Enlivex Ltd 6-K, filed Nov 12, 2020
Enlivex Ltd. (ENLV)
About this 6-K
Enlivex Ltd filed this 6-K on November 12, 2020.
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 2020
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 ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulations S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulations S-T Rule 101(b)(7): ☐
On November 11, 2020, Enlivex Therapeutics Ltd., a company organized under the laws of the State of Israel, issued a press release announcing that it will present the clinical development schedule for its Sepsis, COVID-19 and Solid Cancer programs during a fireside chat at H.C. Wainwright’s 6th Annual Israel Conference on Thursday, November 12, 2020, at 10:00 a.m. Eastern Time. 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 November 11, 2020. |
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:<br><br> <br>Title: | Oren Hershkovitz<br><br>Chief Executive Officer |
Date: November 12, 2020
Exhibit 99.1
Enlivex to Present Schedule for Sepsis, COVID-19 and Solid Cancer Programs at H.C. Wainwright’s 6^th^ Annual Israel Conference
Nes Ziona, Israel, November 11, 2020 (GLOBE NEWSWIRE)--Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage immunotherapy company, today announced that it will present the clinical development schedule for its Sepsis, COVID-19 and Solid Cancer programs during a fireside chat at H.C. Wainwright’s 6^th^ Annual Israel Conference. See below for more details.
Conference Details:
Event: H.C. Wainwright 6^th^ Annual Israel Conference
Format: Fireside chat (virtual)
Date & Time: Thursday November 12, 10:00 EST.
Webcast Link: https://journey.ct.events/view/016a15e6-144a-4951-9b8a-7bce37f27340
During the fireside chat, company management will provide an update on the clinical and preclinical development of Allocetra^TM^ for the following indications:
Sepsis
| · | Phase IIb trial in sepsis patients remains on track for initiation<br>in Q4 2020. |
|---|---|
| · | This Phase IIb trial expects to enroll up to 160 patients. |
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| · | Interim clinical results are expected in Q3 2021. |
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COVID-19
| · | Phase II trial ongoing, interim clinical results expected by year-end<br>2020. |
|---|---|
| · | Approved vaccines are not expected to eliminate the need for effective<br>COVID-19 treatments. |
| --- | --- |
| o | Assuming approved vaccines will have an average efficacy of 85%, expected cases of severe and critical COVID-19 are likely<br>to be at 15% of the rate of current severe/critical cases. |
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| o | Some of the population may choose to remain unvaccinated. |
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| · | Positive Phase II data, if obtained, could potentially open regulatory<br>pathways to initiate clinical trials in other indications associated with organ dysfunction and failure. |
| --- | --- |
Solid Cancers
| · | Additional preclinical characterization of the mechanism of action<br>of Allocetra^TM^ in solid cancers that have no effective therapies remains ongoing. |
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| · | Enlivex is working to establish preclinical and clinical collaborations<br>with leading cancer medical centers in the U.S. |
| --- | --- |
ABOUT ENLIVEX
Enlivex is a clinical stage immunotherapy company, developing an allogeneic drug pipeline for immune system rebalancing. Immune system rebalancing is critical for the treatment of life-threatening immune and inflammatory conditions which involve hyper-expression of cytokines (Cytokine Release Syndrome) and for which there are no approved treatments (unmet medical needs) such as sepsis and COVID-19, as well as enhancement of immune activity against solid tumors in combination with CAR-T or immune checkpoint therapies.
For more information, visit http://www.enlivex.com.
Safe Harbor Statement: This press release containsforward-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 resultsof 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 ReformAct of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivex’sbusiness and prospects, including the risks that Enlivex may not succeed in generating any revenues or developing any commercialproducts; that the products in development may fail, may not achieve the expected results or effectiveness and/or may not generatedata 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 resultsto differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produceresults that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials maydiffer significantly from the results of more developed, later-stage trials. The development of any products using the ALLOCETRA^TM^ productline could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additionaltime requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitiveproducts 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, technologicaland other factors discussed in Enlivex’s filings with the Securities and Exchange Commission, including in the Company’smost recent Annual Report on Form 20-F filed with the Securities and Exchange Commission. The forward-looking statementscontained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to updateforward-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