Filed
Pursuant to Rule 424(b)(5)
Registration
No. 333-232009
Prospectus
Supplement
to
Prospectus dated June 21, 2019
ENLIVEX
THERAPEUTICS LTD.
Up
to $25,000,000 of Ordinary Shares
This
prospectus supplement comprises a part of the prospectus we previously filed as a part of our “shelf” registration
statement on Form F-3 (file No. 333-232009). On October 22, 2020 we entered into an at-the-market agreement, or the ATM Agreement,
with H.C. Wainwright & Co., LLC, or the Sales Agent, as sales agent relating to our ordinary shares, par value NIS 0.40 per
share, specified in this prospectus supplement. Pursuant to this prospectus supplement, we may elect to sell ordinary shares having
an aggregate offering price of up to only $25,000,000 from time to time through the Sales Agent acting as our sales agent. However,
we are not obligated to sell any shares pursuant to the ATM Agreement.
If
we elect from time to time to sell ordinary shares under this prospectus supplement, such sales may be made in transactions that
are deemed to be “at-the-market” offerings as defined in Rule 415 under the Securities Act of 1933, as amended,
or the Securities Act, including sales made directly on or through the Nasdaq Capital Market, the existing trading market for
our ordinary shares, or any other existing trading market in the United States for our ordinary shares, sales made to or through
a market maker other than on an exchange or otherwise, directly to the Sales Agent as principal, in negotiated transactions, or
in any other method permitted by law, which may include block trades.
If
we elect from time to time to sell ordinary shares under this prospectus supplement, the Sales Agent will not be
required to sell any specific amount, but will act as our sales agent using commercially reasonable efforts consistent
with its normal trading and sales practices. There is no arrangement for funds to be received in any escrow, trust or similar
arrangement.
Subject
to the ATM Agreement, if we elect from time to time to sell ordinary shares pursuant to his prospectus supplement, we will pay
the Sales Agent a commission equal to 3.0% of the gross sales price per ordinary share issued by us and sold through it as Sales
Agent. In connection with the sales of the ordinary shares on our behalf, the Sales Agent will be deemed to be an “underwriter”
within the meaning of the Securities Act, and the compensation of the Sales Agent will be deemed to be underwriting commissions
or discounts.
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 October
19, 2020 was $13.38 per share. The last reported sale price of our ordinary shares on the Tel Aviv Stock Exchange on October 19,
2020 was NIS 46.35 or $13.72 per share (based on the exchange rate reported by the Bank of Israel on the same day).
Until
December 31, 2019, we were an “emerging growth company” as defined under the U.S. federal securities laws and, as
such, had elected to comply with certain reduced public company reporting requirements.
Investing
in our securities 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
prospectus, respectively.
Neither
the Securities and Exchange Commission, the Israel Securities Authority 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.
H.C.
Wainwright & Co.
The
date of this prospectus supplement is October 22, 2020
tABLE
OF CONTENTS
We
have not, and the Sales Agent 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 securities 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.
All
references to “$” and “U.S. Dollars” are to United States dollars and all references to “NIS”
are to New Israeli Shekels.
This
prospectus supplement and the accompanying prospectus form part of a registration statement on Form F-3 that we filed with the
Securities and Exchange Commission, or the SEC, utilizing the SEC’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.
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 securities 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, 2019 and in other documents incorporated herein by reference.
Our
Company
Overview
We
are 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, or Cytokine Release Syndrome, and for which there are no U.S. Food and Drug Administration-approved treatments,
as well as treating solid tumors by modulating such tumors’ microenvironment. Our innovative immunotherapy candidates, Allocetra™
and Allocetra™ from matched-donor cells, are novel immunotherapy candidates based on a unique mechanism of action
that targets clinical indications that are defined as “unmet medical needs.” Allocetra™ has been developed to
treat acute organ failure associated with sepsis and, more recently, Allocetra™ has been administered in an investigator-initiated
trial to treat acute organ failure in COVID-19 patients in severe or critical condition. See “—Recent Developments—Positive
Top-Line Results from Investigator-Initiated Trial of Allocetra in COVID-19 Patients in Severe/Critical Condition.” Allocetra™ from
matched-donor cells has been developed to prevent or treat complications associated with bone marrow transplants and/or hematopoietic
stem cell transplants. Because the candidates are based on the same unique mechanism of action and are otherwise substantially
identical, we refer to both as Allocetra™, unless indicated otherwise.
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.
We
believe 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. Our 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, we believe that it can use Allocetra™ to shape
a patient’s innate immune response to a disease, leading to a decrease in unwanted immune response.
There
are many clinical conditions in which a patient has the potential to develop Cytokine Release Syndrome. Those clinical conditions
include complications associated with sepsis, HSCT and several autoimmune and inflammatory conditions, such as Crohn’s disease,
rheumatoid arthritis, gout and multiple sclerosis.
We
are required to pay royalties to the State of Israel (represented by the Israel Innovation Authority), computed on the basis
of proceeds from the sale or license of products, the development of which was supported by State grants. These royalties are
generally 3% to 5% of sales until repayment of 100% of the grants (linked to the U.S. Dollar) received by us plus annual
interest at an applicable LIBOR-based rate. Our aggregate contingent obligation to pay royalties as of June 30, 2020 was
approximately $5,804,000, which represented the gross amount of grants actually received by us from the Israel Innovation
Authority to such date, including accrued interest. As of June 30, 2020, we had not paid any royalties to the Israel
Innovation Authority. For a description of our obligations in connection with the grants from the Israel Innovation
Authority, see “Item 3.D.—Risk Factors—Risks Related to Israeli Law and Our Operations in Israel” in
our Annual Report on Form 20-F for the year ended December 31, 2019.
Recent
Developments
Positive
Top-Line Results from Investigator-Initiated Trial of Allocetra in COVID-19 Patients in Severe/Critical Condition
On
October 1, 2020, we announced positive top-line results from an investigator-initiated trial of AllocetraTM in
COVID-19 patients in severe or critical condition. The clinical trial included five COVID-19 patients, three in severe condition
and two in critical condition. All five patients recovered from their respective severe or critical condition and were released
from the hospital after an average of five days (for patients in severe condition) and nine days (for patients in critical condition),
following administration of AllocetraTM, at which time they were all COVID-19 PCR negative. There were no reported
severe adverse events relating to the administration of AllocetraTM in the patients, and the therapy was well-tolerated.
Based
on the positive results of the first five COVID-19 patients in severe or critical condition, taken together with the positive
safety and efficacy results of AllocetraTM in 10 sepsis patients in a previous study, we have currently determined
to shift recruitment of additional patients from the investigator-initiated clinical trial into a larger Phase II clinical trial
of COVID-19 patients in severe or critical condition which commenced on October 21, 2020 with the dosing of the first two patients
in such trial.
Israeli
Ministry of Health Authorization of Phase II Clinical Trial Evaluating Allocetra in Severe and Critical COVID-19 Patients
On
October 13, 2020, the Israeli Ministry of Health authorized the initiation of a proposed investigator-initiated Phase II clinical
trial evaluating Allocetra in severe and critical COVID-19 patients. The planned COVID-19 study is a multi-center investigator-initiated,
Phase II clinical trial. The trial is expected to recruit up to twenty-four COVID-19 patients in severe or critical condition,
and is designed to assess AllocetraTM in combination with standard of care treatment. The trial plans to evaluate safety,
tolerability, cytokine profile and efficacy parameters.
Recent
Warrant Exercises
Certain
investors who acquired warrants from us in our previously reported registered direct offerings consummated during the first quarter
of 2020 recently exercised warrants for an aggregate of 782,000 ordinary shares at an exercise price of $9.00 per share and warrants
for an aggregate of 147,646 ordinary shares at an exercise price of $10.00 per share. The foregoing warrant exercise provided
us with aggregate gross proceeds of $8,514,460.
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., or Enlivex R&D, formerly known as Enlivex Therapeutics Ltd., with Enlivex R&D remaining as the surviving
entity in the merger, or 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.
The
Offering
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Ordinary
shares offered by us
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Ordinary
shares with aggregate gross sale proceeds of up to $25,000,000.
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Ordinary
shares to be outstanding immediately after this offering(1)
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Up
to 1,868,460 additional ordinary shares may be outstanding following consummation of this offering, assuming a sales price
of $13.38 per ordinary share, which was the closing price of our ordinary shares on the Nasdaq Capital Market on October 19,
2020. The actual number of ordinary shares issued will depend on whether and to what extent we elect to sell shares pursuant
to this prospectus supplement and the price at which such ordinary shares are actually sold during this offering.
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Form
of offering
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The
Sales Agent may, according to the terms of the ATM Agreement, sell the ordinary shares offered under this prospectus supplement
in an “at-the-market” offering as defined in Rule 415 under the Securities Act. The Sales Agent has agreed to
use commercially reasonable efforts consistent with its normal trading and sales practices to make sales of the ordinary shares
offered hereby. See “Plan of Distribution.”
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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 13,463,771 shares outstanding as of June 30, 2020, which excludes:
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1,378,598
options held by our employees and directors to purchase ordinary shares under our Global
Share Incentive Plan (2019), or the 2019 Plan, at a weighted average exercise price of
$6.15 per share, of which 692,032 options were exercisable as of June 30, 2020, at a
weighted average exercise price of $5.96 per share;
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499,115 options to
purchase ordinary shares under options granted to consultants under existing stock-option plans, or the Consultants’
stock options, at a weighted average exercise price of $4.04 per share, of which 405,920 options were exercisable as of June
30, 2020 at a weighted average exercise price of $3.48 per share;
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166,290
ordinary shares available for future issuance under the 2019 Plan as of June 30, 2020;
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27,016
warrants issued by Bioblast Pharma Ltd. in March 2016 that became exercisable in September
2016 at an exercise price of $180 per share;
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216,563
ordinary shares issuable upon exercise of placement agent warrants at an exercise price
of $10.00 per share; and
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2,093,750
ordinary shares issuable upon exercise of investor warrants at an exercise price of $9.00
per share.
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Unless
otherwise indicated, all information in this prospectus supplement assumes no exercise of outstanding options or warrants described
above. Additionally, the information above does not reflect the recent exercise of certain warrants issued in our previously reported
registered direct offerings consummated during the first quarter of 2020. See “—Our Company—Recent Developments—Recent
Warrant Exercises.”
Risk
Factors
Investing
in our securities 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,
2019, 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 securities. 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 securities.
Risks
Related to this Offering
We
do not know whether a market for our ordinary shares will be sustained or what the market price of our ordinary shares will be
and as a result it may be difficult for you to sell your shares.
The
trading price of our ordinary shares is likely to be volatile. The following factors, some of which are beyond our control, in
addition to other risk factors described in this section and in our Annual Report on Form 20-F for the year ended December 31,
2019, which is incorporated by reference in this prospectus supplement and the accompanying prospectus, may have a significant
impact on the market price of our ordinary shares:
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inability
to obtain the approvals necessary to commence further clinical trials;
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unsatisfactory
results of clinical trials;
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announcements
of regulatory approval or the failure to obtain it, or specific label indications or
patient populations for its use, or changes or delays in the regulatory review process;
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announcements
of therapeutic innovations or new products by us or our competitors;
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adverse
actions taken by regulatory agencies with respect to our clinical trials, manufacturing
supply chain or sales and marketing activities;
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changes
or developments in laws or regulations applicable to our product candidates;
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any
adverse changes to our relationship with manufacturers or suppliers;
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any
product liability actions or intellectual property infringement actions in which we may
become involved;
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announcements
concerning our competitors or the pharmaceutical or biotechnology industries in general;
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achievement
of expected product sales and profitability or our failure to meet expectations;
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our
commencement of, or involvement in, litigation;
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any
major changes in our board of directors, management or other key personnel;
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legislation
in the United States, Europe and other foreign countries relating to the sale or pricing
of pharmaceuticals
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announcements
by us of significant strategic partnerships, out-licensing, in-licensing, joint ventures,
acquisitions or capital commitments;
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expiration
or terminations of licenses, research contracts or other collaboration agreements;
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public
concern as to the safety of therapeutics we, our licensees or others develop;
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success
of research and development projects;
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variations
in our and our competitors’ results of operations;
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changes
in earnings estimates or recommendations by securities analysts, if our ordinary shares
are covered by analysts;
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developments
by our licensees, if any; and
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future
issuances of ordinary shares or other securities.
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These
factors may materially and adversely affect the market price of our ordinary shares, which could result in substantial losses
by our investors.
In
addition, the stock market in general, and the Nasdaq Capital Market and the market for biotechnology companies in particular,
have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance
of companies like ours. Broad market and industry factors may negatively affect the market price of our ordinary shares, regardless
of our actual operating performance. Further, a systemic decline in the financial markets and related factors beyond our control
may cause our share price to decline rapidly and unexpectedly. Price volatility of our ordinary shares might be worse if the trading
volume of our ordinary shares is low.
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
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 $1.30 per share to our existing shareholders, and an immediate dilution of $9.84 per share to investors
purchasing shares in this offering, assuming that an aggregate of 1,868,460 ordinary shares are sold at a public offering price
of $13.38 per share, the last reported sale price of our ordinary shares on the Nasdaq Capital Market on October 19, 2020 for
aggregate gross proceeds of approximately $25,000,000, and after deducting estimated commissions 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 offering price, you will incur further dilution. Please see the section in the prospectus
supplement entitled “Dilution” for a more detailed discussion of the dilution you will incur in this offering.
If
we raise additional capital in the future, your ownership in us could be diluted.
In
order to raise additional capital, we may at any time, including during this offering, offer additional ordinary shares or other
securities convertible into or exchangeable for our ordinary shares at prices that may not be the same as the price per ordinary
share in this offering. We may sell ordinary shares or other securities in any other offering at a price per ordinary share that
is less than the price per ordinary share paid by investors in this offering, and investors purchasing ordinary shares or other
securities in the future could have rights superior to existing shareholders, including investors who purchase ordinary shares
in this offering. The price per share at which we sell additional ordinary shares or securities convertible into ordinary shares
in future transactions may be higher or lower than the price per ordinary share 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 June 30, 2020, we had 13,463,771 ordinary shares outstanding, excluding ordinary shares issuable upon exercise of outstanding
warrants and shares that are issuable under our existing equity compensation plans. In addition, we may issue and sell additional
ordinary shares in the public markets, including under this prospectus supplement. Sales of a substantial number of our ordinary
shares in the public markets, including during this offering, 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 the Nasdaq Capital Market and the Tel Aviv Stock Exchange, 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 Tel Aviv Stock Exchange), 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.
The
ordinary shares offered hereby will be sold in “at-the-market” offerings, and investors who buy ordinary
shares at different times will likely pay different prices.
Investors
who purchase ordinary shares under this prospectus supplement at different times will likely pay different prices, and so may
experience different outcomes in their investment results. We will have discretion, subject to market demand, to vary the timing,
prices, and numbers of ordinary shares sold, and there is no minimum or maximum sales price. Investors may experience a decline
in the value of their ordinary shares as a result of ordinary share sales made at prices lower than the prices they paid.
The
actual number of ordinary shares we will issue under the ATM Agreement, at any one time or in total, is uncertain.
Subject
to certain limitations in the ATM Agreement and compliance with applicable law, we have the discretion to deliver a sales notice
to the Sales Agent at any time throughout the term of the ATM Agreement. The number of ordinary shares that are sold by the Sales
Agent after delivering a sales notice will fluctuate based on the market price of the ordinary shares during the sales period
and limits we set with the Sales Agent. Because the price per ordinary share of each ordinary share sold will fluctuate based
on the market price of our ordinary shares during the sales period, it is not possible at this stage to predict the number of
ordinary shares that will be ultimately issued.
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, or 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, 2019, 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 trial 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, 2019,
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
may issue and sell ordinary shares having aggregate sales proceeds of up to $25,000,000 from time to time. The amount of proceeds
from this offering will depend upon the number of ordinary shares sold and the market price at which they are sold. There can
be no assurance that we will be able to sell any ordinary shares under or fully utilize the ATM Agreement with the Sales Agent.
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. Pending any such uses, we intend to hold the net proceeds in cash and cash equivalents (which may include
investments in highly liquid, short term investment instruments).
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 presents our capitalization as determined in accordance with United States generally accepted accounting principles
as of June 30, 2020:
|
|
●
|
on
an actual basis; and
|
|
|
●
|
on
an as adjusted basis, to give effect to the assumed sale of an aggregate of 1,868,460
ordinary shares in this offering at a public offering price of $13.38 per share, the
last reported sale price of our ordinary shares on the Nasdaq Capital Market on October
19, 2020, for aggregate gross proceeds of approximately $25,000,000, after deducting
estimated commissions and offering expenses payable by us.
|
This
table should be read in conjunction with our financial statements and the notes thereto incorporated by reference herein.
|
|
|
As of
June 30, 2020
|
|
|
|
|
Actual
|
|
|
As Adjusted
|
|
|
|
|
(U.S. dollars in thousands (except share data))
|
|
|
Non-Current Liabilities:
|
|
|
|
|
|
|
|
Lease liabilities
|
|
$
|
236
|
|
|
$
|
236
|
|
|
Total non-current liabilities
|
|
$
|
236
|
|
|
$
|
236
|
|
|
Shareholders’ equity:
|
|
|
|
|
|
|
|
|
|
Common stock of NIS 0.40 ($0.11) par value:
|
|
|
|
|
|
|
|
|
|
Authorized: 45,000,000 shares as of June 30, 2020; Issued and outstanding: 13,463,771 as of June 30, 2020 and 15,332,231 as of June 30, 2020, as adjusted
|
|
$
|
1,513
|
|
|
$
|
1,734
|
|
|
Additional paid in capital
|
|
$
|
59,615
|
|
|
$
|
83,499
|
|
|
Foreign currency translation adjustments
|
|
$
|
(1,428
|
)
|
|
$
|
(1,428
|
)
|
|
Accumulated deficit
|
|
$
|
(29,508
|
)
|
|
$
|
(29,508
|
)
|
|
Total shareholders’ equity
|
|
$
|
30,192
|
|
|
$
|
54,297
|
|
|
Total capitalization
|
|
$
|
30,428
|
|
|
$
|
54,533
|
|
The
above table is based on 13,463,771 shares outstanding as of June 30, 2020, which excludes:
|
|
●
|
1,378,598
options held by our employees and directors to purchase ordinary shares under the 2019
Plan at a weighted average exercise price of $6.15 per share, of which 692,032 options
were exercisable as of June 30, 2020, at a weighted average exercise price of $5.96 per
share;
|
|
|
●
|
499,115
options to purchase ordinary shares under the Consultants’ stock options at a weighted
average exercise price of $4.04 per share, of which 405,920 options were exercisable
as of June 30, 2020 at a weighted average exercise price of $3.48 per share;
|
|
|
●
|
166,290
ordinary shares available for future issuance under the 2019 Plan as of June 30, 2020;
|
|
|
●
|
27,016
warrants issued by Bioblast Pharma Ltd. in March 2016 that became exercisable in September
2016 at an exercise price of $180 per share;
|
|
|
●
|
216,563
ordinary shares issuable upon exercise of placement agent warrants at an exercise price
of $10.00 per share; and
|
|
|
●
|
2,093,750
ordinary shares issuable upon exercise of investor warrants at an exercise price of $9.00
per share.
|
Additionally,
the above table does not reflect the recent exercise of certain warrants issued in our previously reported registered direct offerings
consummated during the first quarter of 2020. For information on recent warrant exercises, see “Summary—Our Company—Recent
Developments—Recent Warrant Exercises.”
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 book value as of June 30, 2020 was approximately $30.2 million,
or approximately $2.24 per share. Net tangible book value per share represents our total tangible assets less total tangible liabilities,
divided by the number of ordinary shares outstanding as of June 30, 2020.
Dilution
in net tangible book value per share represents the difference between the 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 that an aggregate of 1,868,460 ordinary shares are sold at a public offering
price of $13.38 per share, the last reported sale price of our ordinary shares on the Nasdaq Capital Market on October 19, 2020
for aggregate gross proceeds of approximately $25,000,000, and after deducting the estimated commissions and estimated offering
expenses payable by us, our net tangible book value as of June 30, 2020 would have been approximately $54.3 million, or approximately
$3.54 per ordinary share. This represents an immediate increase of $1.30 in net tangible book value per share to our existing
shareholders and an immediate dilution of $9.84 per share to purchasers of ordinary shares in this offering. The following table
illustrates this per share dilution:
|
Assumed offering price per share
|
|
$
|
13.38
|
|
|
Net tangible book value per share as of June 30, 2020
|
|
$
|
2.24
|
|
|
Increase in net tangible book value per share attributable to new investors
|
|
$
|
1.30
|
|
|
Adjusted net tangible book value per share as of June 30, 2020, after giving effect to the offering
|
|
$
|
3.54
|
|
|
Dilution per share to investors purchasing ordinary shares in the offering
|
|
$
|
9.84
|
|
The
above discussion and tables do not include the following:
|
|
●
|
1,378,598
options held by our employees and directors to purchase ordinary shares under the 2019
Plan at a weighted average exercise price of $6.15 per share, of which 692,032 options
were exercisable as of June 30, 2020, at a weighted average exercise price of $5.96 per
share;
|
|
|
●
|
499,115
options to purchase ordinary shares under the Consultants’ stock options at a weighted
average exercise price of $4.04 per share, of which 405,920 options were exercisable
as of June 30, 2020 at a weighted average exercise price of $3.48 per share;
|
|
|
●
|
166,290
ordinary shares available for future issuance under the 2019 Plan as of June 30, 2020;
|
|
|
●
|
27,016
warrants issued by Bioblast Pharma Ltd. in March 2016 that became exercisable in September
2016 at an exercise price of $180 per share;
|
|
|
●
|
216,563
ordinary shares issuable upon exercise of placement agent warrants at an exercise price
of $10.00 per share; and
|
|
|
●
|
2,093,750
ordinary shares issuable upon exercise of investor warrants at an exercise price of $9.00
per share.
|
To
the extent that any of these outstanding options or warrants are exercised or we issue additional ordinary shares under our equity
incentive plans, there will be further dilution to new investors. In addition, we may choose to raise additional capital at any
time, including during this offering, due to market conditions or strategic considerations even if we believe we have sufficient
funds for our current or future operating plans. To the extent that additional capital is raised through the sale of equity or
convertible debt securities, the issuance of these securities could result in further dilution to new investors participating
in this offering.
Additionally,
the information above does not reflect the recent exercise of certain warrants issued in our previously reported registered direct
offerings consummated during the first quarter of 2020. For information on recent warrant exercises, see “Summary—Our
Company—Recent Developments—Recent Warrant Exercises.”
Plan
of Distribution
We
have entered into the ATM Agreement, dated as of October 22, 2020, with the Sales Agent as sales agent, under which we may elect
to sell up to $25,000,000 of our ordinary shares from time to time through the Sales Agent as our agent. The ATM Agreement provides
that if we elect from time to time to sell ordinary shares under this prospectus supplement, such sales may be made in sales deemed
to be “at-the-market” equity offerings as defined in Rule 415(a)(4) promulgated under the Securities Act, including
sales made directly on the Nasdaq Capital Market or sales made to or through a market maker other than on an exchange, or otherwise,
directly to the Sales Agent as principal, in negotiated transactions, or in any other method permitted by law, which may include
block trades. From time to time during the term of the ATM Agreement, we may deliver a sales notice to the Sales Agent specifying
the length of the selling period, the amount of ordinary shares to be sold and the minimum price below which sales may not be
made. Once we have so instructed the Sales Agent, unless the Sales Agent declines to accept the terms of the notice, the Sales
Agent has agreed to use its commercially reasonable efforts consistent with its normal trading and sales practices to sell such
ordinary shares up to the amount specified on such terms. We or the Sales Agent may suspend the offering of our ordinary shares
hereunder at any time upon proper notice and subject to other conditions, at which time any standing sales notice will immediately
terminate. Settlement for sales of our ordinary shares will occur at 10:00 a.m. (New York City time), or at some other time that
is agreed upon by us and the Sales Agent in connection with a particular sales notice, on the second trading day following the
date any sales were made. The obligations of the Sales Agent under the ATM Agreement to sell ordinary shares representing our
ordinary shares are subject to a number of conditions, which the Sales Agent may waive in its sole discretion. Sales of our ordinary
shares as contemplated in this prospectus will be settled through the facilities of The Depository Trust Company or by such other
means as we and the Sales Agent may agree upon. There is no arrangement for funds to be received in an escrow, trust or similar
arrangement.
If
we elect from time to time to sell ordinary shares pursuant to this prospectus supplement, we will pay the Sales Agent a commission
equal to 3.0% of the gross sales price per ordinary share issued by us and sold through it as Sales Agent. Because there is no
minimum offering amount required as a condition to close this offering, the actual total public offering amount, commissions and
proceeds to us, if any, are not determinable at this time. We have also agreed to reimburse the Sales Agent for certain specified
expenses, including the fees and disbursements of its legal counsel in an amount not to exceed $50,000. Additionally, pursuant
to the terms of the ATM Agreement, we have agreed to reimburse the Sales Agent for the documented fees and costs of its legal
counsel reasonably incurred in connection with the Sales Agent’s ongoing diligence, drafting and other filing requirements
arising from the transactions contemplated by the ATM Agreement in an amount not to exceed $2,500 in the aggregate per calendar
quarter.
In
connection with the potential future sales of the ordinary shares on our behalf under the ATM Agreement, the Sales Agent will
be deemed to be an “underwriter” within the meaning of the Securities Act, and the compensation of the Sales Agent
will be deemed to be underwriting commissions or discounts. We have agreed to provide indemnification and contribution to the
Sales Agent and specified other persons against certain civil liabilities, including liabilities under the Securities Act and
the Exchange Act.
We
will report at least quarterly the number of our ordinary shares sold through the Sales Agent, as our sales agent, in this offering
and, to the extent applicable, the number of our ordinary shares issued upon settlement of any terms agreements, and the net proceeds
to us in connection with such sales of our ordinary shares.
The
offering of our ordinary shares pursuant to the ATM Agreement will terminate upon the earliest of (1) the sale of all our ordinary
shares subject to the ATM Agreement; or (2) termination of the ATM Agreement at the election of either us or the Sales Agent as
provided therein.
To
the extent required by Regulation M under the Exchange Act, the Sales Agent will not engage in any market making activities involving
our ordinary shares or ordinary shares while the offering is ongoing under this prospectus supplement.
The
Sales Agent and its affiliates may in the future provide various investment banking and other financial services for us and our
affiliates, for which services they may in the future receive customary fees. We estimate that the total expenses for the offering,
excluding compensation and reimbursements payable to the Sales Agent under the terms of the ATM Agreement, will be approximately
$145,000.
Legal
Matters
Greenberg
Traurig, P.A., Miami, Florida, has passed upon certain legal matters regarding the securities offered hereby under U.S. law, and
Yigal Arnon & Co., Jerusalem, Israel, has passed upon certain legal matters regarding the securities offered hereby under
Israeli law. The Sales Agent is being represented by McDermott Will & Emery 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, 2019 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.
Expenses
The
following table sets forth costs and expenses, other than any commissions and expenses, we expect to incur in connection with
the offering.
|
Legal fees and expenses
|
|
$
|
125,000
|
|
|
Accounting fees and expenses
|
|
$
|
15,000
|
|
|
Miscellaneous fees and expenses
|
|
$
|
5,000
|
|
|
Total
|
|
$
|
145,000
|
|
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 documents listed below and any future filings made with the SEC under
Sections 13(a), 13(c), 14, or 15(d) of the Exchange Act made subsequent to the date of this prospectus supplement until the termination
of the offering of the securities described in this prospectus supplement (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):
|
|
●
|
Annual
Report on Form 20-F for the year ended December 31, 2019, filed with the SEC on April 30, 2020; and
|
|
|
|
|
|
|
●
|
Our Reports on Form
6-K filed with the SEC on May 18, 2020, May 19, 2020, June 29, 2020, and our Report on Form 6-K/A filed with the SEC on October 13, 2020.
|
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:
+972.2.6208072
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 1 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 18.
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:
|
|
●
|
our expectations regarding the timing of clinical trials with respect to Allocetra™;
|
|
|
●
|
the continued listing of our ordinary shares on Nasdaq;
|
|
|
●
|
our expectations regarding the progress of our clinical trials, including the duration, cost and whether such trials will be
conducted at all;
|
|
|
●
|
our intention to successfully complete clinical trials in order to be in a position to submit applications for accelerated
regulatory paths in the EU and the United States;
|
|
|
●
|
the possibility that we will apply in the future for regulatory approval for our current and any future product candidates
we may develop, and the costs and timing of such regulatory approvals;
|
|
|
●
|
the likelihood of regulatory approvals for any product candidate we may develop;
|
|
|
●
|
the timing, cost or other aspects of the commercial launch of any product candidate we may develop, including the possibility
that we will build a commercial infrastructure to support commercialization of our current and any future product candidates we
may develop;
|
|
|
●
|
future sales of our product candidates or any other future products or product candidates;
|
|
|
●
|
our ability to achieve favorable pricing for our product candidates;
|
|
|
●
|
the potential for our product candidates to receive orphan drug designations;
|
|
|
●
|
that any product candidate we develop potentially offers effective solutions for various diseases;
|
|
|
●
|
whether we will develop any future product candidates internally or through strategic partnerships;
|
|
|
●
|
our expectations regarding the manufacturing and supply of any product candidate for use in our clinical trials, and the commercial
supply of those product candidates;
|
|
|
●
|
third-party payer reimbursement for our current or any future product candidates;
|
|
|
●
|
our estimates regarding anticipated expenses, capital requirements and our needs for substantial additional financing;
|
|
|
●
|
patient market sizes and market adoption of our current or any future product candidates by physicians and patients;
|
|
|
●
|
completion and receiving favorable results of clinical trials for our product candidates;
|
|
|
●
|
protection of our intellectual property, including issuance of patents to us by the United States Patent and Trademark Office,
or USPTO, and other governmental patent agencies;
|
|
|
●
|
our intention to pursue marketing and orphan drug exclusivity periods that are available to us under regulatory provisions
in certain countries;
|
|
|
●
|
the development and approval of the use of our current or any future product candidates for additional indications other than
complications associated with bone marrow transplants, GvHD and preventing cytokine storm associated organ failure in sepsis patients;
|
|
|
●
|
our expectations regarding commercial and pre-commercial activities;
|
|
|
●
|
our expectations regarding licensing, acquisitions, and strategic operations; and
|
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: +972.2.6208072
Exhibits to the filings
will not be sent, however, unless those exhibits have specifically been incorporated by reference in such filings.
ENLIVEX
THERAPEUTICS LTD.
Up
to $25,000,000 of Ordinary Shares
PROSPECTUS
SUPPLEMENT
H.C.
Wainwright & Co.
October
22, 2020
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