[6-K] Enlivex Therapeutics Ltd. Current Report (Foreign Issuer)

Rhea-AI Filing Summary

Enlivex Therapeutics Ltd. (ENLV) filed a Form 6-K reporting that it has released six-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 its Allocetra™ therapy in patients with moderate-to-severe knee osteoarthritis. The company furnished a detailed press release and an investor presentation as exhibits to this report. Selected topline data from the press release and key slides from the investor presentation are also incorporated by reference into several of Enlivex’s existing registration statements on Forms S-8 and F-3, linking these new clinical results to documents that can support potential future securities offerings.

Insights

Biotech and securities disclosure analyst

Enlivex reports Phase IIa topline Allocetra™ data and links it into key SEC registration statements.

Enlivex has announced six-month topline data from the Phase IIa portion of ENX-CL-05-001, a Phase I/II trial of Allocetra™ in moderate-to-severe knee osteoarthritis. The study is described as multi-center, two-stage, double-blind, randomized, and placebo-controlled, indicating a standard, relatively rigorous clinical design for this stage of development.

The company furnished both a press release and an investor presentation, and explicitly incorporates the four bullets under the press release topline summary and slides 12–25 of the presentation into several S-8 and F-3 registration statements. This means those specific clinical data points are now formally part of the disclosure package that underlies existing and potential future securities offerings, rather than purely marketing material.

The filing itself does not state whether the topline data are favorable or unfavorable; that detail resides in the referenced exhibits. Any investment impact therefore depends on the actual content of those bullets and slides, which are now integrated into Enlivex’s U.S. securities law disclosure framework.

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 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 November 24, 2025, Enlivex Therapeutics Ltd., a company organized under the laws of the State of Israel (“Enlivex”), issued a press release announcing six-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. Also attached as Exhibit 99.2 to this Report on Form 6-K and incorporated herein by reference is a copy of Enlivex’s investor presentation in respect of such six-month topline data. The information (i) in the four bullets immediately under the heading “Summary of the 6-month Topline Data” in such press release and (ii) in slides 12 through 25, inclusive, contained in such investor presentation 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 Issues by Enlivex Therapeutics Ltd. on November 24, 2025
99.2		Investor Presentation

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: November 24, 2025

2

FAQ

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

Enlivex reported that it released six-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, and furnished a press release and investor presentation with further details.

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

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

Which Enlivex (ENLV) documents contain the detailed 6-month topline data?

The detailed six-month topline data are contained in a press release (Exhibit 99.1) and an investor presentation (Exhibit 99.2) that Enlivex furnished with this Form 6-K.

How are the Allocetra™ topline results used in Enlivex’s SEC registrations?

The information in the four bullets under the heading “Summary of the 6-month Topline Data” in the press release and in slides 12 through 25 of the investor presentation is incorporated by reference into Enlivex’s registration statements on Forms S-8, F-3 and F-3MEF.

Which Enlivex (ENLV) registration statements are updated with this trial data?

The incorporated topline data apply to Enlivex’s registration statements on Forms S-8, F-3 and F-3MEF with file numbers 333-256799, 333-232413, 333-232009, 333-252926 and 333-286956.

Does the Form 6-K say whether the knee osteoarthritis data are positive or negative?

The Form 6-K excerpt states that six-month topline data were released and incorporated into other filings but does not characterize the results as positive or negative; that assessment would come from reviewing the attached press release and investor presentation.