ENLV Enlivex Therapeutics Ltd

 

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 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 May 28, 2024, Enlivex Therapeutics Ltd., a company organized under the laws of the State of Israel (“Enlivex”), issued a press release announcing that it has entered into a definitive agreement with a single healthcare-focused institutional investor for the issuance and sale in a registered direct offering of an aggregate of 3,571,429 of its ordinary shares, par value NIS 0.40 per share (the “Ordinary Shares”) (or Ordinary Share equivalents in lieu thereof), Series A warrants to purchase up to 3,571,429 Ordinary Shares and Series B warrants to purchase up to 3,571,429 Ordinary Shares, at a purchase price of $1.40 per Ordinary Share (or Ordinary Share equivalents in lieu thereof) and associated warrants. The offering is expected to close on or about May 29, 2024, subject to the satisfaction of customary closing conditions. A copy of such press release is furnished as Exhibit 99.1 to this Report on Form 6-K and incorporated herein by reference.

 

Neither this Report on Form 6-K, nor the exhibit attached hereto, is an offer to sell or the solicitation of an offer to buy the securities described herein or therein.

  

Exhibit No.
99.1		Press Release issued by Enlivex Therapeutics Ltd. on May 28, 2024.

  

 

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: May 28, 2024

 

 

2

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-stage macrophage reprogramming immunotherapy company, today announced that it has entered into a definitive agreement with a single healthcare-focused institutional investor for the issuance and sale in a registered direct offering of an aggregate of 3,571,429 ordinary shares (or ordinary share equivalents in lieu thereof) and clinical milestone-linked warrants, composed of Series A warrants to purchase up to 3,571,429 ordinary shares and Series B warrants to purchase up to 3,571,429 ordinary shares, at a purchase price of $1.40 per ordinary share (or ordinary share equivalents in lieu thereof) and associated warrants.

 

The warrants will have an exercise price of $1.40 per share and will be exercisable immediately upon issuance. The Series A warrants will expire upon the earlier of 18 months following the issuance date and 60 days following the Company’s public announcement of positive topline results from the ENX-CL-05-001 trial of Allocetra^TM for the treatment of moderate-to-severe knee osteoarthritis. The Series B warrants will expire upon the earlier of five and one-half years following the issuance date and 60 days following the Company’s public announcement of its filing with the FDA for approval for Allocetra’s^TM osteoarthritis related indication.

 

The offering is expected to close on or about May 29, 2024, subject to the satisfaction of customary closing conditions. The gross proceeds to the Company from the offering are expected to be approximately $5.0 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The potential gross proceeds from the warrants, if fully exercised on a cash basis, will be approximately $10.0 million. No assurance can be given that any of the warrants will be exercised. The Company intends to use the net proceeds for working capital and general corporate purposes.

 

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

 

The securities described above are being offered and sold by the Company in a registered direct offering pursuant to a “shelf” registration statement on Form F-3 (File No. 333-264561), including a base prospectus, that was originally filed with the Securities and Exchange Commission (the “SEC”) on April 29, 2022, and declared effective by the SEC on May 5, 2022. The offering of such securities in the registered direct offering is being made only by means of a prospectus supplement that forms a part of such effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus may also be obtained, when available, from H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com.

 

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein or any other securities, nor shall there be any sale of the securities described herein or any other securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

 

 

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 and life-debilitating conditions. For more information, visit https://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, ALLOCETRA^TM programs. All such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivex’s business and prospects, including market and other conditions; the ability of the Company to satisfy all conditions precedent to the closing of the offering; the completion of the offering; the ability of the Company to achieve certain milestone events; the exercise of the warrants upon the achievement of such milestone events or otherwise prior to their expiration; the risks that Enlivex may not succeed in generating any revenues or developing any commercial products; that the products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the ALLOCETRA^TM product line could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Enlivex’s filings with the Securities and Exchange Commission, including in the Company’s most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law.

 

ENLIVEX CONTACT

 

Shachar Shlosberger, CFO

Enlivex Therapeutics, Ltd.

shachar@enlivexpharm.com

 

INVESTOR RELATIONS CONTACT

 

Dave Gentry, CEO

RedChip Companies Inc.

1-407-644-4256

 

ENLV@redchip.com

 

 

 

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