United
States
Securities and Exchange Commission
Washington, D.C. 20549
FORM
20-F/A
Amendment
No. 2
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For
the fiscal year ended December 31, 2018
Commission
file number: 001-36578
Enlivex
Therapeutics Ltd.
(Exact name of Registrant as specified in its charter)
State
of Israel
(Jurisdiction of incorporation or organization)
14
Einstein Street, Nes Ziona, Israel 7403618
(Address of principal executive offices)
Shachar
Shlosberger
Tel: +972.2.6708072
Email: Shachar@enlivexpharm.com
Facsimile: +972.2.6708070
14 Einstein Street, Nes Ziona, Israel 7403618
(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)
Securities
registered or to be registered pursuant to Section 12(b) of the Act:
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Title
of each class:
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Trading
Symbol(s):
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Name
of each exchange on which registered:
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Ordinary
Shares, par value of NIS 0.40
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ENLV
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Nasdaq
Capital Market
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Securities
registered or to be registered pursuant to Section 12(g) of the Act: None
Securities
for which there is a reporting obligation pursuant to Section 15(d) of the Act: None
Indicate
the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period
covered by the annual report.
420,554
Ordinary Shares, par value NIS 0.40 per share as of December 31, 2018
Indicate
by check mark whether the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
☐ Yes ☒ No
If
this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934.
☐ Yes ☒ No
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports),
and (2) has been subject to such filing requirements for the past 90 days.
☒ Yes ☐ No
Indicate
by check mark whether the registrant has submitted electronically and posted on its corporate Website, if any, every Interactive
Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the
preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
☒ Yes ☐ No
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging
growth company. See definition of “large accelerated filer, “accelerated filer,” and “emerging growth
company” in Rule 12b-2 of the Exchange Act.
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Large Accelerated Filer ☐
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Accelerated Filer ☐
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Non-Accelerated Filer ☒
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Emerging Growth Company ☒
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If
an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by checkmark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:
U.S.
GAAP ☒
International
Financial Reporting Standards as issued by the International Accounting Standards Board ☐
Other ☐
If “Other” has been checked in response to the previous question, indicate by check mark which financial statement
item the registrant has elected to follow.
Item
17 ☐ Item 18 ☐
If
this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange
Act).
☐ Yes ☒ No
EXPLANATORY
NOTE
Enlivex
Therapeutics Ltd., a company organized under the laws of the State of Israel (“Enlivex”, the “Company”,
“we”, “us” or “our”), is filing this Amendment No. 2 on Form 20-F/A (this
“Amendment No. 2”) to amend its Annual Report on Form 20-F for the year ended December 31, 2018, which Enlivex
filed with the U.S. Securities and Exchange Commission (the “SEC”) on April 30, 2019 (the “Original
20-F”), as amended by Amendment No. 1 on Form 20-F/A (“Amendment No. 1”) filed with the SEC on January
23, 2020.
As
previously reported, on March 26, 2019 (the “Closing Date”), Bioblast Pharma Ltd., a company organized under
the laws of the State of Israel (“Bioblast”), and Enlivex Therapeutics R&D Ltd., a company organized under
the laws of the State of Israel (f/k/a Enlivex Therapeutics Ltd., “Enlivex R&D”), consummated a merger
transaction whereby Enlivex R&D merged with a merger subsidiary of Bioblast, with Enlivex R&D as the surviving entity
in the merger (the “Merger”). As a result of the Merger, Enlivex R&D became a wholly owned subsidiary of
Bioblast. Concurrently with the Merger, Bioblast changed its name to Enlivex Therapeutics Ltd.
The
Merger has been treated as a reverse recapitalization of Bioblast for financial accounting and reporting purposes. As such, Enlivex
R&D is treated as the acquirer for accounting and financial reporting purposes while Bioblast is treated as the acquired entity
for accounting and financial reporting purposes.
The
purpose of this Amendment No. 2 is to revise Part II, Item 15 to Amendment No. 1 to reflect management's conclusion that the Company’s
internal control over financial reporting and disclosure controls and procedures were not effective at December 31, 2018 due to
a material weakness in internal control over financial reporting, resulting in the filing of Enlivex R&D’s historical
audited financial statements for the year ended December 31, 2018 in the Original 20-F rather than those of Bioblast, and to disclose
the remediation undertaken by management subsequent to such date.
Pursuant
to Rule 12b-15 promulgated under the Securities Exchange Act of 1934, as amended, we have included the entire text of Part II,
Item 15 of Form 20-F in this Amendment No. 2. Other than as described above and the inclusion with this Amendment No. 2 of new
certifications by management and related amendments to the List of Exhibits contained in Part III, Item 19 herein, this Amendment
No. 2 speaks only as of the time period covered in Amendment No. 1 and does not amend, supplement or update any information contained
in Amendment No. 1 or the Original 20-F to give effect to any subsequent events. Accordingly, this Amendment No. 2 should be read
in conjunction with Amendment No. 1, the Original 20-F and our reports filed with the SEC subsequent to the Original 20-F.
Notwithstanding
the existence of the material weakness described in Part II. Item 15, we believe that the consolidated financial statements in
Amendment No. 1 fairly present, in all material respects, the financial position, results of operations and cash flows of Bioblast,
as of the dates, and for the periods, presented, in conformity with U.S. generally accepted accounting principles.
Enlivex
expects to file with the SEC its Annual Report on Form 20-F for the year ended December 31, 2019 on or prior to May 1, 2020, which
is the deadline for filing such Annual Report.
TABLE
OF CONTENTS
PART
TWO
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ITEM
15.
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CONTROLS
AND PROCEDURES
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(a)
Disclosure Controls and Procedures
Our
management, with the participation of our interim Chief Executive Officer and our Principal Financial Officer, has evaluated the
effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the
Exchange Act) as of December 31, 2018, or the Evaluation Date. Based on such evaluation, those officers had concluded that, as
of the Evaluation Date, our disclosure controls and procedures were effective in recording, processing, summarizing and reporting,
on a timely basis, information required to be included in periodic filings under the Exchange Act and that such information is
accumulated and communicated to management, including our principal executive and financial officers, as appropriate to allow
timely decisions regarding required disclosure.
Subsequent
to that evaluation, as a result of the material weakness in the Company's internal control over financial reporting described
in Item 15(b) below, our Chief Executive Officer and Principal Financial Officer concluded that the Company’s disclosure
controls and procedures were not effective as of December 31, 2018.
(b)
Management’s Annual Report on Internal Control over Financial Reporting (as revised)
Our
management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is
defined in Rule 13a-15(f) under the Exchange Act. Under the supervision and with the participation of our management, including
our Chief Executive Officer and our Principal Financial Officer, we conducted an evaluation of the effectiveness of our internal
control over financial reporting based principally on the framework and criteria established in Internal Control - Integrated
Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission as of the end of the period covered
by this report. Based on that evaluation, our management had concluded that our internal control over financial reporting was
effective as of December 31, 2018 at providing reasonable assurance regarding the reliability of financial reporting and the preparation
of financial statements for external purposes in accordance with generally accepted accounting principles.
As
described below, the Company’s management has reevaluated the effectiveness of our internal control over financial reporting
as of December 31, 2018 and has subsequently concluded that the material weakness described below existed as of December 31, 2018.
The material weakness was due to a deficiency in the design of controls to appropriately perform effective and timely review of
the accounting for, and disclosure of, non-routine business combinations. As a result, management has concluded that the Company
did not maintain effective internal control over financial reporting as of December 31, 2018. The Company therefore has amended
this Management's Annual Report on Internal Control Over Financial Reporting. A material weakness in internal control over financial
reporting is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is
a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected
on a timely basis.
The
Company's management did not design and maintain effective internal controls related to non-routine material business combinations,
resulting in the filing of Enlivex R&D’s historical audited financial statements for the year ended December 31, 2018
in the Original 20-F rather than those of Bioblast, which the Company ultimately filed with Amendment No. 1. Accordingly, the
Company has determined that this control deficiency constituted a material weakness.
As
at the date of this Amendment No. 2, we believe the identified material weakness has been fully remediated and the Company’s
management has taken steps to strengthen the Company's controls relating to non-routine material business combination activity,
including, enhancing policies and procedures and strengthening communication and information flows between legal and finance personnel.
Management is committed to maintaining a strong internal control environment and believes the above noted efforts will represent
significant improvements to the internal control environment.
(c)
Attestation Report of the Registered Public Accounting Firm
This
annual report does not include an attestation report of our registered public accounting firm because we are a non-accelerated
filer and an emerging growth company.
(d)
Changes in Internal Control over Financial Reporting
During
the year ended December 31, 2018, there were no changes in our internal control over financial reporting that have materially
affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART
THREE
EXHIBIT
INDEX
EXHIBIT
NUMBER
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DESCRIPTION
OF DOCUMENT
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1.1
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Amended and Restated Articles of Association of the Company, filed as Exhibit 3.2 to Form F-1/A filed on July 8, 2014 (File No. 333-193824) and incorporated herein by reference.
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4.1
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Bioblast Pharma Ltd. 2013 Incentive Option Plan, as amended, filed as Exhibit 4.1 to Form 20-F filed on March 29, 2016 (File No. 001-36578), and incorporated herein by reference.
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4.2
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Form of Indemnification Agreement, filed as Exhibit 10.4 to Form F-1/A filed on April 8, 2014 (File No. 333-193824) and incorporated herein by reference.
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4.3
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Bioblast Pharma Ltd. Compensation Policy for Company Office Holders, included in Exhibit 99.1 to Form 6-K filed on March 31, 2015 (File No. 001-36578), and incorporated herein by reference.
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4.4
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Form of Ordinary Share Purchase Warrant issued to investors on March 22, 2016, filed as Exhibit 4.1 to Form 6-K filed on March 18, 2016 (File No. 001-36578), and incorporated herein by reference.
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4.5
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Agreement and Plan of Merger, dated November 19, 2018 by and among Bioblast Pharma Ltd., Treblast Ltd. and Enlivex Therapeutics Ltd., filed as Exhibit 99.1 to Form 6-K filed on November 19, 2018 (File No. 001-36578), and incorporated herein by reference.
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4.6
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Contingent Value Rights Agreement, dated November 19, 2018, filed as Exhibit 99.2 to Form 6-K filed on November 19, 2018 (File No. 001-36578), and incorporated herein by reference.
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12.1
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Certification of the Chief Executive Officer pursuant to rule 13a-14(a) of the Securities Exchange Act of 1934.
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12.2
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Certification of the Principal Financial Officer pursuant to rule 13a-14(a) of the Securities Exchange Act of 1934.
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13.1
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Certification of the Chief Executive Officer pursuant to 18 U.S.C. 1350, furnished herewith.
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13.2
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Certification of the Principal Financial Officer pursuant to 18 U.S.C. 1350, furnished herewith.
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15.1*
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Consent of Kost, Forer, Gabbay & Kasierer, a member of EY Global
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15.2*
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Consent of Yarel + Partners
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101*
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The
following materials from our Annual Report on Form 20-F/A for the year ended December 31, 2018 formatted in XBRL (eXtensible
Business Reporting Language): (i) the Consolidated Balance Sheets, (ii) the Consolidated Statements of Operations,
(iii) the Consolidated Statements of Changes in Shareholders’ Equity, (iv) the Consolidated Statements of Cash Flows
and (v) the Consolidated Notes to Financial Statements, tagged as blocks of text and in detail.
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*
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Previously
filed with the Annual Report on Form 20-F originally filed on January 23, 2020.
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SIGNATURES
Enlivex
Therapeutics Ltd. (f/k/a Bioblast Pharma Ltd.), hereby certifies that it meets all of the requirements for filing on Form 20-F
and that it has duly caused and authorized the undersigned to sign this Amendment No. 2 to its annual report on its behalf.
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Enlivex
Therapeutics Ltd. (f/k/a Bioblast Pharma Ltd.)
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By:
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/s/
Shachar Shlosberger
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Shachar
Shlosberger
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Chief
Financial Officer
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Date:
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January
31, 2020
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3
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