# EDGAR Filing Document

**Accession Number:** 0001596812
**File Stem:** 0001213900-23-000679
**Filing Date:** 2023-1
**Character Count:** 10240
**Document Hash:** 88dfdf5bcec3b30eadbb55ec5c730349
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001213900-23-000679.hdr.sgml**: 20230104

**ACCESSION NUMBER**: 0001213900-23-000679

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 3

**CONFORMED PERIOD OF REPORT**: 20230104

**FILED AS OF DATE**: 20230104

**DATE AS OF CHANGE**: 20230104

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Enlivex Therapeutics Ltd.
- **CENTRAL INDEX KEY:** 0001596812
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 000000000
- **STATE OF INCORPORATION:** L3
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 6-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-36578
- **FILM NUMBER:** 23504395

**BUSINESS ADDRESS:**
- **STREET 1:** 37 DEREH MENACHEM BEGIN ST.
- **STREET 2:** 15TH FLOOR
- **CITY:** TEL AVIV
- **STATE:** L3
- **ZIP:** 6522042
- **BUSINESS PHONE:** 972 (0) 3 7326616

**MAIL ADDRESS:**
- **STREET 1:** 37 DEREH MENACHEM BEGIN ST.
- **STREET 2:** 15TH FLOOR
- **CITY:** TEL AVIV
- **STATE:** L3
- **ZIP:** 6522042

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Bioblast Pharma Ltd.
- **DATE OF NAME CHANGE:** 20160919

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** BIO BLAST PHARMA LTD.
- **DATE OF NAME CHANGE:** 20140113

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

<u>ENLIVEX THERAPEUTICS LTD.</u>

(Translation of registrant's name into English)

<u>14 Einstein Street, Nes Ziona, Israel 7403618</u>

(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F ☒ Form 40-F ☐

On January 4, 2023, Enlivex Therapeutics Ltd., a company organized under the laws of the State of Israel (the "<u>Company</u>"), issued a press release announcing that the French Agency for Food, Environmental and Occupational Health and Safety and the Belgian Federal Agency for Medicines and Health Products have cleared the amended protocol of the Company's Phase II trial evaluating Allocetra™ in patients with sepsis, which enables the treatment of newly recruited patients with a frozen Allocetra™ formulation, as well as an expansion of the study's target population, which was originally limited to patients with pneumonia-associated sepsis, to include patients whose septic condition stems from biliary, urinary tract or abdominal infections. A copy of such press release is furnished as Exhibit 99.1 to this Report on Form 6-K and incorporated herein by reference.

---

| | |
|:---|:---|
| **Exhibit No.** |  |
| 99.1 | [Press Release issued by Enlivex Therapeutics Ltd. on January 4, 2023.](ea171170ex99-1_enlivexthera.htm) |

---

**<u>SIGNATURES</u>**

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

---

| | |
|:---|:---|
| Enlivex Therapeutics Ltd. | Enlivex Therapeutics Ltd. |
| (Registrant) | (Registrant) |
| By: | /s/ Oren Hershkovitz |
| Name: <br> Title: | Oren Hershkovitz<br> Chief Executive Officer |

---

Date: January 4, 2023

## Exhibit 99.1

**Exhibit 99.1**

![](image_001.jpg)

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 Occupational Health and Safety (ANSES) and the Belgian Federal Agency for Medicines and Health Products (FAMHP) have cleared the amended protocol of the Company's Phase II trial evaluating Allocetra™ in patients with sepsis. The approved protocol, which previously received clearances in Israel, Greece and Spain, enables the treatment of newly recruited patients with a frozen Allocetra™ formulation, as well as an expansion of the study's target population, which was originally limited to patients with pneumonia-associated sepsis, to include patients whose septic condition stems from biliary, urinary tract or abdominal infections.

The Phase II trial is expected to include 80 to 160 patients across four cohorts, receiving varying doses of either Allocetra<sup>TM</sup> or a placebo, all in addition to standard-of-care therapy. The trial's two primary endpoints are safety (number and severity of adverse events and severe adverse events) and efficacy (change from baseline in sequential organ failure (SOFA) score) assessments throughout a 28-day follow-up period. The trial is supported by previously reported positive results from a Phase Ib investigator-initiated trial that showed vastly improved clinical outcomes, including SOFA scores, duration of hospitalization, and mortality, in Allocetra<sup>TM</sup>-treated sepsis patients, as compared to a group of matched historical controls who received standard-of-care therapy.

Oren Hershkovitz, Ph.D., CEO of Enlivex, commented, "Expanding the study to France and Belgium with frozen formulation Allocetra<sup>TM</sup> is an important step in the execution of our ongoing Phase II sepsis trial. We also believe that this is a notable regulatory achievement that provides additional validation for our amended study design and Allocetra<sup>TM</sup> frozen formulation."

**ABOUT THE PHASE II SEPSIS TRIAL**

Enlivex's Phase II sepsis trial is a placebo-controlled, randomized, dose-finding, multi-center study that is currently enrolling patients across four cohorts. Patients enrolled in the study receive varying doses of Allocetra™ or placebo, all in addition to standard-of-care therapy. The trial's two primary endpoints are safety (number and severity of adverse events and severe adverse events) and efficacy (change from baseline in SOFA score), which will be assessed throughout a 28-day follow-up period. Additionally, the trial's secondary endpoint is 28-day all-cause mortality among other important secondary endpoints.

**ABOUT ALLOCETRA™**

Allocetra™ is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra™ has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as "unmet medical needs", as a stand-alone therapy or in combination with leading therapeutic agents.

**ABOUT ENLIVEX**

Enlivex is a clinical stage macrophage reprogramming immunotherapy company developing Allocetra™, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of life-threatening conditions. For more information, visit http://www.enlivex.com.

*Safe Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "would", "could," "intends," "estimates," "suggests," "has the potential to" and other words of similar meaning, including statements regarding expected cash balances, market opportunities for the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, ALLOCETRATM programs. All such forward- looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivex's business and prospects, including the risks that Enlivex may not succeed in generating any revenues or developing any commercial products; that the products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the ALLOCETRATM product line could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Enlivex's filings with the Securities and Exchange Commission, including in the Company's most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law.*

 

**ENLIVEX CONTACT**

Shachar Shlosberger,

CFO Enlivex Therapeutics, Ltd.

shachar@enlivexpharm.com

**INVESTOR RELATIONS CONTACT**

Eric Ribner

LifeSci Advisors

eric@lifesciadvisors.com