Allocetra Phase IIa knee osteoarthritis topline data from Enlivex (ENLV)

Rhea-AI Filing Summary

Enlivex Therapeutics Ltd. filed a Form 6-K to furnish a press release announcing three-month topline data from the Phase IIa stage of ENX-CL-05-001, a multi-center, two-stage Phase I/II double-blind, randomized, placebo-controlled trial of Allocetra™ in patients with moderate-to-severe knee osteoarthritis. The press release, dated August 18, 2025, is attached as Exhibit 99.1. The information in the two bullets immediately under the heading “ENX-CL-05-001 Trial: 3-months topline data” in that press release is also incorporated by reference into Enlivex’s existing registration statements on Forms S-8, F-3 and F-3MEF.

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Biotech and regulatory filings analyst

Enlivex links new Phase IIa Allocetra knee OA topline data into its existing SEC registration statements.

Enlivex Therapeutics is reporting three-month topline data from the Phase IIa stage of ENX-CL-05-001, a multi-center Phase I/II trial of Allocetra in moderate-to-severe knee osteoarthritis, via a press release furnished on Form 6-K. The study is described as double-blind, randomized and placebo-controlled, which is a standard design for generating comparative safety and efficacy data.

The company explicitly incorporates the two bullet points under “ENX-CL-05-001 Trial: 3-months topline data” from the press release into several registration statements on Forms S-8, F-3 and F-3MEF. That step makes these clinical datapoints part of the formal disclosure set supporting potential securities offerings under those shelves and plans, aligning future capital markets activity with the latest trial information.

While the excerpt does not detail efficacy or safety outcomes, it establishes that early Phase IIa data now form part of Enlivex’s public record. Subsequent reviews of the full press release and later company filings will be needed to understand how these results influence the development path for Allocetra in knee osteoarthritis.

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 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 August 18, 2025, Enlivex Therapeutics Ltd., a company organized under the laws of the State of Israel (“Enlivex”), issued a press release announcing three-month topline data from the Phase IIa stage of ENX-CL-05-001, a multi-center, two-stage Phase I/II double-blind, randomized, placebo-controlled clinical trial evaluating Allocetra™ in patients with moderate-to-severe knee osteoarthritis A copy of such press release is furnished as Exhibit 99.1 to this Report on Form 6-K and incorporated herein by reference. The information in the two bullets immediately under the heading “ENX-CL-05-001 Trial:  3-months topline data” in such press release is incorporated by reference into Enlivex’s registration statements on Forms S-8, F-3 and F-3MEF (File No. 333-256799, File No. 333-232413, File No. 333-232009, File No. 333-252926 and File No. 333-286956), filed with the Securities and Exchange Commission.

Exhibit No.
99.1	Press Release issued by Enlivex Therapeutics Ltd. on August 18, 2025.

1

SIGNATURES

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

	Enlivex Therapeutics Ltd.
	(Registrant)
	By:	/s/ Oren Hershkovitz
	Name:	Oren Hershkovitz
	Title:	Chief Executive Officer

Date: August 18, 2025

2

FAQ

What did Enlivex Therapeutics (ENLV) report in this Form 6-K?

Enlivex Therapeutics Ltd. furnished a press release announcing three-month topline data from the Phase IIa stage of ENX-CL-05-001, a multi-center Phase I/II trial evaluating Allocetra™ in patients with moderate-to-severe knee osteoarthritis.

What is the ENX-CL-05-001 trial mentioned by Enlivex Therapeutics (ENLV)?

ENX-CL-05-001 is described as a multi-center, two-stage Phase I/II double-blind, randomized, placebo-controlled clinical trial evaluating Allocetra™ in patients with moderate-to-severe knee osteoarthritis.

Which Enlivex SEC registration statements now include the new Allocetra trial data?

The information in the two bullets under the heading “ENX-CL-05-001 Trial: 3-months topline data” in the press release is incorporated by reference into Enlivex’s registration statements on Forms S-8, F-3 and F-3MEF, including File Nos. 333-256799, 333-232413, 333-232009, 333-252926 and 333-286956.

How is the Allocetra knee osteoarthritis topline data being communicated to investors?

The topline data are communicated through a press release dated August 18, 2025, which is furnished as Exhibit 99.1 to the Form 6-K and incorporated by reference into several of Enlivex’s SEC registration statements.

Who signed Enlivex Therapeutics’ Form 6-K related to the Allocetra trial data?

The Form 6-K was signed on behalf of Enlivex Therapeutics Ltd. by Oren Hershkovitz, who is identified as the company’s Chief Executive Officer.