Mga Batayang Estadistika
LEI | 549300BG1T7KL678Y212 |
CIK | 1596812 |
SEC Filings
SEC Filings (Chronological Order)
August 29, 2025 |
Exhibit 99.1 ENLIVEX THERAPEUTICS LTD. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2025 AND DECEMBER 31, 2024 AND FOR THE THREE AND SIX MONTH PERIODS ENDED JUNE 30, 2025 AND 2024 ENLIVEX THERAPEUTICS LTD. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2025 AND DECEMBER 31, 2024 AND FOR THE THREE AND SIX MONTH PERIODS ENDED JUNE 30, 2025 AND 2024 INDEX TO CONDENSED CONSOL |
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August 29, 2025 |
OPERATING AND FINANCIAL REVIEW AND PROSPECTS 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, inclu |
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August 29, 2025 |
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 2025 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 exec |
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August 18, 2025 |
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 2025 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 exec |
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August 18, 2025 |
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 2025 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 exec |
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August 18, 2025 |
Exhibit 99.1 Enlivex Announces Positive Topline Data From Multi-Country, Randomized, Controlled, Phase I/II Trial Evaluating Allocetra in Patients With Moderate-To-Severe Knee Osteoarthritis ENX-CL-05-001 Trial: 3-months topline data - In the overall modified intention-to-treat (mITT) population, improvements across all efficacy and secondary endpoints, including 24% reduction in knee pain and 26% |
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August 18, 2025 |
Exhibit 99.1 ENLIVEX THERAPEUTICS PHASE IIA TOPLINE RESULTS Aug 2025 These slides and the accompanying oral presentation contain forward - looking statements and information. Forward - looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially diffe |
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August 14, 2025 |
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 2025 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 exec |
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August 14, 2025 |
Exhibit 99.1 Enlivex to Present 3-Month Topline Data from Phase IIa Moderate/Severe Knee Osteoarthritis Trial on August 18 Webinar Webinar to Review Results from Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Allocetra™ in Patients with Moderate to Severe Knee Osteoarthritis Nes-Ziona, Israel, August 14, 2025 (GLOBE NEWSWIRE) - Enlivex Therapeutics Ltd. (Nasdaq: ENLV, |
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July 28, 2025 |
Enlivex Reaffirms August 18, 2025 As Target Date For Announcement of Phase II Topline Data Exhibit 99.1 Enlivex Reaffirms August 18, 2025 As Target Date For Announcement of Phase II Topline Data Nes-Ziona, Israel, July 28, 2025 (GLOBE NEWSWIRE) - Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that all 134 patients in its Phase II stage of its randomized, controlled, blinded Phase I/II trial of All |
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July 28, 2025 |
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: July 2025 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 execut |
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May 30, 2025 |
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: May 2025 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 executi |
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May 30, 2025 |
OPERATING AND FINANCIAL REVIEW AND PROSPECTS 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, inclu |
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May 30, 2025 |
Exhibit 99.1 ENLIVEX THERAPEUTICS LTD. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF MARCH 31, 2025 AND DECEMBER 31, 2024 AND FOR THE THREE-MONTH PERIODS ENDED MARCH 31, 2025 AND 2024 ENLIVEX THERAPEUTICS LTD. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF MARCH 31, 2025 AND DECEMBER 31, 2024 AND FOR THE THREE-MONTH PERIODS ENDED MARCH 31, 2025 AND 2024 INDEX TO CONDENSED CONSOLIDATED FINAN |
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May 13, 2025 |
Up to 8,800,000 Ordinary Shares Filed pursuant to Rule 424(b)(3) Registration No. 333-286956 Prospectus Up to 8,800,000 Ordinary Shares On December 30, 2022, we entered into a sales agreement (the “Sales Agreement”), with Cantor Fitzgerald & Co. and Citizens JMP Securities, LLC, as agents (each an “Sales Agent” and together the “Sales Agents”), relating to the sale of our ordinary shares, par value NIS 0.40 per share (“ordinary |
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May 8, 2025 |
Enlivex Therapeutics Ltd. 14 Einstein Street Ness Ziona Israel 7403618 Enlivex Therapeutics Ltd. 14 Einstein Street Ness Ziona Israel 7403618 May 8, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, D.C. 20549 Attention: Tyler Howes RE: Enlivex Therapeutics Ltd. (the “Company”) Registration Statement on Form F-3 (the “Registration Statement”) Filed May 2, 2025 File No. 333-286956 Dear Mr. Howe |
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May 2, 2025 |
As filed with the Securities and Exchange Commission on May 2, 2025 As filed with the Securities and Exchange Commission on May 2, 2025 Registration No. |
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May 2, 2025 |
Exhibit 107 Calculation of Filing Fee Tables Form F-3 (Form Type) Enlivex Therapeutics, Ltd. |
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April 30, 2025 |
CONSENT OF INDEPENDENT ACCOUNTANTS Exhibit 15.1 CONSENT OF INDEPENDENT ACCOUNTANTS We hereby consent to the incorporation by reference in the Registration Statement 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) of Enlivex Therapeutics Ltd. of our report dated March 31, 2025 with respect to the consolidated financial statements and the effect |
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April 30, 2025 |
CERTIFICATION PURSUANT TO EXCHANGE ACT RULE 13a-14(a) or 15d-14(a) Exhibit 12.1 CERTIFICATION PURSUANT TO EXCHANGE ACT RULE 13a-14(a) or 15d-14(a) I, Dr. Oren Hershkovitz, certify that: 1. I have reviewed this Annual Report on Form 20-F of Enlivex Therapeutics Ltd.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances und |
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April 30, 2025 |
THIRD AMENDMENT TO CONSULTING AGREEMENT Exhibit 4.21 THIRD AMENDMENT TO CONSULTING AGREEMENT THIS THIRD AMENDMENT (the “Third Amendment”) is entered into as of November 7, 2024, by and between Enlivex Therapeutics, Ltd., a company organized under the laws of the State of Israel, corporate number 51373620, whose address is at 14 Einstein Street, Ness Ziona, Israel 7403618 (the “Company”) and A.S. Novik Ltd., a company organized under the |
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April 30, 2025 |
CERTIFICATION PURSUANT TO 18 U.S.C. Section 1350 Exhibit 13.2 CERTIFICATION PURSUANT TO 18 U.S.C. Section 1350 In connection with the filing of the Annual Report on Form 20–F for the period ended December 31, 2024 (the “Report”) by Enlivex Therapeutics Ltd. (the “Company”), the undersigned, as the Chief Financial Officer of the Company, hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley |
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April 30, 2025 |
CERTIFICATION PURSUANT TO 18 U.S.C. Section 1350 Exhibit 13.1 CERTIFICATION PURSUANT TO 18 U.S.C. Section 1350 In connection with the filing of the Annual Report on Form 20–F for the period ended December 31, 2024 (the “Report”) by Enlivex Therapeutics Ltd. (the “Company”), the undersigned, as the Chief Executive Officer of the Company, hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley |
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April 30, 2025 |
Exhibit 11.1 ENLIVEX THERAPEUTICS LTD. INSIDER TRADING POLICY AND GUIDELINES WITH RESPECT TO CERTAIN TRANSACTIONS IN COMPANY SECURITIES Date: June 23, 2015 This Insider Trading Policy (the “Policy”) provides guidelines to directors, officers, employees and other related individuals of Enlivex Therapeutics Ltd, an Israeli company (the “Company”), with respect to transactions in the Company’s securi |
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April 30, 2025 |
CERTIFICATION PURSUANT TO EXCHANGE ACT RULE 13a-14(a) or 15d-14(a) Exhibit 12.2 CERTIFICATION PURSUANT TO EXCHANGE ACT RULE 13a-14(a) or 15d-14(a) I, Shachar Shlosberger, certify that: 1. I have reviewed this Annual Report on Form 20–F of Enlivex Therapeutics Ltd.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances unde |
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April 30, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXC |
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April 23, 2025 |
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: April 2025 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 execu |
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April 23, 2025 |
Exhibit 99.1 Enlivex Therapeutics to Showcase Allocetra’s Potential in Osteoarthritis at OARSI 2025 World Congress Presentations to underscore AllocetraTM’s novel mechanism targeting immune imbalance in joint disease Ness-Ziona, Israel, April 23, 2025 (GLOBE NEWSWIRE) - Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today a |
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April 21, 2025 |
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: April 2025 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 execu |
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April 21, 2025 |
Exhibit 99.1 Enlivex Announces Completion of Enrollment In The Phase II stage Of Its Phase I/II Trial Evaluating Allocetra In Patients With Moderate To Severe Knee Osteoarthritis Nes-Ziona, Israel, April 21, 2025 (GLOBE NEWSWIRE) - Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Company completed enr |
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April 3, 2025 |
Exhibit 99.1 Enlivex Announces the Dosing of the First Patient in a Phase I Trial Evaluating Allocetra in Patients with TMJ Osteoarthritis ● Temporomandibular joint (TMJ) osteoarthritis is a degenerative, debilitating and progressive disease, the second most common musculoskeletal condition affecting five to 12% of the population globally ● TMJ causes pain and stiffness in the jaw, making it diffi |
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April 3, 2025 |
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: April 2025 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 execu |
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March 31, 2025 |
CONSENT OF INDEPENDENT ACCOUNTANTS Exhibit 99.2 CONSENT OF INDEPENDENT ACCOUNTANTS We hereby consent to the incorporation by reference in the Registration Statement 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) of Enlivex Therapeutics Ltd. of our report dated March 31, 2025 with respect to the consolidated financial statements and the effect |
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March 31, 2025 |
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: March 2025 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 execu |
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March 31, 2025 |
Exhibit 99.1 ENLIVEX THERAPEUTICS LTD. FINANCIAL STATEMENTS AS OF DECEMBER 31, 2024 ENLIVEX THERAPEUTICS LTD. FINANCIAL STATEMENTS AS OF DECEMBER 31, 2024 INDEX Page Report of Independent Registered Public Accounting Firm F-2 Consolidated Balance Sheets F-5 Consolidated Statements of Operations and Comprehensive Loss F-6 Consolidated Statements of Changes in Shareholders’ Equity F-7 Consolidated S |
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March 17, 2025 |
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: March 2025 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 execu |
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March 17, 2025 |
Exhibit 99.1 Enlivex Receives Notice of Allowance for Chinese Patent Application Covering the Use of Allocetra in Patients with Osteoarthritis Nes-Ziona, Israel, March 17, 2025 (GLOBE NEWSWIRE) - Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the China National Intellectual Property Administration (CNIP |
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March 4, 2025 |
Exhibit 99.1 Enlivex Therapeutics Announces Investor Webinar to Discuss Positive Interim Data from Phase I/II Allocetra™ Trial in Knee Osteoarthritis Ness-Ziona, Israel – March 4, 2025 – Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, is pleased to invite investors to a live investor webinar on March 5, 2025, at 11:00 a.m. E |
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March 4, 2025 |
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: March 2025 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 execu |
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March 3, 2025 |
Exhibit 99.1 Enlivex Announces Positive Interim Data – Statistically Significant 47.0% Durable and Persistent Pain Reduction At Six Months, in Patients with Moderate to Severe Knee Osteoarthritis Nes-Ziona, Israel, March 03, 2025 (GLOBE NEWSWIRE) - Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced positive inte |
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March 3, 2025 |
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: March 2025 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 execu |
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February 18, 2025 |
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: February 2025 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 ex |
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February 18, 2025 |
Enlivex Issues Urgent Statement on Fraudulent News Dissemination Exhibit 99.1 Enlivex Issues Urgent Statement on Fraudulent News Dissemination Ness-Ziona, Israel, Feb. 18, 2025 — Enlivex Therapeutics Ltd. (Nasdaq and TASE: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, alerts investors and the public that a completely false and misleading report regarding the Company was intentionally published this morning by the website |
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December 11, 2024 |
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: December 2024 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal ex |
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December 11, 2024 |
Exhibit 99.1 Enlivex Receives Regulatory Authorization for the Initiation of a Phase I Trial Evaluating Allocetra in Patients with TMJ Osteoarthritis Ness-Ziona, Israel, December 11, 2024 (GLOBE NEWSWIRE) - Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Israeli Ministry of Health authorized the init |
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December 3, 2024 |
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: December 2024 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal ex |
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December 3, 2024 |
Exhibit 99.1 Enlivex Announces Positive Interim Efficacy Data from Allocetra Trial in Patients with Moderate to Severe Knee Osteoarthritis Nes-Ziona, Israel, Dec. 03, 2024 (GLOBE NEWSWIRE) - Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced positive interim efficacy data from the Phase I stage of its randomized |
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November 29, 2024 |
OPERATING AND FINANCIAL REVIEW AND PROSPECTS 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, inclu |
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November 29, 2024 |
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: November 2024 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal ex |
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November 29, 2024 |
Exhibit 99.1 ENLIVEX THERAPEUTICS LTD. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF SEPTEMBER 30, 2024 AND DECEMBER 31, 2023 AND FOR THE THREE AND NINE MONTH PERIODS ENDED SEPTEMBER 30, 2024 AND 2023 ENLIVEX THERAPEUTICS LTD. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF SEPTEMBER 30, 2024 AND DECEMBER 31, 2023 AND FOR THE THREE AND NINE MONTH PERIODS ENDED SEPTEMBER 30, 2024 AND 2023 IND |
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November 20, 2024 |
Enlivex Adopts Bitcoin Treasury Reserve Strategy Exhibit 99.1 Enlivex Adopts Bitcoin Treasury Reserve Strategy Nes-Ziona, Israel, November 20, 2024 (GLOBE NEWSWIRE) - Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Company’s Board of Directors approved the purchase of up to $1 million of Bitcoin as part of its cash management strategy. “As demand f |
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November 20, 2024 |
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: November 2024 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal ex |
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November 14, 2024 |
ENLV / Enlivex Therapeutics Ltd. / ARMISTICE CAPITAL, LLC Passive Investment SC 13G 1 armistice-enlv093024.htm UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* Enlivex Therapeutics Ltd. (Name of Issuer) Ordinary Shares, par value NIS 0.40 per share (Title of Class of Securities) M4130Y106 (CUSIP Number) September 30, 2024 (Date of Event Which Requires Filing of this Statement) Che |
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November 14, 2024 |
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: November 2024 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal ex |
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November 14, 2024 |
Exhibit 99.1 Enlivex Announces the Dosing of the First Patient in a Phase I Clinical Trial Evaluating Allocetra in Patients with Psoriatic Arthritis Nes-Ziona, Israel, November 14, 2024 (GLOBE NEWSWIRE) - Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced the completion of the dosing and initial follow-up period |
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November 12, 2024 |
Exhibit 99.1 Enlivex Announces the Enrollment and Dosing of the First 10 Patient in the Randomized Phase II Stage of its Allocetra Trial in Patients with Moderate to Severe Knee Osteoarthritis Nes-Ziona, Israel, Nov. 11, 2024 (GLOBE NEWSWIRE) - Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced the enrollment an |
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November 12, 2024 |
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: November 2024 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal ex |
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November 8, 2024 |
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: November 2024 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal ex |
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October 31, 2024 |
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: October 2024 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal exe |
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October 30, 2024 |
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: October 2024 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal exe |
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October 30, 2024 |
Exhibit 99.1 Enlivex Receives Notice of Allowance for Japanese Patent Application Covering the Use of Allocetra™ in Patients with Osteoarthritis Nes-Ziona, Israel, October 30, 2024 (GLOBE NEWSWIRE) - Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Japanese Patent Office issued a notice of allowance f |
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October 15, 2024 |
Exhibit 99.1 Enlivex Therapeutics Ltd. (the “Company”) Amended and Restated Compensation Policy for Company Office Holders 1. The Objective of the Document The objective of this compensation policy (the “Policy”) is to define and describe the Company’s Office Holder compensation policy as required by the Israeli Companies Law – 1999 the “Companies Law”). It is emphasized that this Policy does not |
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October 15, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K/A (Amendment No. 1) Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 under the Securities Exchange Act of 1934 For the month of: October 2024 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Addr |
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September 26, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 under the Securities Exchange Act of 1934 For the month of: September 2024 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal e |
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September 26, 2024 |
Exhibit 99.1 Enlivex Receives Authorization from the Danish Medicines Agency to Initiate the Phase II Stage of its Phase I/II Trial of Allocetra in Patients with Moderate to Severe Knee Osteoarthritis Nes-Ziona, Israel, Sept. 26, 2024 (GLOBE NEWSWIRE) - Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the |
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September 24, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 under the Securities Exchange Act of 1934 For the month of: September 2024 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal e |
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September 24, 2024 |
Exhibit 99.1 Enlivex Announces Positive DSMB Recommendation to Initiate the Phase II Stage of its Phase I/II Trial of Allocetra in Patients with Moderate to Severe Knee Osteoarthritis Nes-Ziona, Israel, Sept. 24, 2024 (GLOBE NEWSWIRE) - Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the independent Data |
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September 11, 2024 |
Exhibit 99.2 THIS PROXY WHEN PROPERLY EXECUTED WILL BE VOTED AS DIRECTED HEREIN. EXCEPT AS MENTIONED OTHERWISE IN THE PROXY STATEMENT AND BELOW ON THIS PROXY, IF NO DIRECTION IS INDICATED, THIS PROXY WILL BE VOTED “FOR” THE PROPOSALS HEREIN. Please mark your vote as in this example PROPOSAL NO. 1: To elect the following persons to the Board of Directors, each to serve until the next annual general |
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September 11, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 under the Securities Exchange Act of 1934 For the month of: September 2024 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal e |
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September 11, 2024 |
Exhibit 99.1 ENLIVEX THERAPEUTICS LTD. NOTICE OF ANNUAL GENERAL MEETING OF SHAREHOLDERS To be held on October 31, 2024 Dear Shareholder: We cordially invite you to attend the Annual General Meeting of Shareholders (the “Meeting”) of Enlivex Therapeutics Ltd. (the “Company”), to be held on Thursday, October 31, 2024, at 7:00 p.m. (Israel time), at the offices of the Company at 14 Einstein Street, N |
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August 30, 2024 |
Exhibit 99.1 ENLIVEX THERAPEUTICS LTD. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2024 AND DECEMBER 31, 2023 AND FOR THE THREE AND SIX MONTH PERIODS ENDED JUNE 30, 2024 AND 2023 ENLIVEX THERAPEUTICS LTD. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2024 AND DECEMBER 31, 2023 AND FOR THE THREE AND SIX MONTH PERIODS ENDED JUNE 30, 2024 AND 2023 INDEX TO CONDENSED CONSOL |
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August 30, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 under the Securities Exchange Act of 1934 For the month of: August 2024 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal exec |
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August 30, 2024 |
OPERATING AND FINANCIAL REVIEW AND PROSPECTS 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, inclu |
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July 23, 2024 |
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: July 2024 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal execut |
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July 23, 2024 |
Exhibit 99.1 Enlivex Receives Regulatory Authorization For The Initiation Of A Phase I Clinical Trial To Evaluate Allocetra In Patients With Psoriatic Arthritis ● First study of AllocetraTM in psoriatic arthritis, a chronic inflammatory condition that causes joint pain, swelling and stiffness, affects as many as 30% of people with psoriasis1, and has limited treatment options Nes-Ziona, Israel, Ju |
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June 24, 2024 |
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: June 2024 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal execut |
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June 24, 2024 |
Exhibit 99.1 Enlivex Announces the Dosing of the First Patient in a Randomized, Placebo-Controlled Phase I/II Trial Evaluating AllocetraTM in up to 46 Patients with Thumb Osteoarthritis · First patient dosed with AllocetraTM in thumb osteoarthritis, a degenerative, debilitating and progressive disease that affects millions of people · Thumb osteoarthritis currently has no FDA-approved therapy and |
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June 20, 2024 |
Exhibit 99.1 Join Enlivex Therapeutics’ Chief Executive Officer for a Live Investor Webinar and Q&A Session on June 25 Ness-Ziona, Israel, June 20, 2024 (GLOBE NEWSWIRE) - Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company” or “Enlivex”), a clinical-stage macrophage reprogramming immunotherapy company, is pleased to invite investors to a webinar on June 25, 2024, at 4:15 p.m. ET. The event, hos |
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June 20, 2024 |
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: June 2024 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal execut |
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June 17, 2024 |
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: June 2024 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal execut |
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June 17, 2024 |
Figure 1: Reduction in average pain, reported by patients Exhibit 99.1 Enlivex Announces Positive Interim Data Readout from a Phase I/II Trial Evaluating Allocetra in End-Stage Knee Osteoarthritis Key Highlights ● Enrolled patients with severe knee osteoarthritis who were indicated for knee-replacement surgery received a single local injection of AllocetraTM into the knee as a “last resort” ● Three-month data readout showed a significant reduction in pai |
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June 14, 2024 |
OPERATING AND FINANCIAL REVIEW AND PROSPECTS 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, inclu |
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June 14, 2024 |
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: June 2024 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal execut |
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June 14, 2024 |
Exhibit 99.1 ENLIVEX THERAPEUTICS LTD. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF MARCH 31, 2024 AND DECEMBER 31, 2023 AND FOR THE THREE-MONTH PERIODS ENDED MARCH 31, 2024 AND 2023 ENLIVEX THERAPEUTICS LTD. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF MARCH 31, 2024 AND DECEMBER 31, 2023 AND FOR THE THREE-MONTH PERIODS ENDED MARCH 31, 2024 AND 2023 INDEX TO CONDENSED CONSOLIDATED FINAN |
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June 3, 2024 |
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: June 2024 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal execut |
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June 3, 2024 |
Exhibit 99.1 Enlivex Receives Regulatory Authorization for the Initiation of a Placebo-Controlled Phase I/II Trial Evaluating Allocetra in Up To 46 Patients with Thumb Osteoarthritis ● First study of AllocetraTM in thumb osteoarthritis, a debilitating disease that affects millions of people in the U.S., and has no FDA-approved therapy ● Third study of AllocetraTM in osteoarthritis, following the o |
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May 29, 2024 |
SERIES B PLACEMENT AGENT ORDINARY SHARE PURCHASE WARRANT Enlivex Therapeutics Ltd. Exhibit 4.5 SERIES B PLACEMENT AGENT ORDINARY SHARE PURCHASE WARRANT Enlivex Therapeutics Ltd. Warrant Shares: Issue Date: May 29, 2024 Initial Exercise Date: May 29, 2024 THIS SERIES B PLACEMENT AGENT ORDINARY SHARE PURCHASE WARRANT (the “Warrant”) certifies that, for value received, or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the condi |
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May 29, 2024 |
PRE-FUNDED ORDINARY SHARE PURCHASE WARRANT Enlivex Therapeutics Ltd. Exhibit 4.3 PRE-FUNDED ORDINARY SHARE PURCHASE WARRANT Enlivex Therapeutics Ltd. Warrant Shares: Issue Date:, 2024 Initial Exercise Date: , 2024 THIS PRE-FUNDED ORDINARY SHARE PURCHASE WARRANT (the “Warrant”) certifies that, for value received, or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time |
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May 29, 2024 |
Exhibit 1.1 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of May 27, 2024, between Enlivex Therapeutics Ltd., a company organized under the laws of the State of Israel (the “Company”), and each purchaser identified on the signature pages hereto (each, including its successors and assigns, a “Purchaser” and collectively the “Purchasers”). WHEREAS, s |
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May 29, 2024 |
SERIES A ORDINARY SHARE PURCHASE WARRANT Enlivex Therapeutics Ltd. Exhibit 4.1 SERIES A ORDINARY SHARE PURCHASE WARRANT Enlivex Therapeutics Ltd. Warrant Shares: Issue Date: May 29, 2024 Initial Exercise Date: May 29, 2024 THIS SERIES A ORDINARY SHARE PURCHASE WARRANT (the “Warrant”) certifies that, for value received, or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at |
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May 29, 2024 |
Enlivex Therapeutics Closes up to $15 Million Registered Direct Offering Exhibit 99.1 Enlivex Therapeutics Closes up to $15 Million Registered Direct Offering Nes-Ziona, Israel, May 29, 2024 (GLOBE NEWSWIRE) - Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced the closing of its previously announced registered direct offering to a single healthcare-focused institutional investor of a |
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May 29, 2024 |
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: May 2024 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal executi |
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May 29, 2024 |
SERIES B ORDINARY SHARE PURCHASE WARRANT Enlivex Therapeutics Ltd. Exhibit 4.2 SERIES B ORDINARY SHARE PURCHASE WARRANT Enlivex Therapeutics Ltd. Warrant Shares: Issue Date: May 29, 2024 Initial Exercise Date: May 29, 2024 THIS SERIES B ORDINARY SHARE PURCHASE WARRANT (the “Warrant”) certifies that, for value received, or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at |
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May 29, 2024 |
SERIES A PLACEMENT AGENT ORDINARY SHARE PURCHASE WARRANT Enlivex Therapeutics Ltd. Exhibit 4.4 SERIES A PLACEMENT AGENT ORDINARY SHARE PURCHASE WARRANT Enlivex Therapeutics Ltd. Warrant Shares: Issue Date: May 29, 2024 Initial Exercise Date: May 29, 2024 THIS SERIES A PLACEMENT AGENT ORDINARY SHARE PURCHASE WARRANT (the “Warrant”) certifies that, for value received, or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the condi |
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May 29, 2024 |
Filed Pursuant to Rule 424(b)(5) Registration No. 333-264561 Prospectus Supplement to Prospectus dated May 5, 2022 ENLIVEX THERAPEUTICS LTD. 2,060,000 Ordinary Shares Pre-Funded Warrants to Purchase Up to 1,511,429 Ordinary Shares Series A Investor Warrants to Purchase Up to 3,571,429 Ordinary Shares Series B Investor Warrants to Purchase Up to 3,571,429 Ordinary Shares Series A Placement Agent Wa |
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May 28, 2024 |
Enlivex Therapeutics Announces up to $15 Million Registered Direct Offering Exhibit 99.1 Enlivex Therapeutics Announces up to $15 Million Registered Direct Offering ● Single healthcare-focused institutional investor ● $5 million upfront with up to an additional $10 million of gross proceeds upon the exercise in full of clinical milestone-linked warrants Nes-Ziona, Israel, May 28, 2024 (GLOBE NEWSWIRE) – Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-s |
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May 28, 2024 |
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: May 2024 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal executi |
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April 30, 2024 |
Enlivex Therapeutics Ltd. Executive Officer Clawback Policy Exhibit 97.1 Enlivex Therapeutics Ltd. Executive Officer Clawback Policy Approved by the Board of Directors on November 28, 2023 (the “Adoption Date”) I. Purpose This Executive Officer Clawback Policy describes the circumstances under which Covered Persons of Enlivex Therapeutics Ltd., a company organized under the laws of the State of Israel, and any of its direct or indirect subsidiaries (collec |
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April 30, 2024 |
CERTIFICATION PURSUANT TO EXCHANGE ACT RULE 13a-14(a) or 15d-14(a) Exhibit 12.2 CERTIFICATION PURSUANT TO EXCHANGE ACT RULE 13a-14(a) or 15d-14(a) I, Shachar Shlosberger, certify that: 1. I have reviewed this Annual Report on Form 20–F of Enlivex Therapeutics Ltd.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances unde |
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April 30, 2024 |
CONSENT OF INDEPENDENT ACCOUNTANTS Exhibit 15.1 CONSENT OF INDEPENDENT ACCOUNTANTS We hereby consent to the incorporation by reference in the Registration Statement 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) of Enlivex Therapeutics Ltd. of our report dated March 25, 2024 with respect to the consolidated financial statements and the effect |
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April 30, 2024 |
Exhibit 1.1 Articles of Association of Enlivex Therapeutics Ltd. A Company Limited by Shares Under The Companies Law, 5759-1999 Chapter 1 General 2 Chapter 2 Shares and Share Capital 3 Chapter 3 General Meetings 7 Chapter 4 The Board of Directors 11 Chapter 5 Committees of the Board of Directors 15 Chapter 6 General Manager 16 Chapter 7 Exemption, Insurance, and Indemnification 16 Chapter 8 Intern |
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April 30, 2024 |
Exhibit 4.18 AGREEMENT This Agreement ( “Agreement”), made effective as of 31th of Marc, 2024 (“Effective Date”), is entered into by and between BioHarvest Ltd., an Israeli company, having an address at 3th Pekeris St. Rehovot (“BioHarvest”), and Enlivex Therapeutics R&D, Ltd., an Israeli company having an address at EINSTEIN 14TH St, NESS ZIONA (“Enlivex”). WHEREAS, Enlivex is the lessee of a pro |
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April 30, 2024 |
DESCRIPTION OF ORDINARY SHARES Exhibit 2.1 DESCRIPTION OF ORDINARY SHARES As of the end of the period covered by the most recent Annual Report on Form 20-F of Enlivex Therapeutics Ltd. (the “Company”) to which this Exhibit is filed, or incorporated by reference, as an exhibit, the Company’s ordinary shares, with a par value of NIS 0.40 per share (the “ordinary shares”), were registered under Section 12 of the Securities Exchang |
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April 30, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXC |
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April 30, 2024 |
CERTIFICATION PURSUANT TO EXCHANGE ACT RULE 13a-14(a) or 15d-14(a) Exhibit 12.1 CERTIFICATION PURSUANT TO EXCHANGE ACT RULE 13a-14(a) or 15d-14(a) I, Dr. Oren Hershkovitz, certify that: 1. I have reviewed this Annual Report on Form 20-F of Enlivex Therapeutics Ltd.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances und |
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April 30, 2024 |
CERTIFICATION PURSUANT TO 18 U.S.C. Section 1350 Exhibit 13.2 CERTIFICATION PURSUANT TO 18 U.S.C. Section 1350 In connection with the filing of the Annual Report on Form 20–F for the period ended December 31, 2023 (the “Report”) by Enlivex Therapeutics Ltd. (the “Company”), the undersigned, as the Chief Financial Officer of the Company, hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley |
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April 30, 2024 |
CERTIFICATION PURSUANT TO 18 U.S.C. Section 1350 Exhibit 13.1 CERTIFICATION PURSUANT TO 18 U.S.C. Section 1350 In connection with the filing of the Annual Report on Form 20–F for the period ended December 31, 2023 (the “Report”) by Enlivex Therapeutics Ltd. (the “Company”), the undersigned, as the Chief Executive Officer of the Company, hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley |
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April 29, 2024 |
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: April 2024 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal execu |
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April 29, 2024 |
Enlivex CEO Issues Letter to Shareholders – Perspectives on Recent Events Exhibit 99.1 Enlivex CEO Issues Letter to Shareholders – Perspectives on Recent Events Nes-Ziona, Israel, April 29, 2024 (GLOBE NEWSWIRE) – Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company” or “Enlivex”), a clinical-stage macrophage reprogramming immunotherapy company, today issued the following update to shareholders from Chief Executive Officer, Oren Hershkovitz. Dear fellow shareholders, I |
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April 22, 2024 |
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: April 2024 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal execu |
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April 22, 2024 |
Exhibit 99.1 Enlivex Announces Dosing of First Two Patients in its Randomized, Controlled Phase I/II Trial Evaluating Allocetra™ in Patients with Knee Osteoarthritis Nes-Ziona, Israel, April 22, 2024 (GLOBE NEWSWIRE) - Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the first two patients have been dosed |
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April 16, 2024 |
Exhibit 99.1 Enlivex Announces Authorization from the Danish Regulatory Agency for the Company’s Randomized, Controlled Phase I/II Trial Evaluating Allocetra in Patients with Knee Osteoarthritis Nes-Ziona, Israel, April 16, 2024 (GLOBE NEWSWIRE) - Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Danis |
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April 16, 2024 |
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: April 2024 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal execu |
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April 11, 2024 |
Exhibit 99.2 Nasdaq: ENLV COMPANY PRESENTATION April 2024 2 | Nasdaq: ENLV FORWARD - LOOKING STATEMENTS These slides and the accompanying oral presentation contain forward - looking statements and information. Forward - looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or |
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April 11, 2024 |
Exhibit 99.1 Enlivex Announces Topline Results of Its Phase II Trial Evaluating Allocetra™ In Patients With Sepsis ● Analysis of eligible1 patients from the sepsis Phase II study (NCT# NCT04612413) ■ In accordance with the study protocol, the safety and efficacy topline analysis includes sequential organ failure assessment (SOFA) scores and mortality for the 28-day period post treatment. ■ Efficac |
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April 11, 2024 |
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: April 2024 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal execu |
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March 29, 2024 |
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: March 2024 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal execu |
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March 29, 2024 |
CONSENT OF INDEPENDENT ACCOUNTANTS Exhibit 99.2 CONSENT OF INDEPENDENT ACCOUNTANTS We hereby consent to the incorporation by reference in the Registration Statement 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) of Enlivex Therapeutics Ltd. of our report dated March 25, 2024 with respect to the consolidated financial statements and the effect |
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March 29, 2024 |
Exhibit 99.1 ENLIVEX THERAPEUTICS LTD. FINANCIAL STATEMENTS AS OF DECEMBER 31, 2023 ENLIVEX THERAPEUTICS LTD. FINANCIAL STATEMENTS AS OF DECEMBER 31, 2023 INDEX Page Report of Independent Registered Public Accounting Firm F-2 Consolidated Balance Sheets F-5 Consolidated Statements of Operations and Comprehensive Loss F-6 Consolidated Statements of Changes in Shareholders’ Equity F-7 Consolidated S |
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February 7, 2024 |
Exhibit 99.1 Enlivex Announces Issuance of New U.S. Patent Covering Allocetra Cells and Their Manufacturing Method Nes-Ziona, Israel, Feb. 07, 2024 (GLOBE NEWSWIRE) – Enlivex Therapeutics Ltd., (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the U.S. Patent and Trademark Office issued a new patent, number US 11,883,429, covering |
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February 7, 2024 |
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: February 2024 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal ex |
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January 22, 2024 |
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: January 2024 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal exe |
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January 17, 2024 |
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: January 2024 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal exe |
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January 17, 2024 |
Exhibit 99.1 Enlivex Receives IMOH Regulatory Authorization for the Initiation of a Multi-Country, Randomized, Controlled Phase I/II Trial Evaluating Allocetra in Up To 160 Patients with Moderate to Severe Knee Osteoarthritis ● Second study of Allocetra in knee osteoarthritis, following the on-going Phase I/II trial in pre-surgery, end-stage osteoarthritis, that is continuing to enroll patients Ne |
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December 20, 2023 |
Exhibit 99.1 Enlivex Announces Completion of Enrollment of Its Phase II Trial Evaluating Allocetra In Patients With Sepsis · Enrollment completed in placebo-controlled, randomized, dose-finding, multi-country, multi-center Phase II sepsis study · Topline Data Expected in late Q1 2024 Nes-Ziona, Israel, Dec. 19, 2023 (GLOBE NEWSWIRE) - Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clin |
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December 20, 2023 |
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: December 2023 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal ex |
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November 9, 2023 |
OPERATING AND FINANCIAL REVIEW AND PROSPECTS 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, inclu |
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November 9, 2023 |
Exhibit 99.1 ENLIVEX THERAPEUTICS LTD. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF SEPTEMBER 30, 2023 AND DECEMBER 31, 2022 AND FOR THE THREE AND NINE MONTH PERIODS ENDED SEPTEMBER 30, 2023 AND 2022 ENLIVEX THERAPEUTICS LTD. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF SEPTEMBER 30, 2023 AND DECEMBER 31, 2022 AND FOR THE THREE AND NINE MONTH PERIODS ENDED SEPTEMBER 30, 2023 AND 2022 IND |
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November 9, 2023 |
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: November 2023 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal ex |
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November 7, 2023 |
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: November 2023 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal ex |
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November 2, 2023 |
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: November 2023 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal ex |
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October 26, 2023 |
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: October 2023 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal exe |
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September 18, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 under the Securities Exchange Act of 1934 For the month of: September 2023 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Ness Ziona, Israel 7403618 (Address of principal |
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September 13, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 under the Securities Exchange Act of 1934 For the month of: September 2023 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal e |
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September 13, 2023 |
Exhibit 99.1 ENLIVEX THERAPEUTICS LTD. NOTICE OF ANNUAL GENERAL MEETING OF SHAREHOLDERS To be held on October 26, 2023 Dear Shareholder: We cordially invite you to attend the Annual General Meeting of Shareholders (the “Meeting”) of Enlivex Therapeutics Ltd. (the “Company”), to be held on Thursday, October 26, 2023, at 7:00 p.m. (Israel time), at the offices of the Company at 14 Einstein Street, N |
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September 13, 2023 |
Exhibit 99.2 THIS PROXY WHEN PROPERLY EXECUTED WILL BE VOTED AS DIRECTED HEREIN. EXCEPT AS MENTIONED OTHERWISE IN THE PROXY STATEMENT AND BELOW ON THIS PROXY, IF NO DIRECTION IS INDICATED, THIS PROXY WILL BE VOTED “FOR” THE PROPOSALS HEREIN. Please mark your vote as in this example ☒ PROPOSAL NO. 1: To elect the following persons to the Board of Directors, each to serve until the next annual gener |
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September 11, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 under the Securities Exchange Act of 1934 For the month of: September 2023 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal e |
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September 11, 2023 |
Enlivex Announces Reprioritization Plan and Second Quarter 2023 Financial Results Exhibit 99.1 Enlivex Announces Reprioritization Plan and Second Quarter 2023 Financial Results ● The Company intends to increase its existing focus on inflammatory and autoimmune indications. The Company, since its inception, considered the inherent properties of AllocetraTM as an innovative, highly-differentiated modality for immune resolution across a wide variety of inflammatory and auto-immune |
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September 1, 2023 |
OPERATING AND FINANCIAL REVIEW AND PROSPECTS 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, inclu |
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September 1, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 under the Securities Exchange Act of 1934 For the month of: September 2023 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal e |
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September 1, 2023 |
Exhibit 99.1 ENLIVEX THERAPEUTICS LTD. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2023 AND DECEMBER 31, 2022 AND FOR THE THREE AND SIX MONTH PERIODS ENDED JUNE 30, 2023 AND 2022 ENLIVEX THERAPEUTICS LTD. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2023 AND DECEMBER 31, 2022 AND FOR THE THREE AND SIX MONTH PERIODS ENDED JUNE 30, 2023 AND 2022 INDEX TO CONDENSED CONSOL |
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August 2, 2023 |
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 2023 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal exec |
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August 2, 2023 |
Exhibit 99.1 Enlivex Announces Peer-Reviewed Publication in Frontiers in Immunology of Clinical Data Details Resolution of Acute Respiratory Distress Syndrome (ARDS) from two Phase I/II Trials Evaluating Allocetra in Patients with COVID-19 Data published in Frontiers in Immunology show a robust safety profile and rapid resolution from ARDS and parallel resolution of inflammation markers and elevat |
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July 31, 2023 |
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: July 2023 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal execut |
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July 31, 2023 |
Exhibit 99.1 Enlivex Announces Dosing of First Patient Under The Amended Protocol Of Its Phase II trial Evaluating Allocetra™ In Patients With Sepsis Nes-Ziona, Israel, Jul 31, 2023 (GLOBE NEWSWIRE) – Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the first patient has been dosed under the amended proto |
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June 26, 2023 |
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: June 2023 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal execut |
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June 26, 2023 |
Enlivex Announces First Quarter 2023 Financial Results and Provides a Business Update Exhibit 99.1 Enlivex Announces First Quarter 2023 Financial Results and Provides a Business Update ● Enrollment of patients in the Phase I/II evaluating Allocetra™ in combination with chemotherapy in patients with peritoneal metastases from advanced solid tumors is proceeding as planned, with 50% (lower dose cohorts) already enrolled. ● The integration of tislelizumab, an anti-PD-1 immune checkpoi |
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June 16, 2023 |
Exhibit 99.1 ENLIVEX THERAPEUTICS LTD. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF MARCH 31, 2023 AND DECEMBER 31, 2022 AND FOR THE THREE MONTH PERIODS ENDED MARCH 31, 2023 AND 2022 ENLIVEX THERAPEUTICS LTD. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF MARCH 31, 2023 AND DECEMBER 31, 2022 AND FOR THE THREE MONTH PERIODS ENDED MARCH 31, 2023 AND 2022 INDEX TO CONSOLIDATED FINANCIAL STATE |
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June 16, 2023 |
OPERATING AND FINANCIAL REVIEW AND PROSPECTS 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, inclu |
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June 16, 2023 |
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: June 2023 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal execut |
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May 31, 2023 |
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: May 2023 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal executi |
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May 31, 2023 |
Exhibit 99.1 Enlivex Selected for an Elevator Pitch Presentation and two additional Poster Presentations at the 2023 Annual Meeting of the International Society for Cell & Gene Therapy Nes-Ziona, Israel, May 31, 2023 (GLOBE NEWSWIRE) - Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages, today annou |
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May 8, 2023 |
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: May 2023 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal executi |
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May 8, 2023 |
Exhibit 99.1 Enlivex Announces Issuance of European Patent Covering the Use of Allocetra™ to Prevent Cytokine Release Syndrome (CRS) Resulting from CAR T-Cell Therapy Nes-Ziona, Israel, May 08, 2023 (GLOBE NEWSWIRE) – Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced the issuance of a European patent, numbered |
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April 19, 2023 |
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: April 2023 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal execu |
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April 19, 2023 |
Exhibit 99.1 Enlivex Receives Notice of Allowance for U.S. Patent Application Covering the Use of Allocetra™ in Patients Receiving CAR T-Cell Therapy Nes-Ziona, Israel, April 19, 2023 (GLOBE NEWSWIRE) - Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages, today announced that the U.S. Patent and Tra |
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April 17, 2023 |
6-K 1 ea176973-6kenlivex.htm CURRENT REPORT 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: April 2023 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona |
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April 17, 2023 |
Enlivex Appoints Andrew Singer to its Board of Directors Exhibit 99.1 Enlivex Appoints Andrew Singer to its Board of Directors ● Mr. Singer brings over 25 years of experience in biotechnology, corporate finance, mergers and acquisitions, and business strategy ● Former EVP and CFO of Epizyme and Senior Biotech Investment Banker at Credit Suisse, Wells Fargo Securities and RBC Capital Markets ● Led financing, partnering and M&A biopharmaceutical transacti |
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April 10, 2023 |
Exhibit 12.2 CERTIFICATION PURSUANT TO EXCHANGE ACT RULE 13a-14(a) or 15d-14(a) I, Shachar Shlosberger, certify that: 1. I have reviewed this Annual Report on Form 20–F of Enlivex Therapeutics Ltd.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances unde |
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April 10, 2023 |
Certification of the Chief Financial Officer pursuant to 18 U.S.C. 1350, furnished herewith. Exhibit 13.2 CERTIFICATION PURSUANT TO 18 U.S.C. Section 1350 In connection with the filing of the Annual Report on Form 20–F for the period ended December 31, 2022 (the “Report”) by Enlivex Therapeutics Ltd. (the “Company”), the undersigned, as the Chief Financial Officer of the Company, hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley |
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April 10, 2023 |
Certification of the Chief Executive Officer pursuant to 18 U.S.C. 1350, furnished herewith. Exhibit 13.1 CERTIFICATION PURSUANT TO 18 U.S.C. Section 1350 In connection with the filing of the Annual Report on Form 20–F for the period ended December 31, 2022 (the “Report”) by Enlivex Therapeutics Ltd. (the “Company”), the undersigned, as the Chief Executive Officer of the Company, hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley |
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April 10, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXC |
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April 10, 2023 |
Exhibit 12.1 CERTIFICATION PURSUANT TO EXCHANGE ACT RULE 13a-14(a) or 15d-14(a) I, Dr. Oren Hershkovitz, certify that: 1. I have reviewed this Annual Report on Form 20-F of Enlivex Therapeutics Ltd.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances und |
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April 10, 2023 |
Exhibit 15.1 CONSENT OF INDEPENDENT ACCOUNTANTS We hereby consent to the incorporation by reference in the Registration Statement 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) of Enlivex Therapeutics Ltd. of our report dated March 31, 2023 with respect to the consolidated financial statements and the effect |
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April 4, 2023 |
Exhibit 99.1 Enlivex Announces Tislelizumab Clinical Collaboration, Full Year 2022 Financial Results, and Provides Business Updates ● Clinical collaboration with BeiGene announced on April 3, 2023 to evaluate the safety and efficacy of Allocetra™, an investigational macrophage-reprogramming cell therapy, in combination with tislelizumab, an anti-PD-1 immune checkpoint inhibitor, for the treatment |
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April 4, 2023 |
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: April 2023 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal execu |
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April 3, 2023 |
Exhibit 99.1 Enlivex Announces Clinical Collaboration to Evaluate Combinations of Allocetra and PD-1 Inhibitor Tislelizumab for Patients with Solid Tumors Nes-Ziona, Israel, April 3, 2023 (GLOBE NEWSWIRE) – Enlivex Therapeutics Ltd. (Nasdaq: ENLV, “Enlivex”), a clinical-stage macrophage reprogramming immunotherapy company, today announced a clinical collaboration with BeiGene. to evaluate the safe |
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April 3, 2023 |
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: April 2023 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal execu |
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March 31, 2023 |
Exhibit 99.1 ENLIVEX THERAPEUTICS LTD. FINANCIAL STATEMENTS AS OF DECEMBER 31, 2022 ENLIVEX THERAPEUTICS LTD. FINANCIAL STATEMENTS AS OF DECEMBER 31, 2022 INDEX Page Report of Independent Registered Public Accounting Firm F-2 Consolidated Balance Sheets F-3 Consolidated Statements of Operations and Comprehensive Loss F-4 Consolidated Statements of Changes in Shareholders’ Equity F-5 Consolidated S |
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March 31, 2023 |
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: March 2023 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal execu |
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March 31, 2023 |
CONSENT OF INDEPENDENT ACCOUNTANTS Exhibit 99.2 CONSENT OF INDEPENDENT ACCOUNTANTS We hereby consent to the incorporation by reference in the Registration Statement 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) of Enlivex Therapeutics Ltd. of our report dated March 31, 2023 with respect to the consolidated financial statements and the effect |
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March 20, 2023 |
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: March 2023 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal execu |
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March 20, 2023 |
Exhibit 99.1 Enlivex Receives Positive DSMB Recommendation and IMOH Clearance to Continue Phase I/II Trial of Allocetra combined with chemotherapy in patients with peritoneal metastases arising from solid cancers Nes-Ziona, Israel, March 20, 2023 (GLOBE NEWSWIRE) - Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announ |
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February 23, 2023 |
Exhibit 99.1 Enlivex Receives Clearance From Spanish Agency of Medicines and Medical Devices For Treatment of Patients with Advanced Solid Malignancies in the Ongoing Allocetra Phase I/II Clinical Trial Nes-Ziona, Israel, Feb. 23, 2023 (GLOBE NEWSWIRE) - Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that th |
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February 23, 2023 |
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: February 2023 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal ex |
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February 15, 2023 |
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: February 2023 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal ex |
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February 15, 2023 |
Exhibit 99.1 Enlivex Announces Issuance of Israeli Patent Covering the Use of Allocetra™ to Prevent Cytokine Release Syndrome (CRS) Resulting from CAR T-Cell Therapy, Infectious Diseases or Any Non-Infectious Source of CRS Nes-Ziona, Israel, Feb 15, 2023 (GLOBE NEWSWIRE) – Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, toda |
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January 25, 2023 |
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: January 2023 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal exe |
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January 25, 2023 |
Exhibit 99.1 Enlivex Announces Positive DSMB Recommendation and IMOH Clearance to Continue Phase I/II Trial of Allocetra in Patients with Advanced Solid Tumors Nes-Ziona, Israel, January 25, 2023 (GLOBE NEWSWIRE) – Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that an independent Data and Safety Monitoring |
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January 4, 2023 |
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: January 2023 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Einstein Street, Nes Ziona, Israel 7403618 (Address of principal exe |
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January 4, 2023 |
Exhibit 99.1 Enlivex Receives Authorizations from French and Belgian Regulatory Agencies To Expand Its Phase II Sepsis Clinical Trial Into France and Belgium Nes-Ziona, Israel, January 4, 2023 (GLOBE NEWSWIRE) – Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the French Agency for Food, Environmental and |
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December 30, 2022 |
ENLIVEX THERAPEUTICS LTD. Up to $100,000,000 of Ordinary Shares Filed Pursuant to Rule 424(b)(5) Registration No. 333-264561 Prospectus Supplement to Prospectus dated June 5, 2022 ENLIVEX THERAPEUTICS LTD. Up to $100,000,000 of Ordinary Shares This prospectus supplement amends a prospectus we previously filed as a part of our “shelf” registration statement on Form F-3 (file No. 333-264561), under which we registered for offer and sale up to $300.0 million of c |
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December 30, 2022 |
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: December 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 ex |
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December 30, 2022 |
EX-10.1 3 ea171003ex10-1enlivexthera.htm SALES AGREEMENT, DATED DECEMBER 30, 2022, BY AND AMONG ENLIVEX THERAPEUTICS LTD. AND CANTOR FITZGERALD & CO. AND JMP SECURITIES LLC Exhibit 10.1 Enlivex Therapeutics Ltd. Ordinary Shares (par value NIS0.40 per share) Controlled Equity OfferingSM Sales Agreement December 30, 2022 Cantor Fitzgerald & Co. 499 Park Avenue New York, NY 10022 JMP Securities LLC 6 |
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December 5, 2022 |
Enlivex Announces Third Quarter 2022 Financial Results and Provides a Business Update Exhibit 99.1 Enlivex Announces Third Quarter 2022 Financial Results and Provides a Business Update ? Received frozen-formulation Allocetra? IND clearance from The U.S. Food And Drug Administration (FDA) for treatment of patients with advanced solid tumors ? The protocol of the IND includes intravenous administration of frozen-formulation Allocetra?, stand-alone, and in combination with a PD1 check |
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December 5, 2022 |
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: December 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 ex |
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December 2, 2022 |
OPERATING AND FINANCIAL REVIEW AND PROSPECTS 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, inclu |
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December 2, 2022 |
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: December 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 ex |
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December 2, 2022 |
Exhibit 99.1 ENLIVEX THERAPEUTICS LTD. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF SEPTEMBER 30, 2022 AND DECEMBER 31, 2021 AND FOR THE THREE AND NINE MONTH PERIODS ENDED SEPTEMBER 30, 2022 AND 2021 ENLIVEX THERAPEUTICS LTD. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF SEPTEMBER 30, 2022 AND DECEMBER 31, 2021 AND FOR THE THREE AND NINE MONTH PERIODS ENDED SEPTEMBER 30, 2022 AND 2021 IND |
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November 28, 2022 |
Exhibit 99.1 Enlivex Receives Allocetra IND Clearance From The U.S. Food And Drug Administration For Treatment Of Patients with Advanced Solid Malignancies ● IND filing followed encouraging preclinical studies conducted in collaboration with Yale Cancer Center that showed a substantial, statistically significant survival benefit when Allocetra™ was combined with a PD1 checkpoint inhibitor in a mur |
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November 28, 2022 |
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: November 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 ex |
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November 15, 2022 |
Exhibit 99.1 Enlivex Announces Dosing of the First Patient in Phase I/II Trial Evaluating Allocetra Alone and in Combination with a PD1 Checkpoint Inhibitor in Patients with Advanced Solid Tumors ● Multi-center trial of AllocetraTM in advanced solid tumor patients ● AllocetraTM is administered to the patients either intravenously or locally, depending upon tumor locations, as both monotherapy and |
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November 15, 2022 |
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: November 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 ex |
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October 5, 2022 |
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: October 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 exe |
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October 5, 2022 |
Notice of Internet Availability of Proxy Materials Exhibit 99.3 |
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October 5, 2022 |
Form of Enlivex Therapeutics Ltd. Proxy Card. Exhibit 99.2 |
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October 5, 2022 |
Exhibit 99.1 ENLIVEX THERAPEUTICS LTD. NOTICE OF ANNUAL GENERAL MEETING OF SHAREHOLDERS To be held on November 17, 2022 Dear Shareholder: We cordially invite you to attend the Annual General Meeting of Shareholders (the ?Meeting?) of Enlivex Therapeutics Ltd. (the ?Company?), to be held on Thursday, November 17, 2022, at 7:00 p.m. (Israel time), at the offices of the Company at 14 Einstein Street, |
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September 12, 2022 |
Exhibit 99.1 Enlivex Announces New Preclinical Data in Murine Mesothelioma Model Showing a Substantial Survival Benefit with Allocetra as Monotherapy and in Combination with Cisplatin at the ESMO Congress 2022 ? Currently used cisplatin-based combination treatments have limited efficacy against mesothelioma, which is one of the deadliest solid cancers ? Combining cisplatin with Allocetra? led to a |
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September 12, 2022 |
6-K 1 ea165439-6kenlivex.htm REPORT OF FOREIGN PRIVATE ISSUER UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 under the Securities Exchange Act of 1934 For the month of: September 2022 Commission file number: 001-36578 ENLIVEX THERAPEUTICS LTD. (Translation of registrant’s name into English) 14 Eins |
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September 6, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 under the Securities Exchange Act of 1934 For the month of: September 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 e |
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September 6, 2022 |
Exhibit 99.1 Enlivex Receives Notice of Allowance for U.S. Patent Application Covering the Use of Allocetra? to Prevent Cytokine Release Syndrome in Patients Receiving CAR T Cell Therapy Nes-Ziona, Israel, Sept. 06, 2022 (GLOBE NEWSWIRE) ? Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the ?Company?), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages in patie |
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August 29, 2022 |
Exhibit 99.1 Enlivex Receives Notice of Allowance for Japanese Patent Application Covering Allocetra Derived from Pooled Donor Cells Nes-Ziona, Israel, Aug. 29, 2022 (GLOBE NEWSWIRE) - Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the ?Company?), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages in patients with sepsis and solid tumors, today announced that |
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August 29, 2022 |
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 exec |
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August 24, 2022 |
Exhibit 99.1 Enlivex Announces Regulatory Clearance in Multiple Countries for Integration of Frozen Allocetra Formulation and Expansion of Patient Population in its Sepsis Phase II Clinical Trial ? Sepsis Phase II protocol amendments have been cleared by regulatory authorities in Israel, Spain, and Greece. In addition to these clearances, Enlivex plans to obtain clearances for these protocol amend |
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August 24, 2022 |
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 exec |
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August 22, 2022 |
OPERATING AND FINANCIAL REVIEW AND PROSPECTS 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, inclu |
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August 22, 2022 |
Enlivex Announces Second Quarter 2022 Financial Results and Provides a Business Update 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 checkpo |
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August 22, 2022 |
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 exec |
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August 22, 2022 |
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 FIN |
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August 17, 2022 |
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 exec |
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August 17, 2022 |
Exhibit 99.1 Enlivex Receives Israeli Ministry of Health Approval for the Initiation of a Phase I/II Trial Evaluating Allocetra? Alone and in Combination with a PD1 Checkpoint Inhibitor in Patients with Advanced Solid Tumors ? Trial builds on encouraging preclinical studies conducted in collaboration with Yale Cancer Center that showed a substantial, statistically significant survival benefit when |
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August 3, 2022 |
Exhibit 99.1 Enlivex Receives Notice of Allowance for U.S. Patent Application Covering Methods of Treating Sepsis with Allocetra™ Nes-Ziona, Israel, Aug 3, 2022 (GLOBE NEWSWIRE) – Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages in patients with sepsis and solid tumors, today announced that the U |
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August 3, 2022 |
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 exec |
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July 6, 2022 |
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: July 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 execut |
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July 6, 2022 |
Exhibit 99.1 Sheba Medical Center and Enlivex Announce Dosing of the First Patient in Phase I/II Trial Evaluating Allocetra Combined with Chemotherapy in Patients with Peritoneal Metastases Arising from Solid Cancers l First clinical trial of Allocetra? in patients with cancer builds upon promising preclinical studies demonstrating its broadly applicable immunotherapeutic effects in solid tumor mo |
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June 6, 2022 |
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: June 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 execut |
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June 6, 2022 |
Exhibit 99.1 Enlivex Receives Israeli Ministry of Health Authorization for the Initiation of a Phase I/II Trial Evaluating Allocetra Combined with Chemotherapy in Patients with Peritoneal Metastases Arising from Solid Cancers ? Trial will be the first clinical study of Allocetra? in patients with cancer, following encouraging preclinical data presented at the International Society for Gene and Cel |
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May 31, 2022 |
Exhibit 99.1 Enlivex Announces New Preclinical Data in Ovarian Cancer Showing a Substantial Survival Benefit when Allocetra is Combined with PD-1 Checkpoint Inhibition at the American Society of Clinical Oncology (ASCO) Annual Meeting ? Stand-alone therapy with PD1 checkpoint inhibitors has shown limited efficacy against ovarian cancer, with response rates in prior clincical trials ranging from 7- |
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May 31, 2022 |
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: May 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 executi |
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May 27, 2022 |
Exhibit 99.1 ENLIVEX THERAPEUTICS LTD. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF MARCH 31, 2022 AND DECEMBER 31, 2021 AND FOR THE THREE MONTH PERIODS ENDED MARCH 31, 2022 AND 2021 ENLIVEX THERAPEUTICS LTD. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF MARCH 31, 2022 AND DECEMBER 31, 2021 AND FOR THE THREE MONTH PERIODS ENDED MARCH 31, 2022 AND 2021 INDEX TO CONSOLIDATED FINANCIAL STATE |
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May 27, 2022 |
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: May 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 executi |
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May 27, 2022 |
OPERATING AND FINANCIAL REVIEW AND PROSPECTS 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, inclu |
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May 25, 2022 |
Exhibit 99.1 Enlivex Awarded Its Third Non-Dilutive Israel Innovation Authority Grant to Support the Clinical Development of Allocetra in Sepsis Patients ? Grant provides $1.2 million in non-dilutive funding for 2022 sepsis clinical trial expenses ? To date, Enlivex has received a total of $7.8 million in non-dilutive grants from the Israel Innovation Authority, excluding this new grant Nes Ziona, |
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May 25, 2022 |
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: May 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 executi |
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May 23, 2022 |
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: May 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 executi |
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May 23, 2022 |
Enlivex Appoints Dr. Roger J. Pomerantz to its Board of Directors as Vice Chairman Exhibit 99.1 Enlivex Appoints Dr. Roger J. Pomerantz to its Board of Directors as Vice Chairman ? Former Worldwide Head of Licensing and Acquisition and Knowledge Management at Merck & Co., where he led the completion of more than150 business development transactions ? Former Global Head of Infectious Diseases for Johnson & Johnson Pharmaceuticals ? Former Venture Partner at Flagship Pioneering, a |
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May 9, 2022 |
Exhibit 99.1 Enlivex Presented Substantial Survival Benefit of Allocetra in Combination with Immune Checkpoint Inhibitor in Mesothelioma Cancer Study at the International Society for Cell and Gene Therapy Annual 2022 Meeting ? Mesothelioma is one of the deadliest solid cancers, with few treatment options, all of which have limited efficacy. Immune checkpoint inhibitors targeting CTLA4 and PD1 are |
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May 9, 2022 |
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: May 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 executi |
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May 5, 2022 |
Enlivex Announces Issuance of Two U.S. Patents Covering Methods of Treating Sepsis with Allocetra Exhibit 99.1 Enlivex Announces Issuance of Two U.S. Patents Covering Methods of Treating Sepsis with Allocetra Nes-Ziona, Israel, May 5, 2022 (GLOBE NEWSWIRE) ? Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the ?Company?), a clinical-stage macrophage reprogramming immunotherapy company, today announced the issuance of U.S. Patent Nos. 11,304,976 and 11,318,163. Each patent provides Enlivex with added i |
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May 5, 2022 |
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: May 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 executi |
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May 3, 2022 |
Enlivex Therapeutics Ltd.. 14 Einstein Street Nes Ziona Israel 7403618 Enlivex Therapeutics Ltd.. 14 Einstein Street Nes Ziona Israel 7403618 May 3, 2022 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, D.C. 20549 Attention: Michael Davis RE: Enlivex Therapeutics Ltd. (the ?Company?) Registration Statement on Form F-3 (the ?Registration Statement?) Filed April 29, 2022 File No. 333-264561 Dear Mr. |
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April 29, 2022 |
As filed with the Securities and Exchange Commission on April 29, 2022 Registration No. |
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April 29, 2022 |
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: April 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 execu |
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April 29, 2022 |
Exhibit 12.1 CERTIFICATION PURSUANT TO EXCHANGE ACT RULE 13a-14(a) or 15d-14(a) I, Shachar Shlosberger, certify that: 1. I have reviewed this Annual Report on Form 20?F of Enlivex Therapeutics Ltd.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances unde |
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April 29, 2022 |
Exhibit 107 Calculation of Filing Fee Tables Form F-3 (Form Type) Enlivex Therapeutics, Ltd. |
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April 29, 2022 |
Exhibit 12.1 CERTIFICATION PURSUANT TO EXCHANGE ACT RULE 13a-14(a) or 15d-14(a) I, Dr. Oren Hershkovitz, certify that: 1. I have reviewed this Annual Report on Form 20-F of Enlivex Therapeutics Ltd.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances und |
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April 29, 2022 |
Certification of the Chief Financial Officer pursuant to 18 U.S.C. 1350, furnished herewith. Exhibit 13.2 CERTIFICATION PURSUANT TO 18 U.S.C. Section 1350 In connection with the filing of the Annual Report on Form 20?F for the period ended December 31, 2021 (the ?Report?) by Enlivex Therapeutics Ltd. (the ?Company?), the undersigned, as the Chief Financial Officer of the Company, hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley |
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April 29, 2022 |
Exhibit 99.1 Enlivex Announces Full Year 2021 Financial Results, Completion of Development of Frozen Formulation Allocetra? Ahead of Schedule, and Provides Strategic & Business Updates ? Development of frozen formulation Allocetra?, a primary cornerstone of Enlivex?s R&D efforts during the last two years, was successfully completed in Q1 2022, twelve months ahead of schedule ? Frozen formulation A |
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April 29, 2022 |
Exhibit 15.1 CONSENT OF INDEPENDENT ACCOUNTANTS We hereby consent to the incorporation by reference in the Registration Statement on Form S-8 (Registration No. 333-210459 and 333-256799) of Enlivex Therapeutics Ltd. of our report dated April 25, 2022 with respect to the consolidated financial statements and the effectiveness of internal control over financial reporting of Enlivex Therapeutics Ltd. |
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April 29, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ? REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ? ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXC |
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April 29, 2022 |
Certification of the Chief Executive Officer pursuant to 18 U.S.C. 1350, furnished herewith. Exhibit 13.1 CERTIFICATION PURSUANT TO 18 U.S.C. Section 1350 In connection with the filing of the Annual Report on Form 20?F for the period ended December 31, 2021 (the ?Report?) by Enlivex Therapeutics Ltd. (the ?Company?), the undersigned, as the Chief Executive Officer of the Company, hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley |
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April 29, 2022 |
Exhibit 4.25 SECOND AMENDMENT TO CONSULTING AGREEMENT THIS SECOND AMENDMENT (the ?Second Amendment?) is entered into as of November 4, 2021 by and between Enlivex Therapeutics, Ltd., a company organized under the laws of Israel, corporate number 51373620, whose address is at Kiriat Hadassa P.O.B 1267 Jerusalem Israel 91129 (the ?Company?) and A.S. Novik Ltd., a company organized under the laws of |
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March 8, 2022 |
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: March 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 execu |
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March 8, 2022 |
Enlivex Announces Issuance of Israeli Patent Covering Allocetra Derived from Pooled Donor Cells Exhibit 99.1 Enlivex Announces Issuance of Israeli Patent Covering Allocetra Derived from Pooled Donor Cells Nes-Ziona, Israel, March 8, 2022 (GLOBE NEWSWIRE) ? Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the ?Company?), a clinical-stage macrophage reprogramming immunotherapy company, today announced the issuance of Israeli Patent Number 255119 entitled, ?Therapeutic Pooled Blood Apoptotic Cell Prepa |
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February 22, 2022 |
Exhibit 99.1 Enlivex Strengthens Management Team with the Appointment of Biotech Industry Veteran Einat Galamidi, M.D., as Vice President, Medical ? Dr. Galamidi joins Enlivex after 10 years at Gamida Cell Ltd., where she most recently served as Vice President of Clinical Development ? At Gamida Cell, Dr. Galamidi led clinical development for omidubicel, a cell therapy that successfully completed |
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February 22, 2022 |
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: February 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 ex |
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December 13, 2021 |
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: December 2021 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 ex |
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December 13, 2021 |
Exhibit 99.1 Enlivex Receives Regulatory Authorization to Expand its Phase IIb Trial Evaluating Allocetra in Severe and Critical COVID-19 Patients into Greece Nes-Ziona, Israel, December 13, 2021 (GLOBE NEWSWIRE) ? Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the ?Company?), a clinical-stage macrophage reprogramming immunotherapy company, today announced that, following a review of the Company?s precl |
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December 7, 2021 |
Enlivex Receives Regulatory Authorization to Expand its Phase II Sepsis Trial into Greece Exhibit 99.1 Enlivex Receives Regulatory Authorization to Expand its Phase II Sepsis Trial into Greece Nes-Ziona, Israel, December 7, 2021 (GLOBE NEWSWIRE) ? Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the ?Company?), a clinical-stage macrophage reprogramming immunotherapy company, today announced that, following a review of the Company?s preclinical and clinical data, study design, and manufacturing |
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December 7, 2021 |
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: December 2021 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 ex |