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: August 2024
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, 2024 and 2023, 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: August 30, 2024
2
Exhibit 99.1
ENLIVEX THERAPEUTICS LTD.
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AS OF JUNE 30, 2024 AND DECEMBER 31, 2023
AND FOR THE THREE AND SIX MONTH PERIODS ENDED
JUNE 30, 2024 AND 2023
ENLIVEX THERAPEUTICS LTD.
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AS OF JUNE 30, 2024 AND DECEMBER 31, 2023
AND FOR THE THREE AND SIX MONTH PERIODS ENDED
JUNE 30, 2024 AND 2023
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, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
ASSETS | |
| | |
| |
Current Assets | |
| | |
| |
Cash and cash equivalents | |
$ | 3,747 | | |
$ | 813 | |
Short-term interest-bearing deposits | |
| 22,195 | | |
| 26,507 | |
Prepaid expenses and other receivables | |
| 2,400 | | |
| 1,336 | |
Assets classified as held for sale | |
| 228 | | |
| 5,108 | |
Total Current Assets | |
| 28,570 | | |
| 33,764 | |
| |
| | | |
| | |
Non-Current Assets | |
| | | |
| | |
Other receivables | |
| 898 | | |
| - | |
Property and equipment, net | |
| 1,158 | | |
| 1,539 | |
Other assets | |
| 1,276 | | |
| 1,528 | |
Total Non-Current Assets | |
| 3,332 | | |
| 3,067 | |
TOTAL ASSETS | |
$ | 31,902 | | |
$ | 36,831 | |
| |
| | | |
| | |
LIABILITIES AND SHAREHOLDERS’ EQUITY | |
| | | |
| | |
Current Liabilities | |
| | | |
| | |
Accounts payable | |
$ | 303 | | |
$ | 827 | |
Accrued expenses and other liabilities | |
| 2,538 | | |
| 4,001 | |
Liability classified as held for sale | |
| - | | |
| 1,233 | |
Total Current Liabilities | |
| 2,841 | | |
| 6,061 | |
| |
| | | |
| | |
Non-Current Liabilities | |
| | | |
| | |
Other long-term liabilities | |
| 499 | | |
| 686 | |
Total Non-Current Liabilities | |
| 499 | | |
| 686 | |
| |
| | | |
| | |
Commitments and Contingent Liabilities | |
| | | |
| | |
| |
| | | |
| | |
TOTAL LIABILITIES | |
| 3,340 | | |
| 6,747 | |
| |
| | | |
| | |
SHAREHOLDERS’ EQUITY | |
| | | |
| | |
Ordinary shares of NIS 0.40 par value per share: | |
| | | |
| | |
Authorized: 45,000,000 shares as of June 30, 2024 and December 31, 2023; Issued and outstanding: 20,883,312 and 18,598,555 as of June 30, 2024 and December 31, 2023, respectively; | |
| 2,385 | | |
| 2,137 | |
Additional paid in capital | |
| 144,405 | | |
| 138,939 | |
Foreign currency translation adjustments | |
| 1,101 | | |
| 1,101 | |
Accumulated deficit | |
| (119,329 | ) | |
| (112,093 | ) |
TOTAL SHAREHOLDERS’ EQUITY | |
| 28,562 | | |
| 30,084 | |
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | |
$ | 31,902 | | |
$ | 36,831 | |
The accompanying notes are an integral part of the condensed consolidated
financial statements.
ENLIVEX THERAPEUTICS LTD.
CONDENSED CONSOLIDATED STATEMENTS
OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)
U.S. dollars in thousands (except share and
per share data)
| |
For the three months ended | | |
For the six months ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Revenues | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development expenses | |
| 1,999 | | |
| 5,035 | | |
| 4,856 | | |
| 10,211 | |
General and administrative expenses | |
| 987 | | |
| 1,614 | | |
| 2,080 | | |
| 3,221 | |
Loss on disposal group of assets held for sale | |
| - | | |
| - | | |
| 201 | | |
| - | |
| |
| 2,986 | | |
| 6,649 | | |
| 7,137 | | |
| 13,432 | |
| |
| | | |
| | | |
| | | |
| | |
Operating loss | |
| (2,986 | ) | |
| (6,649 | ) | |
| (7,137 | ) | |
| (13,432 | ) |
| |
| | | |
| | | |
| | | |
| | |
Finance income (expense) | |
| (110 | ) | |
| (143 | ) | |
| (99 | ) | |
| (578 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss | |
| (3,096 | ) | |
| (6,792 | ) | |
| (7,236 | ) | |
| (14,010 | ) |
| |
| | | |
| | | |
| | | |
| | |
Basic & diluted loss per share | |
$ | (0.16 | ) | |
$ | (0.37 | ) | |
$ | (0.38 | ) | |
$ | (0.76 | ) |
Weighted average number of shares outstanding | |
| 19,545,056 | | |
| 18,584,801 | | |
| 19,138,066 | | |
| 18,550,702 | |
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, 2023 | |
| 18,598,555 | | |
| 2,137 | | |
| 138,939 | | |
$ | 1,101 | | |
| (112,093 | ) | |
| 30,084 | |
Changes during the three months period ended March 31, 2024: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Restricted stock units vested | |
| 34,295 | | |
| 3 | | |
| (3 | ) | |
| - | | |
| - | | |
| - | |
Issuance of shares for cash consideration of 540 net of $16 of issuance costs | |
| 178,931 | | |
| 20 | | |
| 504 | | |
| - | | |
| - | | |
| 524 | |
Stock based compensation | |
| - | | |
| - | | |
| 383 | | |
| - | | |
| - | | |
| 383 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| (4,140 | ) | |
| (4,140 | ) |
Balance as of March 31, 2024 (unaudited) | |
| 18,811,781 | | |
| 2,160 | | |
| 139,823 | | |
| 1,101 | | |
| (116,233 | ) | |
| 26,851 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Changes during the three months period ended June 30, 2024: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Issuance of shares for cash consideration of $5,001 net of $582 of issuance costs | |
| 2,061,776 | | |
| 224 | | |
| 4,195 | | |
| - | | |
| - | | |
| 4,419 | |
Restricted stock units vested | |
| 9,755 | | |
| 1 | | |
| (1 | ) | |
| - | | |
| - | | |
| - | |
Exercise of options | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
Stock based compensation | |
| - | | |
| - | | |
| 388 | | |
| - | | |
| - | | |
| 388 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| (3,096 | ) | |
| (3,096 | ) |
Balance as of June 30, 2024 (unaudited) | |
| 20,883,312 | | |
$ | 2,385 | | |
$ | 144,405 | | |
$ | 1,101 | | |
$ | (119,329 | ) | |
$ | 28,562 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
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 of 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 of 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 | |
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, | |
| |
2024 | | |
2023 | |
Cash flows from operating activities | |
| | |
| |
Net loss | |
$ | (7,236 | ) | |
$ | (14,010 | ) |
Adjustments required to reflect net cash used in operating activities: | |
| | | |
| | |
Income and expenses not involving cash flows: | |
| | | |
| | |
Depreciation | |
| 348 | | |
| 421 | |
Capital gain on sale of property and equipment | |
| (79 | ) | |
| - | |
Loss on short-term bank deposits | |
| 166 | | |
| 1,626 | |
Gain on assets and liabilities classified as held for sale | |
| (66 | ) | |
| - | |
Non-cash operating lease expenses | |
| 181 | | |
| 434 | |
Share-based compensation | |
| 771 | | |
| 1,144 | |
Changes in operating asset and liability items: | |
| | | |
| | |
Decrease in prepaid expenses and other receivables | |
| 1,792 | | |
| (169 | ) |
Decrease in accounts payable | |
| (524 | ) | |
| (240 | ) |
Decrease in accrued expenses and other liabilities | |
| (1,453 | ) | |
| (1,389 | ) |
Operating lease liabilities | |
| (207 | ) | |
| (624 | ) |
Net cash used in operating activities | |
| (6,307 | ) | |
| (12,807 | ) |
| |
| | | |
| | |
Cash flows from investing activities | |
| | | |
| | |
Purchase of property and equipment | |
| (59 | ) | |
| (200 | ) |
Proceeds from sale of property and equipment | |
| 171 | | |
| 82 | |
Proceeds from sale of assets held for sale | |
| 54 | | |
| - | |
Investment in short-term interest-bearing bank deposits | |
| (18,774 | ) | |
| (34,218 | ) |
Release of short-term interest-bearing bank deposits | |
| 22,912 | | |
| 288 | |
Net cash provided by (used in) investing activities | |
| 4,304 | | |
| (34,048 | ) |
| |
| | | |
| | |
Cash flows from financing activities | |
| | | |
| | |
Proceeds from issuance of shares and warrants, net | |
| 4,943 | | |
| 360 | |
Proceeds from exercise of options | |
| - | | |
| - | |
Net cash provided by financing activities | |
| 4,943 | | |
| 360 | |
| |
| | | |
| | |
Increase (decrease) in cash and cash equivalents | |
| 2,940 | | |
| (46,495 | ) |
Cash and cash equivalents - beginning of period | |
| 1,226 | | |
| 50,357 | |
| |
| | | |
| | |
Cash and cash equivalents - end of period | |
$ | 4,166 | | |
$ | 3,862 | |
Supplemental disclosures of cash flow information: | |
| | | |
| | |
Cash paid for taxes | |
$ | - | | |
$ | - | |
Cash received for interest, net | |
$ | 906 | | |
$ | 233 | |
The accompanying notes are an integral part of the condensed consolidated
financial statements.
ENLIVEX THERAPEUTICS LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2024
(UNAUDITED)
NOTE 1 - GENERAL INFORMATION
Enlivex Therapeutics Ltd. (the “Parent”
and, including its consolidated subsidiaries, “we”, “us”, “our” or the “Company”) was
originally incorporated on January 22, 2012 under the laws of the State of Israel.
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 debilitating and life-threatening conditions. Non-homeostatic macrophages contribute significantly to the
severity of certain diseases, which include, sepsis, osteoarthritis 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, 2024, had an accumulated deficit of $119,329 thousand.
The Company expects to continue to
incur losses for the foreseeable future, 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 following the filing of these financial
statements on Form 6-K. The Company may determine, however, to raise additional capital during such period as the Board deems prudent.
The Company’s management plans to finance its operations with issuances of the Company’s equity securities and, in the longer
term, revenues. There are no assurances, however, that the Company will be successful in obtaining the financing necessary for its long-term
development. The Company’s ability to continue to operate in the long term is dependent upon additional financial support.
NOTE 2 - SIGNIFICANT ACCOUNTING
POLICIES
Basis of Presentation
These unaudited condensed consolidated
financial statements include the accounts of the Company and have been prepared in accordance with U.S. generally accepted accounting
principles (“U.S. GAAP”) for interim financial information. Accordingly, certain information and footnote disclosures normally
included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. In the opinion of management, all
adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been made.
ENLIVEX THERAPEUTICS LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2024
(UNAUDITED)
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 2023 Annual Report on Form 20-F, as filed with the U.S. Securities and Exchange Commission on April 30, 2024. The
results of operations for these interim periods are not necessarily indicative of the operating results for any future period. The December 31,
2023 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 transaction.
1 U.S. dollar = 3.759 NIS and 3.627
NIS as of June 30, 2024 and December 31, 2023, respectively.
The U.S. dollar increased against the
NIS 2.12%, 3.64%, 2.35% and 5.14% in the three and six month periods ended June 30, 2024 and 2023, respectively.
Recently Adopted Accounting Standards
During the three months ended June
30, 2024, the Company was not required to adopt any recently issued accounting standards.
Recently Issued Accounting Pronouncements
Not Yet Adopted
In November 2023, the FASB issued ASU
2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which is intended to provide enhanced segment
disclosures. The standard will require disclosures about significant segment expenses and other segment items and identifying the Chief
Operating Decision Maker and how they use the reported segment profitability measures to assess segment performance and allocate resources.
These enhanced disclosures are required for all entities on an interim and annual basis, even if they have only a single reportable segment.
The standard is effective for years beginning after December 15, 2023 and interim periods within annual periods beginning after December
15, 2024, and early adoption is permitted. The Company does not believe that adoption of this ASU will have a material impact on the Company’s
consolidated financial statements.
In December 2023, the FASB issued ASU
2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which is intended to provide enhancements to annual income
tax disclosures. The standard will require more detailed information in the rate reconciliation table and for income taxes paid, among
other enhancements. The standard is effective for years beginning after December 15, 2024, early adoption is permitted. The Company does
not believe that adoption of this ASU will have a material impact on the Company’s consolidated financial statements.
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, 2023.
ENLIVEX THERAPEUTICS LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2024
(UNAUDITED)
NOTE 3 – CASH, CASH EQUIVALENTS
AND RESTRICTED CASH
| |
June 30, | | |
December 31, | |
(in thousands) | |
2024 | | |
2023 | |
| |
| | |
| |
Cash held in banks | |
$ | 3,747 | | |
$ | 813 | |
Total cash and cash equivalents | |
| 3,747 | | |
| 813 | |
Restricted cash – current – Prepaid expenses and other receivables | |
| 113 | | |
| 113 | |
Restricted cash – noncurrent – Other assets | |
| 306 | | |
| 300 | |
Total cash, cash equivalents and restricted cash shown in the statement of cash flows | |
$ | 4,166 | | |
$ | 1,226 | |
NOTE 4 – SHORT TERM DEPOSITS
| |
June 30, | | |
December 31, | |
(in thousands) | |
2024 | | |
2023 | |
| |
| | |
| |
Bank deposits in U.S.$ (annual average interest rates 5.86% and 6.195%) | |
$ | 9,652 | | |
$ | 6,240 | |
Bank deposits in NIS (annual average interest rates 4.317% and 4.568%) | |
| 12,543 | | |
| 20,267 | |
Total short-term deposits | |
$ | 22,195 | | |
$ | 26,507 | |
NOTE 5 – PREPAID EXPENSES AND OTHER RECEIVABLES
| |
June 30, | | |
December 31, | |
(in thousands) | |
2024 | | |
2023 | |
| |
| | |
| |
Prepaid expenses | |
$ | 1,141 | | |
$ | 1,107 | |
Tax authorities | |
| 47 | | |
| 116 | |
Others | |
| 1,212 | | |
| 113 | |
| |
$ | 2,400 | | |
$ | 1,336 | |
NOTE 6 – PROPERTY AND EQUIPMENT
Property and equipment, net consists of the following:
| |
June 30, | | |
December 31, | |
(in thousands) | |
2024 | | |
2023 | |
| |
| | |
| |
Cost: | |
| | | |
| | |
Laboratory equipment | |
$ | 2,130 | | |
$ | 2,412 | |
Computers | |
| 431 | | |
| 380 | |
Office furniture & equipment | |
| 184 | | |
| 186 | |
Leasehold improvements | |
| 1,431 | | |
| 1,431 | |
Total cost | |
| 4,176 | | |
| 4,409 | |
Accumulated depreciation: | |
| | | |
| | |
Laboratory equipment | |
| 1,876 | | |
| 1,891 | |
Computers | |
| 296 | | |
| 263 | |
Office furniture & equipment | |
| 47 | | |
| 40 | |
Leasehold improvements | |
| 799 | | |
| 676 | |
Total accumulated depreciation | |
| 3,018 | | |
| 2,870 | |
Depreciated cost | |
$ | 1,158 | | |
$ | 1,539 | |
Depreciation expenses for the three and six month periods
ended June 30, 2024 and 2023 were $160, $348, $212 and $421 thousand, respectively.
ENLIVEX THERAPEUTICS LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2024
(UNAUDITED)
NOTE 7 – OTHER ASSETS
| |
June 30, | | |
December 31, | |
(in thousands) | |
2024 | | |
2023 | |
| |
| | |
| |
Restricted cash | |
$ | 306 | | |
$ | 300 | |
Long Term Deposit | |
| 8 | | |
| 8 | |
Long-term prepaid expenses | |
| 92 | | |
| 179 | |
Right-of-Use assets, net | |
| 870 | | |
| 1,041 | |
| |
$ | 1,276 | | |
$ | 1,528 | |
NOTE 8 – ACCRUED EXPENSES AND OTHER LIABILITIES
| |
June 30, | | |
December 31, | |
(in thousands) | |
2024 | | |
2023 | |
| |
| | |
| |
Vacation, convalescence and bonus accruals | |
$ | 291 | | |
$ | 341 | |
Employees and payroll related | |
| 314 | | |
| 422 | |
Short term operating lease liabilities | |
| 336 | | |
| 346 | |
Accrued expenses and other | |
| 1,597 | | |
| 2,892 | |
| |
$ | 2,538 | | |
$ | 4,001 | |
NOTE 9 – LEASES
The Company is a party to operating
leases for its corporate offices, laboratory space, plant space and vehicles.
| |
Six months ended
June 30, | |
(in thousands) | |
2024 | | |
2023 | |
| |
| | |
| |
The components of lease expense were as follows: | |
| | | |
| | |
Operating leases expenses | |
$ | 207 | | |
$ | 522 | |
Supplemental consolidated cash flow information related to operating leases follows: | |
| | | |
| | |
Cash used in operating activities | |
$ | 212 | | |
$ | 520 | |
Non-cash activity: | |
| | | |
| | |
Right of use assets obtained in exchange for new operating lease liabilities | |
$ | 25 | | |
$ | 145 | |
| | June 30, | | | December 31, | |
(in thousands) | | 2024 | | | 2023 | |
Supplemental information related to operating leases, including location of amounts reported in the accompanying consolidated balance sheets, follows: | | | | | | | | |
Other assets - Right-of-Use assets | | $ | 1,722 | | | $ | 2,161 | |
Accumulated amortization | | | 852 | | | | 1,120 | |
Operating lease Right-of-Use assets, net | | $ | 870 | | | $ | 1,041 | |
Lease liabilities – current - Accounts payable and accrued liabilities | | $ | 336 | | | $ | 346 | |
Lease liabilities – noncurrent | | | 499 | | | | 686 | |
Total operating lease liabilities | | $ | 835 | | | $ | 1,032 | |
Weighted average remaining lease term in years | | | 2.89 | | | | 3.3 | |
Weighted average annual discount rate | | | 6.8 | % | | | 6.7 | % |
ENLIVEX THERAPEUTICS LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2024
(UNAUDITED)
Maturities of operating lease liabilities as of June 30, 2024, were as follows: | |
| |
2024 (after June 30) | |
$ | 191 | |
2025 | |
| 355 | |
2026 | |
| 193 | |
2027 | |
| 117 | |
2028 and onwards | |
| 89 | |
Total undiscounted lease liability | |
| 945 | |
Less: Imputed interest | |
| (110 | ) |
Present value of lease liabilities | |
$ | 835 | |
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 annual interest at a SOFR-based rate.
The gross amount of grants received
by the Company from the IIA, including accrued interest as of June 30, 2024, was approximately 9.9 million. As of June 30, 2024, the Company
had not paid any royalties to the IIA.
NOTE 11 – EQUITY
| a) | On May 27, 2024, the Company entered into a securities purchase agreement with a single institutional investor in connection with
the issuance and sale by the Company in a registered direct offering (the “Offering”) of (i) 2,060,000 Ordinary Shares, (ii)
pre-funded warrants to purchase up to 1,511,429 Ordinary Shares (the “Pre-Funded Warrants”), (iii) Series A warrants to purchase
up to 3,571,429 Ordinary Shares (the “Series A Warrants”) and (iv) Series B warrants to purchase up to 3,571,429 Ordinary
Shares (the “Series B Warrants” and, together with the Series A Warrants, the “Investor Warrants”), at a combined
purchase price of (a) $1.40 per Ordinary Share and the associated Investor Warrants, each to purchase one Ordinary Share, and (b) $1.399
per Pre-Funded Warrant and the associated Investor Warrants, each to purchase one Ordinary Share, pursuant to the Company’s effective
shelf registration statement on Form F-3 (File No. 333-364561) and related base prospectus and prospectus supplement. |
Each Investor Warrant has an exercise price of $1.40 per
Ordinary Share and is immediately exercisable. The Series A Warrants expire upon the earlier of 18 months following the issuance date
and 60 days following the Company’s public announcement of positive topline trail results of AllocetraTM for the treatment
of moderate-to-severe knee osteoarthritis (the “Series A Milestone Event”). The Series B warrants expire upon the earlier
of five and one-half years following the issuance date and 60 days following the Company’s public announcement of its filing with
the U.S. Food and Drug Administration (the “FDA”) for approval for AllocetraTM’s osteoarthritis related indication
(the “Series B Milestone Event”). Each Pre-Funded Warrant has an exercise price of $0.001 per Ordinary Share, is immediately
exercisable, may be exercised at any time and has no expiration date.
H.C. Wainwright & Co. (“Wainwright”) acted
as placement agent in connection with the Offering, and in consideration therefor the Company agreed to register and issue to Wainwright
warrants (the “Placement Agent Warrants”, and together with the Investor Warrants and the Pre-Funded Warrants, the “Warrants”)
to purchase up to 250,000 Ordinary Shares. The Placement Agent Warrants comprise Series A Warrants to purchase 125,000 Ordinary Shares
and Series B Warrants to purchase 125,000 Ordinary Shares, containing the same terms as the Investor Warrants, except that they are exercisable
at a price of $1.75 per Ordinary Share, and the Series B Warrants will expire upon the earlier of five years following the commencement
of the sale of the securities offered in the Offering and 60 days following the Company’s public announcement of its filing with
the FDA for approval for AllocetraTM’s osteoarthritis related indication.
In addition, the Company agreed to pay Wainwright an aggregate
cash fee equal to 7% of the gross proceeds raised in the Offering, a management fee equal to 1% of the gross proceeds raised in the Offering
and $90,950 for various fees and expenses.
ENLIVEX THERAPEUTICS LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2024
(UNAUDITED)
The closing of the Offering occurred on May 29, 2024. The
net proceeds from the Offering were approximately $4.5 million after deducting Wainwright’s fees and other expenses relating to
the Offering. The Company intends to use the net proceeds from the Offering for working capital and other general corporate purposes.
| b) | All Company warrants are classified as components 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, require physical settlement and do not provide any
guarantee of value or return (unless, in accordance with ASC 815-40-55-3, there is a fundamental transaction, as defined in the warrant
agreements, which allows the holders of the warrants to receive the same form of consideration payable to the holders of Ordinary Shares,
in which case equity treatment is not precluded). |
| |
Number of Warrants | | |
Weighted
average
exercise price | |
Outstanding January 1, 2024 | |
| 202,251 | | |
$ | 23.31 | |
Issued | |
| 8,904,287 | | |
$ | 1.17 | |
Outstanding and exercisable June 30, 2024 | |
| 9,106,538 | | |
$ | 1.66 | |
Composed of:
Number of Warrants | | | Exercise
Price
Per
Share | | | Issuance
date | | Expiration
date |
| 22,750 | | | $ | 10.00 | | | February 26, 2020 | | February 24, 2025 |
| 160,727 | | | $ | 25.00 | | | February 12, 2021 | | February 9, 2026 |
| 18,774 | | | $ | 25.00 | | | February 17, 2021 | | February 9, 2026 |
| 1,511,429 | | | $ | 0.001 | | | May 29, 2024 | | No expiration date |
| 3,571,429 | | | $ | 1.40 | | | May 29, 2024 | | December 1, 2025(i) |
| 3,571,429 | | | $ | 1.40 | | | May 29, 2024 | | November 29, 2029 (ii) |
| 125,000 | | | $ | 1.75 | | | May 29, 2024 | | December 1, 2025(i) |
| 125,000 | | | $ | 1.75 | | | May 29, 2024 | | May 27, 2029 (iii) |
| 9,106,538 | | | | | | | | | |
| c) | During the six months ended June 30, 2024 the Company issued 180,707 Ordinary Shares under our ATM agreement with Cantor Fitzgerald
& Co. and JMP Securities LLC for a gross consideration of $543 thousand net of $16 thousand of issuance expenses. |
NOTE 12 – SHARE-BASED COMPENSATION
| a) | As of June 30, 2024, 5,028,704 Ordinary Shares were authorized for issuance to employees, directors and consultants under the 2019
Equity Incentive Plan (the “2019 Plan”), of which 966,057 shares remained available for future grant. |
ENLIVEX THERAPEUTICS LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2024
(UNAUDITED)
| b) | The following table contains information concerning options granted under the 2019 Plan: |
| |
Three
months ended
June 30, | |
| |
2024 | | |
2023 | |
| |
Number
of options | | |
Weighted
average exercise price | | |
Number of
options | | |
Weighted
average exercise price | |
Outstanding at beginning of period | |
| 3,007,624 | | |
$ | 5.41 | | |
| 2,929,868 | | |
$ | 5.84 | |
Forfeited and expired | |
| (21,921 | ) | |
$ | 5.06 | | |
| (14,375 | ) | |
$ | 6.82 | |
Outstanding at end of period | |
| 2,985,703 | | |
$ | 5.41 | | |
| 2,915,493 | | |
$ | 5.84 | |
Exercisable at end of period | |
| 2,228,902 | | |
$ | 5.67 | | |
| 2,090,378 | | |
$ | 5.59 | |
| |
| | | |
| | | |
| | | |
| | |
Non-vested at beginning of period | |
| 772,301 | | |
$ | 4.67 | | |
| 876,851 | | |
$ | 6.48 | |
Vested | |
| - | | |
$ | - | | |
| (37,861 | ) | |
$ | 11.13 | |
Forfeited | |
| (13,750 | ) | |
$ | 3.79 | | |
| (13,875 | ) | |
$ | 5.90 | |
Non-vested at the end of period | |
| 758,551 | | |
$ | 4.6 8 | | |
| 825,115 | | |
$ | 6.27 | |
| |
Six months ended
June 30, | |
| |
2024 | | |
2023 | |
| |
Number of options | | |
Weighted average exercise price | | |
Number of options | | |
Weighted average exercise price | |
Outstanding at beginning of period | |
| 2,842,496 | | |
$ | 5.63 | | |
| 2,939,434 | | |
$ | 5.85 | |
Granted | |
| 250,000 | | |
$ | 3.21 | | |
| - | | |
$ | - | |
Forfeited and expired | |
| (106,793 | ) | |
$ | 6.00 | | |
| (23,941 | ) | |
$ | 6.71 | |
Outstanding at end of period | |
| 2,985,703 | | |
$ | 5.41 | | |
| 2,915,493 | | |
$ | 5.84 | |
Exercisable at end of period | |
| 2,228,902 | | |
$ | 5.67 | | |
| 2,090,378 | | |
$ | 5.59 | |
| |
| | | |
| | | |
| | | |
| | |
Non vested at beginning of period | |
| 596,503 | | |
$ | 5.53 | | |
| 986,005 | | |
$ | 6.46 | |
Granted | |
| 250,000 | | |
$ | 3.21 | | |
| - | | |
$ | - | |
Forfeited and expired | |
| (24,313 | ) | |
$ | 5.04 | | |
| (15,375 | ) | |
$ | 6.73 | |
vested | |
| (63,639 | ) | |
$ | 6.75 | | |
| (145,515 | ) | |
$ | 7.44 | |
Outstanding at end of period | |
| 758,551 | | |
$ | 4.68 | | |
| 825,115 | | |
$ | 6.27 | |
During the
three and six month periods ended June 30, 2024 and 2023, the Company recognized $237, $460, $427 and $957 thousand, respectively, of
share-based compensation expenses related to stock options. As of June 30, 2024, the total unrecognized estimated compensation cost related
to outstanding non-vested stock options was $1,061 thousand, which is expected to be recognized over a weighted average period of 1.36
years.
ENLIVEX THERAPEUTICS LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2024
(UNAUDITED)
| c) | Set forth below is data regarding the range of exercise prices
and remaining contractual life for all options outstanding at June 30, 2024: |
Exercise price | | | Number of options outstanding | | | Remaining contractual Life (in years) | | | Intrinsic Value of Options Outstanding (in thousands) | | | No. of options exercisable | |
$ | 2.69 | | | | 649,591 | | | | 0.92 | | | $ | - | | | | 649,591 | |
$ | 3.21 | | | | 240,000 | | | | 9.63 | | | | - | | | | - | |
$ | 3.53 | | | | 53,192 | | | | 9.35 | | | | - | | | | - | |
$ | 3.66 | | | | 250,000 | | | | 5.84 | | | | - | | | | 250,000 | |
$ | 4.68 | | | | 34,500 | | | | 5.75 | | | | - | | | | 34,500 | |
$ | 5.34 | | | | 160,750 | | | | 7.75 | | | | - | | | | 84,000 | |
$ | 5.34 | | | | 442,410 | | | | 8.39 | | | | - | | | | 178,176 | |
$ | 5.96 | | | | 150,000 | | | | 8.39 | | | | - | | | | 37,500 | |
$ | 6.22 | | | | 552,883 | | | | 2.67 | | | | - | | | | 552,883 | |
$ | 8.19 | | | | 150,000 | | | | 5.39 | | | | - | | | | 150,000 | |
$ | 9.02 | | | | 40,500 | | | | 6.38 | | | | - | | | | 30,375 | |
$ | 10.12 | | | | 10,407 | | | | 4.43 | | | | - | | | | 10,407 | |
$ | 12.23 | | | | 250,000 | | | | 6.91 | | | | - | | | | 250,000 | |
$ | 21.40 | | | | 970 | | | | 5.07 | | | | - | | | | 970 | |
$ | 90.16 | | | | 500 | | | | 0.42 | | | | - | | | | 500 | |
| | | | | 2,985,703 | | | | | | | $ | - | | | | 2,228,902 | |
| d) | The following table contains information concerning restricted stock units granted
under the 2019 Plan: |
| |
Three months ended
June 30, | |
| |
2024 | | |
2023 | |
| |
Number
of shares | | |
Weighted
average
grant date fair
value | | |
Number
of shares | | |
Weighted
average
grant date fair
value | |
Nonvested at beginning of period | |
| 571,460 | | |
$ | 2.65 | | |
| 114,329 | | |
$ | 9.97 | |
Granted | |
| | | |
$ | | | |
| - | | |
$ | - | |
Vested | |
| (3,444 | ) | |
$ | 10.28 | | |
| (3,438 | ) | |
$ | 10.28 | |
Forfeited | |
| (5,757 | ) | |
$ | 3.87 | | |
| (313 | ) | |
$ | 14.67 | |
Nonvested at end of period | |
| 562,259 | | |
$ | 2.59 | | |
| 110,578 | | |
$ | 9.95 | |
| |
Six months ended
June 30, | |
| |
2024 | | |
2023 | |
| |
Number
of shares | | |
Weighted
average
grant date fair
value | | |
Number
of shares | | |
Weighted
average
grant date fair
value | |
Nonvested at beginning of period | |
| 621,135 | | |
$ | 3.14 | | |
| 157,560 | | |
$ | 10.02 | |
Granted | |
| - | | |
$ | - | | |
| - | | |
$ | - | |
Vested | |
| (44,050 | ) | |
$ | 9.9 | | |
| (46,544 | ) | |
$ | 10.15 | |
Forfeited | |
| (14,826 | ) | |
$ | 3.64 | | |
| (438 | ) | |
$ | 14.67 | |
Nonvested at end of period | |
| 562,259 | | |
$ | 2.59 | | |
| 110,578 | | |
$ | 9.95 | |
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).
ENLIVEX THERAPEUTICS LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2024
(UNAUDITED)
For the three and six month periods
ended June 30, 2024 and 2023, the Company recognized $151, $311, $84 and $187 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, 2024 was $653 thousand, which is expected to be recognized
over a weighted average period of 1.27 years.
| e) | The following table summarizes share-based compensation expenses included in the
statements of operations related to grants under the 2019 Plan: |
| |
Three months ended
June 30, | | |
Six months ended
June 30, | |
(in thousands) | |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Research & development | |
$ | 145 | | |
$ | 122 | | |
$ | 269 | | |
$ | 318 | |
General & administrative | |
| 243 | | |
| 389 | | |
| 502 | | |
| 826 | |
Total | |
$ | 388 | | |
$ | 511 | | |
$ | 771 | | |
$ | 1,144 | |
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, 2024 and December 31, 2023:
(in thousands) | |
June 30, 2024 | |
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Cash and cash equivalents | |
$ | 3,747 | | |
$ | | | |
$ | - | | |
$ | - | |
Short term deposits | |
| 22,195 | | |
| | | |
| - | | |
| - | |
Restricted cash | |
| 306 | | |
| | | |
| - | | |
| - | |
Total financial assets | |
$ | 26,248 | | |
$ | | | |
$ | - | | |
$ | - | |
(in thousands) | |
December 31, 2023 | |
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Cash and cash equivalents | |
$ | 813 | | |
$ | 813 | | |
$ | - | | |
$ | - | |
Short term deposits | |
| 26,507 | | |
| 26,507 | | |
| - | | |
| - | |
Restricted cash | |
| 413 | | |
| 413 | | |
| - | | |
| - | |
Total financial assets | |
$ | 27,733 | | |
$ | 27,733 | | |
$ | - | | |
$ | - | |
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 the following subsequent event necessitated disclosure:
| 1. | In July 2024, 518,429 Pre-Funded Warrants were exercised for 518,429 Ordinary Shares. |
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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, 2023. 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. By restoring macrophage homeostasis, Allocetra™
has the potential to provide a novel immunotherapeutic mechanism of action for debilitating and life-threatening clinical indications
that are defined as “unmet medical needs,” as a stand-alone therapy or in combination with leading therapeutic agents.
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 affecting 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 clinical program verticals as its main inflammatory and autoimmune indications: sepsis and osteoarthritis. Additionally,
the Company is seeking external collaborations or out-licensing opportunities for the development of Allocetra™ as a next-generation
solid cancer immunotherapy. The Company believes that negatively-reprogrammed macrophages may be key contributors to disease severity
across the Indications (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 and Operational 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 Israeli Innovation Authority (“IIA”) and the sale of equity and equity linked securities in
public and private offerings. As of June 30, 2024, we had approximately $26 million in cash and cash equivalents and short-term bank deposits
and had an accumulated deficit of approximately $119 million, see “—Liquidity and Capital Resources” below.
In
September 2023, we announced a strategic reprioritization plan, pursuant to which we determined to increase our existing focus on inflammatory
and autoimmune indications. As part of the strategic reprioritization plan, in addition to the ongoing Phase II trial of AllocetraTM
in patients with sepsis, the Company initiated a clinical program in osteoarthritis, which is a degenerative disease with low grade
inflammation and an indication with a substantial unmet medical need that potentially represents a multibillion dollar commercial market.
Within the osteoarthritis program, the Company announced the dosing of the first patient in a Phase I/II investigator-initiated clinical
trial enrolling patients with severe knee osteoarthritis who had been indicated for knee replacement surgeries and are offered to inject
AllocetraTM locally into the diseased knee as a potential alternative for pain resolution and knee functionality in lieu of
replacement surgery. In addition to this Phase I/II trial, following receipt of the approval of the Israeli Ministry of Health (the “IMOH”)
in January 2024, the Company initiated a multi-country randomized, controlled Phase I/II clinical trial evaluating AllocetraTM
in patients with moderate knee osteoarthritis in early 2024. In April 2024, we announced that the Danish Medicines Agency authorized
the expansion of this trial into Denmark, as well as the dosing of the first two patients in the trial. This
Phase I/II clinical trial is expected to enroll up to 160 patients and is designed to be a multi-center, multi-country, double-blinded,
placebo-controlled and statistically-powered study to evaluate efficacy as well as safety of AllocetraTM, and potentially allow
the Company to design and initiate a clinical registrational trial upon its completion.
The
Company’s revised strategy is targeted at obtaining a topline data readout from the randomized, controlled Phase I/II trial in up
to 160 patients with moderate knee osteoarthritis by the third quarter of 2025 and from the Phase I/II investigator-initiated clinical
trial in 12 patients with severe knee osteoarthritis who had been indicated for knee replacement surgeries by the end of the third quarter
of 2024.
Pursuant
to the strategic reprioritization plan, and in light of the new guidelines and regulatory initiatives set by the FDA for drug development
in oncology, which may result in longer clinical development cycles as foundations for regulatory approvals, the Company ceased the internal
clinical development of its various oncology indications and plans to seek external collaborations or out-licensing opportunities for
the development of Allocetra™ as a next-generation solid cancer immunotherapy.
As
a result of the Company’s reprioritization of its clinical indications and focus on the inflammatory and auto-immune verticals,
the Company reduced its workforce by approximately 50%. The workforce reductions and the savings associated with the reclassification
of the oncology indications as candidates for external collaborations or out-licensing opportunities in lieu of internal development has
resulted in a substantial extension of the Company’s cash runway. Given the implementation of our reprioritization plan, the sale
of our manufacturing facility in Yavne, Israel in April 2024 and the receipt of approximately $4,416 thousand of net proceeds from
the May 2024 Offering (as defined below), management currently believes that our existing cash resources will be sufficient to fund our
projected cash requirements through the end of 2026. Management currently expects that the Company’s
existing cash and cash equivalents support the timeline for the topline data readouts from the end-stage knee osteoarthritis Phase I/II
trial, the randomized, controlled Phase I/II clinical trial in knee osteoarthritis, and the randomized, controlled Phase II clinical trial
in basal thumb osteoarthritis, as well as the one-year follow up for each of the foregoing trials. Additionally, management expects that
our current cash and cash equivalents will continue to support additional research and development activities related to our Allocetra™
platform.
We expect that we will continue
to incur operating losses, which may be substantial over the next several years, and we may need to obtain additional funds to further
develop our research and development programs
Recent Developments
IMOH Approval of Investigator-Initiated Phase I/II Trial
In June 2024, the IMOH authorized
the initiation of an investigator-initiated, randomized, placebo-controlled Phase I/II trial to evaluate the efficacy, safety and tolerability
of Allocetra™ following injection into patients with basal thumb joint (first carpometacarpal (CMC) joint) osteoarthritis. The investigator-initiated
Phase I/II trial plans to recruit up to 46 patients and is composed of two stages. The first stage is a safety run-in, open-label dose
escalation phase to characterize the safety and tolerability of Allocetra™ injection to patients with osteoarthritis of the first
basal thumb joint (first CMC joint) of the target thumb who have failed conventional therapies, to identify the dose for the randomized
stage. The second stage is a double-blind, randomized, placebo-controlled stage, which is expected to be initiated following the completion
of the safety run-in stage and selection of the safe and tolerable dose. Up to 40 patients will be randomized in a 1:1 ratio for treatment
with Allocetra™ at the selected dose or placebo. The primary safety endpoint will measure the frequency and severity of adverse
events and serious adverse events and the efficacy endpoints will include assessments of change from baseline in pain and function for
up to 12 months.
Topline Interim Data Readout
In June 2024, the Company
released a positive interim data readout from a Phase I/II investigator-initiated clinical trial of Allocetra™ in patients with
end-stage knee osteoarthritis who had been indicated for knee replacement surgery. In this study, patients with end-stage knee osteoarthritis
are offered a single Allocetra™ injection to the knee as a potential “last resort” alternative for pain resolution and
knee functionality in lieu of knee-replacement surgery. A total of nine patients have been enrolled and treated with a single Allocetra™
injection to the knee and evaluated for at least three months following treatment. Patients reported pain using a scale of zero (0, representing
no pain) to ten (10, representing maximum pain).
At the three-month follow
up, a substantial reduction (51%) in average reported pain was observed compared to baseline, with 89% (8/9) of treated patients reporting
an improvement in their knee pain compared to their baseline pain prior to treatment, and 22% (2/9) of the patients reporting complete
pain relief from an average pain level of 9 to a pain level of 0.
During the three-month period
post injection of Allocetra™, only a single patient (1/9, 11%) decided to move forward with knee-replacement surgery, while 89%
(8/9) of the patients decided not to proceed with such surgery. In all cases, dosing was successfully completed, and no severe related
adverse events were reported following treatment.
Recruitment to the study and
long-term follow up are ongoing. The study aims to enroll a total of 18 patients to be treated with a single injection of Allocetra™
to the afflicted knee. Patients are assessed for safety following dosing, and pain and function responses to treatment up to 12 months
following injection.
IMOH Approval of Phase I Clinical Trial
In July 2024, the Company
announced that the IMOH has authorized the initiation of a Phase I clinical trial to evaluate the safety and tolerability of Allocetra™
following injection into an affected joint in patients with psoriatic arthritis.
The trial currently plans
to recruit six patients who have insufficiently responded to conventional therapies for psoriatic arthritis. The primary safety endpoint
will measure the frequency and severity of adverse events and serious adverse events, and secondary endpoints will include assessments
of change from baseline in pain and other parameters of disease activity for up to 12 months following administration of Allocetra™.
Recent Developments In Israel
In October 2023, Hamas terrorists
infiltrated Israel’s southern border from the Gaza Strip and conducted a series of attacks on civilian and military targets. Hamas
also launched extensive rocket attacks on the Israeli population and industrial centers located along Israel’s border with the Gaza
Strip and in other areas within the State of Israel. These attacks resulted in thousands of deaths and injuries, and Hamas additionally
kidnapped many Israeli civilians and soldiers. Following the attack, Israel’s security cabinet declared war against Hamas and commenced
a military campaign against Hamas.
In April 2024, Israel experienced
a direct attack from Iran, involving hundreds of drones and missiles launched towards various parts of the country, mostly targeting military
bases. The Israeli defense systems, aided by international allies, successfully intercepted the majority of these attacks, minimizing
physical damage and casualties. Additionally, Since October 2023, the Houthis, a military organization based in Yemen, have launched a
series of attacks on global shipping routes in the Red Sea, as well as direct attacks on various parts of Israel. Such incidents contribute
to regional instability and could potentially escalate into broader conflicts with Iran and its proxies in the Middle East, affecting
Israel’s political and trade relations, especially with neighboring countries and global allies. The situation remains fluid, and
the potential for further escalation exists.
The ongoing war with Hamas,
and the conflict with Iran and its proxies have not, to date, materially impacted our business or operations. Furthermore, we do not expect
any delays to any of our clinical trials or programs as a result of such conflicts. However, we cannot currently predict the intensity
or duration of Israel’s war against Hamas or the conflict with Iran and its proxies, nor can we predict how such conflicts will
ultimately affect our business and operations or Israel’s economy in general.
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 for the foreseeable future as we continue to develop our
product candidates. Increases or decreases in research and development expenditures are primarily 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 and clinical studies for, among other things, toxicology, safety and efficacy.
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 development of our product candidates 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 financial position and 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, 2023 as filed with the U.S. Securities and Exchange Commission (the “SEC”)
on April 30, 2024.
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.
Preclinical and clinical
trial accruals
The Company makes estimates
of its accrued expenses as of each balance sheet date in the financial statements based on the facts and circumstances known at that time.
Accrued expenses for preclinical studies and clinical trials are based on estimates of costs incurred and fees that may be associated
with services provided by contract research organizations, clinical trial sites and other clinical trial-related activities. Payments
under certain contracts with such parties depend on factors such as successful enrollment of patients, site initiation and the completion
of clinical trial milestones. If possible, the Company obtains information regarding unbilled services directly from these service providers.
However, the Company may be required to estimate these services based on other available information. If the Company underestimates or
overestimates the activities or fees associated with a study or service at a given point in time, adjustments to research and development
expenses may be necessary in future periods. Historically, estimated accrued liabilities have approximated actual expense incurred.
Results of Operations
Six-Months Ended June 30,
2024 Compared to Six-Months Ended June 30, 2023
The table below provides our results
of operations for the six months ended June 30, 2024 and June 30, 2023:
| |
Six Months Ended June 30 | |
| |
2024 | | |
2023 | |
| |
(In thousands, except per share data) (unaudited) | |
Research and development expenses | |
$ | 4,856 | | |
$ | 10,211 | |
General and administrative expenses | |
| 2,080 | | |
| 3,221 | |
Loss on disposal group of assets held for sale | |
| 201 | | |
| | |
Operating loss | |
| (7,137 | ) | |
| (13,432 | ) |
Finance expenses, net | |
| (99 | ) | |
| (578 | ) |
Operating loss post other expenses, net | |
| (7,236 | ) | |
| (14,010 | ) |
Taxes on income | |
| - | | |
| - | |
Net loss | |
| (7,236 | ) | |
| (14,010 | ) |
| |
| | | |
| | |
Basic loss per share | |
$ | (0.38 | ) | |
$ | (0.76 | ) |
Diluted loss per share | |
$ | (0.38 | ) | |
$ | (0.76 | ) |
Three-Months
Ended June 30, 2024 Compared to Three-Months Ended June 30, 2023
The table
below provides our results of operations for the three months ended June 30, 2024 and June 30, 2023:
| |
Three Months Ended June 30 | |
| |
2024 | | |
2023 | |
| |
(In thousands, except per share data) (unaudited) | |
Research and development expenses | |
$ | 1,999 | | |
$ | 5,035 | |
General and administrative expenses | |
| 987 | | |
| 1,614 | |
Loss on disposal group of assets held for sale | |
| - | | |
| - | |
Operating loss | |
| (2,986 | ) | |
| (6,649 | ) |
Finance expenses, net | |
| (110 | ) | |
| (143 | ) |
Operating loss post other expenses, net | |
| | | |
| (6,792 | ) |
Taxes on income | |
| - | | |
| - | |
Net loss | |
| (3,096 | ) | |
| (6,792 | ) |
| |
| | | |
| | |
Basic loss per share | |
$ | (0.16 | ) | |
$ | (0.37 | ) |
Diluted loss per share | |
$ | (0.16 | ) | |
$ | (0.37 | ) |
Research and Development
Expenses
For the six months ended June
30, 2024 and 2023, we incurred research and development expenses in the aggregate of $4,856,000 and $10,211,000, respectively. The decrease
of $5,355,000, or 52%, in research and development expenses for the six months ended June 30, 2024 as compared to the comparable six month
period in 2023 was primarily due to a $1,472,000 decrease in salaries as a result of the reduction
in workforce as part of the strategic reprioritization plan, a $3,702,000 decrease
in expenses for clinical studies and pre-clinical studies and purchase of materials due to a decrease in the number of AllocetraTM
doses that were manufactured, and a $227,000 decrease in lease and overhead expenses.
For the three months ended
June 30, 2024 and 2023, we incurred research and development expenses in the aggregate of $1,999,000 and $5,035,000, respectively. The
decrease of $3,036,000, or 60%, in research and development expenses for the three months ended June 30, 2024 as compared to the second
quarter of 2023 was primarily due to a $731,000 decrease in salaries as a result of the reduction
in workforce as part of the strategic reprioritization plan, and a $2,414,000 decrease
in expenses for clinical studies and pre-clinical studies and purchase of materials due to a decrease in the number of AllocetraTM
doses that were manufactured.
General and Administrative
Expenses
For the six months ended June
30, 2024 and 2023, we incurred general and administrative expenses in the aggregate of $2,080,000 and $3,221,000, respectively. The decrease
of $1,141,000 or 35%, in general and administrative expenses for the six months ended June 30, 2024 as compared to the comparable six
month period in 2023 was primarily due to a $324,000 decrease in expense with respect to equity awards granted to directors, officers
and employees, a $136,000 decrease in insurance expenses (due to a decrease in our directors’ and officer’s liability insurance
premium), a $292,000 decrease in lease and overhead expense, a $116,000 decrease in professional fees related to intellectual property
regulatory expenses, and a $125,000 decrease in salaries.
For the three months ended
June 30, 2024 and 2023, we incurred general and administrative expenses in the aggregate of $987,000 and $1,614,000, respectively. The
decrease of $627,000, or 39%, in general and administrative expenses for the three months ended June 30, 2024 as compared to the second
quarter of 2023 was primarily due to a $146,000 decrease in expense with respect to equity awards granted to directors, officers and employees,
a $202,000 decrease in lease and overhead expense, a $80,000 decrease in professional fees related to intellectual property regulatory
expenses, a $49,000 decrease in professional fees, and a $78,000 decrease in salaries.
Loss on Disposal Group of Assets
Held for Sale
During 2023, the Company adopted
its strategic reprioritization plan, as described above, as part of which the Company determined to sell its manufacturing plant facility
in Yavne, Israel. Therefore, the right of use of the manufacturing plant, the lease liability relating to the manufacturing plant and
the leasehold improvements installed in the leased plant were classified as assets held for sale and liability held for sale (as applicable).
As a result, for the year ended December 31, 2023, we recognized a loss of $4,244,000 on the group of assets held for sale. For the first
half of 2024, we recorded an additional $201,000 loss on the group of assets held for sale.
In September 2021, we entered
into a lease agreement for a 2,500 square meter property in Yavne, Israel to construct a new 1,600 square meter facility for the manufacture
of Allocetra™, which was completed in the fourth quarter of 2022. As part of our strategic
reprioritization plan, we determined to sell such leased manufacturing facility, together with related equipment, and assign the lease
agreement. On March 31, 2024, we entered into a sale agreement with a purchaser, pursuant to which the purchaser agreed to acquire such
equipment and assume all of our obligations under the lease agreement, effective as of April 1, 2024. The 13.0 million NIS (approximately
$3.5 million) aggregate purchase price payable to the Company, which is payable in installments, consists of an initial payment of NIS
4.0 million (approximately $1.08 million), which was paid on April 2, 2024, and 24 equal monthly installment payments of NIS 375,000 (approximately
$102,000), commencing on April 1, 2024. Under the sale agreement, title to the equipment will transfer to the purchaser only upon full
payment of the total purchase price, but risk of loss to the equipment passed to the purchaser on April 1, 2024. Subject to certain conditions,
the purchaser may, in its sole discretion, prior to October 1, 2025, prepay (i) all of the remaining outstanding purchase price at a 4%
discount, or (ii) a portion of the remaining outstanding purchase price, in an amount of not less than NIS 4.0 million (approximately
$1.08 million), at a 2% discount, in which case, the purchase price remaining outstanding thereafter shall continue to be paid in monthly
instalments of NIS 375,000 each (approximately $102,000).
Operating Loss
Due to a decrease in research
and development expenses and a decrease in general and administrative expenses for the six and three months ended June 30, 2024, our operating
loss was $7,137,000 and $2,986,000, respectively, representing a decrease of $6,295,000 and $3,663,000, or 47%% and 55%, respectively,
as compared to our operating loss of $13,432,000 and $6,649,000 for the six and three months ended June 30, 2023, respectively. This decrease
resulted primarily from a decrease in research and development expenses, including expenses relating to conducting studies and trials,
and a decrease in salaries as a result of the reduction in workforce as part of the strategic reprioritization plan, in each case as described
above.
Finance expenses, net
Finance expenses, net consists
of the following:
|
● |
Interest earned on our cash and cash equivalents and bank deposits; and |
|
● |
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. |
For the six and three months
ended June 30, 2024 and 2023, we recorded finance expenses, net of $99,000, $110,000, $578,000 and $143,000 respectively. The decrease
of $479,000, or 83%, in finance expenses, net for the six months ended June 30, 2024 as compared to the six months ended June 30, 2023
was primarily due to $540,000 of interest income earned on cash equivalents and bank deposits in 2024, as compared to $884,000 in 2023,
offset by a loss of $639,000 resulting from foreign exchange currency fluctuations on cash and cash equivalents in 2024 as compared to
a loss of $1,458,000 in 2023.
The decrease of $33,000, or
23%, in finance expenses, net for the three months ended June 30, 2024 as compared to the three months ended June 30, 2023 was primarily
due to $265,000 interest income on bank deposits in 2024 as compared to $422,000 in 2023, offset by a loss of $375,000 resulting from
foreign exchange currency fluctuations on cash and cash equivalents in 2024 as compared to $558,000 in 2023.
Net Loss
For
the six and three months ended June 30, 2024 and 2023, our net loss was $7,236,000, $3,096,000, $14,010,000 and $6,792,000, respectively,
representing a decrease of $6,774,000 and $3,696,000, or 48% and 54%, respectively, as compared to our net loss for the comparable prior
year periods.
This decrease resulted primarily
from a decrease in clinical and pre-clinical studies, material consumption and salaries, and from an increase in finance income, net.
Cash Flows
Six Months Ended June
30, 2024 Compared to Six Months Ended June 30, 2023
For the six months ended June
30, 2024 and 2023, net cash used in operations was $6,307,000 and $12,807,000, respectively. The decrease in net cash used in operations
for 2024 was primarily due to a decrease in payments to suppliers, service providers and employees as result of a decrease in payroll
and insurance expenses, as well as a decrease in research and development expenses, mainly from decreased clinical and pre-clinical study
expenses.
For the six months ended June
30, 2024 and 2023, net cash provided by (used in) investing activities was $4,304,000 and $(34,048,000) respectively. The increase in
net cash provided by investing activities for 2024 as compared to 2023 resulted primarily from a net release of investments in bank deposits
of $4,138,000 in 2024 as compared to a net investment in bank deposits of $33,930,000 in the comparable prior year period.
For the six months ended June
30, 2024 and 2023, net cash provided by financing activities was $4,943,000 and $360,000, respectively. This increase in cash provided
by financing activities for 2024 as compared to 2023 resulted primarily from net proceeds of $4,416,000 from issuance of ordinary shares
and warrants in the May 2024 Offering (as defined below) and from net proceeds of $527,000 from our issuance of ordinary shares under
the ATM Agreement (as defined below), as compared to net proceeds of $360,000 from our issuance of ordinary shares under the ATM Agreement
in the comparable prior year period.
Liquidity and Capital Resources
We have incurred substantial
losses since our inception. As of June 30, 2024, we had an accumulated deficit of approximately $119.3 million and working capital (current
assets less current liabilities) of approximately $25.7 million. We expect to incur losses from operations for the foreseeable future.
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 end of 2026. 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 agreements 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 our 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 2024, we
received aggregate net proceeds of approximately $527,000 from the sale of 180,707 ordinary shares under the ATM Agreement.
May 2024 Financing
On May 27, 2024, we entered
into a securities purchase agreement with a single institutional investor in connection with the issuance and sale by the Company in a
registered direct offering (the “May 2024 Offering”) of (i) 2,060,000 of our ordinary shares, (ii) pre-funded
warrants to purchase up to 1,511,429 ordinary shares (the “Pre-Funded Warrants”), (iii) Series A warrants to purchase
up to 3,571,429 ordinary shares (the “Series A Warrants”) and (iv) Series B warrants to purchase up to 3,571,429 ordinary
shares (the “Series B Warrants” and, together with the Series A Warrants, the “Investor Warrants”),
at a combined purchase price of (a) $1.40 per ordinary share and the associated Investor Warrants, each to purchase one ordinary share,
and (b) $1.399 per Pre-Funded Warrant and the associated Investor Warrants, each to purchase one ordinary share, pursuant to the Company’s
effective shelf registration statement on Form F-3 (File No. 333-264561) and a related base prospectus, together with the related prospectus
supplement, dated as of May 27, 2024, filed with the SEC.
Each Investor Warrant has
an exercise price of $1.40 per ordinary share and is immediately exercisable. The Series A Warrants expire upon the earlier of 18 months
following the issuance date and 60 days following our public announcement of positive topline results from the ENX-CL-05-001 trial of
AllocetraTM for the treatment of moderate-to-severe knee osteoarthritis. The Series B warrants expire upon the earlier of five
and one-half years following the issuance date and 60 days following our public announcement of our filing with the U.S. Food and Drug
Administration (the “FDA”) for approval for AllocetraTM’s osteoarthritis related indication. Each Pre-Funded
Warrant has an exercise price of $0.001 per ordinary share, is immediately exercisable and may be exercised at any time and has no expiration
date. The Investor Warrants and the Pre-Funded Warrants are subject to customary adjustments; however, no such warrants contain any “ratchet”
or other financial antidilution provisions. None of the Investor Warrants may be exercised if the aggregate number of ordinary shares
beneficially owned by the holder thereof would exceed 4.99% immediately after exercise thereof, subject to increase to 9.99% at the option
of the holder. None of the Pre-Funded Warrants may be exercised if the aggregate number of ordinary shares beneficially owned by the holder
thereof would exceed 9.99% immediately after exercise thereof.
H.C. Wainwright & Co.
(“Wainwright”) acted as placement agent in connection with the May 2024 Offering, and in consideration therefor we
agreed to register and issue to Wainwright warrants (the “Placement Agent Warrants”) to purchase up to 250,000 of our
ordinary shares pursuant to the above noted registration statement. The Placement Agent Warrants comprise Series A Warrants to purchase
125,000 of our ordinary shares and Series B Warrants to purchase 125,000 of our ordinary shares, containing the same terms as the Investor
Warrants, except that they are exercisable at a price of $1.75 per ordinary share, and the Series B Warrants will expire upon the earlier
of five years following the commencement of the sale of the securities offered in the May 2024 Offering and 60 days following the public
announcement of our filing with the FDA for approval for AllocetraTM’s osteoarthritis related indication. The net proceeds
from the May 2024 Offering were approximately $4,416 thousand after deducting Wainwright’s fees and other offering expenses. We
intend to use the net proceeds from the May 2024 Offering for working capital and other general corporate purposes.
Foreign Currency Exchange Risk
Our foreign currency exposures
give rise to market risk associated with exchange rate movements of the NIS mainly against the U.S. dollar, and vice versa, because a
considerable portion of our expenses are denominated in the NIS. Our NIS expenses consist principally of payments made to employees, sub-contractors
and consultants for preclinical studies, clinical trials and other research and development activities. We anticipate that a sizable portion
of our expenses will continue to be denominated in the NIS. Our financial position, results of operations and cash flow are subject to
fluctuations due to changes in foreign currency exchange rates. Our results of operations and cash flow are, therefore, subject to fluctuations
due to changes in foreign currency exchange rates and may be adversely affected in the future due to changes in foreign exchange rates.
10
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v3.24.2.u1
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Current Assets |
|
|
Cash and cash equivalents |
$ 3,747
|
$ 813
|
Short-term interest-bearing deposits |
22,195
|
26,507
|
Prepaid expenses and other receivables |
2,400
|
1,336
|
Assets classified as held for sale |
228
|
5,108
|
Total Current Assets |
28,570
|
33,764
|
Non-Current Assets |
|
|
Other receivables |
898
|
|
Property and equipment, net |
1,158
|
1,539
|
Other assets |
1,276
|
1,528
|
Total Non-Current Assets |
3,332
|
3,067
|
TOTAL ASSETS |
31,902
|
36,831
|
Current Liabilities |
|
|
Accounts payable |
303
|
827
|
Accrued expenses and other liabilities |
2,538
|
4,001
|
Liability classified as held for sale |
|
1,233
|
Total Current Liabilities |
2,841
|
6,061
|
Non-Current Liabilities |
|
|
Other long-term liabilities |
499
|
686
|
Total Non-Current Liabilities |
499
|
686
|
Commitments and Contingent Liabilities |
|
|
TOTAL LIABILITIES |
3,340
|
6,747
|
SHAREHOLDERS’ EQUITY |
|
|
Ordinary shares of NIS 0.40 par value per share Authorized: 45,000,000 shares as of June 30, 2024 and December 31, 2023; Issued and outstanding: 20,883,312 and 18,598,555 as of June 30, 2024 and December 31, 2023, respectively; |
2,385
|
2,137
|
Additional paid in capital |
144,405
|
138,939
|
Foreign currency translation adjustments |
1,101
|
1,101
|
Accumulated deficit |
(119,329)
|
(112,093)
|
TOTAL SHAREHOLDERS’ EQUITY |
28,562
|
30,084
|
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY |
$ 31,902
|
$ 36,831
|
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v3.24.2.u1
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|
Jun. 30, 2024 |
Dec. 31, 2023 |
Statement of Financial Position [Abstract] |
|
|
Ordinary shares, par value (in Dollars per share) |
$ 0.4
|
$ 0.4
|
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45,000,000
|
45,000,000
|
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20,883,312
|
18,598,555
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20,883,312
|
18,598,555
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.24.2.u1
Condensed Consolidated Statements Of Operations And Comprehensive Loss (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Income Statement [Abstract] |
|
|
|
|
Revenues |
|
|
|
|
Operating expenses: |
|
|
|
|
Research and development expenses |
1,999
|
5,035
|
4,856
|
10,211
|
General and administrative expenses |
987
|
1,614
|
2,080
|
3,221
|
Loss on disposal group of assets held for sale |
|
|
201
|
|
Total |
2,986
|
6,649
|
7,137
|
13,432
|
Operating loss |
(2,986)
|
(6,649)
|
(7,137)
|
(13,432)
|
Finance income (expense) |
(110)
|
(143)
|
(99)
|
(578)
|
Net loss |
$ (3,096)
|
$ (6,792)
|
$ (7,236)
|
$ (14,010)
|
Basic loss per share (in Dollars per share) |
$ (0.16)
|
$ (0.37)
|
$ (0.38)
|
$ (0.76)
|
Weighted average number of shares outstanding (in Shares) |
19,545,056
|
18,584,801
|
19,138,066
|
18,550,702
|
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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|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Income Statement [Abstract] |
|
|
|
|
Basic & diluted loss per share |
$ (0.16)
|
$ (0.37)
|
$ (0.38)
|
$ (0.76)
|
X |
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v3.24.2.u1
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, 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
|
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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
|
|
|
|
|
Balance at Dec. 31, 2023 |
$ 2,137
|
138,939
|
1,101
|
(112,093)
|
$ 30,084
|
Balance (in Shares) at Dec. 31, 2023 |
18,598,555
|
|
|
|
18,598,555
|
Restricted stock units vested |
$ 3
|
(3)
|
|
|
|
Restricted stock units vested (in Shares) |
34,295
|
|
|
|
|
Issuance of shares for cash consideration |
$ 20
|
504
|
|
|
524
|
Issuance of shares for cash consideration (in Shares) |
178,931
|
|
|
|
|
Stock based compensation |
|
383
|
|
|
383
|
Net loss |
|
|
|
(4,140)
|
(4,140)
|
Balance at Mar. 31, 2024 |
$ 2,160
|
139,823
|
1,101
|
(116,233)
|
26,851
|
Balance (in Shares) at Mar. 31, 2024 |
18,811,781
|
|
|
|
|
Balance at Dec. 31, 2023 |
$ 2,137
|
138,939
|
1,101
|
(112,093)
|
$ 30,084
|
Balance (in Shares) at Dec. 31, 2023 |
18,598,555
|
|
|
|
18,598,555
|
Net loss |
|
|
|
|
$ (7,236)
|
Balance at Jun. 30, 2024 |
$ 2,385
|
144,405
|
1,101
|
(119,329)
|
$ 28,562
|
Balance (in Shares) at Jun. 30, 2024 |
20,883,312
|
|
|
|
20,883,312
|
Balance at Mar. 31, 2024 |
$ 2,160
|
139,823
|
1,101
|
(116,233)
|
$ 26,851
|
Balance (in Shares) at Mar. 31, 2024 |
18,811,781
|
|
|
|
|
Restricted stock units vested |
$ 1
|
(1)
|
|
|
|
Restricted stock units vested (in Shares) |
9,755
|
|
|
|
|
Exercise of options |
|
|
|
|
|
Issuance of shares for cash consideration |
$ 224
|
4,195
|
|
|
4,419
|
Issuance of shares for cash consideration (in Shares) |
2,061,776
|
|
|
|
|
Stock based compensation |
|
388
|
|
|
388
|
Net loss |
|
|
|
(3,096)
|
(3,096)
|
Balance at Jun. 30, 2024 |
$ 2,385
|
$ 144,405
|
$ 1,101
|
$ (119,329)
|
$ 28,562
|
Balance (in Shares) at Jun. 30, 2024 |
20,883,312
|
|
|
|
20,883,312
|
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Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Cash flows from operating activities |
|
|
Net loss |
$ (7,236)
|
$ (14,010)
|
Income and expenses not involving cash flows: |
|
|
Depreciation |
348
|
421
|
Capital gain on sale of property and equipment |
(79)
|
|
Loss on short-term bank deposits |
166
|
1,626
|
Gain on assets and liabilities classified as held for sale |
(66)
|
|
Non-cash operating lease expenses |
181
|
434
|
Share-based compensation |
771
|
1,144
|
Changes in operating asset and liability items: |
|
|
Decrease in prepaid expenses and other receivables |
1,792
|
(169)
|
Decrease in accounts payable |
(524)
|
(240)
|
Decrease in accrued expenses and other liabilities |
(1,453)
|
(1,389)
|
Operating lease liabilities |
(207)
|
(624)
|
Net cash used in operating activities |
(6,307)
|
(12,807)
|
Cash flows from investing activities |
|
|
Purchase of property and equipment |
(59)
|
(200)
|
Proceeds from sale of property and equipment |
171
|
82
|
Proceeds from sale of assets held for sale |
54
|
|
Investment in short-term interest-bearing bank deposits |
(18,774)
|
(34,218)
|
Release of short-term interest-bearing bank deposits |
22,912
|
288
|
Net cash provided by (used in) investing activities |
4,304
|
(34,048)
|
Cash flows from financing activities |
|
|
Proceeds from issuance of shares and warrants, net |
4,943
|
360
|
Proceeds from exercise of options |
|
|
Net cash provided by financing activities |
4,943
|
360
|
Increase (decrease) in cash and cash equivalents |
2,940
|
(46,495)
|
Cash and cash equivalents - beginning of period |
1,226
|
50,357
|
Cash and cash equivalents - end of period |
4,166
|
3,862
|
Supplemental disclosures of cash flow information: |
|
|
Cash paid for taxes |
|
|
Cash received for interest, net |
$ 906
|
$ 233
|
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v3.24.2.u1
General Information
|
6 Months Ended |
Jun. 30, 2024 |
General Information [Abstract] |
|
GENERAL INFORMATION |
NOTE 1 - GENERAL INFORMATION
Enlivex Therapeutics Ltd. (the “Parent”
and, including its consolidated subsidiaries, “we”, “us”, “our” or the “Company”) was
originally incorporated on January 22, 2012 under the laws of the State of Israel.
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 debilitating and life-threatening conditions. Non-homeostatic macrophages contribute significantly to the
severity of certain diseases, which include, sepsis, osteoarthritis 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, 2024, had an accumulated deficit of $119,329 thousand.
The Company expects to continue to
incur losses for the foreseeable future, 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 following the filing of these financial
statements on Form 6-K. The Company may determine, however, to raise additional capital during such period as the Board deems prudent.
The Company’s management plans to finance its operations with issuances of the Company’s equity securities and, in the longer
term, revenues. There are no assurances, however, that the Company will be successful in obtaining the financing necessary for its long-term
development. The Company’s ability to continue to operate in the long term is dependent upon additional financial support.
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v3.24.2.u1
Significant Accounting Policies
|
6 Months Ended |
Jun. 30, 2024 |
Significant Accounting Policies [Abstract] |
|
SIGNIFICANT ACCOUNTING POLICIES |
NOTE 2 - SIGNIFICANT ACCOUNTING
POLICIES
Basis of Presentation
These unaudited condensed consolidated
financial statements include the accounts of the Company and have been prepared in accordance with U.S. generally accepted accounting
principles (“U.S. GAAP”) for interim financial information. Accordingly, certain information and footnote disclosures normally
included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. In the opinion of management, all
adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been made. These unaudited condensed consolidated
financial statements should be read in conjunction with the Company’s audited annual financial statements and notes thereto included
in the Company’s 2023 Annual Report on Form 20-F, as filed with the U.S. Securities and Exchange Commission on April 30, 2024. The
results of operations for these interim periods are not necessarily indicative of the operating results for any future period. The December 31,
2023 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 transaction.
1 U.S. dollar = 3.759 NIS and 3.627
NIS as of June 30, 2024 and December 31, 2023, respectively.
The U.S. dollar increased against the
NIS 2.12%, 3.64%, 2.35% and 5.14% in the three and six month periods ended June 30, 2024 and 2023, respectively.
Recently Adopted Accounting Standards
During the three months ended June
30, 2024, the Company was not required to adopt any recently issued accounting standards.
Recently Issued Accounting Pronouncements
Not Yet Adopted
In November 2023, the FASB issued ASU
2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which is intended to provide enhanced segment
disclosures. The standard will require disclosures about significant segment expenses and other segment items and identifying the Chief
Operating Decision Maker and how they use the reported segment profitability measures to assess segment performance and allocate resources.
These enhanced disclosures are required for all entities on an interim and annual basis, even if they have only a single reportable segment.
The standard is effective for years beginning after December 15, 2023 and interim periods within annual periods beginning after December
15, 2024, and early adoption is permitted. The Company does not believe that adoption of this ASU will have a material impact on the Company’s
consolidated financial statements.
In December 2023, the FASB issued ASU
2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which is intended to provide enhancements to annual income
tax disclosures. The standard will require more detailed information in the rate reconciliation table and for income taxes paid, among
other enhancements. The standard is effective for years beginning after December 15, 2024, early adoption is permitted. The Company does
not believe that adoption of this ASU will have a material impact on the Company’s consolidated financial statements.
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, 2023.
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v3.24.2.u1
Cash, Cash Equivalents and Restricted Cash
|
6 Months Ended |
Jun. 30, 2024 |
Cash, Cash Equivalents and Restricted Cash [Abstract] |
|
CASH, CASH EQUIVALENTS AND RESTRICTED CASH |
NOTE 3 – CASH, CASH EQUIVALENTS
AND RESTRICTED CASH
| |
June 30, | | |
December 31, | |
(in thousands) | |
2024 | | |
2023 | |
| |
| | |
| |
Cash held in banks | |
$ | 3,747 | | |
$ | 813 | |
Total cash and cash equivalents | |
| 3,747 | | |
| 813 | |
Restricted cash – current – Prepaid expenses and other receivables | |
| 113 | | |
| 113 | |
Restricted cash – noncurrent – Other assets | |
| 306 | | |
| 300 | |
Total cash, cash equivalents and restricted cash shown in the statement of cash flows | |
$ | 4,166 | | |
$ | 1,226 | |
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v3.24.2.u1
Short Term Deposits
|
6 Months Ended |
Jun. 30, 2024 |
Short Term Deposits [Abstract] |
|
SHORT TERM DEPOSITS |
NOTE 4 – SHORT TERM DEPOSITS
| |
June 30, | | |
December 31, | |
(in thousands) | |
2024 | | |
2023 | |
| |
| | |
| |
Bank deposits in U.S.$ (annual average interest rates 5.86% and 6.195%) | |
$ | 9,652 | | |
$ | 6,240 | |
Bank deposits in NIS (annual average interest rates 4.317% and 4.568%) | |
| 12,543 | | |
| 20,267 | |
Total short-term deposits | |
$ | 22,195 | | |
$ | 26,507 | |
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v3.24.2.u1
Property and Equipment
|
6 Months Ended |
Jun. 30, 2024 |
Property and Equipment [Abstract] |
|
PROPERTY AND EQUIPMENT |
NOTE 6 – PROPERTY AND EQUIPMENT
Property and equipment, net consists of the following:
| |
June 30, | | |
December 31, | |
(in thousands) | |
2024 | | |
2023 | |
| |
| | |
| |
Cost: | |
| | | |
| | |
Laboratory equipment | |
$ | 2,130 | | |
$ | 2,412 | |
Computers | |
| 431 | | |
| 380 | |
Office furniture & equipment | |
| 184 | | |
| 186 | |
Leasehold improvements | |
| 1,431 | | |
| 1,431 | |
Total cost | |
| 4,176 | | |
| 4,409 | |
Accumulated depreciation: | |
| | | |
| | |
Laboratory equipment | |
| 1,876 | | |
| 1,891 | |
Computers | |
| 296 | | |
| 263 | |
Office furniture & equipment | |
| 47 | | |
| 40 | |
Leasehold improvements | |
| 799 | | |
| 676 | |
Total accumulated depreciation | |
| 3,018 | | |
| 2,870 | |
Depreciated cost | |
$ | 1,158 | | |
$ | 1,539 | |
Depreciation expenses for the three and six month periods
ended June 30, 2024 and 2023 were $160, $348, $212 and $421 thousand, respectively.
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Other Assets
|
6 Months Ended |
Jun. 30, 2024 |
Other Assets [Abstract] |
|
OTHER ASSETS |
NOTE 7 – OTHER ASSETS
| |
June 30, | | |
December 31, | |
(in thousands) | |
2024 | | |
2023 | |
| |
| | |
| |
Restricted cash | |
$ | 306 | | |
$ | 300 | |
Long Term Deposit | |
| 8 | | |
| 8 | |
Long-term prepaid expenses | |
| 92 | | |
| 179 | |
Right-of-Use assets, net | |
| 870 | | |
| 1,041 | |
| |
$ | 1,276 | | |
$ | 1,528 | |
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Accrued Expenses and Other Liabilities
|
6 Months Ended |
Jun. 30, 2024 |
Accrued Expenses and Other Liabilities [Abstract] |
|
ACCRUED EXPENSES AND OTHER LIABILITIES |
NOTE 8 – ACCRUED EXPENSES AND OTHER LIABILITIES
| |
June 30, | | |
December 31, | |
(in thousands) | |
2024 | | |
2023 | |
| |
| | |
| |
Vacation, convalescence and bonus accruals | |
$ | 291 | | |
$ | 341 | |
Employees and payroll related | |
| 314 | | |
| 422 | |
Short term operating lease liabilities | |
| 336 | | |
| 346 | |
Accrued expenses and other | |
| 1,597 | | |
| 2,892 | |
| |
$ | 2,538 | | |
$ | 4,001 | |
|
X |
- DefinitionThe entire disclosure for accounts payable and accrued liabilities at the end of the reporting period.
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Leases
|
6 Months Ended |
Jun. 30, 2024 |
Leases [Abstract] |
|
LEASES |
NOTE 9 – LEASES
The Company is a party to operating
leases for its corporate offices, laboratory space, plant space and vehicles.
| |
Six months ended
June 30, | |
(in thousands) | |
2024 | | |
2023 | |
| |
| | |
| |
The components of lease expense were as follows: | |
| | | |
| | |
Operating leases expenses | |
$ | 207 | | |
$ | 522 | |
Supplemental consolidated cash flow information related to operating leases follows: | |
| | | |
| | |
Cash used in operating activities | |
$ | 212 | | |
$ | 520 | |
Non-cash activity: | |
| | | |
| | |
Right of use assets obtained in exchange for new operating lease liabilities | |
$ | 25 | | |
$ | 145 | |
| | June 30, | | | December 31, | | (in thousands) | | 2024 | | | 2023 | | Supplemental information related to operating leases, including location of amounts reported in the accompanying consolidated balance sheets, follows: | | | | | | | | | Other assets - Right-of-Use assets | | $ | 1,722 | | | $ | 2,161 | | Accumulated amortization | | | 852 | | | | 1,120 | | Operating lease Right-of-Use assets, net | | $ | 870 | | | $ | 1,041 | | Lease liabilities – current - Accounts payable and accrued liabilities | | $ | 336 | | | $ | 346 | | Lease liabilities – noncurrent | | | 499 | | | | 686 | | Total operating lease liabilities | | $ | 835 | | | $ | 1,032 | | Weighted average remaining lease term in years | | | 2.89 | | | | 3.3 | | Weighted average annual discount rate | | | 6.8 | % | | | 6.7 | % |
Maturities of operating lease liabilities as of June 30, 2024, were as follows: | |
| |
2024 (after June 30) | |
$ | 191 | |
2025 | |
| 355 | |
2026 | |
| 193 | |
2027 | |
| 117 | |
2028 and onwards | |
| 89 | |
Total undiscounted lease liability | |
| 945 | |
Less: Imputed interest | |
| (110 | ) |
Present value of lease liabilities | |
$ | 835 | |
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- DefinitionThe entire disclosure for operating leases of lessee. Includes, but is not limited to, description of operating lease and maturity analysis of operating lease liability.
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v3.24.2.u1
Commitments and Contingent Liabilities
|
6 Months Ended |
Jun. 30, 2024 |
Commitments and Contingent Liabilities [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 annual interest at a SOFR-based rate.
The gross amount of grants received
by the Company from the IIA, including accrued interest as of June 30, 2024, was approximately 9.9 million. As of June 30, 2024, the Company
had not paid any royalties to the IIA.
|
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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.24.2.u1
Equity
|
6 Months Ended |
Jun. 30, 2024 |
Equity [Abstract] |
|
EQUITY |
NOTE 11 – EQUITY
| a) | On May 27, 2024, the Company entered into a securities purchase agreement with a single institutional investor in connection with
the issuance and sale by the Company in a registered direct offering (the “Offering”) of (i) 2,060,000 Ordinary Shares, (ii)
pre-funded warrants to purchase up to 1,511,429 Ordinary Shares (the “Pre-Funded Warrants”), (iii) Series A warrants to purchase
up to 3,571,429 Ordinary Shares (the “Series A Warrants”) and (iv) Series B warrants to purchase up to 3,571,429 Ordinary
Shares (the “Series B Warrants” and, together with the Series A Warrants, the “Investor Warrants”), at a combined
purchase price of (a) $1.40 per Ordinary Share and the associated Investor Warrants, each to purchase one Ordinary Share, and (b) $1.399
per Pre-Funded Warrant and the associated Investor Warrants, each to purchase one Ordinary Share, pursuant to the Company’s effective
shelf registration statement on Form F-3 (File No. 333-364561) and related base prospectus and prospectus supplement. |
Each Investor Warrant has an exercise price of $1.40 per
Ordinary Share and is immediately exercisable. The Series A Warrants expire upon the earlier of 18 months following the issuance date
and 60 days following the Company’s public announcement of positive topline trail results of AllocetraTM for the treatment
of moderate-to-severe knee osteoarthritis (the “Series A Milestone Event”). The Series B warrants expire upon the earlier
of five and one-half years following the issuance date and 60 days following the Company’s public announcement of its filing with
the U.S. Food and Drug Administration (the “FDA”) for approval for AllocetraTM’s osteoarthritis related indication
(the “Series B Milestone Event”). Each Pre-Funded Warrant has an exercise price of $0.001 per Ordinary Share, is immediately
exercisable, may be exercised at any time and has no expiration date.
H.C. Wainwright & Co. (“Wainwright”) acted
as placement agent in connection with the Offering, and in consideration therefor the Company agreed to register and issue to Wainwright
warrants (the “Placement Agent Warrants”, and together with the Investor Warrants and the Pre-Funded Warrants, the “Warrants”)
to purchase up to 250,000 Ordinary Shares. The Placement Agent Warrants comprise Series A Warrants to purchase 125,000 Ordinary Shares
and Series B Warrants to purchase 125,000 Ordinary Shares, containing the same terms as the Investor Warrants, except that they are exercisable
at a price of $1.75 per Ordinary Share, and the Series B Warrants will expire upon the earlier of five years following the commencement
of the sale of the securities offered in the Offering and 60 days following the Company’s public announcement of its filing with
the FDA for approval for AllocetraTM’s osteoarthritis related indication.
In addition, the Company agreed to pay Wainwright an aggregate
cash fee equal to 7% of the gross proceeds raised in the Offering, a management fee equal to 1% of the gross proceeds raised in the Offering
and $90,950 for various fees and expenses. The closing of the Offering occurred on May 29, 2024. The
net proceeds from the Offering were approximately $4.5 million after deducting Wainwright’s fees and other expenses relating to
the Offering. The Company intends to use the net proceeds from the Offering for working capital and other general corporate purposes.
| b) | All Company warrants are classified as components 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, require physical settlement and do not provide any
guarantee of value or return (unless, in accordance with ASC 815-40-55-3, there is a fundamental transaction, as defined in the warrant
agreements, which allows the holders of the warrants to receive the same form of consideration payable to the holders of Ordinary Shares,
in which case equity treatment is not precluded). |
| |
Number of Warrants | | |
Weighted
average
exercise price | |
Outstanding January 1, 2024 | |
| 202,251 | | |
$ | 23.31 | |
Issued | |
| 8,904,287 | | |
$ | 1.17 | |
Outstanding and exercisable June 30, 2024 | |
| 9,106,538 | | |
$ | 1.66 | |
Composed of:
Number of Warrants | | | Exercise
Price
Per
Share | | | Issuance
date | | Expiration
date | | 22,750 | | | $ | 10.00 | | | February 26, 2020 | | February 24, 2025 | | 160,727 | | | $ | 25.00 | | | February 12, 2021 | | February 9, 2026 | | 18,774 | | | $ | 25.00 | | | February 17, 2021 | | February 9, 2026 | | 1,511,429 | | | $ | 0.001 | | | May 29, 2024 | | No expiration date | | 3,571,429 | | | $ | 1.40 | | | May 29, 2024 | | December 1, 2025(i) | | 3,571,429 | | | $ | 1.40 | | | May 29, 2024 | | November 29, 2029 (ii) | | 125,000 | | | $ | 1.75 | | | May 29, 2024 | | December 1, 2025(i) | | 125,000 | | | $ | 1.75 | | | May 29, 2024 | | May 27, 2029 (iii) | | 9,106,538 | | | | | | | | | |
(i) | The earlier of (a) December 1, 2025 and (b) the 60th day
following the occurrence of the Series A Milestone Event. |
(ii) | The earlier of (a) November 29, 2029 and (b) the 60th day
following the occurrence of the Series B Milestone Event. |
(iii) | The earlier of (a) May 27, 2029 and (b) 60 days following
the Company’s public announcement of its filing with the FDA for approval for AllocetraTM’s osteoarthritis related
indication. |
| c) | During the six months ended June 30, 2024 the Company issued 180,707 Ordinary Shares under our ATM agreement with Cantor Fitzgerald
& Co. and JMP Securities LLC for a gross consideration of $543 thousand net of $16 thousand of issuance expenses. |
|
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v3.24.2.u1
Share-Based Compensation
|
6 Months Ended |
Jun. 30, 2024 |
Share-Based Compensation [Abstract] |
|
SHARE-BASED COMPENSATION |
NOTE 12 – SHARE-BASED COMPENSATION
| a) | As of June 30, 2024, 5,028,704 Ordinary Shares were authorized for issuance to employees, directors and consultants under the 2019
Equity Incentive Plan (the “2019 Plan”), of which 966,057 shares remained available for future grant. |
| b) | The following table contains information concerning options granted under the 2019 Plan: |
| |
Three
months ended
June 30, | |
| |
2024 | | |
2023 | |
| |
Number
of options | | |
Weighted
average exercise price | | |
Number of
options | | |
Weighted
average exercise price | |
Outstanding at beginning of period | |
| 3,007,624 | | |
$ | 5.41 | | |
| 2,929,868 | | |
$ | 5.84 | |
Forfeited and expired | |
| (21,921 | ) | |
$ | 5.06 | | |
| (14,375 | ) | |
$ | 6.82 | |
Outstanding at end of period | |
| 2,985,703 | | |
$ | 5.41 | | |
| 2,915,493 | | |
$ | 5.84 | |
Exercisable at end of period | |
| 2,228,902 | | |
$ | 5.67 | | |
| 2,090,378 | | |
$ | 5.59 | |
| |
| | | |
| | | |
| | | |
| | |
Non-vested at beginning of period | |
| 772,301 | | |
$ | 4.67 | | |
| 876,851 | | |
$ | 6.48 | |
Vested | |
| - | | |
$ | - | | |
| (37,861 | ) | |
$ | 11.13 | |
Forfeited | |
| (13,750 | ) | |
$ | 3.79 | | |
| (13,875 | ) | |
$ | 5.90 | |
Non-vested at the end of period | |
| 758,551 | | |
$ | 4.6 8 | | |
| 825,115 | | |
$ | 6.27 | |
| |
Six months ended
June 30, | |
| |
2024 | | |
2023 | |
| |
Number of options | | |
Weighted average exercise price | | |
Number of options | | |
Weighted average exercise price | |
Outstanding at beginning of period | |
| 2,842,496 | | |
$ | 5.63 | | |
| 2,939,434 | | |
$ | 5.85 | |
Granted | |
| 250,000 | | |
$ | 3.21 | | |
| - | | |
$ | - | |
Forfeited and expired | |
| (106,793 | ) | |
$ | 6.00 | | |
| (23,941 | ) | |
$ | 6.71 | |
Outstanding at end of period | |
| 2,985,703 | | |
$ | 5.41 | | |
| 2,915,493 | | |
$ | 5.84 | |
Exercisable at end of period | |
| 2,228,902 | | |
$ | 5.67 | | |
| 2,090,378 | | |
$ | 5.59 | |
| |
| | | |
| | | |
| | | |
| | |
Non vested at beginning of period | |
| 596,503 | | |
$ | 5.53 | | |
| 986,005 | | |
$ | 6.46 | |
Granted | |
| 250,000 | | |
$ | 3.21 | | |
| - | | |
$ | - | |
Forfeited and expired | |
| (24,313 | ) | |
$ | 5.04 | | |
| (15,375 | ) | |
$ | 6.73 | |
vested | |
| (63,639 | ) | |
$ | 6.75 | | |
| (145,515 | ) | |
$ | 7.44 | |
Outstanding at end of period | |
| 758,551 | | |
$ | 4.68 | | |
| 825,115 | | |
$ | 6.27 | |
During the
three and six month periods ended June 30, 2024 and 2023, the Company recognized $237, $460, $427 and $957 thousand, respectively, of
share-based compensation expenses related to stock options. As of June 30, 2024, the total unrecognized estimated compensation cost related
to outstanding non-vested stock options was $1,061 thousand, which is expected to be recognized over a weighted average period of 1.36
years. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2024
(UNAUDITED)
| c) | Set forth below is data regarding the range of exercise prices
and remaining contractual life for all options outstanding at June 30, 2024: |
Exercise price | | | Number of options outstanding | | | Remaining contractual Life (in years) | | | Intrinsic Value of Options Outstanding (in thousands) | | | No. of options exercisable | | $ | 2.69 | | | | 649,591 | | | | 0.92 | | | $ | - | | | | 649,591 | | $ | 3.21 | | | | 240,000 | | | | 9.63 | | | | - | | | | - | | $ | 3.53 | | | | 53,192 | | | | 9.35 | | | | - | | | | - | | $ | 3.66 | | | | 250,000 | | | | 5.84 | | | | - | | | | 250,000 | | $ | 4.68 | | | | 34,500 | | | | 5.75 | | | | - | | | | 34,500 | | $ | 5.34 | | | | 160,750 | | | | 7.75 | | | | - | | | | 84,000 | | $ | 5.34 | | | | 442,410 | | | | 8.39 | | | | - | | | | 178,176 | | $ | 5.96 | | | | 150,000 | | | | 8.39 | | | | - | | | | 37,500 | | $ | 6.22 | | | | 552,883 | | | | 2.67 | | | | - | | | | 552,883 | | $ | 8.19 | | | | 150,000 | | | | 5.39 | | | | - | | | | 150,000 | | $ | 9.02 | | | | 40,500 | | | | 6.38 | | | | - | | | | 30,375 | | $ | 10.12 | | | | 10,407 | | | | 4.43 | | | | - | | | | 10,407 | | $ | 12.23 | | | | 250,000 | | | | 6.91 | | | | - | | | | 250,000 | | $ | 21.40 | | | | 970 | | | | 5.07 | | | | - | | | | 970 | | $ | 90.16 | | | | 500 | | | | 0.42 | | | | - | | | | 500 | | | | | | | 2,985,703 | | | | | | | $ | - | | | | 2,228,902 | |
| d) | The following table contains information concerning restricted stock units granted
under the 2019 Plan: |
| |
Three months ended
June 30, | |
| |
2024 | | |
2023 | |
| |
Number
of shares | | |
Weighted
average
grant date fair
value | | |
Number
of shares | | |
Weighted
average
grant date fair
value | |
Nonvested at beginning of period | |
| 571,460 | | |
$ | 2.65 | | |
| 114,329 | | |
$ | 9.97 | |
Granted | |
| | | |
$ | | | |
| - | | |
$ | - | |
Vested | |
| (3,444 | ) | |
$ | 10.28 | | |
| (3,438 | ) | |
$ | 10.28 | |
Forfeited | |
| (5,757 | ) | |
$ | 3.87 | | |
| (313 | ) | |
$ | 14.67 | |
Nonvested at end of period | |
| 562,259 | | |
$ | 2.59 | | |
| 110,578 | | |
$ | 9.95 | |
| |
Six months ended
June 30, | |
| |
2024 | | |
2023 | |
| |
Number
of shares | | |
Weighted
average
grant date fair
value | | |
Number
of shares | | |
Weighted
average
grant date fair
value | |
Nonvested at beginning of period | |
| 621,135 | | |
$ | 3.14 | | |
| 157,560 | | |
$ | 10.02 | |
Granted | |
| - | | |
$ | - | | |
| - | | |
$ | - | |
Vested | |
| (44,050 | ) | |
$ | 9.9 | | |
| (46,544 | ) | |
$ | 10.15 | |
Forfeited | |
| (14,826 | ) | |
$ | 3.64 | | |
| (438 | ) | |
$ | 14.67 | |
Nonvested at end of period | |
| 562,259 | | |
$ | 2.59 | | |
| 110,578 | | |
$ | 9.95 | |
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, 2024 and 2023, the Company recognized $151, $311, $84 and $187 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, 2024 was $653 thousand, which is expected to be recognized
over a weighted average period of 1.27 years.
| e) | The following table summarizes share-based compensation expenses included in the
statements of operations related to grants under the 2019 Plan: |
| |
Three months ended
June 30, | | |
Six months ended
June 30, | |
(in thousands) | |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Research & development | |
$ | 145 | | |
$ | 122 | | |
$ | 269 | | |
$ | 318 | |
General & administrative | |
| 243 | | |
| 389 | | |
| 502 | | |
| 826 | |
Total | |
$ | 388 | | |
$ | 511 | | |
$ | 771 | | |
$ | 1,144 | |
|
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v3.24.2.u1
Fair Value Measurement
|
6 Months Ended |
Jun. 30, 2024 |
Fair Value Measurement [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, 2024 and December 31, 2023:
(in thousands) | |
June 30, 2024 | |
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Cash and cash equivalents | |
$ | 3,747 | | |
$ | | | |
$ | - | | |
$ | - | |
Short term deposits | |
| 22,195 | | |
| | | |
| - | | |
| - | |
Restricted cash | |
| 306 | | |
| | | |
| - | | |
| - | |
Total financial assets | |
$ | 26,248 | | |
$ | | | |
$ | - | | |
$ | - | |
(in thousands) | |
December 31, 2023 | |
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Cash and cash equivalents | |
$ | 813 | | |
$ | 813 | | |
$ | - | | |
$ | - | |
Short term deposits | |
| 26,507 | | |
| 26,507 | | |
| - | | |
| - | |
Restricted cash | |
| 413 | | |
| 413 | | |
| - | | |
| - | |
Total financial assets | |
$ | 27,733 | | |
$ | 27,733 | | |
$ | - | | |
$ | - | |
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- DefinitionThe entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.
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v3.24.2.u1
Events Subsequent to the Balance Sheet Date
|
6 Months Ended |
Jun. 30, 2024 |
Events Subsequent to the Balance Sheet Date [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 the following subsequent event necessitated disclosure:
| 1. | In July 2024, 518,429 Pre-Funded Warrants were exercised for 518,429 Ordinary Shares. |
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v3.24.2.u1
Accounting Policies, by Policy (Policies)
|
6 Months Ended |
Jun. 30, 2024 |
Significant Accounting Policies [Abstract] |
|
Basis of Presentation |
Basis of Presentation These unaudited condensed consolidated
financial statements include the accounts of the Company and have been prepared in accordance with U.S. generally accepted accounting
principles (“U.S. GAAP”) for interim financial information. Accordingly, certain information and footnote disclosures normally
included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. In the opinion of management, all
adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been made. These unaudited condensed consolidated
financial statements should be read in conjunction with the Company’s audited annual financial statements and notes thereto included
in the Company’s 2023 Annual Report on Form 20-F, as filed with the U.S. Securities and Exchange Commission on April 30, 2024. The
results of operations for these interim periods are not necessarily indicative of the operating results for any future period. The December 31,
2023 financial information has been derived from the Company’s audited financial statements.
|
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 transaction. 1 U.S. dollar = 3.759 NIS and 3.627
NIS as of June 30, 2024 and December 31, 2023, respectively. The U.S. dollar increased against the
NIS 2.12%, 3.64%, 2.35% and 5.14% in the three and six month periods ended June 30, 2024 and 2023, respectively.
|
Recently Adopted Accounting Standards |
Recently Adopted Accounting Standards
During the three months ended June
30, 2024, 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 In November 2023, the FASB issued ASU
2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which is intended to provide enhanced segment
disclosures. The standard will require disclosures about significant segment expenses and other segment items and identifying the Chief
Operating Decision Maker and how they use the reported segment profitability measures to assess segment performance and allocate resources.
These enhanced disclosures are required for all entities on an interim and annual basis, even if they have only a single reportable segment.
The standard is effective for years beginning after December 15, 2023 and interim periods within annual periods beginning after December
15, 2024, and early adoption is permitted. The Company does not believe that adoption of this ASU will have a material impact on the Company’s
consolidated financial statements. In December 2023, the FASB issued ASU
2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which is intended to provide enhancements to annual income
tax disclosures. The standard will require more detailed information in the rate reconciliation table and for income taxes paid, among
other enhancements. The standard is effective for years beginning after December 15, 2024, early adoption is permitted. The Company does
not believe that adoption of this ASU will have a material impact on the Company’s consolidated financial statements.
|
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, 2023.
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v3.24.2.u1
Cash, Cash Equivalents and Restricted Cash (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Cash, Cash Equivalents and Restricted Cash [Abstract] |
|
Schedule of Cash and Cash Equivalents and Restricted Cash |
| |
June 30, | | |
December 31, | |
(in thousands) | |
2024 | | |
2023 | |
| |
| | |
| |
Cash held in banks | |
$ | 3,747 | | |
$ | 813 | |
Total cash and cash equivalents | |
| 3,747 | | |
| 813 | |
Restricted cash – current – Prepaid expenses and other receivables | |
| 113 | | |
| 113 | |
Restricted cash – noncurrent – Other assets | |
| 306 | | |
| 300 | |
Total cash, cash equivalents and restricted cash shown in the statement of cash flows | |
$ | 4,166 | | |
$ | 1,226 | |
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v3.24.2.u1
Short Term Deposits (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Short Term Deposits [Abstract] |
|
Schedule of Short Term Deposits |
| |
June 30, | | |
December 31, | |
(in thousands) | |
2024 | | |
2023 | |
| |
| | |
| |
Bank deposits in U.S.$ (annual average interest rates 5.86% and 6.195%) | |
$ | 9,652 | | |
$ | 6,240 | |
Bank deposits in NIS (annual average interest rates 4.317% and 4.568%) | |
| 12,543 | | |
| 20,267 | |
Total short-term deposits | |
$ | 22,195 | | |
$ | 26,507 | |
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v3.24.2.u1
Property and Equipment (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Property and Equipment [Abstract] |
|
Schedule of Property and Equipment |
Property and equipment, net consists of the following:
| |
June 30, | | |
December 31, | |
(in thousands) | |
2024 | | |
2023 | |
| |
| | |
| |
Cost: | |
| | | |
| | |
Laboratory equipment | |
$ | 2,130 | | |
$ | 2,412 | |
Computers | |
| 431 | | |
| 380 | |
Office furniture & equipment | |
| 184 | | |
| 186 | |
Leasehold improvements | |
| 1,431 | | |
| 1,431 | |
Total cost | |
| 4,176 | | |
| 4,409 | |
Accumulated depreciation: | |
| | | |
| | |
Laboratory equipment | |
| 1,876 | | |
| 1,891 | |
Computers | |
| 296 | | |
| 263 | |
Office furniture & equipment | |
| 47 | | |
| 40 | |
Leasehold improvements | |
| 799 | | |
| 676 | |
Total accumulated depreciation | |
| 3,018 | | |
| 2,870 | |
Depreciated cost | |
$ | 1,158 | | |
$ | 1,539 | |
|
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v3.24.2.u1
Other Assets (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Other Assets [Abstract] |
|
Schedule of Other Assets |
| |
June 30, | | |
December 31, | |
(in thousands) | |
2024 | | |
2023 | |
| |
| | |
| |
Restricted cash | |
$ | 306 | | |
$ | 300 | |
Long Term Deposit | |
| 8 | | |
| 8 | |
Long-term prepaid expenses | |
| 92 | | |
| 179 | |
Right-of-Use assets, net | |
| 870 | | |
| 1,041 | |
| |
$ | 1,276 | | |
$ | 1,528 | |
|
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v3.24.2.u1
Leases (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Leases [Abstract] |
|
Schedule of Operating Lease |
The Company is a party to operating
leases for its corporate offices, laboratory space, plant space and vehicles.
| |
Six months ended
June 30, | |
(in thousands) | |
2024 | | |
2023 | |
| |
| | |
| |
The components of lease expense were as follows: | |
| | | |
| | |
Operating leases expenses | |
$ | 207 | | |
$ | 522 | |
Supplemental consolidated cash flow information related to operating leases follows: | |
| | | |
| | |
Cash used in operating activities | |
$ | 212 | | |
$ | 520 | |
Non-cash activity: | |
| | | |
| | |
Right of use assets obtained in exchange for new operating lease liabilities | |
$ | 25 | | |
$ | 145 | |
|
Schedule of Supplemental Information Related to Operating Leases |
| | June 30, | | | December 31, | | (in thousands) | | 2024 | | | 2023 | | Supplemental information related to operating leases, including location of amounts reported in the accompanying consolidated balance sheets, follows: | | | | | | | | | Other assets - Right-of-Use assets | | $ | 1,722 | | | $ | 2,161 | | Accumulated amortization | | | 852 | | | | 1,120 | | Operating lease Right-of-Use assets, net | | $ | 870 | | | $ | 1,041 | | Lease liabilities – current - Accounts payable and accrued liabilities | | $ | 336 | | | $ | 346 | | Lease liabilities – noncurrent | | | 499 | | | | 686 | | Total operating lease liabilities | | $ | 835 | | | $ | 1,032 | | Weighted average remaining lease term in years | | | 2.89 | | | | 3.3 | | Weighted average annual discount rate | | | 6.8 | % | | | 6.7 | % |
|
Schedule of Maturities of Operating Lease Liabilities |
Maturities of operating lease liabilities as of June 30, 2024, were as follows: | |
| |
2024 (after June 30) | |
$ | 191 | |
2025 | |
| 355 | |
2026 | |
| 193 | |
2027 | |
| 117 | |
2028 and onwards | |
| 89 | |
Total undiscounted lease liability | |
| 945 | |
Less: Imputed interest | |
| (110 | ) |
Present value of lease liabilities | |
$ | 835 | |
|
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v3.24.2.u1
Equity (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Equity [Abstract] |
|
Schedule of Number of Ordinary Shares Upon Exercise |
| |
Number of Warrants | | |
Weighted
average
exercise price | |
Outstanding January 1, 2024 | |
| 202,251 | | |
$ | 23.31 | |
Issued | |
| 8,904,287 | | |
$ | 1.17 | |
Outstanding and exercisable June 30, 2024 | |
| 9,106,538 | | |
$ | 1.66 | |
|
Schedule of Changes in Exercisable Ordinary Shares Warrants |
Composed of: Number of Warrants | | | Exercise
Price
Per
Share | | | Issuance
date | | Expiration
date | | 22,750 | | | $ | 10.00 | | | February 26, 2020 | | February 24, 2025 | | 160,727 | | | $ | 25.00 | | | February 12, 2021 | | February 9, 2026 | | 18,774 | | | $ | 25.00 | | | February 17, 2021 | | February 9, 2026 | | 1,511,429 | | | $ | 0.001 | | | May 29, 2024 | | No expiration date | | 3,571,429 | | | $ | 1.40 | | | May 29, 2024 | | December 1, 2025(i) | | 3,571,429 | | | $ | 1.40 | | | May 29, 2024 | | November 29, 2029 (ii) | | 125,000 | | | $ | 1.75 | | | May 29, 2024 | | December 1, 2025(i) | | 125,000 | | | $ | 1.75 | | | May 29, 2024 | | May 27, 2029 (iii) | | 9,106,538 | | | | | | | | | |
(i) | The earlier of (a) December 1, 2025 and (b) the 60th day
following the occurrence of the Series A Milestone Event. |
(ii) | The earlier of (a) November 29, 2029 and (b) the 60th day
following the occurrence of the Series B Milestone Event. |
(iii) | The earlier of (a) May 27, 2029 and (b) 60 days following
the Company’s public announcement of its filing with the FDA for approval for AllocetraTM’s osteoarthritis related
indication. |
|
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v3.24.2.u1
Share-Based Compensation (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Share-Based Compensation [Abstract] |
|
Schedule of Employees and Directors Stock Options Granted Under the 2019 Plan |
The following table contains information concerning options granted under the 2019 Plan:
| |
Three
months ended
June 30, | |
| |
2024 | | |
2023 | |
| |
Number
of options | | |
Weighted
average exercise price | | |
Number of
options | | |
Weighted
average exercise price | |
Outstanding at beginning of period | |
| 3,007,624 | | |
$ | 5.41 | | |
| 2,929,868 | | |
$ | 5.84 | |
Forfeited and expired | |
| (21,921 | ) | |
$ | 5.06 | | |
| (14,375 | ) | |
$ | 6.82 | |
Outstanding at end of period | |
| 2,985,703 | | |
$ | 5.41 | | |
| 2,915,493 | | |
$ | 5.84 | |
Exercisable at end of period | |
| 2,228,902 | | |
$ | 5.67 | | |
| 2,090,378 | | |
$ | 5.59 | |
| |
| | | |
| | | |
| | | |
| | |
Non-vested at beginning of period | |
| 772,301 | | |
$ | 4.67 | | |
| 876,851 | | |
$ | 6.48 | |
Vested | |
| - | | |
$ | - | | |
| (37,861 | ) | |
$ | 11.13 | |
Forfeited | |
| (13,750 | ) | |
$ | 3.79 | | |
| (13,875 | ) | |
$ | 5.90 | |
Non-vested at the end of period | |
| 758,551 | | |
$ | 4.6 8 | | |
| 825,115 | | |
$ | 6.27 | |
| |
Six months ended
June 30, | |
| |
2024 | | |
2023 | |
| |
Number of options | | |
Weighted average exercise price | | |
Number of options | | |
Weighted average exercise price | |
Outstanding at beginning of period | |
| 2,842,496 | | |
$ | 5.63 | | |
| 2,939,434 | | |
$ | 5.85 | |
Granted | |
| 250,000 | | |
$ | 3.21 | | |
| - | | |
$ | - | |
Forfeited and expired | |
| (106,793 | ) | |
$ | 6.00 | | |
| (23,941 | ) | |
$ | 6.71 | |
Outstanding at end of period | |
| 2,985,703 | | |
$ | 5.41 | | |
| 2,915,493 | | |
$ | 5.84 | |
Exercisable at end of period | |
| 2,228,902 | | |
$ | 5.67 | | |
| 2,090,378 | | |
$ | 5.59 | |
| |
| | | |
| | | |
| | | |
| | |
Non vested at beginning of period | |
| 596,503 | | |
$ | 5.53 | | |
| 986,005 | | |
$ | 6.46 | |
Granted | |
| 250,000 | | |
$ | 3.21 | | |
| - | | |
$ | - | |
Forfeited and expired | |
| (24,313 | ) | |
$ | 5.04 | | |
| (15,375 | ) | |
$ | 6.73 | |
vested | |
| (63,639 | ) | |
$ | 6.75 | | |
| (145,515 | ) | |
$ | 7.44 | |
Outstanding at end of period | |
| 758,551 | | |
$ | 4.68 | | |
| 825,115 | | |
$ | 6.27 | |
|
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 at June 30, 2024: Exercise price | | | Number of options outstanding | | | Remaining contractual Life (in years) | | | Intrinsic Value of Options Outstanding (in thousands) | | | No. of options exercisable | | $ | 2.69 | | | | 649,591 | | | | 0.92 | | | $ | - | | | | 649,591 | | $ | 3.21 | | | | 240,000 | | | | 9.63 | | | | - | | | | - | | $ | 3.53 | | | | 53,192 | | | | 9.35 | | | | - | | | | - | | $ | 3.66 | | | | 250,000 | | | | 5.84 | | | | - | | | | 250,000 | | $ | 4.68 | | | | 34,500 | | | | 5.75 | | | | - | | | | 34,500 | | $ | 5.34 | | | | 160,750 | | | | 7.75 | | | | - | | | | 84,000 | | $ | 5.34 | | | | 442,410 | | | | 8.39 | | | | - | | | | 178,176 | | $ | 5.96 | | | | 150,000 | | | | 8.39 | | | | - | | | | 37,500 | | $ | 6.22 | | | | 552,883 | | | | 2.67 | | | | - | | | | 552,883 | | $ | 8.19 | | | | 150,000 | | | | 5.39 | | | | - | | | | 150,000 | | $ | 9.02 | | | | 40,500 | | | | 6.38 | | | | - | | | | 30,375 | | $ | 10.12 | | | | 10,407 | | | | 4.43 | | | | - | | | | 10,407 | | $ | 12.23 | | | | 250,000 | | | | 6.91 | | | | - | | | | 250,000 | | $ | 21.40 | | | | 970 | | | | 5.07 | | | | - | | | | 970 | | $ | 90.16 | | | | 500 | | | | 0.42 | | | | - | | | | 500 | | | | | | | 2,985,703 | | | | | | | $ | - | | | | 2,228,902 | |
|
Schedule of Restricted Stock Units Granted Under the 2019 Plan |
The following table contains information concerning restricted stock units granted
under the 2019 Plan:
| |
Three months ended
June 30, | |
| |
2024 | | |
2023 | |
| |
Number
of shares | | |
Weighted
average
grant date fair
value | | |
Number
of shares | | |
Weighted
average
grant date fair
value | |
Nonvested at beginning of period | |
| 571,460 | | |
$ | 2.65 | | |
| 114,329 | | |
$ | 9.97 | |
Granted | |
| | | |
$ | | | |
| - | | |
$ | - | |
Vested | |
| (3,444 | ) | |
$ | 10.28 | | |
| (3,438 | ) | |
$ | 10.28 | |
Forfeited | |
| (5,757 | ) | |
$ | 3.87 | | |
| (313 | ) | |
$ | 14.67 | |
Nonvested at end of period | |
| 562,259 | | |
$ | 2.59 | | |
| 110,578 | | |
$ | 9.95 | |
| |
Six months ended
June 30, | |
| |
2024 | | |
2023 | |
| |
Number
of shares | | |
Weighted
average
grant date fair
value | | |
Number
of shares | | |
Weighted
average
grant date fair
value | |
Nonvested at beginning of period | |
| 621,135 | | |
$ | 3.14 | | |
| 157,560 | | |
$ | 10.02 | |
Granted | |
| - | | |
$ | - | | |
| - | | |
$ | - | |
Vested | |
| (44,050 | ) | |
$ | 9.9 | | |
| (46,544 | ) | |
$ | 10.15 | |
Forfeited | |
| (14,826 | ) | |
$ | 3.64 | | |
| (438 | ) | |
$ | 14.67 | |
Nonvested at end of period | |
| 562,259 | | |
$ | 2.59 | | |
| 110,578 | | |
$ | 9.95 | |
|
Schedule of Share-Based Compensation Expenses Related to Grants Under the 2019 Plan |
The following table summarizes share-based compensation expenses included in the
statements of operations related to grants under the 2019 Plan:
| |
Three months ended
June 30, | | |
Six months ended
June 30, | |
(in thousands) | |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Research & development | |
$ | 145 | | |
$ | 122 | | |
$ | 269 | | |
$ | 318 | |
General & administrative | |
| 243 | | |
| 389 | | |
| 502 | | |
| 826 | |
Total | |
$ | 388 | | |
$ | 511 | | |
$ | 771 | | |
$ | 1,144 | |
|
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v3.24.2.u1
Fair Value Measurement (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Fair Value Measurement [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, 2024 and December 31, 2023:
(in thousands) | |
June 30, 2024 | |
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Cash and cash equivalents | |
$ | 3,747 | | |
$ | | | |
$ | - | | |
$ | - | |
Short term deposits | |
| 22,195 | | |
| | | |
| - | | |
| - | |
Restricted cash | |
| 306 | | |
| | | |
| - | | |
| - | |
Total financial assets | |
$ | 26,248 | | |
$ | | | |
$ | - | | |
$ | - | |
(in thousands) | |
December 31, 2023 | |
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Cash and cash equivalents | |
$ | 813 | | |
$ | 813 | | |
$ | - | | |
$ | - | |
Short term deposits | |
| 26,507 | | |
| 26,507 | | |
| - | | |
| - | |
Restricted cash | |
| 413 | | |
| 413 | | |
| - | | |
| - | |
Total financial assets | |
$ | 27,733 | | |
$ | 27,733 | | |
$ | - | | |
$ | - | |
|
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v3.24.2.u1
Cash, Cash Equivalents and Restricted Cash (Details) - Schedule of Cash and Cash Equivalents and Restricted Cash - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Jun. 30, 2023 |
Dec. 31, 2022 |
Schedule of Cash and Cash Equivalents and Restricted Cash [Abstract] |
|
|
|
|
Cash held in banks |
$ 3,747
|
$ 813
|
|
|
Total cash and cash equivalents |
3,747
|
813
|
|
|
Restricted cash – current – Prepaid expenses and other receivables |
113
|
113
|
|
|
Restricted cash – noncurrent – Other assets |
306
|
300
|
|
|
Total cash, cash equivalents and restricted cash shown in the statement of cash flows |
$ 4,166
|
$ 1,226
|
$ 3,862
|
$ 50,357
|
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Property and Equipment (Details) - Schedule of Property and Equipment - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Property, Plant and Equipment [Line Items] |
|
|
Total cost |
$ 4,176
|
$ 4,409
|
Total accumulated depreciation |
3,018
|
2,870
|
Depreciated cost |
1,158
|
1,539
|
Laboratory equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Total cost |
2,130
|
2,412
|
Total accumulated depreciation |
1,876
|
1,891
|
Computers [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Total cost |
431
|
380
|
Total accumulated depreciation |
296
|
263
|
Office furniture & equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Total cost |
184
|
186
|
Total accumulated depreciation |
47
|
40
|
Leasehold improvements [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Total cost |
1,431
|
1,431
|
Total accumulated depreciation |
$ 799
|
$ 676
|
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Equity (Details) - USD ($) $ / shares in Units, $ in Thousands |
|
|
6 Months Ended |
May 29, 2024 |
May 27, 2024 |
Jun. 30, 2024 |
Equity [Line Items] |
|
|
|
Issuance of shares |
|
|
180,707
|
Cash fee percentage |
|
|
7.00%
|
Management fee percentage |
|
|
1.00%
|
Various fees and expenses related to offering (in Dollars) |
|
|
$ 90,950
|
Net proceeds from the offering on may 2024 (in Dollars) |
$ 4,500
|
|
|
Gross consideration from ATM (in Dollars) |
|
|
543
|
Issuance expenses from ATM (in Dollars) |
|
|
$ 16
|
Warrant [Member] |
|
|
|
Equity [Line Items] |
|
|
|
Pre- funded warrants |
|
1,511,429
|
|
Exercise price pre-funded warrants (in Dollars per share) |
|
|
$ 0.001
|
Series A Warrant [Member] |
|
|
|
Equity [Line Items] |
|
|
|
Series A warrants |
|
3,571,429
|
|
Exercise price of warrant (in Dollars per share) |
|
$ 1.4
|
|
Warrants expire term |
|
|
18 months
|
Placement agent warrants |
|
|
125,000
|
Exercise price placement agent warrants (in Dollars per share) |
|
|
$ 1.75
|
Series B Warrants [Member] |
|
|
|
Equity [Line Items] |
|
|
|
Series B warrants |
|
3,571,429
|
|
Exercise price of warrant (in Dollars per share) |
|
$ 1.4
|
|
Warrants expire term |
|
|
5 years
|
Warrants expire upon earlier |
|
|
five and one-half years
|
Placement agent warrants |
|
|
125,000
|
Exercise price placement agent warrants (in Dollars per share) |
|
|
$ 1.75
|
Ordinary Shares [Member] |
|
|
|
Equity [Line Items] |
|
|
|
Issuance of shares |
|
2,060,000
|
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Equity (Details) - Schedule of Changes in Exercisable Ordinary Shares Warrants - Warrant [Member]
|
6 Months Ended |
Jun. 30, 2024
$ / shares
shares
|
Schedule of Changes in Exercisable Ordinary Shares Warrants [Line Items] |
|
|
Number of Warrants |
9,106,538
|
|
10.00 [Member] |
|
|
Schedule of Changes in Exercisable Ordinary Shares Warrants [Line Items] |
|
|
Number of Warrants |
22,750
|
|
Exercise price per share | $ / shares |
$ 10
|
|
Issuance date |
Feb. 26, 2020
|
|
Expiration date |
Feb. 24, 2025
|
|
25.00 [Member] |
|
|
Schedule of Changes in Exercisable Ordinary Shares Warrants [Line Items] |
|
|
Number of Warrants |
160,727
|
|
Exercise price per share | $ / shares |
$ 25
|
|
Issuance date |
Feb. 12, 2021
|
|
Expiration date |
Feb. 09, 2026
|
|
25.00 [Member] |
|
|
Schedule of Changes in Exercisable Ordinary Shares Warrants [Line Items] |
|
|
Number of Warrants |
18,774
|
|
Exercise price per share | $ / shares |
$ 25
|
|
Issuance date |
Feb. 17, 2021
|
|
Expiration date |
Feb. 09, 2026
|
|
0.001 [Member] |
|
|
Schedule of Changes in Exercisable Ordinary Shares Warrants [Line Items] |
|
|
Number of Warrants |
1,511,429
|
|
Exercise price per share | $ / shares |
$ 0.001
|
|
Issuance date |
May 29, 2024
|
|
1.40 [Member] |
|
|
Schedule of Changes in Exercisable Ordinary Shares Warrants [Line Items] |
|
|
Number of Warrants |
3,571,429
|
|
Exercise price per share | $ / shares |
$ 1.4
|
|
Issuance date |
May 29, 2024
|
|
Expiration date |
Dec. 01, 2025
|
[1] |
1.40 [Member] |
|
|
Schedule of Changes in Exercisable Ordinary Shares Warrants [Line Items] |
|
|
Number of Warrants |
3,571,429
|
|
Exercise price per share | $ / shares |
$ 1.4
|
|
Issuance date |
May 29, 2024
|
|
Expiration date |
Nov. 29, 2029
|
[2] |
1.75 [Member] |
|
|
Schedule of Changes in Exercisable Ordinary Shares Warrants [Line Items] |
|
|
Number of Warrants |
125,000
|
|
Exercise price per share | $ / shares |
$ 1.75
|
|
Issuance date |
May 29, 2024
|
|
Expiration date |
Dec. 01, 2025
|
[1] |
1.75 [Member] |
|
|
Schedule of Changes in Exercisable Ordinary Shares Warrants [Line Items] |
|
|
Number of Warrants |
125,000
|
|
Exercise price per share | $ / shares |
$ 1.75
|
|
Issuance date |
May 29, 2024
|
|
Expiration date |
May 27, 2029
|
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v3.24.2.u1
Share-Based Compensation (Details) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Share-Based Compensation [Line Items] |
|
|
|
|
Share-based compensation expense |
$ 388
|
$ 511
|
$ 771
|
$ 1,144
|
Share-Based Payment Arrangement, Option [Member] |
|
|
|
|
Share-Based Compensation [Line Items] |
|
|
|
|
Share-based compensation expense |
237
|
460
|
427
|
957
|
Unrecognized estimated compensation cost |
1,061
|
|
$ 1,061
|
|
Weighted average period |
|
|
1 year 4 months 9 days
|
|
Restricted Stock Units [Member] |
|
|
|
|
Share-Based Compensation [Line Items] |
|
|
|
|
Share-based compensation expense |
151
|
$ 311
|
$ 84
|
$ 187
|
Weighted average period |
|
|
1 year 3 months 7 days
|
|
Share-based compensation expense not yet recognized |
$ 653
|
|
$ 653
|
|
Common Stock [Member] |
|
|
|
|
Share-Based Compensation [Line Items] |
|
|
|
|
Ordinary shares were authorized for issuance to employe, directors and consultants (in Shares) |
5,028,704
|
|
5,028,704
|
|
Shares available for future grant (in Shares) |
966,057
|
|
966,057
|
|
X |
- DefinitionAmount of expense for award under share-based payment arrangement. Excludes amount capitalized.
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v3.24.2.u1
Share-Based Compensation (Details) - Schedule of Employees and Directors Stock Options Granted Under the 2019 Plan - Stock Option Plan [Member] - $ / shares
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Schedule of Employees and Directors Stock Options [Line Items] |
|
|
|
|
Number of options, Outstanding at beginning of period |
3,007,624
|
2,929,868
|
2,842,496
|
2,939,434
|
Weighted average exercise price, Outstanding at beginning of period |
$ 5.41
|
$ 5.84
|
$ 5.63
|
$ 5.85
|
Number of options, Granted |
|
|
250,000
|
|
Weighted average exercise price, Granted |
|
|
$ 3.21
|
|
Number of options, Forfeited and expired |
(21,921)
|
(14,375)
|
(106,793)
|
(23,941)
|
Weighted average exercise price, Forfeited and expired |
$ 5.06
|
$ 6.82
|
$ 6
|
$ 6.71
|
Number of options, Outstanding at end of period |
2,985,703
|
2,915,493
|
2,985,703
|
2,915,493
|
Weighted average exercise price, Outstanding at end of period |
$ 5.41
|
$ 5.84
|
$ 5.41
|
$ 5.84
|
Number of options, Exercisable at end of period |
2,228,902
|
2,090,378
|
2,228,902
|
2,090,378
|
Weighted average exercise price, Exercisable at end of period |
$ 5.67
|
$ 5.59
|
$ 5.67
|
$ 5.59
|
Number of options, Non-vested at beginning of period |
772,301
|
876,851
|
596,503
|
986,005
|
Weighted average exercise price, Non-vested at beginning of period |
$ 4.67
|
$ 6.48
|
$ 5.53
|
$ 6.46
|
Number of options, Vested |
|
(37,861)
|
(63,639)
|
(145,515)
|
Weighted average exercise price, Vested |
|
$ 11.13
|
$ 6.75
|
$ 7.44
|
Number of options, Forfeited |
(13,750)
|
(13,875)
|
(24,313)
|
(15,375)
|
Weighted average exercise price, Forfeited |
$ 3.79
|
$ 5.9
|
$ 5.04
|
$ 6.73
|
Number of options, Non-vested at the end of period |
758,551
|
825,115
|
758,551
|
825,115
|
Weighted average exercise price, Non-vested at the end of period |
$ 4.68
|
$ 6.27
|
$ 4.68
|
$ 6.27
|
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v3.24.2.u1
Share-Based Compensation (Details) - Schedule of Exercise Prices and Remaining Contractual Life - Stock Options [Member]
|
6 Months Ended |
Jun. 30, 2024
USD ($)
$ / shares
shares
|
Schedule of Exercise Prices and Remaining Contractual Life [Line Items] |
|
Number of options outstanding |
2,985,703
|
Intrinsic Value of Options Outstanding (in Dollars) | $ |
|
No. of options exercisable |
2,228,902
|
Exercise Price One [Member] |
|
Schedule of Exercise Prices and Remaining Contractual Life [Line Items] |
|
Exercise price (in Dollars per share) | $ / shares |
$ 2.69
|
Number of options outstanding |
649,591
|
Remaining contractual Life (in years) |
11 months 1 day
|
Intrinsic Value of Options Outstanding (in Dollars) | $ |
|
No. of options exercisable |
649,591
|
Exercise Price Two [Member] |
|
Schedule of Exercise Prices and Remaining Contractual Life [Line Items] |
|
Exercise price (in Dollars per share) | $ / shares |
$ 3.21
|
Number of options outstanding |
240,000
|
Remaining contractual Life (in years) |
9 years 7 months 17 days
|
Intrinsic Value of Options Outstanding (in Dollars) | $ |
|
No. of options exercisable |
|
Exercise Price Three [Member] |
|
Schedule of Exercise Prices and Remaining Contractual Life [Line Items] |
|
Exercise price (in Dollars per share) | $ / shares |
$ 3.53
|
Number of options outstanding |
53,192
|
Remaining contractual Life (in years) |
9 years 4 months 6 days
|
Intrinsic Value of Options Outstanding (in Dollars) | $ |
|
No. of options exercisable |
|
Exercise Price Four [Member] |
|
Schedule of Exercise Prices and Remaining Contractual Life [Line Items] |
|
Exercise price (in Dollars per share) | $ / shares |
$ 3.66
|
Number of options outstanding |
250,000
|
Remaining contractual Life (in years) |
5 years 10 months 2 days
|
Intrinsic Value of Options Outstanding (in Dollars) | $ |
|
No. of options exercisable |
250,000
|
Exercise Price Five [Member] |
|
Schedule of Exercise Prices and Remaining Contractual Life [Line Items] |
|
Exercise price (in Dollars per share) | $ / shares |
$ 4.68
|
Number of options outstanding |
34,500
|
Remaining contractual Life (in years) |
5 years 9 months
|
Intrinsic Value of Options Outstanding (in Dollars) | $ |
|
No. of options exercisable |
34,500
|
Exercise Price Six [Member] |
|
Schedule of Exercise Prices and Remaining Contractual Life [Line Items] |
|
Exercise price (in Dollars per share) | $ / shares |
$ 5.34
|
Number of options outstanding |
160,750
|
Remaining contractual Life (in years) |
7 years 9 months
|
Intrinsic Value of Options Outstanding (in Dollars) | $ |
|
No. of options exercisable |
84,000
|
Exercise Price Seven [Member] |
|
Schedule of Exercise Prices and Remaining Contractual Life [Line Items] |
|
Exercise price (in Dollars per share) | $ / shares |
$ 5.34
|
Number of options outstanding |
442,410
|
Remaining contractual Life (in years) |
8 years 4 months 20 days
|
Intrinsic Value of Options Outstanding (in Dollars) | $ |
|
No. of options exercisable |
178,176
|
Exercise Price Eight [Member] |
|
Schedule of Exercise Prices and Remaining Contractual Life [Line Items] |
|
Exercise price (in Dollars per share) | $ / shares |
$ 5.96
|
Number of options outstanding |
150,000
|
Remaining contractual Life (in years) |
8 years 4 months 20 days
|
Intrinsic Value of Options Outstanding (in Dollars) | $ |
|
No. of options exercisable |
37,500
|
Exercise Price Nine [Member] |
|
Schedule of Exercise Prices and Remaining Contractual Life [Line Items] |
|
Exercise price (in Dollars per share) | $ / shares |
$ 6.22
|
Number of options outstanding |
552,883
|
Remaining contractual Life (in years) |
2 years 8 months 1 day
|
Intrinsic Value of Options Outstanding (in Dollars) | $ |
|
No. of options exercisable |
552,883
|
Exercise Price Ten [Member] |
|
Schedule of Exercise Prices and Remaining Contractual Life [Line Items] |
|
Exercise price (in Dollars per share) | $ / shares |
$ 8.19
|
Number of options outstanding |
150,000
|
Remaining contractual Life (in years) |
5 years 4 months 20 days
|
Intrinsic Value of Options Outstanding (in Dollars) | $ |
|
No. of options exercisable |
150,000
|
Exercise Price Eleven [Member] |
|
Schedule of Exercise Prices and Remaining Contractual Life [Line Items] |
|
Exercise price (in Dollars per share) | $ / shares |
$ 9.02
|
Number of options outstanding |
40,500
|
Remaining contractual Life (in years) |
6 years 4 months 17 days
|
Intrinsic Value of Options Outstanding (in Dollars) | $ |
|
No. of options exercisable |
30,375
|
Exercise Price Twelve [Member] |
|
Schedule of Exercise Prices and Remaining Contractual Life [Line Items] |
|
Exercise price (in Dollars per share) | $ / shares |
$ 10.12
|
Number of options outstanding |
10,407
|
Remaining contractual Life (in years) |
4 years 5 months 4 days
|
Intrinsic Value of Options Outstanding (in Dollars) | $ |
|
No. of options exercisable |
10,407
|
Exercise Price Thirteen [Member] |
|
Schedule of Exercise Prices and Remaining Contractual Life [Line Items] |
|
Exercise price (in Dollars per share) | $ / shares |
$ 12.23
|
Number of options outstanding |
250,000
|
Remaining contractual Life (in years) |
6 years 10 months 28 days
|
Intrinsic Value of Options Outstanding (in Dollars) | $ |
|
No. of options exercisable |
250,000
|
Exercise Price Fourteen [Member] |
|
Schedule of Exercise Prices and Remaining Contractual Life [Line Items] |
|
Exercise price (in Dollars per share) | $ / shares |
$ 21.4
|
Number of options outstanding |
970
|
Remaining contractual Life (in years) |
5 years 25 days
|
Intrinsic Value of Options Outstanding (in Dollars) | $ |
|
No. of options exercisable |
970
|
Exercise Price Fifteen [Member] |
|
Schedule of Exercise Prices and Remaining Contractual Life [Line Items] |
|
Exercise price (in Dollars per share) | $ / shares |
$ 90.16
|
Number of options outstanding |
500
|
Remaining contractual Life (in years) |
5 months 1 day
|
Intrinsic Value of Options Outstanding (in Dollars) | $ |
|
No. of options exercisable |
500
|
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v3.24.2.u1
Share-Based Compensation (Details) - Schedule of Restricted Stock Units Granted Under the 2019 Plan - $ / shares
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Schedule of Restricted Stock Units Granted Under the 2019 Plan [Line Items] |
|
|
|
|
Number of shares, Nonvested at beginning of period |
571,460
|
114,329
|
621,135
|
157,560
|
Weighted average grant date fair value, Nonvested at beginning of period |
$ 2.65
|
$ 9.97
|
$ 3.14
|
$ 10.02
|
Number of shares, Granted |
|
|
|
|
Weighted average grant date fair value, Granted |
|
|
|
|
Number of shares, Vested |
(3,444)
|
(3,438)
|
(44,050)
|
(46,544)
|
Weighted average grant date fair value, Vested |
$ 10.28
|
$ 10.28
|
$ 9.9
|
$ 10.15
|
Number of shares, Forfeited |
(5,757)
|
(313)
|
(14,826)
|
(438)
|
Weighted average grant date fair value, Forfeited |
$ 3.87
|
$ 14.67
|
$ 3.64
|
$ 14.67
|
Number of shares, Nonvested at end of period |
562,259
|
110,578
|
562,259
|
110,578
|
Weighted average grant date fair value, Nonvested at end of period |
$ 2.59
|
$ 9.95
|
$ 2.59
|
$ 9.95
|
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