use in current operations. The Company’s marketable equity securities are measured at fair
value with gains and losses recognized in other expense, net.
Net (loss) realized on equity securities
for the three and six month periods ended June 30, 2023 and 2022 was $0, $0, $0 and $(1,982) thousand, respectively.
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v3.23.2
Cash, Cash Equivalents and Restricted Cash
|
6 Months Ended |
Jun. 30, 2023 |
Cash and Cash Equivalents [Abstract] |
|
CASH, CASH EQUIVALENTS AND RESTRICTED CASH |
NOTE 3 – CASH, CASH EQUIVALENTS
AND RESTRICTED CASH
| |
June 30, | | |
December 31, | |
(in thousands) | |
2023 | | |
2022 | |
Cash held in banks | |
$ | 1,024 | | |
$ | 2,123 | |
Bank deposits in U.S.$ (annual average interest rates 4.29%% and 0.1%) | |
| 2,434 | | |
| 47,822 | |
Total cash and cash equivalents | |
| 3,458 | | |
| 49,945 | |
Restricted cash – current – Prepaid expenses and other receivables | |
| 113 | | |
| 113 | |
Restricted cash – noncurrent – Other assets | |
| 291 | | |
| 299 | |
Total cash, cash equivalents and restricted cash shown in the statement of cash flows | |
$ | 3,862 | | |
$ | 50,357 | |
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v3.23.2
Property and Equipment
|
6 Months Ended |
Jun. 30, 2023 |
Property, Plant and Equipment [Abstract] |
|
PROPERTY AND EQUIPMENT |
NOTE 6 – PROPERTY AND EQUIPMENT
Property and equipment, net consisted of the following:
| |
June 30, | | |
December 31, | |
(in thousands) | |
2023 | | |
2022 | |
| |
| | |
| |
Cost: | |
| | |
| |
Laboratory equipment | |
$ | 2,837 | | |
$ | 2,851 | |
Computers | |
| 276 | | |
| 276 | |
Office furniture & equipment | |
| 317 | | |
| 249 | |
Leasehold improvements | |
| 8,672 | | |
| 8,606 | |
| |
| 12,102 | | |
| 11,982 | |
Accumulated depreciation: | |
| | | |
| | |
Laboratory equipment | |
| 1,690 | | |
| 1,432 | |
Computers | |
| 242 | | |
| 203 | |
Office furniture & equipment | |
| 34 | | |
| 28 | |
Leasehold improvements | |
| 562 | | |
| 444 | |
| |
| 2,528 | | |
| 2,107 | |
Depreciated cost | |
$ | 9,574 | | |
$ | 9,875 | |
Depreciation expenses for the three and six month periods
ended June 30, 2023 and 2022 were $212, $421, $176 and $364 thousand, respectively.
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v3.23.2
Other Assets
|
6 Months Ended |
Jun. 30, 2023 |
Other Assets [Abstract] |
|
OTHER ASSETS |
NOTE 7 – OTHER ASSETS
| |
June 30, | | |
December 31, | |
(in thousands) | |
2023 | | |
2022 | |
| |
| | |
| |
Restricted cash | |
$ | 291 | | |
$ | 299 | |
Long-term prepaid expenses | |
| 485 | | |
| 113 | |
Right-of-Use assets, net | |
| 4,734 | | |
| 5,025 | |
| |
$ | 5,510 | | |
$ | 5,437 | |
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Accrued Expenses and Other Liabilities
|
6 Months Ended |
Jun. 30, 2023 |
Accrued Expenses and Other Liabilities [Abstract] |
|
ACCRUED EXPENSES AND OTHER LIABILITIES |
NOTE 8 – ACCRUED EXPENSES AND OTHER LIABILITIES
| |
June 30, | | |
December 31, | |
(in thousands) | |
2023 | | |
2022 | |
| |
| | |
| |
Vacation, convalescence and bonus accruals | |
$ | 461 | | |
$ | 759 | |
Employees and payroll related | |
| 612 | | |
| 539 | |
Short term operating lease liabilities | |
| 667 | | |
| 653 | |
Accrued expenses and other | |
| 1,697 | | |
| 2,708 | |
| |
$ | 3,437 | | |
$ | 4,659 | |
|
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v3.23.2
Leases
|
6 Months Ended |
Jun. 30, 2023 |
Leases [Abstract] |
|
LEASES |
NOTE 9 – LEASES
The Company is a party to operating
leases for its corporate offices, laboratory space and vehicles. The Company’s real property operating leases have remaining lease
terms of up to 3.25 years, some of which include options to extend the leases for up to five years.
| |
Six months ended June 30, | |
(in thousands) | |
2023 | | |
2022 | |
| |
| | |
| |
The components of lease expense were as follows: | |
| | |
| |
Operating leases expenses | |
$ | 522 | | |
$ | 517 | |
Supplemental consolidated cash flow information related to operating leases follows: | |
| | | |
| | |
Cash used in operating activities | |
$ | 520 | | |
$ | 478 | |
Non-cash activity: | |
| | | |
| | |
Right of use assets obtained in exchange for new operating lease liabilities | |
$ | 145 | | |
$ | 91 | |
| |
June 30, | | |
December 31, | |
(in thousands) | |
2023 | | |
2022 | |
Supplemental information related to operating leases, including location of amounts reported in the accompanying consolidated balance sheets, follows: | |
| | |
| |
Other assets - Right-of-Use assets | |
$ | 6,590 | | |
$ | 6,445 | |
Accumulated amortization | |
| 1,856 | | |
| 1,420 | |
Operating lease Right-of-Use assets, net | |
$ | 4,734 | | |
$ | 5,025 | |
Lease liabilities – current - Accounts payable and accrued liabilities | |
$ | 667 | | |
$ | 653 | |
Lease liabilities – noncurrent | |
| 3,702 | | |
| 4,194 | |
Total operating lease liabilities | |
$ | 4,369 | | |
$ | 4,847 | |
Weighted average remaining lease term in years | |
| 7.1 | | |
| 7.6 | |
Weighted average annual discount rate | |
| 3.4 | % | |
| 3.4 | % |
Maturities
of operating lease liabilities as of June 30, 2022, were as follows:
2023(after June 30) | |
$ | 344 | |
2024 | |
| 696 | |
2025 | |
| 717 | |
2026 | |
| 581 | |
2027 | |
| 551 | |
2028 and onwards | |
| 2,069 | |
Total undiscounted lease liability | |
$ | 4,958 | |
Less: Imputed interest | |
$ | (589 | ) |
Present value of lease liabilities | |
$ | 4,369 | |
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v3.23.2
Commitments and Contingent Liabilities
|
6 Months Ended |
Jun. 30, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
COMMITMENTS AND CONTINGENT LIABILITIES |
NOTE 10 – COMMITMENTS AND CONTINGENT LIABILITIES
The Company is required to pay royalties
to the State of Israel (represented by the Israeli Innovation Authority (the “IIA”)), computed on the basis of proceeds
from the sale or license of products for which development was supported by IIA grants. These royalties are generally 3% - 5% of sales
until repayment of 100% of the grants (linked to the dollar) received by the Company plus accrued interest
The gross amount of grants received
by the Company from the IIA, including accrued interest as of June 30, 2023, was approximately $9.6 million. As of June 30, 2023, the
Company had not paid any royalties to the IIA.
|
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v3.23.2
Equity
|
6 Months Ended |
Jun. 30, 2023 |
Equity [Abstract] |
|
EQUITY |
NOTE 11 – EQUITY
All
Company warrants are classified as a component of shareholders’ equity because such warrants are free standing financial instruments
that are legally detachable, separately exercisable, do not embody an obligation for the Company to repurchase its own shares, and permit
the holders to receive a fixed number of Ordinary Shares upon exercise, requires physical settlement and do not provide any guarantee
of value or return.
|
|
Number of
Warrants |
|
|
Weighted
average
exercise
price |
|
Outstanding January 1, 2023 |
|
|
202,251 |
|
|
$ |
23.31 |
|
Outstanding and exercisable June 30, 2023 |
|
|
202,251 |
|
|
$ |
23.31 |
|
Composed of the following:
Number of
Warrants |
|
|
Exercise Price
Per Share |
|
|
Issuance date |
|
Expiration date |
|
22,750 |
|
|
$ |
10 |
|
|
February 26, 2020 |
|
February 24, 2025 |
|
160,727 |
|
|
$ |
25 |
|
|
February 12, 2021 |
|
February 9, 2026 |
|
18,774 |
|
|
$ |
25 |
|
|
February 17, 2021 |
|
February 9, 2026 |
|
202,251 |
|
|
|
|
|
|
|
|
|
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v3.23.2
Share-Based Compensation
|
6 Months Ended |
Jun. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
SHARE-BASED COMPENSATION |
NOTE 12 – SHARE-BASED COMPENSATION
| a) | As of June 30, 2023, 5,028,704 Ordinary Shares were authorized
for issuance to employees, directors and consultants under the 2019 Equity Incentive Plan, of which 1,537,973 shares were available for
future grant. |
| b) | The following table contains information concerning options
granted under the existing equity incentive plan: |
| |
Three months ended June 30, | |
| |
2023 | | |
2022 | |
| |
Number of
options | | |
Weighted
average
exercise
price | | |
Number of
options | | |
Weighted
average
exercise
price | |
Outstanding at beginning of period | |
| 2,929,868 | | |
$ | 5.84 | | |
| 2,399,622 | | |
$ | 5.95 | |
Forfeited and expired | |
| (14,375 | ) | |
$ | 6.82 | | |
| (3,000 | ) | |
$ | 5.34 | |
Exercised | |
| - | | |
$ | - | | |
| (7,625 | ) | |
$ | 6.49 | |
Outstanding at end of period | |
| 2,915,493 | | |
$ | 5.84 | | |
| 2,388,997 | | |
$ | 5.95 | |
Exercisable at end of period | |
| 2,090,378 | | |
$ | 5.59 | | |
| 1,728,623 | | |
$ | 5.10 | |
| |
| | | |
| | | |
| | | |
| | |
Non-vested at beginning of period | |
| 876,851 | | |
$ | 6.48 | | |
| 722,749 | | |
$ | 7.67 | |
Vested | |
| (37,861 | ) | |
$ | 11.13 | | |
| (59,375 | ) | |
$ | (8.78 | ) |
Forfeited | |
| (13,875 | ) | |
$ | 5.90 | | |
| (3,000 | ) | |
$ | (5.34 | ) |
Non-vested at the end of period | |
| 825,115 | | |
$ | 6.27 | | |
| 660,374 | | |
$ | 7.59 | |
| |
Six months ended June 30, | |
| |
2023 | | |
2022 | |
| |
Number of
options | | |
Weighted
average
exercise
price | | |
Number of
options | | |
Weighted
average
exercise
price | |
Outstanding at beginning of period | |
| 2,939,434 | | |
$ | 5.85 | | |
| 2,142,547 | | |
$ | 6.02 | |
Granted | |
| - | | |
| | | |
$ | 264,700 | | |
$ | 5.48 | |
Forfeited and expired | |
| (23,941 | ) | |
$ | 6.71 | | |
| (3,000 | ) | |
$ | 5.34 | |
Exercised | |
| - | | |
| | | |
$ | (15,250 | ) | |
$ | 6.49 | |
Outstanding at end of period | |
| 2,915,493 | | |
$ | 5.84 | | |
| 2,388,997 | | |
$ | 5.95 | |
Exercisable at end of period | |
| 2,090,378 | | |
$ | 5.59 | | |
| 1,728,623 | | |
$ | 5.10 | |
| |
| | | |
| | | |
| | | |
| | |
Non vested at beginning of period | |
| 986,005 | | |
$ | 6.46 | | |
| 529,082 | | |
$ | 8.69 | |
Granted | |
| - | | |
$ | - | | |
| 264,700 | | |
$ | 5.48 | |
Forfeited and expired | |
| (15,375 | ) | |
$ | 6.73 | | |
| (3,000 | ) | |
$ | 5.34 | |
vested | |
| (145,515 | ) | |
$ | 7.44 | | |
| (130,408 | ) | |
$ | 7.82 | |
Outstanding at end of period | |
| 825,115 | | |
$ | 6.27 | | |
| 660,374 | | |
$ | 7.59 | |
During the three and six month periods ended June 30, 2023
and 2022, the Company recognized $427, $957, $509 and $1,074 thousand, respectively, of share-based compensation expenses related to stock
options.
As of June 30, 2023, the total
unrecognized estimated compensation cost related to outstanding non-vested stock options was $1,766 thousand, which is expected to be
recognized over a weighted average period of 1.32 years.
| c) | Set forth below is data regarding the range of exercise prices
and remaining contractual life for all options outstanding on June 30, 2023: |
Exercise
price | | |
Number of
options outstanding | | |
Remaining
contractual
Life (in years) | | |
Intrinsic
Value of
Options
Outstanding
(in thousands) | | |
No. of options
exercisable | |
$ | 2.69 | | |
| 649,883 | | |
| 1.92 | | |
| - | | |
| 649,883 | |
$ | 3.66 | | |
| 250,000 | | |
| 6.84 | | |
| - | | |
| 250,000 | |
$ | 4.68 | | |
| 48,750 | | |
| 6.75 | | |
| - | | |
| 36,563 | |
$ | 5.34 | | |
| 208,825 | | |
| 8.75 | | |
| - | | |
| 53,800 | |
$ | 5.34 | | |
| 445,792 | | |
| 9.38 | | |
| - | | |
| 69,263 | |
$ | 5.96 | | |
| 150,000 | | |
| 9.38 | | |
| - | | |
| - | |
$ | 6.22 | | |
| 634,177 | | |
| 4.00 | | |
| - | | |
| 634,177 | |
$ | 8.19 | | |
| 150,000 | | |
| 6.38 | | |
| - | | |
| 112,500 | |
$ | 8.23 | | |
| 12,500 | | |
| 8.38 | | |
| - | | |
| 5,000 | |
$ | 9.02 | | |
| 40,500 | | |
| 7.38 | | |
| - | | |
| 20,250 | |
$ | 10.12 | | |
| 12,126 | | |
| 5.43 | | |
| - | | |
| 12,126 | |
$ | 12.23 | | |
| 250,000 | | |
| 7.91 | | |
| - | | |
| 194,444 | |
$ | 14.00 | | |
| 60,500 | | |
| 7.82 | | |
| - | | |
| 50,417 | |
$ | 21.40 | | |
| 1,940 | | |
| 6.07 | | |
| - | | |
| 1,455 | |
$ | 90.16 | | |
| 500 | | |
| 1.42 | | |
| - | | |
| 500 | |
| | | |
| 2,915,493 | | |
| | | |
| - | | |
| 2,090,378 | |
| d) | The following table contains information concerning restricted
stock units granted under the existing equity incentive plan: |
| |
Three months ended June 30, | |
| |
2023 | | |
2022 | |
| |
Number of
shares | | |
Weighted
average
grant date
fair value | | |
Number of
shares | | |
Weighted
average
grant date
fair value | |
Nonvested at beginning of period | |
| 114,329 | | |
$ | 9.97 | | |
| 184,787 | | |
$ | 10.02 | |
Vested | |
| (3,438 | ) | |
$ | 10.28 | | |
| (3,437 | ) | |
$ | 10.28 | |
Forfeited | |
| (313 | ) | |
$ | 14.67 | | |
| - | | |
$ | - | |
Nonvested at end of period | |
| 110,578 | | |
$ | 9.95 | | |
| 181,350 | | |
$ | 10.02 | |
| |
Six months ended June 30, | |
| |
2023 | | |
2022 | |
| |
Number of
shares | | |
Weighted average grant date
fair value | | |
Number of
shares | | |
Weighted average grant date
fair value | |
Nonvested at beginning of period | |
| 157,560 | | |
$ | 10.02 | | |
| 229,331 | | |
$ | 10.08 | |
Vested | |
| (46,544 | ) | |
$ | 10.15 | | |
| (47,981 | ) | |
$ | 10.29 | |
Forfeited | |
| (438 | ) | |
$ | 14.67 | | |
| - | | |
$ | - | |
Nonvested at end of period | |
| 110,578 | | |
$ | 9.95 | | |
| 181,350 | | |
$ | 10.02 | |
The Company estimates the fair value
of restricted stock units based on the closing sales price of the Ordinary Shares on the date of grant (or the closing bid price, if no
sales were reported). For the three and six month periods ended June 30, 2023 and 2022, the Company recognized $84, $187, $188 and $411
thousand, respectively, of share-based compensation expense related to restricted stock units. Total share-based compensation expense
related to restricted stock units not yet recognized as of June 30, 2023 was $331 thousand, which is expected to be recognized over a
weighted average period of 0.66 years.
| e) | The
following table summarizes share-based compensation expenses related to grants under the existing equity incentive plan included in the
statements of operations: |
| |
Three months ended
June 30, | | |
Six months ended
June 30, | |
(in thousands) | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Research & development | |
$ | 122 | | |
$ | 119 | | |
$ | 318 | | |
$ | 509 | |
General & administrative | |
| 389 | | |
| 578 | | |
| 826 | | |
| 976 | |
Total | |
$ | 511 | | |
$ | 697 | | |
$ | 1,144 | | |
$ | 1,485 | |
|
X |
- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.23.2
Fair Value Measurement
|
6 Months Ended |
Jun. 30, 2023 |
Fair Value Disclosures [Abstract] |
|
FAIR VALUE MEASUREMENT |
NOTE 13 – FAIR VALUE MEASUREMENT
The Company’s financial assets and liabilities measured
at fair value on a recurring basis consisted of the following types of instruments as of June 30, 2023 and December 31, 2022:
(in thousands) | |
June 30, 2023 | |
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Cash and cash equivalents | |
$ | 3,862 | | |
$ | 3,862 | | |
$ | - | | |
$ | - | |
Short term deposits | |
| 25,443 | | |
| 25,443 | | |
| - | | |
| - | |
Long term deposits | |
| 7,159 | | |
| 7,159 | | |
| - | | |
| - | |
Restricted cash current | |
| 113 | | |
| 113 | | |
| - | | |
| - | |
Restricted cash non-current | |
| 291 | | |
| 291 | | |
| - | | |
| - | |
Total financial assets | |
$ | 38,868 | | |
$ | 38,868 | | |
$ | - | | |
$ | - | |
(in thousands) | |
December 31, 2022 | |
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Cash and cash equivalents | |
$ | 49,945 | | |
$ | 49,945 | | |
$ | - | | |
$ | - | |
Short term deposits | |
| 299 | | |
| 299 | | |
| - | | |
| - | |
Restricted cash current | |
| 113 | | |
| 113 | | |
| - | | |
| - | |
Restricted cash non-current | |
| 299 | | |
| 299 | | |
| - | | |
| - | |
Total financial assets | |
$ | 50,656 | | |
$ | 50,656 | | |
$ | - | | |
$ | - | |
|
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v3.23.2
Events Subsequent to the Balance Sheet Date
|
6 Months Ended |
Jun. 30, 2023 |
Subsequent Events [Abstract] |
|
EVENTS SUBSEQUENT TO THE BALANCE SHEET DATE |
NOTE 14 – EVENTS SUBSEQUENT TO THE BALANCE
SHEET DATE
The Company evaluated all events and
transactions that occurred subsequent to the balance sheet date and prior to the date on which these unaudited condensed consolidated
financial statements were issued and determined that no subsequent event necessitated disclosure.
|
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v3.23.2
Accounting Policies, by Policy (Policies)
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Use of Estimates |
Use of Estimates The preparation of interim financial
statements in conformity with U.S. GAAP requires management to make certain estimates, judgments and assumptions that affect the reported
amounts in the consolidated balance sheets and statements of operations, it also requires that management exercise its judgment in applying
the Company’s accounting policies. On an ongoing basis, management evaluates its estimates, including estimates related to its stock-based
compensation expense and implicit interest rate on new lease liabilities. Significant estimates in these interim financial statements
include estimates made for accrued research and development expenses and stock-based compensation expenses.
|
Functional Currency and Translation to The Reporting Currency |
Functional Currency and Translation
to The Reporting Currency The functional currency of the Company
is the U.S. dollar because the U.S. dollar is the currency of the primary economic environment in which the Company operates and expects
to continue to operate in the foreseeable future. Balances related to non-monetary assets
and liabilities are based on translated amounts as of the date of the change, and non-monetary assets acquired and liabilities were translated
at the approximate exchange rate prevailing at the date of the transaction. Transactions included in the statement of income were translated
at the approximate exchange rate in effect at the time of the applicable transaction. 1 U.S. dollar = 3.7 NIS and 3.519 NIS
as of June 30, 2023 and December 31, 2022, respectively. The U.S. dollar increased against the
NIS: 2.35%, 5.14%, 10.2% and 12.54% in the three and six month periods ended June 30, 2023 and 2022, respectively.
|
Recently Adopted Accounting Standards |
Recently Adopted Accounting Standards
During the six months ended June 30,
2023, the Company was not required to adopt any recently issued accounting standards.
|
Recently Issued Accounting Pronouncements Not Yet Adopted |
Recently Issued Accounting Pronouncements
Not Yet Adopted The Company has evaluated other recently
issued accounting pronouncements and does not currently believe that any of these pronouncements will have a material impact on its condensed
consolidated financial statements and related disclosures.
|
Significant Accounting Policies |
Significant Accounting Policies There have been no material changes
to the significant accounting policies previously disclosed in the Company’s Annual Report on Form 20-F for the year ended December
31, 2022.
|
Marketable Securities. |
Marketable Securities. The Company has an investment policy
that includes guidelines on acceptable investment securities, minimum credit quality, maturity parameters, and concentration and diversification.
The Company from time-to-time invests a portion of its excess cash in mutual funds that are classified based on the nature of their underlying
securities and their availability for use in current operations. The Company’s marketable equity securities are measured at fair
value with gains and losses recognized in other expense, net. Net (loss) realized on equity securities
for the three and six month periods ended June 30, 2023 and 2022 was $0, $0, $0 and $(1,982) thousand, respectively.
|
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v3.23.2
Cash, Cash Equivalents and Restricted Cash (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Cash and Cash Equivalents [Abstract] |
|
Schedule of Cash and Cash Equivalents and Restricted Cash |
CASH, CASH EQUIVALENTS
AND RESTRICTED CASH
| |
June 30, | | |
December 31, | |
(in thousands) | |
2023 | | |
2022 | |
Cash held in banks | |
$ | 1,024 | | |
$ | 2,123 | |
Bank deposits in U.S.$ (annual average interest rates 4.29%% and 0.1%) | |
| 2,434 | | |
| 47,822 | |
Total cash and cash equivalents | |
| 3,458 | | |
| 49,945 | |
Restricted cash – current – Prepaid expenses and other receivables | |
| 113 | | |
| 113 | |
Restricted cash – noncurrent – Other assets | |
| 291 | | |
| 299 | |
Total cash, cash equivalents and restricted cash shown in the statement of cash flows | |
$ | 3,862 | | |
$ | 50,357 | |
|
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v3.23.2
Short Term Interest-Bearing Bank Deposits (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Short Term Interest-Bearing Bank Deposits [Abstract] |
|
Schedule of Short Term Deposits |
SHORT TERM INTEREST-BEARING BANK DEPOSITS
| |
June 30, | | |
December 31, | |
(in thousands) | |
2023 | | |
2022 | |
Bank deposits in U.S.$ (annual average interest rates 5.94% and 0.3%) | |
$ | 6,165 | | |
$ | 299 | |
Bank deposits in NIS (annual average interest rates 4.31%) | |
| 19,278 | | |
| - | |
Total short-term deposits | |
$ | 25,443 | | |
$ | 299 | |
|
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v3.23.2
Property and Equipment (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Property, Plant and Equipment [Abstract] |
|
Schedule of Property and Equipment |
Property and equipment, net consisted of the following:
| |
June 30, | | |
December 31, | |
(in thousands) | |
2023 | | |
2022 | |
| |
| | |
| |
Cost: | |
| | |
| |
Laboratory equipment | |
$ | 2,837 | | |
$ | 2,851 | |
Computers | |
| 276 | | |
| 276 | |
Office furniture & equipment | |
| 317 | | |
| 249 | |
Leasehold improvements | |
| 8,672 | | |
| 8,606 | |
| |
| 12,102 | | |
| 11,982 | |
Accumulated depreciation: | |
| | | |
| | |
Laboratory equipment | |
| 1,690 | | |
| 1,432 | |
Computers | |
| 242 | | |
| 203 | |
Office furniture & equipment | |
| 34 | | |
| 28 | |
Leasehold improvements | |
| 562 | | |
| 444 | |
| |
| 2,528 | | |
| 2,107 | |
Depreciated cost | |
$ | 9,574 | | |
$ | 9,875 | |
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v3.23.2
Other Assets (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Other Assets [Abstract] |
|
Schedule of Other Assets |
OTHER ASSETS
| |
June 30, | | |
December 31, | |
(in thousands) | |
2023 | | |
2022 | |
| |
| | |
| |
Restricted cash | |
$ | 291 | | |
$ | 299 | |
Long-term prepaid expenses | |
| 485 | | |
| 113 | |
Right-of-Use assets, net | |
| 4,734 | | |
| 5,025 | |
| |
$ | 5,510 | | |
$ | 5,437 | |
|
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v3.23.2
Leases (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Leases [Abstract] |
|
Schedule of Operating Lease |
The Company is a party to operating
leases for its corporate offices, laboratory space and vehicles. The Company’s real property operating leases have remaining lease
terms of up to 3.25 years, some of which include options to extend the leases for up to five years.
| |
Six months ended June 30, | |
(in thousands) | |
2023 | | |
2022 | |
| |
| | |
| |
The components of lease expense were as follows: | |
| | |
| |
Operating leases expenses | |
$ | 522 | | |
$ | 517 | |
Supplemental consolidated cash flow information related to operating leases follows: | |
| | | |
| | |
Cash used in operating activities | |
$ | 520 | | |
$ | 478 | |
Non-cash activity: | |
| | | |
| | |
Right of use assets obtained in exchange for new operating lease liabilities | |
$ | 145 | | |
$ | 91 | |
|
Schedule of Supplemental Information Related to Operating Leases |
| |
June 30, | | |
December 31, | |
(in thousands) | |
2023 | | |
2022 | |
Supplemental information related to operating leases, including location of amounts reported in the accompanying consolidated balance sheets, follows: | |
| | |
| |
Other assets - Right-of-Use assets | |
$ | 6,590 | | |
$ | 6,445 | |
Accumulated amortization | |
| 1,856 | | |
| 1,420 | |
Operating lease Right-of-Use assets, net | |
$ | 4,734 | | |
$ | 5,025 | |
Lease liabilities – current - Accounts payable and accrued liabilities | |
$ | 667 | | |
$ | 653 | |
Lease liabilities – noncurrent | |
| 3,702 | | |
| 4,194 | |
Total operating lease liabilities | |
$ | 4,369 | | |
$ | 4,847 | |
Weighted average remaining lease term in years | |
| 7.1 | | |
| 7.6 | |
Weighted average annual discount rate | |
| 3.4 | % | |
| 3.4 | % |
|
Schedule of Maturities of Operating Lease Liabilities |
Maturities
of operating lease liabilities as of June 30, 2022, were as follows:
2023(after June 30) | |
$ | 344 | |
2024 | |
| 696 | |
2025 | |
| 717 | |
2026 | |
| 581 | |
2027 | |
| 551 | |
2028 and onwards | |
| 2,069 | |
Total undiscounted lease liability | |
$ | 4,958 | |
Less: Imputed interest | |
$ | (589 | ) |
Present value of lease liabilities | |
$ | 4,369 | |
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v3.23.2
Equity (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Equity [Abstract] |
|
Schedule of Number of Ordinary Shares Upon Exercise |
All
Company warrants are classified as a component of shareholders’ equity because such warrants are free standing financial instruments
that are legally detachable, separately exercisable,
|
|
Number of
Warrants |
|
|
Weighted
average
exercise
price |
|
Outstanding January 1, 2023 |
|
|
202,251 |
|
|
$ |
23.31 |
|
Outstanding and exercisable June 30, 2023 |
|
|
202,251 |
|
|
$ |
23.31 |
|
|
Schedule of Changes in Exercisable Ordinary Shares Warrants |
Composed of the following
Number of
Warrants |
|
|
Exercise Price
Per Share |
|
|
Issuance date |
|
Expiration date |
|
22,750 |
|
|
$ |
10 |
|
|
February 26, 2020 |
|
February 24, 2025 |
|
160,727 |
|
|
$ |
25 |
|
|
February 12, 2021 |
|
February 9, 2026 |
|
18,774 |
|
|
$ |
25 |
|
|
February 17, 2021 |
|
February 9, 2026 |
|
202,251 |
|
|
|
|
|
|
|
|
|
|
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v3.23.2
Share-Based Compensation (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
Schedule of Employees and Directors Stock Options |
The following table contains information concerning options
granted under the existing equity incentive plan
| |
Three months ended June 30, | |
| |
2023 | | |
2022 | |
| |
Number of
options | | |
Weighted
average
exercise
price | | |
Number of
options | | |
Weighted
average
exercise
price | |
Outstanding at beginning of period | |
| 2,929,868 | | |
$ | 5.84 | | |
| 2,399,622 | | |
$ | 5.95 | |
Forfeited and expired | |
| (14,375 | ) | |
$ | 6.82 | | |
| (3,000 | ) | |
$ | 5.34 | |
Exercised | |
| - | | |
$ | - | | |
| (7,625 | ) | |
$ | 6.49 | |
Outstanding at end of period | |
| 2,915,493 | | |
$ | 5.84 | | |
| 2,388,997 | | |
$ | 5.95 | |
Exercisable at end of period | |
| 2,090,378 | | |
$ | 5.59 | | |
| 1,728,623 | | |
$ | 5.10 | |
| |
| | | |
| | | |
| | | |
| | |
Non-vested at beginning of period | |
| 876,851 | | |
$ | 6.48 | | |
| 722,749 | | |
$ | 7.67 | |
Vested | |
| (37,861 | ) | |
$ | 11.13 | | |
| (59,375 | ) | |
$ | (8.78 | ) |
Forfeited | |
| (13,875 | ) | |
$ | 5.90 | | |
| (3,000 | ) | |
$ | (5.34 | ) |
Non-vested at the end of period | |
| 825,115 | | |
$ | 6.27 | | |
| 660,374 | | |
$ | 7.59 | |
| |
Six months ended June 30, | |
| |
2023 | | |
2022 | |
| |
Number of
options | | |
Weighted
average
exercise
price | | |
Number of
options | | |
Weighted
average
exercise
price | |
Outstanding at beginning of period | |
| 2,939,434 | | |
$ | 5.85 | | |
| 2,142,547 | | |
$ | 6.02 | |
Granted | |
| - | | |
| | | |
$ | 264,700 | | |
$ | 5.48 | |
Forfeited and expired | |
| (23,941 | ) | |
$ | 6.71 | | |
| (3,000 | ) | |
$ | 5.34 | |
Exercised | |
| - | | |
| | | |
$ | (15,250 | ) | |
$ | 6.49 | |
Outstanding at end of period | |
| 2,915,493 | | |
$ | 5.84 | | |
| 2,388,997 | | |
$ | 5.95 | |
Exercisable at end of period | |
| 2,090,378 | | |
$ | 5.59 | | |
| 1,728,623 | | |
$ | 5.10 | |
| |
| | | |
| | | |
| | | |
| | |
Non vested at beginning of period | |
| 986,005 | | |
$ | 6.46 | | |
| 529,082 | | |
$ | 8.69 | |
Granted | |
| - | | |
$ | - | | |
| 264,700 | | |
$ | 5.48 | |
Forfeited and expired | |
| (15,375 | ) | |
$ | 6.73 | | |
| (3,000 | ) | |
$ | 5.34 | |
vested | |
| (145,515 | ) | |
$ | 7.44 | | |
| (130,408 | ) | |
$ | 7.82 | |
Outstanding at end of period | |
| 825,115 | | |
$ | 6.27 | | |
| 660,374 | | |
$ | 7.59 | |
|
Schedule of Exercise Prices and Remaining Contractual Life |
Set forth below is data regarding the range of exercise prices
and remaining contractual life for all options outstanding on June 30, 2023
Exercise
price | | |
Number of
options outstanding | | |
Remaining
contractual
Life (in years) | | |
Intrinsic
Value of
Options
Outstanding
(in thousands) | | |
No. of options
exercisable | |
$ | 2.69 | | |
| 649,883 | | |
| 1.92 | | |
| - | | |
| 649,883 | |
$ | 3.66 | | |
| 250,000 | | |
| 6.84 | | |
| - | | |
| 250,000 | |
$ | 4.68 | | |
| 48,750 | | |
| 6.75 | | |
| - | | |
| 36,563 | |
$ | 5.34 | | |
| 208,825 | | |
| 8.75 | | |
| - | | |
| 53,800 | |
$ | 5.34 | | |
| 445,792 | | |
| 9.38 | | |
| - | | |
| 69,263 | |
$ | 5.96 | | |
| 150,000 | | |
| 9.38 | | |
| - | | |
| - | |
$ | 6.22 | | |
| 634,177 | | |
| 4.00 | | |
| - | | |
| 634,177 | |
$ | 8.19 | | |
| 150,000 | | |
| 6.38 | | |
| - | | |
| 112,500 | |
$ | 8.23 | | |
| 12,500 | | |
| 8.38 | | |
| - | | |
| 5,000 | |
$ | 9.02 | | |
| 40,500 | | |
| 7.38 | | |
| - | | |
| 20,250 | |
$ | 10.12 | | |
| 12,126 | | |
| 5.43 | | |
| - | | |
| 12,126 | |
$ | 12.23 | | |
| 250,000 | | |
| 7.91 | | |
| - | | |
| 194,444 | |
$ | 14.00 | | |
| 60,500 | | |
| 7.82 | | |
| - | | |
| 50,417 | |
$ | 21.40 | | |
| 1,940 | | |
| 6.07 | | |
| - | | |
| 1,455 | |
$ | 90.16 | | |
| 500 | | |
| 1.42 | | |
| - | | |
| 500 | |
| | | |
| 2,915,493 | | |
| | | |
| - | | |
| 2,090,378 | |
|
Schedule of Restricted Stock Units |
The following table contains information concerning restricted
stock units granted under the existing equity incentive plan
| |
Three months ended June 30, | |
| |
2023 | | |
2022 | |
| |
Number of
shares | | |
Weighted
average
grant date
fair value | | |
Number of
shares | | |
Weighted
average
grant date
fair value | |
Nonvested at beginning of period | |
| 114,329 | | |
$ | 9.97 | | |
| 184,787 | | |
$ | 10.02 | |
Vested | |
| (3,438 | ) | |
$ | 10.28 | | |
| (3,437 | ) | |
$ | 10.28 | |
Forfeited | |
| (313 | ) | |
$ | 14.67 | | |
| - | | |
$ | - | |
Nonvested at end of period | |
| 110,578 | | |
$ | 9.95 | | |
| 181,350 | | |
$ | 10.02 | |
| |
Six months ended June 30, | |
| |
2023 | | |
2022 | |
| |
Number of
shares | | |
Weighted average grant date
fair value | | |
Number of
shares | | |
Weighted average grant date
fair value | |
Nonvested at beginning of period | |
| 157,560 | | |
$ | 10.02 | | |
| 229,331 | | |
$ | 10.08 | |
Vested | |
| (46,544 | ) | |
$ | 10.15 | | |
| (47,981 | ) | |
$ | 10.29 | |
Forfeited | |
| (438 | ) | |
$ | 14.67 | | |
| - | | |
$ | - | |
Nonvested at end of period | |
| 110,578 | | |
$ | 9.95 | | |
| 181,350 | | |
$ | 10.02 | |
|
Schedule of Share-Based Compensation Expenses Related to Grants Under the Equity Incentive Plan |
The
following table summarizes share-based compensation expenses related to grants under the existing equity incentive plan included in the
statements of operations
| |
Three months ended
June 30, | | |
Six months ended
June 30, | |
(in thousands) | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Research & development | |
$ | 122 | | |
$ | 119 | | |
$ | 318 | | |
$ | 509 | |
General & administrative | |
| 389 | | |
| 578 | | |
| 826 | | |
| 976 | |
Total | |
$ | 511 | | |
$ | 697 | | |
$ | 1,144 | | |
$ | 1,485 | |
|
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v3.23.2
Fair Value Measurement (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Fair Value Disclosures [Abstract] |
|
Schedule of Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis |
The Company’s financial assets and liabilities measured
at fair value on a recurring basis consisted of the following types of instruments as of June 30, 2023 and December 31, 2022:
(in thousands) | |
June 30, 2023 | |
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Cash and cash equivalents | |
$ | 3,862 | | |
$ | 3,862 | | |
$ | - | | |
$ | - | |
Short term deposits | |
| 25,443 | | |
| 25,443 | | |
| - | | |
| - | |
Long term deposits | |
| 7,159 | | |
| 7,159 | | |
| - | | |
| - | |
Restricted cash current | |
| 113 | | |
| 113 | | |
| - | | |
| - | |
Restricted cash non-current | |
| 291 | | |
| 291 | | |
| - | | |
| - | |
Total financial assets | |
$ | 38,868 | | |
$ | 38,868 | | |
$ | - | | |
$ | - | |
(in thousands) | |
December 31, 2022 | |
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Cash and cash equivalents | |
$ | 49,945 | | |
$ | 49,945 | | |
$ | - | | |
$ | - | |
Short term deposits | |
| 299 | | |
| 299 | | |
| - | | |
| - | |
Restricted cash current | |
| 113 | | |
| 113 | | |
| - | | |
| - | |
Restricted cash non-current | |
| 299 | | |
| 299 | | |
| - | | |
| - | |
Total financial assets | |
$ | 50,656 | | |
$ | 50,656 | | |
$ | - | | |
$ | - | |
|
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v3.23.2
Cash, Cash Equivalents and Restricted Cash (Details) - Schedule of Cash and Cash Equivalents and Restricted Cash - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
Schedule of Cash and Cash Equivalents and Restricted Cash [Abstract] |
|
|
Cash held in banks |
$ 1,024
|
$ 2,123
|
Bank deposits in U.S.$ (annual average interest rates 4.29%% and 0.1%) |
2,434
|
47,822
|
Total cash and cash equivalents |
3,458
|
49,945
|
Restricted cash – current – Prepaid expenses and other receivables |
113
|
113
|
Restricted cash – noncurrent – Other assets |
291
|
299
|
Total cash, cash equivalents and restricted cash shown in the statement of cash flows |
$ 3,862
|
$ 50,357
|
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v3.23.2
Property and Equipment (Details) - Schedule of Property and Equipment - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] |
|
|
Cost |
$ 12,102
|
$ 11,982
|
Total accumulated depreciation |
2,528
|
2,107
|
Depreciated cost |
9,574
|
9,875
|
Laboratory equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Cost |
2,837
|
2,851
|
Total accumulated depreciation |
1,690
|
1,432
|
Computers [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Cost |
276
|
276
|
Total accumulated depreciation |
242
|
203
|
Office furniture & equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
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Cost |
317
|
249
|
Total accumulated depreciation |
34
|
28
|
Leasehold improvements [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Cost |
8,672
|
8,606
|
Total accumulated depreciation |
$ 562
|
$ 444
|
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Leases (Details) - Schedule of Supplemental Information Related to Operating Leases - USD ($) $ in Thousands |
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Dec. 31, 2022 |
Schedule of Operating Lease Related Activities [Abstract] |
|
|
Other assets - Right-of-Use assets |
$ 6,590
|
$ 6,445
|
Accumulated amortization |
1,856
|
1,420
|
Operating lease Right-of-Use assets, net |
4,734
|
5,025
|
Lease liabilities – current - Accounts payable and accrued liabilities |
667
|
653
|
Lease liabilities – noncurrent |
3,702
|
4,194
|
Total operating lease liabilities |
$ 4,369
|
$ 4,847
|
Weighted average remaining lease term in years |
7 years 1 month 6 days
|
7 years 7 months 6 days
|
Weighted average annual discount rate |
3.40%
|
3.40%
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v3.23.2
Equity (Details) - Schedule of Changes in Exercisable Ordinary Shares Warrants
|
6 Months Ended |
Jun. 30, 2023
$ / shares
shares
|
Class of Warrant or Right [Line Items] |
|
Number of Warrants |
202,251
|
Exercise Price 10 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of Warrants |
22,750
|
Exercise price per share | $ / shares |
$ 10
|
Issuance date |
Feb. 26, 2020
|
Expiration date |
Feb. 24, 2025
|
Exercise Price 25 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of Warrants |
160,727
|
Exercise price per share | $ / shares |
$ 25
|
Issuance date |
Feb. 12, 2021
|
Expiration date |
Feb. 09, 2026
|
Exercise Price 25 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of Warrants |
18,774
|
Exercise price per share | $ / shares |
$ 25
|
Issuance date |
Feb. 17, 2021
|
Expiration date |
Feb. 09, 2026
|
X |
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v3.23.2
Share-Based Compensation (Details) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Share-Based Compensation (Details) [Line Items] |
|
|
|
|
Ordinary shares authorized (in Shares) |
5,028,704
|
|
5,028,704
|
|
Share-based compensation expenses |
$ 427
|
$ 957
|
$ 509
|
$ 1,074
|
Employees' Stock Option [Member] |
|
|
|
|
Share-Based Compensation (Details) [Line Items] |
|
|
|
|
Total unrecognized estimated compensation cost |
|
|
$ 1,766
|
|
Weighted average period |
|
|
1 year 3 months 25 days
|
|
Consultants' Stock Options [Member] |
|
|
|
|
Share-Based Compensation (Details) [Line Items] |
|
|
|
|
Total unrecognized estimated compensation cost |
|
|
$ 331
|
|
Weighted average period |
|
|
7 months 28 days
|
|
2019 Equity Incentive Plan [Member] |
|
|
|
|
Share-Based Compensation (Details) [Line Items] |
|
|
|
|
Future grant share (in Shares) |
1,537,973
|
|
1,537,973
|
|
Restricted Stock [Member] |
|
|
|
|
Share-Based Compensation (Details) [Line Items] |
|
|
|
|
Share-based compensation expenses |
$ 84
|
$ 187
|
$ 188
|
$ 411
|
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v3.23.2
Share-Based Compensation (Details) - Schedule of Employees and Directors Stock Options - $ / shares
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Schedule of Employees and Directors Stock Options [Abstract] |
|
|
|
|
Number of options, Outstanding at beginning of period |
2,929,868
|
2,399,622
|
2,939,434
|
2,142,547
|
Weighted average exercise price, Outstanding at beginning of period |
$ 5.84
|
$ 5.95
|
$ 5.85
|
$ 6.02
|
Number of options, Granted |
|
|
|
264,700
|
Weighted average exercise price, Granted |
|
|
|
$ 5.48
|
Number of options, Forfeited and expired |
(14,375)
|
(3,000)
|
(23,941)
|
(3,000)
|
Weighted average exercise price, Forfeited and expired |
$ 6.82
|
$ 5.34
|
$ 6.71
|
$ 5.34
|
Number of options, Exercised |
|
(7,625)
|
|
(15,250)
|
Weighted average exercise price, Exercised |
|
$ 6.49
|
|
$ 6.49
|
Number of options, Outstanding at end of period |
2,915,493
|
2,388,997
|
2,915,493
|
2,388,997
|
Weighted average exercise price, Outstanding at end of period |
$ 5.84
|
$ 5.95
|
$ 5.84
|
$ 5.95
|
Number of options, Exercisable at end of period |
2,090,378
|
1,728,623
|
2,090,378
|
1,728,623
|
Weighted average exercise price, Exercisable at end of period |
$ 5.59
|
$ 5.1
|
$ 5.59
|
$ 5.1
|
Number of options, Non-vested at beginning of period |
876,851
|
722,749
|
986,005
|
529,082
|
Weighted average exercise price, Non-vested at beginning of period |
$ 6.48
|
$ 7.67
|
$ 6.46
|
$ 8.69
|
Number of options, Vested |
(37,861)
|
(59,375)
|
(145,515)
|
(130,408)
|
Weighted average exercise price, Vested |
$ 11.13
|
$ (8.78)
|
$ 7.44
|
$ 7.82
|
Number of options, Forfeited |
(13,875)
|
(3,000)
|
(15,375)
|
(3,000)
|
Weighted average exercise price, Forfeited |
$ 5.9
|
$ (5.34)
|
$ 6.73
|
$ 5.34
|
Number of options, Non-vested at the end of period |
825,115
|
660,374
|
825,115
|
660,374
|
Weighted average exercise price, Non-vested at the end of period |
$ 6.27
|
$ 7.59
|
$ 6.27
|
$ 7.59
|
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v3.23.2
Share-Based Compensation (Details) - Schedule of Exercise Prices and Remaining Contractual Life - Stock Options [Member]
|
6 Months Ended |
Jun. 30, 2023
USD ($)
$ / shares
shares
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Number of options outstanding |
2,915,493
|
Intrinsic Value of Options Outstanding (in Dollars) | $ |
|
No. of options exercisable |
2,090,378
|
Exercise Price One [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise price (in Dollars per share) | $ / shares |
$ 2.69
|
Number of options outstanding |
649,883
|
Remaining contractual Life (in years) |
1 year 11 months 1 day
|
Intrinsic Value of Options Outstanding (in Dollars) | $ |
|
No. of options exercisable |
649,883
|
Exercise Price Two [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise price (in Dollars per share) | $ / shares |
$ 3.66
|
Number of options outstanding |
250,000
|
Remaining contractual Life (in years) |
6 years 10 months 2 days
|
Intrinsic Value of Options Outstanding (in Dollars) | $ |
|
No. of options exercisable |
250,000
|
Exercise Price Three [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise price (in Dollars per share) | $ / shares |
$ 4.68
|
Number of options outstanding |
48,750
|
Remaining contractual Life (in years) |
6 years 9 months
|
Intrinsic Value of Options Outstanding (in Dollars) | $ |
|
No. of options exercisable |
36,563
|
Exercise Price Four [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise price (in Dollars per share) | $ / shares |
$ 5.34
|
Number of options outstanding |
208,825
|
Remaining contractual Life (in years) |
8 years 9 months
|
Intrinsic Value of Options Outstanding (in Dollars) | $ |
|
No. of options exercisable |
53,800
|
Exercise Price Five [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise price (in Dollars per share) | $ / shares |
$ 5.34
|
Number of options outstanding |
445,792
|
Remaining contractual Life (in years) |
9 years 4 months 17 days
|
Intrinsic Value of Options Outstanding (in Dollars) | $ |
|
No. of options exercisable |
69,263
|
Exercise Price Six [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise price (in Dollars per share) | $ / shares |
$ 5.96
|
Number of options outstanding |
150,000
|
Remaining contractual Life (in years) |
9 years 4 months 17 days
|
Intrinsic Value of Options Outstanding (in Dollars) | $ |
|
No. of options exercisable |
|
Exercise Price Seven [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise price (in Dollars per share) | $ / shares |
$ 6.22
|
Number of options outstanding |
634,177
|
Remaining contractual Life (in years) |
4 years
|
Intrinsic Value of Options Outstanding (in Dollars) | $ |
|
No. of options exercisable |
634,177
|
Exercise Price Eight [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise price (in Dollars per share) | $ / shares |
$ 8.19
|
Number of options outstanding |
150,000
|
Remaining contractual Life (in years) |
6 years 4 months 17 days
|
Intrinsic Value of Options Outstanding (in Dollars) | $ |
|
No. of options exercisable |
112,500
|
Exercise Price Nine [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise price (in Dollars per share) | $ / shares |
$ 8.23
|
Number of options outstanding |
12,500
|
Remaining contractual Life (in years) |
8 years 4 months 17 days
|
Intrinsic Value of Options Outstanding (in Dollars) | $ |
|
No. of options exercisable |
5,000
|
Exercise Price Ten [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise price (in Dollars per share) | $ / shares |
$ 9.02
|
Number of options outstanding |
40,500
|
Remaining contractual Life (in years) |
7 years 4 months 17 days
|
Intrinsic Value of Options Outstanding (in Dollars) | $ |
|
No. of options exercisable |
20,250
|
Exercise Price Eleven [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise price (in Dollars per share) | $ / shares |
$ 10.12
|
Number of options outstanding |
12,126
|
Remaining contractual Life (in years) |
5 years 5 months 4 days
|
Intrinsic Value of Options Outstanding (in Dollars) | $ |
|
No. of options exercisable |
12,126
|
Exercise Price Twelve [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise price (in Dollars per share) | $ / shares |
$ 12.23
|
Number of options outstanding |
250,000
|
Remaining contractual Life (in years) |
7 years 10 months 28 days
|
Intrinsic Value of Options Outstanding (in Dollars) | $ |
|
No. of options exercisable |
194,444
|
Exercise Price Thirteen [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise price (in Dollars per share) | $ / shares |
$ 14
|
Number of options outstanding |
60,500
|
Remaining contractual Life (in years) |
7 years 9 months 25 days
|
Intrinsic Value of Options Outstanding (in Dollars) | $ |
|
No. of options exercisable |
50,417
|
Exercise Price Fourteen [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise price (in Dollars per share) | $ / shares |
$ 21.4
|
Number of options outstanding |
1,940
|
Remaining contractual Life (in years) |
6 years 25 days
|
Intrinsic Value of Options Outstanding (in Dollars) | $ |
|
No. of options exercisable |
1,455
|
Exercise Price Fifteen [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise price (in Dollars per share) | $ / shares |
$ 90.16
|
Number of options outstanding |
500
|
Remaining contractual Life (in years) |
1 year 5 months 1 day
|
Intrinsic Value of Options Outstanding (in Dollars) | $ |
|
No. of options exercisable |
500
|
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v3.23.2
Share-Based Compensation (Details) - Schedule of Restricted Stock Units - $ / shares
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Schedule of Restricted Stock Units [Abstract] |
|
|
|
|
Number of shares, Nonvested at beginning of period |
114,329
|
184,787
|
157,560
|
229,331
|
Weighted average grant date fair value, Nonvested at beginning of period |
$ 9.97
|
$ 10.02
|
$ 10.02
|
$ 10.08
|
Number of shares, Vested |
(3,438)
|
(3,437)
|
(46,544)
|
(47,981)
|
Weighted average grant date fair value, Vested |
$ 10.28
|
$ 10.28
|
$ 10.15
|
$ 10.29
|
Number of shares, Forfeited |
(313)
|
|
(438)
|
|
Weighted average grant date fair value, Forfeited |
$ 14.67
|
|
$ 14.67
|
|
Number of shares, Nonvested at end of period |
110,578
|
181,350
|
110,578
|
181,350
|
Weighted average grant date fair value, Nonvested at end of period |
$ 9.95
|
$ 10.02
|
$ 9.95
|
$ 10.02
|
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Share-Based Compensation (Details) - Schedule of Share-Based Compensation Expenses Related to Grants Under the Equity Incentive Plan - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Total |
$ 511
|
$ 697
|
$ 1,144
|
$ 1,485
|
Research & development [Member] |
|
|
|
|
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Total |
122
|
119
|
318
|
509
|
General & administrative [Member] |
|
|
|
|
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Total |
$ 389
|
$ 578
|
$ 826
|
$ 976
|
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v3.23.2
Fair Value Measurement (Details) - Schedule of Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
Fair Value Measurement (Details) - Schedule of Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis [Line Items] |
|
|
Cash and cash equivalents |
$ 3,862
|
$ 49,945
|
Short term deposits |
25,443
|
299
|
Long term deposits |
7,159
|
|
Restricted cash current |
113
|
113
|
Restricted cash non-current |
291
|
299
|
Total financial assets |
38,868
|
50,656
|
Level 1 [Member] |
|
|
Fair Value Measurement (Details) - Schedule of Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis [Line Items] |
|
|
Cash and cash equivalents |
3,862
|
49,945
|
Short term deposits |
25,443
|
299
|
Long term deposits |
7,159
|
|
Restricted cash current |
113
|
113
|
Restricted cash non-current |
291
|
299
|
Total financial assets |
38,868
|
50,656
|
Level 2 [Member] |
|
|
Fair Value Measurement (Details) - Schedule of Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis [Line Items] |
|
|
Cash and cash equivalents |
|
|
Short term deposits |
|
|
Long term deposits |
|
|
Restricted cash current |
|
|
Restricted cash non-current |
|
|
Total financial assets |
|
|
Level 3 [Member] |
|
|
Fair Value Measurement (Details) - Schedule of Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis [Line Items] |
|
|
Cash and cash equivalents |
|
|
Short term deposits |
|
|
Long term deposits |
|
|
Restricted cash current |
|
|
Restricted cash non-current |
|
|
Total financial assets |
|
|
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Enlivex Therapeutics (NASDAQ:ENLV)
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Enlivex Therapeutics (NASDAQ:ENLV)
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