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Enlivex Ltd.
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Enlivex Ltd.
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Enlivex Ltd.
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Enlivex Ltd.
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Enlivex Ltd.
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Enlivex Ltd.
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Enlivex Ltd.
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Enlivex Ltd.
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Enlivex Ltd.
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SEC wrote to company
2014-03-27
Enlivex Ltd.
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Enlivex Ltd.
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SEC wrote to company
2014-03-06
Enlivex Ltd.
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-12-30 | Company Response | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2025-12-29 | SEC Comment Letter | Enlivex Ltd. | Israel | 333-292417 | Read Filing View |
| 2025-05-08 | Company Response | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2025-05-07 | SEC Comment Letter | Enlivex Ltd. | Israel | 333-286956 | Read Filing View |
| 2022-05-03 | Company Response | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2022-05-02 | SEC Comment Letter | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2020-02-03 | SEC Comment Letter | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2020-01-31 | Company Response | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2020-01-27 | SEC Comment Letter | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2019-12-12 | SEC Comment Letter | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2019-07-05 | Company Response | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2019-07-03 | SEC Comment Letter | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2019-06-19 | Company Response | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2019-06-13 | SEC Comment Letter | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2015-08-10 | Company Response | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2015-08-07 | SEC Comment Letter | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2014-07-28 | Company Response | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2014-07-28 | Company Response | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2014-07-25 | Company Response | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2014-07-24 | SEC Comment Letter | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2014-04-07 | Company Response | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2014-03-27 | SEC Comment Letter | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2014-03-14 | Company Response | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2014-03-06 | SEC Comment Letter | Enlivex Ltd. | Israel | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-12-29 | SEC Comment Letter | Enlivex Ltd. | Israel | 333-292417 | Read Filing View |
| 2025-05-07 | SEC Comment Letter | Enlivex Ltd. | Israel | 333-286956 | Read Filing View |
| 2022-05-02 | SEC Comment Letter | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2020-02-03 | SEC Comment Letter | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2020-01-27 | SEC Comment Letter | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2019-12-12 | SEC Comment Letter | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2019-07-03 | SEC Comment Letter | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2019-06-13 | SEC Comment Letter | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2015-08-07 | SEC Comment Letter | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2014-07-24 | SEC Comment Letter | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2014-03-27 | SEC Comment Letter | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2014-03-06 | SEC Comment Letter | Enlivex Ltd. | Israel | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-12-30 | Company Response | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2025-05-08 | Company Response | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2022-05-03 | Company Response | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2020-01-31 | Company Response | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2019-07-05 | Company Response | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2019-06-19 | Company Response | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2015-08-10 | Company Response | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2014-07-28 | Company Response | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2014-07-28 | Company Response | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2014-07-25 | Company Response | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2014-04-07 | Company Response | Enlivex Ltd. | Israel | N/A | Read Filing View |
| 2014-03-14 | Company Response | Enlivex Ltd. | Israel | N/A | Read Filing View |
2025-12-30 - CORRESP - Enlivex Ltd.
CORRESP 1 filename1.htm Enlivex Therapeutics Ltd. 14 Einstein Street Ness Ziona Israel 7403618 December 30, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, D.C. 20549 Attention: Jimmy McNamara RE: Enlivex Therapeutics Ltd. (the "Company") Registration Statement on Form F-3 (the "Registration Statement") Filed December 23, 2025 File No. 333-292417 Dear Mr. McNamara: The Company hereby requests, pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, acceleration of effectiveness of the Registration Statement so that such Registration Statement will become effective as of 4:00 p.m. on January 2, 2026, or as soon thereafter as practicable. [Signature page follows] Very truly yours, Enlivex Therapeutics Ltd . By: /s/ Oren Hershkovitz Name: Oren Hershkovitz Title: Chief Executive Officer
2025-12-29 - UPLOAD - Enlivex Ltd. File: 333-292417
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> December 29, 2025 Shachar Shlosberger Chief Financial Officer Enlivex Therapeutics Ltd. FISCHER (FBC & Co.) 146 Menachem Begin Street Tel Aviv 6492103, Israel Re: Enlivex Therapeutics Ltd. Registration Statement on Form F-3 Filed December 23, 2025 File No. 333-292417 Dear Shachar Shlosberger: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Jimmy McNamara at 202-551-7349 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Drew M. Altman </TEXT> </DOCUMENT>
2025-05-08 - CORRESP - Enlivex Ltd.
CORRESP 1 filename1.htm Enlivex Therapeutics Ltd. 14 Einstein Street Ness Ziona Israel 7403618 May 8, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, D.C. 20549 Attention: Tyler Howes RE: Enlivex Therapeutics Ltd. (the "Company") Registration Statement on Form F-3 (the "Registration Statement") Filed May 2, 2025 File No. 333-286956 Dear Mr. Howes: The Company hereby requests, pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, acceleration of effectiveness of the Registration Statement so that such Registration Statement will become effective as of 4:00 p.m. on May 12, 2025, or as soon thereafter as practicable. [Signature page follows] Very truly yours, Enlivex Therapeutics Ltd . By: /s/ Shai Novik Name: Shai Novik Title: Chairman of the Board of Directors
2025-05-07 - UPLOAD - Enlivex Ltd. File: 333-286956
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> May 7, 2025 Oren Hershkovitz Chief Executive Officer Enlivex Therapeutics Ltd. 14 Einstein Street Ness Ziona Israel 7403618 Re: Enlivex Therapeutics Ltd. Registration Statement on Form F-3 Filed May 2, 2025 File No. 333-286956 Dear Oren Hershkovitz: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Tyler Howes at 202-551-3370 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Win Rutherfurd, Esq. </TEXT> </DOCUMENT>
2022-05-03 - CORRESP - Enlivex Ltd.
CORRESP
1
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Enlivex Therapeutics Ltd..
14 Einstein Street
Nes Ziona
Israel 7403618
May 3, 2022
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington, D.C. 20549
Attention: Michael Davis
RE:
Enlivex Therapeutics Ltd. (the “Company”)
Registration Statement on Form F-3 (the “Registration Statement”)
Filed April 29, 2022
File No. 333-264561
Dear Mr. Davis:
The Company hereby requests,
pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, acceleration of effectiveness of the Registration Statement
so that such Registration Statement will become effective as of 5:00 p.m. on May 5, 2022, or as soon thereafter as practicable.
[Signature page follows]
Very truly yours,
Enlivex Therapeutics Ltd.
By:
/s/ Oren Hershkovitz
Name: Oren Hershkovitz
Title: Chief Executive Officer
2022-05-02 - UPLOAD - Enlivex Ltd.
United States securities and exchange commission logo
May 2, 2022
Oren Hershkovitz
Chief Executive Officer
Enlivex Therapeutics Ltd.
14 Einstein Street
Nes Ziona
Israel 7403618
Re:Enlivex Therapeutics Ltd.
Registration Statement on Form F-3
Filed April 29, 2022
File No. 333-264561
Dear Mr. Hershkovitz:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Michael Davis at 202-551-4385 or Laura Crotty at 202-551-7614 with any
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Bob Grossman
2020-02-03 - UPLOAD - Enlivex Ltd.
February 3, 2020
Shachar Schlosberger
Chief Financial Officer
Enlivex Therapeutics Ltd.
14 Einstein Street
Nes Ziona, Israel 7403618
Re:Enlivex Therapeutics Ltd.
Form 20-F for the year ended December 31, 2018
Filed on April 30, 2019
Form 20-F/A for the year ended December 31, 2018
Filed on January 23, 2020
File No. 001-36578
Dear Ms. Schlosberger:
We have completed our review of your filings. We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2020-01-31 - CORRESP - Enlivex Ltd.
CORRESP
1
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January 31, 2019
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Ameen Hamady
Jeanne Baker
Re: Enlivex Therapeutics Ltd.
Form 20-F for the year
ended December 31, 2018
Filed on April 30, 2019
Form 20-F/A for the year
ended December 31, 2018
Filed on January 23,
2020
File No. 001-36578
Ladies and Gentlemen:
On behalf of Enlivex Therapeutics
Ltd., a company organized under the laws of the State of Israel (“Enlivex” or the “Company”),
the following response is to the comment letter, dated January 27, 2020 (the “Comment Letter”), concerning the
above referenced Form 20-F filed on April 30, 2019, as amended by the Form 20-F/A filed on January 23, 2020 (the “Form
20-F”). Set forth below is the Company’s response to the comment of the staff (the “Staff”)
of the Securities and Exchange Commission (the “SEC”) contained in the Comment Letter.
In the response below,
references to “we”, “our” and “us” refer to the Company. We have reproduced the text of the
Staff’s comment in bold-face, followed by the Company’s response. Concurrently
with this response, the Company is filing with the SEC Amendment No. 2 to the Form 20-F (the “Amendment”, and
the 20-F as amended by the Amendment, the “Amended 20-F”), which incorporates revisions to the Form 20-F.
Item 15. Controls and Procedures, page
64
1. In light of the fact that the Company amended its Form 20-F for the fiscal year ended December
31, 2018 to include the required disclosures and financial statements of Bioblast Pharma Ltd (Bioblast), please tell us how you
concluded that Bioblast’s disclosure controls and procedures and internal controls over financial reporting were effective
as of December 31, 2018. Please advise or revise your conclusions accordingly.
The Company’s Response:
Further
to discussions with the Staff, the Amendment amends Item 15 of the Amended 20-F in response to the Staff’s comment.
* * *
If you or any other member
of the Staff should have any further comments or questions regarding this response, please contact the Company’s outside
counsel, Robert L. Grossman, Esq. at (305) 579-0756 or Drew M. Altman, Esq. at (305) 579-0589, each of Greenberg Traurig, P.A.
Sincerely,
Enlivex Therapeutics Ltd.
/s/ Shachar Schlosberger
Shachar Schlosberger
Chief Financial Officer
cc:
Robert L. Grossman
Drew M. Altman
Greenberg Traurig, P.A.
2020-01-27 - UPLOAD - Enlivex Ltd.
January 27, 2020
Shachar Schlosberger
Chief Financial Officer
Enlivex Therapeutics Ltd.
14 Einstein Street
Nes Ziona, Israel 7403618
Re:Enlivex Therapeutics Ltd.
Form 20-F for the year ended December 31, 2018
Filed on April 30, 2019
Form 20-F/A for the year ended December 31, 2018
Filed on January 23, 2020
File No. 001-36578
Dear Ms. Schlosberger:
We have limited our review of your filing to the financial statements and related
disclosures and have the following comments. In some of our comments, we may ask you to
provide us with information so we may better understand your disclosure.
Please respond to these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comments apply to your facts and circumstances, please tell us why in your response.
After reviewing your response to these comments, we may have additional comments.
Form 20-F/A for the Fiscal Year ended December 31, 2018
Item 15. Controls and Procedures, page 64
1.In light of the fact that the Company amended its Form 20-F for the fiscal year ended
December 31, 2018 to include the required disclosures and financial statements of
Bioblast Pharma Ltd (Bioblast), please tell us how you concluded that Bioblast's
disclosure controls and procedures and internal controls over financial reporting
were effective as of December 31, 2018. Please advise or revise your conclusions
accordingly.
In closing, we remind you that the company and its management are responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or
absence of action by the staff.
FirstName LastNameShachar Schlosberger
Comapany NameEnlivex Therapeutics Ltd.
January 27, 2020 Page 2
FirstName LastName
Shachar Schlosberger
Enlivex Therapeutics Ltd.
January 27, 2020
Page 2
You may contact Ameen Hamady at 202-551-3891 or in his absence, Jeanne Baker at
202-551-3691 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2019-12-12 - UPLOAD - Enlivex Ltd.
December 12, 2019
Shachar Schlosberger
Chief Financial Officer
Enlivex Therapeutics Ltd.
14 Einstein Street
Nes Ziona, Israel 7403618
Re:Enlivex Therapeutics Ltd.
Form 20-F for the year ended December 31, 2018
Filed on April 30, 2019
File No. 001-36578
Dear Ms. Schlosberger:
We have limited our review of your filing to the financial statements and related
disclosures and have the following comments. In some of our comments, we may ask you to
provide us with information so we may better understand your disclosure.
Please respond to these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comments apply to your facts and circumstances, please tell us why in your response.
After reviewing your response to these comments, we may have additional comments.
Form 20-F for the year ended December 31, 2018
General
1.We note that on March 26, 2019 Bioblast Pharma Ltd (Bioblast) and Enlivex Therapeutics
Ltd (Enlivex) consummated a merger transaction that was treated as a reverse
capitalization of Bioblast with Enlivex identified as the accounting acquirer for financial
accounting and reporting purposes. We further note that the information presented in your
Form 20-F for the year ended December 31, 2018, including the financial statements
presented in Item 18, is that of Enlivex. However, because the reverse capitalization
occurred on March 26, 2019, Bioblast, as the legal acquirer and reporting entity, was
required to file all its periodic reports as they become due for periods that ended before
the consummation of the merger. As such, please amend your Form 20-F. Ensure your
amended Form 20-F includes the required disclosures and financial statements for each
Item as they relate to Bioblast, including but not limited to, an updated management
assessment of the effectiveness of internal controls over financial reporting and disclosure
FirstName LastNameShachar Schlosberger
Comapany NameEnlivex Therapeutics Ltd.
December 12, 2019 Page 2
FirstName LastName
Shachar Schlosberger
Enlivex Therapeutics Ltd.
December 12, 2019
Page 2
controls and procedures as of December 31, 2018.
In closing, we remind you that the company and its management are responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or
absence of action by the staff.
You may contact Ameen Hamady at 202-551-3891 or in his absence, Jeanne Baker at
202-551-3691 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2019-07-05 - CORRESP - Enlivex Ltd.
CORRESP
1
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Enlivex
Therapeutics Ltd.
14
Einstein Street
Nes
Ziona
Israel
7403618
July
5, 2019
Via
EDGAR
United
States Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Attention: Ada
D. Sarmento
Re: Enlivex
Therapeutics Ltd.
Registration
Statement filed on Form F-3
Filed
on June 28, 2019
File
No. 333-232413
Dear
Ms. Sarmento:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Enlivex Therapeutics Ltd. (the “Company”) hereby requests
acceleration of the effective date of the above-referenced registration statement so that it will become effective at 5:00 p.m.,
Eastern Daylight Time, on Tuesday, July 9, 2019, or as soon as practicable thereafter.
Should
you have any questions or comments regarding this matter, please contact the undersigned at +972.2.6708072 or the Company’s
legal counsel, Robert L. Grossman, Esq. at (305) 579-0756 or Drew Altman, Esq. at (305) 579-0589, each of Greenberg Traurig, P.A.
The
Company hereby authorizes Drew M. Altman of Greenberg Traurig, P.A. to orally modify or withdraw this request for acceleration.
Sincerely,
Enlivex
Therapeutics, Ltd.
By:
/s/
Shai Novik
Name:
Shai
Novik
Title:
Executive
Chairman
cc: Robert
L. Grossman, Esq.
Drew
M. Altman, Esq.
Greenberg
Traurig, P.A.
2019-07-03 - UPLOAD - Enlivex Ltd.
July 3, 2019
Shmuel Hess
Chief Executive Officer
Enlivex Therapeutics Ltd.
14 Einstein Street
Nes Ziona
Israel 7403618
Re:Enlivex Therapeutics Ltd.
Registration Statement on Form F-3
Filed June 28, 2019
File No. 333-232413
Dear Mr. Hess:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Ada D. Sarmento at 202-551-3798 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Robert L. Grossman, Esq.
2019-06-19 - CORRESP - Enlivex Ltd.
CORRESP
1
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ENLIVEX THERAPEUTICS LTD.
14 Einstein Street
Nes Ziona
Israel 7403618
VIA EDGAR
June 19, 2019
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549-0404
Attn: Jeffrey Gabor
Re:
Enlivex Therapeutics Ltd.
Registration
Statement on Form F-3
File
No. 333-232009
Filed
June 7, 2019
Dear Mr. Gabor,
In accordance with Rule 461 under the Securities
Act of 1933, as amended, we hereby request acceleration of the effective date of the Registration Statement on Form F-3 (File No.
333-232009) (the “Registration Statement”) of Enlivex Therapeutics Ltd. (the “Registrant”). We respectfully
request that the Registration Statement become effective as of 4:00 p.m., Eastern time, on June 21, 2019, or as soon as practicable
thereafter.
The Registrant hereby authorizes Drew M. Altman
of Greenberg Traurig, P.A. to orally modify or withdraw this request for acceleration.
Once the Registration Statement has been declared
effective, please orally confirm that event with our counsel, Greenberg Traurig, P.A., by calling Drew M. Altman at 305-579-0589.
Thank you for your assistance in this matter.
Respectfully yours,
ENLIVEX THERAPEUTICS LTD.
By:
/s/ Shai Novik
Shai Novik
Chairman of the Board of Directors
2019-06-13 - UPLOAD - Enlivex Ltd.
June 12, 2019
Shmuel Hess, Ph.D.
Chief Executive Officer
Enlivex Therapeutics Ltd.
14 Einstein Street
Nes Ziona
Israel 7403618
Re:Enlivex Therapeutics Ltd.
Registration Statement on Form F-3
Filed June 7, 2019
File No. 333-232009
Dear Dr. Hess:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Jeffrey Gabor at 202-551-2544 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Drew M. Altman, Esq.
2015-08-10 - CORRESP - Enlivex Ltd.
CORRESP
1
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August 10, 2015
Via EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street NE
Washington, DC 20549
Attn: Jeffrey P. Riedler, Division of Corporate Finance
RE:
Bio Blast Pharma Ltd.
Registration Statement on Form F-3
Filed on August 3, 2015
File No. 333-206032
Ladies and Gentlemen:
Bio Blast Pharma Ltd. (“BioBlast”)
hereby requests acceleration of the effectiveness of the above-referenced registration statement pursuant to Rule 460 and Rule
461 under the Securities Act of 1933, as amended (the “Securities Act”), so that it may become effective on
August 12, 2015, at 4:30 p.m., Eastern Time, or as soon thereafter as is practicable.
BioBlast acknowledges that:
· should the Commission or the staff, acting pursuant to delegated authority, declare the above-referenced registration statement
effective, it does not foreclose the Commission from taking any action with respect to the above-referenced registration statement;
· the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the above-referenced registration
statement effective, does not relieve BioBlast from its full responsibility for the adequacy and accuracy of the disclosure in
the above-referenced registration statement; and
· BioBlast may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the
Commission or any person under the federal securities laws of the United States.
Securities and Exchange Commission
August 10, 2015
Page 2
BioBlast understands that the Commission
will consider this request for acceleration of the effective date of this above-referenced registration statement as a confirmation
of the fact that BioBlast is aware of its respective responsibilities under the Securities Act and the Securities Exchange Act
of 1934, as amended, as they relate to the proposed public offering of the securities specified in the referenced above registration
statement.
Very truly yours,
/s/ Colin Foster
Colin Foster
Chief Executive Officer and President
Cc: Shy S. Baranov, Esq.
2015-08-07 - UPLOAD - Enlivex Ltd.
Mail Stop 4720 August 7 , 2015 Via E -mail Colin Foster Chief Executive Officer Bio Blast Pharma Ltd. 37 Dereh Menachem Begin St. 15th Floor Tel Aviv 6522042 Israel Re: Bio Blast Pharma Ltd. Registration Statement on Form F-3 Filed August 3 , 2015 File No. 333-206032 Dear Mr. Foster : This is to advise you that we have not reviewed and will not review your registration statement . We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 193 3 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In the event you request acceleration of the effective date of the pending regist ration statement , please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; the action of the Commission or the staff, acting pursuant t o delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effect iveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Colin Foster Bio Blast Pharma Ltd. August 7 , 2015 Page 2 Please refer to Rules 460 and 461 regarding requests for acceleration . We will consider a written request for acceler ation of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the registered securities . Please contact Johnny Gharib at (202) 551 -3170 or me at (202) 551 -3715 with any questions. Sincerely, /s/ Jeffrey P. Riedler Jeffrey P. Riedler Assistant Director Office of Healthcare and Insurance cc: Via E-mail Howard Berkenblit, Esq. Sullivan & Worcester LLP
2014-07-28 - CORRESP - Enlivex Ltd.
CORRESP
1
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Oppenheimer
& Co. Inc.
85 Broad Street
New York, New York 10004
Roth
Capital Partners, LLC
888 San Clemente Drive
Newport Beach, CA 92660
July 28, 2014
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Re: Bio Blast Pharma Ltd.
Registration Statement on Form F-1 (SEC File No. 333-193824)
Ladies and Gentlemen:
In connection with the above-referenced Registration Statement,
and pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), we, the representatives of the several
underwriters (the “Representative”), hereby join in the request of Bio Blast Pharma Ltd. (the “Company”)
that the effective time of the Registration Statement be accelerated so that it will be declared effective at 5:00 p.m., Eastern
time, on July 30, 2014 or at such later time as the Company or its counsel may orally request via telephone call to the staff of
the Division of Corporation Finance of the Securities and Exchange Commission.
Pursuant to Rule 460 under the Securities Act, please be advised
that during the period from July 17, 2014 to the date of this letter, the preliminary prospectus dated July 14, 2014 and the preliminary
prospectus dated July 25, 2014, in connection with the Registration Statement were distributed approximately as follows:
Copies to underwriters:
0
Copies to prospective dealers:
0
Copies to prospective institutional investors:
579
Copies to prospective retail investors and others:
931
Total:
1,510
The Representatives confirm on behalf of themselves and the
several underwriters that they have complied and will continue to comply with the requirements of Rule 15c2-8 promulgated under
of the Securities Exchange Act of 1934, as amended, in connection with the above-referenced issue.
Very truly yours,
By: OPPENHEIMER & CO. INC.
By: /s/ Douglas Cameron
Name: Douglas Cameron
Title: Head of Equity Capital Markets
By: ROTH CAPITAL PARTNERS, LLC
By: /s/ Aaron Gurewitz
Name: Aaron Gurewtiz
Title: Head of Equity Capital Markets
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Bio Blast Pharma Ltd.
37 Dereh Menachem Begin St., 15th
Floor
Tel Aviv 6522042 Israel
July 28, 2014
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
Bio Blast Pharma Ltd. (CIK 0001596812)
Registration Statement No. 333-193824 on Form F-1
Ladies and Gentlemen:
Bio Blast Pharma Ltd.
(the “Registrant”) hereby requests acceleration of the effectiveness of the above-referenced Registration Statement
pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Securities Act”), so that it may become
effective on July 30, 2014, at 5:00 p.m., Eastern Time, or as soon thereafter as is practicable.
The Registrant acknowledges
that:
· should the Securities and Exchange Commission
(the “Commission”) or its staff, acting pursuant to delegated authority, declare the Registration Statement
effective, it does not foreclose the Commission from taking any action with respect to the Registration Statement;
· the action of the Commission or its staff,
acting pursuant to delegated authority, in declaring the Registration Statement effective, does not relieve the Registrant from
its full responsibility for the adequacy and accuracy of the disclosure in the Registration Statement; and
· The Registrant may not assert staff comments
and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal
securities laws of the United States.
The Registrant
understands that the Commission will consider this request for acceleration of the effective date of the Registration Statement
as a confirmation of the fact that the Registrant is aware of its responsibilities under the Securities Act as they relate to the
proposed public offering of the securities specified in the Registration Statement.
Very truly yours,
BIO BLAST PHARMA LTD.
By: /s/ Dr. Dalia Megiddo
Dr. Dalia Megiddo, Chief Executive
Officer
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BIO BLAST PHARMA LTD.
37 Dereh Menachem Begin St., 15th
Floor
Tel Aviv 6522042 Israel
July 25, 2014
Via EDGAR
Jeffrey P. Riedler, Assistant Director
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington, DC 20549
Re:
Bio Blast Pharma Ltd.
Amendment No. 4 to Registration Statement on Form F-1
Filed July 15, 2014
File No. 333-193824
Dear Mr. Riedler:
The purpose of this letter is to respond to your letter of July
24, 2014 regarding the above-referenced amended registration statement. For your convenience, your comments appear in italics,
followed by our responses. We are concurrently filing via EDGAR Amendment No. 5 to the Form F-1 (“Amendment No. 5”).
Page references in our response are to Amendment No. 5.
Business, page 57
1. We note your statement throughout the registration statement
that if the results of your ongoing Phase 2/3 clinical trial for Cabaletta are successful, you believe it could be a pivotal trial.
Please expand your disclosure to state the basis for your belief. Specifically, disclose whether this belief resulted from discussions
with the FDA.
We have revised our disclosure on pages 1, 3, 51, 57, 58 and 60
of Amendment No. 5 to add the following: “We believe, based on discussions with the FDA, that if the Phase 2/3 trial shows
positive results, the data could be considered pivotal data, considering, among other things, the applicable FDA guidance for the industry called
“Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products.”
Signatures, page II-5
2. Please amend your registration statement to include the
signature of your principal accounting officer or controller.
We have revised page II-5 of Amendment No. 5 to indicate that
Udi Gilboa is our Principal Financial Officer and Principal Accounting Officer.
1
* * *
We appreciate your comments and welcome
the opportunity to discuss with you our responses provided above. Please call our attorney, Shy Baranov (617) 338-2932 of Zysman,
Aharoni, Gayer and Sullivan & Worcester LLP, if you have any questions or require additional information.
Sincerely,
Bio Blast Pharma Ltd.
By: /s/ Udi Gilboa
Name: Udi Gilboa
Title: Chief Financial Officer
cc, with a marked copy of Amendment No. 5:
Christina De Rosa
Shy Baranov, Zysman, Aharoni, Gayer and Sullivan & Worcester
LLP
Oded Har-Even, Zysman, Aharoni, Gayer and Sullivan & Worcester
LLP
2
2014-07-24 - UPLOAD - Enlivex Ltd.
July 24 , 2014 Via E -mail Udi Gilboa Chief Financial Officer Bio Blast Pharma Ltd. 35 Ahad Ha'am St. Tel Aviv 6520206 Israel Re: Bio Blast Pharma Ltd. Amendment No. 4 to Registration Statement on Form F -1 Filed July 15 , 2014 File No. 333 -193824 Dear Mr. Gilboa: We have reviewed your amended registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by amending your registration statement and providing the requested information. If you do not believe our comments apply to your facts and circumstances or do not bel ieve an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your registration statement and the information you provide in response to these comments, we may have additional comments. Business, page 57 1. We note your statement throughout the registration statement that if the results of your ongoing Phase 2/3 clinical trial for Cabaletta are successful, you believe it could be a pivotal trial. Please expand your disclosure to state the basis for your belief. Spec ifically, disclose whether this belief resulted from discussions with the FDA. Signatures, page II -5 2. Please amend your registration statement to include the signature of your principal accounting officer or controller. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 1933 and Udi Gilboa Bio Blast Pharma Ltd. July 24, 2014 Page 2 all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. Notwithstanding our comments, in the event you request acceleration of the effective date of the pending registration statement please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commissi on from taking any action with respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and acc uracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 461 regarding requests for acceleration. We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of thei r respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to rev iew any amendment prior to the requested effective date of the registration statement. Please contact Christina De Rosa at (202) 551 -3577, John Krug at (202) 551 -3862 or me at (202) 551 -3715 with any questions. Sincerely, /s/ Jeffrey P. Riedler Jeffrey P. Riedler Assistant Director cc: Via E -mail Shy S. Baranov, Esq. Zysman, Aharoni, Gayer and Sullivan & Worcester LLP 1633 Broadway New York, NY 10019
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BIO BLAST PHARMA LTD.
35 Ahad Ha’am Street
Tel Aviv 6520206 Israel
April 7, 2014
Via EDGAR
Jeffrey P. Riedler, Assistant Director
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington, DC 20549
Re: Bio Blast Pharma Ltd.
Amendment No. 1 to Registration Statement on
Form F-1
Filed March 17, 2014
File No. 333-193824
Dear Mr. Riedler:
The purpose of this letter is to respond to your letter of March
27, 2014 regarding the above amended registration statement. For your convenience, your comments appear in italics, followed by
our responses. We are concurrently filing via EDGAR Amendment No. 2 to the Form F-1. Page references in our response are to Amendment
No. 2.
General
1. We note your response to our prior comment 4. For the
first graphic on the page after the prospectus cover page, we do not find the context you provided to make the map sufficiently
clear to an investor. Specifically, while most of the pinpoints on the map reference a specific institution, the pinpoints for
Germany and China are much more general. Without further context, it is unclear why “Absorption Systems” and “Protein
labs” would be considered “centers of excellence.” In addition, you have not described your “operation
mode” or the nature of collaboration. Please remove this graphic.
We have removed the first graphic on the page after the prospectus
cover page.
2. For the second graphic on the page before the table of
contents, we note your reference to a Phase 2 clinical trial for SCA3 anticipated in Q3 2014. Please be advised that including
reference in a pipeline table to anticipated clinical trials is inappropriate. We also note you have not provided any context or
definitions for the terms used in the graphic. Please eliminate the product pipeline table in its entirety. In this regard, we
note a similar chart appears on page 2 with context and definitions to enable a prospective investor to understand the presentation.
We have removed the second graphic on the page before the table
of contents.
3. We note your response to our prior comment 5. However,
we do not find all of the images in your registration statement to be easily readable. Specifically, all of the images on page
66 appear to contain writing that is illegible in their current format. Please remove the images contained on page 66.
We have removed the images contained on page 66.
Business
Product Candidates – Disease background, rationale for treatment…, page 62
4. We note your response to our prior comment 21. However,
although you reference the prevalence of many diseases in several different geographic locations, you have not provided a numerical
estimate of the number of people for each geographic location that are affected by such disease. For example, you state on page
64 that OPMD “is more prevalent among people of French Canadian origin residing in Canada and in the U.S.,” but you
do not include a numerical estimate of the number of people in Canada who are affected by the disease. Please revise your discussion
of market potential for each disease to include an estimated number of people affected for each geographical location mentioned.
We have revised our disclosure on pages 62-69 of Amendment No.
2 to include for each disease an estimated number of people affected for each geographical location.
* * *
We appreciate your comments and welcome
the opportunity to discuss with you our responses provided above. Please call our attorney, Shy Baranov (617) 338-2932 of Zysman,
Aharoni, Gayer and Sullivan & Worcester LLP, if you have any questions or require additional information.
Sincerely,
Bio Blast Pharma Ltd.
By: /s/ Udi Gilboa
Name: Udi Gilboa
Title: Chief Financial Officer
cc, with a marked copy of Amendment No. 2:
Christina De Rosa
Shy Baranov, Zysman, Aharoni, Gayer and Sullivan & Worcester
LLP
Oded Har-Even, Zysman, Aharoni, Gayer and Sullivan & Worcester
LLP
Joseph Walsh, Troutman Sanders LLP
2014-03-27 - UPLOAD - Enlivex Ltd.
March 27, 2014 Via E -mail Udi Gilboa Chief Financial Officer Bio Blast Pharma Ltd. 35 Ahad Ha'am St. Tel Aviv 6520206 Israel Re: Bio Blast Pharma Ltd. Amendment No. 1 to Registration Statement on Form F -1 Filed March 17, 2014 File No. 333 -193824 Dear Mr. Gilboa: We have reviewed your amended registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by amending your registration statement and providing the requested information. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is a ppropriate, please tell us why in your response. After reviewing any amendment to your registration statement and the information you provide in response to these comments, we may have additional comments. General 1. We note your response to our prior comment 4. For the first graphic on the page after the prospectus cover page, we do not find the context you provided to make the map sufficiently clear to an investor. Specifically, while most of the pinpoints on the map reference a specific institution , the pinpoints for Germany and China are much more general. Without further context, it is unclear why “Absorption Systems” and “Protein labs” would be considered “centers of excellence.” In addition, you have not described your “operation mode” or the n ature of collaboration. Please remove this graphic. 2. For the second graphic on the page before the table of contents, we note your reference to a Phase 2 clinical trial for SCA3 anticipated in Q3 2014. Please be advised that including reference in a pi peline table to anticipated clinical trials is inappropriate. We also note you have not provided any context or definitions for the terms used in the graphic. Please eliminate the product pipeline table in its entirety. In this regard, we note Udi Gilboa Bio Blast Pharma Ltd. March 27, 2014 Page 2 a similar chart appears on page 2 with context and definitions to enable a prospective investor to understand the presentation. 3. We note your response to our prior comment 5. However, we do not find all of the images in your registration statement to be easily re adable. Specifically, all of the images on page 66 appear to contain writing that is illegible in their current format. Please remove the images contained on page 66. Business Product Candidates – Disease background, rationale for treatment…, page 62 4. We note your response to our prior comment 21. However, although you reference the prevalence of many diseases in several different geographic locations, you have not provided a numerical estimate of the number of people for each geographic location that are affected by such disease. For example, you state on page 64 that OPMD “ is more prevalent among people of French Canadian origin resi ding in Canada and in the U.S.,” but you do not include a numerical estimate of the number of people in Canada who are affected by the disease. Please revise your discussion of market potential for each disease to include an estimated number of people affected for each geographical location mentioned. We urge all persons who are responsible for the accuracy and adequacy o f the disclosure in the filing to be certain that the filing includes the information the Securities Act of 1933 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s d isclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. Notwithstanding our comments, in the event you request acceleration of the effective date of the pending registration statement please provide a written sta tement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Udi Gilboa Bio Blast Pharma Ltd. March 27, 2014 Page 3 Please refer to Rules 460 and 461 regarding requests for acceleration. We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to review any amendment prior to the requested effective date o f the registration statement. Please contact Christina De Rosa at (202) 551 -3577, John Krug at (202) 551 -3862 or me at (202) 551 -3715 with any questions. Sincerely, /s/ Daniel Greenspa n for Jeffrey P. Riedler Assistant Director cc: Via E -mail Shy S. Baranov, Esq. Zysman, Aharoni, Gayer and Sullivan & Worcester LLP 1633 Broadway New York, NY 10019
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BIO BLAST PHARMA LTD.
35 Ahad Ha’am Street
Tel Aviv 6520206 Israel
March 14, 2014
Via EDGAR
Jeffrey P. Riedler, Assistant Director
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington, DC 20549
Re:
Bio Blast Pharma Ltd.
Registration Statement on Form F-1
Filed February 7, 2014
File No. 333-193824
Dear Mr. Riedler:
The purpose of this letter is to respond to your letter of March
6, 2014 regarding the above registration statement. For your convenience, your comments appear in italics, followed by our responses.
We are concurrently filing via EDGAR Amendment No. 1 to the Form F-1. Page references in our responses are to Amendment No. 1.
General
1. Please submit all exhibits as soon as practicable. We
may have further comments upon examination of these exhibits.
We have submitted certain exhibits with Amendment No. 1 and
will submit all remaining exhibits as soon as they are available.
2. Please confirm that the images included in your registration
statement are all of the graphic, visual or photographic information you will be including. If you intend to use any additional
images, please provide us proofs of such materials. Please note that we may have comments regarding this material.
We have added a few new images to Amendment No. 1 at pages
65, 66, 67, 69 and 70. We do not intend to use any additional images.
3. Please supplementally provide us with copies of all written
communications, as defined in Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf, present
to potential investors in reliance on Section 5(d) of the Securities Act, whether or not they retain copies of the communications.
Similarly, please supplementally provide us with any research reports about you that are published or distributed in reliance upon
Section 2(a)(3) of the Securities Act of 1933 added by Section 105(a) of the Jumpstart Our Business Startups Act by any broker
or dealer that is participating or will participate in your offering.
1
We will supplementally provide the requested copies of all such
written communications and all such research reports. At this time there are none.
4. Please remove the two pages of graphics between the prospectus
cover page and the table of contents or move the graphics to another section of the prospectus. If retained, please provide context
to enable the reader to understand the presentation.
We have added text to the two pages of graphics between the
prospectus cover page and the table of contents to enable the reader to understand the presentation.
5. Please ensure that the text provided in all images included
in your registration statement can be easily read by investors. For example, portions of the text in the image on pages 58 and
60 are difficult to read.
We have revised the images on pages
65, 66, 67, 69 and 70 of Amendment No. 1.
Prospectus Summary, page 1
6. Please define the following scientific terms at their
first use to provide a reasonable investor with understanding of such terms:
· “pathophysiological;”
· “myopathy;”
· “pharmacopeial;” and
· “disaccharide chemical chaperone.”
We have revised our disclosures on pages 1, 2, 56 and
58 of Amendment No. 1 to define the requested terms.
Implications of being an Emerging Growth Company, page
5
7. Please expand this discussion to clarify the relief a
company gets as a Foreign Private Issuer in addition to the relief that you will enjoy as an emerging growth company. Please also
revise your prospectus to indicate that you have decided to avail yourselves of the relief from adopting new accounting standards.
We have revised our disclosure on page 6 of Amendment No.
1 to address the relief we get as a Foreign Private Issuer and to address that we have decided to avail ourselves of the relief
relating to the adoption of new accounting standards.
8. We note your statement that you “have not made a
decision whether to take advantage of any or all” of the applicable JOBS Act exemptions. Please reconcile this statement
with your risk factor on pages 34 and 35 that states that you intend to take advantage of specific listed exemptions until you
are no longer an emerging growth company.
2
We have revised our disclosure on page 6 of Amendment No.
1 to provide that we intend to take advantage of the disclosed exemptions and other exemptions available to emerging growth companies.
Risk Factors
“We may find it difficult to enroll patients…,”
page 12
9. Please disclose any past difficulties you have experienced
enrolling patients in clinical trials.
We have not yet encountered any difficulties in enrolling
patients in clinical trials and we have revised our disclosure on page 14 of Amendment No. 1 to provide that
“although we have not yet encountered difficulty enrolling patients in clinical studies in the past, we may
experience delays in our clinical studies if we encounter difficulties in enrollment in the future.”
“Our product candidates may cause undesirable side
effects…,” page 14
10. Please expand the discussion to state whether you have
product liability insurance and the amount of coverage.
We do not currently have product liability insurance, and we
have revised our disclosure on page 16 of Amendment No. 1 to provide that “We do not currently hold product liability insurance
and do not anticipate obtaining product liability insurance until such time as we have received FDA or other comparable foreign
authority approval for a product and there is a product that is being provided to third parties outside of clinical trials.”
“We may not be able to protect our intellectual
property rights throughout the world…,” page 27
11. We note your statement on page 64 that China is one of
the countries in which you intend to protect your proprietary rights. Accordingly, in this risk factor, please disclose that China
is one of the foreign countries that has not protected a company’s intellectual property rights to the same extent as federal
and state laws in the United States.
We have revised our disclosure on page 31 of Amendment No.
1 to provide that China is a country where we intend to protect our intellectual property rights to the extent possible.
“The JOBS Act and our status as a foreign private
issuer will allow us to postpone the date by which we must comply with some of the laws and regulations intended to protect investors…,”
page 34
12. Please provide one or more examples of the “certain
governance requirements” from which your status as a foreign private issuer exempts you.
We have revised our disclosure on page 40 of Amendment No.
1 to state that we are exempt from the requirement for independent director oversight of the nomination of directors and executive
compensation.
3
Passive Foreign Investment Company (“PFIC”)
Risk Factor
13. Please add a risk factor that discusses the risk that
you may be classified as a PFIC for the current taxable year or for future years. Include in the risk factor a brief description
of what it means to be classified as a PFIC and the consequences for your shareholders should you be classified as a PFIC. Further
disclose that you do not intend to provide the information that would enable investors to take a qualified electing fund (“QEF”)
election that could mitigate the adverse U.S. federal income tax consequences should you be classified as a PFIC.
We have added a risk factor on page 36 of Amendment No. 1
to address the foregoing comment.
Use of Proceeds, page 39
14. Please expand the discussion to indicate what stage of
clinical program completion you expect to achieve for each allocation of proceeds.
We have added disclosure to page 7 and page 45 of Amendment
No. 1 to indicate the stage of clinical program completion we expect to achieve for each allocation of proceeds.
Dilution, page 41
15. Please revise the presentation to start with the historical
net tangible book value instead of pro forma net tangible book value.
We have revised our disclosure on page 48 of Amendment No.
1 as requested.
Management’s Discussion and Analysis of Financial
Condition and Results of Operations
Financial Overview
Research and Development Expenses, page 43
16. Please expand your disclosures to include the total costs
incurred during each period presented and to date for each key research and development project.
We have revised and expanded our disclosure on pages 52
and 53 of Amendment No. 1 to include the total costs incurred during each period presented for each key research and
development project.
Critical Accounting Policies and Estimate
JOBS Act, page 44
17. You state that you have elected to delay such adoption
of new or revised accounting standards under Section 107 of the JOBS Act. Please revise your disclosure to state that, as a result
of this election, your financial statements may not be comparable to companies that comply with public company effective dates.
Include a similar statement in your risk factor disclosure.
4
We have revised our disclosure on pages 40 and 51
of Amendment No. 1 to indicate that as a result of the election not to adopt new or revised accounting standards under
Section 107 to the JOBS Act, our financial statements may not be comparable to companies that comply with the public
company effective date.
Stock-Based Compensation and Fair Value of Ordinary Shares,
page 44
18. We may have additional comments on your accounting for
stock compensation or any beneficial conversion features once you have disclosed an estimated offering price. Please supplementally
provide us with a quantitative and qualitative analysis explaining the difference between the estimated offering price and the
fair value of each equity issuance through the date of effectiveness for the preceding twelve months.
We wish to supplementally clarify to the Staff that in the preceding
twelve months we had only one grant of options (83,579) on May 13, 2013, as described in Note 8 (d) to the financial statements.
We sold 2,130,159 ordinary shares in two equal installments
in June 2013 and January 2014, at a price of $0.95 per share to a third party, non-affiliated investor. The price per share was
determined on an arms’ length basis, and the price per share of the second installment was agreed as of June 2013. In May
2013 the fundamental terms and conditions of this sale were known so we used the price per share of this sale as a basis for the
estimation of the fair value of the options granted.
In addition, on February 6, 2014, we issued 782,537 ordinary
shares to outside private placement investors in an arms’ length transaction at a price per share of $6.07.
The reasons for the increase in the price per share from June
2013 through February 2014 are as follows:
• The probability for an initial public offering increased
immensely.
• Progress in clinical trials and entering into Phase II with two projects prior to the planned initial public offering, one
of which will become global in Israel.
• Pre-IND meeting already scheduled for one project.
• One of the projects is IP allowed.
Other than the one grant of options (mentioned above), no other
options were granted in the last twelve months and no debts incurred that may raise a beneficial conversion feature expense.
Business
Overview, page 49
5
19. Please disclose if any investigational new drug applications
for your products have been submitted to the FDA. If so, please state the relevant date(s) and if any application was not submitted
under your name, the name under which the application was submitted.
We have revised our disclosure on page 56 of Amendment No.
1 to provide that we have not yet submitted any investigational new drug applications for our products to the FDA.
Product Candidates – Disease background, rationale
for treatment…, page 54
20. Where you refer to planned clinical trials, please state
the countries in which you intend to conduct such clinical trials.
We have revised our disclosure on pages 64-70 of Amendment
No.1 to indicate the countries in which we intend to conduct clinical trials.
21. For each discussion of market potential for your product
candidates, please provide a numerical estimate of the number of people afflicted by each applicable disease.
We have revised our disclosure on pages 64-68 of
Amendment No.1 to provide estimates of the number of people afflicted by the applicable disease.
22. Where you have already provided numerical estimates,
please explain how the estimates were determined. In this regard, we note the statement on page 58 that Friedreich’s ataxia
affects about 1 in every 50,000 people in the United States and that the estimated number of Friedreich’s ataxia patients
in the United States is approximately 15,000. This ratio and estimated potential market does not appear to be consistent with the
population of the United States.
We have revised our disclosure on page 67 of Amendment No.
1 to provide that there are approximately 6,000 Friedreich’s ataxia patients in the United States and 15,000 worldwide.
Management
Corporate Governance Practices
External Directors, page 83
23. Please clarify the difference between an “external
director” under the Israeli Companies Law and an “independent director” under Nasdaq listing rules. For example,
would an external director also qualify as an independent director?
We have revised our disclosure on page 95 of Amendment No.
1 to clarify the difference between an “external director” under the Israeli Companies Law and an “independent
director” under Nasdaq listing rules.
Approval of Related Party Transactions Under Israeli Law,
page 92
6
24. Please provide one or more examples of the “certain
defined types of extraordinary transactions between a public company and its controlling shareholder” that are exempted from
the shareholder approval requirements under Israeli Companies Law regulations.
We have revised our disclosure on page 106 of Amendment No.
1 to provide examples of extraordinary transactions between a public company and its controlling shareholder that are exempted
from the shareholder approval requirements under Israeli Companies Law regulations.
Compensation of Executive Officers and Directors, page
94
25. Please supplementally advise, with a view to disclosure,
whether you are required to disclose, or have disclosed, in Israel the annual compensation of your named executive officers and
directors on an individual basis for the most recently completed fiscal year. See Item 6.B.1 of Form 20-F.
We supplementally advise the Staff that we are not required
to provide individual disclosure of the annual compensation to our directors and senior management for the most recently completed
fiscal year under the laws of the State of Israel, nor have we otherwise disclosed such information in the past.
According to the Israeli Securities Law, only a company that
qualifies as a public reporting company is required to comply with the reporting obligations stated in the Israeli Securities Law
and the regulations promulgated thereunder. Since we will not be offering shares to the public in Israel, we are not regarded as
a reporting corporation under the Israeli Securities Law. Accordingly, we believe that we are permitted to furnish compensation
information on an aggregate basis under Item 6.B of Form 20-F.
Pursuant to Israeli law, within nine months of the initial public
offering, we will be required to present a compensation policy for approval by our shareholders. The compensation policy will contain
a framework for compensation of directors and senior management, including a number of mandatory elements, so that even if individual
compensation is not disclosed, investors will still have an understanding of the compensation of directors and senior management.
In addition, we will be required to disclose, and seek s
2014-03-06 - UPLOAD - Enlivex Ltd.
March 6 , 2014 Via E -mail Udi Gilboa Chief Financial Officer Bio Blast Pharma Ltd. 35 Ahad Ha'am St. Tel Aviv 6520206 Israel Re: Bio Blast Pharma Ltd. Registration Statement on Form F-1 Filed February 7, 2014 File No. 333 -193824 Dear Mr. Gilboa: We have reviewed your registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by amending your registration statement and providing the requested information. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your registration statement and the information you provide in response to these comments, we may have additional comments. General 1. Please submit all exhibits as soon as practicable. We may have further comments upon examination of these exhibits. 2. Please confirm that the images included in your registration statement are all of the graphic, visual or photographic information you will be including. If you intend to use any additional images , please provide us proofs of such materials. Please note that we may have comments regarding this material. 3. Please supplementally provide us with copies of all written communications, as defined in Rule 405 under the Securities Act, that you, or anyone a uthorized to do so on your behalf, present to potential investors in reliance on Section 5(d) of the Securities Act, whether or not they retain copies of the communications. Similarly, please supplementally provide us with any research reports about you th at are published or Udi Gilboa Bio Blast Pharma Ltd. March 6, 2014 Page 2 distributed in reliance upon Section 2(a)(3) of the Securities Act of 1933 added by Section 105(a) of the Jumpstart Our Business Startups Act by any broker or dealer that is participating or will participate in your offering. 4. Please r emove the two pages of graphics between the prospectus cover page and the table of contents or move the graphics to another section of the prospectus. If retained, please provide context to enable the reader to understand the presentation. 5. Please ensur e that the text provided in all images included in your registration statement can be easily read by investors. For example, portions of the text in the image on pages 58 and 60 are difficult to read. Prospectus Summary, page 1 6. Please define the followi ng scientific terms at their first use to provide a reasonable investor with understanding of such terms: “pathophysiological;” “myopathy;” “pharmacopeial;” and “disaccharide chemical chaperone.” Implications of being an Emerging Growth Company, page 5 7. Please expand this discussion to clarify the relief a company gets as a Foreign Private Issuer in addition to the relief that you will enjoy as an emerging growth company. Please also revise your prospectus to indicate that you have decided to avail yours elves of the relief from adopting new accounting standards. 8. We note your statement that you “have not made a decision whether to take advantage of any or all” of the applicable JOBS Act exemptions. Please reconcile this statement with your risk factor on pages 34 and 35 that states that you intend to take advantage of specific listed exemptions until you are no longer an emerging growth company. Risk Factors “We may find it difficult to enroll patients…,” page 12 9. Please disclose any past difficulties y ou have experienced enrolling patients in clinical trials. “Our product candidates may cause undesirable side effects…,” page 14 10. Please expand the discussion to state whether you have product liability insurance and the amount of coverage. Udi Gilboa Bio Blast Pharma Ltd. March 6, 2014 Page 3 “We may not be able to protect our intellectual property rights throughout the world …,” page 27 11. We note your statement on page 64 that China is one of the countries in which you intend to protect your proprietary rights. Accordingly, in this risk factor, please disclose that China is one of the foreign countries that has not protected a company’s intellectual property rights to the same extent as federal and state laws in the United States. “The JOBS Act and our status as a foreign private issuer will allow us to postpone the date by whic h we must comply with some of the laws and regulations intended to protect investors…,” page 34 12. Please provide one or more examples of the “certain governance requirements” from which your status as a foreign private issuer exe mpts you. Passive Foreign Investment Company (“PFIC”) Risk Factor 13. Please add a risk factor that discusses the risk that you may be classified as a PFIC for the current taxable year or for future years. Include in the risk factor a brief description of what it means to be classified as a PFIC and the consequences for your shareholders should you be classified as a PFIC. Further disclose that you do not intend to provide the information that would enable investors to take a qualified electing fund (“QEF”) election that could mitigate the adverse U.S. federal income tax consequences should you be classified as a PFIC. Use of Proceeds, page 39 14. Please expand the discussion to indicate what stage of clinical program completion you expect to achieve for each allocation of proceeds. Dilution, page 41 15. Please revise the presentation to start with the historical net tangible book value instead of pro forma net tangible book value. Management’s Discussion and Analysis of Financial Condition and Results of Operations Financial Overview Research and Development Expenses, page 43 16. Please expand your disclosures to include the total costs incurred during each period presented and to date for each key research and development project. Udi Gilboa Bio Blast Pharma Ltd. March 6, 2014 Page 4 Critical Accounting Polic ies and Estimate JOBS Act, page 44 17. You state that you have elected to delay such adoption of new or revi sed accounting standards under S ection 107 of the JOBS Act. Please revise your disclosure to state that, as a result of this election, your financial statements may not be comparable to companies that comply with public company effective dates. Include a similar statement in your risk factor disclosure. . Stock -Based Compensation and Fair Value of Ordinary Shares, page 44 18. We may have additional comme nts on your accounting for stock compensation or any beneficial conversion features once you have disclosed an estimated offering price. Please supplementally provide us with a quantitative and qualitative analysis explaining the difference between the est imated offering price and the fair value of each equity issuance through the date of effectiveness for the preceding twelve months. Business Overview, page 49 19. Please disclose if any investigational new drug applications for your products have been submi tted to the FDA. If so, please state the relevant date(s) and if any application was not submitted under your name, the name under which the application was submitted. Product Candidates – Disease background, rationale for treatment…, page 54 20. Where you refer to planned clinical trials, please state the countries in which you intend to conduct such clinical trials. 21. For each discussion of market potential for your product candidates, please provide a numerical estimate of the number of people afflicted by each applicable disease. 22. Where you have already provided numerical estimates, please explain how the estimates were determined. In this regard, we note the statement on page 58 that Friedreich’s ataxia affects about 1 in every 50,000 people in the United States and that the estimated number of Friedreich’s ataxia patients in the United States is approximately 15,0 00. This ratio and estimated potential market does not appear to be consistent with the population of the United States. Udi Gilboa Bio Blast Pharma Ltd. March 6, 2014 Page 5 Management Corporate Governance Practices External Directors , page 83 23. Please c larify the difference between an “external director” under the Israeli Companies Law and an “independent director” under Nasdaq listing rules. For example, would an external director also qualify as an independent director? Approval of Related Party Tran sactions Under Israeli Law , page 92 24. Please provide one or more examples of the “certain defined types of extraordinary transactions between a public company and its controlling shareholder” that are exempted from the shareholder approval requirements unde r Israeli Companies Law regulations. Compensation of Executive Officers and Directors , page 94 25. Please supplementally advise, with a view to disclosure, whether you are required to disclose, or have disclosed, in Israel the annual compensation o f your named executive officers and directors on an individual basis for the most recently completed fiscal year. See Item 6.B .1 of Form 20 -F. 26. Please disclose the total amounts set aside or accrued by you to provide pension, retirement or similar benefit s for your named executive officers and directors. See Item 6.B.2 of Form 20 -F. Principal Shareholders, page 98 27. Please disclose the percentage of shares held in the United States and the number of United States shareholders. Shares Eligible for Future Sale Lock -up agreements, page 106 28. When available, please file a form of lock -up agreement as an exhibit to the registration statement. Rule 144 , page 106 29. We note your statement that “any person who is not our affiliate and has held their shares for at least six months. . .may sell shares without restriction.” However, such a person would be subject to the current public information condition under Rule 144(c). Please revise accordingly. Udi Gilboa Bio Blast Pharma Ltd. March 6, 2014 Page 6 Financial Statements General 30. We note that you conduct substa ntially all of your operations outside of the United States. In order to enhance our understanding of how you prepare your financial statements, we ask that you provide us with information that will help us answer the following questions: How do you maint ain your books and records and prepare your financial statements? o Describe the controls you maintain to ensure that the activities you conduct and the transactions you consummate are recorded in accordance with U.S. GAAP. What is the background of the peo ple involved in your financial reporting? We would like to understand more about the background of the people who are primarily responsible for preparing and supervising the preparation of your financial statements and their knowledge of U.S. GAAP and SEC rules and regulations. Do not identify people by name, but for each person, please tell us: o What role he or she takes in preparing your financial statements; o What relevant education and ongoing training he or she has had relating to U.S. GAAP; o The nature of his or her contractual or other relationship to you; o Whether he or she holds and maintains any professional designations such as Certified Public Accountant (U.S.) or Certified Management Accountant; and o About his or her professional experience, includi ng experience in preparing and/or auditing financial statements prepared in accordance with U.S. GAAP. If you retain an accounting firm or other similar organization to prepare your financial statements or evaluate your internal control over financial rep orting, please tell us: o The name and address of the accounting firm or organization; o The qualifications of their employees who perform the services for your company; o How and why they are qualified to prepare your financial statements; o How many hours they s pent last year performing these services for you; and Udi Gilboa Bio Blast Pharma Ltd. March 6, 2014 Page 7 o The total amount of fees you paid to each accounting firm or organization in connection with the preparation of your financial statements for the most recent fiscal year end. If you retain individuals w ho are not your employees and are not employed by an accounting firm or other similar organization to prepare your financial statements, do not provide us with their names, but please tell us: o Why you believe they are qualified to prepare your financial st atements; o How many hours they spent last year performing these services for you; and o The total amount of fees you paid to each individual in connection with the preparation of your financial statements for the most recent fiscal year end. Note 7 -Conting ent Liabilities and Commitments c. License Agreement, page F -13 31. Please disclose the consideration you paid or have agreed to pay Yissum Research Development Company for entering into the agreement. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 1933 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. Notwithstanding our comments, in the event you request acceleration of the effective date of the pending registration statement please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commissi on from taking any action with respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and acc uracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Udi Gilboa Bio Blast Pharma Ltd. March 6, 2014 Page 8 Please refer to Rules 460 and 461 regarding requests for acceleration. We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to revi ew any amendment prior to the requested effective date of the registration statement. You may contact James Peklenk at (202) 551 -3661 or Joel Parker at (202) 551 -3651 if you have questions regarding comments on the financial statements and related ma tters. Please contact Christina De Rosa at (202) 551 -3577, John Krug at (202) 551 -3862 or me at (202) 551 - 3715 with any other questions. Sincerely, /s/ Daniel Greenspan for Jeffrey P. Riedler Assistant Director cc: Via E -mail Shy S. Baranov, Esq. Zysman, Aharoni, Gayer and Sullivan & Worcester LLP 1633 Broadway New York, NY 10019