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:
| Title of each class: | Trading Symbol(s): | Name of each exchange on which registered: | ||
| Ordinary Shares, par value of NIS 0.40 | ENLV | Nasdaq Capital Market |
Securities registered or to be registered pursuant to Section 12(g) of the Act: None
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act: None
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.
| Large Accelerated Filer ☐ | Accelerated Filer ☐ | Non-Accelerated Filer ☒ |
| Emerging Growth Company ☒ |
If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by 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
| Item Number | Title | Page | ||
| PART TWO | 1 | |||
| Item 15. | Controls and procedures | 1 | ||
| PART THREE | 2 | |||
| Item 19. | Exhibits | 2 |
| ITEM 15. | CONTROLS AND PROCEDURES |
(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.
1
| ITEM 19. | EXHIBITS |
EXHIBIT INDEX
| * | Previously filed with the Annual Report on Form 20-F originally filed on January 23, 2020. |
2
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.
| Enlivex Therapeutics Ltd. (f/k/a Bioblast Pharma Ltd.) | ||
| By: | /s/ Shachar Shlosberger | |
| Shachar Shlosberger | ||
| Chief Financial Officer | ||
| Date: | January 31, 2020 | |
3
Exhibit 12.1
CERTIFICATION PURSUANT TO
EXCHANGE ACT RULE 13a-14(a) or 15d-14(a)
I, Dr. Oren Hershkovitz, certify that:
1. I have reviewed this annual report on Form 20–F/A (Amendment No. 2) of Enlivex Therapeutics Ltd. (f/k/a Bioblast Pharma Ltd.);
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report;
4. The company’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the company and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting; and
5. The company’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the company’s auditors and the audit committee of the company’s board of directors (or persons performing the equivalent functions):
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the company’s ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting.
|
Date: January 31, 2020 |
/s/ Dr. Oren Hershkovitz |
| Dr. Oren Hershkovitz | |
| Chief Executive Officer |
Exhibit 12.2
CERTIFICATION PURSUANT TO
EXCHANGE ACT RULE 13a-14(a) or 15d-14(a)
I, Shachar Shlosberger, certify that:
1. I have reviewed this annual report on Form 20–F/A (Amendment No. 2) of Enlivex Therapeutics Ltd. (f/k/a Bioblast Pharma Ltd.);
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report;
4. The company’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the company and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting; and
5. The company’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the company’s auditors and the audit committee of the company’s board of directors (or persons performing the equivalent functions):
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the company’s ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting.
| Date: January 31, 2020 | /s/ Shachar Shlosberger |
| Shachar Shlosberger | |
| Chief Financial Officer |
Exhibit 13.1
CERTIFICATION PURSUANT TO
18 U.S.C. Section 1350
In connection with the filing of the Annual Report on Form 20–F/A (Amendment No. 2) for the period ended December 31, 2018 (the “Report”) by Enlivex Therapeutics Ltd. (f/k/a Bioblast Pharma Ltd.) (the “Company”), the undersigned, as the Chief Executive Officer of the Company, hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to my knowledge:
(1) the Report fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934; and
(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
| /s/ Dr. Oren Hershkovitz | |
| Dr. Oren Hershkovitz | |
| Chief Executive Officer | |
| January 31, 2020 |
Exhibit 13.2
CERTIFICATION PURSUANT TO
18 U.S.C. Section 1350
In connection with the filing of the Annual Report on Form 20–F/A (Amendment No. 2) for the period ended December 31, 2018 (the “Report”) by Enlivex Therapeutics Ltd. (f/k/a Bioblast Pharma Ltd.) (the “Company”), the undersigned, as principal financial officer of the Company, hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to my knowledge:
(1) the Report fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934; and
(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
| /s/ Shachar Shlosberger | |
| Shachar Shlosberger | |
| Chief Financial Officer | |
| January 31, 2020 |