Filed Pursuant to Rule 424(b)(5)
Registration No. 333-232009
The information in this preliminary prospectus is not complete
and may be changed. This preliminary prospectus is not an offer to sell these securities nor a solicitation of an offer to buy
these securities in any jurisdiction where the offer or sale is not permitted.
SUBJECT TO COMPLETION, DATED NOVEMBER
20, 2019
Prospectus Supplement
to Prospectus dated June 21, 2019
$
ENLIVEX
THERAPEUTICS LTD.
Ordinary Shares
This prospectus supplement
relates to the offer and sale of ordinary shares, par value NIS 0.40 per share (the “ordinary shares”), of Enlivex
Therapeutics Ltd.
Our ordinary shares
are listed on the Nasdaq Capital Market under the symbol “ENLV” and on the Tel Aviv Stock Exchange under the symbol
“ENLV.” The last reported sale price of our ordinary shares on the Nasdaq Capital Market on November 20, 2019 was
$8.28 per share (based on the exchange rate reported by the Bank of Israel on the same day). The last reported sale price of our
ordinary shares on the Tel Aviv Stock Exchange on November 20, 2019 was NIS 30.44 or approximately $8.77 per share (based on the
exchange rate reported by the Bank of Israel on the same day).
We are an “emerging
growth company” as defined under the U.S. federal securities laws and, as such, have elected to comply with certain reduced
public company reporting requirements.
Investing in our
ordinary shares involves a high degree of risk. See the risks described in the “Risk Factors” section on page S-4 of
this prospectus supplement, and in the documents incorporated by reference into this prospectus supplement and the accompanying
base prospectus, respectively.
Neither the Securities
and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the
accuracy or adequacy of this prospectus supplement or the accompanying prospectus. Any representation to the contrary is a criminal
offense.
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Per Share
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Total
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Public Offering Price
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$
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$
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Underwriting Discounts*
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$
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$
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Proceeds to Us (before expenses)
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$
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$
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*
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The underwriting discount shall be adjusted for shares
delivered to certain investors previously identified to the underwriters. See “Underwriting” for additional
information regarding total compensation payable to the underwriter, including expenses for which we have agreed to reimburse
the underwriter.
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Delivery of the ordinary
shares is expected to be made on or about , 2019. We have granted the underwriter an option for a period of 45 days from the date
of this prospectus supplement to purchase up to additional ordinary shares. If the underwriter exercises the option in full, the
total underwriting discounts and commissions payable by us will be $ , and the total proceeds to us, before expenses, will be approximately
$ , assuming no sale of shares to existing shareholders of the Company or any investor introduced by us to the underwriter (each,
a "Company Investor" and collectively, the "Company Investors").
Sole Book-Running
Manager
Aegis
Capital Corp.
_______________________________________________________________
Prospectus Supplement dated , 2019.
tABLE OF
CONTENTS
We have not, and the
underwriter has not, authorized anyone to provide any information or to make any representations other than those contained or
incorporated by reference in this prospectus supplement or in the accompanying prospectus. We take no responsibility for, and can
provide no assurance as to the reliability of, any other information that others may give you. This prospectus supplement and the
accompanying prospectus is an offer to sell only the ordinary shares offered hereby, but only under circumstances and in jurisdictions
where it is lawful to do so. The information contained in this prospectus supplement and the accompanying prospectus is current
only as of the respective dates of such documents.
About this
Prospectus Supplement
All references to the
terms the “Company,” “Enlivex,” “we,” “us” and “our” in this prospectus
supplement refer to Enlivex Therapeutics Ltd., a company organized under the laws of the State of Israel, and its consolidated
subsidiaries, unless the context requires otherwise.
This prospectus supplement
and the accompanying base prospectus form part of a registration statement on Form F-3 that we filed with the Securities and Exchange
Commission (the “Commission” or the “SEC”) utilizing the Commission’s “shelf” registration
rules. This document consists of two parts, this prospectus supplement, which provides you with specific information about this
offering, and the accompanying prospectus, which provides more general information, some of which may not apply to this offering.
When we refer in this prospectus supplement to the term “this prospectus,” we are referring collectively to this prospectus
supplement, the accompanying prospectus and any free-writing prospectus we may utilize pursuant to Rule 433 of the Securities Act
of 1933, as amended (the “Securities Act”).
This prospectus supplement
and the documents incorporated by reference herein may add, update or change information contained in the accompanying prospectus.
To the extent that any statement that we make in this prospectus supplement is inconsistent with statements made in the accompanying
prospectus, the statements made in this prospectus supplement will be deemed to modify or supersede those made in the accompanying
prospectus. You should read carefully this prospectus supplement, the accompanying prospectus and the additional information described
under the headings “Where You Can Find More Information,” and “Incorporation of Certain Documents by Reference”
before making an investment decision.
You should rely only
on the information contained or incorporated by reference in this prospectus supplement and the accompanying prospectus relating
to the offering described in this prospectus supplement. We have not authorized any person to provide you with different or additional
information. If anyone provides you with different or additional information, you should not rely on it.
You should not assume
that the information in this prospectus supplement, the accompanying prospectus or any documents we incorporate by reference herein
or therein is accurate as of any date other than the respective dates on the front cover of those documents. Our business, financial
condition, results of operations and prospects may have changed since those dates.
We are not offering
or selling the ordinary shares offered hereby in any jurisdiction or to any person if such offer or sale is not permitted by applicable
law, rule or regulation.
Prospectus
Supplement Summary
The following summary
of our business highlights some of the information contained elsewhere in or incorporated by reference into this prospectus supplement
or the accompanying prospectus. Because this is only a summary, it does not contain all of the information that may be important
to you. You should carefully read this prospectus supplement and the accompanying prospectus, including the documents incorporated
by reference herein and therein, which are identified under “Incorporation of Certain Documents by Reference” in this
prospectus supplement and under “Incorporation of Certain Documents by Reference” in the accompanying prospectus. You
should also carefully consider the matters discussed in the section in this prospectus supplement entitled “Risk Factors”
and in the accompanying prospectus, in our Annual Report on Form 20-F for the year ended December 31, 2018 and in other documents
incorporated herein by reference.
Our Company
Overview
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 the hyper-expression
of cytokines (Cytokine Release Syndrome) and for which there are no U.S. Food and Drug Administration-approved treatments, as well
as treating solid tumors via modulating immune-checkpoint rebalancing. The Company’s innovative immunotherapy candidate,
Allocetra™, is a novel immunotherapy candidate based on a unique mechanism of action that targets clinical indications that
are defined as “unmet medical needs,” such as preventing or treating complications associated with bone marrow transplants
and/or hematopoietic stem cell transplants, sepsis and acute multiple organ failure. The Company also intends to develop its cell-based
therapy to be combined with effective treatments of solid tumors via immune checkpoint rebalancing to increase the efficacy of
various anti-cancer therapies, including Chimeric Antigen Receptor T-Cell Therapy and T-Cell Receptor Therapy.
Cytokines are a broad
and loose category of small proteins (~5–20 kDa) produced by a broad range of cells, including immune cells, and are especially
important in the immune system as they promote, modulate and balance immune responses. They are released by cells and affect the
behavior of other cells, and include chemokines, interferons, interleukins, lymphokines, tumor necrosis factors and others, but
generally not hormones or growth factors. Cytokines are important in health and disease, specifically in host responses to infection,
immune responses, inflammation, trauma, sepsis, cancer and other conditions. Cytokine Release Syndrome is a systemic inflammatory
response in which cytokine release composition and amplitude spirals out of control. It is considered difficult to treat with traditional
small molecules or biologics because the condition involves dozens of cytokines that induce multiple biological paths of hyper
immune activity. Such hyper immune activity may result in an attack of immune killer cells (e.g., T-Cells, B-Cells and Natural
Killer Cells) on healthy organs of the patient, including the heart, brain, lungs, liver, kidney and others, which may lead to
organ damage, multiple organ failure and mortality. There are many clinical conditions in which a patient has the potential
to develop Cytokine Release Syndrome. Those clinical conditions include complications associated with hematopoietic stem-cell transplantation
(HSCT), sepsis, and several autoimmune and inflammatory conditions, such as Crohn’s disease, rheumatoid arthritis, gout and
multiple sclerosis.
The Company believes
that the only approach to handling such a multi-factorial complex life-threatening situation is via an integrated cell-based immunotherapy
that induces the immune system to rebalance itself to normal levels of operation utilizing a mechanism of action used regularly
by the immune system and developed through evolution. The Company’s unique therapeutic approach is based on inducing immunotolerance
and the specific normal rebalancing of the immune system by infusing early and stable apoptotic cells (dying cells) into the patient.
Once infused, such apoptotic cells interact with macrophages and dendritic cells via well-defined mechanisms causing rebalancing
of an over-agitated immune response. Using this inherent immune pathway, the Company believes that it can use Allocetra™
to shape a patient’s innate immune response to a disease, leading to a decrease in unwanted immune response.
The Company plans,
subject to regulatory approvals, to initiate in the first quarter of 2020 Phase II/III clinical trials with Allocetra™ for
the prevention and treatment of complications post-HSCT and Phase II/III clinical trials with Allocetra™ for the prevention
and treatment of sepsis related organ dysfunction.
Corporate Information
We were originally
incorporated on January 22, 2012 under the laws of the State of Israel as Bioblast Pharma Ltd. Upon consummation of a merger transaction,
pursuant to which our wholly owned subsidiary, Treblast Ltd., merged with and into Enlivex Therapeutics R&D Ltd. (“Enlivex
R&D”, formerly known as Enlivex Therapeutics Ltd.), with Enlivex R&D remaining as the surviving entity in the merger,
we changed our name to Enlivex Therapeutics Ltd. Our primary operating subsidiary, Enlivex Therapeutics R&D Ltd., was incorporated
in September 2005 under the laws of the State of Israel as an Israeli privately held company under the name Tolarex Ltd. In February
2010, Enlivex R&D changed its name to Enlivex Therapeutics Ltd., and, upon consummation of the Merger, to Enlivex Therapeutics
R&D Ltd. Our principal executive offices are located at 14 Einstein Street, Nes Ziona, Israel 7403618, and our telephone number
is: +972 26208072.
Recent Developments
Appointment of New
CEO
On September 25, 2019, Dr. Shmuel Hess,
Chief Executive Officer of the Company, delivered his notice of resignation to the Company. Dr. Hess resigned for personal reasons.
On October 22, 2019, the Company appointed Dr. Oren Hershkovitz to serve as the Company’s new Chief Executive Officer. Dr.
Hess’ resignation and Dr. Hershkovitz’ appointment became effective on November 16, 2019.
Dr. Hershkovitz, 42, is a biotech executive
who has extensive experience in the development and management of global pharmaceutical programs from preclinical stage through
phase III clinical trials. Since 2011, Dr. Hershkovitz has been employed by OPKO Biologics, Ltd. (formerly Prolor Biotech Ltd.),
first as Vice President of R&D from 2011 to 2014, then as Co-General Manager until 2017 and subsequently as General Manager
from 2017 through the present. Dr. Hershkovitz received his Ph.D. from Ben Gurion University of the Negev in 2008.
Positive
Interim Safety and Efficacy Data from Ongoing Trial of Off-The-Shelf Allocetra
On November 4,
2019, the Company announced positive interim efficacy data from the Company’s ongoing
Phase Ib clinical trial of off-the-shelf Allocetra (“OTS Allocetra”) in patients with severe sepsis. The interim analysis
is based on a dataset of 43 patients with severe sepsis. Six patients admitted to Hadassah Medical Center’s intensive care
unit with sepsis were administered OTS Allocetra upon their admission, while 37 patients were matched controls that received standard
of care treatment during 2016-2019, but did not receive OTS Allocetra. The primary safety parameter was 28 days mortality. None
of the six OTS Allocetra -treated patients died during this period, as compared to 11 of 37 (29%) in the matched control group
who died during this period. OTS Allocetra treatment resulted in improved efficacy in all analyzed parameters, which included the
sequential organ failure assessment (SOFA) score (the higher the score, the worse the clinical condition of various organs), as
well as recovery from sepsis, number of days of hospitalization in the intensive care unit and others. The matching of the
37 patients to the OTS Allocetra-treated group was based on similar organ failure clinical SOFA score at admission, overall clinical
state, age group, sex, and source of severe sepsis (pneumonia, endovascular, or urinal tract infections). All matched patients
were treated at the same hospital as the OTS Allocetra-treated group.
Sepsis is defined
as a life-threatening organ dysfunction caused by a dysregulated immune response to infection. Sepsis, which has been identified
by the World Health Organization as a global health priority, has no proven pharmacologic treatment other than appropriate antibiotic
agents, fluids, and vasopressors. Sepsis affects approximately 1.7 million adults in the United States each year and potentially
contributes to more than 250,000 deaths. Various studies estimate that sepsis is present in 30% to 50% of hospitalizations that
culminate in death.
Clarifications of Certain Disclosures in the Company’s
Operating and Financial Review and Prospects
For the six months ended June 30, 2019, net cash used in operations
was $3,344,000.
Research
and development expenses for the nine months ended September 30, 2019 as compared to the nine months ended September 30, 2018
increased by $1,219,000, or 46%. General and administrative expenses for the nine months ended September 30, 2019 as
compared to the nine months ended September 30, 2018 increased by $1,330,000, or 222%. For the quarter ended September
30, 2019, general and administrative expenses increased $349,000, or 178%, as compared to the third quarter of 2018.
Operating loss for the nine and three months ended September 30, 2019 was $5,780,000 and $2,121,000, respectively,
representing an increase of $2,549,000 and $880,000, or 79% and 71%, respectively, as compared to the nine and three months
ended September 30, 2018.
The Offering
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Ordinary shares offered by us
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ordinary shares (or ordinary shares if the underwriter option is exercised in full).
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Offering price
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$ per ordinary share.
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Ordinary shares to be outstanding immediately after this offering(1)
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ordinary shares (or ordinary shares if the underwriter option is exercised in full).
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Underwriter’s option
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We have granted the underwriter an option to purchase from us up to additional ordinary shares at the public offering price, less underwriting discounts and commissions, within 45 days from the date of this prospectus supplement.
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Use of proceeds
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We intend to use the net proceeds from this offering for (i) clinical, regulatory, manufacturing and research and development activities; (ii) potential acquisitions and in-licensing; and (iii) other general corporate purposes. See “Use of Proceeds” for additional information.
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Nasdaq Capital Market symbol
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“ENLV.”
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Tel Aviv Stock Exchange symbol
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“ENLV.”
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Risk factors
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Investing in our securities involves risks. You should read carefully the “Risk Factors” section of this prospectus supplement beginning on page S-4, the accompanying prospectus and in the documents incorporated by reference herein and therein for a discussion of factors that you should carefully consider before deciding to invest in our securities.
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(1)
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The number of our ordinary shares outstanding is based
on 10,334,126 shares outstanding as of September 30, 2019, which excludes:
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1,080,613 options held by our employees and directors
to purchase ordinary shares under the Company’s Global Share Incentive Plan (2019) (the “2019 Plan”) at a weighted
average exercise price of $4.88 per share, of which 550,656 options were exercisable
as of September 30, 2019, at a weighted average exercise price of $3.67 per share;
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514,614 options to purchase ordinary shares under options
granted to consultants under existing stock-option plans (the “Consultants’ stock options”) at a weighted average
exercise price of $6.64 per share, of which 373,613 options were exercisable as of September 30, 2019 at a weighted average exercise
price of $3.08 per share;
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523,132 ordinary shares available for future issuance
under our 2019 Plan as of September 30, 2019; and
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Warrants issued in September and October 2017 by Bioblast Pharma Ltd. that are exercisable into 27,016 ordinary shares, at
an exercise price of $180 per ordinary share.
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Unless otherwise indicated, all information in this prospectus
supplement assumes:
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No exercise of outstanding options described above;
and
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No exercise by the underwriter of its option to purchase
up to additional ordinary shares.
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Risk Factors
Investing in our
ordinary shares involves a high degree of risk. You should consider carefully the risks and uncertainties described below, the
risks described under the heading “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31,
2018, which is incorporated by reference in this prospectus supplement and the accompanying prospectus, and under similar headings
in our subsequently filed reports on Form 6-K, and other information contained in or incorporated by reference in this prospectus
supplement and the accompanying prospectus, including our audited consolidated financial statements and the related notes, as well
as our unaudited condensed consolidated financial statements and the related notes, before you decide whether to purchase our ordinary
shares. If any of the following risks actually occur, our business, financial condition, results of operations, cash flow and prospects
could be materially and adversely affected. As a result, the trading price of our ordinary shares could decline and you could lose
all or part of your investment in our ordinary shares.
Risks Related to this Offering and our Ordinary Shares
The market price of our ordinary shares has been,
and may continue to be volatile, and the value of your investment could decline significantly.
The trading price for our ordinary shares
has been, and we expect it to continue to be, volatile. The price at which our ordinary shares trade depends upon a number of factors,
including our historical and anticipated operating results, results from our clinical trials, our financial condition, announcements
of technological developments or new products or product candidates by us or our competitors, our ability or inability to raise
the additional capital we may need and the terms on which we raise it, and general market and economic conditions, most of which
are beyond our control. The foregoing factors, among others, may contribute to the volatility of the market price of our ordinary
shares, leading to broad market fluctuations that could lower the market price of our ordinary shares, resulting in a loss of all
or part of your investment in our ordinary shares.
Management will have broad discretion as to the
use of the net proceeds from this offering, and we may not use the proceeds effectively.
Our management will
have broad discretion as to the application of the net proceeds from this offering and could use them for purposes other than those
contemplated at the time of this offering, as described in “Use of Proceeds”. Our shareholders may not agree with the
manner in which our management chooses to allocate and spend the net proceeds. Moreover, our management may use the net proceeds
for corporate purposes that may not increase our market value.
You will experience immediate and substantial dilution.
The public
offering price for the ordinary shares offered pursuant to this prospectus supplement is substantially higher than the net
tangible book value of each outstanding share of our ordinary shares. Purchasers of ordinary shares in this offering will
experience immediate and substantial dilution on a book value basis. Following this offering, there will be an immediate
increase in net tangible book value of approximately $ per share to our existing shareholders, and an
immediate dilution of $ per share to
investors purchasing shares in this offering, based on an initial public offering price of
$ per share, and after deducting the underwriting discount and
estimated offering expenses, payable by us. If the holders of outstanding options or other securities convertible into
our ordinary shares exercise those options or other such securities at prices below the public offering price, you will incur
further dilution. Please see the section in this prospectus supplement entitled “Dilution” for a more detailed
discussion of the dilution you will incur in this offering.
Sales of a substantial number
of our ordinary shares, or the perception that such sales might occur, could adversely affect the trading price of our ordinary
shares.
As of September 30,
2019, we had 10,334,126 ordinary shares outstanding, excluding ordinary shares issuable upon exercise of outstanding options and
shares that are issuable under our existing equity compensation plans. Sales of ordinary shares underlying stock options, or the
perception in the market that the holders of a large number of shares intend to sell shares, could reduce the market price of our
ordinary shares. A decline in the price of our ordinary shares might impede our ability to raise capital through the issuance of
additional ordinary shares or other equity securities and could result in a decline in the value of your investment in our ordinary
shares.
Our ordinary shares are listed in
two markets and this may result in price variations that could affect the trading price of our ordinary shares.
Our ordinary shares
are listed on Nasdaq Capital Market and the TASE, both under the symbol “ENLV.” Trading in our ordinary shares on these
markets is made in different currencies (U.S. dollars on the Nasdaq Capital Market and New Israeli Shekels on the TASE),
and at different times (due to the different time zones, different trading days and different public holidays in the United States
and Israel). The trading prices of our ordinary shares on these two markets may differ due to these and other factors. Any decrease
in the trading price of our ordinary shares on one of these markets could cause a decrease in the trading price of our ordinary
shares on the other market.
Cautionary
Statement About Forward-Looking Information
This prospectus supplement,
the accompanying prospectus and the documents and information incorporated by reference herein and therein may contain “forward-looking
statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act,
and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements
may include, but are not limited to, statements relating to our objectives, plans and strategies as well as statements, other than
historical facts, that address activities, events, or developments that we intend, expect, project, believe or anticipate will
or may occur in the future. These statements are often characterized by terminology such as “may,” “will,”
“should,” “expects,” “plans,” “anticipates,” “could,” “intends,”
“target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,”
“potential,” or “continue” or the negative of these terms or other similar expressions.
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. 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 prospectus supplement, the accompanying prospectus, our Annual Report on Form 20-F
for the year ended December 31, 2018, which is incorporated by reference in this prospectus supplement and the accompanying prospectus,
or in the other reports and documents incorporated by reference in this prospectus supplement and the accompanying prospectus would
not be interpreted differently in light of additional research, clinical and preclinical trails results. Factors which could cause
actual results to differ materially from those indicated by the forward-looking statements include those factors described under
the caption “Risk Factors” contained in this prospectus supplement and in the accompanying prospectus, as well as under
the caption “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2018, which is incorporated
by reference in this prospectus supplement and the accompanying prospectus, as well as the other risks and uncertainties described
in the other documents incorporated by reference herein and therein.
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. You should not place undue reliance on these forward-looking statements, which reflect our
views only as of the respective dates on which the statements were made, and we undertake no obligation to update these forward-looking
statements in the future, except as required by applicable law.
Use of Proceeds
We estimate that the
net proceeds to us from this offering of ordinary shares will be approximately $ million (or $ million if the underwriter exercises
its option to purchase additional shares in full), after deducting the underwriter’s discount and commission and our estimated
expenses relating to the offering.
We intend to use the
net proceeds from this offering for (i) clinical, regulatory, manufacturing and research
and development activities; (ii) potential acquisitions and in-licensing; and (iii) other general corporate purposes.
This expected use of
the net proceeds from this offering represents our intentions based upon our current plans and business conditions. The amounts
and timing of our actual expenditures may vary significantly depending on numerous factors, including the progress of our development
efforts, the status of and results from clinical trials, as well as any collaborations that we may enter into with third parties,
and any unforeseen cash needs. As a result, our management will retain broad discretion over the allocation of the net proceeds
from this offering.
Capitalization
The following table sets forth our cash
and cash equivalents and consolidated capitalization as of September 30, 2019:
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on an actual basis reflecting our consolidated cash and cash equivalents and capitalization; and
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on an as-adjusted basis reflecting our consolidated cash and cash equivalents and capitalization
to give effect to this offering and the use of the net proceeds from this offering (assuming no exercise of the underwriter’s
option to purchase additional ordinary shares).
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The information in this table should be
read in conjunction with “Use of Proceeds,” included elsewhere in this prospectus supplement, and “Operating
and Financial Review and Prospects” and the consolidated financial statements and the related notes for the quarterly period
ended September 30, 2019 contained in our Form 6-K filed on November 14, 2019, which are incorporated by reference into this prospectus
supplement and the accompanying prospectus, as well as the other financial information incorporated by reference into this prospectus
supplement and the accompanying prospectus.
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As of September 30, 2019
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Actual
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As Adjusted
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(unaudited) (in thousands)
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Cash and Cash Equivalents
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$
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5,488
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$
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Liabilities:
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Current Liabilities
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4,550
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4,550
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Non-current Liabilities
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884
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884
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Total
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$
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5,434
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$
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5,434
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Equity:
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Ordinary shares of NIS 0.4 ($0.11) par value as of September 30, 2019 and December 31, 2018: Authorized: 45,000,000 and 11,861,073 shares; Issued and outstanding: 10,334,126 and 3,509,405 shares (1))
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$
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1,151
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$
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Additional paid-in capital
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36,805
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Foreign currency translation adjustments
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(1,367
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)
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Accumulated deficit
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(22,806
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)
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Total shareholders’ equity
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13,783
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Total capitalization
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$
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19,217
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$
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(1)
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Does not include 924,270
ordinary shares issuable upon exercise of outstanding stock options as of September 30, 2019.
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Dilution
If you invest in the
ordinary shares being offered by this prospectus supplement, you will suffer immediate and substantial dilution in the net tangible
book value per ordinary share. Our net tangible deficit as of September 30, 2019 was approximately $13.8 million, or approximately
$1.332 per share. Net tangible deficit per share represents our total tangible assets less total tangible liabilities, divided
by the number of ordinary shares outstanding as of September 30, 2019.
Dilution in net tangible
book value per share represents the difference between the public offering price per share paid by purchasers in this offering
and the net tangible book value per share of our ordinary shares immediately after this offering. After giving effect to the sale
by us of shares in this offering, assuming all shares are sold, at a public offering price of $ per share, after deducting underwriting
discounts and commissions and estimated offering expenses payable by us, our net tangible book value as of September 30, 2019 would
have been approximately $ million, or approximately $ per ordinary share. This represents an immediate increase of $ in net tangible
book value per share to our existing shareholders and an immediate dilution of $ per share to purchasers of ordinary shares in
this offering. The following table illustrates this per share dilution:
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Public offering price per share
|
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$
|
|
|
|
Net tangible book value deficit per share as of September 30, 2019
|
|
$
|
1.332
|
|
|
Increase in net tangible book value per share attributable to new investors
|
|
$
|
|
|
|
Adjusted net tangible book value deficit per share as of September 30, 2019, after giving effect to the offering
|
|
$
|
|
|
|
Dilution per share to new investors in the offering
|
|
$
|
|
|
If the
underwriter exercises its right to purchase an
additional ordinary shares in this offering in full,
the as adjusted net tangible book value after the offering would be
$ per share, the increase in as adjusted net tangible book
value per share to existing shareholders would be $ and the
dilution per share to new investors would be $ per share,
in each case after deducting estimated offering expenses payable by us. If any shares are issued upon exercise of outstanding
options at exercise prices below the public offering price in this offering, you will experience further dilution.
The above discussion
and tables do not include the following:
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|
●
|
1,080,613 options held by our employees and directors
to purchase ordinary shares under the 2019 Plan at a weighted average exercise price of $4.88 per share, of which 550,656
options were exercisable as of September 30, 2019, at a weighted average exercise price of $3.67
per share;
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|
|
●
|
514,614 options to purchase
ordinary shares under options granted to consultants under the Consultants’ stock options at a weighted average exercise
price of $6.64 per share, of which 373,613 options were exercisable as of September 30, 2019 at a weighted average exercise price
of $3.08 per share;
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|
|
●
|
523,132 ordinary shares available for future issuance
under our 2019 Plan as of September 30, 2019; and
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|
|
●
|
Warrants issued in September and October 2017 by Bioblast Pharma Ltd. that are exercisable into 27,016 ordinary shares, at
an exercise price of $180 per ordinary share.
|
Underwriting
Aegis Capital Corp.
is acting as the underwriter of this offering. We have entered into an underwriting agreement dated , 2019 with the underwriter.
Pursuant to the terms and subject to the conditions set forth in the underwriting agreement, we have agreed to sell to the underwriter
and the underwriter has agreed to purchase, at the public offering price less the underwriting discounts set forth on the cover
page of this prospectus supplement, the following number of our ordinary shares.
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Underwriter
|
|
Number of
Shares
|
|
Aegis Capital Corp.
|
|
|
The underwriter is
committed to purchase all of the ordinary shares offered by us other than those covered by the option to purchase additional shares
described below, if they purchase any shares. The obligations of the underwriter may be terminated upon the occurrence of certain
events specified in the underwriting agreement. Furthermore, pursuant to the underwriting agreement, the underwriter’s obligations
are subject to customary conditions, representations and warranties contained in the underwriting agreement, such as receipt by
the underwriter of officers’ certificates and legal opinions.
We have agreed to indemnify
the underwriter against specified liabilities, including liabilities under the Securities Act, and to contribute to payments the
underwriter may be required to make in respect thereof.
The underwriter is
offering the ordinary shares, subject to prior sale, when, as and if issued to and accepted by them, subject to approval of legal
matters by their counsel and other conditions specified in the underwriting agreement. The underwriter reserves the right to withdraw,
cancel or modify offers to the public and to reject orders in whole or in part.
The underwriter proposes
to offer the ordinary shares offered by us to the public at the public offering price set forth on the cover of this prospectus
supplement. In addition, the underwriter may offer some of the ordinary shares to other securities dealers at such price less a
concession of $ per share.
We have granted the
underwriter an over-allotment option. This option, which is exercisable for up to 45 days after the date of this prospectus supplement,
permits the underwriter to purchase a maximum of additional ordinary shares from us to cover over-allotments. If the underwriter
exercises all or part of this option, they will purchase ordinary shares covered by the option at the public offering price that
appears on the cover page of this prospectus supplement, less the underwriting discount. If this option is exercised in full, the
total price to the public will be approximately $ and the total proceeds to us, before expenses, will be approximately
$ , assuming no sale of shares to Company Investors.
Discounts and Commissions.
The following table shows the public offering price, underwriting discount and proceeds, before expenses, to us. The information
assumes either no exercise or full exercise by the underwriter of its over-allotment option.
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Total
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|
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Per Share
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|
|
Without
Over-Allotment
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|
|
With
Over-Allotment
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|
|
Public offering price
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
Underwriting discount(1)
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|
$
|
|
|
|
$
|
|
|
|
$
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|
|
|
Non-accountable expense allowance(2)
|
|
$
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|
|
|
|
|
|
|
|
|
|
|
Proceeds, before expenses, to us
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
(1)
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The underwriting discount shall be $ per share for ordinary shares delivered to Company Investors, for up to a maximum of $1,000,000
in gross proceeds received from the Company Investors. The underwriter will not receive an underwriting discount with respect
to gross proceeds from Company Investors above this $1,000,000 threshold.
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(2)
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The non-accountable expense allowance shall be $ per share for ordinary shares delivered to Company Investors, for up to a maximum
of $1,000,000 in gross proceeds received from the Company Investors. The underwriter will not receive a non-accountable expense
allowance with respect to gross proceeds from Company Investors above this $1,000,000 threshold.
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We have paid an expense
deposit of $25,000 (the “Advance”) to the underwriter, which will be applied against the actual out-of-pocket accountable
expenses that will be payable by us to the underwriter in connection with this offering. Any portion of the Advance shall be returned
back to us to the extent expenses in respect thereof are not actually incurred.
We have also agreed
to pay all expenses relating to the offering, including (a) all filing fees and expenses relating to the registration of the ordinary
shares to be sold in the offering (including ordinary shares sold upon exercise of the underwriter’s over-allotment option)
with the Commission; (b) all fees associated with the review of the offering by FINRA and all fees and expenses relating to the
listing of such ordinary shares on the Nasdaq Capital Market and the TASE; (c) all fees, expenses and disbursements relating to
the registration, qualification or exemption of securities offered under the “blue sky” securities laws designated
by the underwriter; (d) all fees, expenses and disbursements relating to the registration, qualification or exemption of securities
offered under the securities laws of foreign jurisdictions designated by the underwriter; (e) transfer and/or stamp taxes, if any,
payable upon the transfer of the ordinary shares from the Company to the underwriter; (f) fees and expenses of our legal counsel
and accountants; and (g) “road show” expenses, diligence fees and the fees and expenses of the underwriter’s
legal counsel not to exceed $75,000.
Discretionary Accounts.
The underwriter does not intend to confirm sales of the ordinary shares offered hereby to any accounts over which it has discretionary
authority.
Lock-Up Agreements.
Pursuant to certain “lock-up” agreements, (a) our executive officers and directors as of the pricing date of the offering,
have agreed, subject to certain exceptions, not to offer, issue, sell, contract to sell, encumber, grant any option for the sale
of or otherwise dispose of any securities of the company without the prior written consent of the underwriter, for a period of
90 days from the date of the offering, and (b) we, and any successor, have agreed, subject to certain exceptions, not to for a
period of 90 days from the date of the pricing of the offering (1) offer, sell or otherwise transfer or dispose of, directly or
indirectly, any shares of capital stock of the Company in excess of an aggregate of $10,000,000 or at an effective price per ordinary
share equal to or lower than the public offering price per share in this offering or (2) file or caused to be filed any registration
statement with the SEC relating to the offering of any shares of our capital stock or any securities convertible into or exercisable
or exchangeable for shares of our capital stock. This lock-up provision applies to ordinary shares and to securities convertible
into or exchangeable or exercisable for ordinary shares. It also applies to ordinary shares owned now or acquired later by the
person executing any such “lock-up” agreement or for which the person executing such agreement later acquires the power
of disposition. The exceptions referred to in the first sentence of this paragraph permit, among other things and subject to certain
restrictions, the issuance of ordinary shares upon the exercise of outstanding stock options and warrants or other outstanding
convertible securities.
Tail. If prior
to May 14, 2020, the Company completes any public or private offering or other financing or capital-raising transaction of any
kind to the extent that such financing or capital is provided to the Company by investors whom the underwriter has introduced to
the Company, subject to certain requirements, as well as by such investors that participated in the offering, then the Company
will pay to the underwriter upon the closing of such offering, financing or transaction 7% of the gross proceeds of such offering,
financing or transaction and a non-accountable expense allowance equal to 1% of the gross proceeds of such offering, financing
or transaction.
Electronic Offer,
Sale and Distribution of Shares. A prospectus supplement in electronic format may be made available on the websites maintained
by the underwriter and the underwriter may distribute prospectus supplements electronically. The underwriter may agree to allocate
a number of shares for sale to its online brokerage account holders. Internet distributions will be allocated by the underwriter
and on the same basis as other allocations. Other than the prospectus supplement in electronic format, the information on these
websites is not part of this prospectus supplement or the registration statement of which this prospectus supplement forms a part,
has not been approved or endorsed by us or the underwriter in its capacity as underwriter, and should not be relied upon by investors.
Other Relationships.
The underwriter and its affiliates may in the future provide various investment banking, commercial banking and other financial
services for us and our affiliates for which they may receive customary fees; however, except as disclosed in this prospectus supplement,
we have no present arrangements with the underwriter for any further services.
Stabilization.
In connection with this offering, the underwriter may engage in stabilizing transactions, over-allotment transactions, syndicate
covering transactions, penalty bids and purchases to cover positions created by short sales.
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●
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Stabilizing transactions permit bids to purchase shares
so long as the stabilizing bids do not exceed a specified maximum, and are engaged in for the purpose of preventing or retarding
a decline in the market price of the shares while the offering is in progress.
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●
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Over-allotment transactions involve sales by the underwriter
of shares in excess of the number of shares the underwriter is obligated to purchase. This creates a syndicate short position
which may be either a covered short position or a naked short position. In a covered short position, the number of shares over-allotted
by the underwriter is not greater than the number of shares that it may purchase in the over-allotment option. In a naked short
position, the number of shares involved is greater than the number of shares in the over-allotment option. The underwriter may
close out any short position by exercising its over-allotment option and/or purchasing shares in the open market.
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●
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Syndicate covering transactions involve purchases of
shares in the open market after the distribution has been completed in order to cover syndicate short positions. In determining
the source of shares to close out the short position, the underwriter will consider, among other things, the price of shares available
for purchase in the open market as compared with the price at which they may purchase shares through exercise of the over-allotment
option. If the underwriter sells more shares than could be covered by exercise of the over-allotment option and, therefore, has
a naked short position, the position can be closed out only by buying shares in the open market. A naked short position is more
likely to be created if the underwriter is concerned that after pricing there could be downward pressure on the price of the shares
in the open market that could adversely affect investors who purchase in the offering.
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|
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●
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Penalty bids permit the underwriter to reclaim a selling
concession from a syndicate member when the shares originally sold by that syndicate member are purchased in stabilizing or syndicate
covering transactions to cover syndicate short positions.
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These stabilizing transactions,
over-allotment transactions, syndicate covering transactions and penalty bids may have the effect of raising or maintaining the
market price of our ordinary shares or preventing or retarding a decline in the market price of our ordinary shares. As a result,
the price of our ordinary shares in the open market may be higher than it would otherwise be in the absence of these transactions.
Neither we nor the underwriter make any representation or prediction as to the effect that the transactions described above may
have on the price of our ordinary shares. These transactions may be effected on the Nasdaq Capital Market or otherwise.
Passive Market Making.
In connection with this offering, the underwriter and selling group members may engage in passive market making transactions in
our ordinary shares in accordance with Rule 103 of Regulation M under the Exchange Act, during a period before the commencement
of offers or sales of the shares and extending through the completion of the distribution. A passive market maker must display
its bid at a price not in excess of the highest independent bid of that security. However, if all independent bids are lowered
below the passive market maker’s bid, that bid must then be lowered when specified purchase limits are exceeded.
Notice to Non-U.S. Investors
Other
than in the United States, no action has been taken by us or the underwriter that would permit a public offering of the securities
offered by this prospectus in any jurisdiction where action for that purpose is required. The securities offered by this prospectus
may not be offered or sold, directly or indirectly, nor may this prospectus or any other offering material or advertisements in
connection with the offer and sale of any such securities be distributed or published in any jurisdiction, except under circumstances
that will result in compliance with the applicable rules and regulations of that jurisdiction. Persons into whose possession this
prospectus comes are advised to inform themselves about and to observe any restrictions relating to the offering and the distribution
of this prospectus. This prospectus does not constitute an offer to sell or a solicitation of an offer to buy any securities offered
by this prospectus in any jurisdiction in which such an offer or a solicitation is unlawful.
Israel
This document does
not constitute a prospectus under the Israeli Securities Law, 5728-1968, or the Securities Law, and has not been filed with or
approved by the Israel Securities Authority. In Israel, this prospectus supplement is being distributed only to, and is directed
only at, and any offer of the ordinary shares is directed only at, (i) a limited number of persons in accordance with the Israeli
Securities Law and (ii) investors listed in the first addendum, or the Addendum, to the Israeli Securities Law, consisting primarily
of joint investment in trust funds, provident funds, insurance companies, banks, portfolio managers, investment advisors, members
of the Tel Aviv Stock Exchange, underwriters, venture capital funds, entities with equity in excess of NIS 50 million and “qualified
individuals,” each as defined in the Addendum (as it may be amended from time to time), collectively referred to as qualified
investors (in each case, purchasing for their own account or, where permitted under the Addendum, for the accounts of their clients
who are investors listed in the Addendum). Qualified investors are required to submit written confirmation that they fall within
the scope of the Addendum, are aware of the meaning of same and agree to it.
United Kingdom
This prospectus supplement
is only being distributed to, and is only directed at, persons in the United Kingdom that are qualified investors within the meaning
of Article 2(1)(e) of the Prospectus Directive that are also (i) investment professionals falling within Article 19(5) of the Financial
Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended, or the Order, and/or (ii) high net worth entities falling
within Article 49(2)(a) to (d) of the Order and other persons to whom it may lawfully be communicated (each such person being referred
to as a “relevant person”).
This prospectus supplement
and its contents are confidential and should not be distributed, published or reproduced (in whole or in part) or disclosed by
recipients to any other persons in the United Kingdom. Any person in the United Kingdom that is not a relevant person should not
act or rely on this document or any of its contents.
Legal Matters
The validity of the
securities offered hereby will be passed upon by Yigal Arnon & Co. Aegis Capital Corp. is being represented in connection with
this offering by Sichenzia Ross Ference LLP, New York, New York.
Experts
Our audited consolidated
financial statements included in our Annual Report on Form 20-F for the year ended December 31, 2018 are incorporated herein by
reference in reliance on the report of Yarel + Partners, an independent registered public accounting firm, given on the authority
of such firm as an expert in accounting and auditing.
Where You
Can Find More Information
We file annual reports
on Form 20-F, reports on Form 6-K, and other information with the SEC under the Exchange Act. The SEC maintains an Internet site
that contains reports and other information that we file electronically with the SEC and which are available at the SEC’s
website at http://www.sec.gov. In addition, we maintain an Internet website at www.enlivex.com. Information contained
on, or accessible through, our website is not incorporated into or made a part of this prospectus supplement or the accompanying
prospectus or the registration statement of which this prospectus supplement and the accompanying prospectus form a part.
This prospectus supplement
is part of a registration statement on Form F-3 that we filed with the SEC to register the securities to be offered hereby. This
prospectus supplement does not contain all of the information included in the registration statement, including certain exhibits
and schedules. You may obtain the registration statement and exhibits to the registration statement from the SEC at the address
listed above or from the SEC’s website listed above.
Incorporation
of Certain Documents by Reference
The SEC allows us to
incorporate by reference certain information that we filed with the SEC prior to the date of this prospectus supplement and that
we will file in the future, which means that we can disclose important information to you by referring you to those documents.
The information that we incorporate by reference is considered to be part of this prospectus supplement and the accompanying prospectus
and should be read with the same care. Information that we file with the SEC in the future and incorporate by reference in this
prospectus supplement automatically updates and supersedes previously filed information as applicable.
We incorporate by reference
into this prospectus supplement the following documents filed by us with the SEC, other than any portion of any such documents
that is not deemed “filed” under the Exchange Act in accordance with the Exchange Act and applicable SEC rules:
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●
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Annual Report on Form 20-F for the year ended December 31, 2018, filed with the SEC on April 30, 2019; and
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●
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Our Reports on Form 6-K filed with the SEC on May 20, 2019, July 26, 2019, September 30, 2019, October 24, 2019 and November 14, 2019.
|
All annual reports
we file with the SEC pursuant to the Exchange Act on Form 20-F after the date of this prospectus supplement and prior to termination
or expiration of the registration statement of which this prospectus supplement forms a part shall be deemed incorporated herein
by reference and to be part hereof from the date of filing of such documents. We may incorporate by reference any Form 6-K subsequently
submitted to the SEC by identifying in such Form 6-K that it is being incorporated by reference into this prospectus supplement.
Any statement contained
in a document incorporated or deemed to be incorporated by reference in this prospectus supplement or in the accompanying prospectus
shall be deemed to be modified or superseded for purposes of this prospectus supplement or the accompanying prospectus, as applicable,
to the extent that a statement contained herein, therein or in any subsequently filed document that is also incorporated by reference
herein or therein modifies or replaces such statement. Any statements so modified or superseded shall not be deemed, except as
so modified or superseded, to constitute a part of this prospectus supplement or the accompanying prospectus.
We will provide without
charge to each person, including any shareholder, to whom a prospectus supplement is delivered, upon written or oral request of
that person, a copy of any and all of the information incorporated by reference in this prospectus supplement or in the accompanying
prospectus. Please direct requests to us at the following address:
Enlivex Therapeutics
Ltd.
Attention: Shachar Shlosberger
14 Einstein Street
Nes Ziona
Israel 7403618
Tel: +972.2.6708072
Exhibits to the filings
will not be sent, however, unless those exhibits have specifically been incorporated by reference in such filings
PROSPECTUS
$100,000,000
ENLIVEX
THERAPEUTICS LTD.
Ordinary Shares
Warrants
Units
We may from time to time sell our ordinary
shares, warrants and units described in this prospectus in one or more offerings. The aggregate initial offering price of the securities
that we may offer and sell under this prospectus will not exceed $100,000,000.
This prospectus provides a general description
of these securities, which we may offer and sell in amounts, at prices and on terms to be determined at the time of sale and set
forth in a supplement to this prospectus. Each time we sell the securities described in this prospectus, we will provide specific
terms of the securities offered in a supplement to this prospectus. The prospectus supplement may also add, update or change information
contained in this prospectus. You should read this prospectus and the applicable prospectus supplement carefully before you invest
in any of our securities. This prospectus may not be used to consummate a sale of our securities unless accompanied by an applicable
prospectus supplement.
We may offer the securities from time through
public or private transactions, and in the case of our ordinary shares, on or off the Nasdaq Capital Market, at prevailing market
prices or at privately negotiate prices. These securities may be offered and sold in the same offering or in separate offerings,
to or through underwriters, dealers and agents, or directly to purchasers. The names of any underwriters, dealers, or agents involved
in the sale of our securities registered hereunder and any applicable fees, commissions or discounts will be described in the applicable
prospectus supplement. Our net proceeds from the sale of securities will also be set forth in the applicable prospectus supplement.
Our ordinary shares are traded on the Nasdaq
Capital Market under the symbol “ENLV.”
Investing in our securities involves
risks. See “RISK FACTORS” beginning on page 2 for information you should consider before investing in our securities.
Neither the Securities and Exchange Commission
nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of
this prospectus. Any representation to the contrary is a criminal offense.
The date of this prospectus is June 21, 2019
TABLE OF CONTENTS
About This
Prospectus
This
prospectus is part of a “shelf” registration statement on Form F-3 that we filed with the United States Securities
and Exchange Commission, or the SEC. Under this shelf registration statement, we may sell any one or more or a combination of the
securities described in this prospectus in one or more offerings, up to a total dollar amount of $100,000,000. This prospectus
provides you with a general description of the securities we may offer. Each time we use this prospectus to offer securities, we
will provide a prospectus supplement that contains specific information about any offering by us with respect to the securities
registered hereunder. The prospectus supplement may also add, update or change the information contained in this prospectus. You
should read carefully both this prospectus, any prospectus supplement and any free writing prospectus related to the applicable
offering that is prepared by us or on our behalf or that is otherwise authorized by us, together with additional information described
under the heading “Where You Can Find More Information” located on page 19.
You
should rely only on the information contained or incorporated by reference in this prospectus, any prospectus supplement and any
free writing prospectus related to the applicable offering of securities that is prepared by us or on our behalf or that is otherwise
authorized by us. We have not authorized any other person to provide you with different information. You must not rely upon any
information or representation not contained or incorporated by reference in this prospectus, any accompanying prospectus supplement
or any free writing prospectus that is prepared by us or on our behalf or that is otherwise authorized by us. This prospectus and
any accompanying supplement to this prospectus do not constitute an offer to sell or the solicitation of an offer to buy any securities
other than the registered securities to which they relate, nor do this prospectus and any accompanying supplement constitute an
offer to sell or the solicitation of an offer to buy securities in any jurisdiction to any person to whom it is unlawful to make
such offer or solicitation in such jurisdiction. You should not assume that the information contained in this prospectus and any
accompanying prospectus supplement is accurate on any date subsequent to the date set forth on the front of this prospectus and
such accompanying prospectus supplement or that any information we have incorporated by reference is correct on any date subsequent
to the date of the document incorporated by reference, even though this prospectus and any accompanying prospectus supplement are
delivered, or securities sold, on a later date.
References in this
prospectus to the “Registrant,” “Enlivex,” “we,” “us” and “our” refer
to Enlivex Therapeutics Ltd., a company organized under the laws of the State of Israel, and its consolidated subsidiaries, unless
the context requires otherwise.
Risk Factors
Investing in our securities
involves risks. Before deciding to purchase any of our securities, you should carefully consider the discussion of risks and uncertainties
under the heading “Risk Factors” contained in our Annual Report on Form 20-F for the fiscal year ended December 31,
2018, which is incorporated by reference in this prospectus, and under similar headings in our subsequently filed reports on Form
6-K and annual reports on Form 20-F, as well as the other risks and uncertainties described in any applicable prospectus supplement
or free writing prospectus and in the other documents incorporated by reference in this prospectus. See the section entitled “Where
You Can Find More Information” in this prospectus. The risks and uncertainties we discuss in the documents incorporated by
reference in this prospectus are those we currently believe may materially affect our business, prospects, financial condition
and results of operation. Additional risks and uncertainties not presently known to us or that we currently believe are immaterial
also may materially and adversely affect our business, prospects, financial condition and results of operations.
Cautionary
Statement Regarding Forward-Looking Statements
This prospectus 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:
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our expectations regarding the timing of clinical trials with respect to Allocetra™;
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the continued listing of our ordinary shares on Nasdaq;
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our expectations regarding the progress of our clinical trials, including the duration, cost and whether such trials will be
conducted at all;
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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;
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●
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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;
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the likelihood of regulatory approvals for any product candidate we may develop;
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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;
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future sales of our product candidates or any other future products or product candidates;
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our ability to achieve favorable pricing for our product candidates;
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the potential for our product candidates to receive orphan drug designations;
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that any product candidate we develop potentially offers effective solutions for various diseases;
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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;
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third-party payer reimbursement for our current or any future product candidates;
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our estimates regarding anticipated expenses, capital requirements and our needs for substantial additional financing;
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patient market sizes and market adoption of our current or any future product candidates by physicians and patients;
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completion and receiving favorable results of clinical trials for our product candidates;
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protection of our intellectual property, including issuance of patents to us by the United States Patent and Trademark Office,
or USPTO, and other governmental patent agencies;
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our intention to pursue marketing and orphan drug exclusivity periods that are available to us under regulatory provisions
in certain countries;
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the development and approval of the use of our current or any future product candidates for additional indications other than
complications associated with bone marrow transplants, GvHD and preventing cytokine storm associated organ failure in sepsis patients;
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our expectations regarding commercial and pre-commercial activities;
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our expectations regarding licensing, acquisitions, and strategic operations; and
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In some cases, forward-looking statements
are identified by terminology such as “may,” “will,” “could,” “should,” “expects,”
“plans,” “anticipates,” “believes,” “intends,” “estimates,” “predicts,”
“hopes,” “targets,” “potential,” 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. 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 prospectus or in our Annual Report
on Form 20-F for the fiscal year ended December 31, 2018, which is incorporated by reference in this prospectus, would not be interpreted
differently in light of additional research, clinical and preclinical trails results. Factors which could cause actual results
to differ materially from those indicated by the forward-looking statements include those factors described under the caption “Risk
Factors” in our Annual Report on Form 20-F for the fiscal year ended December 31, 2018, which is incorporated by reference
in this prospectus, as well as the other risks and uncertainties described in any applicable prospectus supplement or free writing
prospectus and in the other documents incorporated by reference in this prospectus. 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, after the date of this prospectus.
Our Company
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 the hyper-expression of cytokines
(Cytokine Release Syndrome) and for which there are no U.S. Food and Drug Administration-approved treatments, as well as treating
solid tumors via modulating immune-checkpoint rebalancing. The Company’s innovative immunotherapy candidate, Allocetra™,
is a novel immunotherapy candidate based on a unique mechanism of action that targets clinical indications that are defined as
“unmet medical needs” such as preventing or treating complications associated with bone marrow transplants and/or hematopoietic
stem cell transplants, sepsis and acute multiple organ failure. The Company also intends to develop its cell-based therapy to be
combined with effective treatments of solid tumors via immune checkpoint rebalancing to increase the efficacy of various anti-cancer
therapies, including Chimeric Antigen Receptor T-Cell Therapy and therapies targeting T-Cell Receptor Therapy.
On March 26, 2019,
the Company (f/k/a Bioblast Pharma Ltd.), and Enlivex Therapeutics R&D Ltd., referred to as Enlivex R&D (f/k/a Enlivex
Therapeutics Ltd.), consummated a merger transaction whereby Enlivex R&D merged with a merger subsidiary of the Company, with
Enlivex R&D as the surviving entity in the merger, referred to as the Merger. As a result of the Merger, Enlivex R&D became
a wholly owned subsidiary of the Company. Concurrently with the Merger, the Company changed its name to Enlivex Therapeutics Ltd.
Certain Information About Us In This
Prospectus
We were originally incorporated on January
22, 2012 under the laws of the State of Israel as Bioblast Pharma Ltd. Upon consummation of the Merger, we changed our name to
Enlivex Therapeutics Ltd. Our primary operating subsidiary, Enlivex Therapeutics R&D Ltd. ,was incorporated in September 2005
under the laws of the State of Israel as an Israeli privately held company under the name Tolarex Ltd. In February 2010, Enlivex
R&D changed its name to Enlivex Therapeutics Ltd., and, upon consummation of the Merger, to Enlivex Therapeutics R&D Ltd.
Our principal executive offices are located at 14 Einstein Street, Nes Ziona, Israel 7403618, and our telephone number is: +972
26208072.
Use of Proceeds
Unless we specify otherwise
in the applicable prospectus supplement, we expect to use the net proceeds from the sale of the securities offered hereby for general
corporate purposes, which may include:
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acquisitions of assets and businesses;
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repayment of indebtedness outstanding at that time; and
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general working capital.
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Any specific allocation
of the net proceeds of an offering of securities to a specific purpose will be determined at the time of such offering and will
be described in the related supplement to this prospectus.
Description
of Ordinary Shares
General
This prospectus describes the general terms
of our ordinary shares, which description is qualified in its entirety by reference to applicable Israeli law and the terms and
provisions contained in our amended and restated articles of association. When we offer to sell ordinary shares, we will describe
the specific terms of such offering in a supplement to this prospectus. Accordingly, for a description of the terms of a particular
offering of our ordinary shares, you must refer to both this prospectus and the applicable prospectus supplement. To the extent
the information contained in the prospectus supplement differs from this summary description, you should rely on the information
contained in the prospectus supplement.
Under our amended and restated articles
of association, the total number of shares of all classes of stock that we have authority to issue is 45,000,000 ordinary shares
with a par value of NIS 0.40 per share. As of June 5, 2019, there were 10,113,707 ordinary shares outstanding.
Rights, Preferences,
Restrictions of Shares and Shareholders Meetings
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General. Our share capital is NIS 18,000,000 divided into 45,000,000 ordinary shares with
a nominal value of NIS 0.40 each.
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Voting. The ordinary shares do not have cumulative voting rights in the election of directors.
As a result, the holders of ordinary shares that represent more than 50% of the voting power have the power to elect all the members
of our board of directors (the “Board of Directors”).
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Dividend and liquidation rights. Our Board of Directors may declare a dividend to be paid
to the holders of our ordinary shares according to their rights and interests in our profits and may fix the record date for eligibility
and the time for payment. Our Board of Directors may determine that a dividend may be paid, wholly or partially, by the distribution
of certain of our assets or by a distribution of paid up shares, debentures or debenture stock or any of our securities or of any
other companies or in any one or more of such ways in the manner and to the extent permitted by the Israeli Companies Law 5759-1999
(the “Companies Law”).
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Transfer of shares; record dates. Fully paid up ordinary shares may be freely transferred
pursuant to our amended and restated articles of association unless such transfer is restricted or prohibited by another instrument
or securities laws. Each shareholder who would be entitled to attend and vote at a general meeting of shareholders is entitled
to receive notice of any such meeting. For purposes of determining the shareholders entitled to notice and to vote at such meeting,
the Board of Directors will fix a record date.
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Voting; annual general and extraordinary meetings. Subject to any rights or restrictions
for the time being attached to any class or classes of shares, each shareholder shall have one vote for each share of which he
or she is the holder, whether on a show of hands or on a poll. Our amended and restated articles of association do not permit cumulative
voting and it is not mandated by Israeli law. Votes may be given either personally or by proxy. A proxy need not be a shareholder.
If any shareholder is without legal capacity, he may vote by means of a trustee or a legal custodian, who may vote either personally
or by proxy. If two or more persons are jointly entitled to a share then, in voting upon any question, the vote of the senior person
who tenders a vote, whether in person or by proxy, shall be accepted to the exclusion of the votes of the other registered holders
of the share and, for this purpose seniority shall be determined by the order in which the names stand in the shareholder register.
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Quorum for general meetings. The quorum required for our general meetings of shareholders
consists of at least two shareholders present in person, by proxy or written ballot who holds or represent between them at least
one-third of the total outstanding voting rights. A meeting adjourned for lack of a quorum is generally adjourned to the same day
in the following week at the same time and place or to a later time/date if so specified in the summons or notice of the meeting.
At the reconvened meeting, any two or more shareholders present in person or by proxy shall constitute a lawful quorum.
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Notice of general meetings. Unless a longer period for notice is prescribed by the Companies
Law, at least 4 days and not more than 40 days’ notice of any general meeting shall be given, specifying the place, the day
and the hour of the meeting and, in the case of special business, the nature of such business, shall be given in the manner hereinafter
mentioned, to such shareholders as are under the provisions of our amended and restated articles of association, entitled to receive
notices from us. Only shareholders of record as reflected on our share register at the close of business on the date fixed by the
Board of Directors as the record date determining the then shareholders who will be entitled to vote, shall be entitled to notice
of, and to vote, in person or by proxy, at a general meeting and any postponement or adjournment thereof.
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Annual; agenda; calling a general meeting. General meetings are held at least once in every
calendar year at such time (within a period of 15 months after the holding of the last preceding general meeting), and at such
time and place as may be determined by the Board of Directors. At a general meeting, decisions shall be adopted only on matters
that were specified on the agenda. The Board of Directors is obligated to call an extraordinary general meeting of the shareholders
upon a written request in accordance with the Companies Law. The Companies Law provides that an extraordinary general meeting of
shareholder may be called by the Board of Directors or by a request of two directors or 25% of the directors in office, or by shareholders
holding at least 5% of the issued share capital of the company and at least 1% of the voting rights, or of shareholders holding
at least 5% of the voting rights of the company.
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Majority vote. Except as otherwise provided in the amended and restated articles of association,
any resolution at a general meeting shall be deemed adopted if approved by the holders of a majority of our voting rights represented
at the meeting in person or by proxy and voting thereon. In the case of an equality of votes, the chairman of the meeting shall
not be entitled to a further vote.
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Discrimination against shareholders. According to our amended and restated articles of association,
there are no discriminating provisions against any existing or prospective holders of our shares as a result of a shareholder holding
a substantial number of shares.
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Modification of Class Rights
If, at any time, the
share capital is divided into different classes of shares, the rights attached to any class (unless otherwise provided by the terms
of issuance of the shares of that class) may be varied with the consent in writing of the holders of all the issued shares of that
class, or with the sanction of a majority vote at a meeting of the shareholders passed at a separate meeting of the holders of
the shares of the class. The provisions of our amended and restated articles of association relating to general meetings shall
apply, mutatis mutandis, to every such separate general meeting. Any holder of shares of the class present in person or by proxy
may demand a secret poll.
Unless otherwise provided
by the conditions of issuance, the enlargement of an existing class of shares, or the issuance of additional shares thereof, shall
not be deemed to modify or abrogate the rights attached to the previously issued shares of such class or of any other class. These
conditions provide for the minimum shareholder approvals permitted by the Companies Law.
Restrictions on Shareholders Rights to Own Securities
Our amended and restated
articles of association and the laws of the State of Israel do not restrict in any way the ownership or voting or our shares by
non-residents of Israel, except with respect to subjects of countries which are in a state of war with Israel.
Securities Register
We are registered with
the Israeli Registrar of Companies. Our registration number is 51-471648-9. Our amended and restated articles of association provide
that we may engage in any type of lawful business.
Board of Directors
The Companies Law requires
that certain transactions, actions and arrangements be approved as provided for in a company’s articles of association and
in certain circumstances by the Company’s Audit Committee, Company’s the Compensation Committee, by the Board of Directors
itself and by the shareholders. The vote required by the Audit Committee, Compensation Committee and the Board of Directors for
approval of such matters, in each case, is a majority of the disinterested directors participating in a duly convened meeting.
If, however, a majority of the members participating in such meeting have a personal interest in the approval of such matter, then
all directors may participate in the discussions and the voting on approval thereof and in such case the matter shall be subject
to further shareholder approval.
The Companies Law
requires that an office holder promptly disclose to the Board of Directors any personal interest that he or she may have concerning
any existing or proposed transaction with a company, as well as any substantial information or document with respect thereof. An
interested office holder’s disclosure must be made promptly and in any event no later than the first meeting of the Board
of Directors at which the transaction is considered. A personal interest includes an interest of any person in an act or transaction
of a company, including a personal interest of one’s relative or of a corporate body in which such person or a relative of
such person is a 5% or greater shareholder, director or general manager or in which he or she has the right to appoint at least
one director or the general manager, but excluding a personal interest stemming from one’s ownership of shares in the company.
A personal interest furthermore includes the personal interest of a person for whom the office holder holds a voting proxy or the
interest of the office holder with respect to his or her vote on behalf of the shareholder for whom he or she holds a proxy even
if such shareholder itself has no personal interest in the approval of the matter. An office holder is not, however, obliged to
disclose a personal interest if it derives solely from the personal interest of a relative of such office holder in a transaction
that is not considered an extraordinary transaction. Under the Companies Law, an extraordinary transaction is defined as any of
the following:
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a transaction other than in the ordinary course of business;
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a transaction that is not on market terms; or
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a transaction that may have a material impact on a company’s profitability, assets or liabilities.
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If it is determined
that an office holder has a personal interest in a transaction, approval by the Board of Directors is required for the transaction,
unless the company’s articles of association provide for a different method of approval. Further, so long as an office holder
has disclosed his or her personal interest in a transaction, the Board of Directors may approve an action by the office holder
that would otherwise be deemed a breach of duty of loyalty. However, a company may not approve a transaction or action that is
adverse to the company’s interest or that is not performed by the office holder in good faith. Approval first by the company’s
Audit Committee and subsequently by the Board of Directors is required for an extraordinary transaction in which an office holder
has a personal interest. Arrangements regarding the compensation, indemnification or insurance of an office holder require the
approval of the Compensation Committee, Board of Directors and, in certain circumstances, the shareholders, in that order.
Pursuant to Israeli
law, the disclosure requirements regarding personal interests that apply to directors and executive officers also apply to a controlling
shareholder of a public company. The term “controlling shareholder” is defined in the Companies Law as a shareholder
with the ability to direct the activities of the company, other than by virtue of being an office holder. A shareholder is presumed
to be a controlling shareholder if the shareholder holds 50% or more of the voting rights in a company or has the right to appoint
the majority of the directors of the company or its general manager.
In the context of
(i) extraordinary transactions with a controlling shareholder or in which a controlling shareholder has a personal interest, (ii)
certain private placements in which the controlling shareholder has a personal interest, (iii) certain transactions with a controlling
shareholder or relative with respect to services provided to or employment by the company, (iv) the terms of employment and compensation
of the general manager, and (v) the terms of employment and compensation of office holders of the company when such terms deviate
from the compensation policy previously approved by the company’s shareholders, the definition of a “controlling shareholder”
also includes any shareholder who holds 25% or more of the voting rights if no other shareholder holds more than 50% of the voting
rights. Two or more shareholders with a personal interest in the approval of the same transaction are deemed to be a single shareholder
and may be deemed a controlling shareholder for the purpose of approving such transaction. Extraordinary transactions, including
private placement transactions, with a controlling shareholder or in which a controlling shareholder has a personal interest, and
engagements with a controlling shareholder or his or her relative, directly or indirectly, including through a corporation in his
or her control, require the approval of the Audit Committee, the Board of Directors and the shareholders of the company, in that
order. In addition, the shareholder approval must fulfill one of the following requirements:
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a disinterested majority; or
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the votes of shareholders who have no personal interest in the transaction and who are present
and voting, in person, by proxy or by voting deed at the meeting, and who vote against the transaction may not represent more than
two percent (2%) of the voting rights of the company.
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To the extent that
any such transaction with a controlling shareholder is for a period extending beyond three years, approval is required once every
three years, unless the Audit Committee determines that the duration of the transaction is reasonable given the circumstances related
thereto.
Arrangements regarding
the terms of engagement and compensation of a controlling shareholder who is an office holder, and the terms of employment of a
controlling shareholder who is an employee of the company, require the approval of the Compensation Committee, Board of Directors
and, generally, the shareholders, in that order.
Under the Companies
Law, generally, actions taken by an office holder which were in excess of his or her authority or without authorization (other
than those which contravened the purposes of the company), may be approved retroactively by the same organ of governance of a company
that should have originally approved that action and by the same majority, provided further that the act was performed bona fide
and for the benefit of the company.
Pursuant to Israeli
law, a director who has a personal interest in an extraordinary transaction which is brought for discussion before our Board of
Directors or our Audit Committee shall neither vote in nor attend discussions concerning the approval of such transaction. If the
director did vote or attend as aforesaid, the approval given to the aforesaid activity or arrangement will be invalid.
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Our amended and restated articles of association provide that, subject to the Companies Law, our
Board of Directors may delegate its authority, in whole or in part, to such committees of the Board of Directors as it deems appropriate,
and it may from time to time revoke such delegation.
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Arrangements regarding compensation of directors require the approval of the Compensation Committee,
our Board of Directors and the shareholders.
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Borrowing Powers
Pursuant to the Companies
Law and our amended and restated articles of association, our Board of Directors may exercise all powers and take all actions that
are not required under law or under our amended and restated articles of association to be exercised or taken by our shareholders
or other corporate bodies, including the power to borrow money for company purposes.
Acquisitions under
Israeli Law
Full tender offer
A person wishing to
acquire shares of an Israeli public company and who would as a result hold over 90% of the target company’s issued and outstanding
share capital or of the issued and outstanding share capital of a certain class of shares is required by the Companies Law to make
a tender offer to all of the company’s shareholders for the purchase of all of the issued and outstanding shares of the company
or of all of the issued and outstanding shares of the same class.
If the shareholders
who do not respond to or accept the offer hold less than 5% of the issued and outstanding share capital of the company or of the
applicable class of the shares, and more than half of the shareholders who do not have a personal interest in the offer accept
the offer, all of the shares that the acquirer offered to purchase will be transferred to the acquirer by operation of law. However,
a tender offer will be accepted, even without the approval of a disinterested majority, if the shareholders who do not accept it
hold less than 2% of the issued and outstanding share capital of the company or of the applicable class of the shares.
Upon a successful completion
of such a full tender offer, any shareholder that was an offeree in such tender offer, whether such shareholder accepted the tender
offer or not, may, within six months from the date of acceptance of the tender offer, petition the Israeli court to determine whether
the tender offer was for less than fair value and that the fair value should be paid as determined by the court. However, under
certain conditions, the offeror may determine in the terms of the tender offer that an offeree who accepted the offer will not
be entitled to petition the Israeli court as described above.
If the shareholders
who did not respond or accept the tender offer hold at least 5% of the issued and outstanding share capital of the company or of
the applicable class, the acquirer may not acquire shares of the company that will increase its holdings to more than 90% of the
company’s issued and outstanding share capital or of the applicable class from shareholders who accepted the tender offer.
Special tender offer
The Companies Law provides
that an acquisition of shares of an Israeli public company must be made by means of a special tender offer if as a result of the
acquisition the purchaser would become a holder of at least 25% of the voting rights in the company. This rule does not apply if
there is already another holder of at least 25% of the voting rights in the company.
Similarly, the Companies
Law provides that an acquisition of shares in a public company must be made by means of a special tender offer if as a result of
the acquisition the purchaser would become a holder of more than 45% of the voting rights in the company, if there is no other
shareholder of the company who holds more than 45% of the voting rights in the company.
These requirements
do not apply if the acquisition (i) occurs in the context of a private offering, on the condition that the shareholders meeting
approved the acquisition as a private offering whose purpose is to give the acquirer at least 25% of the voting rights in the company
if there is no person who holds at least 25% of the voting rights in the company, or as a private offering whose purpose is to
give the acquirer 45% of the voting rights in the company, if there is no person who holds 45% of the voting rights in the company;
(ii) was from a shareholder holding at least 25% of the voting rights in the company and resulted in the acquirer becoming a holder
of at least 25% of the voting rights in the company; or (iii) was from a holder of more than 45% of the voting rights in the company
and resulted in the acquirer becoming a holder of more than 45% of the voting rights in the company.
A special tender offer
must be extended to all shareholders of a company, but the offeror is not required to purchase shares representing more than 5%
of the voting power attached to the company’s outstanding shares, regardless of how many shares are tendered by shareholders.
The special tender offer may be consummated only if (i) at least 5% of the voting power attached to the company’s outstanding
shares will be acquired by the offeror and (ii) the special tender offer is accepted by a majority of the votes of those offerees
who gave notice of their position in respect of the offer; in counting the votes of offerees, the votes of a holder of control
in the offeror, a person who has personal interest in acceptance of the special tender offer, a holder of at least 25% of the voting
rights in the company, or any person acting on their or on the offeror’s behalf, including their relatives or companies under
their control, are not taken into account.
In the event that a
special tender offer is made, a company’s Board of Directors is required to express its opinion on the advisability of the
offer or shall abstain from expressing any opinion if it is unable to do so, provided that it gives the reasons for its abstention.
An office holder in
a target company who, in his or her capacity as an office holder, performs an action the purpose of which is to cause the failure
of an existing or foreseeable special tender offer or is to impair the chances of its acceptance, is liable to the potential purchaser
and shareholders for damages resulting from his acts, unless such office holder acted in good faith and had reasonable grounds
to believe he or she was acting for the benefit of the company. However, office holders of the target company may negotiate with
the potential purchaser in order to improve the terms of the special tender offer, and may further negotiate with third parties
in order to obtain a competing offer.
If a special tender
offer was accepted by a majority of the shareholders who announced their stand on such offer, then shareholders who did not respond
to the special offer or had objected to the special tender offer may accept the offer within four days of the last day set for
the acceptance of the offer.
In the event that a
special tender offer is accepted by the disinterested majority, then the purchaser or any person or entity controlling it and any
corporation controlled by them shall refrain from making a subsequent tender offer for the purchase of shares of the target company
and may not execute a merger with the target company for a period of one year from the date of the offer, unless the purchaser
or such person or entity undertook to effect such an offer or merger in the initial special tender offer.
Merger
The Companies Law permits
merger transactions if approved by each party’s Board of Directors and, unless certain requirements described under the Companies
Law are met, a majority of each party’s shareholders, by a majority of each party’s shares that are voted on the proposed
merger at a shareholders’ meeting.
The Board of Directors
of a merging company is required pursuant to the Companies Law to discuss and determine whether in its opinion there exists a reasonable
concern that as a result of a proposed merger, the surviving company will not be able to satisfy its obligations towards its creditors,
taking into account the financial condition of the merging companies. If the Board of Directors has determined that such a concern
exists, it may not approve a proposed merger. Following the approval of the Board of Directors of each of the merging companies,
the Boards of Directors must jointly prepare a merger proposal for submission to the Israeli Registrar of Companies.
For purposes of the
shareholder vote, unless a court rules otherwise, the merger will not be deemed approved if a majority of the shares voting at
the shareholders meeting (excluding abstentions) that are held by parties other than the other party to the merger, any person
who holds 25% or more of the means of control of the other party to the merger or any one on their behalf including their relatives
or corporations controlled by any of them, vote against the merger.
If the transaction
would have been approved but for the separate approval of each class of shares or the exclusion of the votes of certain shareholders
as provided above, a court may still rule that the company has approved the merger upon the request of holders of at least 25%
of the voting rights of a company, if the court holds that the merger is fair and reasonable, taking into account the appraisal
of the merging companies’ value and the consideration offered to the shareholders.
Under the Companies
Law, each merging company must send a copy of the proposed merger plan to its secured creditors. Unsecured creditors are entitled
to receive notice of the merger, as provided by the regulations promulgated under the Companies Law. Upon the request of a creditor
of either party to the proposed merger, the court may delay or prevent the merger if it concludes that there exists a reasonable
concern that, as a result of the merger, the surviving company will be unable to satisfy the obligations of the target company.
The court may also give instructions in order to secure the rights of creditors.
In addition, a merger
may not be completed unless at least 50 days have passed from the date that a proposal for approval of the merger was filed with
the Israeli Registrar of Companies and 30 days from the date that shareholder approval of both merging companies was obtained.
Potential Issues that Could Delay a Merger
Certain provisions
of Israeli corporate and tax law may have the effect of delaying, preventing or making more difficult any merger or acquisition
of us.
Requirement of
Disclosure of Shareholder Ownership
There are no provisions
of our amended and restated articles of association governing the ownership threshold above which shareholder ownership must be
disclosed. We are subject, however, to U.S. securities rules that require beneficial owners of more than 5% of our ordinary shares
to make certain filings with the SEC.
Changes in Capital
Our amended and restated
articles of association do not impose any conditions governing changes in capital that are more stringent than required by the
Companies Law.
Listing
Our ordinary shares
are traded on the Nasdaq Capital Market under the symbol “ENLV.”
Description
of Warrants
General
We may issue warrants
to purchase our ordinary shares. The warrants may be issued independently or together with ordinary shares offered by this prospectus
and may be attached to or separate from those ordinary shares.
While the terms we
have summarized below will apply generally to any warrants we may offer under this prospectus, we will describe the particular
terms of any warrants that we may offer in more detail in the applicable prospectus supplement. The terms of any warrants we offer
under a prospectus supplement may differ from the terms we describe below, and you should refer to the applicable prospectus supplement
for the specific terms of any warrants that we offer.
We may issue the warrants
under a warrant agreement, which we will enter into with a warrant agent to be selected by us. Each warrant agent will act solely
as our agent under the applicable warrant agreement and will not assume any obligation or relationship of agency or trust with
any holder of any warrant. A single bank or trust company may act as warrant agent for more than one issue of warrants. A warrant
agent will have no duty or responsibility in case of any default by us under the applicable warrant agreement or warrant, including
any duty or responsibility to initiate any proceedings at law or otherwise, or to make any demand upon us. Any holder of a warrant
may, without the consent of the related warrant agent or the holder of any other warrant, enforce by appropriate legal action its
right to exercise, and receive the ordinary shares purchasable upon exercise of, its warrants.
We may issue warrants
in such numerous distinct series as we determine.
We will incorporate
by reference into the registration statement of which this prospectus forms a part the form of warrant agreement, including a form
of warrant certificate, that describes the terms of the series of warrants we are offering before the issuance of the related series
of warrants. The following summaries of material provisions of the warrants and the warrant agreements are subject to, and qualified
in their entirety by reference to, all the provisions of the warrant agreement applicable to a particular series of warrants. We
urge you to read the applicable prospectus supplements related to the warrants that we sell under this prospectus, as well as the
complete warrant agreements that contain the terms of the warrants.
We will set forth in
the applicable prospectus supplement the terms of the warrants in respect of which this prospectus is being delivered, including,
when applicable, the following:
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the title of the warrants;
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the aggregate number of the warrants;
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the price or prices at which the warrants will be issued;
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the designation, number, and terms of ordinary shares purchasable upon exercise of the warrants;
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the date, if any, on and after which the warrants and the related ordinary shares will be separately
transferable;
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the price at which each ordinary share purchasable upon exercise of the warrants may be purchased;
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the date on which the right to exercise the warrants will commence and the date on which such right
will expire;
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the minimum or maximum amount of the warrants that may be exercised at any one time;
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any information with respect to book-entry procedures;
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the effect of any merger, consolidation, sale, or other disposition of our business on the warrant
agreement and the warrants;
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any other terms of the warrants, including terms, procedures, and limitations relating to the transferability,
exchange, and exercise of such warrants;
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the terms of any rights to redeem or call, or accelerate the expiration of, the warrants;
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the date on which the right to exercise the warrants begins and the date on which that right expires;
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the material U.S. federal income tax consequences of holding or exercising the warrants; and
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any other specific terms, preferences, rights, or limitations of, or restrictions on, the warrants.
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Unless specified in
an applicable prospectus supplement, warrants will be in registered form only.
A holder of warrant
certificates may exchange them for new certificates of different denominations, present them for registration of transfer, and
exercise them at the corporate trust office of the warrant agent or any other office indicated in the applicable prospectus supplement.
Until any warrants are exercised, holders of the warrants will not have any rights of holders of the underlying ordinary shares,
including any rights to receive dividends or to exercise any voting rights, except to the extent set forth under the heading “Warrant
Adjustments” below.
Exercise of Warrants
Each warrant will entitle
the holder to purchase for cash ordinary shares at the applicable exercise price set forth in, or determined as described in, the
applicable prospectus supplement. If we so indicate in the applicable prospectus supplement, holders of the warrants may surrender
securities as all or a part of the exercise price for the warrants. Warrants may be exercised at any time up to the close of business
on the expiration date of the warrants, as set forth in the applicable prospectus supplement. After the close of business on the
expiration date, unexercised warrants will become void.
Warrants may be exercised
by delivering to the corporation trust office of the warrant agent or any other officer indicated in the applicable prospectus
supplement (a) the warrant certificate properly completed and duly executed and (b) payment of the amount due upon exercise. As
soon as practicable following exercise, we will issue the underlying ordinary shares subject to such exercise to the applicable
warrantholder. If less than all of the warrants represented by a warrant certificate are exercised, a new warrant certificate will
be issued for the remaining warrants.
Amendments and Supplements to the Warrant Agreements
We may amend or supplement
a warrant agreement without the consent of the holders of the applicable warrants to cure ambiguities in the warrant agreement,
to cure or correct a defective provision in the warrant agreement, or to provide for other matters under the warrant agreement
that we and the warrant agent deem necessary or desirable, so long as, in each case, such amendments or supplements do not materially
and adversely affect the interests of the holders of the warrants.
Warrant Adjustments
Unless the applicable
prospectus supplement states otherwise, the exercise price of, and the number of ordinary shares covered by a warrant will be adjusted
proportionately if we subdivide or combine our ordinary shares. In addition, unless the prospectus supplement states otherwise,
if we, without payment:
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issue capital stock or other securities convertible into or exchangeable for ordinary shares, or
any rights to subscribe for, purchase, or otherwise acquire ordinary shares, as a dividend or distribution to holders of our ordinary
shares;
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pay any cash to holders of our ordinary shares other than a cash dividend paid out of our current
or retained earnings;
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issue any evidence of our indebtedness or rights to subscribe for or purchase our indebtedness
to holders of our ordinary shares; or
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issue ordinary shares or additional stock or other securities or property to holders of our ordinary
shares by way of spinoff, split-up, reclassification, combination of shares, or similar corporate rearrangement,
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then the holders of warrants will be entitled
to receive upon exercise of the warrants, in addition to the ordinary shares otherwise receivable upon exercise of the warrants
and without paying any additional consideration, the amount of stock and other securities and property such holders would have
been entitled to receive had they held the ordinary shares issuable under the warrants on the dates on which holders of those securities
received or became entitled to receive such additional stock and other securities and property.
Except as stated above,
the exercise price and number of securities covered by a warrant, and the amounts of other securities or property to be received,
if any, upon exercise of those warrants, will not be adjusted or provided for if we issue those securities or any securities convertible
into or exchangeable for those securities, or securities carrying the right to purchase those securities or securities convertible
into or exchangeable for those securities.
Holders of warrants
may have additional rights under the following circumstances:
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certain reclassifications, capital reorganizations, or changes of the ordinary shares;
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certain share exchanges, mergers, or similar transactions involving us and which result in changes
of the ordinary shares; or
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certain sales or dispositions to another entity of all or substantially all of our property and
assets.
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If one of the above
transactions occurs and holders of our ordinary shares are entitled to receive stock, securities, or other property with respect
to or in exchange for their ordinary shares, the holders of the warrants then outstanding, as applicable, will be entitled to receive
upon exercise of their warrants the kind and amount of shares of stock and other securities or property that they would have received
upon the applicable transaction if they had exercised their warrants immediately before the transaction.
Description
of Units
The following description,
together with the additional information we include in any applicable prospectus supplement, summarizes the material terms and
provisions of the units that we may offer under this prospectus. Units may be offered independently or together with ordinary shares
and warrants offered by any prospectus supplement, and may be attached to or separate from those securities. While the terms we
have summarized below will generally apply to any units that we may offer under this prospectus, we will describe the particular
terms of any series of units that we may offer in more detail in the applicable prospectus supplement. The terms of any units offered
under a prospectus supplement may differ from the terms described below, and you should refer to the applicable prospectus supplement
for the specific terms of any units that we offer.
We will incorporate
by reference into the registration statement of which this prospectus forms a part the form of unit agreement, including a form
of unit certificate, if any, that describes the terms of the series of units we are offering before the issuance of the related
series of units. The following summaries of material provisions of the units and the unit agreements are subject to, and qualified
in their entirety by reference to, all the provisions of the unit agreement applicable to a particular series of units. We urge
you to read the applicable prospectus supplements related to the units that we sell under this prospectus, as well as the complete
unit agreements that contain the terms of the units.
General
We may issue units
consisting of ordinary shares and warrants. Each unit will be issued so that the holder of the unit is also the holder of each
security included in the unit. Thus, the holder of a unit will have the rights and obligations of a holder of each security included
in the unit. The unit agreement under which a unit is issued may provide that the securities included in the unit may not be held
or transferred separately, at any time, or at any time before a specified date.
We will describe in
the applicable prospectus supplement the terms of the series of units, including the following:
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the designation and terms of the units and of the securities comprising the units, including whether
and under what circumstances those securities may be held or transferred separately;
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any provisions of the governing unit agreement that differ from those described below; and
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any provisions for the issuance, payment, settlement, transfer, or exchange of the units or of
the securities comprising the units.
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The provisions described
in this section, as well as those described under “Description of Ordinary Shares” and “Description of Warrants,”
will apply to each unit and to any ordinary share or warrant included in each unit, respectively.
Issuance in Series
We may issue units
in such amounts and in such numerous distinct series as we determine.
Enforceability of Rights by Holders of Units
Each unit agent, if
any, will act solely as our agent under the applicable unit agreement and will not assume any obligation or relationship of agency
or trust with any holder of any unit. A single bank or trust company may act as unit agent for more than one series of units. A
unit agent will have no duty or responsibility in case of any default by us under the applicable unit agreement or unit, including
any duty or responsibility to initiate any proceedings at law or otherwise, or to make any demand upon us. Any holder of a unit,
without the consent of the related unit agent or the holder of any other unit, may enforce by appropriate legal action its rights
as holder under any security included in the unit.
Title
We, the unit agent,
and any of their agents may treat the registered holder of any unit certificate as an absolute owner of the units evidenced by
that certificate for any purposes and as the person entitled to exercise the rights attaching to the units so requested, despite
any notice to the contrary.
Plan of
Distribution
We may sell the securities offered hereby
from time to time pursuant to underwritten public offerings, negotiated transactions, block trades or a combination of these methods.
We may sell the securities (1) through underwriters or dealers, (2) through agents and/or (3) directly to one or more purchasers.
We may distribute the securities from time to time in one or more transactions:
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at a fixed price or prices, which may be changed;
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at market prices prevailing at the time of sale;
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at prices related to such prevailing market prices; or
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We may directly solicit offers to purchase
the securities being offered by this prospectus. We may also designate agents to solicit offers to purchase the securities from
time to time. We will name in a prospectus supplement any agent involved in the offer or sale of our securities.
If we utilize a dealer in the sale of the
securities being offered by this prospectus, we will sell the securities to the dealer, as principal. The dealer may then resell
the securities to the public at varying prices to be determined by the dealer at the time of resale.
If we utilize an underwriter in the sale
of the securities being offered by this prospectus, we will execute an underwriting agreement with the underwriter at the time
of sale and provide the name of any underwriter in the prospectus supplement that the underwriter will use to make resales of the
securities to the public. In connection with the sale of the securities, we, or the purchasers of securities for whom the underwriter
may act as agent, may compensate the underwriter in the form of underwriting discounts or commissions. The underwriter may sell
the securities to or through dealers, and the underwriter may compensate those dealers in the form of discounts, concessions or
commissions.
We will provide in the applicable prospectus
supplement any compensation we pay to underwriters, dealers or agents in connection with the offering of the securities, and any
discounts, concessions or commissions allowed by underwriters to participating dealers. Underwriters, dealers and agents participating
in the distribution of the securities may be deemed to be underwriters within the meaning of the Securities Act, and any discounts
and commissions received by them and any profit realized by them on resale of the securities may be deemed to be underwriting discounts
and commissions. We may enter into agreements to indemnify underwriters, dealers and agents against civil liabilities, including
liabilities under the Securities Act, or to contribute to payments they may be required to make in respect thereof.
An underwriter may engage in over-allotment,
stabilizing transactions, short covering transactions and penalty bids in accordance with securities laws. Over-allotment involves
sales in excess of the offering size, which creates a short position. Stabilizing transactions permit bidders to purchase the underlying
security so long as the stabilizing bids do not exceed a specified maximum. Short covering transactions involve purchases of the
securities in the open market after the distribution is completed to cover short positions. Penalty bids permit the underwriters
to reclaim a selling concession from a dealer when the securities originally sold by the dealer are purchased in a covering transaction
to cover short positions. Those activities may cause the prices of the securities to be higher than they would otherwise be. The
underwriters may engage in these activities on any exchange or other market in which the securities may be traded. If commenced,
the underwriters may discontinue these activities at any time. The effect of these transactions may be to stabilize or maintain
the market price of the securities at a level above that which might otherwise prevail in the open market. These transactions may
be discontinued at any time.
The underwriters, dealers and agents may
engage in transactions with us, or perform services for us, in the ordinary course of business.
Expenses
The following table
sets forth the expenses (other than underwriting discounts and commissions or agency fees and other items constituting underwriters’
or agents’ compensation, if any) expected to be incurred by us in connection with a possible offering of securities registered
under this registration statement.
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SEC Registration Fee
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$
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12,120
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Legal Fees and Expenses
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*
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Accounting Fees and Expenses
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*
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Printing Expenses
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*
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Blue Sky Fees
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*
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Transfer Agent Fees and Expenses
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*
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Miscellaneous
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*
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Total
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* To be provided by a
prospectus supplement or a Report on Form 6-K that is incorporated by reference into this prospectus.
Legal Matters
The validity of the
securities offered hereby will be passed upon for us by Yigal Arnon & Co. and Greenberg Traurig, P.A.
Experts
Our consolidated financial
statements included in our Annual Report on Form 20-F for the year ended December 31, 2018 are incorporated herein by reference
in reliance on the report of Yarel + Partners, an independent registered public accounting firm, given on the authority of such
firm as an expert in accounting and auditing.
Enforceability
of Civil Liabilities
We are incorporated
under the laws of the State of Israel. Service of process upon us and upon our directors and officers and any Israeli experts named
in this registration statement, most of whom reside outside of the United States, may be difficult to obtain within the United
States. Furthermore, because a majority of our assets and most of our directors and officers are located outside of the United
States, any judgment obtained in the United States against us or certain of our directors and officers may be difficult to collect
within the United States.
We have been informed
by our legal counsel in Israel, Yigal Arnon & Co., that it may be difficult to assert U.S. securities law claims in original
actions instituted in Israel. Israeli courts may refuse to hear a claim based on a violation of U.S. securities laws because Israel
is not the most appropriate forum to bring such a claim. In addition, even if an Israeli court agrees to hear a claim, it may determine
that Israeli law and not U.S. law is applicable to the claim. If U.S. law is found to be applicable, the content of applicable
U.S. law must be proved as a fact which can be a time-consuming and costly process. Certain matters of procedure will also be governed
by Israeli law.
Subject to specified
time limitations and legal procedures, Israeli courts may enforce a United States judgment in a civil matter which, subject to
certain exceptions, is non-appealable, including a judgment based upon the civil liability provisions of the Securities Act or
the Exchange Act and including a monetary or compensatory judgment in a non-civil matter, provided that, among other things:
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the judgment is obtained after due process before a court of competent jurisdiction, according
to the laws of the state in which the judgment is given and the rules of private international law currently prevailing in Israel;
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the judgment is final and is not subject to any right of appeal, and is executory in the state
in which it was given;
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the prevailing law of the foreign state in which the judgment was rendered allows for the enforcement
of judgments of Israeli courts;
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adequate service of process has been effected and the defendant has had a reasonable opportunity
to be heard and to present his or her evidence and arguments;
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the judgment and the enforcement of the civil liabilities set forth in the judgment is not contrary
to the law or public policy in Israel nor likely to impair the security or sovereignty of Israel;
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the judgment was not obtained by fraud and does not conflict with any other valid judgments in
the same matter between the same parties;
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an action between the same parties in the same matter is not pending in any Israeli court at the
time the lawsuit is instituted in the foreign court; and
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the judgment and the obligations imposed by the judgment are enforceable according to the laws
of Israel and according to the law of the foreign state in which the relief was granted.
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If a foreign judgment
is enforced by an Israeli court, it generally will be payable in Israeli currency, which can then be converted into non-Israeli
currency and transferred out of Israel. The usual practice in an action before an Israeli court to recover an amount in a non-Israeli
currency is for the Israeli court to issue a judgment for the equivalent amount in Israeli currency at the rate of exchange in
force on the date of the judgment, but the judgment debtor may make payment in foreign currency. Pending collection, the amount
of the judgment of an Israeli court stated in Israeli currency ordinarily will be linked to the Israeli consumer price index plus
interest at the annual statutory rate set by Israeli regulations prevailing at the time. Judgment creditors must bear the risk
of unfavorable exchange rates.
Where You
Can Find More Information
We file annual reports
on Form 20-F, reports on Form 6-K, and other information with the SEC under the Securities Exchange Act of 1934, as amended (the
“Exchange Act”). The SEC maintains an Internet site that contains reports and other information that we file
electronically with the SEC and which are available at the SEC’s website at http://www.sec.gov. In addition, we maintain
an Internet website at www.enlivex.com. Information contained on our website is not incorporated into or made a part of
this prospectus or the registration statement of which this prospectus forms a part.
This prospectus is
part of a registration statement that we filed with the SEC. The registration statement contains more information than this prospectus
regarding us and our securities, including certain exhibits. You can obtain a copy of the registration statement from the SEC at
the address listed above or from the SEC’s website listed above.
Incorporation
of Certain Documents by Reference
The SEC allows us to
“incorporate by reference” the information we file with it, which means that we can disclose important information
to you by referring to those documents. The information incorporated by reference is an important part of this prospectus, and
information that we file later with the SEC will automatically update, modify and supersede this information. We incorporate by
reference the following documents we have filed with the SEC:
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Annual Report on Form 20-F for the year ended December
31, 2018, filed with the SEC on April 30, 2019; and
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All annual reports
we file with the SEC pursuant to the Exchange Act on Form 20-F after the date of this prospectus and prior to termination or expiration
of this registration statement shall be deemed incorporated by reference into this prospectus and to be part hereof from the date
of filing of such documents. We may incorporate by reference any Form 6-K subsequently submitted to the SEC by identifying in such
Form 6-K that it is being incorporated by reference into this prospectus (including any such Form 6-K that we submit to the SEC
after the date of the registration statement of which this prospectus forms a party and prior to the date of effectiveness of such
registration statement).
Any statements made
in this prospectus or in a document incorporated or deemed to be incorporated by reference in this prospectus will be deemed to
be modified or superseded for purposes of this prospectus to the extent that a statement contained in this prospectus or in any
other subsequently filed document that is also incorporated or deemed to be incorporated by reference in this prospectus modifies
or supersedes the statement. Any statement so modified or superseded will not be deemed, except as so modified or superseded, to
constitute a part of this prospectus.
We will provide without
charge to each person, including any shareholder, to whom a prospectus is delivered, upon written or oral request of that person,
a copy of any and all of the information incorporated by reference into this prospectus. Please direct requests to us at the following
address:
Enlivex Therapeutics
Ltd.
Attention: Shachar Shlosberger
14 Einstein Street
Nes Ziona
Israel 7403618
Tel: +972.2.6708072
Exhibits to the filings
will not be sent, however, unless those exhibits have specifically been incorporated by reference in such filings.
ENLIVEX THERAPEUTICS LTD.
$
Ordinary Shares
PROSPECTUS
SUPPLEMENT
Sole Book-Running
Manager
Aegis
Capital Corp.
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