Enlivex Therapeutics : Report of Periodic or Interim Report

Submission Data File

	General Information
Form Type*	20-F
Contact Name	EDGAR AGENTS, LLC
Contact Phone	212-265-3347
Filer Accelerated Status*	Non-Accelerated Filer
Filer File Number
Filer CIK*	0001596812 (Enlivex Therapeutics Ltd.)
Filer CCC*	**********
Filer is Shell Company*	N
Filer is Voluntary Filer*	N
Filer is Well Known Seasoned Issuer*	N
Confirming Copy	No
Notify via Website only	No
Return Copy	No
SROS*	NASD
Period*	12-31-2023
Emerging Growth Company	No
Elected not to use extended transition period	No
	(End General Information)

	Document Information
File Count*	32
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Document Type 1*	20-F
Document Description 1	Annual Report
Document Name 2*	ea020457001ex1-1_enlivex.htm
Document Type 2*	EX-1.1
Document Description 2	Amended and Restated Articles of Association of the Company
Document Name 3*	ea020457001ex2-1_enlivex.htm
Document Type 3*	EX-2.1
Document Description 3	Description of Ordinary Shares
Document Name 4*	ea020457001ex4-18_enlivex.htm
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Document Description 4	Agreement, dated as of March 31, 2024, by and between Enlivex
	Therapeutics R&D Ltd. and BioHarvest Ltd
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	(End Document Information)
	Notifications
Notify via Website only	No
E-mail 1	[e-mail]

(End Notifications)

ea0204570-20f_enlivex.htm	Form Type: 20-F	Page 1
Edgar Agents LLC	ENLIVEX THERAPEUTICS LTD.	04/30/2024 12:12 PM

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 20-F

(Mark One)

• REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934
  OR

• • • ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023
      OR
  • TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
  • 
    OR
• SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of event requiring this shell company report _____

For the transition period from ____ to ____

Commission file number 001-36578

Enlivex Therapeutics Ltd.

(Exact name of Registrant as specified in its charter)

State of Israel

(Jurisdiction of incorporation or organization)

14 Einstein Street, Ness Ziona, Israel 7403618

(Address of principal executive offices)

Mr. Oren Hershkovitz

Tel: [phone]

Email: [e-mail]

Facsimile: +972.2.6208070

14 Einstein Street, Ness Ziona, Israel 7403618

(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person) Securities registered or to be registered pursuant to Section 12(b) of the Act:

Title of each class	Trading symbol	Name of each exchange on which registered
Ordinary Shares, par value NIS 0.40 per share	ENLV	Nasdaq Capital Market

Securities registered or to be registered pursuant to Section 12(g) of the Act: None

Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act: None

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Indicate the number of outstanding shares of each of the issuer's classes of capital or common stock as of the close of the period covered by the annual report.

18,598,555 ordinary shares, par value NIS 0.40 per share, as of December 31, 2023

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.

Yes ☐ No ☒

If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.

Yes ☐ No ☒

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).

Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. See the definitions of "large accelerated filer," "accelerated filer," and "emerging growth company" in Rule 12b-2 of the Exchange Act.

Large accelerated filer	☐	Accelerated filer	☐
Non-Accelerated filer	☒	Emerging growth company	☐

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards† provided pursuant to Section 13(a) of the Exchange Act. ☐

• The term "new or revised financial accounting standard" refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.

Indicate by check mark whether the registrant has filed a report on and attestation to its management's assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☒

If securities are being registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statement. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant's executive officers during the relevant recovery period pursuant to §240.1D-1(b).☐

Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:

U.S. GAAP ☒	International Financial Reporting Standards as	Other ☐
issued by the International Accounting Standards Board ☐

If "Other" has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow.

Item 17 ☐ Item 18 ☐

If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act)

Yes ☐ No ☒

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Edgar Agents LLC	ENLIVEX THERAPEUTICS LTD.	04/30/2024 12:12 PM

	TABLE OF CONTENTS
INTRODUCTION	ii
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS	v
RISK FACTOR SUMMARY	vii
PART ONE		1
ITEM 1.	IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS	1
ITEM 2.	OFFER STATISTICS AND EXPECTED TIMETABLE	1
ITEM 3.	KEY INFORMATION	1
ITEM 4.	INFORMATION ON THE COMPANY	34
ITEM 4A.	UNRESOLVED STAFF COMMENTS	60
ITEM 5.	OPERATING AND FINANCIAL REVIEW AND PROSPECTS	60
ITEM 6.	DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES	69
ITEM 7.	MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS	79
ITEM 8.	FINANCIAL INFORMATION	85
ITEM 9.	THE OFFER AND LISTING	86
ITEM 10.	ADDITIONAL INFORMATION	86
ITEM 11.	QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK	97
ITEM 12.	DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES	97
PART TWO		98
		98
ITEM 13.	DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES	98
ITEM 14.	MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS	98
ITEM 15.	CONTROLS AND PROCEDURES	98
ITEM 16.	[RESERVED]	98
ITEM 16A.	AUDIT COMMITTEE FINANCIAL EXPERT	98
ITEM 16B.	CODE OF ETHICS	98
ITEM 16C.	PRINCIPAL ACCOUNTANT FEES AND SERVICES	99
ITEM 16D.	EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES	99
ITEM 16E.	PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS	99
ITEM 16F.	CHANGE IN REGISTRANT'S CERTIFYING ACCOUNTANT	99
ITEM 16G.	CORPORATE GOVERNANCE	100
ITEM 16H.	MINE SAFETY DISCLOSURE	101
ITEM 16I.	DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS	101
ITEM 16J.	INSIDER TRADING POLICIES	101
ITEM 16K.	CYBERSECURITY	101
PART THREE		103
ITEM 17.	FINANCIAL STATEMENTS	103
ITEM 18.	FINANCIAL STATEMENTS	103
ITEM 19.	EXHIBITS	104
SIGNATURES		106

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INTRODUCTION

Business Description of Enlivex

Enlivex Therapeutics Ltd., a company organized under the laws of the State of Israel (including its consolidated subsidiaries, "Enlivex", "we",

"us", "our" or the "Company"), is a clinical-stage macrophage reprogramming immunotherapy company, developing AllocetraTM, 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 debilitating and life-threatening conditions. Non-homeostatic macrophages contribute significantly to the severity of diseases. By restoring macrophage homeostasis, Allocetra™ has the potential to provide a novel immunotherapeutic mechanism of action for debilitating and life-threatening clinical indications that are defined as "unmet medical needs," as a stand-alone therapy or in combination with leading therapeutic agents.

Macrophages are tissue-resident or infiltrating immune cells critical for innate immunity, normal tissue development, and repair of damaged tissue. Macrophages' function is a result of their original designation, their local micro-environment, and the type of metabolites, substances, or pathogens to which they are exposed. Reprogrammed out of their homeostatic state, macrophages contribute to the pathophysiology of multiple inflammatory diseases, including sepsis, osteoarthritis and other inflammatory disorders.

We believe the Company's primary innovative immunotherapy, AllocetraTM, represents a paradigm shift in macrophage reprogramming, moving from targeting a specific subset of macrophages or a specific pathway affecting macrophages activity, to a fundamental view of macrophage homeostasis. Restoring macrophage homeostasis may induce the immune system to rebalance itself to normal levels of operation, thereby promoting disease resolution.

The Company is focused on two clinical program verticals as its main inflammatory and autoimmune indications: sepsis and osteoarthritis (the "Indications"). Additionally, the Company is seeking external collaborations or out-licensing opportunities for the development of Allocetra™ as a next- generation solid cancer immunotherapy. The Company believes that negatively-reprogrammed macrophages may be key contributors to disease severity across the Indications, and effective reprogramming of these negative-reprogrammed macrophages into their respective homeostatic states may facilitate disease resolution for the Indications, some of which are considered "unmet medical needs." All planned and expected timelines for execution of the clinical trials in the Indications are subject to certain risks and uncertainties. For further discussion of risks and uncertainties related to our clinical trial in the Indications please see Item 3.D. "Risk Factors" below.

Strategic Reprioritization Plan

In September 2023, we announced a strategic reprioritization plan, pursuant to which we determined to increase our existing focus on

inflammatory and autoimmune indications. As part of the strategic reprioritization plan, in addition to the ongoing Phase II trial of AllocetraTM in patients with sepsis, we initiated a clinical program in osteoarthritis, which is a degenerative disease with low grade inflammation and an indication with a substantial unmet medical need that potentially represents a multibillion commercial market.

Pursuant to the strategic reprioritization plan, and in light of the new guidelines and regulatory initiatives set by the U.S. Food and Drug Administration (the "FDA") for drug development in oncology, which may result in longer clinical development cycles as foundations for regulatory approvals, the Company ceased the internal clinical development of its various oncology indications and plans to seek external collaborations or out- licensing opportunities for the development of Allocetra™ as a next-generation solid cancer immunotherapy.

As a result of the Company's reprioritization of its clinical indications and focus on the inflammatory and auto-immune verticals, the Company reduced its workforce by approximately 50%. The workforce reduction and the savings associated with the reclassification of the oncology indications as candidates for external collaborations or out-licensing opportunities in lieu of internal development are expected to result in a substantial extension of the Company's cash runway through the end of 2025. The revised, extended cash runway is expected to support the timeline for the topline data readouts of the end-stage knee osteoarthritis Phase I/II trial as well as the randomized, controlled Phase II clinical trial in osteoarthritis.

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Sepsis: Topline Results of Phase II Trial Evaluating Allocetra™ in Patients with Sepsis

In 2021, we initiated a placebo-controlled, randomized, dose-finding,multi-center, Phase II trial evaluating liquid Allocetra™ in patients with pneumonia-associated sepsis. During 2022, we amended the protocol of this clinical trial to treat newly recruited patients with frozen formulation Allocetra™ and expand the study population to include patients whose septic condition stemmed from biliary, urinary tract or peritoneal infections. An additional amendment to the study protocol was filed in the second quarter of 2023, to include an increase in the patients' sequential organ failure assessment ("SOFA") score range, effectively allowing recruitment of patients with higher levels of sepsis severity, and a change to two cohorts (treatment and placebo) in lieu of the four-cohort structure previously contemplated. The first patient was dosed under the amended protocol during the second quarter of 2023, and, in December 2023, we completed enrollment of all 120 patients in the trial.

In April 2024, we announced the 28-day topline data from the Phase II trial evaluating AllocetraTM in patients with sepsis. Stand-alone analysis1

of the AllocetraTM-treated patients, of which 78% had septic shock and 58% had invasive ventilation at screening, demonstrated substantial reductions in SOFA scores and a 65% reduction in overall mortality rate as compared with expected mortality based on real-world data and recent sizeable clinical studies in sepsis. By day 28, the analysis showed 90% reductions of SOFA scores for sepsis patients whose infection source was urinary tract, 68% for patients whose infection source was community-acquired pneumonia, and 36% for patients whose infection source was an internal abdominal infection. Relative analysis demonstrates a potential indication of effect of Allocetra™, as compared with placebo, in the high-risk severe sepsis patient population originating from urinary tract infections ("High-RiskUTI"). Up to an estimated 31% of sepsis cases start as urinary tract infections, representing up to 9.8 million cases and up to 1.6 million deaths annually worldwide (G. Bonkat et. al. 2018), which represents a substantial potential market opportunity for Allocetra™. We intend to consider a potential follow-on, randomized, controlled study of a solely High-Risk UTI sepsis population upon reviewing the totality of the data.

The study was designed for patients to be randomized with equal degree of SOFA scores across treatment and placebo groups. The randomization resulted in the Allocetra™-treated cohorts having 20% higher frequency of septic shock and 35% higher frequency of invasive ventilation prior to treatment, as compared with the control group. Both of these patient attributes are associated with a significantly higher degree of difficulty of treatment and higher mortality rates. These imbalances made it challenging to deduce the relative effect in other patient subgroups.

Finally, stand-alone and placebo-compared analysis across all sepsis patient subgroups and risk categories demonstrated acceptable safety and tolerability profile of Allocetra™ IV infusions.

For additional information on the topline results of our Phase II sepsis trial, see Item 4.B. "Information on the Company-Business Overview."

Our Phase II sepsis trial is supported by previously reported positive results from a Phase Ib trial that demonstrated AllocetraTM's favorable safety profile and showed vastly improved clinical outcomes, including SOFA scores, duration of hospitalization, and mortality in Allocetra-treated sepsis patients compared to a group of matched historical controls who received standard-of-care therapy. Sepsis is a life-threatening disease with no therapies approved by the FDA and a high unmet medical need. According to the U.S. Centers for Disease Control and Prevention (the "CDC"), each year, at least 1.7 million adults in the United States develop sepsis, with approximately 270,000 dying of the disease.

1 Analysis of modified intent-to-treat (mITT) population for all patients who were randomized, received the high dose of AllocetraTM or placebo, had a screening total SOFA score >= 5 points above pre-admission total SOFA score, had at least one post-baseline total SOFA score, and determined as eligible by an adjudication committee.

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Knee Osteoarthritis: First End-Stage Patient Dosed and Initiation of Randomized Controlled Phase I/II Study Clinical Trials

During 2023, we reprioritized our clinical program and initiated a clinical program in osteoarthritis, which is the most common chronic degenerative joint disease characterized by cartilage degradation, low grade inflammation, pain and disability. Osteoarthritis is an indication with a substantial unmet medical need that potentially represents a multibillion commercial market.

In the third quarter of 2023, we announced the dosing of the first patient with a direct injection of AllocetraTM to the knee in a Phase I/II

investigator-initiated clinical trial evaluating the safety and initial efficacy of AllocetraTM in end-stage knee osteoarthritis patients indicated for knee replacement surgery. In January 2024, following our receipt of regulatory approval from the Israeli Ministry of Health ("IMOH"), we initiated a Company-sponsoredmulti-country,double-blind, randomized, placebo-controlled Phase I/II trial to evaluate the efficacy, safety and tolerability of Allocetra™ following injections into the target knee joint of up to 160 moderately to severely symptomatic osteoarthritis patients. In April 2024, we announced that the Danish Medicines Agency authorized the expansion of this trial into Denmark, as well as the dosing of the first two patients in the trial. This Phase I/II multi-center trial is composed of two stages. The first stage is a safety run-in,open-label dose escalation phase to characterize the safety and tolerability of Allocetra™ injections to the target knee in order to identify the dose and injection regimen for the second, randomized stage. The second stage is a double-blind, randomized, placebo-controlled stage, which we expect to initiate following the completion of the safety run-in stage and confirmation by the safety and tolerability independent Data and Safety Monitoring Board. In addition to evaluating safety, the blinded randomized stage is statistically-powered to assess the efficacy of Allocetra™ injections into the knee. We expect that the primary measurements will evaluate joint- pain and joint-function compared to placebo at three months, six months and 12 months. We are targeting to receive the topline readout from the randomized stage of the study by the third quarter of 2025.

The initiation of the clinical program in osteoarthritis followed preclinical evidence of the potential applicability of Allocetra'sTM mechanism of action to resolve chronic low-grade inflammation of joints afflicted with osteoarthritis, as well as a substantial recovery in a case of a 70-year old patient who suffered for many years from vanishing bone disease (Gorham-Stout syndrome). Despite exhaustive therapeutic attempts, the patient's disease

remained refractory to treatment, requiring extended hospitalization for a duration of nine months prior to compassionate treatment with AllocetraTM to

the shoulder joint. Following five intra-articular AllocetraTM injections, substantial improvement was documented in multiple clinical parameters, and the patient was successfully discharged from the hospital. At a two-yearfollow-up, the improvement in the afflicted shoulder was maintained, and no subsequent hospital re-admissions were required.

Manufacturing Plant Update

In September 2021, we entered into a lease agreement (the "Lease Agreement") for a 2,500 square meter property in Yavne, Israel to construct a new 1,600 square meter facility for the manufacture of Allocetra™, which was completed in the fourth quarter of 2022. As part of our strategic reprioritization plan, we determined to sell such leased manufacturing facility, together with the equipment installed by us therein (the "Equipment"), and assign the Lease Agreement.

On March 31, 2024, we entered into an agreement (the "Yavne Facility Sale Agreement") with BioHarvest Ltd., an Israeli company (the "purchaser"), pursuant to which the purchaser agreed to acquire the Equipment and assume all of our obligations under the Lease Agreement, effective as of April 1, 2024, for an aggregate purchase price (the "Purchase Price") payable to the Company of 13.0 million New Israeli Shekels ("NIS") (approximately $3.5 million). The Purchase Price is payable in installments, consisting of an initial payment of NIS 4.0 million (approximately $1.08 million), which was paid on April 2, 2024, and 24 equal monthly installment payments of NIS 375,000 (approximately $102,000), commencing on April 1, 2024. Pursuant to the Yavne Facility Sale Agreement, title to the Equipment will transfer to the purchaser only upon full payment of the total Purchase Price, but risk of loss to the Equipment passed to the purchaser on April 1, 2024. Subject to certain conditions, the purchaser may, in its sole discretion, prior to October 1, 2025, prepay (i) all of the remaining outstanding Purchase Price at a 4% discount, or (ii) a portion of the remaining outstanding Purchase Price, in an amount of not less than NIS 4.0 million (approximately $1.08 million), at a 2% discount, in which case, the Purchase Price remaining outstanding thereafter shall continue to be paid in monthly instalments of NIS 375,000 each (approximately $102,000).

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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Annual Report on Form 20-F contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of

1995 and other U.S. Federal securities laws. These forward-looking statements include, but are not limited to:

• our expectations regarding the timing of clinical trials with respect to Allocetra™;
• the continued listing of our ordinary shares on Nasdaq;
• our expectations regarding the progress of our clinical trials, including the duration, cost and whether such trials will be conducted at all;
• our intention to successfully complete clinical trials in order to be in a position to submit applications for accelerated regulatory paths in the EU and the United States;
• the possibility that we will apply in the future for regulatory approval for our current and any future product candidates we may develop, and the costs and timing of such regulatory approvals;
• the likelihood of regulatory approvals for any product candidate we may develop;
• the timing, cost or other aspects of the commercial launch of any product candidate we may develop, including the possibility that we will build a commercial infrastructure to support commercialization of our current and any future product candidates we may develop;
• future sales of our product candidates or any other future products or product candidates;
• our ability to achieve favorable pricing for our product candidates;
• the potential for our product candidates to receive orphan drug designations;
• that any product candidate we develop potentially offers effective solutions for various diseases;
• whether we will develop any future product candidates internally or through strategic partnerships;

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• our expectations regarding the manufacturing and supply of any product candidate for use in our clinical trials, and the commercial supply of those product candidates;
• third-partypayer reimbursement for our current or any future product candidates;
• our estimates regarding anticipated expenses, capital requirements and our needs for substantial additional financing;
• patient market sizes and market adoption of our current or any future product candidates by physicians and patients;
• completion and receiving favorable results of clinical trials for our product candidates;
• protection of our intellectual property, including issuance of patents to us by the United States Patent and Trademark Office (the "USPTO"), and other governmental patent agencies;
• our intention to pursue marketing and orphan drug exclusivity periods that are available to us under regulatory provisions in certain countries;
• the development and approval of the use of our current or any future product candidates for the Indications;
• our expectations regarding commercial and pre-commercial activities;
• our expectations regarding licensing, acquisitions, and strategic operations;
• our liquidity; and
• the impact of the economic, public health, political and security situation in Israel, the U.S. and other countries in which we may operate or obtain approvals for AllocetraTM and any future product candidates.

In some cases, forward-looking statements are identified by terminology such as "may," "will," "could," "should," "expects," "plans," "anticipates," "believes," "intends," "estimates," "predicts," "hope," "targets," "potential," "goal" or "continue" or the negative of these terms or other comparable terminology. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results or performance to differ materially from those suggested in such forward-looking statements. These statements are current only as of the date of this Annual Report on Form 20-F and are subject to known and unknown risks, uncertainties, and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from those suggested in the forward-looking statements. In addition, historic results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials would not suggest different conclusions or that historic results referred to in this Annual Report on Form 20-F would not be interpreted differently in light of additional research, clinical and preclinical trials results. The forward-looking statements contained in this Annual Report on Form 20-F are subject to risks and uncertainties, including those discussed in Item 3.D. "Risk Factors" and in our other filings with the Securities and Exchange Commission (the "SEC"). Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this Annual Report on Form 20-F. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements. Except as required by law, we do not intend to (and expressly disclaim any such obligation to) update or revise any of the forward-looking statements, whether as a result of new information, future events or otherwise.

vi