6-K

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 2022

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 ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulations S-T Rule 101(b)(1): ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulations S-T Rule 101(b)(7): ☐

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, 2022 and 2021, 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.

On August 22, 2022, Enlivex issued a press release (the “Press Release”) announcing its unaudited financial and operating results for the three and six month periods ended June 30, 2022, together with a business update. A copy of the Press Release is furnished as Exhibit 99.3 to this Report on Form 6-K and incorporated herein by reference. The information contained in the Press Release furnished as Exhibit 99.3 to this Report on Form 6-K, and incorporated herein by reference, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any of the Enlivex’s filings under the Securities Act of 1933, as amended (including, without limitation, 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), or the Exchange Act, whether made before or after the date hereof, except as shall be expressly set forth by specific reference in any such filing.

Exhibit No.
99.1	Unaudited condensed consolidated financial statements for Enlivex as of June 30, 2022 and December 31, 2021 and for the three and six month periods ended June 30, 2022 and 2021.
99.2	Operating and Financial Review and Prospects as of and for the three and six month periods ended June 30, 2022 and 2021.
99.3	Press Release issued by Enlivex Therapeutics Ltd. on August 22, 2022.

1

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:  Title:	Oren Hershkovitz Chief Executive Officer

Date: August 22, 2022

2

EX-99.1

Exhibit 99.1

ENLIVEX THERAPEUTICS LTD.

CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

AS OF JUNE 30, 2022 AND DECEMBER 31, 2021

AND FOR THE THREE AND SIX MONTH PERIODS ENDED JUNE 30, 2022 AND 2021

ENLIVEX THERAPEUTICS LTD.

CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

AS OF JUNE 30, 2022 AND DECEMBER 31, 2021

AND FOR THE THREE AND SIX MONTH PERIODS ENDED JUNE 30, 2022 AND 2021

INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

	Page
Condensed Consolidated Balance Sheets	F-2
Condensed Consolidated Statements of Operations and Comprehensive Loss	F-3
Condensed Consolidated Statements of Changes in Shareholders’ Equity	F-4
Condensed Consolidated Cash Flow Statements	F-5
Notes to the Condensed Consolidated Financial Statements	F-6

;

F-1

ENLIVEX THERAPEUTICS LTD.

CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)

U.S. dollars in thousands (except share data)

	June 30,			December 31,
	2022			2021
ASSETS
Current Assets
Cash and cash equivalents	$	20,151		$	11,202
Short term deposits		42,334			10,004
Marketable securities		-			62,924
Prepaid expenses and other receivables		2,453			2,199
Cash held with respect to CVR Agreement		113			113
Total Current Assets		65,051			86,442
Non-Current Assets
Property and equipment, net		6,517			2,530
Other assets		5,773			6,174
Total Non-Current Assets		12,290			8,704
TOTAL ASSETS	$	77,341		$	95,146
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current Liabilities
Accounts payable trade	$	667		$	878
Accrued expenses and other liabilities		3,433			3,727
CVR holders		113			113
Total Current Liabilities		4,213			4,718
Non-Current Liabilities
Other long-term Liabilities		4,642			5,389
Total Non-Current Liabilities		4,642			5,389
Commitments and Contingent Liabilities
TOTAL LIABILITIES		8,855			10,107
SHAREHOLDERS’ EQUITY
Ordinary shares of NIS 0.4 par value: Authorized: 45,000,000 shares as of June 30, 2022 and December 31, 2021; Issued and outstanding: 18,381,052 and 18,331,507 as of June 30 and December 31, 2021;		2,113			2,107
Additional paid in capital		135,375			133,796
Foreign currency translation adjustments		1,101			1,101
Accumulated deficit		(70,103	)		(51,965	)
TOTAL SHAREHOLDERS’ EQUITY		68,486			85,039
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY	$	77,341		$	95,146

The accompanying notes are an integral part of the condensed consolidated financial statements.

F-2

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,
	2022			2021			2022			2021
Revenues	$	-		$	-		$	-		$	-
Operating expenses:
Research and development expenses		4,110			2,539			8,792			5,036
General and administrative expenses		1,761			1,269			3,483			2,574
		5,871			3,808			12,275			7,610
Operating loss		(5,871	)		(3,808	)		(12,275	)		(7,610	)
Other income/(expense), net		(4,042	)		700			(5,863	)		1,302
Net (loss)		(9,913	)		(3,108	)		(18,138	)		(6,308	)
Other comprehensive income (loss)
Exchange differences arising from translating financial statements from functional to presentation currency		-			2,055			-			(733	)
Total other comprehensive income (loss)		-			2,055			-			(733	)
Total comprehensive (loss)	$	(9,913	)	$	(1,053	)	$	(18,138	)	$	(7,041	)
Basic & diluted (loss) per share	$	(0.54	)	$	(0.17	)	$	(0.99	)	$	(0.36	)
Weighted average number of shares outstanding		18,375,206			18,305,882			18,372,521			17,397,860

The accompanying notes are an integral part of the condensed consolidated financial statements.

F-3

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, 2021		18,331,507	$	2,107	$	133,796		$	1,101		$	(51,965	)	$	85,039
Changes during the three months period ended March 31, 2022:
Restricted stock units vested		34,295		4		(4	)		-			-			-
Exercise of options		7,625		1		49			-			-			50
Stock based compensation		-		-		788			-			-			788
Net loss		-		-		-			-			(8,225	)		(8,225	)
Balance as of March 31, 2022 (unaudited)		18,373,427		2,112		134,629			1,101			(60,190	)		77,652
Changes during the three months period ended June 30, 2022:
Exercise of options		7,625		1		49			-			-			50
Stock based compensation		-		-		697			-			-			697
Net loss		-		-		-			-			(9,913	)		(9,913	)
Balance as of June 30, 2022 (unaudited)		18,381,052		2,113		135,375			1,101			(70,103	)		68,486
Balance as of December 31, 2020		14,587,934	$	1,646	$	70,361		$	977		$	(37,497	)	$	35,487
Changes during the three months period ended March 31, 2021:
Issuance of shares and warrants for cash consideration of $57,629 net of $4,455 issuance costs		2,848,629		352		52,822			-			-			53,174
Exercise of options		13,435		2		38			-			-			40
Exercise of warrants		855,813		104		7,598			-			-			7,702
Stock based compensation		-		-		190			-			-			190
Other comprehensive loss		-		-		-			(2,788	)		-			(2,788	)
Net loss		-		-		-			-			(3,200	)		(3,200	)
Balance as of March 31, 2021 (unaudited)		18,305,811		2,104		131,009			(1,811	)		(40,697	)		90,605
Changes during the three months period ended June 30, 2021:
Exercise of options		375		*		2			-			-			2
Stock based compensation		-		-		652			-			-			652
Other comprehensive loss		-		-		-			2,055			-			2,055
Net loss		-		-		-			-			(3,108	)		(3,108	)
Balance as of June 30, 2021 (unaudited)		18,306,186	$	2,104	$	131,663		$	244		$	(43,805	)	$	90,206

* Less than $1

The accompanying notes are an integral part of the condensed consolidated financial statements.

F-4

ENLIVEX THERAPEUTICS LTD.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)

U.S. dollars in thousands

	For the six months ended June 30,
	2022			2021
Cash flows from operating activities
Net (loss)	$	(18,138	)	$	(6,308	)
Adjustments required to reflect net cash used in operating activities:
Income and expenses not involving cash flows:
Depreciation		364			239
Non-cash operating lease expenses		411			107
Share-based compensation		1,485			842
Loss (income) on marketable securities and short-term bank deposits		4,886			(1,583	)
Changes in operating asset and liability items:
Decrease in prepaid expenses and other receivables		(205	)		(195	)
Increase (decrease) in accounts payable trade		(211	)		101
Increase (decrease) in accrued expenses and other liabilities		(307	)		153
Operating lease liabilities		(827	)		(106	)
Net cash (used in) provided by operating activities		(12,542	)		(6,750	)
Cash flows from investing activities
Purchase of property and equipment		(4,351	)		(472	)
Release (investment) in short-term bank deposits		(35,234	)		19,563
Purchases of marketable securities		(1,608	)		(85,695	)
Proceeds from sales of marketable securities		62,549			19,217
Net cash provided by (used in) investing activities		21,356			(47,387	)
Cash flows from financing activities
Proceeds from issuance of shares and warrants net of $4,455 issuance expenses		-			53,174
Proceeds from exercise of warrants		-			7,702
Proceeds from exercise of options		100			42
Net cash provided by financing activities		100			60,918
Increase (decrease) in cash and cash equivalents		8,914			6,781
Cash and cash equivalents - beginning of period		11,636			7,012
Exchange rate differences on cash and cash equivalents		-			(210	)
Cash and cash equivalents - end of period	$	20,550		$	13,583
Non-cash transactions:
Warrants issued in settlement of issuance costs to a placement agent	$	-		$	2,095
Supplemental disclosures of cash flow information:
Cash paid for taxes	$	-		$	-
Cash paid (received) for interest, net	$	45		$	62

The accompanying notes are an integral part of the condensed consolidated financial statements.

F-5

ENLIVEX THERAPEUTICS LTD.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2022 (UNAUDITED)

NOTE 1 - GENERAL

a. Enlivex Therapeutics Ltd. (the “Parent” and, including its consolidated subsidiaries, “we”, “us”, “our” or the “Company”) is a clinical-stage macrophage reprogramming immunotherapy company originally incorporated on January 22, 2012 under the laws of the State of Israel.

Enlivex Therapeutics R&D Ltd. (“Enlivex R&D”) was incorporated in September 2005 under the laws of the State of Israel. On March 26, 2019, upon consummation of a merger transaction between the Parent and Enlivex R&D, Enlivex R&D became a wholly owned subsidiary of the Company.

In January 2015, Enlivex Therapeutics Inc. was incorporated in the State of Delaware as a wholly owned subsidiary of the Parent.

On June 21, 2021 Enlivex Therapeutics RDO Ltd. was incorporated in Israel as a wholly owned subsidiary of the Parent.

The Company is a clinical stage macrophage reprogramming immunotherapy company, developing Allocetra^TM, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of life-threatening conditions. Non-homeostatic macrophages contribute significantly to the severity of certain diseases, which include solid tumors, sepsis and others.

AllocetraTM is based on the discoveries of Professor Dror Mevorach, an expert on immune activity, macrophage activation and clearance of dying (apoptotic) cells, in his laboratory in the Hadassah University Hospital located in the State of Israel.

The Company’s ordinary shares, 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.

b. Financial Resources

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, 2022, had an accumulated deficit of $70,103 thousand.

The Company expects to continue to incur losses for at least the next several years, and the Company will need to raise additional debt or equity financing or enter into partnerships to fund its development. If the Company is not able to achieve its funding requirements, it may be required to reduce discretionary spending, may not be able to continue the development of its product candidates or may be required to delay its development programs, which could have a material adverse effect on the Company’s ability to achieve its intended business objectives. There can be no assurances that additional financing will be secured or, if secured, will be on favorable terms. The ability of the Company to transition to profitability in the longer term is dependent on developing products and product revenues to support its expenses.

The Company’s management and board of directors (the “Board”) are of the opinion that the Company’s current financial resources will be sufficient to continue the development of the Company’s product candidates for at least twelve months from the 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.

F-6

ENLIVEX THERAPEUTICS LTD.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2022 (UNAUDITED)

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 2021 Annual Report on Form 20-F, as filed with the SEC on April 29, 2022. The results of operations for these interim periods are not necessarily indicative of the operating results for any future period. The December 31, 2021 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.

Until September 30, 2021, the functional currency of Enlivex R&D was the New Israeli Shekel (“NIS”).

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 incurred after September 30, 2021 were translated at the approximate exchange rate prevailing at the date of the transaction. Transactions included in the statement of income for the three and six month periods ended June 30, 2022 were translated at the approximate exchange rate in effect at the respective times of the transactions. Transactions included in the statement of income for the three and six month periods ended June 30, 2021 were translated at average exchange rates during the applicable period. Gains or losses resulting from translation adjustments for the three and six month periods ended June 30, 2021 are reported in other comprehensive income (loss).

one U.S. dollar = 3.50 NIS and 3.11 NIS as of June 30, 2022 and December 31, 2021, respectively.

The U.S. dollar increased (decreased) against the NIS: 10.20%, 12.54%, (2.22%) and 1.4% in the three and six month periods ended June 30, 2022 and 2021, respectively.

Reclassification of Prior Year Presentation

Certain prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications had no effect on the reported results of operations.

Recently Adopted Accounting Standards

In August 2020, the FASB issued ASU 2020-06, Debt - Debt with Conversion and other Options (Subtopic 470-20) and Derivatives and Hedging: Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”). ASU 2020-06 simplifies the complexity associated with applying GAAP for certain financial instruments with characteristics of liabilities and equity by removing certain accounting models which separate the embedded conversion features from the host contract for convertible instruments. The standard also enhances the consistency of earnings-per-share calculations by requiring that an entity use the if-converted method and that the effect of potential share settlement be included in diluted earnings-per-share calculations. ASU 2020-06 became effective for fiscal years and interim periods within those fiscal years beginning after December 15, 2021. The Company evaluated ASU 2020-06 and determined that its adoption did not have an impact on the Company’s condensed consolidated financial statements and related disclosures.

F-7

ENLIVEX THERAPEUTICS LTD.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2022 (UNAUDITED)

Recently Issued Accounting Pronouncements Not Yet Adopted

The Company has evaluated other recently issued accounting pronouncements and does not currently believe that any of these pronouncements will have a material impact on its condensed consolidated financial statements and related disclosures.

Significant Accounting Policies

There have been no material changes to the significant accounting policies previously disclosed in the Company’s Annual Report on Form 20-F for the year ended December 31, 2021.

Marketable Securities.

The Company has an investment policy that includes guidelines on acceptable investment securities, minimum credit quality, maturity parameters, and concentration and diversification. The Company invests its excess cash primarily in mutual funds that are classified based on the nature of their underlying securities and their availability for use in current operations. The Company’s marketable equity securities are measured at fair value with gains and losses recognized in other income/(expense), net.

Net (loss) income recognized on equity securities for the three and six month periods ended June 30, 2022 and 2021 was $0, $(1,982), $1,195 and $1,583 thousand of which $0, $0, $950 and $1,342 thousand, respectively, were not realized.

NOTE 3 – CASH, CASH EQUIVALENTS AND RESTRICTED CASH

	June 30,		December 31,
(in thousands)	2022		2021
Cash held in banks	$	2,133	$	1,199
Bank deposits in U.S.$  (annual average interest rates 3.02% and 0.1%)		18,018		10,003
Total cash and cash equivalents		20,151		11,202
Cash held with respect to CVR Agreement		113		113
Restricted cash – noncurrent – Other assets		286		321
Total cash, cash equivalents and restricted cash shown in the statement of cash flows	$	20,550	$	11,636

NOTE 4 – SHORT TERM DEPOSITS

	June 30,		December 31,
(in thousands)	2022		2021
Bank deposits in U.S.$ and NIS (average annual interest rates 0.7% and 0.6%)	$	42,334	$	10,004
Total short-term deposits	$	42,334	$	10,004

F-8

ENLIVEX THERAPEUTICS LTD.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2022 (UNAUDITED)

NOTE 5 – PROPERTY AND EQUIPMENT

Property and equipment, net consists of the following:
	June 30,		December 31,
(in thousands)	2022		2021
Cost:
Laboratory equipment	$	2,253	$	1,891
Computers		276		256
Office furniture & equipment		218		192
Leasehold improvements		5,464		1,521
		8,211		3,860
Accumulated depreciation:
Laboratory equipment		1,176		960
Computers		170		138
Office furniture & equipment		22		15
Leasehold improvements		326		217
		1,694		1,330
Depreciated cost	$	6,517	$	2,530

Depreciation expenses for the three and six month periods ended June 30, 2022 and 2021 were $176, $364, $122 and $239 thousand, respectively.

NOTE 6 – OTHER ASSETS

	June 30,		December 31,
(in thousands)	2022		2021
Restricted cash	$	286	$	321
Long-term prepaid expenses		118		164
Right-of-Use assets, net		5,369		5,689
	$	5,773	$	6,174

NOTE 7 – ACCRUED EXPENSES AND OTHER LIABILITIES

	June 30,		December 31,
(in thousands)	2022		2021
Vacation, convalescence and bonus accruals	$	528	$	1,068
Employees and payroll related		639		519
Short term operating lease liabilities		629		617
Accrued expenses and other		1,637		1,523
	$	3,433	$	3,727

NOTE 8 – LEASES

The Company is a party to operating leases for its corporate offices, laboratory space and vehicles. The Company’s real property operating leases have remaining lease terms of up to 3.25 years, some of which include options to extend the leases for up to five years.

	Six months ended June 30,
(in thousands)	2022		2021
The components of lease expense were as follows:
Operating leases expenses	$	517	$	139
Supplemental consolidated cash flow information related to operating leases follows:
Cash used in operating activities	$	478	$	135
Non-cash activity:
Right of use assets obtained in exchange for new operating lease liabilities	$	91	$	29

F-9

ENLIVEX THERAPEUTICS LTD.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2022 (UNAUDITED)

	June 30,			December 31,
(in thousands)	2022			2021
Supplemental information related to operating leases, including location of amounts reported in the accompanying consolidated balance sheets, follows:
Other assets - Right-of-Use assets	$	6,420		$	6,329
Accumulated amortization		1,051			640
Operating lease Right-of-Use assets, net	$	5,369		$	5,689
Lease liabilities – current - Accounts payable and accrued liabilities	$	629		$	617
Lease liabilities – noncurrent		4,642			5,389
Total operating lease liabilities	$	5,271		$	6,006
Weighted average remaining lease term in years		8.1			8.6
Weighted average annual discount rate		3.6	%		3.6	%

Maturities of operating lease liabilities as of June 30, 2022, were as follows:
2022 (after June 30)	$	386
2023		786
2024		679
2025		714
2026 and onwards		3,497
Total undiscounted lease liability	$	6,062
Less: Imputed interest	$	(791	)
Present value of lease liabilities	$	5,271

NOTE 9 – 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 LIBOR-based rate.

The gross amount of grants received by the Company from the IIA, including accrued interest as of June 30, 2022, was approximately $8.9 million. As of June 30, 2022, the Company had not paid any royalties to the IIA.

In January 2022, the Company submitted a new grant application to the IIA to approve the expenditure of $4.8 million of its clinical development program for the prevention of cytokine storms and organ dysfunction associated with sepsis for a period commencing January 1, 2022 and ending December 31, 2022 (the “2022 Sepsis Grant Application”). In May 2020, the IIA selected this program to receive a non-dilutive grant of approximately $1.0 million for expenses associated with the Company’s ongoing sepsis clinical Phase II trial.

F-10

ENLIVEX THERAPEUTICS LTD.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2022 (UNAUDITED)

NOTE 10 – EQUITY

All Company warrants are classified as a component of shareholders’ equity because such warrants are free standing financial instruments that are legally detachable, separately exercisable, do not embody an obligation for the Company to repurchase its own shares, and permit the holders to receive a fixed number of Ordinary Shares upon exercise, requires physical settlement and do not provide any guarantee of value or return.

	Number of Warrants			Weighted average exercise price
Outstanding January 1, 2022		704,355		$	13.18
Forfeited and expired		(502,104	)	$	9.50
Outstanding and exercisable June 30, 2022		202,251		$	23.31

Comprised as follows:

Number of Warrants		Exercise Price Per Share		Issuance date	Expiration date
	22,750	$	10	February 26, 2020	February 24, 2025
	160,727	$	25	February 12, 2021	February 9, 2026
	18,774	$	25	February 17, 2021	February 9, 2026
	202,251

NOTE 11 – SHARE-BASED COMPENSATION

a) As of June 30, 2022, 4,150,704 Ordinary Shares were authorized for issuance to employees, directors and consultants under the 2019 Equity Incentive Plan, of which 1,189,363 shares were available for future grant.

b) The following table contains information concerning options granted under the existing equity incentive plans:

	Three months ended June 30,
	2022					2021
	Number of options			Weighted average exercise price		Number of options			Weighted average exercise price
Outstanding at beginning of period		2,399,622		$	5.95		1,870,485		$	5.54
Granted		-		$	-		310,500		$	12.57
Forfeited and expired		(3,000	)	$	5.34		(2,685	)	$	7.38
Exercised		(7,625	)	$	6.49		(375	)	$	4.68
Outstanding at end of period		2,388,997		$	5.95		2,177,925		$	6.54
Exercisable at end of period		1,728,623		$	5.10		1,404,809		$	5.50
Non-vested at beginning of period		722,749		$	7.67		544,163		$	6.04
Granted		-		$	-		310,500		$	12.57
Vested		(59,375	)	$	(8.78)		(78,862	)	$	13.15
Forfeited)		(3,000	)	$	(5.34)		(2,685	)	$	7.38
Non-vested at the end of period		660,374		$	7.59		773,116		$	8.19

F-11

ENLIVEX THERAPEUTICS LTD.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2022 (UNAUDITED)

	Six months ended June 30,
	2022					2021
	Number of options			Weighted average exercise price		Number of options			Weighted average exercise price
Outstanding at beginning of period		2,142,547		$	6.02		1,884,420		$	5.52
Granted		264,700		$	5.48		310,500		$	12.57
Forfeited and expired		(3,000	)	$	5.34		(3,185	)	$	6.96
Exercised		(15,250	)	$	6.49		(13,810	)	$	2.99
Outstanding at end of period		2,388,997		$	5.95		2,177,925		$	6.54
Exercisable at end of period		1,728,623		$	5.10		1,404,809		$	5.50
Non vested  at beginning of period		529,082		$	8.69		601,227		$	5.93
Granted		264,700		$	5.48		310,500		$	12.57
Forfeited and expired		(3,000	)	$	5.34		(135,426	)	$	8.22
vested		(130,408	)	$	7.82		(3,185	)	$	6.96
Outstanding at end of period		660,374		$	7.59		773,116		$	8.19

During the three and six month periods ended June 30, 2022 and 2021, the Company recognized $509, $1,074, $603 and $778 thousand, respectively, of share-based compensation expenses related to stock options. As of June 30, 2022, the total unrecognized estimated compensation cost related to outstanding non-vested stock options was $1,780 thousand, which is expected to be recognized over a weighted average period of 1.5 years.

c) Set forth below is data regarding the range of exercise prices and remaining contractual life for all options outstanding at June 30, 2022:

Exercise price		Number of options outstanding		Remaining contractual Life (in years)		Intrinsic Value of Options Outstanding		No. of options exercisable
							(in thousands)
$	2.69		649,883		2.92		1,189,284		649,883
$	3.66		250,000		7.84		214,250		180,556
$	4.68		55,500		7.75		-		27,750
$	5.35		231,200		9.75		-
$	6.22		634,177		5.00		-		620,879
$	6.49		15,250		0.03		-		-
$	8.19		150,000		7.38		-		75,000
$	8.23		20,000		9.39		-		-
$	8.30		15,000		9.10		-		-
$	9.02		40,500		8.38		-		10,125
$	10.12		12,126		6.43		-		9,700
$	12.21		2,421		6.74		-		1,816
$	12.23		250,000		8.91		-		111,111
$	14.00		60,500		8.82		-		40,333
$	21.40		1,940		7.07		-		970
$	90.16		500		2.42		-		500
			2,388,997			$	1,403,534		1,728,623

F-12

ENLIVEX THERAPEUTICS LTD.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2022 (UNAUDITED)

d) The following table contains information concerning restricted stock units granted under the existing equity incentive plans:

	Three months ended  June 30,
	2022					2021
	Number of shares			Weighted average grant date fair value		Number of shares			Weighted average grant date fair value
Nonvested at beginning of period		184,787		$	10.02		48,375		$	14.67
Granted		-		$	-		13,750		$	10.28
Vested		(3,437	)	$	10.28		-		$	-
Forfeited		-			-		(2,000	)	$	14.67
Nonvested at end of period		181,350		$	10.02		60,125		$	13.67

	Six months ended  June 30,
	2022					2021
	Number of shares			Weighted average grant date fair value		Number of shares			Weighted average grant date fair value
Nonvested at beginning of period		229,331		$	10.08		-		$	-
Granted		-		$	-		62,125		$	13.7
Vested		(47,981	)	$	10.29		-		$	-
Forfeited		-		$	-		(2,000	)	$	14.67
Nonvested at end of period		181,350		$	10.02		60,125		$	13.67

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, 2022 and 2021, the Company recognized $188, $411, $49 and $64 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, 2022 was $889 thousand, which is expected to be recognized over a weighted average period of 1.5 years.

e) The following table summarizes share-based compensation expenses related to grants under the existing equity incentive plans included in the statements of operations:

	Three months ended June 30,				Six months ended June 30,
(in thousands)	2022		2021		2022		2021
Research & development	$	119	$	358	$	509	$	446
General & administrative		578		294		976		396
Total	$	697	$	652	$	1,485	$	842

F-13

ENLIVEX THERAPEUTICS LTD.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2022 (UNAUDITED)

NOTE 12 – 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, 2022 and December 31, 2021:

	June 30, 2022
(in thousands)	Total		Level 1		Level 2		Level 3
Cash and cash equivalents	$	20,550	$	20,550	$	-	$	-
Short term deposits		42,334		42,334		-		-
Cash held with respect to CVR Agreement		113		113		-		-
Restricted cash		286		286		-		-
Total financial assets	$	63,283	$	63,283	$	-	$	-

	December 31, 2021
(in thousands)	Total		Level 1		Level 2		Level 3
Cash and cash equivalents	$	11,202	$	11,202	$	-	$	-
Short term deposits		10,004		10,004		-		-
Cash held with respect to CVR Agreement		113		113		-		-
Marketable securities		62,924		62,924		-		-
Restricted cash		321		321		-		-
Total financial assets	$	84,564	$	84,564	$	-	$	-

NOTE 13 – 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 there were no events that necessitated disclosure:

F-14

EX-99.2

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, ALLOCETRA^TM 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 ALLOCETRA^TM 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, 2021.  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 Allocetra^TM, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of life-threatening conditions. Non-homeostatic macrophages contribute significantly to the severity of the respective diseases, which include solid tumors, sepsis and others.

We believe the Company’s primary innovative immunotherapy, Allocetra^TM, represents a paradigm shift in macrophage reprogramming, moving from targeting a specific subset of macrophages or a specific pathway effecting macrophages activity, to a fundamental view of macrophage homeostasis. Restoring macrophage homeostasis may induce the immune system to rebalance itself to normal levels of operation, thereby promoting disease resolution.

The Company is focused on two main clinical verticals, sepsis and solid tumors (the “Indications”). The Company believes that negatively-reprogrammed macrophages may be key contributors to disease severity across these two Indications, and thus effective reprogramming of these previously negative-reprogrammed macrophages into their respective homeostatic state may provide diseases resolution for these Indications, some of which are considered “unmet medical needs”, such as preventing or treating complications associated with sepsis and certain solid tumors.

Financial Overview

Since inception, we have incurred significant losses in connection with our research and development and have not generated any revenue. We have funded our operations primarily through grants from the Israel Innovation Authority (the “IIA”) and the sale of equity and equity linked securities in public and private offerings. As of June 30, 2022, we had approximately $62.5 million in cash and cash equivalents and short-term bank deposits and had an accumulated deficit of approximately $70.1 million, see “—Liquidity and Capital Resources” below.

For the six months ended June 30, 2022, our cash expenditures included a one-time, non-recurring expense of $4.2 million related to the construction of our new manufacturing facility, which is expected to be completed in the fourth quarter of 2022. 

Although we provide no assurance, we believe that our existing funds will be sufficient to continue our business and operations as currently conducted through the third quarter of 2024. 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.

Costs and Operating Expenses

Our current costs and operating expenses consist of two components: (i) research and development expenses; and (ii) general and administrative expenses.

Research and Development Expenses

Our research and development expenses consist primarily of research and development activities at our laboratory in Israel, including drug and laboratory supplies and costs for facilities and equipment, outsourced development expenses, including the costs of regulatory consultants and certain other service providers, salaries and related personnel expenses (including share based compensation) and fees paid to external service providers and the costs of preclinical studies and clinical trials. We charge all research and development expenses to operations as they are incurred. We expect our research and development expenses to remain our primary expenses in the near future as we continue to develop our product candidates. Increases or decreases in research and development expenditures are attributable to the number and duration of our preclinical and clinical studies.

We expect that a large percentage of our research and development expenses in the future will be incurred in support of our current and future preclinical and clinical development projects. Due to the inherently unpredictable nature of preclinical and clinical development processes, we are unable to estimate with any certainty the costs we will incur in the continued development of our product candidates in our pipeline for potential commercialization. Furthermore, although we expect to obtain additional grants from the Israel Innovation Authority, we cannot be certain that we will do so. Clinical development timelines, the probability of success and development costs can differ materially from expectations. We expect to continue to test our product candidates in preclinical studies for toxicology, safety and efficacy and to conduct additional clinical trials for our product candidates.

While we are currently focused on advancing our product development, our future research and development expenses will depend on the clinical success of our product candidates, as well as ongoing assessments of each candidate’s commercial potential. As we obtain results from clinical trials, we may elect to discontinue or delay clinical trials for our product candidates in certain Indications in order to focus our resources on more promising indications for any such product candidate. Completion of clinical trials may take several years or more, but the length of time generally varies according to the type, complexity, novelty and intended use of a product candidate.

We expect our research and development expenses to increase in the future as we continue the advancement of our clinical product development for the Indications and as we potentially pursue additional indications. The lengthy process of completing clinical trials and seeking regulatory approval for our product candidates requires the expenditure of substantial resources. Any failure or delay in completing clinical trials, or in obtaining regulatory approvals, could cause a delay in generating product revenue and cause our research and development expenses to increase and, in turn, have a material adverse effect on our operations.

General and Administrative Expenses

General and administrative expenses consist primarily of compensation (including share-based compensation) for employees in executive and operational roles, including accounting, finance, investor relations, information technology and human resources. Our other significant general and administrative expenses include facilities costs, professional fees for outside accounting and legal services, including legal work in connection with patent applications, travel costs and insurance premiums.

2

Other income (expenses), net

Other income (expenses) consists of bank fees, exchange rate differences and gains and losses resulting from our investments in short term deposits and marketable securities.

Other Comprehensive income (Loss)

Our functional currency is the U.S. dollar because the U.S. dollar is the currency of the primary economic environment in which we operate and expect to continue to operate for the foreseeable future.

The functional currency of our primary operating subsidiary, Enlivex Therapeutics R&D Ltd. (“Enlivex R&D”) had been the New Israeli Shekel (“NIS”). We reassessed Enlivex R&D’s functional currency and determined that, as of September 30, 2021, the U.S. dollar became the functional currency of Enlivex R&D. Significant elements supporting such determination included (i) a change in our business strategy resulting from our planned initiation of oncology clinical trials, and (ii) our newly-developed frozen formulation of Allocetra^TM, which eliminates the constraints of short shelf life and long-term storage of the liquid formulation, enabling us to conduct clinical trials for sepsis and oncology outside of Israel. Additional elements were the fact that our main sources of financing have been the U.S. capital markets and U.S. dollar denominated government grants from the IIA and the fact that all of our budgeting and planning is conducted solely in U.S. dollars. Monetary assets and liabilities denominated in foreign currencies were translated into U.S. dollars using exchange rates in effect at the balance sheet date. 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 non-monetary liabilities incurred after September 30, 2021 are translated at the approximate exchange rate prevailing at the date of the particular transaction. Transactions included in the statement of income until the date of change were translated at average exchange rates during the applicable period, and transactions after September 30, 2021 were translated at the approximate exchange rate in effect at the time of the particular transaction. Gains or losses resulting from translation adjustments until September 30, 2021 are reported in other comprehensive income (loss).

Critical Accounting Policies and Estimate

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, 2021 as filed with the SEC on April 29, 2022.

Share-Based Compensation

We have issued 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.

3

We estimate the grant date fair value of share options and the related compensation expense, using the Black-Scholes option valuation model. This option valuation model requires the input of subjective assumptions including: (1) expected life (estimated period of time outstanding) of the options granted, (2) volatility, (3) risk-free rate and (4) dividends. In general, the assumptions used in calculating the fair value of share-based payment awards represent management’s best estimates, but the estimates involve inherent uncertainties and the application of management judgment.

Leases: 

We determine if an arrangement includes a lease at inception. Right-of-use assets represent our right to use an underlying asset for the lease term; and lease liabilities represent our obligation to make lease payments arising from the lease. Right-of-use assets and lease liabilities are recognized at the commencement date of the lease, renewal date of the lease or significant remodeling of the lease space based on the present value of the remaining future minimum lease payments. Leases with a term greater than one year are recognized on the balance sheet as right-of-use assets and short-term and long-term lease liabilities, as applicable.

Operating lease liabilities and their corresponding right-of-use assets are initially recorded based on the present value of lease payments over the expected remaining lease term. The interest rate implicit in lease contracts is typically not readily determinable. As a result, we utilize our incremental borrowing rate to discount lease payments, which reflects the fixed rate at which we could borrow on a collateralized basis the amount of the lease payments in the same currency, for a similar term, in a similar economic environment.

Our leases include options to extend or terminate the lease. In determining the lease term, management uses its judgement to determine whether or not an option would be reasonably certain to be exercised. Management considers all facts and circumstances, including their past practice and any cost that will be incurred to change the asset if an option to extend is not taken, to help determine the lease term. Extension options are only included in the lease term if the lease is reasonably certain to be extended.

4

Results of Operations

Six-Months Ended June 30, 2022 Compared to Six-Months Ended June 30, 2021

The table below provides our results of operations for the six months ended June 30, 2022 and June 30, 2021:

	Six Months Ended June 30
	2022			2021
	(In thousands, except per share data) (unaudited)
Research and development expenses	$	8,792		$	5,036
General and administrative expenses		3,483			2,574
Operating loss		(12,275	)		(7,610	)
Other income (expense), net		(5,863	)		1,302
Operating income (loss) post-finance expense & other income, net		(18,138	)		(6,308	)
Taxes on income		-			-
Net income (loss)		(18,138	)		(6,308	)
Other comprehensive income (loss)		-			(733	)
Total comprehensive income (loss)	$	(18,138	)	$	(7,041	)
Basic income (loss) per share	$	(0.99	)	$	(0.36	)
Diluted income (loss) per share	$	(0.99	)	$	(0.36	)

Three-Months Ended June 30, 2022 Compared to Three-Months Ended June 30, 2021

The table below provides our results of operations for the three months ended June 30, 2022 and June 30, 2021:

	Three Months Ended June 30
	2022			2021
	(In thousands, except per share data) (unaudited)
Research and development expenses	$	4,110		$	2,539
General and administrative expenses		1,761			1,269
Operating loss		(5,871	)		(3,808	)
Other income(expenses), net		(4,042	)		700
Operating income (loss) post-finance expense & other income, net		(9,913	)		(3,108	)
Taxes on income
Net income (loss)		(9,913	)		(3,108	)
Other comprehensive income (loss)		-			2,055
Total comprehensive income (loss)	$	(9,913	)	$	(1,053	)
Basic income (loss) per share	$	(0.54	)	$	(0.17	)
Diluted income (loss) per share	$	(0.54	)	$	(0.17	)

5

Research and Development Expenses

For the six and three months ended June 30, 2022 and 2021, we incurred research and development expenses in the aggregate of $8,792,000, $4,110,000, $5,036,000 and $2,539,000, respectively. The increase of $3,756,000, or 75%, in research and development expenses for the six months ended June 30, 2022 as compared to the six months ended June 30 2021 was primarily due to (a) a $1,826,000 increase in expenses for clinical studies, pre-clinical studies and an increase in the number of Allocetra^TM doses that were manufactured and inventoried, which represents 49% of the increase in the research and development expenses for such period, (b) a $1,000,000 increase in salaries as a result of hiring additional personnel and certain pay increases for existing personnel, which represents 27% of the increase in the research and development expenses for such period, (c) a $652,000 increase in lease payments and overhead expenses with respect to the lease of our plant space used for the manufacture of Allocetra^TM to support ongoing clinical trials, which represents 17% of the of the increase in the research and development expenses for such period.

The increase of $1,571,000, or 62%, in research and development expenses for the three months ended June 30, 2022 as compared to the second quarter of 2021 was primarily due to a $395,000 increase in salaries, a $866,000 increase in pre-clinical studies, clinical studies and consumption of materials, and a $286,000 increase in lease payments and overhead expenses with respect to the lease of our plant space used for the manufacture of Allocetra^TM to support ongoing clinical trials

General and Administrative Expenses

For the six and three months ended June 30, 2022 and 2021, we incurred general and administrative expenses in the aggregate of $3,483,000, $1,761,000, $2,574,000 and $1,269,000 respectively. The increase of $909,000, or 35%, in general and administrative expenses for the six months ended June 30, 2022 as compared to the 2021 period was primarily due to a $279,000 increase in salaries as a result of hiring additional personnel and certain pay raises for existing personnel, a $580,000 increase in share based compensation, a $188,000 increase in professional fees and a $87,000 increase in insurance expenses, partially offset by a $366,000 decrease in compensation to directors.

The increase of $492,000, or 38%, in general and administrative expenses for the three months ended June 30, 2022 as compared to the 2021 period was primarily due to a $198,000 increase in salaries as a result of hiring additional personnel and certain pay raises for existing personnel, a $112,000 increase in professional fees and $112,000 increase in share based compensation

Operating Loss

Due to an increase in research and development and general and administrative expenses for the six and three month periods ended June 30, 2022, our operating loss was $12,275,000 and $5,871,000, respectively, representing an increase of $4,655,000 and $2,063,000, or 61% and 54%, respectively, as compared to our operating loss for the six and three month periods ended June 30, 2021. A $1,826,000 increase in expenses for clinical studies, pre-clinical studies and an increase in the number of Allocetra doses that were manufactured and inventoried represents 40% of the increase in the operating loss for the for the six months ended June 30 2022 over the six months ended June 30 2021. In addition, a $1,000,000 increase in salaries as a result of hiring additional personnel and certain pay increases for existing personnel represents 21.5% of the increase in the operating loss for the respective periods, and a $580,000 non-cash expenses increase in share based compensation represents 12.5% of the increase in the operating loss for the respective periods.

Other Income (Expenses), Net

Other income (expenses), net consist of the following:

● Interest earned on our cash and cash equivalents; 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; and

●  Gain and losses from marketable equity securities.

6

For the six and three months ended June 30, 2022 and 2021, we recorded other (expenses) income net of $(5,863,000), $(4,042,000), $1,302,000 and $700,000, respectively. The increase in other expenses for the six and three months ended June 30, 2022 as compared to the six and three months ended June 30, 2021 was primarily due to a loss from changes in the fair value of marketable equity securities, and an increase in expenses resulting from currency fluctuations on cash and cash equivalents and deposits denominated in NIS currency.

Net Loss

For the six and three months ended June 30, 2022, our net loss was $18,138,000 and $9,913,000, respectively, representing an increase of $11,830,000 and $6,805,000, or 187% and 218%, respectively, as compared to our net loss for the comparable prior year periods. This increase resulted primarily from a $5,863,000 non-cash charge associated with fair value of marketable securities and currency fluctuations on cash and cash equivalents and deposits denominated in NIS currency for the six month ended June 30 2022 as compared to a non-cash gain of $1,302,000 for the six month ended June 30 2021, together representing $7,165,000, or 60%, of the increase in the loss. In addition, a $1,826,000 increase in expenses for clinical studies, pre-clinical studies and increase in the number of Allocetra doses that were manufactured and inventoried represents another 15% of the increase in the loss for the respective periods.

Other Comprehensive Income (Loss)

As of October 1, 2021, the U.S. dollar had become the functional currency of Enlivex R&D; therefore, for the six and three months ended June 30, 2022, we did not record any other comprehensive income (loss) from exchange rate differences arising from the translation of our unaudited condensed consolidated financial statements from our functional to our presentation currency.

Cash Flows

Six Months Ended June 30, 2022 Compared to Six Months Ended June 20, 2021

For the six months ended June 30, 2022 and 2021, net cash used in operations was $12,542,000 and $6,750,000), respectively. The increase in net cash used in operations for 2022 was primarily due to a $1,826,000 increase in expenses for clinical studies, pre-clinical studies and increase in the number of Allocetra doses that were manufactured and inventoried, as well as a $1,000,000 increase in salaries as a result of hiring additional personnel and certain pay increases for existing personnel, and a $652,000 increase in lease payments and overhead expenses with respect to the lease of our plant space used for the manufacture of Allocetra^TM to support ongoing clinical trials

For the six months ended June 30, 2022 and 2021, net cash provided by (used in) investing activities was $21,356,000 and $(47,387,000), respectively. The increase in net cash provided by investing activities for 2022 as compared to 2021 resulted primarily from proceeds from sales of marketable securities as compared to purchase of marketable securities in the comparable prior year period. In addition, We incurred a non-recurring expense of $4.2 million related to the buildup¹ of our new manufacturing facility.

For the six months ended June 30, 2022 and 2021, net cash provided by financing activities was $100,000 and $60,918,000, respectively. This decrease in cash provided by financing activities for 2022 as compared to 2021 resulted primarily from net proceeds of $53,174,000 from our issuance of ordinary shares and warrants in an offering in February 2021 and proceeds of $7,702,000 from the exercise of warrants in the comparable prior year period.

Liquidity and Capital Resources

We have incurred substantial losses since our inception. As of June 30, 2022, we had an accumulated deficit of approximately $70.1 million and working capital (current assets minus current liabilities) of approximately $60.8 million. We expect to incur losses from operations for the foreseeable future, and we expect to incur increasing research and development expenses, , conducting preclinical studies and clinical trials and outsourcing of certain development activities. We expect that general and administrative expenses will also increase as we expand our finance and administrative staff and add infrastructure.

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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, due to our 2021 financing activity, as described above, will be sufficient to fund our projected cash requirements approximately through the third quarter of 2024. 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.  

We currently do not have any commitments for future external funding. In the future, we will need to raise additional funds, and we may decide to raise additional funds even before we need such funds if the conditions for raising capital are favorable. Until we can generate significant recurring revenues, we expect to satisfy our future cash needs through debt or equity financings, credit facilities or by out-licensing applications of our product candidates. The sale of equity 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 Israel Innovation Authority, 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.

 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 most of our expenses are denominated in NIS and the U.S. dollar. Our NIS and U.S. dollar 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 and U.S. dollar. Our financial position, 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.

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EX-99.3

Exhibit 99.3

Enlivex Announces Second Quarter 2022 Financial Results and Provides a Business Update

● Dosed first patient in Phase I/II trial evaluating Allocetra™ combined with chemotherapy in patients with peritoneal metastases arising from solid cancers

● Received Israeli Ministry of Health approval to initiate a Phase I/II trial evaluating Allocetra™ alone and in combination with a PD1 checkpoint inhibitor in patients with advanced solid tumors.

● Announced preclinical data in ovarian cancer (in collaboration with Yale Cancer Center) and mesothelioma showing substantial, statistically significant survival benefits when Allocetra™ is combined with PD1 or CTLA4 checkpoint inhibition, respectively

● Appointed new Vice Chairman of the Board, Dr. Roger J. Pomerantz, who previously served as Worldwide Head of Licensing and Acquisition and Knowledge Management at Merck & Co., Global Head of Infectious Diseases for Johnson & Johnson Pharmaceuticals, Venture Partner at Flagship Pioneering, and President, CEO, and Chairman of the Board of Seres Therapeutics

Nes-Ziona, Israel, August 22, 2022 (GLOBE NEWSWIRE) – Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today filed with the SEC its financial results and related management’s discussion for the second quarter ended June 30, 2022.

“Our recent progress was highlighted by key advancements in our oncology program, including the initiation of our first oncology clinical trial and important preclinical data announcements,” said Oren Hershkovitz, Ph.D., Chief Executive Officer of Enlivex. “Studies in murine models of ovarian cancer, in collaboration with the Yale Cancer Center, and mesothelioma, showed substantial, synergistic survival benefits when checkpoint inhibitors were combined with Allocetra™, showcasing its broadly applicable immunotherapeutic effects. Together with prior data, we believe that these findings support our ongoing chemotherapy combination trial and provide a strong scientific rationale for an upcoming trial designed to evaluate Allocetra™ alone and in combination with a PD1 checkpoint inhibitor in patients with advanced solid tumors.”

Dr. Hershkovitz continued, “Alongside our progress in oncology, we began a regulatory effort to incorporate Allocetra’s™ frozen formulation into our Phase II sepsis trial and to expand the study’s target patient population to include various sources of sepsis in order to potentially accelerate its development and optimize our commercial prospects. We also secured additional non-dilutive funding for our sepsis program and strengthened our Board by adding Dr. Roger Pomerantz as Vice Chairman. We maintained a strong balance sheet as we executed on our objectives, and believe that we are well capitalized through Q3 2024.”

Business Highlights and Upcoming Milestones

Oncology:

Currently, the efficacy of many anti-cancer agents is hampered by tumor mechanisms that facilitate the recruitment of macrophages that become “pro-tumor” tumor associated macrophages (TAMs) rather than “anti-tumor” macrophages. The TAMs typically form a physical layer on top of the solid tumor and induce immunosuppression in the solid tumor microenvironment. Moreover, TAMs promote tumor growth and metastasis by various mechanisms and contribute to poor clinical outcomes and response to therapy. During the second quarter of 2022, Enlivex presented preclinical data from murine solid tumor models that suggest Allocetra™ has the potential to reprogram pro-tumor macrophages back to their homeostatic state and thereby may promote disease resolution and enhance the efficacy of other anti-cancer agents. In July 2022, the Company announced it had initiated dosing in a Phase I/II trial evaluating Allocetra™ combined with chemotherapy in patients with peritoneal metastases arising from solid cancer. [In August 2022, the Company received Israeli Ministry of Health approval to initiate a Phase I/II trial evaluating Allocetra™ alone and in combination with a PD1 checkpoint inhibitor in patients with advanced solid tumors.]

Phase I/II trial in patients with peritoneal metastases arising from solid cancer:

Patients with peritoneal cancer are in urgent need of new therapies, as standard-of-care chemotherapy currently provides only modest survival benefits. The median survival of patients with peritoneal metastases differs based on the location of the primary tumor but is frequently poor, with survival rates of 2.9 months, 6.5 months, and 6.9 months reported for cancers of pancreatic, gastric, and colorectal origins, respectively.

In July 2022, Enlivex announced it had initiated dosing in an open-label Phase I/II trial designed to evaluate the safety and efficacy of Allocetra™ combined with chemotherapy in patients with peritoneal metastases arising from solid cancers. The trial is expected to enroll a total of approximately 12 patients across four cohorts. The primary endpoint is the number and severity of Allocetra™-related adverse events and serious adverse events during a 16-week period, starting from the first administration of study treatment. Secondary endpoints include efficacy assessments, such as best overall response rate, progression-free survival, and overall survival. Changes from baseline in macrophage and immune cell characteristics in peritoneal fluid and tissues will be assessed as an exploratory endpoint.

Phase I/II trial of Allocetra™ alone and in combination with a PD-1 checkpoint inhibitor

Though commercially successful, checkpoint inhibitors have limited efficacy in many cancers, with a 2019 study estimating less than 13% of all U.S. cancer patients responded to these therapies. Preclinical data presented during the second quarter of 2022 suggest that Allocetra™ has the potential to enhance the efficacy of checkpoint inhibitors by reprogramming pro-tumor macrophages back to their homeostatic state.

[In August 2022, Enlivex received Israeli Ministry of Health approval to initiate a Phase I/II trial evaluating Allocetra™ alone and in combination with a PD1 checkpoint inhibitor in patients with advanced solid tumors.] The trial is expected to enroll up to 48 patients across two trial stages, with Stage 1 evaluating Allocetra™ monotherapy, and Stage 2 evaluating Allocetra™-anti-PD1 combination therapy. The primary objective of the study is to evaluate safety and tolerability throughout the treatment period and through one week after the last administration of Allocetra™. Key secondary endpoints include efficacy assessments, such as best overall response rate, progression-free survival, and overall survival. Changes in immune cell/cytokine profiling in peritoneal fluid will also be assessed as an exploratory endpoint.

Preclinical data on Allocetra™-anti-PD1 combination therapy in ovarian cancer:

PD1 checkpoint inhibitor monotherapy has shown response rates of only 7-15% in prior clinical trials in ovarian cancer, which is currently the fifth leading cause of cancer death among women. Preclinical studies conducted in collaboration with Yale Cancer Center and featured in a poster at the 2022 American Society of Clinical Oncology Annual Meeting demonstrated the ability of Allocetra™ to synergistically enhance the efficacy of a PD1 checkpoint inhibitor in a murine ovarian cancer model. Treating mice with anti-PD1 therapy in combination with Allocetra™ led to a substantial and statistically significant survival benefit, with survival rates of up to 50% (5/10) observed in the combination therapy group versus rates between 0-10% observed in untreated and monotherapy groups. Additionally, treatment with the combination therapy led to an 83% increase in median survival duration versus untreated controls, compared to increases of 42% and 58% with anti-PD1 and Allocetra™ monotherapy, respectively.

Preclinical data on Allocetra-anti-CTLA4 combination therapy in mesothelioma:

Mesothelioma is one of the deadliest solid cancers, as the few approved treatment options available offer limited efficacy. Preclinical studies featured in a poster at the International Society of Cell and Gene Therapy Annual Meeting showed Allocetra™ synergistically combining with a commercially available CTLA4 checkpoint inhibitor to provide substantial, statistically significant survival benefits in a murine mesothelioma model. Treatment with Allocetra-anti-CTLA4 combination therapy resulted in a 100% survival rate and complete cancer remission when administered at the higher of two Allocetra™ doses evaluated. This compared to survival rates of 6%, 25%, and 28.5% in mice that were untreated, treated with anti-CTLA4 or treated with Allocetra™ monotherapy, respectively. Overall, the marked and statistically significant preclinical results achieved with Allocetra™-based combinations suggest that Allocetra™ might exhibit broadly applicable efficacy across a range of difficult-to-treat solid cancers when used in combination with various anti-cancer agents.

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Sepsis:

In 2021, Enlivex initiated a placebo-controlled, randomized, dose-finding, multi-center, Phase II trial evaluating liquid Allocetra™ in patients with pneumonia-associated sepsis. In the second quarter of 2022, the Company submitted protocol amendments to global regulators to enable the treatment of newly recruited patients with a frozen formulation of Allocetra™ and to expand the study population to include patients whose septic condition stems from biliary, urinary tract, or peritoneal infections. Broad acceptance of the proposed amendments is expected to shorten the timeline for potential regulatory approval of Allocetra’s™ frozen formulation in sepsis and its associated commercial launch. In addition, the frozen formulation of Allocetra™ is expected to have a shelf-life spanning multiple years, versus a shelf life of 96 hours for the liquid formulation. This is expected to dramatically improve manufacturing scalability, shipping logistics, and production costs.

The ongoing Phase II trial is supported by previously reported positive results from a Phase Ib trial that demonstrated Allocetra’s™ favorable safety profile and showed vastly improved clinical outcomes, including SOFA (sequential organ failure assessment) scores, duration of hospitalization, and mortality, in Allocetra™-treated sepsis patients compared to a group of matched historical controls who received standard-of-care therapy. Sepsis is a life-threatening disease with no FDA-approved therapies and a high unmet need. Each year, more than 1.7 million adults in the United States develop sepsis, with more than 270,000 dying of the disease.

Corporate:

In May 2022, Enlivex appointed Roger J. Pomerantz, M.D., FACP, to its Board of Directors as Vice Chairman of the Board. Dr. Pomerantz is a pharmaceutical and biotech industry veteran who has led scientific, drug and business development functions throughout his stellar career. His past roles include Worldwide Head of Licensing and Acquisition and Knowledge Management at Merck & Co., Global Head of Infectious Diseases for Johnson & Johnson Pharmaceuticals, Venture Partner at Flagship Pioneering, and President, CEO, and Chairman of the Board of Seres Therapeutics.

In May 2022, Enlivex was awarded a non-dilutive Israel Innovation Authority (IIA) grant of approximately $1.2 million to support the clinical development of Allocetra™ in sepsis. To date, the Company has received a total of $7.8 million in non-dilutive grants from the IIA for clinical trials and product development, excluding this recently approved grant.

Throughout the second quarter and early third quarter of 2022, Enlivex strengthened its intellectual property portfolio in the United States with the issuance of two patents and a Notice of Allowance for a pending application. Each patent and application contains claims covering methods of treating sepsis with Allocetra™ and is expected to provide protection in the United States until at least 2036.

Second Quarter 2022 Financial Results:

Research and development expenses were $4.1 million for the three months ended June 30, 2022, compared to $2.5 million for the same period in 2021. 73% of the increase was associated with expenses relating to clinical studies, pre-clinical studies, an increase in the number of Allocetra™ doses that were manufactured and inventoried, and lease payments and overhead expenses with respect to our new manufacturing plant. 25% of the increase was associated with an increase in salaries as a result of hiring additional R&D personnel and certain pay increases for existing R&D personnel.

3

General and administrative expenses were $1.8 million for the three months ended June 30, 2022, compared to $1.3 million for the same period in 2021. 40% of the increase was associated with expenses relating to salaries of newly recruited management team members, 22% to an increase in professional fees (legal, auditing and others) and 22% in share-based compensation (a non-cash charge). For the six month period ending June 30, 2022, compensation paid to executive and non-executive board members, in the aggregate, decreased by $366,000.

Net loss for the three months ended June 30, 2022 was $9.9 million, as compared to a net loss of $3.1 million for the three months ended June 30, 2021. This increase resulted primarily from a non-cash charge associated with fair value of marketable securities and currency fluctuations on cash and cash equivalents and deposits denominated in New Israeli Shekels.

As of June 30, 2022, Enlivex had cash, cash equivalents, and short-term deposits of $62.5 million. The Company believes its existing cash, cash equivalents, and short-term deposits will be sufficient to fund its operating expenses and capital expenditure requirements through the third quarter of 2024.

ABOUT ALLOCETRA™

Allocetra™ is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, and many others reprogram macrophages out of their homeostatic state. These 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 life-threatening clinical indications that are defined as “unmet medical needs”, as a stand-alone therapy or in combination with leading therapeutic agents.

ABOUT ENLIVEX

Enlivex is a clinical stage macrophage reprogramming immunotherapy company developing Allocetra™, 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. For more information, visit http://www.enlivex.com.

4

Safe Harbor Statement:  This press release 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 of similar meaning, including statements regarding expected cash balances, market opportunities for the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, ALLOCETRA^TM programs. All such forward-looking 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 ALLOCETRA^TM 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 the Company’s most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission.  The forward-looking statements contained in this press release 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.

ENLIVEX CONTACT 
Shachar Shlosberger, CFO
Enlivex Therapeutics, Ltd. 
shachar@enlivexpharm.com

INVESTOR RELATIONS CONTACT

Eric Ribner

LifeSci Advisors

eric@lifesciadvisors.com

5

XML

Document And Entity Information	6 Months Ended
	Jun. 30, 2022
Document Information Line Items
Entity Registrant Name	ENLIVEX THERAPEUTICS LTD.
Document Type	6-K
Current Fiscal Year End Date	--12-31
Amendment Flag	false
Entity Central Index Key	0001596812
Document Period End Date	Jun. 30, 2022
Document Fiscal Year Focus	2022
Document Fiscal Period Focus	Q2
Entity File Number	001-36578
Entity Address, Address Line One	14 Einstein Street
Entity Address, Address Line Two	Nes Ziona
Entity Address, Country	IL
Entity Address, Postal Zip Code	7403618

XML

Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands	Jun. 30, 2022	Dec. 31, 2021
Current Assets
Cash and cash equivalents	$ 20,151	$ 11,202
Short term deposits	42,334	10,004
Marketable securities		62,924
Prepaid expenses and other receivables	2,453	2,199
Cash held with respect to CVR Agreement	113	113
Total Current Assets	65,051	86,442
Non-Current Assets
Property and equipment, net	6,517	2,530
Other assets	5,773	6,174
Total Non-Current Assets	12,290	8,704
TOTAL ASSETS	77,341	95,146
Current Liabilities
Accounts payable trade	667	878
Accrued expenses and other liabilities	3,433	3,727
CVR holders	113	113
Total Current Liabilities	4,213	4,718
Non-Current Liabilities
Other long-term Liabilities	4,642	5,389
Total Non-Current Liabilities	4,642	5,389
Commitments and Contingent Liabilities
TOTAL LIABILITIES	8,855	10,107
SHAREHOLDERS’ EQUITY
Ordinary shares of NIS 0.4 par value: Authorized: 45,000,000 shares as of June 30, 2022 and December 31, 2021; Issued and outstanding: 18,381,052 and 18,331,507 as of June 30 and December 31, 2021;	2,113	2,107
Additional paid in capital	135,375	133,796
Foreign currency translation adjustments	1,101	1,101
Accumulated deficit	(70,103)	(51,965)
TOTAL SHAREHOLDERS’ EQUITY	68,486	85,039
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY	$ 77,341	$ 95,146

XML

Condensed Consolidated Balance Sheets (Unaudited) (Parentheticals) - ₪ / shares	Jun. 30, 2022	Dec. 31, 2021
Statement of Financial Position [Abstract]
Ordinary shares, par value (in New Shekels per share)	₪ 0.4	₪ 0.4
Ordinary shares, authorized	45,000,000	45,000,000
Ordinary shares, Issued	18,381,052	18,331,507
Ordinary shares, outstanding	18,381,052	18,331,507

XML

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021
Income Statement [Abstract]
Revenues
Operating expenses:
Research and development expenses	4,110	2,539	8,792	5,036
General and administrative expenses	1,761	1,269	3,483	2,574
Total operating expenses	5,871	3,808	12,275	7,610
Operating loss	(5,871)	(3,808)	(12,275)	(7,610)
Other income/(expense), net	(4,042)	700	(5,863)	1,302
Net (loss)	(9,913)	(3,108)	(18,138)	(6,308)
Other comprehensive income (loss)
Exchange differences arising from translating financial statements from functional to presentation currency		2,055		(733)
Total other comprehensive income (loss)		2,055		(733)
Total comprehensive (loss)	$ (9,913)	$ (1,053)	$ (18,138)	$ (7,041)
Basic & diluted (loss) per share (in Dollars per share)	$ (0.54)	$ (0.17)	$ (0.99)	$ (0.36)
Weighted average number of shares outstanding (in Shares)	18,375,206	18,305,882	18,372,521	17,397,860

XML

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) (Parentheticals) - $ / shares	3 Months Ended		6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021
Income Statement [Abstract]
Basic & diluted (loss) per share (in Dollars per share)	$ (0.54)	$ (0.17)	$ (0.99)	$ (0.36)

XML

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, 2020	$ 1,646		$ 70,361	$ 977	$ (37,497)	$ 35,487
Balance (in Shares) at Dec. 31, 2020	14,587,934
Issuance of shares and warrants for cash consideration of $57,629 net of $4,455 issuance costs	$ 352		52,822			53,174
Issuance of shares and warrants for cash consideration of $57,629 net of $4,455 issuance costs (in Shares)	2,848,629
Exercise of options	$ 2		38			40
Exercise of options (in Shares)	13,435
Exercise of warrants	$ 104		7,598			7,702
Exercise of warrants (in Shares)	855,813
Stock based compensation			190			190
Other comprehensive loss				(2,788)		(2,788)
Net loss					(3,200)	(3,200)
Balance at Mar. 31, 2021	$ 2,104		131,009	(1,811)	(40,697)	90,605
Balance (in Shares) at Mar. 31, 2021	18,305,811
Exercise of options		[1]	2			2
Exercise of options (in Shares)	375
Stock based compensation			652			652
Other comprehensive loss				2,055		2,055
Net loss					(3,108)	(3,108)
Balance at Jun. 30, 2021	$ 2,104		131,663	244	(43,805)	90,206
Balance (in Shares) at Jun. 30, 2021	18,306,186
Balance at Dec. 31, 2021	$ 2,107		133,796	1,101	(51,965)	85,039
Balance (in Shares) at Dec. 31, 2021	18,331,507
Restricted stock units vested	$ 4		(4)
Restricted stock units vested (in Shares)	34,295
Exercise of options	$ 1		49			50
Exercise of options (in Shares)	7,625
Stock based compensation			788			788
Net loss					(8,225)	(8,225)
Balance at Mar. 31, 2022	$ 2,112		134,629	1,101	(60,190)	77,652
Balance (in Shares) at Mar. 31, 2022	18,373,427
Exercise of options	$ 1		49			50
Exercise of options (in Shares)	7,625
Stock based compensation			697			697
Net loss					(9,913)	(9,913)
Balance at Jun. 30, 2022	$ 2,113		$ 135,375	$ 1,101	$ (70,103)	$ 68,486
Balance (in Shares) at Jun. 30, 2022	18,381,052

[1] Less than $1

XML

Condensed Consolidated Statements of Changes in Shareholders' Equity (Unaudited) (Parentheticals) $ in Thousands	3 Months Ended
	Mar. 31, 2021 USD ($)
Statement of Stockholders' Equity [Abstract]
Cash consideration	$ 57,629
Net of issuance costs	$ 4,455

XML

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021
Cash flows from operating activities
Net (loss)	$ (18,138)	$ (6,308)
Adjustments required to reflect net cash used in operating activities:
Depreciation	364	239
Non-cash operating lease expenses	411	107
Share-based compensation	1,485	842
Loss (income) on marketable securities and short-term bank deposits	4,886	(1,583)
Changes in operating asset and liability items:
Decrease in prepaid expenses and other receivables	(205)	(195)
Increase (decrease) in accounts payable trade	(211)	101
Increase (decrease) in accrued expenses and other liabilities	(307)	153
Operating lease liabilities	(827)	(106)
Net cash (used in) provided by operating activities	(12,542)	(6,750)
Cash flows from investing activities
Purchase of property and equipment	(4,351)	(472)
Release (investment) in short-term bank deposits	(35,234)	19,563
Purchases of marketable securities	(1,608)	(85,695)
Proceeds from sales of marketable securities	62,549	19,217
Net cash provided by (used in) investing activities	21,356	(47,387)
Cash flows from financing activities
Proceeds from issuance of shares and warrants net of $4,455 issuance expenses		53,174
Proceeds from exercise of warrants		7,702
Proceeds from exercise of options	100	42
Net cash provided by financing activities	100	60,918
Increase (decrease) in cash and cash equivalents	8,914	6,781
Cash and cash equivalents - beginning of period	11,636	7,012
Exchange rate differences on cash and cash equivalents		(210)
Cash and cash equivalents - end of period	20,550	13,583
Non-cash transactions:
Warrants issued in settlement of issuance costs to a placement agent		2,095
Supplemental disclosures of cash flow information:
Cash paid for taxes
Cash paid (received) for interest, net	$ 45	$ 62

XML

Condensed Consolidated Statements of Cash Flows (Unaudited) (Parentheticals) - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021
Statement of Cash Flows [Abstract]
Issuance expenses	$ 4,455	$ 4,455

XML

General

6 Months Ended

Jun. 30, 2022

Organization, Consolidation and Presentation of Financial Statements [Abstract]

GENERAL

NOTE 1 - GENERAL

a. Enlivex Therapeutics Ltd. (the “Parent” and, including its consolidated subsidiaries, “we”, “us”, “our” or the “Company”) is a clinical-stage macrophage reprogramming immunotherapy company originally incorporated on January 22, 2012 under the laws of the State of Israel.

Enlivex Therapeutics R&D Ltd. (“Enlivex R&D”) was incorporated in September 2005 under the laws of the State of Israel. On March 26, 2019, upon consummation of a merger transaction between the Parent and Enlivex R&D, Enlivex R&D became a wholly owned subsidiary of the Company.

In January 2015, Enlivex Therapeutics Inc. was incorporated in the State of Delaware as a wholly owned subsidiary of the Parent.

On June 21, 2021 Enlivex Therapeutics RDO Ltd. was incorporated in Israel as a wholly owned subsidiary of the Parent.

The Company is a clinical stage macrophage reprogramming immunotherapy company, developing Allocetra^TM, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of life-threatening conditions. Non-homeostatic macrophages contribute significantly to the severity of certain diseases, which include solid tumors, sepsis and others.

AllocetraTM is based on the discoveries of Professor Dror Mevorach, an expert on immune activity, macrophage activation and clearance of dying (apoptotic) cells, in his laboratory in the Hadassah University Hospital located in the State of Israel.

The Company’s ordinary shares, 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.

b. Financial Resources

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, 2022, had an accumulated deficit of $70,103 thousand.

The Company expects to continue to incur losses for at least the next several years, and the Company will need to raise additional debt or equity financing or enter into partnerships to fund its development. If the Company is not able to achieve its funding requirements, it may be required to reduce discretionary spending, may not be able to continue the development of its product candidates or may be required to delay its development programs, which could have a material adverse effect on the Company’s ability to achieve its intended business objectives. There can be no assurances that additional financing will be secured or, if secured, will be on favorable terms. The ability of the Company to transition to profitability in the longer term is dependent on developing products and product revenues to support its expenses.

The Company’s management and board of directors (the “Board”) are of the opinion that the Company’s current financial resources will be sufficient to continue the development of the Company’s product candidates for at least twelve months from the 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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Significant Accounting Policies

6 Months Ended

Jun. 30, 2022

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 2021 Annual Report on Form 20-F, as filed with the SEC on April 29, 2022. The results of operations for these interim periods are not necessarily indicative of the operating results for any future period. The December 31, 2021 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.

Until September 30, 2021, the functional currency of Enlivex R&D was the New Israeli Shekel (“NIS”).

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 incurred after September 30, 2021 were translated at the approximate exchange rate prevailing at the date of the transaction. Transactions included in the statement of income for the three and six month periods ended June 30, 2022 were translated at the approximate exchange rate in effect at the respective times of the transactions. Transactions included in the statement of income for the three and six month periods ended June 30, 2021 were translated at average exchange rates during the applicable period. Gains or losses resulting from translation adjustments for the three and six month periods ended June 30, 2021 are reported in other comprehensive income (loss).

one U.S. dollar = 3.50 NIS and 3.11 NIS as of June 30, 2022 and December 31, 2021, respectively.

The U.S. dollar increased (decreased) against the NIS: 10.20%, 12.54%, (2.22%) and 1.4% in the three and six month periods ended June 30, 2022 and 2021, respectively.

Reclassification of Prior Year Presentation

Certain prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications had no effect on the reported results of operations.

Recently Adopted Accounting Standards

In August 2020, the FASB issued ASU 2020-06, Debt - Debt with Conversion and other Options (Subtopic 470-20) and Derivatives and Hedging: Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”). ASU 2020-06 simplifies the complexity associated with applying GAAP for certain financial instruments with characteristics of liabilities and equity by removing certain accounting models which separate the embedded conversion features from the host contract for convertible instruments. The standard also enhances the consistency of earnings-per-share calculations by requiring that an entity use the if-converted method and that the effect of potential share settlement be included in diluted earnings-per-share calculations. ASU 2020-06 became effective for fiscal years and interim periods within those fiscal years beginning after December 15, 2021. The Company evaluated ASU 2020-06 and determined that its adoption did not have an impact on the Company’s condensed consolidated financial statements and related disclosures.

Recently Issued Accounting Pronouncements Not Yet Adopted

The Company has evaluated other recently issued accounting pronouncements and does not currently believe that any of these pronouncements will have a material impact on its condensed consolidated financial statements and related disclosures.

Significant Accounting Policies

There have been no material changes to the significant accounting policies previously disclosed in the Company’s Annual Report on Form 20-F for the year ended December 31, 2021.

Marketable Securities.

The Company has an investment policy that includes guidelines on acceptable investment securities, minimum credit quality, maturity parameters, and concentration and diversification. The Company invests its excess cash primarily in mutual funds that are classified based on the nature of their underlying securities and their availability for use in current operations. The Company’s marketable equity securities are measured at fair value with gains and losses recognized in other income/(expense), net.

Net (loss) income recognized on equity securities for the three and six month periods ended June 30, 2022 and 2021 was $0, $(1,982), $1,195 and $1,583 thousand of which $0, $0, $950 and $1,342 thousand, respectively, were not realized.

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Cash, Cash Equivalents and Restricted Cash

6 Months Ended

Jun. 30, 2022

Cash and Cash Equivalents [Abstract]

CASH, CASH EQUIVALENTS AND RESTRICTED CASH

NOTE 3 – CASH, CASH EQUIVALENTS AND RESTRICTED CASH

	June 30,		December 31,
(in thousands)	2022		2021
Cash held in banks	$	2,133	$	1,199
Bank deposits in U.S.$  (annual average interest rates 3.02% and 0.1%)		18,018		10,003
Total cash and cash equivalents		20,151		11,202
Cash held with respect to CVR Agreement		113		113
Restricted cash – noncurrent – Other assets		286		321
Total cash, cash equivalents and restricted cash shown in the statement of cash flows	$	20,550	$	11,636

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Short Term Deposits

6 Months Ended

Jun. 30, 2022

Debt Disclosure [Abstract]

SHORT TERM DEPOSITS

NOTE 4 – SHORT TERM DEPOSITS

	June 30,		December 31,
(in thousands)	2022		2021
Bank deposits in U.S.$ and NIS (average annual interest rates 0.7% and 0.6%)	$	42,334	$	10,004
Total short-term deposits	$	42,334	$	10,004

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Property and Equipment

6 Months Ended

Jun. 30, 2022

Property, Plant and Equipment [Abstract]

PROPERTY AND EQUIPMENT

NOTE 5 – PROPERTY AND EQUIPMENT

Property and equipment, net consists of the following:
	June 30,		December 31,
(in thousands)	2022		2021
Cost:
Laboratory equipment	$	2,253	$	1,891
Computers		276		256
Office furniture & equipment		218		192
Leasehold improvements		5,464		1,521
		8,211		3,860
Accumulated depreciation:
Laboratory equipment		1,176		960
Computers		170		138
Office furniture & equipment		22		15
Leasehold improvements		326		217
		1,694		1,330
Depreciated cost	$	6,517	$	2,530

Depreciation expenses for the three and six month periods ended June 30, 2022 and 2021 were $176, $364, $122 and $239 thousand, respectively.

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Other Assets

6 Months Ended

Jun. 30, 2022

Other Assets [Abstract]

OTHER ASSETS

NOTE 6 – OTHER ASSETS

	June 30,		December 31,
(in thousands)	2022		2021
Restricted cash	$	286	$	321
Long-term prepaid expenses		118		164
Right-of-Use assets, net		5,369		5,689
	$	5,773	$	6,174

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Accrued Expenses and Other Liabilities

6 Months Ended

Jun. 30, 2022

Payables and Accruals [Abstract]

ACCRUED EXPENSES AND OTHER LIABILITIES

NOTE 7 – ACCRUED EXPENSES AND OTHER LIABILITIES

	June 30,		December 31,
(in thousands)	2022		2021
Vacation, convalescence and bonus accruals	$	528	$	1,068
Employees and payroll related		639		519
Short term operating lease liabilities		629		617
Accrued expenses and other		1,637		1,523
	$	3,433	$	3,727

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Leases

6 Months Ended

Jun. 30, 2022

Leases [Abstract]

LEASES

NOTE 8 – LEASES

The Company is a party to operating leases for its corporate offices, laboratory space and vehicles. The Company’s real property operating leases have remaining lease terms of up to 3.25 years, some of which include options to extend the leases for up to five years.

	Six months ended June 30,
(in thousands)	2022		2021
The components of lease expense were as follows:
Operating leases expenses	$	517	$	139
Supplemental consolidated cash flow information related to operating leases follows:
Cash used in operating activities	$	478	$	135
Non-cash activity:
Right of use assets obtained in exchange for new operating lease liabilities	$	91	$	29

	June 30,			December 31,
(in thousands)	2022			2021
Supplemental information related to operating leases, including location of amounts reported in the accompanying consolidated balance sheets, follows:
Other assets - Right-of-Use assets	$	6,420		$	6,329
Accumulated amortization		1,051			640
Operating lease Right-of-Use assets, net	$	5,369		$	5,689
Lease liabilities – current - Accounts payable and accrued liabilities	$	629		$	617
Lease liabilities – noncurrent		4,642			5,389
Total operating lease liabilities	$	5,271		$	6,006
Weighted average remaining lease term in years		8.1			8.6
Weighted average annual discount rate		3.6	%		3.6	%

Maturities of operating lease liabilities as of June 30, 2022, were as follows:
2022 (after June 30)	$	386
2023		786
2024		679
2025		714
2026 and onwards		3,497
Total undiscounted lease liability	$	6,062
Less: Imputed interest	$	(791	)
Present value of lease liabilities	$	5,271

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Commitments and Contingent Liabilities

6 Months Ended

Jun. 30, 2022

Commitments and Contingencies Disclosure [Abstract]

COMMITMENTS AND CONTINGENT LIABILITIES

NOTE 9 – 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 LIBOR-based rate.

The gross amount of grants received by the Company from the IIA, including accrued interest as of June 30, 2022, was approximately $8.9 million. As of June 30, 2022, the Company had not paid any royalties to the IIA.

In January 2022, the Company submitted a new grant application to the IIA to approve the expenditure of $4.8 million of its clinical development program for the prevention of cytokine storms and organ dysfunction associated with sepsis for a period commencing January 1, 2022 and ending December 31, 2022 (the “2022 Sepsis Grant Application”). In May 2020, the IIA selected this program to receive a non-dilutive grant of approximately $1.0 million for expenses associated with the Company’s ongoing sepsis clinical Phase II trial.

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Equity

6 Months Ended

Jun. 30, 2022

Equity [Abstract]

EQUITY

NOTE 10 – EQUITY

All Company warrants are classified as a component of shareholders’ equity because such warrants are free standing financial instruments that are legally detachable, separately exercisable, do not embody an obligation for the Company to repurchase its own shares, and permit the holders to receive a fixed number of Ordinary Shares upon exercise, requires physical settlement and do not provide any guarantee of value or return.

	Number of Warrants			Weighted average exercise price
Outstanding January 1, 2022		704,355		$	13.18
Forfeited and expired		(502,104	)	$	9.50
Outstanding and exercisable June 30, 2022		202,251		$	23.31

Comprised as follows:

Number of Warrants		Exercise Price Per Share		Issuance date	Expiration date
	22,750	$	10	February 26, 2020	February 24, 2025
	160,727	$	25	February 12, 2021	February 9, 2026
	18,774	$	25	February 17, 2021	February 9, 2026
	202,251

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Share-Based Compensation

6 Months Ended

Jun. 30, 2022

Share-Based Payment Arrangement [Abstract]

SHARE-BASED COMPENSATION

NOTE 11 – SHARE-BASED COMPENSATION

a) As of June 30, 2022, 4,150,704 Ordinary Shares were authorized for issuance to employees, directors and consultants under the 2019 Equity Incentive Plan, of which 1,189,363 shares were available for future grant.

b) The following table contains information concerning options granted under the existing equity incentive plans:

	Three months ended June 30,
	2022					2021
	Number of options			Weighted average exercise price		Number of options			Weighted average exercise price
Outstanding at beginning of period		2,399,622		$	5.95		1,870,485		$	5.54
Granted		-		$	-		310,500		$	12.57
Forfeited and expired		(3,000	)	$	5.34		(2,685	)	$	7.38
Exercised		(7,625	)	$	6.49		(375	)	$	4.68
Outstanding at end of period		2,388,997		$	5.95		2,177,925		$	6.54
Exercisable at end of period		1,728,623		$	5.10		1,404,809		$	5.50
Non-vested at beginning of period		722,749		$	7.67		544,163		$	6.04
Granted		-		$	-		310,500		$	12.57
Vested		(59,375	)	$	(8.78)		(78,862	)	$	13.15
Forfeited)		(3,000	)	$	(5.34)		(2,685	)	$	7.38
Non-vested at the end of period		660,374		$	7.59		773,116		$	8.19

	Six months ended June 30,
	2022					2021
	Number of options			Weighted average exercise price		Number of options			Weighted average exercise price
Outstanding at beginning of period		2,142,547		$	6.02		1,884,420		$	5.52
Granted		264,700		$	5.48		310,500		$	12.57
Forfeited and expired		(3,000	)	$	5.34		(3,185	)	$	6.96
Exercised		(15,250	)	$	6.49		(13,810	)	$	2.99
Outstanding at end of period		2,388,997		$	5.95		2,177,925		$	6.54
Exercisable at end of period		1,728,623		$	5.10		1,404,809		$	5.50
Non vested  at beginning of period		529,082		$	8.69		601,227		$	5.93
Granted		264,700		$	5.48		310,500		$	12.57
Forfeited and expired		(3,000	)	$	5.34		(135,426	)	$	8.22
vested		(130,408	)	$	7.82		(3,185	)	$	6.96
Outstanding at end of period		660,374		$	7.59		773,116		$	8.19

During the three and six month periods ended June 30, 2022 and 2021, the Company recognized $509, $1,074, $603 and $778 thousand, respectively, of share-based compensation expenses related to stock options. As of June 30, 2022, the total unrecognized estimated compensation cost related to outstanding non-vested stock options was $1,780 thousand, which is expected to be recognized over a weighted average period of 1.5 years.

c) Set forth below is data regarding the range of exercise prices and remaining contractual life for all options outstanding at June 30, 2022:

Exercise price		Number of options outstanding		Remaining contractual Life (in years)		Intrinsic Value of Options Outstanding		No. of options exercisable
							(in thousands)
$	2.69		649,883		2.92		1,189,284		649,883
$	3.66		250,000		7.84		214,250		180,556
$	4.68		55,500		7.75		-		27,750
$	5.35		231,200		9.75		-
$	6.22		634,177		5.00		-		620,879
$	6.49		15,250		0.03		-		-
$	8.19		150,000		7.38		-		75,000
$	8.23		20,000		9.39		-		-
$	8.30		15,000		9.10		-		-
$	9.02		40,500		8.38		-		10,125
$	10.12		12,126		6.43		-		9,700
$	12.21		2,421		6.74		-		1,816
$	12.23		250,000		8.91		-		111,111
$	14.00		60,500		8.82		-		40,333
$	21.40		1,940		7.07		-		970
$	90.16		500		2.42		-		500
			2,388,997			$	1,403,534		1,728,623

d) The following table contains information concerning restricted stock units granted under the existing equity incentive plans:

	Three months ended  June 30,
	2022					2021
	Number of shares			Weighted average grant date fair value		Number of shares			Weighted average grant date fair value
Nonvested at beginning of period		184,787		$	10.02		48,375		$	14.67
Granted		-		$	-		13,750		$	10.28
Vested		(3,437	)	$	10.28		-		$	-
Forfeited		-			-		(2,000	)	$	14.67
Nonvested at end of period		181,350		$	10.02		60,125		$	13.67

	Six months ended  June 30,
	2022					2021
	Number of shares			Weighted average grant date fair value		Number of shares			Weighted average grant date fair value
Nonvested at beginning of period		229,331		$	10.08		-		$	-
Granted		-		$	-		62,125		$	13.7
Vested		(47,981	)	$	10.29		-		$	-
Forfeited		-		$	-		(2,000	)	$	14.67
Nonvested at end of period		181,350		$	10.02		60,125		$	13.67

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, 2022 and 2021, the Company recognized $188, $411, $49 and $64 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, 2022 was $889 thousand, which is expected to be recognized over a weighted average period of 1.5 years.

e) The following table summarizes share-based compensation expenses related to grants under the existing equity incentive plans included in the statements of operations:

	Three months ended June 30,				Six months ended June 30,
(in thousands)	2022		2021		2022		2021
Research & development	$	119	$	358	$	509	$	446
General & administrative		578		294		976		396
Total	$	697	$	652	$	1,485	$	842

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Fair Value Measurement

6 Months Ended

Jun. 30, 2022

Fair Value Disclosures [Abstract]

FAIR VALUE MEASUREMENT

NOTE 12 – 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, 2022 and December 31, 2021:

	June 30, 2022
(in thousands)	Total		Level 1		Level 2		Level 3
Cash and cash equivalents	$	20,550	$	20,550	$	-	$	-
Short term deposits		42,334		42,334		-		-
Cash held with respect to CVR Agreement		113		113		-		-
Restricted cash		286		286		-		-
Total financial assets	$	63,283	$	63,283	$	-	$	-

	December 31, 2021
(in thousands)	Total		Level 1		Level 2		Level 3
Cash and cash equivalents	$	11,202	$	11,202	$	-	$	-
Short term deposits		10,004		10,004		-		-
Cash held with respect to CVR Agreement		113		113		-		-
Marketable securities		62,924		62,924		-		-
Restricted cash		321		321		-		-
Total financial assets	$	84,564	$	84,564	$	-	$	-

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Events Subsequent to the Balance Sheet Date

6 Months Ended

Jun. 30, 2022

Subsequent Events [Abstract]

EVENTS SUBSEQUENT TO THE BALANCE SHEET DATE

NOTE 13 – 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 there were no events that necessitated disclosure:

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Accounting Policies, by Policy (Policies)

6 Months Ended

Jun. 30, 2022

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 2021 Annual Report on Form 20-F, as filed with the SEC on April 29, 2022. The results of operations for these interim periods are not necessarily indicative of the operating results for any future period. The December 31, 2021 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.

Until September 30, 2021, the functional currency of Enlivex R&D was the New Israeli Shekel (“NIS”).

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 incurred after September 30, 2021 were translated at the approximate exchange rate prevailing at the date of the transaction. Transactions included in the statement of income for the three and six month periods ended June 30, 2022 were translated at the approximate exchange rate in effect at the respective times of the transactions. Transactions included in the statement of income for the three and six month periods ended June 30, 2021 were translated at average exchange rates during the applicable period. Gains or losses resulting from translation adjustments for the three and six month periods ended June 30, 2021 are reported in other comprehensive income (loss).

one U.S. dollar = 3.50 NIS and 3.11 NIS as of June 30, 2022 and December 31, 2021, respectively.

The U.S. dollar increased (decreased) against the NIS: 10.20%, 12.54%, (2.22%) and 1.4% in the three and six month periods ended June 30, 2022 and 2021, respectively.

Reclassification of Prior Year Presentation

Reclassification of Prior Year Presentation

Certain prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications had no effect on the reported results of operations.

Recently Adopted Accounting Standards

Recently Adopted Accounting Standards

In August 2020, the FASB issued ASU 2020-06, Debt - Debt with Conversion and other Options (Subtopic 470-20) and Derivatives and Hedging: Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”). ASU 2020-06 simplifies the complexity associated with applying GAAP for certain financial instruments with characteristics of liabilities and equity by removing certain accounting models which separate the embedded conversion features from the host contract for convertible instruments. The standard also enhances the consistency of earnings-per-share calculations by requiring that an entity use the if-converted method and that the effect of potential share settlement be included in diluted earnings-per-share calculations. ASU 2020-06 became effective for fiscal years and interim periods within those fiscal years beginning after December 15, 2021. The Company evaluated ASU 2020-06 and determined that its adoption did not have an impact on the Company’s condensed consolidated financial statements and related disclosures.

Recently Issued Accounting Pronouncements Not Yet Adopted

Recently Issued Accounting Pronouncements Not Yet Adopted

The Company has evaluated other recently issued accounting pronouncements and does not currently believe that any of these pronouncements will have a material impact on its condensed consolidated financial statements and related disclosures.

Significant Accounting Policies

Significant Accounting Policies

There have been no material changes to the significant accounting policies previously disclosed in the Company’s Annual Report on Form 20-F for the year ended December 31, 2021.

Marketable Securities.

Marketable Securities.

The Company has an investment policy that includes guidelines on acceptable investment securities, minimum credit quality, maturity parameters, and concentration and diversification. The Company invests its excess cash primarily in mutual funds that are classified based on the nature of their underlying securities and their availability for use in current operations. The Company’s marketable equity securities are measured at fair value with gains and losses recognized in other income/(expense), net.

Net (loss) income recognized on equity securities for the three and six month periods ended June 30, 2022 and 2021 was $0, $(1,982), $1,195 and $1,583 thousand of which $0, $0, $950 and $1,342 thousand, respectively, were not realized.

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Cash, Cash Equivalents and Restricted Cash (Tables)

6 Months Ended

Jun. 30, 2022

Cash and Cash Equivalents [Abstract]

Schedule of cash and cash equivalents and restricted cash

	June 30,		December 31,
(in thousands)	2022		2021
Cash held in banks	$	2,133	$	1,199
Bank deposits in U.S.$  (annual average interest rates 3.02% and 0.1%)		18,018		10,003
Total cash and cash equivalents		20,151		11,202
Cash held with respect to CVR Agreement		113		113
Restricted cash – noncurrent – Other assets		286		321
Total cash, cash equivalents and restricted cash shown in the statement of cash flows	$	20,550	$	11,636

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Short Term Deposits (Tables)

6 Months Ended

Jun. 30, 2022

Debt Disclosure [Abstract]

Schedule of short term deposits

	June 30,		December 31,
(in thousands)	2022		2021
Bank deposits in U.S.$ and NIS (average annual interest rates 0.7% and 0.6%)	$	42,334	$	10,004
Total short-term deposits	$	42,334	$	10,004

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Property and Equipment (Tables)

6 Months Ended

Jun. 30, 2022

Property, Plant and Equipment [Abstract]

Schedule of property and equipment

Property and equipment, net consists of the following:
	June 30,		December 31,
(in thousands)	2022		2021
Cost:
Laboratory equipment	$	2,253	$	1,891
Computers		276		256
Office furniture & equipment		218		192
Leasehold improvements		5,464		1,521
		8,211		3,860
Accumulated depreciation:
Laboratory equipment		1,176		960
Computers		170		138
Office furniture & equipment		22		15
Leasehold improvements		326		217
		1,694		1,330
Depreciated cost	$	6,517	$	2,530

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Other Assets (Tables)

6 Months Ended

Jun. 30, 2022

Other Assets [Abstract]

Schedule of other assets

	June 30,		December 31,
(in thousands)	2022		2021
Restricted cash	$	286	$	321
Long-term prepaid expenses		118		164
Right-of-Use assets, net		5,369		5,689
	$	5,773	$	6,174

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Accrued Expenses and Other Liabilities (Tables)

6 Months Ended

Jun. 30, 2022

Payables and Accruals [Abstract]

Schedule of accrued expenses and other liabilities

	June 30,		December 31,
(in thousands)	2022		2021
Vacation, convalescence and bonus accruals	$	528	$	1,068
Employees and payroll related		639		519
Short term operating lease liabilities		629		617
Accrued expenses and other		1,637		1,523
	$	3,433	$	3,727

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Leases (Tables)

6 Months Ended

Jun. 30, 2022

Leases [Abstract]

Schedule of operating lease

	Six months ended June 30,
(in thousands)	2022		2021
The components of lease expense were as follows:
Operating leases expenses	$	517	$	139
Supplemental consolidated cash flow information related to operating leases follows:
Cash used in operating activities	$	478	$	135
Non-cash activity:
Right of use assets obtained in exchange for new operating lease liabilities	$	91	$	29

Schedule of operating lease related activities

	June 30,			December 31,
(in thousands)	2022			2021
Supplemental information related to operating leases, including location of amounts reported in the accompanying consolidated balance sheets, follows:
Other assets - Right-of-Use assets	$	6,420		$	6,329
Accumulated amortization		1,051			640
Operating lease Right-of-Use assets, net	$	5,369		$	5,689
Lease liabilities – current - Accounts payable and accrued liabilities	$	629		$	617
Lease liabilities – noncurrent		4,642			5,389
Total operating lease liabilities	$	5,271		$	6,006
Weighted average remaining lease term in years		8.1			8.6
Weighted average annual discount rate		3.6	%		3.6	%

Schedule of maturities of operating lease liabilities

Maturities of operating lease liabilities as of June 30, 2022, were as follows:
2022 (after June 30)	$	386
2023		786
2024		679
2025		714
2026 and onwards		3,497
Total undiscounted lease liability	$	6,062
Less: Imputed interest	$	(791	)
Present value of lease liabilities	$	5,271

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Equity (Tables)

6 Months Ended

Jun. 30, 2022

Equity [Abstract]

Schedule of number of ordinary shares upon exercise

	Number of Warrants			Weighted average exercise price
Outstanding January 1, 2022		704,355		$	13.18
Forfeited and expired		(502,104	)	$	9.50
Outstanding and exercisable June 30, 2022		202,251		$	23.31

Schedule of changes in exercisable ordinary shares warrants

Number of Warrants		Exercise Price Per Share		Issuance date	Expiration date
	22,750	$	10	February 26, 2020	February 24, 2025
	160,727	$	25	February 12, 2021	February 9, 2026
	18,774	$	25	February 17, 2021	February 9, 2026
	202,251

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Share-Based Compensation (Tables)

6 Months Ended

Jun. 30, 2022

Share-Based Payment Arrangement [Abstract]

Schedule of employees and directors stock options

	Three months ended June 30,
	2022					2021
	Number of options			Weighted average exercise price		Number of options			Weighted average exercise price
Outstanding at beginning of period		2,399,622		$	5.95		1,870,485		$	5.54
Granted		-		$	-		310,500		$	12.57
Forfeited and expired		(3,000	)	$	5.34		(2,685	)	$	7.38
Exercised		(7,625	)	$	6.49		(375	)	$	4.68
Outstanding at end of period		2,388,997		$	5.95		2,177,925		$	6.54
Exercisable at end of period		1,728,623		$	5.10		1,404,809		$	5.50
Non-vested at beginning of period		722,749		$	7.67		544,163		$	6.04
Granted		-		$	-		310,500		$	12.57
Vested		(59,375	)	$	(8.78)		(78,862	)	$	13.15
Forfeited)		(3,000	)	$	(5.34)		(2,685	)	$	7.38
Non-vested at the end of period		660,374		$	7.59		773,116		$	8.19

	Six months ended June 30,
	2022					2021
	Number of options			Weighted average exercise price		Number of options			Weighted average exercise price
Outstanding at beginning of period		2,142,547		$	6.02		1,884,420		$	5.52
Granted		264,700		$	5.48		310,500		$	12.57
Forfeited and expired		(3,000	)	$	5.34		(3,185	)	$	6.96
Exercised		(15,250	)	$	6.49		(13,810	)	$	2.99
Outstanding at end of period		2,388,997		$	5.95		2,177,925		$	6.54
Exercisable at end of period		1,728,623		$	5.10		1,404,809		$	5.50
Non vested  at beginning of period		529,082		$	8.69		601,227		$	5.93
Granted		264,700		$	5.48		310,500		$	12.57
Forfeited and expired		(3,000	)	$	5.34		(135,426	)	$	8.22
vested		(130,408	)	$	7.82		(3,185	)	$	6.96
Outstanding at end of period		660,374		$	7.59		773,116		$	8.19

Schedule of exercise prices and remaining contractual life

Exercise price		Number of options outstanding		Remaining contractual Life (in years)		Intrinsic Value of Options Outstanding		No. of options exercisable
							(in thousands)
$	2.69		649,883		2.92		1,189,284		649,883
$	3.66		250,000		7.84		214,250		180,556
$	4.68		55,500		7.75		-		27,750
$	5.35		231,200		9.75		-
$	6.22		634,177		5.00		-		620,879
$	6.49		15,250		0.03		-		-
$	8.19		150,000		7.38		-		75,000
$	8.23		20,000		9.39		-		-
$	8.30		15,000		9.10		-		-
$	9.02		40,500		8.38		-		10,125
$	10.12		12,126		6.43		-		9,700
$	12.21		2,421		6.74		-		1,816
$	12.23		250,000		8.91		-		111,111
$	14.00		60,500		8.82		-		40,333
$	21.40		1,940		7.07		-		970
$	90.16		500		2.42		-		500
			2,388,997			$	1,403,534		1,728,623

Schedule of restricted stock units

	Three months ended  June 30,
	2022					2021
	Number of shares			Weighted average grant date fair value		Number of shares			Weighted average grant date fair value
Nonvested at beginning of period		184,787		$	10.02		48,375		$	14.67
Granted		-		$	-		13,750		$	10.28
Vested		(3,437	)	$	10.28		-		$	-
Forfeited		-			-		(2,000	)	$	14.67
Nonvested at end of period		181,350		$	10.02		60,125		$	13.67

	Six months ended  June 30,
	2022					2021
	Number of shares			Weighted average grant date fair value		Number of shares			Weighted average grant date fair value
Nonvested at beginning of period		229,331		$	10.08		-		$	-
Granted		-		$	-		62,125		$	13.7
Vested		(47,981	)	$	10.29		-		$	-
Forfeited		-		$	-		(2,000	)	$	14.67
Nonvested at end of period		181,350		$	10.02		60,125		$	13.67

Schedule of share-based compensation expenses related to grants under the equity incentive plan

	Three months ended June 30,				Six months ended June 30,
(in thousands)	2022		2021		2022		2021
Research & development	$	119	$	358	$	509	$	446
General & administrative		578		294		976		396
Total	$	697	$	652	$	1,485	$	842

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Fair Value Measurement (Tables)

6 Months Ended

Jun. 30, 2022

Fair Value Disclosures [Abstract]

Schedule of financial assets and liabilities measured at fair value on a recurring basis

	June 30, 2022
(in thousands)	Total		Level 1		Level 2		Level 3
Cash and cash equivalents	$	20,550	$	20,550	$	-	$	-
Short term deposits		42,334		42,334		-		-
Cash held with respect to CVR Agreement		113		113		-		-
Restricted cash		286		286		-		-
Total financial assets	$	63,283	$	63,283	$	-	$	-

	December 31, 2021
(in thousands)	Total		Level 1		Level 2		Level 3
Cash and cash equivalents	$	11,202	$	11,202	$	-	$	-
Short term deposits		10,004		10,004		-		-
Cash held with respect to CVR Agreement		113		113		-		-
Marketable securities		62,924		62,924		-		-
Restricted cash		321		321		-		-
Total financial assets	$	84,564	$	84,564	$	-	$	-

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General (Details) $ in Thousands	Jun. 30, 2022 USD ($)	Jun. 30, 2022 ₪ / shares	Dec. 31, 2021 USD ($)
General (Textual)
Aggregate of ordinary shares | ₪ / shares		₪ 40
Accumulated deficit | $	$ (70,103)		$ (51,965)

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Significant Accounting Policies (Details) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2022 USD ($)	Jun. 30, 2021 USD ($)	Jun. 30, 2022 USD ($)	Jun. 30, 2021 USD ($)	Dec. 31, 2021
Significant Accounting Policies (Details) [Line Items]
Net (loss) income recognized	$ 0	$ 950	$ 0	$ 1,342
NIS [Member]
Significant Accounting Policies (Details) [Line Items]
Exchange rate for 1 $ = NIS	3.5		3.5		3.11
Increase (decrease) against the NIS	10.20%	(2.22%)	(12.54%)	(1.40%)
Equity Securities [Member]
Significant Accounting Policies (Details) [Line Items]
Net (loss) income recognized	$ 0	$ 1,195	$ (1,982)	$ 1,583

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Cash, Cash Equivalents and Restricted Cash (Details) - Schedule of cash and cash equivalents and restricted cash - USD ($) $ in Thousands	Jun. 30, 2022	Dec. 31, 2021	Jun. 30, 2021	Dec. 31, 2020
Schedule Of Cash And Cash Equivalents And Restricted Cash Abstract
Cash held in banks	$ 2,133	$ 1,199
Bank deposits in U.S.$ (annual average interest rates 3.02% and 0.1%)	18,018	10,003
Total cash and cash equivalents	20,151	11,202
Cash held with respect to CVR Agreement	113	113
Restricted cash – noncurrent – Other assets	286	321
Total cash, cash equivalents and restricted cash shown in the statement of cash flows	$ 20,550	$ 11,636	$ 13,583	$ 7,012

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Cash, Cash Equivalents and Restricted Cash (Details) - Schedule of cash and cash equivalents and restricted cash (Parentheticals)	Jun. 30, 2022	Dec. 31, 2021
Schedule Of Cash And Cash Equivalents And Restricted Cash Abstract
Annual average interest rates	3.02%	0.10%

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Short Term Deposits (Details) - Schedule of short term deposits - USD ($) $ in Thousands	Jun. 30, 2022	Dec. 31, 2021
Schedule Of Short Term Deposits Abstract
Bank deposits in U.S.$ and NIS (average annual interest rates 0.7% and 0.6%)	$ 42,334	$ 10,004
Total short-term deposits	$ 42,334	$ 10,004

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Short Term Deposits (Details) - Schedule of short term deposits (Parentheticals)	6 Months Ended	12 Months Ended
	Jun. 30, 2022	Dec. 31, 2021
Schedule Of Short Term Deposits Abstract
Bank deposits in(average annual interest rates	0.70%	0.60%

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Property and Equipment (Details) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021
Property, Plant and Equipment [Abstract]
Depreciation expenses	$ 176	$ 122	$ 364	$ 239

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Property and Equipment (Details) - Schedule of property and equipment - USD ($) $ in Thousands	Jun. 30, 2022	Dec. 31, 2021
Property, Plant and Equipment [Line Items]
Cost	$ 8,211	$ 3,860
Total accumulated depreciation	1,694	1,330
Depreciated cost	6,517	2,530
Laboratory equipment [Member]
Property, Plant and Equipment [Line Items]
Cost	2,253	1,891
Total accumulated depreciation	1,176	960
Computers [Member]
Property, Plant and Equipment [Line Items]
Cost	276	256
Total accumulated depreciation	170	138
Office furniture & equipment [Member]
Property, Plant and Equipment [Line Items]
Cost	218	192
Total accumulated depreciation	22	15
Leasehold improvements [Member]
Property, Plant and Equipment [Line Items]
Cost	5,464	1,521
Total accumulated depreciation	$ 326	$ 217

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Other Assets (Details) - Schedule of other assets - USD ($) $ in Thousands	Jun. 30, 2022	Dec. 31, 2021
Schedule Of Other Assets Abstract
Restricted cash	$ 286	$ 321
Long-term prepaid expenses	118	164
Right-of-Use assets, net	5,369	5,689
Total	$ 5,773	$ 6,174

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Accrued Expenses and Other Liabilities (Details) - Schedule of accrued expenses and other liabilities - USD ($) $ in Thousands	Jun. 30, 2022	Dec. 31, 2021
Schedule Of Accrued Expenses And Other Liabilities Abstract
Vacation, convalescence and bonus accruals	$ 528	$ 1,068
Employees and payroll related	639	519
Short term operating lease liabilities	629	617
Accrued expenses and other	1,637	1,523
Accrued expenses and other liabilities, Total	$ 3,433	$ 3,727

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Leases (Details)	6 Months Ended
	Jun. 30, 2022
Leases [Abstract]
Operating lease remaining term	3 years 3 months

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Leases (Details) - Schedule of operating lease - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021
The components of lease expense were as follows:
Operating leases expenses	$ 517	$ 139
Supplemental consolidated cash flow information related to operating leases follows:
Cash used in operating activities	478	135
Non-cash activity:
Right of use assets obtained in exchange for new operating lease liabilities	$ 91	$ 29

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Leases (Details) - Schedule of operating lease related activities - USD ($) $ in Thousands	Jun. 30, 2022	Dec. 31, 2021
Schedule Of Operating Lease Related Activities Abstract
Other assets - Right-of-Use assets	$ 6,420	$ 6,329
Accumulated amortization	1,051	640
Operating lease Right-of-Use assets, net	5,369	5,689
Lease liabilities – current - Accounts payable and accrued liabilities	629	617
Lease liabilities – noncurrent	4,642	5,389
Total operating lease liabilities	$ 5,271	$ 6,006
Weighted average remaining lease term in years	8 years 1 month 6 days	8 years 7 months 6 days
Weighted average annual discount rate	3.60%	3.60%

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Leases (Details) - Schedule of maturities of operating lease liabilities $ in Thousands	Jun. 30, 2022 USD ($)
Schedule Of Maturities Of Operating Lease Liabilities Abstract
2022 (after June 30)	$ 386
2023	786
2024	679
2025	714
2026 and onwards	3,497
Total undiscounted lease liability	6,062
Less: Imputed interest	(791)
Present value of lease liabilities	$ 5,271

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Commitments and Contingent Liabilities (Details) $ in Millions	6 Months Ended
	Jun. 30, 2022 USD ($)
Commitments and Contingent Liabilities (Details) [Line Items]
Total gross amount of grants including accrued interest (in Dollars)	$ 8.9
Minimum [Member]
Commitments and Contingent Liabilities (Details) [Line Items]
Percentage of royalties in sales	3.00%
Maximum [Member]
Commitments and Contingent Liabilities (Details) [Line Items]
Percentage of royalties in sales	5.00%

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Equity (Details) - Schedule of number of ordinary shares upon exercise - Warrants [Member]	6 Months Ended
	Jun. 30, 2022 $ / shares shares
Equity (Details) - Schedule of number of ordinary shares upon exercise [Line Items]
Number of Warrants Outstanding beginning balance | shares	704,355
Weighted average exercise price Outstanding beginning balance | $ / shares	$ 13.18
Number of Warrants Forfeited and expired | shares	(502,104)
Weighted average exercise price Forfeited and expired | $ / shares	$ 9.5
Number of Warrants Outstanding ending balance | shares	202,251
Weighted average exercise price Outstanding ending balance | $ / shares	$ 23.31

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Equity (Details) - Schedule of changes in exercisable ordinary shares warrants	6 Months Ended
	Jun. 30, 2022 $ / shares shares
Class of Warrant or Right [Line Items]
Number of Warrants	202,251
Exercise Price 10 [Member]
Class of Warrant or Right [Line Items]
Number of Warrants	22,750
Exercise price per share | $ / shares	$ 10
Issuance date	Feb. 26, 2020
Expiration date	Feb. 24, 2025
Exercise Price 25 [Member]
Class of Warrant or Right [Line Items]
Number of Warrants	160,727
Exercise price per share | $ / shares	$ 25
Issuance date	Feb. 12, 2021
Expiration date	Feb. 09, 2026
Exercise Price 25 [Member]
Class of Warrant or Right [Line Items]
Number of Warrants	18,774
Exercise price per share | $ / shares	$ 25
Issuance date	Feb. 17, 2021
Expiration date	Feb. 09, 2026

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Share-Based Compensation (Details) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021
Share-Based Compensation (Details) [Line Items]
Ordinary shares authorized (in Shares)	4,150,704		4,150,704
Share-based compensation expenses	$ 509	$ 1,074	$ 603	$ 778
Employees' Stock Option [Member]
Share-Based Compensation (Details) [Line Items]
Total unrecognized estimated compensation cost				$ 1,780
Weighted average period				1 year 6 months
Consultants' stock options [Member]
Share-Based Compensation (Details) [Line Items]
Total unrecognized estimated compensation cost			$ 889
Weighted average period			1 year 6 months
2019 Equity Incentive Plan [Member]
Share-Based Compensation (Details) [Line Items]
Future grant share (in Shares)	1,189,363		1,189,363
Restricted Stock [Member]
Share-Based Compensation (Details) [Line Items]
Share-based compensation expenses	$ 188	$ 411	$ 49	$ 64

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Share-Based Compensation (Details) - Schedule of employees and directors stock options - $ / shares	3 Months Ended		6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021
Schedule Of Employees And Directors Stock Options Abstract
Number of options, Outstanding at beginning of period	2,399,622	1,870,485	2,142,547	1,884,420
Weighted average exercise price, Outstanding at beginning of period	$ 5.95	$ 5.54	$ 6.02	$ 5.52
Number of options, Granted		310,500	264,700	310,500
Weighted average exercise price, Granted		$ 12.57	$ 5.48	$ 12.57
Number of options, Forfeited and expired	(3,000)	(2,685)	(3,000)	(3,185)
Weighted average exercise price, Forfeited and expired	$ 5.34	$ 7.38	$ 5.34	$ 6.96
Number of options, Exercised	(7,625)	(375)	(15,250)	(13,810)
Weighted average exercise price, Exercised	$ 6.49	$ 4.68	$ 6.49	$ 2.99
Number of options, Outstanding at end of period	2,388,997	2,177,925	2,388,997	2,177,925
Weighted average exercise price, Outstanding at end of period	$ 5.95	$ 6.54	$ 5.95	$ 6.54
Number of options, Exercisable at end of period	1,728,623	1,404,809	1,728,623	1,404,809
Weighted average exercise price, Exercisable at end of period	$ 5.1	$ 5.5	$ 5.1	$ 5.5
Number of options, Non-vested at beginning of period	722,749	544,163	529,082	601,227
Weighted average exercise price, Non-vested at beginning of period	$ 7.67	$ 6.04	$ 8.69	$ 5.93
Number of options, Granted		310,500	264,700	310,500
Weighted average exercise price, Granted		$ 12.57	$ 5.48	$ 12.57
Number of options, Vested	(59,375)	(78,862)	(130,408)	(3,185)
Weighted average exercise price, Vested	$ (8.78)	$ 13.15	$ 7.82	$ 6.96
Number of options, Forfeited	(3,000)	(2,685)	(3,000)	(135,426)
Weighted average exercise price, Forfeited	$ (5.34)	$ 7.38	$ 5.34	$ 8.22
Number of options, Non-vested at the end of period	660,374	773,116	660,374	773,116
Weighted average exercise price, Non-vested at the end of period	$ 7.59	$ 8.19	$ 7.59	$ 8.19

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Share-Based Compensation (Details) - Schedule of exercise prices and remaining contractual life $ / shares in Units, $ in Thousands	6 Months Ended
	Jun. 30, 2022 USD ($) $ / shares shares
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]
Number of options outstanding	2,388,997
Intrinsic Value of Options Outstanding (in Dollars) | $	$ 1,403,534
No. of options exercisable	1,728,623
Exercise Price One [Member] | Option [Member]
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]
Exercise price (in Dollars per share) | $ / shares	$ 2.69
Number of options outstanding	649,883
Remaining contractual Life (in years)	2 years 11 months 1 day
Intrinsic Value of Options Outstanding (in Dollars) | $	$ 1,189,284
No. of options exercisable	649,883
Exercise Price Two [Member] | Option [Member]
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]
Exercise price (in Dollars per share) | $ / shares	$ 3.66
Number of options outstanding	250,000
Remaining contractual Life (in years)	7 years 10 months 2 days
Intrinsic Value of Options Outstanding (in Dollars) | $	$ 214,250
No. of options exercisable	180,556
Exercise Price Three [Member] | Option [Member]
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]
Exercise price (in Dollars per share) | $ / shares	$ 4.68
Number of options outstanding	55,500
Remaining contractual Life (in years)	7 years 9 months
Intrinsic Value of Options Outstanding (in Dollars) | $
No. of options exercisable	27,750
Exercise Price Four [Member] | Option [Member]
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]
Exercise price (in Dollars per share) | $ / shares	$ 5.35
Number of options outstanding	231,200
Remaining contractual Life (in years)	9 years 9 months
Intrinsic Value of Options Outstanding (in Dollars) | $
No. of options exercisable
Exercise Price Five [Member] | Option [Member]
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]
Exercise price (in Dollars per share) | $ / shares	$ 6.22
Number of options outstanding	634,177
Remaining contractual Life (in years)	5 years
Intrinsic Value of Options Outstanding (in Dollars) | $
No. of options exercisable	620,879
Exercise Price Six [Member] | Option [Member]
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]
Exercise price (in Dollars per share) | $ / shares	$ 6.49
Number of options outstanding	15,250
Remaining contractual Life (in years)	10 days
Intrinsic Value of Options Outstanding (in Dollars) | $
No. of options exercisable
Exercise Price Seven [Member] | Option [Member]
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]
Exercise price (in Dollars per share) | $ / shares	$ 8.19
Number of options outstanding	150,000
Remaining contractual Life (in years)	7 years 4 months 17 days
Intrinsic Value of Options Outstanding (in Dollars) | $
No. of options exercisable	75,000
Exercise Price Eight [Member] | Option [Member]
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]
Exercise price (in Dollars per share) | $ / shares	$ 8.23
Number of options outstanding	20,000
Remaining contractual Life (in years)	9 years 4 months 20 days
Intrinsic Value of Options Outstanding (in Dollars) | $
No. of options exercisable
Exercise Price Nine [Member] | Option [Member]
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]
Exercise price (in Dollars per share) | $ / shares	$ 8.3
Number of options outstanding	15,000
Remaining contractual Life (in years)	9 years 1 month 6 days
Intrinsic Value of Options Outstanding (in Dollars) | $
No. of options exercisable
Exercise Price Ten [Member] | Option [Member]
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]
Exercise price (in Dollars per share) | $ / shares	$ 9.02
Number of options outstanding	40,500
Remaining contractual Life (in years)	8 years 4 months 17 days
Intrinsic Value of Options Outstanding (in Dollars) | $
No. of options exercisable	10,125
Exercise Price Eleven [Member] | Option [Member]
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]
Exercise price (in Dollars per share) | $ / shares	$ 10.12
Number of options outstanding	12,126
Remaining contractual Life (in years)	6 years 5 months 4 days
Intrinsic Value of Options Outstanding (in Dollars) | $
No. of options exercisable	9,700
Exercise Price Twelve [Member] | Option [Member]
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]
Exercise price (in Dollars per share) | $ / shares	$ 12.21
Number of options outstanding	2,421
Remaining contractual Life (in years)	6 years 8 months 26 days
Intrinsic Value of Options Outstanding (in Dollars) | $
No. of options exercisable	1,816
Exercise Price Thirteen [Member] | Option [Member]
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]
Exercise price (in Dollars per share) | $ / shares	$ 12.23
Number of options outstanding	250,000
Remaining contractual Life (in years)	8 years 10 months 28 days
Intrinsic Value of Options Outstanding (in Dollars) | $
No. of options exercisable	111,111
Exercise Price Fourteen [Member] | Option [Member]
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]
Exercise price (in Dollars per share) | $ / shares	$ 14
Number of options outstanding	60,500
Remaining contractual Life (in years)	8 years 9 months 25 days
Intrinsic Value of Options Outstanding (in Dollars) | $
No. of options exercisable	40,333
Exercise Price Fifteen [Member] | Option [Member]
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]
Exercise price (in Dollars per share) | $ / shares	$ 21.4
Number of options outstanding	1,940
Remaining contractual Life (in years)	7 years 25 days
Intrinsic Value of Options Outstanding (in Dollars) | $
No. of options exercisable	970
Exercise Price Sixteen [Member] | Option [Member]
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]
Exercise price (in Dollars per share) | $ / shares	$ 90.16
Number of options outstanding	500
Remaining contractual Life (in years)	2 years 5 months 1 day
Intrinsic Value of Options Outstanding (in Dollars) | $
No. of options exercisable	500

XML

Share-Based Compensation (Details) - Schedule of restricted stock units - $ / shares	3 Months Ended		6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021
Schedule Of Restricted Stock Units Abstract
Number of shares, Nonvested at beginning of period	184,787	48,375	229,331
Weighted average grant date fair value, Nonvested at beginning of period	$ 10.02	$ 14.67	$ 10.08
Number of shares, Granted		13,750		62,125
Weighted average grant date fair value, Granted		$ 10.28		$ 13.7
Number of shares, Vested	(3,437)		(47,981)
Weighted average grant date fair value, Vested	$ 10.28		$ 10.29
Number of shares, Forfeited		(2,000)		(2,000)
Weighted average grant date fair value, Forfeited		$ 14.67		$ 14.67
Number of shares, Nonvested at end of period	181,350	60,125	181,350	60,125
Weighted average grant date fair value, Nonvested at end of period	$ 10.02	$ 13.67	$ 10.02	$ 13.67

XML

Share-Based Compensation (Details) - Schedule of share-based compensation expenses related to grants under the equity incentive plan - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total	$ 697	$ 652	$ 1,485	$ 842
Research & development [Member]
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total	119	358	509	446
General & administrative [Member]
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total	$ 578	$ 294	$ 976	$ 396

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Fair Value Measurement (Details) - Schedule of financial assets and liabilities measured at fair value on a recurring basis - USD ($) $ in Thousands	Jun. 30, 2022	Dec. 31, 2021
Fair Value Measurement (Details) - Schedule of financial assets and liabilities measured at fair value on a recurring basis [Line Items]
Cash and cash equivalents	$ 20,550	$ 11,202
Short term deposits	42,334	10,004
Cash held with respect to CVR Agreement	113	113
Marketable securities		62,924
Restricted cash	286	321
Total financial assets	63,283	84,564
Level 1 [Member]
Fair Value Measurement (Details) - Schedule of financial assets and liabilities measured at fair value on a recurring basis [Line Items]
Cash and cash equivalents	20,550	11,202
Short term deposits	42,334	10,004
Cash held with respect to CVR Agreement	113	113
Marketable securities		62,924
Restricted cash	286	321
Total financial assets	63,283	84,564
Level 2 [Member]
Fair Value Measurement (Details) - Schedule of financial assets and liabilities measured at fair value on a recurring basis [Line Items]
Cash and cash equivalents
Short term deposits
Cash held with respect to CVR Agreement
Marketable securities
Restricted cash
Total financial assets
Level 3 [Member]
Fair Value Measurement (Details) - Schedule of financial assets and liabilities measured at fair value on a recurring basis [Line Items]
Cash and cash equivalents
Short term deposits
Cash held with respect to CVR Agreement
Marketable securities
Restricted cash
Total financial assets